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Title:
FLAT PANEL X-RAY IMAGING DEVICE - TWIN FLAT DETECTOR SIGNAL SYNCHRONIZATION
Document Type and Number:
WIPO Patent Application WO/2019/226083
Kind Code:
A1
Abstract:
A mobile digital fluoroscopy system comprising a mobile X-ray system carrier unit (1) comprising a first and a second X-ray device (19, 20) each having a transmitter (21, 23) and a receiver (22, 24), wherein the respective first and second X-ray devices (19, 20) are configured to enable X-ray imaging in mutually intersecting planes, a synchronization units (800A, 800B); and; wherein a mobile control unit (2a) is communicatively coupled to the mobile X-ray system carrier (1) via a cable (150), wherein the mobile control unit (2a) is configured to receive a first set of image data (1000A, 1000B) from the synchronization units (800A, 800B) and sending a control signal to the synchronization units (800A, 800B) upon completion of receiving of the image data (1000A, 1000B), wherein synchronization units (800A, 800B) are configured to generate a synchronization signal (820A, 820B) to the transmitters (21, 23) and receivers (22, 24) and to send a second set of image data (1000A, 1000B) received from receivers (22, 24) to the mobile control unit (2a).

Inventors:
NEUMANN VOLKER (DE)
SJÖSTRÖM HANS (SE)
Application Number:
PCT/SE2018/050517
Publication Date:
November 28, 2019
Filing Date:
May 22, 2018
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SCANFLEX HEALTHCARE AB (SE)
International Classes:
A61B6/00; A61B6/02; H05G1/30
Foreign References:
US20160287200A12016-10-06
US6104780A2000-08-15
US20150238159A12015-08-27
US20160232661A12016-08-11
US20100303323A12010-12-02
US20150182175A12015-07-02
US20040213371A12004-10-28
US5923721A1999-07-13
US7810996B12010-10-12
Other References:
See also references of EP 3796840A4
Attorney, Agent or Firm:
BERGENSTRÅHLE & PARTNERS STOCKHOLM AB (SE)
Download PDF:
Claims:
Claims

1. A mobile digital fluoroscopy system for bi-planar imaging with synchronization

operation, comprising an X-ray carrier unit (1) and a mobile control unit (2a), wherein the X-ray carrier unit (1) comprises a first X-ray image device (19) having a first

transmitter unit (21) and a first receiver unit (22), arranged to generate one or more X-ray images in a first plane Pl, and a second X-ray image device (20), having second transmitter unit (23) and a second receiver unit (24) arranged to generate one or more X- ray images in a second plane P2, wherein said first and second X-ray devices are arranged such that the first plane Pl intersects the second plane P2; and wherein the control unit (2a), comprises a first synchronization unit (800A) and a second synchronization unit (800B)

communicatively coupled to the first and second receivers (22, 24) and configured to synchronize the respective X-ray device of the fluoroscopy system by generating synchronization signals (810, 820A, 820B) and image data signals (1000A, 1000B), wherein the synchronization signal (810) is an intra- synchronization signal between the two synchronization units (800A, 800B) and the synchronization signals (820A, 820B) are communicatively coupled to the transmitter units (21, 23), whereby the first synchronization unit (800A) is configured to cooperate with the second synchronization unit (800B) to generate synchronization signals (820A, 820B) to the first and second transmitters units (21, 23) respectively, so that the operation of the transmitter units (21,23) is performed with an alternating pattern of transmitted signals, so: (i) a dark-image is formed in the receivers (22, 24) when there is no signal generation

(2000A) in the transmitters (21,23);

(ii) one of the transmitters (21,23) transmits an X-ray pulse to one of the receivers (22, 24) which are controlling image synchronization units (800A, 800B), thereby forming an acquisition step (2000B); (iii) the synchronization unit is linked to the respective transmitter, and upon receiving the signal from the receivers generates a synchronization signal (820A, 820B) to terminate the X-ray pulse generation, thereby completing the acquisition step (2000B);

(iv) an image-readout step (2000C), is performed with a pre-defined time starts during which the synchronization unit simultaneously generates two signals:

(a) a signal (810) for activating the second synchronization unit for controlling the inactive transmitter and

(b) a signal (1000A, 1000B) for transmitting the image data to the display units (4a, 4b, 3) from the respective receivers (21,23); (v) upon completion of step (iv), the image read-out step (2000C) terminates, thus terminating the operation of the active image device (19, 20) and the operation is switched to the X-ray image device (19,20), inactive during steps (i) to (iv) and a second acquisition step (2000C) starts;

(vi) the second acquisition step (2000D) and a second read-out step (2000E) are performed similar to the first image acquisition step (2000B) and first image read-out step

(2000C), and the steps (ii) to (v) are repeated with the second transmitter;

(vii) upon completion of step (vi), the first transmitter starts operation and repeats the steps (ii) to (v) thereby forming an alternating signal pattern for image generation and acquisition by the X-ray image devices (19, 20). (viii) upon completion of step (vii), the second transmitter starts operation by repeating the sequence defined in steps (ii) to (v), thus forming the alternating signal pattern for image generation and acquisition by the image devices (19, 20).

2. A mobile digital fluoroscopy system according to claim 1, wherein the width of said X-ray pulses preferably are from 2 to 40 milliseconds. 3. A mobile digital fluoroscopy system with synchronization operation according to claim 1 or 2, further transmitting an Automatic Brightness Signal (1001A, 1001B) during the acquisition steps (2000A, 2000C).

4. A mobile digital fluoroscopy system according to any of the preceding claims, wherein said first and second X-ray image devices (19,20) are arranged such that the first plane Pl intersects the second plane P2 at locations to create an offset angle of 90 degrees or another angle.

5. A mobile digital fluoroscopy system according any of the preceding claims that is configured that the system can be operated in any kind of fluoroscopy modes including but not limited to Automatic, Continious Fluoro, Pulse Fluoro, Snap shoot, Digital subtraction angiography (DSA), Automatic Brightness Mode (ABS), Road map.

6. A mobile digital fluoroscopy system according to any of the preceding claims further comprising a 3 -pedal foot switch and/or a hand-held operating console and/or a set of control buttons located on a panel board and/or a touch screen of a display unit 4a in order to operate the mobile fluoroscopy system.

7. A mobile digital fluoroscopy system according to any of the preceding claims comprising a transmitter unit and a receiver unit, wherein the receiver unit allows to increase or decrease the Source-to-Image (SID) distance between the receiver and transmitter in a respective plane Pl, P2.

8. A mobile digital fluoroscopy system according to any of the preceding claims, wherein the mobile control unit (2a) comprises a programmable logic controller [PLC], programmable logic relay or other type of controlling device (950) coupled to a Personal computer unit (960) adapted for controlling the operation of the X-ray transmitters (21,23).

9. A mobile digital fluoroscopy system according to any one of the preceding claims, wherein the control unit (2a) is further configured to control the synchronized operation by timing generating and emitting X-ray radiation pulses by a timer in said transmitters (21, 23).

10. A mobile digital fluoroscopy system according to claim 8 or 9, wherein the control unit (2a) is further configured to control the synchronized operation by timing the capturing of an image by the respective receiver (22, 24).

11. The mobile digital fluoroscopy system according to any of the 8-10, wherein the PLC unit (950) and the PC unit (960) are configured to receive a first set of image data transmitted from said first or said second receiver (22, 24), wherein it is communicatively coupled to its respective first and second synchronization units 800A and 800B, which generate

synchronization signals to the PLC unit (950) and/or generate the controlling signal to the transmitter units (22, 24).

12. The mobile digital fluoroscopy system according to any of the preceding claims, wherein the synchronization units (800A, 800B) and the transmitters units (21,23) are further configured to emit X-ray radiation in an alternative alternating pattern, wherein the X-ray pulses are emitted simultaneously from both transmitter units (21, 23) with a pre-defined time margin.

13. The mobile digital fluoroscopy system according to any of the preceding claims, wherein the synchronization, ABS and image data signals (810, 820A, 820B, 1000A, 1000B, 1001 A, 1001B) are configured to achieve at least one of the following results selected from the group of:

• first synchronization signal (820A) for controlling the transmitter unit (21) and the synchronization unit (800A) and is configured to control a first X-ray pulse width;

• second synchronization signal (820B) for controlling the transmitter unit (23) and the synchronization unit (800B) and is configured to control a second X-ray pulse width;

• image data signal (1000A, 1000B) for transmitting the image data from the receivers (22,24) in a raw data format to the PC unit (960) for further processing and displaying the image on the display units (4a, 4b, 3);

• intra-synchronization signal 810 for controlling the synchronization units (800A, 800B) and is configured to control the inactive transmitter (21,23) by controlling the inactive synchronization unit (800A, 800B); and

• ABS signal (1001A, 1000B) for automatically control of X-Ray kV the transmitter output (21,23).

14. Method in a mobile digital fluoroscopy system of performing a synchronized operation of X-ray image devices (19, 20), comprising:

• receiving a first set of image data 1000A, 1000B, by mobile control unit 2a, from the synchronization units 800A, 800B; and

• sending, by mobile control unit 2a, a control signal to the synchronization units 800A, 800B upon completion of receiving of the image data 1000A, 1000B; and

• generating a synchronization signal 820A, 820B to the transmitters 21, 23 and

receivers 22, 24; and

• sending image data 1000 A, 1000B received from receivers 22, 24 to the mobile

control unit 2a.

15. Method in a mobile digital fluoroscopy system of performing a synchronized operation of X-ray image devices according to claim 14 further comprising:

• generating a first and/or a second image control signal coming to the first and/or second synchronization units (800A, 800B) from the respective first and/or second receivers (22,24) during a first acquisition step;

• generating a first and/or a second ABS signals (1001 A, 1001B);

• generating a first and/or a second synchronization signals (820A, 820B) to stop

operation of the first active transmitter (21,23) to finish the acquisition step;

• generating an intra- synchronization signal (810) to control the transmittance of X-ray pulses from the inactive transmitter (21,23);

• generating a first and/or a second image data signal (1000A, 1000B) for transmitting the image data to the display units (4a, 4b, 3), the method further comprising: · generating a control signal to the first and/or second synchronization device (800A,

800B) to communicate that an energy threshold has been reached in the receivers (22,24);

• generating ABS and/or synchronization signals (820A, 820B), preferably

simultaneously, to stop operation of the active transmitter (21,23);

· generating an intra- synchronization signal (810) and/or image data signal (1000A,

1000B), preferably simultaneously, to perform display of the image data and generation of a pulse from the inactive transmitter (21,23).

16. A method in a mobile digital fluoroscopy system according to claim 14 or claim 15 for controlling synchronized operation of X-ray image devices (19,20) wherein the method further comprises generating a signal from a controlling device (950) to a PC unit (960) that control the timing of an X-ray pulse from a transmitter unit (21,23).

Description:
Flat panel x-ray imaging device - Twin Flat Detector Signal Synchronization

Field of the invention

The present disclosure relates in general to a preferably mobile digital fluoroscopy system consisting of one or more X-ray generation devices for use in medical imaging of the patient’s body.

More specifically, the present disclosure relates to synchronization of signals of emitting X- ray radiation pulses and radiation pulse acquisition by the detectors in a fluoroscopy system having multiple x-ray generation and acquisition devices, which are preferably flat digital x- ray detectors, where the multiple x-ray generation and acquisition devices are oriented in multiple axes (sagittal and axial planes) to provide different views of the location of interest in the patient with the ability to control the area of the patient exposed to the X-ray beam via a user interface.

Background of the invention

In surgical operations like orthopedic surgery there is a need for imaging the patient’ s inner area of interest, that can be displayed in two independently planes, to perform surgical operations more effectively and in order to reduce the risk to the patient and to increase the comfort of the physician performing the operation. Therefore, X-ray imaging using C-stands or G-stands comprising imaging systems are commonly used, wherein a C-stand only has one X-ray imaging device while a so-called G-stand comprises two such imaging devices, with their axes oriented at an angle to each other.

A problem with conventional C-arms consisting of one imaging device is that the physician needs to adjust the position of the C-arm multiple times during the operation to image the ROI and obtain images needed for performing an effective surgery. Because the field of view (FOV) is limited in diameter and varies in different systems, the physician needs to make multiple mechanical adjustments of imaging assembly during the operation to locate ROI. On top of that, during the operation the physician needs to change the position of the C-arm and switch it to another plane because the physician operates in a 3D plane setting, but conventional systems allow to image only in a 2D Technique This results in an increased radiation to the patient and to the personnel since the physician is taking multiple unnecessary images to find the right region of interest (ROI) in the first and second planes. Due to the variations in organ density, this might result in additional dose, because the physician or his assistant might care for different object thickness when they change mechanical positioning and planes during the operation. This results in unnecessary time spent in positioning of the C-arm, additional dose to the patient and to the personnel and not equal image quality, which might considerably affect patient’s and personnel safety. Another problem is that during the adjustments, the cable connecting the X-ray imaging assembly with the control panel is more stressed and more maintenance is needed.

The current invention solves this problem by introducing 2 imaging devices (G-stand configuration) in intersecting planes, which could help the physician to make the transition from a 2D imaging configuration to a 3D imaging application. By using 2 imaging devices, the physician might reduce the operation time and decrease the dose.

A G-stand is generally preferable to a C-stand in fluoroscopy, since it comprises two preferably, but not necessarily perpendicularly to each other, mounted X-ray imaging devices, and is thereby able to provide both frontal and lateral X-ray imaging with fixed or dynamic settings set separately an independently on both the devices without moving patient or device. The ability to simultaneously see the surgical area in both a frontal and lateral view reduces the need to move and mechanical adjust or establish new positioning of the equipment during surgery, thus reducing both surgery time, radiation dose to the patient due to the need to adjust the imaging protocols and to search for the region-of-interest (ROI) during the operation and the personnel, thus providing better and faster diagnostic information to the physician performing the operation. This has also an effect of reducing the number of images taken during the operation, thus further decreasing the absorbed dose to the patient and the personnel. A G-stand can be further arranged to be tilted and/or be rotatable in order to increase access and views.

To reduce the number of images taken and thus to limit the radiation exposure dose, a synchronization algorithm is needed that improves image quality and limits the dose by limiting the number of images taken. A further problem is because due to the nature of the radiation exposure, the radiation transmits in multiple directions simultaneously, thus the inactive detector is controlled to switch off X-Ray when X-ray photons are present at the second receiver. Even if there are two imaging planes, which will reduce the number of images taken, there is still a problem of acquiring images with the highest quality with the lowest dose possible according to a medical physicist practice named as low-as-reasonably-achievable (ALARA) or according to another practice named“As Far As Possible” (AFAP). During the surgery, the physicians have a tendency of making many unnecessary images, since the images are taken in sequences and are taken as long as the physician is pushing a footswitch or via remote control (option). With the introduction of G-arm system this mal function increases because there are now 2 imaging assemblies. Additionally, there are no known algorithms for synchronizing the production of images on two planes in a fluoroscopy device in use during e.g. orthopedic procedures, which means that physician will still need to operate first and second imaging devices separately.

Summary of the invention

The following abbreviations are used

APR Automatic Programmable Radioscopy DC Direct Current

AC Alternated Current

ROI Region of interest

SID Source image distance (transmitter to receiver distance)

FOV Field of View PLC Programmable Logic (Generator host) controller

GUI Graphic User Interface

CMOS Complementary metal oxide-semiconductor

DICQM Digital imaging and communications in medicine

PACS Picture archiving and communication system ALARA As low as reasonably achievable

AFAP As far as possible SNR Sienal-to-noise ratio

DQE Detective quantum efficiency

DAP Dose area product

Objects of the invention One general object of the invention is to provide improvements in a digital fluoroscopy system for medical applications operating with first and second X-ray imaging devices configured to generate X-ray images along two mutually intersecting axes. More specific objects of the invention are to synchronize image generation and acquisition by the two image devices, thus decreasing the patient’s dose, improving signal-to-noise ratio (SNR) and improving the resulting image by controlling the exposure output parameters in function of the required dose.

It is an additional object of the invention to introduce a G-arm assembly having several transmitters and receivers and to introduce a synchronization algorithm, which controls how the transmitters transmit and the detectors detect images, thus providing a new way of operation of a G-arm apparatus.

A further problem is that since the first and second X-ray imaging devices are mounted on the G-stand to generate X-ray images along two mutually intersecting axes the images captured by one of the X-ray imaging devices are typically noisy, due to interference between X-ray radiation emitted along the first plane and X-ray radiation emitted along the second plane. Further, the first and second X-ray imaging devices may be in alternate operation, generating alternate images in the first and in the second plane, respectively. Alternatively, only one of the X-ray imaging device may be in operation. Thus, there is a need of further improved control of the operation of the respective first and second X-ray image device, which is one of the intentions of the present invention. One object of the invention is to provide methods and systems comprising synchronization of the signal communication between the first and second X-ray devices 19, 20 and the mobile control unit 2a, as further described and claimed herein.

Thus, it is further object of the invention to introduce a synchronization algorithm to limit the amount of dose and to improve the quality of the surgery performed by the physician. of the current invention

A G-arm assembly with two imaging devices each consisting a transmitter, a detector and a synchronization unit linked to a control unit consisting of a Personal computer unit and multiple displays (GUI) is presented. In one embodiment, a mobile digital fluoroscopy system, having a mobile X-ray system carrier unit having a first and a second X-ray system each having a transmitter and a receiver, the respective first and second X-ray systems being configured, e.g. by being mounted on a G-arm, to enable X-ray imaging in mutually independently intersecting planes.

The present invention is intended to solve the early mentioned problems with a system, which is introduced further. The present invention introduces a mobile digital fluoroscopy system for bi-planar imaging with synchronization operation, which comprises an X-ray carrier unit and a mobile control unit, wherein the X-ray carrier unit comprises a first X-ray image device having a first transmitter unit and a first receiver unit, arranged to generate one or more X-ray images in a first plane Pl, and a second X-ray image device, having second transmitter unit and a second receiver unit arranged to generate one or more X-ray images in a second plane P2, wherein said first and second X-ray devices are arranged such that the first plane Pl intersects the second plane P2.

The control unit of the invention comprises a first synchronization unit and a second synchronization unit communicatively coupled to the first and second receivers and configured to synchronize the respective X-ray device of the fluoroscopy system by generating synchronization signals and image data signals, wherein the synchronization signal is an intra- synchronization signal between the two synchronization units and the

synchronization signals are communicatively coupled to the transmitter units, whereby the first synchronization unit is configured to cooperate with the second synchronization unit to generate synchronization signals to the first and second transmitters units respectively, so that the operation of the transmitter units is performed with an alternating pattern of transmitted signals.

The purpose of the transmitter is to generate X-ray pulses by generating a certain amount of X-Ray voltage (kVp) and a certain amount of current X-Ray (mA). The purpose of the receiver is to acquire the radiation coming from the transmitters and passing through the patient. With the present invention, the synchronization units solve the problem of patient dose by regulating the image generation between both imaging devices by switching between them when an image in one of the imaging planes is acquired. Further the synchronization units can regulate the kVp values dependent on previous output, which results in a well- regulated and controlled kV output which the user can view and adjust accordingly if needed and fewer images taken during the surgery. The X-Ray mA and pulse time are pre-set via APR setting and not part in the regulation circuit comprising the synchronization units. The APR are being set via the GUI.

The mobile control unit is configured to receive synchronization signal from a

synchronization unit. In some cases, the synchronization unit can also send an automatic brightness signal to control the amount of X-Ray voltage produced by the transmitter and to control / limit the dose received by the patient.

The system can further comprise a kV unit configured to receive a measured voltage value from the transmitter, calculates a regulated voltage value based on required dose value and sends the regulated voltage value to the HV supply via an inverter. The inverter unit is configured to generate a voltage value to transmitter based on and corresponding to the required dose.

WO 2015/76743 further describes the function of X-Ray generators used with the present invention.

In the present invention, the mobile control unit is configured to control, based on the generated synchronization signals, synchronized emittance of X-ray pulses by the respective first and second X-ray image devices. The generated synchronization signal is initiated with a margin in time in relation to the activation of the respective first and/or second X-ray image device to be controlled.

According to embodiments herein, the mobile control unit is configured to control synchronized operation such that the respective first and second X-ray image device are in operation generating one or more X-ray images one at a time.

According to embodiments herein, the control unit is configured to control synchronized operation by timing generating and emitting an X-ray radiation pulse to control the transmitters.

According to embodiments herein, the control unit is configured to control synchronized operation by timing the capturing of an image by the respective receiver. According to embodiments herein, the personal computer unit is to receive a first set of image data transmitted from the first or the second receiver, and to generate and to send a control signal to the first synchronization unit in response to the completion of receiving the first set of image data. According to embodiments herein, the synchronizing units may further be configured to receive the control signal from the personal computer unit, to generate the synchronization signal in response to the received control signal, and to synchronize the execution of tasks of the transmitters and/or the receivers.

According to embodiments herein, the synchronization signals may comprise four signal parts, a first signal part sent to the first transmitter, a second signal part sent to the second transmitter, a third signal part sent to the first receiver, and a fourth signal part sent to the second receiver.

According to embodiments herein, the first signal part may comprise timing of emitting an X- ray radiation pulse in the first transmitter, and the second signal part may comprise timing of emitting an X-ray radiation pulse in the second transmitter, and the third signal part may comprise timing of capturing an image by the first receiver, and the fourth signal part may comprise timing of capturing an image by the second receiver.

According to embodiments herein, the system may further comprise a radiation control unit, and the synchronization units may be integrated in, implemented in or communicatively coupled to the radiation control unit.

According to embodiments herein, the personal computer unit may further be configured to receive a second set of image data to control timing of the first receiver and the second receiver to capture and to send a second set of image data to the radiation control unit.

According to embodiments herein, the mobile control unit may be communicatively coupled to the mobile digital fluoroscopy system and to the synchronization unit via a wireless communication network or via a cable.

According to embodiments herein, the PC unit is linked to a Programmable logic controller (PLC) unit, wherein the PLC unit acquires signals from the synchronization units and sends signals via inverter to the transmitters. In one embodiment a computer program product comprising a computer readable code is configured to, when executed in a processor, perform any or all of the method steps described herein.

In one embodiment the PC unit comprises a non-transitory computer readable memory wherein a computer readable code is stored is configured to, when executed in a processor, perform any or all of the method steps described herein.

According to embodiments herein, the mobile fluoroscopy system further comprises a generator input unit linked to at least one of the following external control devices:

-a 3-pedal foot switch linked to the fluoroscopy system via a cable or via a wireless connection; operation modes are: release plane Pl, release plane P2 and release planes Pl and P2 in an alternated mode;

-a hand-held control device linked to the fluoroscopy system via a cable or via a wireless connection;

-a set of controlling buttons in the mobile control unit 2a;

-a touch screen located on the display unit 3b, wherein the display units 4a, 4b are sterile and are used for observing the images.

The purpose of the external control device is to be controlled by the physician or his assistant performing the operation and to emit the radiation from the first transmitter by pushing the first pedal, to emit radiation by pushing the second pedal from the second transmitter, or to have a synchronized operation by pushing a third pedal. It is further objective of this invention, to introduce a synchronization mode of operation of the device, which acquires the images in a pattern of acquisition. In some embodiments, the images can be acquired in alternated mode According to another aspect, a method in a mobile digital fluoroscopy system for controlling synchronized operation of X-ray image devices is provided. The system comprises a first X-ray image device arranged to generate one or more X-ray images in a first plane (Pl) and a second X-ray image device arranged to generate one or more X-ray images in a second plane (P2). The first and second X-ray devices are arranged such that the first plane intersects the second plane at a certain angle. The system further comprises several synchronization units and a mobile control unit being communicatively coupled to the mobile digital fluoroscopy system and to the synchronization units. The method comprises generation of multiple synchronization signals and with generation of image data transfer signals. The generated synchronization signal is initiated with a margin in time in relation to the activation of the respective first and/or second X-ray image device to be controlled. Controlling, based on the generated synchronization signal, synchronized operation of the respective first and second X-ray image device is performed.

One embodiment is a mobile digital fluoroscopy system has the following details:

-a mobile X-ray system carrier unit and a mobile control unit comprising:

-a first and a second X-ray device each having a transmitter and a receiver wherein the respective first and second X-ray devices are configured to enable X-ray imaging in mutually intersecting planes,

-a first synchronization unit and a second synchronization unit ; and

wherein the mobile control unit 2a is configured to receive a first set of image data from the synchronization units and sending a control signal to transmitters upon completion of receiving of the image data;

wherein synchronization units are configured to generate synchronization signals to the transmitters and receivers and to send a second set of image data received from receivers to the display units (3b, 4a, 4b) of the control unit.

The synchronization signals control several parts of the device and comprise of the following signals:

-a first and/or a second image control signal coming to the first and/or second synchronization units from the respective first and/or second receivers;

-a first and/or a second automatic brightness system (ABS) signals;

-a first and/or a second synchronization signal to stop operation of the first active transmitter;

-an intra- synchronization signal to control the transmittance of X-ray pulses from the inactive transmitter;

-a first and/or a second image data signals for transmitting the image data to the display units for further review of the images by the physician.

According to embodiments herein, generated signals can further comprise emittance of a signal from the controlling device to the PC unit and transmitter unit to time the operation of the transmitter units. Another embodiment is a method in a mobile digital fluoroscopy system with a mobile X-ray system carrier unit and a mobile control unit comprising of the following steps:

-a first and a second X-ray device each having a transmitter and a receiver, wherein the respective first and second X-ray devices are configured to enable X-ray imaging in mutually intersecting planes,

-a synchronization units and the a mobile control unit is communicatively coupled to the mobile X-ray system carrier, wherein the method comprises:

-receiving a first set of image data, by mobile control unit, from the synchronization units, -sending, by mobile control unit 2a, a control signal to the synchronization units upon completion of receiving of the image data,

-generating a synchronization signals to the transmitters and receivers;

-sending image data received from receivers to the mobile control unit.

Another embodiment is a method in a mobile digital fluoroscopy system with a mobile X-ray system carrier unit and a mobile control unit comprising of the following steps:

1. Generating a dark- image in the receivers when there is no signal generation in the transmitters, but the receivers could detect some background radiation;

2. Transmitting an X-ray pulse to one of the receivers, which are controlling image

synchronization units;

3. The synchronization unit is linked to the respective transmitter, and upon receiving the signal from the receivers generates a synchronization signal (820A, 820B) to terminate the X-ray pulse generation;

4. The synchronization unit simultaneously generates two signals:

(a) a signal (810) for activating the second synchronization unit for controlling the inactive transmitter and

(b) a signal (1000A, 1000B) for transmitting the image data to the display units from the respective receivers;

5. The active image device terminates its operation and the inactive device is switched on;

6. The system performs image generation analogous to the steps described above; 7. The system repeats the transmittance from the first transmitter, thus forming an alternating pattern of operation.

Further embodiments are described in the claims and below the description.

Brief description of the drawings

The present disclosure will be further explained below with reference to the accompanying drawings, in which:

Fig la and Fig lb shows a schematic overview of an exemplifying G-Arm system embodiments in a digital fluoroscopy system; Fig. 2 shows a schematic view of an exemplifying embodiment of a G-Arm system and mobile control unit;

Fig. 3 shows a schematic view of embodiments of signal synchronization.

Fig. 4 shows a schematic function block diagram view of the synchronization signal and components array; Fig. 5a, 5b shows a schematic view of synchronization signals 820A, 820B and an image discard pattern

Fig. 6 shows a more detailed example of the synchronization pattern.

Detailed description

System overview The present disclosure concerns an X-ray apparatus configured as a system of components illustrated in the Figures la, lb, 2 adapted for use in connection with surgical operations. The system comprises a first X-ray image device 19 arranged to generate one or more X-ray images in a first plane Pl, and a second X-ray image device 20 arranged to generate one or more X-ray images in a second plane P2 (Fig. la). The first and second X-ray devices 19, 20 are arranged such that the first plane Pl intersects the second plane P2. The system further comprises synchronization units 800A, 800B configured to generate synchronization signals 820A, 820B, and a mobile control unit 2a being communicatively coupled to the mobile digital fluoroscopy system and to the synchronization units 800A, 800B (Fig.4). The mobile control unit 2a is configured to control, based on the generated synchronization signals 820A, 820B synchronized operation of the respective first and second X-ray image device 19, 20. The generated synchronization signals 820A, 820B are initiated with a margin in time in relation to the activation of the respective first and/or second X-ray image device 19, 20 to be controlled. The margin may be defined by a predetermined value, or may be set by a user of the system. Alternatively, the margin may be determined dynamically, based on parameters relating to the current and voltage of the system. An advantage with such a margin is that it is ensured that a correct pulse width of the synchronization signal 820A, 820B is received in due time for the respective target X-ray image device 19, 20 to respond upon.

The apparatus shown in Fig la and Fig lb comprises a mobile unit 1, i.e. a mobile X-ray system carrier unit 1 provided with two X-ray systems 19, 20 mounted to operate and transmit X-ray beams along mutually intersecting axes Pl, P2. The arm 18 of the embodiment illustrated in Fig la and Fig lb is referred to as a G-arm.

An embodiment of a mobile control unit 2a, also called console 2a, is provided with a base module 106 on wheels, a pulpit stand module 108 having a larger main part and a back part with a slot 5 in between (Fig. 2). An operator control interface in the form of a touch screen 3b devised for presentation of one or more graphical user interfaces and a physical button panel 116 are mounted on the main part of the pulpit stand module to form a lectern like control panel, in this example also comprising a handle 118 configured for gripping when moving around the console and for resting to support ergonomic operation of the control interface. The back part of the pulpit stand module is configured for mounting display monitors or screens (4a, 4b) for presenting X-ray images.

An object, typically a body of a patient undergoing surgery, is placed inside the mobile unit 1 so that beam axis Pl and beam axis P2 of the two X-ray systems cross within the object. The first X-ray device 19 includes a first transmitter 21 (an X-ray tube or X-tube) for emitting X- rays and a first receiver 22 (e.g. image intensifiers, flat detectors, semiconductor sensors or CMOS devices) for receiving X-rays emitted by the first transmitter 21 and having passed through the object. The first transmitter 21 may be located down below on the arm 18 and the first receiver 22 at the top of the arm 18. The second X-ray device 20 includes a second transmitter 23 (an X-ray tube or x-tube) for emitting X-rays and a second receiver 24 (e.g. image intensifier or semiconductor sensors) for receiving X-rays emitted by the second transmitter 23 and having passed through the object. The receivers 22, 24 may each comprise image intensifying means and an image capturing device, typically a CCD or CMOS camera, for converting X-rays into a visible image. High definition monitors (also called radiological monitors) 4a, 4b face the surgeon displaying the X-ray images in two different orthogonal planes either in real time (life image) or in so called“cine mode” that replay to review exactly how and precisely where a prosthetic joint component has been placed without the necessity of exposing the patient and surgeon to ore X-ray radiation.

The radiological display monitors 4a, 4b can be turned to face the operator of the console or can be turned to face a different direction. During an operation, the high definition monitors will typically be turned around to present the fluoroscopic images to the surgeon. The cables 150 connecting the G-stand to the console can be wound up and stored in the slot 5 when the console and the G-stand are close to each other. The console shown in Fig. 2 has a touch screen graphic user interface (GUI) 3b, comprising in this case two fields which can be configured in various ways. The GUI may be presented with a configuration in which the left half of the touchscreen has a keyboard for inputting and recording information to identify patient or operation information for example“cine” or“spot” recordings.

With reference to fig. 4 and fig. la the fluoroscopy system may in addition to comprising high resolution monitors for presenting images to a surgeon for example also comprise components such as a foot switch (1010) to enable the surgeon with sterile hands to switch between images taken in the respective planes. Such a system may also comprise a hand-held remote (1011) control for operation by the assistant. The control unit preferably further comprises at least one touch screen display for displaying image data, a control panel, and a data processor comprising image processing means adapted to receive images transmitted from the image capturing devices comprised in the receivers 22, 24. The mobile unit 1 and the control unit 2a are communicatively coupled to each other, for instance by means of a cable or through wireless signal transmission.

In one or more embodiments the control unit further comprises a display configured to receive a display signal from a processor 960 and to display the received signal as a displayed image, e.g. to a user control.

In one or more embodiments the control unit 2a and the x-ray carrier unit 1 further comprise one or more external control devices, which are linked to the generator input devices 940A, 940B: -a 3-pedal foot switch linked to the fluoroscopy system via a cable or via a wireless connection;

-a hand-held control device linked to the fluoroscopy system via a cable or via a wireless connection; -a set of controlling buttons in the mobile control unit 2a;

-a touch screen located on control unit 2a and/or the display unit 3b.

In one or more embodiments the control unit 2a further comprises an input device, e.g.

integrated in the touch screen, configured to receive input or indications from a user as user input data. In the current invention a 3 -pedal foot switch or other forms of control are configured to emit X-ray pulses from first transmitter by activating the first pedal, emitting the X-ray pulses from the second transmitter by activating the second pedal and emitting the X-ray pulses in a synchronization mode from the first and the second transmitter and/or emitting the pulses simultaneously by activating the third pedal. According to embodiments herein, the mobile control unit 2a may further be configured to control synchronized operation such that the respective first and second X-ray image device 19, 20 is in operation generating one or more X-ray images one at a time. Thereby, the problem of images being noisy, due to interference from X-ray radiation emitted along the first plane and X-ray radiation emitted along the second plane and due to the incorrect timing of X-ray pulse emittance, is eliminated.

The mobile control unit 2a can comprise a personal computer (PC) unit 960, and the synchronization units 800A, 800B may be integrated in, implemented in or communicatively coupled to the personal computer unit 960 and/or to the transmitters 21,23. The personal computer unit may be a processor or any other unit capable of processing the methods steps and functions disclosed herein.

The mobile control unit 2a can be communicatively coupled to the mobile digital fluoroscopy system and to the synchronization unit via a wireless communication network or via a cable.

In an embodiment, the mobile control unit 2a is provided with a base module 106, a pulpit stand module 108 and an operator control interface 3b, 116. The first and the second X-ray image devices 19, 20 may each comprise a respective transmitter 21, 23, and a respective receiver 22, 24, and the mobile control unit 2a may further be configured to control synchronization operation such that the first transmitter 21 or the second transmitter 23 emits X-ray energy. By controlling the operation of the transmitters 21, 23 such that only one of them emits X-ray energy at a time, the problem with interference already mentioned is eliminated.

The control unit 2a may further be configured to control synchronized operation by timing generating and emitting an X-ray radiation pulses in the transmitters 21, 23. According to embodiments herein, the control unit 2a may further be configured to control synchronized operation by timing the capturing of an image by the respective receivers. Timing of the different operational steps ensures proper operation of the system, and ensures high quality images with reduced dose to the patient and personnel.

The personal computer unit 960 can be configured to receive a first set of image data transmitted from the first or the second receivers 22, 24, and to generate and to send a control signal to the synchronization units 800A, 800B in response to the completion of receiving the first set of image data. The synchronization units 800A, 800B may further be configured to receive the control signals from the personal computer unit 960, to generate the

synchronization signal 820A, 820B in response to the received control signal, and to synchronize the execution of tasks of the transmitters 21, 23 and/or the receivers 22, 24.

The synchronization signals 820A, 820B can comprise four signal parts, a first signal part sent to the first transmitter, a second signal part sent to the second transmitter, a third signal part sent to the first receiver, and a fourth signal part sent to the second receiver. The first signal part may comprise timing of emitting an X-ray radiation pulse in the first transmitter, and the second signal part may comprise timing of emitting an X-ray radiation pulse in the second transmitter, and the third signal part may comprise timing of capturing an image by the first receiver, and the fourth signal part may comprise timing of capturing an image by the second receiver.

The system can further comprise a radiation control unit, and the synchronization units 800A, 800B may be integrated in, implemented in or communicatively coupled to the radiation control unit. It is to be noted that the radiation control unit may be named the synchronization units in some parts of the description. The mobile digital fluoroscopy system 1 and/or the transmitters 21, 23 can incorporate a set of filters that are positioned in the collimator, which improves beam quality and consequently reduces patient dose and improves resulting image quality.

The personal computer unit 960 may further be configured to receive a second set of image data to control timing of the first receiver and the second receiver to capture and to send a second set of image data to the radiation control unit.

The synchronization units 800A, 800B can further send an Automatic Brightness System (ABS) signals 1001A, 1001B. Alternatively, these signals are called Automatic Brightness Control (ABC) signals. ABS signals are configured to be sent to the generator input devices 940A, 940B and are configured to change the output of the generator units 940A, 940B by varying the current and/or voltage of the exposure. The variation of these signals achieves the technical effect of image brightness control, thus limiting the amount of output radiation by searching for the“optimal” parameters of the exposure and controlling the dose.

According to fig 4, the method comprises of multiple synchronization signals that control several parts of the device by emitting multiple signals, where the system emits the following signals:

-a first and/or a second image control signal 1002 A, 1002B coming to the first and/or second synchronization devices 800A, 800B from the respective first and/or second receivers 22,24;

-a first and/or a second automatic brightness system (ABS) signals 1001A, 1001B; -a first and/or a second synchronization signals 820A, 820B to stop operation of the first and/or second active transmitter 21,23;

-an intra- synchronization signal 810 to control the transmittance of X-ray pulses from the inactive transmitter 21,23;

-a first and/or a second image data signal 1000A, 1000B for transmitting the image data to the display units for further review of the images by the physician.

According to embodiments herein, the method further comprises of emittance of a signal from the controlling device to the PC unit 960 and transmitter units 21,23 to time the operation of the transmitter units. According to an embodiment, there is provided a mobile digital fluoroscopy system, comprising a mobile unit 1, also called a mobile X-ray system carrier unit 1, having a stand having a G-arm 18 suspended on a chassis frame 7; a first X-ray device 19 mounted on the G- arm 18 to transmit an X-ray beam along a first plane Pl, the first X-ray device 19 having a first receiver 22 mounted on the G-arm 18 and a first transmitter 21 mounted on the G-arm 18 opposite the first receiver 22; a second X-ray device 20 mounted on the G-arm 18 to transmit an X-ray beam along a second plane P2 intersecting the first axis Pl of the first X-ray device, the second X-ray device 20 having a second receiver 24 In an embodiment, the X-ray system carrier unit 1 further comprises a synchronization units 800A, 800B configured to generate a synchronization signal 820A, 820B to the transmitters 21, 23 and receivers 22, 24 and to send a second set of image data 1000A, 1000B received from receivers 22, 24 to the mobile control unit 2a, wherein the synchronization signal 820A, 820B is configured to control timing of the first and/or second transmitter to emit/not to emit X-ray energy based on the synchronization signals 820A, 820B and to control timing of the first receiver 22 and the second receiver 24 to capture and send a second set of image data to the synchronization units 800A, 800B. In an embodiment, the first and second receivers 22 and 24 are image intensifiers, according to any configuration known in the art, mounted at respective ends of the G-arm. In an embodiment, the first and second receivers 22 and 24 are flat digital X-ray detectors.

The control unit is further configured to receive user indications via the touch screen as user input data in the form of user input data signals, to process user input data to control data indicative of a desired adjustments of functions in system, to send the control data as control signals to such functions, to receive functional status data as status control signals from a respective functions, to process function status data to a visual representation of the function status data and to send the visual representation to the touch screen as a display signal, wherein the touch screen is configured to display the visual representation to a user.

The control unit further comprises a programmable logic control unit (PLC) 950

communicatively coupled to the PC unit 960, wherein the PLC unit is provided with specifically designed programming or program code portions configured to control the personal computer unit and/or transmitter units 21,23 to perform the steps and functions of embodiments of the method described herein. The control unit further comprises at least one memory 930 configured to store data values or parameters received from the PLC 960 or to retrieve and send data values or parameters to the PC unit 950. The control unit further comprises a communications interface 940 configured to send or receive data values or parameters to/from a processor 960 to/from external units via the communications interface 940. In some embodiments the PLC can be replaced by a programmable logic relay or other type of a real-time controlling equipment.

In the schematic overview of Fig. 4, synchronization units 800A, 800B are integrated in, implemented in or communicatively coupled to the PC unit 960 and to the image devices consisting of respective transmitters 21,23 and receivers 22,24. The synchronization units 800A, 800B are integrated in, implemented in or communicatively coupled to the PLC unit 950, which controls the operation of the PC unit 960 and/or transmitters 21,23. The synchronization units 800A, 800B are configured to synchronize the signal communication between the first and second X-ray devices 19, 20 and the mobile control unit 2a.

In the schematic overview of Fig. 4, the receivers 22, 24 send image control signals 1002A, 1002B to the synchronization units 800A, 800B. Upon receiving the signals, the

synchronization units send synchronization signals 820A, 820B to the generator input units 940A, 940B. The generator input units send the controlling signals to the transmitters to stop operation of X-ray energy acquisition.

The generator input units 940A, 940B are configured to send the controlling signals through the PLC unit 960, operation of which was described previously. By sending the signals to the PLC unit, the signals are further configured to limit the amount of radiation and time the generation of X-ray energy coming from the transmitters 21,23 thus further improving the image quality and limiting the amount of radiation received by the patient and personnel.

The signals from the PLC unit to the generator input devices 940A, 940B are configured to be sent to the synchronization units 800A, 800B and is configured to be sent to the receivers 22,24 to time acquisition of the x-ray radiation by the receivers 22,24.

The signals from the PLC unit are configured to be sent to the inverter unit 700A, 700B, which is configured to control the operation of the transmitters by transforming DC current to AC current coming from the kV generator module. How kV generator and inverter units are related to each other is known for the skilled person art and won’t be discussed in detailed in this description.

One/both of the synchronization units 800A, 800B can further send image data signals (1000A, 1000B) to the PC unit 960. The image data signals (1000A, 1000B) are configured to contain essential image data about the scanned object during operation of image devices 19,20. In some embodiments these signals are in form of raw data intended to be further processed by the PC unit 960 and are configured to be displayed in the processed form to the operator of the fluoroscopy system through the display devices 4a, 4b, 3 a.

One of the synchronization units 800A, 800B can further send an intra- synchronization signal 810 to the other synchronization unit 800A, 800B. Signal 810 is configured to enable the generation of the X-ray pulse from the transmitter 21,23 during the operation of the active transmitter 21,23. The generation X-ray pulse generation from the inactive transmitter is generated with a margin of time, which has been described previously in this application.

In some embodiments, the synchronization units 800A, 800B are configured to send one or more of the specified signals 820A, 820B, 1000A, 1000B, 1001 A, 1001B, 810 one at a time or in some combination to achieve the best Signal-to-noise ratio (SNR) and/or Detective quantum efficiencies (DQE) from the transmitters 21,23.

In embodiments, there is provided a mobile digital fluoroscopy system, comprising: a mobile X-ray system carrier unit 1 having a first and a second X-ray device 19, 20 each having a transmitter 21, 23 and a receiver 22, 24, the respective first and second X-ray devices 19, 20 being mounted on a G-arm 18 to enable X-ray imaging in mutually intersecting planes; a mobile control unit 2a, wherein the mobile X-ray system carrier 1 is communicatively coupled to the mobile control unit 2a; a PC unit 960 implemented in the mobile control unit 2a ; the synchronizing units 800A, 800B are integrated in, implemented in or

communicatively coupled to the PC unit 960 or transmitters 21,23. The PC unit 960 is according to embodiments configured to receive an image 1000 A, 1000B transmitted from the first or second receiver 22, 24 through the synchronization units 800A, 800B and to generate a control signal in response to the completion of transmission of an image from the first or second receiver 22, 24. The synchronization units 800A, 800B are in turn configured to receive a control signal from the PC unit 960, the control signal indicating that an image 1000A, 1000B has been completely transmitted from the first or second receiver 22, 24, and to synchronize the execution of tasks of the transmitters 21, 23 and/or receivers 22, 24.

The synchronization units 800A, 800B can configured to generate a synchronization signal 820A, 820B in response to the received control signal from the PC unit 960; and control the timing of generating and emitting an X-ray radiation pulse in the transmitters 21, 23 and/or control the timing of capturing an image receivers 22, 24 of the first and second X-ray systems 19, 20, based on the synchronization signal 820A, 820B. The first and second transmitters 21, 23 can be configured to interpret the synchronization signal 820A, 820B, and to adjust the timing of generating and emitting an X-ray radiation pulse in response to information comprised in the synchronization signal 820A, 820B.

In embodiments, the first and second receivers 22, 24 are configured to interpret the synchronization signal 820A, 820B and adjust the timing of capturing an image in response to information comprised in the synchronization signal 820A, 820B.

The processor/personal computer unit 960 can be a processor such as a general or specific purpose processor/personal computer unit for example a microprocessor, microcontroller or other control logic that comprises sections of code or code portions, stored on a computer readable storage medium, such as a memory 930, that are fixed to perform certain tasks but also other alterable sections of code, stored on a computer readable storage medium, that can be altered during use. Such alterable sections of code can comprise parameters that are to be used as input for the various tasks, such as receiving user indications.

The communications interface of the system as described can include at least one of a Local Area Network (LAN), Metropolitan Area Network (MAN), Global System for Mobile Network (GSM), Enhanced Data GSM Environment (EDGE), High Speed Downlink Packet Access (HSDPA), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth®, Zigbee®, Wi-Fi, Voice over Internet Protocol (VoIP), LTE Advanced, IEEE802.l6m, WirelessMAN- Advanced, Evolved High-Speed Packet Access (HSPA+), 3GPP Long Term Evolution (LTE), Mobile WiMAX (IEEE 802. l6e), Ultra Mobile Broadband (UMB) (formerly Evolution-Data Optimized (EV-DO) Rev. C), Fast Low-latency Access with Seamless Handoff Orthogonal Frequency Division Multiplexing (Flash-OFDM), High Capacity Spatial Division Multiple Access (iBurst®) and Mobile Broadband Wireless Access (MBWA) (IEEE 802.20) systems, High Performance Radio Metropolitan Area Network (HIPERMAN), Beam-Division

Multiple Access (BDMA), World Interoperability for Microwave Access (Wi-MAX), infrared communications and ultrasonic communication, etc., but is not limited thereto.

The PC unit 960 is communicatively coupled and communicates with a memory 930 where data and parameters are kept ready for use by the personal computer unit 960. The one or more memories 930 may comprise a selection of a hard RAM, disk drive, a floppy disk drive, a magnetic tape drive, an optical disk drive, a CD or DVD drive (R or RW), or other removable or fixed media drive. The control unit PC comprises a graphical user interface (GUI). The PC unit may be specially adapted for performing the steps of methods of the present disclosure, or encompass a general processor/personal computer unit 960 according to the description herein and to process the raw data coming from the synchronization units 800A,800B through the signals 1000A, 1000B. The GUI unit may be specially adapted for converting the processed data into human- readable format and for displaying the data.

The mobile control unit 2a, which incorporates the PC system and the GUI system, can further comprises at least one display, that can be rotated around its foot axis, and displays scan images, e.g. to operator of the control unit, G-arm and the persons operating on the patient, wherein the scan images are processed or non-processed images generated by the x- ray system 1. The mobile control unit 2a can further comprises a control interface, e.g. a touch screen, keyboard, mouse or other devices with ability to interact with a user.

The receivers 22,24 are configured to convert x-ray radiation into information e.g. displaying visible x-ray image of the scanned area. The receivers can comprise a camera, a CMOS device, a semiconductor, an image intensifier or any other device that converts x-ray radiation into raw data and/or to pixels on the display units.

One problem with conventional X-ray system is the distribution of the signals used for imaging, because the absence of image signal distribution and/or overexposure of the image and/or wrong timing of generation/acquisition and other factors can cause the image to be noisy by decreasing the SNR value. Hence, the distribution of functionality is no trivial task as all systems are closely interrelated and need to maintain synchronization, e.g. to minimize inter transmitter inter-plane interference and data overflow when transferring data, such as X- ray images, between modules in the system, such as the X-ray system carrier unit and the mobile control unit 2a.

The present invention solves the current problem by distributing functionality between the X- ray system carrier unit 1 and the mobile control unit 2a, synchronize transfer of image data and capturing of new image data, synchronize image capturing in different planes and timing of capturing and/or generating of different image data.

With present invention, the inter transmitter inter-plane interference is reduced and bandwidth requirements between the X-ray system carrier unit and the mobile control unit 2a are reduced, which facilitates a further technical effect. In some embodiments this allows to decrease the diameter of the cable 150, which connects the x-ray carrier unit 1 and the control device 2a.

In Fig. 3 a schematic view of embodiments of a signal synchronization is shown. In this figure there are two image transmission sequences 700 and 710, with images captured by and transmitted from the first and second receiver 22, 24, respectively. As can be seen from the figure, images 701, 702 et cetera are transmitted from the first receiver 22, to the mobile control unit 2a, at a frame rate P. Images 711, 712 et cetera are transmitted from the second receiver 22, to the mobile control unit 2a, at a frame rate P, but with a delay of P/2 compared to the frames being transmitted from the first receiver 22.

When an image 701 has been fully received (complete transmission) by the PC unit 960 of the mobile control unit 2a, the PC unit 960 communicates this to the synchronization units 800A, 800B, using a control signal, thereby triggering the synchronization units 800A, 800B to generate a synchronization signal 820A, 820B. If the latest received image frame, e.g. 701, was captured by and transmitted from the first receiver 22, the synchronization signal is communicated to the second transmitter 23, thereby triggering the second transmitter 23 to generate and emit an X-ray pulse; and to the second receiver 24 thereby triggering the second receiver 23 to capture and an image 702 and to transmit the image to the mobile control unit 2a. On the other hand, if the latest received image frame was captured by and transmitted from the second receiver 24, e.g. image 702, the synchronization signal is communicated to the first transmitter 21, thereby triggering the first transmitter 21 to generate and emit an X- ray pulse; and to the first receiver 22 thereby triggering the first receiver 22 to capture and an image 703 and to transmit the image to the mobile control unit 2a. Thereby, the emission of X-rays, image capturing and transmission of images is alternated between the first and the second X-ray devices 19, 20.

Through this alternating mode, achieved through synchronization of the X-ray devices 19, 20 based on the rate of capturing and transmission of images to the mobile control unit 2a, the problem of having noisy images with decreased SNR value is solved. As no X-ray pulse is generated and no image is captured until the previously captured image has been completely transmitted to, or read out at, the mobile control unit 2a, there will be no interference between X-ray radiation emitted along the first plane and X-ray radiation emitted along the second plane. Thereby, higher quality images, with reduced amount of noise, are obtained. The images are also easier for an observer to interpret, as noise that may have drawn attention to non-important image information, or hidden important image information, is removed. Scan images can be stored within the system and presented as last image hold or a set of scan images stored in a flow as a last sequence hold. This furthers perception of scanned parts as well as progress and status of operation. One use case scenario can be to monitor the effects and progress of operation on the patient by having the option to see scan image before a small operation and thus see a full extent of last surgical operation made.

The control unit is outfitted with several displays 4a, 4b. Top displays can be outfitted at top of control unit with turn able foot giving the option for surgeon to view scan images on display without moving from operation position. Displays can further be outfitted at control panel on the control unit resulting in enhanced control of x-ray emitters as well as the option to view scan images while the top display is turned in other direction from user of control unit. The user of the control unit can operate collimator in order to control/focus the field of view (FOV) that is being diagnosed and thus to control the dosage of irradiation onto the area of interest causing the patient to be exposed to a decreased dosage of radiation. Wherein control of the collimators is performed by control unit table e.g. by touch screen, keyboard and/or other types of controlling devices.

A computer program product comprising non-transitory computer readable code configured to, when executed in a processor, perform any or all of the method steps or functions described herein.

Use case scenarios for the use of the mobile fluoroscopy unit can be presented in the following way: the user at the control unit 2a is inputting an estimated kV value for the X-ray exposure in the system. Estimated kV value might not be high enough to scan the patient in an optimal manner (e.g. not high enough energy to penetrate the patient, which means that the generated photons will contribute to the absorbed dose of the patient) in order to get a clear view of area of interest. Mobile control unit uses computer methods, which perform machine calculations to regulate how much additional kV the system needs to add to the exposure in order to successfully expose the area of interest. This works in both cases of too high and too low initial kV value, wherein the regulated kV value is being sent for the system to compensate for. The regulated kV value can be zero as well, which means that the pre-defined kV value is optimal. This is beneficial for the user operating the control unit as the user can view a displayed value at the control unit as well the last image scanned and the regulated value of kV displayed by the system. Accordingly, the unnecessary radiation and the time calibration time is thus optimized. The kV can be adjusted manually by the user or by transmitting the ABS signal described before in this document.

The X-Ray mA and pulse length can be pre set via APR selectable via GUI from physics and depents to the examined planned organ.

The system can be operated as follows:

-the receivers 22, 24 send image control signals 1002A, 1002B to the synchronization units 800A, 800B;

-the synchronization units 800A, 800B receive image data from first receiver 22 and the second receiver 24 and to send one or more signals to control further the operation of the x- ray carrier unit 1 ;

-the generator input units 940A, 940B receive one or more of the synchronization signals 820A, 820B from the synchronization units 800A, 800B and to send a control signal to the PLC unit 950 and/or to the transmitters 21,23 to stop the operation of the transmitters 21,23;

-the generator input units 940A, 940B receive one or more of the ABS control signals 1001 A, 1001B from the synchronization units 800A, 800B and to send a control signal to the PLC unit 950 and/or to the transmitters 21,23 to alter the value of the voltage and/or the current to improve the image quality;

-the generator input units 940A, 940B receive control signals from the operator foot switch 1010 and/or from the console on the mobile control unit 2a and or from the display unit 3 a with a touch screen interface and/or from the remote control;

-the generator input PLC unit is configured to receive the signals from the generator input units 940A, 940B and further configured to transmit to the PC unit 960 and/or to the transmitter units 21,23 to further control the timing of the X-ray pulse acquisition;

-the synchronization units 800A, 800B send image control signals to the PC unit 960 for further processing of the raw image data and displaying them on the display units 4a, 4b, 3b;

-the synchronization units 800A, 800B send an intra-synchronization signal 810 for sending the signal to the inactive transmitter 21,23.

Fig 5a shows a schematic view of a synchronization signal 820A, 820B and an image discard pattern. The synchronization signal 820A, 820B comprise a first signal part (1310) sent to the first transmitter 21, a second signal part (1320) sent to the second transmitter 23, a third signal part (1330) sent to the first receiver 22 and a fourth signal part (1340) sent to the second receiver 24, wherein the first part 1310 comprises timing of emitting an X-ray radiation pulse in the first transmitter 21, wherein the second part 1320 comprises timing of emitting an X- ray radiation pulse in the second transmitter 23, wherein the third part comprises timing of capturing an image by the first receiver 22, wherein the fourth part comprises timing of capturing an image by the second receiver 22. A high synchronization signal 820A, 820B value, such as a signal value 1351 shown in Fig. 5a, indicates activation and a low

synchronization signal 820A, 820B value indicates de- activation of transmitters 21, 23 or receivers 22, 24. The image discard pattern, retrieved from the synchronization units, is overlaid on the synchronization signal 820A, 820B in Fig. 5a. Images denoted by“X” represents images captured by a receiver 22, 24 when the corresponding transmitter 21, 23 oriented in the same plane is emitting X-ray energy which are sent to the control unit 2a, e.g. when the second transmitter is active 1351, a second image 1353 comprising image data is captured by the second receiver and sent to the control unit 2a. Images denoted by“S” represents images captured by a receiver (22,24) when the corresponding transmitter (21,23) oriented in the same plane is not emitting X-ray energy and which are discarded, e.g. when the second transmitter is active 1351, a first image 1352 comprising image data is captured by the first receiver discarded by the synchronization units 800A, 800B. The energy captured by the first receiver in this case is mainly scattered energy from the first transmitter oriented in a different plane. The energy captured by the second receiver in this case is mainly energy from the second transmitter oriented in the same plane. In embodiments, the first signal part (1310) is sent and the second signal part (1320) for the transmitter have longer active periods or pulse width than active periods for the corresponding third signal part 1330 and fourth signal part 1340 for the receivers. The third signal part 1330 and fourth signal part 1340 for the receivers have longer active periods or pulse width than active periods for the first signal part sent 1310 and the second signal part 1320 for the transmitter.

Fig. 5b shows a schematic view of synchronization signals 820A, 820B and an image discard pattern. The synchronization signals 820A, 820B comprise a first signal part sent 1310 to the first transmitter 21, a second signal part 1320 sent to the second transmitter 23, a third signal part 1330 sent to the first receiver 22 and a fourth signal part 1340 sent to the second receiver 24, wherein the first part 1310 comprises timing of emitting an X-ray radiation pulse in the first transmitter 21, wherein the second part 1320 comprises timing of emitting an X-ray radiation pulse in the second transmitter 23, wherein the third part comprises timing of capturing an image by the first receiver 22, wherein the fourth part comprises timing of capturing an image by the second receiver 22. A peak synchronization signal 820A, 820B, such as a signal value 1351 shown in Fig. 5a, indicates activation and a low synchronization signal 820A, 820B value indicates de-activation of transmitters 21, 23 or receivers 22, 24. The image discard pattern, retrieved from a memory 1032 is communicatively coupled to the synchronization units, is overlaid on the synchronization signal 820A, 820B in Fig. 5b, wherein the image discard pattern defines the intended use for a captured image, e.g. send to control unit 2a, discard image or be used as a“dark image” for removing dark current noise, i.e. noise present when none of the transmitters are transmitting or emitting X-ray energy. Images denoted by“X” represents images captured by a receiver 22, 24 when the

corresponding transmitter 21, 23 oriented in the same plane is emitting X-ray energy which are sent to the control unit 2a, e.g. when the second transmitter is active 1351, a second image 1353 comprising image data is captured by the second receiver and sent to the control unit 2a. Images denoted by“S” represents images captured by a receiver 22, 24 when the

corresponding transmitter 21, 23 oriented in the same plane is not emitting X-ray energy and which are discarded, e.g. when the second transmitter is active (1351), a first image (1352) comprising image data is captured by the first receiver discarded by the synchronization units 800A, 800B. The energy captured by the first receiver in this case is mainly scattered energy from the second transmitter oriented in a different plane. The energy captured by the second receiver in this case is mainly energy from the second transmitter oriented in the same plane. Images denoted by“D” represents images captured by a receiver 22, 24 when neither of the transmitters 21, 23 are emitting X-ray energy, i.e. the so-called“dark image”. As can be seen from the image the D images may be captured at the beginning and at the end of an image sequence and can be used directly in the synchronization units 800A, 800B or after being sent to the control unit 2a for reducing background noise or dark current noise. In one example, this is done by subtracting image data values from the D-image 1350 from data values from an X-image 1351, as would be understood by the skilled person.

Fig. 6 shows another schematic view of a synchronization signal 820A, 820B and an image discard pattern where the X-ray image devices 19, 20 are operating in alternating mode. If the latest received image frame was captured by and transmitted from the first receiver 22, the synchronization signal is communicated to the second transmitter 23, thereby triggering the second transmitter 23 to generate and emit an X-ray pulse; and to the second receiver 24 thereby triggering the second receiver 23 to capture and an image and to transmit the image to the mobile control unit 2a. Thereby, the emission of X-rays, image capturing and transmission of images is alternated between the first and the second X-ray devices 19, 20. The diagram further shows using the detector not being in use for image capturing for detection of stray radiation.

Details of the synchronization signal 820A, 820B with the plurality of signal parts are shown in the diagram.

R =” Read out” by detector T

A =” Acquisition” the detector detects X-ray radiation

X = Active X-ray source

S= stray radiation

AX = Acquisition of active image plane

RX = Read-out of image data from active plane

AS = Acquisition of stray radiation

RS = read out data generated by stray radiation from the other image plane

In the current invention, the method in a mobile digital fluoroscopy system is performing a synchronized operation of X-ray image devices (19, 20), comprising:

-generating a first and/or a second image control signal coming to the first and/or second synchronization units (800A, 800B) from the respective first and/or second receivers (22,24) during a first acquisition step;

-generating a first and/or a second ABS signals (1001 A, 1001B);

-generating a first and/or a second synchronization signals (820A, 820B) to stop operation of the first active transmitter (21,23) to finish the acquisition step;

-generating an intra- synchronization signal (810) to control the transmittance of X-ray pulses from the inactive transmitter (21,23);

-generating a first and/or a second image data signal (1000A, 1000B) for transmitting the image data to the display units (4a, 4b, 3),

According to the current invention, the method further comprises: -generating a control signal to the first and/or second synchronization device (800A, 800B) to communicate that an energy threshold has been reached in the receivers (22,24);

-generating ABS and/or synchronization signals (820A, 820B), preferably simultaneously, to stop operation of the active transmitter (21,23); -generating an intra- synchronization signal (810) and/or image data signal (1000A, 1000B), preferably simultaneously, to perform display of the image data and generation of a pulse from the inactive transmitter (21,23).

Figure 6 shows a method in fluoroscopy system according to the invention for synchronizing of emitting X-ray radiation pulses, of capturing images receivers and of transferring image data from the X-ray system carrier unit 1 to the mobile control unit 2a, the method comprising:

-forming a dark-image in the receivers (22, 24) when there is no signal generation (2000A) in the transmitters (21,23);

-transmitting an X-ray pulse to one of the receivers (22, 24) from the transmitters 21,23 that are controlling image synchronization units (800A, 800B), thereby forming an acquisition step (2000B);

-generating a synchronization signal (820A, 820B) to terminate the X-ray pulse generation, thereby completing the acquisition step (2000A);

-generating two signals preferably simultaneously, wherein signal 810 is generated for activating the second synchronization unit for controlling the inactive transmitter and signal (1000A, 1000B) is generated for transmitting the image data to the display units (4a, 4b, 3);

-switching the operation to the inactive image device and generating an X-ray pulse from the inactive transmitter to the inactive receiver;

-repeating these steps in order to obtain an alternating signal pattern. According to the invention, the method can further comprise:

-generating a control signal to the first and/or second synchronization device (800A, 800B) to communicate that an energy threshold has been reached in the receivers (22,24); -generating ABS and/or synchronization signals, preferably simultaneously, to stop operation of the active transmitter (21,23);

-generating an intra- synchronization and/or image data signals, preferably simultaneously, to perform display of the image data and generation of the pulse from the inactive transmitter.

Wherein the Images denoted by“X” represents images captured by a receiver 22, 24 when the corresponding transmitter 21, 23 oriented in the same plane is emitting X-ray energy which are sent to the control unit 2a, e.g. when the second transmitter is active, a second image comprising image data is captured by the second receiver and sent to the control unit 2a. Images denoted by“S” represents images captured by a receiver (22,24) when the

corresponding transmitter (21,23) oriented in the same plane is not emitting X-ray energy and which are discarded, e.g. when the second transmitter is active, a first image comprising image data is captured by the first receiver discarded by the synchronization units 800A, 800B.

One problem when operating an X-ray system having a first and second X-ray device is that the receiver 24 is configured to receive an X-ray beam along the second plane P2 will register radiation emitted by the first transmitter 21, aligned along the plane Pl, due to scattering radiation. To reduce this inter-transmitter interference, transmission/emission by the first transmitter and the second transmitter could be separated temporally as described in fig 3.

The present invention solves this problem by synchronizing transmitter activation timing and image retrieval timing from the receivers. The interference between X-ray radiation emitted by a first transmitter along the first plane and X-ray radiation emitted by a second emitter along the second plane is reduced.

The synchronization units 800A, 800B can further be configured to calculate a regulated voltage value by determining an image quality /dose request (high, normal/low dose e.g. pediatric) value based on image intensity and perform a look-up operation in a predefined look-up table based on the image quality valuations to obtain a regulated voltage and/or current value.

The X-ray transmitters can be further configured to obtain dose area product (DAP) measurement values from a DAP chamber, also referred to as ionization chamber. Dose area product (DAP) is a quantity used in assessing the radiation risk from diagnostic x-ray examinations and interventional procedures. It is defined as the absorbed dose multiplied by the area irradiated, typically expressed in gray square centimeters (Gy*cm 2 ), mGy*cm 2 or cGy*cm 2 . Examples of DAP measurement values are cumulative dose, DAP dose and entrance dose.

In the current invention, a non-transitory computer readable memory on which the computer readable code is configured to be stored, when executed in a processor, performs any or all of the method steps described herein.

A tangibly embodied computer-readable medium including executable code that, when executed, causes a control unit to perform any or all of the method steps described herein.

The mobile control unit (2a) of the system described can be configured to control, based on the generated synchronization signal, synchronized operation of the respective first and second X-ray image device (19, 20) such that generation of one or more X-ray images is performed by one of the X-ray image devices, and that detection of stray radiation during the generation of the one or more X-ray images. This is performed by the other X-ray image device. Further, the synchronization signals 820A, 820B are configured to control timing of the first and/or second transmitter to emit or not to emit X-ray energy based on the synchronization signals 820A, 820B and to control timing of the first receiver 22 and the second receiver 24 to capture and send a second set of image data to the synchronization units 800A, 800B.

The mobile control unit (2a) of the system described can be configured to contain a dedicated electronic device, which is configured for grabbing digital still frames from an analog video signal, a digital video stream signal, audio signal multiple or concurrent video inputs. The dedicated electronic device could be a frame grabber or any other type of device. The frame grabber can be configured to perform other operations not limited to deinterlacing, text or graphics overlay, image transformation or real-time compression. The frame grabber (not shown on the pictures) could be a stand-alone device or integrated together with a graphic card in the machine.

The herein described fluoroscopy system can be configured to correct images during acquisition of the images (1002A, 1002B), processing or post-processing periods in the machine. The correction in the images can be of any type known in the art. The corrections can be of a software type (image corrections) or of a hardware type (receiver corrections). The corrections could be configured to include dark image correction, gain correction, offset correction, flat-field correction, dynamic flat-field correction or any other type of correction techniques. The techniques used for correction are known in the art and will not be discussed in-detail.

The herein described fluoroscopy system can be configured to contain a software part that corrects the images due to the incorrect image acquisition. During operation of the device there is a chance that during the acquisition of the last image, there will be a problem with the last image, which will appear as a noisy image in the system. It is a further object of the present invention to provide a software portion that corrects the last image taken during the acquisition of the images. The herein described fluoroscopy system can be configured to be connected to a PACS server where the PACS is configured to be receiving images from the control unit 2a and allows to physician to study the medical examinations on high-resolution monitors, the so-called radiological work stations.

The transmitted images from the systems as described can be configured to be in a DICOM (Digital Imaging and Communications in Medicine) format, where the DICOM format is enabling the physician to use the integrated network of additional devices associated with this format. DICOM is known to the skilled person and won’t be discussed in-detail in this document.