Patent Application
20220000580
The invention relates to marking and/or tracking a region of interest of a human body. In particular, the invention relates to an active marker device, a tracking system, and an examination apparatus.
In surgery, there may be a need to provide intra-operative imaging. This is because the anatomy that has been imaged pre-operatively may change significantly during surgery. For example, deformations may be caused by tissue cutting or by the movement of an organ, e.g. the liver, in the human body. Thus, there may be a significant non-linear deformation of the tissue and a simple registration of intra-operative imaging with pre-operative imaging may be difficult.
For this purpose, it is known to use tissue markers in order to find back the relevant tissue identified in pre-operative imaging during a subsequent procedure. Such markers are introduced into the tissue during the pre-operative phase. For example, X-ray absorbing markers may be used that are visible in an X-ray image acquired intra-operatively.
However, the usage of X-rays during surgery should be limited, not only to limit a dose of harmful radiation received by a patient, but also for example due to the fact that the surgery environment has to be sterile. This is more difficult when applying X-ray imaging, as intraoperative X-ray imaging requires the surgeon to wear for example lead shielding cloths, which may be inconvenient.
There may be a need to provide a marking device adapted for a precise and reliable marking of an object of interest of a human body.
The invention is lined out in the independent claims. Further advantages and embodiments are lined out in the dependent claims, the description and the figures.
A first aspect of the invention relates to a marker device being introducable into a tissue for marking a region of interest of a subject, such as a body of a patient. The marker device comprises a light source adapted for emitting light such that the marker device is visible to an optical sensor. Furthermore, the marker device comprises a switch adapted for operating the light source in a pulsed mode.
Hereinafter, a marker device according to the invention is also referred to as an “active marker device”, i.e. a marker device comprising an active emitter, in particular a light source. This is contrary to “passive” marker devices, such as an X-ray absorbing marker.
A gist of the invention may be seen in providing an optical marker for tracking and/or registering an object or region of interest of a human body. For this purpose, the active marker device described in the context of the invention is provided. It may be understood that the light source of the active marker device is in particular configured for emitting pulsed light.
The active marker can be implanted into the body during a pre-operative phase. During a subsequent procedure, the active marker device can be tracked using a suitable tracking device, which preferably comprises an optical sensor and more preferably at least one time-of-flight camera. Thus, the marked tissue structures can directly be linked to the coordinate system in the surgery room, and for example also to the coordinate system of a medical imaging system, such as an X-ray system.
By emitting pulsed light, the active marker device consumes less electrical power. Moreover, the active marker device emitting pulsed light can be detected more reliably by a time-of-flight camera. Further, the pulsed light emitted from the active marker device is better distinguishable from surrounding light, e.g. light emitted by a surgical task light or by lighting fixtures in the ceiling of the operating room, than a static light source.
In addition, the active marker device may be identifiable through a property of the pulsed light, e.g., the frequency or a specific pulse pattern. A further advantage of pulsing a LED may be the ability to over-drive the LED, i.e. the peak power may be larger than the maximum average power. In this way, the average LED temperature may be lower such that efficiency is improved and brighter light flashes may be emitted from the LED.
Although the active marker device is described for being introducible into a human tissue, the active marker device may be adapted for being introduced into animal tissue, e.g., for veterinary purposes. Moreover, the active marker device may be adapted for being introduced into dead tissue, e.g., for pathology.
The active marker device thus relates to a temporarily implantable light emitting marker, which is adapted for being detected outside the body, for example during a medical procedure. Preferably, the active marker device is adapted for emitting light pulses that can be detected with a time-of-flight camera. The active marker device may comprise an epoxy resin (e.g. EPO-TEK 301) into which the electronic components of the active marker device (e.g. the light source and the switch) are encapsulated. In other words, the active marker device may comprise a capsule into which the light source and the switch and p other components may be encapsulated. The capsule of the active marker device may comprise an elongated shape and may fit into a cannula of an insertion needle.
The light source may be a light emitting diode (LED), e.g., a low power LED or a semiconductor laser diode. The light source may also be another kind of light source having a low power consumption and a small size.
The light source may be configured to emit light with a luminous intensity greater than 150 mcd, preferably greater than 500 mcd, even more preferred, greater than 1000 mcd. Furthermore, the light source may be configured to emit light with a luminous flux greater than 1 lm, preferably greater than 5 lm, even more preferred greater than 10 lm.
The switch may relate to an electronic circuit for switching on and off the light source and for operating the light source in the pulsed mode. There may be different possibilities how the switch can be structured. For example, the switch may be a mechanical switch such that the active marker device may be manually activated by operating the switch, e.g., just prior to the implantation of the active marker device. The switch may for example be operated by pressing a miniature button.
Furthermore, the switch may be adapted for being operated in a contactless manner such that the light source of the active marker device can be remotely activated, i.e. activated from outside a patient's body, in a contactless manner, for example after the active marker device has been temporarily implanted into body tissue. For example, the light source may be activated by means of a magnetic field. For being activated with a magnetic field, the switch may for example comprise a miniature bi-stable reed switch. Furthermore, the switch may comprise an electronic fuse which may be activated via RF pulses. The switch may also comprise phase change materials. The phase change of the phase change material can for example be induced by an external heating or by the body heat when the active marker is introduced into the body. In this case, the switch may be operated by an expansion or contraction of the phase change material which causes a mechanical force (e.g. a pressure) onto a mechanical switch such that an electrical circuit is closed. The switch may alternatively comprise a material which changes its electrical conductivity upon a phase change of the material for operating the switch.
The switch may comprise an electrical circuit for operating the light source in the pulsed mode. For example, the switch may comprise a timer for operating the light source in the pulsed mode. Furthermore, the switch may comprise a receiving unit for being triggered remotely. In other words, the light source may be operated to emit separated pulses of light. The pulsed mode of the light source may for example be characterized by a frequency of the pulses. The frequency may for example be between 0.1 Hz and 100 MHz. In other words, a pulsed mode may relate to a frequency with which the pulsed light is emitted by the light source. The pulse duration may be, e.g., 50% of the duty cycle of the pulsed mode of the light source. However, the pulse duration may also be more or less than 50% of the duty cycle. Alternatively or additionally, the pulsed mode may be characterized by one or more specific pulse patterns.
Furthermore, it is possible to provide a plurality of active marker devices, wherein each marker device emits light with a different pulsed mode, e.g. with a different frequency of pulses or a different pulse pattern. Moreover, each active marker device of the plurality of active marker devices may be uniquely identifiable via the pulsed mode.
According to an exemplary embodiment of the invention the switch is configured for operating the light source in a plurality of different pulsed modes. Furthermore, the switch is configurable for operating the light source in one specific pulsed mode of the plurality of different pulsed modes.
In this way, a plurality of active marker devices can be used for tracking an object of interest, wherein each active marker device has its own pulsed mode and is uniquely identifiable via its pulsed mode.
For example, the switch can be adapted for operating the light source with different frequencies. The switch may be programmable to emit light with a specific pulsed mode, e.g. a specific frequency, or a specific pulse pattern. The switch may also comprise a mechanic switch for mechanically switching between different pulsed modes. Furthermore, the switch may comprise a receiving unit for receiving an information about the pulsed mode with which the light source shall emit light.
According to a further exemplary embodiment of the invention, the active marker device further comprises a receiving unit adapted for receiving an activation signal for the light source. Moreover, the switch is configured to switch the light source on when the receiving unit receives the activation signal. The receiving unit may be encapsulated in a capsule of the active marker device.
The receiving unit may be a wireless receiving unit, e.g. an RF (radio frequency) antenna. The switch may be adapted for operating the light source in the pulsed mode, only when the receiving unit receives the activation signal, e.g. only when the RF antenna receives a radio signal.
In this way, the active marker device can be activated remotely, when the object of interest is to be tracked optically. Thus, it may be ensured that the active marker device only consumes electrical power while it is being used for tracking the object of interest.
According to a further exemplary embodiment of the invention, the receiving unit is configured for receiving a signal comprising information about a property of the pulsed mode. Furthermore, the switch is configured for operating the light source in the pulsed mode having said property.
The property of the pulsed mode may for example be a frequency of the pulses emitted by the light source.
In this way, a signal can be sent to the active marker device such that the active marker device emits light in a specific pulsed mode. Thus, the active marker device can be operated to emit light in a specific pulsed mode such that the light can be processed by an optical sensor and a processing unit coupled to said optical sensor, e.g., for identifying the marker device.
According to a further exemplary embodiment of the invention, the receiving unit is configured for receiving a triggering signal triggering the generation of a pulse by the light source. Furthermore, the switch is configured for turning the light source on, only when the triggering signal is received by the receiving unit.
In other words, the pulses generated by the light source can be triggered by an external triggering signal, e.g. a RF triggering signal. In this way, the pulsed mode can be defined by an external source emitting the signal triggering the pulses of the light source. Thus, the specific pulsed mode can be determined during the operation of the active marker device and does not need to be determined before implanting the active marker device.
According to a further exemplary embodiment of the invention, the active marker device further comprises an energy source adapted for supplying the light source with electrical energy.
The energy source may be encapsulated in a capsule of the active marker device.
According to a further exemplary embodiment of the invention, the energy source comprises a battery.
To provide power for the light source, the energy source may comprise a Lithium-ion battery. Moreover, the battery can be configured to provide energy to the light source only for less than 24 hours, preferably less than 10 hours, even more preferable less than 5 hours, since the active marker only needs to emit light during surgery. Thus, the battery can be made small enough such that it is prevented that the active marker device becomes bulky.
According to a further exemplary embodiment of the invention, the energy source comprises an LC circuit for a wireless power supply of the energy source.
According to a further exemplary embodiment of the invention, the active marker device is configured for being introduced into a cannula of an insertion needle.
For example, the active marker device can have an outer diameter which is smaller than 2.4 mm. Moreover, the active marker device may have dimensions such that it fits into the channel of 16 gauge, preferably 14 gauge, even more preferred 11 gauge, of an insertion needle.
According to a further exemplary embodiment of the invention, the light source is configured for emitting light with a wavelength in the range between 600 nm and 1300 nm, preferably between 700 nm and 1000 nm.
For said range of wavelength the human tissue may have a low absorption which allows the active marker device to be tracked even deep inside the tissue.
The light source may alternatively be configured to emit light with a wavelength, which is absorbed by the tissue to a greater extent. In this way, not only the active marker can be found but it can also enhance the visibility of the tissue structure to the physician.
Furthermore, the active marker device can also be configured to be used in conjunction with a contrast agent that has been injected into the patient. Since the light source may be inserted into the tissue, a good illumination of the contrast agent (which may be a fluorescent contrast agent) can be achieved.
A second aspect of the invention relates to a tracking system for tracking an object of interest of a human tissue. The tracking system comprises an active marker described in the context of the invention and an optical sensor adapted for detecting the light emitted by the light source of the active marker device. Furthermore, the tracking system comprises a processing unit adapted for determining a position of the active marker device on the basis of the light detected by the optical sensor.
In other words, the tracking system can be configured for determining a position of the active marker device on an optical basis. The optical sensor of the tracking system may have imaging capabilities. For example, the optical sensor may be an optical camera. The optical sensor may also be configured to detect infrared light emitted by the light source of the active marker device.
According to a further exemplary embodiment, the optical sensor comprises at least two optical cameras. Furthermore, the processing unit is configured for performing a triangulation on the basis of images recorded by the at least two optical cameras for determining the position of the active marker device.
According to an exemplary embodiment of the invention, the optical sensor comprises at least one time-of-flight camera for receiving the light emitted by the active marker device. The processing unit is configured for determining the position of the active marker device by triangulation.
As is understood in the art, a time-of-flight (TOF) camera is a camera that produces a depth image; each pixel of such camera encodes the distance to a corresponding point in the field of view of the camera. TOF cameras are typically configured to measure phase delays of incoming light, in accordance to the invention in particular light pulses emitted by an active marker device.
According to an exemplary embodiment, the processing unit is configured for determining three spherical surfaces, on which the active marker device is located. Furthermore, the processing unit is configured for determining the position of the marker device by determining an intersection of the three spherical surfaces. In other words, the position of the active marker device in 3D space can be determined. Information associated with the receipt of a light pulse emitted by the active marker device by at least one pixel of a TOF camera, such as the estimated time of flight of the light pulse, can be used for determining the path length between the active marker device and a surface point, for example a point on an exterior surface of a patient associated with the at least one pixel of the TOF camera. Thus, a spherical surface can be determined in 3D space on which the active marker device is located. By determining the intersection point of three such spherical surfaces, the marker location in 3D space can be identified with high accuracy.
For example, the optical sensor comprises a single time-of-flight camera, which comprises at least three image points or pixels. The time-of-flight camera may comprise at least three pixels for receiving the light emitted by the marker device, wherein the processing unit may be configured for determining a spherical surface for each one of the at least three pixels Furthermore, the processing unit may be configured for determining the position of the marker device by determining an intersection of the three spherical surfaces.
The tracking system can be configured to determine the position of the active marker device in that different pixels of a single time-of-flight camera receive a light pulse of the active marker device emitted from a plurality of corresponding points (e.g. 3 points) on the surface of the body. Moreover, the tracking system can be configured to determine the position of said points on the surface of the body, e.g. during the registration procedure and/or by a standard reflective time-of-flight measurement. As the positions of the points on the surface of the body are known, the tracking system may be configured to determine the distance between each of said points on the surface and the active marker device from a phase delay in signals of the TOF camera signals representing a receipt of the emitted light pulse at the different pixels. Thus, the tracking system can be configured for triangulating the position of the active marker device, i.e. determining spherical surfaces for each of said points and for determining the intersection of the spherical surfaces yielding the position of the active marker device.
The tracking system may be configured for triggering a pulse of the light source of the active marker device, e.g. by emitting a RF signal. Furthermore, the tracking system may be configured for determining the time period between transmitting the RF signal for triggering the pulse of the light source and between detecting the pulse by the time-of-flight camera. In this way, the tracking device can determine the distance between the active marker device and each time-of-flight camera.
Moreover, the tracking system may also comprise more than one time-of-flight camera for improving the robustness of the system. In this way, the position in 3D space can also be determined if one camera cannot capture the light of the active marker device. Furthermore, the tracking system may be configured for taking into account light propagation time between tissue and air in order to determine the distance between the active marker device and the time-of-flight camera more accurately. For example, the distance between the each time-of-flight camera and the active marker device can be estimated using a patient surface model which may be registered in the surgical setup.
According to a further exemplary embodiment of the invention, the processing unit is configured for identifying the active marker device on the basis of the pulsed mode of the light received by the camera.
For example, the processing unit can identify the active marker device on the basis of the frequency of the pulses emitted by the light source.
According to a further exemplary embodiment of the invention, the tracking system further comprises a transmitting unit for transmitting an activation signal to the marker device.
A third aspect of the invention relates to a medical examination apparatus, comprising a medical imaging apparatus and a tracking system described in the context of the invention.
The medical imaging apparatus may be an X-ray device, a MRI, a US, a PET-CT or another imaging device. For example, the medical imaging apparatus may comprise a C-arm, on which the optical sensor or sensors of the tracking system is or are attached.
Furthermore, the exact position of the active marker device may be determined first by the imaging device, e.g. the X-ray system or other modality (MRI, X-ray, CT, US). Once the exact position of the active marker device is known, small movements of the active marker device can be tracked with the cameras with high precision.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.
The figures are schematic and not true to scale. If in the following description elements of different figures are labeled with the same reference signs, they refer to the same or similar elements. The same or similar elements may, however, also be labeled with different reference signs.
In
For example, the active marker device 100 comprises a low power LED 101 such as a Nichia NESL 157AT-H3 LED. This LED typically has a luminous flux of 11.5 lm and a luminous intensity of 4.0 cd. The LED 101 may, e.g., be connected to a small battery 103 and the switch 102 may be switchable from the distance. The LED can also be an HSMW white ChipLED having a size of 1.5×0.8×0.6 mm. Furthermore, the LED can be a PICOLED of ROHM having a size of 1.0×0.52×0.2 mm. The LED and the electronics of the active marker 100 may be capsulated in a capsule 105 of epoxy resin (e.g. EPO-TEK 301) that is biocompatible and optically transparent. The capsule 105 is made in an elongated shape such hat it fits inside a cannula of an insertion needle.
In
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In
The active marker device 501 comprises an LC circuit 503 having a coil 504 and a capacitor 505. Furthermore, the active marker device comprises a load circuit 506 including a coil 508 and a LED driving electronics 507.
The electrical energy is wirelessly provided to the active marker device 501 by an energy supplying device 502. The energy supplying device 502 comprises an LC circuit 509 including a coil 510 and a capacitor 511. The energy supplying device 502 further comprises a source circuit including an alternating energy source and a coil 514.
The source circuit 512 is configured to couple the energy into the resonant LC circuit 509 via the coils 514 and 510. The LC circuit 503 of the active marker device receives a part of the electromagnetic flux generated by the LC circuit 509 and couples the energy into the load circuit 506 which supplies the LED driver electronics with electrical energy.
In
Furthermore, a human body 606 is located between the X-ray source 603 and the X-ray detector 602 of the C-arm. The human body 606 comprises a region of interest, e.g. a tumor. Moreover, an active marker device 608 is implanted into the human body at or near the region of interest 607. In this way, the active marker device 608 and/or the region of interest can be tracked without having to activate the X-ray source, e.g., when the human body is moved during surgery. The processing unit 610 is adapted for determining a position, e.g. a 3D position, of the active marker device 608 on the basis of the light detected by the optical sensors 604, 605. The processing unit 610 is adapted to determine the position of the active marker device 608 by applying triangulation.
In
A body of a patient 706 having a tumor (region of interest) 707 is schematically shown. Furthermore, three implanted active marker devices 708, 709 and 710 circumscribing the tumor are shown. The tracking system 700 is configured for determining the position of the active marker devices 708, 709 and 710 by determining an intersection of the three spherical surfaces determined by at least three time-of-flight cameras of the four time-of-flight cameras 702, 703, 704 and 705. In other words, the position of the active marker device in 3D space is determined using path information of the pulsed light emitted by the active marker devices 708, 709, 710, as detected by the time-of-flight cameras. The estimated time of flight of the light pulse, which represents a path length for the emitted light from the active marker device to the camera, is used for determining the spherical surface on which the active marker device is located.
In order to explain the working principle of the time-of-flight camera, exemplary embodiments in a simplified 2D representation are shown in
In
Preferably, an additional third time-of-flight camera (not shown) may be used so that a 3D position of the active marker device 802 corresponds to a single intersection point of three spherical surfaces, one for each camera device.
In
At the first pixel that receives light from the surface point 809, the measured value is composed of sum of the distances 810 and 818. Equally, at the second pixel that receives light from the surface point 813, the measured value is composed of sum of the distances 814 and 819. Similar to the previous embodiment, the phase delay measured at the first and second pixel of the time-of-flight camera corresponds to the difference in path length between the sum of the paths 810 and 818 and the sum of the paths 814 and 819.
As the length of the paths 818 and 819 are known from the 3D position of points 809 and 813 and the 3D position of the time-of-flight camera 817, the tracking system can determine the distances 810 and 814 and subsequently triangulate the position of the active marker device by determining the intersection of spherical surfaces 820 and 821.
In 3D, preferably the position of the active marker device is determined using signals from at least three separate pixels of the time-of-flight camera. That is, based on a phase delay between these signals, the distances from the active marker device to at least three surface points observed by the corresponding pixels of the single time-of-flight camera may be determined. Again, the position of the active marker device is subsequently triangulated by determining the single intersection point of the three spherical surfaces corresponding to these distances.
A typical image may have many more surface points visible to different pixels of the TOF camera. Thus, preferably, signals from additional pixels receiving the light pulse from the marker at different time instances may be relied upon in order to further improve the accuracy of the marker position determination.
Optionally, a collimator may be used to restrict the image information received by the different pixels to a limited area of the total surface. That is, for example, the first pixel may receive light from surface point 809 but the collimator prevents light from surface point 813 from reaching the first pixel. Similarly, the collimator prevents light from surface point 809 from reaching the second pixel of the time-of-flight camera.
While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments.
Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measured cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.
| Number | Date | Country | Kind |
|---|---|---|---|
| 14198296.7 | Dec 2014 | EP | regional |
This application is a Continuation of application Ser. No. 15/535,455, filed Jun. 13, 2017 which is the U.S. National Phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2015/079513, filed on Dec. 14, 2015, which claims the benefit of European Patent Application No. 14198296.7, filed on Dec. 16, 2014. These applications are hereby incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15535455 | Jun 2017 | US |
| Child | 17477795 | US |
