Patent Grant
10350089
This application is a national phase application of International Application No. PCT/EP2013/067006 filed Aug. 14, 2013, published in the English language, which claims priority to International Application No. PCT/EP2013/066867 filed on Aug. 13, 2013, which is hereby incorporated herein by reference.
The invention relates to a method (in particular a data processing method) of determining a spatial relationship between a marker device and a resection plane associated with an anatomical structure of a patient's body. The invention also relates to a corresponding program, a computer executing such a program, a signal wave carrying information representing the program and an apparatus (for example a navigation system) comprising the mentioned computer.
When preparing medical procedures such as a surgical procedure on the knee, it is often required to determine geometric characteristics of the respective leg such as the positions of specific landmarks on the tibia. In known applications, this is achieved by determining the position of the landmark such as the distal end point of the mechanical, in particular proximodistal and/or longitudinal, tibia axis based on for example identifying the malleoli with a tracked pointer device and detecting the position of the pointer device in relation to a bone reference with a stationary camera of a navigation system. This, however, requires the tracked pointer and the bone reference to be visible during landmark acquisition. Moreover, the bone reference needs to be visible whenever the calculated registration is used for navigation purposes. Depending on the conditions in e.g. the operating room, this may not always be the case, especially with the camera being placed several meters away from the operating table.
A specific medical procedure may for example be the creation of a resection plane at the proximal end of the tibia or the distal end of the femur, which needs to have a predetermined orientation relative to the longitudinal axis of the tibia or the longitudinal axis of the femur. Creating this predetermined orientation would be hampered if, for example the acquisition of information about the positions about the required landmarks on the tibia or the femur is hampered.
A problem to be solved by the invention therefore is to provide a method which allows reliable determination of the spatial relationship between a marker device and a resection plane associated with an anatomical structure.
This problem is solved by the subject-matter of any appended independent claim. Advantages, advantageous features, advantageous embodiments and advantageous aspects of the present invention are disclosed in the following and contained in the subject-matter of the dependent claims. Different advantageous features can be combined in accordance with the invention wherever technically expedient and feasible. Specifically, a feature of one embodiment which has the same or a similar function to another feature of another embodiment can be exchanged with said other feature. A feature of one embodiment which adds an additional function to another embodiment can in particular be added to said other embodiment.
In this section, the invention is described by way of an example. This example shall not be construed to limit the invention to those features which are described in this section. Rather, this section merely offers a concise description of specific features of the present invention.
In order to solve the aforementioned problem, the inventive method is directed to in particular determining a spatial relationship between a marker device and a resection plane which is associated with an anatomical structure such as a tibia or a femur. The marker device preferably is video-detectable and comprises a graphical feature which can be detected by an imaging unit and can be analysed from an image thus generated. The imaging unit preferably is a camera of a handheld data processing device such as a mobile phone or a personal digital assistant. Preferably, the imaging unit is placed in a predetermined spatial relationship relative to the resection plane, so that in particular the position and orientation of the imaging unit relative to the resection plane is known. Preferably, the marker device rests in a global coordinate system while being imaged by the imaging unit. Based on imaging the marker device with the imaging unit (which has the predetermined spatial relationship relative to the resection plane), an orientation-dependent image appearance of the marker device is generated which serves as a basis for determining for the spatial relationship between the resection plane and the marker device. On this basis, the spatial relationship between the resection plane and the marker device can be determined, for example in order to determine whether the resection plane has the envisaged position and orientation with regard to the anatomical structure (i.e. the tibia or the femur). In one embodiment of the invention, the marker device has a fixed position relative to the anatomical structure, in another embodiment of the present invention, the marker device does not have a fixed position relative to the anatomical structure, in particular the anatomical structure can be moved relative to the marker device while imaging the marker device with the imaging unit. During this movement, the imaging unit preferably has a fixed spatial relationship relative to the anatomical structure.
In this section, a description of the general features of the invention is offered. In particular, the preferred features of the invention are described in detail.
The inventive method is in particular a data processing method, further particularly a medical data processing method and a data processing method usable in connection with medical applications. The method is preferably constituted to be executed by a computer and comprises the following preferred steps and features.
Preferably, the inventive method is suitable for determining a spatial relationship (in particular at least one of position and orientation) between a marker device and a resection plane, in particular it is suitable to determine at least one of position and orientation of the marker device relative to the resection plane and/or to determine at least one of position and orientation of the resection plane relative to the marker device. The resection plane is preferably associated with an anatomical structure of a patient's body. The anatomical structure may be any anatomical structure, i.e. it may be an anatomical structure comprising both hard and soft tissue. Preferably, however, the anatomical structure comprises hard tissue and is in particular a bony structure. According to two preferred embodiments, the anatomical structure is a tibia or a femur. The resection plane is associated with the anatomical structure in the sense that it is envisaged that the resection plane shall be generated in the anatomical structure. However, it is neither an explicit nor an implicit feature which is required to implement the disclosed invention that the resection plane has already been generated when the inventive method is carried out. In particular, the inventive method does not involve or encompass an invasive step which would represent a substantial physical interference to the body requiring professional medical expertise to be carried out and entailing a substantial health risk even when carried out with the required professional care and expertise. In particular, no part of the inventive method involves or encompasses a surgical step, and in particular the inventive method does not involve or encompass a step of treating a human or animal body using surgery or therapy. Rather, the invention is directed to in particular data processing. For at least this reason, no surgical or therapeutic activity (in particular no surgical or therapeutic step) is necessitated or implied by carrying out the invention.
The marker device preferably is video-detectable for detection by an imaging unit. The imaging unit preferably is an imaging unit operating in the visible wavelength spectrum, in particular the imaging unit is a camera, more particularly a digital camera, advantageously the digital camera of a handheld mobile device such as a mobile phone or a personal digital assistant. Preferably, the imaging unit is a video camera which is combined with a display unit in a single device. The display unit is in particular a monitor (in particular an LCD monitor) of the mobile device to which the video camera belongs. The display unit and the imaging unit are preferably disposed in a common housing. The marker device being video-detectable means in particular that the marker device is visible in the visible wavelength spectrum so that it can be detected (in particular imaged) by an imaging unit operating in that wavelength range. Advantageously, the marker device is two-dimensional and allows determining its distance and orientation from and to, respectively, the imaging unit based on analysing its image appearance in an image taken by the imaging unit. For example, the marker device is a planar marker device comprising a plurality of graphical markers, in particular graphical patterns (also called graphical marker patterns). These patterns preferably have a predetermined geometry which is in particular known to the inventive method such that, on the basis of analysing (in particular segmenting) an image of the marker device taken by the imaging unit allows to determine the spatial relationship between the marker device and the imaging unit can be determined.
Preferably, image unit position data is acquired which describes a predetermined spatial relationship between the imaging unit and the resection plane. In particular, this predetermined spatial relationship has been established beforehand. The predetermined spatial relationship is at least one of position and orientation of the imaging unit relative to the resection plane. For example, the imaging unit is fastened to a medical device or the anatomical structure at a position which has a known spatial relationship relative to the position of the resection plane. As an example, the imaging unit is fastened to a medical device which is a cutting block for cutting the proximal end of the tibia or the distal end of the femur, respectively, which has been fastened to the anatomical structure. The cutting block comprises a slot for insertion of a cutting device (e.g. a saw). The position and orientation of the slot define the position and orientation of the resection plane. It is notable that it is not necessary to perform any surgical activity in order to fasten the cutting block. Rather, it would suffice to position the cutting block with a known spatial relationship relative to the envisaged resection plane, which may happen for example before the patient is placed ready for operation. Such may be done for example for the framework of pre-operative planning.
Preferably, marker device position data is acquired which describes a spatial relationship between the marker device and the imaging unit. This is done preferably based on (in particular by) imaging the marker device with the imaging unit in order to generate an orientation-dependent image appearance of the marker device. The marker device preferably has a predetermined position which is advantageously fixed and further advantageously represents a fixed spatial relationship relative to the resection plane. This is particularly suitable for determining the longitudinal axis of the tibia. For determining the centre of rotation of a hip joint, the marker device preferably does not have a fixed spatial relationship relative to the resection plane and may be placed away from the anatomical structure, for example on a structure having a fixed spatial relationship in a global coordinate system, for example the marker device may be fastened to an operation table. The predetermined spatial relationship between the imaging unit and the resection plane is preferably established such that the marker device is in the viewing area of the imaging unit in order to enable acquisition of the marker device position data. The spatial relationship between the marker device and the imaging unit is at least one of the position and the orientation of the marker device relative to the imaging unit or vice versa (namely of the imaging unit relative to the marker device). The image appearance of the marker device in an image of the marker device acquired by the imaging unit depends on the spatial relationship, in particular on at least one of the orientation and the position, between the imaging unit and the marker device. One of the objects of the present invention is to determine the orientation of the resection plane, for example in a varus/valgus direction and the anteroposterior direction of the tibia. Another object of the invention is to determine a centre of rotation of the hip joint which is characterized in particular by the range of angles which the femur is able to go through during rotation in the hip joint. In this context, it suffices in particular to have knowledge of the orientation of the marker device relative to the unit (in particular relative to the imaging plane of the imaging unit, which may be defined by the planar extension of an imaging chip used in a digital imaging unit) in order to determine data describing the angles which characterise the orientation of the resection plane relative to the characteristic geometry of the anatomical structure with which it is associated.
The spatial relationship between the resection plane and the marker device, in particular the orientation of the resection plane relative to the marker device and/or the orientation of the marker device relative to the resection plane, is described in particular by resection plane data which is determined preferably based on the imaging unit position data and the marker device position data as well as based on the orientation-dependent image of the marker device. In particular, information about the video-detectable geometry of the marker device is predetermined and known to the inventive method. Analysis of the image of the marker device taken by the imaging unit (for example by a known image segmentation algorithm) may serve to determine the orientation of the marker device relative to the imaging unit on the basis of that image. Thereby, the angular relationship between the resection plane and the marker device can be determined, since the spatial relationship between the imaging unit and the resection plane is predetermined. For example, the predetermined spatial relationship is established by establishing a mechanical contact between contact of a surface of an adapter and the cutting block, wherein the adapter is fastened to the imaging unit in a fixed and known (in particular predetermined) spatial relationship and wherein the surface is for example planar and is inserted into the slot of a cutting block which defines the resection plane. The cutting block preferably has a predetermined spatial relationship relative to the anatomical structure and is in particular attached to the anatomical structure so as to define the position of and orientation of the resection plane relative to the anatomical structure.
The spatial relationship between the resection plane and the marker device may additionally to the orientation also describe the position of the resection plane relative to the marker device (and/or the position of the marker device relative to the resection plane). Based on information about this position, resection height data describing a resection height associated with the resection plane is preferably determined. The resection height describes the distance from the marker device (and/or the tip of a pointer having a known spatial relationship relative to the marker device) to the resection plane. For example, the resection height describes the longitudinal extension (i.e. the thickness) of the bone part which is to be resected from the proximal end of the tibia or the distal end of the femur, respectively. In particular, the marker device is placed with a predetermined (in particular known) spatial relationship (in particular position) relative to an anatomical land mark such as the ankle of the leg on the body side of the leg with which the resection plane is associated. The positions of two landmarks can be determined for example by identifying the left and right malleoli of the respective tibia and fibula. The spatial relationship between the ankle and for example the natural proximal end of the tibia can be determined from for example medical image data of the tibia which was acquired beforehand for example by x-ray or computer tomography imaging. For example, a marker device is placed (with a predetermined (in particular known) spatial relationship in the cutting slot of a cutting block placed in a predetermined position relative to the tibia (such that the position and orientation of the cutting slot defines the desired position and orientation of the resection place on the tibia), and a pointer to which the imaging unit is fastened in a predetermined (in particular known) and preferably fixed spatial relationship is placed on a point on the proximal surface of the tibia while the imaging unit detects the marker device. From the resulting image, the distance between the position of the marker device (and therefore the cutting slot which represents the resection plane) and the marker device and/or the pointer tip can be determined. This distance equals the resection height.
According to a preferred embodiment, the anatomical structure is a tibia and the resection height data (in particular the value of the resection height) is determined by identifying the position of a point on the proximal surface of the tibia with a pointer tool while imaging it with the imaging unit. In that case, the pointer tool is preferably provided with a video-detectable marker device such as the one described above. According to another preferred embodiment, the anatomical structure is a femur and the resection height data is determined by identifying the position of a point on the distal surface of the femur. In particular, of the pointer tool has a predetermined and in particular known spatial relationship relative to the imaging unit. For example, the pointer tool is attached to the imaging unit.
According to a preferred embodiment of the invention, the marker device is placed on the patient's ankle on the body side with which the body plane is associated, for example in case the tibia is a right tibia, the marker device is placed on the patient's right ankle. Preferably, the marker device is provided with a fastening mechanism such as a clip mechanism or a strap mechanism which allows placing the marker device in a predetermined spatial relationship relative to the landmarks such as the malleoli. Detection of the marker device by the imaging unit and correspondingly determining its position then allows determining the position of the landmarks. For example, a pointer tool fixedly fastened to the imaging unit is placed in a known spatial relationship relative to a resection plane at the proximal tibia end while the imaging unit images the marker device placed on the ankle.
Preferably, the resection plane data is determined as soon as the marker device is in the viewing area of the imaging unit. In particular, a computer which is operatively coupled to the imaging unit and executes an image analysis algorithm for analysing images taken by the imaging unit is provided with predetermined information about the possible appearance of the marker device and on this basis continuously checks whether the marker device is being imaged or not. If it is detected that the marker device is being imaged, the computer executes the steps required to determine the resection plane data.
Preferably, the anatomical structure is a tibia and resection plane angular data is determined which describes at least one of a varus/valgus angle and a flexion angle of the resection plane relative to in particular the longitudinal axis and the anteroposterior axis of the tibia. The resection plane angular data is determined based preferably on the resection plane data (in particular on the orientation of the resection plane relative to the marker device) and further based on the following:
The above-mentioned three types of data describing positions of specific points (or axes) on the tibia may be determined for example from medical image data in particular relative to the position of an easily identifiable landmarks such as the malleoli. Alternatively, the data describing the position of the proximal end-point of the proximodistal axis of the tibia is acquired by identifying the position of the proximal end point of the proximodistal axis of the tibia with a pointer tool, wherein the spatial relationship between the pointer tool and the imaging unit is preferably predetermined, in particular known to the inventive method. For example, the imaging unit is attached to a pointer tool which is provided with a planar abutment piece which is designed to be flush with a resection plane when placed onto the resection plane. In particular, the spatial relationship between the planar abutment piece and the imaging unit is predetermined, in particular known, and preferably such that it is possible to place the planar abutment piece on the resection plane while imaging the marker device with the imaging unit.
According to another preferred embodiment, the anatomical structure is a femur and resection plane angular data is determined which describes at least one of a varus/valgus angle and a flexion angle of the resection plane relative to in particular the longitudinal (i.e. proximodistal) femur axis and the anteroposterior plane of the femur. In this case, the resection plane angular data is determined based on the resection plane position data, in particular based on the orientation of the resection plane relative to the marker device, and based on the following:
In this embodiment, the marker device is preferably based in a fixed position which is not located on the patient's body, for example it is positioned at a fixed position in a global coordinate system which serves to determine positional information in the framework of the inventive method. For example, the marker device is attached to the operating table. A predetermined and fixed spatial relationship between the imaging unit and the femur is established, for example by inserting an adapter to which the imaging unit is attached into a cutting block having a predetermined and fixed spatial relationship relative to the femur (in particular relative to the position of the resection plane on the femur), and the femur is brought into at least preferably four different positions while imaging the marker device with the imaging unit in order to determine the spatial relationship between the position of the femur relative to the marker device in each of these at least four positions. On this basis, a rotational profile of the femur is acquired and the centre of rotation of the femoral head in the hip joint is determined. The data describing the position of the distal end point of the mechanical, in particular proximodistal and/or longitudinal, femur axis and the data describing the orientation of the anteroposterior axis of the femur is acquired preferably from medical image information. Alternatively, the data describing the position of the distal end point of the mechanical, in particular proximodistal and/or longitudinal, femur axis is acquired by identifying the distal end point of the mechanical, in particular proximodistal and/or longitudinal, femur axis with the pointer tool, for example the aforementioned planar abutment piece fastened to the imaging unit, while imaging the marker device with the imaging unit.
The invention also relates to an apparatus comprising the aforementioned imaging unit for imaging the marker device, a display unit for displaying an image of a marker device acquired with the imaging unit, and a computer which is configured to execute a program which, when running on the computer, causes a computer to perform the method steps as described above. The imaging unit and the display unit are operatively connected to the computer.
The invention also relates to a program which, when running on a computer or when loaded onto a computer, causes the computer to perform one or more or all of the method steps described herein and/or to a program storage medium on which the program is stored (in particular in a non-transitory form) and/or to a computer on which the program is running or into the memory of which the program is loaded and/or to a signal wave, in particular a digital signal wave, carrying information which represents the program, in particular the aforementioned program, which in particular comprises code means which are adapted to perform any or all of the method steps described herein.
In the following, definitions of specific terminology are disclosed which also form part of the present disclosure.
Within the framework of the invention, computer program elements can be embodied by hardware and/or software (this includes firmware, resident software, micro-code, etc.). Within the framework of the invention, computer program elements can take the form of a computer program product which can be embodied by a computer-usable, in particular computer-readable data storage medium comprising computer-usable, in particular computer-readable program instructions, “code” or a “computer program” embodied in said data storage medium for use on or in connection with the instruction-executing system. Such a system can be a computer; a computer can be a data processing device comprising means for executing the computer program elements and/or the program in accordance with the invention, in particular a data processing device comprising a digital processor (central processing unit or CPU) which executes the computer program elements, and optionally a volatile memory (in particular a random access memory or RAM) for storing data used for and/or produced by executing the computer program elements. Within the framework of the present invention, a computer-usable, in particular computer-readable data storage medium can be any data storage medium which can include, store, communicate, propagate or transport the program for use on or in connection with the instruction-executing system, apparatus or device. The computer-usable, in particular computer-readable data storage medium can for example be, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system, apparatus or device or a medium of propagation such as for example the Internet. The computer-usable or computer-readable data storage medium could even for example be paper or another suitable medium onto which the program is printed, since the program could be electronically captured, for example by optically scanning the paper or other suitable medium, and then compiled, interpreted or otherwise processed in a suitable manner. The data storage medium is preferably a non-volatile data storage medium. The computer program product and any software and/or hardware described here form the various means for performing the functions of the invention in the example embodiments. The computer and/or data processing device can in particular include a guidance information device which includes means for outputting guidance information. The guidance information can be outputted, for example to a user, visually by a visual indicating means (for example, a monitor and/or a lamp) and/or acoustically by an acoustic indicating means (for example, a loudspeaker and/or a digital speech output device) and/or tactilely by a tactile indicating means (for example, a vibrating element or a vibration element incorporated into an instrument). A computer herein is a technical computer which comprises in particular technical, in particular tangible components, in particular mechanical and/or electronic components. Any device mentioned herein is a technical, in particular tangible device.
A landmark is a defined element of an anatomical body part which is always identical or recurs with a high degree of similarity in the same anatomical body part of multiple patients. Typical landmarks are for example the epicondyles of a femoral bone or the tips of the transverse processes and/or dorsal process of a vertebra. The points (main points or auxiliary points) can represent such landmarks. A landmark which lies on (in particular on the surface of) a characteristic anatomical structure of the body part can also represent said structure. The landmark can represent the anatomical structure as a whole or only a point or part of it. A landmark can also for example lie on the anatomical structure, which is in particular a prominent structure. An example of such an anatomical structure is the posterior aspect of the iliac crest. Another example of a landmark is one defined by the rim of the acetabulum, for instance by the centre of said rim. In another example, a landmark represents the bottom or deepest point of an acetabulum, which is derived from a multitude of detection points. Thus, one landmark can in particular represent a multitude of detection points. As mentioned above, a landmark can represent an anatomical characteristic which is defined on the basis of a characteristic structure of the body part. Additionally, a landmark can also represent an anatomical characteristic defined by a relative movement of two body parts, such as the rotational centre of the femur when moved relative to the acetabulum.
The method in accordance with the invention is in particular a data processing method. The data processing method is preferably performed using technical means, in particular a computer. The data processing method is preferably constituted to be executed by or on a computer, in particular it is executed by or on the computer. In particular, all the steps or merely some of the steps (i.e. less than the total number of steps) of the method in accordance with the invention can be executed by a computer. The computer in particular comprises a processor and a memory in order to process the data, in particular electronically and/or optically. The calculating steps described are in particular performed by a computer. Determining steps or calculating steps are in particular steps of determining data within the framework of the technical data processing method, in particular within the framework of a program. A computer is in particular any kind of data processing device, in particular electronic data processing device. A computer can be a device which is generally thought of as such, for example desktop PCs, notebooks, netbooks, etc., but can also be any programmable apparatus, such as for example a mobile phone or an embedded processor. A computer can in particular comprise a system (network) of “sub-computers”, wherein each sub-computer represents a computer in its own right. The term “computer” includes a cloud computer, in particular a cloud server. The term “cloud computer” includes a cloud computer system which in particular comprises a system of at least one cloud computer and in particular a plurality of operatively interconnected cloud computers such as a server farm. Such a cloud computer is preferably connected to a wide area network such as the world wide web (WWW) and located in a so-called cloud of computers which are all connected to the world wide web. Such an infrastructure is used for “cloud computing”, which describes computation, software, data access and storage services which do not require the end user to know the physical location and/or configuration of the computer delivering a specific service. In particular, the term “cloud” is used in this respect as a metaphor for the Internet (world wide web). In particular, the cloud provides computing infrastructure as a service (IaaS). The cloud computer can function as a virtual host for an operating system and/or data processing application which is used to execute the method of the invention. The cloud computer is for example an elastic compute cloud (EC2) as provided by Amazon Web Services™. A computer in particular comprises interfaces in order to receive or output data and/or perform an analogue-to-digital conversion. The data are in particular data which represent physical properties and/or are generated from technical signals. The technical signals are in particular generated by means of (technical) detection devices (such as for example devices for detecting marker devices) and/or (technical) analytical devices (such as for example devices for performing imaging methods), wherein the technical signals are in particular electrical or optical signals. The technical signals in particular represent the data received or outputted by the computer. The computer is preferably operatively coupled to a display device which allows to display information outputted by the computer e.g. to a user. An example of a display device is an augmented reality device (also called augmented reality glasses) which may be used as goggles for navigating. A specific example of such augmented reality glasses is Google Glass (trademark of Google Inc.). An augmented reality device may be used to both input information into the computer by user interaction and to display information outputted by that computer.
The expression “acquiring data” in particular encompasses (within the framework of a data processing method) the scenario in which the data are determined by the data processing method or program. Determining data in particular encompasses measuring physical quantities and transforming the measured values into data, in particular digital data, and/or computing the data by means of a computer and in particular within the framework of the method in accordance with the invention. The meaning of “acquiring data” also in particular encompasses the scenario in which the data are received or retrieved by the data processing method or program, for example from another program, a previous method step or a data storage medium, in particular for further processing by the data processing method or program. The expression “acquiring data” can therefore also for example mean waiting to receive data and/or receiving the data. The received data can for example be inputted via an interface. The expression “acquiring data” can also mean that the data processing method or program performs steps in order to (actively) receive or retrieve the data from a data source, for instance a data storage medium (such as for example a ROM, RAM, database, hard drive, etc.), or via the interface (for instance, from another computer or a network). The data can be made “ready for use” by performing an additional step before the acquiring step. In accordance with this additional step, the data are generated in order to be acquired. The data are in particular detected or captured (for example by an analytical device). Alternatively or additionally, the data are inputted in accordance with the additional step, for instance via interfaces. The data generated can in particular be inputted (for instance into the computer). In accordance with the additional step (which precedes the acquiring step), the data can also be provided by performing the additional step of storing the data in a data storage medium (such as for example a ROM, RAM, CD and/or hard drive), such that they are ready for use within the framework of the method or program in accordance with the invention. The step of “acquiring data” can therefore also involve commanding a device to obtain and/or provide the data to be acquired. In particular, the acquiring step does not involve an invasive step which would represent a substantial physical interference with the body, requiring professional medical expertise to be carried out and entailing a substantial health risk even when carried out with the required professional care and expertise. In particular, the step of acquiring data, in particular determining data, does not involve a surgical step and in particular does not involve a step of treating a human or animal body using surgery or therapy. In order to distinguish the different data used by the present method, the data are denoted (i.e. referred to) as “XY data” and the like and are defined in terms of the information which they describe, which is then preferably referred to as “XY information” and the like.
In the following, the invention is described with reference to the Figures, wherein the invention shall not be limited only to the features described with reference to and shown in the Figures.
In
| Number | Date | Country | Kind |
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| WO2015/022022 | 2/19/2015 | WO | A |
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