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    • 专利摘要:
    The present invention relates to methods for validating the correct position of a patient-specific device on a selected anatomy of the human body, as well as to such patient-specific devices. More specifically, the devices include mounting means, which allows alignment of the patient-specific device with one or more predetermined patient-specific landmarks.
    公开号:BE1021547B1
    申请号:E2012/0316
    申请日:2012-05-11
    公开日:2015-12-11
    发明作者:Karim Chellaoui
    申请人:Materialise N.V.；
    IPC主号:
    专利说明:

    METHODS AND DEVICES FOR VALIDATING THE POSITION OF
    PATIENT-SPECIFIC DEVICES
    FIELD OF THE INVENTION
    The invention relates to devices and methods for validating the correct position of a patient-specific device on a selected anatomy of the human body, as well as to patient-specific devices comprising such devices.
    BACKGROUND OF THE INVENTION
    Conventional orthopedic implants such as knee and hip implant systems have been in use with great success for many years. Moreover, the use of custom-designed implant components based on patient-specific anatomy has overcome many shortcomings of the older models. Such patient-specific devices can be developed using commercially available software. Such devices are usually used for orthopedic procedures on the spine, hip, knee and / or radius. Patient-specific devices that are available on the market include patient-specific knee prostheses, patient-specific femur and tibial cutting blocks, distal radius drilling and cutting templates. While patient-specific guides are now typically used to accurately place pins, guide bone-cutting, or place implants during orthopedic procedures, the correct positioning of these patient-specific devices remains a crucial factor with a significant impact on the result of the procedure.
    Patient-specific devices are made according to a pre-operative plan formed from an MRI or CT scan of the patient and rely for the correct position on the matching of an anatomical element. Typically, they contain at least one surface that specifically fits the surface of the bone. They further contain one or more functional elements such as cylinders that determine the orientation of a drill or pin in the correct predetermined position in the bone.
    Although finding the correct position of the patient-specific devices seems straightforward since the operator only needs to determine the correct patient-specific assembly, it was often observed that minor deviations from the perfect assembly will not be observed by the operator. There are many causes for this, one of the most important being the presence of soft tissue that was not completely removed from the bone. The actual placement of the patient-specific device in the correct position is therefore not always so straightforward for the operator, leading to an uncertainty for the operator and the possible improper placement of the patient-specific device, resulting in deviations from the surgical planning. Since the best orthopedic results are achieved when the procedure is performed under the best conditions, ie including not only the device that is positioned correctly, but also the operator who is assured of the correct position of the patient-specific device, There is a need in the art for devices that make it possible to ensure that a patient-specific device is positioned correctly.
    The present invention is directed to providing methods and devices that make it possible to ensure the correct position of a patient-specific device, without a large additional burden on the operator during the operation.
    SUMMARY OF THE INVENTION
    The present invention relates to methods and devices for validating the correct position of a patient-specific device on a selected anatomy of the human body. More particularly, the invention relates to improved patient-specific devices that, in addition to at least one patient-specific element, further comprise a mounting means that allows the alignment of the patient-specific device with the line of sight of the user or with the direction in which the image is taken by a medical imaging device, and then allows alignment of the device with one or more predetermined patient-specific landmarks. When the patient-specific device is mounted on the bone in the correct position, the alignment of the mounting means with the user's line of sight or with the medical imaging device must ensure the alignment of the mounting means with predetermined patient-specific landmarks, to the operator to ensure that the patient-specific device was correctly positioned. Incorrect assembly will therefore lead to an assembly means that is not aligned with the predetermined patient-specific landmarks when the assembly means is aligned with the imaging device and / or with the user's line of sight.
    The present invention relates to methods for validating the correct position of a patient-specific device on a selected anatomy of the human body, the method comprising the steps of: - positioning said patient-specific device on said selected anatomy of the human body, wherein the patient-specific device comprises; (a) a patient-specific surface complementary to at least a portion of the body or bone structure of said patient, and; (b) a mounting means comprising supporting means for connecting said mounting means to said patient-specific device and: (i) at least one functional alignment element, for correct alignment of said device with a line of sight of the user or with a medical imaging device, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position; - aligning said functional alignment element with the user's line of sight or with a medical imaging device wherein said device is held in said position on said selected anatomy, and - checking whether said one or more patient-specific orientation elements are aligned with said predetermined patient-specific landmark on said selected anatomy, thereby validating the correct position of a patient-specific device on a selected anatomy of the human body.
    More specifically, methods are provided wherein one or more of said predetermined patient-specific landmarks on said selected anatomy is an edge, a cavity, a convexity, a peak, or a lump on the periphery of a bone.
    More specifically, methods are provided wherein at least one of said patient-specific orientation elements is elongated and, if correctly positioned, is aligned with a specific point on a patient-specific landmark.
    More specifically, methods are provided in which at least one of said patient-specific orientation elements, when the device has been correctly positioned, is aligned with a portion of the contour of said selected anatomy (such as a bone) or a portion or element thereof.
    More specifically, methods are provided in which at least one of said patient-specific orientation elements, when the device has been correctly positioned, is aligned with an axis parallel to or perpendicular to said selected anatomy.
    More in particular, methods are provided wherein the step of aligning said functional alignment element with the user's line of sight and / or with a medical imaging device comprises the alignment of the direction of the image and / or the viewing direction of said alignment element.
    More specifically, methods are provided wherein the step of checking whether said patient-specific orientation element is aligned with said predetermined patient-specific landmark is performed by imaging using a radiographic scan and / or an ultrasound.
    The present invention also relates to patient-specific surgical, therapeutic or diagnostic devices, comprising a patient-specific surface, wherein said patient-specific surface is complementary to at least a portion of a patient's body or bone structure, and further comprising a mounting means for ensuring the correct mounting of said device on the selected anatomy of the human body, ie checking whether the device is placed in the correct, ie desired, position. More particularly, said mounting means comprises supporting means for connecting said mounting means to said patient-specific device and (i) at least one functional alignment element, for correctly aligning said device with the user's line of sight and / or with a medical device imaging device when the device is placed on the bone, and (ii) one or more orientation elements that, when said device is in said correct position, are aligned with one or more predetermined patient-specific landmarks on said selected anatomy.
    More specifically, patient-specific devices are provided wherein said mounting means is an integrated part of said patient-specific device. in specific embodiments, patient-specific devices are provided wherein said mounting means is removable from said patient-specific device.
    More specifically, patient-specific devices are provided wherein said patient-specific orientation element (s) and / or said functional alignment element are laser-generating devices that are positioned such that the generated laser beam can be used for correctly aligning said device with the user's line of sight or with a medical imaging device and / or aligned with said patient-specific landmark (s).
    More specifically, patient-specific devices are provided wherein said patient-specific orientation element (s) and / or said functional alignment element are made at least partially from a radiopaque material.
    More specifically, patient-specific devices are provided, further comprising means such as tunnels, loops, slots or dents for providing additional functionalities on said device.
    The present invention also relates to methods for manufacturing the patient-specific device comprising an assembly means according to the invention. More specifically, said methods comprise the following steps of: - obtaining patient-specific information about the selected anatomy of the human body on which the patient-specific device is to be placed; - the use of said patient-specific information for designing said patient-specific device such that said device is provided with: (a) a patient-specific surface that is complementary to at least a part of the body or bone structure of said patient , and; (b) a patient-specific mounting means comprising supporting means for connecting to said patient-specific device and (i) at least one functional alignment element, for correctly aligning said device with the user's line of sight and / or with a medical device imaging device, when placed on the selected anatomy, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position is; wherein the position of said orientation elements with respect to said functional alignment element is patient-specific; and - manufacturing said patient-specific device.
    More particularly, production methods are provided wherein the step of obtaining patient-specific information comprises performing a radiographic scan, an MRI scan and / or a CT scan.
    More in particular, production methods are provided wherein said production step is carried out by additive production.
    These and other aspects and embodiments are described in the following paragraphs and in the claims.
    BRIEF DESCRIPTION OF THE FIGURES
    Figure 1 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 2 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 3 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 4 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 5 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 6 shows a patient-specific device according to a specific embodiment of the present invention.
    Figure 7 shows a patient-specific device according to a specific embodiment of the present invention.
    List of reference numbers used in the Figures: (1) Anatomical part; (2) Patient-specific device; (3) Mounting means; (4) Patient-specific orientation elements; (5) Functional alignment element; (6) Pre-identified landmarks (7) Pointer holders; (8) Specific contour patient-specific orientation element; (9) Specific annular patient-specific orientation element; (10) Specific patient-specific orientation element.
    Each of these illustrations represents certain embodiments of the elements involved and the associated elements are not to be construed as being limited to this specific embodiment.
    DETAILED DESCRIPTION OF THE INVENTION
    Before describing the current method and devices used in the invention, it is to be understood that this invention is not limited to certain methods, components or devices described, since such methods, components and devices may, of course, vary. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the present invention is limited only by the appended claims.
    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is generally understood by one skilled in the art to which this invention belongs. Although all methods and materials that are the same or equivalent to those described herein can be used in practice or in testing the present invention, the preferred methods and materials are now described.
    As used herein, the singular forms "a," "an," and "the" include both the singular and plural unless the context clearly dictates otherwise.
    The terms "comprising", "comprising", and "includes" as used herein are synonymous with "inclusive," containing "," containing "and" contains ", and are inclusive or open-ended and include additional, non-named members, elements, or process steps. The terms comprising "," comprising ", and" includes "also include the term" consisting of ".
    Naming numeric ranges by endpoints includes all numbers and fractions housed within the respective ranges, as well as the recited endpoints.
    The term "about" as used herein when referring to a measurable value, such as a parameter, an amount, a duration, and the like, is intended to include variations of +/- 10% or less, preferably +/- 5% or less, more preferably +/- 1% or less, and even more preferably +/- 0.1% or less of the stated value, as far as such variations may exist within the described invention. It is to be understood that the value to which the term "approximately" refers is itself specific, and is preferably mentioned.
    All documents mentioned in the current description are hereby incorporated by reference in their entirety.
    Unless otherwise specified, all terms used in the disclosure of the invention, including technical and scientific terms, have the meaning as generally understood by one skilled in the art to which this invention belongs. Through further guidance, the definitions were included for the terms used in the description to better appreciate the teachings of the present invention.
    A reference throughout this description to "one embodiment" or "an embodiment" means that a particular element, structure, or feature described in connection with the embodiment is included in at least one embodiment of the present invention. For example, the sentences "in one embodiment" or "in an embodiment" at different places in this description do not necessarily all refer to the same embodiment, but they can do so. In addition, the specific features, structures or properties can be combined in any suitable manner, as will be apparent from this disclosure to one skilled in the art, in one or more embodiments. In addition, although some embodiments described herein include a number of features, but not others included in other embodiments, combinations of features of the different embodiments are intended to fall within the scope of the invention, and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.
    The present invention relates to methods and devices for validating the correct position of a patient-specific device, such as an implant or conductor, on a selected anatomy of the human body. More particularly, the invention relates to improved patient-specific devices, such as an implant or conductor, which in addition to at least one patient-specific element, further comprise a mounting means which, after the device has been placed on the chosen anatomy, on the one hand allows the alignment of the patient-specific device with the line of sight of the user and / or with a medical imaging device, and secondly allows the alignment of the device with one or more predetermined patient-specific landmarks. When the patient-specific device, such as an implant or conductor, is mounted on the bone in the correct position, the alignment of the mounting means must be with the user's line of sight or with the medical imaging device (maintaining its position on the bone) ensuring alignment of the mounting means with predetermined patient-specific landmarks, so that the operator can be assured that the patient-specific device is positioned in the correct (ie pre-operatively determined) manner. Incorrect assembly will therefore result in a mounting means that is not aligned with the predetermined patient-specific landmarks when the mounting means is aligned with the user's line of sight and / or the imaging device.
    As used herein, the term "patient-specific device" refers to any surgical, therapeutic, or diagnostic device or device such as an implant or conductor that is designed based on a patient's individual anatomy to include features that include a have custom editing or perform a custom function for a specific location in a specific patient. The use of patient-specific guides and implants makes it possible to guarantee a better or optimized surgical procedure accuracy and an improved anatomical fitting for prosthetic structures, to ensure an optimized functionality for each patient. Even if such devices are used in combination with standard implants, devices, devices, surgical procedures and / or other methods, important advantages in placement accuracy can be obtained. It should further be noted that while the teachings of the present invention are primarily directed to the use of the invention with adapted implants or limb bone guides, the present invention can also be applied to any type of patient-specific device, such as an implant or conductor , which requires accurate positioning on any type of biological tissue, such as bone, teeth, cartilage and skin. Accordingly, the term "patient-specific device" is used to refer to a customized device specific to the anatomy of the individual patient. Therefore, the device is a device comprising at least one surface adapted to or complementary to at least a portion of the patient's anatomy. The complementary surface is also referred to herein as the "patient-specific element". Devices comprising one or more patient-specific elements are known in the art.
    Accordingly, the patient-specific aspect of the surgical, therapeutic, or diagnostic devices or devices, such as implants or guides, as defined herein, is characterized in that the device contains or includes information obtained by and / or based on anatomical images of the patient. More specifically, the information is patient-related anatomical information. In a particular embodiment, the patient-specific information contained or included in the device is configured by a contact surface to conform to or match the anatomy of the specific patient, and in particular configured to complement a three-dimensional image of the patient surface of the patient's bone (with or without cartilage or other soft tissue). Consequently, the patient-specific information is contained or included in the device by the shape and / or structure of the contact surface.
    The devices according to the invention are characterized in that they are provided with a mounting means. The term "mounting means" as used herein refers to an element placed on the patient-specific device, such as an implant or conductor, or reversibly connected thereto that comprises at least one functional alignment element and one or more patient-specific orientation elements.
    In particular embodiments, one or more mounting means are connected to or positioned on the patient-specific device, such as an implant or conductor. More specifically, two or more mounting means are connected to or positioned on the patient-specific device.
    The functional alignment element or elements are used to ensure the correct position of the patient-specific device, such as an implant or conductor, with respect to the direction in which the image is taken. So this is used to indicate in which position the patient-specific device must be visualized by the user or a medical imaging device to be able to judge the correct position of the device on the patient (based on the matching between the patient-specific orientation elements and the landmarks on intra-operative modality.
    Thus, based on the alignment element (s), the position of the device in relation to the position of the user or the medical imaging device is adjusted so that the user is able to correctly assess whether the patient-specific device, such as an implant or conductor , is placed in the correct position.
    The patient-specific orientation element or elements are used to determine the correct position of the patient-specific device, such as an implant or conductor, relative to the patient. This makes it possible to assess the relationship between the relative position of the device and the identified landmarks on the planning modality and the relative position of the device and the associated landmarks on the intra-operative modality.
    It should be noted that the mounting means can be classified either as a one-piece element placed on the patient-specific device, such as an implant or conductor, with the orientation elements and the functional alignment elements integrated, or as a cluster of individual elements individually placed on the patient-specific device, wherein each of the individual elements can function as patient-specific orientation elements, functional alignment elements or both.
    As used herein, the term "patient-specific landmark" refers to a feature whose presence, size, or shape is specific to the patient's anatomy, and that is recognizable in the imaging modality used to determine surgical planning sets referred to in the description as the "planning modality", as well as in the imaging modality that is used intra-operatively, which is also referred to as the "intra-operative modality."
    The anatomical landmarks contemplated in the context of the present invention can be of any shape and size and can be selected depending on the specific configuration of the patient. Examples of such anatomical landmarks can be, but are not limited to, points, lines, planes, circles, edges, intersections between curves, convexity, cavities ... They must be recognizable by the user in both planning and intra-operative modalities. The selection of the landmarks depends on the intended use and on the characteristics of the imaging modalities used such as depth of the scan, contrast levels, visibility of tissues, distance to the mounting device, etc. A landmark can be any shape that is recognizable on images by the user to allow pattern correlation. These landmarks may be clearly visible (e.g., angular points or lines) or may be derived by the user (e.g., the major axis of an elongated shape, parallel or perpendicular lines). Because the same landmarks may be displayed differently depending on the imaging modality used, a specific landmark must be defined in a specific way when viewed in a particular imaging modality.
    The definition of a landmark depends solely on the ability of the user to identify the landmark in a certain modality. An example of this can be given for bone tissue that can be displayed in white when viewed on a CT scan, but can appear in black on an MRI scan. Planning modalities can be conventional methods of X-ray imaging and processing, X-ray tomosynthesis, ultrasound including A-scan, B-scan, C-scan, computed tomography (CT-scan), magnetic resonance imaging (MRI), optical coherence tomography, single photon emission tomography (SPECT) and positron emission tomography (PET), 3D virtual tissue models generated from these modalities, optical imaging within the field. Intra-operative modalities can be fluoroscopy; infrared, X-rays, optical imaging or any other imaging modality that is compatible with the imaging modality used during planning within the art. However, other imaging techniques that are known in the art are also possible. The planning and the intra-operative modalities do not have to differ from each other. An example of such an anatomical landmark is a corner point visible on the circumference of the end of a radius described in the anatomy literature under the name "styloid process of the radius." That landmark can be identified on a CT scan as a planning modality and on a fluoroscopy scan as an intra-operative modality.
    The mounting means of the devices described herein further comprises supporting means or supporting structures. These supporting structures comprise elements that fit on the patient-specific device, such as an implant or conductor, on which the various elements of the mounting means, i.e. the functional alignment element and / or the patient-specific orientation elements (optionally reversible) can be mounted. The supporting structure with the alignment and / or orientation elements may be either integrated or removable from the patient-specific device. In particular embodiments, the mounting means fit on the guide and the supporting structures include elements that fit reversibly on one or more of the guide cylinder drill cylinders. The mounting means can be used for correct positioning of the conductor and then removed for the actual use of the conductor.
    The orientation and / or alignment elements of the mounting means according to the invention may form part of the device or may be mechanisms used in combination with the device at the location to be checked. An advantage of a system consisting of different parts, i.e. the functions are separate parts that can be mounted in a certain direction, is that it becomes possible to use the same indication / alignment element (s) with different mounting devices. Indeed, in certain embodiments, the orientation and / or alignment elements are removable.
    As indicated above, the mounting means comprises supporting means or structures that are removable and adjustable in certain embodiments, so that the orientation and / or alignment mechanism can be introduced at a specific position and location. In alternative embodiments, the orientation and / or alignment elements (and the associated supporting means) are an integral part of the mounting means. More specifically, they can be produced as one piece in the mounting means. In certain embodiments, the supporting means are cylinders and the orientation and / or alignment element is a (standard) pin to be incorporated therein. In further particular embodiments, the supporting means comprise slots into which a (standard) pointing mechanism is introduced in a unique manner.
    In further particular embodiments, the supporting structure is integrated in the surgical device, so that the orientation and / or alignment mechanism is directly positionable or integratable in the surgical device.
    Various embodiments are within the scope of the invention, as long as the indicator elements can be fixed in the mounting means in a patient-specific orientation to adequately represent the correct relative position of the alignment element and the landmarks.
    It can be clearly seen from the foregoing that the exact shape and size of the alignment and orientation elements are not critical, provided that they can be correctly positioned to display the correct position of the patient-specific device, such as an implant or conductor. to give.
    As explained above, the purpose of the functional alignment element is to place the device in the correct orientation in which positional control can be done. The shape or functionality of the functional alignment element allows the user to accurately determine the correct direction and angle at which the device is visualized, made directly or in the image by an imaging device. The one or more functional alignment elements may be elements visible on the image, but may also be radio-opaque so that when an imaging device is used, the device can be aligned through this element with the light beam of the imaging system. The one or more functional alignment elements can be fixed parts or devices that transmit signals. An example of such a signal-emitting device can be a laser diode. In certain embodiments, the diode is positioned on the device such that only when the device is positioned in the correct alignment with the direction in which the photograph is taken by the imaging device, the laser is displayed as a dot.
    Consequently, the one or more alignment elements can have any shape as long as their orientation can be correlated from the user's perspective with a specific orientation of the device.
    In particular embodiments, the functional alignment elements are elements such as a pin, a cylinder, a cone, or another element with a shape that allows direct visual alignment with the central axis. In particular embodiments, the cylinder or cone is placed directly or integrated on the surgical device. In an alternative embodiment, the functional alignment element is present on a connectable structure which is removably positioned on the surgical device. In further embodiments, the functional alignment element is an element which is connected to the mounting means via an orientation element.
    The patient-specific orientation elements can be any mechanism that, visualized through a certain imaging modality with a certain angle, correlates with the identified landmarks. The term "correlates with" in the context of the orientation elements usually means "coincides with". More specifically, this means that the orientation elements either point to, or have one or more visual aspects that correspond to or can be aligned with the contour or part of the contour of the landmark on the anatomy of interest. Examples of such mechanisms can be, but are not limited to: hands, rays, extensions of the mounting means, or signal-emitting devices. An example of a signal emitting device can be a laser diode that emits a laser beam that is only visible with the aid of an infrared imaging device. The common features between the various intended embodiments are that they can be correlated with the landmarks identified on the planning modality and that they can be mounted on the patient-specific device, such as an implant or conductor, to achieve detection accuracy of the mounting in the magnitude of the resolution of the imaging modalities used. These functions can be radio-opaque so that when a radiographic imaging device is used, subcutaneous anatomical landmarks can also be identified. There are countless ways to correlate, for example, pointer elements and landmarks. In some embodiments, a point defined on the orientation element will superimpose with a landmark identified on the intra-operative modality if the patient-specific device is correctly positioned. In some embodiments, a curve determined by the orientation element will be aligned with a curve of a landmark identified on the intra-operative modality when the patient-specific device is correctly positioned. In some embodiments, a segment on the orientation element has a specific orientation relative to an orientation element on the anatomy. In some embodiments, the orientation element specifically fits the contour line of a bone circumference or a portion of the bone, such as a specific anatomical function on the bone, when the device is placed in the mounting position. It should be noted that this alignment is to be considered as viewed / recorded by the imaging device and therefore refers to a visual alignment or correspondence rather than a physical alignment (although a physical alignment is not excluded).
    In certain embodiments, metal pins are used as orientation elements. The metal pins are connected to the patient-specific device, such as an implant or conductor, and are used as a means for verifying the position of the implant or conductor when scanning with an imaging device such as a fluoroscope. The metal pins are preferably connected to the conductor or implant at 2, 3, 4, 5 or more different points and are positioned with respect to each other and with respect to the implant or conductor at different angles. In particularly preferred forms, the pins are positioned such that when the implant or conductor is aligned with an imaging device, the free ends of the pins coincide visually with a patient-specific orientation element, such as, for example, the extreme point of the radius. Figure 7a shows a special embodiment of such a device, wherein Figures 7b (wrong position) and 7c (correct position) show images of the free ends of the pins taken with a fluoroscope. Preferably, the pins are positioned such that the free ends (visually) coincide with a given point (typically a patient-specific orientation element) and an image perpendicular to the operating or imaging table. In this position a medical image is taken which is used to measure and validate the coincident ends of the metal pins.
    Where the orientation element is a pin, the conductor or implant, or the mounting means for mounting on the conductor or implant, is provided with holes for securing the pins on the implant or conductor.
    In certain embodiments, the mounting means of the present invention may further comprise one or more surfaces that are patient-specific. More specifically, it is intended that the one or more orientation elements can be connected to a carrier (i.e., other than the one used for the patient-specific device), which further ensures their correct position. In certain embodiments, the orientation elements are "hands" and the mounting means includes one or more "pointer holders" that the hands can support and optionally include a (patient-specific) surface. The patient-specific surface can be a surface on the device or on the patient's anatomy. The support structures or pointer holders can be an integral part of the mounting means and can be connected to the orientation elements and / or the functional alignment element. In certain embodiments, the pointer holders are specially designed to fit in the hands of the mounting means (such that they have a specific orientation). In certain embodiments, the pointer holders are separate components that can be placed by the user after the positioning of the patient-specific device of the invention.
    In particular embodiments, the orientation elements and / or the functional alignment elements are the same, in particular one element on the patient-specific device which assumes both the role of the orientation element and the alignment element. This is, for example, the case where the orientation element and the alignment element is a single pin that can be aligned with an imaging device (thereby acting as an alignment element), and wherein the position of the aligned pin corresponds to a predetermined patient-specific element (thereby acting as an orientation element). When the elements have both the role of orientation element and alignment element, two or more orientation elements / alignment elements are typically used. More specifically, the patient-specific device is provided with at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more of these orientation elements and / or alignment elements.
    Accordingly, in one aspect, the invention provides patient-specific surgical, therapeutic, or diagnostic devices, such as implants or guides for surgical devices, that, in addition to comprising a patient-specific surface that is complementary to at least a portion of a selected anatomy of a patient, further comprising mounting means for ensuring correct mounting of said device on the selected anatomy of said patient. More specifically, the mounting means comprises supporting means for connecting the mounting means to the rest of the patient-specific device, such as an implant or conductor, and (i) at least one functional alignment element for correct alignment of said device with the line of sight of the user or with a medical imaging device, and (ii) one or more orientation elements aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position.
    In certain embodiments, the patient-specific devices, such as an implant or conductor, according to the present invention include additional means, such as tunnels, loops, slots, or dents, to provide specific functionalities on said device.
    The functional alignment elements are usually selected from pins, wires, columns, blocks or any other type of geometric elements that allow accurate orientation.
    The orientation elements are usually selected from pointers, pins, arms, hands, wires or any other type of geometric element that allows accurate orientation.
    The devices of the present invention are characterized by the presence of a mounting means. Typically, the orientation elements of the mounting means of the devices of the invention are designed such that one or more of the predetermined patient-specific landmarks on the selected anatomy is an edge, a cavity, a convexity, a peak, or a lump on the circumference of a bone or on a specific anatomical characteristic of the bone.
    In certain embodiments, the mounting means of the devices according to the invention are designed such that at least one of the patient-specific orientation elements is elongated and, when the patient-specific device, such as an implant or conductor, is placed in the correct position, is aligned with a certain point on a patient-specific landmark (in the image of the imaging device).
    In certain embodiments, the mounting means of the devices of the present invention ensure that at least one of said patient-specific orientation elements is aligned with a portion of the contour of a bone of said patient when the device is in the correct position on said chosen anatomy. Alternatively, the patient-specific orientation elements may also be aligned with a portion of the contour of an anatomical element on a bone of said patient.
    In certain embodiments, the mounting means of the devices according to the invention ensure that, when the device is positioned at the correct position of the selected anatomy, at least one of said patient-specific orientation elements is aligned with an axis parallel to or perpendicular to said chosen anatomy.
    In further particular embodiments, the orientation element is a circle or a cylinder that is positioned above or on the patient's anatomical element, so that when the device is correctly positioned on the selected anatomy, the orientation element is positioned exactly in the center of the circle or the cylinder. In further embodiments, the orientation element is connected to a functional alignment element. In particular embodiments, the mounting means comprises different pins as functional alignment elements and the orientation element is a cylinder which can be coupled to the free end of one or more of the pins.
    To correctly position a patient-specific device, such as an implant or conductor, on the affected patient, the surgeon can typically only rely on his visual senses and his sense of checking the correct mounting of the device. The patient-specific devices of the invention only fit correctly in a single position, but some factors can cause the surgeon to be mistaken. The surgeon may be misled into thinking that the device is in the correct mounting position while it is not. This can be caused by, for example, a lack of visibility of the bone and / or the device during placement, a lack of experience of the surgeon, a lack of precision in the mounting surface, etc.
    The present invention allows the user to control the placement of the device using preoperatively identified patient-specific anatomical landmarks. The advantage of this invention is that it offers the user a way to control the correct assembly of the device intraoperatively with a high precision.
    A further aspect of the invention thus relates to a method for validating the correct position of a patient-specific device, more particularly a patient-specific implant or a patient-specific conductor positioned on a selected anatomy of the human body, wherein the patient-specific implant or the patient-specific the guide comprises: (a) a patient-specific surface complementary to at least a portion of the body or bone structure of said patient, and; (b) a mounting means comprising supporting means for connecting said mounting means to said patient-specific implant or said patient-specific conductor and: (i) at least one functional alignment element for optically aligning said implant or conductor, either directly by the user or with a medical imaging device, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device, being implant or conductor, is in said correct position; the method comprising the steps of: - aligning said functional alignment element in the user's line of sight or with a medical imaging device, and - checking whether said one or more patient-specific orientation elements are aligned with said predetermined patient-specific landmark on said selected anatomy, thereby validating the correct position of a patient-specific implant or conductor on a selected anatomy of the human body.
    In particular embodiments, methods are provided for validating the correct position of a patient-specific device, such as an implant or conductor, on a selected anatomy of the human body, the method comprising the steps of: - positioning the patient- specific device on said selected human body anatomy, wherein the patient-specific device comprises; (a) a patient-specific surface complementary to at least a portion of said patient's body or bone structure on said selected anatomy; and; (b) a mounting means, comprising supporting means for connecting to said patient-specific device and (i) at least one functional alignment element, for correct alignment of said device with a line of sight of the user or with a medical imaging device, and ( ii) one or more patient-specific orientation elements that align with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position; - aligning said functional alignment element with the user's line of sight or with a medical imaging device, while maintaining said device in said position on said selected anatomy, and - checking whether said one or more patient-specific orientation elements align with said predetermined patient-specific landmark on said selected anatomy, whereby the correct position of a patient-specific device can be validated on a selected anatomy of the human body.
    Where the patient-specific device, such as an implant or conductor, is correctly positioned (i.e., in the predetermined position) on the selected anatomy, the one or more patient-specific orientation elements will be aligned with the corresponding landmarks. The mounting means can then optionally be removed and the operation continued with the patient-specific device in place. When the orientation elements of the device are not aligned with the corresponding landmarks after alignment of the device (positioned on the chosen anatomy) with the line of sight of the user or the medical imaging device, this implies that the patient-specific device is not fully aligned is positioned in accordance with pre-operative planning. There may be several reasons for this, for example (small) errors in the planning, (small) errors in the manufacture of the patient-specific device, etc. It can then be decided to adjust the position of the device on the bone. However, in certain embodiments, this can lead to rejection of the patient-specific device.
    The direction in which the said functional alignment element of the device is aligned after the device is positioned on the patient depends on the type of functional alignment element. The alignment can take place such that the direction in which the image is taken by the device (or the line of sight of the user) is exactly perpendicular to the alignment element (in the same direction). For example, if the alignment element is a pin-like structure, the required alignment may be such that the resulting image of the alignment element by the user or device is a circle (i.e., the pin viewed from above). Or the required alignment may be the positioning of the line of sight or the image of any other angle, for example if the alignment element provides a certain signal at that angle. More particularly in the methods of the present invention, the alignment of said functional alignment element with the user's line of sight or with a medical imaging device includes positioning of said alignment element in parallel with the direction in which the photograph was taken by the device. The alignment can be done either by moving the medical imaging device or the user's line of sight into the correct alignment position or by moving the patient-specific device (and thus also the anatomical part of the patient on which it is positioned) into the correct alignment position.
    Once the device is correctly aligned with the imaging device (or the user's viewing direction) using the alignment elements, it is possible for the user to check the correct position of the device on the anatomical part based on the orientation elements. Provided that the device is correctly aligned with the view of the user and / or the imaging device, the orientation features of the mounting means should correspond to the orientation points on the anatomical part. In specific embodiments, this means that the orientation elements are aligned with (e.g., directly directed at or parallel to) the corresponding orientation element. Where the orientation elements do not correspond to the corresponding landmarks, this means that the device is not fully positioned correctly on the anatomical part.
    In particular embodiments of the methods of the present invention, the step of checking whether one or more patient-specific orientation element (s) are aligned with said predetermined patient-specific orientation element (s) is performed by imaging said device with the aid of a radiographic scan and / or an ultrasound at a certain angle determined by the said alignment element.
    In the devices of the invention, such as an implant or conductor, the patient-specific mounting means, including a functional alignment element and a patient-specific orientation element, is designed and placed on the patient-specific device based on patient-specific information that was obtained before the operation.
    A further aspect of the invention provides a method for developing a patient-specific device, such as an implant or conductor, comprising a mounting means, said method comprising the steps of: - optionally obtaining patient-specific information about the selected anatomy of the human body on which the patient-specific device is to be placed; - the use of said patient-specific information for designing said patient-specific device such that said device is provided with: (a) a patient-specific surface that is complementary to at least a part of the body or bone structure of said patient , and; (b) a patient-specific mounting means comprising supporting means, such as a means for connecting said mounting means to said patient-specific device and: (i) at least one functional alignment element, for aligning said device with the line of sight of the user and / or with a medical imaging device, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific orientation elements on said selected anatomy when said device is in said correct position; wherein the position of said orientation elements with respect to the functional alignment element is patient-specific.
    In particular embodiments, these methods include the step of - manufacturing said patient-specific device.
    In certain embodiments of the method as described herein, the step of obtaining patient-specific information includes performing a radiographic scan, an MRI scan, and / or a CT scan.
    The step of obtaining patient-specific information about the selected anatomy of the human body generally involves identifying landmarks that can be used to determine the correct position of the device. This implies that an orientation element can be designed on the basis of this, which guarantees that when the orientation element and the landmark correspond, the device is correctly positioned.
    In certain embodiments of the method, the production step is accomplished by additive production.
    In a further particular embodiment, Additive Production (AP) techniques are used to manufacture the surgical workpieces according to the invention, or parts thereof. AP techniques are particularly useful for manufacturing patient-specific contact surfaces, or producing the surgical workpieces in one piece. For example, the production of patient-specific surgical devices based on medical imaging via AP is described in U.S. Patent No. 5,768,134 (Swaelens et al.). AP can be defined as a group of techniques used to fabricate a tangible model of an object usually using three-dimensional (3-D) computer-aided design (CAD) data of the object. Currently, many Additive Production Techniques are available including Stereolithography, Selective Laser Sintering, Fused Déposition Modeling, foil-based techniques, etc.
    Selective laser sintering uses a strong laser or other targeted heat source to sinter or weld small particles of plastic, metal or ceramic powders into a mass that represents the 3-dimensional object to be formed.
    Fused Déposition Modeling and related techniques use a temporary transition from a solid to a liquid state, usually due to heating. The material is driven through an extrusion nozzle in a controlled manner and deposited at the desired location as described, inter alia, in U.S. Pat. 5,141,680.
    Foil-based techniques attach layers to each other by gluing or photopolymerization or other techniques and cut the article from these layers or polymerize the article. Such a technique is described in US. Patent No. 5,192,539.
    Usually AP techniques start from a digital representation of the 3-D object to be formed. In general, the digital representation is cut into a series of cross-sectional layers that can be superimposed to form the object as a whole. The AP equipment uses this data to build the object on a layer-by-layer basis. The cross-sectional data representing the layer data of the 3-D object can be generated using a computer system and computer-assisted design and fabrication software (CAD / CAM).
    The devices according to the present invention can be made from various materials. Usually only materials that are biocompatible (e.g. USP class V1 compatible) with the animal or human body are eligible. Preferably, the surgical workpiece is formed from a heat-resistant material so that it tolerates high-temperature sterilization. In case selective laser sintering is used as an AP technique, the surgical model can be made from a polyamide such as PA 2200 as supplied by EOS, Munich, Germany or any other material known to be used is with the skilled person. The present invention is illustrated below with reference to some non-limiting examples.
    EXAMPLES
    Example 1
    This example describes a specific, but non-limiting, embodiment of the patient-specific device according to the present invention. As shown in Figure 1a, a patient-specific conductor or implant (2) is provided on an anatomical part (1) of a patient, the radius in the current case. The patient-specific implant or patient-specific guide (2) is provided with a patient-specific surface (not visible) and a mounting means (3) which comprises a functional alignment element (5) and two patient-specific orientation elements (4). According to the present embodiment, the patient-specific orientation elements (4) are made of 2 metal wires of 1.25 mm diameter, inserted into the holes provided for this purpose in the supporting element of the mounting means which are visible on a fluorescence scan. One additional 1.25 mm diameter metal pin is used as a functional alignment element (5) for visual alignment. In the present embodiment, the supporting element comprises three cylinders with tunnels in the center where the pins can be inserted and supported. Although the supporting means are shown here with cylindrical shapes, they can have any shape (block, sphere, etc.) that can hold pins in place with elements such as tunnels, dents, loops, etc.
    The control of the positioning of the patient-specific implant or patient-specific conductor (2) can be performed when the functional alignment element (5) is aligned with the line of sight of the user or the medical imaging unit, such as a fluoroscope. Only in that position is the tip of the metal pin visible to the user.
    When the patient-specific implant or patient-specific guide (2) is aligned and is in the correct position on the bone, the two patient-specific orientation elements (4) are visible on the fluoroscope and cross the contour of the bone on the predetermined landmarks (6), as shown in Figure 1b. In this case the conductor or implant is mounted on a radius, the landmarks are the projection of the radius (dots in Figure 1b).
    Only in that specific position will the patient-specific orientation elements (4) cross the landmarks (6), a problem in the position of the patient-specific implant or the patient-specific conductor (2) will result in a non-correlation of the patient- specific orientation elements (4) with the orientation points, as shown in Figure 1c.
    Example 2
    This example, illustrated by Figures 2a-c, describes a specific, but non-limiting, embodiment of the patient-specific implant or patient-specific conductor according to the present invention. As shown in Figure 2b, a patient-specific conductor or implant (2) is provided on an anatomical part (1) of a patient, i.e., in the present case, the tibia. the patient-specific implant or patient-specific guide (2) is provided with a patient-specific surface (not visible) that fits on the tibia (1).
    The conductor or implant further comprises a mounting means comprising a supporting element (3) and a functional alignment element (5), and two patient-specific orientation elements (4) positioned thereon. According to this embodiment, the patient-specific orientation elements (4) are two pointers that rotate about a central axis, the central axis being the functional alignment element (5).
    The supporting element of the mounting means (3) is removable (see Figure 2a) and can be made of metal, plastic or any other material that is safe to be used in surgery. The material can be radio-opaque or not.
    Once placed in the provided slot on the supporting element of the mounting means (3), the hands (4) are positioned in the pointer holders (7) of the supporting element and the central axis is aligned with the line of sight of the user or with the medical line imaging unit such as a fluoroscope. If the guide or implant is correctly positioned, the protruding ends of the hands will point directly to the predetermined anatomical landmarks (6). Here, the landmarks are the medial and lateral ends of the tibial plateau in the AP plane.
    Example 3
    This example describes a specific, but non-limiting, embodiment of the patient-specific implant or patient-specific conductor according to the present invention. As shown in Figure 3a, a patient-specific guide or implant (2) is provided on an anatomical part (1) of a patient, the tibia in the present case, the patient-specific implant or the patient-specific guide (2) is provided with a patient -specific surface (not visible) and the mounting means comprises an individual functional alignment element (5) and two patient-specific orientation elements (4), which are positioned on and integrated into the patient-specific implant or patient-specific conductor (2). The patient-specific orientation elements (4) according to the illustrated embodiment have sharp pointed ends and are located outside the boundary of the patient-specific implant or the patient-specific guide (2). The functional alignment element (5) comprises a cone with a flattened head. Alignment of the conductor or implant in the line of sight is done by centering the contour of the flat surface relative to the contour of the cone base. In the aligned position, the central axis of the cone corresponds to the line of sight. If the landmarks (6) are not visible during the operation, the hands are made radio-opaque so that they are visible on an intra-operative imaging modality.
    The edge of the ends of the patient-specific orientation elements (4) can be seen as points. When the guide / implant is placed in the correct position and viewed at the defined angle, these orientation elements are optically aligned with the identified anatomical landmarks. In this embodiment, the landmarks (6) are the medial and lateral ends of the tibial plateau in the AP plane. When the conductor or implant is not displayed at the correct angle, the edges of the indicator elements do not coincide with the identifiable anatomical landmarks, as shown in Figure 3b.
    Example 4
    This example describes a specific, but non-limiting, embodiment of the patient-specific implant or patient-specific conductor according to the present invention. As shown in Figure 4a, a patient-specific implant or patient-specific guide (2) is provided from an anatomical part (1) of a patient, in the present case, the femur. The patient-specific implant or patient-specific guide (2) is provided with a patient-specific surface (not visible), a mounting means (3) that has a functional alignment element (5), and patient-specific orientation elements (8, 9.10) includes. Three examples of possible patient-specific orientation elements (8, 9, 10) are provided in the current example. One type of patient-specific orientation element (9) provides a correlation between the anatomical landmark with the spherical shape of the head of the femur and the annular shape of the patient-specific orientation element. Another type of patient-specific orientation element (8) makes it possible to check the correct positioning of the conductor or implant by ensuring that the contours of the patient-specific orientation element visually follow the contour of the bone when the device is the correct position and is well aligned with the line of sight. The third type of patient-specific orientation element (10) correlates with the thickness of the bone. The device is correctly positioned if the two ends of the suspended radius of the pointer element correlate with the contour of the bone. The various orientation elements are positioned on the device by means of a supporting structure.
    Other forms of correlations between the landmarks and the patient-specific orientation elements are also possible. The patient-specific orientation elements may be radio-opaque, depending on the requirements for the procedure.
    Example 5
    This example describes a specific, but non-limiting, embodiment of the patient-specific device according to the present invention. As shown in Figures 5a and 5b, a patient-specific conductor or implant (2) is provided on an anatomical part (1) of a patient. The patient-specific guide or patient-specific implant (2) is provided with a patient-specific surface (not visible), a mounting means (3) which comprises a functional alignment element (5) and a patient-specific orientation element (4). The mounting means (3) is reversibly connected to the conductor / implant (2) through a supporting structure. Figure 5c shows how the patient-specific device is placed on an anatomical part, but not yet in the correct position.
    Validating the position of the patient-specific device (conductor or implant) (2) occurs when the functional alignment element (5) is evaluated with the line of sight of the user or the medical imaging device such as a fluoroscope (Figure 5d). Only the tip of the pin is visible in this position. When the patient-specific device (2) is aligned and in the correct position on the bone, the two patient-specific orientation elements (4) are visible and overlap with predetermined anatomical landmarks.
    Example 6
    This example describes a specific, but non-limiting, embodiment of the patient-specific device which is a conductor that includes cutting slots and guide boreholes. As shown in Figures 6a and 6c, a patient-specific guide (2) is provided on an anatomical part (1) of a patient. The patient-specific conductor (2) is provided with a patient-specific surface (not visible) and a connection structure (integrated in the patient-specific device) comprising holes for positioning various functional alignment elements (5). The position of each functional alignment element (5) also functions as a patient-specific orientation element (4), corresponding to specific points on the contour of the bone.
    Validating the position of the patient-specific guide (2) occurs when the functional alignment elements (5) are aligned with the user's line of sight or the medical imaging device such as a fluoroscope. Figures 6b and 6d show the image through the imaging device corresponding to Figures 6a and 6c, respectively. In the correct aligned position (Figure 6d), only the tips of the alignment elements (5) are visible. When the patient-specific guide (2) is aligned and in the correct position on the bone, the alignment elements (5) act as patient-specific orientation elements (4) which are visible and overlap with predetermined anatomical orientation points.
    Example 7
    This example describes a specific, but non-limiting, embodiment of the patient-specific device which is a conductor that includes a mounting means. As shown in Figure 7, a patient-specific guide (2) is provided on an anatomical part (1) of a patient. The patient-specific guide (2) is provided with a patient-specific surface (not visible). In addition to a functional alignment element (5), the device also comprises three patient-specific orientation elements (4). The patient-specific orientation elements (4) are pins that can be inserted into the patient-specific guide (2). Validating the position of the patient-specific guide (2) occurs when it is aligned with the user's line of sight or the medical imaging device such as a fluoroscope. The correct position is validated when the free ends of the pins visually coincide with the extreme distal point of the radius (indicated by the circle). The pins are positioned such that their free ends coincide at one point in a view perpendicular to the operating or imaging table. Figure 7b (wrong position) and 7c (correct position) show fluoroscopic images of the coincident ends of the pins.
    权利要求:
    Claims (15)
    [1]
    CONCLUSIONS
    A patient-specific surgical, therapeutic or diagnostic device, being an implant or conductor, comprising a patient-specific surface, wherein said patient-specific surface is complementary to at least a portion of a patient's body or bone structure, and a mounting means for ensuring the correct mounting of said device on the selected anatomy of the human body, wherein said mounting means comprises supporting structures for connecting said mounting means to said patient-specific device and: (i) at least one functional alignment element, for correctly aligning said device with the user's line of sight or with a medical imaging device and (ii) one or more orientation elements aligned with one or more predetermined patient-specific landmarks at said selected anatomy when said device is in said correct position is.
    [2]
    The patient-specific device according to claim 1, wherein said mounting means is an integrated part of said patient-specific direction.
    [3]
    The patient-specific device according to claim 1, wherein said mounting means is removable from said patient-specific device.
    [4]
    A patient-specific device according to any of claims 1 to 3, wherein said patient-specific orientation element (s) and / or said functional alignment element are laser-generating devices that are positioned such that the generated laser beam can be used to correctly align said device with the user's line of sight or with a medical imaging device and / or is aligned with said patient-specific landmark (s).
    [5]
    The patient-specific device according to any of claims 1 to 4, wherein said patient-specific orientation element (s) and / or said functional alignment element are made at least partially from a radiopaque material.
    [6]
    The patient-specific device according to any of claims 1 to 5, further comprising means such as tunnels, loops, slots or dents for providing additional functionalities on said device.
    [7]
    A method of manufacturing a patient-specific device, being an implant or conductor, comprising a mounting means, the method comprising the steps of: - obtaining patient-specific information about the selected anatomy of the human body on which the patient-specific device must be installed; - the use of said patient-specific information for designing said patient-specific device such that said device is provided with: (a) a patient-specific surface that is complementary to at least a part of the body or bone structure of said patient , and; (b) a patient-specific mounting means comprising supporting means for connecting to said patient-specific device and (i) at least one functional alignment element, for correctly aligning said device with the user's line of sight or with a medical imaging device, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position; wherein the position of said orientation elements with respect to said functional alignment element is patient-specific; and - manufacturing said patient-specific device.
    [8]
    The method of claim 7, wherein the step of obtaining patient-specific information comprises performing a radiographic scan, an MRI scan and / or a CT scan.
    [9]
    A method for validating the correct position of a patient-specific device, being an implant or conductor, positioned on a selected anatomy of the human body, the device comprising: (a) a patient-specific surface complementary to at least a part of the body or bone structure of said patient, and; (b) a mounting means comprising supporting means for connecting said mounting means to said patient-specific device and: (i) at least one functional alignment element for optically aligning said device, either directly by the user or with a medical imaging device, and (ii) one or more patient-specific orientation elements, aligned with one or more predetermined patient-specific landmarks on said selected anatomy when said device is in said correct position; the method comprising the steps of; - aligning said functional alignment element in the user's line of sight or with a medical imaging device, and - checking whether said one or more patient-specific orientation elements are aligned with said predetermined patient-specific landmark on said selected anatomy, thereby the correct position of a patient-specific device, being an implant or conductor, is validated on a selected anatomy of the human body.
    [10]
    The method of claim 9, wherein one or more of said predetermined patient-specific landmarks on said selected anatomy is an edge, a cavity, a convexity, a peak, or a lump on the periphery of a bone.
    [11]
    The method of claim 9 or 10, wherein at least one of said patient-specific orientation elements is elongated and aligned with a specific point on a patient-specific landmark.
    [12]
    The method of any one of claims 9 to 11, wherein at least one of said patient-specific orientation elements is aligned with a portion of the contour of a bone or a portion thereof of said patient.
    [13]
    A method according to any of claims 9 to 12, wherein at least one of said patient-specific orientation elements is aligned with an axis parallel to or perpendicular to said selected anatomy.
    [14]
    A method according to any of claims 9 to 13, wherein the step of aligning said functional alignment element comprises alignment of the direction of the alignment element with the direction of the user's line of sight or the direction in which the photograph was taken by the said medical imaging device.
    [15]
    The method of any one of claims 9 to 14, wherein the step of checking whether said patient-specific orientation elements are aligned with said predetermined patient-specific landmark is performed by imaging said device using a radiographic scan and / or an ultrasound.
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    法律状态:
    2018-04-25| FG| Patent granted|Effective date: 20151211 |
    2018-04-25| MM| Lapsed because of non-payment of the annual fee|Effective date: 20170531 |
    优先权:
    申请号 | 申请日 | 专利标题
    EP111658449|2011-05-12|
    EP11165844|2011-05-12|
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