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    • 专利摘要:
    The present invention relates to an adjustable therapeutic, diagnostic, or surgical guide for intraoperative adjustment of a guide element to a pre-planned position. An advantage and innovation of the present invention is that it provides a template or guide that adapts in a controlled manner to an intraoperative anatomical situation that has changed from the standard planned situation. This adjustment can be purely positional, but can also include force feedback.
    公开号:BE1018900A5
    申请号:E2010/0538
    申请日:2010-09-10
    公开日:2011-10-04
    发明作者:Wilfried Vancraen；Ben Geebelen；Roel Wirix-Speetjens；Louis James Keppler
    申请人:Materialise Nv；
    IPC主号:
    专利说明:

    CUSTOMIZABLE THERAPEUTIC, DIAGNOSTIC, OR SURGICAL
    CONDUCTION
    Technical field of the invention
    The present invention relates to a medical, e.g. therapeutic, diagnostic, or surgical guide for invasive medical treatments. More specifically, but not exclusively, it relates to a medical or surgical guide for treatments that are supported or planned with the aid of the computer, in cases where the guide must be adjusted intraoperatively to an area of a patient in which is interested.
    BACKGROUND OF THE INVENTION
    Today, there is an increasing number of surgical procedures where it is advantageous to use specific surgical guides based on medical imaging, as described, for example, in patent applications US-A1-2005 / 0203528 and EP-A1-1.486. 900.
    For this reason, surgical guides are currently being produced that enable unique anatomical positioning that is consistent with a pre-operative surgical plan specific to a particular patient. This plan is based on images of the patient, assuming that the anatomy of the patient has not changed significantly within the period, which can be months, since the recording of the images. If the anatomy of the patient on which the guidance was based changes during this waiting period, the guidance will not fit precisely.
    A second limitation on the use of a static and image-based guide is that the images in certain areas may be unclear. The effect of this is twofold: first, incorrect planning based on unclear anatomical landmarks becomes possible, for example, a cut may be deeper than expected; and second, the resulting guidance may not fit in certain zones. A complete surface agreement is often not possible with the static guide models. Gaps or hinges can be inserted between the patient's guide and anatomy as a result of a non-perfect image segmentation or a change in the patient's anatomy between the time of imaging and that of the actual surgical procedure.
    Surface hinges are very detrimental to the fit of the guide because they limit the remaining surface contact making a unique fit impossible. To compensate for possible hinges, large gaps are deliberately provided over these zones so that most of the surface can still make contact to achieve an accurate fit. However, when less surface contact is available, the probability of an incorrect fit even increases. This incorrect application may give rise to incorrect surgical results since the active elements are in a position that may be different from those that were planned preoperatively.
    Often windows are added to the guide so that the surgeon can perform a check on any gaps along the surface of the guide to check the quality of the fit. This ensures a compromise between the visibility of the fit and the use of a possible locking surface. The more securing surface is used to realize the guidance, the less visibility the surgeon has to check whether or not the fit is correct.
    A third limitation of current surgical guides is that they transmit a surgical plan based solely on the images and intra-operative visual data. With certain interventions, however, there are good reasons to adjust the original plan during the surgical procedure, based on tangible information. The inequality of tension in the ligaments of a joint (for example, "ligament balancing" in knee operations) cannot be visualized in most cases, but it is an element that is taken into consideration by many surgeons.
    The consequence of this is that many surgical procedures are difficult to perform by using a guide, and thus in fact ultimately depend on mental navigation as soon as a difference with the planned anatomy of the patient is detected. For certain medical conditions, adjustable guides have been designed that allow a certain intra-operative variability to adjust the functional reference elements such as guides for boreholes or cutting faces (US-12 / 039,849). These adjustments to preoperative planning must be performed manually by shifting or rotating active elements of the guide in such a way that they are visually aligned with respect to certain anatomical structures or landmarks. It would be possible to define a specific range of likely surgical results based on the maximum rotation, or translation, of the active components. However, the exact point within this range is determined based on visual references and is reached manually. These adjustable guides also present the same risks as static guides in that they can be placed incorrectly on the anatomical surface because they use a static surface contact. If this happens, the surgeon can no longer rely on the preoperative schedule because the reference position is inaccurate.
    The adjustment may therefore be necessary but is problematic for the same reasons as those that influence the use of guides, but also because the position of the patient's body on the operating table may be significantly different from of these at the time when the images were recorded.
    An alternative approach to the problem is to perform a number of surgical procedures that require high accuracy while the patient is being scanned. Theoretically, this provides the best guidance feedback to the surgeon because he can see in real time what he is doing. However, recording images for long periods during an operation also involves a risk to the patient and to the medical staff, for example due to radiation exposure.
    Summary of the invention
    It is the object of the present invention to provide an alternative medical, for example therapeutic, diagnostic, or surgical guide for invasive medical treatments, in particular a medical, for example therapeutic, diagnostic, or surgical guide for treatments supported by a computer and are planned, in cases where the guidance must be adjusted intraoperatively to an area of a patient in which one is interested.
    This object is achieved on the basis of a medical, for example therapeutic, diagnostic, or surgical guiding according to the present invention. An advantage and innovation of the present invention is that it provides a template or guide that is adapted in a controlled manner to a changed intra-operative anatomical situation relative to the standard planned situation. The adjustment can be used to provide feedback to the surgeon regarding the medical situation, intra-operatively or pre-operatively, but can also be used to compensate for production tolerances. This adjustment can be purely positional but can also include a force feedback. Feedback, be it visual or force feedback, that results in an adaptation of a conductive element is also an aspect of the present invention. For example, the feedback may contain information regarding the fit of the guide or the template on a bone (in the case that the guide or the template fits on a bone), or concerning the relative position of two bones or bone fragments (e.g. the tension in the ligaments between a femur and tibia).
    Accordingly, the present invention provides a medical, e.g., therapeutic, diagnostic, or surgical guide with a conductive element that allows intraoperative positioning of the guide or of a conductive element in a pre-planned position, comprising: a first reference element, - at least one contact element which is arranged elastically with respect to the first reference element by using at least one elastic element, the conductive element being connected to the first reference element, and wherein a deformation of the at least one elastic element corresponds to the intra-operative position of the at least one contact element. The position of the elastic element that corresponds to the intra-operative position of the at least one contact element or the position of the contact element itself provides at least one visual feedback. The feedback can be provided by visual feedback means, for example markers, shapes, colors, etc. that directly or indirectly indicate the intra-operative position of the contact elements. The feedback may be a simple correct / incorrect indication or may include a graduated indication.
    In a particular embodiment, the conductive element of the therapeutic, diagnostic, or surgical guide is adaptably connected to the first reference element in such a way that the adaptation of the conductive element is achieved by the deformation of the at least one elastic element that allows a correspondence with an intra-operative position of the at least one contact element.
    In a particular embodiment, the present invention provides a new design of medical, for example, therapeutic, diagnostic, or surgical guides based on the use of a mechanical guidance system based on medical imaging that fits accurately into an area of the patient in which one interested, and that makes it possible to accurately achieve the purpose of surgical procedures and to accurately check the procedures themselves.
    A medical, e.g., therapeutic, diagnostic, or surgical guide according to the present invention serves as the basis for a clearly defined and adaptable positioning of medical, e.g., therapeutic, diagnostic, or surgical guides or functional conductive elements. The conductive elements make it possible to perform an invasive therapeutic, diagnostic, or surgical procedure (such as applying a biopsy needle), placing reference pins, drilling holes, or applying surgical cuts (such as applying osteotomy). -cuts) and all this accurately according to a predefined surgical plan that was prepared using 3D imaging technology such as: optical, CT, MRI, PET, or ultrasonic imaging. In certain situations, the functional conductive elements may even include or interface with an electronic surgical navigation system.
    In the present invention there is provided a first reference element such as a frame or a substrate to which other elements are connected. The first reference element does not necessarily have to be patient-specific; for example, the first reference element can be of any suitable shape and the distance (s) with respect to a contact element or with respect to contact elements is or are set in such a way that the contact parts of the contact elements are placed in a patient-specific manner, that that is, their envelope forms a negative shape of a body part. The contact points may be multiple contact points or the contact elements may have an envelope, i.e. a surface formed in a patient-specific manner, in other words they have the negative shape of a part of the patient's anatomy.
    Alternatively, the first reference element can be given a patient-specific shape, and the one contact element or the plurality of contact elements is or are arranged at a specific distance from the reference element, in such a way that the one contact element or the contact elements has contact parts or which are also located in particular positions, i.e. on an envelope that is patient-specific due to the shape of the reference element.
    Yet another possibility is that neither the first reference element nor the contact elements are given a patient-specific shape, but that the feedback means, i.e. the markings on the elastic means, are located at patient-specific points. As soon as the guidance is applied in this way, the relationship between the patient-specific markings and the individual positions of the elastic elements will provide the visual feedback for the physician.
    The present invention also includes in one of its embodiments that a second reference element is provided. The second reference element is preferably patient-specific, that is, it has the negative shape of a part of the patient's anatomy.
    In any case, the contact elements having one or more predefined outer surfaces or multiple contact points defining a surface or envelope that is patient-specific, that is, it has the negative shape of a part of the patient's anatomy, at preferably made in accordance with the preoperative plan of the surgical procedure.
    The contact element may comprise a surface or point contact which is intended to be brought into contact with the area of the patient in which one is interested, the contact element being the mirror image of the surface of the area of the patient in which one is interested. For example, it can be applied at a specific distance from the reference surface. The contact element may comprise more than one surface or may consist of multiple point contacts such as in a multi-point or multi-surface arrangement, the position of the contact points or surfaces being patient-specific, i.e. defining a surface or envelope that or the negative shape of a body part. The contact parts of the contact element can move relative to the surface of the first reference element. The surface of the contact element is in contact with the anatomy of the patient and adapts to or adapts to this shape. The relative movement between the adjusted contact surface (s) or contact point (s) and a fixed external reference surface can allow the user to compare the predicted fit of the surface with the actual anatomy of the patient. Gaps are then noticed when the contact surface or contact surfaces or point (s) are or are spaced from the external reference surface, while so-called "hinges" would bring the two surfaces closer together. This immediately provides the advantage that hinges do not necessarily cancel the complete fit of the guide because the contact surface is formed from a plurality of independent elements. A correct fit can be determined on the basis of a percentage of the internal surface of the contact element that remains within a consistent distance from the external reference surface.
    In certain embodiments of the present invention, the surface of the external reference element and the internal contact surfaces are interconnected and their relationship is measured by using elastically deformable elements. These physical elements can either be used to display the fitting data directly or can be connected to other measuring devices such as micrometers or strain gauges, for example to obtain a digital readout. On the basis of this reading, the physician can adjust the position of the conductive element in order to obtain the most optimal surface agreement, or he can reject the conduction if he finds an incorrect fit. This drastically reduces the risk that a surgical guide would be used in an incorrect position, and allows the surgeon to consider the surfaces of the surgical guide contact element that are not visible along the outer edge or windows.
    Spring-loaded, elastically deformable conductive element structures can also be used. These deformable conductive elements can be activated by the movement of the contact elements in such a way that the position of the conductive elements depends on the intra-operative position of the contact elements. The movement of the conductive elements can be controlled by a transducer element. These deformable conductive elements can exert a clamping force on an anatomical zone. By exerting a force on well-defined curves, the guide can be reliably fixed to the area of the patient in which one is interested.
    In a preferred embodiment of the present invention, the first reference element consists of a rigid structure with adjustable contact elements suitable for fitting in the specific area of an individual patient in which one is interested. In this way, the first reference element and the contact elements, possibly in cooperation with a second reference element, will reliably reflect the plan for the surgical intervention supported by the computer.
    In another preferred embodiment of the present invention, the medical, e.g., therapeutic, diagnostic, or surgical guide comprises at least two contact elements.
    By using at least two contact elements, such as multiple point contact elements, the zones of the patient in which there is an incorrect fit can be interestingly better defined so that they can be better identified by the surgeon, while the zones with a perfect fit become more numerous. *
    Preferably, the at least one elastic element is selected from the group consisting of a strain gauge, a spring, a deformable rubber or foam piece, and an inflatable cushion.
    The first purpose of the elastic element is to ensure that the surface or the contact point of the contact element remains in contact with the anatomical zone of the patient. The elastic elements can also fulfill an indicator function, that is, they can be used to directly indicate the fit data (i.e., for use during optical navigation). Alternatively, they can be operatively connected to other measuring devices - as is the case when strain gauges are used - in order to enable an analog or digital readout. Based on this reading, the physician can adjust the position of the guide to achieve the most optimal match between surfaces, or to reject the guide if an incorrect fit is found. This greatly reduces the risk that a guide would be used in an incorrect position, and allows the surgeon to consider the contact surfaces of the guide that are not visible along the outer edge or windows.
    In another preferred embodiment of the present invention, the surgical guide comprises a transducer element connected to the at least one elastic element and in operative contact with the conductive element.
    By coupling the possible deformation of the elastic element directly to the movement of the functional conductive elements via the transducer element, there is provided a means for automatic adaptation of the conductive element to the changes of the patient's zone, without this manual intervention by the surgeon.
    The transducer element can include an actual transducer portion, as well as a portion that defines the transferring function to the functional conductive element. The actual transducer part is provided in such a way that it can move relative to the moving surface of the contact element. This movement is then the input for the functional transducer part. The motion data provided by the transducer can also be converted into a digital signal that can be used for analysis and for guidance adjustment.
    The transducer function must be the connection between the final position of the moving surface of the contact element and the resulting plan position of the functional conductive element. Although it can be represented in the form of a physical curve for the purpose of a conceptual demonstration, it can also be implemented by using physical elements such as transmissions, hinges, screws, etc., or by using an electronic one ( digital) function which then provides a resulting position of the functional conductive element.
    The present invention therefore provides a medical, e.g. therapeutic, diagnostic, or surgical template or guide that provides feedback (visual, positive, or by force) comprising: at least one reference element (this may or may not be) be patient-specific and is typically a rigid zone of the template); at least one flexible patient-specific element, i.e. a contact element that is typically a point or a surface that is made flexible by means of an elastic element; and an indicator or actuator that provides visual and patient-specific feedback, or enables the force feedback with respect to the position of the flexible contact element relative to the reference element.
    In a number of embodiments, fitting data is obtained when both the reference and the flexible elements are positioned on the same part of the patient's anatomy. In certain embodiments, when the reference element is applied to a part of the patient's anatomy, for example, a bone or a bone fragment, and when the flexible element is applied to another part of the patient's anatomy, for example, a different bone or bone fragment, data is obtained regarding the position between the bones (for example, as determined by the tension in the ligaments).
    The adjustable surgical guide according to the present invention is preferably used for medical treatments, in particular in cases where the surgical guide must be adjusted intraoperatively to the area of the patient in which one is interested. Such pre-planned surgical procedures are most advantageous when an intra-operative adjustment of the conductive elements is required to reflect changes in the fit of patient-specific and pre-fabricated guidance.
    Other features and advantages of the present invention will become apparent from the following detailed description which is to be read in the light of the accompanying drawings which illustrate, by way of example, the principles of the invention.
    Brief description of the drawings
    Figures 1A-C are schematic representations of parts of a guide that can be used with the present invention.
    Figures 1D and 1E are views of a first embodiment of an adjustable surgical guide according to the present invention.
    Figure 2 is a schematic representation of a second embodiment of an adjustable surgical guide according to the present invention.
    Figure 3 is a schematic representation of a third embodiment of an adjustable surgical guide according to the present invention.
    Figure 4 is a representation of the intra-operative position of the guide of Figure 3.
    Figure 5 is a representation of the intra-operative function of the guide of Figure 3.
    Figure 6 is a schematic representation of a fourth embodiment of an adjustable surgical guide according to the present invention, which may be used as an alternative to any of the embodiments of Figures 1A-C.
    Figure 7 is a schematic representation of a computer system according to the present invention.
    Description of the preferred embodiments
    The present invention will be described with reference to specific embodiments and with the aid of a number of drawings, without, however, limiting the invention thereto, but on the contrary being exclusively defined by the claims. The drawings are only schematic and have no limiting character whatsoever.
    Figure 1A is a schematic representation of a feedback device intended to be used in a surgical guide 1 according to the present invention. For a better understanding of the general operating principles, the elements of the inventive guidance are shown in a very simplified and schematic form.
    An adaptable surgical guide 1 for an intra-operative adaptation of a contact element to a predetermined position comprises the feedback device which is provided with a first reference element 3 which is represented in the form of a plate structure. The feedback device is represented as a cutting surface defined by the surfaces of the individual parts connected to the contact elements 4. Four contact elements 4 are connected to the reference plate 3 by means of separate elastic elements 5 provided between the reference element 3 and the contact elements 4. The contact elements are movable thanks to the elastic elements. The position of the contact elements can be determined from the position of indicators 2 that allow a visualization of a later agreement with the intra-operative position of the contact elements.
    Figure 1B is a schematic representation of another feedback device intended to be used in a surgical guide 1 according to the present invention, similar to the representation of Figure 1A except that the contact element 4 is located more rearwardly. The indicator 2 extends beyond the outer surface of the reference element 3 and indicates the position of the contact element 4 which is elastically fixed relative to the spring 5. A second reference surface 6 is provided and can, for example, determine the position of the contact element 4 check or limit. It is a particular aspect of the present invention that the second reference surface 6 that acts as a second reference element is preferably patient-specific in shape, that is, it has the negative shape of a portion of the patient's anatomy. The second reference element can be used to enable good visual feedback as to whether or not the guide is positioned correctly.
    Figure 1C is a schematic representation of yet another feedback device intended to be used in a surgical guide 1 according to the present invention, similar to the representation of Figure 1A, with the difference that the elastic element is a curved spring 5 whose distortion causes the indicator 2 to move relative to the outer surface of the first reference element 3. The contact element 4, in the form of a point or a surface, is provided by a part of the curved spring on the side of the reference element 3 located away from the indicator 2. Optionally, a second reference element surface 6 can be provided, for example a surface which can limit or control the position of the contact element 4.
    How the above feedback devices can be used in a medical, e.g., therapeutic, diagnostic, or surgical guide 1 will be described with reference to Figures 1D and 1E. Figure 1D shows a medical, for example therapeutic, diagnostic, or surgical guide 1 which is provided with a reference element 3 with a specific shape that is the mirror image of a part of a patient, for example a bone such as a part of a thigh bone. The reference element 3 can be made by using any of the methods described below in which, for example, a layered production techniques, an active method, or a rapid prototype method are used. The reference element 3 can be made using methods based on a suitably recorded image, for example a CT scan, an MRI scan, an ultrasound scan, a PET scan, and so on. On the outer surface of the reference element 3 there are indicators 2 which are distributed over the surface. These indicators 2 are operatively connected to elastic elements 5, see figure 1E in which the inner surface of the guide 1 is shown. The elastic elements can be any of the elastic elements shown in Figures 1A to C. In this case, they are, for example, curved springs that are similar to those found in Figure 1C. The guide also has a second reference element in the form of a patient-specific surface 6, i.e. it has the negative shape of a part of the patient's anatomy. This patient-specific surface forms the mirror image of the shape of a part of the patient's anatomy. When the guide is in the correct position, this is indicated by the indicators 2. The curved springs 5 also form contact points or surfaces 4 in such a way that, when the guide is arranged in the patient, the curved springs minus or more will cooperate with the anatomy of the patient as a function of the accuracy of the positioning of the guide 1, i.e. whether the second reference element and more particularly the surface 6 is in the correct position. Errors in the positioning will be made clear in the form of movements of the indicators 2, and these therefore provide an optical feedback. These indicators 2 will protrude more or less through the reference element 3, depending on the accuracy of the fit. The indicators 2 can be provided with the colored strips or with other markings which enable a better visualization of the extent to which they protrude through the reference element. By changing the position of the guide 1, the surgeon can look for the best fit. The guide 1 is also provided with one or more conductive elements 9 which are shown here as conductive elements in the form of drill guides. However, the conductive element 9 can also be of any type of guide for invasive procedures, such as a cutting guide for surgical procedures.
    Figure 2 gives a schematic representation of an additional feedback device intended to be used with a surgical guide 1 according to the present invention in a second embodiment. Again, the elements of the inventive guidance are shown in a very simplified and schematic manner with a view to a better understanding of the general operating principle. The reference element 3 is represented as a plate on which a spring is connected as elastic element 5. At the corresponding end of the spring 5 a contact element 4 is provided which is also shown in the form of a plate. The reference element carries a hinge structure comprising a pivot point 11 to which the functional conductive element 9 is mounted so that it can also be moved (along an accurate path) by the corresponding movement of a transducer element 7 when the contact element 4 performs a movement. The conductive element 9 is shown as a conductive element such as a drill guide with two holes for guiding drills. However, the conductive element 9 can be any type of guide for invasive operations, such as a cutting guide for surgical procedures. The transducer element 7 comprises two different parts 7a and 7b which are intended to translate the adaptive movement of the contact element 4 relative to the reference element 3, and thus relative to the functional conductive element 9. Reference numeral 7a designates an actuator portion and reference numeral 7b designates the transducer portion defining the transducer function of the functional conductive element 9. As can be seen, for the purpose of demonstrating the conceptual principle, the transducer function is represented as a curved path or a curved path of the conductive element 9, but it is also possible to provide other paths or paths by using other physical elements such as transmissions, hinges, screws, etc. or by using an electronic function that then has a resulting position of the functional conductive element 9. Another (second) reference element 6 can for instance be positioned at a fixed distance with respect to the first reference element 3. The fixed distance describes, for example, the distance that the contact element should have with respect to the first reference element 3 according to the predefined planning of the surgical procedure. In this way deviations of the contact element 4 from the correspondence with the second reference element 6 can easily be observed. Due to the fact that the conductive element 9 is driven by the position of the contact element, this embodiment provides more than just a visual feedback. In this case, the feedback is used to obtain the intra-operative position of the conductive element 9 from the intra-operative anatomical position of anatomical elements of the patient.
    In an alternative embodiment of the present invention, the functional conductive element can be fixed in its final (intra-operative) position by any suitable locking means, for example a means that prevents rotation around the pivot point.
    Figure 3 is a schematic representation of yet another feedback device intended to be used with a surgical guide 1 according to the present invention in a third embodiment. The third embodiment can be obtained by providing an elastically deformable element 5 between two known surfaces of the reference element 3 and the contact element 4. The reference element 3 has a surface that is patient-specific, that is to say it is the negative shape has a part of the patient's anatomy. The relative distance between these surfaces, which is proportional to a force exerted on the elastically deformable element 5, describes a way to measure a force between two anatomical structures, and this as an aid to surgical planning. This feedback can be used to adjust the functional conductive elements 9 to the anatomy. For example, the force between the medial and lateral condyle can be measured through the guide to accurately balance the tension of the ligaments with the resulting cutting and implantation position. Although the illustration shows the correction by rotation, it is also possible to provide other paths or trajectories by using other physical elements such as transmissions (can be found in Figure 4), hinges, screws, etc. or by using an electronic function which then supplies the resulting position of the functional conductive element 9. The conductive element 9 is represented as a drill guide with two holes for guiding drills. However, the conductive element can be any type of guide for invasive operations such as a cutting guide for surgical procedures.
    In an alternative embodiment of the present invention, that functional conductive element can be locked in its final (intra-operative) position by any suitable locking means, for example a means that prevents rotation around the pivot point.
    An important innovation of this guidance is that it enables a force feedback that is derived from the intra-operative position of anatomical elements, such as the knee condyle. The operation of the guide will be described with reference to Figures 3, 4, and 5. Figure 4 shows the intra-operative position of the guide. The contact elements 4 are in position and the angle between the mechanical axes of the femur and the tibia cause the angle of the conductive element 9 to change due to rotation around the pivot point 11 - see Figure 5. The guiding device not only measures every difference between the positions of the condyli ma'ar also exert a force on it so that they are placed in a more balanced anatomical position. Force feedback has a number of problems that people have to deal with with the current design of guides. Because soft tissue forces are not taken into account in preoperative planning, surgical schedules are established based on a mechanical alignment of the skeleton. Soft tissue balancing, and hence force balancing, is not possible with static or manually adjustable guides, and surgeons must adjust their surgical setting or philosophy to mechanical alignment when using these guides and corresponding surgical schedules. By introducing a device with which forces can be measured, for example with a force feedback, intra-operative soft tissue forces can be calculated by measuring their effects on intra-articular skeletal forces or they can also be balanced
    This measurement can be made by using spring-loaded surfaces or embedded strain gauges. These measuring devices are arranged between the contact surfaces of the joint. Spring-loaded surfaces 4 can be connected to the functional conductive elements 9 such as cutting edges or boreholes, so that intra-operative soft tissue measurements have a direct influence on surgical planning. The spring constant of the elastic element 5 can be varied based on the anatomy of the patient and the expected force. The ratio of the connecting transmission or the position of the hinge or of the hinge point 11 also offers possibilities to vary the functional guidance of element 9 so as to make them patient-specific. Horizontal bars as elastic elements 5 could provide a measurement reading and the guides 1 could then be adjusted manually to be able to absorb the force.
    An anatomically corresponding reference element 3 of a known zone and position is provided. Reference elements 3 can be used on two different anatomical surfaces or between the device and an anatomical surface.
    A spring that offers resistance between two surface positions can be provided as an elastic element 5. The change of the elastically deformable element 5 can be converted into force calculations. A force indicator (not shown) may be provided which gives a reading of the force occurring between the two surfaces. This force measurement can be used as input for the transducer function.
    The relative forces created by the elastically deformable elements 5 act on a functional transducer part 7 which subsequently moves the functional conductive element 9.
    The conductive elements 9 for the surgical procedure can be described by cutting edges, pinholes, or by a number of other surgical conductive elements.
    Although Figure 3 has been described with reference to the use of a feedback device according to Figure 2, any feedback device can be included in a patient-specific reference element 3 of the type shown in Figure 3. The feedback device according to Figures 1A, 1B, or 1C can therefore also be included in a reference element as shown in figure 3, be it alone or in combination.
    Although Figs. 1D and 1E have been described with reference to the use of a feedback device according to Fig. 1C, any feedback device can be included in a patient-specific reference element 3 of the type shown in Fig. 1D or E. The feedback device of Fig. 1A or 1B, or 2 or 3 can be included in a reference element as shown in Figure 1D and in Figure 1 E, be it alone or in combination.
    Figure 6 shows an additional embodiment of the present invention. This embodiment can be used as an alternative to any of the above-described embodiments, such as those from Figures 1A, B, C. In this embodiment, neither the reference element 3 nor the contact elements 4 are necessarily patient-specific, i.e. they do not necessarily have to take the negative shape of part of the patient's anatomy. Instead, the contact elements 4 are in the form of pins of the same length. However, when the guide 1 is placed in or on the patient's anatomy, the pins will move over different distances from the surface of the second reference element 6, and indicators 2 will indicate different lengths from the surface of the first reference element 3. Markings can be applied to the pins in a patient-specific manner such that when the guide 1 is in the correct position, the markings give a visual feedback of this fact. Such markings can be applied by using additive production methods, for example, layered production techniques, sometimes referred to as rapid prototype production techniques. In addition, the contact elements 4 are interconnected by a series of elastic elements 5, instead of being previously driven by only a single elastic element 5. The result of this may be that this guide is less accurate than the previous embodiments, but easier to produce. and can be made more compact.
    Any of the feedback devices and / or guides mentioned above can or can be manufactured using layered production techniques such as rapid prototype production techniques and additive production methods. This approach provides a cost-efficient production technology because the different reference elements, contact elements, conductive elements, and elastic elements can be produced in one and the same form so that large quantities of them with complex shapes can be incorporated into the design of a specific guide. However, the invention does not exclude that components made by using other technologies may also be assembled to realize, for example, the transducer function.
    Additive Manufacturing (AM) can be defined as a group of techniques that is used to quickly produce a scale model of an object that typically uses object data from three-dimensional (3-D) computer-aided design techniques (CAD - computer aided design). At present, there are many Additive Manufacturing techniques available including stereolithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), film-based techniques, and so on. Stereolitography, nowadays the most widely used AM technique, uses a reservoir containing liquid photopolymer “resin” to form an object, layer by layer. On each layer, an electromagnetic beam, for example, one or more laser beams driven by a computer, will be used to trace a specific pattern on the surface of the liquid resin defined by the two-dimensional cross-section of the object to be formed. The exposure to the electromagnetic radiation polymerizes or hardens the pattern traced on the resin, thereby bonding it to the underlying layer. After a layer has been polymerized, the platform drops a single layer thickness and a subsequent layer pattern is applied and bonded to the previous layer. A complete 3-D object is thus produced using this method.
    Selective laser sintering (SLS) uses a high-power laser or another focused heat source to sinter or weld small particles of plastic, metal, or ceramic powder into a mass that represents the three-dimensional object to be formed.
    Fused deposition counting (FDM) and related techniques use a temporary transition from a solid material to a liquid state, usually as a result of heating. The material is forced in a controlled manner through an extrusion manifold and deposited at the desired location, as described, for example, in U.S. Patent No. 5,141,680.
    Film-based techniques fix coatings on each other by using gluing or photopolymerization, or other techniques, and cut the object from these coatings or polymerize the object. Such a technique is described in U.S. Patent No. 5,192,539.
    Typical AM techniques start from a digital representation of the three-dimensional object to be formed. Typically, the digital display is cut into a series of layers that correspond to cross sections and that can be superimposed to form the entire object. The AM device uses this data to form the object on a layer-by-layer basis. The cross-sectional data representing the layer data of the three-dimensional object can be generated using a computer system and computer-aided design and production software (CAD / CAM - computer aided design / computer aided manufacturing).
    A selective laser sintering device (SLS) is particularly preferred for manufacturing the surface that is the negative shape of a body part (as well as its support) based on a computer model. However, it is to be understood that various types of additive production methods and tools can be used to accurately produce these surfaces, including the supports, without being limited to stereolitography (SLA), fused deposition modeling (FDM), or grinding. .
    The support for such a surface can be made from different materials. Preferably, only material that is biocompatible with the human body is considered. In the case where SLS is used as AM technology, the surface support can be produced from a polyamide such as PA 2200 as supplied by EOS, Munich, Germany, or Duraform PA from 3D Systems, South Carolina, USA, or another material known to those skilled in the art.
    The guides of the present invention can be made by using a method based on images. Optionally, they can be made by using additive or layered production methods, for example rapid prototype production methods, or direct basis of medical images of the patient such as optical, MRI, PET scan, CT scan images or images taken using ultrasonic methods from which a surface can be generated, for example by segmentation. Patient-specific surfaces (i.e., with the negative shape of a part of the patient's anatomy) can be produced using this method, just like patient-specific markings on the indicators 2.
    Other parts of the guides 1, such as the reference element 3 or the conductive elements 9, can also be produced by using additive or layered production methods, for example rapid prototype production methods which use medical images of the patient as optical, for example, MRI, PET scan, CT scan images or images taken by ultrasonic methods. For example, a conductive element 9 can be introduced into images, and then produced using an additive or layered production method such as Rapid Prototyping or other additive manufacturing techniques, or with conventional CNC technology.
    The present invention provides all embodiments that image-based techniques can be used to produce all or part of the guides in accordance with embodiments of the present invention. A scanner such as an optical, CT scan, MRI, PET, X-ray, or ultrasonic imaging device can be used to generate a digital 3D geometry of the relevant shape, for example one or more of the patient-specific elements as obtained by scanning the relevant body part. The image may be in the form of a cloud of dots, a solid surface consisting of triangles or may be in any format for recording and storing a three-dimensional geometry. Another way to achieve the required geometry is by manually making a plaster cast from the body part such as a limb, and by taking the shape of the cast using any suitable technique, such as scanning. Alternatively, a positive form of the cast can be scanned.
    The geometry of the particular body part can be digitally imported into a computer program and can be converted using algorithms known in the art of CAD / CAM technology to generate a three-dimensional computer model of a relevant surface. A computer program such as 3-matic ™ as supplied by Materialize N.V., Leuven,
    Belgium, can be used to form this three-dimensional model. This geometric data can be used immediately in the computer program or can be stored in a digital file.
    Once the three-dimensional model of a patient-specific surface (i.e. with the negative shape of a part of the patient's anatomy) is generated, this can be manipulated manually, semi-automatically, or automatically to design a three-dimensional model of the relevant guidance . These manipulations can include, but are not limited to, one or more of the following processes: 1. changing the scale of the geometry along a well-defined axis 2. assigning to the geometry a thickness that can be varied throughout the part 3. creating hollow spaces in this thickness 4. adding new surface shapes in specific parts, such as local elevations 5. adding predetermined three-dimensional elements from a database system (E) 6. integrating the interventions into an optimum shape 7. adding connection features that make it possible to attach straps or other means to attach the device to the person for whom it is designed 8. adding holes or other features
    A preferred method for performing these actions uses a computer program such as 3-matic available from Materialize N.V., Leuven, Belgium.
    A library of one or more three-dimensional models of relevant structures or their mathematical representations stored in a database can then be used to include at least one functional structure in the three-dimensional model of the device; for example, a conductive element 9, a contact element 4, or a reference element 3 can be introduced. The elements in the library can be selected manually or automatically from the database based on predetermined properties, such as their physical dimensions, their appearance, or their mechanical properties. It is to be understood that the dimensions and values relating to the operation of all such imported structures available in the library can be scaled to any dimension to obtain the preferred or expected mechanical properties and operation. Functions that represent these elements and their operation are preferably stored in this database so that they can be called up when required, be it automatically or manually by the user, and can be integrated into the three-dimensional design by using the design software . Either specific structures can be called up from the library, or all structures can be called up that meet certain operating parameters, so that the user can choose a specific location and target. More than one structure can be selected by the library system to give specific properties to specific zones of the device.
    Figure 7 is a schematic representation of a computer system that can be used with the methods and in a system of the present invention, including computer programs such as 3-matic ™ as available from Materialize N.V., Leuven, Belgium. A computer 150 is shown which may include a video display terminal 159, data entry means such as a keyboard 155, and graphical user interface indicating means such as a mouse 156. The computer 150 may be implemented in the form of a general-purpose computer, e.g., to UNIX workstation or a PC.
    The computer 150 includes a central processing unit (CPU - central processing unit) 151, such as a conventional microprocessor of which a Pentium processor supplied by Intel Corp. from the USA is only an example, as well as a number of other units interconnected via a bus system 154. The bus system 154 can be any suitable bus system - Figure 7 is only a schematic representation. The computer 150 comprises at least one memory. The memory may comprise any of a variety of data storage means well known to those skilled in the art, such as RAM (random access memory), ROM (read only memory), or non-volatile read / write memory such as a hard disk, such as well known to those skilled in the art. The computer 150 may, for example, furthermore comprise RAM memory 153, read-only memory (ROM) 153, as well as a display adapter 1512 for connecting a system bus 154 to a video display terminal 159, as well as an optional input / output adapter (1 / O) 1511 with for the purpose of connecting peripheral devices (e.g., disk and tape devices 158) to the system bus 154. The video display terminal 159 may be the visual output of computer 150, which may be similar to any suitable display device such as a CRT-based video display that is well known in the field of computer hardware. However, in the case of a desktop computer, a laptop, or a notebook, the video display terminal 159 may be replaced by a flat LCD or plasma display. The computer 150 additionally includes a user interface adapter 1510 for connecting a keyboard 155, a mouse 156, and optionally a loudspeaker 157. The relevant data describing the three-dimensional object to be formed can either be entered directly into the computer by use from keyboard 155, or from storage means such as 158, after which a processor then performs a method in accordance with the present invention. The results of the methods can be transferred to an additional nearby or remote location, for example a CAD / CAM processing facility, to produce the template in accordance with the details provided by the computer 150.
    A CAD / CAM producing unit 1516 can also be connected to bus 154 via a communication adapter 1517, so that the computer 150 is connected to a data network such as Internet, an intranet, a Local or Wide Are NetWork (LAN or WAN), or a CAN . The producing unit 1116 can receive an output value or a descriptive file of the support directly from the computer 150 on which a computer program runs for the support design in accordance with the present invention, or a value or a descriptive file derived from such an output of computer 150. Alternatively, the unit 1516 may receive the relevant design data indirectly via a suitable signal storage medium such as a floppy disk, a replaceable hard disk, an optical storage device such as a CD-ROM or a DVD-ROM, a magnetic tape, or the like.
    Computer 150 also includes a graphical user interface that is contained in machine-readable media in order to control the operation of the computer 150. Any suitable machine-readable medium may include the graphical user interface, such as RAM 152, read-only memory (ROM) 153, a magnetic disk, magnetic tape, or an optical disk (the latter three to be placed in disk and tape devices 158). Any suitable operating system and the associated graphical user interface (e.g. Microsoft Windows, Linux) can or can control the CPU 151.
    In addition, the computer 150 includes a check program 1517 stored in the computer's memory 1516. The control program 1517 contains instructions that, when executed on the CPU 151, enable the computer 150 to perform the operations described in the context of any of the methods of the present invention.
    Those skilled in the art will appreciate that the hardware shown in Figure 7 may vary for different applications. For example, other peripheral devices such as optical disk media, audio adapters, or chip programming programming devices, such as PAL or EPROM programming devices that are well known in the art of computer hardware, and the like can be used in addition to or in place of the hardware already described.
    In the example shown in Figure 7, the computer program product for performing a method according to the present invention can be stored in any memory suitable for this purpose. However, it is important that, although the present invention has been and will be described with reference to embodiments, it will be apparent to those skilled in the art that the mechanisms of the present invention may be divided into the form of a computer program product in a variety of forms, and that the present invention remains applicable irrespective of the type of medium with which the signal is transmitted and which is used to make the distribution possible. Examples of computer-readable signal transferring media include: recordable-type media, such as floppy disks and CD-ROMs, as well as transmission-type media such as digital and analog communication links.
    Accordingly, the present invention also includes a software product that, when executed on a suitable computer device, performs any of the methods of the present invention. Suitable software can be obtained by programming in a suitable higher programming language such as C, and by compiling on a compiler suitable for the processor of the target computer.
    Although the invention has been described and explained on the basis of preferred embodiments, it will be apparent to those skilled in the art that various changes or modifications in form and detail can be made without departing from the scope and spirit of these. invention.
    权利要求:
    Claims (16)
    [1]
    A therapeutic, diagnostic, or surgical guide (1) with a conductive element, suitable for intraoperative positioning of the guide or of the conductive element (2) in a pre-planned position, comprising: - a reference element (3) ), and - at least one contact element (4) which is elastically fixed with respect to the reference element by means of at least one elastic element (5); wherein the conductive element (9) is connected to the reference element (3), and wherein the deformation of the at least one elastic element (5) corresponds to an intra-operative position of the at least one contact element.
    [2]
    Therapeutic, diagnostic, or surgical guide (1) according to claim 1, wherein the conductive element (9) is adaptably connected to the reference element (3) in such a way that the adaptation of the conductive element ( 9) is obtained by the deformation of the at least one elastic element (5) corresponding to the intra-operative position of the at least one contact element.
    [3]
    Therapeutic, diagnostic, or surgical guidance according to claim 1 or claim 2, wherein the reference element (3) comprises a rigid structure suitable for fitting in a specific zone of a particular patient in which one is interested.
    [4]
    Therapeutic, diagnostic, or surgical guide according to one of claims 1, 2, or 3, wherein the surgical guide (1) comprises at least two contact elements (4).
    [5]
    Therapeutic, diagnostic, or surgical guidance according to claim 4, wherein the at least two contact elements (4) define a plurality of points or surfaces suitable for fitting into a specific area of a particular patient in which one is interested.
    [6]
    The therapeutic, diagnostic, or surgical guide of any one of claims 1-5, wherein the at least one elastic element (5) is selected from the group consisting of a strain gauge, a spring, rubber, deformable foam, and an inflatable cushion .
    [7]
    The therapeutic, diagnostic, or surgical guide of any one of claims 1-6, wherein the guide (1) comprises an additional reference element (6) positioned at a fixed distance from the first reference element (3) .
    [8]
    The therapeutic, diagnostic, or surgical guide of any one of claims 1-7, wherein the guide (1) comprises a force feedback element that is in effective contact with the conductive element (9).
    [9]
    The therapeutic, diagnostic, or surgical guide of claim 8, wherein the force feedback element comprises a transducer element (7A) connected to the at least one elastic element (5) and in operative contact with the conductive element (9).
    [10]
    The therapeutic, diagnostic, or surgical guidance of claim 8 or claim 9, wherein the force feedback element comprises an actuator element (7A) connected to the at least one contact element (5).
    [11]
    A therapeutic, diagnostic, or surgical guide according to any one of the preceding claims, further comprising means for securing the conductive element.
    [12]
    A medical, for example therapeutic, diagnostic, or surgical template that provides feedback, comprising: at least one reference element; at least one flexible, patient-specific element; and an indicator or actuator that provides visual feedback or that allows a force feedback with respect to the position of the flexible and patient-specific element relative to the reference element.
    [13]
    The template of claim 12, wherein the feedback is visual, a position, or a force.
    [14]
    The template of claim 12 or claim 13, wherein the reference element is in a form that is patient-specific.
    [15]
    A template according to any of claims 12-14, wherein the at least one flexible and patient-specific element is a contact element that comprises a point or a surface, and is made flexible by means of an elastic element.
    [16]
    A method of manufacturing a guide according to any of claims 1 to 11, or a template according to claims 12 to 15, wherein the method comprises an additive production technique such as a rapid prototype technique or a layered production technique.
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    同族专利:
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    GB0915947D0|2009-10-28|
    JP2013504350A|2013-02-07|
    US20120179147A1|2012-07-12|
    EP2475311A1|2012-07-18|
    US8702686B2|2014-04-22|
    EP2475311B1|2016-05-04|
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    法律状态:
    优先权:
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    GB0915947|2009-09-11|
    US24295209P| true| 2009-09-16|2009-09-16|
    US24295209|2009-09-16|
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