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  • 专利说明
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    • 专利摘要:
    Interactive procedure for the design and creation of patient-specific surgical instruments (IPE) (1) of the skeletal system characterized in that it comprises a method in which, through a direct interaction between the surgeon and the designer/engineer, the specific patient surgical instruments are designed by adapting it. to the specific needs to address the surgery. This instrument is characterized by the fact that it unfailingly comprises the following elements: contact element, stabilizer element, guide element and information element or infographic. Its design and subsequent manufacture is carried out following a procedure, which may be interactive, between surgeon and designer (engineer), based on the surgical marking that will be carried out, according to the surgeon's instructions, on the virtual anatomical model generated from the images in 3d technology, or similar, obtained from the CT or similar and sent by the medical center to the designer. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2792649A1
    申请号:ES201900086
    申请日:2019-05-09
    公开日:2020-11-11
    发明作者:Coretti Stephan Meschian；Lledo Raquel Serrano
    申请人:Medicmodel S L P；
    IPC主号:
    专利说明:

    [0002] Interactive procedure for the creation of patient-specific surgical instruments for the skeletal system
    [0004] Technical sector
    [0006] The present invention belongs to the field of medical-surgical equipment for surgeries in the skeletal system and, specifically, to the interactive design and construction of patient-specific surgical instruments (hereinafter, IPE) that necessarily comprises four elements: contact element, stabilizer element, guide element and informational element or infographic. Its design and subsequent manufacture is carried out following a procedure, which may be interactive, between surgeon and designer, based on the surgical marking that the surgeon will perform on the virtual anatomical model generated from images in 3D technology, or similar. obtained from the TAC or similar and sent by the medical center to the designer.
    [0008] This system in combination with conventional instruments will favor the precision of the surgery and the reduction of its execution time.
    [0010] Background of the invention
    [0012] In the field of skeletal system surgery, specific and personalized surgical instruments have been used for each patient and their use is common in the implantation of joint prostheses.
    [0014] In this way, its applications have been diverse and its field of action has been expanding every day due to the benefits they have in terms of precision in the execution of the surgery. Thus, thanks to the diffusion of the use of specific patient guides, in the specialties that treat the locomotor system, the applications for the use of said instruments have been expanded, while procedures through which the surgeon is increasingly necessary become a direct participant in the design and creation of said instruments that he will use in the performance of his surgery.
    [0016] In an ideal scenario, the surgeon himself would be the architect and responsible for creating his own specific surgical instruments for each patient, which would be perfectly adapted to the surgical planning that he himself has designed.
    [0018] But to conceive this scenario it would be required that the surgeon, in addition to managing the medical-surgical knowledge of his specialty, also had a series of specific technical knowledge related to the computer software essential for the design and manufacture of the instruments themselves.
    [0020] For this reason, the method we propose describes the steps necessary to design and manufacture the patient-specific instruments (IPE) through a direct interaction between the surgeon and the designer, making the former participate in the most complex and important steps of the creation of the guide that are: the choice of the contact area, the choice of the location and direction of the guide elements and the location and direction of the stabilization / fixing elements.
    [0021] To comply with this method we propose an interactive computer software, through which it can determine the points described above and communicate in real time with the designer to agree on the essential aspects in the design of the IPE.
    [0022] Reference: EP 3065651 B1 describes a method for constructing a specific surgical guide for each patient.
    [0023] Explanation of the invention
    [0024] The invention is defined in the claims that make up the present specification / description of the invention.
    [0025] Specifically, the procedure for the creation of specific patient surgical instruments for the skeletal system, object of this invention, comprises an interactive procedure or method that allows its design and manufacture, involving the surgeon who has planned the intervention and designing the instruments adapting it to their needs. specific needs to address surgery. In this way, a method is offered that exceeds the characteristics of currently existing solutions and that adds new elements and the possibility of an interactive technique for its design and creation that will facilitate precision in the definition of the four elements that compose it, as well as a saving in time for the execution of surgical interventions.
    [0026] Thus, the invention provides a procedure for the creation of patient-specific surgical instruments that unfailingly comprises four elements:
    [0027] - Contact element: This element allows the correct positioning of the instruments in a unique and precise position in relation to the skeletal area to be treated, which allows the actions for which it has been designed to be carried out with greater accuracy. - Stabilization / fixation elements: Since the instruments will not be possible to keep them positioned in the same location during the entire surgical process, since this would require being excessively constrained to the anatomical structure, its adaptation being difficult and therefore subject to technical difficulties that on many occasions they would make the instruments useless. Not even in the scenario where an adaptation was sufficiently constrained to counteract the forces of gravity, it could withstand the vibrations exerted by conventional instruments when acting through them (saws, drills or burs). Therefore, the presence of this element is essential for its proper functioning in the real framework of clinical practice.
    [0028] - Guide element: Through this the conventional instruments will be introduced that will perform the action desired by the surgeon on the chosen anatomical area. Generally sharp and pointed instruments.
    [0029] - Infographics or informative elements: These include any information that assists the surgeon in the use of patient-specific instruments: information on location, positioning, depth gauges, etc.
    [0030] In this way, taking into account these elements, the work flow for the design and manufacture of the instruments object of this invention is as follows:
    [0031] A) Obtaining the images of the patient to be treated in 3D visualization technology, or similar, through CT (Computerized Axial Tomography), of the patient to be treated, performed at the medical center.
    [0032] B) Sending medical images to the center for the design and complementary information of the surgery: surgical technique, approach route, and conventional instruments planned for the intervention.
    [0033] C) Rendering of the sections to obtain the virtual anatomical model of the area to be treated. Transformation of pixels to voxels using approved medical software and with medical supervision).
    [0034] D) Selection of the area of interest ( Region of interest - ROI) eliminating what can interfere with the creation process of the specific instruments through cropping techniques,
    [0035] or by selective transformation of pixels with a value of 1 to a value of 0, or in a group of voxels with a value of 1 to a value of 0 (using approved medical software and with medical supervision. This way we will obtain the Area of Interest.
    [0036] E) Image segmentation to obtain a solid in the form of a coarse mesh, (by means of approved medical software).
    [0037] F) Mesh processing to obtain a watertight and manufacturable solid (without non-manifold geometries ) using hole closure techniques (close trivial), elimination of duplicate triangles ( remove double triangles), reorientation of Inverted triangles ( fix flipped triangles), elimination of degenerated faces ( remove degenerated faces), elimination of tiny layers (remove tiny shells) or not related to the meshing of the area of interest, elimination of non-manufacturable geometries ( remove non-manifold geometry), conversion to a closed mesh (conversion to watertight mesh).
    [0038] G) Implementation of the surgical and contact surface marks in the position desired by the surgeon on the virtual anatomical model and sending the virtual model with the corresponding markers to the surgeon for approval / modification / rectification. This marking can be carried out using specific software that is interactive between the designer and the surgeon in real time. Alternatively, such implementation may be carried out exclusively by the designer according to the instructions given by the surgeon.
    [0039] H) Design of the instruments from the surgical marking indicated on the virtual anatomical model.
    [0040] I) Manufacture using additive manufacturing methods of the definitive version of patient-specific surgical instruments in biocompatible material.
    [0041] Another aspect of the invention is a computer program product comprising computer-readable instructions that, when loaded and executed in a suitable system, perform the steps of the method described above and, in particular, the implementation of the surgical markings traversing the surface of the virtual anatomical model, this software allowing an interaction, in real time, between designer and surgeon, to specify and define the marking.
    [0042] Brief description of the drawings
    [0043] To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, a set of drawings is attached as an integral part of said description in which, with an illustrative and non-limiting nature, it has been represented the next:
    [0044] Figure 1 shows a front view of the tibia (4) with a possible embodiment of the different elements of its IPE, as a contact element (1), the guide element (2) and the fixing element (3) according to the present invention.
    [0045] Figure 2 shows an example perspective view of IPE in an anatomical model of the tibia (3) with a possible embodiment of the contact element (1) and its fixing element (2) according to the present invention.
    [0046] Figure 3 shows an example perspective view of an IPE with an anatomical model of the pelvis (3) with a possible embodiment of the guide element in the form of a groove (1), through which an osteotomy saw will be inserted into a pelvis and a fixation element (2) according to the present invention.
    [0047] Figure 4 shows a side view with a possible exemplary embodiment of a stabilizer element (1) in the form of a handle integrated in the specific patient instruments (2) that achieves better stability in the contact area (3) according to the present invention.
    [0048] Figure 5 shows a side view of a possible exemplary embodiment of a separate handle-shaped stabilizer element (1) that forms part of conventional instruments that are coupled to the IPE (2) according to the present invention.
    [0049] Figure 6 shows a perspective view with a possible exemplary embodiment of a fixing element in the form of two hollow cylinders to introduce two needles, Schanz or converging pins (1 and 2) according to the present invention.
    [0050] Figure 7 shows a perspective view with a possible exemplary embodiment of a fixing element in the form of a hollow cylinder (1) to introduce a compression screw with a cavity detail to house the screw head and offer a more homogeneous pressure distribution. of this in the anatomical model of the pelvis (2) and cutting element (3) according to the present invention.
    [0051] Figure 8 shows a view of the anatomical model of the pelvis (1) with a possible exemplary embodiment of surgical marks corresponding to the location of the parallelepiped-shaped guide element corresponding to the osteotomy plane (2) and of the stabilization / fixation element in cylinder shape (3) according to the present invention.
    [0052] Figure 9 shows a view of the anatomical model of the pelvis (1) with a possible exemplary embodiment of surgical marks corresponding to the location of the parallelepiped-shaped guide element corresponding to the osteotomy plane (2), of the stabilization / stabilization element in cylinder shape (3) and the result of the final IPE according to the present invention.
    [0053] Preferred embodiment of the invention
    [0055] In view of the aforementioned figures and in accordance with the numbering adopted, an example of a preferred embodiment of the invention can be seen in them, which comprises the parts and elements that are indicated and described in detail below .
    [0057] Thus, as can be seen in Figures 1 to 9, the preferred embodiment of the procedure for creating specific patient surgical instruments for the skeletal system essentially comprises the following elements:
    [0059] 1) A contact element (fig. 1 and 2) taking into account the surgical approach to be used in the patient, must be adapted to the bone surface by means of a design of the bone relief mold offered by the patient. For this, it will be preferable to use areas with prominences or bony angulations that optimize the adaptability of the specific instruments. Sometimes more than one point of contact may be required to increase the reliability of the procedure.
    [0061] 2) A guide element (fig. 3) consisting of the holes that pass through the body of the guide through which conventional instruments are introduced in a specific location and direction. Generally, said holes will longitudinally pass through a cylindrical structure or a solid prism, attached to the body of the contact element, which constitutes the body of the guide element whose purpose is to improve the precision of the action of conventional instruments.
    [0063] 3) A stabilization element consisting of a handle or element of fastening elements that facilitate the adaptation of the contact elements by maintaining the same position on the bone during the time required for the specific instruments to perform their action; This requires exerting a certain pressure of the specific instruments on the bone surface in order to obtain an optimal adaptation and stability of the instruments while they perform the function for which they have been designed.
    [0065] These stabilization elements may be:
    [0067] ■ Designed and integrated into the specific instruments themselves (Fig. 4). It is recommended to use them in the case of the design of guides for non-standardized surgical procedures or in cases in which this element can also constitute an element of cohesion.
    [0069] ■ Which are part of a conventional instrument in which the specific instruments are integrated (Fig. 5) In these cases, said specific instruments must provide some structure that adapts to the handle of the general instruments and that facilitates the adaptation of the specific instrument by offering various positions of grip or grip. This is usually recommended when the specific instruments are integrated into conventional surgery systems in standardized surgeries such as arthroplasties.
    [0071] Alternatively, the stabilization element can be constituted by an element or hole for fixation to the bone to facilitate cases of osteotomies where a saw is going to be inserted through its specific slot, producing significant vibrations.
    [0073] There are different forms of fixation to the bone that will take into account different surgical aspects such as: area or area on which the intervention is going to be performed, surgical material that is to be to be used with the guide, bone quality of the patient, extended functions of the instruments, surgical comfort. The design of these must consider the trajectory of the guide elements so as not to interfere with them at any time.
    [0074] ■ Holes whose diameter will depend on the fixation instruments used in each case and may be:
    [0075] ■ Needles, pins and bits of different sizes and diameters, threaded or not (fig. 6).
    [0076] The diameter of these will be determined by the size and nature of the conventional instruments to be inserted. The more vibration it produces, the thicker the fixation instruments should be. In these cases, it is recommended that they be inserted convergently to optimize the hold.
    [0077] ■ Schanz screws or similar (fig. 6): they can offer an alternative to needles and pins, and these are also essential in cases where integration with conventional devices is required, such as external fixators or other manipulation / reduction devices.
    [0078] ■ Compression screws (Fig. 7): Provided that the anatomical area allows it, this will be the preferred method when using conventional instruments that produce significant vibrations that can mobilize the specific instruments.
    [0079] In this preferred embodiment, as can be seen from the elements described above and corresponding to figures 1 to 7, the procedure to follow until obtaining the specific patient surgical instruments is characterized by:
    [0080] ■ Obtaining the image of the anatomical structure of the patient:
    [0081] The medical image in 3D technology, or similar, of the anatomical structure of the patient is acquired in a preliminary step that is not specifically included in the method object of this invention. In this sense, said medical image in 3D visual technology, or similar, can be acquired at any time before carrying out this method, using any suitable technique such as Computerized Tomography (CT).
    [0082] The creation of the virtual anatomical model of the area to be treated, necessary for the creation of the specific instruments, is divided into three steps, the first two being carried out using an approved medical viewing software. The necessary steps are as follows:
    [0083] - Determination of the area of interest or area to be treated (ROI): this includes the area of the surgical approach, the area on which to act and sometimes the bone segment necessary to determine the planned changes in the axes. For this, we will work in a volumetric representation environment ( Volume rendering).
    [0084] - Segmentation: Which can be automatic, manual or mixed. Through this, the limits of the ROI are defined by selecting the area that will later be transformed into a coarse mesh.
    [0085] - Processing of the coarse mesh to obtain a tight anatomical model ( "watertight ') and manufacturable (no geometries" non - manifold').
    [0086] Likewise, the process can be carried out by means of interactive computer software that includes at least one processor capable of carrying out the treatment of the medical image in 3D and the construction of the elements of the specific surgical instruments (IPE). The system may also include a display device, such as a screen, to display the 3D image so that the user can select the region (s) of interest, if applicable, and / or to view the different elements of guide during construction. In addition, this interactive software provides a real-time communication mechanism between the designer and the surgeon. Through which the surgeon is the author of the most important step in surgical planning and this is the determination of the approach route and therefore the exposed bone surface. As well as the location and direction of the gestures to be carried out on the bone structure. All of them can be represented in the form of planes, prisms and axes / cylinders on a virtual anatomical model.
    [0088] The interactive software will consist of an app for portable devices or any other computer equipment, and will contain the necessary modules to carry out all the necessary steps for the design and creation of the specific patient surgical instruments.
    [0090] ■ Determination of the area of interest (hereinafter ROI):
    [0092] The selection of this will be implicit in the request for the CT study carried out by the doctor and must take into account the following aspects: area of the surgical approach, area to be treated, areas of the bone that can inform about bone axes or changes in position of these planned by the surgeon or other useful anatomical references for the rest of the creative process. In general, it will be advisable to select the entire bone structure to be treated, which is present in the CT study. Given the improvement in both the software and hardware for 3D imaging, selecting a wide area of interest will not pose a problem in terms of processing time and will avoid gaps when planning surgery.
    [0094] Therefore, when determining the ROI, the work will be aimed at eliminating all that bone structure around the ROI and not included in it that can interfere with the rest of the creative process.
    [0096] Initially, the selection of the ROI is carried out in a volumetric representation environment where the pixels that make up the 2D images of the strata obtained with CT are transformed into Voxels, then the gradient of Hounsfield values to be displayed will be selected, in the case that we are dealing with will generally be between 200-1000 since this is the density of the bone.
    [0098] To determine the ROI, in this environment, two tools will be used, fundamentally:
    [0100] - Croping: by means of this, the computer software generates an orthohedron that can be manipulated by the operator, giving it the necessary shape and size to include the ROI inside, eliminating all the structures that are not inside.
    [0101] - Free manual selection of a group of voxels that are not part of the bone structure and their elimination.
    [0103] In cases where there is more than one ROI, each bone structure must be isolated from the rest to form an independent model. This will require that sometimes the process described above must be repeated for each of the bone structures that we wish to individualize and subsequently segment. At other times this procedure will be performed only once and we will include all the desired bone structures, which will later be separated during the segmentation process.
    [0104] ■ Segmentation of the virtual anatomical image to define the limits of the ROI:
    [0105] Through this process we are going to define which pixels of each of the sequences will be part of the resulting three-dimensional model, therefore, the value of said pixels will be set to "0 = not included" or "1 = included" in the model. This can be done following three procedures:
    [0106] - Automatic: by means of which a minimum threshold of Hounsfield value is established from which the pixels acquire the value 1. In the case of bone, these are usually values above 200. Although there may be variations depending on bone quality, technique, soft tissue, etc.
    [0107] This method is quick, although it can sometimes be imprecise.
    [0108] - Manual: which consists of determining the pixels with value 1, cut by cut. This procedure is very slow, although very precise.
    [0109] - Mixed: which consists of first performing an automatic segmentation with the desired threshold value and later manually reviewing the pixel values in certain cuts, eliminating those that do not correspond to the ROI, for a better definition of the bone limits. This will be recommended in cases where automatic segmentation does not obtain the necessary precision.
    [0110] Most medical image visualization software allows the segmentation of several ROIs by assigning a label, which are generally color-coded, to each segmented area for subsequent generation into a solid three-dimensional mesh. This mesh transformation procedure is performed automatically by the software.
    [0111] The end result will be the obtaining of a three-dimensional solid in the form of a coarse mesh that must be processed to allow the next steps of the creative process.
    [0112] ■ Mesh processing to obtain the watertight and manufacturable anatomical model:
    [0113] The meshing obtained from medical software requires a transformation both to be able to be materialized through additive manufacturing, and to be able to perform the operations required to create the IPE. The ultimate purpose of post-processing is to obtain a watertight and manufacturable mesh.
    [0114] ■ Watertight: insofar as it is a closed mesh, there are no holes in it that put the outside of the solid in contact with the inside.
    [0115] ■ Manufactured: For this, all non-manifold geometries must be eliminated, which are those that cannot be represented in reality, they are impossible geometries as a result of the mathematical calculations made by the algorithms of medical software used.
    [0116] This is obtained after the application of different filters and automatic or manual mesh processing techniques such as:
    [0117] - Mesh smoothing.
    [0118] - Closure of holes.
    [0119] - Reorientation of inverted triangles.
    [0120] - Elimination of degenerate faces.
    [0121] - Elimination of tiny layers.
    [0122] - Elimination of non-manufacturable geometries.
    [0123] - Conversion to closed mesh.
    [0124] - Remeshing: variation in the number of triangles that make up the anatomical model. After applying the aforementioned procedures, we will obtain a mesh with triangular faces for most of the software (although these can be quadrangular or polygonal) with the necessary characteristics to continue with the manufacturing process.
    [0125] ■ Implementation of the surgical marking and the contact surface on the anatomical model:
    [0126] The surgical mark (fig. 8 and 9) is defined as any line (in the form of a vector, axis or cylinder), plane or geometric figure that crosses the anatomical model and that indicates the action that the surgeon is going to carry out on the bone or cartilaginous structure and therefore must pass through the IPE to form the guide and fixation holes through which the surgeon will perform the action for which said instruments have been designed.
    [0127] In the same way, the marking of the contact surface on the anatomical model will be carried out by coloring the area that is expected to be exposed after the surgical approach, in a different tone from the rest of the model, the outside of the triangles that make up the mesh in the location on which we wish to apply the IPE contact element.
    [0128] Surgical marks will be inserted into the anatomical model by qualified personnel and stored together with the anatomical model to later be sent to the surgeon for approval. These can be uploaded to an external server to be viewed with the appropriate software or mobile application.
    [0129] Surgical marking will be done by:
    [0130] Axes, vectors and cylinders that cross the surface of the anatomical model: These will represent the action of the sharp instruments during surgery: needles, drills, drills, screws, pins, Schanz, etc. Indicating the position and the angles of introduction. They will be used to later create the fixing and guide elements of the IPE.
    [0131] Planes and Prisms: Which represent the action of the cutting elements: saws, chisels, etc ... From these the guide elements will be generated fundamentally. In addition, the contact surface will be marked on the model, through which the surgeon describes the area of the anatomical structure that will be exposed during the surgery and therefore the contact surface will be generated inside.
    [0132] The implementation of the surgical marks and the exposed surface is the step in the creation of the IPE in which the surgeon must be more participative and the technician must vary these as many times as necessary to forward them to the surgeon for approval.
    [0133] Since sometimes this work requires making numerous changes to satisfy the surgeon's requirements with sending and forwarding files. Precisely in this step, it seems more important to us to integrate an interactive software that allows the surgeon to move the surgical marks, as well as color the contact surface to establish communication in real time with the designer technician and thus shorten the time in the most step. complex for the designer and important in the creation of the guide.
    [0135] ■ Design of the specific patient instruments based on the surgeon's marking:
    [0137] From the marking made by the surgeon, three of the essential components of the guide are generated: the contact element (s); fixing elements and guide elements; the infographic element will depend on the designer technician.
    [0139] - Definition of contact elements:
    [0141] It is obtained from the marked or colored area on the surface of the model. There are different techniques for obtaining this contact area:
    [0143] (i) T-spline method : Making an approximation of a mesh or T-spline lines to the contact area of the anatomical surface. There are three techniques to do it:
    [0145] - Manual approximation: Using this technique, different T-spline lines are generated by placing the control points transversely surrounding a section of the bone around the contact area of the anatomical model, at a certain distance and so on in different sections separated by a certain distance to by joining the lines longitudinally to form a T-spline mesh .
    [0147] - Automatic approach: This is carried out by different software automatically. The initial steps consist of creating a mesh with a specific density of faces and positioning it on the desired anatomical model contact surface to later carry out an automatic approximation of this mesh, superimposing it on the anatomical surface of the model.
    [0149] - Semi-automatic approach: the first steps of the automatic are repeated to later manually change certain control points so that they better fit the surface of the anatomical model.
    [0151] - Conversion of an anatomical model mesh (triangular, quadrangular or polygonal) into a T-spline solid by means of the appropriate software and subsequent selection and isolation of the mesh corresponding to the contact area.
    [0153] The meshing obtained by any of the T-spline approximation methods can be extruded following the normal of its component faces and in the opposite direction to the surface of the anatomical model to form a solid. Alternatively, the meshing of the contact zone can be duplicated to be transferred to a certain distance in the opposite direction to that of the anatomical model and later, when both meshes are closed, it constitutes the solid that represents the contact element.
    [0154] In addition, both the initial mesh and the solid after being extruded the first, can be transformed into a triangular mesh exporting them to a mesh processing medium / software to be able to cut to the desired shape and adjust the extension of said mesh to the contact area desired.
    [0156] (ii) Offset method: By means of which a layer identical to part or all of the area marked on the anatomical model is generated from the surface of the anatomical model, but separated, by a certain distance, from the surface of the anatomical model following the direction of the normal of the triangles that compose it and in the opposite direction to the surface of the anatomical model. To later extrude said layer with a certain thickness, following the direction of the normal of the triangles that compose it in the opposite direction to that of the anatomical model, to form the solid.
    [0158] (iii) Solid or Boolean subtraction method: This is especially useful when the contact element needs to be integrated into the guide or fixation element since it is obtained by generating the solids from the surgical marks implemented by the surgeon. that pass through the anatomical model and from which said anatomical model will subsequently be subtracted to obtain the mold of the contact surface in the generated solid.
    [0160] ■ Definition of the fixing and guide elements:
    [0162] The generation of these elements is identical and is performed directly from the surgical marks implemented by the surgeon.
    [0164] Although in most cases the guide and fixing elements will pass through the body of the contact element or will constitute a contact element itself, there may be situations in which this technique varies, such as, for example, when these elements must be inserted percutaneously.
    [0166] We are going to differentiate two groups of elements depending on the shape of the instruments that are going to cross the bone or cartilaginous surface of the anatomical structure:
    [0168] Sharp material: For them the marks will be vectors, axes that will be transformed into cylinders or cylinders directly that cross the anatomical model. In the case of being a cylinder and therefore a solid, this in addition to having a direction and length will have a diameter that will correspond to the diameter of the hole through which the conventional instruments are to be inserted into the guide / fixation element. To be able to be subtracted from the body of said element and to form the hole of the appropriate diameter.
    [0170] Cutting material: in these cases the planes or prisms, marked by the surgeon, that cross the surface of the anatomical model are used to generate a solid with the thickness and size of conventional instruments that is going to be inserted through the slot that they generate when subtracted. to the body of the contact element. In cases where the surgical marking is a plane, the solid can be generated by symmetric extrusion of both sides or by positioning a prism with the desired dimensions on the plane with it traversing its longitudinal axis symmetrically.
    [0172] In all cases, the body of the guide or fixing element can also be obtained from the surgical marks when required, since said body will confer greater precision to the guide element and greater stability to the fixing element. To do this, the cylinder or prism will first be duplicated, generating one of the size to be given to the body of the guide that will be combined or added with the contact element to later subtract the smaller cylinder / prism from said combination to obtain the desired holes. . When the body of the guide is generated by this mechanism, said body can be moved along its longitudinal axis to the desired position to later be integrated into the body of the contact element. When required, the anatomical model can also be subtracted from the body of the guide element after having positioned it where desired.
    [0173] Alternatively, the body of the guide and fixation elements can be generated by dragging or extruding the mesh that constitutes the contact element following the longitudinal axis of the surgical marks in the opposite direction to that of the anatomical model.
    [0174] In specific cases in which it is not desired that the fixing and guide elements come into contact with the anatomical surface and therefore the conventional instruments that are expected to be inserted through their holes act percutaneously; These guide elements must be generated from the surgical marks that will acquire the desired volume and will later be transferred following the longitudinal axis in the desired position and joined to the body of the contact element by means of a cohesion element that must provide a sufficiently rigid joint. to allow the passage of conventional instruments without altering the planned trajectory.
    [0175] ■ Definition of manual stabilization elements:
    [0176] On certain occasions, mechanical fixation of the instruments to the bone structure will not be required, due to the characteristics of the conventional instruments to be used with the IPE. It will be enough to create a holding handle that can be integrated into the IPE itself or be part of an external system.
    [0177] The choice of the type and shape of the handle can be chosen from a list of possibilities in the specific software.
    [0178] ■ Definition of informational elements or infographics:
    [0179] The generation of this element will be carried out by the designer pointing out signs, letters and numbers, in relief, and implemented in the body of the IPE. Its purpose is to assist the surgeon in the correct use of the IPE. The information for the generation of this element will be based on:
    [0180] Location: Especially useful in cases where several pieces of IPE are required for the same surgery. It will determine which is the position of each of the IPE. Positioning: As they can be distal-proximal. Before, after. They assist in the correct positioning of the guide with respect to the anatomical surface.
    [0181] Depth: Generally implemented in the fixing and guide elements. For its correct operation, it will be required that the conventional instruments present some marks that inform about the depth reached when relating them to the IPE infographic.
    [0182] Information on the conventional instruments or implants (such as measurements of these) for which the IPE has been designed.
    [0183] ■ Sending the prototype of the IPE created to the surgeon for approval:
    [0184] Final approval by the surgeon of the designed IPE may be made through two mechanisms, not mutually exclusive:
    [0185] Sending the printed anatomical model together with the IPE prototype for the surgeon to reproduce the steps to be carried out during surgery on the anatomical model before surgery. This method will be especially desirable whenever special, unconventional, or infrequent surgery is to be performed. (As an example in tumor surgery).
    [0186] Delivery of the design of the anatomical model with the instruments attached in the appropriate position and with the surgical marks crossing both. Through specific software or other 3D solid viewing software on eg, smartphones or tables. This method of communication can only be used when more conventional surgeries are performed or those that the surgeon performs with a certain frequency. (As an example in arthroplasties).
    [0187] ■ Creation of definitive IPE:
    [0188] After approval by the surgeon of the IPE prototype, it is manufactured in the final material using any additive manufacturing system. The parameters of the elements that make up the IPE must be calculated taking into account the manufacturing margins of any additive manufacturing system, especially the holes, their diameters during the design of the IPE must be oversized in some cases to allow the passage of the instruments wanted.
    权利要求:
    Claims (6)
    [1]
    1. Interactive procedure for the design and creation of patient-specific surgical instruments (IPE) (1) of the skeletal system characterized in that it comprises a method in which, through a direct interaction between the surgeon and the designer, the specific patient surgical instruments are designed by adapting them to the specific needs to address the surgery designed by him. This instrument inevitably includes the following elements for its creation: one or more contact elements, one or more stabilizing or fixing elements, one or more guide elements and, additionally, an informational element or infographic. And, characterized in that it comprises:
    - Receive a medical image using 3D visualization technology or similar from the CT (Computerized Axial Tomography) of the anatomical structure of the patient.
    - Determination, in said medical image, the region of interest to be treated (ROI) that will contain the area of the surgical approach, the area of action and when necessary the segment of the bone structure that informs the surgeon about changes in the axes; In any case, it can be determined from the segmentation of the entire image of the bone structure to be treated from the CT medical test.
    - Segmentation, using approved software, of the image to obtain, externally, a solid reconstruction in the form of a mesh.
    - Mesh processing , to obtain a watertight and manufacturable anatomical model (without non-manifold geometries ).
    - Assisted implementation between the surgeon and the designer of the necessary surgical marking (vectors, etc.) that represent the surgery on the reconstructed virtual anatomical model.
    - Construction of the contact element to be included on the surface of the virtual anatomical model; conversion of the guide and stabilization elements on the anatomical structure from the surgical marks implemented interactively by the surgeon.
    - Sending the printed anatomical model and the IPE prototype to the surgeon for approval or modification; Alternatively, the anatomical model coupled to the IPE with the surgical marking running through both can be displayed in a virtual 3D environment. - Construction of the specific patient guide in a rigid body or solid using any additive manufacturing system, which includes, in all cases, contact elements, stabilization / fixation elements, and guide elements in biocompatible material.
    [2]
    2. Interactive procedure for the design and creation of patient-specific surgical instruments for surgeries in the skeletal system (1) according to claim 1 characterized by the existence of one or more stabilization elements that will allow to counteract the incidence of conventional instruments when acting through of this element (saws, drills, or strawberries) and that includes the existence of:
    ■ Manual stabilization element: Handle or fastening elements that facilitate the adaptation of the contact elements, maintaining the same position on the bone for the time required for the specific instruments to perform their action; This requires exerting a certain pressure of the specific instruments on the bone surface in order to obtain an optimal adaptation and stability of the instruments while they perform the function for which they have been designed. These elements may be:
    ■ Designed and integrated into the specific instruments themselves. It is recommended to use them in the case of the design of guides for non-standardized surgical procedures or in cases in which this element can also constitute an element of cohesion.
    ■ That they are part of a conventional instrument in which the specific instruments are integrated. In these cases, said specific instruments must provide some structure that adapts to the handle of the general instruments and that facilitates the adaptation of the specific one by offering various holding or gripping positions. This is usually recommended when the specific instruments are integrated into conventional surgery systems in standardized surgeries such as arthroplasties.
    ■ Bone fixation elements or holes: Especially useful in cases of osteotomies where a saw is to be inserted through its specific slot, producing significant vibrations. There are different forms of fixation to the bone, said fixation will be carried out taking into account different surgical aspects such as: zone or area on which the intervention is going to be carried out, surgical material to be used with the guide, bone quality of the patient, expanded instrument functions, surgical comfort. The design of these must consider the trajectory of the guide elements so as not to interfere with them at any time. The instruments must provide holes whose diameter will depend on the fixation instruments used in each case, among them we can find:
    ■ Needles, pins and bits of different sizes and diameters, threaded or not. The diameter of these will be determined by the size and nature of the conventional instruments to be inserted. The more vibration it produces, the thicker the fixation instruments should be. In these cases, it is recommended that they be inserted convergently to optimize the hold.
    ■ Schanz screws or similar: they can offer an alternative to needles and pins, and these are also essential in cases where integration with conventional devices such as external fixators or other manipulation / reduction devices is required.
    ■ Compression screws: Whenever the anatomical area allows it, it will be the preferred method when using conventional instruments that produce significant vibrations that can mobilize the specific instruments.
    [3]
    3. Interactive procedure for the design and creation of patient-specific surgical instruments for surgeries in the skeletal system (1), according to claims 1 to 2, characterized in that the surgical marking will be entered into the virtual anatomical model by qualified personnel using the vector coordinates ( V1, V2, V3), axes (x, y, z) or cylinders (with a certain diameter) that correspond to the trajectory of the sharp objects to be used in surgery; cutting planes (P, u, V) or prisms that correspond to the trajectory of sharp objects to be used in surgery. Sending the virtual model with the markers to the surgeon for approval.
    This surgical marking can alternatively be carried out using specific software that allows the manipulation of the surgical markings, as well as the marking of the preferred contact area by the surgeon and that allows the visualization of the changes made in these and the communication in real time between surgeon and qualified personnel. The software that the surgeon manipulates should automatically limit and offer only the manipulation possibilities that are adapted to the implant specifications. In the same way in case of allowing the choice of the location of the fixing elements, preventing the trajectories that could interfere with the correct operation of the guide element. Alternatively, the surgeon can choose, if required, the shape and size of the stabilizing element in the form of a handle in the specific software.
    [4]
    4. Interactive procedure for the design and creation of patient-specific surgical instruments for surgeries in the skeletal system (1) according to claims 1 to 3, comprising the definition of the guide and stabilization elements for the creation of the instruments by means of the conversion of the marks surgical procedures into solids and therefore characterized by the transformation of the axes or vectors into solid guide cylinders, and the planes into solid guide polyhedra. These solids will have the dimensions of the instruments that are going to be introduced inside them. Subsequently, said solids will be subtracted from the body of the IPE to obtain the desired hole through which the instruments are to be inserted. Thus ensuring that the surgeon's choice is respected. Alternatively, the conversion of the axes or vectors into guiding or fixing elements can be carried out by means of the “snap” or similar function of a cylinder of the required dimensions on one of the faces of the guide cylinder to later be dragged / translated on the longitudinal axis. of the surgical mark or guide cylinder to the desired position. Likewise, for the planes or guide polyhedra, these can be obtained by symmetrical extrusion of both sides of the plane or by dragging the polyhedron provided that said drag allows the guide polyhedron to be positioned precisely and preferably automatically with the guide plane, symmetrically crossing its axis. longitudinal. The cylinders and polyhedron generated from the surgical axes and planes may serve to constitute both the body of the guide / fixation element and the hole after its subsequent subtraction from the body.
    Alternatively, a selective extrusion can be performed in parametric software or selective dragging of some faces in sculpting software, following the longitudinal axis of the surgical marks and in the opposite direction to the contact surface, to form the body of the guide and fixing elements. from which the cylinders or guide polyhedra with the dimensions of the conventional instruments to be used must be subtracted later.
    [5]
    5. Interactive procedure for the design and creation of specific patient surgical instruments for surgeries in the skeletal system (1) according to claims 1 to 4 in which for the creation of the contact surface it will be carried out by creating a T-spline mesh that conforms to the anatomical surface. This can be done through an automated process of the specific software, manually, or in a mixed way (initially automated process with subsequent manual adjustments of the control points) or by transforming the triangular mesh into a T-spline model . This new layer generated by the T-spline technique will be extruded following the normal in the opposite direction to the contact surface to the desired thickness to form the body of the contact element. Alternatively, the thickness can be obtained by doubling the meshing of the contact surface and separating it at a certain distance in the opposite direction to the bone surface and subsequently closing the space between both meshes to form a solid.
    [6]
    6. A system, according to claims 1 to 5, comprising a process for the creation of surgical instruments for a specific patient for surgeries in the skeletal system characterized by the following steps:
    ■ Obtaining the images of the patient to be treated in 3D visualization technology, or similar, through the CAT scan (Computerized Axial Tomography) performed at the medical center. (CT), in the medical center, of the patient to be treated.
    ■ Sending the medical images to the center for the design and complementary information of the surgery: surgical technique, approach, and conventional instruments planned for the intervention.
    ■ Rendering of the cuts to obtain the virtual anatomical model of the area to be treated. (Transformation of pixels to voxels using approved medical software and with medical supervision).
    ■ Selection of the area of interest ( Region of interest - ROI) eliminating that which may interfere with the creation process of the specific instruments by means of cropping techniques or by selective transformation of pixels with a value of 1 to a value of 0, or in a group of voxels with value 1 to value 0 (using approved medical software and with medical supervision. Thus we will obtain the Area of Interest.
    ■ Image segmentation to obtain a solid in the form of a coarse mesh of the ROI using approved medical software.
    ■ Mesh processing to obtain a watertight and manufacturable solid (without non-manifold geometries ). Through hole closure techniques (close trivial), elimination of duplicate triangles ( remove double triangles), reorientation of inverted triangles ( fix flipped triangles), elimination of degenerated faces ( remove degenerated faces), elimination of tiny layers (remove tiny shells) or unrelated to meshing the area of interest, removal of non-manufacturable geometries ( remove non-manifold geometry), conversion to a closed mesh (conversion to watertight mesh ).
    ■ Implementation of the surgical and contact surface marks in the position desired by the surgeon on the virtual anatomical model and sending the virtual model with the corresponding markers to the surgeon for approval / modification / rectification. This marking can be carried out using specific software that is interactive between the designer and the surgeon in real time. Alternatively, such implementation may be carried out exclusively by the designer according to the instructions given by the surgeon.
    ■ Design of the instruments from the surgical marking indicated on the virtual anatomical model.
    ■ Manufacture using additive manufacturing methods of the definitive version of patient-specific surgical instruments in biocompatible material.
    ■ A computer program product comprising computer-readable instructions that, when loaded and executed in a suitable system, perform the steps of the method described, above and, in particular, the implementation of the surgical markings on the contact surface of the virtual anatomical model, This software allows a real-time interaction between designer and surgeon, to specify and define the surgical marking.
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    同族专利:
    公开号 | 公开日
    ES2792649B2|2021-11-08|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US20070288030A1|2006-06-09|2007-12-13|Biomet Manufacturing Corp.|Patient Specific Knee Alignment Guide And Associated Method|
    WO2012151589A1|2011-05-05|2012-11-08|Wright Medical Technology, Inc.|Orthopedic surgical guide|
    US20120290272A1|2011-05-11|2012-11-15|Bryan Jason A|Generating patient specific instruments for use as surgical aids|
    EP3065651A1|2013-11-08|2016-09-14|Orthotaxy|Method for constructing a patient-specific surgical guide|
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