![]() Surgical guide for orthopedic correction, method of manufacture and use, and kit that contains it (M
专利摘要:
A guide device for cutting and aligning bone pieces comprising a semi-cylindrical body with a c-section, whose internal face is the negative side of the surface of a bone portion in the area of intervention, and which is adjusted to the bone by a self-healing system. Attachable and fixation by pressure or "snap fit". The customizable self-engaging guide defines a slot for guiding a blade in each cutting plane. The slot is oriented at a certain preselected angle and in a position relative to two anteroposterior and transverse anatomical axes of the patient, when coupled to the corresponding portion of the bone to be intervened. The position and angle are selected during presurgical planning, it also includes notches or signals to determine the alignment on the sagittal axis or rotation of the post-osteotomy bone ends. The position of the reference signals for the alignment on the axis of rotation is selected during presurgical planning. (Machine-translation by Google Translate, not legally binding) 公开号:ES2554568A2 申请号:ES201430932 申请日:2014-06-19 公开日:2015-12-21 发明作者:Claudio Iván SERRA AGUADO;Luis DOMENECH BALLESTER 申请人:Luis DOMENECH BALLESTER;Claudio Ivan SERRA AGUADO; IPC主号:
专利说明:
2 DESCRIPTION SURGICAL GUIDE FOR ORTHOPEDIC CORRECTION, METHOD OF MANUFACTURE AND USE, AND KIT CONTAINING IT 5 FIELD OF THE INVENTION The present invention relates to orthopedic surgical guides, and manufacturing methods thereof. The present invention also relates to methods for correcting angular deviations of long bones. The surgical guide according to the present invention has been designed for surgical procedures that require the replacement of anatomical parts with a specific alignment and rotation that allows maximum functionality with the least bone shortening, but also allows surgical procedures to be guided as a cut, drilling, screwing, remodeling, rearmament and implant placement. BACKGROUND Within the usual orthopedic pathologies, both in humans and animals, it is common to find alterations in the long bones, which imply some kind of angular deviation in one or more of the three planes of space. Some bone defects (such as Halux valgus, coxa vara, genu valgum and genu varum) and some consolidation defects of long bone fractures are treated by osteotomy (bone cutting) and ostectomies (double bone cutting with the extraction of the intermediate fragment ) for lengthening, shortening or realignment of bones. 25 The success or failure of several surgical procedures, such as angular corrections of long bones, depend on the tight replacement of the anatomical parts in the three axes of space, which allow maximum functionality. In cases where the osteotomy pursues the resection of a wedge bone portion to achieve alignment, it is key to achieve it with the least residual shortening of bone. After correcting the structural or anatomical problem, as few foreign or foreign elements as possible should be left as possible, since these elements can be a source of problems in the correct healing and recovery of patients. 353 Osteotomy and reorientation of anatomical parts can be planned based on medical images such as CT or MRI, and the pre-surgical plan can be correlated with intraoperative Rx imaging to help the surgeon find the correct orientation. 5 There are several templates and surgical guides designed specifically for a patient described in the state of the art, which are used to locate needles or screws tightly, to guide bone cuts, to guide the realignment of bone pieces or to insert implants during orthopedic surgical procedures. 10 To perform these functions, it is often necessary to attach different components that, although they get support from the surgeon in achieving a better correction, lengthen and complicate the performance of the surgical act. In addition, these guides must be attached, at least some of the components, to the patient's bone using needles and screws. Once fixed, they are usually left inserted even if they have finished their function, 15 assuming an additional foreign element of risk in the recovery of patients. In case of being removed, in the same act or later, there will have been an additional unwanted injury to the bone at the fixation point. On the other hand, although the alignment in 2 planes is adequately achieved with correctly planned cutting guides, the problem of alignment aligned on the axis of rotation continues to exist, which can lead to residual joint dysfunctionalities. Finally, the use by surgeons of these devices requires specific training and the adaptation of their use to particular cases implies a degree of uncertainty in the final result obtained. Therefore there is still a need for improvement in surgical guides that mitigate at least 25 of the problems described above. SUMMARY OF THE INVENTION To solve the problems set forth, the present application comprises: 1. A guiding device that is fixed by pressure, the use of screws or needles not being necessary, which avoids the injuries that necessarily cause other systems of fixation, it is removable at the end of the intervention, the intervention time is shortened and all this contributes to the patient's recovery time being shorter. 35 2. The procedure for manufacturing the device.4 3. The kit comprising the aforementioned device is also claimed. The guide device for cutting and aligning bone pieces, comprises a semi-cylindrical body with a C-section, which contains a custom-shaped internal three-dimensional bone adaptation surface being the negative of the surface 5 of a long bone portion of the patient in the intervention zone, and that adjusts to the bone by a self-attachable and pressure fixation system, also called “Snap Fit”. The custom self-attachable guide defines a groove to guide a blade in each cutting plane. The groove is oriented at a certain preselected angle and in a position relative to two anteroposterior and transverse anatomical axes of the patient, 10 when coupled to the corresponding portion of the bone to be intervened. The position and angle are selected during pre-surgical planning. The custom self-attachable guide also includes notches or signals to determine the alignment on the sagittal axis or the rotation of the post-osteotomy bone ends. The position of the reference signals for alignment on the axis of rotation is selected during pre-surgical planning. The device may be made of any biocompatible flexible material, including, among others, metal or plastic. In another embodiment, the custom self-attachable guide defines two slots for guiding blades. The grooves are oriented in a certain preselected angle and in a position relative to two anatomical axes of the patient, (anteroposterior and transverse) when coupled to the corresponding portion of the bone to be intervened, so that they delimit a central wedge section of bone to dry out and two extremes. The position and angle are selected during pre-surgical planning. The self-attachable custom guide also includes a hole in the section delimited by the cutting planes, to accommodate a screw fixing the bone wedge to be resected. The custom self-attachable guide also includes notches or signals to determine the alignment on the sagittal axis or the rotation of the post-ostectomy bone ends. The position of the reference notches for alignment on the axis of rotation is selected during pre-surgical planning. 30 The self-attachable custom guide also includes channels suitable for holding drill bits that serve as a guide for locating the position of prosthetic fixation elements. The size, position, orientation and direction of the channels will be determined during pre-surgical planning. 355 In another aspect, the present application includes a procedure for producing the surgical device that comprises, but does not limit, the following steps: 1. Data collection, in particular obtaining a 3D image of the bone to be intervened, through Any possible system, such as computerized axial tomography (CT) or Magnetic Nuclear Resonance (NMR) 2. The virtual reconstruction of the bone, based on the data obtained. 10 3. Surgical planning, in which the determination of parameters such as, but not limited to, the alignment planes of the adjacent joints, the anteroposterior, transverse and sagittal axes and the orientation of the surgical approach will be performed. With the determined parameters, personalized calculations are made for the location and spatial orientation of different aspects to be considered in the guide. For example, calculations such as, but not limited to, the estimation of the best position and orientation of the cutting planes will be made. In a particular embodiment, the estimation of the cutting planes is calculated in a way that ensures the best realignment with the smallest section of bone to be resected. • the estimation of the minimum surface area that the device must have for its correct self-fixation to the bone by pressure or “Snap Fit” system without the need for additional fixing systems. 25 • the estimation of the position of alignment in the sagittal axis or of rotation of the ends resulting from the osteotomy. • the positioning of holes that can accommodate fixing systems such as screws or needles. • the positioning and orientation of channels intended to house drill bits 30 to drill bone at points where subsequently fasteners and / or implants have to be screwed. • The most appropriate thickness and length estimation of screws to be applied. • The selection of the type, shape and size of fixation systems and / or implants to be used. 356 4. Design of the guiding device, with the calculations made and through assisted design techniques and systems, for example by computer (CAD). In a particular embodiment, the device has a semi-cylindrical shape with a C-section, with the necessary length calculated to ensure its self-fixation by pressure, "Snap Fit" system, its internal surface has the exact shape of the negative of the bone to intervene in the decided location, and it contains at least one groove for cutting at the calculated location and orientation and a system for marking the realignment of the post-osteotomy bone ends. In another particular embodiment, the guide design further contains holes for accommodating needles or screws at predetermined locations in the calculations and drill channels with the precalculated location and orientation. 5. Physical manufacturing of the guide device. The designed guide device can be manufactured, among others, by machining techniques or any of the rapid prototyping technologies, such as 3D printing or laser sintering among others. 6. Optionally, the reference bone can also be manufactured in order to be able to carry out a quality control of the manufactured custom guide and / or carry out a pre-intervention test or ex-vivo training. In another aspect of the present application, a kit is included that comprises the surgical aid guide device, as well as the elements necessary to perform the surgical intervention, such as, but not limited to cutting blades, needles, screws, plates and 25 prostheses, according to the calculations and custom designs established in the manufacturing process. In another aspect of the application, two copies of the guide and the necessary elements for the intervention are included in the kit, together with a reproduction identical to the bone to be intervened, in order to practice the ex-vivo intervention. BRIEF DESCRIPTION OF IMAGES AND FIGURES FIGURE 1 shows the guide device (5) attached to the bone (3). 357 FIGURE 2 shows two views of a bone with angular deviation, the cranio-caudal view (1) and the lateral-medial view (2). FIGURE 3 shows the cutting planes (4) calculated on the bone bone (3). 5 FIGURE 4 shows the device (5) in interior elevation view. In the figure you can see the internal face (6) that corresponds to the bone negative, the channels (8) to accommodate drill bits, the grooves for the cutting guide (9) and the breaking points (11) . 10 FIGURE 5 shows the device (5) in exterior elevation view. The figure shows the grooves for the cutting guide (9), the channels (8) to accommodate drill bits and the hole to fix the device to the bone (10) in the area to be dried. FIGURE 6 shows a section of the device (5) in side view, being able to observe the extension of its extensions (7) that allows the self-fixing by pressure or "Snap Fit". FIGURE 7 shows a cross-section of the device (5) coupled to a cross-section of the bone (3) and a drill (14) suitable for insertion through the channel (8) and drilling the bone (3). FIGURE 8 shows, schematically, a side of the intervention area where the bone (3), the device (5) can be seen, in this case the attachment of the device to the bone has been reinforced by means of a screw (12) screwed to the bone by the area to be removed, the breaking points (11) of the device, the blade (13) represented only partially, suitable for running through the grooves (9) of the guide. FIGURE 9 shows the device (5) in side view. The figure shows the channels (8) to accommodate drill bits, the grooves for the cutting guide (9) and the marks (15) to align the rotation. FIGURE 10 shows, schematically, a side of the intervention area where the bone (3), the cross-sectional device (5), the slots for the cutting guide (9), the channels ( 8) to accommodate drill bits and drill bit (14) by drilling the bone (3). 358 DESCRIPTION OF A MODE FOR CARRYING OUT THE INVENTION A way of carrying out the invention is described below, which is merely explanatory and therefore cannot be understood as limiting it. The object of the present extends to other possible executions of the invention that share the technical solutions that are claimed even when they may vary in terms of the specific way of executing, both in the process by adding or omitting steps, and in the device by adding or removed elements or the number in which they are found, or the kit including other devices or giving it a different configuration or content. In a first aspect, the present invention consists of a removable surgical guide device (5), designed for a single use, specific for a patient, with semi-cylindrical shape and C-section as described in Figure 6, whose method of attachment to The selected surgical area, known as Snap Fit, is based on its own semi-cylindrical shape, the flexibility of the materials with which it is constructed and the pressure that its extensions (7) exert towards the interior, whose internal part (6) is the negative of the patient's own bone (3), thus achieving a perfect adjustment to the pre-selected area where it is fixed by the pressure that its extensions (7) make 20 inwards or “snap fit” technique. This feature, which ensures the adjustment to the bone without the need for needles or screws, allows the guide device to be removed during or at the end of the procedure without causing any damage to the bone that will remain in use. The guide device (5) self-coupled to the area of the bone (3) to be operated, is shown in Figure 1. 25 The guide device described comprises, but does not limit its use for example for the correction of angular deviations of long bones as shown in figure 2. In one possible embodiment, the guide device (5) comprises a groove (9) that delimits a plane with a pre-determined orientation in two spatial axes, to incorporate the saw blade ( 13) and guide the osteotomy cut. In a second possible embodiment, the guide device comprises two grooves (9) to orient the cut in two planes (4), which allows the resection of a wedge-shaped bone segment. In a specific case, the definition of the cutting planes is such that it ensures9 the congruence of the ends of the resection for subsequent reconstruction, ensuring the minimum resection of bone necessary for the correction of the defect. In order to keep the assembly together until the moment of the intervention but at the same time favoring the free movement of the blade through the grooves, some breakpoints (11) are provided. 5 The guide device (5) comprises marks or signals (15), which may have the form of notches, holes, or any other shape, at predetermined points during surgical planning, which will direct, during reconstruction, the proper alignment not only in the antero-posterior and transverse plane (achieved by the cutting planes (4), but also on the sagittal or rotation axis. 10 The guiding device (5) comprises at least one hole (10) at a predetermined point during the planning surgical, to accommodate and direct the placement of fixation systems such as needles or screws.In a specific case, a hole (10) will accommodate a screw (12) or bone fixation needle, in the wedge to be resected. Another particular example, the orifice 15 of the guide can determine a channel (8), such as that described in Figure 7, with a certain direction and direction, estimated during surgical planning, which can accommodate and direct a a drill 14 for making holes in the bone, which will subsequently house screws 12, for example but not limited to the fixation of bone ends or plates, implants or prostheses. 20 For the purpose of this application it is possible to carry out an orthopedic intervention that includes but does not limit the following steps: 1. Place the device on the bone (3). The guide device (5) will auto-engage in 25 the only place where it fits and is fixed, due to its custom design, as shown in figure 1. 2. If deemed necessary, fix the guide device (5) with a screw (12), in the hole (10) defined in the area of the wedge bone to be resected, according to the planning done previously, as shown in Figure 8. 3. Mark the bone marks on the bone. rotation, following the signals defined in the guide device 15, in a particular case the signals are notched. 3510 4. Insert the drill bits into the channels defined in guide 8 and drill the bone to accommodate screws intended for preselected implants in the planning. 5. Insert the saw blade (13) through the grooves defined (9) and make the cuts following the plans defined by the guide. 5 6. Remove the resected bone segment with the guide portion attached to it. 7. Remove the remaining part of the guide device, decoupling it from the bone ends. 10 8. Reduce both bone fragments so that the rotation marks are aligned. 9. Stabilize the fragments in their predetermined position with the implants chosen, using the holes made in the bone in step 4. 15 10. Proceed to close the surgical field. In another aspect, the present application includes a method for producing the surgical device that comprises, but does not limit, the following steps: First stage of data collection, in particular obtaining medical images with sufficient resolution to collect with sufficient quality the details of the anatomical structures of interest. The images can be acquired by any of the available medical imaging systems. The acquired images 25 can be digitized, if they were not from the acquisition process. Typically at present, the image is computed tomography (CT) or Magnetic Nuclear Resonance (NMR). A second stage of virtual three-dimensional reconstruction of the bone to intervene in each particular case, based on the data obtained. For the reconstruction of the bone model to be intervened, any of the available or specific medical imaging computer systems can be used. A third stage of surgical planning in which, based on the model built 35 in the previous stage, the determination of parameters such as, but not11 limited to, the alignment planes of adjacent joints, the anteroposterior, transverse and sagittal axes and the orientation in which the surgical approach will be performed. In a particular embodiment, the need for implant placement, and / or fixation systems to be applied on the bone ends during bone reconstruction in the intervention, to ensure proper healing and functional recovery is also determined. This surgical planning can be done, either manually, or using available or specific computer systems. With the determined parameters, personalized calculations are made for the location and spatial orientation of different aspects to consider in the guide. For example, calculations such as, but not limited to 10 • will be made to estimate the best position and orientation of the cutting planes. In a particular embodiment, the estimation of the cutting planes is calculated so as to ensure the best realignment with the smallest section of bone to be resected. 15 • the estimation of the minimum surface area that the device should have for proper self-fixation to the bone by pressure or “Snap Fit” system without the need for additional fixation systems. 20 • the estimation of the position of alignment in the sagittal axis or of rotation of the resulting ends to the osteotomy. • the most appropriate positioning of holes that can accommodate fixing systems such as screws or needles. 25 • the positioning and orientation of channels intended to house drill bits for drilling bone at points where fasteners and / or implants have to be screwed later. 30 • The most appropriate thickness and length estimate of screws to apply. • The selection of the type, shape and size of fixation systems and / or implants to be used. 3512 A fifth stage of the design of the guide device (5), with the calculations made and by means of techniques and systems of computer-aided design (CAD). In a particular embodiment, the guide device has a semi-cylindrical shape with a C-section, with the necessary length of its extensions (7) calculated to ensure its self-fixing by pressure or "Snap Fit" system, its internal surface (6) has the Exact form 5 of the bone negative (3) to intervene in the decided location, and contains at least one slot (9) for cutting at the calculated location and orientation and a system for marking the realignment of the post-osteotomy bone ends. In another particular embodiment, the guide device contains two slots (9) for cutting guide, so that they determine the area of the bone to be resected. In another particular embodiment, the guide design further contains holes (8) for accommodating needles or screws in predetermined locations in the calculations and channels (10) for bits (14) with the precalculated location and orientation. A sixth stage, physical manufacturing of the guide. The designed guide device may be manufactured, among others, by machining techniques or any of the rapid prototyping technologies, such as but not limited to 3D printing, laser sintered. The guide device can be made of any flexible material that allows the coupling and fixation to the bone by pressure, which is biocompatible, including but not limited to, metal or plastic. In a particular embodiment, the manufacturing process includes an additional step for the manufacture of a physical bone model, identical to the reference bone. Manufacturing will be done based on the bone modeled in the second stage of the procedure described above. The custom model bone can be manufactured, among others, by 25 machining techniques or any of the rapid prototyping technologies, such as but not limited to 3D printing, laser sintered. The custom model bone can be made of any material. Typically the material will have a consistency similar to the reference bone, whether biocompatible or not. In a particular embodiment, the manufactured reference bone is used, among others, to be able to perform a quality control 30 of the manufactured custom guide. In another particular embodiment, the manufactured reference bone is used among others, to carry out a pre-intervention test or ex-vivo training. In another aspect of the present application, a kit is included comprising the surgical help guide 35, as well as the custom selected elements, necessary for13 perform at least part of the surgical procedure, such as, but not limited to, cutting blades of a certain length and thickness appropriate to the grooves designed in the guide, as well as, but not limited to needles, screws, plates and prostheses, of determined shapes, thicknesses and sizes, according to the calculations and custom designs established in the manufacturing process. These elements can be manufactured in different materials 5 according to the function to be performed, typically these materials are biocompatible and allow high temperature sterilization, being able to be custom designed or selected from available standards. In another aspect of the application, the kit includes, at least two copies of the guide and the 10 elements necessary for performing at least part of the intervention, together with the physical bone model, reproduction identical to the bone to be intervened, to be able to practice the ex-vivo intervention.
权利要求:
Claims (1) [1] 14 CLAIMS 1. SURGICAL GUIDANCE DEVICE characterized in that it comprises a tubular body made totally or partially of flexible and biocompatible material, longitudinally open, with a “C” cross section with extensions (7) which in turn comprises an internal surface (6) reproduces , negatively, the surface of the bone (3) in the area to be intervened, and is suitable for coupling and pressure fixing the device to the area of the bone to intervene, and guide elements comprising at least one slot (9) that sections, totally or partially, the body of the guide device. 102 SURGICAL GUIDING DEVICE according to claim 1, characterized in that the guide elements comprise two grooves (9), which determine pre-determined cutting planes (4). 3. SURGICAL GUIDING DEVICE according to claims 1 and 2 characterized by the fact that the device area between both slots has a hole (10) to house fixing elements. 4. GUIDE DEVICE A SURGICAL according to any of the preceding claims, characterized in that it comprises guide elements (15) for alignment in the sagittal or rotational axis. 5. SURGICAL GUIDANCE DEVICE according to any of the preceding claims, characterized in that the guide elements comprise through holes (8) between the outer and inner face of the device, to guide drill bits (14) to make holes in bone (3) with a pre-determined direction and sense. 6. SURGICAL GUIDANCE DEVICE according to any of the preceding claims, characterized in that the interior of the grooves (9) has breaking points (11) .307. PROCEDURE FOR THE MANUFACTURE OF A SURGICAL GUIDE, which comprises obtaining a volume of information about the specific bone through intervene, the virtual three-dimensional modeling of the bone to intervene, the planning of the surgical intervention and the design of the guide described in the 35 claims tions 1 to 6 characterized by taking as a basis the data obtained and15the virtual or physical modeling of the bone to be intervened, the following sub-processes are carried out: Sub-process for determining the angle of modification of the bone that comprises the following phases: 5th. Determination of the axis on which the deviation exists. b. Calculation of the cutting angle necessary to counteract the angle of deviation of the bone in that axis. Sub-process for determining the point of the bone where to perform the resection, which comprises the following phases: 10a. Calculation of the bone sections in the different possible Cut points b. Comparison of bone sections at different cut points c. Selection of the cut point where the bone section is smaller. Sub-process for the calculation of the minimum interior surface of the device for its fixation by pressure to the area of the intervention. 8.-Kit that includes the surgical guide and a reproduction of the bone to intervene
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同族专利:
公开号 | 公开日 ES2554568B1|2016-12-01| ES2554568R1|2016-02-23|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 WO2019076421A1|2017-10-22|2019-04-25|Hafez Mahmoud Alm El Din|A method for treating and repairing knee fractures resulting from benign tumors using patient-specific electronic templates|US5449360A|1991-08-23|1995-09-12|Schreiber; Saul N.|Osteotomy device and method| ZA933167B|1992-05-03|1993-11-14|Technology Finance Corp|Surgical instruments| US5613969A|1995-02-07|1997-03-25|Jenkins, Jr.; Joseph R.|Tibial osteotomy system| GB2334214B|1998-02-12|2003-01-22|John Knowles Stanley|Cutting guide|
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2015-08-13| PC2A| Transfer of patent|Owner name: CLAUDIO IVAN SERRA AGUADO Effective date: 20150807 | 2016-12-01| FG2A| Definitive protection|Ref document number: 2554568 Country of ref document: ES Kind code of ref document: B1 Effective date: 20161201 | 2021-09-29| FD2A| Announcement of lapse in spain|Effective date: 20210929 |
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申请号 | 申请日 | 专利标题 ES201430932A|ES2554568B1|2014-06-19|2014-06-19|SURGICAL GUIDE FOR ORTHOPEDIC CORRECTION, METHOD OF MANUFACTURE AND USE, AND KIT CONTAINING IT|ES201430932A| ES2554568B1|2014-06-19|2014-06-19|SURGICAL GUIDE FOR ORTHOPEDIC CORRECTION, METHOD OF MANUFACTURE AND USE, AND KIT CONTAINING IT| 相关专利
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