• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    It is the first piece that without maintaining the usual anatomy, favors the transmission of anterior load from the last lumbar vertebra to both iliacos. This load represents between 70 - 80% of the transmission of the same. With this, the subsequent reconstruction is demonstrated with biomechanical studies, that there is less option of failure of it. With its osseointegration, it can allow a direct stabilization with the incorporated osteosynthesis. It implies a more simplified procedure from the surgical point of view within the complexity and duration of these resection surgeries. It provides immediate stability to the lumbopelvic junction. It does not prevent the contribution of graft, car or halo, in the posterolateral area, presumably with greater posterolateral arthrodesis capacity. Not incompatible with chemotherapy. It does not prevent radiotherapy that in cases with conventional reconstruction performed at this time is not possible. This morphology of reconstruction could be carried out in the future with non-metallic materials, what is important is the morphology of the implant that transmits the lumbopelvic physiological load. The reconstruction in cases of root preservation L5- S1 ... may be compatible with the use of this piece. This piece maintains the axes and physiological biomechanical loads. Maintains lordosis and the lumbopelvic relation with its physiological parameters. Less surgical time, more effectiveness. The fact that it reconstructs the anterior column of a uniform and anatomical fauna makes it possible to distribute the loads from the spine to the pelvis in the most anatomical way possible, preventing overloads in these structures. The fact that only the first sacral vertebra and the EBM technique have been reconstructed means that the piece is individualized, presents a low weight and an adequate size so as not to overload the instruments that connect it to the lumbar spine and the pelvis. In addition, as the ESM technique allows modeling according to the criteria of the group designing the piece, it is possible to adapt it to allow a comfortable and noncompressed passage of the neural structures. The sacral replacement piece may be a good solution to initiate early mobilization in patients undergoing total sacrectomy. The EBM additive manufacturing technique involves a manufacturing cost and a time of manufacture and marketing of the implant reduced. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2712653A1
    申请号:ES201700774
    申请日:2017-11-14
    公开日:2019-05-14
    发明作者:Benlloch Juan Antonio Martin
    申请人:Benlloch Juan Antonio Martin；
    IPC主号:
    专利说明:

    [0001] D E S C R I P C l b N
    [0002]
    [0003] PRACTICE OF SACRO A. MARTIN
    [0004]
    [0005] DESCRIPTION
    [0006]
    [0007] The present invention belongs to the sector of the medical-surgical equipment and more specifically to that of the osteosynthesis materials.
    [0008]
    [0009] The sacrum is shaped like a curia, located between the iliac bones and forms the roof and posterosuperior wall of the posterior half of the pelvis. Its triangular shape is due to the rapid decrease in size experienced by the lateral masses of the sacral vertebrae. The lower half of the sacrum does not support weight, so its mass decreases in a very obvious way. The sacrum provides strength and stability to the pelvis, and transmits the weight the body to the pblvica waist, the osseous ring constituted by the bones of the hip and the sacrum, which join the lower limbs. The sacrum supports the vertebral columns and constitutes the posterior part of the osseous pelvis.
    [0010]
    [0011] The tumoral pathology of the sacrum that implies its resection as a result of its involvement of a tumor of malignant or benignant-aggressive characteristics, implies a challenge for the reconstruction of the union of the columns and their transmission of the load from the mechanical point of view. to both ilfacos.
    [0012]
    [0013] Until the invention of the prosthesis of the sacrum, it is possible to perform: (1) a posterior stabilization with instruments with pedicle and iliac screws, which are connected by means of bars. To add to this reconstruction a posterolateral graft contribution between the L4-L5 minimum and both ilfacos. (2) Another option is the placement of some type of fulcrum of support of the 5th lumbar vertebra on a bench halograft located transversally at the level of the iliacs, either by grafting diaphyseal bone, self-graft from the patient himself, or graft from bone bank. (3) Another alternative option is to manufacture titanium meshes that transmit the load from the body of the last lumbar vertebra, and the ilfacos so that the load is transmitted from the axial axis to the ilfacos.
    [0014]
    [0015] All these possibilities are usually very unstable and of doubtful success at medium long term. The failure rate can exceed 50% (according to publications). If the reconstruction is decided by the elements of the Bible, there is a problem in terms of the volume of the element that can facilitate the contamination of the surgical field. On the other hand, it does not ensure integration from a biological point of view, so that the previous load will maintain a certain degree of micromotion that can cause reconstruction and subsequent instrumentation to fail, as shown in different biomechanical studies given the large component of instability in this type of resection. The degree of instability is the maximum given that the alteration of the load transmission occurs with a total discontinuity after the sacrectomy from the anatomical point of view.
    [0016]
    [0017] It is an impiante developed prior to the surgical procedure from the images obtained by CT scan to adapt the angulations of the last persistent lumbar vertebra and both iliacs. The idea is to perform an intersomatic implant but in this location transmits the load from the last vertebral body to both iliac with a piece made by 3D printer with the means obtained in the previous CT study. To favor the osteointegration of the sacrificial part of the sacrum fabricated, its contact surface with the pelvis and the lumbar spine has pores of adequate sizes and interconnections that allow colonization by neovascularization and osteoblastic and osteoclastic cells. In addition, they must also allow the diffusion of nutrients and gases along with the metabolic removal of cellular activity. These porosities range from 100-150 pm in the cortical bone, and from 500-600 pm in the cancellous bone. This can be controlled by a CAD program that makes it possible to generate structures of different geometries and dtserios and with nest pore sizes.
    [0018] It has been demonstrated that the titanium alloy (Ti6AI4V) treated with EBM (additive manufacturing technique) presents a good biocompatibility, stimulates adhesion, growth and cellular differentiation. Adembs provides good cytocompatibility, blood biocompatibility, and gives non-sensitizing or irritant properties both in vivo and in vitro.
    [0019]
    [0020] In this substitute piece, the trajectories for the stabilization screws that would penetrate in the vertebral body of the last vertebrae instrumented in a sense from bottom to top and from front to front, with a diametre of 7 to 8 mm, are prepared in advance to the surrogate surgical procedure. and a length dependent on the size of the vertebral body receptor, this contact surface possesses pores suitable for the vascularization of osteoblastic osteoblastic osteoblastic osteoblastic osteoblastic and osteoclastic cells. The sides, the lateral surface areas that will maintain contact and transmit the load to both iliac presenting the same type of osseointegration surface as well as the holes for the trajectory previously determined for the areas of resection of the sacrum and reception of the prosthesis.
    [0021]
    [0022] Once the transmission of the axial load on the iliac is reconstructed, a standard stabilization is made by pedicular instrumentation. This piece presents an inverted "Y" morphology whose vertical axis has the size and shape of the plate of the last vertebra respected and laterally the two ends maintain the morphology similar to the upper part of the sacrum that would correspond to the first sacral vertebra, with the extension of both wings of the sacrum. It can be made and provided that in the posterior area said piece can maintain and can include a polyaxial thyme head that favors a union to the pedicle screws of the upper segments L4, 5.
    [0023]
    [0024] Figure 0: The conceptual design of the piece is appreciated. This presents an anatomical shape emulating the morphology of the vertebra S1. It was decided not to model the lower part of the sacrum because it was demonstrated that the lumboplavic stability in the case of sacrectomy is provided by the first sacral vertebra. In this way, by not modeling the entire sacrum, the weight of the piece was reduced and interference with nerve structures was avoided. It was decided that the piece was manufactured with a central part of solid titanium to support high loads and a peripherical part, which contacted the porous titanium pelvis, which contacted the pelvis and the spine, to facilitate osseointegration.
    [0025]
    [0026] Figure 1: The starting point for the design of the replacement part of the sacrum was the reconstruction of the lumbar spine, the sacrum and the pelvis generated by a three-dimensional model from the CT of a patient with a primary sacral tumor before surgery. resection (50-year-old male affected by a sacral cordoma who underwent total sacrectomy). From the CT scan, the design of the position of the spine and pelvis and the shape of the superior segments of the sacrum were reproduced. The column, pelvis and sacrum were reconstructed with the MIMICS 17 program and the data was exported to 3-MIMICS 9.0, the program with which the design was finally carried out.
    [0027] Figure 2: Firstly, the base surface of the replacement piece was reconstructed according to the anatomy of the first sacral vertebra in order to obtain a good support in the pelvis and in the spine and to maintain the position and the mPI of the patient. It was given a suitable morphology to avoid interferences of the piece between the transverse apbphysis of L5 and allow the passage of the roots of L5 avoiding being injured by the piece.
    [0028]
    [0029] Figure 3: Secondly, the porous areas (areas of contact with the pelvis and the spine) of the sacral replacement piece were designed, leaving bands to favor osseointegration.
    [0030]
    [0031] Figure 4: Thirdly, the position of the holes for the screws directed to the body of L5 and iliacos was defined and they were made with drills. A flat surface was left in the back to fix a plate that by means of 2 vertical bars the body of the substitute piece to the pedicular screws of L4 and L5 to improve the stability of the assembly before flexion efforts in the sagittal plane.
    [0032]
    [0033] Figure 5: Fourth, to facilitate the grip of the piece to the pelvis, sharp titanium areas were designed to facilitate the transmission of the load between the parts and avoid unwanted movements.
    [0034]
    [0035] Figure 9 and 10: After its manufacture the piece was removed from the machine, the supports were removed, the machining of the holes in the piece was carried out, sand was made to improve the surface quality of the piece and, finally, it was apply a chemical cleaning to ensure the absence of titanium powder in the area of the structure. images of the sacrificial part of the sacrum after its extraction from the EBM machine.
    [0036]
    [0037] Figure 11: The modeling of the pedicle screws, connectors and fixation bars was done with one-dimensional bar-type elements of 2 nodes (BEAM4). The section and the characteristics of these elements depended on the material they simulated. the screws (pedicle and iliac) and bars, a titanium alloy (Ti6A! 4V) was used. The vertical bars, the L-bars and the transylphal bar were CoCr. The connectors (2 of unibn between the bars in L and 2 of unibn between the bars in L between the iliacos and united to the screws of L5) were of Ti6AI4V. The sacrificial piece was constructed with titanium To detect and porous titanium in the contact areas (L5 and pelvis). The contact between the titanium sacrum and the pelvis was modeled using TARGE170 and CONTA173.
    [0038]
    [0039] Figure 12: The contact area of the replacement part with respect to the pelvis and L5 (green areas) in the pelvis was approximately 13000 mm2 and in L5 approximately 2500 mm2
    [0040]
    [0041] Figures 13 and 14: show the complete assembly. The systems used were PolarisTM 5.5 Spinal System (Zimmer Biomet) and OmegaTM 21 Spinal Fixation System (Zimmer Biomet). Monoaxial pedicle screws were placed in L4 and L5 with the hands-free technique, the individual titanium substitute piece that allows a direct support between the vertebral columns and the pelvis. The piece has orifices oriented to lodge 2 illicit screws in each ilt'aco with divergent trajectories and 2 thymes to the vertebral body of L5. The two vertical bars connect the pedicle screws of L4 and L5 to a plate attached to the sacral replacement piece, with 3 fixed central screws, which join the plate with the piece, and 2 holes with a certain clearance to allow bonding of the teeth. vertical bars fixed to the pedicle screws to those of the soma of L5
    [0042]
    [0043] Figure 15 and 16: The trajectories of the thyme from the sacral to pelvis substitute and to the vertebral body of L5.
    [0044]
    [0045] Figure 17: The polyamide model was introduced in the INSTRON 8870 biaxial testing machine (+/- 25 kN) and / - 100 Nm.
    [0046] Pelvic moorings were designed that were rigidly placed at the lower level of the machine.
    [0047]
    [0048] Figure 18: A fresh cadaveric specimen (L2-pelvis), 64-year-old, 77.8 kg, and 1.82 m.
    [0049] Before the experiment, the specimen was subjected to lateral radiography to exclude conditions of osteopenia or anatomical abnormalities, fractures, deformities or tumor disease.
    [0050] The soft tissues for vertebrates were dissected, preserving vertebral ligaments, discs, 6th and joint structures. Subsequently a sacrectomy was performed and the assembly of the prosthesis of sacrum A. Martin, with the same material with which the spinopelvic reconstruction of the study of fatigue was carried out. Then a study was performed with CT and simple x-ray.
    [0051]
    [0052] Figure 19: Subsequently, the specimen was placed in the INSTRON 8872/287 test machine for 3 days under ambient temperature conditions of 24oC and 61% humidity.
    [0053] The cadaver is held firmly at the level of L1 superiorly and the pelvis caudally on the vertical piano to simulate the standing. In the upper plate of L1 a piece of polyethylene was fitted with a semi-spherical seat, so as to allow the load to be applied centered across the column. Each of the ischia was embedded in bone cement (SR Triplex Cold), inside 2 cups, so that the pubic symphysis went into the air.
    [0054] The model is anchored to the lower actuator of the test machine without restricting the lateral displacement of the same. The oargas were transmitted to the model through a sphere connected to the upper actuator.
    [0055]
    [0056] Figure 20, 21, 22 and 23: The reconstruction model of the sacrum supported 250,000 cycles without observing its failure. There were also no signs of loosening or implant failure.
    权利要求:
    Claims (21)
    [1]
    1. Orthopedic fixation piece to fix a first fragment of bone (first lumbar vertebra) to a second fragment of bone (bones iiiacos) by means of stabilization screws that penetrate the vertebral body of the last vertebrae instrumented in a sense from below upwards and from back to front, with a diameter of 7 to 8 mm and a length according to the size of the vertebral body of the receiver. On the sides of the piece, the screws of the same diameter are inserted. A polyaxial thyme head is included in the posterior part of the piece in order to favor the joining of the pedicle screws of the upper segments of the vertebrae 4 and 5. This piece is characterized by its disposition in "Y The pedicle screws are monoaxial in the L4 and L5 vbtebras, the piece allows a direct support between the vertebral column and the pelvis. The piece has orifices oriented to lodge 2 thyroid screws in each ilfaco with divergent trajectories and 2 thymes to the vertebral body of the vertebra L5. The two vertical bars join the pedicle screws of the vertebrae L4 and L5 to a plate attached to the piece, with 3 fixed central screws, which join the plate with the piece, and 2 holes with a clerest clearance to allow the union of the bars vertical fixed to the pedicular thyroids to those of the soma of the vertebra L5.
    [2]
    2. Piece according to claim 1, characterized in that its disposition in "Y" presents a vertical axis with size and shape of the plate of the last vertebra respected, and laterally the two ends maintain the morphology similar to the upper part of the sacrum corresponding to the first sacral vertebra, with the extension of both wings of the sacrum.
    [3]
    Piece according to previous claims, characterized in that the position of the holes for the screws directed to the body of L5 and iiiacos is made with a drill. It has a flat surface on the back to fix a plate by 2 vertical bars to the body of the piece and to the pedicle screws of the L4 and L5 vertebrae in order to improve the stability of the assembly before flexion efforts in the sagittal plane.
    [4]
    Piece according to previous claims, characterized in that the screws (pedicles and iiiacos) and bars are of titanium alloy (Ti6AI4V). The vertical bars, the L-shaped bars and the transiliac bar are CoCr. The connectors (2 of unibn between the bars in L and 2 of union between the bars in L between the iliacos and united to the thyme of the vertebra L5) are of H6AI4V. The sacrificial piece of the sacral is made of standard titanium and porous titanium in the contact areas (the vertebra L5 and the pelvis). For the contact zone between the titanium sacrum and the pelvis, it is modeled using TARGE170 and CONTA173.
    [5]
    Piece according to previous claims, characterized in that the contact area of the piece with the pelvis and the vertebra L5 in the pelvis is 13000 mm2 and in the vertebra L5 of 2500 mm2.
    [6]
    Piece according to previous claims, characterized in that it has a central part of solid titanium to support high loads and a peripheral part that contacts the porous titanium pelvis, which contacts the pelvis and the vertebral column and facilitates osseointegration.
    [7]
    Piece according to the previous claims, characterized in that with its "Y" shape it allows the posterior reconstruction and it is demonstrated with biomechanical studies that there is less option of failure of the technique with the piece.It allows with its osseointegration a direct stabilization with osteosynthesis incorporated.
    [8]
    Piece according to the preceding claims, characterized in that, without preserving the usual anatomy as indicated in claim 2, it favors the transmission of anterior load from the last lumbar vertebra to both iliacs. This load is between 70-80% of the transmission of the same.
    [9]
    Piece according to the preceding claims, characterized in that it allows a direct stabilization with the incorporated osteosynthesis of the screws described in claim 1.
    [10]
    Piece according to the previous claims, characterized in that it avoids interferences of the piece between the transverse apdixes of the L5 vertebra and allows the passage of the roots of L5 avoiding being injured by the piece.
    [11]
    11. Piece according to the preceding claims, characterized in that the design has porous areas (areas of contact with the pelvis and spine), and leave some bands to promote osseointegration.
    [12]
    Piece according to the preceding claims, characterized in that its morphology and arrangement of the rings and its composition implies a more simplified procedure, from the surgical point of view, within the complexity and duration of these resection surgeries.
    [13]
    13. Piece according to the preceding claims, characterized in that with the morphology and composition of standard and porous titanium material provides immediate stability to the lumbopblvica junction.
    [14]
    Piece according to the preceding claims, characterized in that with the composition of the standard and porous titanium material, does not prevent the contribution of graft, car or halo, in the posterolateral area, and achieves a greater capacity of posterolateral arthrodesis.
    [15]
    Piece according to the preceding claims, characterized in that the composition of the standard and porous titanium material is not incompatible with chemotherapy.
    [16]
    Piece according to the preceding claims, characterized in that with the composition of the standard and porous titanium material, does not prevent radiotherapy.
    [17]
    Piece according to the previous claims, characterized in that with the morphology and the transmission of loads it maintains the axes and the physiological biomechanical loads. Maintains lordosis and the lumboplavic relation with its physiological parameters. The sacral reconstruction model supports 250,000 cycles without failure. There are also no signs of loosening or implant failure.
    [18]
    Piece according to the previous claims, characterized in that with the morphology and composition of standard and porous titanium material it means less surgical time, and more effectiveness in the final result of the recovery of the patient.
    [19]
    Piece according to the preceding claims, characterized in that with the morphology and composition of standard and porous titanium material the anterior column of A uniform and anatomical shape makes it possible to distribute the loads of the vertebral column to the pelvis in the most anatomical way possible, preventing overloads in these structures.
    The first vertebra will be reconstructed by the EMB technique and this implies that the piece is individualized, presents a low weight and a suitable size so as not to overload the instruments that join it to the lumbar spine and the pelvis. In addition, the EBM technique allows you to model the piece, according to the criteria of the group that designs it, and makes it possible to adapt it to allow a comfortable and uncompressed passage of the neural structures.
    [20]
    Piece according to the previous claims, characterized in that with the morphology and composition of standard and porous titanium material is the solution to initiate an early mobilization in patients subjected to a total sacrectomy.
    [21]
    Piece according to the preceding claims, characterized in that with the morphology and composition of standard and porous titanium material by the EBM additive manufacturing technique, it involves a manufacturing cost and a reduced time of manufacture and marketing of the implant.
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    同族专利:
    公开号 | 公开日
    ES2712653B2|2020-07-27|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    FR2714591A1|1994-01-06|1995-07-07|Euros Sa|Lumbar-sacral prosthetic implant for use in treatment of scoliosis or degenerative diseases|
    ES2225176T3|1999-07-23|2005-03-16|Eurosurgical|POLIAXIAL CONNECTOR FOR RAQUIDEO IMPLANT.|
    CN201026248Y|2007-02-01|2008-02-27|杨惠林|Artificial sacral vertebra prosthesis|
    法律状态:
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    优先权:
    申请号 | 申请日 | 专利标题
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