CN108670504B - Personalized artificial vertebral body implant based on additive manufacturing and design method thereof - Google Patents
Personalized artificial vertebral body implant based on additive manufacturing and design method thereof Download PDFInfo
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- CN108670504B CN108670504B CN201810338418.1A CN201810338418A CN108670504B CN 108670504 B CN108670504 B CN 108670504B CN 201810338418 A CN201810338418 A CN 201810338418A CN 108670504 B CN108670504 B CN 108670504B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30968—Sintering
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/3097—Designing or manufacturing processes using laser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
Abstract
The invention relates to the field of medical instruments, and discloses a personalized artificial vertebral body implant based on additive manufacturing, which comprises an artificial vertebral body, wherein the artificial vertebral body comprises an inner pore layer and an outer dense layer wrapping the periphery of the inner pore layer, the inner pore layer is a lightweight designed pore structure, the porosity of the pore structure is 75% -80%, the diameter of a pore is 500-700 mu m, two nail placing holes are respectively arranged on the upper end surface and the lower end surface of the inner pore layer, four nail placing holes form two nail paths, and the thickness of the outer dense layer is more than 2 mm. The personalized artificial vertebral body implant based on additive manufacturing and the design method thereof can reconstruct physiological curvature and accurately match with a bone defect region, and are beneficial to bone fusion and long-term stability of a patient.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a personalized artificial vertebral body implant based on additive manufacturing and a design method thereof.
Background
The vertebral body is the main part of the load bearing of the vertebral column, the inside is filled with cancellous bone, the cortical bone on the surface is thinner, the upper surface and the lower surface are rough, the vertebral body is connected with the adjacent vertebrae by means of intervertebral fibrocartilage, the rear edge of the vertebral body is slightly sunken and forms vertebral holes together with the vertebral arch, and each vertebral hole is communicated to form a vertebral canal for containing the spinal cord.
At present, the classical reconstruction method aiming at the massive bone defect caused by spinal tumors is formed by filling a titanium mesh into bone grafting and fixing an anterior steel plate screw or a posterior pedicle screw. The titanium mesh is placed at the defect part of the vertebral body to play a role in supporting and fixing, and the titanium plate screw or the pedicle screw fixing system is used for fixedly connecting the upper vertebral body and the lower vertebral body which are adjacent to the removed vertebral body. The long-term follow-up finds that the postoperative long-term stability of the reconstruction technology is not satisfactory, and the main reason is that the titanium mesh reconstructed in the anterior way is manually manufactured in the operation of an operator, a good matching relation is difficult to form between the titanium mesh and bone contact surfaces of an upper vertebral body and a lower vertebral body, complications such as long-term fixing failure and the like of inclination, displacement, subsidence, extraction and displacement of titanium plate screws or pedicle screws and the like of the titanium mesh easily occur after the operation, and serious patients need secondary anterior surgery and (or) posterior decompression fixing surgery. In addition, the front titanium plate and the titanium mesh are manufactured by a uniform process, the titanium plate matched with anatomical morphology is lacked, the intraoperative shaping of the titanium mesh completely depends on the operation experience of an operator, the requirement of accurate matching with a reconstruction region cannot be met, the operation time is increased, the operation bleeding amount is increased, the possibility of intraoperative infection is increased, and meanwhile, the possibility of basic diseases of heart, lung, liver and kidney and the incidence rate of various complications caused by poor basic conditions and (or) old patients are increased.
In view of the above, there is a need for a better method for designing a reconstruction implant for spinal tumor bone defect, which can ensure the physiological curvature of the reconstruction region and the precise matching of the bone contact surface, and is helpful for the bone fusion and long-term stabilization of patients.
Disclosure of Invention
The invention aims to overcome the defects of the technology, and provides a personalized artificial vertebral body implant based on additive manufacturing and a design method thereof, which can reconstruct physiological curvature and accurately match with a bone defect region, and are beneficial to bone fusion and long-term stability of a patient.
In order to achieve the purpose, the personalized artificial vertebral body implant based on additive manufacturing comprises an artificial vertebral body, wherein the artificial vertebral body comprises an inner pore layer and an outer dense layer wrapping the periphery of the inner pore layer, the inner pore layer is of a pore structure designed in a light weight mode, the porosity of the pore structure is 75% -80%, the pore diameter is 500-700 mu m, two nail placing holes are respectively formed in the upper end face and the lower end face of the inner pore layer, the four nail placing holes form two nail paths, and the thickness of the outer dense layer is larger than 2 mm.
Preferably, bone grafting areas are arranged on the upper end face and the lower end face of the internal pore layer to facilitate bone grafting in an operation, coatings are arranged on the upper end face and the lower end face of the internal pore layer, the coatings are formed by hydroxyapatite through one or more of plasma spraying, electrochemical deposition or bionic deposition, the pore structure adopted by the internal pore layer is matched with the placement position of the artificial vertebral body implant and the data of the bone defect area of the patient, the pore structure is made of one of titanium alloy, high polymer material or bioceramic through one of a laser sintering technology, a selective laser melting technology or an electron surgery melting technology, the upper end face of the internal pore layer corresponds to the contact surface of an upper vertebral body in a target reconstruction area, and the lower end face of the internal pore layer corresponds to the contact surface of a lower vertebral body in the target reconstruction area, the upper end face and the lower end face form an included angle matched with physiological radians of front edges of upper and lower vertebral bodies of a pathological change simulation operation segment of a patient, the upper end face and the lower end face are rough faces simulating bone, target bone defect region data of the patient are extracted from preoperative imaging original data of the patient to establish a spine model, curved faces of artificial vertebral body plants in contact with the spine model are designed according to the target bone defect region data of the patient, and the spine model is enabled to be tightly attached to the upper end face and the lower end face of the inner pore space layer.
Preferably, the upper end face and the lower end face correspond to a lower end plate of an upper vertebral body and an upper end plate of a lower vertebral body of the target reconstruction region respectively, the length of a transverse axis of the upper end face and the length of a transverse axis of the lower end face are less than 6mm of the maximum transverse diameter of the end plate of the vertebral body, and the length of a longitudinal axis of the upper end face and the length of a longitudinal axis of the lower end face are less than 5mm of the maximum median sagittal diameter.
Preferably, the external compact layer is divided into a front end surface and a rear vertebral canal surface, the front end surface is matched with the physiological radian of the front edges of the upper and lower vertebral bodies of the pathological change surgical planned segment of the patient, the rear vertebral canal surface is a smooth surface, and the central part of the rear vertebral canal surface is in an arc-shaped concave shape and narrows down.
Preferably, still include two symmetrical arrangement and be in the supplementary fixing device in side of artifical centrum main part both sides, supplementary fixing device in side is according to the design of walking shape of patient's lesion department pedicle of vertebral arch, supplementary fixing device in side's position and patient's lesion department pedicle of vertebral arch position phase-match, supplementary fixing device in side with artifical centrum main part forms the contained angle with patient's pedicle of vertebral arch actual angle assorted, supplementary fixing device in side's the axis of ordinates length is not less than 1.5 times of pedicle of vertebral arch nail length, supplementary fixing device in side forms through the additive manufacturing technology manufacturing.
Preferably, two pedicle screw channels are respectively arranged in the two lateral auxiliary fixing devices, the inner diameter of each pedicle screw channel is larger than the outer diameter of each pedicle screw, the inner walls of the pedicle screw channels are rough, the anterior decompression and posterior fixation are facilitated, bone cement can be used in the operation to connect the posterior pedicle screws with the anterior artificial vertebral body, and the three-column fixation is really realized.
Preferably, draw the defective regional data of patient's target bone and establish backbone model in the image original data before the patient art, artifical centrum main part basis backbone model simulates two the nail way, the transversal kidney shape of personally submitting of artifical centrum main part, if the lesion centrum does not take place to collapse, artifical centrum main part design height is than lesion centrum motion unit height 2mm less, if the lesion centrum takes place to collapse, artifical centrum main part design height is than the high average value of lower position centrum motion unit 2mm less, artifical centrum main part links to each other with way of escape pedicle screw, artifical centrum main part forms through the manufacturing of vibration material disk technique.
Preferably, the direction of the nail placing hole is determined according to the median sagittal plane of an upper vertebral body and a lower vertebral body in a patient target reconstruction region, the front edge of the artificial vertebral body points to the rear upper edge of the vertebral body, threads convenient for locking a front screw are arranged at the opening of the nail placing hole, the aperture of the nail placing hole is larger than 4.6mm, the cohesion angle of the nail placing hole is matched with the data of the vertebral body of a patient, and the cohesion direction of the nail placing hole is respectively matched with the upper end face and the lower end face to form an included angle matched with the data of the vertebral body of the patient.
A method of designing an additive manufacturing based personalized artificial vertebral implant, comprising the steps of:
A) collecting preoperative CT and MRI data of a patient;
B) designing a profile of the artificial vertebral body based on the pre-operative CT and MRI data of the patient collected in the step a);
C) designing the nail path based on the pre-operative CT and MRI data of the patient collected in the step A);
D) performing Boolean operation on the artificial vertebral body contour and the nail path obtained in the step B) and the step C) in CAD software to obtain the positions of four nail placing holes on the artificial vertebral body;
E) further dividing the artificial vertebral body obtained in the step D) into an outer compact layer, wherein the thickness of the outer compact layer is more than 2 mm;
F) performing Boolean operation on the artificial vertebral body obtained in the step D) and the external compact layer obtained in the step E) to obtain an internal pore layer;
G) respectively manufacturing bone grafting areas on the upper end surface and the lower end surface of the internal pore layer obtained in the step F), wherein the positions of the bone grafting areas are matched with the areas of the upper end surface and the lower end surface of the artificial vertebral body;
H) selecting a pore structure matched with the focus position according to the focus position;
I) and D) carrying out assembling Boolean operation on the pore structure selected in the step H) and the external compact layer obtained in the step E) to obtain the artificial vertebral body.
Preferably, in the step G), when the area of the upper and lower end surfaces of the artificial vertebral body is small, the bone grafting region is not formed on the upper end surface and the lower end surface of the internal pore layer obtained in the step F), and in the step I), if the lesion site of the patient meets the anterior-posterior combined fixation condition, the lateral auxiliary fixation device is designed to be synthesized with the artificial vertebral body to form the artificial vertebral implant.
Compared with the prior art, the invention has the following advantages:
1. the artificial vertebral body implant designed by the invention has high matching degree for reconstruction of a defect area, the fixed position of the locking screw is accurate, the operation in the operation is simpler, more accurate and more reliable than the traditional mode, and the personalized accurate reconstruction of the target defect area can be realized by detailed planning before the operation aiming at the defect of the reconstruction scheme of the traditional titanium mesh and titanium plate;
2. the personalized artificial vertebral body implant is more suitable for the personalized spine pathological change part, the personalized spine physiological curvature and the personalized bone defect area in the operation of a patient, saves the operation time of cutting titanium meshes, bending plates and the like in the operation of an operator, reduces the operation time of the patient, reduces the operation risk and is more beneficial to the recovery of the spine function of the patient;
3. the cross section of the artificial vertebral body is kidney-shaped, and one side close to the spinal cord is concave to avoid the spinal cord, so that the stenosis of the vertebral canal or the nerve compression caused by osteophyte which is possibly proliferated at the later stage can be prevented;
4. the artificial vertebral body is designed in a layered mode, different pores are designed according to the individualized operation area of a patient, the weight of an internal implant is reduced to the greatest extent while the bearing capacity of the artificial vertebral body is guaranteed, and osseointegration is promoted;
5. the artificial vertebral body adopts a fixing concept of '0' notch fixing, so that the stimulation to the front soft tissue is further reduced, and the front screw is prevented from falling out by adopting a locking and fixing mode for the steel plate screw hole;
6. bone grafting areas are arranged on the upper end surface and the lower end surface of the internal pore layer of the artificial vertebral body main body, so that bone grafting operation in an operation is facilitated, and postoperative bony fusion is accelerated;
7. two be equipped with a pedicle of vertebral arch nail passageway in the supplementary fixing device of side respectively, the internal diameter is a bit bigger than pedicle of vertebral arch nail external diameter, and the inner wall is coarse, is favorable to anterior way decompression back way fixed, and usable bone cement makes the artificial centrum main part in place of rear pedicle of vertebral arch nail and place ahead continuous in the art, really realizes "three posts" and fixes.
Drawings
FIG. 1 is a schematic structural view of an additive manufacturing-based personalized artificial vertebral body implant according to the present invention;
FIG. 2 is a side view of the structure of FIG. 1;
fig. 3 is a schematic top view of the structure of fig. 1.
The components in the figures are numbered as follows:
the artificial vertebral body comprises an artificial vertebral body 1, a lateral auxiliary fixing device 2, an upper end surface 3, a lower end surface 4, a front end surface 5, a rear vertebral canal surface 6, a nail placing hole 7, an external compact layer 8, an internal pore layer 9 and a bone grafting area 10.
Detailed Description
The invention is described in further detail below with reference to the figures and the specific embodiments.
As shown in fig. 1, 2 and 3, the personalized artificial vertebral body implant based on additive manufacturing of the invention comprises an artificial vertebral body 1, wherein the artificial vertebral body 1 comprises an inner pore layer 9 and an outer dense layer 8 wrapping the periphery of the inner pore layer 9, the inner pore layer 9 is a pore structure with a light weight design, the porosity of the pore structure is 75%, the pore diameter is 500 μm, two nail placing holes 7 are arranged on the upper end surface 3 of the inner pore layer 9, two nail placing holes 7 corresponding to the two nail placing holes 7 on the upper end surface 3 are arranged on the lower end surface 4, two nail paths are formed by the four nail placing holes 7 in a vertically corresponding manner, and the thickness of the outer dense layer 8 is 3 mm.
Bone grafting areas are arranged on the upper end surface 3 and the lower end surface 4 of the internal pore layer 9, coatings are arranged on the upper end surface 3 and the lower end surface 4 of the internal pore layer 9, the coatings are formed by hydroxyapatite in a plasma spraying mode, in other embodiments, the coatings can also be formed by hydroxyapatite in an electrochemical deposition or bionic deposition mode, the pore structure adopted by the internal pore layer 9 is matched with the placement position of the artificial vertebral body implant and the bone defect area data of a patient, the pore structure is made of titanium alloy by a laser sintering technology, in other embodiments, the pore structure can also be made of high polymer materials or bioceramic, the manufacturing method can also adopt a selective laser melting technology or an electron surgery melting technology, the upper end surface 3 of the internal pore layer 9 corresponds to a contact surface of an upper vertebral body in a target reconstruction area, and the lower end surface 4 of the internal pore layer 9 corresponds to a contact surface below the target reconstruction area, the upper end face 3 and the lower end face 4 form an included angle matched with physiological radians of front edges of upper and lower vertebral bodies of a pathological change operation planned segment of a patient, the upper end face 3 and the lower end face 4 are rough faces simulating bone, target bone defect region data of the patient are extracted from preoperative imaging original data of the patient to establish a spine model, a curved surface of an artificial vertebral body implant in contact with the spine model is designed according to the target bone defect region data of the patient, and the spine model is tightly attached to the upper end face 3 and the lower end face 4 of the inner pore layer 9.
The upper end face 3 and the lower end face 4 correspond to a lower end plate of an upper vertebral body and an upper end plate of a lower vertebral body of the target reconstruction region respectively, the length of a transverse axis of the upper end face 3 and the length of a transverse axis of the lower end face 4 are 6mm less than the maximum value of the transverse diameter of the end plates of the vertebral bodies, and the length of a longitudinal axis of the upper end face 3 and the length of a longitudinal axis of the lower end face 4 are 5mm less than.
The external compact layer 8 is divided into a front end face 5 and a rear vertebral canal face 6, the front end face 5 is matched with the physiological radian of the front edge of the upper and lower vertebral bodies of the pathological change surgical section of the patient, the rear vertebral canal face 6 is a smooth face, and the central part of the rear vertebral canal face 6 is in an arc-shaped concave shape and narrows down.
In addition, still include two symmetrical arrangement in the supplementary fixing device 2 of side of artificial centrum main part 1 both sides, supplementary fixing device 2 in side is according to the design of walking to appear of patient's lesion department pedicle of vertebral arch, the position of supplementary fixing device 2 in side and patient's lesion department pedicle of vertebral arch position phase-match, supplementary fixing device 2 in side and artificial centrum main part 1 form with the actual angle assorted contained angle of patient's pedicle of vertebral arch, the axis of ordinates length of supplementary fixing device 2 in side is not less than 1.5 times of pedicle of vertebral arch nail length, supplementary fixing device 2 in side is made through the vibration material manufacturing technology, respectively be equipped with a pedicle of vertebral arch nail passageway in two supplementary fixing device in side 2, the internal diameter of pedicle of vertebral arch nail passageway is greater than pedicle of vertebral.
The method comprises the steps of extracting target bone defect region data of a patient from preoperative imaging original data of the patient to establish a spine model, simulating two nail paths by an artificial vertebral body 1 according to the spine model, wherein the cross section of the artificial vertebral body 1 is kidney-shaped, in the embodiment, a damaged vertebral body does not collapse, the designed height of the artificial vertebral body 1 is 2mm less than the height of a damaged vertebral body movement unit, in other embodiments, the damaged vertebral body collapses, the designed height of the artificial vertebral body 1 is 2mm less than the average height of an upper vertebral body movement unit and a lower vertebral movement unit, the artificial vertebral body 1 is connected with a posterior pedicle screw, and the artificial vertebral body 1 is manufactured through an additive manufacturing technology.
The direction of the nail placing hole 7 is determined according to the median sagittal plane of the upper vertebral body and the lower vertebral body of the patient target reconstruction region, the front edge of the artificial vertebral body 1 points to the back upper edge of the vertebral body, threads convenient for locking a front screw are arranged at the opening of the nail placing hole 7, the aperture of the nail placing hole 7 is 5mm, the cohesion angle of the nail placing hole 7 is matched with the data of the vertebral body of the patient, and the cohesion direction of the nail placing hole 7 forms an included angle matched with the data of the vertebral body of the patient with the upper end face 3 and the lower end face 4 respectively.
The design method of the personalized artificial vertebral body implant based on the additive manufacturing comprises the following steps:
A) collecting preoperative CT and MRI data of a patient;
B) designing the outline of the artificial vertebral body 1 based on the CT and MRI data before the operation of the patient collected in the step A);
C) designing a nail path based on the CT and MRI data before the operation of the patient collected in the step A);
D) performing Boolean operation on the contour and the nail path of the artificial vertebral body 1 obtained in the steps B) and C) in CAD software to obtain the positions of four nail placing holes 7 on the artificial vertebral body 1;
E) further dividing the artificial vertebral body 1 obtained in the step D) into an external compact layer 8, wherein the thickness of the external compact layer 8 is more than 2 mm;
F) performing Boolean operation on the artificial vertebral body 1 obtained in the step D) and the external compact layer 8 obtained in the step E) to obtain an internal pore layer 9;
G) respectively manufacturing bone grafting areas on the upper end surface 3 and the lower end surface 4 of the internal pore layer 9 obtained in the step F), wherein the positions of the bone grafting areas are matched with the areas of the upper end surface and the lower end surface of the artificial vertebral body 1;
H) selecting a pore structure matched with the position of the focus according to the position of the focus;
I) and (3) carrying out assembling Boolean operation on the pore structure selected in the step H) and the external compact layer 8 obtained in the step E) to obtain an artificial vertebral body 1, wherein the position of the focus of the patient meets the anterior-posterior joint fixing condition, and designing a lateral auxiliary fixing device 2 to be synthesized with the artificial vertebral body 1 to form the artificial vertebral body implant.
The personalized artificial vertebral body implant based on additive manufacturing has high strength, conforms to physiological curvature and has high matching degree with a reconstruction region; the artificial vertebral body 1 adopts a layered design, can provide a large-scale bone grafting area, and reduces the weight of an internal implant as much as possible on the premise of ensuring the strength of the vertebral body; the artificial vertebral body 1 reduces the stimulation to the front soft tissue by an oblique zero-notch fixing mode; the two sides of the artificial vertebral body main body 1 are provided with the lateral auxiliary fixing devices 2 which are used for being connected with the rear pedicle screws, so that the whole artificial vertebral body main body more accords with the three-column fixing concept, the accuracy and the reliability of operation in the operation can be ensured by matching with the personalized pedicle screw guide plate, the defect of the traditional titanium plate and titanium mesh reconstruction scheme is overcome, and the personalized accurate reconstruction of a bone defect area is realized through detailed preoperative planning.
Claims (8)
1. An additive manufacturing based personalized artificial vertebral body implant comprising an artificial vertebral body (1), characterized in that: the artificial vertebral body (1) comprises an inner pore layer (9) and an outer compact layer (8) wrapping the periphery of the inner pore layer (9), the inner pore layer (9) is of a pore structure designed in a light weight mode, the porosity of the pore structure is 75% -80%, the pore diameter is 500-700 mu m, two nail placing holes (7) are respectively formed in the upper end face (3) and the lower end face (4) of the inner pore layer (9), two nail channels are formed by the four nail placing holes (7), and the thickness of the outer compact layer (8) is larger than 2 mm;
the artificial vertebral body comprises an artificial vertebral body (1) and is characterized by further comprising two lateral auxiliary fixing devices (2) symmetrically arranged on two sides of the artificial vertebral body (1), wherein the lateral auxiliary fixing devices (2) are designed according to the shape of the vertebral pedicle at the lesion of a patient, the position of each lateral auxiliary fixing device (2) is matched with the position of the vertebral pedicle at the lesion of the patient, each lateral auxiliary fixing device (2) and the artificial vertebral body (1) form an included angle matched with the actual angle of the vertebral pedicle of the patient, the length of a longitudinal axis of each lateral auxiliary fixing device (2) is not less than 1.5 times of the length of a vertebral pedicle screw, and each lateral auxiliary fixing device (2) is manufactured through an additive manufacturing technology;
two pedicle screw channels are respectively arranged in the two lateral auxiliary fixing devices (2), the inner diameter of each pedicle screw channel is larger than the outer diameter of each pedicle screw, and the inner wall of each pedicle screw channel is rough.
2. The additive manufacturing-based personalized artificial vertebral body implant of claim 1, wherein: bone grafting areas are arranged on the upper end face (3) and the lower end face (4) of the internal pore layer (9), coatings are arranged on the upper end face (3) and the lower end face (4) of the internal pore layer (9), the coatings are formed by hydroxyapatite through one or more modes of plasma spraying, electrochemical deposition or bionic deposition, the pore structure adopted by the internal pore layer (9) is matched with the placing position of the artificial vertebral implant and the bone defect area data of the patient, the pore structure is made of one of titanium alloy, high polymer material or bioceramic through one of laser sintering technology, selective laser melting technology or electron surgery melting technology, the upper end face (3) of the internal pore layer (9) corresponds to the contact surface of an upper vertebral body in a target reconstruction area, and the lower end face (4) of the internal pore layer (9) corresponds to the contact surface of a lower vertebral body in the target reconstruction area, the spine model is characterized in that an included angle matched with physiological radians of front edges of upper and lower vertebral bodies of a pathological change operation-planned segment of a patient is formed by the upper end face (3) and the lower end face (4), the upper end face (3) and the lower end face (4) are rough faces simulating bone, target bone defect region data of the patient are extracted from preoperative imaging original data of the patient to establish a spine model, a curved surface of an artificial vertebral body implant in contact with the spine model is designed according to the target bone defect region data of the patient, and the spine model is tightly attached to the upper end face (3) and the lower end face (4) of the inner pore layer (9).
3. The additive manufacturing-based personalized artificial vertebral body implant of claim 2, wherein: the upper end face (3) and the lower end face (4) correspond to a lower end plate of an upper vertebral body and an upper end plate of a lower vertebral body in a target reconstruction region respectively, the length of a transverse axis of the upper end face (3) and the length of a transverse axis of the lower end face (4) are less than 6mm of the maximum value of the transverse diameter of the vertebral body end plate, and the length of a longitudinal axis of the upper end face (3) and the length of a longitudinal axis of the lower end face (4) are less than 5mm of the maximum value.
4. The additive manufacturing-based personalized artificial vertebral body implant of claim 1, wherein: the external compact layer (8) is divided into a front end face (5) and a rear vertebral canal face (6), the front end face (5) is matched with the physiological radians of the front edges of the upper and lower vertebral bodies of the pathological change surgical segment of the patient, the rear vertebral canal face (6) is a smooth face, and the central part of the rear vertebral canal face (6) is in an arc-shaped concave narrowing mode.
5. The additive manufacturing-based personalized artificial vertebral body implant of claim 1, wherein: draw the defective regional data of patient's target bone and establish backbone model in the image original data before the patient art, artifical centrum main part (1) is according to backbone model simulation is two the nail way, the transversal kidney shape of personally submitting of artifical centrum main part (1), if the lesion centrum does not take place to sink, artifical centrum main part (1) design height is than lesion centrum motion unit height 2mm less, if the lesion centrum takes place to sink, artifical centrum main part (1) design height is than the lower position centrum motion unit height average value 2mm less, artifical centrum main part (1) links to each other with way of escape pedicle screw, artifical centrum main part (1) is made through the vibration material disk technique and is formed.
6. The additive manufacturing-based personalized artificial vertebral body implant of claim 1, wherein: put the direction of nail hole (7) and rebuild regional upper vertebral body and the middle sagittal plane of the lower centrum according to patient's disease target and confirm, follow the directional centrum back upper limb of artificial centrum main part (1) leading edge, the opening part of putting nail hole (7) all is equipped with the screw thread that the front screw of being convenient for carries out the locking, the aperture of putting nail hole (7) is greater than 4.6mm, put the cohesion angle and the patient centrum data phase-match of nail hole (7), put the cohesion direction of nail hole (7) respectively with up end (3) and lower terminal surface (4) form with patient centrum data phase-matched contained angle.
7. A design method of the personalized artificial vertebral body implant based on additive manufacturing according to any one of claims 1-6, characterized in that: the method comprises the following steps:
A) collecting preoperative CT and MRI data of a patient;
B) designing a contour of the artificial vertebral body (1) based on pre-operative CT and MRI data of the patient collected in the step a);
C) designing the nail path based on the pre-operative CT and MRI data of the patient collected in the step A);
D) performing Boolean operation on the contour of the artificial vertebral body (1) and the nail path obtained in the steps B) and C) in CAD software to obtain the positions of four nail placing holes (7) on the artificial vertebral body (1);
E) further dividing the artificial vertebral body (1) obtained in the step D) into an outer compact layer (8), wherein the thickness of the outer compact layer (8) is more than 2 mm;
F) performing Boolean operation on the artificial vertebral body (1) obtained in the step D) and the external compact layer (8) obtained in the step E) to obtain an internal pore layer (9);
G) respectively manufacturing bone grafting areas on the upper end surface (3) and the lower end surface (4) of the internal pore layer (9) obtained in the step F), wherein the positions of the bone grafting areas are matched with the areas of the upper end surface and the lower end surface of the artificial vertebral body (1);
H) selecting a pore structure matched with the focus position according to the focus position;
I) and D) carrying out assembling Boolean operation on the pore structure selected in the step H) and the external compact layer (8) obtained in the step E) to obtain the artificial vertebral body (1).
8. The method for designing a personalized artificial vertebral body implant based on additive manufacturing according to claim 7, wherein: and G), when the areas of the upper end surface and the lower end surface of the artificial vertebral body (1) are smaller, bone grafting areas are not manufactured on the upper end surface (3) and the lower end surface (4) of the internal pore layer (9) obtained in the step F), and in the step I), if the focus position of the patient meets the front-back path combined fixing condition, a lateral auxiliary fixing device (2) is designed to be synthesized with the artificial vertebral body (1) to form the artificial vertebral body implant.
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| CN110141405A (en) * | 2019-06-21 | 2019-08-20 | 上海长征医院 | Upper cervical spine artificial vertebral body and upper cervical spine implanting device |
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