CN101816590A - Method for manufacturing navigation template of human bone surgery and female die thereof - Google Patents
Method for manufacturing navigation template of human bone surgery and female die thereof Download PDFInfo
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Abstract
The invention discloses a method for manufacturing a navigation template of human bone surgery and a female die thereof. The method comprises the following steps of: a, acquiring raw data of a patient bone, and establishing a three-dimensional model on a computer; b, analyzing the three-dimensional model, extracting a bone curve image near a surgical screw inlet part, and designing a screw positioning rod; c, establishing a reverse template fitted with a bone curve near the surgical screw inlet part to make the screw positioning rod matched with the reverse template through reverse engineering software, establishing a three-dimensional model of the female die of the surgical navigation template, and manufacturing a physical model of the female die; and d, pouring biomedical materials into the physical model of the female die to make the bottom three-dimensional shape of the biomedical material model fitted and consistent with the bone curve near the surgical screw inlet part, and hardening to form the biocompatible navigation template of human bone surgery. The biocompatible navigation template of the human bone surgery manufactured by the invention makes the surgery safer and achieves better effect.
Description
Technical field
The present invention relates to a kind of medical operating submodel and its manufacture method, relate in particular to a kind of manufacture method of navigation template of human bone surgery and the structure of former thereof.
Background technology
Implant is used more and more in bone surgery at present, in general, in orthopaedics implant operation screw accurately insert for operation safety the most important, reset as spinal trauma, in the operation such as malformation correction, generally all can adopt the pedicle screw fixation operation, but because the pedicle of vertebral arch inboard is the canalis spinalis of important structure such as traveling spinal cord, in case pedicle screw is implanted in the canalis spinalis, will cause spinal cord injury and cause paralysis, complication such as gatism, and make progress from lumbar vertebra, thoracic vertebra, the pedicle of vertebral arch cross-sectional diameter of cervical vertebra is more and more littler, has strengthened operating difficulty and risk.
Therefore, people begin to seek and can accurate localized navigation system carry out CAOS, guarantee accurately carrying out safely of operation.The navigation system of using generally has following operation principle at present: the doctor is hand-held through the operation tool after improving, in general on the operation tool gauge point is housed, surgical target implementation and operation to the patient, the space multistory location of operation tool and aiming process are all under the real-time control of tracker, and tracker can accurately provide in the art before the region of anatomy and art or the position relation between the multi-mode image such as X line/CT/MRI in the art, through corresponding Coordinate Conversion, as translation, rotation etc., the control operation tool meets the requirements of the position, thereby implements corresponding operation technique.But the computer airmanship equally also exists some shortcomings in the clinical practice at present, prolong as equipment price costliness, complicated operation, operating time, and the template degree of accuracy is not high, has rejection property etc. with human body cell, has limited this technology in clinical extensive use.
The patent of invention in office's on March 25th, 2009 disclosed " a kind of localized navigation template manufacture method of pedicle of vertebral arch that can be used for " (publication number CN 101390773A) is known by state, this patent of invention combines reverse-engineering with the rapid shaping manufacturing, before the art patient is carried out CT scan, gather the digital picture in corrective surgery zone.Utilize three-dimensional reconstruction software that the data of being gathered are analyzed, derive the three-dimensional reconstruction model of the vertebra of waiting to perform the operation.Use reverse working software, the best according to the three-dimensional reconstruction modelling pedicle of vertebral arch of vertebra is entered the ailing road, and the surface information at extraction vertebral plate rear portion, in system, set up the reverse template model consistent, utilize rapid laser-shaping technique to make the reverse navigation template that has the pedicle nail road at last with the anatomic form at vertebral plate rear portion.This patent of invention just completes navigation template before operation, need not use the location that miscellaneous equipment carries out pedicle of vertebral arch in art, has significantly reduced the time of operation, has reduced the patient suffering.But the foregoing invention method is to produce into dolly set plate by rapid shaping technique, and promptly the reverse navigation template has been ignored the safety of the technology making material of reverse navigation template.Up to now, the used material of various rapid forming equipments is not a biological safety, to tissue is unsafe, and the described Technology Need of this patent of invention directly pastes the produced reverse navigation template of rapidform machine with the corrective surgery surface of bone mutually, in the implant into body, visible the method has potential danger.
Foregoing invention only is applicable to the making of the localized navigation template of pedicle of vertebral arch in addition, other position orthopedic surgery navigation template of human body is made do not have explanation, lacks the making mould of general navigation template.Particularly to surgical screw enter to follow closely the position and angle is not made analysis in conjunction with human body bone situation, lack actual operation.
Summary of the invention
The present invention provides a kind of manufacture method and former thereof of navigation template of human bone surgery, utilize the medical image three-dimensional reconstruction technique, former in conjunction with reverse engineering software design surgical navigational template, produce orthopedic surgery navigation template, make safer, the better effects if of operation with biocompatibility.
The embodiment of the invention provides a kind of manufacture method of navigation template of human bone surgery, comprises step:
The collagen beginning data that a, collection patient need perform the operation are set up threedimensional model on computers;
B, analyze described threedimensional model, extract surgical screw and advance to follow closely near the position bone surface chart picture, design the screw locating rod;
C, pass through reverse engineering software, set up with described surgical screw and advance to follow closely the reverse template that near the bone curved surface in position matches, described screw locating rod position and described reverse template are complementary, set up the former threedimensional model of surgical navigational template on computers, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up;
D, adopt biomaterial for medical purpose to the pourable molding of human body safety, such as bone cement or medical denture base material etc., below be that example is filled in the former mock-up with the bone cement, make the bottom surface 3D shape of bone cement model in the former identical consistent with near the bone curved surface surgical screw enters to follow closely the position, treat from former, to take out bone cement after the bone cement scleroma, form orthopedic surgery navigation template with biocompatibility.
Described step a specifically comprises: gather the Digital Image Data that bone that the patient need perform the operation comprises shape, size, length, structure by CT machine scanning or MRI equipment or X-ray production apparatus, set up threedimensional model on computers.
Further, among the described step c: the former mock-up of making adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, makes things convenient for biomaterial for medical purpose fully to pour into.
Concrete, when described operative site bone is vertebra, in reverse engineering software Geomagic, extract the curved surface of vertebral plate rear portion bone, and extract its contour line, set up a upright plane consistent with the spinal column major axis at the vertebral plate rear, to be projected to upright plane behind the vertebra curved surface profile alignment, and in Geomagic software, adopt " generation bridge " function that the contour line of vertebra curved surface profile line and projection amplification is coupled together, form a surface model; By the function of " offset " in the Geomagic software, 2-4mm thickness is set subsequently, and imports the screw locating rod that designs, form the threedimensional model of former by Boolean calculation described surface model expansion organizator model.
Described step a also comprises: the virtual three-dimensional model of patient's bone is produced mock-up by rapid shaping technique, can observe the matching degree with described orthopedic surgery navigation template.
Further again, described method also comprises step e: external described orthopedic surgery navigation template and patient's bony process object model are fitted, the passage that advances to follow closely that utilizes the screw locating rod to form advances nail, observes the operation accuracy of this orthopedic surgery navigation template.
The embodiment of the invention also provides a kind of former of making according to said method, described former is that stereomodel is used to pour into the orthopedic surgery navigation template that biomaterial for medical purpose formation has biocompatibility, and near the bone curved surface that described former bottom surface 3D shape and surgical screw are advanced to follow closely the position matches; Described former inside is provided with the screw locating rod, the angle of its setting with by detecting the bone curved surface, need the screw of fixing operation screw to advance to follow closely the channel angle unanimity.
Further, described former is that thickness is 2-4mm; About described screw locating rod is divided into 2, diameter is 2-4mm.
Further, described former adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, makes things convenient for bone cement fully to pour into.
The manufacture method of a kind of navigation template of human bone surgery that the embodiment of the invention provides and former thereof, utilize the medical 3 D scanning technique, analyze the bone situation that all kinds of patients need perform the operation, the Digital Image Data that comprises shape, size, length, bone density, structure, design the former of three-dimensional surgical navigational template in conjunction with reverse engineering software, the size of its screw and advance to follow closely channel position and be chosen in pedicle of vertebral arch central authorities or suitable advance to follow closely in the passage, guaranteeing not can Spinal Cord and other important structure; The convenient simultaneously bone situation according to the need operation is in time adjusted the position of surgical screw and is advanced to follow closely angle.
The former of making according to the various bones that need perform the operation is used to pour into biomaterial for medical purpose, forms the orthopedic surgery navigation template with biocompatibility.Described former adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, and this is to consider short, the mobile not good problem of biomaterial for medical purpose setting time, makes things convenient for abundant form of short time.
Produce the orthopedic surgery navigation template with biocompatibility by the inventive method, material has biocompatibility, is fit to various operation skeletal sites, and the screw that operation is installed is more accurate, makes safer, the better effects if of operation.
Description of drawings
Fig. 1 is the manufacture method flow chart of a kind of navigation template of human bone surgery of providing of the embodiment of the invention one;
Fig. 2 is the former side structural representation that the embodiment of the invention four provides;
Fig. 3 is the former plan structure sketch map that the embodiment of the invention four provides;
Fig. 4 is surgical navigational template and the vertebra coupling scheme of installation to forming behind the former injection molding that the embodiment of the invention four provides.
The specific embodiment
For making the purpose, technical solutions and advantages of the present invention clearer, the present invention is described in further detail below in conjunction with accompanying drawing.
As shown in Figure 1, the embodiment of the invention one provides a kind of manufacture method of navigation template of human bone surgery, comprises step:
101, gather patient's collagen beginning data, set up threedimensional model on computers.
Digital Image Data by CT machine scanning or MRI equipment or X-ray production apparatus are gathered the bone that the patient need perform the operation comprises Digital Image Data such as shape, size, length, bone density, structure, sets up threedimensional model on computers.Such as the treatment vertebrae is example, before art, the vertebra in corrective surgery zone is carried out thin-layer CT scanning, gathers the CT initial data, is input in the computer.
102, analyze described threedimensional model, extract surgical screw and advance to follow closely near the bone surface chart picture in position, design the screw locating rod.
With the treatment spinal column is example, needs to extract the pedicle of vertebral arch surface profile.The continuous faultage image data of the vertebra of CT operative region is imported three-dimensional reconstruction software Mimics, " threshold value is cut apart " that integrated application software carries, functions such as " region growings ", rebuild the threedimensional model of vertebra, derive with the STL form, show 3-D view at computer screen, be used for better designing the screw locating rod, the screw locating rod the position is set, be surgical screw advance to follow closely channel position, select to be installed in pedicle of vertebral arch central authorities, install like this and firmly and not damage spinal cord in the canalis spinalis, and the size of surgical screw, it also is that the skeleton parameter that need perform the operation according to the patient is (as shape that length is selected, size, length, bone density, structure) chooses, accomplish to mate fully the adaptation patient.
103, pass through reverse engineering software, set up with described surgical screw and advance to follow closely the reverse template that near the bone curved surface in position matches, described screw locating rod position and described reverse template are complementary, set up the former threedimensional model of surgical navigational template on computers, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up.
When described operative site bone was vertebra, the screw locating rod of design was positioned at pedicle of vertebral arch central authorities, making LOCATION OF PEDICLE SCREW FIXATION that operation implants in pedicle of vertebral arch central authorities, and damaging spinal cord in the canalis spinalis.Concrete, in reverse engineering software Geomagic, extract the curved surface of vertebral plate rear portion bone, and extract its contour line, set up a upright plane consistent with the spinal column major axis at the vertebral plate rear, to be projected to upright plane behind the vertebra curved surface profile alignment, and in Geomagic software, adopt " generation bridge " function that the contour line of vertebra curved surface profile line and projection amplification is coupled together, form a surface model; Pass through the function of offset in the Geomagic software subsequently, 2-4mm thickness is set with described surface model expansion organizator model, and import the screw locating rod design, just formed the threedimensional model of former by Boolean calculation, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up.
The former mock-up of making adopts the perfusion inlet of horn mouth shape, or the open design of employing coupling operative site bone, this is to consider short, the mobile not good problem of biomaterial for medical purpose setting time, makes things convenient for abundant form of biomaterial for medical purpose short time.
104, adopt biomaterial for medical purpose to be filled in the former mock-up, can adopt bone cement or medical denture base material etc. such as described biomaterial for medical purpose, make the bottom surface 3D shape of bone cement model in the former identical consistent with near the bone curved surface surgical screw enters to follow closely the position, treat from former, to take out bone cement after the bone cement scleroma, formation has the orthopedic surgery navigation template of biocompatibility, and this orthopedic surgery navigation template can be directly used in operation after sterilization.
As a kind of improved procedure, the embodiment of the invention two provides a kind of manufacture method of navigation template of human bone surgery, and is as follows with the difference of embodiment one,
Described step 101 also comprises: the virtual three-dimensional model of patient's bone is produced mock-up by rapid shaping technique, such as producing mock-up by photocuring molding method, laminated solid mass autofrettage, selective laser sintering method, fusion sediment autofrettage.
Also comprise step 105: described orthopedic surgery navigation template and patient's bone mock-up are fitted external, as shown in Figure 4, the passage that advances to follow closely that utilizes the screw locating rod to form advances nail, observes the coupling accuracy of this orthopedic surgery navigation template, guarantees to advance to follow closely angle and advance to follow closely degree of depth the best.
The manufacture method of described navigation template of human bone surgery and former thereof also can be applicable to other structures of human body such as joint, femur, neck, it makes principle substantially equally, the embodiment of the invention three is at the patient of Fracture of femur, and the manufacture method step of the navigation template of human bone surgery of employing is as follows:
201, gather patient's femur initial data, set up the femur threedimensional model on computers.
Digital Image Data by the scanning of CT machine or MRI equipment or X-ray production apparatus collection patient bone comprises shape, size, length, bone density, structure, sets up threedimensional model on computers.Before art, the proximal femur in corrective surgery zone is carried out thin-layer CT scanning, gather the CT initial data.The continuous faultage image data of the femur of CT operative region is imported three-dimensional reconstruction software Mimics, functions such as " threshold value is cut apart " that integrated application software carries, " region growing ", the threedimensional model of reconstruction femur.
202, analyze described threedimensional model, extract surgical screw and advance to follow closely near the bone surface chart picture in position, design the screw locating rod.
The femur threedimensional model of rebuilding is imported in the 3ds MAX software with the STL form, shows 3-D view at computer screen, design screw locating rod, promptly surgical screw advance to follow closely channel position, be chosen in femur central authorities.
203, pass through reverse engineering software, set up with described surgical screw and advance to follow closely the reverse template that near the bone curved surface in position matches, described screw locating rod position and described reverse template are complementary, set up the former threedimensional model of surgical navigational template on computers, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up.
When described operative site bone was femur, the screw locating rod of design was positioned at neck of femur central authorities, and the LOCATION OF PEDICLE SCREW FIXATION that makes the operation implantation is in neck of femur central authorities.Concrete, in reverse engineering software Geomagic, extract the curved surface that femur advances near the bone nail mouthful, and extract its contour line, set up a upright plane consistent in lateral side of femur with the femur major axis, with the extremely upright plane of femoral curvatures contour line back projection, and in Geomagic software, adopt " generation bridge " function that the contour line of femoral curvatures contour line and projection amplification is coupled together, form a surface model; Pass through the function of offset in the Geomagic software subsequently, 2-4mm thickness is set with described surface model expansion organizator model, and import the screw locating rod design, just formed the threedimensional model of former by Boolean calculation, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up.
The former mock-up of making adopts the perfusion inlet of horn mouth shape, or the open design of employing coupling operative site bone, this is to consider short, the mobile not good problem of biomaterial for medical purpose setting time, makes things convenient for abundant form of biomaterial for medical purpose short time.
204, adopt biomaterial for medical purpose to be filled in the former mock-up, can adopt bone cement or medical denture base material etc. such as described biomaterial for medical purpose, make the bottom surface 3D shape of bone cement model in the former identical consistent with near the bone curved surface surgical screw enters to follow closely the position, treat from former, to take out bone cement after the bone cement scleroma, formation has the femoral surgery navigation template of biocompatibility, and this femoral surgery navigation template can be directly used in operation after sterilization.
By embodiment three as seen, when the bone of need operations was femur or joint, the screw locating rod of design was positioned at femur or joint central authorities, the screw that operation is implanted be fixed in neck of femur or joint suitable advance to follow closely in the passage and important structure such as injured nerve blood vessel not.Concrete operating process is the same with the processing vertebra, is to customize out the former mock-up respectively according to every patient.
Shown in Fig. 2,3, the embodiment of the invention four also provides a kind of former of making according to said method, described former is that stereomodel is used to pour into biomaterial for medical purpose, such as bone cement or medical denture base material, forms the orthopedic surgery navigation template with biocompatibility.Among Fig. 2, be provided with two screw locating rods 2 in the described former 1.
As shown in Figure 4, near bone 4 curved surfaces that surgical navigational template 5 bottom surface 3D shapes that form behind the described former injection molding and surgical screw are advanced to follow closely the position match; Described former inside is provided with screw locating rod 2, and the angle of its setting is with advance to follow closely passage 3 angles by the screw of detect to need installing consistent.
Described former is that medical non-toxic material is made, and thickness is 2-4mm; About the locating rod of screw described in the figure 2 is divided into two, diameter is 2-4mm.Described former adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, makes things convenient for biomaterial for medical purpose fully to pour into.
Need to prove that the manufacture method of navigation template of human bone surgery of the present invention and former thereof are not limit by the foregoing description.For example, utilize the vertebra data of equipment collections such as MRI also can be used for the reconstruction of patient's vertebra threedimensional model; Secondly, utilize other three-dimensional reconstruction software, three dimensional analysis software, reverse engineering software can carry out the design of orthopedic surgery navigation template too; Simultaneously, also can use other forming technique, make actual practical navigation template in the art; In addition, the manufacture method of described navigation template and former thereof also can be applicable to other structures of human body such as joint, neck of femur, and the making principle is the same with process, just makes former and orthopedic surgery navigation template according to different bone form fit.
Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention, can also make some improvement and change, these improvement and change also are considered as protection scope of the present invention.
Claims (10)
1. the manufacture method of a navigation template of human bone surgery is characterized in that, comprises step:
The collagen beginning data that a, collection patient need perform the operation are set up threedimensional model on computers;
B, analyze described threedimensional model, extract surgical screw and advance to follow closely near the position bone surface chart picture, design the screw locating rod;
C, pass through reverse engineering software, set up with described surgical screw and advance to follow closely the reverse template that near the bone curved surface in position matches, described screw locating rod position and described reverse template are complementary, set up the former threedimensional model of surgical navigational template on computers, by three-dimensional printer the former threedimensional model is printed again, and produce the former mock-up;
D, employing are filled in the former mock-up the biomaterial for medical purpose of human body safety and pourable molding, make the bottom surface 3D shape of medical biomaterial model in the former identical consistent with near the bone curved surface surgical screw enters to follow closely the position, treat from former, to take out after the biomaterial for medical purpose scleroma, form orthopedic surgery navigation template with biocompatibility.
2. according to the manufacture method of the described navigation template of human bone surgery of claim 1, it is characterized in that described step a specifically comprises:
Gather the Digital Image Data that bone that the patient need perform the operation comprises shape, size, length, bone density, structure by CT machine scanning or MRI equipment or X-ray production apparatus, set up threedimensional model on computers.
3. according to the manufacture method of the described navigation template of human bone surgery of claim 1, it is characterized in that, among the described step c:
The former mock-up of making adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, makes things convenient for biomaterial for medical purpose fully to pour into.
4. according to the manufacture method of claim 1 or 3 described navigation template of human bone surgery, it is characterized in that dabbling described biomaterial for medical purpose is medical bone cement or medical denture base material.
5. according to the manufacture method of claim 1 or 3 described navigation template of human bone surgery, it is characterized in that, among the described step c:
When need operative site bone is vertebra, in reverse engineering software Geomagic, extract the curved surface of vertebral plate rear portion bone, and extract its contour line, set up a upright plane consistent with the spinal column major axis at the vertebral plate rear, to be projected to upright plane behind the vertebra curved surface profile alignment, and in Geomagic software, adopt " generation bridge " function that the contour line of vertebra curved surface profile line and projection amplification is coupled together, form a surface model; Pass through the function of " offset " in the Geomagic software subsequently, 2-4mm thickness is set with described surface model expansion organizator model, and importing the screw locating rod that designs, the surgical screw that operation is implanted is fixed in pedicle of vertebral arch central authorities, has just formed the threedimensional model of former again by Boolean calculation.
6. according to the manufacture method of the described navigation template of human bone surgery of claim 1, it is characterized in that described step a also comprises:
The virtual three-dimensional model of patient's bone is produced mock-up by rapid shaping technique, can observe matching degree with described orthopedic surgery navigation template.
7. according to the manufacture method of claim 1 or 6 described navigation template of human bone surgery, it is characterized in that, also comprise step e:
External described orthopedic surgery navigation template and patient's bony process object model are fitted, the passage that advances to follow closely that utilizes the screw locating rod to form advances nail, observes the operation accuracy of this orthopedic surgery navigation template.
8. former of making according to claim 1 method, it is characterized in that, described former is that stereomodel is used to pour into the orthopedic surgery navigation template that biomaterial for medical purpose formation has biocompatibility, and near the bone curved surface that described former bottom surface 3D shape and surgical screw are advanced to follow closely the position matches; Described former inside is provided with the screw locating rod, the angle of its setting with by detecting the bone curved surface, need the screw of fixing operation screw to advance to follow closely the channel angle unanimity.
9. the former made of method according to Claim 8 is characterized in that described former thickness is 2-4mm; About described screw locating rod is divided into 2, diameter is 2-4mm.
10. the former made of method according to Claim 8 is characterized in that described former adopts the perfusion inlet of horn mouth shape, or adopts the open design of coupling operative site bone, makes things convenient for biomaterial for medical purpose fully to pour into; Described biomaterial for medical purpose is medical bone cement or medical denture base material.
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| JP2010005392A (en) * | 2008-06-26 | 2010-01-14 | Hogyoku Seigi Kofun Yugenkoshi | Method of manufacturing surgical template used for computer guided artificial dental root surgery |
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2010
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| CN101361682A (en) * | 2007-08-09 | 2009-02-11 | 上海国睿生命科技有限公司 | Special shape tissue engineering bracket and construction method and use thereof |
| CN101390773A (en) * | 2007-09-19 | 2009-03-25 | 陆声 | Production method of navigation template for positioning the pediculus arcus vertebrae |
| JP2010005392A (en) * | 2008-06-26 | 2010-01-14 | Hogyoku Seigi Kofun Yugenkoshi | Method of manufacturing surgical template used for computer guided artificial dental root surgery |
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