WO2022143348A1 - 髋关节置换用髋臼侧导板组件及其装配方法 - Google Patents
髋关节置换用髋臼侧导板组件及其装配方法 Download PDFInfo
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- WO2022143348A1 WO2022143348A1 PCT/CN2021/140553 CN2021140553W WO2022143348A1 WO 2022143348 A1 WO2022143348 A1 WO 2022143348A1 CN 2021140553 W CN2021140553 W CN 2021140553W WO 2022143348 A1 WO2022143348 A1 WO 2022143348A1
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- WIPO (PCT)
- Prior art keywords
- hip joint
- acetabular
- fitting
- side guide
- guide plate
- Prior art date
Links
- 210000004394 hip joint Anatomy 0.000 title claims abstract description 158
- 238000000034 method Methods 0.000 title claims abstract description 33
- 210000000588 acetabulum Anatomy 0.000 title claims abstract description 29
- 238000005070 sampling Methods 0.000 claims description 33
- 238000004088 simulation Methods 0.000 claims description 21
- 238000010146 3D printing Methods 0.000 claims description 18
- 238000003860 storage Methods 0.000 claims description 16
- 238000003384 imaging method Methods 0.000 claims description 14
- 238000004590 computer program Methods 0.000 claims description 13
- 210000000988 bone and bone Anatomy 0.000 claims description 12
- 238000011540 hip replacement Methods 0.000 claims description 10
- 238000003709 image segmentation Methods 0.000 claims description 9
- 238000004364 calculation method Methods 0.000 claims description 8
- 238000012545 processing Methods 0.000 claims description 8
- 238000009434 installation Methods 0.000 claims description 7
- 238000000605 extraction Methods 0.000 claims description 3
- 238000004513 sizing Methods 0.000 claims description 3
- 238000012795 verification Methods 0.000 claims description 3
- 208000035965 Postoperative Complications Diseases 0.000 abstract description 2
- 238000010586 diagram Methods 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 238000001356 surgical procedure Methods 0.000 description 6
- 238000011882 arthroplasty Methods 0.000 description 4
- 238000009826 distribution Methods 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 210000001624 hip Anatomy 0.000 description 4
- 238000002513 implantation Methods 0.000 description 4
- 238000004891 communication Methods 0.000 description 3
- 238000012952 Resampling Methods 0.000 description 2
- 238000002591 computed tomography Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 238000003754 machining Methods 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 238000011541 total hip replacement Methods 0.000 description 2
- 206010073767 Developmental hip dysplasia Diseases 0.000 description 1
- 208000007446 Hip Dislocation Diseases 0.000 description 1
- 208000012659 Joint disease Diseases 0.000 description 1
- 206010028851 Necrosis Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 210000000845 cartilage Anatomy 0.000 description 1
- 230000001054 cortical effect Effects 0.000 description 1
- 238000013500 data storage Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000003032 molecular docking Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 210000004197 pelvis Anatomy 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Images
Classifications
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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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4607—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of hip femoral endoprostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1732—Guides or aligning means for drills, mills, pins or wires for bone breaking devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
-
- 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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4687—Mechanical guides for implantation instruments
Definitions
- the present application relates to the technical field of medical devices, and in particular, to an acetabular side guide plate assembly for hip joint replacement and an assembling method thereof.
- Total hip arthroplasty is an important means of treating hip joint diseases such as necrosis of the femoral head and hip dysplasia.
- hip joint diseases such as necrosis of the femoral head and hip dysplasia.
- total hip arthroplasty has gradually been accepted by more doctors and patients.
- Some studies have proved that in total hip replacement surgery, the positional deviation of the prosthesis will increase the impact force on the prosthesis, accelerate the bone dissolution and migration around the prosthesis, change the biomechanical stability of the human body, and eventually lead to The prosthesis failed. Therefore, the precise positioning of prosthesis installation in total hip arthroplasty is particularly important, but the learning curve of artificial total hip arthroplasty is long, and there are high requirements for the operator's experience, preoperative planning, and intraoperative operations.
- the present application provides an acetabular side guide plate assembly for hip joint replacement and an assembling method thereof, which are used to solve the problem that the installation of the artificial total hip joint replacement surgery prosthesis cannot be accurately positioned in the prior art.
- the application provides an acetabular side guide plate assembly for hip joint replacement, including: a fitting guide plate, a support rod, a surgical instrument support and a positioning pin;
- the fitting guide plate includes a fitting base, a guide rod and a positioning connector, and the fitting base It is suitable for fitting and matching with the human acetabular fossa, and the guide rod extends from the top surface of the fitting base along the radial direction of the fitting base;
- the support rod is suitable for cooperating with the positioning connecting piece for positioning, and suitable for disengaging from the positioning connecting piece;
- positioning The peg is adapted to fix the support rod in the outer region of the acetabular fossa, and the surgical instrument support is configured to be able to co-locate with the support rod and to be detachably connected to the support rod.
- the positioning connector includes a connecting part and a positioning sleeve, the connecting part is respectively fixedly connected with the fitting base and the positioning sleeve, and the two ends of the positioning sleeve are open and the axis The direction is parallel to the axis direction of the guide rod; the support rod is suitable for being sleeved in the positioning sleeve.
- the support rod is provided with a guide sleeve
- the guide sleeve is fixedly connected with the support rod, and an angle is formed with the guide sleeve, and the guide sleeve is suitable for connection and positioning nail.
- acetabular side guide plate assembly for hip joint replacement provided by the present application, two guide sleeves are provided, and the two guide sleeves are placed on both sides of a support rod.
- the positioning pin includes a threaded segment and an external segment, the threaded segment is suitable for being screwed into a body bone for fixation, and the external segment is suitable for external drive member.
- the thread pitch of the thread segment is 2 mm and the diameter is 4 mm.
- one end of the threaded segment facing away from the external segment has a tip, and a cut groove is provided at the tip.
- a quick-connection notch is provided at one end of the external segment away from the threaded segment.
- the surgical instrument support includes a burr ring and a press-fit ring, and the burr ring and the press-fit ring each include a butt sleeve, a connecting rod and a clip which are connected in sequence.
- the butt sleeve is suitable for sleeve engagement with the support rod
- the connecting rod is perpendicular to the axis of the butt sleeve
- the ferrule has a lateral opening, which is suitable for clamping and fixing surgical instruments.
- the present application also provides a method for assembling an acetabular side guide plate assembly for hip joint replacement as described above, comprising the following steps:
- the image data of the hip joint is obtained and preoperative planning is performed according to the image data, and the acetabular side guide assembly for hip joint replacement is determined based on the preoperative planning data.
- dimensional data including:
- Image processing is performed based on the magnification ratio to obtain the size data of the hip joint.
- the image data of the hip joint is obtained and preoperative planning is performed according to the image data, and the acetabular side guide assembly for hip joint replacement is determined based on the preoperative planning data.
- dimensional data including:
- Dimensional data for the hip replacement device is determined based on the simulation results.
- the two points in the acetabulum and one point at the labrum are taken, and the fitting guide plate is fixed and fixed by three-point fitting, including:
- the fitting points within the acetabulum are determined based on the reserved sampling points.
- the acetabular side guide plate assembly for hip joint replacement and its assembling method provided by the present application, by fitting the fitting guide plate to the acetabular fossa of the human body, the precise positioning of the support rod can be realized, and after the support rod is fixed, the operation is connected through the support rod
- the instrument support, the surgical instrument support can support surgical instruments such as rasping rods or press-fitting rods, and ensure that the rasping rods and press-fitting rods reach the anteversion and abduction angles consistent with the preoperative planning.
- the application also provides an assembling device for the acetabular side guide plate assembly for hip joint replacement, comprising:
- the data acquisition module is configured to acquire hip joint imaging data, perform preoperative planning according to the imaging data, and determine size data of the acetabular side guide assembly for hip joint replacement based on the preoperative planning data.
- a 3D printing module configured to 3D print an acetabular side guide assembly for hip replacement based on the dimensional data.
- the three-point fitting module is configured to take two points in the acetabulum and one point at the labrum, and fix the fitting guide by three-point fitting.
- the assembling and fixing module is configured to assemble the support rod and fix the support rod by the positioning nail.
- a removal module is configured to remove the fitting guide.
- a file mounting module is configured to mount a file ring to the support rod, and to mount a file rod through the file ring.
- a press-fit installation module configured to remove the filing rod and the filing ring, install the press-fit ring to the support rod, and install the press-fit rod through the press-fit ring.
- the data acquisition module includes:
- the image data acquisition unit is configured to acquire image data of X-ray imaging of the hip joint.
- the magnification ratio acquiring unit is configured to acquire the magnification ratio of the projection of the image data.
- the size data acquisition unit is configured to perform image processing based on the enlargement ratio to acquire size data of the hip joint.
- a scatter model unit configured to establish a scatter model based on the image data of the hip joint
- the model verification unit is configured to perform numerical simulation calculations on the model to verify the accuracy of the hip joint model.
- the model simulation unit is configured to select angular parameters for the simulation based on the validated hip joint model.
- a model sizing unit configured to determine dimensional data of the hip replacement device based on the simulation results.
- the three-point fitting module includes:
- the image segmentation unit is configured to extract the acetabular rim based on the hip joint image segmentation.
- the sampling point extraction unit is configured to obtain sampling points based on the extracted acetabular rim.
- An error removal unit configured to remove error data based on the acquired sampling points.
- a fitting point determination unit configured to determine a fitting point within the acetabulum based on the reserved sampling points.
- Another embodiment of the present application provides an electronic device comprising a memory and a processor, the memory storing a computer program, wherein the computer program executes steps in the processor that can implement the method as described above.
- Yet another embodiment of the present application provides a storage medium storing a computer program, wherein the computer program executes the steps of the above-described method in a processor.
- the fitting base is individually designed according to the anatomical shape and pathological state of the acetabulum of different patients, so as to ensure that each patient can accurately place the acetabular cup prosthesis, from The three-dimensional angle determines the implantation position of the prosthesis, which can reduce the deviation of the implantation position of the prosthesis, improve the accuracy of the implantation position of the prosthesis, ensure that the prosthesis is placed in the optimal position, and reduce the dislocation of the prosthesis, the loosening of the prosthesis, etc.
- the incidence of complications such as pain.
- Fig. 1 is the structural representation of the fitting guide plate in the acetabular side guide plate assembly for hip joint replacement provided by the application;
- Fig. 2 is the structural representation of the support rod in the acetabular side guide plate assembly for hip joint replacement provided by the application;
- FIG. 3 is a schematic structural diagram of a positioning pin in an acetabular side guide plate assembly for hip joint replacement provided by the present application;
- Fig. 4 is the structural representation of the reaming ring in the acetabular side guide plate assembly for hip joint replacement provided by the present application;
- FIG. 5 is a schematic structural diagram of a press-fit ring in the acetabular side guide plate assembly for hip joint replacement provided by the present application;
- Fig. 6 is one of the use state diagrams of the acetabular side guide plate assembly for hip joint replacement provided by the present application;
- FIG. 7 is the second use state diagram of the acetabular side guide plate assembly for hip joint replacement provided by the present application.
- FIG. 8 is the third use state diagram of the acetabular side guide plate assembly for hip joint replacement provided by the present application.
- Fig. 9 is the flow chart of the assembling method of the acetabular side guide plate assembly for hip joint replacement provided by the present application.
- FIG. 10 is a schematic structural diagram of an assembling device for an acetabular side guide plate assembly for hip joint replacement provided by the present application.
- connection and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, Or integral connection; it can be mechanical connection or electrical connection; it can be directly connected or indirectly connected through an intermediate medium.
- connection should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, Or integral connection; it can be mechanical connection or electrical connection; it can be directly connected or indirectly connected through an intermediate medium.
- the first feature "on” or “under” the second feature may be in direct contact with the first and second features, or the first and second features pass through the middle indirect contact with the media.
- the first feature being “above”, “over” and “above” the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
- the first feature being “below”, “below” and “below” the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
- the acetabular side guide plate assembly for hip joint replacement includes a fitting guide plate 100 , a support rod 200 , a surgical instrument support and a positioning pin 400 . .
- the fitting guide plate 100 includes a fitting base 110, a guide rod 120 and a positioning connector 130, wherein the fitting base 110 has an acetabular fossa fitting surface and a mounting surface, and the acetabular fossa fitting surface is fitted and matched with the inner side of the acetabular fossa. , the installation surface is arranged on the top of the fitting surface of the acetabular fossa, and a plane structure can be adopted, which is suitable for connecting the guide rod 120 and the positioning connecting piece 130 .
- One end of the guide rod 120 is fixedly connected to the fitting base 110 , and optionally, one end of the guide rod 120 is fixedly connected to the mounting surface of the fitting base 110 .
- One end of the guide rod 120 facing away from the fitting base extends along the axial direction of the fitting base 110 , and the guide rod 120 is coaxially disposed with the fitting base 110 .
- the positioning connector 130 includes a connecting portion 131 and a positioning sleeve 132 .
- the connecting portion 131 is fixedly connected to the fitting base 110 and the positioning sleeve 132 respectively, so that the relative positions of the positioning sleeve 132 and the fitting base 110 are fixed.
- the positioning sleeve 132 can be adapted to connect to the support rod 200.
- the shape and size of the inner cross-section of the positioning sleeve 132 are the same as or match with the cross-sectional shape and size of the support rod 200, so that the support rod 200 can be inserted
- the positioning sleeve 132 is pulled out from the positioning sleeve 132 .
- the support rod 200 is designed as a non-circular rod body structure with a polygonal, elliptical, irregular shape and other cross-section, so that the positioning sleeve 132 can be connected to the support rod 200 to form an axial rotation limit, so that the positioning sleeve 132 can be connected to form an axial rotation limit.
- 132 and the support rod 200 move relative to each other in the axial direction.
- the fitting base 110 , the guide rod 120 and the positioning connector 130 can adopt an integral molding structure.
- three-dimensional modeling can be performed according to the image data of the hip joint and obtained by 3D printing, so that the fitting base 110 can better fit the acetabulum.
- the nests fit together. For different patients, it can be customized according to the anatomical shape and case status of the acetabulum to ensure that each patient can be accurately implanted with the acetabular cup prosthesis.
- the support rod 200 is inserted into the positioning sleeve 132, precise positioning is achieved under the action of the positioning sleeve 132, and then the support rod 200 is fixed in the outer area of the acetabular fossa through the positioning nails 400. At this time, the support rod is removed after the fitting guide plate 100 is removed. The position of 200 will not move.
- the surgical instrument support is adapted to be fixed in cooperation with the support rod 200, and is adapted to support and fix the surgical instrument for at least one of the surgical rasping rod 500 and the press-fitting rod 600, so as to facilitate at least one of the following operations: rasping, Implantation of acetabular cup prosthesis.
- rasping Implantation of acetabular cup prosthesis.
- the rasping rod 500 and the press-fit rod 600 is axially fixed, enabling precise operation.
- a guide sleeve 210 is provided on the support rod 200 , and the guide sleeve 210 is fixedly connected to the support rod 200 .
- the axis of the guide sleeve 210 and the axis of the support rod 200 are spatially intersected, so that an included angle is formed between the guide sleeve 210 and the support rod 200 .
- the guide sleeve 210 is a cylindrical structure with openings at both ends, which is suitable for connecting the positioning nail 400. When the support rod 200 is fixed, one end of the positioning nail 400 can be axially passed through the guide sleeve 210 and then fixedly connected to the outside of the acetabular fossa. .
- two guide sleeves 210 are provided, and the two guide sleeves 210 are located on both sides of the support rod 200 and are parallel to each other.
- the positioning nails 400 provided by the present application may adopt self-locking positioning nails.
- the self-locking positioning nail 400 includes a threaded section 410 and an external section 420 that are coaxial and integrally arranged.
- the outer wall of the threaded section 410 is provided with a screw thread, which is suitable for being screwed into a body bone for internal fixation; the external wall of the external section 420 is smooth and suitable for external connection.
- the driver, the external driver can be a hand-held instrument such as an electric drill.
- the cancellous bone of the human body is spongy and is formed by intertwined bone trabeculae, which are arranged in the interior of the bone. Ordinary surgical nails cannot achieve a good fixation effect.
- the diameter of the thread segment 410 is 4mm, which increases the stability of its fixation.
- the positioning nail 400 in the embodiment of the present application can achieve a strong self-locking effect.
- the end of the threaded segment 410 away from the circumscribed segment 420 has a tip 411 , and a slot 412 is provided at the tip 411 , which can better break the cortical bone when the positioning pin 400 is rotated.
- the end of the circumscribed segment 420 facing away from the threaded segment 410 is provided with a quick connection notch 421 , so that the end of the circumscribed segment 420 away from the threaded segment 410 is semi-cylindrical.
- the setting of the quick connection notch 421 can facilitate the quick connection between the positioning nail 400 and the external driving member.
- the surgical instrument support includes a filing ring 301 and a press-fit ring 302
- the filing ring 301 and the press-fit ring 302 both include a butt sleeve 310 connected in sequence, a connection Rod 320 and ferrule 330.
- One end of the butt sleeve 310 is open, and the other end is fixedly connected with the connecting rod 320 .
- the open end of the butt sleeve 310 can be sleeved outside the support rod 200 .
- the connecting rod 320 is perpendicular to the axis of the docking sleeve 310.
- the ferrule 330 has a lateral opening, and is suitable for clipping and fixing at least one of the rasping rod 500 for surgery and the press-fitting rod 600 for surgery.
- the ferrule 330 can fix the direction of at least one of the surgical rasping rod 500 and the surgical press-fitting rod 600, so as to be accurately positioned when the rasping or acetabular cup prosthesis is implanted.
- the following describes the assembling method of the acetabular side guide plate assembly for hip joint replacement provided by the application, the assembling method of the acetabular side guide plate assembly for hip joint replacement described below and the hip joint replacement described above.
- a method for assembling an acetabular side guide plate assembly for hip joint replacement includes:
- the imaging data of the hip joint is obtained, preoperative planning is performed according to the imaging data, and size data of the acetabular side guide assembly for hip joint replacement is determined based on the preoperative planning data.
- the image data of the hip joint is obtained through CT scanning and other technologies, and the size of the acetabular side guide assembly for hip joint replacement is determined according to the image data.
- the dimensions are obtained so that the conforming base 110 can be matched to the shape of the acetabular socket.
- the obtained size data is exported, and the size data can be used to perform 3D printing with the aid of a 3D printing device to obtain a fitting guide 100 , a support rod 200 , a surgical instrument support, and a positioning pin 400 .
- the acetabular side guide assembly for hip joint replacement is obtained by 3D printing based on the dimensional data.
- the preoperative planning scheme is obtained based on the size data, and then the acetabular side guide assembly for hip joint replacement is obtained through 3D printing technology, which can make the structure of the acetabular side guide assembly for hip joint replacement consistent with the preoperative planning, thereby ensuring the intraoperative safety. positioning accuracy.
- the positioning pins 400 therein can also be made by machining.
- the fitting guide 100 is positioned in a three-point fitting manner, which can ensure that the angle and direction of the fitting guide 100 correspond to the structure of the acetabular cup.
- the support rod 200 from the lower end of the positioning sleeve 132 , realize the positioning of the support rod 200 by fitting the guide plate 100 , connect the positioning nail 400 to the external driving member, and the external driving member drives the positioning nail 400 to rotate, so that the positioning nail 400 After passing through the guide sleeve 210 , the tip 411 is connected with the external thread of the acetabular fossa to realize the fixation of the support rod 200 .
- the obtained hip joint image data and preoperative planning are carried out according to the image data, and the size data of the acetabular side guide plate assembly for hip joint replacement is determined based on the data of the preoperative planning, including:
- the non-connected points of the model are removed, and a curved surface is generated to simplify the model.
- a hip joint prosthesis model is established, and the hip joint model and the hip joint prosthesis model are matched.
- Resampling the hip joint image data extracting the shape parameters of the bone tissue data in the hip joint image to calculate the acetabular gap width, and extracting the acetabular margin data according to the acetabular gap width.
- the sampling points are extracted through the equidistant grid, and the center of the circle is selected according to the sampling points to establish the coordinate system divergent line, and then the intersection of the ray and the acetabular edge is extracted as a new sampling point.
- the acetabular edge data Based on the acetabular edge data, determine the center of the acetabular surface as the origin to establish a coordinate system, and then use the coordinate system to determine the mean value of the acetabular edge from the center of the circle as the radius. According to the radius, the surface data is compared with the acquired sampling points, and the deviation exceeds the threshold. The sampling points are removed as error data.
- the ellipsoid is fitted based on the reserved sampling points, and two fitting points in the acetabulum are extracted.
- the acetabular side guide plate assembly for hip joint replacement and the assembling method thereof provided in the embodiments of the present application, through 3D printing the fitting guide plate 100, so that the fitting base 110 can be individually designed according to the anatomical shape and pathological state of the acetabulum of different patients , so as to ensure that each patient can be accurately placed in the acetabular cup, providing clinicians with a more individualized and applicable surgical plan.
- the fitting guide plate 100 adopts three-point fitting and fixation, and uses two medial parts of the acetabulum and one acetabular labrum as the fulcrum, and avoids the transverse ligament and the acetabular cartilage to achieve precise positioning.
- an assembling device of an acetabular side guide plate assembly for hip joint replacement provided by the present application includes:
- the data acquisition module 101 is configured to acquire hip joint image data, perform preoperative planning according to the image data, and determine size data of the acetabular side guide assembly for hip joint replacement based on the preoperative planning data.
- the image data of the hip joint is obtained through CT scanning and other technologies, and the size of the acetabular side guide assembly for hip joint replacement is determined according to the image data.
- the dimensions are obtained so that the conforming base 110 can be matched to the shape of the acetabular socket.
- the obtained size data is exported, and the size data can be used to perform 3D printing with the aid of a 3D printing device to obtain a fitting guide 100 , a support rod 200 , a surgical instrument support, and a positioning pin 400 .
- the 3D printing module 102 is configured to 3D print an acetabular side guide assembly for hip joint replacement based on the dimensional data.
- the preoperative planning scheme is obtained based on the size data, and then the acetabular side guide assembly for hip joint replacement is obtained through 3D printing technology, which can make the structure of the acetabular side guide assembly for hip joint replacement consistent with the preoperative planning, thereby ensuring the intraoperative safety. positioning accuracy.
- the positioning pins 400 therein can also be made by machining.
- the three-point fitting module 103 is configured to take two points in the acetabulum and one point at the labrum, and fix the fitting guide plate through three-point fitting.
- the fitting guide 100 is positioned in a three-point fitting manner, which can ensure that the angle and direction of the fitting guide 100 correspond to the structure of the acetabular cup.
- the assembling and fixing module 104 is configured to assemble the support rod and fix the support rod by the positioning pins.
- the support rod 200 from the lower end of the positioning sleeve 132 , realize the positioning of the support rod 200 by fitting the guide plate 100 , connect the positioning nail 400 to the external driving member, and the external driving member drives the positioning nail 400 to rotate, so that the positioning nail 400 After passing through the guide sleeve 210 , the tip 411 is connected with the external thread of the acetabular fossa to realize the fixation of the support rod 200 .
- the removal module 105 is configured to remove the fitting guide plate. By pulling the fitting guide plate 100 upward by the guide rod 120 , the positioning sleeve 132 is disengaged from the support rod 200 . At this time, the support rod 200 can still maintain the original fixed position and angle under the action of the positioning nail 400 .
- the rasp mounting module 106 is configured to mount the rasp ring to the support rod, and to mount the rasp rod through the rasp ring.
- the press-fit installation module 107 is configured to remove the filing rod and the filing ring, install the press-fit ring to the support rod, and install the press-fit rod through the press-fit ring.
- the data acquisition module 101 includes:
- the image data acquisition unit is configured to acquire image data of X-ray imaging of the hip joint.
- the magnification ratio acquiring unit is configured to acquire the magnification ratio of the projection of the image data.
- the size data acquisition unit is configured to perform image processing based on the enlargement ratio to acquire size data of the hip joint.
- a scatter model unit configured to establish a scatter model based on the image data of the hip joint
- the non-connected points of the model are removed, and a curved surface is generated to simplify the model.
- a hip joint prosthesis model is established, and the hip joint model and the hip joint prosthesis model are matched.
- the model verification unit is configured to perform numerical simulation calculations on the model to verify the accuracy of the hip joint model.
- the model simulation unit is configured to select angular parameters for the simulation based on the validated hip joint model.
- a model sizing unit configured to determine dimensional data of the hip replacement device based on the simulation results.
- the three-point fitting module includes:
- the image segmentation unit is configured to extract the acetabular rim based on the hip joint image segmentation.
- Resampling the hip joint image data extracting the shape parameters of the bone tissue data in the hip joint image to calculate the acetabular gap width, and extracting the acetabular margin data according to the acetabular gap width.
- the sampling point extraction unit is configured to obtain sampling points based on the extracted acetabular rim.
- the sampling points are extracted through the equidistant grid, and the center of the circle is selected according to the sampling points to establish the coordinate system divergent line, and then the intersection of the ray and the acetabular edge is extracted as a new sampling point.
- An error removal unit configured to remove error data based on the acquired sampling points.
- the acetabular edge data Based on the acetabular edge data, determine the center of the acetabular surface as the origin to establish a coordinate system, and then use the coordinate system to determine the mean value of the acetabular edge from the center of the circle as the radius. According to the radius, the surface data is compared with the acquired sampling points, and the deviation exceeds the threshold. The sampling points are removed as error data.
- a fitting point determination unit configured to determine a fitting point within the acetabulum based on the reserved sampling points.
- the ellipsoid is fitted based on the reserved sampling points, and two fitting points in the acetabulum are extracted.
- the embodiments of the present application further include an electronic device, including a memory and a processor, wherein the memory stores a computer program, and the computer program is configured to implement the above-mentioned assembly method of components when executed in the processor, and the method include:
- the present application also provides a readable storage medium, where a computer program is stored in the readable storage medium, and the computer program is configured to implement the above when executed by a processor.
- Assembly method of components the method includes:
- the readable storage medium is a computer storage medium and also a communication medium.
- Communication media includes any medium that facilitates transfer of a computer program from one place to another.
- Computer storage media is any available media that can be accessed by a general purpose or special purpose computer.
- a readable storage medium is coupled to the processor such that the processor can read information from, and write information to, the readable storage medium.
- the readable storage medium is also an integral part of the processor.
- the processor and the readable storage medium are located in Application Specific Integrated Circuits (ASIC). Additionally, the ASIC resides in the user equipment.
- the processor and the readable storage medium also exist in the communication device as discrete components.
- the readable storage media are read only memory (ROM), random access memory (RAM), CD-ROMs, magnetic tapes, floppy disks, optical data storage devices, and the like.
- the present application also provides a program product including execution instructions stored in a readable storage medium. At least one processor of the device reads the execution instructions from the readable storage medium, and the at least one processor executes the execution instructions to cause the device to implement the methods provided by the various embodiments described above.
- the processor is a central processing unit (English: Central Processing Unit, CPU), or other general-purpose processors, digital signal processors (English: Digital Signal Processor, DSP), etc.
- a general purpose processor is a microprocessor or the processor is any conventional processor or the like. The steps of the method disclosed in the present application are directly embodied as being executed by a hardware processor, or executed by a combination of hardware and software modules in the processor.
- modules or steps of the present application are implemented by general-purpose computing devices, which are concentrated on a single computing device, or distributed on a network composed of multiple computing devices,
- they are implemented with program codes executable by a computing device, so that they are stored in a storage device and executed by the computing device, or they are separately made into individual integrated circuit modules, or a plurality of modules of them Or the steps are made into a single integrated circuit module to realize.
- the present application is not limited to any particular combination of hardware and software.
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Abstract
一种髋关节置换用髋臼侧导板组件及其装配方法，其中髋关节置换用髋臼侧导板组件包括：拟合导板（100）、支撑杆（200）、手术器械支撑件和定位钉（400）；拟合导板（100）包括贴合底座（110）、导杆（120）和定位连接件（130），贴合底座（110）适于与人体髋臼窝贴合匹配，导杆（120）由贴合底座（110）的顶面沿贴合底座（110）的径向延伸；支撑杆（200）适于与定位连接件（130）配合定位，以及适于与定位连接件（130）脱离；定位钉（400）适于将支撑杆（200）固定在髋臼窝外部区域，手术器械支撑件适于与支撑杆（200）配合固定，手术器械支撑件被设置为能够与支撑杆（200）配合定位，并且与支撑杆（200）可拆卸连接。髋关节置换用髋臼侧导板组件及其装配方法能够保证可以精确地置入髋臼杯假体，提高手术精度，降低术后并发症发生率。
Description
相关申请的交叉引用
本申请要求于2020年12月31日提交中国专利局，申请号为2020116345657，申请名称为“髋关节置换用髋臼侧导板组件及其装配方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
本申请涉及医疗器械技术领域，尤其涉及一种髋关节置换用髋臼侧导板组件及其装配方法。
人工全髋关节置换术是治疗股骨头坏死、髋关节发育不良等髋关节疾病的重要手段。近年来，随着手术技术的进步、手术入路的不断优化，人工全髋关节置换术逐渐被更多的医生和病人所接受。某些研究已经证明，人工全髋关节置换手术中，安装假体的位置偏差会增加假体受到的冲击力，加速假体周围的骨溶解与迁移，改变了人体的生物力学稳定性，最终导致假体失效。所以人工全髋关节置换手术中假体安装的精准定位显得尤为重要，但人工全髋关节置换术学习曲线较长，对术者经验、术前规划、术中操作等都有较高要求。而在术中导航方面，除仅有极少数医院配备有机器人，绝大多数人工全髋关节置换术都是术者凭借个人经验以及粗略的测量完成的，这将显著增加髋关节置换手术的变异度。以上方法对于经验丰富的医生而言，可取得良好的手术效果，但年轻且经验较少的医生无法凭借以上方法取得理想的手术效果，甚至会提高术后并发症发生率。目前国内最主要的帮助术者定位假体置入位置的术前规划为X线模板测量法，这种以X线为基础的术前规划常常无法从三维角度确定假体的置入位置，同时骨盆的倾斜对假体的置入角度影响也比较大。
申请内容
本申请提供一种髋关节置换用髋臼侧导板组件及其装配方法，用以解决现有技术中人工全髋关节置换手术假体安装无法精准定位的问题。
本申请提供一种髋关节置换用髋臼侧导板组件，包括：拟合导板、支撑杆、手术器械支撑件和定位钉；拟合导板包括贴合底座、导杆和定位连接件，贴合底座适于与人体髋臼窝贴合匹配，导杆由贴合底座的顶面沿贴合底座的径向延伸；支撑杆适于与定位连接件配合定位，以及适于与定位连接件脱离；定位钉适于将支撑杆固定在髋臼窝外部区域，手术器械支撑件被设置为能够与支撑杆配合定位，并且与支撑杆可拆卸连接。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，定位连接件包括连接部和定位套筒，连接部分别与贴合底座和定位套筒固定连接，定位套筒两端开口且轴线方向平行于导杆的轴线方 向；支撑杆适于套接在定位套筒内。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，支撑杆上设置有导向套，导向套与支撑杆固定连接，且与导向套之间形成有夹角，导向套适于连接定位钉。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，导向套设置有两个，两个导向套分置于支撑杆两侧。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，定位钉包括螺纹段和外接段，螺纹段适于钉入体骨固定，外接段适于外接驱动件。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，螺纹段的螺距为2mm，直径为4mm。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，螺纹段上背离外接段的一端具有尖端，且在尖端位置设置有切槽。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，外接段上背离螺纹段的一端设置有快接缺口。
根据本申请提供的一种髋关节置换用髋臼侧导板组件，手术器械支撑件包括磨锉环和压配环，磨锉环和压配环均包括依次连接的对接套筒、连接杆和卡套，对接套筒适于与支撑杆套接配合，连接杆垂直于对接套筒轴线，卡套具有侧向开口，适于卡接固定手术器械。
本申请还提供一种如上任一项的髋关节置换用髋臼侧导板组件的装配方法，包括以下步骤：
获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据；
基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件；
取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板；
装配支撑杆并通过定位钉固定支撑杆；
取下拟合导板；
将磨锉环安装至支撑杆，并通过磨锉环安装磨锉杆；
取下磨锉杆和磨锉环，将压配环安装至支撑杆，并通过压配环安装压配杆。
根据本申请提供的髋关节置换用髋臼侧导板组件的装配方法，所述获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据，包括：
获取髋关节的X射线成像的影像数据；
获取影像数据投影的放大比例；
基于放大比例进行图像处理，获取髋关节的尺寸数据。
根据本申请提供的髋关节置换用髋臼侧导板组件的装配方法，所述获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据，包括：
基于髋关节的影像数据建立散点模型；
对模型进行数值模拟计算，验证髋关节模型准确性；
基于验证过的髋关节模型，选取角度参数代入模拟；
基于模拟结果确定髋关节置换装置的尺寸数据。
根据本申请提供的髋关节置换用髋臼侧导板组件的装配方法，所述取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板，包括：
基于髋关节影像分割提取髋臼边缘；
基于提取的髋臼边缘获取采样点；
基于获取的采样点去除误差数据；
基于保留的采样点确定髋臼内的拟合点。
本申请提供的髋关节置换用髋臼侧导板组件及其装配方法，通过将拟合导板与人体的髋臼窝拟合可实现支撑杆的精确定位，将支撑杆固定后，通过支撑杆连接手术器械支撑件，手术器械支撑件能够支撑磨锉杆或压配杆等手术器械，保证磨锉杆和压配杆达到与术前规划一致的前倾角和外展角。
本申请还提供一种髋关节置换用髋臼侧导板组件的装配装置包括：
数据获取模块，被配置为获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据。3D打印模块，被配置为基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件。
三点拟合模块，被配置为取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板。
装配固定模块，被配置为装配支撑杆并通过定位钉固定所述支撑杆。
拆取模块，被配置为取下所述拟合导板。
磨锉安装模块，被配置为将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆。
压配安装模块，被配置为取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
根据本申请提供的髋关节置换用髋臼侧导板组件的装配装置，所述数据获取模块，包括：
影像数据获取单元，被配置为获取髋关节的X射线成像的影像数据。
放大比例获取单元，被配置为获取影像数据投影的放大比例。
尺寸数据获取单元，被配置为基于放大比例进行图像处理，获取髋关节的尺寸数据。
散点模型单元，被配置为基于髋关节的影像数据建立散点模型；
模型验证单元，被配置为对模型进行数值模拟计算，验证髋关节模型准确性。
模型模拟单元，被配置为基于验证过的髋关节模型，选取角度参数代入模拟。
模型尺寸确定单元，被配置为基于模拟结果确定髋关节置换装置的尺寸数据。
根据本申请提供的髋关节置换用髋臼侧导板组件的装配装置，所述三点拟合模块，包括：
影像分割单元，被配置为基于髋关节影像分割提取髋臼边缘。
采样点提取单元，被配置为基于提取的髋臼边缘获取采样点。
误差去除单元，被配置为基于获取的采样点去除误差数据。
拟合点确定单元，被配置为基于保留的采样点确定髋臼内的拟合点。
本申请的另一实施例提供了一种电子设备，包括存储器和处理器，所述存储器存储计算机程序，其中，所述计算机程序在所述处理器中执行可实现如上所述的方法的步骤。
本申请的再一实施例提供了一种存储介质，存储计算机程序，其中，所述计算机程序在处理器中执行可实现如上所述的方法的步骤。基于三维术前规划的3D打印拟合导板，贴合底座根据不同患者的髋臼的解剖形态及病理状态进行个性化设计，从而保证每位患者都可以精确地置入髋臼杯假体，从三维角度确定假体的置入位置，可以减少假体的置入位置的偏差，提高假体的置入位置的精准度，保证假体置于最优位置，降低假体脱位、假体松动、疼痛等并发症的发生率。
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作一简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请提供的髋关节置换用髋臼侧导板组件中拟合导板的结构示意图；
图2是本申请提供的髋关节置换用髋臼侧导板组件中支撑杆的结构示意图；
图3是本申请提供的髋关节置换用髋臼侧导板组件中定位钉的结构示意图；
图4是本申请提供的髋关节置换用髋臼侧导板组件中磨锉环的结构示意图；
图5是本申请提供的髋关节置换用髋臼侧导板组件中压配环的结构示意图；
图6是本申请提供的髋关节置换用髋臼侧导板组件的使用状态图之一；
图7是本申请提供的髋关节置换用髋臼侧导板组件的使用状态图之二；
图8是本申请提供的髋关节置换用髋臼侧导板组件的使用状态图之三；
图9是本申请提供的髋关节置换用髋臼侧导板组件的装配方法的流程图；
图10是本申请提供的髋关节置换用髋臼侧导板组件的装配装置的结构示意图。
附图标记：
100、拟合导板； 110、贴合底座； 120、导杆；
130、定位连接件； 131、连接部； 132、定位套筒；
200、支撑杆； 210、导向套； 301、磨锉环；
302、压配环； 310、对接套筒； 320、连接杆；
330、卡套； 400、定位钉； 410、螺纹段；
411、尖端； 412、切槽； 420、外接段；
421、快接缺口； 500、磨锉杆； 600、压配杆。
下面结合附图和实施例对本申请的实施方式作进一步详细描述。以下实施例用于说明本申请，但不能用来限制本申请的范围。
在本申请实施例的描述中，需要说明的是，术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请实施例和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请实施例的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请实施例的描述中，需要说明的是，除非另有明确的规定和限定，术语“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请实施例中的具体含义。
在本申请实施例中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本 申请实施例的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外，在不相互矛盾的情况下，本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
下面结合图1至图5描述本申请实施例的髋关节置换用髋臼侧导板组件，髋关节置换用髋臼侧导板组件包括拟合导板100、支撑杆200、手术器械支撑件和定位钉400。
拟合导板100包括贴合底座110、导杆120和定位连接件130，其中，贴合底座110具有髋臼窝贴合面和安装面，髋臼窝贴合面与髋臼窝内侧贴合匹配，安装面设置于髋臼窝贴合面的顶部，可采用平面结构，适于连接导杆120和定位连接件130。导杆120的一端与贴合底座110固定连接，可选地，导杆120一端与贴合底座110的安装面固定连接。导杆120背离贴合底座一端沿贴合底座110的轴向延伸，且导杆120与贴合底座110同轴设置。
定位连接件130包括连接部131和定位套筒132，连接部131分别与贴合底座110和定位套筒132固定连接，使定位套筒132与贴合底座110的相对位置固定。定位套筒132能够适于连接支撑杆200，可选地，定位套筒132的筒内横截面的形状及尺寸与支撑杆200的横截面形状及尺寸相同或相匹配，使支撑杆200能够插入定位套筒132内或由定位套筒132内拔出。可选地，支撑杆200设计为截面呈多边形、椭圆形、不规则图形等非圆形的杆体结构，能够使定位套筒132与支撑杆200连接后形成轴向旋转限位，使定位套筒132与支撑杆200产生轴向的相对移动。
贴合底座110、导杆120和定位连接件130可以采用一体成型结构，生产时可根据髋关节的影像数据进行三维建模并通过3D打印获得，使贴合底座110能够更好的与髋臼窝配合在一起。针对不同的患者，可根据髋臼的解剖形态及病例状态进行个性化定制，以保证每位患者都可以精确地植入髋臼杯假体。
支撑杆200插入定位套筒132后，在定位套筒132的作用下实现精确定位，再通过定位钉400使支撑杆200固定在髋臼窝外部区域，此时取下拟合导板100后支撑杆200的位置不会移动。
手术器械支撑件适于与支撑杆200配合固定，并适于支撑固定手术用磨锉杆500、压配杆600中至少之一的手术器械，以方便进行以下操作中至少之一：磨锉、髋臼杯假体的植入。在支撑杆200和手术器械支撑件的支撑作用下，磨锉杆500、压配杆600中至少之一的轴向固定，能够实现精准操作。
参见图2，在本申请一个实施例中，支撑杆200上设置有导向套210，导向套210与支撑杆200固定连接。导向套210的轴线与支撑杆200的轴线空间交叉，从而使导向套210与支撑杆200之间形成夹角。导向套210为两端开口的筒状结构，能够适于连接定位钉400，对支撑杆200进行 固定时，可使定位钉400的一端轴向穿过导向套210后与髋臼窝外部固定连接。
可选地，导向套210设置有两个，两个导向套210分置于支撑杆200两侧且相互平行。定位钉400与导向套210对应的设置有两个，两个导向套210分别通过定位钉400进行固定，使支撑杆200更牢固的固定在髋臼窝外部，同时能够避免支撑杆200绕定位钉400旋转。
参见图3，在一些优选的实施方式中，本申请提供的定位钉400可以采用自锁式定位钉。该自锁式定位钉400包括共轴线且一体设置的螺纹段410和外接段420，螺纹段410外壁上设置有螺纹，适于钉入体骨内固定；外接段420的外壁平滑，适于外接驱动件，该外接驱动件可以为电钻等类型的手持器械。
人体的松质骨呈海绵状，由相互交织的骨小梁排列而成，配布于骨的内部，普通外科钉不能很好起到固定的效果，而本申请中定位钉400的螺纹段410螺距为2mm，较大螺距与导向套210内螺纹匹配，便于卡住松质骨并固定；并且螺纹段410直径为4mm，增加其固定的稳定性。本申请实施例中的定位钉400能够达到强力自锁效果。
螺纹段410上背离外接段420的一端具有尖端411，且在尖端411位置设置有切槽412，能够使定位钉400旋转时更好破开皮质骨。
外接段420背离螺纹段410的一端设置有快接缺口421，使外接段420背离螺纹段410的一端呈半圆柱形。快接缺口421的设置能方便将定位钉400与外接驱动件快速对接。
参见图4和图5，在本申请一个实施例中，手术器械支撑件包括磨锉环301和压配环302，磨锉环301和压配环302均包括依次连接的对接套筒310、连接杆320和卡套330。对接套筒310的一端开口，另一端与连接杆320固定连接。对接套筒310的开口端能够套接在支撑杆200外。连接杆320垂直于对接套筒310轴线，将手术器械支撑件与支撑杆200套接配合时，连接杆320朝向髋臼窝一侧。卡套330具有侧向开口，适于卡接固定手术用磨锉杆500、手术用压配杆600中至少之一。卡套330能够使手术用磨锉杆500、手术用压配杆600中至少之一的方向固定，从而在磨锉或髋臼杯假体植入时准确定位。
结合图6和图9，下面对本申请提供的髋关节置换用髋臼侧导板组件的装配方法进行描述，下文描述的髋关节置换用髋臼侧导板组件的装配方法与上文描述的髋关节置换用髋臼侧导板组件可相互对应参照。
本申请提供的一种髋关节置换用髋臼侧导板组件的装配方法包括：
S1、获得髋关节影像数据并根据影像数据确定髋关节置换装置的尺寸数据。
可选地，获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据。如，通过CT扫描等技术获得髋关节影像数据，根据该影像 数据确定髋关节置换用髋臼侧导板组件的尺寸，髋关节置换用髋臼侧导板组件中贴合底座110的尺寸根据髋臼窝的尺寸获得，使贴合底座110能够与髋臼窝形状匹配。将获得的尺寸数据导出，使用该尺寸数据即可借助3D打印设备进行3D打印，获得拟合导板100、支撑杆200、手术器械支撑件、定位钉400。
S2、基于尺寸数据3D打印获得髋关节置换装置。
可选地，基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件。
基于尺寸数据获得术前规划方案，再通过3D打印技术获得髋关节置换用髋臼侧导板组件，能够使髋关节置换用髋臼侧导板组件的结构与术前规划一致，进而可保证术中的定位精度。其中的定位钉400也可以通过机械加工制得。
S3、取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板100。
采用三点拟合的方式对拟合导板100进行定位，能够保证拟合导板100的角度及方向与髋臼杯的结构对应。
S4、装配支撑杆200并通过定位钉400固定支撑杆200。
先将支撑杆200由定位套筒132的下端插入，通过拟合导板100实现支撑杆200的定位，将定位钉400连接至外接驱动件上，外接驱动件带动定位钉400旋转，使定位钉400的尖端411穿过导向套210后与髋臼窝外部螺纹连接，实现支撑杆200的固定。
S5、取下拟合导板100。通过导杆120向上拉动拟合导板100，定位套筒132与支撑杆200脱离，此时支撑杆200在定位钉400的作用下仍能维持原固定位置及角度。
S6、将磨锉环301安装至支撑杆200，并通过磨锉环301安装磨锉杆500。
先将磨锉环301的连接杆320调整至朝向髋臼窝一侧，再将磨锉环301由支撑杆200的上方沿支撑杆200的延伸方向下移，使对接套筒310与支撑杆200的上端套接，此时磨锉环301在支撑杆200的支撑下位置固定。再将磨锉杆500与卡套330配合，能够磨锉杆500达到与术前规划一致的前倾角与外展角。
S7、取下磨锉杆500和磨锉环301，将压配环302安装至支撑杆200，并通过压配环302安装压配杆600。
将磨锉杆500由卡套330上取下，将压配环302的连接杆320调整至朝向髋臼窝一侧，再将压配环302由支撑杆200的上方沿支撑杆200的延伸方向下移，使对接套筒310与支撑杆200的上端套接，此时压配环302在支撑杆200的支撑下位置固定。再将压配杆600与卡套330配合，能够压配杆600达到与术前规划一致的前倾角与外展角。
可选地，所述获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定 髋关节置换用髋臼侧导板组件的尺寸数据，包括：
S110、获取髋关节的X射线成像的影像数据。
S120、获取影像数据投影的放大比例。
S130、基于放大比例进行图像处理，获取髋关节的尺寸数据。
S140、基于髋关节的影像数据建立散点模型。
基于散点模型，去除模型的非连接点，生成曲表面进行模型简化处理，根据简化处理后的模型建立髋关节假体模型，对髋关节模型和髋关节假体模型进行匹配。
S150、对模型进行数值模拟计算，验证髋关节模型准确性。
获取骨密度的材料属性，通过材料属性对髋关节各部位进行边界划分，根据边界划分的位置建立坐标系计算模型，基于计算出的模型与测量数据进行数据比照。
S160、基于验证过的髋关节模型，选取角度参数代入模拟。
获取各角度参数下髋关节模型的应变分布数据，基于应变分布数据调整髋关节模型的角度参数，并根据调整的结果获取髋关节模型的数据。
S170、基于模拟结果确定髋关节置换装置的尺寸数据。
可选地，所述取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板，包括：
S210、基于髋关节影像分割提取髋臼边缘。
对髋关节影像数据进行重采样，提取髋关节影像中的骨组织数据的外形参数计算髋臼间隙宽度，根据髋臼间隙宽度提取髋臼边缘数据。
S220、基于提取的髋臼边缘获取采样点。
基于髋臼边缘通过等距栅格提取采样点，根据采样点选取圆心建立坐标系发散射线，再提取射线与髋臼边缘的交点作为新的采样点。
S230、基于获取的采样点去除误差数据。
基于髋臼边缘数据确定髋臼曲面的圆心作为原点建立坐标系，再通过坐标系确定髋臼边缘距离圆心的均值作为半径，根据半径确定曲面数据与获取的采样点进行比对，将偏差超过阈值的采样点作为误差数据去除。
S240、基于保留的采样点确定髋臼内的拟合点。
基于保留的采样点拟合得到椭球面，并提取髋臼内两个拟合点。
本申请实施例提供的髋关节置换用髋臼侧导板组件及其装配方法，通过3D打印拟合导板100，使贴合底座110能够根据不同患者的髋臼的解剖形态及病理状态进行个性化设计，从而保证每位患者都可以精确地置入髋臼杯，为临床医师提供更个体化更适用的手术方案。拟合导板100采用 三点拟合固定，以髋臼内侧两处与髋臼盂唇一处为支点，并且避开横韧带与髋臼内软骨，实现精确定位。
参见图10，本申请提供的一种髋关节置换用髋臼侧导板组件的装配装置包括：
数据获取模块101，被配置为获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据。如，通过CT扫描等技术获得髋关节影像数据，根据该影像数据确定髋关节置换用髋臼侧导板组件的尺寸，髋关节置换用髋臼侧导板组件中贴合底座110的尺寸根据髋臼窝的尺寸获得，使贴合底座110能够与髋臼窝形状匹配。将获得的尺寸数据导出，使用该尺寸数据即可借助3D打印设备进行3D打印，获得拟合导板100、支撑杆200、手术器械支撑件、定位钉400。
3D打印模块102，被配置为基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件。
基于尺寸数据获得术前规划方案，再通过3D打印技术获得髋关节置换用髋臼侧导板组件，能够使髋关节置换用髋臼侧导板组件的结构与术前规划一致，进而可保证术中的定位精度。其中的定位钉400也可以通过机械加工制得。
三点拟合模块103，被配置为取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板。
采用三点拟合的方式对拟合导板100进行定位，能够保证拟合导板100的角度及方向与髋臼杯的结构对应。
装配固定模块104，被配置为装配支撑杆并通过定位钉固定所述支撑杆。
先将支撑杆200由定位套筒132的下端插入，通过拟合导板100实现支撑杆200的定位，将定位钉400连接至外接驱动件上，外接驱动件带动定位钉400旋转，使定位钉400的尖端411穿过导向套210后与髋臼窝外部螺纹连接，实现支撑杆200的固定。
拆取模块105，被配置为取下所述拟合导板。通过导杆120向上拉动拟合导板100，定位套筒132与支撑杆200脱离，此时支撑杆200在定位钉400的作用下仍能维持原固定位置及角度。
磨锉安装模块106，被配置为将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆。
先将磨锉环301的连接杆320调整至朝向髋臼窝一侧，再将磨锉环301由支撑杆200的上方沿支撑杆200的延伸方向下移，使对接套筒310与支撑杆200的上端套接，此时磨锉环301在支撑杆200的支撑下位置固定。再将磨锉杆500与卡套330配合，能够磨锉杆500达到与术前规划一致的前倾角与外展角。
压配安装模块107，被配置为取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
将磨锉杆500由卡套330上取下，将压配环302的连接杆320调整至朝向髋臼窝一侧，再将 压配环302由支撑杆200的上方沿支撑杆200的延伸方向下移，使对接套筒310与支撑杆200的上端套接，此时压配环302在支撑杆200的支撑下位置固定。再将压配杆600与卡套330配合，能够压配杆600达到与术前规划一致的前倾角与外展角。
可选地，所述数据获取模块101，包括：
影像数据获取单元，被配置为获取髋关节的X射线成像的影像数据。
放大比例获取单元，被配置为获取影像数据投影的放大比例。
尺寸数据获取单元，被配置为基于放大比例进行图像处理，获取髋关节的尺寸数据。
散点模型单元，被配置为基于髋关节的影像数据建立散点模型；
基于散点模型，去除模型的非连接点，生成曲表面进行模型简化处理，根据简化处理后的模型建立髋关节假体模型，对髋关节模型和髋关节假体模型进行匹配。
模型验证单元，被配置为对模型进行数值模拟计算，验证髋关节模型准确性。
获取骨密度的材料属性，通过材料属性对髋关节各部位进行边界划分，根据边界划分的位置建立坐标系计算模型，基于计算出的模型与测量数据进行数据比照。
模型模拟单元，被配置为基于验证过的髋关节模型，选取角度参数代入模拟。
获取各角度参数下髋关节模型的应变分布数据，基于应变分布数据调整髋关节模型的角度参数，并根据调整的结果获取髋关节模型的数据。
模型尺寸确定单元，被配置为基于模拟结果确定髋关节置换装置的尺寸数据。
可选地，所述三点拟合模块，包括：
影像分割单元，被配置为基于髋关节影像分割提取髋臼边缘。
对髋关节影像数据进行重采样，提取髋关节影像中的骨组织数据的外形参数计算髋臼间隙宽度，根据髋臼间隙宽度提取髋臼边缘数据。
采样点提取单元，被配置为基于提取的髋臼边缘获取采样点。
基于髋臼边缘通过等距栅格提取采样点，根据采样点选取圆心建立坐标系发散射线，再提取射线与髋臼边缘的交点作为新的采样点。
误差去除单元，被配置为基于获取的采样点去除误差数据。
基于髋臼边缘数据确定髋臼曲面的圆心作为原点建立坐标系，再通过坐标系确定髋臼边缘距离圆心的均值作为半径，根据半径确定曲面数据与获取的采样点进行比对，将偏差超过阈值的采样点作为误差数据去除。
拟合点确定单元，被配置为基于保留的采样点确定髋臼内的拟合点。
基于保留的采样点拟合得到椭球面，并提取髋臼内两个拟合点。
本申请实施例，还包括一种电子设备，包括存储器和处理器，所述存储器存储计算机程序，所述计算机程序在所述处理器中执行时被配置为实现上述的组件的装配方法，该方法包括：
S1、获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据；
S2、基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件；
S3、取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板；
S4、装配支撑杆并通过定位钉固定所述支撑杆；
S5、取下所述拟合导板；
S6、将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆；
S7、取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
还包括一个实施例，本实施例中，本申请还提供了一种可读存储介质，所述可读存储介质中存储有计算机程序，所述计算机程序被处理器执行时被配置为实现上述的组件的装配方法，该方法包括：
S1、获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据；
S2、基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件；
S3、取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板；
S4、装配支撑杆并通过定位钉固定所述支撑杆；
S5、取下所述拟合导板；
S6、将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆；
S7、取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
其中，可读存储介质是计算机存储介质，也是通信介质。通信介质包括便于从一个地方向另一个地方传送计算机程序的任何介质。计算机存储介质是通用或专用计算机能够存取的任何可用介质。例如，可读存储介质耦合至处理器，从而使处理器能够从该可读存储介质读取信息，且可向该可读存储介质写入信息。当然，可读存储介质也是处理器的组成部分。处理器和可读存储介质位于专用集成电路(Application Specific Integrated Circuits，ASIC)中。另外，该ASIC位于用户设备中。当然，处理器和可读存储介质也作为分立组件存在于通信设备中。可读存储介质是只读存储器(ROM)、随机存取存储器(RAM)、CD-ROM、磁带、软盘和光数据存储设备等。
本申请还提供一种程序产品，该程序产品包括执行指令，该执行指令存储在可读存储介质中。设备的至少一个处理器从可读存储介质读取该执行指令，至少一个处理器执行该执行指令使得设 备实施上述的各种实施方式提供的方法。
在上述终端或者服务器的实施例中，应理解，处理器是中央处理单元(英文：Central Processing Unit，CPU)，还是其他通用处理器、数字信号处理器(英文：Digital Signal Processor，DSP)等。通用处理器是微处理器或者该处理器也是任何常规的处理器等。结合本申请所公开的方法的步骤直接体现为硬件处理器执行完成，或者用处理器中的硬件及软件模块组合执行完成。
需要说明的是，在附图的流程图示出的步骤在诸如一组计算机可执行指令的计算机系统中执行，并且，虽然在流程图中示出了逻辑顺序，但是在某些情况下，以不同于此处的顺序执行所示出或描述的步骤。
显然，本领域的技术人员应该明白，上述的本申请的各模块或各步骤用通用的计算装置来实现，它们集中在单个的计算装置上，或者分布在多个计算装置所组成的网络上，可选地，它们用计算装置可执行的程序代码来实现，从而，将它们存储在存储装置中由计算装置来执行，或者将它们分别制作成各个集成电路模块，或者将它们中的多个模块或步骤制作成单个集成电路模块来实现。这样，本申请不限制于任何特定的硬件和软件结合。
最后应说明的是：以上实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围。
Claims (19)
- 一种髋关节置换用髋臼侧导板组件，其中，包括：拟合导板、支撑杆、手术器械支撑件和定位钉；所述拟合导板包括贴合底座、导杆和定位连接件，所述贴合底座被设置为能够与人体髋臼窝贴合匹配，所述导杆设置于所述贴合底座的顶面且沿所述贴合底座的轴向延伸；所述支撑杆适于与所述定位连接件配合定位，并且与所述定位连接件可拆卸连接；所述定位钉适于将所述支撑杆固定在髋臼窝外部区域；所述手术器械支撑件被设置为能够与所述支撑杆配合定位，并且与所述支撑杆可拆卸连接。
- 根据权利要求1所述的髋关节置换用髋臼侧导板组件，其中，所述定位连接件包括连接部和定位套筒，所述连接部分别与所述贴合底座和所述定位套筒固定连接，所述定位套筒两端开口且轴线方向平行于所述导杆的轴线方向；所述支撑杆适于套接在所述定位套筒内。
- 根据权利要求1所述的髋关节置换用髋臼侧导板组件，其中，所述支撑杆上设置有导向套，所述导向套与所述支撑杆固定连接，且与所述导向套之间形成有夹角，所述导向套适于连接所述定位钉。
- 根据权利要求3所述的髋关节置换用髋臼侧导板组件，其中，所述导向套设置有两个，两个所述导向套分置于所述支撑杆两侧。
- 根据权利要求1所述的髋关节置换用髋臼侧导板组件，其中，所述定位钉包括螺纹段和外接段，所述螺纹段适于钉入体骨固定，所述外接段适于外接驱动件。
- 根据权利要求5所述的髋关节置换用髋臼侧导板组件，其中，所述螺纹段的螺距为2mm，直径为4mm。
- 根据权利要求5所述的髋关节置换用髋臼侧导板组件，其中，所述螺纹段上背离所述外接段的一端具有尖端，且在所述尖端处设置有切槽。
- 根据权利要求5所述的髋关节置换用髋臼侧导板组件，其中，所述外接段上背离所述螺纹段的一端设置有快接缺口。
- 根据权利要求1所述的髋关节置换用髋臼侧导板组件，其中，所述手术器械支撑件包括磨锉环和压配环，所述磨锉环和所述压配环均包括依次连接的对接套筒、连接杆和卡套，所述对接套筒适于与所述支撑杆套接配合，所述连接杆垂直于所述对接套筒轴线，所述卡套具有侧向开口，适于卡接固定手术器械。
- 一种如权利要求1至9任一项所述的髋关节置换用髋臼侧导板组件的装配方法，其中，包括以下步骤：获得髋关节影像数据并根据影像数据确定髋关节置换装置的尺寸数据；基于尺寸数据3D打印获得髋关节置换装置；取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板；装配支撑杆并通过定位钉固定所述支撑杆；取下所述拟合导板；将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆；取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
- 根据权利要求10所述的髋关节置换用髋臼侧导板组件的装配方法，其中，所述获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据，包括：获取髋关节的X射线成像的影像数据；获取影像数据投影的放大比例；基于放大比例进行图像处理，获取髋关节的尺寸数据。
- 根据权利要求10所述的髋关节置换用髋臼侧导板组件的装配方法，其中，所述获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据，包括：基于髋关节的影像数据建立散点模型；对模型进行数值模拟计算，验证髋关节模型准确性；基于验证过的髋关节模型，选取角度参数代入模拟；基于模拟结果确定髋关节置换装置的尺寸数据。
- 根据权利要求10所述的髋关节置换用髋臼侧导板组件的装配方法，其中，所述取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板，包括：基于髋关节影像分割提取髋臼边缘；基于提取的髋臼边缘获取采样点；基于获取的采样点去除误差数据；基于保留的采样点确定髋臼内的拟合点。
- 一种髋关节置换用髋臼侧导板组件的装配装置，其中，包括：数据获取模块，被配置为获得髋关节影像数据并根据影像数据进行术前规划，基于术前规划的数据确定髋关节置换用髋臼侧导板组件的尺寸数据；3D打印模块，被配置为基于尺寸数据3D打印获得髋关节置换用髋臼侧导板组件；三点拟合模块，被配置为取髋臼内两点和盂唇处一点，通过三点拟合固定拟合导板；装配固定模块，被配置为装配支撑杆并通过定位钉固定所述支撑杆；拆取模块，被配置为取下所述拟合导板；磨锉安装模块，被配置为将磨锉环安装至所述支撑杆，并通过磨锉环安装磨锉杆；压配安装模块，被配置为取下磨锉杆和磨锉环，将压配环安装至所述支撑杆，并通过压配环安装压配杆。
- 根据权利要求14所述的髋关节置换用髋臼侧导板组件的装配装置，其中，所述数据获取模块，包括：影像数据获取单元，被配置为获取髋关节的X射线成像的影像数据；放大比例获取单元，被配置为获取影像数据投影的放大比例；尺寸数据获取单元，被配置为基于放大比例进行图像处理，获取髋关节的尺寸数据。
- 根据权利要求14所述的髋关节置换用髋臼侧导板组件的装配装置，其中，所述数据获取模块，包括：散点模型单元，被配置为基于髋关节的影像数据建立散点模型；模型验证单元，被配置为对模型进行数值模拟计算，验证髋关节模型准确性；模型模拟单元，被配置为基于验证过的髋关节模型，选取角度参数代入模拟；模型尺寸确定单元，被配置为基于模拟结果确定髋关节置换装置的尺寸数据。
- 根据权利要求14所述的髋关节置换用髋臼侧导板组件的装配装置，其中，所述三点拟合模块，包括：影像分割单元，被配置为基于髋关节影像分割提取髋臼边缘；采样点提取单元，被配置为基于提取的髋臼边缘获取采样点；误差去除单元，被配置为基于获取的采样点去除误差数据；拟合点确定单元，被配置为基于保留的采样点确定髋臼内的拟合点。
- 一种电子设备，包括存储器和处理器，所述存储器存储计算机程序，其中，所述计算机程序在所述处理器中执行可实现权利要求10至13中任一种方法的步骤。
- 一种存储介质，存储计算机程序，其中，所述计算机程序在处理器中执行可实现权利要求10至13中任一种方法的步骤。
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