CN215535337U - Metal 3D prints customized sleeve matched stack formula femoral intramedullary needle prosthesis - Google Patents
Metal 3D prints customized sleeve matched stack formula femoral intramedullary needle prosthesis Download PDFInfo
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- CN215535337U CN215535337U CN202120126355.0U CN202120126355U CN215535337U CN 215535337 U CN215535337 U CN 215535337U CN 202120126355 U CN202120126355 U CN 202120126355U CN 215535337 U CN215535337 U CN 215535337U
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- 239000002184 metal Substances 0.000 title claims abstract description 22
- 229910052751 metal Inorganic materials 0.000 title claims abstract description 22
- 210000000689 upper leg Anatomy 0.000 claims abstract description 45
- 238000010146 3D printing Methods 0.000 claims abstract description 25
- 239000007769 metal material Substances 0.000 claims abstract description 12
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 3
- 210000000988 bone and bone Anatomy 0.000 description 21
- 208000010392 Bone Fractures Diseases 0.000 description 11
- 206010017076 Fracture Diseases 0.000 description 11
- 238000004519 manufacturing process Methods 0.000 description 11
- 206010020100 Hip fracture Diseases 0.000 description 7
- 238000005516 engineering process Methods 0.000 description 6
- 238000011282 treatment Methods 0.000 description 6
- 230000007547 defect Effects 0.000 description 5
- 210000001624 hip Anatomy 0.000 description 5
- 210000004394 hip joint Anatomy 0.000 description 5
- 238000013461 design Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000000527 greater trochanter Anatomy 0.000 description 4
- 238000003384 imaging method Methods 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 229910000831 Steel Inorganic materials 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 239000002639 bone cement Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 238000007639 printing Methods 0.000 description 3
- 239000010959 steel Substances 0.000 description 3
- 208000034656 Contusions Diseases 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
- 230000037118 bone strength Effects 0.000 description 2
- 208000034526 bruise Diseases 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 238000011540 hip replacement Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 230000000399 orthopedic effect Effects 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 208000024779 Comminuted Fractures Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 238000011882 arthroplasty Methods 0.000 description 1
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- 238000010586 diagram Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
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- 238000011105 stabilization Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
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Abstract
The utility model relates to a femoral intramedullary pin prosthesis assembled by a metal 3D printing customized sleeve, which comprises a sleeve and a femoral intramedullary pin handle, wherein the sleeve is prepared by 3D printing customization of a metal material; the intramedullary needle type femoral stem comprises a femoral connecting body, a neck body and a stem body which are sequentially connected, wherein the outer surface of the neck body has a taper matched with the sleeve, the stem body is provided with a front bow, and the distal end of the stem body is provided with a locking nail hole for fixing with the distal end of a femur; the intramedullary pin type femoral stem is inserted into the sleeve, the femoral connector is nested and matched with the notch, and the sleeve and the neck body are fixed at the matched and fixed position in a taper press fit mode. The utility model can realize the biological fixation of the near end, and the far end realizes the anti-rotation and prevents the early sinking of the prosthesis through the locking nail hole and the screw of the handle body.
Description
Technical Field
The utility model relates to the technical field of artificial prostheses, in particular to a femoral intramedullary needle prosthesis assembled by a metal 3D printing customized sleeve.
Background
For patients who need revision for femoral intertrochanteric comminuted fracture of old age and for whom the proximal femur has an inclusive bone defect after hip replacement, the current treatment measures mainly include using a biological elongated handle to perform tight press-fit fixation through the distal isthmus of the femur, as shown in fig. 1 and 2; the bone cement lengthening handle can also be used for patients with poor bone quality and poor bone quantity. However, long-term follow-up shows that most of the distal-end fixed prostheses do not have the anatomical anterior arch design, the tip of the distal femoral prosthesis is easy to penetrate out, the anti-rotation effect is poor, the proximal femoral stress is shielded, the prosthesis sinks and fails after bone absorption, and the revision operation has to be performed again in a short term, and fig. 3 and 4 are schematic diagrams of different biological elongated handle fixing modes after the revision operation respectively. For patients with a large trochanteric fracture, additional internal fixation is often needed to fix the fracture, causing additional cost and increasing the burden of the patients. The bone cement type prosthesis is not recommended clinically at present because of the problems of fatal bone cement anaphylactic reaction possibly occurring in the operation, difficult repair after loosening and the like.
Therefore, for the elderly intertrochanteric fracture and the postoperative patients with proximal femoral inclusive bone defects, a proximal isthmus-added fixed prosthesis is used as a first choice. It is noted that a significant proportion of the proximal femur anatomy of an adult hip does not match the geometry of the femoral prosthesis most commonly found in total hip arthroplasty. A study based on CT showed that only 25% of the hip anatomy had good conformity to the femoral prosthesis (distance less than 2 mm), while 29% of the hip had considerable mismatch to the femoral prosthesis (distance ≧ 6 mm). In this context, some studies have pointed out differences in the femoral anatomy of the global population, and the size of prostheses developed in europe may not be optimal for other continental populations. Meanwhile, due to individual differences, the anatomical morphology and the bone quality of the proximal femoral medullary cavity are different, the mass production of proximal matching type integrated prostheses is not easy to realize, the proximal stability cannot be formed, the rotation prevention effect of the prostheses is not good, and the prostheses sink easily.
In summary, to achieve optimal intramedullary femoral stem filling and restore patient individualized hip biomechanics, a modular femoral prosthesis of multiple shapes and multiple eccentricity selections may provide better metaphysis fit.
Disclosure of Invention
In order to solve the problems of artificial prostheses used for femoral intertrochanteric fracture treatment and hip joint replacement in the prior art, the utility model provides a femoral intramedullary needle prosthesis assembled by a metal 3D printing customized sleeve.
In order to achieve the purpose, the utility model adopts the following technical scheme:
a femoral intramedullary needle prosthesis assembled by a metal 3D printing customized sleeve comprises a sleeve and an intramedullary needle type femoral stem;
the sleeve is prepared by 3D printing customization of a metal material, the outer surface of the sleeve is of a microporous structure and is matched with the shape of a medullary cavity at the proximal end of a femur, the sleeve is integrally hollow and cylindrical, a gap is formed in the side wall close to the upper end of the sleeve, the inner surface of the side wall close to the lower end of the sleeve is provided with a taper, and a locking screw hole for fixedly connecting with other fixing devices is formed in the shoulder part opposite to the gap;
the intramedullary needle type femoral stem comprises a femoral connecting body, a neck body and a stem body which are sequentially connected, the outer surface of the neck body has a taper matched with the sleeve, the stem body is provided with a front bow, and the distal end of the stem body is provided with a locking nail hole for fixing with the distal end of a femur;
the sleeve and the intramedullary needle type femoral stem are connected and fixed in a way that: the intramedullary pin type femoral stem is inserted into the sleeve, the femoral connector is nested and matched with the notch, and the sleeve and the neck body are fixed at an assembly fixing position in a taper press fit mode.
Compared with the prior art, the utility model has the following beneficial effects:
(1) the sleeve prepared by the metal material 3D printing customization is matched with the intramedullary needle type femoral stem capable of being produced in batches through the taper, so that the near-end biological fixation is realized, the far end realizes the rotation prevention and prevents the early sinking of the prosthesis through the locking nail hole and the screw of the stem body, and the stability of the prosthesis is further improved;
(2) the sleeve is prepared by 3D printing customization of a metal material, can be matched with the shape of a medullary cavity at the proximal end of a femur, solves the problem that the conventional artificial hip joint prosthesis is not matched with a fracture part at the proximal end of the femur in the intertrochanteric fracture treatment, is completely matched to increase the fixing strength of the prosthesis, also solves the problems that the proximal end of the femur has reduced bone mass and reduced bone strength caused by stress shielding due to distal end fixing of the artificial prosthesis, and reduces complications;
(3) the sleeve is extended near the shoulder part of the proximal end of the femur, so that the sleeve can be used for fixing the fracture of the greater trochanter, the problems of incomplete femoral greater trochanter and difficult reconstruction of the femoral abduction function are solved, the cost is reduced by using an additional steel plate at the outer side, and the burden of a patient is reduced; meanwhile, the shoulder part of the sleeve is provided with a locking screw hole, so that the prosthesis has higher expansibility, a fixed interface can be provided for a patient needing abduction muscle reconstruction for the megatrochanter fracture, and the aim of recovering the abduction function of the hip joint of the patient is fulfilled;
(4) the metal 3D printing technology can be used for manufacturing more advanced prosthesis coatings, and the design of the microporous structure on the outer surface of the sleeve is favorable for bone ingrowth, so that the prosthesis and the bone have better initial stability, and the purpose of biological fixation of the bone ingrowth is achieved in a long term;
(5) the handle body in the intramedullary needle type femoral handle is provided with the front arch, so that the far end of the femur can be prevented from penetrating out, and meanwhile, the far end of the handle body is provided with the locking nail hole, so that the vertical direction and the rotating stability of the prosthesis can be improved, the prosthesis is prevented from rotating and sinking, and the intramedullary needle type femoral handle can be used for fixing the fracture around the prosthesis;
(6) the sleeve and the intramedullary needle type femoral stem are fixed in a taper press fit mode, the fixing mode reduces the manufacturing difficulty of the femoral stem, the effect of the femoral stem prosthesis is changed from matching and fixing with the femur into connecting the sleeve and the femur, the novel fixing mode reduces the femoral bruise in the traditional prosthesis replacement operation, and the amount of the distal femur is reserved.
Drawings
FIG. 1 is a schematic view of a prior art biologic elongate stem held in a tight press fit through the distal isthmus of a femur;
FIG. 2 is another illustration of a prior art biologic elongate stem held in a tight press fit through the distal isthmus of a femur;
FIG. 3 is a schematic view of the fixation of a biological elongated handle after revision;
FIG. 4 is another illustration of the biological elongated stem fixation after revision;
FIG. 5 is a schematic perspective view of a femoral intramedullary needle prosthesis assembled by a metal 3D printed customized sleeve according to the present invention;
FIG. 6 is a front view of a metal 3D printed custom sleeve assembled femoral intramedullary needle prosthesis according to the present invention;
FIG. 7 is a left side view of a metal 3D printed custom sleeve assembled femoral intramedullary needle prosthesis according to the present invention;
FIG. 8 is a perspective view of the sleeve of the present invention;
FIG. 9 is a front view of the sleeve of the present invention;
FIG. 10 is a right side view of the sleeve of the present invention;
FIG. 11 is a top view of the sleeve of the present invention;
FIG. 12 is a perspective view of an intramedullary pin-type femoral stem according to the present invention;
FIG. 13 is a front view of an intramedullary pin-type femoral stem in accordance with the present invention;
fig. 14 is a left side view of an intramedullary pin type femoral stem in accordance with the present invention.
Detailed Description
The technical solution of the present invention will be described in detail with reference to the accompanying drawings and preferred embodiments.
As shown in fig. 5-7, the present invention provides a metal 3D printed customized sleeve-assembled femoral intramedullary needle prosthesis, which comprises a sleeve 1 and an intramedullary needle type femoral stem 2 matched with the sleeve 1. The prosthesis adopts a proximal end fixing mode, realizes matching and fixing of the proximal end of the femur by using a 3D printing individualized customized sleeve, locks the distal end of the long handle with an anterior arch intramedullary needle shape, prevents rotation and prosthesis sinking, and further realizes prosthesis stabilization.
Specifically, the sleeve 1 is made of a metal material through 3D printing and customization, the outer surface of the sleeve 1 is of a microporous structure, and the outer surface of the sleeve 1 is matched with the shape of a medullary cavity at the proximal end of a femur, so that the purpose of tightly press-fitting and fixing the sleeve 1 and the medullary cavity of the femur is achieved. As shown in fig. 8-11, the sleeve 1 is hollow and cylindrical, a notch is formed on the side wall near the upper end, the inner surface of the side wall near the lower end has a taper, and a locking screw hole 3 for fixedly connecting with other fixing devices is formed on the shoulder opposite to the notch.
The sleeve 1 of the present invention is a 3D printed customized component that is manufactured from the imaging data of the proximal femur of a patient, can be perfectly matched to the cortical inner wall of the proximal femur bone, providing a reliable initial mechanical stability. Further, the manufacturing process of the sleeve 1 comprises the following steps:
the method comprises the following steps: acquiring imaging data of the proximal femur of a patient;
step two: making a customized 3D digital model according to the imaging data;
step three: and printing and manufacturing the sleeve by adopting a metal material according to the 3D digital model.
The sleeve 1 prepared through the steps in an individual mode can be completely matched with the proximal medullary cavity of the femur, and the complete matching improves the fixing strength of the prosthesis.
The metal 3D printing sleeve component of the product is used for manufacturing a 3D digital model through imaging data, and a completely matched metal 3D printing component is manufactured in an individualized way according to the reconstructed proximal femur shape;
although 3D printing technology has been widely applied to the manufacture of orthopedic instruments such as prostheses, the preparation of all prostheses by using 3D printing technology is still difficult to realize, the process is not only complicated, but also the required printing time is long and the material cost is high. The sleeve 1 is prepared by using a 3D printing technology, the key problem of fixation is solved by manufacturing the prosthesis at the key position, the printing time cost and the material cost are reduced, and the key problem of prosthesis implantation after the proximal femur defect can be solved in clinic.
Optionally, the metal material for preparing the sleeve 1 in the present invention is a titanium alloy. At present, the metal material of the artificial joint is mainly titanium alloy. In the process of research and development of some new materials, the main purpose is to solve the problem that the survival rate of the prosthesis is influenced by stress shielding caused by large difference of material coefficients between metal and bone tissues at present.
The outer surface of the sleeve 1 is designed with a microporous structure so as to be beneficial to bone ingrowth, so that the sleeve 1 can be in long-term biological fixation with the femur through bone ingrowth at the later stage. Optionally, the microporous structure is a cubic structure, the porosity of the cubic structure is 70%, the diameter of the micropores ranges from 200 μm to 400 μm, for example, the diameter of the micropores may be 200 μm, 320 μm, and 400 μm.
Preferably, the diameter of the micropores is 320 μm for optimal bone ingrowth in vivo experiments.
The shoulder of the sleeve 1 is designed with a locking screw hole 3 as required to connect other fixation devices, such as steel plates, to cooperate with the reconstructive femur abduction device.
Preferably, the number of locking screw holes 3 is 6, and each locking screw hole 3 has a diameter of 3.5 mm. The hole pitch of the locking screw hole 3 only needs to meet the fixation purpose, and can be specifically designed according to the requirements of a CAD model.
As shown in fig. 12-14, the intramedullary pin-type femoral stem 2 comprises a femoral connecting body 4, a neck body 5 and a stem body 6 which are connected in sequence, the outer surface of the neck body 5 has a taper matched with that of the sleeve 1, the stem body 6 is provided with an anterior arch, and the distal end of the stem body 6 is provided with a locking nail hole 7, and the locking nail hole 7 can be driven with a screw transversely to fix the stem body 6 with the distal end of the femur, so as to prevent sinking and rotation of the primary prosthesis.
The intramedullary pin type femoral stem 2 can be set and manufactured into models with different diameters in batches, and prostheses with corresponding models can be matched according to the medullary cavity of a patient in the operation.
The sleeve 1 and the intramedullary pin type femoral stem 2 are connected with the upper sleeve to wrap around and prevent rotation and lower taper to be press-fitted and fixed. Specifically, the sleeve 1 and the intramedullary needle type femoral stem 2 are connected and fixed in the following way: the intramedullary pin type femoral stem 2 is inserted into the sleeve 1, the femoral connector 4 is nested and matched with the notch, and the sleeve 1 and the neck body 5 are fixed at the assembly fixing position in a taper press fit mode, so that the stability in the vertical direction is realized. The shape of the femoral connector 4 is similar to a rectangle, the femoral connector can be nested and matched with a notch formed in the sleeve 1, and the sleeve 1 limits the femoral connector 4, so that the anti-rotation stability is improved.
The metal 3D printing customized sleeve assembly type femoral intramedullary needle prosthesis has the following beneficial effects:
(1) the sleeve prepared by the metal material 3D printing customization is matched with the intramedullary needle type femoral stem capable of being produced in batches through the taper, so that the near-end biological fixation is realized, the far end realizes the rotation prevention and prevents the early sinking of the prosthesis through the locking nail hole and the screw of the stem body, and the stability of the prosthesis is further improved;
(2) the sleeve is prepared by 3D printing customization of a metal material, can be matched with the shape of a medullary cavity at the proximal end of a femur, solves the problem that the conventional artificial hip joint prosthesis is not matched with a fracture part at the proximal end of the femur in the intertrochanteric fracture treatment, is completely matched to increase the fixing strength of the prosthesis, also solves the problems that the proximal end of the femur has reduced bone mass and reduced bone strength caused by stress shielding due to distal end fixing of the artificial prosthesis, and reduces complications;
the sleeve in the utility model is matched with the proximal medullary cavity of the femur by adopting a 3D printing technology, and because fracture lines and fracture positions are uncertain, the prosthesis in the prior art cannot realize proximal fixation, and the stability of the prosthesis is obtained by adopting a mode of fixing a lengthened femoral stem at a far end. The primary replacement femoral stem prosthesis is matched and fixed at the near end, the fixation does not conform to the anatomical structure of the near end of the femur, the prosthesis is placed and fixed after the plasticity of a medullary cavity file, and the anatomical form is not matched in an anatomical mode, so that the primary prosthesis cannot be used in intertrochanteric fracture, the sleeve is used for matching the shape of the medullary cavity at the near end of the femur, the fixation strength of the prosthesis is increased, and the problems of the prosthesis in the prior art are solved;
(3) the sleeve is extended near the shoulder part of the proximal end of the femur, so that the sleeve can be used for fixing the fracture of the greater trochanter, the problems of incomplete femoral greater trochanter and difficult reconstruction of the femoral abduction function are solved, the cost is reduced by using an additional steel plate at the outer side, and the burden of a patient is reduced; meanwhile, the shoulder part of the sleeve is provided with a locking screw hole, so that the prosthesis has higher expansibility, a fixed interface can be provided for a patient needing abduction muscle reconstruction for the megatrochanter fracture, and the aim of recovering the abduction function of the hip joint of the patient is fulfilled;
(4) the metal 3D printing technology can be used for manufacturing more advanced prosthesis coatings, and the design of the microporous structure on the outer surface of the sleeve is favorable for bone ingrowth, so that the prosthesis and the bone have better initial stability, and the purpose of biological fixation of the bone ingrowth is achieved in a long term;
(5) the handle body in the intramedullary needle type femoral handle is provided with the front arch, so that the far end of the femur can be prevented from penetrating out, and meanwhile, the far end of the handle body is provided with the locking nail hole, so that the vertical direction and the rotating stability of the prosthesis can be improved, the prosthesis is prevented from rotating and sinking, and the intramedullary needle type femoral handle can be used for fixing the fracture around the prosthesis;
as the diameters of the medullary cavities of different patients are different, manufacturers need to design models with different thicknesses to match different patients to the maximum extent for the traditional prosthesis, thereby achieving the purpose of preventing the prosthesis from sinking and rotating; the assembled prosthesis of the utility model mainly depends on the customized 3D printing sleeve to realize the aim of preventing the prosthesis from sinking and rotating, and does not depend on the complete matching of the femoral stem and the medullary cavity, so that a manufacturer can only produce the femoral stem with fixed size to adapt to all patients, thereby greatly reducing the production cost and simplifying the step of implanting the femoral stem in the operation;
(6) the sleeve and the intramedullary needle type femoral stem are fixed in a taper press fit mode, the fixing mode reduces the manufacturing difficulty of the femoral stem, the effect of the femoral stem prosthesis is changed from matching and fixing with the femur into connecting the sleeve and the femur, the novel fixing mode reduces the femoral bruise in the traditional prosthesis replacement operation, and the amount of the distal femur is reserved.
The metal 3D printing customized sleeve assembled femoral intramedullary needle prosthesis provided by the utility model can be applied to the following clinical operation treatments:
1. the medicine is used for treating femoral intertrochanteric fracture of old people;
2. the composition is used for treating proximal femur benign and malignant tumors;
3. the femur proximal end orthopedic treatment;
4. the proximal femur bone defect remodeling instrument is used for reconstructing proximal femur inclusion bone defects after hip replacement.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the utility model. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (5)
1. A femoral intramedullary needle prosthesis assembled by a metal 3D printing customized sleeve is characterized by comprising a sleeve (1) and an intramedullary needle type femoral stem (2);
the sleeve (1) is prepared by 3D printing and customizing of a metal material, the outer surface of the sleeve (1) is of a microporous structure and is matched with the shape of a medullary cavity at the proximal end of a femur, the sleeve (1) is integrally hollow and cylindrical, a notch is formed in the side wall close to the upper end, the inner surface of the side wall close to the lower end is provided with a taper, and a locking screw hole (3) for fixedly connecting with other fixing devices is formed in the shoulder part opposite to the notch;
the intramedullary needle type femoral stem (2) comprises a femoral connecting body (4), a neck body (5) and a stem body (6) which are sequentially connected, the outer surface of the neck body (5) has a taper matched with the sleeve (1), the stem body (6) is provided with an anterior bow, and the distal end of the stem body (6) is provided with a locking nail hole (7) for fixing with the distal end of a femur;
the sleeve (1) and the intramedullary needle type femoral stem (2) are connected and fixed in a way that: the intramedullary pin type femoral stem (2) is inserted into the sleeve (1), the femoral connector (4) is nested and matched with the notch, and the sleeve (1) and the neck body (5) are fixed at an assembly fixing position in a taper press-fit mode.
2. The metal 3D-printed customized sleeve-assembled femoral intramedullary needle prosthesis of claim 1,
the microporous structure is a cubic structure, the porosity of the cubic structure is 70%, and the diameter range of micropores is 200-400 microns.
3. The metal 3D-printed customized sleeve-assembled femoral intramedullary needle prosthesis of claim 2,
the diameter of the micropores was 320. mu.m.
4. The metal 3D-printed customized sleeve-assembled femoral intramedullary needle prosthesis of claim 1,
the number of the locking screw holes (3) is 6, and the diameter of each locking screw hole (3) is 3.5 mm.
5. The metal 3D-printed customized sleeve-assembled femoral intramedullary needle prosthesis of claim 1,
the metal material is titanium alloy.
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