阅读说明：本技术 一种用于骨缺损的填充块和制造其的方法 (Filling block for bone defect and method for manufacturing same ) 是由 解凤宝 史春宝 王金博 于 2020-06-22 设计创作，主要内容包括：本发明属于医疗器械领域,具体涉及一种用于骨缺损的填充块和制造其的方法。本发明的用于骨缺损的填充块用于与髋臼外杯配合固定,填充块包括用于填补人体骨缺损部位的填充本体,填充本体包括顶部边梁、底部固定边梁和连接在顶部边梁与底部固定边梁间的支撑固定梁,顶部边梁的两端分别与底部固定边梁的两端相连,顶部边梁、底部固定边梁和支撑固定梁共同形成有用于与髋臼外杯的至少部分外表面贴合的弧形内表面和用于与人体骨缺损部位的内表面贴合的外表面,支撑固定梁包括连接在顶部边梁与底部固定边梁间的至少两个子支撑固定梁。本发明的用于骨缺损的填充块具有更高的结构强度,能够更稳定地填充并固定在患者的骨缺损部位。(The invention belongs to the field of medical instruments, and particularly relates to a filling block for bone defects and a method for manufacturing the filling block. The filling block for bone defect is used for being matched and fixed with an acetabulum outer cup, the filling block comprises a filling body for filling a human body bone defect part, the filling body comprises a top boundary beam, a bottom fixing boundary beam and a supporting and fixing beam connected between the top boundary beam and the bottom fixing boundary beam, two ends of the top boundary beam are respectively connected with two ends of the bottom fixing boundary beam, the top boundary beam, the bottom fixing boundary beam and the supporting and fixing beam jointly form an arc-shaped inner surface for being attached with at least part of the outer surface of the acetabulum outer cup and an outer surface for being attached with the inner surface of the human body bone defect part, and the supporting and fixing beam comprises at least two sub-supporting and fixing beams connected between the top boundary beam and the bottom fixing boundary beam. The filling block for bone defect of the present invention has higher structural strength, and can be filled and fixed in a bone defect site of a patient more stably.)

1. The filling block for bone defects is used for being matched and fixed with an acetabulum outer cup, and is characterized in that the filling block comprises a filling body for filling human bone defect parts, the filling body comprises a top boundary beam, a bottom fixing boundary beam and a supporting and fixing beam connected between the top boundary beam and the bottom fixing boundary beam, two ends of the top boundary beam are respectively connected with two ends of the bottom fixing boundary beam, the top boundary beam, the bottom fixing boundary beam and the supporting and fixing beam are jointly formed into an arc-shaped inner surface used for being attached to at least part of the outer surface of the acetabulum outer cup and an outer surface used for being attached to the inner surface of the human bone defect parts, and the supporting and fixing beam comprises at least two sub-supporting and fixing beams connected between the top boundary beam and the bottom fixing boundary beam.

2. The spacer for bone defects according to claim 1 wherein at least two of said sub-support fixation beams are arranged in parallel to form at least three through holes in said spacer body.

3. The spacer for bone defects according to claim 1 wherein at least two of said sub-support fixation beams are arranged crosswise to form at least four through holes in said spacer body.

4. The spacer for bone defects according to any one of claims 1 to 3 wherein different said sub-strut fixation beams have the same radial cross-sectional width, the radial cross-sectional width of the same said sub-strut fixation beam decreasing from said arcuate inner surface in a direction towards said outer surface.

5. The spacer for bone defects according to any one of claims 1 to 3 wherein the bottom fixation boundary beam is formed with a first fixation hole and each of the sub-support fixation beams is formed with a second fixation hole, the axes of the first fixation hole and each of the second fixation holes intersecting.

6. The spacer for bone defects according to any one of claims 1 to 3 further comprising a tantalum metal layer formed on the outer surface of the spacer body, wherein the top and bottom fixing side beams and the supporting and fixing beams of the spacer body are integrally formed by a porous mesh-shaped glassy carbon scaffold, and the tantalum metal layer is formed on the outer surface of the glassy carbon scaffold so that the spacer is constructed in a porous tantalum metal trabecular structure.

7. The filling block for bone defects according to claim 6, wherein the pore size of the filling block is in the range of 100-900 μm, and the wire diameter of the filling block is in the range of 50-800 μm.

8. A method for manufacturing a filling block for bone defects according to any one of claims 1 to 7, comprising placing a glassy carbon scaffold in a gas precipitation reaction chamber, and uniformly depositing tantalum metal on the outer surface of the glassy carbon scaffold by a chemical vapor deposition method, thereby forming the filling block into a trabecular bone three-dimensional porous structure with a tantalum metal layer.

9. The method of claim 8, wherein the gas precipitation reaction chamber comprises a first reaction chamber in which solid pure tantalum is disposed and a second reaction chamber in communication with the first reaction chamber in which the glassy carbon scaffold is disposed, the method comprising the steps of:

simultaneously introducing chlorine and hydrogen into the first reaction chamber to generate tantalum metal compound gas flowing to the second reaction chamber;

and introducing hydrogen and inert gas into the second reaction chamber, and reacting the tantalum metal compound gas and the hydrogen at the temperature of 800-1200 ℃ for 6-8h to form the tantalum metal layer on the glassy carbon support.

10. The method of a spacer for bone defects of claim 9 further comprising: and carrying out tail gas treatment on the hydrogen chloride and the tantalum metal compound gas in the second reaction chamber at the outlet of the second reaction chamber.

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a filling block for bone defects and a method for manufacturing the filling block.

Background

The filling block is an implanted prosthesis for joint revision, is used for providing a selectable structural implanted prosthesis for surgeons, is suitable for reconstructing bone defects caused by serious degeneration, trauma or other pathological changes, or is used for revision and repair of bone defects in the past joint reconstruction and implant failure, and is mainly suitable for segmental acetabular defects or treating femoral head necrosis patients without femoral head collapse.

Although the filling blocks for bone defects on the market at present have different specifications, the basic structures and the shapes of the filling blocks with different specifications are the same, and for patients with different bone defects, especially for patients with serious bone defects, even if the filling blocks with proper specifications can be applied, the filling blocks can not be stably filled and fixed at the bone defect parts of the patients so as to be fully adapted to the bone defect parts of the patients; in addition, the existing filling block is not high in structural strength, and potential safety hazards may exist after long-term stress or impact.

Disclosure of Invention

In order to improve the structural strength of a filling block for a bone defect so that the filling block can be more stably filled and fixed at a bone defect site of a patient, the present invention provides a filling block for a bone defect and a method of manufacturing the same.

According to the filling block for bone defect, the filling block is used for being matched and fixed with the acetabulum outer cup, the filling block comprises a filling body for filling a human body bone defect part, the filling body comprises a top edge beam, a bottom fixing edge beam and a supporting and fixing beam connected between the top edge beam and the bottom fixing edge beam, two ends of the top edge beam are respectively connected with two ends of the bottom fixing edge beam, the top edge beam, the bottom fixing edge beam and the supporting and fixing beam jointly form an arc-shaped inner surface for being attached to at least part of the outer surface of the acetabulum outer cup and an outer surface for being attached to the inner surface of the human body bone defect part, and the supporting and fixing beam comprises at least two sub-supporting and fixing beams connected between the top edge beam and the bottom fixing edge beam.

Further, at least two sub-support fixing beams are arranged in parallel to form at least three through holes on the filling body.

Further, at least two sub-support fixing beams are arranged in a crossed mode to form at least four through holes in the filling body.

Further, different sub-support fixing beams have the same radial cross-sectional width, and the radial cross-sectional width of the same sub-support fixing beam is gradually reduced from the arc-shaped inner surface to the outer surface.

Furthermore, a first fixing hole is formed in the bottom fixing edge beam, a second fixing hole is formed in each sub-supporting fixing beam, and the axes of the first fixing hole and the second fixing holes are intersected.

Further, the filling block further comprises a tantalum metal layer formed on the outer surface of the filling body, wherein the top and bottom fixing edge beams and the supporting and fixing beam of the filling body are integrally formed by a porous net-shaped glassy carbon support, and the tantalum metal layer is formed on the outer surface of the glassy carbon support, so that the filling block is constructed into a porous tantalum metal bone trabecular structure.

Furthermore, the aperture range of the filling block is 100-900 μm, and the filament diameter range of the filling block is 50-800 μm.

The invention also provides a method for manufacturing the filling block for the bone defect, which comprises the steps of placing the glassy carbon support in a gas precipitation reaction chamber, and uniformly depositing tantalum metal on the outer surface of the glassy carbon support by a chemical vapor deposition method, so that the filling block is formed into a trabecular bone three-dimensional porous structure with the tantalum metal layer.

Further, the gas precipitation reaction chamber comprises a first reaction chamber in which solid pure tantalum is placed and a second reaction chamber which is communicated with the first reaction chamber and in which a glassy carbon support is placed, and the method comprises the following steps: simultaneously introducing chlorine and hydrogen into the first reaction chamber to generate tantalum metal compound gas flowing to the second reaction chamber; and introducing hydrogen and inert gas into the second reaction chamber, and reacting the tantalum metal compound gas with the hydrogen at the temperature of 800-1200 ℃ for 6-8h to form the tantalum metal layer on the glassy carbon support.

Further, the method further comprises: and carrying out tail gas treatment on the hydrogen chloride and the tantalum metal compound gas in the second reaction chamber at the outlet of the second reaction chamber.

Compared with the prior art, the filling block for bone defects has the following advantages:

1) the filling block for bone defect comprises at least two sub-supporting fixing beams connected between the top side beam and the bottom fixing side beam, so that the filling block has higher structural strength, and the contact area between the two sub-supporting fixing beams and the defect part of the acetabulum of a patient is larger, therefore, after the filling block is connected with the defect part of the acetabulum of the patient, the filling block can be stably filled and fixed at the bone defect part of the patient so as to be fully adapted to the bone defect part of the patient; in addition, the quantity also can make the top boundary beam and the fixed boundary beam in bottom have better structural stability for the setting of two at least sub-support fixed beams, and this makes the fixed boundary beam in top boundary beam and bottom can stably accept or be fixed in the surface of acetabular cup, and long term atress or the back that receives the impact in the filling block also can not have the potential safety hazard.

2) The at least two parallel sub-support fixing beams are arranged to form at least three through holes on the filling body, so that the at least two sub-support fixing beams are arranged at intervals, the structural strength of the filling block is improved, and meanwhile, the formed through holes enable fixing parts such as screws and the like penetrating out of the acetabulum outer cup to simultaneously penetrate through the through holes to be fixed with the acetabulum part of a patient, the use of raw materials can be reduced, the economy is higher, and meanwhile, the weight of the filling block is reduced.

3) The at least two crossed sub-support fixing beams are arranged to form at least four through holes on the filling body, so that the crossed sub-support fixing beams are connected with each other, the structural strength is higher, the positions of the through holes are different, the number of the through holes is more, and the acetabular cup filling device can be suitable for different acetabular outer cups.

4) The filling block is constructed into a porous tantalum metal bone trabecula structure, so that the pores of the filling block can well induce the bone ingrowth of the bone defect part of the acetabulum of the patient, the bone of the bone defect part of the acetabulum of the patient can grow into the pores of the filling block more quickly and effectively, and the filling block is fused with the filling block to form stable connection and fixation relation.

Compared with the prior art, the filling block for the bone defect is manufactured by adopting a chemical vapor deposition method, has higher economical efficiency, and can form a uniform tantalum metal layer on the outer surface of the glassy carbon bracket.

Drawings

FIG. 1 is a schematic structural view of a filling block for bone defects according to a first embodiment of the present invention;

FIG. 2 is a schematic structural view of a filling block for bone defects according to a second embodiment of the present invention;

FIG. 3 is a schematic structural view of an acetabular outer cup mated with a filler block for a bone defect according to an embodiment of the invention;

FIG. 4 is a schematic structural view of a process device used in implementing a method of manufacturing a filling block for a bone defect according to an embodiment of the present invention;

fig. 5 is a flow chart illustrating steps of a method of manufacturing a spacer for a bone defect according to an embodiment of the present invention.

Detailed Description

For a better understanding of the objects, structure and function of the invention, the filling block for bone defects and the method for manufacturing the same according to the present invention will be described in further detail with reference to the accompanying drawings.

Fig. 1 and 2 show the structure of a filling block 100 for bone defect according to the present invention, the filling block 100 is used for being fixed with the outer cup 7 of acetabulum shown in fig. 3, the filling block 100 comprises a filling body 1 for filling the defect site of human bone, the filling body 1 comprises a top side beam 11, a bottom fixing side beam 12 and a supporting fixing beam 13 connected between the top side beam 11 and the bottom fixing side beam 12, two ends of the top side beam 11 are respectively connected with two ends of the bottom fixing side beam 12, the top side beam 11, the bottom fixing side beam 12 and the supporting fixing beam 13 together form an arc inner surface (not shown in the figure) for being attached with at least part of the outer surface 7 of the outer cup 103 of acetabulum and an outer surface 14 for being attached with the inner surface of the defect site of human bone, wherein the support fixing beam 13 includes at least two sub-support fixing beams 131 connected between the top and bottom fixing side beams 11 and 12.

Taking a bone defect at an acetabular site as an example, when the filling block 100 for a bone defect of the present invention is used, an operator places the filling block 100 for a bone defect of an acetabular bone of a patient at the bone defect site of the acetabular bone of the patient, fixes the filling block 100 and the bone defect site of the acetabular bone of the patient together by the bottom fixing edge beam 12, and fixes the filling block 100 and the acetabular outer cup 103 together by the support fixing beam 13. Thus, the filling block 100 can be filled and fixed at the bone defect part of the acetabulum of the patient, so that the hip joint prosthesis can be well matched with the acetabulum part of the patient.

The filling block 100 for bone defect of the embodiment of the invention comprises at least two sub-supporting fixing beams 131 connected between the top side beam 11 and the bottom fixing side beam 12 by arranging the supporting fixing beams 13, so that the filling block 100 has higher structural strength, and the contact area between the two sub-supporting fixing beams 131 and the defect part of the acetabulum of the patient is larger, therefore, after the filling block 100 is connected with the defect part of the acetabulum of the patient, the filling block 100 can be stably filled and fixed at the bone defect part of the patient to fully adapt to the bone defect part of the patient; in addition, the arrangement of at least two sub-support fixing beams 131 also enables better structural stability between the top side beam 11 and the bottom fixing side beam 12, so that the top side beam 11 and the bottom fixing side beam 12 can be stably received or fixed on the outer surface 7 of the acetabular outer cup 103, and no potential safety hazard exists after the filling block 100 is stressed or impacted for a long time.

In the first embodiment as shown in fig. 1, at least two sub-support fixing beams 131 may be arranged in parallel to form at least three through holes 15 on the packing body 1. Through the arrangement, at least two sub-support fixing beams 131 are arranged at intervals, the structural strength of the filling block 100 is improved, and the through holes 15 formed at the same time enable fixing components such as screws and the like penetrating out of the acetabulum outer cup 103 to simultaneously penetrate through the through holes 15 to be fixed with the acetabulum part of a patient, so that the use of raw materials is reduced, the economy is higher, and the weight of the filling block 100 is reduced.

In the second embodiment as shown in fig. 2, at least two sub-support fixing beams 131 may be arranged to intersect to form at least four through holes 15 on the packing body 1. The at least two crossed sub-support fixing beams 131 are arranged to enable the crossed sub-support fixing beams 131 to be connected with each other, so that the structure strength is higher, meanwhile, the positions of the through holes 15 are different, the number of the through holes is more, and the acetabulum cup can adapt to different acetabulum cups 103 (namely, the positions and the numbers of the fixing holes on different acetabulum cups 103 are different, for example, fixing parts such as screws penetrate through the fixing holes on the acetabulum cups 103 and penetrate out of the through holes 15, and the phenomenon that the fixing parts such as screws are blocked by the sub-support fixing beams 131 can not occur).

Preferably, different sub support fixing beams 131 may have the same radial cross-sectional width b, and the radial cross-sectional width b of the same sub support fixing beam 131 may be gradually reduced from the arc-shaped inner surface toward the outer surface 14. Through the arrangement, the inner surface of the filling block 100, which is attached to the outer acetabular cup 103, has a larger area and can be better attached to the outer acetabular cup 103, so that the outer acetabular cup 103 is more stably supported, and meanwhile, the through hole 15 has a larger volume, so that raw materials can be further saved, the weight of the filling block 100 is reduced, and the filling block has better economy.

As shown in fig. 1, the bottom fixing side frame 12 may be formed with a first fixing hole 121, each sub-support fixing beam 131 may be formed with a second fixing hole 132, and axes of the first fixing hole 121 and each second fixing hole 132 may intersect. With this arrangement, when an operator uses an external fixing component such as a screw to pass through the first fixing hole 121 and the acetabular region of the patient, the second fixing hole 132 and the acetabular outer cup 103, an included angle is formed between the external fixing components, that is, each external fixing component can fix the filling block 100 and the acetabular outer cup 103 of the acetabular prosthesis in a plurality of different directions or fix the filling block 100 and the bone defect region of the patient in a plurality of different directions, so that the fixation of the filling block 100 and the bone defect region of the patient and the fixation of the filling block 100 and the acetabular outer cup 103 of the acetabular prosthesis are not easy to loosen.

Preferably, a first fixing hole 121 may be formed on a region of the bottom fixing side beam 12 corresponding to each through hole 15 to further improve fixing strength; further preferably, the first fixing holes 121 are formed only in the regions of the bottom fixing side beam 12 corresponding to the through holes 15 on both sides, that is, the first fixing holes 121 are not formed in the regions of the bottom fixing side beam 12 corresponding to the through holes 15 in the middle (as shown in fig. 1), and this embodiment can reduce the number of the first fixing holes 121 on the basis of achieving a good fixing effect of the filling block 100, which helps to improve the structural strength of the filling block 100.

It is also preferable that, as shown in fig. 2, a first fixing hole 121 be formed on a region of the bottom fixing side beam 12 corresponding to each through hole 15 to further improve fixing strength; further preferably, the first fixing holes 121 are formed only in the regions of the bottom fixing side beam 12 corresponding to the through holes 15 on both sides, that is, the first fixing holes 121 are not formed in the regions of the bottom fixing side beam 12 corresponding to the through holes 15 in the middle, and this embodiment can reduce the number of the first fixing holes 121 on the basis of achieving a good fixing effect of the filling block 100, which helps to improve the structural strength of the filling block 100.

According to the filling block 100 for a bone defect of an embodiment of the present invention, the filling block 100 may further include a tantalum metal layer (not shown) formed on an outer surface of the filling body 1, wherein the top and bottom side sills 11 and 12 and the supporting and fixing beams 13 of the filling body 1 may be integrally formed of a porous mesh-shaped glassy carbon scaffold, and the tantalum metal layer may be formed on an outer surface of the glassy carbon scaffold, so that the filling block 100 is configured in a porous tantalum metal trabecular structure.

The term "glassy carbon scaffold" as used herein refers to a scaffold having a spatial three-dimensional lattice structure formed by a plurality of glassy carbon filaments which are connected to each other in a staggered manner, wherein a plurality of pores are formed by the plurality of glassy carbon filaments which are connected to each other in a staggered manner, and the pores are communicated with each other and may have the same or different diameters. Meanwhile, the tantalum metal layer is formed on the surface of the glassy carbon support, the strength and the ductility of the tantalum metal are good, the tantalum metal belongs to inert metal, the chemical property is very stable, and the chemical corrosion can be resisted; and has good biocompatibility, so the acetabulum fusion protein is easy to fuse with the acetabulum part of a patient; the tantalum metal trabecular bone structure has a smaller elastic modulus of about 3GPa and is between that of cortical bone and cancellous bone, so that stress shielding can be effectively reduced (namely when two or more materials with different rigidity bear an external force together, the material with higher rigidity can bear more load, and the load with lower rigidity only needs to bear lower load), and the specific porous structure of the tantalum metal trabecular bone structure is favorable for inducing bone ingrowth and bone remodeling.

By constructing the filling block 100 into a porous tantalum metal bone trabecular structure, the pores of the filling block 100 can well induce the bone ingrowth of the bone defect part of the acetabulum of the patient, so that the bone of the bone defect part of the acetabulum of the patient can grow into the pores of the filling block 100 more quickly and effectively, and is fused with the filling block 100 to form a stable connection and fixation relationship.

According to the present embodiment, the aperture of the filling block 100 can be in the range of 100-900 μm, and the filament diameter of the filling block 100 can be in the range of 50-800 μm. Through the arrangement, the tantalum metal bone trabecular structure of the filling block 100 is more similar to the bone trabecular structure of a human body, and bone ingrowth and bone fusion are facilitated.

Preferably, the pore diameter of the filling block 100 can be in the range of 200-.

Also preferably, the porosity of the filling block 100 may range from 50% to 95%. And more preferably 60% -90%, by which the porosity of the filling block 100 is higher, and the bone material of the bone defect part of the acetabulum of the patient can grow in from more pores to form a stable connection and fixation relation with the filling block 100.

In addition, the tantalum metal layer may have a thickness ranging from 40 to 100 μm. More preferably 60 to 80 μm.

Referring to fig. 4 and 5, the present invention further provides a method 200 for manufacturing the above-mentioned filling block 100 for bone defect, which comprises placing a glassy carbon scaffold in a gas precipitation reaction chamber 103, and uniformly depositing tantalum metal on the outer surface of the glassy carbon scaffold by a chemical vapor deposition method, thereby forming the filling block 100 into a trabecular bone three-dimensional porous structure D with a tantalum metal layer. Since the chemical vapor deposition method has the advantages of simple device and higher flexibility, and is also suitable for coating the surface of a part with a complex shape, the filling block 100 manufactured by the chemical vapor deposition method has higher economy, and a uniform tantalum metal layer can be formed on the outer surface of the glassy carbon support.

Referring to fig. 4 and 5, the gas precipitation reaction chamber may include a first reaction chamber 101 in which solid pure tantalum C is placed and a second reaction chamber 102 in communication with the first reaction chamber 101 in which a glassy carbon support is placed, and the method 200 may include the steps of: step one S01: simultaneously introducing chlorine A and hydrogen B into the first reaction chamber 101 to generate tantalum metal compound gas E (namely tantalum pentachloride gas) flowing to the second reaction chamber 102; step two S02: and introducing hydrogen B and inert gas F into the second reaction chamber 102, and reacting the tantalum metal compound gas E with the hydrogen B at the temperature of 800-1200 ℃ for 6-8h to form a tantalum metal layer on the glassy carbon support.

Preferably, the tantalum metal compound gas E is reacted with hydrogen gas B at a temperature of 1000 ℃ for 6 hours.

The tantalum metal layer of the filling block 100 obtained by the method has higher purity (can reach 99 percent purity), so that the filling block 100 has better biocompatibility, and the filling block 100 can be better fused with the bone defect part of the acetabulum of a patient.

Preferably, the method may further include: and step three S03, performing tail gas treatment on the hydrogen chloride and the tantalum metal compound gas G in the second reaction chamber 102 at the outlet of the second reaction chamber 102. Through the arrangement, the tail gas after reaction can be timely and efficiently treated, and the air outside the gas precipitation reaction chamber 103 is prevented from being polluted after the hydrogen chloride and the tantalum metal compound gas G are directly discharged.

Preferably, in the above method, before the step S01, a vacuum process S00 may be performed on the inside of the first reaction chamber 101 and the second reaction chamber 102, so that the first reaction chamber 101 and the second reaction chamber 102 are in a vacuum environment, and the tantalum metal compound gas E, i.e., the tantalum pentachloride gas, is prevented from reacting with water in the air to generate TaOCl₃Impurities.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description. In particular, the technical features mentioned in the embodiments can be combined in any way as long as there is no structural conflict. It is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.