Antibiotic slow-release device for infectious bone defect treatment

Abstract

The invention discloses an antibiotic slow-release device for infectious bone defect treatment, relates to the technical field of bone defect treatment instruments, and provides the following scheme that the antibiotic slow-release device comprises an outer-layer slow-release part, a middle-layer slow-release part and an inner-layer slow-release part, the outer-layer slow-release part comprises a 3D printing framework, and the middle-layer slow-release part comprises an inner-layer slow-release part and an outer-layer slow-release part; the surface of the outer layer of the 3D printing framework is fixedly covered with a porous ceramic support, and an outer framework drug-loaded coating is attached to the surface of the outer side of the porous ceramic support. According to the technical scheme, the strength of the infectious bone defect part is improved through the inner-layer skeleton, the middle-layer skeleton and the outer-layer skeleton, the effect of promoting osseointegration and bone repair is achieved by increasing the overall rigidity of a solid, the inner-layer skeleton, the middle-layer skeleton and the outer-layer skeleton are all porous media, and antibiotics are filled in the skeletons, so that the bone repair effect is improved. The effect of multi-layer slow release of antibiotics is achieved through the microporous structure of the skeleton, continuous slow release of the antibiotics of the implant is achieved, the effective blood concentration is maintained, and the sustained and effective sterilization effect is achieved.

Description

Technical Field

[0001] The invention relates to the technical field of bone defect treatment instruments, and in particular to an antibiotic sustained-release device for treating infectious bone defects. Background Art

[0002] Infected bone defects refer to bone defects that are accompanied by infection or that occur during the treatment of bone infection and require surgical intervention. They are a global problem in the field of trauma orthopedics. Conventional treatment methods mainly include thorough debridement, bone grafting or bone transfer, and the application of systemic and local antibiotics. However, at present, osteomyelitis or infected bone defects will leave bone defects of different sizes after debridement surgery. Currently, bone cement (calcium sulfate, calcium phosphate, etc.) or bioactive glass or 3D printing materials (titanium alloy / tantalum alloy, etc.) need to be implanted, but these materials cannot be mixed internally or the surface cannot effectively load antibiotics, making it difficult to achieve sustained release of antibiotics to maintain an effective bactericidal concentration. Summary of the invention

[0003] In view of the above background technology, it is proposed that after debridement surgery for osteomyelitis or infected bone defects, bone defects of different sizes will be left behind. Currently, bone cement or bioactive glass or 3D printed materials need to be implanted, but these materials cannot be mixed internally or antibiotics cannot be effectively loaded on the surface, making it difficult to achieve sustained release of antibiotics to maintain an effective bactericidal concentration. Therefore, a technical solution of an antibiotic sustained-release device for the treatment of infected bone defects is provided.

[0004] It includes an outer layer sustained-release component, a middle layer sustained-release component and an inner layer sustained-release component, wherein the outer layer sustained-release component includes a 3D printed skeleton, the outer surface of the 3D printed skeleton is covered and fixed with a porous ceramic bracket, the outer surface of the porous ceramic bracket is attached with an exoskeleton drug-loaded coating, and the outer surface of the porous ceramic bracket is provided with 20-30 rows of equidistantly arranged conical drug-releasing holes; specifically, the shape of the 3D printed skeleton, the mesoporous nano-silica lining and the TUD mesoporous core is constructed by 3D printing according to the modeling of the infected bone defect area; when in use, the antibiotic adopts a mixed agent or granules of Fuping and Moxifloxacin. The antibiotics on the surface of the exoskeleton drug-loaded coating contact with the patient's tissue fluid, and after the antibiotics on the surface of the exoskeleton drug-loaded coating slowly dissolve and release, the micropores inside the exoskeleton drug-loaded coating allow the tissue fluid to penetrate into the porous ceramic bracket.

[0005] The middle-layer sustained-release component includes a middle-layer sustained-release component filled and fixed inside the drug storage chamber; the middle-layer sustained-release component includes a mesoporous nano-silica lining, 7-10 annular cavities are equidistantly arranged inside the mesoporous nano-silica lining, and the inner cavity of the annular cavity is filled with an antibiotic mixture; specifically, after the tissue fluid penetrates into the antibiotic release channel along the porous ceramic stent, the antibiotic mixture inside the annular cavity is slowly dissolved by the immersion of the tissue fluid, penetrates into the conical drug release holes inside the porous ceramic stent along the antibiotic release channel, and is released with the help of the micropores inside the porous ceramic stent and the exoskeleton drug-loaded coating and the conical drug release holes. Since the porous ceramic stent is filled with conical drug release holes, and the outer port of the conical drug release hole is small and the inner port is large, the antibiotic solvent is blocked by the conical drug release hole to slow down its circulation speed and play a sustained release role.

[0006] The inner layer sustained-release component includes an inner layer sustained-release component filled and fixed on the inner side of the 3D printed skeleton; the inner layer sustained-release component includes a TUD mesoporous core, a plurality of annular cavities filled in the inner cavity of the TUD mesoporous core, and a silicone support column is connected to the upper and lower positions of the inner cavity of the TUD mesoporous core. Specifically, when the patient moves, the skeleton in the infected bone defect area will swing with the movement, causing the mixed antibiotic particles in contact with each other in the antibiotic particle storage cavity to rub against each other, and because of the elasticity of the silicone support column, the C-shaped friction plate is forced to squeeze the mixed antibiotic particles up and down, so that the mixed antibiotic particles are ground into powder under double pressure, and released into the mesoporous nano-silica lining through the micropores inside the TUD mesoporous core, and then released into the patient's body through the porous ceramic scaffold and the exoskeleton drug-loaded coating.

[0007] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: a drug storage chamber is opened inside the 3D printed skeleton, and 10-20 rows of antibiotic release through holes arranged at equal distances are opened on the outer surface of the 3D printed skeleton, and the antibiotic release through holes are connected to the inner cavity of the drug storage chamber.

[0008] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: 7-10 rows of antibiotic release channels communicating with the annular cavity are provided inside the mesoporous nano-silica lining.

[0009] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: the ends of the silicone support columns that are close to each other are connected to C-shaped friction plates, and the ends of the C-shaped friction plates that are close to each other are in contact with the surface of the mixed antibiotic particles.

[0010] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: the inner surface of the 3D printed skeleton is in close contact with the outer surface of the TUD mesoporous core through an adhesive, and the two ends of the antibiotic release through-hole respectively penetrate the inner and outer surfaces of the 3D printed skeleton.

[0011] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: the inner surface of the porous ceramic support and the outer surface of the 3D printed skeleton are tightly adhered and contacted by an adhesive, and the outer port diameter of the conical drug release hole is 1 / 2 of the inner port diameter of the conical drug release hole.

[0012] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: 1-3 layers of antibiotics are provided on the outer surface of the drug-loaded coating of the exoskeleton by immersion.

[0013] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: the outer surface and the inner surface of the mesoporous nano-silica lining are respectively adhered and fixed to the inner cavity side wall of the drug storage chamber by adhesive, and the outer port of the antibiotic release channel is coaxially connected with the antibiotic release through-hole on the outer surface of the 3D printed skeleton.

[0014] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infected bone defects, preferably: an antibiotic particle storage cavity for placing and filling mixed antibiotic particles is opened inside the TUD mesoporous core.

[0015] In the technical solution of the above-mentioned antibiotic sustained-release device for treating infectious bone defects, preferably: the elasticity of the silicone support column is maximized to allow C-shaped friction plates to contact each other, and the surface of the C-shaped friction plates on one side close to each other has friction particles.

[0016] It can be seen from the above technical scheme that the present invention provides an antibiotic sustained-release device for treating infected bone defects. Compared with the prior art, the present invention has the following beneficial effects:

[0017] In the technical solution of the present invention, a three-layer skeleton structure is used to improve the strength of the infected bone defect site through the inner, middle and outer three-layer skeleton, and the effect of promoting bone integration and bone repair is achieved by increasing the overall rigidity of the solid. Moreover, the inner, middle and outer three-layer skeletons are all porous media, and antibiotics are filled inside the skeleton. The porous microporous structure of the skeleton realizes the effect of multi-layer sustained-release antibiotics, and the content of antibiotics is increased, so that the antibiotics of the implant are continuously and slowly released, and it has a sustained and effective bactericidal effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces and describes the drawings required for use in the embodiments of the present invention or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 It is a schematic diagram of the overall structure of the antibiotic sustained-release device;

[0020] Figure 2 This is a schematic diagram of the antibiotic sustained-release device after its explosion and decomposition;

[0021] Figure 3 is a schematic diagram of an outer layer sustained-release component;

[0022] Figure 4 is a schematic diagram of a middle-layer sustained-release component;

[0023] Figure 5 Schematic diagram of the inner layer sustained-release component.

[0024] Attached Figure 1 - Attachment Figure 5 The corresponding relationship of the parts is as follows:

[0025] 1. 3D printed skeleton; 2. Exoskeleton drug-loaded coating; 3. Inner sustained-release component; 31. TUD mesoporous core; 32. Antibiotic particle storage cavity; 33. Silicone support column; 34. C-shaped friction plate; 35. Mixed antibiotic particles; 4. Porous ceramic support; 5. Middle sustained-release component; 51. Mesoporous nano-silica lining; 52. Antibiotic release channel; 53. Annular cavity; 54. Antibiotic mixture; 6. Conical drug release hole; 7. Drug storage chamber; 8. Antibiotic release through hole. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described below are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] In order to more clearly explain and illustrate the technical solution and implementation of the present invention, several preferred specific embodiments for implementing the technical solution of the present invention are introduced below.

[0028] Embodiment: A preferred technical solution of an antibiotic sustained-release device for treating infected bone defects:

[0029] Refer to the instruction manual Figure 1 As shown: it includes an outer layer sustained-release component, a middle layer sustained-release component and an inner layer sustained-release component, the outer layer sustained-release component includes a 3D printed skeleton 1, the outer surface of the 3D printed skeleton 1 is covered and fixed with a porous ceramic bracket 4, the outer surface of the porous ceramic bracket 4 is attached with an outer skeleton drug-loaded coating 2, and the outer surface of the porous ceramic bracket 4 is provided with 20-30 rows of equidistantly arranged conical drug-releasing holes 6;

[0030] Refer to the instruction manual Figure 4 As shown: the middle-layer sustained-release component includes a middle-layer sustained-release component 5 filled and fixed inside the drug storage chamber 7; the middle-layer sustained-release component 5 includes a mesoporous nano-silica lining 51, 7-10 annular cavities 53 are equidistantly arranged inside the mesoporous nano-silica lining 51, and the inner cavity of the annular cavity 53 is filled with an antibiotic mixture 54;

[0031] Refer to the instruction manual Figure 5 As shown: the inner layer slow-release component includes an inner layer slow-release component 3 filled and fixed on the inner side of the 3D printed skeleton 1; the inner layer slow-release component 3 includes a TUD mesoporous core 31, a plurality of annular cavities 53 filled in the inner cavity of the TUD mesoporous core 31, and a silicone support column 33 is connected to the upper and lower positions of the inner cavity of the TUD mesoporous core 31.

[0032] Refer to the instruction manual Figure 3 As shown: a drug storage chamber 7 is opened inside the 3D printed skeleton 1, and 10-20 rows of antibiotic release through holes 8 arranged at equal distances are opened on the outer surface of the 3D printed skeleton 1, and the antibiotic release through holes 8 are connected to the inner cavity of the drug storage chamber 7.

[0033] Refer to the instruction manual Figure 4 As shown, 7 to 10 rows of antibiotic release channels 52 communicating with the annular cavity 53 are provided inside the mesoporous nano-silica lining 51 .

[0034] Refer to the instruction manual Figure 5 As shown: the ends of the silica gel support columns 33 that are close to each other are connected to the C-shaped friction plate 34, and the ends of the C-shaped friction plate 34 that are close to each other are in contact with the surface of the mixed antibiotic particles 35.

[0035] Refer to the instruction manual Figure 3 As shown: the inner surface of the 3D printed skeleton 1 is in close contact with the outer surface of the TUD mesoporous core 31 through an adhesive, and the two ends of the antibiotic release through hole 8 respectively penetrate the inner and outer surfaces of the 3D printed skeleton 1. The inner surface of the porous ceramic support 4 is in close contact with the outer surface of the 3D printed skeleton 1 through an adhesive, and the outer port diameter of the conical drug release hole 6 is 1 / 2 of the inner port diameter of the conical drug release hole 6. 1-3 layers of antibiotics are provided on the outer surface of the exoskeleton drug-loaded coating 2 by immersion.

[0036] Refer to the instruction manual Figure 4 As shown: the outer surface and the inner surface of the mesoporous nano-silica lining 51 are respectively fixed to the inner cavity side wall of the drug storage chamber 7 by adhesive, and the outer port of the antibiotic release channel 52 is coaxially connected with the antibiotic release through hole 8 on the outer surface of the 3D printed skeleton 1.

[0037] Refer to the instruction manual Figure 5 As shown: the interior of the TUD mesoporous core 31 is provided with an antibiotic particle storage cavity 32 for placing and filling mixed antibiotic particles 35. The elasticity of the silicone support column 33 is maximized to allow the C-shaped friction plates 34 to contact each other, and the surfaces of the C-shaped friction plates 34 that are close to each other have friction particles.

[0038] According to the above-mentioned preferred technical solution, the workflow of the technical solution is described as follows:

[0039] According to the modeling of the infected bone defect area, the shapes of the 3D printed skeleton 1, the mesoporous nano-silica lining 51 and the TUD mesoporous core 31 are constructed by 3D printing. When in use, the antibiotics are mixed agents or particles of Fuping and Moxifloxacin. The antibiotics on the surface of the exoskeleton drug-loaded coating 2 are in contact with the patient's tissue fluid. After the antibiotics on the surface of the exoskeleton drug-loaded coating 2 are slowly dissolved and released, the micropores inside the exoskeleton drug-loaded coating 2 allow the tissue fluid to penetrate into the porous ceramic scaffold 4.

[0040] After the tissue fluid penetrates into the antibiotic release channel 52 along the porous ceramic stent 4, the antibiotic mixture 54 in the annular cavity 53 is slowly dissolved by the tissue fluid, penetrates into the tapered drug release hole 6 inside the porous ceramic stent 4 along the antibiotic release channel 52, and is released through the porous ceramic stent 4 and the micropores inside the exoskeleton drug-loaded coating 2 and the tapered drug release hole 6. Since the porous ceramic stent 4 is full of tapered drug release holes 6, and the outer port of the tapered drug release hole 6 is small and the inner port is large, the antibiotic solvent is blocked by the tapered drug release hole 6 to slow down its circulation speed and play a slow release role.

[0041] When the patient moves, the skeleton in the infected bone defect area will swing with the movement, causing the mixed antibiotic particles 35 in contact with each other inside the antibiotic particle storage cavity 32 to rub against each other. The elasticity of the silicone support column 33 forces the C-shaped friction plate 34 to squeeze the mixed antibiotic particles 35 up and down, so that the mixed antibiotic particles 35 are ground into powder under double pressure and released into the mesoporous nano-silica lining 51 through the micropores inside the TUD mesoporous core 31, and then released into the patient's body through the porous ceramic support 4 and the exoskeleton drug-loaded coating 2.

[0042] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone should be aware that any structural changes made under the inspiration of the present invention, and any technical solutions that are the same or similar to the present invention, fall within the protection scope of the present invention. Finally, it should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the restrictive conditions that can be implemented in this application, so they have no technical substantive significance. Any structural modification, change in proportional relationship or adjustment of size, without affecting the effects that can be produced by this application and the purposes that can be achieved, should still fall within the scope that can be covered by the technical content disclosed in this application.

Claims

1. An antibiotic sustained-release device for treating infected bone defects, comprising an outer sustained-release component, a middle sustained-release component and an inner sustained-release component, characterized in that: The outer layer sustained-release component comprises a 3D printed skeleton (1), the outer surface of the 3D printed skeleton (1) is covered and fixed with a porous ceramic support (4), the outer surface of the porous ceramic support (4) is attached with an outer skeleton drug-carrying coating (2), and the outer surface of the porous ceramic support (4) is provided with 20 to 30 rows of equidistantly arranged conical drug-releasing holes (6); The middle-layer sustained-release component comprises a middle-layer sustained-release component (5) filled and fixed inside the drug storage chamber (7); the middle-layer sustained-release component (5) comprises a mesoporous nano-silicon dioxide lining (51), 7 to 10 annular cavities (53) equidistantly arranged inside the mesoporous nano-silicon dioxide lining (51), and the inner cavity of the annular cavity (53) is filled with an antibiotic mixture (54); The inner layer slow-release component comprises an inner layer slow-release component (3) filled and fixed on the inner side of a 3D printed skeleton (1); the inner layer slow-release component (3) comprises a TUD mesoporous inner core (31), and a plurality of annular cavities (53) filled in the inner cavity of the TUD mesoporous inner core (31); a silicone support column (33) is connected to the upper and lower positions of the inner cavity of the TUD mesoporous inner core (31).

2. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The 3D printed skeleton (1) is provided with a drug storage chamber (7) inside, and the outer surface of the 3D printed skeleton (1) is provided with 10-20 rows of antibiotic release through holes (8) arranged at equal distances, and the antibiotic release through holes (8) are connected to the inner cavity of the drug storage chamber (7).

3. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The mesoporous nano-silica lining (51) is provided with 7 to 10 rows of antibiotic release channels (52) that are connected to the annular cavity (53).

4. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: One end of the silica gel support column (33) close to each other is connected to a C-shaped friction plate (34), and one end of the C-shaped friction plate (34) close to each other is in contact with the surface of the mixed antibiotic particles (35).

5. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The inner surface of the 3D printed skeleton (1) is in close contact with the outer surface of the TUD mesoporous core (31) via an adhesive, and both ends of the antibiotic release through hole (8) respectively penetrate the inner and outer surfaces of the 3D printed skeleton (1).

6. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The inner surface of the porous ceramic support (4) and the outer surface of the 3D printed skeleton (1) are tightly adhered to each other via an adhesive, and the outer port diameter of the conical drug release hole (6) is 1 / 2 of the inner port diameter of the conical drug release hole (6).

7. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: One to three layers of antibiotics are provided on the outer surface of the exoskeleton drug-carrying coating (2) by immersion.

8. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The outer surface and the inner surface of the mesoporous nano-silica lining (51) are respectively adhered and fixed to the inner cavity side wall of the drug storage chamber (7) by adhesive, and the outer port of the antibiotic release channel (52) is coaxially connected with the antibiotic release through hole (8) on the outer surface of the 3D printed skeleton (1).

9. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The interior of the TUD mesoporous core (31) is provided with an antibiotic particle storage cavity (32) for placing and filling the mixed antibiotic particles (35).

10. The antibiotic sustained-release device for treating infected bone defects according to claim 1, characterized in that: The maximum elasticity of the silicone support column (33) enables the C-shaped friction plates (34) to contact each other, and the surfaces of the C-shaped friction plates (34) on one side close to each other are provided with friction particles.

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