CN212346690U - Biological reinforced intramedullary nail - Google Patents

Biological reinforced intramedullary nail Download PDF

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CN212346690U
CN212346690U CN202021101621.6U CN202021101621U CN212346690U CN 212346690 U CN212346690 U CN 212346690U CN 202021101621 U CN202021101621 U CN 202021101621U CN 212346690 U CN212346690 U CN 212346690U
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nail
head
main
hole
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张里程
唐佩福
尹鹏滨
崔翔
吕厚辰
李佳
李建涛
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Chinese PLA General Hospital
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Chinese PLA General Hospital
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Abstract

The utility model discloses a biological enhanced intramedullary nail, which comprises a main nail, a head nail and an injection device; the main nail is arranged along the length direction of the femur and consists of a proximal part, a transition part and a distal part; the proximal part is provided with a fixing hole which is inclined and arranged to penetrate through the proximal part, and the head nail passes through the fixing hole and is arranged in the femur; the main nail and the head nail are internally provided with communicated fluid holes, and the injection device is connected with the fluid holes in the head nail so as to inject fluid into the inner cavity of the femur through the head nail and the main nail. The utility model provides a biological enhancement mode intramedullary nail, its is rational in infrastructure, sets up the fluid hole in the inside of main nail and head nail to pour into hydrogel into, both satisfied the fixed mechanics reinforcing function of fracture, realized the biological reinforcing function to regeneration microenvironment regulation and control again, solve the technical problem that malformation healing, healing position mechanical properties are not enough, do not connect the bone even.

Description

Biological reinforced intramedullary nail
Technical Field
The utility model relates to the technical field of medical equipment, in particular to a biological enhanced intramedullary nail.
Background
The current clinical fracture treatment concepts comprise a strong fixation concept and a biological fixation concept, wherein the strong fixation concept only considers the mechanical property and fails to give consideration to regulation and enhancement of a biological microenvironment; compared with a strong fixation concept method, the biological fixation concept method is changed from mechanical mechanics to biology, so that blood circulation is protected better, interference on a local bone biological microenvironment is reduced, and the problem of regeneration and repair caused by biological environment damage after fracture is still not solved completely. For example, for intramedullary nails, this symmetrical center splint type fixation may have deformity healing caused by displacement of the broken ends, insufficient mechanical properties of the healing part, and even bone nonunion.
Patent CN111012463A discloses an intramedullary nail system for treating proximal femoral fracture, which comprises a main nail, a head nail and a support nail, wherein the main nail is composed of a proximal portion, a transition portion and a distal portion, the head nail passes through a head nail hole located at the proximal portion, the support nail passes through a support nail hole located at the transition portion, and the tail end of the support nail is abutted against the lower side of the head nail; the main nail, the head nail and the supporting nail form a triangular structure at the near end of the femur. The patent belongs to a strong fixation idea and fails to give consideration to regulation and enhancement of a biological microenvironment.
Therefore, there is a need to design a bio-enhanced intramedullary nail, which can regulate and enhance the biological microenvironment, and solve the technical problems in the prior art.
Disclosure of Invention
The utility model aims at the above technical problem, the utility model provides a pair of biological enhancement mode intramedullary nail, its is rational in infrastructure, sets up the fluid hole in the inside of main nail and head nail to pour into biological reinforcing aquogel into, both satisfied the fixed mechanics enhancement function of fracture, realized the biological enhancement function to regeneration microenvironment regulation and control again, solve the technical problem that malformation healing, healing position mechanical properties are not enough, the bone does not connect even.
In order to solve the technical problem, the utility model provides a biological enhanced intramedullary nail, which comprises a main nail, a head nail and an injection device; the main nail is arranged along the length direction of the femur and consists of a proximal part, a transition part and a distal part; the proximal part is provided with a fixing hole which is inclined and arranged to penetrate through the proximal part, and the head nail passes through the fixing hole and is arranged in the femur; the main nail and the head nail are internally provided with communicated fluid holes, and the injection device is connected with the fluid holes in the head nail so as to inject fluid into the inner cavity of the femur through the head nail and the main nail.
In some embodiments, the main nail is provided with a main nail hole passage which extends downwards along the length direction of the main nail and is positioned at the lower part of the fixing hole.
In some embodiments, a head nail hole passage and a vertical hole passage are arranged inside the head nail, the head nail hole passage is arranged along the length direction of the head nail, the vertical hole passage is arranged along the radial direction of the head nail and is communicated with the vertical hole passage, and the vertical hole passage is communicated with the fluid hole of the main nail.
In some embodiments, the outer periphery of the head nail is provided with a limiting groove, and the limiting groove is arranged opposite to the vertical hole.
In some embodiments, the main nail is further provided with a circumferential hole which is arranged along the radial direction of the main nail and is communicated with the main nail hole.
In some embodiments, the fluid injected by the injection device is a bio-enhancing hydrogel.
In some embodiments, the outer end of the stud is provided with a connecting portion, which is arranged coaxially with the stud aperture.
In some embodiments, the injection device is connected to the stud port via an adapter and tubing, the adapter being sealingly connected to the connection.
In some embodiments, the outer end of the stud is further provided with a tightening portion that enters the fixation hole of the proximal portion by rotation.
In some embodiments, the circumferential channel is located at a distal portion of the main nail and has an inner diameter no greater than an inner diameter of the main nail channel.
The utility model discloses beneficial effect:
the utility model provides a pair of biological enhancement mode intramedullary nail, it is rational in infrastructure, set up the fluid hole in the inside of main nail and head nail to pour into aquogel or medicine carrying microballon into, both satisfied the fixed mechanics reinforcing function of fracture, realized the biological reinforcing function to regeneration microenvironment regulation and control again, solve the technical problem that deformity healing, healing position mechanical properties are not enough, bone do not connect even.
Drawings
The above advantages of the present invention will become more apparent and more readily appreciated from the detailed description taken in conjunction with the following drawings, which are given by way of illustration only and do not limit the present invention, and in which:
fig. 1 is a schematic structural view of a bio-enhanced intramedullary nail according to the present invention;
FIG. 2 is an exploded view of the bio-enhanced intramedullary nail of FIG. 1;
fig. 3 is a cross-sectional view of the main nail of the present invention;
fig. 4 is a schematic structural view of the stud of the present invention;
fig. 5 is a cross-sectional view of the stud of the present invention;
fig. 6 is a schematic view of the injection device of the present invention;
FIG. 7 is a schematic view of an embodiment of the bio-enhanced intramedullary nail according to the present invention;
FIG. 8 is a schematic illustration of a static torque testing apparatus.
In the figure:
10. a main nail; 11. a proximal portion; 12. a transition portion; 13. a distal portion; 14. a fixing hole; 15. a main nail hole channel; 16. a circumferential channel;
20. head nails; 20a, a connecting part; 20b. a tightening part; 21. a head pin passage; 22. a vertical duct; 23. a limiting groove;
30. an injection device; 31. and (6) an adapter.
Detailed Description
The biologically enhanced intramedullary nail of the present application is described in detail below with reference to the following specific embodiments and accompanying drawings.
The embodiments described herein are specific embodiments of the present invention, and are intended to be illustrative of the concepts of the present invention, which are intended to be illustrative and exemplary, and should not be construed as limiting the scope of the embodiments of the present invention. In addition to the embodiments described herein, those skilled in the art will be able to employ other technical solutions which are obvious based on the disclosure of the claims and the specification of the present application, and these technical solutions include technical solutions which make any obvious replacement or modification for the embodiments described herein.
The drawings in the present specification are schematic views to assist in explaining the concept of the present invention, and schematically show the shapes of the respective portions and the mutual relationships thereof. Note that, in order to clearly show the structure of each component of the embodiment of the present invention, the same reference numerals are used to denote the same parts.
Fig. 1 shows a schematic structural diagram of a bio-enhanced intramedullary nail according to the present invention, which includes a main nail 10, a head nail 20 and an injection device 30. Fig. 2 is an exploded view of the components of the bio-enhanced intramedullary nail.
The main nail 10 is arranged along the length direction of the femur, and the main nail 10 is composed of a proximal end part 11, a transition part 12 and a distal end part 13, as shown in fig. 3; the proximal part 11 is provided with a fixing hole 14 which is inclined and arranged through the proximal part 11, and the head nail 20 passes through the fixing hole 14 and is arranged in the femur; the main nail 10 and the head nail 20 are provided with fluid holes communicated with each other inside, and the injection device 30 is connected with the fluid holes inside the head nail 20 to inject fluid into the inner cavity of the femur through the head nail 20 and the main nail 10.
In the present invention, the fluid injected by the injection device 30 is hydrogel commonly used in orthopedics, such as chitosan hydrogel, or preferably the hydrogel component includes (1) polyacrylic acid (PAA-NHS) grafted with N-hydrogen succinimide ester, having bone tissue adhesion property; (2) the a-cyanoacrylate adhesive (ethyl a-cyanoacrylate) has metal adhesion performance, so that the performance of the hydrogel for simultaneously adhering bone and metal can be enhanced, the intramedullary nail and the bone can be adhered, and the mechanical performance is enhanced; on the other hand, the hydrogel can be used as a physical filler, and occupies the physical space between the implanted intramedullary nail and the bone, so that the mechanical support is stronger; intramedullary nail here refers to the assembly formed by the main nail and the head nail inside the femur. In addition, the hydrogel promotes new bones to grow into the channels on the peripheral side wall of the main nail to form a net structure, so that the intramedullary nail and bone tissues are tightly combined into a whole, and the mechanical stability is improved. The polymer system of the hydrogel can provide a good matrix for the transplantation and differentiation of cells, endogenous regeneration, biological repair, wound healing and continuous drug delivery, and the three-dimensional network system of the hydrogel can simulate the microstructure of the original extracellular matrix, provides living ecological conditions for the survival of cells and has biological enhancement performance.
Preferably, the drug-loaded microcapsules are injectable into the hydrogel by an injection device. The medicine-carrying microcapsule comprises: the 4 medicine carrying microspheres preferably carry medicine for resisting infection (antibiotics), promoting angiogenesis (VEGF) medicine carrying, promoting bone repair (BMP-2) medicine carrying and improving inflammatory reaction (IL-10/2-Methoxylustradiol and the like can promote M1 macrophages to convert into M2 macrophages). Therefore, the regeneration microenvironment can be regulated and controlled, and the biological enhancement function can be realized.
As an embodiment of the present invention, the main nail 10 is provided with a main nail hole 15 inside, which extends downward along the length direction of the main nail 10 and is located at the lower portion of the fixing hole 14. It is understood that the main nail hole 15 may be extended from the upper end of the main nail 10 to the lower end of the main nail 10 for convenience of processing, as shown in fig. 3.
Fig. 4 and 5 are schematic structural diagrams of the stud 20, the inside of the stud 20 is provided with a stud hole 21 and a vertical hole 22, the stud hole 21 is followed the length direction of the stud 20 is set, the vertical hole 22 is followed the radial setting of the stud 20 and the vertical hole 22 are linked together, the vertical hole 22 is linked together with the fluid hole of the main stud 10. Specifically, the vertical hole 22 communicates with the main nail hole 15 of the main nail 10.
In fig. 5, a stopper groove 23 is provided on the outer peripheral side of the stud 20, and the stopper groove 23 is provided opposite to the vertical hole 22. The structure of the intramedullary nail of the present invention is similar to patent CN111012463A, the upper portion of the head nail 10 is also provided with a locking bolt, which is not shown, and the locking bolt is fixed in the main nail 10 from the upper portion and is connected to the spacing groove 23 of the head nail 20. Because the limiting groove 23 is arranged opposite to the vertical pore passage 22, whether the vertical pore passage 22 is communicated with the main nail pore passage 15 can be judged by whether the locking bolt is clamped in the limiting groove 23 or not.
In fig. 3, the main nail 10 is further provided with a circumferential hole 16, and the circumferential hole 16 is arranged along the radial direction of the main nail 10 and is communicated with the main nail hole 15. The hydrogel in the injection device 30 enters the main nail hole 15 of the main nail 10 through the nail hole 21 and the vertical hole 22 of the nail 20, and the hydrogel entering the main nail hole 15 is uniformly diffused to the intramedullary cavity through the circumferential hole 16, so as to ensure the biological enhancement function of the hydrogel. As an example of the present invention, the circumferential channel 16 is located at the distal end portion 13 of the main nail 10, and its inner diameter is not larger than the inner diameter of the main nail channel 15. In the embodiment shown in fig. 3, the inner diameter of the circumferential orifices 16 is smaller than the inner diameter of the main nail orifices 15. Specifically, the inner diameter of the circumferential hole 16 is 60% -80% of the inner diameter of the main nail hole 15.
As an embodiment of the present invention, the outer end of the stud 20 is provided with a connecting portion 20a, and the connecting portion 20a and the stud hole 21 are coaxially disposed. The outer end of the stud 20 is also provided with a tightening portion 20b which enters the fixing hole 14 of the proximal portion 11 by rotation.
Fig. 6 is a schematic structural diagram of the injection device of the present invention, wherein the injection device 30 is connected to the stud hole 21 through an adapter 31 and a pipeline, and the adapter 31 is connected to the connecting portion 20a in a sealing manner.
Fig. 7 is a schematic view of an embodiment of the bio-enhanced intramedullary nail according to the present invention, wherein the main nail 10 is disposed along the length direction of the femur, the head nail 20 passes through the fixing hole 14 and is disposed in the femur, and the injection device 30 is connected to the fluid hole inside the head nail 20 to inject the hydrogel into the inner cavity of the femur through the head nail 20 and the main nail 10.
Comparative test
Comparing the hydrogel intramedullary nail and the non-hydrogel intramedullary nail (common femoral intramedullary nail), wherein each group comprises 5 samples and 10 samples to determine the intramedullary nail with stronger torsional rigidity. The test was conducted in a dry, room temperature environment with the test set-up as shown in fig. 8 and the test parameters detailed in tables 1 and 2. The slope of the linear part of the torque-torsion angle curve is the torsional rigidity of the intramedullary nail.
TABLE 1 static torsion test parameters
Working distance Rate of torsion Angle of torsion
70mm 5°/min
TABLE 2 hydrogel groups
Figure DEST_PATH_GDA0002822861520000061
Figure DEST_PATH_GDA0002822861520000071
As can be seen from table 2, the hydrogel group had a greater average torsional stiffness than the non-hydrogel group.
The results of the biotoxicity test of the hydrogel are shown in Table 3.
Table 3 blood test results show
Figure DEST_PATH_GDA0002822861520000072
The results in table 3 show that the hydrogel is not cytotoxic.
Compared with the prior art, the utility model provides a pair of biological enhancement mode intramedullary nail, its is rational in infrastructure, sets up the fluid hole in the inside of main nail and head nail to pour into biological reinforcing aquogel into, both satisfied the fixed mechanics enhancement function of fracture, realized the biological enhancement function to regeneration microenvironment regulation and control again, solve the technical problem that malformation healing, healing position mechanical properties are not enough, do not connect even the bone.
The present invention is not limited to the above embodiments, and any person can obtain other products in various forms without departing from the scope of the present invention, but any change in shape or structure is included in the technical solution that is the same as or similar to the present invention.

Claims (10)

1. A biological enhanced intramedullary nail is characterized by comprising a main nail, a head nail and an injection device; the main nail is arranged along the length direction of the femur and consists of a proximal part, a transition part and a distal part; the proximal part is provided with a fixing hole which is inclined and arranged to penetrate through the proximal part, and the head nail passes through the fixing hole and is arranged in the femur; the main nail and the head nail are internally provided with communicated fluid holes, and the injection device is connected with the fluid holes in the head nail so as to inject fluid into the inner cavity of the femur through the head nail and the main nail.
2. The bio-enhanced intramedullary nail of claim 1, wherein the main nail is internally provided with a main nail hole channel extending downward along a length of the main nail and located at a lower portion of the fixation hole.
3. The bio-enhanced intramedullary nail according to claim 1, wherein a head nail hole and a vertical hole are formed in the head nail, the head nail hole is formed along the length direction of the head nail, the vertical hole is formed along the radial direction of the head nail and is communicated with the vertical hole, and the vertical hole is communicated with the fluid hole of the main nail.
4. The bio-enhanced intramedullary nail of claim 3, wherein a circumferential side of the head nail is provided with a limiting groove, the limiting groove being disposed opposite the vertical bore.
5. The bio-enhanced intramedullary nail according to claim 2, wherein the main nail is further provided with a circumferential channel disposed radially of the main nail and communicating with the main nail channel.
6. The bio-enhanced intramedullary nail of claim 1, wherein the fluid injected by the injection device is a hydrogel.
7. The bio-enhanced intramedullary nail of claim 3, wherein an outer end of the head nail is provided with a connecting portion, the connecting portion being disposed coaxially with the head nail bore.
8. The bio-enhanced intramedullary nail of claim 7, wherein the injection device is coupled to the head nail bore by an adapter and a conduit, the adapter being sealingly coupled to the coupling portion.
9. The bio-enhanced intramedullary nail of claim 7, wherein the outer end of the head nail is further provided with a tightening portion that enters the fixation hole of the proximal portion by rotation.
10. The bio-enhanced intramedullary nail of claim 5, wherein the circumferential channel is located at a distal portion of the main nail and has an inner diameter no greater than an inner diameter of the main nail channel.
CN202021101621.6U 2020-06-15 2020-06-15 Biological reinforced intramedullary nail Active CN212346690U (en)

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