Disclosure of Invention
The patent is provided for solving the existing requirements, and the technical problem to be solved by the patent is to provide an antibacterial copper-containing titanium alloy three-dimensional adjustable minimally invasive interbody fusion cage so as to improve the implantation effect of the interbody fusion cage.
In order to solve the above problem, the technical solution provided by the present disclosure includes:
an antibacterial copper-titanium-alloy-containing three-dimensional adjustable minimally invasive interbody fusion cage is characterized by comprising: n edges connected end to end are pivotally connected with each other to form a closed N-edge shape, wherein N is an integer larger than three; the adjusting rod is arranged between the first angle and the second angle which are not adjacent to each other of the N-edge shape in an adjustable length mode, and a triangular structure is formed by the adjusting rod and two edges between the first angle and the second angle of the N-edge shape; three sides of the triangular structure are pivotally connected with each other; when the adjusting rod is contracted, the other two sides of the triangular structure are close to each other so as to expand the fusion cage until the fusion cage enters a locking position; the adjusting rod is provided with a locking mechanism, and the locking mechanism at least locks the locking position of the adjusting rod.
Preferably, each of the N sides includes an upper plate and a lower plate, the upper plate and the lower plate are spaced apart by a predetermined distance to form a bone grafting cavity, and the upper plate and the lower plate are provided with through holes.
Preferably, the adjusting lever includes: the fixing part is arranged at one end of the rod body and is pivoted between the upper plate and the lower plate of the first corner part; the other end of the rod is provided with an upper bulge and a lower bulge; a sliding part including an upper sliding part and a lower sliding part which are separately provided and pivotally provided on the upper plate and the lower plate of the second corner part, respectively; the sliding part comprises a sliding groove, a guide groove and a locking table board; the sliding groove comprises an upper sliding groove and a lower sliding groove which are arranged in a split mode, the shapes of the upper sliding groove and the lower sliding groove correspond to the shape of the rod body, and through holes matched with the upper bulge and the lower bulge are formed in the upper sliding groove and the lower sliding groove respectively; the locking table top comprises an upper locking table top and a lower locking table top, and the upper locking table top and the lower locking table top are respectively and pivotally arranged on the upper plate and the lower plate of the second corner part; the upper locking table top and the lower locking table top are respectively provided with a concave part which is matched with the upper bulge and the lower bulge in a locking way, so that the sliding rod is positioned on the locking table top; a guide groove is arranged between the sliding groove and the locking table top, the guide groove comprises an upper guide groove and a lower guide groove, the upper guide groove is transited from the upper sliding groove to the upper locking table top, and the lower guide groove is transited from the lower sliding groove to the lower guiding table top; the upper sliding groove and the lower sliding groove are separated by a first distance, the upper guide groove and the lower guide groove are separated by a second distance, and the upper locking table board and the lower locking table board are separated by a third distance; the first distance is greater than the second distance, which is greater than the third distance.
Preferably, the sliding rod is cylindrical; the upper sliding groove and the lower sliding groove are respectively formed into a semi-cylinder matched with the cylinder in shape, and the upper guide groove and the lower guide groove are oppositely arranged to respectively form a semi-conical guide surface; the upper end of the upper locking table top is connected with the upper frame through a pivot, and the lower end of the lower locking table top is connected with the lower frame through a pivot.
Preferably, the upper frame and the lower frame are of a quadrilateral frame structure, four corners of the quadrilateral are formed into round corners, and at least one corner is provided with a position where a vertically-arranged arc baffle blocks the corner.
Preferably, a reinforcing plate is disposed between the upper frame and the lower frame, and one of the reinforcing plates between two adjacent sides extends along a length direction of the corresponding side thereof, and the other extends along a width direction of the corresponding side thereof.
Preferably, the upper plate has a fixed tooth formed on an upper surface thereof; the lower surface of the lower plate is also formed with stationary teeth.
Preferably, the fusion cage is integrally made of a copper-containing titanium alloy.
Preferably, the copper-containing titanium alloy is prepared by taking a titanium alloy and pure copper as raw materials, and the mass percentage of copper element in the copper-containing titanium alloy is 1-30%; the yield strength of the copper-containing titanium alloy can be 600-1200 MPa, and the tensile strength can be 700-1300 MPa.
Preferably, the titanium alloy as the raw material is Ti6Al 4V.
The fusion cage is made of copper-titanium alloy with good performance and a polygonal hinge structure, the shape of the fusion cage is adjusted by adjusting the rod, the fusion cage can be implanted from a wound in a proper shape during implantation, and the fusion cage is easily and operationally propped open at a preset position to achieve a good fixing effect.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
In the description of the embodiments of the present disclosure, it should be noted that, unless otherwise explicitly stated or limited, the term "connected" should be interpreted broadly, and may be, for example, a fixed connection, a detachable connection, or an integral connection, which may be a mechanical connection, an electrical connection, which may be a direct connection, or an indirect connection via an intermediate medium. The specific meaning of the above terms in the present disclosure can be understood by those of ordinary skill in the art as appropriate.
For the purpose of facilitating understanding of the embodiments of the present application, the following description will be made in terms of specific embodiments with reference to the accompanying drawings, which are not intended to limit the embodiments of the present application.
The specific embodiment provides an antibacterial copper-titanium alloy-containing three-dimensional adjustable minimally invasive intervertebral fusion cage.
Minimally invasive spinal surgery has incomparable advantages with other types of surgery, and the minimally invasive surgery is less harmful to the body of a patient and can be quickly recovered. The use of minimally invasive surgery in spinal surgery has been increasingly recognized as advantageous.
For example, in intervertebral fusion, the use of minimally invasive surgery has advantages that are not comparable to traditional surgical approaches. However, in the intervertebral fusion, the minimally invasive surgery is performed on the premise of having a cage that can be adapted to a minimally invasive opening, and the cage can be implanted into a body in the minimally invasive opening and can be expanded in the body to have a good fusion effect, which needs to be convenient to operate and fix, so that the excellent intervertebral cage becomes an important part of the minimally invasive intervertebral fusion.
Therefore, the structure of the three-dimensional adjustable minimally invasive intervertebral fusion cage containing the antibacterial copper-titanium alloy is shown in fig. 1 to 6. In the state of fig. 1, it can be folded to have a smaller section, and in the state of fig. 2, it can be spread to be well fixed between vertebral bodies, if it is easy to meet the requirements of minimally invasive intervertebral fusion.
In the specific embodiment, the antibacterial copper-titanium alloy-containing three-dimensional adjustable minimally invasive intervertebral fusion cage is integrally formed into a plurality of strip-shaped sides 2, and the sides 2 are mutually hinged end to form a polygon. The polygon has a number of sides greater than three. If the polygon is three sides, the polygon is a triangle in an end-to-end manner, and the triangle is not favorable for having a small section when being implanted and having a large section after being implanted into a body due to the stable shape. Therefore, the polygon in the present embodiment is a polygon having a number of sides of 4 or more. The number of sides of the polygon and the number of corners of the polygon are equal, i.e. when the polygon has N sides, it also has N corners.
The polygon with the hinged edges end to end can be conveniently stretched to reduce the section size in one direction, and can also be conveniently stretched to meet the requirement of supporting the spine by matching with a fusion cage. However, the property of being easily deformable is not sufficient for the fusion cage because the fusion cage needs to have a stable structure after being implanted into the body and have sufficient strength to support the vertebral body, and therefore, how to maintain the stability of the shape in a required state while being able to be easily deformed, and further, in consideration of the convenience of the operation, and having sufficient structural strength and good implantation effect, is actually a spear body in which a plurality of factors are mutually restricted to some extent.
In order to facilitate understanding of the inventive concept of the present disclosure, a quadrilateral is exemplified in the present embodiment.
In the present embodiment, each side 2 of the quadrangle includes an upper plate 3 and a lower plate 4, and the upper plate and the lower plate may be fixedly connected by a connection plate 5 for the side that does not need to be adjusted in the vertical direction. The upper and lower plates may be provided separately from each other at the sides where the distance between the upper and lower plates needs to be adjusted. The upper and lower plates are spaced apart by a predetermined distance, thus forming a hollow structure 6 to facilitate bone grafting. By means of the edges of this construction a stable shape can be formed while maintaining a certain strength.
In the present embodiment, the upper plate and the lower plate are both provided with openings 7, and the openings are communicated with the hollow structure between the upper plate and the lower plate to facilitate bone grafting.
Furthermore, the upper surface of the upper plate and the lower surface of the lower plate are both provided with fixing teeth 8, the surfaces are contacted with vertebrae after the fusion cage is implanted into a vertebral body, and the fixing teeth can play a role in preventing falling.
Further, in the natural state, the height of each side is kept basically consistent with the height of the upper and lower sides of the side in the whole, so that each side can be kept to be fully contacted with the implantation surface of the vertebra. The end edge of each side is formed in a circular arc shape so as not to cause additional damage to the body when implanted.
In the embodiment, the sides of the quadrangle are hinged end to form a closed and adjustable quadrangle. The end-to-end hinge can be realized by arranging pivots at the connecting part, and two adjacent edges are connected through the same pivot to form the hinge structure. Since both adjacent edges comprise an upper and a lower plate, in order to facilitate the connection, in this embodiment the upper and lower plates of the first edge may be received between the upper and lower plates of the second edge, which facilitates the connection. When the corresponding end part of the first edge and the corresponding end part of the second edge are both set to be in proper arc shapes, the arc shapes of the corner parts can be kept when the first edge and the second edge rotate relatively, and the body of an implant is prevented from being injured.
It is further preferred that the first edge is formed with a circular arc baffle 9 between the respective joined ends to form the ends into a substantially closed shape to facilitate implantation and maintain structural stability.
In this embodiment, the end-to-end hinged polygons can transform shape based on articulation, but the cage should be easily manipulated after implantation to support the vertebral bodies and maintain the corresponding distracted shape sufficiently stable. There are high demands on the ease of handling and structural stability, which are contradictory to the ease of deformation of the hinge structure.
In the present embodiment, an adjustment lever 10 is provided to facilitate the expanding operation and to fix the expanded shape. The adjusting rod is pivoted between two nonadjacent angles in a length-adjustable manner, and the overall shape of the fusion cage is adjusted by adjusting the length of the adjusting rod to change the distance between the two nonadjacent angles.
The adjusting rod and two adjacent sides form a triangle, one side of the triangle is the adjusting rod, the other two sides of the triangle are the sides of the polygon, and the three sides are in end-to-end pivot connection with each other. The triangle can be elongated when the length of the adjusting rod is elongated, thereby forming a state convenient for implantation, and when the length of the adjusting rod is shortened, the other two sides are expanded, thereby being convenient for supporting the vertebral body.
The adjusting rod is beneficial to minimally invasive operation and fixation of the fusion device and the vertebral body if the length of the adjusting rod can be conveniently adjusted and can be stably kept at the position needing to be expanded.
In this embodiment, preferably, the adjusting lever comprises
A rod 11, one end of which is provided with a fixing part 12, and the fixing part is fixedly arranged with the pivot; the other end of the rod is provided with a projection 14, i.e. an upper projection and a lower projection. One end of the rod is pivotally connected with the first corner of the quadrangle, and the other end of the rod is connected with the sliding part in a matching way. In order to increase the strength, the one end of the rod may be formed in a thickened structure, which not only can reinforce the strength of the rod but also can form a support at the connection position.
The sliding portion 13 includes an upper sliding portion and a lower sliding portion which are separately provided. The upper and lower sliding portions are pivotally provided at the upper plate lower surface and the lower plate upper surface of the second corner, respectively. The sliding part comprises a sliding groove, a guide groove and a locking table board.
The sliding groove is integrally formed into a cylindrical shape, accommodates the other end of the rod, and is matched with the rod and the cylinder to form sliding connection. The sliding groove comprises an upper sliding groove 15 and a lower sliding groove 16 which are arranged in a split mode, guide holes 17 matched with the upper protrusions and the lower protrusions are formed in the upper sliding groove and the lower sliding groove respectively and used for guiding the guide rod to slide back and forth in the sliding groove, and meanwhile the inner side end of each guide hole can limit the position of each protrusion, so that the maximum length of the adjusting rod is limited.
The locking table 18 comprises an upper locking table and a lower locking table, which are arranged separately. In the present embodiment, the upper locking table is pivotally connected to the upper plate of the second corner, and the lower locking table is pivotally connected to the lower plate of the second corner, and the upper locking table and the lower locking table are provided with a recess 21, which may be a groove or a hole, for locking engagement with the upper protrusion and the lower protrusion, and the minimum length of the slide bar is limited by the engagement of the protrusion and the recess. And locking the slide bar in position on the locking deck.
Further preferably, a baffle 19 is further provided outside the locking counter, different baffles may be provided on the upper and lower locking counter, respectively, the baffles further blocking the shortest position of the rod in the sliding portion.
The sliding groove and the locking table surface are provided with a guide groove therebetween, the guide groove 20 comprises an upper guide groove and a lower guide groove, the upper guide groove is transited from the upper sliding groove to the upper locking table surface, and the lower guide groove is transited from the lower sliding groove to the lower locking table surface.
The upper sliding groove and the lower sliding groove are separated by a first distance, the upper guide groove and the lower guide groove are separated by a second distance, and the upper table top and the lower table top are separated by a third distance; the first distance is greater than the second distance, which is greater than the third distance. In this way, when the adjustment rod is shortened, the second corner is gradually expanded, the cage is formed into a shape with one side higher and the other side lower as a whole, which is advantageous for fusion with a vertebral body.
The sliding rod is cylindrical; the upper sliding groove and the lower sliding groove are respectively formed into a semi-cylinder matched with the cylinder in shape, and the upper guide groove and the lower guide groove are oppositely arranged to respectively form a semi-conical guide surface; this configuration facilitates sliding and guiding to avoid displacement and deflection.
In the minimally invasive surgery, the fusion cage is implanted from the wound by taking the extension state of the adjusting rod as an initial state, the adjusting rod is gradually shortened based on sliding until the adjusting rod is positioned and kept on the locking table surface in the process of pushing the fusion cage after the fusion cage is implanted, the locking table surface can adapt to the shape of the vertebral body after being unfolded, and the protrusion is stably kept on the table surface due to the action of elastic force so as to form a stable structure to be fused with the vertebral body. In this embodiment, a quadrilateral structure is preferably adopted, so that one adjusting rod can be used to divide the device into two triangles, and as long as the length of the adjusting rod is fixed, the triangles have stable structures so as to keep the shape of the fusion device unchanged.
This construction is easy to handle, reliable in fixation but also has high requirements on the material. In the present embodiment, the cage may be integrally formed using a copper-containing titanium alloy.
Preferably, 4.8 wt% of copper element is added into the titanium alloy (Ti6Al4V), the copper-containing titanium alloy Ti6Al4V-4.8Cu with uniformly distributed elements is prepared by repeated smelting for 3 times, and after high-temperature heat treatment at 1100 ℃, copper-containing titanium alloy bars with the length of 400mm and the diameter of 6mm are finally forged at 850 ℃.
The prepared copper-containing titanium alloy bar is tested on a calibrated universal testing machine at a stretching speed of 1mm/min, and the yield strength of the copper-containing titanium alloy bar is 1040MPa and the tensile strength of the copper-containing titanium alloy bar is 1120MPa according to a standard calculation formula.
According to the experimental requirement of YY/T0119.4, the distance a between two inner side roll shafts is 76mm, the distance h between the outer side roll shaft and the nearest roll shaft is 76mm, the prepared copper-containing titanium alloy bar is subjected to four-point bending test at the displacement rate of 5mm/min, and the yield bending moment is 19Nm and the ultimate bending moment is 26 Nm.
The method is characterized in that gram-positive bacteria staphylococcus aureus which is easy to infect in the clinical service process of an implant is used for carrying out an antibacterial experiment on the copper-containing titanium alloy Ti6Al4V-4.8Cu, the titanium alloy Ti6Al4V is used as a reference, the experiment is repeated for 10 times each time, 5 parallel samples are selected each time, and the antibacterial ratio calculation formula is passed:
D(%)=(B-B1)/B×100
in the formula: d is the antibacterial ratio (%), B is the average number of bacteria recovered (cfu) of the titanium alloy control sample, B1 is the average number of bacteria recovered (cfu) of the copper-containing titanium alloy Ti6Al4V-4.8Cu sample
Test results show that the antibacterial capacity of the copper-containing titanium alloy Ti6Al4V-4.8Cu is 99% compared with that of a titanium alloy Ti6Al4V sample.
The above-mentioned embodiments, objects, technical solutions and advantages of the present application are described in further detail, it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present application, and are not intended to limit the scope of the present application, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present application should be included in the scope of the present application.