Magnesium metal slow release apparatus and method

Abstract

The present application provides a magnesium metal slow release apparatus and method and relates to the technical field of slow release devices. The magnesium metal slow release apparatus comprises a first container, a second container, and a supporting structure. The first container comprises a first cavity, and the first cavity can be configured for storing a solution; the second container is arranged in the first cavity, and the second container comprises a second cavity and an liquid-passing structure that allows the second cavity to be in communication with the first cavity; the supporting structure is arranged in the second cavity and comprises a supporting end surface, the supporting end surface is configured for the placement of magnesium metal, and when the second container is in an upright position, the supporting end surface is arranged at a height not lower than that of the liquid-passing structure.

Description

Magnesium metal slow release device and method

[0001] Related applications

[0002] The present application claims priority to Chinese Patent Application No. 202410468402.8, filed on April 18, 2024, and incorporates by reference the entire disclosure of the aforementioned patent application as part of the present application. TECHNICAL FIELD

[0003] The present application relates to the technical field of slow release devices, in particular to a magnesium metal slow release device and method. BACKGROUND

[0004] Magnesium metal has a wide application prospect as a biomedical material. In an aqueous solution, magnesium metal can produce magnesium ions and hydrogen gas. Magnesium ions have antibacterial effects and can help promote cell proliferation and tissue regeneration, such as wound healing, relief of muscle edema, relief of muscle soreness, promotion of vascular regeneration, bone regeneration, cartilage regeneration, and peripheral nerve regeneration, etc. At the same time, the hydrogen gas produced by magnesium metal in an aqueous solution has the effects of antioxidant, reducing inflammation, and promoting wound healing. However, as time increases, the hydrogen gas in the solution will escape, reducing the content of hydrogen gas and failing to exert the biological effects. Therefore, by precisely controlling the start and end reaction times of magnesium metal, the maximum biological effects of magnesium ion solution can be exerted. In addition, magnesium ions can also exert antibacterial, anti-aging, and wound healing effects in an alkaline environment. Magnesium metal has become a potential biomedical material due to its multifunctionality, providing a broad possibility for various medical applications. However, in the actual application of magnesium metal, there is a possibility of rapid or excessive degradation of magnesium metal. When the concentration of magnesium ions is too high, it will lead to an increase in the concentration of the alkaline environment, and a large amount of hydrogen gas is released, which will exacerbate the inflammatory response and cause tissue necrosis. In addition, a high concentration of magnesium ions can also increase the magnesium concentration in the body, and even cause the risk of sudden cardiac arrest.

[0005] Therefore, how to precisely control the release amount of magnesium metal degradation products has become a technical problem to be solved. Based on years of experience and practice in the relevant industry, the present inventors propose a magnesium metal slow release device to improve the defects of the prior art. SUMMARY

[0006] In order to overcome the above-mentioned defects of the prior art, the technical problem to be solved by the embodiments of the present application is to provide a magnesium metal slow release device and method for precisely controlling the release amount of magnesium metal degradation products.

[0007] The above-mentioned purposes of the present application can be achieved by using the following technical solutions. The present application provides a magnesium metal slow release device, comprising:

[0008] A first container, the first container comprising a first chamber, the first chamber being configured to store a solution;

[0009] A second container, the second container being disposed in the first chamber, the second container comprising a second chamber, and a flow structure communicating the second chamber and the first chamber;

[0010] A support structure, the support structure being disposed in the second chamber, the support structure comprising a support end face, the support end face being configured to place a magnesium metal, the support end face having a disposed height not lower than a disposed height of the flow structure when the second container is in an upright position.

[0011] In an exemplary embodiment of the present application, when the second container is in the upright position, the second container is divided into a reaction section and a flow section in a height direction, the reaction section having a preset volume, the reaction section being configured to store hydrogen gas generated by a reaction of the magnesium metal, and the flow structure being disposed on the flow section, at least part of the flow structure being disposed at the same height as a top end of the flow section.

[0012] In an exemplary embodiment of the present application, the flow structure comprises at least one flow hole disposed on the second container, the flow hole communicating the first chamber and the second chamber.

[0013] In an exemplary embodiment of the present application, the flow hole is provided in plurality, and the plurality of flow holes are arranged at intervals on a side wall of the second container and / or a bottom of the second container.

[0014] In an exemplary embodiment of the present application, the support structure comprises a support base, one end of the support base being connected with the second container, and the other end of the support base being provided with the support end face.

[0015] In an exemplary embodiment of the present application, the magnesium metal slow-release device further comprises a sealing member, the sealing member being slidably disposed in the second container and sleeved on the support structure, the sealing member being configured to seal a gap between the support structure and an inner wall of the second container.

[0016] In an exemplary embodiment of the present application, the first container is provided with an openable cover, the cover being configured to sealingly connect the first container.

[0017] In an exemplary embodiment of the present application, the sealing member comprises a sealing piston, the sealing piston being slidably and sealingly disposed between the inner wall of the second container and the support structure.

[0018] In an exemplary embodiment of the present application, the first container and the second container are both formed by non-degradable medical materials.

[0019] In an exemplary embodiment of the present application, the first container is formed by degradable medical materials, and the second container is formed by non-degradable medical materials.

[0020] In an exemplary embodiment of the present application, the non-degradable medical materials include one or more of a combination of polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, glass, stainless steel, or aluminum alloy.

[0021] In an exemplary embodiment of the present application, the degradable medical materials include one or more of a combination of degradable polyurethane, poly-L-lactide-caprolactone, starch, cellulose, alginic acid, hyaluronic acid, chitosan, collagen, gelatin, degradable phosphate, degradable silicate, or degradable carbonate.

[0022] In an exemplary embodiment of the present application, the support structure includes a support base and an anchoring portion connected to the support base, the other end of the anchoring portion is extended and arranged outside the first container, and the anchoring portion is used to anchor the hard tissue in the body.

[0023] In an exemplary embodiment of the present application, the anchoring portion includes an anchoring screw which is integrally arranged with the support base.

[0024] In an exemplary embodiment of the present application, the anchoring portion is formed by one or more materials of titanium, nickel-titanium alloy, stainless steel, titanium alloy, and polylactic acid.

[0025] The present application also provides a magnesium metal slow-release method, including the following steps:

[0026] Installing and checking the magnesium metal slow-release device;

[0027] Arranging a first pre-set volume of solution in the first container;

[0028] Placing the magnesium metal on the support end surface of the support structure in the second container;

[0029] Immersing the second container in the solution in the first container, so that the overflow structure on the second container is completely immersed in the solution in the first container;

[0030] Making the magnesium metal in the second container contact with the solution to carry out a degradation reaction, using the hydrogen generated by the degradation reaction to push the liquid level in the second container to drop, so as to release the magnesium ion solution generated by the degradation reaction to the solution in the first container through the overflow structure;

[0031] When the liquid level in the second container continues to drop to the point that the solution in the second container is out of contact with the magnesium metal, the degradation reaction of the magnesium metal is automatically stopped, thereby obtaining a magnesium ion solution;

[0032] Based on the volume of hydrogen gas in the second container, the amount of degradation reaction of the magnesium metal and / or the concentration of magnesium ions in the magnesium ion solution is calculated.

[0033] In an exemplary embodiment of the present application, the step of contacting the magnesium metal in the second container with a solution to perform a degradation reaction specifically includes the following steps:

[0034] The second container is placed in an upright position;

[0035] A second pre-set volume of solution is injected into the second container;

[0036] The solution in the second container is contacted with the magnesium metal to perform a degradation reaction.

[0037] In an exemplary embodiment of the present application, the magnesium metal slow-release device includes a sealing member, and the second container includes a reaction section and a flow-through section; the step of contacting the magnesium metal in the second container with a solution to perform a degradation reaction specifically includes the following steps:

[0038] The second container is placed in an inverted position, and the reaction section in the second container is sealed by the sealing member;

[0039] A third pre-set volume of solution and a fourth pre-set volume of gas are injected into the reaction section; the sum of the third pre-set volume and the fourth pre-set volume does not exceed the volume of the reaction section;

[0040] The magnesium metal is isolated from the solution in the second container by the gas in the second container;

[0041] When the degradation reaction is needed, the second container is placed in an upright position, so that the solution in the second container is contacted with the magnesium metal to perform a degradation reaction.

[0042] The technical solution of the present application has the following remarkable beneficial effects:

[0043] Because the amount of hydrogen gas generated and the amount of magnesium ions generated in the solution have a chemical relationship when the magnesium metal performs a degradation reaction with the solution, for example, the magnesium metal and water, the content of magnesium ions in the solution can be determined based on the amount of hydrogen gas generated. Conversely, by controlling the amount of hydrogen gas generated, the amount of magnesium ions generated in the solution can be accurately controlled.

[0044] The magnesium metal slow-release device is used by injecting a certain volume of solution into the first container, placing the magnesium metal in the second container and on the support end surface of the support structure, and then immersing the second container into the solution in the first container, so that the overflow structure on the second container is completely immersed below the liquid level.

[0045] Then, the magnesium metal in the second container can be controlled to contact the solution to perform a degradation reaction, and the hydrogen gas generated by the degradation reaction of the magnesium metal rises and accumulates in the second container. As the hydrogen gas in the second container increases, the hydrogen gas can push the liquid level in the second container to drop, so that the magnesium ion solution generated by the degradation reaction is released into the solution in the first container through the overflow structure, and then the magnesium ion solution is obtained.

[0046] And, as the liquid level in the second container drops, the solution in the second container gradually comes out of contact with the magnesium metal, thereby gradually reducing the amount of hydrogen gas generated by the degradation reaction, until the magnesium metal is completely separated from the solution and the degradation reaction is terminated, and the amount of magnesium ions generated can be calculated according to the amount of hydrogen gas in the second container at this time.

[0047] The second container and the support structure can be used to control the amount of hydrogen gas generated, and the degradation reaction of the magnesium metal can be automatically stopped, so that the amount of magnesium ions generated can be more accurately controlled, and the error caused by human control is eliminated, and the control accuracy of the concentration of the magnesium ion solution is significantly improved. BRIEF DESCRIPTION OF DRAWINGS

[0048] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application, and those skilled in the art can obtain other drawings according to these drawings without creating any creative labor.

[0049] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the present application in any way. In addition, the shapes and scale of the components in the drawings are only illustrative and are used to help understand the present application, and are not specific limitations on the shapes and scale of the components of the present application. Those skilled in the art can select various possible shapes and scales to implement the present application according to specific circumstances under the guidance of the present application.

[0050] FIG. 1 is a side view of an embodiment of the magnesium metal slow-release device;

[0051] FIG. 2 is a side view of another embodiment of the magnesium metal slow-release device;

[0052] FIG. 3 is a structure diagram of the second container in an inverted position;

[0053] Fig. 4 is a schematic diagram of a structure of a second container of the present application in an upright position;

[0054] Fig. 5 is a schematic diagram of a state of the magnesium metal slow-release device of the present application in a degradation reaction;

[0055] Fig. 6 is a schematic diagram of a state of the magnesium metal slow-release device of the present application in a stop of the degradation reaction;

[0056] Fig. 7 is a schematic diagram of a culture medium in a control group in a L929 cell culture experiment;

[0057] Fig. 8 is a schematic diagram of a culture medium in a L929 cell culture experiment using a magnesium rod leaching solution C0;

[0058] Fig. 9 is a schematic diagram of a culture medium in a L929 cell culture experiment using a magnesium ion solution C1 prepared by the magnesium metal slow-release device;

[0059] Fig. 10 is a schematic diagram of a culture medium in a L929 cell culture experiment using a magnesium ion solution C2 prepared by the magnesium metal slow-release device;

[0060] Fig. 11 is a schematic diagram of a culture medium in a control group in an EA.hy926 cell angiogenesis experiment;

[0061] Fig. 12 is a schematic diagram of a culture medium in an EA.hy926 cell angiogenesis experiment using a magnesium rod leaching solution C0;

[0062] Fig. 13 is a schematic diagram of a culture medium in an EA.hy926 cell angiogenesis experiment using a magnesium ion solution C1 prepared by the magnesium metal slow-release device;

[0063] Fig. 14 is a schematic diagram of a culture medium in an EA.hy926 cell angiogenesis experiment using a magnesium ion solution C2 prepared by the magnesium metal slow-release device;

[0064] Fig. 15 is a schematic diagram of a side view of a cross-sectional structure of an embodiment of the anchoring portion of the present application. DETAILED DESCRIPTION

[0065] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0066] Embodiment One

[0067] Please refer to FIG. 1 and FIG. 2, the embodiment of the present application provides a magnesium metal slow-release device, which comprises a first container 100, a second container 200 and a support structure 400, the first container 100 comprises a first cavity which can be used for storing a solution; the second container 200 is arranged in the first cavity, the second container 200 comprises a second cavity and an overflow structure 300 which communicates the second cavity and the first cavity. The support structure 400 is arranged in the second cavity, the support structure 400 comprises a support end face 410 which is used for placing the magnesium metal 10, when the second container 200 is in an upright position, the arrangement height of the support end face 410 is not lower than the arrangement height of the overflow structure 300.

[0068] Overall, when the magnesium metal slow-release device is used, a certain volume of solution is injected into the first container 100, the magnesium metal 10 is placed in the second container 200 and placed on the support end face 410 of the support structure 400, and then the second container 200 is immersed into the solution in the first container 100, so that the overflow structure 300 on the second container 200 is completely immersed below the liquid level.

[0069] Then, the magnesium metal 10 in the second container 200 can be controlled to contact the solution to carry out a degradation reaction, the hydrogen gas generated by the degradation reaction of the magnesium metal 10 can rise and gather in the second container 200, and as the hydrogen gas in the second container 200 increases, the hydrogen gas can push the liquid level in the second container 200 to drop, so that the magnesium ion solution generated by the degradation reaction is released into the solution in the first container 100 through the overflow structure 300, and then the magnesium ion solution is obtained.

[0070] And, as shown in the embodiments of FIG. 4, FIG. 5 and FIG. 6, as the liquid level in the second container 200 drops (for example, the second container 200 rises under the action of hydrogen gas, so that the liquid level drops), the solution in the second container 200 gradually separates from the magnesium metal 10, thereby gradually reducing the amount of hydrogen gas generated by the degradation reaction, until the magnesium metal 10 completely separates from the solution and the degradation reaction is terminated, at which time the amount of magnesium ions generated can be calculated according to the amount of hydrogen gas in the second container 200.

[0071] The present application can be used to control the amount of hydrogen gas by cooperating the second container 200 with the support structure 400, and the degradation reaction of the magnesium metal 10 can be automatically stopped, which has better timeliness, so that the amount of magnesium ions generated can be more accurately controlled; and the error caused by human control is eliminated, which significantly improves the control accuracy of the concentration of the magnesium ion solution. When the magnesium metal 10 carries out the degradation reaction with the solution, it has better reaction stability, so that problems such as reaction out of control can be avoided.

[0072] The designer can adjust the specific structure of the first container 100 according to the use requirement, for example, the first container 100 can be provided as a cylinder, a cuboid, a tank, etc., which is not specifically limited here.

[0073] The upright position refers to that the opening of the second container faces upward (for example, the upward direction is opposite to the direction of placing the magnesium metal), and the opening of the second container is horizontally or approximately horizontally arranged. Similarly, the inverted position refers to that the opening of the second container faces downward, and the opening of the second container is horizontally or approximately horizontally arranged.

[0074] In the embodiments of the present application, the first container 100 is fixedly connected with the second container 200. For example, the bottom of the second container 200 is fixedly connected with the bottom of the first container 100.

[0075] The designer can adjust the fixed mode of the first container 100 and the second container 200 according to the use requirement, which is not specifically limited here.

[0076] For example, the second container 200 is combined with the first container 100 through the connecting rod 600. For example, the bottom of the second container 200 is combined with the bottom of the first container 100 through the connecting rod 600. Of course, the designer can adjust the setting position and the number of the connecting rod 600 according to the connection requirement, which is not limited here.

[0077] Alternatively, the first container 100 and the second container 200 can also be fixed through welding, bonding, clamping or other modes, which is not specifically limited here.

[0078] In the embodiments of the present application, the sidewall of the first container 100 is provided with the injection part 110. When the second container 200 is in the upright position, the injection part 110 is located between the top of the magnesium metal 10 and the support end face 410.

[0079] By providing the injection part 110 on the first container 100, the syringe and other suction devices can discharge the initial gas in the second container 200 through the injection part 110, so as to make the liquid level in the second container 200 rise to start the reaction.

[0080] The designer can adjust the specific structure of the injection part 110 according to the use requirement, for example, at least part of the sidewall of the first container 100 constitutes the injection part 110, or the injection part 110 is a valve type structure provided on the sidewall of the first container 100, or the injection part 110 can also be other penetrable structure provided on the sidewall of the first container 100, which is not specifically limited here.

[0081] Further, the injection pipe 700 can be arranged, one end of the injection pipe 700 is connected to the injection part 110, and the other end of the injection pipe 700 is communicated with the inner cavity of the second container 200 or the other end of the injection pipe 700 is connected to the side wall of the second container 200. The suction channel can be formed through the inner cavity of the injection pipe 700, so that the needle tube and other suction devices can perform the suction operation or the gas injection operation on the second container 200 along the injection pipe 700, and the use effect is better.

[0082] The second container 200 can be suctioned or gas injected through the injection pipe 700, so that the liquid level inside the second container 200 can be controlled, the start and stop of the reaction can be controlled, and the reaction generation amount and the production timing can be controlled.

[0083] In the embodiment of the present application, as shown in the example of FIG. 2, when the second container 200 is in the upright position, the second container 200 is divided into a reaction section 210 and an overflow section 220 along the height direction, the reaction section 210 has a preset volume, the reaction section 210 can be used to store the hydrogen generated by the magnesium metal 10 reaction, and the overflow structure 300 is arranged on the overflow section 220, and at least part of the overflow structure 300 is arranged at the same height as the top end of the overflow section 220.

[0084] In a specific embodiment, when the second container 200 is in the upright position, the overflow structure 300 is arranged at the middle lower part of the second container 200, so that the middle lower part of the second container 200 forms the overflow section 220, and the middle upper part of the second container 200 forms the reaction section 210, so that the hydrogen generated by the degradation reaction of the magnesium metal 10 can rise and be stored in the middle upper part of the second container 200. In this embodiment, the preset volume of the reaction section 210 can be determined according to the use requirement, and no specific numerical value is limited here.

[0085] Of course, the designer can adjust the specific arrangement height of the overflow structure 300 on the second container 200 according to the use requirement, and no specific limitation is made here.

[0086] Further, the first container 100 and / or the second container 200 can be made of transparent material, and water level graduation lines are arranged on the first container 100 and / or the second container 200, so that the operator can observe the volume change of the contents in the first container 100 and / or the second container 200. The reaction progress can be observed in real time through the water level change, so that the change of the magnesium solution concentration can be mastered.

[0087] Of course, the liquid level in the second container 200 can also be determined according to the gas volume in the suction operation or the gas injection operation of the suction device on the second container 200, and then the gas generation volume can be controlled to control the magnesium solution concentration, and no specific limitation is made here.

[0088] In the embodiments of the present application, the overflow structure 300 comprises at least one overflow hole 310 arranged on the second container 200, the overflow hole 310 being in communication with the first chamber and the second chamber. By arranging the overflow hole 310 on the second container 200, the overflow hole 310 can be used to communicate the first chamber and the second chamber.

[0089] And, when the second container 200 is in the upright position, by controlling the arrangement height of the overflow hole 310, the second container 200 can be divided into the reaction section 210 located above the overflow hole 310, and the overflow section 220 constituted by the other part of the second container 200. The designer can adjust the number and size of the arrangement of the overflow hole 310 according to the use requirement, which is not specifically limited herein.

[0090] In the embodiments of the present application, the overflow hole 310 is arranged in multiple, and the multiple overflow holes 310 are arranged at intervals on the side wall of the second container 200 and / or the bottom of the second container 200.

[0091] By arranging multiple overflow holes 310, the multiple overflow holes 310 can be used to communicate the first chamber and the second chamber cooperatively, which helps to improve the uniformity of the release of the magnesium ion solution.

[0092] In a feasible embodiment, the multiple overflow holes 310 are arranged at intervals on the side wall of the second container 200, so that the solution in the second container 200 can be uniformly released into the first chamber through the multiple overflow holes 310. Exemplarily, the multiple overflow holes 310 are arranged at intervals on the side wall of the second container 200.

[0093] In another feasible embodiment, the multiple overflow holes 310 are arranged at intervals on the bottom of the second container 200, at this time, the height of the overflow section 220 can be considered to be close to zero, and the second container 200 constitutes the reaction section 210. Exemplarily, the multiple overflow holes 310 are arranged at intervals on the bottom of the second container 200.

[0094] In still another feasible embodiment, the multiple overflow holes 310 are arranged at intervals on the side wall of the second container 200 and the bottom of the second container 200, respectively. By arranging the overflow hole 310 on the side wall of the second container 200 and the bottom of the second container 200, the communication effect between the second chamber and the first chamber can be improved, so that the magnesium ion solution in the second chamber can be more uniformly and efficiently released into the solution in the first chamber.

[0095] Of course, the designer can adjust the arrangement mode and arrangement position of the overflow hole 310 according to the use requirement, which is not specifically limited herein.

[0096] In the embodiments of the present application, the support structure 400 comprises a support base, one end of the support base being connected with the second container 200, and the other end of the support base being provided with a support end face 410.

[0097] In a specific embodiment, one end of the support base is connected to the bottom of the second container 200 when the second container 200 is in the upright position. By fixing the support base on the second container 200, the support base is prevented from shaking during use and affecting the degradation reaction of the magnesium metal 10.

[0098] Of course, in other embodiments, the designer can adjust the connection mode of the support base according to the use needs, for example, the support base can also be connected to the side wall of the second container 200, which is not specifically limited here.

[0099] In the present embodiment, the designer can adjust the specific structure of the support base according to the use needs, for example, the support base can be provided in a columnar shape, a block shape or other shapes, which is not specifically limited here.

[0100] In addition, the support end surface 410 can be a planar structure, or the support end surface 410 can also be a non-planar structure, which is not specifically limited here.

[0101] Further, in order to better fix the magnesium metal 10 on the support base, a connection structure can be provided between the support base and the magnesium metal 10, or the magnesium metal 10 can be pasted on the support end surface 410. In the present embodiment, the designer can adjust the specific structure of the connection structure according to the use needs, for example, the connection structure can be a clamping structure or an embedded structure, etc., which is not specifically limited here.

[0102] In the embodiment of the present application, the magnesium metal slow-release device further comprises a sealing member 500, which is slidably arranged in the second container 200 and sleeved on the support structure 400, and the sealing member 500 can be used to seal the gap between the support structure 400 and the inner wall of the second container 200.

[0103] By slidably arranging the sealing member 500 between the second container 200 and the support structure 400, the sealing member 500 can seal the reaction section 210 of the second container 200, thereby helping to control the contact time of the magnesium metal 10 with the solution to control the reaction time of the degradation reaction.

[0104] Specifically, the second container 200 is arranged in an inverted manner, and the reaction section 210 is sealed by the sealing member 500. A pre-set volume of solution and gas can be injected into the reaction section 210, at which time the gas rises in the reaction section 210 and covers the magnesium metal 10 to isolate the solution, thereby preventing the magnesium metal 10 from contacting the solution to perform the degradation reaction.

[0105] When the magnesium metal 10 needs to react with the solution to degrade, as shown in the embodiments of FIG. 3 and FIG. 4, the second container 200 is switched from upside down to right side up, so that the solution contacts the magnesium metal 10 to start the degradation reaction, thereby facilitating more accurate control of the start time of the degradation reaction, with better control flexibility.

[0106] Although the sealing member 500 will seal the overflow hole 310, the hydrogen gas generated by the reaction of the magnesium metal 10 with the solution will push the sealing member 500 to slide until the sealing member 500 is separated from the overflow hole 310, at which time the magnesium ion solution in the reaction section 210 can be released into the first chamber along the overflow hole 310.

[0107] Therefore, by cooperating the sealing member 500 with the second container 200 and the support structure 400, the start time of the degradation reaction of the magnesium metal 10 can be better controlled, and the release of the magnesium ion solution is not affected, which helps to improve the control effect of the magnesium metal slow-release device.

[0108] Among them, the designer can adjust the specific composition of the gas according to the use needs, which is not limited here. For example, the gas basically does not contain hydrogen component and does not react with the magnesium metal 10.

[0109] In a specific embodiment, the sealing member 500 includes a sealing piston which is slidably sealed between the inner wall of the second container 200 and the support structure 400. The designer can adjust the specific structure of the sealing piston according to the use needs, which is not limited here.

[0110] Of course, in other feasible embodiments, the designer can adjust the structure of the sealing member 500 according to the use needs, for example, the sealing member 500 can be provided as a sealing ring, etc., which is not limited here.

[0111] In the embodiments of the present application, the first container 100 is provided with an openable cover which can be sealingly connected to the first container 100.

[0112] By providing the cover on the first container 100, it is convenient to inject the solution into the first chamber of the first container 100, and it is also convenient to take out the magnesium ion solution after reaction from the first container 100. The designer can adjust the specific structure of the cover according to the use needs, which is not limited here.

[0113] In a feasible embodiment of the present application, the first container 100 and the second container 200 are both formed by non-degradable medical materials. By using non-degradable medical materials to form the first container 100 and the second container 200, the magnesium ion slow-release device forms a non-implantable structure.

[0114] The specific components of the non-degradable medical material can be adjusted by the designer according to the use requirement, and are not specifically limited herein. For example, the non-degradable medical material includes, but is not limited to, a combination of one or more of polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, glass, stainless steel, or aluminum alloy.

[0115] In the embodiment, the material of the first container 100 can be the same as the material of the second container 200, or the material of the first container 100 can be different from the material of the second container 200, and is not specifically limited herein.

[0116] Further, the support structure 400 includes a support base. When the first container 100 is formed by a non-degradable medical material, the material of the support base can be the same as the first container 100. Of course, the material of the support base can also be different from the first container 100, and is not specifically limited herein.

[0117] The specific material of the support structure 400 can be adjusted by the designer according to the use requirement, and is not specifically limited herein. For example, the support base is formed by a plastic material or a ceramic material or a glass material.

[0118] In the embodiment, the support base needs not to react with the magnesium metal 10, nor to react with the solution and the hydrogen gas, so as to eliminate the influence of the support base on the degradation reaction, and to help ensure the precision of the degradation reaction.

[0119] In another feasible embodiment of the present application, the first container 100 is formed by a degradable medical material, and the second container 200 is formed by a non-degradable medical material.

[0120] By forming the first container 100 by a degradable medical material and forming the second container 200 by a non-degradable medical material, the magnesium ion sustained-release device can form an implantable structure, so that the magnesium ion sustained-release structure can be implanted into the body for use.

[0121] The specific components of the degradable medical material can be adjusted by the designer according to the use requirement, and are not specifically limited herein. For example, the degradable medical material includes, but is not limited to, a combination of one or more of degradable polyurethane, poly-L-lactide-co-caprolactone, starch, cellulose, alginic acid, hyaluronic acid, chitosan, collagen, gelatin, degradable phosphate, degradable silicate, or degradable carbonate.

[0122] Further, the specific shape of the first container 100 and the second container 200 can be adjusted by the designer according to the use requirement, and is not specifically limited herein. For example, the magnesium ion sustained-release device can be provided in a capsule shape, and then the magnesium ion sustained-release device is facilitated to be implanted into the body.

[0123] When the magnesium ion slow-release device is implanted in the body, the magnesium ion slow-release device is controlled to react, thereby generating a magnesium ion solution and hydrogen gas in the first container 100. When the reaction stops, since the first container 100 is formed by a degradable medical material, the first container 100 gradually degrades in the body, thereby playing a role of releasing degradation products. The magnesium ions, alkaline environment, and hydrogen gas formed by the degradation products can play a biological effect, thereby participating in tissue repair.

[0124] In the present embodiment, the manner of controlling the magnesium ion slow-release device to react includes, but is not limited to, a right-side-up inversion manner or an injection manner, so that the solution in the second container 200 reacts with the magnesium metal 10.

[0125] In an exemplary embodiment of the present application, as shown in the embodiment of FIG. 15, the support structure 400 includes a support base and an anchoring portion 420 connected to the support base, the other end of the anchoring portion 420 is extended and arranged outside the first container 100, and the anchoring portion 420 is used to anchor the hard tissue in the body.

[0126] The magnesium ion slow-release device can be anchored on the hard tissue in the body by the anchoring portion 420, thereby helping to maintain the installation stability of the magnesium ion slow-release device, so that the magnesium ion slow-release device can maintain a right-side-up state.

[0127] In a feasible embodiment, the anchoring portion 420 includes an anchoring screw which is integrally arranged with the support base. By integrally arranging the anchoring portion 420 with the support base, the anchoring portion 420 has better structural strength, which helps to more stably fix the second container 200.

[0128] Of course, in other feasible embodiments, the designer can adjust the specific structure of the anchoring portion 420 according to the use needs, which is not specifically limited here.

[0129] Further, the anchoring portion 420 is formed by one material or multiple materials selected from titanium, nickel-titanium alloy, stainless steel, titanium alloy, and polylactic acid. The material of the support base and the material of the anchoring portion 420 can be the same material or different materials, which is not specifically limited here.

[0130] Of course, in other feasible embodiments, the designer can adjust the specific structure and material of the anchoring portion 420 according to the use needs, which is not specifically limited here.

[0131] Embodiment Two

[0132] The embodiment of the present application provides a magnesium metal slow-release method, which includes the following steps:

[0133] Step 1000: install and check the magnesium metal slow-release device. After the magnesium metal slow-release device is installed, the magnesium metal slow-release device is checked to ensure that the magnesium metal slow-release device can meet the needs of the degradation reaction and avoid problems such as device leakage.

[0134] Step 2000: set a first preset volume of solution in the first container 100. Specifically, the solution is injected into the first chamber of the first container 100, so that the magnesium ions generated by the magnesium metal 10 degradation reaction can be mixed with the solution to form a magnesium ion solution.

[0135] In addition, by controlling the volume of the solution in the first container 100, the concentration of the magnesium ion solution can be better controlled. The designer can adjust the specific numerical value of the first preset volume according to the needs, which is not specifically limited here.

[0136] Step 3000: place the magnesium metal 10 on the support end surface 410 of the support structure 400 in the second container 200. In the present embodiment, the second container 200 is in an upright position, and the setting height of the support end surface 410 is not lower than the setting height of the overflow structure 300, so that the hydrogen gas generated by the reaction of the magnesium metal 10 can completely cover the magnesium metal 10 to terminate the reaction process.

[0137] For example, the setting height of the support end surface 410 is the same as the top end height of the overflow structure 300. When the hydrogen gas fills the reaction section 210 of the second container 200, the hydrogen gas can simultaneously isolate the magnesium metal 10 to stop the degradation reaction, thereby playing a role in precisely controlling the amount of degradation reaction.

[0138] Step 4000: immerse the second container 200 in the solution in the first container 100, so that the overflow structure 300 on the second container 200 is completely immersed in the solution in the first container 100.

[0139] By completely immersing the overflow structure 300 in the solution in the first container 100, the magnesium ions generated by the reaction of the magnesium metal 10 can be released into the solution in the first container 100 through the overflow structure 300.

[0140] In addition, by completely immersing the overflow structure 300 in the solution in the first container 100, the solution in the second container 200 is prevented from flowing out along the overflow structure 300 under the action of gravity and causing atmospheric air to enter the second container 200 and affect the degradation reaction of the magnesium metal 10, which is beneficial to guarantee the accuracy of the degradation reaction of the magnesium metal 10.

[0141] Step 5000: Contacting the magnesium metal 10 in the second container 200 with the solution to perform the degradation reaction, and using the hydrogen generated by the degradation reaction to push the liquid level in the second container 200 to drop, so as to release the magnesium ion solution generated by the degradation reaction into the solution in the first container 100 through the overflow structure 300.

[0142] The designer can adjust the specific way of contacting or separating the magnesium metal 10 from the solution according to the use requirement, which is not specifically limited herein.

[0143] Step 6000: When the liquid level in the second container 200 continues to drop to the point that the solution in the second container 200 is separated from the magnesium metal 10, the degradation reaction of the magnesium metal 10 is automatically stopped, so as to obtain the magnesium ion solution.

[0144] Step 7000: Calculating the amount of the degradation reaction of the magnesium metal 10 and / or the concentration of the magnesium ion in the magnesium ion solution based on the hydrogen volume in the second container 200.

[0145] In an embodiment of the present application, the contacting of the magnesium metal 10 in the second container 200 with the solution to perform the degradation reaction specifically includes the following steps:

[0146] Step 5100: Placing the second container 200 in the upright position.

[0147] Step 5200: Injecting a second preset volume of the solution into the second container 200. The designer can adjust the specific value of the second preset volume according to the use requirement, which is not specifically limited herein.

[0148] Step 5300: Contacting the solution in the second container 200 with the magnesium metal 10 to perform the degradation reaction.

[0149] The operator can adjust the injection method of the second preset volume of the solution according to the use requirement, for example, using a syringe to inject the solution into the second container 200 to start the reaction, or raising the water level by sucking the gas in the second container 200 to start the reaction, which is not specifically limited herein.

[0150] In addition, by controlling the value of the second preset volume, it is convenient to subsequently calculate the total amount of the solution in the first container 100 and the second container 200 to more accurately calculate the concentration of the magnesium ion solution.

[0151] In another embodiment of the present application, the magnesium metal slow-release device includes a sealing member 500, and the second container 200 includes a reaction section 210 and an overflow section 220; the contacting of the magnesium metal 10 in the second container 200 with the solution to perform the degradation reaction specifically includes the following steps:

[0152] Step 5400: The second container 200 is in an inverted position, and the reaction section 210 in the second container 200 is sealed by the sealing member 500.

[0153] By sealing the reaction section 210 by the sealing member 500, the solution and / or gas in the reaction section 210 can be prevented from flowing out of the overflow structure 300, so that the contact between the magnesium metal 10 and the solution to start the degradation reaction can be better controlled.

[0154] Step 5500: A third preset volume of solution and a fourth preset volume of gas are injected into the reaction section 210; wherein the sum of the third preset volume and the fourth preset volume does not exceed the volume of the reaction section 210.

[0155] The designer can adjust the specific values of the third preset volume and the fourth preset volume according to the needs of use, which are not specifically limited here.

[0156] Step 5600: The magnesium metal 10 is isolated from the solution in the second container 200 by the gas in the second container 200.

[0157] When the gas and the solution are injected into the reaction section 210 at the same time, since the second container 200 is in an inverted position, the size of the fourth preset volume is controlled so that the gas can completely cover the magnesium metal 10, thereby preventing the magnesium metal 10 from contacting the solution, and the degradation reaction between the magnesium metal 10 and the solution cannot occur.

[0158] Step 5700: When the degradation reaction is needed, the second container 200 is placed upright so that the solution in the second container 200 contacts the magnesium metal 10 to perform the degradation reaction.

[0159] Of course, in other feasible embodiments, the designer can adjust the contact control mode of the magnesium metal 10 and the solution according to the needs of use, which is not specifically limited here.

[0160] In order to better illustrate the control effect of the magnesium ion solution concentration of the present application, examples are given below.

[0161] Please refer to FIG. 4 and FIG. 5, specifically: the second container 200 is cylindrically arranged, and the magnesium metal slow-release device includes a sealing member 500. In this embodiment, the second container 200 includes a reaction section 210 and an overflow section 220, the radius of the second container 200 is R, and the radius of the support structure 400 in the second container 200 is r.

[0162] Before the degradation reaction, the second container 200 is placed in an inverted position in the first container 100, and the solution and the gas are injected into the second container 200, so that the gas can completely cover the magnesium metal 10, thereby preventing the magnesium metal 10 from contacting the solution to perform the degradation reaction.

[0163] When the degradation reaction is performed, the second container 200 is placed upright in the first container 100, so that the magnesium metal 10 in the second container 200 is in contact with the solution to perform the degradation reaction.

[0164] In the present embodiment, when the second container 200 is placed upright, the initial height of the gas in the reaction section 210 is L0, the initial height of the solution in the reaction section 210 is L1, the setting height of the sealing member 500 is L2, and the height of the second container 200 below the sealing member 500 is L3.

[0165] In a specific embodiment, R is approximately 6 cm, r is approximately 4 cm, L0 is approximately 5 cm, L1 is approximately 5 cm, L2 is approximately 5 cm, and L3 is approximately 5 cm.

[0166] Of course, the designer can adjust the specific values of R, r, L0, L1, L2, and L3 according to the experimental needs, and the specific values are not limited herein.

[0167] As shown in FIG. 5, when the second container 200 is placed upright, the solution in the second container 200 is in contact with the magnesium metal 10 to start the degradation reaction. Then, the hydrogen generated by the degradation reaction pushes the liquid level in the second container 200 to drop, and further pushes the sealing member 500 to move downward to open the overflow structure 300, so that the magnesium ion solution generated by the degradation reaction is released into the solution in the first container 100 through the overflow structure 300. At this time, by measuring the solution in the first container 100, the first magnesium ion concentration C1 in the first container 100 is obtained as 4.66 mM. In the present embodiment, the hydrogen concentration in the solution is 1.6 ppm, which is the saturated hydrogen concentration, and can exert a biological effect.

[0168] As shown in FIG. 6, when the liquid level in the second container 200 continues to drop to the point where the solution in the second container 200 is out of contact with the magnesium metal 10, the degradation reaction of the magnesium metal 10 is automatically stopped, and the magnesium ion solution is obtained. At this time, by measuring the solution in the first container 100, the second magnesium ion concentration C2 in the first container 100 is obtained as 9.32 mM.

[0169] In order to further verify the biological effect of the magnesium ion solution obtained by the present application, a cell culture experiment is performed using the magnesium ion solution obtained by the present application, and a magnesium rod extract C0 is added as an experimental control group.

[0170] In the present embodiment, the magnesium rod extract C0 = 28.39 mM, which is prepared according to ISO10993 and GB / T16886.

[0171] In a specific embodiment, the experimental cells are L929 cells. Please refer to Figs. 7, 8, 9 and 10, in which Fig. 7 is the control group culture medium, Fig. 8 is the magnesium rod extract C0, Fig. 9 is the C1 concentration magnesium ion solution, and Fig. 10 is the C2 concentration magnesium ion solution. By comparison, it can be seen that the magnesium ion solution obtained in the present application significantly increases the proliferation ability of cells compared with the magnesium rod extract, and has better biocompatibility.

[0172] In another specific embodiment, EA.hy926 cell angiogenesis experiments are performed. Please refer to Figs. 11, 12, 13 and 14, in which Fig. 10 is the control group culture medium, Fig. 11 is the magnesium rod extract C0, Fig. 12 is the C1 concentration magnesium ion solution, and Fig. 13 is the C2 concentration magnesium ion solution. By comparison, it can be seen that the magnesium ion solution obtained in the present application significantly increases the cell angiogenesis ability compared with the magnesium rod extract C0, and has better biological effects.

[0173] All articles and references, including patents and publications, disclosed herein are incorporated by reference for all purposes. The term "consisting essentially of to describe a combination shall include the elements, ingredients, components or steps identified, and such other elements ingredients, components or steps that do not materially affect the basic and novel characteristics of the combination. The use of the terms "comprising" or "including" to describe combinations of elements, ingredients, components or steps herein also is taken to mean that "consisting essentially of is also contemplated. By using the term "may" herein, it is intended that any property so described, for example, any attribute, can or can not be present. Multiple elements, ingredients, components or steps can be provided by a single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step might be divided into separate multiple elements, ingredients, components or steps. To "treat" a disease or disorder as used herein means to reduce or eliminate the symptoms of the disease or disorder, or to reduce or eliminate the underlying cause of the disease or disorder.

[0174] Each of the embodiments in the present specification is described in a progressive manner, and each embodiment focuses on the difference from other embodiments. The same or similar parts between embodiments can be referred to each other. The above embodiments are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and it cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A magnesium metal slow release device, characterized by, The magnesium metal slow-release device comprises: a first container comprising a first chamber for storing a solution; a second container disposed in the first chamber, the second container comprising a second chamber and a flow structure communicating the second chamber and the first chamber; and a support structure disposed in the second chamber, the support structure comprising a support end face for placing magnesium metal, the support end face having a height not lower than that of the flow structure when the second container is in an upright position. When the second container is in the upright position, the second container is divided into a reaction section and a flow section in the height direction, the reaction section having a preset volume for storing hydrogen generated by the reaction of magnesium metal, and the flow structure is disposed on the flow section, at least part of the flow structure being disposed at the same height as the top end of the flow section.

2. The magnesium metal slow release device of claim 1, wherein, The flow structure comprises at least one flow hole disposed on the second container, the flow hole communicating the first chamber and the second chamber.

3. The magnesium metal slow release device of claim 1 or 2, wherein, The flow hole is provided in plurality, and the plurality of flow holes are arranged at intervals on the side wall of the second container and / or the bottom of the second container.

4. The magnesium metal slow release device of claim 3, wherein, The support structure comprises a support base, one end of the support base being connected to the second container, and the other end of the support base being provided with the support end face.

5. The magnesium metal slow release device of claim 1, wherein, The magnesium metal slow-release device further comprises a sealing member slidably disposed in the second container and sleeved on the support structure, the sealing member being capable of sealing the gap between the support structure and the inner wall of the second container.

6. The magnesium metal slow release device of claim 1, wherein, The first container is provided with an openable cover, which can be sealingly connected to the first container.

7. The magnesium metal slow release device of claim 6, wherein, The sealing member comprises a sealing piston slidably and sealingly disposed between the inner wall of the second container and the support structure.

8. The magnesium metal slow release device of claim 6, wherein, The first container and the second container are both formed by non-degradable medical materials.

9. The magnesium metal slow release device of claim 1, wherein, The first container is formed by degradable medical materials, and the second container is formed by non-degradable medical materials.

10. The magnesium metal slow release device of claim 1, wherein, The support structure comprises a support base and an anchoring portion connected to the support base, the other end of the anchoring portion extending outwardly of the first container, and the anchoring portion being used for anchoring hard tissues in the body.

11. The magnesium metal slow release device of claim 10, wherein, The method comprises the following steps:

12. A method of slow release of magnesium metal, characterized by installing and checking the magnesium metal slow-release device; disposing a first preset volume of solution in the first container; placing magnesium metal on the support end face of the support structure in the second container; immersing the second container in the solution in the first container so that the flow structure on the second container is completely immersed in the solution in the first container; contacting the magnesium metal in the second container with the solution to perform a degradation reaction, using the hydrogen generated by the degradation reaction to push down the liquid level in the second container, thereby releasing the magnesium ion solution generated by the degradation reaction into the solution in the first container through the flow structure; ​ When the liquid level in the second container continues to drop to the point that the solution in the second container is out of contact with the magnesium metal, the degradation reaction of the magnesium metal is automatically stopped, thereby obtaining a magnesium ion solution; and Based on the hydrogen gas volume in the second container, the degradation reaction amount of the magnesium metal and / or the magnesium ion concentration in the magnesium ion solution is calculated.

13. The method of claim 12, wherein the magnesium metal is released at a rate of about 0.1 to about 0.5 mg / day. The step of contacting the magnesium metal in the second container with a solution to perform a degradation reaction specifically includes the following steps: The second container is placed in an upright position; A second pre-set volume of solution is injected into the second container; and The solution in the second container is contacted with the magnesium metal to perform a degradation reaction.

14. The method of claim 12, wherein the magnesium metal is released at a rate of about 0.1 to about 0.5 mg / day. The magnesium metal slow-release device includes a seal, and the second container includes a reaction section and a flow-through section; the step of contacting the magnesium metal in the second container with a solution to perform a degradation reaction specifically includes the following steps: The second container is placed in an inverted position, and the reaction section in the second container is sealed by the seal; A third pre-set volume of solution and a fourth pre-set volume of gas are injected into the reaction section; wherein the sum of the third pre-set volume and the fourth pre-set volume does not exceed the volume of the reaction section; The magnesium metal and the solution in the second container are isolated by the gas in the second container; and When a degradation reaction is needed, the second container is placed in an upright position, so that the solution in the second container is contacted with the magnesium metal to perform a degradation reaction.

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