An in vitro degradation simulation device for degradable vascular stent

Abstract

The invention provides an in vitro degradation simulation device for a degradable vascular stent, which belongs to the technical field of biomedical materials and comprises: a solution tank, the interior of which is suitable for accommodating a degradation solution; a stent tube, which has retention cavities with two ends passing through, and the retention cavity is suitable for connecting the vascular stent; a driving device, the driving end of which is connected to the stent tube, and the driving device is suitable for driving the stent tube to make the stent tube reciprocate in the solution tank along the center line direction of its retention cavity. The in vitro degradation simulation device for a degradable vascular stent of the invention can quickly and accurately evaluate the in vivo degradation performance of a degradable vascular stent substrate, a stent coating and other aspects, and provides assistance for the research of the degradable stent; at the same time, the device is easy to operate, simple in structure, and the obtained results are true and reliable.

Description

Technical Field

[0001] The invention relates to the technical field of biomedical materials, and in particular to an in vitro degradation simulation device for a degradable vascular stent. Background Art

[0002] The interventional treatment of vascular stents has become a new method for treating cardiovascular stenosis because of its low trauma and good effect. Existing vascular stents include degradable stents, which can maintain a certain mechanical strength and structure during the implantation period. After the treatment is completed, the vascular stents are degraded in the human body environment into products that can be absorbed and metabolized by the human body, and eventually disappear.

[0003] In order to study the degradation of degradable vascular stents in vivo, we need to set up an in vitro degradation simulation device. Summary of the invention

[0004] Therefore, the technical problem to be solved by the present invention is to provide an in vitro degradation simulation device for a degradable vascular stent.

[0005] The present invention provides an in vitro degradation simulation device for a degradable vascular stent, comprising:

[0006] A solution tank, the interior of which is suitable for containing a degradation solution;

[0007] The stent tube has a retention cavity with two ends connected thereto, and the retention cavity is suitable for connecting the blood vessel stent;

[0008] A driving device, a driving end of which is connected to the support tube, is suitable for driving the support tube to make the support tube reciprocate in the solution tank along the center line direction of its retention cavity.

[0009] As a preferred solution, a fixing tube is sleeved on the outer layer of the support tube, and the fixing tube is connected to the support tube via a fixing piece;

[0010] The driving end of the driving device is indirectly connected to the support tube through the fixing tube.

[0011] As a preferred solution, the support tube and the fixing tube are both made of transparent materials.

[0012] As a preferred solution, the support tube is a glass tube.

[0013] As a preferred solution, the fixing piece is made of elastic material.

[0014] As a preferred solution, the fixing member has a gap between the fixing tube and the support tube.

[0015] As a preferred solution, the fixing piece has a plurality of notches, and the plurality of notches are evenly distributed around the support tube.

[0016] As a preferred solution, anti-movement plugs are provided at both ends of the stent tube, and the anti-movement plugs have abutment ends extending inwardly along the inner wall of the stent tube, and the abutment ends are suitable for abutting against the end edge of the vascular stent.

[0017] As a preferred solution, the anti-movement plug has an annular groove suitable for inserting into the edge of the mouth of the bracket tube.

[0018] As a preferred solution, the solution tank is cylindrical, the outer layer of the solution tank is wrapped with a heat preservation structure, and a heating device is provided on the solution tank.

[0019] As a preferred solution, the solution tank is a beaker, the opening of the beaker is covered with a beaker cover, the driving end of the driving device is a driving rod, and the driving rod passes through the beaker cover and is inserted into the beaker.

[0020] As a preferred solution, it also includes:

[0021] The frame has a driving device inside and a control switch and a control panel on the surface;

[0022] A beaker rack, arranged on the frame, suitable for fixing the solution tank longitudinally;

[0023] The support tube is vertically arranged in the solution tank;

[0024] The solution tank is suspended and mounted on the beaker rack;

[0025] The driving rod of the driving device extends vertically downward into the solution tank.

[0026] The technical solution of the present invention has the following advantages:

[0027] 1. The in vitro degradation simulation device of the degradable vascular stent provided by the present invention comprises: a solution tank, a stent tube and a driving device; a degradation solution is placed in the solution tank, the vascular stent is fixed in the retention cavity of the stent tube, the stent tube is immersed in the degradation solution in the solution tank, and the driving device drives the stent tube to reciprocate along the center line direction of the retention cavity; the process simulates the degradation behavior of the degradable vascular stent in the organism, and can quickly and accurately evaluate the in vivo degradation performance of the degradable vascular stent substrate, stent coating and other aspects, providing help for the research of the degradable stent; at the same time, the device is easy to operate, simple in structure, and the results obtained are true and reliable.

[0028] 2. The in vitro degradation simulation device of the degradable vascular stent provided by the present invention comprises an outer spacer sleeve of the stent tube and a fixing tube, and the driving end of the driving device is connected to the fixing tube; the volume of the fixing tube is larger than that of the stent tube, so as to facilitate the connection with the driving device.

[0029] 3. In the in vitro degradation simulation device for the degradable vascular stent provided by the present invention, the stent tube and the fixing tube are both made of transparent materials, which facilitates the observation of the degradable vascular stent.

[0030] 4. The in vitro degradation simulation device of the degradable vascular stent provided by the present invention, wherein the stent tube is a glass tube, and the friction coefficient of the glass is relatively small. After the degradable vascular stent is placed inside the stent tube, if it needs to be taken out, it is only necessary to put the stent tube with the degradable vascular stent into water. With the help of the lubricating effect of water, the degradable vascular stent can slide out of the stent tube without damage.

[0031] 5. In the in vitro degradation simulation device for the degradable vascular stent provided by the present invention, the fixing piece is made of elastic material, and the fixing piece only needs to be snapped into the fixing tube to fix the stent tube and the fixing tube, which is convenient and quick.

[0032] 6. In the in vitro degradation simulation device of the degradable vascular stent provided by the present invention, the fixing part has a plurality of gaps between the fixing tube and the stent tube; the resistance when the fixing tube moves back and forth in the degradation solution is reduced, so that the degradation solution can pass through the vascular stent smoothly, accurately simulating the degradation environment.

[0033] 7. The in vitro degradation simulation device for the degradable vascular stent provided by the present invention controls the temperature of the degradation solution through the heat preservation structure and the heating device, thereby indirectly controlling the temperature of the degradation environment of the degradable vascular stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0035] Figure 1 It is a schematic diagram of the three-dimensional structure of the in vitro degradation simulation device of the degradable vascular stent of the present invention.

[0036] Figure 2 for Figure 1 The front view structural schematic diagram of the solution tank is shown.

[0037] Figure 3 for Figure 2AA section view shown.

[0038] Figure 4 for Figure 3 A local enlarged view of point B is shown.

[0039] Figure 5 for Figure 3 A schematic diagram of the three-dimensional structure of the fixing member shown.

[0040] Description of reference numerals:

[0041] 1. Rack; 2. Control switch; 3. Control panel; 4. Sliding slot; 5. Beaker rack; 6. Beaker; 7. Beaker cover; 8. Driving rod; 9. Fixed tube; 10. Fixing piece; 11. Anti-movement plug; 12. Bracket tube; 13. Fixed clamp; 14. Degradable vascular stent; 15. Mounting hole. DETAILED DESCRIPTION

[0042] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limitations on the present invention.

[0044] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0045] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0046] The in vitro degradation simulation device of the degradable vascular stent 14 provided in this embodiment can be mainly applied to polylactic acid stents, zinc-based stents, iron-based stents, magnesium-based stents, etc. The degradation simulation device includes: a solution tank, a stent tube 12 and a driving device; a degradation solution is placed in the solution tank, the vascular stent is fixed in the retention cavity of the stent tube 12, the stent tube 12 is immersed in the degradation solution in the solution tank, and the driving device drives the stent tube 12 to reciprocate along the center line direction of the retention cavity; the process simulates the degradation behavior of the degradable vascular stent 14 in the body, and can quickly and accurately evaluate the in vivo degradation performance of the degradable vascular stent 14 substrate, stent coating and other aspects, providing help for the research of degradable stents; at the same time, the device is easy to operate, simple in structure, and the results obtained are true and reliable.

[0047] like Figure 1 As shown, the simulation device has a frame 1, the surface of the frame 1 has a control switch 2 and a control panel 3, the frame 1 is provided with a driving device inside, the driving end of the driving device extends out of the front end of the frame 1, and the frame 1 has a sliding groove 4 on the side where the driving end extends out; a beaker 6 is provided at the front end of the frame 1, and a solution tank is suspended in the beaker frame 5, the solution tank is preferably a beaker 6, the beaker 6 is cylindrical, and a beaker cover 7 is provided at the opening of the beaker 6, and the degradation solution is suitable for placing in the beaker 6; specifically, the degradation solution can be a human body simulation solution or other simulation solutions.

[0048] Meanwhile, the driving end of the driving device is a driving rod 8, which passes through the beaker cover 7 and is inserted into the beaker 6. The outer layer of the beaker 6 is wrapped with a heat preservation structure, and a heating device is also arranged on the beaker 6 to control the temperature of the degradation solution in the beaker 6.

[0049] like Figure 2 , 3 As shown, the driving rod 8 extends into the beaker 6 and is connected to the fixed tube 9 through a connecting piece. The fixed tube 9 is in a through-tube shape and is made of transparent glass or transparent plastic. A bracket tube 12 is arranged inside the fixed tube 9 through a fixing piece 10.

[0050] like Figure 4 As shown, the stent tube 12 is made of transparent glass, and the degradable vascular stent 14 to be studied is placed in the stent tube 12, wherein the inner diameter of the stent tube 12 is consistent with the outer diameter of the blood vessel where the degradable vascular stent 14 is implanted; anti-movement plugs 11 are provided at both ends of the stent tube 12 to fix the degradable blood vessels and prevent the vascular stent from sliding out of the stent tube 12;

[0051] Specifically, the anti-migration plug 11 has an annular groove, which is inserted into the edge of the mouth of the stent tube 12. The part inserted into the stent tube 12 has an abutment end, which abuts on the edge of the end between the degradable blood vessels, so that the degradable blood vessel stent 14 cannot move. In order to prevent the movement of the anti-migration plug 11, an elastic fixing ring 13 is sleeved on the outer side of the anti-migration plug 11, so that the anti-migration plug 11 will not fall off the stent tube 12 during the movement of the stent tube 12.

[0052] like Figure 5 As shown, the fixing member 10 is made of elastic rubber material, and a mounting hole 15 for mounting the bracket tube 12 is provided in the middle of the fixing member 10. The outer edge of the fixing member 10 abuts against the inner wall of the fixing tube 9 to achieve the fixation of the bracket tube 12 and the fixing tube 9; a plurality of notches are provided between the fixing tube 9 and the bracket tube 12, and the notches are evenly distributed around the bracket tube 12.

[0053] Meanwhile, a camera, a pH detector, a solution level detector and other devices can also be installed inside the beaker 6 to monitor the situation inside the beaker 6 in real time.

[0054] Usage and principle

[0055] The degradable vascular stent 14 to be evaluated is placed in the degradable stent tube 12, and the two ends of the stent tube 12 are fixed by the anti-movement plug 11. The fixing clamp 13 is sleeved between the anti-movement plug 11 and the stent tube 12 to prevent the anti-movement plug 11 from moving; the stent tube 12 is inserted into the mounting hole 15 of the fixing member 10, and the fixing member 10 abuts against the fixing tube 9, so that the fixing tube 9 and the stent tube 12 are coaxially arranged, and the driving end of the driving device is connected to the fixing tube 9;

[0056] A degradation solution is placed in the beaker 6, the driving end of the driving device is connected to the fixed tube 9 through the beaker cover 7, the fixed tube 9 is placed in the beaker 6, and the beaker cover is closed at the same time. The degradation solution in the beaker 6 is heated by a heating device so that the temperature of the degradation solution is maintained at 37°C ± 1°C.

[0057] The driving device is turned on to drive the fixed tube 9 to reciprocate up and down, with an up and down movement stroke of 55mm±2mm; the reciprocating frequency (up and down frequency) is 30-32 times per minute; at the same time, the up and down frequency and the moving speed per minute are precisely controlled by the control panel 3 and the control switch 2; so that the degradable vascular stent 14 is in relative motion with respect to the degradation solution, which is consistent with the principle that the blood in the human body moves while the degradable vascular stent 14 is stationary; the degradation and flushing effect of the degradation solution on the degradable vascular stent 14 is also consistent with the degradation behavior in the body. The degradable stent is taken out after a certain period of movement for subsequent corresponding evaluation and research.

[0058] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. An in vitro degradation simulation device for a degradable vascular stent, characterized in that: include: A solution tank, the interior of which is suitable for containing a degradation solution; The stent tube (12) has a retention cavity with two ends extending therethrough, wherein the retention cavity is suitable for connecting a blood vessel stent; A driving device, a driving end of which is connected to the support tube (12), the driving device being suitable for driving the support tube (12) so as to cause the support tube (12) to reciprocate in the solution tank along the center line direction of its retention cavity; The outer spacer sleeve of the support tube (12) is provided with a fixing tube (9); the driving end of the driving device is indirectly connected to the support tube (12) via the fixing tube (9); the fixing tube (9) and the support tube (12) are connected via a fixing member (10); the fixing member (10) has a notch between the fixing tube (9) and the support tube (12); a mounting hole (15) for mounting the support tube (12) is provided in the middle of the fixing member (10); the outer edge of the fixing member (10) abuts against the inner wall of the fixing tube (9); the fixing member (10) has a plurality of notches, and the plurality of notches are distributed around the support tube (12).

2. The in vitro degradation simulation device for a degradable vascular stent according to claim 1, characterized in that: The support tube (12) and the fixing tube (9) are both made of transparent materials.

3. The in vitro degradation simulation device for the degradable vascular stent according to claim 2, characterized in that: The support tube (12) is a glass tube.

4. The in vitro degradation simulation device for a degradable vascular stent according to claim 1, characterized in that: The fixing member (10) is made of elastic material.

5. The in vitro degradation simulation device for a degradable vascular stent according to claim 1, characterized in that: The plurality of notches are evenly distributed around the support tube (12).

6. The in vitro degradation simulation device for a degradable vascular stent according to any one of claims 1 to 5, characterized in that: Anti-movement plugs (11) are provided at both ends of the stent tube (12), and the anti-movement plugs (11) have abutment ends extending inwardly along the inner wall of the stent tube (12), and the abutment ends are suitable for abutting against the end edge of the blood vessel stent.

7. The in vitro degradation simulation device for a degradable vascular stent according to claim 6, characterized in that: The anti-movement plug (11) has an annular groove suitable for inserting into the edge of the mouth of the support tube (12).

8. The in vitro degradation simulation device for a degradable vascular stent according to any one of claims 1 to 5, characterized in that: The solution tank is cylindrical, the outer layer of the solution tank is wrapped with a heat preservation structure, and a heating device is arranged on the solution tank.

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