Storage device and storage method for degradable zinc alloy bracket
Technical Field
The invention relates to the technical field of medical instruments, in particular to a storage device and a storage method for a degradable zinc alloy stent.
Background
The coronary artery stent is a medical apparatus for treating cardiovascular stenosis, and the principle of the interventional operation is to re-expand the blocked coronary artery blood vessel by implanting the stent, so that the blood flow is restored to be smooth again. The instrument has been used more and more widely in the cardiovascular disease field at present. The development of interventional stent procedures has progressed from the first generation of balloon-only stents (PTCA), to the second generation of Bare Metal Stents (BMS), and to the third generation of drug-coated stents (DES), to biodegradable stents (BRS).
The biodegradable stent is made of degradable polymer materials (such as polylactic acid) or metal materials (such as magnesium alloy and zinc alloy), can play a role in supporting blood vessels in a short time after being implanted into a diseased site, rebuilds and restores a blood transport channel, and after the treatment is completed and the function of the blood vessels of the diseased site is restored, the biodegradable stent is gradually degraded into organic matters, metal ions, metal compounds and other substances which can be absorbed and metabolized by a human body in the environment of the human body, and finally the stent can disappear in the diseased site without causing the problems of secondary blockage stenosis and the like in the site.
However, the existing biodegradable stent is sensitive to temperature, oxygen, moisture and other environments, and after sterilization processes such as irradiation and the like, the stent material can quickly undergo chemical or physical changes such as aging, creep, degradation, deformation and the like, so that basic technical requirements of the stent, such as extrusion resistance, radial retraction rate and the like, are influenced. The storage aging of the biodegradable scaffold can also be very short if the storage conditions are not controlled, and the application can be further limited.
CN109878907A discloses a magnesium alloy stent storage box and method, which protect the stent by a sealed box and a mixed gas composed of hydrogen and helium inside the sealed box, but there is no suitable and effective method for the packaging and storage method of the degradable zinc alloy stent, which cannot guarantee the longer physical and chemical stability of the degradable zinc alloy stent, and cannot prolong the storage period of the stent, and is not suitable for industrialization.
Disclosure of Invention
The invention aims to solve the technical problems to a certain extent, and provides a storage device for a degradable zinc alloy bracket, which can effectively control the stability of the zinc alloy bracket in the storage and sterilization processes, can prolong the shelf life of the bracket and is convenient for industrialization.
The technical scheme adopted by the invention for solving the technical problems is as follows: the storage device comprises a coil pipe, a three-way valve, a sealing box, a conveying device and a ventilation needle head, wherein the coil pipe is used for loading the degradable zinc alloy stent; the three-way valve is arranged at the end opening of the inner ring of the coil pipe, the left side of the three-way valve is communicated with the initial end of the coil pipe, and the right side of the three-way valve is provided with an opening for inserting the degradable zinc alloy bracket; the sealing box is arranged at the end port of the outer ring of the coil pipe, and the left side of the sealing box is communicated with the tail end of the coil pipe; the conveying device is used for pressing and holding the degradable zinc alloy bracket and loading the degradable zinc alloy bracket into the coil pipe through the three-way valve; the vent needle is arranged at an opening at the upper end of the three-way valve and is used for filling gas into the coil pipe.
In some preferred embodiments, the end face of the three-way valve perpendicular to the direction of the assembling ventilation needle head extends outwards to form a T-shaped cavity structure.
In certain preferred embodiments, a desiccant is provided within the T-cavity body structure of the three-way valve.
In certain preferred embodiments, a sealing ring is contained within the sealed cartridge.
A storage method of a degradable zinc alloy stent comprises the storage device of the degradable zinc alloy stent, and comprises the following steps:
s1, placing the processed and molded degradable zinc alloy bracket in an air-blast drying box for drying and draining to remove residual cleaning solution;
s2, placing the degradable zinc alloy support dried in the step S1 in an environment with the temperature of 15-25 ℃ and the humidity of 20-30% to be matched with a conveying device for pressing and holding treatment, quickly loading the whole body into a coil pipe from an opening at one side of a three-way valve, and enabling a guide wire at the tail end of the conveying device to penetrate through the sealing box in an opening state to achieve the effect of guide wire clamping;
s3, when the degradable zinc alloy support is loaded, inserting the ventilating needle head in the opening state of the three-way valve, enabling the ventilating needle head to keep a gas-filled state towards the interior of the coil pipe all the time, and enabling the gas in the coil pipe to overflow from the sealing box in the opening state;
s4, closing the three-way valve and the sealing box after loading is finished, pulling out the ventilation needle head, and loading the loaded degradable zinc alloy support and the conveying device into a Tyvek inner packaging bag;
s5, the whole processed in the step S4 is placed into an airtight outer packaging bag packaged with a drying agent, and low-temperature irradiation sterilization is carried out to obtain a finished product.
In certain preferred embodiments, the blowing dry box in the step S1 is baked with nitrogen or inert gas.
In certain preferred embodiments, the drying temperature of the forced air drying oven does not exceed 40 ℃.
In certain preferred embodiments, the dwell time for the crimping in the step S2 is 20-90 seconds.
In certain preferred embodiments, the gas filled in the step S3 is nitrogen or an inert gas.
In certain preferred embodiments, the inert gas is helium or argon.
Compared with the prior art, the technical scheme provided by the embodiment of the application has the following advantages:
the system comprises a coil pipe, a three-way valve, a sealing box, a conveying device, a degradable zinc alloy support, a three-way valve, a sealing box, a sealing ring, a sealing box and a sealing ring, wherein the three-way valve is arranged at an inner ring port of the coil pipe, the sealing box is arranged at an outer ring port of the three-way valve, the conveying device is pressed and held with the degradable zinc alloy support, the degradable zinc alloy support penetrates through the three-way valve to be loaded into the coil pipe, nitrogen or inert gas is filled into the coil pipe during loading, and finally the coil pipe is packaged into a non-breathable outer packaging bag of the sealing agent for low-temperature irradiation sterilization, so that the stability of the zinc alloy support in the storage and sterilization processes can be effectively controlled, the shelf life of the support can be prolonged, and industrialization is facilitated;
furthermore, the residual cleaning solution of the degradable zinc alloy bracket after the preparation and cleaning process is removed by means of nitrogen or inert gas drying in the air-blast drying oven, and meanwhile, the bottom of the air-blast drying oven is loaded with a drying agent, and the drying temperature is not more than 40 degrees, so that the thickness of an oxide layer formed on the surface of the zinc alloy can be controlled and protected.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.
In the drawings:
FIG. 1 is a schematic structural diagram of a degradable zinc alloy stent storage device according to the present invention;
FIG. 2 is a schematic structural diagram of a degradable zinc alloy stent storage device according to the present invention;
FIG. 3 is an enlarged view of a portion A of FIG. 1 during storage operation;
FIG. 4 is an enlarged view of a portion B of FIG. 1 during storage operation;
FIG. 5 is an enlarged view of a portion of FIG. 1A after storage;
FIG. 6 is an enlarged view of a portion of FIG. 1 at B after storage;
FIG. 7 is a flow chart of a storage method according to the present invention.
Reference numerals: 1-a coil pipe; 2-three-way valve; 3-sealing the box; 4-a conveying device; 5-T-shaped cavity structure; 6-sealing ring.
Detailed Description
For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, it is to be understood that the orientations and positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "leading", "trailing", and the like are configured and operated in specific orientations based on the orientations and positional relationships shown in the drawings, and are only for convenience of describing the present invention, and do not indicate that the device or element referred to must have a specific orientation, and thus, are not to be construed as limiting the present invention.
It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The terms "first", "second", "third", etc. are only for convenience in describing the present technical solution, and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated, whereby the features defined as "first", "second", "third", etc. may explicitly or implicitly include one or more of such features. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the following description, for purposes of explanation and not limitation, specific details are set forth, such as particular system structures, techniques, etc. in order to provide a thorough understanding of the embodiments of the invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.
As shown in fig. 1-6, the invention provides a storage device for a degradable zinc alloy stent, comprising a coil pipe 1, a three-way valve 2, a sealing box 3, a conveying device 4 and a ventilation needle, wherein the coil pipe 1 is used for loading the degradable zinc alloy stent; the three-way valve 2 is arranged at an inner ring port of the coil pipe 1, the left side of the three-way valve is communicated with the initial end of the coil pipe 1, an opening for inserting the degradable zinc alloy bracket is formed in the right side of the three-way valve, the end surface of the three-way valve 2 perpendicular to the direction of the assembling ventilation needle head extends outwards to form a T-shaped cavity body structure 5, and a drying agent is arranged in the T-shaped cavity body structure 5 of the three-way valve 2; the sealing box 3 is arranged at an outer ring port of the coil 1, the left side of the sealing box is communicated with the tail end of the coil 1, and a sealing ring 6 is arranged in the sealing box 3; the conveying device 4 is used for pressing and holding the degradable zinc alloy bracket and loading the degradable zinc alloy bracket into the coil pipe 1 through the three-way valve 2; the vent needle is arranged at an opening at the upper end of the three-way valve 2 and is used for filling gas into the coil pipe 1.
As shown in fig. 7, a method for storing a degradable zinc alloy stent, which comprises the following steps:
s1, placing the processed and molded degradable zinc alloy bracket in an air-blast drying box for drying and draining to remove residual cleaning solution;
specifically, in the step S1, nitrogen or an inert gas is used in the forced air drying oven to dry and blow off the residual cleaning solution, wherein the inert gas is helium or argon, the drying temperature of the forced air drying oven is 37 ℃, a drying agent is further loaded at the bottom of the forced air drying oven, and the drying agent is a physical adsorbent including but not limited to one or more of silica gel, an alumina molecular sieve, and activated carbon:
s2, placing the degradable zinc alloy stent dried in the step S1 in an environment with the temperature of 20 ℃ and the humidity of 25% to be matched with a conveying device 4 for carrying out pressing and holding treatment, wherein the pressure holding time of pressing and holding in the step S2 is 60 seconds, the whole body is rapidly loaded into the coil pipe 1 from an opening on one side of the three-way valve 2, and a guide wire at the tail end of the conveying device 4 can penetrate through the sealing box 3 in an opening state to achieve the effect of guide wire clamping;
s3, when the degradable zinc alloy bracket is loaded, inserting a ventilation needle in the opening state of the three-way valve 2, and enabling the ventilation needle to keep a gas-filled state towards the interior of the coil 1 all the time, wherein the gas filled in the step S3 is nitrogen or inert gas, the inert gas is helium or argon, and meanwhile, the gas in the coil 1 overflows from the sealing box 3 in the opening state;
s4, after loading is finished, closing the three-way valve 2 and the sealing box 3, pulling out the ventilation needle head, and loading the loaded degradable zinc alloy support and the conveying device 4 into a Tyvek inner packaging bag;
s5, the whole body processed in the step S4 is placed into an airtight outer packaging bag packaged with a drying agent, and low-temperature irradiation sterilization is carried out to obtain a finished product, in the step S5, the airtight packaging bag is made of materials which are difficult to permeate oxygen and moisture, and is not limited to aluminum foil bags, polyester bags and polyethylene bags, and the specific materials have the oxygen permeability coefficient of less than 0.02cm under the conditions that the temperature is minus 20-40 ℃, the humidity is 5-80%, and the atmospheric pressure is3/(cm224 h.0.1 MPa), water vapor transmission of less than 0.02cm3/(cm224h 0.1MPa) and simultaneously performing radiation sterilization under a low-temperature environment (above the freezing point and below 4 ℃), wherein the radiation sterilization comprises alpha rays, beta rays, gamma rays, electron beams, neutron beams and X rays,
in the embodiment, the coil 1 is provided with the three-way valve 2 arranged at the inner ring port, the T-shaped cavity body structure 5 of the three-way valve 2 is internally provided with the drying agent, the outer ring port of the three-way valve 2 is provided with the sealing box 3 with the sealing ring 6, the conveying device 4 is pressed and held with the degradable zinc alloy bracket, the degradable zinc alloy bracket passes through the three-way valve 2 to be loaded into the coil 1, nitrogen or inert gas is filled into the coil 1 during loading, and finally the coil is packaged into the airtight outer packaging bag of the drying agent for low-temperature irradiation sterilization, so that the stability of the zinc alloy bracket in the storage and sterilization processes can be effectively controlled, the shelf life of the bracket can be prolonged, and the industrialization is facilitated; furthermore, the residual cleaning solution of the degradable zinc alloy bracket after the preparation and cleaning process is removed by means of nitrogen or inert gas drying in the air-blast drying oven, and meanwhile, the bottom of the air-blast drying oven is loaded with a drying agent, and the drying temperature is not more than 40 degrees, so that the thickness of an oxide layer formed on the surface of the zinc alloy can be controlled and protected.
It is to be understood that the foregoing examples, while indicating the preferred embodiments of the invention, are given by way of illustration and description, and are not to be construed as limiting the scope of the invention; it should be noted that, for those skilled in the art, the above technical features can be freely combined, and several changes and modifications can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention; therefore, all equivalent changes and modifications made within the scope of the claims of the present invention should be covered by the claims of the present invention.