CN114939980A - Bidirectional microtube expansion and stretching method for full-biodegradable stent - Google Patents

Bidirectional microtube expansion and stretching method for full-biodegradable stent Download PDF

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Publication number
CN114939980A
CN114939980A CN202210512550.6A CN202210512550A CN114939980A CN 114939980 A CN114939980 A CN 114939980A CN 202210512550 A CN202210512550 A CN 202210512550A CN 114939980 A CN114939980 A CN 114939980A
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pipe
expansion
stretching
biodegradable stent
bidirectional
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牛怡
赵登科
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Nanjing Haoyandingye Technology Co ltd
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Nanjing Haoyandingye Technology Co ltd
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C55/00Shaping by stretching, e.g. drawing through a die; Apparatus therefor
    • B29C55/22Shaping by stretching, e.g. drawing through a die; Apparatus therefor of tubes
    • B29C55/26Shaping by stretching, e.g. drawing through a die; Apparatus therefor of tubes biaxial
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7532Artificial members, protheses
    • B29L2031/7534Cardiovascular protheses

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  • Mechanical Engineering (AREA)
  • Shaping By String And By Release Of Stress In Plastics And The Like (AREA)

Abstract

The invention discloses a bidirectional microtubule expansion and stretching method for a full biodegradable stent, which is characterized in that an original degradable tubular product is vertically arranged in a novel forming glass mould, the original tubular product is inflated, the outer side of the glass mould is preheated and heated by a ring-shaped heater, and radial expansion and axial bidirectional stretching are simultaneously carried out, so that a medical microtubule for efficiently manufacturing the biodegradable stent can be obtained.

Description

Bidirectional microtube expansion and stretching method for full-biodegradable stent
Technical Field
The invention belongs to the technical field of biological stents, and particularly relates to a bidirectional microtube expansion and stretching method for a full-biodegradable stent.
Background
The biodegradable stent is used as a substitute for a metal stent to become a main minimally invasive interventional medical instrument for treating cardiovascular system diseases of the next generation, and is currently a hot field of research. The biodegradable stent has the advantages that after the biodegradable stent is implanted into the vascular disease displacement, the mechanical property of the biodegradable stent is equivalent to that of a cash stent, but after the loaded therapeutic drug is completely released, the polymer stent body can be gradually degraded into substances which are harmless to a human body and can be absorbed within a period of time, such as: the polymer stent made of the polylactic acid and the copolymer thereof can be completely degraded in an organism within 36 months, and the degraded component is lactic acid, and the content of the lactic acid after complete degradation is far lower than the normal level of 10-25mg/100ml of blood of a human body.
Currently, there are two types of degradable polymer scaffolds that are internationally licensed for CE certification: BVS stent, Yapek USA and DESlave stent, Elixir Medical USA. Both of the above stents are made of polylactic acid or its copolymer. In China, research institutions and enterprises in related fields are also actively researching various performance indexes and manufacturing methods of biodegradable stents. Under the condition that the material of the stent is basically determined, how to efficiently manufacture the degradable stent meeting the use requirement becomes a hot point of research. In the process of forming and processing the bracket, researchers and manufacturers at home and abroad generally adopt a laser engraving process, and the technology is developed quite mature. Therefore, obtaining high-efficiency qualified pipes for laser processing becomes an important point for researching biodegradable stents. And the processing of the biodegradable stent tube can be divided into two steps of micro-tube forming and micro-tube expansion. Microtubes may be formed by injection molding and extrusion processes, which are well established in the art. The micro-tube expansion process can greatly reduce the wall thickness of the micro-tube and simultaneously improve the mechanical property and the degradation characteristic of the degradable material, so that the micro-tube expansion process becomes a key technology for researching the biodegradable stent. Aiming at the expansion of the microtube, the patent No. CN106361465B solves the problem of the existing manufacturing process of the degradable tube, and simultaneously meets the requirements of the length and the radial strength of the tube, but the sectional translation operation difficulty in the preparation of the degradable tube is higher, and meanwhile, the consistency and the reliability of the segmented tube cannot be well guaranteed. This is another method that the researchers in the field think of the tube expansion is the expansion method of the medical balloon, however, the method is not completely suitable for the expansion of the microtube for the degradable stent due to different purposes and materials, such as: the heating mode is integral heating when the saccule is expanded, and the radial expansion and the axial expansion (stretching) can not be carried out simultaneously. There is therefore a need in the art for a process that efficiently expands microtubes while meeting the requirements of length and radial strength.
Disclosure of Invention
In order to solve the problems, the invention discloses a bidirectional microtube expansion and stretching method for a full biodegradable stent, which can ensure that the expanded tubular product has longer length, higher production efficiency, good mechanical property and degradation performance, and can ensure the reliability and consistency of the biodegradable stent in production.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a bidirectional microtubule expansion and stretching method for a full biodegradable stent comprises the following steps:
(1) vertically arranging a cylindrical glass mold, putting an original pipe into the glass mold along an axis, and sealing two ends of the original pipe;
(2) two annular heaters are arranged at the outer side of the glass mold;
(3) synchronously inflating from two ends of the original pipe, and simultaneously heating by a heater;
(4) the heater moves along the axial direction, and the pipe starts to expand in a bidirectional radial direction and in a bidirectional axial direction under the action of pressure and temperature;
(5) and cooling the expanded tubular product to obtain the medical microtube for manufacturing the biodegradable stent.
The working principle is as follows:
through research, the mechanical properties (including radial supporting force and axial bending or torque, etc.) of the stent are greatly influenced by expansion process parameters, such as: when the radial expansion ratio of the pipe is 200-600% and the axial expansion (stretching) ratio is 100-200%, the crystallinity of the expanded polymer pipe can be between 40-55%, the molecular chain arrangement direction of the polymer of the pipe tends to the diameter direction, the pipe can achieve ideal radial support performance, and the axial stretching simultaneously enhances the bearing capacity of the pipe when the pipe is axially bent or torqued, wherein the radial expansion and the stretching are carried out simultaneously. The above expansion ratio is defined as follows:
Figure DEST_PATH_IMAGE002
meanwhile, in order to ensure that radial expansion is expanded in two directions along the axial direction, a pressurizing pipe can be arranged at the upper part and the lower part inside the original pipe, the two pressurizing pipes are symmetrically distributed at the two sides of the target center of the inner diameter of the original pipe, and the same air pressure needs to be added at the same time in order to ensure that the long-chain polymer molecules are uniformly distributed and arranged in the pipe, so that a longer micro-pipe can be obtained, and the production efficiency can be improved.
Meanwhile, the distribution and arrangement of long-chain polymer molecules in the pipe are ensured to be uniform.
Wherein the content of the first and second substances,
the radial expansion and axial stretching process is performed at a temperature of 70 to 100 °;
the radial expansion and axial stretching processes are performed at gas pressures of 100 to 200 PSI;
the function of the pressure pipe is as follows: the high-pressure gas can extend into the middle part of the original pipe before the pipe expands through the pressurizing pipes, and the pressurizing pipes at two ends are symmetrically distributed at two sides of the target center of the inner diameter of the original pipe; if the pressure pipe is not arranged, high-pressure gas can extend into the middle of the original pipe before being converged and expanded from the two ends of the pipe to the middle, the pressure pipe is additionally arranged, and the high-pressure gas flows from the middle of the pipe to the two ends;
the radial expansion size of the pipe is limited by a customized high-temperature-resistant precise glass mold, and the pipe has the characteristics of high dimensional precision, convenience in cleaning, convenience in observing the expansion condition of the pipe in real time, suitability for a novel heating mode and the like;
when the pipe expands radially, the glass mold and the pipe are heated by adopting a high-efficiency heater heating mode, so that the pipe can be quickly raised to a set temperature, the time of a polymer material in a high-temperature area is reduced, the risk of chain scission of polymer molecules is reduced, and meanwhile, the glass mold and the pipe are heated by adopting a high-efficiency heater heating mode;
the moving position and direction of the high-efficiency heater are consistent with the speed and direction of the expansion of the pipe, and the speed range is 0.1-2 mm/s;
the part of the pipe which finishes radial expansion and axial stretching is immediately cooled to room temperature, so that the uniformity of the expansion and stretching of the pipe can be ensured, and the internal stress and the polymer chain scission phenomenon can be reduced;
in the whole expansion process, the glass mould and the pipe are vertically arranged, so that the uniformity of the pipe in the diameter direction can be ensured.
For the bi-directional radial expansion and axial stretching process, the length and production efficiency of the obtained biodegradable pipe are twice as high as those of the unidirectional radial expansion in the same production time and mold.
The beneficial effects of the invention are as follows:
according to the method for expanding and stretching the bidirectional microtube for the medical fully-biodegradable stent, the extruded or injection-molded microtube is expanded in two directions by heating and pressurizing, so that the medical microtube for efficiently manufacturing the biodegradable stent can be obtained, and the obtained microtube has longer length, higher production efficiency, good mechanical property, good degradation characteristic, and reliability and consistency of tubes in the production process. The microtubule provided by the invention is not only suitable for manufacturing the biodegradable stent, but also suitable for mass production of the biodegradable stent.
Drawings
Fig. 1 is a schematic view of a novel glass mold.
Figure 2 shows a schematic representation of the original pipe before expansion.
Fig. 3 is a top view of the high efficiency heater.
Figure 4 shows a schematic view of a pipe during expansion.
List of reference symbols:
10. glass mold, 11, fixed end, 20, original tube, 21, unexpanded section, 22, expanding section, 23, expanded section, 24 and 24', heater, 25, pressure tube, 30 and 31, and moving direction of heater.
Detailed Description
The present invention will be further illustrated with reference to the accompanying drawings and specific embodiments, which are to be understood as merely illustrative of the invention and not as limiting the scope of the invention.
The expansion method of the microtube provided by the invention comprises the following steps: using a specially-made glass mold; using a high efficiency heater; a novel micro-tube pressurization mode is used; use of a unique configuration;
mounting a glass mold 10 on a device through a fixed end 11, and placing an original pipe 20 in the glass mold 10 (the glass mold 10 is longer than the original pipe 20); the pressurizing pipes 25 are placed along the inner diameter axis of the original pipe 20 and on two sides of the center line and are uniformly distributed; as the high efficiency heater 24 moves, the raw tubing 20 undergoes simultaneous expansion in both radial and axial directions, the radial expansion and axial stretching bi-directional motion and the coupled direction of the high efficiency heaters 24 and 24' being referred to as motion in directions 30 and 31; the tube 23 of the portion in which the expansion is completed is immediately cooled; the initial tube 20 and the glass mold 10 are in a vertical configuration during the expansion process.
Description 1: the pressurization does not expand the original tubular 20, and only after the outside warming up, the original tubular 20 can expand in both radial and axial directions simultaneously.
Description 2: the raw tubing 20 will expand axially when expanded radially, but must be heated to a temperature by a heater so that it expands in both radial and axial directions.
The structure of the glass mold of the present invention is described below with reference to fig. 1.
FIG. 1 is a structural view of a glass mold according to the present invention. The glass mold 10 in fig. 1 has the characteristics of high precision, good light transmittance and the like. It is made of a high temperature resistant borosilicate material, and can still maintain high dimensional and shape accuracy at 100 ° C. The glass mold 10 has chamfered structures at both ends thereof so as to facilitate insertion of the pipe into the glass mold before and after expansion and demolding after expansion, while the glass mold 10 has fixed ends 11 of a frosted structure at both ends thereof so as to stabilize the installation of the glass mold and ensure concentricity thereof.
Figure 2 is a schematic representation of the pipe before expansion. Fig. 2 shows 20 a raw tube before the expansion process in the processing of the biodegradable stent, the tube 20 being obtained by an extrusion process. Tubing 20 has a predetermined inner and outer diameter. Before expansion, the original pipe 20 is placed in a glass mold 10, and the air pressure microtubes 25 are placed on two sides of a central line along the inner diameter axis of the original pipe 20 and are uniformly distributed; the preparation before expansion consists of radial expansion and axial stretching of the raw tubing 20 and the high efficiency heater 24, all of which are performed simultaneously in the same direction.
Fig. 3 is a top view of the high efficiency heater 24. The annular high-efficiency heater 24 shown in fig. 3 can provide precisely controlled energy radiation, is simple, safe, transparent, efficient, fast in heat transfer and convenient to maintain, can realize efficient and uniform heating of a glass mold and an original pipe, and guarantees the consistency and reliability of the original pipe in the expansion process.
Figure 4 is a schematic view of the original pipe during expansion. In the glass mold 10, the original tube 20 has an expanded portion 23, a now expanded portion 22, and an unexpanded portion 21. In the expansion process, the cooling is carried out on the cooling pipe 23, the heating is carried out on the cooling pipe 22, the preheating is carried out on the heating pipe 21, the bidirectional expansion is carried out, the length of the production micro-pipe is increased, and the production efficiency is improved.
Two embodiments of the preparation process according to the invention are described below.
The first embodiment is as follows:
firstly, after a glass mold is installed, putting an extruded original polymer pipe into the glass mold with the inner diameter of 3.4 mm; then, the air pressure micro-tubes at the two ends are respectively placed on the two sides of the central line along the inner diameter axis of the original pipe and are uniformly distributed; secondly, both ends of the pipe are sealed, 100 PSI dry nitrogen gas is filled into the upper end and the lower end of the pipe, the constant pressure is kept strong, and the whole pipe is preheated to 80 degrees C. The moving speed of the biaxial efficient heater arranged in the axial direction of the glass tube was set to 1.5mm/s, the speed of biaxial stretching was also set to 1.5mm/s, and the efficient heater was set at 300W power. And then the high-efficiency heaters start to move towards the two ends respectively at the starting position of the central end of the glass mold, and the temperature of the tube where the heat source arrives reaches is up to 100 degrees C soon later. At this time, the tube starts to expand radially in both directions under the strong pressure of 100 PSI, and at the same time, the tube starts to expand (stretch) in both directions and in the axial direction, and the speed of the axial stretching is set to 1.5 mm/s. In addition, the glass tube together with the tube was rapidly cooled with the cooled nitrogen gas during the expansion. The pipe thus obtained was a pipe having an outer diameter of 3.4 mm and an inner diameter of 3.0 mm, the polymer pipe defined here having a radial expansion ratio of 500% and an axial expansion ratio of 200%. And finally, after the expansion is finished, cooling the glass tube and the tube together by using air at room temperature, unloading the pressure and the clamp after the glass tube and the tube reach the room temperature and are stable, and taking out the tube.
Example two (no pressure tube used):
firstly, after a glass mold is installed, putting an extruded original polymer pipe into the glass mold with the inner diameter of 3.4 mm; secondly, sealing one end of the pipe, filling 100 PSI dry nitrogen and keeping constant pressure, and preheating the whole pipe to 80 degrees C; then, the moving speed of the biaxial efficient heat source disposed in the axial direction of the glass tube was set to 1.5mm/s, the speed of biaxial stretching was also set to 1.5mm/s, and the efficient heater was set at 300W power. And then the high-efficiency heat source starts to move towards the two ends respectively at the initial position of the center end of the glass mold, and the temperature of the pipe where the heat source reaches 100-C soon later. At this time, the tube starts to expand radially in both directions under the strong pressure of 100 PSI, and at the same time, the tube starts to expand (stretch) in both directions and in the axial direction, and the speed of the axial stretching is set to 1.5 mm/s. In addition, the glass tube together with the tube was rapidly cooled with cooled nitrogen gas during the expansion. The pipe thus obtained was a pipe having an outer diameter of 3.4 mm and an inner diameter of 3.0 mm, the polymer pipe defined here having a radial expansion ratio of 500% and an axial expansion ratio of 200%. And finally, cooling the glass tube and the tube by using air at room temperature after the expansion is finished, unloading the pressure and the clamp after the glass tube and the tube reach the room temperature and are stable, and taking out the tube.
It should be noted that the above-mentioned contents only illustrate the technical idea of the present invention, and the protection scope of the present invention is not limited thereby, and it is obvious to those skilled in the art that several modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations fall within the protection scope of the claims of the present invention.

Claims (8)

1. A bidirectional microtube expansion stretching method for a full-biodegradable stent is characterized in that: the method comprises the following steps:
(1) vertically arranging a cylindrical glass mold, putting an original pipe into the glass mold along an axis, and sealing two ends of the original pipe;
(2) two annular heaters are arranged at the outer side of the glass mold;
(3) synchronously inflating from two ends of the original pipe, and simultaneously heating by a heater;
(4) the heater moves along the axial direction, and the pipe starts bidirectional radial expansion and bidirectional axial expansion under the action of pressure and temperature;
(5) and cooling the expanded pipe to obtain the medical micro-pipe for manufacturing the biodegradable stent.
2. The method for expanding and stretching the bidirectional microtube of the fully biodegradable stent as recited in claim 1, wherein: and (2) arranging a pressurizing pipe at the upper part and the lower part inside the original pipe in the step (1), wherein the pressurizing pipe extends into the middle part of the original pipe.
3. The method for stretching the full biodegradable stent by expanding the microtubules in two directions according to claim 1 or 2, wherein the method comprises the following steps: the glass mold in the step (1) is a glass tube with openings at two ends and is made of high-temperature-resistant borosilicate materials, the two ends of the glass mold are provided with chamfering structures, and the two ends of the side surface of the glass mold are provided with installation frosted structures.
4. The method for stretching the full biodegradable stent by expanding the microtubules in two directions according to claim 1 or 2, wherein the method comprises the following steps: when the pipe in the step (4) expands radially, the moving position and the moving direction of the heater are consistent with the speed and the direction of the expansion of the pipe, and the speed range is 0.1-2 mm/s.
5. The method for expanding and stretching the bidirectional microtube of the fully biodegradable stent as recited in claim 4, wherein the method comprises the following steps: the speed of the axial expansion of the pipe in the step (4) is the same as the axial moving speed of the heater, and the speed is also 0.1-2 mm/s.
6. The method for stretching the full biodegradable stent by expanding the microtubules in two directions according to claim 1 or 2, wherein the method comprises the following steps: the tube in the step (4) expands by 200 to 600 percent in the radial direction, and the axial stretching ratio is 100 to 200 percent.
7. The method for stretching the full biodegradable stent by expanding the microtubules in two directions according to claim 1 or 2, wherein the method comprises the following steps: the radial and axial expansion processes of step (4) are performed at a temperature of 70 to 100 °; the radial expansion and axial expansion processes are performed at gas pressures of 100 to 200 PSI.
8. The method for the bidirectional microtube expansion stretching of the fully biodegradable stent according to claim 1 or 2, wherein: in step (5), the glass tube together with the tube was cooled with nitrogen.
CN202210512550.6A 2022-05-12 2022-05-12 Bidirectional microtube expansion and stretching method for full-biodegradable stent Pending CN114939980A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102499999A (en) * 2011-11-22 2012-06-20 深圳市信立泰生物医疗工程有限公司 Deformed polymer tube and completely biodegradable polymer stent prepared by same
CN104191604A (en) * 2014-08-21 2014-12-10 苏州鸿大金属制品有限公司 Auxiliary heating device of thermal pipe shrinking machine
CN106361465A (en) * 2015-07-17 2017-02-01 上海微创医疗器械(集团)有限公司 Manufacture method for degradable tube and degradable stent
CN106618820A (en) * 2012-12-21 2017-05-10 上海微创医疗器械(集团)有限公司 Method for preparing biodegradable polymer scaffold
CN214926864U (en) * 2021-05-12 2021-11-30 石嘴山市塑料厂 Device for biaxially stretching PE (polyethylene) pipe

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102499999A (en) * 2011-11-22 2012-06-20 深圳市信立泰生物医疗工程有限公司 Deformed polymer tube and completely biodegradable polymer stent prepared by same
CN106618820A (en) * 2012-12-21 2017-05-10 上海微创医疗器械(集团)有限公司 Method for preparing biodegradable polymer scaffold
CN104191604A (en) * 2014-08-21 2014-12-10 苏州鸿大金属制品有限公司 Auxiliary heating device of thermal pipe shrinking machine
CN106361465A (en) * 2015-07-17 2017-02-01 上海微创医疗器械(集团)有限公司 Manufacture method for degradable tube and degradable stent
CN214926864U (en) * 2021-05-12 2021-11-30 石嘴山市塑料厂 Device for biaxially stretching PE (polyethylene) pipe

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