CN115670769B - Digestive tract membranous tube and preparation method thereof - Google Patents
Digestive tract membranous tube and preparation method thereof Download PDFInfo
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- CN115670769B CN115670769B CN202310005155.3A CN202310005155A CN115670769B CN 115670769 B CN115670769 B CN 115670769B CN 202310005155 A CN202310005155 A CN 202310005155A CN 115670769 B CN115670769 B CN 115670769B
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- Media Introduction/Drainage Providing Device (AREA)
Abstract
The application provides a digestive tract membrane tube and a preparation method thereof, and relates to the technical field of medical appliances. The digestive tract membrane tube comprises a first membrane tube, a second membrane tube and a third membrane tube; the distal end of the first membrane tube is connected with the proximal end of the second membrane tube, the distal end of the second membrane tube is connected with the proximal end of the third membrane tube, and the cross-sectional area of the second membrane tube decreases from the proximal end to the distal end; wherein, the material of first membrane pipe, second membrane pipe and third membrane pipe contains fluorine-containing polymer, and its coefficient of friction is low, and the resistance that the chyme receives when flowing in the alimentary canal membrane pipe is little. In addition, the cross-sectional area of the second membrane tube is gradually decreased from the proximal end to the distal end, and the third membrane tube connected with the distal end of the second membrane tube is thinner than the first membrane tube connected with the proximal end of the second membrane tube, so that the characteristics that the intestinal tract is gradually narrowed from top to bottom can be well adapted. Therefore, the digestive tract membrane tube is beneficial to the smooth passing of chyme in the practical application process, is not easy to cause intestinal obstruction and is safer.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to a digestive tract membrane tube and a preparation method thereof.
Background
In 2021, the number of overweight or obese people has exceeded 20 billion worldwide. Obesity causes health problems such as fatty liver and diabetes, and has become one of the important factors threatening human health.
With the progress of technology, the stomach food inducer gradually replaces the traditional stomach diversion operation and is used for treating the obese patients, so that the pain of the patients is reduced, and the economic burden of the patients is reduced. The implanted part of the stomach food deflector is a digestive tract membrane tube with a bracket, which plays an important role in shielding the intestinal tract from absorbing chyme.
Existing gut membrane tubes are typically composed of polymeric materials, particularly blow-moldable polymers such as polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polyamide, and polycarbonate.
However, these polymers all have a high coefficient of friction and are resistant to the flow of chyme within the digestive tract membrane tubes. In addition, the diameter of the blow-molded digestive tract membrane tube is uniform, and the blow-molded digestive tract membrane tube cannot adapt to the characteristic that the intestinal tract gradually narrows from top to bottom. The above disadvantages can lead to chyme not passing smoothly through the digestive tract membrane tube, thereby causing intestinal obstruction and endangering the life of the patient.
Disclosure of Invention
In order to solve the problems in the prior art, one of the objects of the present application is to provide a digestive tract membrane tube.
The application provides the following technical scheme:
a digestive tract membrane tube, comprising a first membrane tube, a second membrane tube and a third membrane tube;
the distal end of the first membrane tube is connected with the proximal end of the second membrane tube, the distal end of the second membrane tube is connected with the proximal end of the third membrane tube, the cross-sectional area of the second membrane tube decreases from the proximal end to the distal end, the cross-sectional area of the first membrane tube is not smaller than the cross-sectional area of the proximal end of the second membrane tube, and the cross-sectional area of the third membrane tube is not larger than the cross-sectional area of the distal end of the second membrane tube;
wherein the materials of the first membrane tube, the second membrane tube and the third membrane tube comprise fluorine-containing polymers.
As a further alternative to the gut membrane tube, the wall thickness of each of the first membrane tube, the second membrane tube and the third membrane tube is not less than 10 μm and not more than 50 μm.
As a further alternative to the gut membrane tube, the fluoropolymer is a fluoropolymer homopolymer or a fluoropolymer copolymer.
As a further alternative to the gut membrane tube, the gut membrane tube further comprises a stent, the proximal end of the first membrane tube being connected to the stent.
Another object of the present application is to provide a method for preparing a digestive tract membrane tube.
The application provides the following technical scheme:
a method for preparing a digestive tract membrane tube for preparing the above digestive tract membrane tube, the method comprising:
selecting a fluoropolymer;
preparing the fluoropolymer into a flat membrane with compact surface structure by a thermal processing method;
cutting the flat film to obtain a first film, a second film and a third film;
rolling the first membrane into a tube shape and welding to form a first membrane tube, rolling the second membrane into a tube shape and welding to form a second membrane tube, and rolling the third membrane into a tube shape and welding to form a third membrane tube;
and welding the distal end of the first membrane tube with the proximal end of the second membrane tube, and welding the distal end of the second membrane tube with the proximal end of the third membrane tube.
It is yet another object of the present application to provide a method of preparing a digestive tract membrane tube.
The application provides the following technical scheme:
a method for preparing a digestive tract membrane tube for preparing the above digestive tract membrane tube, the method comprising:
selecting a fluoropolymer and preparing a liquid of the fluoropolymer;
preparing a membrane core according to the structure of the digestive tract membrane tube;
coating the liquid by dipping and pasting the film core;
volatilizing a solvent in the liquid, and solidifying to form the first membrane tube, the second membrane tube and the third membrane tube with compact surfaces;
and (5) demolding.
As a further alternative to the method for preparing a digestive tract membrane tube, the digestive tract membrane tube further comprises a reinforcing rib, one end of the reinforcing rib is arranged on the first membrane tube, the middle part of the reinforcing rib is arranged on the second membrane tube, and the other end of the reinforcing rib is arranged on the third membrane tube;
the surface of the film core is provided with a groove for forming the reinforcing rib.
As a further alternative to the method of preparing a membrane tube of the alimentary canal, the membrane core is kept rotating during the evaporation of the solvent;
after curing to form the first, second and third film tubes, heating the first, second and third film tubes and removing the residual solvent.
As a further alternative to the method of preparing a tube of alimentary canal membrane, the tube of alimentary canal membrane further includes a bracket connecting a proximal end of the first membrane tube;
the digestive tract membrane tube preparation method further comprises the following steps:
after demolding, the stent is obtained and the proximal end of the first membrane tube is welded to the stent.
As a further alternative to the method of preparing a tube of alimentary canal membrane, the tube of alimentary canal membrane further includes a bracket connecting a proximal end of the first membrane tube;
the digestive tract membrane tube preparation method further comprises the following steps:
the stent is obtained and secured to the membrane core prior to dip-coating the liquid from the membrane core.
The embodiment of the application has the following beneficial effects:
the materials of the first membrane tube, the second membrane tube and the third membrane tube comprise fluorine-containing polymers, the friction coefficient is low, and the resistance of chyme in the process of flowing in the digestive tract membrane tubes is small. In addition, the cross-sectional area of the second membrane tube is gradually decreased from the proximal end to the distal end, and the third membrane tube connected with the distal end of the second membrane tube is thinner than the first membrane tube connected with the proximal end of the second membrane tube, so that the characteristics that the intestinal tract is gradually narrowed from top to bottom can be well adapted. Therefore, the digestive tract membrane tube is beneficial to the smooth passing of chyme in the practical application process, is not easy to cause intestinal obstruction and is safer.
In order to make the above objects, features and advantages of the present application more comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic view showing the overall structure of a digestive tract membrane tube according to embodiment 1 of the present application;
fig. 2 is a process flow chart of a method for preparing a digestive tract membrane tube according to embodiment 2 of the present application;
fig. 3 shows a scanning electron microscope image of a flat membrane prepared in step S2 according to the method for preparing a digestive tract membrane preparation provided in embodiment 2 of the present application;
fig. 4 shows a schematic structural diagram of a first membrane cut in step S3 according to the method for preparing a digestive tract membrane according to embodiment 2 of the present application;
fig. 5 shows a schematic structural diagram of a second membrane cut in step S3 according to the method for preparing a digestive tract membrane according to embodiment 2 of the present application;
fig. 6 shows a schematic structural diagram of a third membrane cut in step S3 according to the method for preparing a digestive tract membrane according to embodiment 2 of the present application;
FIG. 7 shows the statistics of the friction force of the digestive tract membrane tubes prepared in examples 2, 3 and 4 of the present application and the conventional polyethylene membrane tube;
FIG. 8 shows a schematic diagram of the pore structure of the surface of a thin-walled expanded polytetrafluoroethylene membrane;
fig. 9 is a process flow chart of a method for preparing a digestive tract membrane tube according to embodiment 3 of the present application;
fig. 10 is a schematic diagram showing the structure of a membrane core in a method for preparing a digestive tract membrane tube according to embodiment 3 of the present application;
FIG. 11 is a scanning electron microscope image of a digestive tract membrane tube prepared by the method for preparing a digestive tract membrane tube according to the embodiment 3 of the present application;
fig. 12 shows a scanning electron microscope image of a digestive tract membrane tube prepared by the digestive tract membrane tube preparation method provided by embodiment 4 of the application.
Description of main reference numerals:
100-a first membrane tube; 200-a second membrane tube; 300-a third membrane tube; 400-a first membrane; 410-a first axial edge; 420-a first proximal edge; 430-a first distal edge; 500-a second membrane; 510-a second axial edge; 520-a second proximal edge; 530-a second distal edge; 600-a third membrane; 610-a third axial edge; 620-a third proximal edge; 630-a third distal edge; 700-membrane core; 710-first segment; 720-a second segment; 730-third segment; 740-grooves.
Detailed Description
Embodiments of the present application are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the application.
It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" another element, there are no intervening elements present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only.
In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the templates herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
Example 1
Referring to fig. 1, the present embodiment provides a digestive tract membrane tube applied to a gastric bypass inducer. The digestive tract membrane tube comprises a bracket, a first membrane tube 100, a second membrane tube 200 and a third membrane tube 300, wherein the bracket is connected with the proximal end of the first membrane tube 100, the distal end of the first membrane tube 100 is connected with the proximal end of the second membrane tube 200, and the distal end of the second membrane tube 200 is connected with the proximal end of the third membrane tube 300.
Wherein, the materials of the first membrane tube 100, the second membrane tube 200 and the third membrane tube 300 comprise fluorine-containing polymers, and have low friction coefficients and small resistance when chyme flows in the digestive tract membrane tubes.
In some embodiments, the fluoropolymer is a fluoropolymer homopolymer including, but not limited to, polyvinyl fluoride, polyvinylidene fluoride, soluble polytetrafluoroethylene, homopolymers of fluoroacrylic monomers, and the like.
In other embodiments, the fluoropolymer is a fluorinated copolymer including, but not limited to, a perfluoroethylene propylene, a vinylidene fluoride-chlorotrifluoroethylene copolymer, a vinylidene fluoride-tetrafluoroethylene-hexafluoropropylene terpolymer, and the like.
Specifically, the first membrane tube 100 is a circular tube, and the diameter of the first membrane tube 100 at any position along the axial direction thereof is kept uniform and matched with the diameter of the stent. Further, the first film tube 100 has a diameter ranging from 40mm to 60mm and a length ranging from 2cm to 14cm.
Preferably, the first film tube 100 has a diameter of 60mm and a length of 4 cm-7 cm.
Specifically, the cross section of the second membrane tube 200 is circular, and the length thereof ranges from 2cm to 10cm. The proximal diameter of the second membrane tube 200 matches the diameter of the first membrane tube 100, and the distal cross section of the second membrane tube 200 is the same as the proximal cross section of the third membrane tube 300. In addition, the cross-sectional area of the second tube 200 decreases from the proximal end to the distal end.
At this time, the third tube 300 connected to the distal end of the second tube 200 is thinner than the first tube 100 connected to the proximal end of the second tube 200, and can be suitably adapted to the feature that the intestinal tract is gradually narrowed from top to bottom.
In combination with the low friction coefficient of the first membrane tube 100, the second membrane tube 200 and the third membrane tube 300, the digestive tract membrane tube is beneficial to smooth passing of chyme, difficult to cause intestinal obstruction and safer in the practical application process.
Preferably, the length of the second membrane tube 200 is 6 cm-9 cm.
In some embodiments, the second membrane tube 200 is a conical tube with a diameter that varies uniformly from the proximal end to the distal end.
Specifically, the cross section of the third membrane tube 300 is circular, the proximal diameter of the third membrane tube 300 is matched with the distal diameter of the second membrane tube 200, and the diameter of each position on the third membrane tube 300 is not larger than the distal diameter of the second membrane tube 200.
Wherein the proximal end diameter of the third membrane tube 300 ranges from 15mm to 35mm, and the length of the third membrane tube 300 ranges from 40cm to 140cm.
Preferably, the proximal end of the third membrane tube 300 has a diameter of 35mm and the length of the third membrane tube 300 is 110cm.
Further, in the above-mentioned digestive tract membrane tube, the membrane tube thickness is set according to the position of the digestive tract and the peristaltic movement of the digestive tract, and the thicknesses of the first membrane tube 100, the second membrane tube 200 and the third membrane tube 300 are all not less than 10 μm and not more than 50 μm.
In a word, the digestive tract membrane tube utilizes the characteristic of low friction coefficient of the fluorine-containing polymer, can ensure that chyme smoothly passes through the digestive tract membrane tube, and obviously reduces the intestinal obstruction symptoms after implantation. In addition, the fluoropolymer has excellent biocompatibility and compliant conformability, and the digestive tract membrane tube obviously reduces discomfort symptoms caused by stimulation to intestinal tracts after implantation.
Example 2
Referring to fig. 2, the present embodiment provides a method for preparing a digestive tract membrane tube (hereinafter, simply referred to as a "preparation method"), specifically a hot working auxiliary forming method, for preparing the digestive tract membrane tube. The preparation method comprises the following steps:
s1, selecting a fluorine-containing polymer.
In some embodiments, soluble Polytetrafluoroethylene (PFA) is selected to prepare the gut membrane tube.
Soluble polytetrafluoroethylene is one of the low coefficient of friction polymeric materials, with the lowest coefficient of friction among the melt-processible fluoropolymers.
S2, preparing the fluorine-containing polymer into a flat membrane with a compact surface structure by a thermal processing method.
Specifically, a polymer extruder special for fluoropolymer processing is used to prepare a flat film through a traditional tape casting process.
Wherein the thickness of the flat film ranges from 10 μm to 50 μm, the width is more than 10cm, and the compact structure of the flat film is represented as shown in FIG. 3.
Preferably, the flat sheet film has a width in the range of 20cm to 50cm.
Preferably, the flat film has a thickness of 15 μm and a width of 35cm.
S3, cutting the flat film to obtain a first film 400, a second film 500 and a third film 600.
Referring also to fig. 4 to 6, in particular, the flat sheet film is cut into the first, second and third films 400, 500 and 600 using the respective cutting blades according to the required size of the first, second and third film pipes 100, 200 and 300.
Wherein the first diaphragm 400 corresponds to the first film tube 100 and has a first axial edge 410, a first proximal edge 420, and a first distal edge 430. The length of the first axial edge 410 ranges from 40mm to 140mm, the length of the first proximal edge 420 matches the length of the first distal edge 430, and the length ranges from 126mm to 188mm.
Preferably, the first axial edge 410 is 60mm in length and the first proximal edge 420 and the first distal edge 430 are 150mm in length.
The second diaphragm 500 corresponds to the second diaphragm tube 200 and has a second axial edge 510, a second proximal edge 520, and a second distal edge 530. The second axial edge 510 has a length in the range of 20mm to 100mm and the second proximal edge 520 has a length that matches the length of the first distal edge 430 on the first diaphragm 400.
Preferably, the second axial edge 510 has a length of 80mm.
The third diaphragm 600 corresponds to the third diaphragm tube 300 and has a third axial edge 610, a third proximal edge 620, and a third distal edge 630. The third axial edge 610 has a length in the range of 40cm to 140cm, the third proximal edge 620 has a length that matches the length of the second distal edge 530 on the second diaphragm 500 and has a length in the range of 47mm to 110mm, and the third distal edge 630 has a length that is no greater than the length of the third proximal edge 620.
Preferably, the third axial edge 610 has a length of 100cm and the third proximal edge 620 has a length of 80mm.
S4, rolling the first membrane 400 into a tube shape and welding to form a first membrane tube 100, rolling the second membrane 500 into a cone shape and welding to form a second membrane tube 200, and rolling the third membrane 600 into a tube shape and welding to form a third membrane tube 300.
Specifically, the first membrane 400 is curled along the first distal edge 430 into a tubular structure, such that the two first axial edges 410 are in contact, and then the two first axial edges 410 are fixed together by laser welding to form the first membrane tube 100.
Similarly, the second membrane 500 is first rolled into a tubular configuration along the second proximal edge 520, the two second axial edges 510 are brought into contact, and then the two second axial edges 510 are secured together by laser welding to form the second membrane tube 200.
The third membrane 600 is first curled along the third proximal edge 620 into a tubular configuration such that the two third axial edges 610 are in contact, and then the two third axial edges 610 are secured together by laser welding to form the third membrane tube 300.
S5, welding the distal end of the first membrane tube 100 with the proximal end of the second membrane tube 200, and welding the distal end of the second membrane tube 200 with the proximal end of the third membrane tube 300.
S6, obtaining a bracket, and welding the proximal end of the first membranous tube 100 with the bracket to form the digestive tract membranous tube.
In some embodiments, the welding in steps S5 and S6 is also laser welding.
In other embodiments, the welding manner in step S4, step S5 and step S6 may be thermal welding, ultrasonic welding, solvent assisted welding, or the like.
In connection with fig. 7, the friction force was tested as follows: the bottom of a 500 g (namely, 5N) weight is fully coated with the prepared film material to be tested, the film material to be tested is placed on a flattened film tube to be tested, then the weight is pulled to slide at the speed of 1 cm/s, the force required for pulling the weight to slide is tested, and the force required for pulling the weight corresponding to a Polyethylene (PE) film tube with similar thickness is tested. Compared with the force required for pulling the common polyethylene membrane tube by 3.10 newtons, the force required for sliding the weight on the PFA membrane tube is 1.15 newtons, the force is obviously reduced, and the intestinal obstruction phenomenon is obviously reduced after the artificial intestinal obstruction is implanted into a human body. In addition, bacteria are also difficult to attach to the fluorine-containing membrane tube, also reducing the risk of infection.
Secondly, because the fluorine-containing polymer has high melting point and high melt viscosity, the fluorine-containing polymer is difficult to prepare into a thin-wall film tube through blow molding. The wall thickness of the fluoropolymer membrane tube prepared by the traditional polymer extrusion molding processing method is not generally lower than 50 mu m, and the wall thickness is not easy to control. As noted in the background section of US4925710, after extrusion of the fluoropolymer into a hollow tube without the use of a mandrel, thick-walled (above 51 microns) fluoropolymer film tubes can be prepared by subsequent processing; however, when the wall thickness of the membrane tube is less than 50 micrometers, the membrane tube can be kinked, folded or flattened in the subsequent processing process; in addition, the machining precision of the inner diameter of the membrane tube is difficult to control, and the requirement of the medical pipeline on the inner diameter precision of +/-2.5 microns cannot be met. Therefore, the thin-wall membrane tube for the digestive tract made of the fluorine-containing polymer is difficult to prepare by adopting the traditional thermal processing method due to the requirement of the wall thickness of the membrane tube.
In addition, part of the thin-wall membrane tube is made of expanded polytetrafluoroethylene, and has the advantage of low friction coefficient of fluorine-containing materials. However, the thin-wall membrane tube is stretched during preparation, so that a hole structure among fibers is inevitably formed, chyme is permeated into the digestive tract, and bacteria are easily accumulated after long-time implantation to cause infection. Therefore, the thin-walled tube is not suitable for use as a digestive tract tube, and the hole structure thereof is shown in fig. 8.
In contrast, the preparation method firstly prepares the fluorine-containing polymer into the flat membrane, and then the flat membrane is cut and welded to obtain the digestive tract membrane tube, so that the problem that the fluorine-containing polymer is difficult to prepare into the thin-wall tubular structure by the traditional hot processing method can be effectively avoided.
In addition, the surface of the digestive tract membrane tube prepared by the preparation method is compact, chyme can be prevented from penetrating into the digestive tract through the digestive tract membrane tube, the weight reduction effect is ensured, the infection risk caused by the adhesion of bacteria on the wall of the digestive tract membrane tube can be reduced, and the comfort of a patient is improved.
Example 3
Referring to fig. 9, the present embodiment provides a method for preparing a digestive tract membrane tube (hereinafter, simply referred to as a "preparation method"), specifically a dip-coating forming method for preparing the above digestive tract membrane tube. The preparation method comprises the following steps:
s10, selecting the fluorine-containing polymer, and preparing the liquid of the fluorine-containing polymer, wherein the liquid can be solution, suspension, emulsion or the like.
In some embodiments, a Fluorinated Ethylene Propylene (FEP) emulsion is selected and a fluorinated ethylene propylene digestive tract membrane tube is prepared.
In other embodiments, a suspension of the perfluoroethylene propylene may also be prepared.
S20, preparing a membrane core 700 according to the structure of the digestive tract membrane tube.
In conjunction with fig. 10, in particular, the membrane core 700 includes a first segment 710, a second segment 720, and a third segment 730.
Wherein the first segment 710 has the same shape and size as the lumen of the first tube 100, the second segment 720 has the same shape and size as the lumen of the second tube 200, and the third segment 730 has the same shape and size as the lumen of the third tube 300.
In some embodiments, the first section 710, the second section 720, and the third section 730 are integrally formed.
In other embodiments, the releasable connection between the first section 710 and the second section 720, and between the second section 720 and the third section 730 facilitates combining the first section 710, the second section 720, and the third section 730 of different lengths together to produce digestive tract membrane tubes of different shapes and sizes.
Further, the inner wall of the digestive tract membranous tube is integrally formed with a plurality of reinforcing ribs. The strengthening ribs are arranged along the length direction of the digestive tract membrane tube, and a plurality of strengthening ribs are uniformly distributed along the circumference of the digestive tract membrane tube. In addition, the reinforcing rib spans the second membrane tube 200, one end of the reinforcing rib is located on the first membrane tube 100, and the other end of the reinforcing rib is located on the third membrane tube 300.
Above-mentioned strengthening rib can avoid the alimentary canal membrane pipe to take place to fold, and then avoids causing the obstruction, guarantees that chyme passes through smoothly.
Accordingly, the surface of the film core 700 is provided with a plurality of elongated grooves 740. The grooves 740 are the same as and correspond to the reinforcing ribs, and the grooves 740 are used for forming the corresponding reinforcing ribs.
Alternatively, the number of the reinforcing ribs is 12, the length of the reinforcing rib on the first membrane tube 100 is 1cm, and the length of the reinforcing rib on the third membrane tube 300 is 5cm.
S30, dipping and adhering the liquid coated with the fluorine-containing polymer by the film core 700.
Specifically, a polyperfluoroethylene propylene emulsion is dip coated on the film core 700.
In some embodiments, the polyperfluoroethylene propylene emulsion is coated on the film core 700.
In other embodiments, the perfluoroethylene propylene emulsion is dip bonded from the film core 700.
In still other embodiments, the polyperfluoroethylene propylene emulsion is sprayed onto the film core 700.
S40, volatilizing the solvent in the fluoropolymer liquid, and curing to form the first film tube 100, the second film tube 200 and the third film tube 300 with compact surfaces.
Specifically, the film core 700 dip-coated with the fluorinated ethylene propylene emulsion is placed in a forced air oven to dry, and the solvent in the fluorinated ethylene propylene emulsion is volatilized.
And S50, heating the first film tube 100, the second film tube 200 and the third film tube 300 at high temperature to remove the residual solvent.
S60, demolding.
Specifically, after the first film tube 100, the second film tube 200 and the third film tube 300 on the film core 700 are cooled, the film tube structure is formed by demolding, and the compact structure characterization of the surface is shown in fig. 11.
And S70, obtaining a stent, and welding the proximal end of the first membranous tube 100 with the stent to form the digestive tract membranous tube.
Wherein the welding mode is thermal welding, ultrasonic welding, solvent auxiliary welding and the like.
In some embodiments, step S70 may also be omitted, and the stent is fixed on the membrane core 700 in advance in step S20, and the digestive tract membrane tube with the stent is prepared at one time.
In other embodiments, steps S30-S60 are repeated three times to prepare the first film tube 100, the second film tube 200, and the third film tube 300, respectively, and then the stent is welded to the first film tube 100, the first film tube 100 is welded to the second film tube 200, and the second film tube 200 is welded to the third film tube 300.
In other embodiments, step S70 is omitted, and steps S30 to S60 are repeated three times to prepare the first film tube 100, the second film tube 200, and the third film tube 300, respectively. Wherein, the bracket is fixed on the membrane core 700 in advance when preparing the first membrane tube 100, and is integrally formed with the first membrane tube 100. The first film tube 100 is then welded to the second film tube 200, and the second film tube 200 is welded to the third film tube 300.
Referring again to fig. 7, after the digestive tract membrane tube was prepared by the above-described preparation method, the frictional force was measured as follows: the bottom of a 500 g (namely, 5N) weight is fully coated with the prepared film material to be tested, the film material to be tested is placed on a flattened film tube to be tested, then the weight is pulled to slide at the speed of 1 cm/s, the force required for pulling the weight to slide is tested, and the force required for pulling the weight corresponding to a Polyethylene (PE) film tube with similar thickness is tested. Compared with the force required for pulling the common polyethylene membrane tube by 3.10N, the force required for sliding the weight on the FEP is 1.30N, the force is obviously reduced, and the intestinal obstruction phenomenon is obviously reduced after the artificial limb is implanted into a human body. In addition, bacteria are also difficult to attach to the fluorine-containing membrane tube, also reducing the risk of infection.
Example 4
The difference from example 3 is that in step S10, a fluorine-containing acrylic acid homopolymer (PMFA) is selected as a material for preparing a digestive tract membrane tube, and the fluorine-containing acrylic acid homopolymer is dissolved in azodicarbonamide to form a uniform solution.
Repeating the steps S30-S70, and preparing the digestive tract membranous tube or the digestive tract membranous tube with the bracket at one time, wherein the compact structure characterization is shown in figure 12.
Referring again to fig. 7, the friction force was tested as follows: the bottom of a 500 g (namely, 5N) weight is fully coated with the prepared film material to be tested, the film material to be tested is placed on a flattened film tube to be tested, then the weight is pulled to slide at the speed of 1 cm/s, the force required for pulling the weight to slide is tested, and the force required for pulling the weight corresponding to a Polyethylene (PE) film tube with similar thickness is tested. Compared with the common polyethylene material membrane tube which needs 3.10 newtons, the force required by the weight sliding on the PFMA membrane tube is reduced to 1.55 newtons, the force is obviously reduced, and the intestinal obstruction phenomenon is obviously reduced after the membrane tube is implanted into a human body. In addition, bacteria are also difficult to attach to the fluorine-containing membrane tube, also reducing the risk of infection.
Any particular values in all examples shown and described herein are to be construed as merely illustrative and not a limitation, and thus other examples of exemplary embodiments may have different values.
It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.
The above examples merely represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the present application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.
Claims (4)
1. The digestive tract membrane tube is characterized by comprising a first membrane tube, a second membrane tube and a third membrane tube;
the distal end of the first membrane tube is connected with the proximal end of the second membrane tube, the distal end of the second membrane tube is connected with the proximal end of the third membrane tube, the cross-sectional area of the second membrane tube decreases from the proximal end to the distal end, the cross-sectional area of the first membrane tube is not smaller than the cross-sectional area of the proximal end of the second membrane tube, and the cross-sectional area of the third membrane tube is not larger than the cross-sectional area of the distal end of the second membrane tube;
wherein the materials of the first membrane tube, the second membrane tube and the third membrane tube comprise fluorine-containing polymers, the fluorine-containing polymers are fluorine-containing homopolymers or fluorine-containing copolymers, and the wall thicknesses of the first membrane tube, the second membrane tube and the third membrane tube are not smaller than 10 mu m and not larger than 50 mu m;
the digestive tract membrane tube further comprises a reinforcing rib, one end of the reinforcing rib is arranged on the first membrane tube, the middle part of the reinforcing rib is arranged on the second membrane tube, and the other end of the reinforcing rib is arranged on the third membrane tube;
the preparation method of the digestive tract membrane tube comprises the following steps:
selecting a fluoropolymer and preparing a liquid of the fluoropolymer;
preparing a membrane core according to the structure of the digestive tract membrane tube, wherein a groove for forming the reinforcing rib is formed on the surface of the membrane core;
coating or spraying the liquid from the film core;
volatilizing a solvent in the liquid, and solidifying to form the first membrane tube, the second membrane tube and the third membrane tube with compact surfaces;
heating the first, second and third membrane tubes and removing residual solvent;
demolding;
wherein the film core is kept rotating during the volatilization of the solvent.
2. The digestive tract membrane tube of claim 1 further comprising a stent, the proximal end of the first membrane tube being connected to the stent.
3. The gut membrane tube according to claim 2, wherein the gut membrane tube production method further comprises:
after demolding, the stent is obtained and the proximal end of the first membrane tube is welded to the stent.
4. The gut membrane tube according to claim 2, wherein the gut membrane tube production method further comprises:
the stent is obtained and secured to the membrane core prior to dip-coating the liquid from the membrane core.
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| CN115670769A (en) | 2023-02-03 |
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