CN111888049A - Preparation process of 3D hernia repair patch with fixed lock edge - Google Patents

Preparation process of 3D hernia repair patch with fixed lock edge Download PDF

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Publication number
CN111888049A
CN111888049A CN202010874482.9A CN202010874482A CN111888049A CN 111888049 A CN111888049 A CN 111888049A CN 202010874482 A CN202010874482 A CN 202010874482A CN 111888049 A CN111888049 A CN 111888049A
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China
Prior art keywords
hernia repair
repair patch
fixed
preparation process
patch
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CN202010874482.9A
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Chinese (zh)
Inventor
刘冲
郭勇
李绍霞
李彦霞
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Rizhao Tianyi Biomedical Technology Co ltd
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Rizhao Tianyi Biomedical Technology Co ltd
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Priority to CN202010874482.9A priority Critical patent/CN111888049A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes

Abstract

The invention provides a preparation process of a 3D hernia repair patch with a fixed lock stitch, belongs to the technical field of hernia repair patches, and particularly relates to a preparation process of a 3D hernia repair patch with a fixed lock stitch. The method comprises the following steps: step 1, designing a hot-pressing forming device according to a physiological curved surface of a hernia of a patient; step 2, cutting the petal-shaped polypropylene mesh; step 3, heating and shaping: placing the polypropylene undetermined mesh in a hot-pressing forming device, and heating and forming to form a 3D hernia repair patch blank; step 4, cooling and mold taking: cooling to 30-45 deg.c and taking out; step 5, fine trimming and shearing: trimming the redundant waste materials to prepare a 3D hernia repair patch; and 6, packaging and sterilizing a finished product: and sterilizing by adopting ethylene oxide to prepare a finished product of the 3D hernia repair patch. The invention has simple process, good supporting capacity and filling capacity, strong fixing force, shortened operation time and relieved pain of patients.

Description

Preparation process of 3D hernia repair patch with fixed lock edge
Technical Field
The invention belongs to the technical field of hernia repair patches, and particularly relates to a preparation process of a 3D hernia repair patch with a fixed lock stitch.
Background
Hernias, i.e., a portion of a body tissue organ that has left the original site, pass through a body space, defect, or weakness and enter another site. At present, artificial materials are generally adopted for tension-free hernia repair, and the method can relieve postoperative pain and has the advantages of quick recovery, low recurrence rate and the like. Currently, the hernia repair patch produced in China is generally a 2D hernia repair patch, the preparation of the 3D hernia repair patch is still in the initial stage, and the preparation technology is not perfect. For example, the invention patent with the application number of 2019113150781 discloses a 3D hernia repair mesh and a preparation method thereof, wherein the edge area of the 3D hernia repair mesh is woven by adopting a 2+2 false rib process and a needle retracting and releasing process, and when the 3D hernia repair mesh prepared by the weaving method is clinically applied, the 3D hernia repair mesh invades the edge area of the 3D hernia repair mesh along with the growth of human tissues, so that the woven yarns are easy to loosen and lose stability. For example, the invention patent with the application number of 2019100327529 discloses a three-dimensional hernia repair patch with anti-curling property and a preparation method thereof, wherein a three-dimensional main body part and an edge reinforcing part of the three-dimensional inguinal hernia repair patch are subjected to two times of hot pressing treatment, the two times of hot pressing treatment method is complex in process and high in manufacturing cost, and burrs are easily cut off from the three-dimensional main body part and the edge reinforcing part, so that human tissues are stabbed, and pain of patients is increased. Therefore, the preparation process of the 3D hernia repair patch with the fixing overlock is urgently needed to be developed, and the preparation process is simple in process and strong in fixing force.
Disclosure of Invention
The invention aims to provide a preparation process of a 3D hernia repair patch with a fixed lock edge, so as to achieve the purposes of simple process, strong fixing force, shortened operation time and relieved pain of a patient.
The invention provides a preparation process of a 3D hernia repair patch with a fixed serging, which is characterized by comprising the following steps of:
step 1, designing a hot-pressing forming device according to the physiological curved surface of the hernia of a patient:
the hot-pressing forming device comprises a base, a cover plate and a 3D pressing block movably arranged between the base and the cover plate; the bottom of the 3D pressing block is provided with a 3D curved surface matched with the physiological curved surface of the hernia; the base is provided with a 3D groove matched with the 3D curved surface; fixed overlock processing grooves are formed in the periphery of the 3D groove; the cover plate is provided with a buckling groove matched with the upper end of the 3D pressing block; fixed overlock processing grooves are formed in the periphery of the buckling groove;
step 2, cutting the petal-shaped polypropylene mesh:
cutting the polypropylene mesh into polypropylene mesh to be shaped;
step 3, heating and shaping:
placing the polypropylene undetermined mesh sheet in a hot-pressing forming device for heating and forming, wherein the pressure is 4-8 Mpa, the heating temperature is 90-200 ℃, and the heating time is 8-15 s, so that a 3D herniorrhaphy sheet blank is formed;
step 4, cooling and mold taking:
cooling the 3D hernia repair patch blank shaped in the step 3 to 30-45 ℃, and taking out;
step 5, fine trimming and shearing:
trimming the redundant waste materials away from the fixed lockrand of the 3D herniorrhaphy patch blank to obtain a 3D herniorrhaphy patch;
and 6, packaging and sterilizing a finished product:
and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide to prepare the 3D hernia repair patch finished product.
Further, the side of 3D briquetting is provided with the physiology adaptation district, and is corresponding, and base and apron are provided with the physiology adaptation district.
Furthermore, the physiological adaptation area is an inward-concave arc-shaped area, and the arc radian of the arc-shaped area is 100-140 degrees.
Further, the 3D pressing block is provided with a through hole, and the through hole penetrates through the 3D pressing block; the cover plate is provided with a release hole, and the release hole is matched with the through hole.
Furthermore, the upper portion of base is provided with the fixed column all around, and the bottom of apron is provided with the fixed slot with fixed column looks adaptation all around.
Further, be provided with the lockage limit groove around the 3D recess, it is corresponding to have the lockage limit groove rather than setting up around the lock recess.
Further, cutting the polypropylene mesh into polypropylene mesh to be shaped by using a laser engraving machine, wherein the cutting speed of the laser engraving machine is 5-20 mm/s.
Further, the polypropylene undetermined mesh sheet is placed in a hot-pressing forming device for heating and forming, wherein the pressure is 6Mpa-7Mpa, the heating temperature of the cover plate is 150 ℃ -200 ℃, the heating temperature of the base is 90 ℃ -120 ℃, and the heating time is 8-12 s, so that a 3D hernia repair sheet blank is formed through forming.
Furthermore, the concentration of the ethylene oxide is 700mg/L-900mg/L, the sterilization pressure is 0.06MPa-0.12MPa, the sterilization humidity is 60% -79%, the sterilization temperature is 56 ℃ -77 ℃, and the sterilization time is 12h-15 h.
Furthermore, the concentration of the ethylene oxide is 750mg/L-850mg/L, the sterilization pressure is 0.08MPa-0.10MPa, the sterilization humidity is 65% -75%, the sterilization temperature is 65 ℃ -75 ℃, and the sterilization time is 12h-15 h.
The preparation process of the 3D hernia repair patch with the fixed serging mainly has the following innovation points and beneficial effects:
1. according to the preparation process of the 3D hernia repair patch with the fixed lockstitch provided by the invention, the hot-pressing forming device is provided with the 3D groove and the fixed lockstitch processing groove, the 3D pressing block is slowly heated, the temperature is low, and the polypropylene mesh in the 3D groove of the base can be shaped to form a three-dimensional main body part. The base and the cover plate are respectively and rapidly heated, the fixed lockstitching processing grooves of the base and the cover plate are not provided with 3D pressing blocks, the heating is rapid, the temperature is high, and the polypropylene mesh can be melted by hot pressurization to form the fixed lockstitching. The preparation of the three-dimensional main body part and the fixed lockstitch can be completed only by carrying out one-time hot pressing, the process is simple, the manufacturing cost is low, the three-dimensional main body part and the fixed lockstitch are of an integrally formed structure, trimming is not needed, burrs are not left, human tissues are not stabbed, and pain of a patient is relieved.
2. According to the preparation process of the 3D hernia repair patch with the fixed overlock, the 3D curved surface at the bottom of the 3D pressing block, the shape and the radian of the physiological adaptation area and the like are designed by combining with the physiological structure of the human body, are adapted to the human body structure of a patient, can combine with the physiological characteristics of the patient, can perform a hernia repair operation quickly, and avoids damaging other tissue structures.
3. According to the preparation process of the 3D hernia repair patch with the fixed serging, provided by the invention, the 3D pressing block is placed on the 3D hernia repair patch blank, so that the hernia repair patch blank can be prevented from being adhered and adsorbed on the cover plate and being prevented from deforming.
4. According to the preparation process of the 3D hernia repair patch with the fixed serging, provided by the invention, after heating and shaping, the mould is cooled and taken, so that the 3D hernia repair patch blank can be prevented from deforming to influence the operation effect.
5. The preparation process of the 3D hernia repair patch with the fixed serging, provided by the invention, packages the finished product, and adopts ethylene oxide for sterilization, so that the mesh plug type patch is sterile, and meets the clinical use requirements.
6. The invention provides a preparation process of a 3D hernia repair patch with a fixed overlock, which is characterized in that the sampling inspection result of a mesh plug type patch processed and prepared is as follows:
Figure DEST_PATH_IMAGE002A
as can be seen from the above table, the 3D hernia repair patch with the fixing overlock prepared by the preparation process of the 3D hernia repair patch with the fixing overlock provided by the invention can meet the related technical requirements.
The 3D hernia repair patch with the fixing overlock is prepared by the preparation process of the 3D hernia repair patch with the fixing overlock, and the fixing overlock can prevent the patch body from dispersing and keep tension. When in operation, the medical doctor can automatically form and fix the surgical clamp after placing the surgical clamp on a human body, and tools such as operating forceps and tweezers are not needed to be used for stretching and fixing, so that the operation time is obviously shortened. Therefore, the invention has simple process, good supporting capability and filling capability, strong fixing force, shortened operation time and relieved pain of patients.
Drawings
The accompanying drawings disclose, in part, specific embodiments of the present invention, wherein,
FIG. 1 is a process flow diagram of the present invention;
FIG. 2 is a schematic view showing the structure of the hot press molding apparatus of the present invention;
FIG. 3 is a top view of the base structure of the present invention;
FIG. 4 is a top view of the structure of a 3D compact of the present invention;
fig. 5 is a schematic structural view of the upper cover of the present invention.
Detailed Description
The invention is further illustrated by the following examples.
Example 1:
step 1, designing a hot-pressing forming device 4 according to the physiological curved surface of the hernia of the patient: if the physiological curved surface of the hernia disease of the patient needs the 3D hernia repair patch with the fixed locking edge of D15cm, the design specification of the hot press forming device 4 is D15 cm. The hot-press molding device 4 comprises a base 1, a cover plate 2 and a 3D pressing block 3 movably arranged between the base and the cover plate; the bottom of the 3D pressing block 3 is provided with a 3D curved surface 31 matched with the physiological curved surface of the hernia; the base 1 is provided with a 3D groove 11 matched with the 3D curved surface; a fixed overlock processing groove 14 is formed in the periphery of the 3D groove 11, and the width of the fixed overlock processing groove 14 is about 1.0-2.0 mm; the cover plate 2 is provided with a buckling groove 21 matched with the upper end of the 3D pressing block 3; the periphery of the buckling groove 21 is provided with a fixed serging processing groove 14, and the width of the fixed serging processing groove 14 is about 1.0-2.0 mm.
Step 2, cutting the petal-shaped polypropylene mesh: and (3) cutting the polypropylene mesh into the polypropylene mesh 5 to be shaped by using a laser engraving machine, wherein the cutting speed of the laser engraving machine is 5-20 mm/s.
Step 3, heating and shaping: and (3) placing the polypropylene undetermined mesh sheet in a hot-pressing forming device for heating and forming, wherein the pressure is 4Mpa-8Mpa, the heating temperature is 90-200 ℃, and the heating time is 8-15 s, so that a 3D herniorrhaphy sheet blank is formed.
Step 4, cooling and mold taking: and (4) cooling the 3D hernia repair patch blank shaped in the step (3) to 30-45 ℃, and taking out.
Step 5, fine trimming and shearing: trimming the redundant waste materials away from the fixed lockrand of the 3D herniorrhaphy patch blank to obtain the 3D herniorrhaphy patch 7.
And 6, packaging and sterilizing a finished product: and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide, wherein the concentration of the ethylene oxide is 700-900 mg/L, the sterilization pressure is 0.06-0.12 MPa, the sterilization humidity is 60-79%, the sterilization temperature is 56-77 ℃, and the sterilization time is 12-15 h, so that the 3D hernia repair patch finished product is prepared.
Example 2:
step 1, designing a hot-pressing forming device 4 according to the physiological curved surface of the hernia of the patient: if the physiological curvature of the hernia disease of the patient requires the 3D hernia repair patch with the fixed locking edge of D12cm, the design specification of the hot press forming device 4 is D12 cm. The side of the 3D pressing block 3 is provided with a physiological adaptation area 34, and correspondingly, the base 1 and the cover plate 2 are provided with the physiological adaptation area 34. The physiological adaptation zone 34 is an inwardly concave arc-shaped zone, and the arc radian of the arc-shaped zone is 110 degrees.
Step 2, cutting the petal-shaped polypropylene mesh: cutting the polypropylene mesh into a polypropylene mesh 5 to be shaped by using a BCL0406N standard laser engraving machine, wherein the cutting speed of the laser engraving machine is 12-18 mm/s;
step 3, heating and shaping: the mesh 5 to be shaped of polypropylene is placed in a 3D groove 21 of a hot-pressing forming device 4, the bottom of a 3D pressing block 3 is placed in the 3D groove 21 of a base 1, and a buckling groove 21 of a cover plate 2 is installed on the upper portion of the 3D pressing block. And the polypropylene mesh 5 is fixed in the base 1 and the cover plate 2 through the 3D pressing block 3. And (3) placing the base 1, the cover plate 2 and the 3D pressing block 3 together with the polypropylene mesh 5 in the base on a full-automatic plate vulcanizing machine for heating and shaping, wherein the pressure is 6Mpa, the heating temperature of the cover plate is 150-200 ℃, the heating temperature of the base is 90-120 ℃, and the heating time is 8-12 s, so that a 3D hernia repair patch blank is shaped.
Step 4, cooling and mold taking: and (4) cooling the 3D hernia repair patch blank shaped in the step (3) to 30-45 ℃, opening the cover plate 2, and taking out the 3D hernia repair patch blank.
Step 5, fine trimming and shearing: trimming the redundant waste materials which are 1mm-2mm away from the fixed overlock of the 3D herniorrhaphy patch blank to obtain the 3D herniorrhaphy patch 7.
And 6, packaging and sterilizing a finished product: and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide, wherein the concentration of the ethylene oxide is 750-850 mg/L, the sterilization pressure is 0.08-0.10 MPa, the sterilization humidity is 65-75%, the sterilization temperature is 65-75 ℃, and the sterilization time is 12-15 h.
Example 3:
step 1, designing a hot-pressing forming device 4 according to the physiological curved surface of the hernia of the patient: if the physiological curvature of the hernia disease of the patient requires the 3D hernia repair patch with the fixed locking edge of D10cm, the design specification of the hot press forming device 4 is D10 cm. The side of the 3D pressing block 3 is provided with a physiological adaptation area 34, and correspondingly, the base 1 and the cover plate 2 are provided with the physiological adaptation area 34. The physiological adaptation zone 34 is an inwardly concave arc-shaped zone, and the arc radian of the arc-shaped zone is 120 degrees.
Step 2, cutting the petal-shaped polypropylene mesh: and (3) cutting the polypropylene mesh into the polypropylene mesh 5 to be shaped by using a laser engraving machine, wherein the cutting speed of the laser engraving machine is 6-10 mm/s.
Step 3, heating and shaping: the mesh 5 to be shaped of polypropylene is placed in a 3D groove 21 of a hot-pressing forming device 4, the bottom of a 3D pressing block 3 is placed in the 3D groove 21 of a base 1, and a buckling groove 21 of a cover plate 2 is installed on the upper portion of the 3D pressing block. And the polypropylene mesh 5 is fixed in the base 1 and the cover plate 2 through the 3D pressing block 3. And (3) placing the base 1, the cover plate 2 and the 3D pressing block 3 together with the polypropylene mesh 5 in the base on a full-automatic plate vulcanizing machine for heating and shaping, wherein the pressure is 5Mpa, the heating temperature of the cover plate is 190 ℃, the heating temperature of the base is 110 ℃, and the heating is carried out for 9s, so as to shape the 3D herniorrhaphy patch blank.
Step 4, cooling and mold taking: and (4) cooling the 3D hernia repair patch blank shaped in the step (3) to 40 ℃, opening the cover plate 2, and taking out the 3D hernia repair patch blank.
Step 5, fine trimming and shearing: trimming the redundant waste materials which are 1.5mm away from the fixed lock seaming of the 3D herniorrhaphy patch blank to obtain the 3D herniorrhaphy patch 7.
And 6, packaging and sterilizing a finished product: and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide, wherein the concentration of the ethylene oxide is 790mg/L, the sterilization pressure is 0.09MPa, the sterilization humidity is 67%, the sterilization temperature is 67 ℃, and the sterilization time is 13 h.
Example 4:
step 1, designing a hot-pressing forming device 4 according to the physiological curved surface of the hernia of the patient: if the physiological curved surface of the hernia disease of the patient needs D12.5cm of the 3D hernia repair patch with the fixed locking edge, the design specification of the hot pressing forming device 4 is D12.5cm. The side of the 3D pressing block 3 is provided with a physiological adaptation area 34, and correspondingly, the base 1 and the cover plate 2 are provided with the physiological adaptation area 34. The physiological adaptation zone 34 is an inwardly concave arc-shaped zone, and the arc radian of the arc-shaped zone is 130 degrees.
Step 2, cutting the petal-shaped polypropylene mesh: and (3) cutting the polypropylene mesh into the polypropylene mesh 5 to be shaped by using a laser engraving machine, wherein the cutting speed of the laser engraving machine is 14-16 mm/s.
Step 3, heating and shaping: the mesh 5 to be shaped of polypropylene is placed in a 3D groove 21 of a hot-pressing forming device 4, the bottom of a 3D pressing block 3 is placed in the 3D groove 21 of a base 1, and a buckling groove 21 of a cover plate 2 is installed on the upper portion of the 3D pressing block. And the polypropylene mesh 5 is fixed in the base 1 and the cover plate 2 through the 3D pressing block 3. And (3) placing the base 1, the cover plate 2 and the 3D pressing block 3 together with the polypropylene mesh 5 in the base on a full-automatic flat vulcanizing machine for heating and shaping, wherein the pressure is 7Mpa, the heating temperature of the cover plate is 170 ℃, the heating temperature of the base is 100 ℃, and the heating is carried out for 11s, so as to shape the 3D herniorrhaphy patch blank.
Step 4, cooling and mold taking: and (4) cooling the 3D hernia repair patch blank shaped in the step (3) to 35 ℃, opening the cover plate 2, and taking out the 3D hernia repair patch blank.
Step 5, fine trimming and shearing: and trimming the redundant waste materials which are 2mm away from the fixed overlock of the 3D herniorrhaphy patch blank to obtain the 3D herniorrhaphy patch 7.
And 6, packaging and sterilizing a finished product: and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide, wherein the concentration of the ethylene oxide is 810mg/L, the sterilization pressure is 0.070MPa, the sterilization humidity is 62%, the sterilization temperature is 62 ℃, and the sterilization time is 14 h.
Example 5:
as shown in fig. 3, 4 and 5, the side of the 3D pressing block 3 is provided with a physiological adaptation area 34, and correspondingly, the base 1 and the cover plate 2 are provided with the physiological adaptation area 34. The physiological adaptation area 34 is an inward-concave arc-shaped area, and the arc radian of the arc-shaped area is 100-140 degrees. The physiological adaptation area 34 is adapted to the human body structure of the patient, especially to the structures of organs such as vas deferens, testicular vessels, nerves and the like of the male patient, and can combine the physiological characteristics of the male patient to avoid the injury of the male patient.
Example 6:
as shown in fig. 4 and 5, the 3D pressing block 3 is provided with a through hole 33, and the through hole 33 penetrates through the 3D pressing block 3; the cover plate 2 is provided with a release hole 23, and the release hole 23 is matched with the through hole 33. When base 1 and apron 2 lock joint, the steam that the 3D recess 11 hot pressurization in-process produced can discharge through-hole 33, avoids steam to remain in 3D recess 11, makes the polypropylene net piece in it produce protruding deformation. The hot air generated in the hot pressing process of the 3D groove 11 enters the release holes 23 for buffering after passing through the through holes 33, and is gradually discharged to the outer sides of the base 1 and the cover plate 2.
Example 7:
as shown in fig. 2, 3 and 5, the fixing posts 12 are disposed around the upper portion of the base 1, and the fixing slots 22 adapted to the fixing posts 12 are disposed around the bottom of the cover plate 2. The fixed column 12 and the fixed slot 22 of mutual adaptation can make base 1, apron 2 and 3D briquetting 3 inseparabler lock together, carry out rapid heating design to the polypropylene net piece in the 3D recess 11. The quantity of fixed column 12 is 4, and 4 fixed column 12 symmetric distributions are around base 1, and the longitudinal section of fixed column 12 is isosceles trapezoid, and fixed column 12 is the round platform shape that upper end cross sectional area is little, and lower extreme cross sectional area is big. Correspondingly, the quantity of fixed slot 22 is 4, and 4 fixed slot 22 symmetric distributions are around apron 2, and the longitudinal section of fixed slot 22 is isosceles trapezoid, and fixed slot 22 is that the upper end cross sectional area is little promptly, and the big round platform of lower extreme cross sectional area is described. The fixing column 12 and the fixing groove 22 in the shape of a truncated cone can enable the fixing column 12 to be quickly installed in the fixing groove 22, so that the base 1 and the cover plate 2 can be conveniently buckled, and time is saved.
Example 8:
as shown in fig. 3 and 5, the 3D groove 11 is provided with a locking edge groove 13 around, and correspondingly, the locking groove 21 is provided with a locking edge groove 13 around. The overlock groove 13 can generate overlock around the 3D herniorrhaphy patch blank when the base 1, the cover plate 2 and the 3D pressing block 3 are subjected to hot pressing to form the 3D herniorrhaphy patch blank, so that the 3D herniorrhaphy patch blank can be trimmed accurately and finished into the 3D herniorrhaphy patch.

Claims (10)

1. A preparation process of a 3D hernia repair patch with a fixed serging is characterized by comprising the following steps:
step 1, designing a hot-pressing forming device (4) according to the physiological curved surface of the hernia of the patient:
the hot-pressing forming device (4) comprises a base (1), a cover plate (2) and a 3D pressing block (3) movably arranged between the base and the cover plate; the bottom of the 3D pressing block (3) is provided with a 3D curved surface (31) matched with the physiological curved surface of the hernia; the base (1) is provided with a 3D groove (11) matched with the 3D curved surface; fixed overlocking processing grooves (14) are formed in the periphery of the 3D groove (11); the cover plate (2) is provided with a buckling groove (21) matched with the upper end of the 3D pressing block (3); fixed overlock processing grooves (14) are arranged around the buckling groove (21);
step 2, cutting the petal-shaped polypropylene mesh:
cutting the polypropylene mesh into polypropylene mesh (5) to be shaped;
step 3, heating and shaping:
placing the polypropylene mesh (5) to be shaped in a hot-press forming device (4) for heating and shaping, wherein the pressure is 4Mpa-8Mpa, the heating temperature is 90-200 ℃, and the heating time is 8s-15s, so as to shape a 3D herniorrhaphy patch blank (6);
step 4, cooling and mold taking:
cooling the 3D hernia repair patch blank shaped in the step 3 to 30-45 ℃, and taking out;
step 5, fine trimming and shearing:
trimming the excess waste materials outside the fixed overlocking of the 3D herniorrhaphy patch blank to obtain a 3D herniorrhaphy patch (7);
and 6, packaging and sterilizing a finished product:
and (5) packaging the 3D hernia repair patch in the step (5) into a finished product, and sterilizing by adopting ethylene oxide to prepare the 3D hernia repair patch finished product.
2. The preparation process of the 3D hernia repair patch with the fixed overlock according to claim 1, wherein the side of the 3D pressing block (3) is provided with a physiological adaptation area (34), and correspondingly, the base (1) and the cover plate (2) are provided with the physiological adaptation area (34).
3. The process for preparing a 3D hernia repair patch with a fixed overlock according to claim 2, wherein the physiologically compatible region (34) is an inwardly concave circular arc with an arc radian of 100-140 °.
4. The preparation process of the 3D hernia repair patch with the fixed overlock according to claim 1, wherein the 3D pressing block (3) is provided with a through hole (33), and the through hole (33) penetrates through the 3D pressing block (3); the cover plate (2) is provided with a release hole (23), and the release hole (23) is matched with the through hole (33).
5. The preparation process of the 3D hernia repair patch with the fixing overlock according to claim 1, wherein fixing columns (12) are arranged around the upper portion of the base (1), and fixing grooves (22) matched with the fixing columns (12) are arranged around the bottom of the cover plate (2).
6. The preparation process of the 3D hernia repair patch with the fixed overlock according to claim 1, wherein overlock grooves (13) are formed around the 3D groove (11), and correspondingly, overlock grooves (13) are correspondingly formed around the buckling groove (21).
7. The preparation process of the 3D hernia repair patch with the fixed overlock according to claim 1, wherein a laser engraving machine is used to trim the polypropylene mesh into the polypropylene mesh (5) to be shaped, and the cutting speed of the laser engraving machine is 5mm/s-20 mm/s.
8. The preparation process of the 3D hernia repair patch with the fixed overlock according to claim 1, wherein the polypropylene mesh (5) to be shaped is placed in a hot-press forming device (4) for heating and shaping, wherein the pressure is 6MPa to 7MPa, the cover plate heating temperature is 150 ℃ to 200 ℃, the base heating temperature is 90 ℃ to 120 ℃, and the heating time is 8s to 12s, so that a 3D hernia repair patch blank is shaped.
9. The preparation process of the 3D hernia repair patch with the fixed serging, according to claim 1, wherein the concentration of the ethylene oxide is 700mg/L-900mg/L, the sterilization pressure is 0.06MPa-0.12MPa, the sterilization humidity is 60% -79%, the sterilization temperature is 56-77 ℃, and the sterilization time is 12h-15 h.
10. The preparation process of the 3D hernia repair patch with the fixed serging, according to claim 9, wherein the concentration of the ethylene oxide is 750mg/L to 850mg/L, the sterilization pressure is 0.08MPa to 0.10MPa, the sterilization humidity is 65% to 75%, the sterilization temperature is 65 ℃ to 75 ℃, and the sterilization time is 12h to 15 h.
CN202010874482.9A 2020-08-27 2020-08-27 Preparation process of 3D hernia repair patch with fixed lock edge Pending CN111888049A (en)

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CN109771085A (en) * 2019-01-14 2019-05-21 东华大学 A kind of three-dimensional hernia reparation sticking patch and preparation method thereof with anti-edge-rolling
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