CN114452034A - Soft tissue repair stent and preparation method thereof - Google Patents
Soft tissue repair stent and preparation method thereof Download PDFInfo
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- CN114452034A CN114452034A CN202111557228.7A CN202111557228A CN114452034A CN 114452034 A CN114452034 A CN 114452034A CN 202111557228 A CN202111557228 A CN 202111557228A CN 114452034 A CN114452034 A CN 114452034A
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- A61F—FILTERS 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
- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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- A61F2/00—Filters 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
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Abstract
The invention relates to the technical field of medical materials, and particularly discloses a soft tissue repair stent and a preparation method thereof. The soft tissue repair scaffold is formed by weaving medical fibers, has a net structure, has the porosity of 12-50 percent and the weight per unit area of 100g/m2～300g/m2The thickness is 0.5-3mm, and the deformation rate under the tensile strength of 16N/cm is less than or equal to 20 percent. The soft tissue repair bracket provided by the invention has the advantages of small deformation rate, excellent mechanical property, moderate thickness, low possibility of creep deformation and tearing in the use process, proper stiffness, and suitability for the structural characteristics of joint soft tissues, and can be widely applied to the repair of the joint soft tissues such as rotator cuff, patella, achilles tendon, biceps or quadriceps tendon, and the like.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a soft tissue repair stent and a preparation method thereof.
Background
Soft tissue injury caused by surgical operation, trauma, diseases and the like is one of common clinical diseases, and seriously threatens human health. The traditional methods for treating soft tissue injury or defect include autograft and allograft, but these methods have the problems of limited donor, large secondary damage to patients and immunological rejection. In recent years, the method of applying tissue engineering technology, with the help of artificially prepared repair products, repairs and replaces damaged soft tissues to become a hot spot.
With the popularization of the fitness exercises of the whole people, the tearing and injury amount of joint soft tissues such as tendons, ligaments and joint capsules caused by the exercises is increased year by year. Once injury occurs, inconvenience is brought to life of a patient, and in addition, joint soft tissue regeneration capacity is poor, repair is required to last for months or even years, so that more and more patients select surgical repair. In the existing operation repair process, a common hernia patch is mainly cut into a certain shape on site by a doctor and is directly or jointly used with autologous tissues (such as fascia lata, biceps and the like) to be implanted into a patient body so as to be used for repairing and reinforcing joint soft tissues such as rotator cuff, patella, achilles tendon, biceps or quadriceps tendon and the like.
Because the existing repair product has large deformation rate, for example, under the pretension force of 10-20N, the deformation rate of a common hernia patch is 20-70%, and the patch is easy to creep, so that the operation fails. In addition, the existing patch has low sewing strength and tensile strength and insufficient thickness, and is frequently used by being overlapped in multiple layers. The patch is easy to relapse and tear due to the breakage of the patch, human tissues are difficult to grow in, scar plates and inflammatory reaction are easy to form, and the multi-layer patch needs to be subjected to edge suture connection by a doctor on site by using sutures, so that the deformation rate of the inside and the edge of the patch is different, and complications such as lasting pain and the like are easy to generate.
In conclusion, in order to meet clinical requirements, it is of great significance to design joint soft tissue repair products with excellent performance and moderate thickness.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a soft tissue repair stent and a preparation method thereof.
In a first aspect, the invention provides a soft tissue repair stent, which adopts the following technical scheme:
a soft tissue repairing scaffold is woven by medical fibers, has a reticular structure, has a porosity of 12-50 percent and a unit area weight of 100g/m2～300g/m2The thickness is 0.5-3 mm.
The soft tissue repair scaffold provided by the scheme is of a net structure with appropriate porosity, and is beneficial to local tissue growth; the bracket has proper weight per unit area, proper thickness and difficult deformation, can play an effective supporting role on soft tissues after being implanted into a human body, is particularly suitable for repairing joint soft tissues, can meet the tissue repairing requirement by using a single piece, does not need edge sewing connection, and can effectively avoid the formation of scar plates and inflammatory reaction.
Preferably, the bursting strength of the soft tissue repair scaffold is more than or equal to 50N/cm, the tensile strength is more than or equal to 95N, the tearing strength is more than or equal to 20N, and the suture strength is more than or equal to 32N.
Preferably, the deformation rate of the soft tissue repair support under the tensile strength of 16N/cm is less than or equal to 20%.
Above-mentioned soft tissue repair support has the mechanical properties of preferred, can effectively prevent to relapse because of the affected part that the support fracture leads to tears, and the support deformation rate is little, is difficult for taking place the creep, is particularly useful for articular soft tissue's restoration, can guarantee the operation success rate.
Preferably, the diameter of the longitude aperture of the soft tissue repairing support is 1mm-8mm, and the diameter of the latitudinal aperture of the soft tissue repairing support is 0.5mm-4 mm.
The warp aperture is the aperture parallel to the weaving direction, the weft aperture is the aperture vertical to the weaving direction, through controlling the proper aperture, the tissue cell growth and the infiltration of macrophage and leucocyte are more facilitated, the anti-infection capability is strong, and the incidence rate of postoperative complications can be effectively reduced.
Preferably, the medical fiber of the woven soft tissue repair scaffold is a single strand fiber.
Preferably, the single-strand fiber comprises 1 to 10 fiber filaments, and each fiber filament has a diameter of 0.08 to 0.24 mm.
Specifically, the diameter and number of filaments contained in each strand of fiber are the same.
Further, when the diameter of the fiber filament is 0.08-0.14mm, the single-strand fiber contains 2-10 fiber filaments, preferably 3-6 fiber filaments; the single-strand fiber contains 1 to 7 filaments, preferably 2 to 3 filaments, when the filament diameter is 0.14 to 0.20 mm; when the filament diameter is larger than 0.20mm, the single-strand fiber contains 1 to 3 filaments, preferably 1 to 2 filaments.
The human body is implanted to the soft tissue repair support that this scheme provided when using, has extremely strict requirement to its security, adopts the single strand fibre to weave, can avoid the pollution of impurity, dust etc. of carrying secretly between each strand fibre among the multistrand fibre weaving process, and the product is changeed and is washd, can effectively guarantee the cleanliness factor and the security of soft tissue support product. By controlling the diameter and the number of the fibers in each strand of fibers, soft tissue repair supports with different specifications and excellent mechanical properties can be prepared, and a patient can conveniently select the soft tissue repair supports according to the actual condition of the repaired part.
Preferably, the fiber material for preparing the soft tissue repair scaffold can be one or more of polyethylene terephthalate, polypropylene, polyethylene, polylactic acid, polyglycolic acid, polycaprolactone, chitosan and silk fibroin.
Different fiber materials can be selected according to the specific condition of the soft tissue to be repaired. If the damaged soft tissue needs to be supported and repaired for a long time, the non-degradable fiber-like material is preferable, and if the damaged soft tissue only needs to be supported and repaired for a short time, the degradable fiber-like material is preferable. The factors such as biomechanical strength, material sources and the like are comprehensively considered, the non-degradable fiber material is preferably polyethylene terephthalate and polypropylene, and the degradable fiber material is preferably polylactic acid and polycaprolactone.
Preferably, the soft tissue repair scaffold is triangular, rectangular, rhombic, hexagonal, horseshoe-shaped, oval or dumbbell-shaped, and the length and the width of the repair scaffold are respectively 20-200mm and 20-80 mm.
Adopt above-mentioned technical scheme, prepare into different specification and shape with soft tissue repair support, during the later stage use, be convenient for choose for use according to waiting to restore the area of soft tissue and the position that locates, the length direction of above-mentioned restoration support is parallel to or perpendicular to and weaves the direction, preferably is on a parallel with the direction of weaving to make fibre direction unanimous with the load direction when using, the adaptation tissue deformation that can be better, the repair effect is better.
On the other hand, the invention provides a preparation method of the soft tissue repair scaffold, which adopts the following technical scheme:
a preparation method of a soft tissue repair stent comprises the following process steps: warping, weaving, shaping, cutting and post-processing. The knitting step is carried out on a warp knitting machine, medical fibers enter a looping system according to a certain warp let-off amount, and a yarn guide needle performs regular yarn laying motion according to yarn laying numbers to form a net-shaped structure.
The warping step is to wind monofilament evenly on a warp beam with certain tension according to the number and length required by the weaving process for the warp knitting machine, and belongs to a conventional operation mode.
Preferably, the weaving step uses three guide bars, specifically, two symmetrical variable warp-flat weaves form a net structure, and one weft insertion weave reinforces meshes; or two symmetrical warp satin weaves form a net structure, and one weft insertion weave reinforces the meshes. Setting proper technological parameters in the weaving process, wherein the transverse density is 15-95 wales/5 cm, and preferably 20-55 wales/5 cm; the density in the machine direction is 15-90 courses/5 cm, preferably 20-50 courses/5 cm.
In the weaving step, the same fibers are used for at least two guide bars constituting the net structure, i.e. the single fibers used for each guide bar have the same filament diameter and number. The fibres used by the bars for reinforcing the meshes may have different diameters of filaments from those used by the other two bars, and the diameter of the filaments is adjacent to that used by the two bars, if the fibres used by the two bars constituting the mesh structure consist of filaments with a diameter of 0.12mm, the fibres used by the bars for reinforcing the meshes may consist of filaments with a diameter of 0.10mm, 0.12mm or 0.14 mm.
Preferably, the three guide bars use the same fibers, i.e. the single fibers used by each guide bar have the same number of filaments and contain filaments of the same diameter.
In addition to the preferred weaving pattern described above, the weaving step may also use two guide bars with varying warp knit stitches forming a web structure, each guide bar using individual fibers having the same filament diameter and number.
The shaping step is that the thermoplastic property of the fiber is utilized to heat the chemical fiber fabric to the required temperature under certain tension, and the chemical fiber fabric is heated for a period of time at the temperature and then is rapidly cooled to keep the size and the shape of the fabric stable. The setting temperature of the fiber fabric is usually between 80 ℃ and 180 ℃, the setting is completed within 0.5-30min, the setting can be selected according to the performance of the fabric material, the setting operation is preferably performed at 120-160 ℃, the specific time is determined by the thermoplasticity and the thickness specification of the fabric material, and the setting time is usually within 2-10 min.
The cutting means that the shaped mesh-shaped braided fabric is cut into shapes of triangles, rectangles, rhombuses, hexagons, horseshoe shapes, ellipses, dumbbell shapes and the like with different specifications according to the specific application of the soft tissue repair support, namely the area and the position of the soft tissue to be repaired.
The post-treatment refers to the treatment of cleaning, packaging, sterilizing, analyzing and the like of the reticular stent cut into different specifications and shapes so as to obtain a final product of the medical soft tissue repair stent. The cleaning step of the scheme of the invention is carried out in a mode of combining one or more of pure water ultrasonic cleaning, pure water soaking cleaning, solvent ultrasonic cleaning or solvent soaking cleaning, and the solvent is preferably one or a combination of more of 0.1-20% of methyl butanone, methyl isobutyl ketone, ethanol, methanol, isopropanol, acetone, methyl acetate, ethyl acetate and propyl acetate aqueous solution.
By adopting the technical scheme, the prepared soft tissue repair scaffold has proper porosity, proper weight per unit area, proper thickness and difficult deformation, can effectively support soft tissues after being implanted into a human body, and is particularly suitable for repairing joint soft tissues.
In summary, the invention has the following beneficial technical effects:
1. the soft tissue repair scaffold provided by the scheme is of a net structure with appropriate porosity, and is beneficial to local tissue growth; the bracket has proper weight per unit area, proper thickness and difficult deformation, can play an effective supporting role on soft tissues after being implanted into a human body, is particularly suitable for repairing joint soft tissues, can meet the tissue repairing requirement by using a single piece, does not need edge sewing connection, and can effectively avoid the formation of scar plates and inflammatory reaction.
2. This scheme chooses suitable material for use, adopts the single strand fibre to weave, can avoid the pollution of impurity, dust etc. of the in-process smuggleing secretly between each strand fibre of stranded fibre, and the product is changeed and is washd, can effectively guarantee the cleanliness factor and the security of soft tissue support product. By controlling the diameter and the number of the fibers in each strand of fibers, soft tissue repair supports with different specifications and excellent mechanical properties can be prepared, and the soft tissue repair supports can be conveniently selected according to the actual conditions of the repaired parts.
3. The soft tissue repair support provided by the scheme has better mechanical property, can effectively prevent the recurrence and tearing of the affected part caused by the fracture of the support, has proper pore diameter, is more favorable for the growth of tissue cells and the infiltration of macrophages and leucocytes, has strong anti-infection capability, and can effectively reduce the incidence rate of postoperative complications.
Drawings
FIG. 1 is a schematic representation of a soft tissue repair scaffold made in example 1;
fig. 2 is a schematic view of a soft tissue repair stent made according to example 25.
Detailed Description
Preferred embodiments of the present invention will be described in detail with reference to the following examples. It is to be understood that the following examples are given for illustrative purposes only and are not intended to limit the scope of the present invention. Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the spirit and scope of this invention.
The experimental procedures used in the following examples are all conventional procedures unless otherwise specified. The materials used in the following examples are commercially available unless otherwise specified.
Example 1
This example uses a polyethylene terephthalate single strand fiber material, each strand of fiber containing 3 filaments, the filaments having a diameter of 0.08 mm. The fiber material is warped and woven, the weaving step is carried out on a warp knitting machine, the fiber enters a looping system according to a certain warp let-off amount, and a yarn guide needle carries out regular yarn laying motion according to yarn laying numbers to form a fabric with a net-shaped structure. Specifically, three guide bars are used, two symmetrical variable warp flat tissues form a net structure, one weft insertion tissue reinforces meshes, and the yarn laying numbers of the three guide bars are respectively as follows: GB1:21/23/10/12/10/23/21/23//, GB2:12/10/23/21/23/10/12/10//, GB3: 00/00/33/33/00/00/33/33//; in the processing parameters, the transverse density is 35 longitudinal rows/5 cm, and the longitudinal density is 30 transverse rows/5 cm.
The obtained medical fiber mesh braided fabric is shaped at 140 ℃, and the shaped mesh braided fabric is cut into a triangle, a rectangle, a rhombus, a hexagon, a horseshoe shape, an ellipse or a dumbbell shape with the length of 20-200mm and the width of 20-80mm, wherein the length direction is parallel to the braiding direction. Such as a rectangle 50mm in length and 20mm in width; a rectangle with the length of 70mm and the width of 50 mm; an oval shape with a length of 100mm and a width of 40 mm; a diamond shape with the length of 150mm and the width of 60 mm; a triangle with a length of 180mm and a width of 80mm, etc. So as to meet the requirements of different joint soft tissue repair parts, and then carrying out post-treatment such as pure water ultrasonic cleaning, drying, packaging, sterilization and the like to finally obtain a soft tissue repair bracket product, which is shown in figure 1.
Examples 2 to 12
Examples 2 to 12 differ from example 1 in the number of filaments per strand and in the diameter of the filaments. See table 1 for details.
Examples 13 to 16
Examples 13-16 differ from example 2 in the lateral density in the processing parameters on the machine. See table 1 for details.
Examples 17 to 20
Examples 17-20 differ from example 2 in the machine direction density in the machine processing parameters. See table 1 for details.
Table 1 table of parameters associated with soft tissue repair scaffolds in examples 1-20
Examples 21 to 24
Example 21 differs from example 2 in that a polypropylene fiber material is used.
Example 22 differs from example 2 in that a polylactic acid fiber material is used.
Example 23 differs from example 2 in that a polycaprolactone fiber material is used.
Example 24 differs from example 2 in that a mixed fibre material is used, in particular: 1 polyethylene fiber yarn and 2 chitosan fiber yarns.
Example 25
Example 25 differs from example 2 in that three guide bars are used in the weaving process, two symmetrical satin weaves constitute the net structure, one weft insertion weave reinforces the mesh, and the yarn laying numbers of the three guide bars are respectively: GB1:10/12/23/21//,/GB 2:23/21/10/12//, GB3: 00/33/00/44//.
Comparative example 1
This comparative example differs from example 2 in that the filament diameter is 0.06 mm.
Comparative example 2
This comparative example differs from example 12 in that the filament diameter is 0.26 mm.
Comparative example 3
The comparative example differs from example 2 in that the transverse density in the machine processing parameters was 10 wales/5 cm.
Comparative example 4
The comparative example differs from example 2 in that the transverse density in the machine processing parameters is 100 wales/5 cm.
Comparative example 5
The comparative example differs from example 2 in that the machine direction density was 10 courses/5 cm.
Comparative example 6
The comparative example differs from example 2 in that the machine direction density was 95 courses/5 cm.
Comparative example 7
Existing soft tissue repair products: LARS rassicology studies and uses Artificial lipids from laboratory corp.
Comparative example 8
Existing soft tissue repair products: ultropro by qiangsheng corporation.
Performance detection
The basic performances such as porosity, unit area weight, thickness and the like and various mechanical properties of the soft tissue repair scaffold products prepared in the examples 1 to 25 and the comparative examples 3 to 8 are tested according to related industry standards. The mechanical properties mainly comprise bursting strength, tensile strength, tearing strength, sewing strength and deformation rate under the tensile strength of 16N/cm.
The bursting strength test is carried out according to the method specified in GB/T19976-2005 Steel ball method for measuring bursting Strength of textiles.
The tensile strength and deformation rate are tested according to the method specified in GB/T3923.1-2013 tensile Property of textile fabrics 1 part determination of breaking strength and breaking elongation (strip method).
The tearing strength is detected by referring to a method for measuring the tearing strength of a trapezoidal sample in the No. 3 part of GB/T3917.3-2009 textile fabric tearing performance.
The seam strength was tested as follows: the sizes of the to-be-tested products are all 50mm in length and 20mm in width, a high-strength suture line penetrates through the to-be-tested products at a position 5mm away from the edge of the to-be-tested products, the suture line is clamped on the upper clamping head, the bottom of the sample is vertically clamped on the lower clamping head, the clamping distance is 100mm, the stretching speed is 12.5mm/min, the suturing strength of the sample is tested, and the average value is calculated.
Specifically, 5 samples were taken from each example/comparative example soft tissue repair scaffold product for testing, and the average value was recorded, and the test results are shown in tables 2 and 3.
Among them, comparative example 1 is too thin in fiber, and the braided stent is too soft and non-stiff, and the operation is difficult. Comparative example 2 the weaving process was difficult to achieve due to too thick and stiff filament diameter. Therefore, comparative examples 1 and 2 were not tested for basic properties and mechanical properties, and no performance data was obtained. Comparative example 7 has no pores, and human tissues are difficult to grow in after use, and the soft tissue repair scaffold with the effect advantage inferior to that of the soft tissue repair scaffold prepared by the scheme of the application can be obtained only by comparing basic performances, and the mechanical property detection method of the product is different from that of a textile, so that the comparative example 7 does not carry out mechanical property test and has no mechanical property detection data.
TABLE 2 basic Properties of Soft tissue repair scaffolds in examples 1-25 and comparative examples 3-8
TABLE 3 mechanical Properties of Soft tissue repair scaffolds in examples 1-25 and comparative examples 3-8
The following data can be seen by combining table 1 with the relevant data in tables 2 and 3: the soft tissue repair scaffolds prepared in examples 1-25 had a porosity of 12% -50% and a weight per unit area of 100g/m2～300g/m2The thickness is 0.5-3mm, the scaffold is a net structure with proper porosity, is favorable for local tissue growth, has proper weight per unit area and proper thickness, is not easy to deform, can play an effective supporting role on soft tissues after being implanted into a human body, is particularly suitable for repairing joint soft tissues, can meet the tissue repairing requirement by using a single piece, does not need edge stitching connection, and can effectively avoid the formation of scar plates and inflammatory reaction. Meanwhile, the soft tissue repair scaffold prepared in the embodiments 1 to 25 has bursting strength of not less than 50N/cm, tensile strength of not less than 95N, tearing strength of not less than 20N, suture strength of not less than 32N, and deformation rate of not more than 20% under 16N/cm tensile strength, has good mechanical properties, can effectively prevent the affected part from recrudescence and tearing caused by scaffold fracture, has small deformation rate and is not easy to creep, is particularly suitable for repairing joint soft tissue, and can ensure the success rate of surgery. In addition, the stent has a suitableThe aperture is more beneficial to the growth of tissue cells and the infiltration of macrophages and leucocytes, the anti-infection capability is strong, and the incidence rate of postoperative complications can be effectively reduced.
In examples 1 to 12, each strand of medical fiber has different diameters and numbers of filaments, and when the diameter of the filament is larger, the number of the filaments is usually smaller, whereas when the diameter of the filament is smaller, the number of the filaments is usually larger, so that the prepared soft tissue repair scaffold has proper stiffness and better mechanical properties, and the requirement of the soft tissue repair operation is met.
Examples 13-20 examined the effect of different machining process parameters on the performance of the soft tissue repair scaffold prepared, wherein examples 13-16 examined the effect of different transverse densities on the soft tissue repair scaffold and examples 17-20 examined the effect of different longitudinal densities on the soft tissue repair scaffold. With reference to table 1, it can be seen from the test data in tables 2 and 3 that, as the transverse density and longitudinal density values in the weaving process increase, the prepared soft tissue repair scaffold product becomes more and more compact, the weight and thickness per unit area also gradually increase, the mechanical properties become stronger and stronger, and with reference to the requirements of practical application scenarios, the transverse density is preferably 20-55 wales/5 cm; the longitudinal density is 20-50 courses/5 cm.
The performance of the soft tissue repair scaffold prepared from different medical fiber materials is examined in examples 21-24, and it can be seen from tables 2 and 3 that the performance difference of the repair scaffold prepared from the fiber materials of different materials is not obvious, the repair scaffold has the same porosity, thickness and aperture, the weight per unit area, mechanical properties and the like are mainly affected by the characteristics of the materials, and the repair scaffold does not have too large difference and meets the requirements of soft tissue repair surgery.
In example 25, soft tissue repair scaffolds are prepared by different weaving methods, and it can be seen by combining the relevant data of examples 13 to 20 that the transverse density and the longitudinal density have a large influence on the performance of soft tissue repair scaffold products during weaving, and the influence of the weaving method is small, and the performance differences of the repair scaffolds prepared by different weaving methods are not obvious, and both meet the requirements of soft tissue repair surgery.
Comparative example 1 the braided stent was too soft and stiff due to too thin filaments, and the operation was difficult. Comparative example 2 the weaving process was difficult to achieve due to too thick and stiff filament diameter.
It can be seen from the data of comparative examples 3-6 and examples 13-20 that when the transverse density or the longitudinal density in the machining process parameters is too low, the prepared soft tissue repair scaffold has too large porosity and too low weight per unit area, cannot well support soft tissue, has insufficient bursting strength and poor mechanical properties, and cannot ensure the success rate of repair surgery. When the transverse density or the longitudinal density in the machining process parameters is too high, the porosity of the prepared soft tissue repair scaffold is too small, tissues can not grow well, and local tissue repair is not facilitated.
Comparative examples 7 to 8 are mainstream medical soft tissue repair scaffolds in the market at present, and the data in tables 2 and 3 show that the repair product in the comparative example 7 has no pores, human tissues are difficult to grow after the repair product is used, and the repair product is not favorable for tissue recovery and is easy to form scar plates. In addition, the repair product has insufficient thickness, is frequently used in a multi-layer overlapping manner when used for repairing soft tissues, needs to be connected by sewing edges, is easy to cause different deformation rates of the interior and the edges, and generates complications such as persistent pain.
In conclusion, the soft tissue repair scaffold provided by the scheme has appropriate porosity, is favorable for local tissue growth, has appropriate weight per unit area, appropriate thickness and difficult deformation, can play an effective supporting role on soft tissues after being implanted into a human body, and is particularly suitable for repairing joint soft tissues.
The above-mentioned embodiments are merely illustrative and not restrictive, and those skilled in the art can modify the embodiments without inventive contribution as required after reading this description, but only fall within the scope of the claims of the present application.
Claims (11)
1. The soft tissue repair scaffold is formed by weaving medical fibers, and is characterized in that the soft tissue repair scaffold is of a net structure, the porosity is 12% -50%, and the weight per unit area is 100g/m2～300g/m2The thickness is 0.5-3 mm.
2. The soft tissue repair scaffold according to claim 1, wherein the soft tissue repair scaffold has a burst strength of not less than 50N/cm, a tensile strength of not less than 95N, a tear strength of not less than 20N, and a suture strength of not less than 32N.
3. The soft tissue repair scaffold according to claim 1, wherein the rate of deformation of the soft tissue repair scaffold at a tensile strength of 16N/cm is 20% or less.
4. The soft tissue repair scaffold according to claim 1, wherein the soft tissue repair scaffold has a warp-wise aperture of 1mm to 8mm and a weft-wise aperture of 0.5mm to 4 mm.
5. The soft tissue repair scaffold according to claim 1, wherein the medical fibre is a single fibre comprising 1-10 filaments, the filaments having a diameter of 0.08-0.24 mm.
6. The soft tissue repair scaffold according to claim 5, wherein the single strand of fibre comprises 2-10 filaments when the fibre filament diameter is 0.08-0.14 mm; when the diameter of the fiber filament is 0.14-0.20mm, the single-strand fiber contains 1-7 fiber filaments; when the diameter of the fiber filament is more than 0.20mm, the single-strand fiber contains 1 to 3 fiber filaments.
7. The soft tissue repair scaffold according to claim 1, wherein the medical fiber is one or more of polyethylene terephthalate, polypropylene, polyethylene, polylactic acid, polyglycolic acid, polycaprolactone, chitosan, and silk fibroin.
8. The soft tissue repair scaffold according to claim 1, wherein the soft tissue repair scaffold is triangular, rectangular, diamond-shaped, hexagonal, horseshoe-shaped, oval or dumbbell-shaped, and the soft tissue repair scaffold is 20-200mm in length and 20-80mm in width.
9. The method for preparing a soft tissue repair scaffold according to any of claims 1 to 8, comprising the process steps of: warping, knitting, shaping, cutting and post-processing, and is characterized in that the knitting step is carried out on a warp knitting machine, medical fibers enter a looping system according to a certain warp let-off amount, and a yarn guide needle carries out regular yarn laying motion according to yarn laying numbers to form a net-shaped structure.
10. The method for preparing a soft tissue repair scaffold according to claim 9, wherein in the weaving step, warp knitting machine process parameters: the transverse density is 15-95 wales/5 cm, preferably 20-55 wales/5 cm; the density in the machine direction is 15-90 courses/5 cm, preferably 20-50 courses/5 cm.
11. The method of making a soft tissue repair scaffold according to claim 9, wherein the step of weaving uses three guide bars, wherein,
two symmetrical variable warp-flat tissues form a net structure, and one weft insertion tissue reinforces meshes; or alternatively
Two symmetrical warp satin weaves form a net structure, and one weft insertion weave reinforces the meshes.
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Application publication date: 20220510 |