CN114732948A - Rotator cuff patch and preparation method thereof - Google Patents
Rotator cuff patch and preparation method thereof Download PDFInfo
- Publication number
- CN114732948A CN114732948A CN202210300200.3A CN202210300200A CN114732948A CN 114732948 A CN114732948 A CN 114732948A CN 202210300200 A CN202210300200 A CN 202210300200A CN 114732948 A CN114732948 A CN 114732948A
- Authority
- CN
- China
- Prior art keywords
- rotator cuff
- gas
- cuff patch
- preparing
- membrane
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
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- A—HUMAN NECESSITIES
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
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Abstract
The invention provides a rotator cuff patch and a preparation method thereof, wherein the preparation method comprises the following steps: twisting polyethylene glycol terephthalate monofilament into yarn to obtain a membrane, dispersing inorganic nano-particle materials and osteogenic factors in a solvent, and adding a natural source matrix material into the mixed solution to obtain a pouring liquid; dispersing an inorganic nano-particle material, an osteogenic factor and a high polymer material in a solvent to obtain a spinning solution; placing the diaphragm in a mould and pouring to obtain a composite diaphragm; spinning the spinning solution on the front side and the back side of the composite membrane by an electrostatic spinning technology, performing crosslinking treatment, and performing vacuum drying; the composite membrane is a loose porous structure and can guide and promote the rapid growth of osteoblasts, wherein the membrane can meet the mechanical property required by the action of the rotator cuff as a mechanical support layer, and the electrostatic spinning layer prepared from the natural source matrix material can be well fused with a tendon-bone interface due to the good biocompatibility of the electrostatic spinning layer, so that the rotator cuff can be promoted to heal.
Description
Technical Field
The invention belongs to the technical field of surgical patch brackets, and particularly relates to a rotator cuff patch and a preparation method thereof.
Background
Rotator cuff tears are common shoulder joint diseases and mainly involve injuries to tendon soft tissues and bone hard tissues at the shoulder joints due to exercise, and the incidence rate gradually increases with age. Rotator cuff tears are common causes of shoulder joint pain, reduced mobility and reduced function, accounting for about 60% of shoulder lesions. Surgical procedures are often used to repair torn tendons, thereby alleviating pain and reestablishing joint function in rotator cuff injured patients who have failed conservative treatment and in patients with extensive rotator cuff injury.
The muscle health is a weak point in the rotator cuff repair process, especially when the defect is large, the intra-operative traction and the attempt to fix the large torn rotator cuff tissue to the original attachment point before the injury are difficult, and at the moment, the rotator cuff structure reinforcement technology is needed to solve the problem of insufficient humeral head coverage when the large rotator cuff is torn, so that the mechanical property of the rotator cuff tissue after the repair is ensured, and the stability function of the rotator cuff is maintained.
The materials currently used for the rotator cuff patch are numerous and are roughly classified into two types, i.e., biological materials (autologous, allogeneic tissues, xenogeneic materials) and artificial materials (non-degradable and degradable), according to the sources. Although these materials can achieve certain clinical effects to some extent when used in a rotator cuff patch, they all have respective problems and application limitations. The Chinese minimally invasive science journal and the international bone science journal have reported: the autologous rotator cuff tissue repair material is mainly derived from autologous tissues such as fascia lata, biceps brachii longhead tendon and the like, and the patch is relatively easy to obtain materials and has good biocompatibility, does not generally cause inflammatory reaction of an organism, but lacks stable mechanical strength and is susceptible to infection after operation. The allogeneic rotator cuff tissue patch is usually derived from homologous rotator cuff tissues, allogeneic patellar tendon tissues, achilles tendon tissues, quadriceps femoris tendon tissues and the like, the material is not only lack of stable mechanical property guarantee, but also easily causes the body to generate immune response after transplantation, has the risk of infecting infectious diseases, and has limited sources. The heterogenous rotator cuff tissue patch comprises animal dermis, small intestine, pericardium and the like, takes an inherent three-dimensional structure, collagen, non-collagen and the like as a bracket, provides conditions for adhesion, proliferation and differentiation of tissues, promotes functional reconstruction of postoperative collagen fibers and a regenerated vascular tendon-bone interface, has good biocompatibility and tensile mechanical properties, and has mechanical strength far lower than mechanical load strength borne by human original muscle cells or ligaments due to different tissue sources, processing methods and sterilization methods. The non-degradable high polymer material rotator cuff patch is commonly made of polypropylene fiber woven materials, polyester patches, polytetrafluoroethylene and nylon high-synthetic materials, and histological research shows that the polytetrafluoroethylene and polycarbonate polyurethane patches are tightly combined with receptors by strong tensile strength, but are easy to cause rejection reaction after operation. The degradable material which can be used for preparing the rotator cuff patch mainly comprises polylactic acid and derivatives thereof, polycaprolactone and degradable polyurethane, and the stent prepared from the material can provide a non-permanent attachment point and has good biocompatibility and mechanical properties, but a certain tissue local acid-base environment is possibly unstable due to degradation products.
In the existing rotator cuff patch, no matter the clinically used porcine dermal patch is not easy to heal at the tendon-bone interface (tendon-bone interface) after rotator cuff repair; therefore, the tissue-induced patch is constructed to migrate precursor cells such as tendon stem cells nearby to the local part of the tendon injury, so that designing a simulated rotator cuff tissue with excellent mechanical strength may be an effective way to solve the problems, and the functional rotator cuff patch with good biocompatibility has important clinical application value for treating rotator cuff injury.
Disclosure of Invention
Aiming at the defects in the prior art, the invention mainly aims to provide a preparation method of a rotator cuff patch.
It is a secondary object of the present invention to provide the rotator cuff patch described above.
In order to achieve the above primary object, the solution of the present invention is:
a preparation method of a rotator cuff patch comprises the following steps:
(1) twisting Polyethylene terephthalate (PET) monofilament into yarn, preparing a mechanically reinforced membrane with a planar structure by using weaving, knitting or non-weaving technology, and then placing the membrane in the middle layer of the rotator cuff patch to be used as a support main body of the whole rotator cuff patch;
(2) dispersing the inorganic nano-particle material and the osteogenesis factor in a solvent, uniformly mixing to obtain a mixed solution, and adding the natural source matrix material into the mixed solution to obtain a pouring liquid serving as a main component at one end of osteogenesis;
(3) dispersing a high molecular material, an inorganic nano-particle material and an osteogenic factor in a solvent to obtain a spinning solution;
(4) placing the diaphragm in the step (1) in a special polytetrafluoroethylene mould, pouring the pouring liquid in the step (2) in the areas of the front and back surfaces of the diaphragm, carrying out freeze drying treatment, and repeating the freeze drying treatment twice to obtain a composite diaphragm with the pouring liquid attached to the front and back surfaces;
(5) and (3) obtaining nano fibers by using the spinning solution obtained in the step (3) through an electrostatic spinning technology, then spinning the nano fibers on the front side and the back side of the composite membrane, carrying out vacuum freeze drying for 48 hours, adding the nano fibers into an organic solvent for crosslinking treatment, and carrying out vacuum drying for 48 hours to obtain the rotator cuff patch.
Preferably, in the step (1), the diameter of the polyethylene terephthalate monofilament is 5-15 μm, and 10-25 monofilaments are twisted into yarn without drawing treatment; the thickness of the membrane is 0.1-10 mm.
In the step (1), the mechanical reinforcing structure is processed by monofilament weaving, one end of the woven scaffold is coated with natural source matrix material mixed liquid for promoting tendon-bone healing from inside to outside, and the outer layer is composed of nano fibers prepared by high polymer materials through electrostatic spinning.
Preferably, in the step (2), the mass ratio of the osteogenesis factor to the inorganic nanoparticle material is 0.5:100-100: 1.
Preferably, in the step (2), the mass volume concentration (w/v) of the mixed solution is 1 to 20%.
Preferably, in the step (2), the mass ratio of the natural source matrix material to the mixed solution is 50:50-80: 20.
Preferably, in step (2), the naturally derived matrix material is selected from one or more of collagen, gelatin, fibroin, laminin, chitosan, lactose, and glucosamine.
Preferably, in the step (2) and the step (3), the osteogenic factor is selected from one or more of bone morphogenetic protein (BMP-2), basic fibroblast growth factor (FGF-2), insulin-like growth factor (IGF-2), Nell-1, deferoxamine and RGD short peptide.
Preferably, in the step (2) and the step (3), the inorganic nanoparticle material is selected from one or more of mesoporous bioglass, hydroxyapatite, mesoporous silica, tricalcium phosphate (β -TCP), calcium phosphorus ceramic, hydrotalcite, attapulgite and illite.
Preferably, in the step (2) and the step (3), the solvent is one or more selected from hexafluoroisopropanol, trifluoroacetic acid, ultrapure water and an aqueous acetic acid solution.
In fact, the step (2) is a pouring liquid preparation process, the step (3) is a spinning solution preparation process, and the raw materials and the solvents adopted by the two are different, so that the emphasis points are different. Namely, the pouring liquid in the step (2) is used as an osteogenic layer, and the nano-fiber prepared by the spinning solution in the step (3) is used as a tendon layer, so that the functions are different.
Preferably, in the step (3), the polymer material is selected from one or more of synthetic polymers and natural polymers.
Preferably, the synthetic polymer is selected from at least one of polylactic acid, polyglycolic acid, polycaprolactone, polyurethane, polylactic acid-glycolic acid copolymer, and poly-L-lactide-caprolactone.
Preferably, the natural polymer is selected from more than one of hyaluronic acid, sodium alginate, spidroin, chitin and cellulose.
Preferably, in the step (4), the casting liquid is cast on the membrane in a volume range of 1-100%.
Preferably, in the step (5), the organic solvent is dichloroethane (EDC)/N-hydroxysuccinimide (NHS)/ethanol mixture (i.e. mixture of EDC, NHS and ethanol), the molar ratio of EDC and NHS is 3:1-5:1, and the mass volume fractions of EDC and NHS after ethanol dissolution are 15-50%.
Preferably, in the step (5), the time for the crosslinking treatment is 1 to 72 hours.
The nano-fibers prepared by electrostatic spinning in the step (5) can be random nano-fibers which are randomly distributed, and can also be oriented nano-fibers.
To achieve the above secondary object, the solution of the present invention is:
a rotator cuff patch is obtained by the preparation method.
Due to the adoption of the scheme, the invention has the beneficial effects that:
firstly, the natural source matrix material used in the invention has a complex reticular structure similar to a cell matrix after being processed, can be used for regulating substance transformation and nutrition transportation between cells and tissues, and after related cell experiments are carried out in the early stage, the rotator cuff patch has a good promotion effect on adhesion, proliferation and migration of cells, the survival rate of the cells is higher than 90%, and the rotator cuff patch is more beneficial to rapid proliferation, migration and growth of host cells on a right-angled surface, thereby realizing rapid regeneration.
Secondly, the woven PET membrane plays a role in supporting tissues of the rotator cuff patch and serves as a total mechanical supporting layer of the patch; the front surface and the back surface of the PET membrane are poured with pouring liquid containing inorganic nanoparticle materials, osteogenic factors and natural source matrix materials, the PET membrane is of a loose porous structure and can guide and promote the rapid growth of osteoblasts, the PET membrane serving as a mechanical support layer can meet the mechanical performance required by the activity of the rotator cuff, and an electrostatic spinning layer prepared from high polymer materials can be well fused with a tendon-bone interface due to good biocompatibility of the electrostatic spinning layer, so that the rotator cuff is promoted to heal. The prepared material has no cytotoxicity and the cell proliferation efficiency is up to more than 85 percent through cytotoxicity experimental tests and hemolytic experimental tests. The tensile strength of the material can reach 1000N by a tensile and compression testing machine to test the mechanical property of the material, and the rotator cuff patch has the mechanical property required by the daily activity of the rotator cuff and can be used for the regeneration treatment of rotator cuff damaged tissue injury diseases; the preparation method of the composite tissue engineering patch is simple and efficient, has low price and good application prospect, and provides a simple and effective preparation technical thought for developing the rotator cuff tissue engineering patch.
Drawings
Fig. 1 is a microscopic view of a mechanically reinforced membrane woven in example 1 of the present invention.
Fig. 2 is a diagram of the osteogenic factor-loaded composite membrane in example 1 of the present invention.
Fig. 3 is a scanning electron microscope image of the nanofibers of the functional rotator cuff patch in example 2 of the present invention.
Detailed Description
The invention provides a rotator cuff patch and a preparation method thereof.
The invention is further described below with reference to the following figures and examples.
Example 1:
as shown in fig. 1 and 2, 15 PET monofilaments having a diameter of 10 μm were twisted into a yarn, and a mechanically reinforced PET film sheet having a planar structure with a thickness of about 0.8mm was prepared by weaving; collagen with the mass ratio of 80:20 and hydroxyapatite carrying BMP-2 (the mass ratio of BMP-2 to hydroxyapatite is 15:100) are dissolved in hexafluoroisopropanol to obtain pouring liquid (the mass volume concentration (w/v) is 10%) which is used as a main component at one end of osteogenesis; dissolving polylactic acid, hydrotalcite and BMP-2 in hexafluoroisopropanol to prepare a spinning solution with the mass volume concentration (w/v) of 8% for later use; placing the prepared PET membrane in a special polytetrafluoroethylene mold, casting the prepared pouring liquid at one end of the PET membrane, pre-freezing and freeze-drying, and repeating the steps for two times to finally prepare the composite membrane with the pouring liquid attached to the two surfaces of the membrane; the prepared spinning solution is spun on the front side and the back side of the composite membrane through an electrostatic spinning technology to obtain nano fibers, the nano fibers are subjected to vacuum drying for 48 hours, then the nano fibers are placed into an EDC/NHS/ethanol mixed solution to be subjected to crosslinking treatment for 72 hours, and after vacuum freeze drying for 48 hours, the functional rotator cuff patch is obtained, and cell experiment results show that the survival rate of cells on the rotator cuff patch is 92%.
Example 2:
as shown in fig. 3, 10 PET monofilaments with a diameter of 15 μm were twisted into a yarn, and a mechanically reinforced PET film sheet with a planar structure having a thickness of about 0.8mm was prepared by weaving; dissolving fibroin and deferoxamine-loaded illite (the mass ratio of deferoxamine to illite is 10:100) in 60:40 in hexafluoroisopropanol to obtain a pouring liquid (the mass volume concentration (w/v) is 10%) as a main component at one end of an osteogenesis body; dissolving hyaluronic acid, hydrotalcite and deferoxamine in hexafluoroisopropanol to prepare a spinning solution with the mass volume concentration (w/v) of 8% for later use; placing the prepared PET membrane in a special polytetrafluoroethylene mold, casting the prepared pouring liquid at one end of the PET membrane, pre-freezing and freeze-drying, repeating the steps for two times, and finally preparing the composite membrane with the pouring liquid attached to the two surfaces of the membrane; the prepared spinning solution is spun on the front side and the back side of the composite membrane through an electrostatic spinning technology to obtain nano fibers, the nano fibers are then placed into an EDC/NHS/ethanol mixed solution for crosslinking treatment for 72 hours after vacuum drying is carried out for 48 hours, the functional rotator cuff patch is obtained after vacuum freeze drying is carried out for 48 hours, according to the experimental result, the cell survival rate of the prepared rotator cuff patch is 89%, and the tensile strength is up to 1032N as shown by the mechanical tensile result.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. It will be readily apparent to those skilled in the art that various modifications to these embodiments and the generic principles defined herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above-described embodiments. Those skilled in the art should appreciate that many modifications and variations are possible in light of the above teaching without departing from the scope of the invention.
Claims (10)
1. A preparation method of a rotator cuff patch is characterized by comprising the following steps: which comprises the following steps:
(1) twisting polyethylene glycol terephthalate monofilament into yarn, and weaving the yarn to obtain a membrane as a cartilage layer;
(2) dispersing inorganic nano-particle materials and osteogenic factors in a solvent, uniformly mixing to obtain a mixed solution, and adding a natural source matrix material into the mixed solution to obtain a pouring liquid serving as an osteogenic layer;
(3) dispersing a high molecular material, an inorganic nano-particle material and an osteogenic factor in a solvent to obtain a spinning solution;
(4) placing the diaphragm in the step (1) into a mold, pouring the pouring liquid in the step (2) in the areas of the front surface and the back surface of the diaphragm, freezing and drying to obtain a composite diaphragm;
(5) and (3) obtaining nano fibers as tendon layers by using the spinning solution obtained in the step (3) through an electrostatic spinning technology, then spinning the nano fibers on the front side and the back side of the composite membrane, freeze-drying, adding an organic solvent for cross-linking treatment, and drying in vacuum to obtain the rotator cuff patch.
2. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (1), the diameter of the polyethylene glycol terephthalate monofilament is 1-15 μm, and each 10-25 monofilaments are twisted into yarn; the thickness of the membrane is 0.1-10 mm.
3. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (2), the mass ratio of the osteogenesis factor to the inorganic nanoparticle material is 0.5:100-100: 1; and/or the presence of a gas in the gas,
in the step (2), the mass volume concentration of the mixed solution is 1-20%; and/or the presence of a gas in the gas,
in the step (2), the mass ratio of the natural source matrix material to the mixed solution is 50:50-80: 20; and/or the presence of a gas in the gas,
in the step (2), the natural source matrix material is selected from more than one of collagen, gelatin, fibroin, laminin, chitosan, lactose and glucosamine.
4. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (2) and the step (3), the osteogenic factor is selected from more than one of bone morphogenetic protein, basic fibroblast growth factor, insulin-like growth factor, Nell-1, deferoxamine and RGD short peptide; and/or the presence of a gas in the gas,
in the step (2) and the step (3), the inorganic nano-particle material is selected from more than one of mesoporous bioglass, hydroxyapatite, mesoporous silicon, tricalcium phosphate, calcium phosphorus ceramic, hydrotalcite, attapulgite and illite.
5. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (3), the polymer material is selected from more than one of synthetic polymer or natural polymer; and/or the presence of a gas in the gas,
the synthetic polymer is selected from more than one of polylactic acid, polyglycolic acid, polycaprolactone, polyurethane, polylactic acid-glycolic acid copolymer and poly L-lactide-caprolactone; and/or the presence of a gas in the atmosphere,
the natural polymer is selected from more than one of hyaluronic acid, sodium alginate, spidroin, chitin and cellulose.
6. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (2) and the step (3), the solvent is one or more selected from hexafluoroisopropanol, trifluoroacetic acid, ultrapure water and an aqueous acetic acid solution.
7. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (4), the casting liquid is cast on the diaphragm in a volume range of 1-100%.
8. Method for preparing a rotator cuff patch according to claim 1, characterized in that: in the step (5), the organic solvent is a dichloroethane/N-hydroxysuccinimide/ethanol mixed solution, the molar ratio of the dichloroethane to the N-hydroxysuccinimide is 3:1-5:1, and the mass volume fractions of the dichloroethane and the N-hydroxysuccinimide after ethanol is dissolved are 15-50%.
9. The method for preparing a rotator cuff patch according to claim 1, wherein: in the step (5), the time of the cross-linking treatment is 1-72 h.
10. A rotator cuff patch characterized by: obtained by the process according to any one of claims 1 to 9.
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| CN117883216A (en) * | 2024-01-19 | 2024-04-16 | 常州集硕医疗器械有限公司 | Bioabsorbable rotator cuff patch and preparation method thereof |
| CN117919507A (en) * | 2024-03-14 | 2024-04-26 | 深圳市迈捷生命科学有限公司 | Composite patch for rotator cuff repair and preparation method thereof |
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