CN117919507A - Composite patch for rotator cuff repair and preparation method thereof - Google Patents
Composite patch for rotator cuff repair and preparation method thereof Download PDFInfo
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- CN117919507A CN117919507A CN202410294154.XA CN202410294154A CN117919507A CN 117919507 A CN117919507 A CN 117919507A CN 202410294154 A CN202410294154 A CN 202410294154A CN 117919507 A CN117919507 A CN 117919507A
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- 239000002131 composite material Substances 0.000 title claims abstract description 22
- 230000008439 repair process Effects 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims description 7
- 229920005615 natural polymer Polymers 0.000 claims abstract description 118
- 238000009954 braiding Methods 0.000 claims abstract description 116
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- 239000011248 coating agent Substances 0.000 claims abstract description 42
- 238000004108 freeze drying Methods 0.000 claims abstract description 37
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- 230000008569 process Effects 0.000 claims abstract description 23
- 229920000642 polymer Polymers 0.000 claims abstract description 21
- 239000000243 solution Substances 0.000 claims description 81
- 238000002791 soaking Methods 0.000 claims description 54
- 102000008186 Collagen Human genes 0.000 claims description 38
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- 238000007710 freezing Methods 0.000 claims description 35
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- KKEYFWRCBNTPAC-UHFFFAOYSA-L terephthalate(2-) Chemical compound [O-]C(=O)C1=CC=C(C([O-])=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-L 0.000 claims 1
- 238000009941 weaving Methods 0.000 claims 1
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Classifications
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Transplantation (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates to the technical field of medical equipment, in particular to a composite patch for rotator cuff repair, which comprises a braiding body, wherein the braiding body is sheet-shaped, one surface or two surfaces of the braiding body are provided with natural polymer coatings, and the natural polymer coatings are formed by combining natural polymers on the braiding body through a cold drying process, and are porous sponge-shaped. The invention adopts a freeze drying process to lead the natural polymer left after the ice crystal sublimation to form a porous and spongy natural polymer coating, and the natural polymer coating and the patch have large bonding area and strong bonding strength; because the coating has a porous structure, the tissue of a human body can grow into the patch more easily, the patch can be tightly combined between the rotator cuff and the humerus head more easily, an integral structure is formed, the healing of the rotator cuff is quickened, and more importantly, the natural polymer coating can reduce the shearing damage of the shearing force of the polymer silk thread to the primary tissue, so that the better and faster reconstruction of the tissue is promoted.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a composite patch for rotator cuff repair and a preparation method thereof.
Background
The rotator cuff injury is common injury of the rotator cuff, and factors such as rotator cuff quality reduction, subacromion impact and trauma can cause rotator cuff injury, and seriously affect the life quality of patients. Literature reports that 50-59 years old people have a prevalence of 13%,60-80 years old people have 20% -30%, and over 80 years old people have as high as 50%, wherein a giant rotator cuff tear accounts for about 40% of all rotator cuff tears, if no positive treatment is obtained after injury, as the disease progresses gradually and the tissue degenerates, the giant rotator cuff tear eventually develops into an irreparable tear.
Currently, the common rotator cuff injury repair technology in clinic includes a single/double-row suture anchor bone penetrating suture technology and rotator cuff repair technology by tendon transfer technology, such as pectoral major muscle transfer technology and latissimus dorsi transfer technology. However, there are still some rotator cuff injuries that cannot be repaired due to the large tearing and contracture of the tissue, and when there is a front-upper unstable or large rotator cuff injury in the shoulder joint of the patient, the effect is not ideal in terms of pain or function.
With the development of arthroscopic techniques, patch techniques have provided new solutions for rotator cuff re-tearing after suturing. The polymer woven patch has higher initial fixing strength, can reach the initial strength of the rotator cuff, and can still maintain mechanical stability after repeated activities; the mechanical stability can be kept when cyclic load is loaded; but the shearing force of the polymer silk yarn on muscle tissues can cause tissue damage and delay repair.
At present, medicines or porous and spongy natural polymer coatings are added around the patch to promote the growth of organisms, the binding force between the natural polymer coatings and the patch is small, and the binding force generated on the patch directly by no natural polymer coating is large.
Ideal rotator cuff repair: the initial fixing strength is higher, and the initial strength of the rotator cuff is achieved; the gap between the rotator cuff and the humeral head is as small as possible; the mechanical stability can be maintained after repeated activities; the mechanical stability can be kept when cyclic load is loaded; optimizing the biological environment of the healing site; and low tissue shear forces. Current rotator cuff repair devices do not have such a capability.
Disclosure of Invention
In order to solve the problems in the background art, the invention provides a composite patch for rotator cuff repair, which solves the problems that the shearing force of a woven body on muscle tissues in a polymer patch in the prior art can cause tissue damage and delay repair.
The invention solves the technical problems by adopting the following scheme: a composite patch for rotator cuff repair comprises a braiding body, wherein the braiding body is sheet-shaped, the braiding body comprises one or more braiding units manufactured through a braiding process, one surface or two surfaces of the braiding body are provided with degradable natural polymer coatings, the natural polymer coatings are formed by enabling natural polymers in natural polymer solutions to be attached to the braiding body through a freeze drying process, the natural polymer solutions are solutions formed by dissolving the natural polymers in physiological saline, and the natural polymer coatings are porous and spongy.
Further, a plurality of braiding units are overlapped in the thickness direction, the shapes of the braiding units are the same, two ends of the braiding units are connected, and a natural polymer coating is arranged between the braiding units to be connected.
Further, the natural polymer comprises animal-derived collagen and/or recombinant collagen and/or gelatin and/or chitosan and/or silk fibroin, the braiding unit is prepared by a non-degradable polymer substrate warp knitting process, and the polymer substrate comprises polyethylene terephthalate and/or polypropylene and/or polyethylene and/or polydioxanone and/or polycaprolactone and/or poly L-lactide and/or polyglycolic acid.
Further, the polymer base material is polyethylene terephthalate, and the natural polymer is collagen.
Further, the thickness of the braiding is 0.1-1.5mm, and the ultimate tensile load of the braiding is 200-1000N.
Further, the thickness of the braiding is 0.4-0.8mm, and the ultimate tensile load of the braiding is 500-800N.
Further, the knitting process is warp knitting or weft knitting.
A method of making a composite patch comprising the steps of:
1. Soaking, namely soaking the braiding bodies in a natural polymer solution, wherein the concentration of the natural polymer is 0.01-1mg/mL, the upper surface of the braiding bodies is 0.01-1mm away from the upper interface of the natural polymer solution, the lower surface of the braiding bodies is 0.01-2mm away from the lower interface of the natural polymer solution, the periphery of the braiding bodies 1 is 0.01-1mm away from the interface of the collagen solution, the soaking time of the braiding bodies is 0.1-60min, and the soaking temperature of the braiding bodies is 0-40 ℃;
2. performing primary freezing, namely freeze-drying the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing to ensure that the pressure of the container is-20 pa, the negative pressure is kept for 15-60min, the freezing cooling speed is 1 ℃/min, and the freezing time is 2h until the temperature is reduced to-20 ℃;
3. and (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to-50 ℃ at a cooling speed of 2 ℃/min, the freeze-drying time is 24 hours to 72 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating is formed on the woven body.
Further, the concentration of the natural polymer is 0.3-0.6mg/mL, the upper surface of the braiding body is 0.2-0.4mm away from the upper interface of the natural polymer solution, the lower surface of the braiding body is 0.4-2mm away from the lower interface of the natural polymer solution, the soaking time of the braiding body is 0.1-20min, and the soaking temperature of the braiding body is 25-35 ℃.
Further, a method for preparing the composite patch comprises the following steps:
1. Soaking, namely soaking a braiding body with the thickness of 0.8mm in a collagen solution, wherein the concentration of collagen is 0.6mg/mL, the upper surface of the braiding body is 0.2mm away from the upper interface of the collagen solution, the lower surface of the braiding body is 2mm away from the lower interface of the collagen solution, the periphery of the braiding body 1 is 0.5mm away from the interface of the collagen solution, the soaking time of the braiding body is 0.1min, and the soaking temperature of the braiding body is 30 ℃;
2. Performing primary freezing, namely performing freeze drying on the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing, keeping the pressure of the container at-20 pa for 15min at a negative pressure maintaining speed of 1 ℃/min until the temperature is reduced to-20 ℃, and freezing for 2h;
3. And (3) freeze-drying, namely cooling to-50 ℃ at a cooling speed of 2 ℃/min after the freezing time is 2h, freeze-drying for 48h, and freeze-drying until the natural polymer in the natural polymer solution is completely dried, wherein the natural polymer is attached to the woven body to form a natural polymer coating.
In summary, the beneficial effects of the invention are as follows: the natural polymer remained after the ice crystal sublimates is formed into a porous and spongy natural polymer coating by adopting a freeze drying process, and the natural polymer coating and the patch have large bonding area and strong bonding strength; because the coating has a porous structure, the tissue of a human body can grow into the patch more easily, the patch can be tightly combined between the rotator cuff and the humerus head more easily, an integral structure is formed, the healing of the rotator cuff is quickened, and more importantly, the natural polymer coating can reduce the shearing damage of the shearing force of the polymer silk thread to the primary tissue, so that the better and faster reconstruction of the tissue is promoted.
The foregoing description is only an overview of the technical solution of the present invention, and may be implemented according to the content of the specification in order to make the technical means of the present invention more clearly understood, and in order to make the above and other objects, features and advantages of the present invention more clearly understood, the following specific preferred embodiment is given by way of the following detailed description in conjunction with the accompanying drawings.
Drawings
Fig. 1 is a structural diagram of the present invention.
In the figure: 1. a braiding body; 2. a natural polymer coating; 3. and knitting the units.
Detailed Description
In order that the invention may be more readily understood, a further description of the invention will be rendered by reference to specific embodiments that are illustrated in the appended drawings.
It should be noted that, as used herein, the terms "center," "upper," "lower," "front," "rear," "left," "right," "inner," "outer," and the like indicate an orientation or a positional relationship based on that shown in the drawings, and are merely for convenience of description and to simplify the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the invention. Unless otherwise indicated, the meaning of "a plurality" is two or more.
Unless specifically stated or limited otherwise, the terms "mounted," "connected," and "coupled" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art in a specific case.
Referring to the drawings, a composite patch for rotator cuff repair comprises a braiding body 1, wherein the braiding body 1 is sheet-shaped, the braiding body 1 comprises one or more braiding units 3 manufactured through a braiding process, one or two surfaces of the braiding body 1 are provided with degradable natural polymer coatings 2, the natural polymer coatings 2 are formed by enabling natural polymers in natural polymer solutions to be attached to the braiding body through a freeze drying process, the natural polymer solutions are solutions formed by dissolving the natural polymers in physiological saline, and the natural polymer coatings 2 are porous and spongy.
Further, the plurality of knitting units 3 are stacked in the thickness direction, the shapes of the plurality of knitting units 3 are the same, both ends of the plurality of knitting units 3 are connected, and the natural polymer coating 2 is arranged between the two knitting units 3 to be connected.
Further, the natural polymer comprises animal-derived collagen and/or recombinant collagen and/or gelatin and/or chitosan and/or silk fibroin, the braiding unit is prepared by a non-degradable polymer substrate warp knitting process, and the polymer substrate comprises polyethylene terephthalate and/or polypropylene and/or polyethylene and/or polydioxanone and/or polycaprolactone and/or poly L-lactide and/or polyglycolic acid.
Further, the polymer base material is polyethylene terephthalate, and the natural polymer is collagen.
Further, the thickness of the braiding part 1 is 0.1-1.5mm, and the ultimate tensile load of the braiding part 1 is 200-1000N.
Further, the thickness of the braiding part 1 is 0.4-0.8mm, and the ultimate tensile load of the braiding part 1 is 500-800N.
Further, the knitting process is warp knitting or weft knitting.
A method of making a composite patch comprising the steps of:
1. Soaking, namely soaking the braiding bodies 1 in a natural polymer solution, wherein the concentration of the natural polymer is 0.01-1mg/mL, the upper surface of the braiding bodies 1 is 0.01-1mm away from the upper interface of the natural polymer solution, the lower surface of the braiding bodies 1 is 0.01-2mm away from the lower interface of the natural polymer solution, the periphery of the braiding bodies 1 is 0.01-1mm away from the interface of the collagen solution, the soaking time of the braiding bodies 1 is 0.1-60min, and the soaking temperature of the braiding bodies 1 is 0-40 ℃;
2. performing primary freezing, namely freeze-drying the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing to ensure that the pressure of the container is-20 pa, the negative pressure is kept for 15-60min, the freezing cooling speed is 1 ℃/min, and the freezing time is 2h until the temperature is reduced to-20 ℃;
3. And (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to-50 ℃ at the cooling speed of 2 ℃/min, the freeze-drying time is 24 hours to 72 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating 2 is formed by attaching the natural polymer in the natural polymer solution on the woven body 1.
Further, the concentration of the natural polymer is 0.3-0.6mg/mL, the upper surface of the braiding body 1 is 0.2-0.4mm away from the upper interface of the natural polymer solution, the lower surface of the braiding body 1 is 0.4-2mm away from the lower interface of the natural polymer solution, the soaking time of the braiding body 1 is 0.1-20min, and the soaking temperature of the braiding body 1 is 25-35 ℃.
Further, in the second step, the repeated vacuum pumping is repeated at least three times.
Embodiment one: the preparation method of the woven body by using the polyethylene terephthalate silk yarns comprises the following steps:
1. Soaking, namely soaking a braiding body 1 with the thickness of 0.4mm in a collagen solution, wherein the concentration of collagen is 0.3mg/mL, the upper surface of the braiding body 1 is 0.2mm away from the upper interface of a natural polymer solution, the lower surface of the braiding body 1 is 0.4mm away from the lower interface of the collagen solution, the periphery of the braiding body 1 is 0.5mm away from the interface of the collagen solution, the soaking time of the braiding body 1 is 20min, and the soaking temperature of the braiding body 1 is 25 ℃;
2. Performing primary freezing, namely performing freeze drying on the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing, keeping the pressure of the container at-20 pa for 15min at a negative pressure maintaining speed of 1 ℃/min until the temperature is reduced to-20 ℃, and freezing for 2h;
3. And (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to-50 ℃ at a cooling speed of 2 ℃/min, the freeze-drying time is 24 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating 2 is formed by attaching the natural polymer in the natural polymer solution to the woven body 1.
Embodiment two: the preparation method of the composite patch with the polyethylene terephthalate silk yarns as the braiding bodies comprises the following steps:
1. soaking, namely soaking a braiding body 1 with the thickness of 0.8mm in a collagen solution, wherein the concentration of collagen is 0.6mg/mL, the upper surface of the braiding body 1 is 0.2mm away from the upper interface of the collagen solution, the lower surface of the braiding body 1 is 2mm away from the lower interface of the collagen solution, the periphery of the braiding body 1 is 0.5mm away from the interface of the collagen solution, the soaking time of the braiding body 1 is 0.1min, and the soaking temperature of the braiding body 1 is 30 ℃;
2. Performing primary freezing, namely performing freeze drying on the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing, keeping the pressure of the container at-20 pa for 15min at a negative pressure maintaining speed of 1 ℃/min until the temperature is reduced to-20 ℃, and freezing for 2h;
3. And (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to minus 50 ℃ at a cooling speed of 2 ℃/min, the freeze-drying time is 72 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating 2 is formed by attaching the natural polymer in the natural polymer solution to the woven body 1.
Embodiment III: the preparation method of the composite patch with the polyethylene terephthalate silk thread as the braiding body 1 comprises the following steps:
1. Soaking, namely soaking a braiding body 1 with the thickness of 0.6mm in a collagen solution, wherein the natural polymer concentration is 0.4mg/mL, the upper surface of the braiding body 1 is 0.3mm away from the upper interface of the collagen solution, the lower surface of the braiding body 1 is 1.1mm away from the lower interface of the collagen solution, the periphery of the braiding body 1 is 0.5mm away from the interface of the collagen solution, the soaking time of the braiding body 1 is 10min, and the soaking temperature of the braiding body 1 is 35 ℃;
2. Performing primary freezing, namely performing freeze drying on the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing, keeping the pressure of the container at-20 pa for 15min at a negative pressure maintaining speed of 1 ℃/min until the temperature is reduced to-20 ℃, and freezing for 2h;
3. And (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to-50 ℃ at a cooling speed of 2 ℃/min, the freeze-drying time is 48 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating 2 is formed by attaching the natural polymer in the natural polymer solution to the woven body 1.
Tensile strength test: and cutting the prepared composite polymer coating into strips by laser to obtain a test sample. The test sample was clamped on the upper and lower clamps of the tensile tester, the tester was started, the moving speed of the clamps was 500mm/min, and the test length and force changes were monitored throughout the test. The polyethylene terephthalate braid 1 coated with collagen was used as a control group. The results are shown in Table 1 below.
TABLE 1 tensile test results
Animal test: test and control samples were subcutaneously implanted in rats, 5 replicates each, and after 1 week of feeding, the vascularization degree was evaluated, the whole implant was cut out along with the skin, photographed, and the percentage of vascularized area was analyzed by ImageJ image.
TABLE 2 vascularization evaluation results
Rabbit rotator cuff model test: the shoulder muscles were exposed by cutting the skin at the front leg and shoulder joints of New Zealand white rabbits, the defects were cut with a knife to a length of 1cm along the direction perpendicular to the muscle fibers, the patch of Experimental example 2 was used to suture and reinforce along the direction of the muscle fibers, evaluation was performed at 4, 8, 12 and 24 weeks, tendon tissues were taken out, and the woven body was peeled off to perform tensile property test. The polyethylene terephthalate braiding body sprayed with collagen is used as a control.
Table 3 results of evaluation of Rabbit rotator cuff model
| Time node | Control group | Experimental group | Percent reinforcement |
| 4 Weeks of | 29±1.5N | 50±1.0N | 72.4％ |
| 8 Weeks of | 54±2.2N | 93±4.8N | 72.2％ |
| For 12 weeks | 98±3.7N | 142±3.3N | 44.9％ |
| 24 Weeks of | 107±3.2N | 149±6.4N | 39.3％ |
From the tensile strength test results, it can be seen that the tensile strength of the knitted body 1 manufactured by the knitting process is high, which means that the knitting process has a great influence on the tensile strength. Compared with the spraying process, the natural polymer coating prepared by the freeze-drying process has higher vascularization degree, which indicates that the natural polymer coating 2 prepared by the freeze-drying process has a porous structure, and is beneficial to the growth and vascularization of human tissues. As can be seen from the test results of the rabbit rotator cuff model, compared with a spraying process, the natural polymer coating manufactured through a freeze-drying process can reduce the shearing damage of polymer threads to muscles under the normal physiological activities of rotator cuff parts, and better promote muscle repair.
The invention adopts a freeze drying process, the natural polymer remained after the ice crystal sublimation forms a porous and spongy natural polymer coating 2, the bonding area between the natural polymer coating and the patch is large, the bonding strength is strong, and the porosity of the composite patch is 50-90%; because the coating has a porous structure, the tissue of a human body can grow into the patch more easily, the patch can be tightly combined between the rotator cuff and the humerus head more easily, an integral structure is formed, the healing of the rotator cuff is quickened, and meanwhile, the natural polymer coating 2 can also reduce the influence of the shearing force of the polymer silk threads on the primary tissue. The invention adopts a pure physical mode to form the natural polymer coating 2, has no other chemical components generated by chemical reaction, and meets the specifications of medical instruments better. The braiding body 1 of the present invention can provide higher initial fixing strength to reach the initial strength of the rotator cuff; the gap between the rotator cuff and the humeral head can be smaller; the braiding parts 1 can still maintain mechanical stability after the human body repeatedly moves; the braiding 1 can still maintain mechanical stability when loading cyclic load; the porous structure of the natural polymer coating 2 can optimize the biological environment of the healing part and reduce the shearing force of the braiding body 1 on the primary tissue, and more importantly, the natural polymer coating can reduce the shearing damage of the shearing force of the polymer silk thread on the primary tissue, thereby promoting better and faster reconstruction of the tissue. In conclusion, the invention is a good rotator cuff repair material.
Specifically has the following technical effects:
1. According to the invention, the concentration of natural high molecules is 0.01-1mg/mL, the upper surface of the braiding body 1 is 0.01-1mm away from the upper interface of the natural high polymer solution, the lower surface of the braiding body 1 is 0.01-2mm away from the lower interface of the natural high polymer solution, and the periphery of the braiding body 1 is 0.01-1mm away from the interface of the collagen solution, so that the moisture in the natural high polymer solution is minimum, a natural high polymer coating 2 with proper thickness can be formed, the influence of the shearing force of high polymer threads on the braiding body 1 on the native tissue can be reduced by the natural high polymer coating 2, more importantly, the shearing damage of the shearing force of the high polymer threads on the native tissue can be reduced by the natural high polymer coating, and the better and faster reconstruction of the tissue can be promoted;
2. According to the invention, through setting freeze drying, water molecules in natural polymers form ice crystals and sublimate, the rest natural polymers form a porous and spongy natural polymer coating 2, the pore structure is favorable for cell adhesion growth, and meanwhile, the influence of the shearing force of the polymer silk threads of the braiding body 1 on the primary tissues is reduced;
3. the knitting unit 3 is prepared by a warp knitting process, and the knitting unit 3 has high tensile strength, mechanical stability and good biological activity;
4. Compared with the method that medicines or porous and spongy natural polymer coating 2 is added around the patch to promote the growth of organisms, the binding force between the natural polymer coating 2 and the patch is small, the method comprises the steps of immersing the braiding unit 3 and then freeze-drying, wherein the binding force between the obtained porous and spongy natural polymer coating 2 and the braiding unit 3 is strong, the binding contact surface is large, and the generated organisms are also strong in binding force with the patch.
The above examples are only preferred embodiments of the present invention, and the scope of the present invention is not limited thereto, but any insubstantial changes and modifications made by those skilled in the art based on the present invention are included in the scope of the present invention.
Claims (10)
1. A composite patch for rotator cuff repair, comprising: the woven body is sheet-shaped, the woven body comprises one or more woven units manufactured through a weaving process, a degradable natural polymer coating is arranged on one surface or two surfaces of the woven body, the natural polymer coating is formed by attaching natural polymers in a natural polymer solution to the woven body through a freeze drying process, the natural polymer solution is a solution formed by dissolving the natural polymers in physiological saline, and the natural polymer coating is porous and spongy.
2. The composite patch of claim 1, wherein: the plurality of braiding units are overlapped in the thickness direction, the shapes of the plurality of braiding units are the same, two ends of the plurality of braiding units are connected, and a natural polymer coating is arranged between the two braiding units for connection.
3. The composite patch of claim 1, wherein: the natural polymer comprises animal-derived collagen and/or recombinant collagen and/or gelatin and/or chitosan and/or silk fibroin, the braiding unit is prepared by a non-degradable polymer substrate warp knitting process, and the polymer substrate comprises polyethylene terephthalate and/or polypropylene and/or polyethylene and/or polydioxanone and/or polycaprolactone and/or poly L-lactide and/or polyglycolic acid.
4. A composite patch according to claim 3, wherein: the polymer base material is polyethylene glycol terephthalate, and the natural polymer is collagen.
5. The composite patch of claim 1, wherein: the thickness of the braiding body is 0.1-1.5mm, and the ultimate tensile load of the braiding body is 200-1000N.
6. The composite patch of claim 5, wherein: the thickness of the braiding body is 0.4-0.8mm, and the ultimate tensile load of the braiding body is 500-800N.
7. The composite patch of claim 1, wherein: the knitting process is warp knitting or weft knitting.
8. A preparation method of a composite patch is characterized by comprising the following steps: the method comprises the following steps:
1. Soaking, namely soaking a braiding body in a natural polymer solution, wherein the concentration of the natural polymer is 0.01-1mg/mL, the upper surface of the braiding body is 0.01-1mm away from the upper interface of the natural polymer solution, the lower surface of the braiding body is 0.01-2mm away from the lower interface of the natural polymer solution, the periphery of the braiding body 1 is 0.01-1mm away from the interface of a collagen solution, the soaking time of the braiding body is 0.1-60min, and the soaking temperature of the braiding body is 0-40 ℃;
2. performing primary freezing, namely freeze-drying the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing to ensure that the pressure of the container is-20 pa, the negative pressure is kept for 15-60min, the freezing cooling speed is 1 ℃/min, and the freezing time is 2h until the temperature is reduced to-20 ℃;
3. and (3) freeze-drying, wherein after the freezing time is 2 hours, the temperature is reduced to-50 ℃ at a cooling speed of 2 ℃/min, the freeze-drying time is 24 hours to 72 hours, and the natural polymer in the natural polymer solution is freeze-dried to be completely dried, so that the natural polymer coating is formed on the woven body.
9. The method of manufacturing according to claim 8, wherein: the concentration of the natural polymer is 0.3-0.6mg/mL, the upper surface of the braiding body is 0.2-0.4mm away from the upper interface of the natural polymer solution, the lower surface of the braiding body is 0.4-2mm away from the lower interface of the natural polymer solution, the soaking time of the braiding body is 0.1-20min, and the soaking temperature of the braiding body is 25-35 ℃.
10. The method of manufacturing according to claim 8, wherein: the method comprises the following steps:
1. Soaking, namely soaking a braiding body with the thickness of 0.8mm in a collagen solution, wherein the concentration of collagen is 0.6mg/mL, the upper surface of the braiding body is 0.2mm away from the upper interface of the collagen solution, the lower surface of the braiding body is 2mm away from the lower interface of the collagen solution, the periphery of the braiding body 1 is 0.5mm away from the interface of the collagen solution, the soaking time of the braiding body is 0.1min, and the soaking temperature of the braiding body is 30 ℃;
2. Performing primary freezing, namely performing freeze drying on the soaking solution in the first step, repeatedly vacuumizing a container for containing the soaking solution for a plurality of times, starting freezing, keeping the pressure of the container at-20 pa for 15min at a negative pressure maintaining speed of 1 ℃/min until the temperature is reduced to-20 ℃, and freezing for 2h;
3. And (3) freeze-drying, namely cooling to-50 ℃ at a cooling speed of 2 ℃/min after the freezing time is 2h, freeze-drying for 48h, and freeze-drying until the natural polymer in the natural polymer solution is completely dried, wherein the natural polymer is attached to the woven body to form a natural polymer coating.
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| CN202410294154.XA CN117919507A (en) | 2024-03-14 | 2024-03-14 | Composite patch for rotator cuff repair and preparation method thereof |
| CN202411094021.4A CN118806992A (en) | 2024-03-14 | 2024-08-09 | A composite patch for rotator cuff repair and preparation method thereof |
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| CN202411094021.4A Pending CN118806992A (en) | 2024-03-14 | 2024-08-09 | A composite patch for rotator cuff repair and preparation method thereof |
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| CN118806992A (en) * | 2024-03-14 | 2024-10-22 | 深圳市迈捷生命科学有限公司 | A composite patch for rotator cuff repair and preparation method thereof |
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| CN107928837A (en) * | 2017-10-23 | 2018-04-20 | 上海利格泰生物科技有限公司 | The part repaired for shoulder sleeve can absorb sticking patch and manufacture method |
| CN114404670A (en) * | 2022-01-19 | 2022-04-29 | 福州市第二医院（福建省福州中西医结合医院、福州市职业病医院） | Rotator cuff patch based on polyethylene and collagen coating and preparation method thereof |
| CN114732948A (en) * | 2022-03-25 | 2022-07-12 | 上海工程技术大学 | Rotator cuff patch and preparation method thereof |
| US20220401627A1 (en) * | 2020-03-12 | 2022-12-22 | Smith & Nephew, Inc. | Tissue repair implant and compositions and method of implantation |
| CN219185109U (en) * | 2023-01-07 | 2023-06-16 | 复旦大学附属华山医院 | Composite bionic patch for surgery |
| CN116899015A (en) * | 2023-08-28 | 2023-10-20 | 浙江星月生物科技股份有限公司 | A composite rotator cuff patch and its preparation method |
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| WO2018144858A1 (en) * | 2017-02-02 | 2018-08-09 | Nanofiber Solutions, Inc. | Methods of improving bone-soft tissue healing using electrospun fibers |
| CN114452034A (en) * | 2021-12-18 | 2022-05-10 | 北京天星博迈迪医疗器械有限公司 | Soft tissue repair stent 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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- 2024-03-14 CN CN202410294154.XA patent/CN117919507A/en not_active Withdrawn
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107928837A (en) * | 2017-10-23 | 2018-04-20 | 上海利格泰生物科技有限公司 | The part repaired for shoulder sleeve can absorb sticking patch and manufacture method |
| US20220401627A1 (en) * | 2020-03-12 | 2022-12-22 | Smith & Nephew, Inc. | Tissue repair implant and compositions and method of implantation |
| CN114404670A (en) * | 2022-01-19 | 2022-04-29 | 福州市第二医院（福建省福州中西医结合医院、福州市职业病医院） | Rotator cuff patch based on polyethylene and collagen coating and preparation method thereof |
| CN114732948A (en) * | 2022-03-25 | 2022-07-12 | 上海工程技术大学 | Rotator cuff patch and preparation method thereof |
| CN219185109U (en) * | 2023-01-07 | 2023-06-16 | 复旦大学附属华山医院 | Composite bionic patch for surgery |
| CN116899015A (en) * | 2023-08-28 | 2023-10-20 | 浙江星月生物科技股份有限公司 | A composite rotator cuff patch and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN118806992A (en) * | 2024-03-14 | 2024-10-22 | 深圳市迈捷生命科学有限公司 | A composite patch for rotator cuff repair and preparation method thereof |
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Application publication date: 20240426 |