CN108403258B - Dead point reconstruction type artificial rotator cuff patch and manufacturing method thereof - Google Patents

Abstract

A manufacturing method of a dead point reconstruction type artificial rotator cuff patch comprises the following specific steps: constructing a patch intermediate layer with a nanofiber structure through electrostatic spinning or constructing a patch intermediate layer with a net-shaped braiding body structure through braiding to serve as a supporting main body of the whole patch; the two ends of the patch interlayer are respectively provided with a tendon part and a dead point part, the tendon part of the patch interlayer is wrapped and crosslinked with a patch tendon part interlayer, and the dead point part of the patch interlayer is wrapped and crosslinked with a patch dead point part interlayer; the upper surfaces of the patch tendon part middle layer and the patch dead point part middle layer are correspondingly coated and crosslinked with a patch upper layer; the lower surfaces of the patch tendon part middle layer and the patch dead point middle layer are correspondingly coated and crosslinked with a patch tendon lower layer and a patch dead point lower layer to form the whole dead point reconstruction type artificial rotator cuff patch. The rotator cuff patch provided by the invention can repair rotator cuff defects and reconstruct tendon-bone dead points, and has good mechanical strength and good biocompatibility.

Description

Insertion reconstruction type artificial rotator cuff patch and manufacturing method thereof

technical field

The invention relates to the technical field of surgical patches, in particular to an insertion reconstruction type artificial rotator cuff patch and a manufacturing method thereof.

Background technique

Rotator cuff injury is one of the common orthopedic diseases, and it is a common cause of shoulder joint pain, limited mobility, and functional impairment. The incidence rate gradually increases with age. For patients who fail conservative treatment and patients with large rotator cuff injuries, surgery is usually required to repair the torn rotator cuff, so as to relieve pain and restore shoulder joint function, but the postoperative effect is not satisfactory, and the failure rate of revision is 20% to 70%. This is related to the extent of rotator cuff tear, tendon contracture, fat infiltration, inappropriate postoperative rehabilitation exercises and other factors, but the difficulty of postoperative tendon-bone interface healing is the main reason. The normal rotator cuff insertion is composed of four layers of tendon, fibrocartilage, mineralized cartilage, and bone tissue, which are gradually transitioned, which is conducive to mechanical conduction and is not prone to tearing. The normal tendon-bone insertion between the repaired rotator cuff and bone tissue cannot be restored, and the continuity can only be restored through scar healing, which is prone to re-tearing. For patients with huge rotator cuff injuries and patients with long-term tendon degeneration and retraction after the injury, it is difficult to fix the retracted and torn rotator cuff in the footprint area of the insertion point during surgery, and it is necessary to use rotator cuff structural reinforcement technology to deal with the rupture. The problem of end retraction and inability to reconstruct the insertion point can be solved, thereby improving the success rate of the operation and improving the shoulder joint function of the patient.

The rotator cuff patch reinforcement technique is a commonly used rotator cuff structural enhancement technique, especially for patients with large rotator cuff tears and chronic rotator cuff injuries with tendon retraction. With the continuous improvement of tissue engineering technology, the development and application of rotator cuff mesh has entered a new stage. Many mesh materials have shown good performance, but there are still some shortcomings. Common rotator cuff mesh materials include synthetic mesh and biomaterial mesh.

Synthetic rotator cuff patches include degradable and non-degradable types, and the main component is polymer. Common non-degradable patch synthetic materials include polypropylene, polyester, polytetrafluoroethylene, and nylon. These patches have good tensile properties and provide stable mechanical protection for the healing of host tissues. Degradable patch synthetic materials include L-polylactic acid, lactic acid glycolic acid, polycaprolactone, and polypropylene glycol copolymers, etc., which can be degraded by tissues and can also provide a certain degree of mechanical strength, but there may be some degradation products. Cytotoxicity. At present, the biocompatibility of the synthetic material rotator cuff patch is not good, and there is a risk of foreign body rejection after surgery, which limits the clinical application of this kind of patch.

Biomaterial patches are mostly derived from tissue graft materials, which can be roughly divided into autologous tissue grafts, allogeneic tissue grafts, and decellularized tissue grafts according to their sources. Autograft materials are mainly derived from the fascia lata and long head tendon of the biceps brachii. The biggest advantage is good biocompatibility, but additional trauma will be caused when the materials are taken, resulting in damage to the donor site. Allogeneic tissue graft materials are usually derived from allogeneic rotator cuff, tibialis anterior tendon, patellar tendon, Achilles tendon, etc. Although the postoperative range of motion and muscle strength of the shoulder joint are significantly improved, they lack stable mechanical strength and are prone to failure after transplantation. There is an immune rejection reaction, there is a risk of infection, and the source is limited. Decellularized tissue grafts mainly include xenogeneic tissue transplantation and allogeneic tissue transplantation, such as animal dermis, small intestine, pericardium, etc., using inherent collagen, non-collagen, and three-dimensional structures as scaffolds to promote postoperative collagen fibers and Angiogenesis and functional reconstruction of the tendon-bone interface have good biocompatibility and ductility, but their mechanical strength cannot meet the mechanical load strength of the rotator cuff.

Current rotator cuff patch materials are limited in clinical application due to factors such as histocompatibility, biomechanical strength, tissue source, and safety. In addition, all rotator cuff patches cannot reconstruct the tendon-bone insertion from the four layers of tendon, fibrocartilage, mineralized cartilage and bone tissue, so the design can reconstruct the tendon-bone insertion, mechanical strength Excellent and biocompatible rotator cuff patches have important clinical application value for the treatment of rotator cuff injuries.

Contents of the invention

In view of this, the purpose of the present invention is to provide a kind of insertion reconstruction type artificial rotator cuff patch and corresponding manufacturing method, the rotator cuff patch can reconstruct the tendon-bone insertion, while using non-degradable materials and biocompatible Materials with good properties can improve the mechanical strength on the one hand and have good biocompatibility on the other hand.

In order to achieve the above object, the technical scheme adopted in the present invention is:

A method for manufacturing an insertion reconstruction type artificial rotator cuff patch, the specific steps are as follows:

S1. Select a non-absorbable synthetic material and hydrogel to make a spinning solution, construct a patch middle layer with a nanofiber structure through electrospinning, or use a non-absorbable synthetic material to construct a net-like weave through weaving The middle layer of the patch with body structure is used as the supporting body of the whole patch;

S2. The two ends of the middle layer of the patch are the tendon part and the insertion point respectively. The tendon part of the middle layer of the patch is wrapped with a cross-linked middle layer of the tendon part of the patch, and the tendon activity is added to the middle layer of the tendon part of the patch. Drugs or tendon-forming active growth factors are wrapped and cross-linked at the insertion point of the patch middle layer, and a cartilage active drug or chondrogenic active growth factor is added to the middle layer of the patch insertion point ;

S3. The upper surface of the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are correspondingly coated and cross-linked with an upper layer of the patch, and a tendon-forming active drug or a tendon-forming active growth factor is added to the upper layer of the patch;

S4. The lower surface of the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are correspondingly coated and cross-linked with the lower layer of the tendon portion of the patch and the lower layer of the insertion point of the patch, and the tendon is added to the lower layer of the tendon portion of the patch Active drugs or tendon-forming active growth factors are added to the lower layer of the insertion point of the patch to form the entire insertion point reconstruction artificial rotator cuff patch.

Preferably, the synthetic material in the step S1 is composed of one or more of polypropylene, polyester, polytetrafluoroethylene and nylon.

Preferably, the middle layer of the tendon part of the patch and the middle layer of the insertion point of the patch in the step S2 are wrapped and cross-linked at both ends of the middle layer of the patch, and then freeze-dried to form a glue layer structure, and the patch During the freeze-drying process, the middle layer of the tendon part and the middle layer of the insertion point of the patch form a plurality of first micropores and second micropores for the growth of human cells, and the inner walls of the first micropores are coated with The tendon-forming induction layer containing tendon-forming active drug or tendon-forming active growth factor, the inner wall of the second micropore is coated with the chondrogenic-forming inducing layer containing chondrogenic active drug or chondrogenic active growth factor, and the patch tendon The middle layer of the center and the middle layer of the insertion point of the patch are composed of biocompatible composite materials, and the composite materials are one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

Preferably, the upper layer of the patch in the step S3 is coated with cross-linking and then freeze-dried to form a glue layer structure, and the upper layer of the patch forms a plurality of third cells for human cells to grow into during the freeze-drying process. micropores, and the inner wall of the third micropores is coated with a tendon-forming induction layer containing tenogenic active drugs or tenogenic active growth factors, and the upper layer of the patch is made of a biocompatible composite material. The composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

Preferably, the lower layer of the tendon portion of the patch and the lower layer of the insertion point of the patch in step S4 are coated and cross-linked to form a glue layer structure after freeze-drying, and the lower layer of the tendon portion of the patch and the lower layer of the insertion point of the patch are During the freeze-drying process, a plurality of fourth micropores and fifth micropores for the growth of human cells are formed inside, and the inner walls of the fourth micropores are coated with active tendon-forming drugs or active tendon-forming growth factors. The tendon induction layer is coated with an osteogenesis induction layer containing osteogenic active drugs or osteogenic active growth factors on the inner wall of the fifth micropore. The capacitive composite material is composed of one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

At the same time, it also provides a kind of artificial rotator cuff patch of insertion point reconstruction, which adopts the above-mentioned manufacturing method, and the insertion point reconstruction type artificial rotator cuff patch is a multi-layer structure, including a tendon part of the patch, and a point of insertion of the patch and the middle layer of the patch, the two ends of the middle layer of the patch are the tendon portion and the insertion point respectively, and the tendon portion of the patch includes the upper layer of the tendon portion of the patch, the middle layer of the tendon portion of the patch and the lower layer of the tendon portion of the patch, The insertion point of the patch includes an upper layer of the insertion point of the patch, an intermediate layer of the insertion point of the patch, and a lower layer of the insertion point of the patch. The upper layer of the tendon portion of the patch and the upper layer of the insertion point of the patch form the upper layer of the patch. The middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are respectively wrapped and cross-linked on the tendon portion and the insertion point of the middle layer of the patch, and the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are respectively wrapped and cross-linked. The upper surface is coated and cross-linked with the upper layer of the patch, and the lower surface of the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are correspondingly coated with the lower layer of the tendon portion of the patch and the lower layer of the insertion point of the patch.

Preferably, the middle layer of the patch is a nanofibrous structure formed by electrospinning the electrospinning solution made of synthetic materials and hydrogel, or the middle layer of the patch is made of non-absorbable and degradable The synthetic material is constructed by weaving to form a net-like braid structure, and constitutes the supporting body of the insertion point reconstruction artificial rotator cuff patch. The synthetic material is made of one of polypropylene, polyester, polytetrafluoroethylene and nylon. One or more compound compositions.

Preferably, the middle layer of the tendon part of the patch is a glue layer structure formed by cross-linking a composite material with biocompatibility and added with tendon-forming active drugs or active tendon-forming growth factors, and the middle layer of the tendon part of the patch is The layer is composed of one or more composite crosslinks among gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, and the middle layer of the tendon part of the patch also has a plurality of first cells for human cells to grow into. Micropores, the inner walls of the first micropores are coated with a tendonogenic induction layer containing tenogenic active drugs or tenogenic active growth factors.

Preferably, the middle layer of the insertion point of the patch is a glue layer structure formed by cross-linking composite materials with biocompatibility and added with chondrogenic active drugs or chondrogenic active growth factors, and the insertion point of the patch is The middle layer of the patch is composed of one or more composite cross-links of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate. The inner wall of the second micropore is coated with a chondrogenic induction layer containing chondrogenic active drug or chondrogenic active growth factor.

Preferably, the upper layer of the patch is a glue layer structure formed by cross-linking a composite material with biocompatibility and added with tendon-forming active drugs or tendon-forming active growth factors. The upper layer of the patch is composed of gelatin, collagen, One or more of hyaluronic acid, chitosan, and sodium alginate are composed of one or more composite crosslinks, and the upper layer of the patch also has a plurality of third micropores for human cells to grow into. The third micropores The inner wall of the skin is coated with a tenogenic induction layer containing tenogenic active drugs or tenogenic active growth factors.

Preferably, the lower layer of the tendon portion of the patch is a glue layer structure formed by cross-linking a composite material with biocompatibility and added with tendon-forming active drugs or active tendon-forming growth factors, and the lower layer of the tendon portion of the patch is composed of Gelatin, collagen, hyaluronic acid, chitosan and sodium alginate are composed of one or more composite cross-links, and the lower layer of the tendon part of the patch also has a plurality of fourth micropores for human cells to grow into. The inner wall of the fourth micropore is coated with a tenogenic induction layer containing tenogenic active drug or tenogenic active growth factor.

Preferably, the lower layer of the insertion point of the patch is a glue layer structure formed by cross-linking composite materials with biocompatibility and osteogenic active drugs or osteogenic growth factors added therein, and the insertion point of the patch is The lower layer is composed of one or more composite cross-links of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate. The inner wall of the fifth micropore is coated with an osteogenic induction layer containing osteogenic active drugs or osteogenic active growth factors.

Compared with the prior art, the present invention provides an insertion reconstruction artificial rotator cuff patch and a corresponding manufacturing method, wherein the middle layer of the rotator cuff patch is made of non-absorbable and degradable material, which can provide sufficient The mechanical strength provides a stable mechanical guarantee for tissue healing. Cross-linking materials with good biocompatibility on the middle layer of the patch can avoid the rejection reaction caused by the middle layer materials, combine the advantages of different materials, and combine non-degradable materials and materials with good biocompatibility, so that The artificial rotator cuff patch has both good mechanical strength and good biocompatibility. By constructing a three-layer structure at the insertion point of the patch, different materials, bioactive drugs and growth factors were compounded to simulate the tendon layer, cartilage layer and bone tissue layer respectively. Differentiate to mineralized cartilage and fibrocartilage, thereby recreating the normal rotator cuff tendon-bone insertion.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. Those skilled in the art can also obtain other drawings based on these drawings without creative work.

FIG. 1 is a schematic structural view of an insertion point reconstruction artificial rotator cuff patch provided by the present invention.

Reference signs and component parts involved in the accompanying drawings:

1. The middle layer of the patch; 2. The middle layer of the tendon of the patch; 3. The lower layer of the tendon; 4. The middle layer of the patch insertion; 5. The lower layer of the patch insertion; 6. The upper layer of the patch.

Detailed ways

The technical solutions of the present invention will be clearly and completely described below through specific embodiments. Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

A method for manufacturing an insertion reconstruction type artificial rotator cuff patch, the specific steps are as follows:

S1. Select a non-absorbable synthetic material and hydrogel to make a spinning solution, construct a patch middle layer with a nanofiber structure through electrospinning, or use a non-absorbable synthetic material to construct a net-like weave through weaving The middle layer of the patch of body structure is used as the supporting body of the whole patch.

The synthetic material is composed of one or more composites of polypropylene, polyester, polytetrafluoroethylene and nylon. This synthetic material is a material that cannot be absorbed and degraded by the human body, so the middle layer of the patch constructed provides a good supply for tissue healing. Stable mechanical guarantee.

S2. The two ends of the middle layer of the patch are the tendon part and the insertion point respectively. The tendon part of the middle layer of the patch is wrapped with a cross-linked middle layer of the tendon part of the patch, and the tendon activity is added to the middle layer of the tendon part of the patch. Drugs or tendon-forming active growth factors are wrapped and cross-linked at the insertion point of the patch middle layer, and a cartilage active drug or chondrogenic active growth factor is added to the middle layer of the patch insertion point .

The middle layer of the tendon part of the patch and the middle layer of the insertion point of the patch are wrapped and cross-linked on both ends of the middle layer of the patch, and then freeze-dried to form a glue layer structure, and the middle layer of the tendon part of the patch and the insertion point of the patch During the freeze-drying process of the middle layer, a plurality of first micropores and second micropores for the growth of human cells are formed inside, and the inner walls of the first micropores are coated with tenogenic active drugs or tenogenic active growth agents. The inner wall of the second micropore is coated with a chondrogenic induction layer containing chondrogenic active drugs or chondrogenic active growth factors.

The middle layer of the tendon part of the patch and the middle layer of the insertion point of the patch are made of a biocompatible composite material, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate kind

The middle layer of the insertion point of the patch is in contact with the cartilage tissue of the human body, and the cartilage tissue cells enter the second micropore in the middle layer of the insertion point of the patch, simulating the human cartilage layer. The chondrogenic active drug or cartilage growth active factor contained in the chondrogenic induction layer on the inner wall of the micropore can induce the formation of tendon-bone insertion cartilage.

S3. The upper surface of the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are correspondingly coated and cross-linked with an upper layer of the patch, and tendonogenic active drugs or active tendonogenic growth factors are added to the upper layer of the patch.

The upper layer of the patch is coated with cross-linking and then freeze-dried to form a glue layer structure. During the freeze-drying process, the upper layer of the patch forms a third micropore for human cells to grow into, and the inner wall of the third micropore Coated with a tenogenic induction layer containing tenogenic active drugs or tenogenic active growth factors.

The upper layer of the patch is made of biocompatible composite material, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate. The use of composite materials with better biocompatibility can avoid the rejection reaction caused by the middle layer material of the patch, and increase the biocompatibility of the patch material.

The upper layer of the patch is in contact with the tendon tissue of the human body, and the tendon tissue cells enter the third micropore on the upper layer of the patch. The added tenogenic active drug or tenogenic active growth factor can improve the ability to repair tendon fibers.

S4. The lower surface of the middle layer of the tendon portion of the patch and the middle layer of the insertion point of the patch are correspondingly coated and cross-linked with the lower layer of the tendon portion of the patch and the lower layer of the insertion point of the patch, and the tendon is added to the lower layer of the tendon portion of the patch Active drugs or tendon-forming active growth factors are added to the lower layer of the insertion point of the patch to form the entire insertion point reconstruction artificial rotator cuff patch.

The lower layer of the tendon part of the patch and the lower layer of the insertion point of the patch were coated with cross-linking and then freeze-dried to form a glue layer structure, and the lower layer of the tendon part of the patch and the lower layer of the insertion point of the patch formed multiple layers during the freeze-drying process. A fourth micropore and a fifth micropore for human cells to grow into, and the inner wall of the fourth micropore is coated with a tendon-forming induction layer containing tendon-forming active drugs or tendon-forming active growth factors, and in the fifth micropore The inner wall is coated with an osteogenic induction layer containing osteogenic active drugs or osteogenic active growth factors.

The lower layer of the tendon part of the patch and the lower layer of the insertion point of the patch are composed of biocompatible composite materials, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, Increase the biocompatibility of the patch material.

The lower layer of the tendon part of the patch is in contact with the tendon tissue cells of the human body, and the tendon tissue cells enter the fourth micropore in the lower layer of the tendon part of the patch. The tendon-forming active drug or tendon-forming active growth factor added in the tendon-forming induction layer on the inner wall of the four micropores can improve the ability of repairing tendon fibers.

The lower layer of the patch insertion point is in contact with the osteoblast tissue of the human body, and the osteoblast cells enter the fifth micropore in the lower layer of the patch insertion point. The lower layer of the patch insertion point simulates the bone tissue layer of the human body, and the patch insertion point The osteogenic active drug or osteogenic active growth factor added in the lower layer and the osteogenic induction layer on the inner wall of the fifth micropore can induce the formation of tendon-bone insertion osteogenesis.

Since the middle layer of the insertion point of the patch simulates the human cartilage layer, due to the difference in the tissue cell composition of the upper and lower interfaces, it can differentiate into mineralized cartilage and fibrocartilage, thereby reconstructing the normal rotator cuff tendon-bone insertion.

Corresponding to the above-mentioned manufacturing method, as shown in FIG. 1 , an artificial rotator cuff patch of insertion point reconstruction is provided. The insertion reconstruction artificial rotator cuff patch has a multi-layer structure, including the tendon portion of the patch, the insertion point of the patch, and the middle layer 1 of the patch. The two ends of the middle layer 1 of the patch are the tendon portion and the insertion point respectively. The tendon portion of the patch includes the upper layer of the tendon portion of the patch, the middle layer of the tendon portion of the patch 2 and the lower layer of the tendon portion of the patch 3, and the insertion point of the patch includes the upper layer of the insertion point portion of the patch, the middle layer of the insertion point portion of the patch 4 and the patch The lower layer 5 of the insertion point, the upper layer of the tendon portion of the patch and the upper layer of the insertion point of the patch form the upper layer 6 of the patch, the middle layer 2 of the tendon portion of the patch and the middle layer 4 of the insertion point portion of the patch are respectively wrapped and cross-linked in the middle layer 1 of the patch On the tendon portion and insertion point portion of the patch, and on the upper surface of the patch tendon portion middle layer 2 and the patch insertion point middle layer 4, the cross-linked patch upper layer 6 is coated, and the patch tendon portion middle layer 2 and the patch The lower surface of the insertion point middle layer 4 is correspondingly coated with the cross-linked patch tendon lower layer 3 and the patch insertion point lower layer 4 .

Specifically, the middle layer 1 of the patch is a nanofiber structure formed by electrospinning the electrospinning solution made of synthetic materials and hydrogel, or the middle layer 1 of the patch is a synthetic material that cannot be absorbed and degraded by the human body. The net-like braid structure formed by weaving constitutes the supporting body of the insertion point reconstruction artificial rotator cuff patch. The synthetic material is composed of one or more of polypropylene, polyester, polytetrafluoroethylene and nylon. constitute.

The middle layer 2 of the tendon part of the patch is a glue layer structure formed by cross-linking of a composite material with biocompatibility and added with tendon-forming active drugs or active tendon-forming growth factors. The middle layer 2 of the tendon part of the patch is made of gelatin, collagen, One or more of hyaluronic acid, chitosan and sodium alginate are composed of composite crosslinks. Wherein, there are also a plurality of first micropores (not shown in the figure) for the growth of human cells in the middle layer 2 of the tendon part of the patch. Tenogenesis-inducing layer of active growth factors (not shown in figure).

The middle layer 4 of the insertion point of the patch is a glue layer structure formed by cross-linking of composite materials with biocompatibility and added with chondrogenic active drugs or active growth factors of chondrogenic activity. The middle layer 4 of the insertion point of the patch is made of gelatin, One or more of collagen, hyaluronic acid, chitosan and sodium alginate are composed of composite crosslinks. Wherein, the intermediary layer 4 of the insertion point of the patch also has a plurality of second micropores (not shown in the figure) for the growth of human cells, and the inner wall of the second micropores is coated with chondrogenic active drugs or Chondrogenic inducing layer of cartilage active growth factor (not shown in figure).

The upper layer 6 of the patch is a glue layer structure formed by cross-linking of a composite material with biocompatibility and added with tendon-forming active drugs or active tendon-forming growth factors. The upper layer 6 of the patch is made of gelatin, collagen, hyaluronic acid, chitosan One or more composite cross-links of sugar and sodium alginate. There are also a plurality of third micropores (not shown) for human cells to grow into in the patch upper layer 6, and the inwall of the third micropores is coated with synthetic tendon-forming active drugs or active tendon-forming growth factors. Tendon induction layer (not shown in figure).

The lower layer 3 of the tendon part of the patch is a glue layer structure formed by cross-linking composite materials with biocompatibility and added with tendon-forming active drugs or active tendon-forming growth factors. The lower layer 3 of the tendon part of the patch is composed of gelatin, collagen, hyaluronic acid Acid, chitosan and sodium alginate one or more composite cross-linked composition. Wherein, there are also a plurality of fourth micropores (not shown in the figure) for the growth of human cells in the lower layer 3 of the tendon part of the patch, and the inner wall of the fourth micropores is coated with tenogenic active drugs or tenogenic active drugs. Tenogenesis-inducing layer of growth factors (not shown in figure).

The lower layer 5 of the insertion point of the patch is a glue layer structure formed by cross-linking of a composite material with biocompatibility and added with osteogenic active drugs or osteogenic active growth factors. The lower layer 4 of the insertion point of the patch is made of gelatin, collagen, One or more of hyaluronic acid, chitosan and sodium alginate are composed of composite crosslinks. Wherein, there is also a plurality of fifth micropores (not shown in the figure) for the growth of human cells in the lower layer 5 of the patch insertion point, and the inner wall of the fifth micropores is coated with osteogenic active drugs or osteogenic drugs. An osteoinductive layer of active growth factors (not shown in the figure).

The present invention provides an insertion reconstruction type artificial rotator cuff patch and a corresponding manufacturing method. The rotator cuff patch can repair rotator cuff defects and reconstruct tendon-bone insertions at the same time. It adopts non-degradable materials and has good biocompatibility. The material, on the one hand, improves the mechanical strength, on the other hand, it also has good biocompatibility.

The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (12)

1. A manufacturing method of a dead point reconstruction type artificial rotator cuff patch is characterized by comprising the following steps of: the method comprises the following specific steps:

s1, mixing a synthetic material which is not absorbable by a human body and hydrogel to prepare a spinning solution, and constructing a patch intermediate layer with a nanofiber structure through electrostatic spinning, or weaving the synthetic material which is not absorbable by the human body to construct a patch intermediate layer with a net-shaped weaving body structure as a supporting main body of the whole patch;

s2, respectively wrapping and crosslinking a tendon part middle layer at two ends of the patch middle layer by using a tendon part and a dead point part, adding a tendon-forming active drug or a tendon-forming active growth factor into the tendon part middle layer of the patch, wrapping and crosslinking a patch dead point part middle layer at the dead point part of the patch middle layer, and adding a cartilage-forming active drug or a cartilage-forming active growth factor into the patch dead point part middle layer;

s3, correspondingly coating and crosslinking a patch upper layer on the upper surfaces of the patch tendon part middle layer and the patch dead point part middle layer, and adding a tendon-forming active drug or a tendon-forming active growth factor into the patch upper layer;

s4, correspondingly coating and crosslinking a patch tendon lower layer and a patch dead point lower layer on the lower surfaces of the patch tendon middle layer and the patch dead point middle layer, adding a tendon active drug or a tendon active growth factor into the patch tendon lower layer, and adding an bone active drug or an bone active growth factor into the patch dead point lower layer to form the whole dead point reconstruction type artificial rotator cuff patch.

2. The method for manufacturing a dead center reconstruction type artificial rotator cuff patch according to claim 1, wherein the method comprises the steps of: the synthetic material in the step S1 is formed by compounding one or more of polypropylene, polyester, polytetrafluoroethylene and nylon.

3. The method for manufacturing a dead center reconstruction type artificial rotator cuff patch according to claim 1, wherein the method comprises the steps of: the patch tendon part middle layer and the patch dead point middle layer in the step S2 are wrapped and crosslinked at two ends of the patch middle layer and then are subjected to freeze-drying treatment to form a glue layer structure, a plurality of first micropores and second micropores for human cells to grow in are respectively formed in the patch tendon part middle layer and the patch dead point middle layer in the freeze-drying treatment process, the inner wall of the first micropores is coated with a tendon forming induction layer containing a tendon forming active drug or a tendon forming active growth factor, the inner wall of the second micropores is coated with a cartilage forming induction layer containing a cartilage forming active drug or a cartilage forming active growth factor, the patch tendon part middle layer and the patch dead point middle layer are formed by a composite material with biocompatibility, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

4. The method for manufacturing a dead center reconstruction type artificial rotator cuff patch according to claim 1, wherein the method comprises the steps of: the patch upper layer in the step S3 is coated and crosslinked and then is subjected to freeze-drying treatment to form a glue layer structure, a plurality of third micropores for human cells to grow in are formed in the patch upper layer in the freeze-drying treatment process, a tendon-forming induction layer containing tendon-forming active drugs or tendon-forming active growth factors is coated on the inner wall of the third micropores, the patch upper layer is made of a biocompatible composite material, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

5. The method for manufacturing a dead center reconstruction type artificial rotator cuff patch according to claim 1, wherein the method comprises the steps of: the lower layers of the tendon of the patch and the lower layers of the dead points of the patch in the step S4 are coated and crosslinked and then are subjected to freeze-drying treatment to form a glue layer structure, a plurality of fourth micropores and fifth micropores for human cells to grow in are respectively formed in the lower layers of the tendon of the patch and the lower layers of the dead points of the patch in the freeze-drying treatment process, the inner wall of the fourth micropores is coated with an osteogenic induction layer containing an osteogenic active drug or an osteogenic active growth factor, the inner wall of the fifth micropores is coated with an osteogenic induction layer containing an osteogenic active drug or an osteogenic active growth factor, and the lower layers of the tendon of the patch and the lower layers of the dead points of the patch are made of a biocompatible composite material, and the composite material is one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate.

6. A dead-center reconstruction type artificial rotator cuff patch, using a method for manufacturing the dead-center reconstruction type artificial rotator cuff patch according to any one of claims 1 to 5, characterized in that: the patch comprises a patch tendon part, a patch dead point part and a patch middle layer, wherein two ends of the patch middle layer are respectively provided with a tendon part and a dead point part, the patch tendon part comprises a patch tendon part upper layer, a patch tendon part middle layer and a patch tendon part lower layer, the patch dead point part comprises a patch dead point part upper layer, a patch dead point part middle layer and a patch dead point part lower layer, the patch tendon part upper layer and the patch dead point part upper layer form a patch upper layer, the patch tendon part middle layer and the patch dead point part middle layer are respectively wrapped and crosslinked on the tendon part and the dead point part of the patch middle layer, the patch upper layer is coated and crosslinked on the upper surfaces of the patch tendon part middle layer and the patch dead point part middle layer, and the lower surfaces of the patch tendon part middle layer and the patch dead point part middle layer are correspondingly coated and crosslinked on the patch lower layer and the patch dead point part lower layer.

7. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the patch intermediate layer is of a nanofiber structure formed by electrostatic spinning construction of electrostatic spinning solution made of synthetic materials and hydrogel, or is of a net-shaped braiding body structure formed by braiding construction of non-absorbable and degradable synthetic materials of a human body, and forms a supporting main body of the dead point reconstruction type artificial rotator cuff patch, and the synthetic materials are formed by compounding one or more of polypropylene, polyester, polytetrafluoroethylene and nylon.

8. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the patch tendon part middle layer is of a glue layer structure formed by crosslinking a composite material which has biocompatibility and is internally added with a tendon-forming active drug or a tendon-forming active growth factor, the patch tendon part middle layer is formed by crosslinking one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, the patch tendon part middle layer is also provided with a plurality of first micropores for human cells to grow in, and the inner wall of each first micropore is coated with a tendon-forming induction layer containing the tendon-forming active drug or the tendon-forming active growth factor.

9. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the patch dead point part middle layer is of a glue layer structure formed by crosslinking a composite material which has biocompatibility and is internally added with a cartilage-forming active drug or a cartilage-forming active growth factor, the patch dead point part middle layer is formed by crosslinking one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, the patch dead point part middle layer is also provided with a plurality of second micropores for human cells to grow in, and the inner wall of each second micropore is coated with a cartilage-forming induction layer containing the cartilage-forming active drug or the cartilage-forming active growth factor.

10. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the patch upper layer is of a glue layer structure formed by crosslinking a composite material which has biocompatibility and is internally added with a tendon-forming active drug or a tendon-forming active growth factor, the patch upper layer is formed by crosslinking one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, the patch upper layer is also provided with a plurality of third micropores for human cells to grow in, and the inner wall of each third micropore is coated with a tendon-forming induction layer containing the tendon-forming active drug or the tendon-forming active growth factor.

11. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the tendon lower layer of the patch is of a glue layer structure formed by crosslinking a composite material which has biocompatibility and is internally added with a tendon-forming active drug or a tendon-forming active growth factor, the tendon lower layer of the patch is formed by crosslinking one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, the tendon lower layer of the patch is also provided with a plurality of fourth micropores for human cells to grow in, and the inner wall of each fourth micropore is coated with a tendon-forming induction layer containing the tendon-forming active drug or the tendon-forming active growth factor.

12. A dead center reconstruction type artificial rotator cuff patch according to claim 6, wherein: the lower layer of the patch dead point is of a glue layer structure formed by crosslinking a composite material which has biocompatibility and is internally added with an osteogenic active drug or an osteogenic active growth factor, the lower layer of the patch dead point is formed by crosslinking one or more of gelatin, collagen, hyaluronic acid, chitosan and sodium alginate, the lower layer of the patch dead point is also provided with a plurality of fifth micropores for human cells to grow in, and the inner wall of each fifth micropore is coated with an osteogenic induction layer containing the osteogenic active drug or the osteogenic active growth factor.