CN117547379A - Preparation method of soft tissue repair stent - Google Patents

Abstract

The invention provides a preparation method of a soft tissue repair stent, which belongs to the technical field of medical materials, and comprises a biological stent and a plurality of sutures, wherein the sutures are respectively and fixedly connected to four corners of the surface of the biological stent; the biological scaffold is made of a biological composite material and consists of porous type I collagen and PLLA fiber wires with the diameter of 15 um; excellent mechanical properties, can support ligament and tendon repair in the whole healing process, and the tissue grows to the implant itself and is finally absorbed by the body of a patient; the engineered structure also promotes regeneration and ingrowth of blood vessels and fibroblasts in the scaffold to fuse with surrounding tissue.

Description

Preparation method of soft tissue repair stent

Technical Field

The invention belongs to the technical field of medical materials, and particularly relates to a preparation method of a soft tissue repair stent.

Background

The rotator cuff function is that the humeral head is pulled to the glenoid direction in the upper arm abduction process, the normal pivot of the humeral head and the glenoid is maintained, the rotator cuff fracture can weaken or even lose the function, the upper limb abduction function is seriously affected, the rotator cuff tear injury is a common disease causing the reduced function and pain of the shoulder joint, but the operation is still accompanied with challenges, because the situation that the patient experiences re-tearing is not rare;

medial Collateral Ligament (MCL) is the most commonly injured ligament of the knee joint, however, in only a few cases surgical treatment is required, traditionally, isolated grade I and grade II MCL injuries can be treated non-surgically, high grade MCL injuries are often accompanied by knee ligament injuries, particularly anterior cruciate ligament, whereas MCL repair or reconstruction is generally retained to patients who continue everting unstably after failure of non-surgical treatment, however, in chronic MCL injuries, the effect of receiving primary repair may be somewhat worse, and satisfactory results can be seen both in repair and reconstruction;

over the last 20 years, there has been interest in bio-inducible implants and dermal transplants that, while enhancing the rotator cuff, alleviate the complications of rotator cuff re-tearing after arthroscopic rotator cuff repair, while both methods have improved, both still suffer from drawbacks, bio-inducible implants are used to induce new tissue formation, but they lack structural strength during implantation time, in contrast, dermal allograft vegetation is used to provide structural strength when implanted, but they do not bond well with tissue and carry the inherent risk of foreign tissue;

publication number "CN108738302B," discloses "tissue-enhancing scaffolds for use with soft tissue fixation repair systems and methods," including one or more tissue-enhancing constructs comprising constructs configured to increase the footprint of a suture that applies a force to the tissue when the suture is cinched onto the tissue. The tissue-enhancing construct can be quickly and easily associated with the repair suture and can be used in many different tissue repair procedures disclosed in this application. In one exemplary embodiment, one or more constructs are provided on a suture threader that can be used to associate the construct with a repair suture for repairing the soft tissue. The tissue-reinforcing construct may include various blocks and patches, as well as other formations. Exemplary methods for making the tissue-reinforcing constructs are also provided.

In the prior art, arthroscope rotator cuff repair has higher failure rate, rotator cuff re-tearing can occur, the primary MCL repair effect is poor, the load cannot be shared to provide the supplement strength, the regeneration is realized, and the effective treatment purpose cannot be achieved; therefore, it is one of the important research subjects in the art to develop an absorbable reinforcing strength soft tissue implant that is more easily fused into host tissue, has the ability to induce new tissue formation, and can strengthen tendons to prevent interstitial spaces or re-tears when they are weakest.

Disclosure of Invention

The invention aims to provide a preparation method of a soft tissue repair bracket, which aims to solve the problems that in the prior art, arthroscope rotator cuff repair has higher failure rate, rotator cuff re-tearing occurs, the primary MCL repair effect is poor, the load cannot be shared to provide the supplement strength, the regeneration is realized, and the effective treatment purpose cannot be achieved.

In order to achieve the above purpose, the present invention provides the following technical solutions:

a method of preparing a soft tissue repair scaffold comprising:

the biological scaffold comprises a biological scaffold and a plurality of sutures, wherein the sutures are respectively and fixedly connected to four corners of the surface of the biological scaffold;

the biological scaffold is made of a biological composite material and consists of porous type I collagen and PLLA fiber wires with the diameter of 15 um.

As a preferable scheme of the invention, the PLLA fiber wires are prepared and collected by an electrostatic spinning technology, the PLLA fiber wires are adhered with the type I collagen composite material, and a spray coating method is used for forming physical connection among fibers, namely a porous stable fiber scaffold.

As a preferred embodiment of the present invention, the preparation of the PLLA fiber line includes:

s1, adding PLLA with a certain mass into TFE, and carrying out ultrasonic oscillation for 0.5-1.5 hours to obtain transparent and stable solution, and respectively preparing spinning solutions with the concentration of 3% by mass, 5% by mass and 8% by mass;

s2, an electrospinning spray head is an injection needle with the inner diameter of 0.65mm and the outer diameter of 1.1mm, a BGG direct current voltage generator is adopted to generate high-voltage direct current, a WZ-50C2 microinjection pump is adopted to supply liquid, a spinning system is self-developed, two self-made devices are adopted to collect the electrospinning fibers, one self-made device is a flat plate collecting device capable of reciprocating in the horizontal direction and used for collecting randomly arranged fibers, the other self-made device is a sharp-angle disc capable of rotating rapidly and used for directionally collecting the fibers, the distance between the device and a spinning nozzle is 13-15cm, the environment temperature of electrospinning is 25 ℃ and 2 ℃, and the environment humidity of electrospinning is 60% and 5%.

As a preferred embodiment of the present invention, the preparation of the composite material of type I collagen and PLLA fibers comprises:

z1, preparing a circular sample with the diameter of 14mm by using a puncher, and winding PLLA fibers on a circular slide with the diameter of 14 mm;

z2, each sample was placed in 24-well tissue culture plates, fixed with steel rings, all samples were immersed in 0.01M NaOH solution, incubated at room temperature for 20min, then immersed in 0.1M 2- (N-morpholinoethanesulfonic acid (MES) solution at 4℃for 30min, N-hydroxysuccinimide (NHS) and 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) were dissolved together in MES solution at 4℃at concentrations of 6mg/mL and 4mg/mL, respectively, the MES solution in the well plates was removed, 1mL of MES/EDC/NHS solution was added to each well, incubated at room temperature for 1h, and finally each sample was rinsed 3 times with MES solution at 4℃and then immersed in 20. Mu.g/mL of laminin collagen solution with gentle shaking at 4 ℃;

after overnight incubation, PLLA fiber yarn with laminin coating was rinsed 3 times with PBS buffer and stored at 4 ℃.

As a preferred solution of the invention, the suture (1) is brought to the side by suturing of the native tendon and soft tissue implant, with a compression bridge arrangement with two PEEK anchors.

Compared with the prior art, the invention has the beneficial effects that:

1. in the invention, the excellent mechanical property can support ligament and tendon repair in the whole healing process, and tissues grow to the implant and are finally absorbed by the body of a patient; the engineered structure also promotes regeneration and ingrowth of blood vessels and fibroblasts in the scaffold to fuse with surrounding tissue.

2. In the invention, the porous structure can provide a larger space for the adsorption and proliferation of host cells and the diffusion of metabolites; the collagen protein with the type I collagen as the main component has good biocompatibility, reduces the antigenicity of the soft tissue scaffold, and is easier to be fused into host tissues.

3. The invention is suitable for various soft tissue indications and is easy to use in various operations.

Drawings

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate the invention and together with the embodiments of the invention, serve to explain the invention. In the drawings:

FIG. 1 is a schematic diagram of the connection structure of the suture and PLLA bioscaffold according to the invention.

In the figure: 1. a suture; 2. a biological scaffold.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Example 1

Referring to fig. 1, the present invention provides the following technical solutions, MCL medial collateral ligament repair and reconstruction:

medial Collateral Ligament (MCL) is the ligament most commonly injured by knee joints; however, only a few cases require surgical treatment, traditionally, isolated grade I and grade II MCL injuries can be treated non-surgically, while isolated grade III injuries can be treated surgically, high grade MCL injuries are often accompanied by knee ligament injuries, particularly anterior cruciate ligaments, while MCL repair or reconstruction is generally reserved for patients who continue to evert unstably after non-surgical treatment failure, synthetic and bioimplants are becoming increasingly popular for enhancing repair and reconstruction to enhance biomechanics and promote healing, accelerate healing rates, provide an environment for soft tissue regeneration and mechanical support, and provide a soft tissue scaffold consisting of highly porous type I collagen and bioabsorbable poly-l-lactic acid microfilaments;

the procedure was as follows:

1. in the case of a patient in a supine position, two dual-load suture anchors are placed posterior to the proximal femur and medial epicondylitis to repair and advance the medial collateral ligament femoral side tear. The ligament is repaired by adopting a horizontal mattress, the knee joint yields 30 degrees, and a stitching mode is adopted when buckling moment is applied;

2. repairing the suture end of the suture anchor using a previously placed Medial Collateral Ligament (MCL), and suturing the soft tissue scaffold into the proximal end; two suture anchors are additionally placed at the shallow MCL insertion position of the distal end of the tibia and are sutured in place under 30 degrees of knee joint flexion and extension;

3. two smaller incisions were used at the medial collateral ligament site, and the femoral and tibial attachments to the medial collateral ligament of the femur were repaired with 2 suture anchors to repair collateral ligament tears based on the medial femur. Shuttling the artificial ligament from the proximal end to the distal end using a flat head forceps; suturing the proximal end of the artificial ligament using a suture anchor; using two additional suture anchors to secure the distal end to complete hyperplasia;

4. the equal length points of the grafts were determined and completed with 2 guide pins and one suture. When the length of the suture line is unchanged, the length of the suture line can be kept equal, and the knee joint keeps bending and stretching radian in the whole process;

5. the medial collateral ligament is reconstructed using the allogeneic tendon, the suture anchors are used for fixation at equidistant guide needle positions, care is taken that the knee joint is in a 30 ° flexion state when the implant is fixed, so as to prevent the implant from loosening, and the artificial ligament is sutured in place by using the rest suture anchors of the suture anchors.

Excellent mechanical properties, can support ligament and tendon repair in the whole healing process, and the tissue grows to the implant itself and is finally absorbed by the body of a patient; the engineering structure can promote the regeneration and the ingrowth of blood vessels and fibroblasts in the bracket so as to be fused with surrounding tissues; the porous structure can provide a larger space for the adsorption, proliferation and metabolite diffusion of host cells; the biocompatibility is good, the collagen mainly comprising the type I collagen reduces the antigenicity of the soft tissue scaffold and is easier to be fused into host tissues; the soft tissue treatment device is suitable for various soft tissue indications and is easy to use in various operations;

example 2

Referring to fig. 1, the present invention provides the following technical solution for rotator cuff injury repair:

the rotator cuff tear injury is a common disease causing the function decline and pain of the rotator cuff, and although the research progress of rotator cuff tear injury and surgical treatment means are greatly advanced at present, the failure rate of rotator cuff repair is still 20% -90%, so that a repairing material capable of effectively improving the mechanical strength and stimulating the intrinsic healing potential of a patient is clinically needed, wherein the biological stent material is considered as the most promising treatment means;

the procedure was as follows:

1. after passing the arthroscopic RCR suture through the native tendon, the repair suture is brought into the side sleeve where it is passed through the soft tissue implant with a puncture gun;

2. to orient the soft tissue implant, the upper surface is marked and fed into the body using a "back grabber" or any standard atraumatic rotator cuff grabber, which is recommended to pass through with a 10 mm or 12 mm diameter cannula, after which a knot pusher is placed at the suture to flush the implant with the tissue;

3. after cross-suturing, the suture is brought to the side by suturing the native tendon and soft tissue implant, and a compression bridge arrangement is performed with two PEEK anchors, and blood of surrounding tissue and bone adheres to the implant even in an aqueous environment.

The working principle and the using flow of the invention are as follows: during the operation, two double-load suture anchors are placed at the proximal end of femur and behind the medial epicondyle under the condition of the supine position of the patient to repair and promote the femoral side tear of the medial collateral ligament. The ligament is repaired by adopting a horizontal mattress, the knee joint yields 30 degrees, and a stitching mode is adopted when buckling moment is applied; repairing the suture end of the suture anchor using a previously placed Medial Collateral Ligament (MCL), and suturing the soft tissue scaffold into the proximal end; two suture anchors are additionally placed at the shallow MCL insertion position of the distal end of the tibia and are sutured in place under 30 degrees of knee joint flexion and extension; two smaller incisions were used at the medial collateral ligament site, and the femoral and tibial attachments to the medial collateral ligament of the femur were repaired with 2 suture anchors to repair collateral ligament tears based on the medial femur. Shuttling the artificial ligament from the proximal end to the distal end using a flat head forceps; suturing the proximal end of the artificial ligament using a suture anchor; using two additional suture anchors to secure the distal end to complete hyperplasia; the equal length points of the grafts were determined and completed with 2 guide pins and one suture. When the length of the suture line is unchanged, the length of the suture line can be kept equal, and the knee joint keeps bending and stretching radian in the whole process; reconstructing an inner collateral ligament by using an allogeneic tendon, fixing the ligament at an equidistant guide needle position by using a suture anchor, taking care that the knee joint is in a buckling state of 30 degrees when fixing the implant so as to prevent the implant from loosening, and suturing the artificial ligament in place by using the residual suture anchor of the suture anchor; repairing the rotator cuff injury, wherein the RCR suture under the arthroscope passes through the primary tendon after the suture is repaired to be taken into the side sleeve, and a puncture gun is used for penetrating through the soft tissue implant; to orient the soft tissue implant, the upper surface is marked and fed into the body using a "back grabber" or any standard atraumatic rotator cuff grabber, which is recommended to pass through with a 10 mm or 12 mm diameter cannula, after which a knot pusher is placed at the suture to flush the implant with the tissue; after cross-suturing, the suture is brought to the side by suturing the native tendon and soft tissue implant, with two PEEK anchors in a compression bridge configuration, and the blood of surrounding tissue and bone adheres to the implant even in an aqueous environment; excellent mechanical properties, can support ligament and tendon repair in the whole healing process, and the tissue grows to the implant itself and is finally absorbed by the body of a patient; the engineering structure can promote the regeneration and the ingrowth of blood vessels and fibroblasts in the bracket so as to be fused with surrounding tissues; the porous structure can provide a larger space for the adsorption, proliferation and metabolite diffusion of host cells; the biocompatibility is good, the collagen mainly comprising the type I collagen reduces the antigenicity of the soft tissue scaffold and is easier to be fused into host tissues; is suitable for various soft tissue indications and is easy to use in various operations.

Finally, it should be noted that: the foregoing description is only a preferred embodiment of the present invention, and the present invention is not limited thereto, but it is to be understood that modifications and equivalents of some of the technical features described in the foregoing embodiments may be made by those skilled in the art, although the present invention has been described in detail with reference to the foregoing embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (5)

1. A method of preparing a soft tissue repair scaffold, comprising:

the biological scaffold comprises a biological scaffold (2) and a plurality of sutures (1), wherein the sutures (1) are respectively and fixedly connected to four corners of the surface of the biological scaffold (2);

the biological scaffold (2) is a biological composite material, and the biological scaffold (2) is composed of porous type I collagen and PLLA fiber wires with the diameter of 15 um.

2. The method for preparing a soft tissue repair stent according to claim 1, wherein PLLA fiber wires are prepared and collected by an electrostatic spinning technology, the PLLA fiber wires are adhered to a type I collagen composite material, and a spray coating method is used for forming physical connection among fibers, namely the porous stable fiber stent.

3. The method of preparing a soft tissue repair scaffold according to claim 2, wherein the preparation of the PLLA fiber line comprises:

s1, adding PLLA with a certain mass into TFE, and carrying out ultrasonic oscillation for 0.5-1.5 hours to obtain transparent and stable solution, and respectively preparing spinning solutions with the concentration of 3% by mass, 5% by mass and 8% by mass;

s2, an electrospinning spray head is an injection needle with the inner diameter of 0.65mm and the outer diameter of 1.1mm, a BGG direct current voltage generator is adopted to generate high-voltage direct current, a WZ-50C2 microinjection pump is adopted to supply liquid, a spinning system is self-developed, two self-made devices are adopted to collect the electrospinning fibers, one self-made device is a flat plate collecting device capable of reciprocating in the horizontal direction and used for collecting randomly arranged fibers, the other self-made device is a sharp-angle disc capable of rotating rapidly and used for directionally collecting the fibers, the distance between the device and a spinning nozzle is 13-15cm, the environment temperature of electrospinning is 25 ℃ and 2 ℃, and the environment humidity of electrospinning is 60% and 5%.

4. A method of preparing a soft tissue repair scaffold according to claim 3, wherein the preparation of the type I collagen and PLLA fiber composite material comprises:

z1, preparing a circular sample with the diameter of 14mm by using a puncher, and winding PLLA fibers on a circular slide with the diameter of 14 mm;

z2, each sample was placed in 24-well tissue culture plates, fixed with steel rings, all samples were immersed in 0.01M NaOH solution, incubated at room temperature for 20min, then immersed in 0.1M 2- (N-morpholinoethanesulfonic acid (MES) solution at 4℃for 30min, N-hydroxysuccinimide (NHS) and 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) were dissolved together in MES solution at 4℃at concentrations of 6mg/mL and 4mg/mL, respectively, the MES solution in the well plates was removed, 1mL of MES/EDC/NHS solution was added to each well, incubated at room temperature for 1h, and finally each sample was rinsed 3 times with MES solution at 4℃and then immersed in 20. Mu.g/mL of laminin collagen solution with gentle shaking at 4 ℃;

after overnight incubation, PLLA fiber yarn with laminin coating was rinsed 3 times with PBS buffer and stored at 4 ℃.

5. The method for preparing a soft tissue repair stent according to claim 4, wherein: the suture (1) is brought to the side by suturing of the native tendon and soft tissue implant, with a compression bridge configuration with two PEEK anchors.