CN116763975A - Developing medical suture for tissue positioning and preparation method thereof - Google Patents
Developing medical suture for tissue positioning and preparation method thereof Download PDFInfo
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Abstract
The invention provides a developing medical suture for tissue positioning and a preparation method thereof, wherein a polymer matrix is crystallized by taking a contrast agent as a crystal nucleus, so that the polymer matrix is tightly combined with the contrast agent to form a composite material with developing performance, a polymer mixture doped with developing substances is prepared in advance, then the temperature and the pressure are limited, the diameter, the strength and the flexibility of the suture are controlled, and the medical suture with developing capability is prepared in a mode of processing and extruding the suture, so that the developing medical suture prepared by the method has the advantages of tight combination of the developing agent and the suture, high developing strength and convenience for positioning, measuring and monitoring of implantation sites.
Description
Technical Field
The invention relates to the field of medical suture, in particular to a developing medical suture for tissue positioning and a preparation method thereof.
Background
Along with the continuous progress of medical technology, the refinement of clinical operations is more and more emphasized, and the accurate positioning of target tissues and target parts under the guidance of medical images and in-vivo measurement play a vital role in the process. In bone surgery, the visualized tissue positioning implant can monitor the extension and migration of Anterior Cruciate Ligament (ACL) grafts, the healing degree of achilles tendon repair, the length of the repair site of the rotator cuff of the shoulder joint, etc. in three-dimensional X-ray based imaging means, such as radiostereotactic analysis (RSA) and CT, to determine if the surgical repair was successful. In addition, in the fields of remodeling of a three-dimensional structure of a heart, myocardial motion tracking, local ablation of solid tumors, radiotherapy positioning and the like, high-precision and repeatable medical modeling and positioning can be realized by combining a medical imaging means under the assistance of a developing tissue positioning implant, so that a plurality of doctors and patients benefit.
Currently, the developed tissue positioning implant is mostly made of metal, including titanium, platinum, gold or stainless steel, and the common types are microsphere, rod, ring, wire, etc. However, metallic imaging tissue positioning implants present some problems that are difficult to overcome and avoid: 1. the metal implant is permanently implanted, is not absorbable, can be taken out only by means of a re-operation, and does not need to be permanently reserved for some operation type or patients needing no long-term image tracking. The long-term retention of metallic implants in the body increases the risk of injury to the human body due to material damage and migration. 2. The presence of a metal implant in the body is contraindicated when nuclear magnetic resonance examination is required, and long-term retention of a metal implant in the body adds unnecessary trouble to their clinical diagnosis and treatment for subsequent patients who need nuclear magnetic examination. 3. Fixation of metal implants is also a major problem during surgery. Metal implants often do not have a fixation means themselves and require fixation by suturing or other means. Implants are generally small in size, and fixation during surgery is quite technically difficult and time-consuming and laborious.
To address the problems with current metallic visualization tissue positioning implants, visualization sutures are considered a preferred option for tissue positioning. The suture is mostly made of polymer materials, and the absorbability and the degradation and absorption time of the suture can be regulated and controlled through polymer chemistry. In addition, the suture can be fixed on tissues through convenient operation, thereby being beneficial to clinical practical use.
Through searching the prior art, CN215503207U discloses a special development suture for a disposable fiber ring under an endoscope, structurally comprises a suture line and a development layer, wherein the development layer is uniformly coated on the surface of the suture line. On the basis of the existing fiber ring suture, the outer surface is covered and coated with a developable coating, and whether the suture is firm or not can be found on an image when a patient performs X-ray scanning after operation. CN111035793B discloses a developing suture capable of monitoring displacement and a preparation method thereof, wherein the preparation method is to perform partial developing treatment on a core wire, and control one of two adjacent subareas to be developable under X-ray and the other to be undeveloped under X-ray. The developing treatment adopts a mode of spraying the developer on the core wire at certain intervals and then drying and hardening. The developed suture prepared by the method can monitor whether the suture has slippage or the tendency of slippage in the body. CN 106725677a discloses a long-standing absorbable suture line developed by X-rays, which comprises an inner core and an outer sleeve, wherein the inner core is formed by tightly weaving 4 single-fiber natural collagens, and the single thread is coated with sodium diatrizoate; the outer sleeve is made of 6-8 common single fiber natural collagen and is tightly woven around the inner core. The invention has the characteristic of X-ray developing mark, and the absorbed time of the outer layer of the suture is controlled by the layer number of the outer sleeve, so that different developing time is maintained.
However, these techniques have a disadvantage in that the developer is applied to the surface of the suture substrate by means of surface coating of the developer, so as to achieve a developing effect. By adopting the surface coating mode, firstly, the binding force between the suture base material and the developer is weak, when the suture is implanted into a body and contacts tissues and body fluid, the developer can be rapidly dispersed, the suture can rapidly lose the developing capability, and long-term monitoring and positioning after operation are difficult to realize. Secondly, the developer exists only on the surface of the suture, the local developer with too high concentration can enhance toxic and side effects and influence the biocompatibility of the suture, and when the developer concentration is low, the developing capability can be influenced. In addition, if an absorbable suture is used as a substrate, since the developing suture has only a developer on the surface, there is a phenomenon that the developing time is not matched with the degradation time of the suture, which limits the clinical value of the developing suture to a certain extent.
Disclosure of Invention
In view of the above, the present invention provides a developing medical suture for tissue positioning and a method for preparing the same, which solve the above problems.
The technical scheme of the invention is realized as follows:
a method of preparing a visualized medical suture for tissue positioning, comprising the steps of:
s1, synthesizing a polymer composite material containing a developing substance: adding 0.4-4 parts of contrast agent and 0.05-0.5 part of polyvinylpyrrolidone (PVP) into 10-50 parts of solvent, stirring for 20-60 min at 300-800 rpm, then adding 1-10 parts of polymer matrix, continuing stirring at room temperature, slowly evaporating the solvent, crystallizing the polymer matrix by taking the contrast agent as crystal nucleus to enable the polymer matrix to be tightly combined with the contrast agent to form a composite material with developing performance, and then vacuum preserving the composite material at room temperature;
s2, processing and extruding to form a suture line: extruding the composite material into filaments at high temperature of 190-250 ℃ and high pressure of 10-30 MPa, and controlling the diameter, strength and flexibility of the suture.
Further, the solvent of S1 includes, but is not limited to, tetrahydrofuran, toluene, chloroform, xylene, dimethyl sulfoxide, and methylene chloride.
Further, the contrast agents of S1 include, but are not limited to, diatrizoic acid, diatrizamine (MD), meglumine, iobiol, iohexol (IHX), iomeprol, iopamidol, ioversol, ioxilan, iodixanol (IDX), and iotrolan.
Further, the polymer matrix of S1 includes, but is not limited to, polylactic acid (PLA), polydioxanone (PDO), polyglycolide-caprolactone (PGCL), polylactic acid-glycolic acid copolymer (PLGA), polypropylene (PP), poly L-lactide-co-epsilon-caprolactone (PLCA), polydioxanone or polydioxanone suture (PDS), polyglycolic acid (PGA), polyglycolic acid, polyvinyl acetate vinylon (PVA), nylon.
Further, the concentration of the solvent in the S1 is 5-40% w/v.
Further, the concentration of the contrast agent in the S1 is 5-40% w/v.
Further, the average molecular weight of the polyvinylpyrrolidone of S1 is 2000-2000000Da.
Further, the developed medical suture prepared according to the preparation method is provided.
Further, the contrast agent in the developed medical suture is distributed in the polymer matrix in an island-shaped structure.
Furthermore, the HU value of the developing medical suture at micro-CT can reach 5500.
Compared with the prior art, the invention has the beneficial effects that:
the invention prepares a developable polymer composite material by tightly combining a contrast agent with a polymer matrix in a blending mode, then tightly combines the contrast agent with the polymer matrix in a blending mode, endows the contrast agent in the developable medical suture with the development capability of the suture under X-ray scanning and CT after entering tissues, has high development strength, still has X-ray imaging capability under the tissues with the thickness of 4cm, and can be conveniently used for positioning, measuring and monitoring implantation sites. The absorbability and degradation period of the suture can be controlled by regulating the type, molecular weight and the like of the polymer matrix, so that the problem that the metal implant stays in the body for a long time is solved; meanwhile, the developer is uniformly distributed in the whole development suture, and the development suture has development capability in the whole period of the development suture existing in the body, so that the condition that the development capability of the suture is not matched with the degradation period can not occur.
Drawings
FIG. 1 is a schematic illustration of the preparation of a developed medical suture;
FIG. 2 is a PDO/IHX/PVPSEM spectrum of the composite material;
FIG. 3 is a micro-CT image of a visualized suture in deep tissue.
Detailed Description
In order to better understand the technical content of the present invention, the following provides specific examples to further illustrate the present invention.
The experimental methods used in the embodiment of the invention are conventional methods unless otherwise specified.
Materials, reagents, and the like used in the examples of the present invention are commercially available unless otherwise specified.
Example 1
A method of preparing a visualized medical suture for tissue positioning, comprising the steps of:
s1, synthesizing a composite material PDO/IHX/PVP containing a developing substance Iohexol (IHX):
to 10 parts DCM (10% w/v) was added 0.4 parts IHX (30% w/v) and 0.01 parts PVP (8K) and stirring was continued for 20min. After adding PDO, continuing stirring at room temperature, slowly evaporating DCM, crystallizing the PDO matrix by taking IHX as a crystal nucleus so that the PDO matrix is tightly combined with contrast agent IHX to form a composite material PDO/IHX/PVP with development performance, and then preserving the PDO/IHX/PVP composite material at room temperature in vacuum;
s2, processing and extruding to form a suture line:
extruding the composite material into filaments at a high temperature of 190 ℃ and a high pressure of 10MPa to obtain the developed medical suture.
Example 2
A method of preparing a visualized medical suture for tissue positioning, comprising the steps of:
s1, synthesizing a composite material PLA/MD/PVP containing a developing substance diatrizoic amine (MD):
to 10 parts THF (10% w/v) were added 0.6 parts MD (30% w/v) and 0.01 parts PVP (40K) and stirring was continued for 20min. After PLA is added, stirring is continued at room temperature, THF is slowly evaporated, the PLA matrix is crystallized by taking MD as a crystal nucleus, so that the PLA matrix is tightly combined with the contrast agent MD to form a composite material PLA/MD/PVP with development performance, and then the PLA/MD/PVP composite material is stored at room temperature in vacuum.
S2, processing and extruding to form a suture line:
extruding the composite material into filaments at a high temperature of 230 ℃ and a high pressure of 15MPa to obtain the developed medical suture.
Example 3
A method of preparing a visualized medical suture for tissue positioning, comprising the steps of:
s1, synthesizing a composite material PGCL/IDX/PVP containing a developing substance Iodixanol (IDX):
to 10 parts DMSO (10% w/v) were added 0.8 parts IDX (30% w/v) and 0.05 parts PVP (360K) and stirring was continued for 20min. After adding PGCL, stirring continuously at room temperature, slowly evaporating DMSO, crystallizing PLA matrix with IDX as crystal nucleus to tightly combine with contrast agent IDX to form composite material PGCL/IDX/PVP with development property, and vacuum preserving the composite material PGCL/IDX/PVP at room temperature.
S2, processing and extruding to form a suture line:
extruding the composite material into filaments at the high temperature of 250 ℃ and the high pressure of 20MPa to obtain the developed medical suture.
1. Scanning Electron Microscope (SEM) analysis of visualized medical sutures:
the composite PDO/IHX/PVP scanning electron microscopy spectra produced by example 1 are shown in fig. 2. Hydrophilic iohexol is dispersed in the form of "islands" in a hydrophobic PDO matrix, reducing the hydrophobicity of the composite surface.
2. micro-CT analysis of visualized medical sutures:
the X-ray imaging ability of the developed medical sutures prepared in examples 1, 2, 3 was evaluated using X-ray micro-computer tomography (Bruker SkyScan1176, U.S.). The composite materials prepared in examples 1, 2 and 3 were hot pressed into sheets having a diameter of 10mm and a thickness of 1 mm. The scanning parameters are as follows: the spatial resolution is 18 μm pixel size, the rotation step size is 0.8 °, the voltage is 45kV, and the aluminum filter is 0.20mm. And analyzing and reconstructing all data by using GPU reconnaissance server software in the micro-CT system. After image reconstruction, HU values were calculated in CTAN software of the micro-CT system, with the results shown in Table 1 below:
TABLE 1 Gray and HU values of development sutures
| Sample of | Gray scale | HU |
| Example 1 | 100 | 5553 |
| Example 2 | 103 | 5580 |
| Example 3 | 101 | 5567 |
The developing medical suture has high developing strength and can meet the requirements of positioning, measuring and monitoring of implantation parts.
3. X-ray imaging of the visualization suture in deep tissue:
x-ray imaging of the visualized suture material in deep tissues was evaluated using a small animal optical imaging device (xtreem, bruker, usa). The composite material prepared in example 1 was hot pressed into sections with a diameter of 10mm and a thickness of 1 mm. A piece of lean meat was cut into 0.6cm thick slices and placed layer by layer on a composite slice to evaluate the X-ray imaging ability of the polymer under deep tissues. The test parameters were set as follows: the X-ray filter is 0.8mm, the exposure time is 1.2s, and the field of view is 19cm.
As the results in fig. 3 show, the developed medical suture has a strong development property so that it is still developed at a tissue thickness of 4 cm.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.
Claims (10)
1. A preparation method of a developing medical suture for tissue positioning is characterized by comprising the following steps: the method comprises the following steps:
s1, synthesizing a polymer composite material containing a developing substance: adding 0.4-4 parts of contrast agent and 0.05-0.5 part of polyvinylpyrrolidone into 10-50 parts of solvent, stirring for 20-60 min at 300-800 rpm, then adding 1-10 parts of polymer matrix, continuing stirring at room temperature, crystallizing the polymer matrix by taking the contrast agent as crystal nucleus to enable the polymer matrix to be tightly combined with the contrast agent to form a composite material with developing performance, and then preserving the composite material at room temperature in vacuum;
s2, processing and extruding to form a suture line: extruding the composite material into filaments at high temperature of 190-250 ℃ and high pressure of 10-30 MPa, and controlling the diameter, strength and flexibility of the suture.
2. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: solvents for S1 include, but are not limited to, tetrahydrofuran, toluene, chloroform, xylene, dimethyl sulfoxide, methylene chloride.
3. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: the contrast agents of S1 include, but are not limited to, diatrizoic acid, diatrizamine, meglumine, iobiol, iohexol, iomeprol, iopamidol, ioversol, ioxilan, iodixanol, and iotrolan.
4. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: the polymer matrix of S1 includes, but is not limited to, poly (lactic acid), poly (p-dioxanone), poly (glycolide-co-caprolactone), poly (lactic acid-co-glycolic acid), polypropylene, poly (L-lactide-co-epsilon-caprolactone), poly (p-dioxanone) or poly (dioxanone) suture, poly (glycolic acid), poly (ethylene glycol carbonate), poly (vinylon acetate), nylon.
5. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: the concentration of the solvent in the S1 is 5-40% w/v.
6. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: the concentration of the contrast agent in the S1 is 5-40% w/v.
7. A method of preparing a visualized medical suture for tissue localization according to claim 1, wherein: the average molecular weight of the polyvinylpyrrolidone of the S1 is 2000-2000000Da.
8. A developed medical suture prepared by the preparation method of any one of claims 1 to 5.
9. A method of preparing a visualized medical suture for tissue localization according to claim 8 wherein: the contrast agent in the developed medical suture is distributed in the polymer matrix in an island-shaped structure.
10. A method of preparing a visualized medical suture for tissue localization according to claim 8 wherein: HU value of the developing medical suture in micro-CT can reach 5500.
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| CN202310940839.2A CN116763975A (en) | 2023-07-28 | 2023-07-28 | Developing medical suture for tissue positioning and preparation method thereof |
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| CN202310940839.2A CN116763975A (en) | 2023-07-28 | 2023-07-28 | Developing medical suture for tissue positioning and preparation method thereof |
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