CN118203738A - Degradable human body support and preparation method thereof - Google Patents
Degradable human body support and preparation method thereof Download PDFInfo
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- CN118203738A CN118203738A CN202410613063.8A CN202410613063A CN118203738A CN 118203738 A CN118203738 A CN 118203738A CN 202410613063 A CN202410613063 A CN 202410613063A CN 118203738 A CN118203738 A CN 118203738A
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Abstract
The invention relates to the technical field of medical equipment, and provides a degradable human body support and a preparation method thereof, wherein the degradable human body support comprises the following steps: the support frame comprises a plurality of support structures, wherein each support structure comprises two support rings and at least three support columns uniformly arranged between the two support rings; the guide pipes are arranged in the support frame, two ends of the guide pipes are fixedly connected with the support rings at two ends of the support frame, and the support structures are mutually abutted to the outside of the guide pipes to form the support frame; the guide tube is made of a first degradable material, the support frame is made of a second degradable material, the degradation rate of the first degradable material is greater than that of the second degradable material, and the strength of the second degradable material is greater than that of the first degradable material. The technical problem that the large uncontrollable fragments generated by the fracture of the bracket can hurt the human body in the prior art is solved, and the controllable degradation and fracture of the bracket can be realized while the supporting and circulating functions are ensured.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a degradable human body support and a preparation method thereof.
Background
At present, various drainage stents are widely applied to different treatment scenes, and aim to solve the problem of obstruction of human body parts caused by pathological changes or physiological abnormalities. The drainage brackets help to restore the physiological functions of patients, relieve symptoms and improve the quality of life through physical support and drainage.
In the treatment of biliary tract diseases, the application of biliary tract stents is particularly critical. Bile flow is not normal when bile ducts are stenosed or blocked by stones, resulting in cholestasis, which causes a series of clinical symptoms. The bile duct bracket helps the bile to be smoothly discharged through the honeycomb duct in the bile duct bracket, and prevents the bile from accumulating at the narrow part, thereby effectively relieving the illness state. Pancreatic duct stents also play an important role in the treatment of diseases such as pancreatitis or pancreatic duct stenosis. In pancreatitis, pancreatic juice is secreted too much or is hindered from being discharged, resulting in damage to pancreatic tissue. The pancreatic duct bracket can drain pancreatic juice, lighten pancreatic inflammation and promote the recovery of pancreatic functions. In addition, the intestinal canal bracket can maintain intestinal canal unobstructed and reduce intestinal obstruction.
In order to reduce the damage to the human body caused by secondary operation extraction of the non-degradable stent, the human body stent can also be prepared from degradable materials. Although the degradable human body stent solves the problem of long-term retention of the stent to a certain extent, in the long-term use process of the existing degradable bile duct or pancreatic duct or intestinal canal stent, the degradation process is difficult to accurately control due to improper movement of a human body or degradation of stent materials, and the like, and the risk of early fracture often exists. The uncontrollable fragments of the size generated after the stent breaks, especially the larger uncontrollable fragments of the size can scratch human tissues, cause infection and the like, and especially the larger size and the uneven section are more easy to cause injury. For example, degradable bile duct stents cause bile leakage or stent fragments scratch the biliary tract, causing secondary injury to the patient.
Therefore, a drainage bracket with controllable fracture and still ensured supporting performance is designed at present, and the fracture is ensured not to affect the human body.
Disclosure of Invention
The invention aims to provide a degradable human body support so as to solve the technical problem that the support fracture in the prior art is uncontrollable.
In a first aspect, embodiments of the present invention provide a degradable human body scaffold comprising: the support frame comprises a plurality of support structures, wherein each support structure comprises two support rings and at least three support columns uniformly arranged between the two support rings, and two ends of each support column are respectively connected with the two support rings; the guide pipes are arranged inside the support frame, two ends of the guide pipes are fixedly connected with the support rings at two ends of the support frame, and the support structures are mutually abutted outside the guide pipes to form the support frame; the guide tube is made of a first degradable material, the scaffold is made of a second degradable material, the degradation rate of the first degradable material is greater than the degradation rate of the second degradable material, and the strength of the second degradable material is greater than the strength of the first degradable material.
Further, the support column comprises a linear support column or an arc support column.
Further, when a certain of the support structures includes the linear support column, the compressive property index of the linear support column is generated based on the length of the linear support column, the diameter of the linear support column, and the second degradable material strength coefficient; when a certain supporting structure comprises the arc-shaped supporting columns, the compressive performance index of the arc-shaped supporting columns is generated based on the arc length of the arc-shaped supporting columns, the chord length of the arc-shaped supporting columns, the diameter of the arc-shaped supporting columns and the strength coefficient of the second degradable material; the compressive property index is greater than a first compressive threshold.
Further, at least one of the plurality of support structures has a diameter greater than the diameter of the other support structures.
Further, the guide tube comprises a bending part and a reinforcing part, wherein the bending part is positioned in a space formed by the three support columns, and the reinforcing part is positioned in a space formed by the two support rings which are mutually abutted.
Further, barbs are arranged on the supporting structures at two ends of the supporting frame.
Further, the support column is hollow.
Further, the first degradable material or/and the second degradable material comprises polylactic acid, or polylactic acid-glycolic acid copolymer, or polycaprolactone, or polylactic acid-caprolactone copolymer, or polydioxanone, or polyglycolic acid, or polyhydroxyalkanoate.
Further, the scaffold includes adding barium sulfate, or bismuth subcarbonate, or bismuth trioxide, or bismuth oxychloride to the second degradable material.
In a second aspect, an embodiment of the present invention provides a method for preparing a degradable human body stent, wherein a first degradable material is selected for preparing a guide tube and a second degradable material is selected for preparing a stent according to a circulation time requirement of a human body part to which the stent is to be applied and an external pressure to which the stent is subjected, and a degradation rate of the first degradable material is greater than a degradation rate of the second degradable material, and a strength of the second degradable material is greater than a strength of the first degradable material.
Further, selecting the second degradable material for preparing the scaffold includes: determining the outer diameter of the support ring according to the inner diameter of the human body part to which the support is to be applied; determining the ring diameter of the support ring according to the flow demand and the external pressure born by the support; selecting the linear support column or the arc support column for a certain support structure; determining the number of the required support structures according to the length of the human body part to which the bracket is applied; selecting a support structure comprising the linear support column or/and a support structure comprising the arc support column to form the support frame.
Further, selecting the linear support column or the arc support column for a certain support structure includes; if the linear support column is selected, determining the length and the diameter of the linear support column according to the fact that the compressive property index of the linear support column is larger than a first compressive threshold, wherein the compressive property index of the linear support column is generated based on the length of the linear support column, the diameter of the linear support column and the strength coefficient of the second degradable material; if the arc-shaped support column is selected, determining the arc length, the chord length and the diameter of the arc-shaped support column according to the fact that the compressive property index of the arc-shaped support column is larger than a first compressive threshold, wherein the compressive property index of the arc-shaped support column is generated based on the arc length of the arc-shaped support column, the chord length of the arc-shaped support column, the diameter of the arc-shaped support column and the strength coefficient of the second degradable material.
The embodiment of the invention has at least the following technical effects:
The degradable human body support provided by the embodiment of the invention has the advantages that the guide tube is positioned in the support frame, and the first function is to help the liquid or substances in the pathological change part of the human body such as a bile duct, a pancreatic duct or an intestinal tract to be drained, so as to keep the pathological change part of the human body unobstructed and prevent blockage or infection; meanwhile, two ends of the guide tube are fixedly connected with supporting rings at two ends of the supporting frame, and a plurality of supporting structures are mutually abutted to the outside of the guide tube to form the supporting frame. Therefore, a plurality of external supporting structures can be penetrated on the guide tube, and the guide tube also plays a role in traction connection to form an external supporting frame.
The support frame is located the outside of guide tube, plays support and fixed effect, prevents that whole support from receiving external pressure and producing huge deformation, keeps the support to support human pathological change position. The support structure is a basic unit of the support frame and comprises two support rings and three support columns connecting the two support rings. The support structure provides local support for the pathological change position of human body, simultaneously, connects two supporting rings through the support column, can increase the stability and the intensity of support. Simultaneously, a plurality of support structures are mutually abutted on the outer part of the guide tube, so that the support is allowed to have certain bending or deformation capacity when being subjected to certain external force, and the support is suitable for bending or deformation of a lesion part of a human body.
The guide tube is made of a first degradable material, the support frame is made of a second degradable material, the degradation rate of the first degradable material is larger than that of the second degradable material, the strength of the second degradable material is larger than that of the first degradable material, after the guide tube is degraded firstly due to the difference of the degradation rate and the strength of the two materials, the support structure is degraded later, so that the support can keep enough supporting force in the degradation process until the support completes the service life of the support. Meanwhile, the guide tube is made of the first degradable material, the softness is high, the toughness is good, the guide tube is not easy to break, the support structure is made of the second degradable material, the strength is high, the support force is good, the support structures are mutually abutted, the deformability of the integral support is improved, and the guide tube is not easy to break. And the function of the later-stage guide tube is completed to be degraded, the support can be directly changed into a section of support structure with controllable size, the annular shape of the support ring does not have uneven sections, and the support ring cannot cause injury to human bodies. The support structure can be gradually degraded in the human body along with the healing of the lesion part of the human body after being peristaltic or not discharged out of the human body, but because the size of the support structure is controllable, uncontrollable fragments with larger size can not be generated to scratch the human body even if the support structure is degraded in the human body.
Therefore, the degradable human body support solves the technical problem that the support breaks to generate larger uncontrollable fragments to hurt human bodies in the prior art, and can realize controllable degradation and breakage of the support through reasonable structural design and material selection while guaranteeing the supporting and circulating functions. Meanwhile, the fracture process of the bracket avoids generating fragments with larger sizes, and reduces the damage risk to human tissues.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a first degradable human body stent according to an embodiment of the present invention;
FIG. 2 is a schematic view of a second degradable human body stent according to an embodiment of the present invention;
FIG. 3 is a schematic view of a first support structure according to an embodiment of the present invention;
FIG. 4 is a schematic view of a second support structure according to an embodiment of the present invention;
FIG. 5 is a schematic view of a third degradable human body scaffold according to an embodiment of the present invention;
FIG. 6 is a schematic view of a fourth degradable human body scaffold according to an embodiment of the present invention;
fig. 7 is a schematic view of a part of the structure of a first degradable human body scaffold according to an embodiment of the present invention;
FIG. 8 is a schematic view of a fifth degradable human body scaffold according to an embodiment of the present invention;
fig. 9 is a schematic diagram of a sixth degradable human body scaffold according to an embodiment of the present invention.
Icon: 1-a guide tube; 2-a support structure; 11-a bend; 12-a reinforcement; 21-a support ring; 22-supporting columns; 23-barbs; 221-straight-line support columns; 222-arc-shaped support columns.
Detailed Description
The technical solutions of the present invention will be clearly and completely described in connection with the embodiments, and it is apparent that the described embodiments are 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.
It will be understood by those skilled in the art that all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs unless defined otherwise. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless expressly stated otherwise, as understood by those skilled in the art. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The term "and/or" as used herein includes all or any element and all combination of one or more of the associated listed items.
In a first aspect, referring to fig. 1 to 4, an embodiment of the present invention provides a degradable human body scaffold, comprising: the support frame comprises a plurality of support structures 2, the support structures 2 comprise two support rings 21 and at least three support columns 22 uniformly arranged between the two support rings 21, and two ends of each support column 22 are respectively connected with the two support rings 21; the guide tube 1 is arranged in the support frame, two ends of the guide tube 1 are fixedly connected with support rings 21 at two ends of the support frame, and a plurality of support structures 2 are mutually abutted outside the guide tube 1 to form the support frame; the guide tube 1 is made of a first degradable material, the scaffold is made of a second degradable material, the degradation rate of the first degradable material is greater than that of the second degradable material, and the strength of the second degradable material is greater than that of the first degradable material.
In this embodiment, the guide tube 1 is located inside the supporting frame, and has the first function of helping the lesion of the human body such as bile duct, pancreatic duct or intestinal canal to keep the lesion of the human body unobstructed and prevent blockage or infection; simultaneously, the two ends of the guide tube 1 are fixedly connected with the supporting rings 21 at the two ends of the supporting frame, and a plurality of supporting structures 2 are mutually abutted to form the supporting frame outside the guide tube 1. In this way, a plurality of external supporting structures 2 can be penetrated on the guide tube 1, and the guide tube 1 also plays a role of traction connection to form an external supporting frame.
The support frame is located the outside of guide tube 1, plays support and fixed effect, prevents that whole support from receiving external pressure and producing huge deformation, keeps the support to support human pathological change position. The support structure 2 is a basic unit of a support frame and comprises two support rings 21 and three support columns 22 connecting the two support rings 21. Of course, the number of the support columns 22 can be increased to more than 3, and can be adjusted according to practical situations, but at least three support columns are uniformly distributed, so that the support structure 2 forms a stable support space. The support structure 2 provides local support for the lesion part of the human body, and simultaneously, the support stability and strength can be increased by connecting the two support rings 21 through the support columns 22. Simultaneously, a plurality of support structures 2 are mutually abutted on the outer part of the guide tube 1, so that the support is allowed to have certain bending or deformation capacity when being subjected to certain external force so as to adapt to the bending or deformation of the pathological change part of the human body.
The guide tube 1 is made of a first degradable material, the supporting frame is made of a second degradable material, the degradation rate of the first degradable material is larger than that of the second degradable material, the strength of the second degradable material is larger than that of the first degradable material, after the diversion effect of the support is completed due to the difference of the degradation rates and the strengths of the two materials, the guide tube 1 is degraded firstly, and the support structure 2 is degraded later, so that the support can maintain enough supporting force in the degradation process until the support completes the service life of the support. Meanwhile, the guide tube 1 is made of the first degradable material, the softness is high, the flexibility is good, the guide tube is not easy to break, even if the guide tube breaks at the later period of use of the support, the support structure 2 is made of the second degradable material because the softness is high, the strength is high, the support structures 2 are in contact with each other, the deformability of the whole support is improved, and the guide tube cannot be broken intentionally. The effect of the later-stage guide tube 1 is degraded, the support can be directly changed into a section of support structure 2 with controllable size, the annular shape of the support ring 21 does not have uneven sections, and the injury caused by the injury to the human body can be avoided. The support structure 2 can then be gradually degraded in the human body over time as the diseased region of the human body heals, peristaltic discharge or inability to discharge from the body, but because the size of the support structure 2 is itself controllable, uncontrollable larger sized fragments will not be produced to scratch the human body even if it is degraded in the body.
Therefore, the degradable human body support solves the technical problem that the support breaks to generate larger uncontrollable fragments to hurt human bodies in the prior art, realizes the controllable breaking of the support, can still ensure the support performance and the circulation performance of the support, and ensures that the breaking of the support does not influence human bodies. Through the design, safer and more effective treatment means can be provided for medical practice, and better treatment effect and life quality are brought for patients.
Optionally, the support column 22 includes a linear support column 221 or an arcuate support column 222. In this embodiment, the linear support column 221 and the arc support column 222 have advantages and functions in the degradable human body support, and the linear support column 221 can provide a relatively stable support structure, and is particularly suitable for supporting a lesion site such as a pipeline or a channel which needs to be supported in a linear manner. The curved support post 222 is better able to accommodate curved or curvilinear lesions because of its curvilinear nature, which better conforms to the anatomy. The arc-shaped support column 222 can enable the support structure 2 to be similar to a spindle, particularly, the support needs to be enlarged at two ends so as to be better clamped at a lesion part, or the diameter of a certain part of the support needs to be enlarged to adapt to special requirements, and the support structure 2 adopting the arc-shaped support column 222 can bring more sexualization choices to the support. In general, the choice of linear support column 221 or arcuate support column 222 depends on the particular application scenario and morphological characteristics of the lesion. The linear support column 221 is suitable for the case where the linear support requirement is high, and the curved support column 222 is more suitable for the case where the curved shape or the curved structure is required.
Optionally, when a certain support structure 2 includes the linear support column 221, the compressive property index K of the linear support column 221 is generated based on the length L1 of the linear support column 221, the diameter D1 of the linear support column 221, the second degradable material strength coefficient S, and the external pressure coefficient P; when a certain support structure 2 comprises an arc-shaped support column 222, the compressive property index K of the arc-shaped support column 222 is generated based on the arc length La of the arc-shaped support column, the chord length Lc of the arc-shaped support column, the diameter D2 of the arc-shaped support column, the second degradable material strength coefficient S and the external pressure coefficient P; the compressive property index K is greater than the first compressive threshold K1.
In this embodiment, when a certain support structure 2 includes a linear support column 221, the compressive property index k= (s×d1 2)/L1, where the compressive property index K characterizes the degree of inward bending and fracture resistance of the support column when the support column is subjected to external pressure, in order to make the compressive property index K meet the requirement, the relationship between these three indexes can be adjusted, increasing the diameter D1 of the linear support column 221 increases the compressive capacity thereof, the strength coefficient S of the second degradable material is the ratio of the strength of the second degradable material to a certain reference value, which can be the specific performance index of the material or the performance of the standard material, the second degradable material with higher strength is selected, i.e. increasing the strength coefficient S of the second degradable material increases the compressive capacity thereof, while increasing the length L1 of the linear support column 221 decreases the compressive capacity of the support column, and these indexes need to be balanced according to the specific application scenario and requirement to achieve the design objective of the support.
Specifically, when a support structure 2 includes an arc-shaped support column 222, the compressive property index k= (s×la×d2 2)/Lc, where La is the curve length of the arc-shaped support column 222, that is, the length along the curve trajectory thereof, lc is the straight line distance between the arc-shaped ends of the arc-shaped support column 222, so that the compressive property index K meets the requirement, the relationship between these four indices may be adjusted, increasing the arc length La of the arc-shaped support column 222 increases the compressive capacity thereof, increasing the chord length Lc of the arc-shaped support column 222 decreases the compressive capacity thereof, increasing the diameter D2 of the arc-shaped support column 222 increases the compressive capacity thereof, and increasing the second degradable material strength coefficient S increases the compressive capacity thereof.
Specifically, the compressive property index K needs to be greater than the first compressive threshold K1, and the first compressive threshold K1 is evaluated by a bending test and a breaking test, taking into account laboratory related test indexes: k1 =x×f OS*FBS, wherein: x is a coefficient used to correct the experimental results, taking into account the differences in experimental conditions and practical applications. F OS is a safety factor in the bending test for taking into account the degree of bending of the support column. It can be derived from a bending test, such as the ratio of the maximum load to the design load before bending to the support column fracture. F BS is a safety factor in the fracture test to consider the degree of fracture resistance of the support column. It can be derived from a fracture test, such as the ratio of the maximum load before the support column breaks to the design load. The formula comprehensively considers the performances of the support column in bending and breaking, and the first compression resistance threshold K1 can be calculated according to laboratory test results and design requirements by adjusting the safety coefficient and the coefficient x. In practical application, the threshold value can be used as a reference for designing the bracket, so that the stability and the safety of the bracket under expected working conditions are ensured, the support column is ensured not to break, and meanwhile, the support function can be realized.
Preferably, an adjustment factor may also be added to the adjustment of the compressive property index K, which takes into account the extent to which the shape of the overall support structure 2 affects the compressive properties of the support. When a certain support structure 2 comprises a linear support column 221, the support structure 2 is cylindrical-like, and assuming that this adjustment factor is denoted as C1, the formula of the compressive property index K can be adjusted as: k= (C1S D1 2)/L1. When a certain support structure 2 comprises an arc-shaped support column 222, the support structure 2 is spindle-like, and assuming that this adjustment factor is denoted as C2, the formula of the compressive property index K can be adjusted as: k= (C2S La D2 2)/Lc. The degree of influence of the shape of the support structure on the compression resistance can be determined through numerical simulation, so that the value range of the adjusting factor is defined. In particular, this adjustment factor can be expressed as a parameter between 0 and 1, 0 indicating that the shape of the support structure has no effect on the compression resistance, and 1 indicating that the shape of the support structure has a great effect on the compression resistance.
Optionally, at least one support structure 2 of the plurality of support structures 2 has a diameter that is larger than the diameter of the other support structures 2. In this embodiment, the diameter of at least one support structure 2 among the plurality of support structures 2 is greater than the diameter of other support structures 2, so that stability can be enhanced, the strength and stability of the whole support can be improved by increasing the diameter of at least one support structure 2, the support structure 2 with larger diameter can play a role of stabilizing the frame in the support frame, excessive deformation or instability of the support is prevented when the support is acted by external force, and thus stability and reliability of the support in a human body are improved. For example, as shown in fig. 5, the support structure 2 formed by the arc-shaped support columns 222 is adopted at two ends of the support, and the diameter of the support structure 2 formed by the arc-shaped support columns 222 is larger than that of the support structure 2 formed by the linear support columns 221, so that the support can be better clamped at a lesion part, and displacement is prevented. Or as shown in fig. 6, a supporting structure 2 formed by arc supporting columns 222 is adopted in a part of the middle of the bracket, and supporting structures 2 formed by linear supporting columns 221 can be adopted at two ends, so that the supporting structure can play a role in directional support, and the supporting structure 2 with a larger diameter can realize the directional support on a specific area, so that the bracket can more effectively support and fix the specific area of a lesion part, and the smoothness of the lesion part is better maintained. The support structure can also support different parts, and the support structure 2 with different diameters can support lesion parts with different sizes or shapes, so that different anatomical structures and lesion conditions can be better adapted, and the applicability and treatment effect of the support are improved. The adaptability of the bracket can also be improved, and according to the conditions and needs of specific lesion sites, the personalized customization of the bracket can be realized by arranging the support structures 2 with different diameters, so that the treatment requirements of different patients can be better met, and the treatment effect and the life quality of the patients can be improved.
Alternatively, the guide tube 1 includes a bending portion 11 and a reinforcing portion 12, the bending portion 11 is located in a space formed by three support columns 22, and the reinforcing portion 12 is located in a space formed by two support rings 21 abutting against each other. In this embodiment, referring to fig. 7, the bending portion 11 of the guide tube 1 is located in the space formed by the support columns, which is helpful for reducing friction and damage between the guide tube 1 and the external environment and prolonging the service life of the guide tube. The curved portion 11 is located inside the support column 22, which helps to optimize the guiding function of the guiding tube 1, so that the guiding tube 1 can more accurately guide liquid or substances through the support structure 2, improving the therapeutic effect and the quality of life of the patient. The reinforcing part 12 is mainly arranged in the guide tube 1 and is mainly used for resisting fracture of the whole guide tube 1, the guide tube 1 is not easy to fracture due to the reinforcing part 12, the reinforcing part 12 is positioned in a space formed by two mutually abutted supporting rings 21, when an external force is applied to bend the support, the reinforcing part 12 is mainly used for bearing bending force, the whole bearing capacity and stability of the support are improved, and the support can better support and maintain the smoothness of a lesion part of a human body.
Optionally, barbs 23 are arranged on the supporting structures 2 at the two ends of the supporting frame. In this embodiment, referring to fig. 8 and 9, barbs 23 are provided at both ends of the stent, and the barbs 23 can be firmly embedded into the wall tissue of the lesion part of the human body, and are mainly used for bile duct or pancreatic duct, preventing slipping and displacement of the stent, and ensuring the stent to stably function. The barbs are embedded into the tube wall, and can stimulate the growth and repair of surrounding tissues, thereby being beneficial to the healing and recovery of the lesion parts of the human body. Of course, only schematic illustrations of the barbs 23 provided on two support brackets are shown, and it is readily possible to provide barbs 23 on other support brackets as well, so long as the effect of increasing the stability of the bracket is achieved.
Optionally, the support column 22 is hollow inside. In this embodiment, the hollow interior design allows fluid to pass through, free flow, and increases the drainage effect of the overall stent if the stent is used in the bile or pancreatic duct.
Alternatively, the first degradable material or the second degradable material comprises polylactic acid, or polylactic acid-glycolic acid copolymer, or polycaprolactone, or polylactic acid-caprolactone copolymer, or polydioxanone, or polyglycolic acid, or polyhydroxyalkanoate. In this embodiment, as the main material of the guide tube 1, the first degradable material needs to have a fast degradation rate so as to be gradually degraded and absorbed by the human body within a period of time after the stent implantation. As the primary material of the support structure 2, the second degradable material needs to have a high strength to provide a stable support effect during stent implantation. Polylactic acid (PLA) has high transparency and good processability; the polylactic acid-glycolic acid copolymer can adjust the degradation rate by adjusting the ratio of lactic acid to glycolic acid; the biological degradation speed of Polycaprolactone (PCL) is low, and the Polycaprolactone (PCL) is suitable for long-term use; the polylactic acid-caprolactone copolymer combines the advantages of PLA and PCL, can regulate the degradation rate and improve the toughness of PLA; the strength of the polydioxanone is high; the polyglycolic acid has high biodegradation speed and is suitable for biomedical materials used in a short period; the polyhydroxyalkanoate has various structures and high selectivity.
Preferably, the first degradable material may be selected from polylactic acid or polylactic acid-glycolic acid copolymer: these materials have a fast degradation rate and are suitable for the portion of the guide tube 1 to degrade rapidly after the drainage function is completed. The second degradable material can be selected from polycaprolactone or polylactic acid-caprolactone copolymer: these materials degrade at a slower rate but have a higher strength and are suitable for use in the scaffold portion to provide long-term support and stability. Such a choice may satisfy the requirements of the stent for degradation after the drainage function is completed, after the guide tube 1 is degraded first, the support structure 2 is then degraded, and ensure that the stent can maintain sufficient supporting force during degradation until the stent has completed its life. Of course, more matching and combination of materials can be performed through component adjustment and actual experimental data so as to realize more diversified requirements.
Optionally, the scaffold comprises adding barium sulfate, or bismuth subcarbonate, or bismuth trioxide, or bismuth oxychloride to the second degradable material. In the embodiment, an X-ray developing material can be added into the support frame, so that the degradation condition of the support frame can be followed in later period and can be observed in time.
In a second aspect, an embodiment of the present invention provides a method for preparing a degradable human body scaffold, including the degradable human body scaffold of the preceding item, selecting a first degradable material for preparing a guide tube 1 and selecting a second degradable material for preparing a scaffold according to a circulation time requirement of a human body part to which the scaffold is to be applied and an external pressure to which the scaffold is subjected, wherein a degradation rate of the first degradable material is greater than a degradation rate of the second degradable material, and a strength of the second degradable material is greater than a strength of the first degradable material. In this embodiment, the circulation time requirement refers to the time required for the stent to maintain the circulation function in the human body, which depends on the condition of the lesion. External pressure refers to the pressure from inside and outside the body that the stent may withstand after implantation. These two points mainly depend on which part of the human body is applied, for example, bile duct, pancreatic duct or intestinal tract, the inner diameters of the parts are different, the circulation time of different diseases is different, and the materials with different degradation rates and strengths are selected according to the circulation time requirement of the part of the human body to which the stent is applied and the external pressure born by the stent, so that the requirements of the stent in different environments can be better met. For example, in the case of a shorter circulation time but a higher external pressure, it is necessary to prepare the guide tube 1 using a material having a faster degradation rate so as to be degraded as soon as possible after the circulation function is completed, reducing the irritation of the stent to the surrounding tissues. While in the scaffold portion, a slower degradation rate but stronger material is required to provide long term support and stability. The preparation method can flexibly adjust the performance of the bracket according to different application requirements, can ensure that the bracket can effectively maintain functions and support after implantation, and can reduce the influence and uncomfortable feeling on human bodies to the greatest extent. Meanwhile, the materials with different degradation rates and strengths can enable the stent to maintain enough supporting force in the degradation process until the stent completes its mission, thereby enhancing the safety and reliability of the stent.
Optionally, selecting the second degradable material for preparing the scaffold includes: determining the outer diameter of the support ring 21 according to the inner diameter of the body part to which the stent is to be applied; determining the ring diameter of the support ring 21 according to the flow rate requirement and the external pressure applied to the support; selecting a linear support column 221 or an arc support column 222 for a certain support structure 2; determining the number of required support structures 2 according to the length of the human body part to which the bracket is to be applied; the support frame is selected from the support structure 2 comprising the linear support columns 221 and/or the support structure 2 comprising the arc-shaped support columns 222.
In this embodiment, the supporting ring 21 is one of the basic structures of the supporting frame, and its outer diameter determines the overall size of the supporting frame, and the ring diameter is related to the size of the internal space of the supporting frame and the flow rate requirement. The outer diameter and the ring diameter of the support ring 21 are determined according to the inner diameter of the human body part to which the stent is to be applied and the flow rate requirement, so that the stent can be ensured to be adapted to the size of the target part and provide sufficient flow rate. The support columns 22 in the support structure 2 may be selected to be linear or arc-shaped, the linear support columns 221 being suitable for situations where linear support is desired, and the arc-shaped support columns 222 being more suitable for situations where a curved shape or a curved structure is desired. According to the specific application scene and the length of the human body part to which the bracket is applied, a proper support column form is selected, so that the support and stability requirements of the bracket can be better met. The whole bracket can adopt the supporting structure 2 comprising the linear supporting columns 221, the supporting structure 2 comprising the arc supporting columns 222 or the two supporting structures 2 in a mixed matching way. The number of support structures 2 required is determined according to the length of the body part to which the stent is to be applied, to ensure that the stent is able to cover the entire lesion and to provide adequate support and stability. The method has the advantage that the structure and the size of the stent are accurately designed according to the factors of the inner diameter, the length, the flow requirement of the human body part to which the stent is applied, the external pressure born by the stent and the like, so as to meet different treatment requirements and environmental conditions. The customized design can improve the adaptability, stability and treatment effect of the bracket in the human body to the greatest extent, and simultaneously reduce the discomfort and the complication risk of the patient. By selecting the appropriate support ring 21 outer diameter, ring diameter and support post 22 form, and determining the appropriate number of support structures 2, it is ensured that the stent can effectively support and maintain patency of the target site, thereby improving treatment success rate and quality of life for the patient.
Optionally, selecting a linear support column 221 or an arc support column 222 for a certain support structure 2 includes; if the linear support column 221 is selected, determining the length and the diameter of the linear support column 221 according to the compression resistance index K of the linear support column 221 being greater than the first compression resistance threshold K1, wherein the compression resistance index K of the linear support column 221 is generated based on the length L1 of the linear support column 221, the diameter D1 of the linear support column 221 and the second degradable material strength coefficient S; if the arc support column 222 is selected, determining the arc length La, the chord length Lc and the diameter D2 of the arc support column 222 according to the compression resistance index K of the arc support column 222 being greater than the first compression resistance threshold K1, wherein the compression resistance index K of the arc support column 222 is generated based on the arc length La of the arc support column 222, the chord length Lc of the arc support column 222, the diameter D2 of the arc support column 222 and the second degradable material strength coefficient S.
In this embodiment, although different support column 22 types are selected, the compressive property indexes K of the different support columns 22 are all larger than the first compressive threshold K1, and the first compressive threshold K1 is evaluated by a bending test and a breaking test, taking into consideration laboratory related test indexes: k1 =x×f OS*FBS, wherein: x is a coefficient used to correct the experimental results, taking into account the differences in experimental conditions and practical applications. F OS is a safety factor in the bending test for taking into account the degree of bending of the support column 22. It can be derived from a bending test, such as a ratio of maximum load to design load before bending to the support column 22 breaks. F BS is a safety factor in the fracture test to consider the degree of fracture resistance of the support column 22. It can be derived from a fracture test, such as the ratio of the maximum load before the support column 22 breaks to the design load. This formula comprehensively considers the performances of the support column 22 in terms of bending and breaking, and by adjusting the safety coefficient and the coefficient x, the first compression threshold K1 can be calculated according to laboratory test results and design requirements. The compressive property index K is greater than the first compressive threshold K1, ensures that the support column 22 is not broken under the working condition, and can stably support the target site. The length L1 and diameter D1 of the linear support column 221, and the arc length La, chord length Lc, and diameter D2 of the arc-shaped support column 222 may be determined according to the relationship between the compressive property index K and the first compressive threshold K1. By adjusting the length, or diameter, or arc length, or chord length of the support post 22, the compressive properties of the support post 22 can be controlled to meet the requirements. This method allows for flexible selection of the appropriate support post 22 form according to the actual requirements and optimization of the support post 22 performance by adjusting the parameters. By properly sizing and material the support post 22, it is possible to ensure that the stent has sufficient stability and safety under working conditions, thereby improving the therapeutic effect and the quality of life of the patient. Further, by evaluating and adjusting the compressive resistance index K and the first compressive threshold value K1, it is possible to ensure that the support column 22 does not break under the intended operating conditions while sufficiently exerting the supporting function.
Those of skill in the art will appreciate that the various operations, methods, steps in the flow, acts, schemes, and alternatives discussed in the present invention may be alternated, altered, combined, or eliminated. Further, other steps, means, or steps in a process having various operations, methods, or procedures discussed herein may be alternated, altered, rearranged, disassembled, combined, or eliminated. Further, steps, measures, schemes in the prior art with various operations, methods, flows disclosed in the present invention may also be alternated, altered, rearranged, decomposed, combined, or deleted.
In the description of the present invention, it should be understood that the terms "center," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate orientations or positional relationships based on the orientation or positional relationships shown in the drawings, merely to facilitate describing the present invention and simplify the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
The terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meanings of the above terms in the present invention can be understood in specific situations by those of ordinary skill in the art.
In the description of the present specification, a particular feature, structure, material, or characteristic may be combined in any suitable manner in one or more embodiments or examples.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (12)
1. A degradable human stent comprising:
The support frame comprises a plurality of support structures, wherein each support structure comprises two support rings and at least three support columns uniformly arranged between the two support rings, and two ends of each support column are respectively connected with the two support rings;
The guide pipes are arranged inside the support frame, two ends of the guide pipes are fixedly connected with the support rings at two ends of the support frame, and the support structures are mutually abutted outside the guide pipes to form the support frame;
The guide tube is made of a first degradable material, the scaffold is made of a second degradable material, the degradation rate of the first degradable material is greater than the degradation rate of the second degradable material, and the strength of the second degradable material is greater than the strength of the first degradable material.
2. The degradable human body support according to claim 1, wherein the support column comprises a linear support column or an arcuate support column.
3. The degradable human stent of claim 2, wherein when a certain of the support structures comprises the linear support column, the compressive property index of the linear support column is generated based on the length of the linear support column, the diameter of the linear support column, and the second degradable material strength coefficient;
when a certain supporting structure comprises the arc-shaped supporting columns, the compressive performance index of the arc-shaped supporting columns is generated based on the arc length of the arc-shaped supporting columns, the chord length of the arc-shaped supporting columns, the diameter of the arc-shaped supporting columns and the strength coefficient of the second degradable material;
the compressive property index is greater than a first compressive threshold.
4. The degradable human stent of claim 2, wherein at least one of the support structures in the plurality of support structures has a diameter that is greater than the diameter of the other support structures.
5. The degradable human body support according to claim 1, wherein the guide tube comprises a bending portion and a reinforcing portion, the bending portion is located in a space formed by the three support columns, and the reinforcing portion is located in a space formed by the two support rings abutting each other.
6. The degradable human body support according to claim 1, wherein barbs are provided on the support structures at both ends of the support frame.
7. The degradable human stent of claim 1, wherein the support column is hollow inside.
8. The degradable human stent of claim 1, wherein the first degradable material or/and the second degradable material comprises polylactic acid, or polylactic acid-glycolic acid copolymer, or polycaprolactone, or polylactic acid-caprolactone copolymer, or polydioxanone, or polyglycolic acid, or polyhydroxyalkanoate.
9. The degradable human body scaffold of claim 1, wherein the scaffold comprises barium sulfate, or bismuth subcarbonate, or bismuth trioxide, or bismuth oxychloride added to the second degradable material.
10. A method for preparing a degradable human body scaffold, comprising the degradable human body scaffold according to any one of claims 1-9, wherein a first degradable material is selected for preparing a guide tube and a second degradable material is selected for preparing a scaffold according to the circulation time requirement of a human body part to which the scaffold is applied and the external pressure to which the scaffold is subjected, wherein the degradation rate of the first degradable material is greater than the degradation rate of the second degradable material, and the strength of the second degradable material is greater than the strength of the first degradable material.
11. The method of claim 10, wherein selecting the second degradable material for preparing the scaffold comprises:
determining the outer diameter of the support ring according to the inner diameter of the human body part to which the support is to be applied;
Determining the ring diameter of the support ring according to the flow demand and the external pressure born by the support;
selecting a linear support column or an arc support column for a certain support structure;
determining the number of the required support structures according to the length of the human body part to which the bracket is applied;
Selecting a support structure comprising the linear support column or/and a support structure comprising the arc support column to form the support frame.
12. The method of claim 11, wherein selecting the linear support column or the arcuate support column for a particular support structure comprises;
If the linear support column is selected, determining the length and the diameter of the linear support column according to the fact that the compressive property index of the linear support column is larger than a first compressive threshold, wherein the compressive property index of the linear support column is generated based on the length of the linear support column, the diameter of the linear support column and the strength coefficient of the second degradable material;
if the arc-shaped support column is selected, determining the arc length, the chord length and the diameter of the arc-shaped support column according to the fact that the compressive property index of the arc-shaped support column is larger than a first compressive threshold, wherein the compressive property index of the arc-shaped support column is generated based on the arc length of the arc-shaped support column, the chord length of the arc-shaped support column, the diameter of the arc-shaped support column and the strength coefficient of the second degradable material.
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| WO2021247024A1 (en) * | 2020-06-03 | 2021-12-09 | Biovascular Therapeutics Pte Ltd | Radiopaque biodegradable metallic scaffold with a non-biodegradable coating, and which includes radial support rings and resiliently flexible, preferentially fracturable axial links therebetween |
| CN114305791A (en) * | 2022-01-07 | 2022-04-12 | 北京阿迈特医疗器械有限公司 | Degradable bile pancreatic duct bracket |
| CN117898868A (en) * | 2024-03-19 | 2024-04-19 | 北京阿迈特医疗器械有限公司 | Biliary pancreatic duct support capable of automatically discharging human body and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20030040754A1 (en) * | 1999-03-18 | 2003-02-27 | Michael Mitchell | Radially expanding stents |
| CN105477690A (en) * | 2014-09-17 | 2016-04-13 | 上海微创医疗器械（集团）有限公司 | Multilayer degradable tube and stent and preparation method thereof |
| WO2021247024A1 (en) * | 2020-06-03 | 2021-12-09 | Biovascular Therapeutics Pte Ltd | Radiopaque biodegradable metallic scaffold with a non-biodegradable coating, and which includes radial support rings and resiliently flexible, preferentially fracturable axial links therebetween |
| CN114305791A (en) * | 2022-01-07 | 2022-04-12 | 北京阿迈特医疗器械有限公司 | Degradable bile pancreatic duct bracket |
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