Degradable artificial fluid tube

Abstract

The embodiment of the invention provides a degradable artificial fluid tube which comprises a tube wall, the tube wall is formed by winding a degradable material membrane material, a tube cavity is formed in the tube wall, the tube cavity is configured to enable fluid to circulate, the degradable material membrane material is of a flexible plane structure, and the degradable material membrane material is of a flexible plane structure. One end of the degradable material membrane material is wound to form the inner wall of the degradable artificial fluid pipe, and the other end of the degradable material membrane material is wound to form the outer wall of the degradable artificial fluid pipe. The degradable artificial fluid pipe provided by the invention has a winding type structure, so that when the degradable artificial fluid pipe is bent in use, the bending moment degree of the pipe wall can be adjusted according to the bending condition of the pipe cavity, and the inner diameter of the pipe cavity is ensured to be sufficient for fluid circulation; and the embolism problem caused by reduction of the cross section in a pipe cavity due to bending of the fluid pipe is effectively avoided.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to a degradable artificial fluid tube. Background Art

[0002] As a Class III implantable medical device, the degradable artificial fluid tube should be non-toxic to the body, have good biocompatibility and blood compatibility, good mechanical strength and a porous structure that can promote cell adhesion and growth. In addition, for some urinary tract defects, artificial ureters are also needed for repair. In the prior art, these pipes for dredging fluids in the human body are mainly made of two types of biomedical materials. One method is to use polymer synthetic materials, and the other method is to use animal tissue materials that have been treated to remove immunogens.

[0003] Polymer materials have the advantages of being naturally free of immunogenic risk, uniform in material and easy to process on a large scale, and are currently the main materials for degradable artificial fluid tubes. Animal-derived tissues, on the other hand, need to be processed to remove the immunogens therein. Since animal-derived tissues have components and structures that are more similar to human tissues, and can degrade and induce tissues to form autologous blood vessels after being implanted in the body, degradable artificial fluid tubes have become a hot topic of research in recent years. However, although the structure of this type of degradable artificial fluid tube is similar to that of human blood vessels, it is easy to cause the structural strength of the degradable artificial fluid tube to decrease due to its high requirements for the removal method of immunogens, and there may be a risk of rupture after implantation. Moreover, in response to the needs of different blood vessel diameters in the human body, it is often necessary to select a large number of animal-derived blood vessel raw materials of different sizes for production, which is not conducive to large-scale production of products. Artificial ureters also face the same technical difficulties. Summary of the invention

[0004] The purpose of the present disclosure is to provide a degradable artificial fluid tube in response to the technical problems in the related art.

[0005] The specific plan is as follows:

[0006] The embodiment of the present application provides a degradable artificial fluid tube, comprising: a tube wall, the tube wall is formed by winding a degradable material film, and a tube cavity is formed inside the tube wall, and the tube cavity is configured to allow fluid to flow.

[0007] The degradable material film is a flexible planar structure, one end of the degradable material film is rolled to form the inner wall of the degradable artificial fluid tube, and the other end of the degradable material film is rolled to form the outer wall of the degradable artificial fluid tube.

[0008] In some embodiments, the tube wall includes: an inner layer and an outer layer, and an intermediate layer disposed between the inner layer and the outer layer, wherein the intermediate layer is provided with one or more layers.

[0009] In some embodiments, the inner diameter of the lumen is between 2-36 mm, and is configured to allow smooth flow of fluid in the lumen; preferably, the diameter is 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 10 mm, 18 mm, 20 mm, 22 mm, 24 mm or 32 mm.

[0010] In some embodiments, a plurality of through holes are disposed through the surface of the intermediate layer, and a plurality of the through hole matrices are arranged on the tube wall.

[0011] In some embodiments, the total area of ​​the plurality of through holes accounts for 30% to 80% of the total flat area of ​​the tube wall.

[0012] In some embodiments, there are ridges between the plurality of through holes, and the ridges are perpendicular or parallel to the winding direction of the degradable material film.

[0013] In some embodiments, the angle between the length extension direction of the through hole and the rolling direction of the degradable material film is 30-60 degrees.

[0014] In some embodiments, the through holes are strip-shaped inclined holes, and the angle between the strip-shaped inclined holes and the rolling direction of the degradable material film is 45 degrees.

[0015] In some embodiments, the through hole is a corrugated hole, which extends along the rolling direction and is configured to increase the torque of the tube wall.

[0016] In some embodiments, the width of the degradable material membrane does not exceed 15 cm. Optionally, the degradable material membrane is a small intestinal submucosa material.

[0017] Compared with the related art, the above solution of the embodiment of the present disclosure has at least the following beneficial effects:

[0018] The degradable artificial fluid tube provided by the present invention has a winding structure. Therefore, when the degradable artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending condition of the lumen to ensure that the inner diameter of the lumen is sufficient for fluid circulation, thereby effectively avoiding embolism caused by the reduction of the cross-section of the lumen due to the bending of the fluid tube.

[0019] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings herein are incorporated into the specification and constitute a part of the specification, showing embodiments consistent with the present disclosure, and together with the specification, are used to explain the principles of the present disclosure. Obviously, the drawings described below are only some embodiments of the present disclosure, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. In the drawings:

[0021] Figure 1 It is a schematic diagram of the side structure of a degradable artificial fluid tube according to an exemplary embodiment.

[0022] Figure 2 It is a schematic diagram of the structure of a degradable artificial fluid tube according to an exemplary embodiment.

[0023] Figure 3 It is a schematic diagram of the structure of a degradable artificial fluid tube according to an exemplary embodiment.

[0024] Figure 4 is a schematic diagram of flattening a tube wall according to an exemplary embodiment.

[0025] Figure 5 is a schematic diagram of flattening another tube wall according to an exemplary embodiment.

[0026] Figure 6 is a schematic diagram of another type of tube wall winding according to an exemplary embodiment.

[0027] Figure 7 is a schematic diagram of flattening another tube wall according to an exemplary embodiment.

[0028] Figure 8 is a schematic diagram of another type of tube wall winding according to an exemplary embodiment.

[0029] Fig. 9 FIG. 1 is a schematic diagram of another flattened tube wall according to an exemplary embodiment.

[0030] The degradable artificial fluid tube 1000 includes a tube wall 100 , a through hole 101 , an inner layer 110 , a middle layer 120 , an outer layer 130 , and a tube cavity 200 . DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solutions and advantages of the present disclosure clearer, the present disclosure will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0032] The terms used in the embodiments of the present disclosure are only for the purpose of describing specific embodiments, and are not intended to limit the present disclosure. The singular forms "a", "said" and "the" used in the embodiments of the present disclosure and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings, and "multiple" generally includes at least two, and other quantifiers are similar.

[0033] It should be understood that, although the terms first, second, third, etc. may be used to describe in the disclosed embodiments, these descriptions should not be limited to these terms. These terms are only used to distinguish the described objects. For example, without departing from the scope of the disclosed embodiments, the first may also be referred to as the second, and similarly, the second may also be referred to as the first. In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0034] In the description of the present disclosure, it should be noted that, unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0035] It should also be noted that the term "includes", "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, so that a commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprising a ..." do not exclude the existence of other identical elements in the commodity or device including the elements.

[0036] The embodiment of the present disclosure is a degradable artificial fluid tube, comprising: a tube wall, wherein the tube wall is formed by winding a biomedical material film, and a tube cavity is formed inside the tube wall, and the tube cavity is configured to allow fluid to flow therein, wherein the degradable material film is a flexible planar structure, one end of the degradable material film is wound to form the inner wall of the degradable artificial fluid tube, and the other end of the degradable material film is wound to form the outer wall of the artificial fluid tube.

[0037] The biomedical material film is provided with a periodically arranged through-hole array, which makes the structural strength of the tube wall in the axial direction of the pipeline change periodically after winding, thereby forming a structure similar to a bellows. After being implanted in the body, this degradable artificial fluid tube can prevent pipeline closure in the case of bending and twisting, thereby ensuring that the fluid can flow smoothly in the tube. In addition, these periodic structures can be used as storage bins for anticoagulant and / or anti-inflammatory drugs. The membrane material forming the inner wall and the outer wall is a complete planar structure. The degradable artificial fluid tube formed by such a material prevents leakage caused by the structure formed by the through-hole array. In addition, the complete plane of the inner wall can ensure the smooth flow of the fluid in the tube.

[0038] The degradable artificial fluid tube provided by the present invention has a winding structure. When the degradable artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending condition of the lumen, and has a bending similar to that of a bellows, thereby ensuring that the inner diameter of the lumen is sufficient for fluid circulation, and effectively avoiding embolism problems caused by the reduction of the cross-section of the lumen due to the bending of the fluid tube.

[0039] The optional embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0040] like Figure 1 As shown, an embodiment of the present application provides a degradable artificial fluid tube 1000, comprising: a tube wall 100 and a tube cavity 200, wherein the tube wall 100 is formed by winding a degradable material film, and a tube cavity 200 is formed inside the tube wall 100, and the tube cavity 200 is configured to allow fluid to flow.

[0041] The degradable material film is a flexible planar structure, one end of the degradable material film is wound to form the inner wall of the degradable artificial fluid tube 1000, and the other end of the degradable material film is wound to form the outer wall of the degradable artificial fluid tube 1000. Specifically, the degradable material film can be SIS material (small intestinal submucosal material). This material can be processed on a large scale, and decellularization and immunogen treatment can be centralized, and planar materials can be centralized processed, and then curled. During the production and processing process, the diameter of the degradable artificial fluid tube can be controlled according to demand, and large-scale production can be carried out, which greatly reduces production costs and product quality stability.

[0042] In some embodiments, Figure 2 As shown, the tube wall 100 includes: an inner layer 110 and an outer layer 130 , and an intermediate layer 120 disposed between the inner layer 110 and the outer layer 130 , wherein the intermediate layer 120 may be provided with multiple layers.

[0043] The degradable material film is wound to form a lumen 200, and the inner layer 110 is the side wall of the lumen 200. The fluid can flow in the lumen 200 wrapped by the inner layer 110. In order to ensure the thickness of the side wall of the degradable artificial fluid tube 1000, multiple layers of the intermediate layer 120 are wound on the outer side of the inner layer 110. The setting of the intermediate layer 120 increases the thickness of the tube wall 100 on the one hand, and improves the elasticity of the tube wall 100 on the other hand, which is more conducive to fluid transportation. The intermediate layer 120 is provided with one or more layers. The outer layer 130 is wound on the outer side of the intermediate layer 120, that is, the intermediate layer 120 is away from the inner layer 110. The outer layer 130 can be the outer wall of the tube wall 100.

[0044] It should be separately explained that the fluid includes but is not limited to at least one of the flowable liquids such as blood, urine, intestinal fluid, etc. In addition, the fluid may also be a gas.

[0045] In some embodiments, Figure 1 As shown, the inner diameter D of the lumen 200 can be between 2-36mm to meet the fluid tube usage requirements of different patients, and the appropriate diameter can ensure normal hemodynamics. If the lumen diameter is not consistent, such as being too small, blood flow resistance will increase, resulting in poor fluid circulation and even possible thrombosis; while a large diameter may cause abnormal conditions such as slow blood flow. Secondly, the limited inner diameter is conducive to anastomosis with the human body's fluid tubes, such as blood vessels, making the surgical operation process smoother and ensuring that the degradable artificial fluid tube 1000 can well replace the diseased fluid tube to perform its function.

[0046] It should be noted that: the inner diameter of the lumen 200 is recorded as D, and the length of the inner layer 110 is at least πD, so that the degradable artificial fluid tube 1000 can form a smooth and closed inner layer 110. Good inner layer sealing can prevent fluid from leaking from the tube wall of the degradable artificial fluid tube 1000, ensuring that the fluid circulates normally in the lumen. At the same time, improving biocompatibility helps the degradable artificial fluid tube 1000 to better adapt to the physiological environment of the human body, reduce the rejection reaction of the human immune system to the degradable artificial fluid tube 1000, and extend the service life of the degradable artificial fluid tube 1000, so that it can play a normal fluid tube replacement function in the body for a longer time, such as: blood vessel replacement function.

[0047] In some embodiments, in response to local bending of the tube wall 100, the regular structural strength changes of the intermediate layer 120 can absorb these bends and form effective support, thereby allowing the lumen 200 to have a sufficient inner diameter, thereby preventing the cross-section of the lumen 200 from being significantly reduced due to bending of the degradable artificial fluid tube 1000, thereby causing embolism.

[0048] Specifically, the middle layer 120 may be provided with a plurality of through holes 101, and ribs are formed between the plurality of through holes 101. When the tube cavity 200 is bent, due to the provision of the ribs, the tube is preferably bent at the location of the through hole 101. On the other hand, due to the provision of the through hole 101, when the degradable artificial fluid tube 1000 provided by the present disclosure is bent during use, the rolling thickness at the location of the through hole 101 will be thinner than the rolling thickness at the location of the ribs, and therefore, the degradable artificial fluid tube 1000 is more likely to bend at the location of the through hole 101. Therefore, when the degradable artificial fluid tube 1000 is bent, due to the setting of the through hole 101 on the middle layer 120, there is a gap between the inner layer 110 and the outer layer 130, so that the lumen 200 can still have a sufficient inner diameter when bending, thereby avoiding the problem of embolism caused by poor fluid circulation due to a significant reduction in the cross-section of the lumen 200 caused by bending of the degradable artificial fluid tube 1000.

[0049] In some embodiments, the ribs are perpendicular or parallel to the winding direction of the degradable material film. To ensure that the artificial fluid tube 1000 has a through hole 101 at the bent position, so that the bent tube wall can be supported by the ribs, the degradable artificial fluid tube 1000 is prevented from causing embolism due to the cross-section of the lumen 200 being greatly reduced due to bending, which causes poor fluid circulation.

[0050] In some embodiments, the through hole 101 occupies 30% to 80% of the flat area of ​​the tube wall 100. On the one hand, the elasticity of the tube wall 100 can be improved.

[0051] On the other hand, it can assist in adjusting the bending support force of the tube wall 100 so that when the degradable artificial fluid tube 1000 is axially bent, the through hole 101 will not be set in the inner layer 110. The inner layer 110 is used to wrap the tube cavity 200 to ensure fluid circulation and prevent the fluid from penetrating from the inner layer 110 into the middle layer 120 or the outer layer 130.

[0052] In some embodiments, Figure 2 As shown, there is no through hole 101 structure on the surface of the outer layer 130. If a through hole 101 is set on the outside of the tube wall 100, when the degradable material film is rolled to form the tube wall 100, the edge of the through hole 101 of the outer layer 130 of the tube wall 100 is easy to scratch other fluid tubes or tissues, which may cause unnecessary harm to the patient.

[0053] In some embodiments, Figure 3As shown, the surface of the intermediate layer 120 is provided with a plurality of through holes 101, and the through holes 101 are arranged in a matrix on the tube wall 100. In response to the fluid flowing through the lumen 200, since the fluid circulation exerts a certain pressure on the lumen 200, that is, the fluid circulation exerts a pressure on the inner layer 110 of the tube wall 100, the provision of the through holes 101 can improve the elasticity of the tube wall 100 on the one hand; on the other hand, when the degradable artificial fluid tube 1000 is bent, the rolling thickness at the location of the through holes 101 will be thinner than the rolling thickness at the location of the ribs, so the bending of the degradable artificial fluid tube 1000 is more likely to occur at the location of the through holes 101. At this time, the ribs provide a periodic bending support force in the axial direction of the intermediate layer 120 to avoid the problem of the degradable artificial fluid tube 1000 causing a significant compression of the lumen space due to bending, resulting in poor fluid transportation.

[0054] Specifically, when the tube wall 100 is bent, at least part of the middle layer 120 and the outer layer 130 are squeezed toward the inside of the through hole 101, so that the tube wall 100 has a certain elastic relaxation space, thereby achieving elastic wrapping of the tube wall 100 on the tube cavity 200 and achieving smooth flow of fluid in the tube cavity 200.

[0055] In some embodiments, the surface of the degradable material film is provided with a plurality of through holes 101, and the angle between the length extension direction of the through holes 101 and the rolling direction of the degradable material film can be 30 to 90 degrees. If the angle between the length extension direction of the through holes 101 and the rolling direction of the degradable material film is less than 30 degrees, when the degradable material film is rolled into a tube wall 100, the length direction of the through holes 101 is nearly perpendicular to the fluid flow direction in the lumen 200, so when the fluid flows through the degradable artificial fluid tube 1000, the elastic pressure applied by the tube wall 100 to the lumen 200 is not suitable for fluid flow.

[0056] In some embodiments, Figure 3 , Figure 4 As shown, if the through hole 101 is in the shape of a rectangular through hole, then the rolling direction of the degradable artificial fluid tube 1000 can be either the length direction of the degradable material film or the width direction of the degradable material film.

[0057] In some embodiments, the inner diameter of the lumen 200 is recorded as D, the through hole can be a square through hole, and the surface of the biodegradable material film is provided with a plurality of square through holes, and the relationship between the inner diameter and the side length of the square through hole and the distance between at least two through holes is defined as follows:

[0058] The side length of the square through hole is denoted as d1: 1 / 8D≤d1≤D;

[0059] The spacing between the plurality of square through holes is W1:3 / 8D<W1≤D.

[0060] Limiting the side length of the square through hole can make the artificial fluid tube 1000 have enough space to compress the film material during the bending process. The appropriate side length of the square through hole can ensure the normal exchange of substances inside and outside the degradable artificial fluid tube 1000, such as: allowing oxygen, nutrients and metabolic waste to pass smoothly, while avoiding the loss of a large number of blood cells or abnormal infiltration of immune cells to cause inflammation, etc., and can also avoid the appearance of creases on the wall of the artificial fluid tube 1000 that affect the fluid circulation. If the square through hole becomes less than 1 / 8D, it is easy to cause creases on the wall of the tube due to insufficient bending buffer space. If the side length of the square through hole is greater than D, it is easy to cause the wall of the tube to become thinner and the delivery speed of the fluid to slow down during transportation.

[0061] Limiting the spacing between the multiple square through holes helps maintain the mechanical properties of the degradable artificial fluid tube 1000. The appropriate through hole spacing allows the degradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to the fluid pressure of the fluid, avoiding the rupture or deformation of the degradable artificial fluid tube 1000 due to uneven local force, and reducing the occurrence of complications such as thrombosis. If the through hole spacing is less than or equal to 3 / 8D, it is easy for the tube wall to be creased due to insufficient bending buffer space; if the square through hole spacing is greater than D, it is easy for the tube wall to become thinner and the fluid delivery speed to slow down during transportation.

[0062] In some embodiments, Figure 5 , Figure 6 As shown, the through hole 101 is a strip-shaped inclined hole, and the angle between the strip-shaped inclined hole and the rolling direction of the degradable material film is 30-60 degrees, preferably 45 degrees.

[0063] When the degradable material film is rolled into the tube wall 100, the length extension direction of the through hole 101 is approximately 45 degrees to the fluid flow direction in the lumen 200. At this time, the degradable artificial fluid tube 1000 can be adjusted to a maximum bending angle, and can maintain the inner diameter of the lumen 200 within a preset range to ensure fluid circulation.

[0064] In some embodiments, the inner diameter of the lumen 200 is denoted as D, and the relationship between the inner diameter and the width, length, and spacing between at least two strip-shaped inclined holes is defined.

[0065] The width of the strip-shaped inclined hole is recorded as d2: 1 / 8D≤d2≤3 / 8D;

[0066] The length of the strip-shaped inclined hole is recorded as L: 1 / 4D≤L≤1 / 2D;

[0067] The spacing between the plurality of strip-shaped inclined holes is denoted as W2, and 3 / 8D<W2≤D.

[0068] Limiting the corrugation width can allow the artificial fluid tube 1000 to have enough space to compress the membrane material during the bending process. The appropriate width of the strip-shaped inclined holes can ensure the normal exchange of substances inside and outside the degradable artificial fluid tube 1000, such as allowing oxygen, nutrients and metabolic waste to pass smoothly, while avoiding the loss of a large number of blood cells or abnormal infiltration of immune cells to cause inflammation, etc. It can also prevent the wall of the artificial fluid tube 1000 from creases that affect fluid circulation. If the width of the strip-shaped inclined holes is less than or equal to 1 / 8D, creases may easily appear on the wall of the tube due to insufficient bending buffer space. If the width of the strip-shaped inclined holes is greater than 3 / 8D, thinning of the wall of the tube may occur, and the delivery speed of the fluid may slow down during transportation. Similarly, the length of the multiple strip-shaped inclined holes must also be limited, and their functions and distances will not be repeated here.

[0069] Limiting the spacing between the multiple strip-shaped inclined holes helps maintain the mechanical properties of the degradable artificial fluid tube 1000. The appropriate spacing between the strip-shaped inclined holes allows the degradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to the fluid pressure of the fluid, avoiding the rupture or deformation of the degradable artificial fluid tube 1000 due to uneven local force, and reducing the occurrence of complications such as thrombosis. If the spacing between the multiple strip-shaped inclined holes is less than 1 / 2D, it is easy for creases to appear on the tube wall due to insufficient bending buffer space; if the spacing between the multiple strip-shaped inclined holes is greater than D, it is easy for the tube wall to become thinner and the delivery speed of the fluid to slow down during transportation.

[0070] In some embodiments, Figure 7 , Figure 8 As shown, the through hole 101 may be a corrugated hole configured to increase the torque of the tube wall 100 , and a plurality of the corrugated holes may be provided, with corrugated ridges formed between the plurality of corrugated holes.

[0071] By squeezing at least a portion of the outer layer 130 or the middle layer 120 toward the through hole 101, the periodic structural strength variation of the middle layer 120 can ensure effective support in the case of bending. Furthermore, the degradable artificial fluid tube 1000 can be bent without affecting the inner diameter of the lumen 200, thereby ensuring the normal flow of the fluid and avoiding thrombosis caused by the inner diameter of the lumen 200 being too narrow.

[0072] Specifically, the extending direction of the wave shape is perpendicular to the rolling direction of the degradable material film. In response to the bending of the degradable artificial fluid tube 1000, the corrugated holes are arranged at intervals in the length direction of the artificial fluid tube 1000. After the degradable material film with corrugated holes is rolled into the artificial fluid tube 1000, the artificial fluid tube 1000 can have better flexibility. Compared with the traditional artificial fluid tube, it can withstand bending at a larger angle without being easily damaged. At the same time, when the artificial fluid tube 1000 is bent, due to the supporting effect of the corrugated ribs, at least two corrugated ribs will be compressed toward the corrugated holes between them, so that the inner diameter of the artificial fluid tube 1000 is kept within a preset range, ensuring smooth fluid circulation. On the other hand, when the artificial fluid tube 1000 is bent within the preset range, the corrugated holes can disperse the stress generated by the bending of the artificial fluid tube 1000. When the artificial fluid tube 1000 is bent, the stress will be distributed in each bent part instead of being concentrated on a certain point, thereby reducing the risk of the artificial fluid tube 1000 rupturing or partial reduction in lumen diameter due to folding, and extending the service life of the artificial fluid tube 1000.

[0073] In some embodiments, the inner diameter D of the lumen 200 and the corrugation width, the crest spacing, and the spacing between at least two corrugated holes of the corrugated holes are defined as follows:

[0074] The width of the corrugated hole is recorded as d3: 1 / 8D≤d3≤3 / 8D;

[0075] The peak distance is recorded as L3: 1 / 2D≤L≤D;

[0076] The spacing between the multiple corrugated holes is recorded as W3, 3 / 8D<W3≤D.

[0077] Limiting the corrugation width can allow the artificial fluid tube 1000 to have enough space to compress the film material during the bending process. The appropriate corrugation width can ensure the normal exchange of substances inside and outside the degradable artificial fluid tube 1000, such as: allowing nutrients and metabolic waste to pass smoothly, while avoiding the loss of a large number of blood cells or abnormal infiltration of immune cells to cause inflammation, etc., and can also prevent the wall of the artificial fluid tube 1000 from creases that affect fluid circulation. If the width of the corrugated hole is less than or equal to 1 / 8D, it is easy for the wall of the tube to be creased due to insufficient bending buffer space. If the width of the corrugated hole is greater than 3 / 8D, it is easy for the wall of the tube to become thinner and the delivery speed of the fluid to slow down during transportation.

[0078] Limiting the peak spacing helps maintain the mechanical properties of the degradable artificial fluid tube 1000. Appropriate peak spacing allows the degradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to the fluid pressure of the fluid, avoids rupture or deformation of the degradable artificial fluid tube 1000 due to local uneven force, and reduces the occurrence of complications such as thrombosis. If the peak spacing is less than 1 / 2D, creases may easily appear on the tube wall due to insufficient bending buffer space; if the peak spacing is greater than D, thinning of the tube wall may occur, and the delivery speed of the fluid may slow down during transportation. Similarly, the spacing between the corrugated holes must also be limited, which will not be elaborated here.

[0079] In some embodiments, the rolling direction may be the length direction or width direction of the degradable material film of the degradable artificial fluid tube 1000. If the through hole 101 is in the shape of a corrugated hole, and the extending direction of the corrugated hole is the length direction of the degradable material film, Figure 6 As shown, the rolling direction of the degradable artificial fluid tube 1000 should be the length direction of the degradable material film; if the shape of the through hole 101 is a corrugated hole, and the extension direction of the corrugated hole is the width direction of the degradable material film, the rolling direction of the degradable artificial fluid tube 1000 should be the width direction of the degradable material film.

[0080] It should be separately explained that the present application does not specifically limit the shape and structure of the through hole 101 . The through hole 101 may be of a regular shape or an irregular shape, as long as it can ensure that the middle layer 120 can wrap the inner layer 110 .

[0081] In other embodiments, the inner layer 110, the middle layer 120 and the outer layer 130 can be an integral structure or a separate structure before the degradable artificial fluid tube 1000 is rolled. Fig. 9 As shown, before the degradable artificial fluid tube 1000 starts to be rolled, the inner layer 110, the middle layer 120 and the outer layer 130 can be a split structure. The inner layer 110, the middle layer 120 and the outer layer 130 of the split structure can be made of membrane materials of different materials. On the one hand, it can improve the adaptability of the degradable artificial fluid tube 1000 to the human body, and on the other hand, it can also make the clinical application scenarios of the degradable artificial fluid tube 1000 more diverse.

[0082] The degradable artificial fluid tube 1000 provided in the present disclosure has a winding structure. Therefore, when the degradable artificial fluid tube 1000 is bent during use, the tube wall 100 can adjust its own bending moment according to the bending condition of the lumen 200 to ensure that the inner diameter of the lumen 200 is sufficient for fluid circulation, thereby effectively avoiding embolism caused by the reduction of the internal cross-section of the lumen 200 due to the bending of the artificial fluid tube 100.

[0083] The artificial fluid tube 1000 provided by the present disclosure can be used for artificial blood vessels or artificial ureters. Small-caliber blood vessels are less than 6mm and can be used for artificial blood vessels of small arteries and small veins in the wrist or foot. They are mainly used to replace the patient's defective arteries and veins, or as shunt channels when arteries are blocked, and as arteriovenous transplant substitutes for kidney patients undergoing hemodialysis. Medium-caliber artificial blood vessels, between 6mm and 10mm, such as 6-8mm artificial blood vessels, can be used for artificial bypass surgery of arteries in various parts of the limbs and the neck arteries, and those around 8mm are often used in some peripheral vascular surgeries. They are suitable for the treatment of various peripheral arterial diseases and hemodialysis. Large-caliber artificial blood vessel diameter: 10mm or more, such as 18-24mm, is mainly used in artificial blood vessel replacement of the thoracic aorta. The 16-20mm Y-shaped artificial blood vessel is mainly used for artificial blood vessel bypass of the abdominal aorta, double iliac (femoral) arteries and artificial bypass of the ascending aorta and double carotid (or double subclavian) arteries. Around 20-30mm is often used for artificial blood vessel replacement of part of the ascending aortic arch, 22-32mm artificial ascending aorta, etc. It is often used in the treatment of aortic diseases, such as aortic dissection, vascular aneurysm, etc. The diameter of the human ureter is 3-7mm. The diameter range of the artificial fluid tube disclosed in the present invention can be 2-6mm, 6-10mm and 10-36mm; or 3-7mm.

[0084] The specific structure, working principle and beneficial effects of the degradable artificial fluid tube 1000 provided in the embodiment of the present disclosure may refer to the degradable artificial fluid tube 1000 described in any of the above embodiments, and will not be elaborated here.

[0085] It should be further explained that the degradable artificial fluid tube 1000 described in the present disclosure can be made of animal-derived materials. The animal-derived materials can be tissue capsules and / or endothels. The pericardium, peritoneum or submucosa can be selected. Preferably, the submucosa of the small intestine, the submucosa of the bladder, the amniotic membrane or a combination thereof can be selected. Preferably, the above-mentioned polymer materials and animal-derived materials are completely degradable materials or at least partially degradable materials after implantation in the body.

[0086] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other. For the system or device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part description.

[0087] The above embodiments are only used to illustrate the technical solutions of the present disclosure, rather than to limit them. Although the present disclosure has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present disclosure.

Claims

1. A degradable artificial fluid tube, characterized in that: include: The tube wall is formed by winding a degradable material film, and a tube cavity is formed inside the tube wall, and the tube cavity is configured to allow fluid to flow. The degradable material film is a flexible planar structure, one end of the degradable material film is rolled to form the inner wall of the degradable artificial fluid tube, and the other end of the degradable material film is rolled to form the outer wall of the degradable artificial fluid tube.

2. The degradable artificial fluid tube according to claim 1, characterized in that: The tube wall comprises: An inner layer and an outer layer, and an intermediate layer arranged between the inner layer and the outer layer, wherein the intermediate layer is provided with one or more layers.

3. The degradable artificial fluid tube according to claim 2, characterized in that: The inner diameter of the lumen is between 2-36 mm and is configured to allow smooth flow of fluid in the lumen; preferably, the diameter is 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 10 mm, 18 mm, 20 mm, 22 mm, 24 mm or 32 mm.

4. The degradable artificial fluid tube according to claim 2, characterized in that: A plurality of through holes are arranged through the surface of the intermediate layer, and a plurality of through hole matrices are arranged on the tube wall.

5. The degradable artificial fluid tube according to claim 4, characterized in that: Ribs are provided between the plurality of through holes, and the ribs are perpendicular or parallel to the winding direction of the degradable material film.

6. The degradable artificial fluid tube according to claim 4, characterized in that: The total area of ​​the plurality of through holes accounts for 30% to 80% of the total flat area of ​​the tube wall.

7. The degradable artificial fluid tube according to claim 4, characterized in that: The angle between the length extension direction of the through hole and any rolling direction of the degradable material film is 30-60 degrees.

8. The degradable artificial fluid tube according to claim 4, characterized in that: The through hole is a strip-shaped inclined hole, and the angle between the strip-shaped inclined hole and any rolling direction of the degradable material film is 45 degrees.

9. The degradable artificial fluid tube according to claim 4, characterized in that: The through hole is a corrugated hole, which extends along the rolling direction and is configured to increase the torque of the tube wall.

10. The degradable artificial fluid tube according to claim 1, characterized in that: The width of the degradable material membrane does not exceed 15 cm. Optionally, the degradable material membrane is a small intestinal submucosa material.

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