Artificial fluid tube

Abstract

The embodiment of the invention provides an artificial fluid pipe which comprises a first pipe wall formed by winding a first membrane material for at least one circle and configured to enable fluid to circulate; the second pipe wall is formed on the outer layer of the first pipe wall by winding a second film material for at least one circle, and the second pipe wall is provided with a plurality of through holes arranged in a matrix mode and is configured to provide periodic bending supporting force in the axial direction of the second pipe wall; the third pipe wall is formed on the outer layer of the second pipe wall by winding a third membrane material for at least one circle; wherein the second pipe wall is made of a high polymer material. When the artificial fluid tube is bent in use, the bending moment degree of the tube wall can be adjusted according to the bending condition of the tube cavity, it is guaranteed that the inner diameter of the tube cavity is enough for blood circulation, and the embolism problem caused by reduction of the cross section in the tube cavity due to blood vessel bending is effectively avoided; reduction of receptor rejection reaction is facilitated, and the service life of the artificial fluid pipe is prolonged.

Description

Technical Field

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

[0002] As a Class III implantable medical device, artificial fluid tubes 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 to repair them. 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 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, artificial fluid tubes have become a hot topic of research in recent years. However, although the structure of this type of artificial fluid tube is similar to that of human blood vessels, it is easy to cause the structural strength of the artificial fluid tube tissue to decrease due to its high requirements for the removal 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 an artificial fluid tube to solve the technical problems in the related art. The specific solution is as follows:

[0005] An embodiment of the present application provides an artificial fluid tube, comprising: a first tube wall, formed by winding a first film material at least once, and configured to allow fluid to flow; a second tube wall, formed by winding a second film material at least once on the outer layer of the first tube wall, the second tube wall having a plurality of through holes arranged in a matrix, configured to provide periodic bending support force in the axial direction of the second tube wall; a third tube wall, formed by winding a third film material at least once on the outer layer of the second tube wall; wherein the second tube wall is made of a polymer material.

[0006] In some embodiments, the polymer material is an animal-derived material membrane with a flexible planar structure; optionally, the animal-derived material membrane is a small intestinal submucosa material; optionally, the width of the animal-derived material membrane does not exceed 15 cm.

[0007] In some embodiments, the animal-derived membrane material is small intestinal submucosa material.

[0008] In some embodiments, the material of the second tube wall is selected from: one or more of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinyl pyrrolidone, polymethyl methacrylate, polyhydroxyethyl methyl methacrylate, polyethylene oxide, polypropylene oxide polysiloxane (silicone rubber), polyurethane, polytetrafluoroethylene, and polyetheretherketone (PEEK), preferably polyethylene.

[0009] In some embodiments, the second tube wall is a degradable polymer material. Optionally, the material of the second membrane material is selected from one or more of polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphazene, preferably polyglycolic acid.

[0010] In some embodiments, the second tube wall is provided with one or more layers.

[0011] In some embodiments, the inner cavity diameter of the first tube wall is between 2-36 mm, and is configured to allow smooth flow of fluid in the first tube wall; 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.

[0012] In some embodiments, a plurality of the through hole matrices are arranged on the second tube wall.

[0013] In some embodiments, the total area of ​​the plurality of through holes accounts for 40% to 90% of the total flat area of ​​the second tube wall.

[0014] In some embodiments, the angle between the length extension direction of the through hole and any rolling direction of the animal-derived material film is 30-60 degrees.

[0015] In some embodiments, the through hole is a corrugated hole configured to increase the torque of the second tube wall.

[0016] Compared with the related art, the above solution of the embodiment of the present disclosure has at least the following beneficial effects:

[0017] The artificial fluid tube provided by the present invention has a winding structure. When the artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending of the lumen to ensure that the inner diameter of the lumen is sufficient for blood circulation, effectively avoiding embolism problems caused by the reduction of the cross-section of the lumen due to the bending of the blood vessel. Moreover, since the second tube wall is made of polymer material, it is beneficial to reduce the receptor rejection reaction and increase the service life of the artificial fluid tube.

[0018] 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

[0019] 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:

[0020] Figure 1 is a schematic side structural diagram of an artificial fluid tube according to an exemplary embodiment.

[0021] Figure 2 is a schematic diagram of flattening a tube wall according to an exemplary embodiment.

[0022] Figure 3 It is a schematic structural diagram of an artificial fluid tube according to an exemplary embodiment.

[0023] Figure 4 is a schematic diagram of flattening a tube wall according to an exemplary embodiment.

[0024] Figure 5 is a schematic diagram of winding of another tube wall according to an exemplary embodiment.

[0025] Figure 6 is a schematic diagram of flattening another tube wall according to an exemplary embodiment.

[0026] Figure 7 is a schematic diagram of winding of another tube wall according to an exemplary embodiment.

[0027] Reference numerals:

[0028] The artificial fluid tube 1000 , the tube wall 100 , the through hole 101 , the first tube wall 110 , the second tube wall 120 , the third tube wall 130 , and the tube cavity 200 . DETAILED DESCRIPTION

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] An embodiment of the present disclosure discloses an artificial fluid tube, comprising: a first tube wall, with a tube cavity formed inside, configured to allow fluid to flow; a third tube wall, wound and arranged on the outside of the first tube wall, configured to protect the tube cavity; a second tube wall, wound and arranged between the first tube wall and the third tube wall, configured to allow fluid to flow smoothly, wherein the second tube wall is made of a polymer material, has through holes penetrating the surface, and is configured to provide moment resistance support.

[0035] The artificial fluid tube provided by the present disclosure has a winding structure. When the artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending of the lumen to ensure that the inner diameter of the lumen is sufficient for fluid circulation, effectively avoiding the embolism problem caused by the reduction of the cross-section in the lumen due to the bending of the blood vessel, and because the second tube wall is made of polymer material, it is conducive to reducing the receptor rejection reaction and improving the service life of the artificial fluid tube. The biomedical material film is provided with a periodically arranged through-hole array, which makes the structural strength of the tube wall along the axial direction of the pipeline have a periodic change after winding, thereby forming a structure similar to a corrugated tube. After implanting in the body, this fluid tube can avoid 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 film material forming the inner wall and the outer wall is a complete planar structure, and the 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.

[0036] The optional embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0037] like Figure 1 As shown, the embodiment of the present application provides an artificial fluid tube 1000, comprising: a tube wall 100 and a tube cavity 200, wherein, as Figure 3 As shown, the tube wall 100 includes: a first tube wall 110 , a second tube wall 120 and a third tube wall 130 . The first tube wall 110 is formed by winding a first film material at least once, and is configured to allow fluid to circulate; the second tube wall 120 is formed by winding a second film material at least once on the outer layer of the first tube wall 110, and the second tube wall 120 has a plurality of through holes 101 arranged in a matrix, and is configured to provide periodic bending support force in the axial direction of the second tube wall 120; the third tube wall 130 is formed by winding a third film material at least once on the outer layer of the second tube wall; wherein the second tube wall 120 is made of a polymer material, and the first film material and the second film material, as well as the second film material and the third film material are split structures. Before rolling the artificial fluid tube 1000, the first tube wall 110, the second tube wall 120 and the third tube wall 130 are independent of each other. In actual applications, the first film material, the second film material and the third film material can select any one of the film materials that can be accepted by the human body according to actual application needs. The split film material is convenient for clinical practice and is conducive to improving the tightness between layers.

[0038] It should be separately explained that the present disclosure does not impose any specific restrictions on the fluid, and the fluid includes but is not limited to at least one flowable liquid such as blood, urine, intestinal fluid, etc. In addition, the fluid may also be a gas.

[0039] Specifically, the first tube wall 110 is wound around to form the side wall of the lumen 200, and the fluid can flow in the lumen 200 wrapped by the first tube wall 110. In order to ensure the thickness of the side wall of the blood vessel, at least one layer of the second tube wall 120 is wound around the outside of the first tube wall 110. The second tube wall 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 third tube wall 130 is wound around the outside of the second tube wall 120, that is, the side of the second tube wall 120 away from the first tube wall 110, and the third tube wall 130 can be the outer wall of the tube wall 100.

[0040] In some embodiments, Figure 1 As shown, the inner diameter D of the lumen 200 can be between 2-36mm to meet the needs of different patients for the use of fluid tubes. The appropriate diameter can ensure normal hemodynamics. The preferred diameters are: 3mm, 4mm, 5mm, 6mm, 7mm, 10mm, 18mm, 20mm, 22mm, 24mm or 32mm. If the lumen diameter does not match, such as being too small, blood flow resistance will increase, resulting in poor fluid or fluid circulation, and may even form thrombus; while a large diameter may cause abnormal conditions such as slow blood flow. Secondly, the limited inner diameter is conducive to anastomosis with human blood vessels, making the surgical operation process smoother and ensuring that the artificial fluid tube 1000 can replace the diseased blood vessels well and perform its function.

[0041] It should be noted that: the inner diameter of the lumen 200 is recorded as D, and the length of the first tube wall 110 is at least πD, so that the artificial fluid tube 1000 can form a smooth and closed first tube wall 110. A good first tube wall closure can prevent fluid from leaking from the tube wall of the artificial fluid tube 1000, ensuring that the fluid circulates normally in the blood vessel cavity. At the same time, improving biocompatibility helps the 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 artificial fluid tube, extend the service life of the artificial fluid tube 1000, and enable it to play a normal vascular replacement function in the body for a longer time.

[0042] In some embodiments, the first membrane material and the third membrane material can be the same type of membrane material, specifically, the first membrane material and the third membrane material can be animal-derived membrane materials. The animal-derived membrane material can be a tissue envelope and / or an inner membrane. The pericardium, peritoneum or submucosa can be selected. Preferably, the small intestine submucosa, bladder submucosa, amniotic membrane or a combination thereof can be selected. Preferably, the animal-derived membrane material is a completely degradable material or at least partially degradable after implantation in the body.

[0043] It should be separately explained that the first film material and the third film material can be the same type of film material or different types of film materials, and the present disclosure does not impose any specific limitation on this.

[0044] In some embodiments, the second film material is selected from one or more of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinyl pyrrolidone, polymethyl methacrylate, polyhydroxyethyl methyl methacrylate, polyethylene oxide, polypropylene oxide polysiloxane (silicone rubber), polyurethane, polytetrafluoroethylene, and polyetheretherketone (PEEK), preferably polyethylene.

[0045] In some embodiments, the second membrane material can be an animal-derived material membrane material, which is a flexible planar structure. One end of the second membrane material is wound to connect and wrap the first membrane material to form the second tube wall 120 of the artificial fluid tube 1000. Preferably, the animal-derived material membrane material can be SIS material (small intestinal submucosal material). This material can be processed on a large scale, and decellularization and immunogen treatment can be concentrated, and planar materials can be processed centrally, and then curled. During the production and processing process, the diameter of the 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.

[0046] In some embodiments, the second film material is a degradable polymer material, for example, one or more of polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphazene, preferably polyglycolic acid.

[0047] In some embodiments, in response to local bending of the tube wall 100, the regular structural strength changes of the second tube wall 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 artificial fluid tube 1000, thereby causing embolism problems.

[0048] Specifically, the second tube wall 120 may be provided with a plurality of through holes 101, and the plurality of through holes 101 are periodically arranged and configured to provide a periodic bending support force in the axial direction of the second tube wall 120. Ribs are formed between the plurality of through holes 101, and when the lumen 200 is bent, due to the setting of the ribs, bending occurs preferentially at the position where the through holes 101 are located. Due to the setting of the through holes 101, when the artificial fluid tube 1000 provided by the present disclosure is bent during use, the rolling thickness at the position where the through holes 101 are located will be thinner than the rolling thickness at the position where the ribs are located, and therefore, the bending of the artificial fluid tube 1000 is more likely to occur at the position where the through holes 101 are located. Therefore, when the artificial fluid tube 1000 is bent, due to the setting of the through hole 101 on the second tube wall 120, a gap exists between the second tube wall 120 and the third tube wall 130, thereby enabling the lumen 200 to have a sufficient inner diameter, 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 the bending of the artificial fluid tube 1000.

[0049] In some embodiments, the through hole 101 occupies 40% to 90% of the flat area of ​​the tube wall 100. The provision of the through hole 101 can improve the elasticity of the tube wall 100 on the one hand, and can assist in adjusting the bending support force of the tube wall 100 on the other hand, so that when the artificial fluid tube 1000 is axially bent, the through hole 101 will not be provided on the first tube wall 110, and the first tube wall 110 is used to wrap the lumen 200 to ensure fluid circulation and prevent the fluid from penetrating from the first tube wall 110 into the second tube wall 120 or the third tube wall 130.

[0050] In some embodiments, Figure 3 As shown, a plurality of through holes 101 are provided on the surface of the second tube wall 120, 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 first tube wall 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, since the fluid tube may be bent during use, when the fluid tube 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 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 second tube wall 120 to avoid the problem of the artificial fluid tube 1000 causing a significant compression of the lumen space due to bending, resulting in poor fluid transportation.

[0051] Specifically, when the tube wall 100 is bent, at least part of the second tube wall 120 and the third tube wall 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 cavity 200 by the tube wall 100 and smooth flow of fluid in the tube cavity 200.

[0052] In some embodiments, a plurality of through holes 101 are provided on the surface of the second tube wall 120, and the angle between the length extension direction of the through holes 101 and the rolling direction of the artificial fluid tube 1000 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 artificial fluid tube 1000 is less than 30 degrees, when the artificial fluid tube 1000 is rolled, 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 artificial fluid tube 1000, the elastic pressure of the tube wall 100 on the lumen 200 is not suitable for causing the fluid to flow.

[0053] 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 artificial fluid tube 1000 can be either the length direction of the polymer material or the width direction of the polymer material.

[0054] In some embodiments, the inner diameter of the lumen 200 is recorded as D, the through hole 101 may be a square through hole, and a plurality of the square through holes are provided on the surface of the second tube wall 120, 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:

[0055] The side length of the square through hole is denoted as d1: 1 / 8D≤d1≤D;

[0056] The spacing between the plurality of square through holes is W1:3 / 8D<W1≤D.

[0057] 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 fluid tube, 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 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 1 / 8D, it is easy to cause creases on the wall of the tube due to insufficient bending buffer space. If the width of the corrugated hole is greater than 3 / 8D, 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.

[0058] Limiting the spacing between multiple square through holes helps maintain the mechanical properties of the artificial fluid tube. Appropriate spacing between through holes 101 can allow the fluid tube to maintain good elasticity and toughness when subjected to fluid pressure, avoid rupture or deformation of blood vessels due to local uneven force, and reduce the occurrence of complications such as thrombosis. If the square through hole spacing is less than or equal to 3 / 8D, it is easy for creases to appear on the tube wall 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.

[0059] In some embodiments, Figure 4 , Figure 5 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 artificial fluid tube 1000 is 30-60 degrees, preferably 45 degrees.

[0060] When the artificial fluid tube 1000 is rolled, 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 artificial fluid tube 1000 can adjust the bending angle to the maximum, and can keep the inner diameter of the lumen 200 within a preset range to ensure fluid circulation.

[0061] 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.

[0062] The width of the strip-shaped inclined hole is recorded as d2: 1 / 8D≤d2≤3 / 8D;

[0063] The length of the strip-shaped inclined hole is recorded as L: 1 / 4D≤L≤1 / 2D;

[0064] The spacing between the plurality of strip-shaped inclined holes is denoted as W2, and 3 / 8D<W2≤D.

[0065] Limiting the width of the corrugations 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 fluid tube, 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 having 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, the wall of the tube may become thinner and the delivery speed of the fluid may become slower 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.

[0066] Limiting the spacing between multiple strip-shaped inclined holes helps maintain the mechanical properties of the artificial fluid tube. The appropriate spacing between the strip-shaped inclined holes can allow the fluid tube to maintain good elasticity and toughness when subjected to fluid pressure, avoid rupture or deformation of blood vessels due to local uneven force, and reduce 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.

[0067] In some embodiments, Figure 6 , Figure 7 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.

[0068] By squeezing at least a portion of the third tube wall 130 or the second tube wall 120 toward the through hole 101, the periodic structural strength variation of the second tube wall 120 can ensure effective support in the case of bending. Furthermore, the 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.

[0069] Specifically, the extension direction of the wave shape is perpendicular to the rolling direction of the artificial fluid tube 1000. In response to the bending of the artificial fluid tube 1000, the corrugated holes are arranged at intervals in the length direction of the artificial fluid tube 1000. After the animal-derived material membrane 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 the 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.

[0070] 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:

[0071] The width of the corrugated hole is recorded as d3: 1 / 8D≤d3≤3 / 8D;

[0072] The peak distance is recorded as L3: 1 / 2D≤L≤D;

[0073] The spacing between the multiple corrugated holes is recorded as W3, 3 / 8D<W3≤D.

[0074] 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 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 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.

[0075] Limiting the peak spacing helps maintain the mechanical properties of the artificial fluid tube 1000. Appropriate peak spacing allows the artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to the fluid pressure of the fluid, avoids blood vessel rupture or deformation 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.

[0076] In some embodiments, the rolling direction may be the length direction or the width direction of the 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 second tube wall 120, Figure 5 As shown, the rolling direction of the artificial fluid tube 1000 can be the length direction of the second tube wall 120; 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 second tube wall 120, the rolling direction of the artificial fluid tube 1000 should be the width direction of the second tube wall 120.

[0077] 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 the second tube wall 120 can wrap the first tube wall 110 .

[0078] The artificial fluid tube 1000 provided in the present invention has a winding structure. Therefore, when the 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 1000.

[0079] 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.

[0080] The specific structure, working principle, and beneficial effects of the artificial fluid tube provided in the embodiments of the present disclosure may refer to the artificial fluid tube described in any of the above embodiments, and will not be elaborated here.

[0081] 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.

[0082] 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. An artificial fluid tube, characterized in that: include: The first tube wall is formed by winding the first film material at least once and is configured to allow the fluid to flow; A second tube wall is formed by winding a second film material at least once on an outer layer of the first tube wall, the second tube wall having a plurality of through holes arranged in a matrix, configured to provide a periodic bending support force in the axial direction of the second tube wall; The third tube wall is formed by winding the third film material at least once on the outer layer of the second tube wall. Wherein, the second tube wall is made of polymer material.

2. The artificial fluid tube according to claim 1, characterized in that: The polymer material is an animal-derived material membrane with a flexible planar structure; optionally, the animal-derived material membrane is a small intestinal submucosa material; optionally, the width of the animal-derived material membrane does not exceed 15 cm.

3. The artificial fluid tube according to claim 1, characterized in that: The second film material is selected from one or more of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinyl pyrrolidone, polymethyl methacrylate, polyhydroxyethyl methyl methacrylate, polyethylene oxide, polypropylene oxide polysiloxane (silicone rubber), polyurethane, polytetrafluoroethylene, and polyetheretherketone (PEEK), preferably polyethylene.

4. The artificial fluid tube according to claim 1, characterized in that: The second film material is a degradable polymer material. Optionally, the material of the second film material is selected from one or more of polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphazene, preferably polyglycolic acid.

5. The artificial fluid tube according to claim 1, characterized in that: The second tube wall is provided with one or more layers.

6. The artificial fluid tube according to claim 1, characterized in that: The inner cavity diameter of the first tube wall is between 2-36 mm, and is configured to allow smooth flow of fluid in the first tube wall; the preferred 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.

7. The artificial fluid tube according to claim 1, characterized in that: A plurality of through hole matrices are arranged on the second tube wall.

8. The artificial fluid tube according to claim 7, characterized in that: The total area of ​​the plurality of through holes accounts for 40% to 90% of the total flat area of ​​the second tube wall.

9. The artificial fluid tube according to claim 7, characterized in that: The included angle between the length extension direction of the through hole and any rolling direction of the second tube wall is 30-60 degrees.

10. The artificial fluid tube according to claim 7, characterized in that: The through hole is a corrugated hole configured to increase the torque of the second tube wall.

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