Artificial fluid conduit

Abstract

This disclosure provides an artificial fluid conduit, comprising: a first wall formed by winding a first membrane material at least once, configured to allow fluid flow; a second wall formed by winding a second membrane material at least once on the outer layer of the first wall, the second wall having a plurality of matrix-arranged through holes configured to provide periodic bending support in the axial direction of the second wall; and a third wall formed by winding a third membrane material at least once on the outer layer of the second wall; wherein the second wall is made of a polymer material. When the artificial fluid conduit bends during use, the wall can adjust its bending moment according to the bending condition of the lumen, ensuring sufficient blood flow within the lumen and effectively avoiding embolism caused by the reduction of the cross-sectional area of ​​the lumen due to vascular bending. Furthermore, since the second wall is made of a polymer material, it helps to reduce receptor rejection and improve the service life of the artificial fluid conduit.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and more specifically, to an artificial fluid tube. Background Technology

[0002] As a Class III implantable medical device, artificial fluid conduits should be non-toxic to the body, have good biocompatibility and blood compatibility, possess good mechanical strength, and have a porous structure that promotes cell adhesion and growth. Furthermore, artificial ureters are also necessary for repairing certain urinary tract defects. Currently, the manufacture of these intra-body fluid-guiding conduits primarily utilizes two types of biomedical materials: one is a synthetic polymer material, and the other is animal-derived tissue material that has undergone immunogen removal treatment.

[0003] Polymer materials, with their advantages of being naturally free of immunogenic risks, having uniform texture, and being easy to process on a large scale, are currently the main materials for artificial fluid tubes. Animal-derived tissues, however, require processing to remove immunogenicity. Because animal-derived tissues have a composition and structure more similar to human tissues, and can degrade and induce autologous blood vessel formation after implantation, artificial fluid tubes have become a research hotspot in recent years. However, while these artificial fluid tubes, prepared using xenogeneic blood vessels, have a structure similar to human blood vessels, the high requirements for immunogenic removal methods can easily lead to a decrease in the structural strength of the artificial fluid tube, potentially causing rupture after implantation. Furthermore, to meet the needs of different blood vessel diameters in the human body, it is often necessary to select large quantities of animal-derived blood vessel materials, which is not conducive to large-scale production. Artificial ureters face similar technical challenges. Summary of the Invention

[0004] The purpose of this disclosure is to address the technical problems in related technologies by providing an artificial fluid tube. The specific solution is as follows:

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

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

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

[0008] In some embodiments, the material of the second pipe wall is selected from one or more of the following: polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinylpyrrolidone, 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 biodegradable polymer material. Optionally, the material of the second membrane is selected from one or more of the following: polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphononitrile, preferably polyglycolic acid.

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

[0011] In some embodiments, the inner diameter of the first pipe wall is between 2 and 36 mm, configured to allow smooth fluid flow within the first pipe 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-holes are arranged in a matrix on the second pipe 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 pipe 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 membrane is 30-60 degrees.

[0015] In some embodiments, the through hole is a wave-shaped hole, configured to increase the torque of the second pipe wall.

[0016] Compared with related technologies, the above-described solutions of this disclosure have at least the following beneficial effects:

[0017] The artificial fluid tube provided in this disclosure has a spiral structure. When the 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 blood flow. This effectively avoids embolism caused by the reduction of the cross-sectional area of ​​the lumen due to vascular bending. Furthermore, since the second tube wall is made of polymer material, it helps to reduce receptor rejection and improve the service life of the artificial fluid tube.

[0018] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0019] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure. It is obvious that the drawings described below are merely some embodiments of this disclosure, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:

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

[0021] Figure 2 This is a schematic diagram of a flattened pipe wall according to an exemplary embodiment.

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

[0023] Figure 4 This is a schematic diagram of a flattened pipe wall according to an exemplary embodiment.

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

[0025] Figure 6 This is a schematic diagram of another flattened pipe wall according to an exemplary embodiment.

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

[0027] Figure label:

[0028] Artificial fluid tube 1000, tube wall 100, through hole 101, first tube wall 110, second tube wall 120, third tube wall 130, lumen 200. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this disclosure clearer, the disclosure will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0030] The terminology used in the embodiments of this disclosure is for the purpose of describing particular embodiments only and is not intended to limit the disclosure. The singular forms “a,” “the,” and “the” as used in the embodiments of this disclosure and the appended claims are also intended to include the plural forms, unless the context clearly indicates otherwise; “multiple” generally includes at least two, and other quantifiers are similarly intended.

[0031] It should be understood that although the terms first, second, third, etc., may be used to describe embodiments of this disclosure, these descriptions should not be limited to these terms. These terms are only used to distinguish the described objects. For example, first may also be referred to as second without departing from the scope of embodiments of this disclosure, and similarly, second may also be referred to as first. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0032] In the description of this disclosure, it should be noted that, unless otherwise expressly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0034] This disclosure discloses an artificial fluid conduit, comprising: a first conduit wall having an internal cavity for fluid flow; a third conduit wall wound around the outside of the first conduit wall for protecting the cavity; and a second conduit wall wound between the first conduit wall and the third conduit wall for smooth fluid flow. The second conduit wall is made of a polymer material and has through holes on its surface for providing bending moment resistance support.

[0035] The artificial fluid tube disclosed herein has a wound structure. When the artificial fluid tube is bent during use, the tube wall can adjust its bending moment according to the bending condition of the lumen, ensuring sufficient fluid flow within the lumen. This effectively avoids embolism caused by the reduction of the cross-sectional area of ​​the lumen due to vascular bending. Furthermore, since the second tube wall is made of a polymer material, it helps reduce receptor rejection and improves the lifespan of the artificial fluid tube. The biomedical material membrane has a periodically arranged array of through-holes, which, after winding, causes the structural strength of the tube wall to change periodically along the axial direction of the tube, forming a corrugated pipe-like structure. This fluid tube, after implantation, will not close under bending and twisting conditions, thus ensuring smooth fluid flow within the tube. In addition, these periodic structures can serve as storage chambers for anticoagulants and / or anti-inflammatory drugs. The membrane forming the inner and outer walls has a complete planar structure, preventing leakage caused by the structure formed by the through-hole array. Furthermore, the complete planar shape of the inner wall ensures stable fluid flow within the tube.

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

[0037] like Figure 1 As shown, this application embodiment provides an artificial fluid tube 1000, including: a tube wall 100 and a lumen 200, wherein, as Figure 3 As shown, the pipe wall 100 includes: a first pipe wall 110, a second pipe wall 120, and a third pipe wall 130. The first tube wall 110 is formed by winding a first membrane material at least once, configured to allow fluid flow; the second tube wall 120 is formed on the outer layer of the first tube wall 110 by winding a second membrane material at least once, and the second tube wall 120 has a plurality of matrix-arranged through holes 101 configured to provide periodic bending support force in the axial direction of the second tube wall 120; the third tube wall 130 is formed on the outer layer of the second tube wall by winding a third membrane material at least once; wherein, the second tube wall 120 is made of a polymer material, and the first membrane material and the second membrane material, as well as the second membrane material and the third membrane material, are separate structures. Before the artificial fluid tube 1000 is rolled, the first tube wall 110, the second tube wall 120, and the third tube wall 130 are independent of each other. In practical applications, the first membrane material, the second membrane material, and the third membrane material can be selected according to the actual application needs, and any membrane material that is suitable for human body acceptance can be selected. The separate membrane materials facilitate clinical practice and help improve the interlayer tightness.

[0038] It should be noted separately that this disclosure does not impose specific limitations on the fluids mentioned. The fluids include, but are not limited to, at least one of the following flowable liquids: blood, urine, intestinal fluid, etc. In addition, the fluids may also be gases.

[0039] Specifically, the first tube wall 110 is rolled around to form the sidewall of the lumen 200, allowing fluid to flow within the lumen 200 enclosed by the first tube wall 110. To ensure the thickness of the vessel sidewall, 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 and improves its elasticity, which is more conducive to fluid transport. The third tube wall 130 is wound around the outside of the second tube wall 120, that is, on the side of the second tube wall 120 away from the first tube wall 110. The third tube wall 130 can be the outer wall of the tube wall 100.

[0040] In some embodiments, such as Figure 1 As shown, the inner diameter D of the lumen 200 can be between 2-36 mm to accommodate the fluid tube needs of different patients. A suitable diameter ensures normal hemodynamics, with preferred diameters being 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 10 mm, 18 mm, 20 mm, 22 mm, 24 mm, or 32 mm. If the lumen diameter is unsuitable, such as being too small, it will increase blood flow resistance, leading to poor fluid flow or even thrombosis; while an excessively large diameter may cause abnormalities such as excessively slow blood flow. Furthermore, a defined inner diameter facilitates anastomosis with human blood vessels, making surgical procedures smoother and ensuring that the artificial fluid tube 1000 can effectively replace the diseased blood vessel.

[0041] It should be noted separately that: Let D be the inner diameter of the lumen 200. In this case, the length of the first tube wall 110 is at least πD, allowing the artificial fluid tube 1000 to form a smooth, closed first tube wall 110. A good first tube wall seal prevents fluid leakage from the tube wall of the artificial fluid tube 1000, ensuring normal fluid circulation within the blood vessel lumen. Simultaneously, improved biocompatibility helps the artificial fluid tube 1000 better adapt to the body's physiological environment, reducing rejection reactions from the immune system, extending its lifespan, and enabling it to perform normal vascular replacement function in the body for a longer period.

[0042] In some embodiments, the first membrane material and the third membrane material may be of the same type; specifically, the first membrane material and the third membrane material may be animal-derived membrane materials. The animal-derived membrane material may be a tissue capsule and / or endothelium. It may be the pericardium, peritoneum, or submucosa. Preferably, it may be the submucosa of the small intestine, the submucosa of the bladder, the amnion, or a combination thereof. Preferably, the animal-derived membrane material is a material that is completely degradable or at least partially degradable after implantation.

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

[0044] In some embodiments, the second membrane material is selected from one or more of the following: polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinylpyrrolidone, 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 may be an animal-derived membrane material, which is a flexible planar structure. One end of the second membrane material is wound around and connected to and wrapped around the first membrane material to form the second tube wall 120 of the artificial fluid tube 1000. Preferably, the animal-derived membrane material may be SIS material (submucosal material of the small intestine). This material can be processed on a large scale, undergoing centralized decellularization and immunogen treatment, and then undergoing centralized processing of planar materials before being rolled up. During the production and processing, the diameter of the fluid tube can be controlled according to the needs, and large-scale production can be carried out, which greatly reduces production costs and improves product quality stability.

[0046] In some embodiments, the second membrane material is a biodegradable polymer material, such as one or more of polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphononitrile, preferably polyglycolic acid.

[0047] In some embodiments, in response to a local bend in the tube wall 100, the regular structural strength variation of the second tube wall 120 can absorb these bends and form effective support, thereby ensuring that the lumen 200 has a sufficient inner diameter to prevent the cross-section of the artificial fluid tube 1000 from being significantly reduced due to bending, which could lead to embolism.

[0048] Specifically, the second tube wall 120 may be provided with a plurality of through holes 101, which are arranged periodically to provide periodic bending support force in the axial direction of the second tube wall 120. Ribs are formed between the plurality of through holes 101. When the tube lumen 200 bends, due to the arrangement of the ribs, bending preferentially occurs at the location of the through hole 101. Due to the arrangement of the through holes 101, when the artificial fluid tube 1000 provided in this disclosure bends 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. Therefore, bending of the artificial fluid tube 1000 is more likely to occur at the location of the through hole 101. Therefore, when the artificial fluid tube 1000 bends, due to the through hole 101 on the second tube wall 120, there is a gap between the second tube wall 120 and the third tube wall 130. This allows the cavity 200 to have a sufficient inner diameter, preventing the artificial fluid tube 1000 from being blocked due to the significant reduction in the cross-section of the cavity 200 caused by bending.

[0049] In some embodiments, the through hole 101 occupies 40% to 90% of the flat area of ​​the pipe wall 100. The through hole 101 can improve the elasticity of the pipe wall 100 and help adjust the bending support force of the pipe wall 100, so that when the artificial fluid pipe 1000 is axially bent, the through hole 101 will not be located in the first pipe wall 110, which is used to wrap the cavity 200, ensure fluid flow, and prevent fluid from penetrating from the first pipe wall 110 into the second pipe wall 120 or the third pipe wall 130.

[0050] In some embodiments, such as Figure 3 As shown, a plurality of through holes 101 are provided through the surface of the second pipe wall 120, and the through holes 101 are arranged in a matrix on the pipe wall 100. In response to the fluid flowing through the cavity 200, since the fluid flow exerts a certain pressure on the cavity 200, that is, the fluid flow exerts pressure on the first pipe wall 110 of the pipe wall 100, the arrangement of the through holes 101 can improve the elasticity of the pipe wall 100 on the one hand; on the other hand, since the fluid pipe may bend during use, when the fluid pipe bends, the rolling thickness at the location of the through hole 101 will be thinner than the rolling thickness at the location of the rib. Therefore, bending of the artificial fluid pipe 1000 is more likely to occur at the location of the through hole 101. At this time, the rib provides periodic bending support force in the axial direction of the second pipe wall 120, which can prevent the artificial fluid pipe 1000 from being greatly compressed in the cavity space due to bending, causing the problem of poor fluid transport.

[0051] Specifically, when the pipe wall 100 bends, at least a portion of the second pipe wall 120 and the third pipe wall 130 are squeezed toward the inside of the through hole 101, so that the pipe wall 100 has a certain elastic expansion space, thereby realizing the elastic wrapping of the pipe wall 100 around the cavity 200 and ensuring smooth fluid flow within the cavity 200.

[0052] In some embodiments, a plurality of through holes 101 are provided through the surface of the second tube wall 120, and the angle between the length extension direction of the through holes 101 and the winding 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 winding direction of the artificial fluid tube 1000 is less than 30 degrees, when the artificial fluid tube 1000 is wound, the length direction of the through holes 101 is nearly perpendicular to the fluid flow direction in the tube cavity 200. Therefore, when the fluid flows through the artificial fluid tube 1000, the elastic pressure exerted by the tube wall 100 on the tube cavity 200 is not suitable for causing the fluid to flow.

[0053] In some embodiments, such as Figure 3 , Figure 4 As shown, if the through hole 101 is rectangular, 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 cavity 200 is denoted as D, the through hole 101 can be a square through hole, and multiple square through holes are provided on the surface of the second pipe wall 120. The relationship between the inner diameter, the side length of the square through hole, and the distance between at least two through holes is defined:

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

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

[0057] Limiting the side length of the square through-hole allows the artificial fluid tube 1000 sufficient space to compress the membrane material during bending. A suitable side length of the square through-hole ensures normal exchange of substances inside and outside the fluid tube, allowing oxygen, nutrients, and metabolic waste to pass smoothly while preventing excessive loss of blood cells or abnormal leakage of immune cells that could cause inflammation. It also prevents creases in the tube wall that could impede fluid flow. If the width of the corrugated hole is less than 1 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall. If the width of the corrugated hole is greater than 3 / 8D, the tube wall may become thinner, resulting in slower fluid transport.

[0058] Limiting the spacing between multiple square through-holes helps maintain the mechanical properties of the artificial fluid tube. A suitable through-hole spacing allows the fluid tube to maintain good elasticity and toughness under fluid pressure, preventing vascular rupture or deformation due to uneven local stress and reducing complications such as thrombosis. If the square through-hole spacing is less than or equal to 3 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall; if the square through-hole spacing is greater than D, problems such as thinning of the tube wall and slower fluid transport speed can easily occur.

[0059] In some embodiments, such as 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 cavity 200. At this time, the artificial fluid tube 1000 can be adjusted to the maximum bending angle, which can keep the inner diameter of the cavity 200 within the preset range and ensure fluid flow.

[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 of the strip-shaped inclined holes and at least two strip-shaped inclined holes is defined.

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

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

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

[0065] Limiting the corrugation width allows the artificial fluid tube 1000 sufficient space to compress the membrane material during bending. A suitable width of the strip-shaped inclined holes ensures normal exchange of substances inside and outside the fluid tube, allowing oxygen, nutrients, and metabolic waste to pass smoothly while preventing excessive loss of blood cells or abnormal leakage of immune cells that could cause inflammation. It also prevents creases in the tube wall that could impede fluid flow. If the width of the strip-shaped inclined holes is less than or equal to 1 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall. If the width is greater than 3 / 8D, the tube wall may become thinner, resulting in slower fluid transport. Similarly, the length of the multiple strip-shaped inclined holes should also be limited; their function and implications will not be elaborated here.

[0066] Limiting the spacing between multiple inclined strip-shaped orifices helps maintain the mechanical properties of the artificial fluid tubing. Appropriate spacing allows the tubing to maintain good elasticity and resilience under fluid pressure, preventing vascular rupture or deformation due to uneven local stress and reducing complications such as thrombosis. If the spacing between the multiple inclined strip-shaped orifices is less than 1 / 2D, insufficient bending buffer space can easily lead to creases in the tubing wall; if the spacing is greater than D, problems such as thinning of the tubing wall and slower fluid delivery speed during transport can easily occur.

[0067] In some embodiments, such as Figure 6 , Figure 7 As shown, the through hole 101 can be a wave-shaped hole, configured to increase the torque of the pipe wall 100. Multiple wave-shaped holes can be provided, and wave-shaped ridges are formed between the multiple wave-shaped holes.

[0068] By pressing 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 change of the second tube wall 120 can ensure effective support under bending conditions. Furthermore, this allows the artificial fluid tube 1000 to bend without affecting the inner diameter of the lumen 200, ensuring normal fluid flow and preventing thrombosis caused by an excessively narrow inner diameter of the lumen 200.

[0069] Specifically, the wavy extension direction is perpendicular to the winding direction of the artificial fluid tube 1000. In response to bending of the artificial fluid tube 1000, the wavy holes are spaced apart along the length of the artificial fluid tube 1000. When the animal-derived material film with wavy holes is rolled into the artificial fluid tube 1000, it can achieve better flexibility. Compared to traditional artificial fluid tubes, it can withstand greater bending angles without easily being damaged. Simultaneously, when the artificial fluid tube 1000 bends, due to the supporting effect of the wavy ridges, at least two wavy ridges will compress towards the wavy holes between them, keeping the inner diameter of the artificial fluid tube 1000 within a preset range and ensuring smooth fluid flow. Furthermore, under the condition of bending within the preset range, the wavy 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 is distributed across the various bends rather than concentrated at a single point, thereby reducing the risk of the artificial fluid tube 1000 breaking or partially shrinking in 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, the corrugation width of the waveform holes, the crest spacing, and the spacing between at least two waveform holes are defined:

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

[0072] The crest spacing is denoted as L3: 1 / 2D≤L≤D;

[0073] The spacing between multiple waveform holes is denoted as W3, where 3 / 8D < W3 ≤ D.

[0074] Limiting the corrugation width allows the artificial fluid tube 1000 sufficient space to compress the membrane material during bending. A suitable corrugation width ensures normal material exchange within and outside the artificial fluid tube 1000, allowing oxygen, nutrients, and metabolic waste to pass smoothly while preventing excessive loss of blood cells or abnormal leakage of immune cells that could cause inflammation. It also prevents creases in the tube wall that could impede fluid flow. If the corrugated orifice width is less than or equal to 1 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall. If the corrugated orifice width is greater than 3 / 8D, the tube wall may become thinner, resulting in slower fluid transport.

[0075] Limiting the crest spacing helps maintain the mechanical properties of the artificial fluid tube 1000. A suitable crest spacing allows the artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to fluid pressure, avoiding vascular rupture or deformation caused by uneven local stress and reducing the occurrence of complications such as thrombosis. If the crest spacing is less than 1 / 2D, insufficient bending buffer space can easily lead to creases in the tube wall; if the crest spacing is greater than D, the tube wall can easily become thinner, resulting in slower fluid transport speed. Similarly, the spacing between the corrugated holes also needs to be limited, which will not be elaborated further here.

[0076] In some embodiments, the rolling direction can be the length direction or the width direction of the artificial fluid tube 1000. If the through hole 101 is a corrugated hole, and the extending direction of the corrugated hole is the length direction of the second tube wall 120, then... Figure 5 As shown, the winding direction of the artificial fluid tube 1000 can be the length direction of the second tube wall 120; if the through hole 101 is shaped as a corrugated hole and the extension direction of the corrugated hole is the width direction of the second tube wall 120, then the winding direction of the artificial fluid tube 1000 should be the width direction of the second tube wall 120.

[0077] It should be noted separately that this application does not specifically limit the shape and structure of the through hole 101. The through hole 101 can be a regular shape or an irregular shape, as long as it can ensure that the second pipe wall 120 can wrap around the first pipe wall 110.

[0078] The artificial fluid tube 1000 provided in this disclosure has a wound 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 tube cavity 200 to ensure that the inner diameter of the tube cavity 200 is sufficient for fluid flow and effectively avoid the embolism problem caused by the reduction of the cross-section inside the tube cavity 200 due to the bending of the artificial fluid tube 1000.

[0079] The artificial fluid catheter 1000 disclosed herein can be used as an artificial blood vessel or artificial ureter. Small-diameter vessels (less than 6 mm) can be used for artificial blood vessels of small arteries and veins in the wrist or foot. They are mainly used to replace missing arteries and veins in patients, or as shunts in cases of arterial obstruction, and as replacement catheters for arterial and venous grafts required for hemodialysis in patients with kidney disease. Medium-diameter artificial blood vessels, between 6 mm and 10 mm, such as 6-8 mm vessels, can be used for artificial bypass procedures of arteries in the limbs and carotid arteries; vessels around 8 mm are commonly used in some peripheral vascular surgeries. They are suitable for the treatment of various peripheral arterial diseases and hemodialysis. Large-diameter artificial blood vessels: 10mm or more, such as 18-24mm, are mainly used in artificial blood vessel replacement surgery of the thoracic aorta. Y-shaped artificial blood vessels of 16-20mm are mainly used in artificial blood vessel bypass surgery of the abdominal aorta, bilateral iliac (femoral) arteries, and artificial blood vessel bypass surgery of the ascending aorta and bilateral carotid (or bilateral subclavian) arteries. Around 20-30mm is often used for partial ascending aortic arch artificial blood vessel replacement. Artificial ascending aortic vessels of 22-32mm are also commonly used for the treatment of aortic diseases, such as aortic dissection and aneurysms. The diameter of the human ureter is 3-7mm. The diameter range of the artificial fluid tube disclosed in this 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 this disclosure can be referred to in any of the above embodiments of the artificial fluid tube, and will not be repeated here.

[0081] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems or apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0082] The above embodiments are only used to illustrate the technical solutions of this disclosure, and are not intended to limit it. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this disclosure.

Claims

1. An artificial fluid tube, characterized in that, include: The first tube wall is formed by winding a first membrane material at least once, configured to allow fluid to flow; The second tube wall is formed on the outer layer of the first tube wall by winding the second membrane material at least once. The second tube wall has a plurality of through holes arranged in a matrix and configured to provide periodic bending support force in the axial direction of the second tube wall. The third tube wall is formed on the outer layer of the second tube wall by winding a third membrane material at least once. Ribs are formed between the plurality of through holes to provide periodic bending support in the axial direction of the second tube wall; the first membrane material and the second membrane material, as well as the second membrane material and the third membrane material, are separate structures; the second tube wall is made of a polymer material.

2. The artificial fluid tube as described in claim 1, characterized in that, The polymer material is a flexible planar animal-derived membrane material.

3. The artificial fluid tube as described in claim 2, characterized in that, The animal-derived membrane material is a material from the submucosa of the small intestine.

4. The artificial fluid tube as described in claim 2, characterized in that, The width of the animal-derived material membrane shall not exceed 15cm.

5. The artificial fluid tube as described in claim 1, characterized in that, The second membrane material is selected from one or more of the following: polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinyl alcohol, polyvinylpyrrolidone, polymethyl methacrylate, polyhydroxyethyl methyl methacrylate, polyethylene oxide, polypropylene oxide, polysiloxane, polyurethane, polytetrafluoroethylene, and polyetheretherketone (PEEK).

6. The artificial fluid tube as described in claim 1, characterized in that, The second membrane material is a biodegradable polymer material.

7. The artificial fluid tube as described in claim 1, characterized in that, The material of the second membrane is selected from one or more of the following: polyglycolic acid, polylactic acid, lactic acid-glycolic acid copolymer (PLGA), poly-ε-caprolactone, polycarbonate, polyphosphate, polyamino acid, polyanhydride, and polyphosphononitrile.

8. The artificial fluid tube as described in claim 1, characterized in that, The second pipe wall has one or more layers.

9. The artificial fluid tube as described in claim 1, characterized in that, The inner diameter of the first pipe wall is between 2 and 36 mm, and it is configured to allow smooth fluid flow within the first pipe wall.

10. The artificial fluid tube as described in claim 1, characterized in that, The inner diameter of the first tube wall is 3mm, 4mm, 5mm, 6mm, 7mm, 10mm, 18mm, 20mm, 22mm, 24mm or 32mm.

11. The artificial fluid tube as claimed in claim 1, 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 pipe wall.

12. The artificial fluid tube as described in claim 1, characterized in that, The angle between the length extension direction of the through hole and any rolling direction of the second tube wall is 30-60 degrees.

13. The artificial fluid tube as described in claim 1, characterized in that, The through hole is a wave-shaped hole, configured to increase the torque of the second pipe wall.

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