Degradable artificial fluid conduit

Abstract

The embodiment of the present disclosure provides a degradable artificial fluid tube, which comprises a tube wall formed by winding a degradable material film and a tube cavity formed in the inside of the tube wall, the tube cavity being configured to allow fluid to flow, wherein the degradable material film is a flexible planar structure, one end of the degradable material film is wound to form an inner wall of the degradable artificial fluid tube, and the other end of the degradable material film is wound to form an outer wall of the degradable artificial fluid tube. The degradable artificial fluid tube provided by the present disclosure has a winding structure, so that when the degradable artificial fluid tube is bent in use, the tube wall can adjust the bending moment degree according to the bending condition of the tube cavity, so as to ensure that the inner diameter of the tube cavity is sufficient for fluid flow, and effectively avoid the embolism problem caused by the reduction of the cross section of the tube cavity due to the bending of the fluid tube.

Description

Technical Field

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

[0002] Biodegradable artificial fluid conduits, classified as Class III implantable medical devices, should be non-toxic to the body, possess good biocompatibility and blood compatibility, and exhibit good mechanical strength and 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-artificial fluid-conducting 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 material composition, and being easy to process on a large scale, are currently the main materials for biodegradable artificial fluid tubes. Animal-derived tissues, however, require processing to remove immunogens. 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, biodegradable artificial fluid tubes have become a research hotspot in recent years. However, while xenogeneic blood vessels used in the fabrication of these biodegradable artificial fluid tubes have a structure similar to human blood vessels, the high requirements for immunogen removal methods can easily lead to a decrease in the structural strength of the biodegradable artificial fluid tube, potentially causing rupture after implantation. Furthermore, to meet the needs of different blood vessel diameters in the human body, large quantities of animal-derived blood vessel materials are often required for fabrication, 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 provide a biodegradable artificial fluid tube to address the technical problems in the related art.

[0005] The specific plan is as follows:

[0006] This application provides a biodegradable artificial fluid tube, comprising: a tube wall formed by winding a biodegradable material membrane, and a cavity formed inside the tube wall, the cavity being configured to allow fluid flow.

[0007] The biodegradable material membrane is a flexible planar structure. One end of the biodegradable material membrane is wound to form the inner wall of the biodegradable artificial fluid tube, and the other end of the biodegradable material membrane is wound to form the outer wall of the biodegradable artificial fluid tube.

[0008] In some embodiments, the pipe 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 and 36 mm, configured to allow smooth fluid flow within 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, the surface of the intermediate layer is provided with a plurality of through holes, and the plurality of through holes are arranged in a matrix 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 pipe wall.

[0012] In some embodiments, ribs are provided between the plurality of through holes, the ribs being perpendicular or parallel to the winding direction of the biodegradable material membrane.

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

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

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

[0016] In some embodiments, the width of the biodegradable membrane material does not exceed 15 cm. Optionally, the biodegradable membrane material is a submucosal material of the small intestine.

[0017] Compared with related technologies, the above-described solutions of this disclosure have at least the following beneficial effects:

[0018] The biodegradable artificial fluid tube provided in this disclosure has a wound structure. Therefore, when the biodegradable artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending condition of the tube cavity, ensuring that the inner diameter of the tube cavity is sufficient for fluid flow and effectively avoiding embolism caused by the reduction of the cross-section of the tube cavity due to the bending of the fluid tube.

[0019] 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

[0020] 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:

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

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

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

[0024] Figure 4 This is a schematic diagram of a flattened pipe wall according to an exemplary embodiment.

[0025] Figure 5 This is a schematic diagram of another flattened pipe wall according to an exemplary embodiment.

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

[0027] Figure 7 This is a schematic diagram of another flattened pipe wall according to an exemplary embodiment.

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

[0029] Figure 9 This is a schematic diagram illustrating another flattened pipe wall according to an exemplary embodiment. Reference numerals:

[0030] Biodegradable artificial fluid tube 1000, tube wall 100, through hole 101, inner layer 110, middle layer 120, outer layer 130, lumen 200. Detailed Implementation

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] This disclosure discloses a biodegradable artificial fluid tube, comprising: a tube wall, wherein a biomedical material membrane is wound to form the tube wall and a cavity is formed inside the tube wall, the cavity being configured to allow fluid to flow therein, wherein the biodegradable material membrane is a flexible planar structure, one end of the biodegradable material membrane is wound to form the inner wall of the biodegradable artificial fluid tube, and the other end of the biodegradable material membrane is wound to form the outer wall of the artificial fluid tube.

[0037] This biomedical membrane material features a periodically arranged array of through-holes. This, when wound, causes the structural strength of the tube wall to vary periodically along the axial direction, forming a corrugated pipe-like structure. This biodegradable artificial fluid tube, once implanted, can withstand bending and twisting without becoming blocked, ensuring unimpeded fluid flow. Furthermore, these periodic structures can serve as storage chambers for anticoagulants and / or anti-inflammatory drugs. The membrane material forming the inner and outer walls has a completely planar structure, preventing leakage caused by the through-hole array. Additionally, the complete planarity of the inner wall ensures smooth fluid flow within the tube.

[0038] The biodegradable artificial fluid tube provided in this disclosure has a wound structure. When the biodegradable artificial fluid tube is bent during use, the tube wall can adjust its own bending moment according to the bending condition of the tube cavity, and has a bend similar to that of a corrugated pipe. This ensures that the inner diameter of the tube cavity is sufficient for fluid flow and effectively avoids the embolism problem caused by the reduction of the cross-sectional area of ​​the tube cavity due to the bending of the fluid tube.

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

[0040] like Figure 1 As shown, this application provides a biodegradable artificial fluid tube 1000, including: a tube wall 100 and a lumen 200. The tube wall 100 is formed by winding a biodegradable material membrane, and the lumen 200 is formed inside the tube wall 100. The lumen 200 is configured to allow fluid to flow.

[0041] The biodegradable membrane is a flexible planar structure. One end of the biodegradable membrane is wound to form the inner wall of the biodegradable artificial fluid tube 1000, and the other end is wound to form the outer wall of the biodegradable artificial fluid tube 1000. Specifically, the biodegradable membrane can 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 processed as a planar material before being rolled up. During the production process, the diameter of the biodegradable artificial fluid tube can be controlled according to requirements, and large-scale production can be carried out, greatly reducing production costs and improving product quality stability.

[0042] In some embodiments, such as Figure 2 As shown, the pipe 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 have multiple layers.

[0043] The biodegradable material membrane is wound to form a cavity 200. The inner layer 110 serves as the sidewall of the cavity 200, allowing fluid to flow within the cavity 200 enclosed by the inner layer 110. To ensure the sidewall thickness of the biodegradable artificial fluid tube 1000, multiple intermediate layers 120 are wound around the outer side of the inner layer 110. The intermediate layers 120 increase the thickness of the tube wall 100 and improve its elasticity, thus facilitating fluid transport. One or more intermediate layers 120 are provided. The outer layer 130 is wound around the outer side of the intermediate layers 120, i.e., the side of the intermediate layers 120 furthest from the inner layer 110. The outer layer 130 can be the outer wall of the tube wall 100.

[0044] It should be noted separately that the fluid includes, but is not limited to, at least one of the following liquids that can flow: blood, urine, intestinal fluid, etc. In addition, the fluid may also be a gas.

[0045] 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. If the lumen diameter is unsuitable, such as being too small, it will increase blood flow resistance, leading to poor fluid flow and even the formation of thrombi; while an excessively large diameter may cause abnormalities such as excessively slow blood flow. Secondly, the defined inner diameter facilitates anastomosis with existing fluid tubes in the human body, such as blood vessels, making surgical procedures smoother and ensuring that the biodegradable artificial fluid tube 1000 can effectively replace the diseased fluid tube.

[0046] It should be noted separately that: Let D be the inner diameter of the lumen 200. The length of the inner layer 110 is at least πD, ensuring that the biodegradable artificial fluid tube 1000 forms a smooth, closed inner layer 110. This good inner layer sealing prevents fluid from leaking out of the tube wall, ensuring normal fluid circulation within the lumen. Simultaneously, improved biocompatibility helps the biodegradable artificial fluid tube 1000 better adapt to the human body's physiological environment, reducing rejection reactions from the immune system and extending its lifespan. This allows it to perform its normal fluid replacement function, such as vascular replacement, more sustainably within the body.

[0047] In some embodiments, in response to local bending of the tube wall 100, the regular structural strength variation of the intermediate layer 120 can absorb these bends and form effective support, thereby enabling the lumen 200 to have a sufficient inner diameter, preventing the biodegradable artificial fluid tube 1000 from experiencing a significant reduction in the cross-section of the lumen 200 due to bending, which could lead to embolism.

[0048] Specifically, the intermediate layer 120 may be provided with multiple through holes 101, and ribs are formed between the multiple through holes 101. When the lumen 200 bends, due to the ribs, bending preferentially occurs at the location of the through hole 101. On the other hand, due to the through holes 101, when the biodegradable 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 biodegradable artificial fluid tube 1000 is more likely to occur at the location of the through hole 101. Therefore, when the biodegradable artificial fluid tube 1000 is bent, due to the through hole 101 on the intermediate layer 120, there is a gap between the inner layer 110 and the outer layer 130. As a result, the lumen 200 can still have a sufficient inner diameter when it is bent, thus avoiding the problem of poor fluid flow and embolism caused by the cross-section of the lumen 200 being greatly reduced due to bending of the biodegradable artificial fluid tube 1000.

[0049] In some embodiments, the ribs are perpendicular or parallel to the winding direction of the biodegradable material membrane. To ensure that the artificial fluid tube 1000 has through holes 101 at the bends, so that the bent tube wall can be supported by ribs, and to prevent the biodegradable artificial fluid tube 1000 from becoming blocked due to a significant reduction in the cross-section of the lumen 200 caused by bending, thus avoiding poor fluid flow.

[0050] In some embodiments, the through hole 101 occupies 30% to 80% of the planar area of ​​the pipe wall 100. This can improve the elasticity of the pipe wall 100.

[0051] On the other hand, it can help adjust the bending support force of the tube wall 100 so that when the biodegradable artificial fluid tube 1000 is bent in the axial direction, 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 flow and prevent fluid from penetrating from the inner layer 110 into the middle layer 120 or the outer layer 130.

[0052] In some embodiments, such as Figure 2 As shown, the outer layer 130 has no through-hole 101 structure. If through-hole 101 is provided on the outside of the tube wall 100, when the biodegradable material membrane is wound to form the tube wall 100, the edge of the through-hole 101 of the outer layer 130 of the tube wall 100 is prone to scraping against other fluid tubes or tissues, which may cause unnecessary harm to the patient.

[0053] In some embodiments, such as Figure 3As shown, the surface of the intermediate layer 120 is provided with a plurality of through holes 101, which are arranged in a matrix on the tube wall 100. In response to the fluid flowing through the cavity 200, the fluid flow exerts a certain pressure on the cavity 200, that is, the fluid flow exerts pressure on the inner layer 110 of the tube wall 100. The through holes 101 can improve the elasticity of the tube wall 100. On the other hand, when the biodegradable artificial fluid tube 1000 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 biodegradable artificial fluid tube 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 intermediate layer 120, which can prevent the biodegradable artificial fluid tube 1000 from being significantly compressed in the cavity space due to bending, thus avoiding the problem of poor fluid transport.

[0054] Specifically, when the pipe wall 100 bends, at least a portion of the intermediate layer 120 and the outer layer 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.

[0055] In some embodiments, a plurality of through holes 101 are provided through the surface of the biodegradable material membrane, and the angle between the length extension direction of the through holes 101 and the rolling direction of the biodegradable material membrane 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 biodegradable material membrane is less than 30 degrees, when the biodegradable material membrane 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 tube cavity 200. Therefore, when the fluid flows through the biodegradable 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.

[0056] In some embodiments, such as Figure 3 , Figure 4 As shown, if the through hole 101 is rectangular, the rolling direction of the biodegradable artificial fluid tube 1000 can be either the length direction of the biodegradable material membrane or the width direction of the biodegradable material membrane.

[0057] In some embodiments, the inner diameter of the lumen 200 is denoted as D, and the through hole 101 can be a square through hole 101. Multiple square through holes 101 are provided on the surface of the biodegradable material membrane. The relationship between the inner diameter, the side length of the square through hole 101, and the distance between at least two through holes 101 is defined as follows:

[0058] The side length of the square through hole 101 is denoted as d1: 1 / 8D≤d1≤D;

[0059] The spacing between multiple square through holes 101 is W1: 3 / 8D < W1 ≤ D.

[0060] Limiting the side length of the square through-hole 101 allows the artificial fluid tube 1000 sufficient space to compress the membrane material during bending. A suitable side length of the square through-hole 101 ensures normal material exchange within and outside the biodegradable 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 square through-hole 101 is less than 1 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall. If the side length of the square through-hole 101 is greater than D, the tube wall may become thinner, resulting in slower fluid transport.

[0061] Limiting the spacing between multiple square through holes 101 helps maintain the mechanical properties of the biodegradable artificial fluid tube 1000. A suitable spacing between the through holes 101 allows the biodegradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to fluid pressure, preventing rupture or deformation due to uneven local stress and reducing the occurrence of complications such as thrombosis. If the spacing between the through holes 101 is less than or equal to 3 / 8D, insufficient bending buffer space can easily lead to creases in the tube wall; if the spacing between the square through holes 101 is greater than D, problems such as thinning of the tube wall and slower fluid transport speed can easily occur.

[0062] In some embodiments, such as 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 biodegradable material film is 30-60 degrees, preferably 45 degrees.

[0063] When the biodegradable material membrane is rolled into a tube wall 100, 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 biodegradable artificial fluid tube 1000 can be adjusted to the maximum bending angle, which can keep the inner diameter of the cavity 200 within a preset range and ensure fluid flow.

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

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

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

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

[0068] 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 biodegradable 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 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.

[0069] Limiting the spacing between multiple strip-shaped inclined holes helps maintain the mechanical properties of the biodegradable artificial fluid tube 1000. A suitable spacing allows the biodegradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to fluid pressure, preventing rupture or deformation due to uneven local stress and reducing the occurrence of complications such as thrombosis. If the spacing between the multiple strip-shaped inclined holes is less than 1 / 2D, insufficient bending buffer space can easily lead to creases in the tube wall; if the spacing is greater than D, problems such as thinning of the tube wall and slower fluid delivery speed during transport can easily occur.

[0070] In some embodiments, such as Figure 7 , Figure 8 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.

[0071] By pressing at least a portion of the outer layer 130 or the intermediate layer 120 toward the through hole 101, the periodic structural strength change of the intermediate layer 120 can ensure effective support under bending conditions. Furthermore, this allows the biodegradable 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.

[0072] Specifically, the wavy extension direction is perpendicular to the rolling direction of the biodegradable material film. In response to bending of the biodegradable artificial fluid tube 1000, the wavy holes are spaced apart along the length of the artificial fluid tube 1000. After the biodegradable material film with wavy holes is rolled into the artificial fluid tube 1000, the artificial fluid tube 1000 has better flexibility. Compared with traditional artificial fluid tubes, it can withstand bending at larger 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.

[0073] 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:

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

[0075] The crest spacing is denoted as L3: 1 / 2D≤L≤D;

[0076] The spacing between multiple waveform holes is denoted as W3, where 3 / 8D < W3 ≤ D.

[0077] 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 exchange of substances inside and outside the biodegradable artificial fluid tube 1000, allowing nutrients and metabolic waste to pass smoothly while preventing excessive loss of blood cells or abnormal exudation 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.

[0078] Limiting the crest spacing helps maintain the mechanical properties of the biodegradable artificial fluid tube 1000. A suitable crest spacing allows the biodegradable artificial fluid tube 1000 to maintain good elasticity and toughness when subjected to fluid pressure, preventing rupture or deformation due to uneven local stress and reducing 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. Similarly, the spacing between the corrugated holes also needs to be limited, which will not be elaborated further here.

[0079] In some embodiments, the rolling direction can be the length or width direction of the biodegradable material membrane of the biodegradable 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 biodegradable material membrane, such as... Figure 6 As shown, the winding direction of the biodegradable artificial fluid tube 1000 should be the length direction of the biodegradable material membrane; if the through hole 101 is a corrugated hole and the extension direction of the corrugated hole is the width direction of the biodegradable material membrane, the winding direction of the biodegradable artificial fluid tube 1000 should be the width direction of the biodegradable material membrane.

[0080] 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 intermediate 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 either a single structure or a separate structure before the biodegradable artificial fluid tube 1000 is rolled up, for example: Figure 9 As shown, before the biodegradable artificial fluid tube 1000 is rolled up, the inner layer 110, the middle layer 120, and the outer layer 130 can be separate structures. The inner layer 110, the middle layer 120, and the outer layer 130 of the separate structure can be made of different types of membrane materials. On the one hand, this can improve the adaptability of the biodegradable artificial fluid tube 1000 to the human body, and on the other hand, it can enrich the clinical application scenarios of the biodegradable artificial fluid tube 1000.

[0082] The biodegradable artificial fluid tube 1000 provided in this disclosure has a wound structure. Therefore, when the biodegradable 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 flow and effectively avoid the embolism problem caused by the reduction of the cross-section of the lumen 200 due to the bending of the artificial fluid tube 100.

[0083] 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.

[0084] The specific structure, working principle, and beneficial effects of the biodegradable artificial fluid tube 1000 provided in this embodiment can be found in any of the above embodiments of the biodegradable artificial fluid tube 1000, and will not be repeated here.

[0085] It should be further noted that the biodegradable artificial fluid tube 1000 described in this disclosure can be made of animal-derived materials. The animal-derived material can be a tissue capsule and / or endothelium. The pericardium, peritoneum, or submucosa can be selected. Preferably, the submucosa of the small intestine, the submucosa of the bladder, the amnion, or combinations thereof can be selected. Preferably, the aforementioned polymeric material and animal-derived material are materials that are completely degradable or at least partially degradable after implantation.

[0086] 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.

[0087] 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. A biodegradable artificial fluid tube, characterized in that, include: The tube wall is formed by winding a biodegradable membrane material, and a cavity is formed inside the tube wall, the cavity being configured to allow fluid flow. The biodegradable material membrane is a flexible planar structure. One end of the biodegradable material membrane is wound to form the inner wall of the biodegradable artificial fluid tube, and the other end of the biodegradable material membrane is wound to form the outer wall of the biodegradable artificial fluid tube. The tube wall includes an inner layer and an outer layer, and an intermediate layer disposed between the inner layer and the outer layer. The intermediate layer has one or more layers and multiple through holes. The inner layer is a non-perforated membrane layer, the outer layer is a non-perforated membrane layer, and multiple perforations are provided only through the intermediate layer; the perforations are configured to provide interlayer deformation space for the intermediate layer when the lumen is bent, so that bending occurs preferentially in the perforation area; the angle between the length extension direction of the perforation and the rolling direction of the biodegradable material membrane is 30 to 90 degrees; there are ribs between the multiple perforations, configured to ensure that the lumen still has a sufficient inner diameter when bending, and to prevent the cross-sectional area of ​​the biodegradable artificial fluid tube from shrinking due to bending.

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

3. The biodegradable artificial fluid tube as described in claim 1, characterized in that, Multiple through-holes are arranged in a matrix on the pipe wall.

4. The biodegradable artificial fluid tube as described in claim 1, characterized in that, The total area of ​​the multiple through holes accounts for 30% to 80% of the total flat area of ​​the pipe wall.

5. The biodegradable 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 biodegradable material membrane is 30-60 degrees.

6. The biodegradable artificial fluid tube as described in claim 1, 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 biodegradable material film is 45 degrees.

7. The biodegradable artificial fluid tube as described in claim 1, characterized in that, The through hole is a corrugated hole that extends along the rolling direction and is configured to increase the torque of the tube wall.

8. The biodegradable artificial fluid tube as described in claim 1, characterized in that, The width of the biodegradable membrane material does not exceed 15cm; the biodegradable membrane material is a submucosal material of the small intestine.

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