Artificial bladder and preparation method thereof

Abstract

The invention belongs to the technical field of artificial organs, and discloses an artificial bladder and a preparation method thereof.The artificial bladder comprises a collagen gel tube I, a urine storage bag and a collagen gel tube II which are sequentially connected and communicated from top to bottom; the size of the urine storage bag is gradually increased and then gradually decreased from top to bottom; the urine storage bag is composed of an elastic warp-knitted fabric and a polyurethane film; the polyurethane film covers the outer layer of the elastic warp-knitted fabric; the elastic warp-knitted fabric is divided into an upper section, a middle section and a lower section, the upper section and the lower section are of tricot stitch structures, and the middle section is of a mesh warp-knitted structure. The preparation method comprises the following steps: (a) preparing the elastic warp-knitted fabric, and reserving thread tassels I and thread tassels II at two ends of the elastic warp-knitted fabric in the preparation process; (b) film covering; (c) sewing; and (d) preparing a collagen gel tube I and a collagen gel tube II. The artificial bladder is simple in structure and preparation method, and the defects in the prior art are effectively overcome.

Description

Technical Field

[0001] The invention belongs to the technical field of artificial organs and relates to an artificial bladder and a preparation method thereof. Background Art

[0002] Bladder dysfunction is a common condition that greatly affects patients' quality of life. While various treatment options are available, including medications, surgery, and implantable devices, these treatments can be associated with a range of limitations and potential complications. There is a need for an artificial bladder that can be implanted in the abdominal cavity to effectively treat bladder dysfunction while minimizing the risk of complications.

[0003] At present, artificial bladders have been widely used, mainly for treating urinary incontinence and bladder diseases. However, there are still some problems and shortcomings in the artificial bladders of the prior art, such as:

[0004] Urine storage bags cannot ensure that the force of urine is evenly distributed when pressing to urinate, so that the abdominal cavity is more evenly stressed and the urine flow is more even; current urine storage bags are usually made of flexible materials, such as silicone or polyurethane, but these materials have poor elasticity and cannot ensure the uniform distribution of urine force during urination, which may lead to poor urination or urine reflux, and then cause infection and other problems; as mentioned in reference 1 (Prevention of hospital infection in special hosts of critical care medicine-organ transplant patients [J]. Peking Union Medical College Journal, 2024, 15(3):513-517.).

[0005] Therefore, an artificial bladder and a preparation method thereof are needed to solve the above-mentioned problems, which is of great significance. Summary of the invention

[0006] The purpose of the present invention is to solve the problems existing in the prior art and to provide an artificial bladder and a preparation method thereof. Specifically, the technical problems to be solved by the present invention include how to ensure that the force of urine is uniform when pressing to urinate, so that the abdominal cavity is subjected to more uniform force and the urine flow is more uniform.

[0007] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] An artificial bladder, comprising a collagen gel tube I, a urine storage bag and a collagen gel tube II which are sequentially connected and communicated from top to bottom;

[0009] The urine storage bag is rugby-shaped, and its size increases first and then decreases from top to bottom. The urine storage bag is composed of an elastic warp knitted fabric and a polyurethane film. The polyurethane film covers the outer layer of the elastic warp knitted fabric, and the elastic warp knitted fabric provides an elastic frame. The polyurethane film mainly plays a sealing role and also provides a certain degree of elasticity.

[0010] The elastic warp knitted fabric is divided into three sections: upper, middle and lower. The upper and lower sections are of warp plain structure, and the middle section is of mesh warp knitted structure. The warp knitted structures of the upper and lower sections of the elastic warp knitted fabric of the present invention are tight, and the warp knitted structure of the middle section is loose. The force on urine at both ends is greater. When urine is loaded, urine gathers in the middle of the urine storage bag, making the patient's abdomen more protruding. The protruding amplitude in the middle can better discharge urine by pressing, which can ensure that the force of urine is uniform when pressing to urinate, so that the force on the abdominal cavity is more uniform and the urine flow is more uniform.

[0011] As the preferred technical solution:

[0012] In the artificial bladder as described above, the elastic warp knitted fabric is composed of elastic yarn, the elastic yarn is a covering yarn, the outer covering yarn is a 20±1 denier PP yarn or a 20±1 denier PE yarn, and the core yarn is a 15±0.7 denier spandex yarn; the breaking strength of the elastic yarn is 7±0.3N, the elastic recovery rate is 73±2%, and the elastic recovery rate of the elastic warp knitted fabric is 70±2%.

[0013] In the artificial bladder as described above, the length of the upper section or the lower section of the elastic warp knitted fabric is 1 / 20-1 / 5 of the total length of the elastic warp knitted fabric, and the mesh of the middle section is a regular hexagon with a side length of 1±0.1 mm.

[0014] As described above, the wall of the collagen gel tube I contains whiskers I, and the length of the whiskers I is 45-55% of the length of the collagen gel tube I; the wall of the collagen gel tube II contains whiskers II, and the length of the whiskers II is 45-55% of the length of the collagen gel tube II; the whiskers I and II are both connected to the yarn in the elastic warp knitted fabric, and the whiskers I and II are the ends of the yarn left at the edge of the elastic warp knitted fabric, which are not woven or not completely fixed.

[0015] There are still some problems and shortcomings in the artificial bladder of the prior art, such as:

[0016] The urine bag and the collagen gel tube need to be connected by glue, which has poor stability. Existing artificial bladder designs usually consist of a urine bag and a collagen gel tube. These two parts need to be connected together by glue to ensure that they can work properly. However, this glue connection has poor stability and is prone to loosening or rupture, leading to urine leakage or other problems. For example, reference 2 (Observation on the effect of the Uresil elastic bandage applied to the fixation of ureteral single J tube [J]. China Medical Device Information, 2021. DOI: 10.3969 / j.issn.1006-6586.2021.04.060.).

[0017] The technical problem to be solved by the present invention also includes how to integrate the urine storage bag and the collagen gel tube without using glue while still ensuring a durable and stable connection. The present invention uses a whisker structure to organically combine the urine storage bag and the collagen gel tube without adding any glue, and the connection strength between the two is higher, making the artificial bladder more durable.

[0018] In the artificial bladder as described above, collagen gel tube I and collagen gel tube II are cylindrical tubes; the inner diameter of collagen gel tube I is 0.5±0.02 cm, and the wall thickness is 0.2±0.01 cm; the inner diameter of collagen gel tube II is 0.75±0.02 cm, and the wall thickness is 0.2±0.01 cm.

[0019] For the artificial bladder as described above, the hydrostatic pressure of the urine storage bag is 20±2cmH2O, the elastic modulus is 8±0.4MPa, and the maximum load is 36±2N;

[0020] If the collagen gel tube I or collagen gel tube II does not contain whiskers, the maximum tensile stress is 0.85MPa±0.1MPa, and the elastic modulus is 2850±10Pa. If it contains whiskers, the maximum tensile stress is 1MPa±0.1MPa, and the elastic modulus is 3230±10Pa. By comparison, it can be seen that after adding whiskers, the ultimate tensile strength is significantly improved.

[0021] The maximum instantaneous flow rate of drainage of the artificial bladder is 82-291 ml / s, and the drainage time is 2.8-8.2 s. It can be seen that the present invention can ensure that the force of urine is uniform when pressing to urinate, so that the abdominal cavity is subjected to more uniform force and the urine flow is more uniform.

[0022] The tensile cycle number of the artificial bladder is 1789±38 times, which shows that the urine storage bag and the collagen gel tube of the present invention can be connected stably and durably.

[0023] The present invention also provides a method for preparing an artificial bladder as described in any one of the above items, comprising the following steps:

[0024] (a) preparing an elastic warp knitted fabric, leaving whiskers I and whiskers II at both ends of the elastic warp knitted fabric during the preparation process;

[0025] (b) coating;

[0026] The elastic warp knitted fabric is placed in a first mold, and water-based polyurethane (manufacturer: Covestro, brand: CD102) is poured into the mold cavity of the first mold and then dried. The first mold consists of a first inner mold and a first outer mold. The first inner mold is a plate-like structure. The elastic warp knitted fabric is flattened radially and then put on the first inner mold.

[0027] (c) suture;

[0028] The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom;

[0029] (d) preparing collagen gel tube I and collagen gel tube II;

[0030] The whisker I is placed in the cavity of the second mold, the whisker II is placed in the cavity of the third mold, and the collagen gel precursor solution is poured into the cavities of the second mold and the third mold respectively for polymerization.

[0031] As the preferred technical solution:

[0032] In the method as described above, in step (b), after drying, the product is washed (i.e., repeatedly washed with anhydrous ethanol and deionized water) and sterilized, and ethylene oxide is used for the sterilization.

[0033] In the method as described above, in step (d), the preparation process of the collagen gel precursor solution is: after mixing sterile acid-soluble type I collagen (for example, a mixture of sterile mouse type I collagen and acetic acid solution (concentration of 2.06 mg / ml) in a volume ratio of 1:1) and smooth muscle cell separation medium (smooth muscle cell separation medium is a culture medium for culturing smooth muscle cells, which provides nutrients, growth factors and other key components required for cell growth. The preparation of the culture medium requires a series of chemical reagents and culture medium components, which are mixed in a specific proportion to finally obtain a liquid culture medium that can promote the growth and proliferation of smooth muscle cells), a sodium hydroxide solution with a concentration of 1±0.01 mol / L is added for neutralization to obtain a collagen gel precursor solution; wherein the volume ratio of sterile acid-soluble type I collagen, smooth muscle cell separation medium and sodium hydroxide solution is 1:2:2.

[0034] In the method as described above, in step (d), after polymerization, the product is subjected to water absorption treatment and sterilization treatment in sequence; the process of water absorption treatment is: firstly wrapping a layer of nylon mesh on the surface of the product, and then wrapping a layer of absorbent paper, the absorbent paper absorbs part of the water in the gel to enhance its mechanical properties, and the nylon mesh is used to separate the absorbent paper and the gel; ethylene oxide is used for sterilization treatment.

[0035] Beneficial effects:

[0036] (1) The artificial bladder of the present invention is integrally formed, thereby avoiding the problem of poor stability caused by the need to connect the urine storage bag and the collagen gel tube with glue.

[0037] (2) The warp knitted structures of the upper and lower sections of the elastic warp knitted fabric of the present invention are tight, and the warp knitted structure of the middle section is loose. The force on urine at both ends is greater. When urine is loaded, the urine gathers in the middle of the urine storage bag, making the patient's abdomen more protruding. The protruding amplitude in the middle can better help to drain urine by pressing, which can ensure that the force of urine is uniform when pressing to urinate, so that the force on the abdominal cavity is more uniform and the urine flow is more uniform.

[0038] (3) The elastic yarn used in the present invention is a covered yarn, which has high strength and excellent sealing performance, can effectively prevent the intrusion of external moisture, gas and dust, and can effectively avoid the corrosion of acid and alkali on the core yarn, thereby slowing down the aging process of the artificial bladder and having better anti-aging performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A schematic diagram of an artificial bladder of the present invention;

[0040] Figure 2 It is a schematic diagram of a local area of ​​the elastic warp knitted fabric of the present invention;

[0041] Figure 3 It is a schematic diagram of the motion trajectory of the first inlay yarn in the weaving process of the elastic warp knitted fabric of the present invention;

[0042] Figure 4 It is a schematic diagram of the motion trajectory of the second inlay yarn in the weaving process of the elastic warp knitted fabric of the present invention;

[0043] Figure 5 It is a schematic diagram of the motion trajectory of the third inlay yarn in the weaving process of the elastic warp knitted fabric of the present invention;

[0044] Figure 6 It is a schematic diagram of the motion trajectory of the fourth inlay yarn in the weaving process of the elastic warp knitted fabric of the present invention;

[0045] Figure 7 It is a schematic diagram of the motion trajectory of the fifth inlay yarn in the weaving process of the elastic warp knitted fabric of the present invention; Figure 3~Figure 7 In the figure, numbers 1 to 6 represent different needle spacing numbers. The black lines in the figure represent the movement trajectory of the yarn held by the needles on the comb bar. GB1 to GB5 represent the first to fifth comb bars respectively. 1-2|2-1|2-3|2-1|1-2|1-2|| is the movement trajectory of a complete cycle of the yarn. By observing the shape of the yarn on the needle, it can be seen that it is a closed or open coil;

[0046] Among them, 4-collagen gel tube I, 5-collagen gel tube II, 6-wire whisker I, 7-urine storage bag, 8-wire whisker II. DETAILED DESCRIPTION

[0047] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0048] The testing methods of the relevant performance indicators in the following embodiments and comparative examples are as follows:

[0049] Breaking strength: The elastic yarns prepared in the examples and comparative examples were tested with reference to GB / T 3923.1-1997 “Determination of tensile breaking strength and elongation at break of fabrics”.

[0050] Elastic recovery of elastic yarn: The elastic yarns prepared in the examples and comparative examples were tested according to ISO 2062:2009 Textiles. Packaged yarns. Determination of breaking strength and elongation of single yarns by fixed ratio tensile (CRE) tester.

[0051] Elastic recovery rate of elastic warp knitted fabric: refer to FZ / T 70006-2022 "Test method for elastic recovery rate of knitted fabric under tension" standard to test the elastic warp knitted fabrics prepared in each embodiment and comparative example.

[0052] Elastic modulus of collagen gel tube: with reference to GB / T 3923.1-1997 "Determination of tensile breaking strength and elongation at break of fabrics" standard, the tensile breaking strength and elongation at break of the collagen gel tubes prepared in each embodiment and comparative example were tested, and the elastic modulus was calculated based on the measured data, and the calculation formula is: elastic modulus = breaking strength / elongation at break; wherein, during the test, a clamp is used to clamp the two ends of the collagen gel tube.

[0053] Maximum tensile stress of collagen gel tube: With reference to GB / T 1040.1-2006 "Determination of tensile properties of plastics Part 1: Conventional method", the collagen gel tubes prepared in each embodiment and comparative example were tested. During the test, a clamp was clamped at both ends of the collagen gel tube, and then the tensile testing machine was operated to stretch the collagen gel tube at a tensile speed of 200 mm / min until the collagen gel tube broke. The tensile stress at this time was the maximum tensile stress of the collagen gel tube.

[0054] Maximum instantaneous flow rate and drainage time: The artificial bladder prepared in each embodiment is used as a sample. First, 500 mL of water is added to the sample, one end of the inlet is closed, and then one end of the outlet is connected to the catheter, and the connection between the outlet and the catheter is sealed. Finally, an electric pressure testing machine is used to apply pressure at the center of the sample, and the pressure is monitored in real time by a sensor and the instantaneous flow rate (mL / s) and drainage time (s) are recorded. The maximum instantaneous flow rate recorded is the maximum instantaneous flow rate; wherein, the applied pressure is maintained at 6N.

[0055] Number of tensile cycles: The artificial bladder prepared in each embodiment and comparative example is used as a sample, and then the two ends of the sample are clamped at the center of the upper jaw and the lower jaw respectively (when the two ends of the sample contain whiskers, the clamping position is the junction of the whiskers and the protein gel tube, and when the two ends of the sample do not contain whiskers, the clamping position is the two ends of the collagen gel tube). After the collagen gel tube is naturally straightened, the jaws are tightened and closed, and then repeated stretching is performed for multiple times until the fabric is damaged, which is the termination condition, and the number of stretching is recorded at the same time; wherein, the test conditions are: the fixed elongation is 50%, the tension is set to 0.5MPa, the sample spacing is 100mm, and the stretching speed is 150mm / min.

[0056] Hydrostatic pressure: The artificial bladders prepared in the embodiments and comparative examples were tested with reference to GB / T 4745-1997 Hydrostatic pressure test for determination of water permeability resistance of textile fabrics.

[0057] Elastic modulus of artificial bladder: The tensile breaking strength and breaking elongation of the artificial bladders prepared in the embodiments and comparative examples were tested for tensile breaking strength and breaking elongation according to GB / T 3923.1-1997 "Determination of tensile breaking strength and breaking elongation of fabrics", and the elastic modulus was calculated based on the measured data. The calculation formula is: elastic modulus = breaking strength / breaking elongation; wherein, during the test, the fixture is clamped at the connection between the collagen gel tube and the urine storage bag at the upper and lower ends of the artificial bladder.

[0058] Maximum load: The artificial bladders prepared in each embodiment and comparative example were tested with reference to GB / T 228.1-2021 "Material Tensile Test Part 1: Room Temperature Test Method". During the test, the fixture was clamped at the connection between the collagen gel tube and the urine storage bag at the upper and lower ends of the artificial bladder, and the load was gradually increased through the force meter until the artificial bladder broke, which is the maximum load-bearing capacity of the artificial bladder; wherein, the load increased each time is 5N, and the load stays for 10s after each increase.

[0059] Example 1

[0060] The preparation method of the artificial bladder comprises the following steps:

[0061] (1) Preparing elastic warp knitted fabrics;

[0062] (1.1) HKV141A covering yarn machine is used for weaving. First, the PP yarn (manufacturer is Anhui Yumin Chemical Fiber Co., Ltd., brand name is YM-19D, specification is 19 denier) as the outer covering yarn is wound onto the spindle, and at the same time, the spandex yarn (manufacturer is Zhejiang Longsheng Group, brand name is LYCRA®, specification is 15 denier) as the core yarn is introduced from bottom to top into the elastic core yarn feeding device, and then the PP yarn spindle obtained by winding is installed on the telescopic covering mechanism, and the PP yarn and the spandex yarn are wound together through the yarn guide hole onto the relaxation winding device, and finally the machine is turned on and the twist direction, pre-draft multiple and covering twist are set. After the setting is completed, the covering can be carried out to obtain the elastic yarn; wherein, the twist direction is Z, the pre-draft multiple is 2.5 times, and the covering twist is 500 twists / m;

[0063] The breaking strength of the elastic yarn was 6.7N and the elastic recovery rate was 71%.

[0064] (1.2) The elastic yarn obtained in step (1.1) is used to prepare an elastic warp knitted fabric, wherein five elastic yarns form a complete cycle, and the five elastic yarns perform different movements along different trajectories to form an elastic warp knitted fabric (the movement trajectories of the five elastic yarns are as shown in FIG. Figures 3 to 7 As shown); wherein, during the preparation process, whiskers I and whiskers II are left at both ends of the elastic warp knitted fabric;

[0065] The elastic warp knitted fabric (local area such as Figure 2 The total length (i.e., the length between whisker I and whisker II) is 18 cm, the diameter is 5.6 cm, the thickness is 0.73 mm, and the surface density is 248 g / m 2 , horizontal row density is 18 rows / m, vertical column density is 17 columns / m; elastic recovery rate of elastic warp knitted fabric is 68%;

[0066] (2) Lamination;

[0067] The elastic warp knitted fabric obtained in step (1) is flattened radially and then put on the first inner mold of a first mold (composed of a first inner mold and a first outer mold, the first inner mold being a plate-like structure), and water-based polyurethane (manufacturer: Covestro AG, brand: Baymedix® CD102) is poured into the mold cavity of the first mold until all meshes are submerged by the water-based polyurethane, followed by drying at 25° C. for 48 h, and then the first inner mold and the first outer mold are removed, and the elastic warp knitted fabric is hung and left to stand in a fume hood for 24 h, and then the elastic warp knitted fabric after standing is washed twice, sterilized with ethylene oxide, and then demolded;

[0068] (3) Suturing;

[0069] The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom;

[0070] (4) preparing collagen gel precursor solution;

[0071] (4.1) Prepare sterile acid-soluble type I collagen;

[0072] Sterile mouse type I collagen (manufacturer: Fuzhou Aoyan Laboratory Equipment Co., Ltd., brand: BS929) and acetic acid aqueous solution were mixed in a volume ratio of 1:1 to obtain sterile acid-soluble type I collagen; wherein the concentration of the acetic acid aqueous solution was 2.06 mg / ml;

[0073] (4.2) Mix the sterile acid-soluble type I collagen and smooth muscle cell separation medium (manufacturer: Chengdu Casco Chemical Products Co., Ltd., brand number: C11995500BT) prepared in step (4.1), and add 1 mol / L sodium hydroxide aqueous solution for neutralization to obtain a collagen gel precursor solution; wherein the volume ratio of the sterile acid-soluble type I collagen, the smooth muscle cell separation medium, and the sodium hydroxide solution is 1:2:2;

[0074] (5) preparing collagen gel tube I and collagen gel tube II;

[0075] Place the whisker I into the cylindrical tubular cavity of the second mold (composed of the second inner mold and the second outer mold), place the whisker II into the cylindrical tubular cavity of the third mold (composed of the third inner mold and the third outer mold), pour the collagen gel precursor solution into the cavities of the second mold and the third mold respectively for polymerization, after solidification, remove the second outer mold and the third outer mold, first wrap a layer of nylon mesh on the surface of the polymerized product, then wrap a layer of absorbent paper for water absorption, and then use ethylene oxide for sterilization. After the treatment, remove the absorbent paper, nylon mesh, second inner mold and third inner mold to obtain an artificial bladder.

[0076] The final artificial bladder is Figure 1 As shown, it includes a collagen gel tube I 4, a urine storage bag 7 and a collagen gel tube II 5 which are sequentially connected and communicated from top to bottom, and the lengths of the collagen gel tube I 4, the urine storage bag 7 and the collagen gel tube II 5 are 10 cm, 8 cm and 11 cm respectively;

[0077] Collagen gel tube I 4 and collagen gel tube II 5 are cylindrical tubes; the inner diameter of collagen gel tube I 4 is 0.48 cm and the wall thickness is 0.19 cm, and the inner diameter of collagen gel tube II 5 is 0.73 cm and the wall thickness is 0.19 cm;

[0078] The tube wall of the collagen gel tube I 4 contains a whisker I 6, and the tube wall of the collagen gel tube II 5 contains a whisker II 8; the length of the whisker I 6 is 50% of the length of the collagen gel tube I 4, and the length of the whisker II 8 is 50% of the length of the collagen gel tube II 5;

[0079] The urine storage bag 7 is in the shape of a rugby ball, and its size increases first and then decreases from top to bottom; the urine storage bag 7 is composed of an elastic warp knitted fabric and a polyurethane film; the elastic warp knitted fabric is divided into three sections: upper, middle and lower; the upper section and the lower section are warp plain structure, and the middle section is a mesh warp knitted structure; the length of the upper section is 3 / 20 of the total length, and the length of the lower section is 3 / 20 of the total length; the mesh of the middle section is a regular hexagon, and the side length of the regular hexagon is 0.9 mm; the elastic warp knitted fabric is composed of elastic yarn, and the elastic yarn is a coated yarn; the polyurethane film covers the outer layer of the elastic warp knitted fabric;

[0080] The whiskers I 6 and II 8 are both connected to the yarn in the elastic warp knitted fabric, and the whiskers I and II are yarn ends left at the edge of the elastic warp knitted fabric and are not woven or completely fixed;

[0081] The elastic modulus of collagen gel tube I in the artificial bladder is 5960Pa, and the maximum tensile stress is 1.1MPa; the elastic modulus of collagen gel tube II is 5960Pa, and the maximum tensile stress is 1.1MPa;

[0082] The maximum instantaneous drainage flow rate of the artificial bladder is 82 ml / s, the drainage time is 2.8 s, the number of tensile cycles is 1827 times, the hydrostatic pressure of the urine storage bag is 22 cmH2O, the elastic modulus is 6.9 MPa, and the maximum load is 38 N. After aging the artificial bladder at 70°C, normal pressure, and low oxygen concentration (40% v / v) for 168 hours, its elastic modulus is 6.7 MPa.

[0083] Comparative Example 1

[0084] The method for preparing an artificial bladder is basically the same as in Example 1, except that: step (1.1) is not performed, and the elastic yarn in step (1.2) is replaced by PE yarn (same as in Example 1);

[0085] The elastic recovery rate of the warp knitted fabric obtained is 55%;

[0086] The fabric used for laminating in step (2) is the warp knitted fabric prepared in this comparative example.

[0087] The final artificial bladder is basically the same as Example 1, except that: the maximum instantaneous drainage flow rate of the artificial bladder is 30 ml / s, the drainage time is 27.3 s, the number of tensile cycles is 1380 times, the hydrostatic pressure of the urine storage bag is 18 cmH2O, the elastic modulus is 5.4 MPa, and the maximum load is 28 N; after aging the artificial bladder at 70°C, normal pressure, and low oxygen concentration (40% v / v) for 168 hours, its elastic modulus is 4.8 MPa.

[0088] By comparing Comparative Example 1 with Example 1, it can be seen that the maximum instantaneous flow rate of the artificial bladder of Comparative Example 1 is reduced, the drainage time is increased, and the number of tensile cycles, hydrostatic pressure, elastic modulus, and maximum load are reduced compared with the artificial bladder of Example 1. This is because the warp knitted fabric of this comparative example is only woven with PE yarn, which will lead to a decrease in the elastic recovery rate of the warp knitted fabric, and the maximum cavity formed by the artificial bladder made therefrom when urine flows through becomes smaller, thereby resulting in a decrease in the maximum instantaneous flow rate and an increase in the drainage time. In addition, due to the low elasticity of the yarn used, the number of tensile cycles, hydrostatic pressure, elastic modulus, and maximum load of the artificial bladder made therefrom will also be reduced; in addition, in Example 1, through the protective effect of the outer yarn, the elastic yarn obtained has high strength and excellent sealing performance, can effectively prevent the invasion of external moisture, gas and dust, and can effectively avoid the corrosion of the core yarn by acid and alkali, thereby slowing down the aging process of the artificial bladder, and the anti-aging performance is better than that of this comparative example.

[0089] Comparative Example 2

[0090] An artificial bladder, which is basically the same as in Example 1, except that the middle section of the elastic warp knitted fabric is a warp plain structure (with the same size as in Example 1);

[0091] The maximum instantaneous flow rate of drainage of the artificial bladder is 78 ml / s.

[0092] Comparing Comparative Example 2 with Example 1, it can be seen that the maximum instantaneous flow rate is reduced. This is because the middle section is a warp-flat tissue, so the tissue elasticity is reduced, and because the protrusion of the middle section is reduced when the urine storage bag is filled with urine, the amount of urine that can be accommodated is reduced.

[0093] Example 2

[0094] The preparation method of the artificial bladder comprises the following steps:

[0095] (1) Preparing elastic warp knitted fabrics;

[0096] (1.1) HKV141A covering yarn machine is used for weaving. First, the PP yarn (manufacturer is Anhui Yumin Chemical Fiber Co., Ltd., brand name is YM-21D, specification is 21 denier) as the outer covering yarn is wound onto the spindle, and at the same time, the spandex yarn (manufacturer is Zhejiang Longsheng Group, brand name is LYCRA®, specification is 15 denier) as the core yarn is introduced from bottom to top into the elastic core yarn feeding device, and then the PP yarn spindle obtained by winding is installed on the telescopic covering mechanism, and the PP yarn and the spandex yarn are wound together through the yarn guide hole onto the relaxation winding device, and finally the machine is turned on and the twist direction, pre-draft multiple and covering twist are set. After the setting is completed, the covering can be carried out to obtain the elastic yarn; wherein, the twist direction is Z, the pre-draft multiple is 3 times, and the covering twist is 740 twists / m;

[0097] The breaking strength of the elastic yarn was 6.9N and the elastic recovery rate was 72%.

[0098] (1.2) The elastic yarn obtained in step (1.1) is used to prepare an elastic warp knitted fabric, wherein five elastic yarns form a complete cycle, and the five elastic yarns perform different movements along different trajectories to form an elastic warp knitted fabric (the movement trajectories of the five elastic yarns are as shown in FIG. Figures 3 to 7 As shown); wherein, during the preparation process, whiskers I and whiskers II are left at both ends of the elastic warp knitted fabric;

[0099] The elastic warp knitted fabric (local area such as Figure 2 The product is cylindrical, with a total length of 18 cm, a diameter of 5.6 cm, a thickness of 0.73 mm, and a surface density of 248 g / m 2 , horizontal row density is 18 rows / m, vertical column density is 17 columns / m; elastic recovery rate of elastic warp knitted fabric is 70%;

[0100] (2) Lamination;

[0101] The elastic warp knitted fabric obtained in step (1) is flattened radially and then put on the first inner mold of a first mold (composed of a first inner mold and a first outer mold, the first inner mold being a plate-like structure), and water-based polyurethane (manufacturer: Covestro AG, brand: Baymedix® CD102) is poured into the mold cavity of the first mold until all meshes are submerged by the water-based polyurethane, followed by drying at 25° C. for 48 h, and then the first inner mold and the first outer mold are removed, and the elastic warp knitted fabric is hung and left to stand in a fume hood for 24 h, and then the elastic warp knitted fabric after standing is washed twice, sterilized with ethylene oxide, and then demolded;

[0102] (3) Suturing;

[0103] The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom;

[0104] (4) preparing collagen gel precursor solution;

[0105] (4.1) Prepare sterile acid-soluble type I collagen;

[0106] Sterile mouse type I collagen (manufacturer: Fuzhou Aoyan Laboratory Equipment Co., Ltd., brand: BS929) and acetic acid aqueous solution were mixed in a volume ratio of 1:1 to obtain sterile acid-soluble type I collagen; wherein the concentration of the acetic acid aqueous solution was 2.06 mg / ml;

[0107] (4.2) Mix the sterile acid-soluble type I collagen and smooth muscle cell separation medium (manufacturer: Chengdu Casco Chemical Products Co., Ltd., brand number: C11995500BT) prepared in step (4.1), and add a 0.99 mol / L sodium hydroxide aqueous solution for neutralization to obtain a collagen gel precursor solution; wherein the volume ratio of the sterile acid-soluble type I collagen, the smooth muscle cell separation medium, and the sodium hydroxide solution is 1:2:2;

[0108] (5) preparing collagen gel tube I and collagen gel tube II;

[0109] Place the whisker I into the cylindrical tubular cavity of the second mold (composed of the second inner mold and the second outer mold), place the whisker II into the cylindrical tubular cavity of the third mold (composed of the third inner mold and the third outer mold), pour the collagen gel precursor solution into the cavities of the second mold and the third mold respectively for polymerization, after solidification, remove the second outer mold and the third outer mold, first wrap a layer of nylon mesh on the surface of the polymerized product, then wrap a layer of absorbent paper for water absorption, and then use ethylene oxide for sterilization. After the treatment, remove the absorbent paper, nylon mesh, second inner mold and third inner mold to obtain an artificial bladder.

[0110] The artificial bladder finally prepared includes a collagen gel tube I, a urine storage bag and a collagen gel tube II which are sequentially connected and communicated from top to bottom, and the lengths of the collagen gel tube I, the urine storage bag and the collagen gel tube II are 10 cm, 8 cm and 11 cm respectively;

[0111] Collagen gel tube I and collagen gel tube II are cylindrical tubes; the inner diameter of collagen gel tube I is 0.49 cm and the wall thickness is 0.19 cm, and the inner diameter of collagen gel tube II is 0.74 cm and the wall thickness is 0.19 cm;

[0112] The tube wall of the collagen gel tube I contains whiskers I, and the tube wall of the collagen gel tube II contains whiskers II; the length of the whiskers I is 45% of the length of the collagen gel tube I, and the length of the whiskers II is 45% of the length of the collagen gel tube II;

[0113] The urine storage bag is rugby-shaped, and its size increases first and then decreases from top to bottom; the urine storage bag is composed of an elastic warp knitted fabric and a polyurethane film; the elastic warp knitted fabric is divided into three sections: upper, middle and lower; the upper section and the lower section are warp plain structure, and the middle section is a mesh warp knitted structure; the length of the upper section is 9 / 50 of the total length, and the length of the lower section is 9 / 50 of the total length; the mesh of the middle section is a regular hexagon, and the side length of the regular hexagon is 1 mm; the elastic warp knitted fabric is composed of elastic yarn, and the elastic yarn is a coated yarn; the polyurethane film covers the outer layer of the elastic warp knitted fabric;

[0114] Both the whiskers I and II are connected to the yarn in the elastic warp knitted fabric, and both the whiskers I and II are yarn ends left at the edge of the elastic warp knitted fabric and are not woven or completely fixed;

[0115] The elastic modulus of collagen gel tube I in the artificial bladder is 5950Pa, and the maximum tensile stress is 0.975MPa; the elastic modulus of collagen gel tube II is 5950Pa, and the maximum tensile stress is 1MPa;

[0116] The maximum instantaneous drainage flow rate of the artificial bladder is 138 ml / s, the drainage time is 4.6 s, the number of tensile cycles is 1783 times, the hydrostatic pressure of the urine storage bag is 20 cmH2O, the elastic modulus is 7.1 MPa, and the maximum load is 39 N. After aging the artificial bladder at 70°C, normal pressure, and low oxygen concentration (50%) for 168 hours, its elastic modulus is 7.0 MPa.

[0117] Example 3

[0118] The preparation method of the artificial bladder comprises the following steps:

[0119] (1) Preparing elastic warp knitted fabrics;

[0120] (1.1) HKV141A covering yarn machine is used for weaving. First, the PE yarn (manufacturer is Anhui Yumin Chemical Fiber Co., Ltd., brand name is YM-19D, specification is 19 denier) as the outer covering yarn is wound onto the spindle, and at the same time, the spandex yarn (manufacturer is Zhejiang Longsheng Group, brand name is LYCRA®, specification is 15 denier) as the core yarn is introduced from bottom to top into the elastic core yarn feeding device, and then the PE yarn spindle obtained by winding is installed on the telescopic covering mechanism, and the PE yarn and the spandex yarn are wound together through the yarn guide hole onto the relaxation winding device, and finally the machine is turned on and the twist direction, pre-draft multiple and covering twist are set. After the setting is completed, the covering can be carried out to obtain the elastic yarn; wherein, the twist direction is Z, the pre-draft multiple is 3 times, and the covering twist is 1250 twists / m;

[0121] The breaking strength of the elastic yarn obtained is 7.1N and the elastic recovery rate is 74%;

[0122] (1.2) The elastic yarn obtained in step (1.1) is used to prepare an elastic warp knitted fabric, wherein five elastic yarns form a complete cycle, and the five elastic yarns perform different movements along different trajectories to form an elastic warp knitted fabric (the movement trajectories of the five elastic yarns are as shown in FIG. Figures 3 to 7 As shown); wherein, during the preparation process, whiskers I and whiskers II are left at both ends of the elastic warp knitted fabric;

[0123] The elastic warp knitted fabric (local area such as Figure 2 The product is cylindrical, with a total length of 18 cm, a diameter of 5.6 cm, a thickness of 0.73 mm, and a surface density of 248 g / m 2 , horizontal row density is 18 rows / m, vertical column density is 17 columns / m; the elastic recovery rate of elastic warp knitted fabric is 71%;

[0124] (2) Lamination;

[0125] The elastic warp knitted fabric obtained in step (1) is flattened radially and then put on the first inner mold of a first mold (composed of a first inner mold and a first outer mold, the first inner mold being a plate-like structure), and water-based polyurethane (manufacturer: Covestro AG, brand: Baymedix® CD102) is poured into the mold cavity of the first mold until all meshes are submerged by the water-based polyurethane, followed by drying at 25° C. for 48 h, and then the first inner mold and the first outer mold are removed, and the elastic warp knitted fabric is hung and left to stand in a fume hood for 24 h, and then the elastic warp knitted fabric after standing is washed twice, sterilized with ethylene oxide, and then demolded;

[0126] (3) Suturing;

[0127] The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom;

[0128] (4) preparing collagen gel precursor solution;

[0129] (4.1) Prepare sterile acid-soluble type I collagen;

[0130] Sterile mouse type I collagen (manufacturer: Fuzhou Aoyan Laboratory Equipment Co., Ltd., brand: BS929) and acetic acid aqueous solution were mixed in a volume ratio of 1:1 to obtain sterile acid-soluble type I collagen; wherein the concentration of the acetic acid aqueous solution was 2.06 mg / ml;

[0131] (4.2) Mix the sterile acid-soluble type I collagen and smooth muscle cell separation medium (manufacturer: Chengdu Casco Chemical Products Co., Ltd., brand number: C11995500BT) prepared in step (4.1), and add 1 mol / L sodium hydroxide aqueous solution for neutralization to obtain a collagen gel precursor solution; wherein the volume ratio of the sterile acid-soluble type I collagen, the smooth muscle cell separation medium, and the sodium hydroxide solution is 1:2:2;

[0132] (5) preparing collagen gel tube I and collagen gel tube II;

[0133] Place the whisker I into the cylindrical tubular cavity of the second mold (composed of the second inner mold and the second outer mold), place the whisker II into the cylindrical tubular cavity of the third mold (composed of the third inner mold and the third outer mold), pour the collagen gel precursor solution into the cavities of the second mold and the third mold respectively for polymerization, after solidification, remove the second outer mold and the third outer mold, first wrap a layer of nylon mesh on the surface of the polymerized product, then wrap a layer of absorbent paper for water absorption, and then use ethylene oxide for sterilization. After the treatment, remove the absorbent paper, nylon mesh, second inner mold and third inner mold to obtain an artificial bladder.

[0134] The artificial bladder finally prepared includes a collagen gel tube I, a urine storage bag and a collagen gel tube II which are sequentially connected and communicated from top to bottom, and the lengths of the collagen gel tube I, the urine storage bag and the collagen gel tube II are 10 cm, 8 cm and 11 cm respectively;

[0135] Collagen gel tube I and collagen gel tube II are cylindrical tubes; the inner diameter of collagen gel tube I is 0.51 cm and the wall thickness is 0.2 cm, and the inner diameter of collagen gel tube II is 0.76 cm and the wall thickness is 0.2 cm;

[0136] The tube wall of the collagen gel tube I contains whiskers I, and the tube wall of the collagen gel tube II contains whiskers II; the length of the whiskers I is 50% of the length of the collagen gel tube I, and the length of the whiskers II is 50% of the length of the collagen gel tube II;

[0137] The urine storage bag is rugby-shaped, and its size increases first and then decreases from top to bottom; the urine storage bag is composed of an elastic warp knitted fabric and a polyurethane film; the elastic warp knitted fabric is divided into three sections: upper, middle and lower; the upper section and the lower section are warp plain structure, and the middle section is a mesh warp knitted structure; the length of the upper section is 11 / 50 of the total length, and the length of the lower section is 11 / 50 of the total length; the mesh of the middle section is a regular hexagon, and the side length of the regular hexagon is 1 mm; the elastic warp knitted fabric is composed of elastic yarn, and the elastic yarn is a coated yarn; the polyurethane film covers the outer layer of the elastic warp knitted fabric;

[0138] Both the whiskers I and II are connected to the yarn in the elastic warp knitted fabric, and both the whiskers I and II are yarn ends left at the edge of the elastic warp knitted fabric and are not woven or completely fixed;

[0139] The elastic modulus of collagen gel tube I in the artificial bladder is 5946Pa, and the maximum tensile stress is 0.95MPa; the elastic modulus of collagen gel tube II is 5940Pa, and the maximum tensile stress is 0.95MPa;

[0140] The maximum instantaneous drainage flow rate of the artificial bladder is 207 ml / s, the drainage time is 6.3 s, the number of tensile cycles is 1807 times, the hydrostatic pressure of the urine storage bag is 20 cmH2O, the elastic modulus is 7.3 MPa, and the maximum load is 40 N. After aging the artificial bladder at 70°C, normal pressure, and low oxygen concentration (50%) for 168 hours, its elastic modulus is 7.2 MPa.

[0141] Example 4

[0142] The preparation method of the artificial bladder comprises the following steps:

[0143] (1) Preparing elastic warp knitted fabrics;

[0144] (1.1) HKV141A covering yarn machine is used for weaving. First, the PE yarn (manufacturer is Anhui Yumin Chemical Fiber Co., Ltd., brand name is YM-21D, specification is 21 denier) as the outer covering yarn is wound onto the spindle, and at the same time, the spandex yarn (manufacturer is Zhejiang Longsheng Group, brand name is LYCRA®, specification is 15 denier) as the core yarn is introduced from bottom to top into the elastic core yarn feeding device, and then the PE yarn spindle obtained by winding is installed on the telescopic covering mechanism, and the PE yarn and the spandex yarn are wound together through the yarn guide hole onto the relaxation winding device, and finally the machine is turned on and the twist direction, pre-draft multiple and covering twist are set. After the setting is completed, the covering can be carried out to obtain the elastic yarn; wherein, the twist direction is Z, the pre-draft multiple is 3.5 times, and the covering twist is 1500 twists / m;

[0145] The breaking strength of the elastic yarn obtained is 7.3N and the elastic recovery rate is 75%;

[0146] (1.2) The elastic yarn obtained in step (1.1) is used to prepare an elastic warp knitted fabric, wherein five elastic yarns form a complete cycle, and the five elastic yarns perform different movements along different trajectories to form an elastic warp knitted fabric (the movement trajectories of the five elastic yarns are as shown in FIG. Figures 3 to 7 As shown); wherein, during the preparation process, whiskers I and whiskers II are left at both ends of the elastic warp knitted fabric;

[0147] The elastic warp knitted fabric (local area such as Figure 2The product is cylindrical, with a total length of 18 cm, a diameter of 5.6 cm, a thickness of 0.73 mm, and a surface density of 248 g / m 2 , horizontal row density is 18 rows / m, vertical column density is 17 columns / m; the elastic recovery rate of elastic warp knitted fabric is 72%;

[0148] (2) Lamination;

[0149] The elastic warp knitted fabric obtained in step (1) is flattened radially and then put on the first inner mold of a first mold (composed of a first inner mold and a first outer mold, the first inner mold being a plate-like structure), and water-based polyurethane (manufacturer: Covestro AG, brand: Baymedix® CD102) is poured into the mold cavity of the first mold until all meshes are submerged by the water-based polyurethane, followed by drying at 25° C. for 48 h, and then the first inner mold and the first outer mold are removed, and the elastic warp knitted fabric is hung and left to stand in a fume hood for 24 h, and then the elastic warp knitted fabric after standing is washed twice, sterilized with ethylene oxide, and then demolded;

[0150] (3) Suturing;

[0151] The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom;

[0152] (4) preparing collagen gel precursor solution;

[0153] (4.1) Prepare sterile acid-soluble type I collagen;

[0154] Sterile mouse type I collagen (manufacturer: Fuzhou Aoyan Laboratory Equipment Co., Ltd., brand: BS929) and acetic acid aqueous solution were mixed in a volume ratio of 1:1 to obtain sterile acid-soluble type I collagen; wherein the concentration of the acetic acid aqueous solution was 2.06 mg / ml;

[0155] (4.2) Mix the sterile acid-soluble type I collagen and smooth muscle cell separation medium (manufacturer: Chengdu Casco Chemical Products Co., Ltd., brand number: C11995500BT) prepared in step (4.1), and add a 1.01 mol / L sodium hydroxide aqueous solution for neutralization to obtain a collagen gel precursor solution; wherein the volume ratio of the sterile acid-soluble type I collagen, the smooth muscle cell separation medium, and the sodium hydroxide solution is 1:2:2;

[0156] (5) preparing collagen gel tube I and collagen gel tube II;

[0157] Place the whisker I into the cylindrical tubular cavity of the second mold (composed of the second inner mold and the second outer mold), place the whisker II into the cylindrical tubular cavity of the third mold (composed of the third inner mold and the third outer mold), pour the collagen gel precursor solution into the cavities of the second mold and the third mold respectively for polymerization, after solidification, remove the second outer mold and the third outer mold, first wrap a layer of nylon mesh on the surface of the polymerized product, then wrap a layer of absorbent paper for water absorption, and then use ethylene oxide for sterilization. After the treatment, remove the absorbent paper, nylon mesh, second inner mold and third inner mold to obtain an artificial bladder.

[0158] The artificial bladder finally prepared includes a collagen gel tube I, a urine storage bag and a collagen gel tube II which are sequentially connected and communicated from top to bottom, and the lengths of the collagen gel tube I, the urine storage bag and the collagen gel tube II are 10 cm, 8 cm and 11 cm respectively;

[0159] Collagen gel tube I and collagen gel tube II are cylindrical tubes; the inner diameter of collagen gel tube I is 0.52 cm and the wall thickness is 0.21 cm, and the inner diameter of collagen gel tube II is 0.77 cm and the wall thickness is 0.21 cm;

[0160] The tube wall of the collagen gel tube I contains whiskers I, and the tube wall of the collagen gel tube II contains whiskers II; the length of the whiskers I is 55% of the length of the collagen gel tube I, and the length of the whiskers II is 55% of the length of the collagen gel tube II;

[0161] The urine storage bag is rugby-shaped, and its size increases first and then decreases from top to bottom; the urine storage bag is composed of elastic warp knitted fabric and polyurethane film; the elastic warp knitted fabric is divided into three sections: upper, middle and lower; the upper section and the lower section are warp plain structure, and the middle section is mesh warp knitted structure; the length of the upper section is 1 / 4 of the total length, the length of the lower section is 1 / 4 of the total length, the mesh of the middle section is a regular hexagon, and the side length of the regular hexagon is 1.1 mm; the elastic warp knitted fabric is composed of elastic yarn, and the elastic yarn is a coated yarn; the polyurethane film covers the outer layer of the elastic warp knitted fabric;

[0162] Both the whiskers I and II are connected to the yarn in the elastic warp knitted fabric, and both the whiskers I and II are yarn ends left at the edge of the elastic warp knitted fabric and are not woven or completely fixed;

[0163] The elastic modulus of collagen gel tube I in the artificial bladder is 5944Pa, and the maximum tensile stress is 1MPa; the elastic modulus of collagen gel tube II is 5953Pa, and the maximum tensile stress is 1MPa;

[0164] The maximum instantaneous drainage flow rate of the artificial bladder is 291 ml / s, the drainage time is 8.2 s, the number of tensile cycles is 1786 times, the hydrostatic pressure of the urine storage bag is 18 cmH2O, the elastic modulus is 7.6 MPa, and the maximum load is 41 N. After aging the artificial bladder at 70°C, normal pressure, and low oxygen concentration (50%) for 168 hours, its elastic modulus is 7.3 MPa.

[0165] Comparative Example 3

[0166] An artificial bladder, which is basically the same as that in Embodiment 4, except that: the upper and lower sections of the elastic warp knitted fabric are mesh warp knitted structures (with the same dimensions as that in Embodiment 4);

[0167] The drainage time of the artificial bladder is 8.5s.

[0168] By comparison, it can be seen that the drainage time of Example 3 is longer than that of Example 4. This is because the upper and lower sections of the elastic warp knitted fabric do not use warp plain tissue, so the urine is subjected to less force at both ends, so that the entire urine bag is filled with urine and the protrusion is reduced. When the bladder is pressed, the force is more uneven, which prolongs the drainage time.

[0169] Example 5

[0170] The preparation method of the artificial bladder is basically the same as that of Example 4, except that: in step (1.2), no whiskers I and II are left at both ends of the elastic warp knitted fabric during the preparation process; in step (4), there is no need to first place the whiskers into the cavity, and the collagen gel precursor solution is directly poured into the cavities of the second mold and the third mold respectively for polymerization, and after the collagen gel tubes I and II are obtained, they are connected to the urine storage bag by glue.

[0171] The final artificial bladder had a tensile cycle number of 1751 times.

Claims

1. An artificial bladder, characterized in that Collagen gel tube I, urine storage bag and collagen gel tube II are sequentially connected and communicated from top to bottom; The urine storage bag is rugby-shaped, and its size increases first and then decreases from top to bottom; the urine storage bag is composed of an elastic warp knitted fabric and a polyurethane film; the polyurethane film covers the outer layer of the elastic warp knitted fabric; The elastic warp knitted fabric is divided into three sections: upper, middle and lower. The upper and lower sections are warp plain structure, and the middle section is a mesh warp knitted structure.

2. The artificial bladder according to claim 1, characterized in that: The elastic warp knitted fabric is composed of elastic yarn, the elastic yarn is a covered yarn, the outer covering yarn is a 20±1 denier PP yarn or a 20±1 denier PE yarn, and the core yarn is a 15±0.7 denier spandex yarn; the breaking strength of the elastic yarn is 7±0.3N, the elastic recovery rate is 73±2%, and the elastic recovery rate of the elastic warp knitted fabric is 70±2%.

3. The artificial bladder according to claim 1, characterized in that: The length of the upper section or the lower section of the elastic warp knitted fabric is 1 / 20-1 / 5 of the total length of the elastic warp knitted fabric, and the mesh of the middle section is a regular hexagon with a side length of 1±0.1 mm.

4. The artificial bladder according to claim 1, characterized in that: The wall of collagen gel tube I contains whiskers I, and the length of whiskers I is 45-55% of the length of collagen gel tube I. The wall of collagen gel tube II contains whiskers II, and the length of whiskers II is 45-55% of the length of collagen gel tube II. Both whiskers I and whiskers II are connected to the yarn in the elastic warp knitted fabric, and whiskers I and whiskers II are yarn ends left at the edge of the elastic warp knitted fabric and are not woven or completely fixed.

5. The artificial bladder according to claim 4, characterized in that: Collagen gel tube I and collagen gel tube II are cylindrical tubes; the inner diameter of collagen gel tube I is 0.5±0.02 cm, and the wall thickness is 0.2±0.01 cm; the inner diameter of collagen gel tube II is 0.75±0.02 cm, and the wall thickness is 0.2±0.01 cm.

6. The artificial bladder according to claim 5, characterized in that: The hydrostatic pressure of the urine storage bag is 20±2cmH2O, the elastic modulus is 8±0.4MPa, and the maximum load is 36±2N; The maximum instantaneous flow rate of artificial bladder drainage is 82~291ml / s, and the drainage time is 2.8~8.2s; The tensile cycle number of the artificial bladder was 1789±38 times.

7. A method for preparing an artificial bladder according to any one of claims 1 to 6, characterized in that: The following steps are involved: (a) preparing an elastic warp knitted fabric, leaving whiskers I and whiskers II at both ends of the elastic warp knitted fabric during the preparation process; (b) coating; The elastic warp knitted fabric is placed in a first mold, and water-based polyurethane is poured into the mold cavity of the first mold and then dried. The first mold consists of a first inner mold and a first outer mold. The first inner mold is a plate-like structure. The elastic warp knitted fabric is flattened in the radial direction and then put on the first inner mold; (c) suture; The shape of the laminated elastic warp knitted fabric is adjusted by sewing so that it is in the shape of a rugby ball after being filled, and the size increases first and then decreases from top to bottom; (d) preparing collagen gel tube I and collagen gel tube II; The whisker I is placed in the cavity of the second mold, the whisker II is placed in the cavity of the third mold, and the collagen gel precursor solution is poured into the cavities of the second mold and the third mold respectively for polymerization.

8. The method according to claim 7, characterized in that In step (b), the product is washed and sterilized after drying, and ethylene oxide is used for sterilization.

9. The method according to claim 7, characterized in that: In step (d), the preparation process of the collagen gel precursor solution is: after mixing sterile acid-soluble type I collagen and smooth muscle cell separation medium, adding a sodium hydroxide solution with a concentration of 1±0.01 mol / L to neutralize, thereby obtaining a collagen gel precursor solution; wherein the volume ratio of sterile acid-soluble type I collagen, smooth muscle cell separation medium, and sodium hydroxide solution is 1:2:

2.

10. The method according to claim 7, characterized in that In step (d), after polymerization, the product is subjected to water absorption treatment and sterilization treatment in sequence; the process of water absorption treatment is: firstly wrapping a layer of nylon mesh on the surface of the product, and then wrapping a layer of absorbent paper; and ethylene oxide is used for sterilization treatment.

Images