Y-shaped anti-adhesion bionic urine outflow channel

Abstract

The utility model discloses a Y-shaped anti-adhesion bionic urine outflow channel which comprises a Y-shaped bionic outflow channel, and the Y-shaped bionic outflow channel comprises an A-area pipeline, a B-area pipeline and a C-area pipeline. The device disclosed by the utility model has the beneficial effects that a layer of mixture of silicone oil and PDMS (Polydimethylsiloxane) is coated on the inner layer of the Y-shaped silica gel pipeline subjected to 3D printing and is cured at high temperature, so that the silicone oil can be stably secreted on the inner surface, and the adhesion of urine crystals, blood and bacterial membranes is effectively resisted; a layer of microneedles capable of slowly releasing medicine is arranged on an outer-layer pipeline, connected with the ureter, of the device, the pipeline can be helped to be embedded with the ureter, medicine such as antibiotics and wound growth can be slowly released, and growth and healing of the embedded position are promoted; the device can be applied to radical bladder resection combined with urine flow diversion, and can replace the bladder of a patient and the intestinal tract needing to be resected for urine drainage.

Description

Technical Field

[0001] The utility model relates to a bionic urine outflow tract, in particular to a Y-shaped anti-adhesion bionic urine outflow tract, belonging to the technical field of medical devices. Background Art

[0002] Bladder cancer is one of the top ten highly prevalent malignant tumors globally. Among the classifications of bladder cancer, muscle-invasive bladder cancer is characterized by high malignancy, high recurrence rate, and easy occurrence of distant metastasis. Its high mortality rate and poor prognosis have a serious impact on society. Radical cystectomy combined with urinary diversion surgery is the preferred treatment method for non-metastatic muscle-invasive bladder cancer. The choice of surgical method will lead to the destruction of the original urine flow channel after bladder resection. Therefore, urinary diversion surgery is required to drain urine to the outside of the body. At the same time, for some congenital urinary system diseases, including posterior urethral valves, exstrophy of the bladder, and neurogenic bladder, due to the reduced capacity of the bladder organ and impaired compliance, it is necessary to reconstruct or replace the dysfunctional urine outflow channel to avoid further kidney injury and failure.

[0003] In the application of existing urinary diversion surgeries after radical cystectomy for muscle-invasive bladder cancer, the following main surgical procedures are included:

[0004] (1) Orthotopic neobladder

[0005] Using the patient's own intestinal tissue (such as the terminal ileum) to construct a new bladder to replace the excised original bladder; the patient does not need an abdominal wall stoma, can restore a near-normal urination habit, maintain the quality of life and self-image; it can be applicable to cases where the urethra is intact, the external sphincter function is good, the renal function is good, and there are no obvious intestinal lesions, etc., but it is prone to complications such as urethral invasion, multiple in-situ bladder cancers, and pelvic lymph node metastasis.

[0006] (2) Ileal conduit

[0007] Directly connecting a section of ileum to the abdominal wall to form a stoma, and urine is discharged through this stoma. The operation is simple, safe, and effective, but the patient needs to wear a urine collection bag for life, which affects the quality of life, and it is prone to complications such as urinary tract infection, pyelonephritis, ureteroileal anastomotic leakage or stenosis.

[0008] (3) Ureterocutaneostomy

[0009] Directly connecting the ureter to the abdominal wall skin to form a stoma, and urine is directly discharged; the operation is simple, but the risks of stoma stenosis and retrograde urinary tract infection are relatively high; however, this method can only be applicable to patients with a short life expectancy, distant metastasis, and intestinal diseases that cannot use the intestine for urinary diversion.

[0010] In the prior art, such as the existing urinary diversion surgery, the contact between urine and the stoma or the neobladder may cause infections, such as urinary tract infections, pyelonephritis, etc. For patients with ureterocutaneostomy and ileal conduit, since urine directly contacts the outside world, the infection risk is relatively high, and patients with ileal conduit and ureterocutaneostomy need to wear a urine collection bag for life, seriously affecting the quality of life. Although the continent urinary diversion surgery solves the problem of wearing a bag, the patient still needs to catheterize frequently, increasing the risk of retrograde infection, and all kinds of urinary diversion surgeries may cause complications, such as stoma stenosis, ureteroileal anastomotic leakage or stenosis, electrolyte disorders, etc. However, its function of intercepting the patient's own healthy ileum to replace the bladder for urine storage and drainage destroys the continuity of the normal intestine, and is prone to complications related to intestinal mucosa such as hypokalemia, hyperchloremic acidosis, calcium and phosphorus metabolism disorders, and retrograde infection after surgery. The orthotopic neobladder may lead to electrolyte and acid-base balance disorders, and the patient needs to drink a large amount of water or take alkaline drugs, and then the patient needs more frequent postoperative follow-up to monitor the electrolyte and acid-base balance. Patients undergoing orthotopic neobladder and ileal bladder surgeries need to strictly control their diet and perform thorough enema and other preoperative preparations before surgery. After surgery, they need to fast and refrain from drinking until intestinal function recovers, which is not conducive to the postoperative recovery of patients with malignant tumors.

[0011] Therefore, the effort to seek artificial materials to replace the ileum for urinary diversion has always been an important direction in the research of urological tissue engineering technology. For example, a multi-lumen catheter for bladder cancer urinary diversion surgery disclosed in the patent publication number CN211357016U, a designed four-lumen catheter, in which two of the surgical instrument lumens can insert the left and right single-J catheters into the left and right kidneys respectively, forming a complete whole with the catheter, which can greatly shorten the time of inserting the single-J catheter from the urethra during the operation, is very convenient and simple, and saves precious operation time. However, compared with normal urethral tissue, the artificial implant materials in the urinary tract lack peristaltic function and micturition function, and urine is prone to form reflux due to body position changes, causing bacterial retrograde infection and urinary crystal deposition. Obstruction is related to bacterial biofilm colonization and urinary crystal deposition. More than 150 million people are affected by urinary tract infections worldwide every year, and infections caused by urinary tract implants are an important cause of morbidity and mortality of urinary tract infections. Any biomaterial that is long-term exposed to the urinary environment is a breeding ground for microbial growth and a heterogeneous site that promotes the nucleation and crystallization of inorganic salts. Therefore, implants in the urinary system are constantly challenged by bacterial colonization and mineralization in the body and are extremely prone to form encrustation or implant-related infections. The high incidence and intractability of implant-related urinary tract infections are also related to the formation of bacterial biofilms on the surface of implants. Bacterial biofilms refer to organized bacterial populations attached to the surface of living or inanimate objects and wrapped by extracellular polysaccharides secreted by bacteria themselves. In addition to water and bacteria, bacterial biofilms also contain macromolecular polymers secreted by bacteria, adsorbed nutrients and metabolites, and bacterial lysis products such as muramic acid and teichoic acid. The first stage of the formation of implant bacterial biofilms is the adhesion of bacteria to the surface of the material to form a grid-like regulatory film. After contacting urine, specific adhesin proteins on the surface of bacteria, including fibronectin and fibrinogen, adhere to the surface of the catheter material through hydrophobic interaction, and then adjust their gene expression to secrete a large amount of adhesion proteins while growing and multiplying, thickening the biofilm. Bacterial biofilms can not only act as a barrier to block the transport of antibiotic molecules to bacterial cells, but also reduce the sensitivity to antibiotics. In addition, biofilms can release virulent factors such as proteases, phospholipases and toxins, which can interfere with the chemotaxis and activation of neutrophils, and thus inhibit the natural defense function of the body. Therefore, once the bacterial biofilm develops maturely, it is very difficult to effectively remove it with antibiotics. It is best to inhibit bacterial adhesion from the material itself and inhibit the formation of bacterial biofilms from the first stage.

[0012] For the artificial implant materials in the urinary tract to exert the ability to resist urinary crystals, blood, and bacterial biofilm adhesion in the body for a long time, they also need to have a lubricating layer similar to that on the surface of the intestinal mucosa, which can continuously secrete mucus to form a stable self-lubricating layer under external mechanical or chemical stimuli, avoiding the loss of the surface structure. In the classic Bricker operation for urinary diversion in urology, a healthy ileum is intercepted to replace the bladder to function as a urinary flow channel because the mucus on the surface of the ileum can not only resist the erosion of urine on the intestinal mucosa but also reduce bacterial adhesion and inhibit the formation of bacterial biofilms to a certain extent. The gastrointestinal mucus layer is a very hydrated and complex viscoelastic medium with mucin in the form of macromolecular gels as the skeletal component. These proteins are tightly wrapped in mucus secretion granules and stored in intestinal epithelial goblet cells in the form of vesicles, and are secreted into the intestinal lumen and quickly unfold to form a large reticulated layered structure. This dense mucin network separates bacteria from intestinal epithelial cells and prevents microorganisms from invading intestinal epithelial cells. At the same time, mucin can bind to flagellated bacteria and inhibit the movement of flagella, such as Proteus mirabilis, Helicobacter pylori, and Escherichia coli, thus preventing bacterial invasion. Summary of the Invention

[0013] The purpose of the present utility model is to provide a Y-shaped anti-adhesion bionic urine outflow tract to solve at least one of the above technical problems.

[0014] The present utility model realizes the above purpose through the following technical solutions: A Y-shaped anti-adhesion bionic urine outflow tract, including a bionic outflow tract, the bionic outflow tract is Y-shaped, the bionic outflow tract includes an A-area pipeline, a B-area pipeline, and a C-area pipeline, the A-area pipeline and the B-area pipeline are located on both sides of the same end of the bionic outflow tract, and the C-area pipeline is located at the other end of the bionic outflow tract;

[0015] The A-area pipeline is sequentially provided with an A-area microneedle, an A-area silicone tube, and an A-area coating from outside to inside, the B-area pipeline is sequentially provided with a B-area microneedle, a B-area silicone tube, and a B-area coating from outside to inside, the C-area pipeline is sequentially provided with a C-area silicone tube and a C-area coating from outside to inside, and the A-area silicone tube, the B-area silicone tube, and the C-area silicone tube are connected and communicated.

[0016] As a further scheme of the present utility model: The A-area silicone tube, the B-area silicone tube, and the C-area silicone tube are integrally formed by 3D printing, and the A-area silicone tube, the B-area silicone tube, and the C-area silicone tube are combined into a Y-shaped silicone pipeline.

[0017] As a further scheme of the present utility model: The A-area coating, the B-area coating, and the C-area coating are all heat-cured coatings formed by mixing PDMS and silicone oil in a certain proportion.

[0018] As a further scheme of the present utility model: Both the A-area microneedle and the B-area microneedle are microneedles made of PDMS wrapped with drugs.

[0019] As a further solution of the present utility model: the inner diameters of the pipelines in area A and area B are set to the inner diameters of the ureters of the patients measured by CT, and the inner diameter range is 5-7 mm.

[0020] As a further solution of the present utility model: the inner diameter of the pipeline in area C is set to the inner diameter of the urinary catheter of the patients measured by CT, and the inner diameter range is 4-10 mm.

[0021] As a further solution of the present utility model: the pipe wall thicknesses of the pipelines in area A, area B and area C are 0.9-1.1 mm.

[0022] The beneficial effects of the present utility model are as follows: a mixture of silicone oil and PDMS is coated on the inner layer of the 3D printed Y-shaped silicone pipeline and cured at high temperature, so that silicone oil can be stably secreted on the inner surface, effectively resisting the adhesion of urine crystals, blood and bacterial biofilms. The outer pipeline connected to the ureter of the device has a layer of microneedles that can slowly release drugs, which can not only help the pipeline to fit with the ureter, but also slowly release drugs such as antibiotics and drugs promoting wound growth, promoting the growth and healing of the fitting part. This device can be applied in radical cystectomy combined with urinary diversion surgery to replace the patient's bladder and the intestine to be removed, and play a role in urine drainage. Description of the Drawings

[0023] Figure 1 It is a schematic diagram of the overall structure of the present utility model;

[0024] Figure 2 It is a schematic diagram of the sectional structure of the pipeline in area A of the present utility model;

[0025] Figure 3 It is a schematic diagram of the sectional structure of the pipeline in area B of the present utility model;

[0026] Figure 4 It is a schematic diagram of the sectional structure of the pipeline in area C of the present utility model.

[0027] In the figure: 1. Pipeline in area A, 11. Microneedles in area A, 12. Silicone tube in area A, 13. Coating in area A, 2. Pipeline in area B, 21. Microneedles in area B, 22. Silicone tube in area B, 23. Coating in area B, 3. Pipeline in area C, 31. Silicone tube in area C, 32. Coating in area C. Detailed Embodiments

[0028] Next, the technical solutions in the embodiments of the present utility model will be clearly and completely described in conjunction with the drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all of the embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present utility model.

[0029] Example 1, as Figures 1 to 4 shown, a Y-shaped anti-adhesion bionic urine outflow tract includes a bionic outflow tract. The bionic outflow tract is Y-shaped and includes an A-region duct 1, a B-region duct 2, and a C-region duct 3. The A-region duct 1 and the B-region duct 2 are located on both sides of the same end of the bionic outflow tract, and the C-region duct 3 is located at the other end of the bionic outflow tract. With the Y-shaped structural design, the A-region duct 1 and the B-region duct 2 are respectively connected and sutured to the bilateral ureters, and the C-region duct 3 is connected and sutured to the urethral catheter, reducing the direct contact between urine and the skin, reducing the incidence of complications such as stoma stenosis, ureteroileal anastomotic leakage or stenosis, eliminating the need to drink a large amount of water or take alkaline drugs as in the orthotopic neobladder surgery, reducing the risk of electrolyte disorders, and eliminating the need for patients to frequently monitor electrolytes and acid-base balance as in the orthotopic neobladder surgery;

[0030] The A-region duct 1 is sequentially provided with an A-region microneedle 11, an A-region silicone tube 12, and an A-region coating 13 from outside to inside. The B-region duct 2 is sequentially provided with a B-region microneedle 21, a B-region silicone tube 22, and a B-region coating 23 from outside to inside. The C-region duct 3 is sequentially provided with a C-region silicone tube 31 and a C-region coating 32 from outside to inside. The A-region silicone tube 12, the B-region silicone tube 22, and the C-region silicone tube 31 are connected and communicated.

[0031] Example 2, in addition to including all the technical features in Example 1, this example further includes: The A-region silicone tube 12, the B-region silicone tube 22, and the C-region silicone tube 31 are integrally formed by 3D printing, and the A-region silicone tube 12, the B-region silicone tube 22, and the C-region silicone tube 31 are combined into a Y-shaped silicone tube. By using the silicone tube as the main body of the bionic outflow tract, it can replace the patient's bladder and the intestine to be removed, avoiding the use of abdominal wall stomas and urine collection bags, and greatly improving the patient's quality of life.

[0032] The A-region coating 13, the B-region coating 23, and the C-region coating 32 are all thermosetting coatings formed by mixing PDMS and silicone oil in equal proportions, which can effectively resist the adhesion of urine crystals, blood, and bacterial biofilms, reducing the risk of infection.

[0033] The A-region microneedle 11 and the B-region microneedle 21 are both microneedles made of PDMS wrapped with drugs, and the microneedles can slowly release antibiotics, further reducing the incidence of infection.

[0034] Example 3, in addition to including all the technical features in Example 1, this example further includes: The inner diameters of the A-region duct 1 and the B-region duct 2 are set to the inner diameters of the patient's ureters measured by CT, and the inner diameter range is 5 - 7 mm.

[0035] The inner diameter of the C-region duct 3 is set to the inner diameter of the patient's urethral catheter measured by CT, and the inner diameter range is 4 - 10 mm.

[0036] The pipe wall thickness of the pipes in Area A 1, Area B 2, and Area C 3 is 0.9 - 1.1 mm.

[0037] Working principle:

[0038] Manufacturing process:

[0039] Use 3D printing to produce a Y-shaped silicone pipe. The inner diameters of the pipes in Areas A and B are set to the inner diameters of the patient's ureters measured by CT, generally 6 mm, and the inner diameter of the pipe in Area C is set to the inner diameter of the patient's urinary catheter measured by CT, generally about 10 mm, with a pipe thickness of 1 mm.

[0040] Use a MoFang Precision microArch® S240 (accuracy: 10 μm) 3D printing device to print a microneedle concave mold. After surface fluoro-silanization treatment, mix antibiotics or wound healing promoting drugs with PDMS and pour the mixture into the microneedle concave mold. After curing at 90°C for 1 hour, demold to obtain a planar microneedle film, and attach it to Areas A and B of the Y-shaped silicone pipe. Coat the joint with PDMS and cure it by ultraviolet irradiation.

[0041] Mix PDMS and 1000cst silicone oil in a certain proportion, evenly coat the inside of the Y-shaped pipe, place it at 90°C for 1 hour to cure the coating and adhere it to the inner pipe. After placing it for 24 hours, when the inner pipe starts to secrete a silicone oil layer, it can be used.

[0042] Usage method:

[0043] For bladder cancer patients, preoperatively evaluate the necessity of total cystectomy, perform a CTU of the urinary system to detect the inner diameters of the bilateral ureters and urethra, and customize a Y-shaped urine outflow tract of appropriate size.

[0044] After subjecting the prepared Y-shaped urine outflow tract to high-temperature and high-pressure or ethylene oxide sterilization, seal it and store it together with a sterilization indicator strip, and use it before the sterilization indicator strip shows invalidation.

[0045] The patient lies in a supine position. After anesthesia, routinely disinfect and drape the patient, and establish a stable airway to keep the patient's airway unobstructed. Establish a laparoscopic access: Make an observation hole under the umbilicus, usually about 10 cm long, and insert a laparoscope. Make 2 - 3 auxiliary holes at other positions on the abdomen for the entry and exit of operating instruments. Free the bladder and surrounding tissues, ligate and cut the bilateral vas deferens, free the lateral wall and apex of the prostate, suture and ligate the dorsal deep vascular complex of the penis, cut the posterior urethra and perform bilateral lymph node dissection to remove possible tumor metastases.

[0046] Constructing a new urine outflow tract in situ: Lead the lower segments of the bilateral ureters out of the incision, insert a No. 6 or No. 7 double J tube, and then insert the double J tube from the A and B areas of the Y-shaped urine outflow tract, and exit from the C area. Adjust the position so that the microneedles in the AB area of the Y-shaped urine outflow tract are embedded in the inner wall of the bilateral ureters. Suture a circle at the joint to make the Y-shaped urine outflow tract and the bilateral ureters fit seamlessly.

[0047] Anastomosis of the Y-shaped urine outflow tract and the urethra: insert the C area of the Y-shaped urine outflow tract into the urethral incision, use sutures to perform 6-point interrupted sutures to connect the urethra and the Y-shaped urine outflow tract. Insert a No. 22 three-chamber balloon catheter into the C area of the Y-shaped urine outflow tract, inject 30ml of water into the balloon to fix the catheter, and tie a double J tube to the catheter.

[0048] Check the patency of the urinary catheter and place a drainage tube: inject 50 ml of normal saline through the urinary catheter, check whether there is obvious leakage in the anastomosis and the Y-shaped urine outflow tract, check whether the intestinal tract is compressed, place a rubber drainage tube in the bilateral iliac fossa for drainage, remove the cannula, and suture the incision. After the operation, the patient needs to check the skin integrity of the compressed area and keep the tube open to prevent slippage.

[0049] It is obvious to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be regarded as exemplary and non-restrictive from any point of view, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims be included in the present invention. Any reference numeral in a claim should not be regarded as limiting the claim to which it relates.

[0050] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A Y-shaped anti-adhesion bionic urine outflow tract, comprising a bionic outflow tract, characterized in that: The bionic outflow tract is Y-shaped and includes an A-region pipe (1), a B-region pipe (2), and a C-region pipe (3). The A-region pipe (1) and the B-region pipe (2) are located on both sides of the same end of the bionic outflow tract, and the C-region pipe (3) is located at the other end of the bionic outflow tract. The A-region pipe (1) is sequentially provided with an A-region microneedle (11), an A-region silicone tube (12), and an A-region coating (13) from outside to inside. The B-region pipe (2) is sequentially provided with a B-region microneedle (21), a B-region silicone tube (22), and a B-region coating (23) from outside to inside. The C-region pipe (3) is sequentially provided with a C-region silicone tube (31) and a C-region coating (32) from outside to inside. The A-region silicone tube (12), the B-region silicone tube (22), and the C-region silicone tube (31) are connected and communicate with each other.

2. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, characterized in that: The A-region silicone tube (12), the B-region silicone tube (22), and the C-region silicone tube (31) are integrally formed by 3D printing, and the A-region silicone tube (12), the B-region silicone tube (22), and the C-region silicone tube (31) are combined into a Y-shaped silicone pipe.

3. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, characterized in that: The A-region coating (13), the B-region coating (23), and the C-region coating (32) are all thermosetting coatings mixed with PDMS and silicone oil.

4. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, wherein: Both the A-region microneedle (11) and the B-region microneedle (21) are microneedles made of PDMS wrapped with drugs.

5. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, characterized in that: The inner diameters of the A-region pipe (1) and the B-region pipe (2) are set to the inner diameter of the patient's ureter measured by CT, and the inner diameter range is 5 - 7 mm.

6. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, characterized in that: The inner diameter of the C-region pipe (3) is set to the inner diameter of the patient's urinary catheter measured by CT, and the inner diameter range is 4 - 10 mm.

7. The Y-shaped anti-adhesion bionic urine outflow tract according to claim 1, characterized in that: The wall thickness of the A-region pipe (1), the B-region pipe (2), and the C-region pipe (3) is 0.9 - 1.1 mm.

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