CN114939003A - Preparation method of bracket tube applied to ureter - Google Patents

Abstract

A preparation method of a bracket tube for ureter application comprises the following steps: using a PTFE membrane as a stent lumen coating; b: coating the surface of the stent tube with an antibacterial anti-crystallization hydrophilic solution; c, changing the shaping time and temperature of the pig tail at the end of the indwelling renal pelvis in the processing of the bracket tube; d: the rear end of the ureter adopts a double-layer TPU anti-reflux film; e: the outer layer of the bracket pipe is made of temperature-sensitive TPU material; f: using a nickel-titanium wire as a manufacturing material of the stent tube instead of a stainless steel wire; g: the whole nickel material of the support tube adopts a spiral structure; h: the pitch is changed through a spiral structure; i, the outer layer of the stent tube has color which can be developed by X-ray. The invention reduces the processing difficulty of the finished product, and after the prepared finished product is placed in the corresponding organ of the human body, the invention can reduce the deposition, crystallization and blockage of the internal cavity of the stent tube, reduce the crystallization and infection on the surface of the stent tube, reduce the sliding probability of the ureteral stent tube, play a role in protecting the renal pressure and improve the urethral catheterization performance.

Description

A kind of stent tube preparation method for ureteral application

technical field

The invention relates to the technical field of medical equipment manufacturing, in particular to a method for preparing a stent tube for ureteral application.

Background technique

Ureteral diseases, such as benign prostatic hyperplasia, are common in older men, with a prevalence of as high as 60% in the 70-year-old. The main clinical manifestations are dysuria, frequent urination, increased nocturia, and in severe cases, hematuria and urinary retention may occur, and the inability to urinate. The current main treatments for BPH are drug therapy and surgery as well as stent placement. In the specific operation of stent placement, the stent tube is implanted into the prostate channel of the human body. The stent tube can push open the proliferative and squeezed prostate tissue, expand the passage of the urethra, relieve the pressure of the urethra, and achieve complete urethral patency, which avoids the need for surgery. It is currently the best choice for the treatment of dysuria due to benign prostatic hyperplasia.

Although the existing stent tube provides technical support for the treatment of ureteral diseases, due to the limitation of the structure, there are still some technical problems more or less, which are embodied as follows. One: The commonly used double-J-type ureteral stent does not solve the problems of crystal blockage and bacterial infection of the ureteral stent, which limits the use time in the patient's body, and can usually only be used as a Class 2 medical device; Second: Due to the relatively unreasonable structure of the stent tube, it is easy to slip in the human body after installation, which will adversely affect it; third: when the human bladder and kidney pressure is too high after implantation in the ureter, it will be transmitted back to the renal pelvis, which will cause harmful substances to enter the blood. Fourth: the existing technology is to use a single-layer anti-reflux tail film on the stent tube, but when opening and closing, the shape change will cause discomfort in the affected part; Discomfort and the probability of blockage; Sixth: The structure of the stent tube is a woven mesh structure, which is relatively more difficult to process and manufacture, and increases production costs; Sixth: Production drilling is easy to cause damage to the cutter head. In conclusion, there is still much room for improvement in existing ureteral manufacturing.

SUMMARY OF THE INVENTION

In order to overcome the drawbacks described in the background due to the limitations of the structure and processing technology in the existing ureteral manufacture, the present invention provides that under the combined action of the related processes, the processing difficulty is reduced, and the prepared finished product can be placed in the corresponding organs of the human body. A method for preparing a stent for ureteral application, which can reduce the blockage of deposited crystals in the inner lumen, reduce the surface crystals and infection of the stent, reduce the probability of the ureteral stent slipping, protect the renal pressure, and improve the catheterization.

The technical scheme adopted by the present invention to solve its technical problems is:

A method for preparing a stent tube for ureteral application, which is characterized by comprising the following processes: A: using a PTFE film as a coating of the inner cavity of the stent tube to reduce the probability that crystals in urine block the inner side of the stent tube; B: using an antibacterial anti-crystallization hydrophilic solution Coat the surface of the stent tube to reduce the probability of crystallization and infection on the surface of the stent tube; C: Change the time and temperature of the pigtail at the indwelling renal pelvis during the processing of the stent tube, so that the hardness of the head end pigtail is larger, and the probability of slippage of the stent tube is reduced, The bladder end is made of soft material to improve the adaptability of the human body; D: The back end of the ureter is made of double-layer TPU anti-reflux membrane, and the outer layer is hard to maintain the shape and reduce the discomfort caused by the shape change; E: The outer layer of the stent tube uses temperature-sensitive TPU material to improve user comfort; F: Use nickel-titanium wire instead of stainless steel wire as the material for the stent tube. After being implanted into the human body, it can recover by itself after being squeezed by a strong transient, reducing the probability of causing blockage and reducing special circumstances. Hazards caused by the pressure and occlusion of the stent tube; G: The overall nickel material of the stent tube adopts a spiral structure, which reduces the processing difficulty and shortens the average production time; H: The screw pitch is changed through the spiral structure to prevent the damage of the punching head and reduce the difficulty of the punching process. ; I: The outer layer of the stent tube has a color that can be visualized by X-ray, which is convenient for inspection and placement in the human body.

Further, in the process A, the thickness of the PTFE film is 20-50 nanometers.

Further, in the process B, the surface coating is improved from two aspects of anti-crystallization and bacteriostasis, and the thickness of the hydrophilic solution is 40-70 nanometers.

Further, in the process F, the probability of blocking can be reduced; the harm caused by special pressure blocking can be reduced.

Further, in the process H, the distribution density of the metal wires at the place to be punched is reduced to improve the safety of punching.

Further, in the process H, left-handed or right-handed inversion can be selected according to the indwelling position of the target client, so as to improve the catheterization of the ureteral stent.

The beneficial effects of the present invention are as follows: the present invention reduces the processing difficulty of the finished product in combination with the relevant preparation process flow, and after the prepared finished product is placed in the corresponding organs of the human body, it can reduce the blockage of deposition crystals in the inner lumen of the stent tube, reduce the surface crystallization of the stent tube and Infection, reducing the probability of ureteral stent slippage, protecting renal pressure, and improving catheterization. The invention overcomes the drawbacks in the prior art due to the limitation of the structure and the preparation process, which will bring about the production and application of the ureteral stent tube. Based on the above, the present invention has a good application prospect.

Description of drawings

Fig. 1 is the outline drawing of the finished product prepared by the present invention.

Figure 2 is a schematic structural diagram of the double-layer reverse flow tail membrane of the present invention.

Detailed ways

As shown in Figures 1 and 2, a method for preparing a stent for ureteral application, (1): use a PTFE film as the inner protective cavity layer of the ureteral stent to reduce the crystallization blockage of mucus in practical applications. (2): Use an antibacterial and anti-crystal hydrophilic solution to coat the surface of the stent tube, reduce the infection of the surface by urine crystals and human tissue, and reduce the recurrence rate (data show that after the use of the existing stent tube, 50% of the patients in clinical practice will suffer from postoperative complications). It will recur in 5 to 10 years. The main reason is that during the indwelling period, deposition crystals form on the surface of the ureteral stent, which directly or during the extraction process pierces or pulls open the ureteral mucosa, so that the bacteria can directly attach to the ureteral wall. On the surface, the deposition is gradually formed; therefore, the present invention improves the surface coating from the two aspects of anti-crystallization and bacteriostasis, and can overcome the shortcomings of the prior art.

As shown in Figures 1 and 2, a method for preparing a stent tube for ureteral application, (3): changing the production and shaping time and temperature of the pigtail at the indwelling renal pelvis end of the stent tube, so that the hardness of the pigtail at the head end is larger, and the stent tube is less placed in the human body. The probability of slippage in the urethra; the mechanical properties of the existing TPU polymer ureteral stents are fully contacted in the human urine environment and attenuate to 5/4 of the original every 30 days; Therefore, the present invention improves the hardness of the pigtail at the end of the renal pelvis, prevents displacement and slippage, and the bladder end of the stent tube is relatively soft to improve the adaptability of the human body. (4): The anti-reflux tail membrane is used to provide protection against renal pressure; in practice, when the bladder and kidney pressure is too high after the stent is implanted into the ureter, it will be transmitted to the renal pelvis, causing harmful substances to enter the blood, so it is necessary to prevent the reflux tail The membrane prevents pressure transmission. The existing practice is to use a single-layer anti-reflux tail membrane, but when it is opened and closed in application, the shape change will cause some discomfort in the human tissue. The present invention designs a double-layer TPU anti-reflux membrane, the outer layer The harder shape keeps the shape and reduces the discomfort caused by the shape change to the human tissue, and the inner layer plays the role of closing and opening. (5): Double-layer anti-reflux tail film to improve user comfort; (6): The outer layer of the stent tube is made of temperature-sensitive TPU material, which can improve user comfort. (7): Change the shaping time and temperature of the pigtail at the end of the bladder, so that the hardness of the pigtail at the tail end is smaller and the user comfort is improved.

As shown in Figures 1 and 2, a method for preparing a stent for ureteral application, (8): use nickel-titanium wire instead of stainless steel wire as the main material. It reduces the probability of causing obstruction; and reduces the harm caused by the compression and occlusion of the stent tube under special circumstances. (9): The nickel-titanium wire stent tube adopts a helical structure, which reduces the difficulty of processing and shortens the average working time; the coiled spring-like structure is much more efficient than the existing stent tube weaving mesh spinning. (10): In the place where the titanium wire spiral stent tube needs to be punched, the screw pitch is changed, which avoids the damage of the hole cutter head and reduces the difficulty of the hole process. The distribution density becomes lower and the punching safety is improved. (11): The PTFE layer has color and can be developed, and the upper layer is transparent, which is convenient for the drilling process and implantation in the human urethra under X-ray. (12): The nickel-titanium wire has two spiral directions. According to the needs of the target customer during the indwelling period, left-handed or right-handed is selected, which can improve the catheterization of the ureteral stent. Combined with the relevant preparation process, the invention reduces the difficulty of processing, and after the prepared product is placed in the corresponding organs of the human body, it can reduce the blockage of deposited crystals in the lumen of the ureteral stent, reduce the surface crystallization and infection of the stent, and reduce the sliding of the ureteral stent. It can protect the renal pressure, improve the catheterization, and overcome the disadvantages of the prior art due to the limitation of the structure and the preparation process, which will bring about the production and application of the ureteral stent.

While the basic principles and main features and advantages of the present invention have been shown and described above, it will be apparent to those skilled in the art that the present invention is limited to the details of the above-described exemplary embodiments without departing from the spirit or essential characteristics of the present invention. In this case, the present invention can be implemented in other specific forms. Therefore, the embodiments are to be regarded in all respects as illustrative and not restrictive, and the scope of the invention is to be defined by the appended claims rather than the foregoing description, which are therefore intended to fall within the scope of the claims. All changes within the meaning and scope of the equivalents of , are included in the present invention.

In addition, it should be understood that although this specification is described according to an embodiment, it does not mean that the embodiment only includes an independent technical solution. This description in the specification is only for the sake of clarity. Those skilled in the art should take the specification as a whole and implement the The technical solutions in the examples can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims (6)

1. A preparation method of a bracket tube for ureter application is characterized by comprising the following steps: the PTFE film is used as the coating of the inner cavity of the stent tube, so that the probability that crystals in urine block the inner side of the stent tube is reduced; b: the surface of the stent tube is coated with the antibacterial anti-crystallization hydrophilic solution, so that the crystallization and infection probability of the surface of the stent tube is reduced; changing the shaping time and temperature of the pig tail at the end of the indwelling renal pelvis in the processing of the bracket tube to ensure that the hardness of the pig tail at the head end is higher, reducing the probability of slippage of the bracket tube, and improving the adaptability of a human body by adopting a soft material at the bladder end; d: the rear end of the ureter adopts a double-layer TPU anti-reflux film, the outer layer is hard to keep the shape and reduce discomfort in a patient body caused by shape change; e: the outer layer of the bracket tube is made of a temperature-sensitive TPU material, so that the comfort of a user is improved; f: the nickel-titanium wire is used as a manufacturing material of the stent tube instead of a stainless steel wire, and can be automatically recovered after being implanted into a human body and subjected to strong transient extrusion, so that the blocking probability is reduced, and the harm caused by the compression and blocking of the stent tube under special conditions is reduced; g: the whole nickel material of the support tube adopts a spiral structure, so that the processing difficulty is reduced, and the average production time is shortened; h: the screw pitch is changed through the spiral structure, the damage probability of the punching cutter head is avoided, and the difficulty of the punching process is reduced; i, the outer layer of the stent tube has color which can be developed by X-ray, and is convenient for examination and placement into a human body.

2. The method for preparing a bracket tube for ureter according to claim 1, wherein in the process A, the PTFE film with the thickness of 20-50 nm is used.

3. The method for preparing a ureteral stent according to claim 1, wherein in the process B, the surface coating is improved from the aspects of crystallization resistance and bacteriostasis, and the thickness of the hydrophilic solution is 40-70 nm.

4. The method for preparing a bracket tube for ureter according to claim 1, wherein in the process F, the probability of blockage is reduced; reduce the harm caused by special pressure occlusion.

5. The method for preparing a bracket tube for ureter according to claim 1, wherein in the process H, the distribution density of the metal wires at the position to be perforated is reduced, and the perforation safety is improved.

6. The method for preparing a stent tube for ureter according to claim 1, wherein in the process H, the left-handed or right-handed reversal can be selected according to the position in the indwelling body of the target customer, so as to improve the catheterization performance of the ureter stent tube.

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