CN110368572A - Catheter capable of realizing long-acting sustained-release administration function and preparation method thereof - Google Patents

Abstract

The present invention relates to a medical device for urinary catheterization, in particular to a urinary catheter capable of realizing long-acting sustained-release drug delivery function and a preparation method thereof. In order to solve the problems in the prior art that the introduced coating is easy to fall off, the drug holding capacity is small, and the release is too fast. The urinary catheter includes a urinary catheter main pipe, which is provided with at least one groove; the groove is formed by a laser processing process; the opening of the groove is located on the outer wall of the urinary catheter in the contact area with the human body. The invention also provides a preparation method of a urinary catheter capable of realizing the function of long-acting sustained-release drug delivery. Compared with the method of coating the medicine on the outer surface of the main urinary catheter in the prior art, the present invention is provided with a groove outside the main urinary catheter, so that the medicine filled in the groove is not easy to fall off, and the specific surface area of the main urinary catheter is improved. , which in turn allows the catheter tube to hold more medication.

Description

Urinary catheter capable of realizing long-acting sustained-release drug delivery function and preparation method thereof

technical field

The present invention relates to a medical device for urinary catheterization, in particular to a urinary catheter capable of realizing long-acting sustained-release drug delivery function and a preparation method thereof.

Background technique

A urinary catheter is a tube that is inserted into the bladder from the urethra to drain urine. After the catheter is inserted, it may cause side effects such as urethral hemorrhage, infection, and atrophy due to various reasons, especially for patients with long-term catheterization. , the probability of side effects is higher; in addition, due to treatment requirements or in order to reduce the occurrence of side effects, the catheter needs to be replaced multiple times, which not only brings great pain and economic burden to the patient, but also increases the medical staff's burden. workload.

In the prior art, in order to reduce or avoid the occurrence of side effects, various antibacterial or sustained-release urinary catheters have appeared, which generally use the method of coating the outer surface of the urinary catheter with drugs. However, these technologies all have problems such as coating peeling off, low drug holding capacity, and too fast release to varying degrees.

SUMMARY OF THE INVENTION

The purpose of the present invention is to solve the problems in the prior art that the coating is easy to fall off, the drug holding capacity is small, and the drug release is too fast, and a urinary catheter that can realize the long-acting sustained-release drug delivery function and its preparation method are provided. .

The technical solution of the present invention is: a urinary catheter capable of realizing a long-acting sustained-release drug delivery function, including a urinary catheter main pipe, the special feature of which is that: the urinary main pipe is provided with at least one groove; The groove is formed by a laser processing technology; the opening of the groove is located in the contact area with the human body on the outer wall of the urinary catheter.

Further, medicines are contained in the grooves, and the medicines are powder medicines.

Further, in order to slow down the release speed of the drug filled in the groove, the outer surface of the urinary catheter tube is covered with a sustained-release protective film, and the sustained-release protective film can be partially or completely coated.

Further, the slow-release protective film is a protein film or a nano-SiO film or a film formed by mixing the _two ;

The medicine is any one or more mixtures of antibacterial agent, lubricant, analgesic agent and anesthetic agent, which can achieve antibacterial effect on the urethra, prevent urethral atrophy, facilitate the insertion of a urinary catheter or other treatment during catheterization. Purpose.

Further, the width of the grooves is less than 1000 microns; the grooves are arranged radially, obliquely, spirally, reticulately and/or circumferentially.

Based on the above-mentioned urinary catheter, the present invention also provides a method for preparing a urinary catheter capable of realizing a long-acting sustained-release drug delivery function, which is special in that it comprises the following steps:

Step 1. Use natural rubber, silicone rubber, polyurethane, polyvinyl chloride (PVC) or metal material to prepare a urinary catheter;

Step 2. Use nanosecond laser, picosecond laser or femtosecond laser to process grooves on the outside of the catheter tube. When the laser forms the groove, the surface of the catheter tube cannot be visually damaged due to the thermal effect of the laser. Noticeable difference in appearance.

Further, the preparation method also includes:

Step 3, filling the medicine in the groove.

Further, after the step 3, it also includes:

In step 4, the outer surface of the catheterized catheter obtained in step 3 is covered with a slow-release protective film.

Further, in the step 3, it also includes detecting the content of the drug filling amount by weighing the increased value of the catheter catheter before and after filling the drug, and the step 3 is specifically:

Step 3.1, weigh the catheter tube;

Step 3.2, loading the medicine in the groove;

Step 3.3, weigh the catheter tube containing the drug;

In step 3.4, the weight obtained in step 3.3 is subtracted from the weight obtained in step 3.1, and the filling amount of the drug can be detected.

Further, in order to improve the efficiency, the laser used in the step 2 is a point laser or a line laser.

The beneficial effects of the present invention are:

1. with respect to the mode of coating medicine on the outer surface of the main urinary catheter, the present invention is provided with a groove outside the main urinary catheter, so that the medicine filled in the groove is not easy to fall off, and improves the performance of the main urinary catheter. The specific surface area, which in turn allows the catheter tube to hold more drugs;

2. The present invention adopts laser processing technology to form grooves, and the laser can be applied to catheters of various materials, and the laser is not easy to form corrosion or mechanical deformation on the surface of the catheter, and the processing speed is also relatively fast;

3. The groove formed by the present invention can also realize the slow release of the encapsulated medicine, and achieve a long-acting slow-release effect; after the medicine is loaded, a slow-release protective film can also be coated on the outer wall of the urinary catheter, which slows down the release rate of the loaded medicine. , to further achieve a long-acting slow-release effect.

Description of drawings

1 is a schematic cross-sectional view of a urinary catheter with radial grooves of the present invention;

Fig. 2 is a schematic cross-sectional view of a urinary catheter with an annular groove of the present invention.

The reference signs are: 1- catheter tube, 2- groove, 3- catheter inner wall, 4- catheter outer wall, 5- sustained release protective film, 6- drug.

Detailed ways

The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

Embodiment 1: As shown in FIG. 1, a urinary catheter capable of realizing long-acting sustained-release drug delivery function includes a urinary catheter main pipe 1, and a plurality of grooves 2 are provided on the outside of the urinary catheter main pipe 1; The groove 2 is formed by a laser processing process; the opening of the groove 2 is located in the contact area with the human body on the outer wall 4 of the urinary catheter. The groove 2 contains a medicine 6, and the medicine 6 is a powder medicine. The outer surface of the urinary catheter 1 is covered with a slow-release protective film 5 . The sustained-release protective film 5 is a protein film; the drug 6 is an antibacterial agent. The width of the grooves 2 is less than 1000 microns; the grooves 2 are arranged radially, obliquely, spirally or in a net shape.

The above-mentioned preparation method of a urinary catheter capable of realizing long-acting sustained-release drug delivery function comprises the following steps:

Step 1), adopting natural rubber to prepare the main catheter 1;

Step 2), use point laser to process groove 2 outside the catheter main pipe 1, the groove 2 is a radial groove, and when the laser is forming the groove 2, the surface of the catheter main pipe 1 cannot be generated because the laser Significant differences in visual appearance of catheter 1 due to thermal effects;

Step 3), the specific implementation steps are as follows:

Step 3.1), weigh the weight of main catheter 1;

Step 3.2), using coating method to fill the medicine 6 in the groove 2;

Step 3.3), weigh the weight of the catheterization main pipe 1 that is equipped with the medicine 6;

Step 3.4), subtracting the weight obtained in step 3.1) from the weight obtained in step 3.3), the filling amount of medicine 6 can be detected;

Step 4), coating the outer surface of the catheter tube 1 filled with the medicine 6 with a protein film.

Embodiment 2: As shown in FIG. 2, a urinary catheter capable of realizing long-acting sustained-release drug delivery function includes a urinary catheter main pipe 1, and a plurality of grooves 2 are provided on the outside of the urinary catheter main pipe 1; The groove 2 is formed by a laser processing process; the opening of the groove 2 is located in the contact area with the human body on the outer wall 4 of the urinary catheter. The groove 2 contains a medicine 6, and the medicine 6 is a powder medicine. The outer surface of the urinary catheter 1 is covered with a slow-release protective film 5 . The sustained-release protective film 5 is a film formed by mixing the nano-SiO ₂ film and the protein film; the drug 6 is an analgesic. The width of the grooves 2 is less than 1000 microns; the grooves 2 are arranged circumferentially.

The above-mentioned preparation method of a urinary catheter capable of realizing long-acting sustained-release drug delivery function comprises the following steps:

Step 1), using polyurethane to prepare the main catheter 1;

Step 2), use a line laser to process groove 2 outside the catheter main pipe 1, and the groove 2 is a circumferential groove. When the laser is forming the groove 2, the surface of the catheter main pipe 1 cannot be generated because the laser Significant differences in visual appearance of catheter 1 due to thermal effects;

Step 3), the specific implementation steps are as follows:

Step 3.1), weigh the weight of main catheter 1;

Step 3.2), using coating method to fill the medicine 6 in the groove 2;

Step 3.3), weigh the weight of the catheterization main pipe 1 that is equipped with the medicine 6;

Step 3.4), subtracting the weight obtained in step 3.1) from the weight obtained in step 3.3), the filling amount of medicine 6 can be detected;

Step 4), the outer surface of the catheter tube 1 filled with the drug 6 is coated with a film formed by mixing the nano-SiO ₂ film and the protein film.

In the present invention, a urinary catheter capable of realizing long-acting sustained-release drug delivery and a preparation method thereof, the step 2) adopts a laser to form the groove 2, which has the advantages that the laser has a wide range of applications and can act on a variety of material, and has no force on the surface of the workpiece, is not easy to produce mechanical deformation, does not corrode the surface of the material, and has a fast processing speed.

Claims (9)

1. a kind of catheter of achievable long-acting slow-release administration functions, including urethral catheterization supervisor (1), it is characterised in that: the urethral catheterization At least one groove (2) is provided on supervisor (1)；

The groove (2) is formed using laser processing technology；

The opening of the groove (2) is located on urethral catheterization pipe outer wall (4) and human contact region.

2. a kind of catheter of achievable long-acting slow-release administration functions according to claim 1, it is characterised in that: the groove (2) it is provided with drug (6), the drug (6) is powder medicaments.

3. a kind of catheter of achievable long-acting slow-release administration functions according to claim 2, it is characterised in that: the urethral catheterization Supervisor (1) outer surface is coated with sustained release protective film (5).

4. a kind of catheter of achievable long-acting slow-release administration functions according to claim 3, it is characterised in that: the sustained release Protective film (5) is protein film, Nano-meter SiO_2₂Film or both mixing is formed by film；

The drug (6) is antibacterial agent, lubricant, analgestic, any one or more of mixing of anesthetic.

5. according to claim 1 to a kind of 4 any catheters of achievable long-acting slow-release administration functions, it is characterised in that: The width of the groove (2) is less than 1000 microns；The groove (2) is radial, oblique, spiral, netted or be arranged circumferentially.

6. a kind of preparation method of the catheter of achievable long-acting slow-release administration functions, it is characterised in that: the following steps are included:

Step 1) prepares urethral catheterization supervisor (1)；

Step 2) is responsible for processing groove (2) on (1) in the urethral catheterization using laser processing technology.

7. a kind of preparation method of the catheter of achievable long-acting slow-release administration functions, feature exist according to claim 6 In: further include:

Drug (6) is filled in the groove (2) by step 3).

8. a kind of preparation method of the catheter of achievable long-acting slow-release administration functions, feature exist according to claim 7 In: after step 3) further include:

Step 4) supervisor's (1) the outer surface cladding sustained release of the urethral catheterization obtained by the step 3) protective film (5).

9. according to a kind of any preparation method of the catheter of achievable long-acting slow-release administration functions of claim 7 or 8, It is characterized in that:

Ultrasonic delivery or negative pressure of vacuum mode is added to load drug using high-pressure injection, coating, electrophoresis, high pressure in the step 3) (6)；

It further include to weigh urethral catheterization supervisor (1) urethral catheterization supervisor (1) weight gain before and after loading drug (6) in the step 3 Method detection drug (6) amount of fill content, the step 3 specifically:

Step 3.1, the weight of urethral catheterization supervisor (1) is weighed；

Step 3.2, by drug (6) loaded in the groove (2)；

Step 3.3, the weight of the urethral catheterization supervisor (1) equipped with drug (6) is weighed；

Step 3.4, step 3.1 gained weight is subtracted with step 3.3 gained weight, can be detected out the amount of fill of drug (6).