CN216629384U - Double-layer medical catheter - Google Patents

Abstract

The utility model provides a double-layer medical catheter which is of a double-layer structure comprising an inner layer and an outer layer, wherein the inner layer of the catheter is made of PVC or TPU, the outer layer of the catheter is made of hydrophilic TPU, and the medical catheter is one of CVC, PICC, catheter and peritoneal dialysis catheter. The hydrophilic TPU is Tecophilic TPU, and the water absorption rate is 50-150%. The catheter outer layer has a thickness of 10% to 25% of the entire catheter. The thickness of the outer layer of the conduit is 0.08-0.20 mm. The double-layer medical catheter is prepared by a co-extrusion process. The double-layer medical catheter has lasting self-lubricating property and high-efficiency antibacterial property, can be applied to interventional medical devices such as hemodialysis catheters (CVCs), peripheral circulation catheters (PICCs), peritoneal dialysis catheters and catheters, and can effectively reduce the pain of catheter placement/extraction of patients, prolong the service life of the devices and reduce the risk of bacterial infection.

Description

Double-layer medical catheter

Technical Field

The utility model relates to the field of medical instruments, in particular to a double-layer medical catheter.

Background

Interventional medical devices such as hemodialysis catheters (CVC), peripheral circulation catheters (PICC), peritoneal dialysis catheters and catheters are widely applied clinically, and the following problems exist in clinical use of the medical devices except that effectiveness and safety are guaranteed:

1. the interventional tube body is required to have low friction coefficient and lubricity, so that the interventional tube body is beneficial to the tube placement/extraction of doctors/nurses, and the pain of patients can be reduced. For example, in the application of a catheter, urinary calculus/crystallization often grows on the outer wall of the catheter body, and the patient suffers from abnormal pain during catheter drawing.

2. Because the tube body is inserted for a long time and part of the tube body is exposed outside the body and is easy to cause bacterial infection, the tube body is required to have antibacterial property, but the current tube body has poor antibacterial effect.

SUMMERY OF THE UTILITY MODEL

In view of the problems in the background art, an object of the present invention is to provide a double-layered medical catheter which has a durable self-lubricity and an efficient antibacterial property, can be applied to interventional medical devices such as hemodialysis catheters (CVCs), peripheral circulation catheters (PICCs), peritoneal dialysis catheters, and urinary catheters, and can effectively reduce the pain of the patient in tube placement/removal, prolong the service life of the device, and reduce the risk of bacterial infection.

In order to achieve the purpose, the utility model provides a double-layer medical catheter which is of a double-layer structure comprising an inner layer and an outer layer, wherein the inner layer of the catheter is made of PVC or TPU, the outer layer of the catheter is made of hydrophilic TPU, and the medical catheter is one of CVC, PICC, catheter and peritoneal dialysis catheter.

Optionally, the hydrophilic TPU is Tecophilic TPU, and the water absorption rate is between 50% and 150%.

Optionally, the thickness of the catheter outer layer is 10% to 25% of the entire catheter.

Optionally, the thickness of the outer layer of the conduit is 0.05-0.50 mm.

Optionally, the thickness of the outer layer of the conduit is 0.08-0.20 mm.

Optionally, the thickness of the outer layer of the conduit is 0.08mm, and the thickness of the inner layer of the conduit is 0.40 mm.

Optionally, the double-layer medical catheter is prepared by a co-extrusion process.

Optionally, the double-layer medical catheter is prepared by means of bonding.

Optionally, the bonding manner is one of solvent bonding, UV glue bonding, thermal welding and high-frequency welding.

The utility model has the following beneficial effects:

the utility model provides a double-layer medical catheter with self-lubricating property and high-efficiency antibacterial property, which is based on clinical attention and pain points. In the application of interventional implantation tube instruments, due to the existence of lubricity, the efficiency of the device can be effectively improved and the pain of a patient can be greatly reduced when the device is used for placing/pulling a tube.

Other features of the present invention and advantages thereof will become apparent from the following detailed description of exemplary embodiments thereof, which proceeds with reference to the accompanying drawings.

Drawings

The above and other objects, features and advantages of the present invention will become more apparent by describing in more detail exemplary embodiments thereof with reference to the attached drawings, in which like reference numerals generally represent like parts throughout.

Figure 1 shows a schematic structural view of a double-layered medical catheter of the present invention.

Detailed Description

The present invention will be described in detail with reference to the accompanying drawings, which are for illustrative purposes only and are not intended to limit the scope of the utility model.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those specifically described and will be readily apparent to those of ordinary skill in the art without departing from the spirit of the present invention, and therefore the present invention is not limited to the specific embodiments disclosed below.

The medical catheter is of a double-layer structure comprising an inner layer and an outer layer, the inner layer 1 of the catheter is made of PVC or TPU, the outer layer 2 of the catheter is made of hydrophilic TPU, and the double-layer medical catheter is one of CVC, PICC, catheter and peritoneal dialysis catheter.

The hydrophilic TPU may comprise the following components in parts by weight: 95-99 parts of hydrophilic thermoplastic polyurethane and 1-5 parts of antibacterial agent.

In an embodiment of the utility model, the hydrophilic TPU (hydrophilic thermoplastic polyurethane) is Tecophilic TPU, and the Tecophilic hydrophilic thermoplastic polyurethane produced by luobo emont usa, abbreviated as TPU, is selected in a specification capable of absorbing 50% -150% of moisture, has a water absorption rate of 50% -150%, has a unique TPU soft segment, and has a capability of absorbing 50% -900% of moisture, and after absorbing moisture, the material has self-lubricity in the presence of moisture, greatly reduces surface friction force, can maintain equivalent mechanical strength after fully absorbing moisture, has long-term self-lubricity on the surface (the self-lubricity in the presence of moisture is available), and can be used as a product used in certain specific environments, such as a catheter, a CVC catheter and the like which need to be inserted into a body in a high-moisture environment.

In one embodiment of the utility model, the antimicrobial agent is a silver ion antimicrobial agent. The silver ions have good antibacterial effect, and can play a role in inhibiting the growth and reproduction of microorganisms or killing the microorganisms at a certain concentration. However, the release rate of the existing silver ions in the plastic is low, so that the antibacterial property is poor, mainly because most of the traditional plastic is hydrophobic materials, the silver ion antibacterial agent is added into the traditional polymer in a blending mode, the plastic tightly wraps the antibacterial agent, the silver ions are difficult to release, although the silver ions can be released in a long time, the release rate is too low to sufficiently and effectively kill bacteria, and the antibacterial effect is not obvious. The silver ion antibacterial agent is mixed in the hydrophilic TPU, because the unique TPU soft segment is introduced, the hydrophilic TPU has the function of absorbing 50 to 900 percent of water, and the introduction of water molecules can provide a better flow channel for the antibacterial agent plasma in a molecular chain, greatly improve the release efficiency of the antibacterial agent plasma, and ensure the antibacterial effect of the antibacterial agent plasma within a quite long time period. The TPU material can efficiently release antibacterial silver ions (5 to 10 times of the traditional silver ion antibacterial plastic). The modified TPU is used for the outer layer of an interventional medical pipeline which needs antibiosis and needs external lubrication, can provide continuous and effective antibiosis effect and lubricity, and can reduce the pain of a patient during catheterization/extubation (self-lubricity) particularly in the use of a catheter; the accumulation of urinary calculus/crystals on the outer tube wall is reduced, and the service life of the catheter is prolonged; since its long-lasting antimicrobial properties also reduce the chance of infection.

In one embodiment, the silver ion antibacterial agent and TPU can be subjected to blending extrusion granulation through a double-screw extruder, or the silver ion antibacterial agent is prepared into antibacterial master batches with the concentration of 10% -45% by taking TPU as a basic raw material, and the master batches and the TPU are used after being dry-mixed in proportion when in use. Tecophilic hydrophilic TPU from Leborgrun, having a water absorption of between 50% and 150%, and dried thoroughly before granulation with a silver ion antimicrobial agent. The preparation and production process can adopt common TPE double-screw granulation equipment, is simple and controllable, and is easy to operate.

The double-layer medical catheter can be used as catheter medical instruments such as CVC, PICC, peritoneal dialysis catheter, catheter and the like which need to be implanted and intervened in the body of a patient for a long time. Use as the catheter as the example, can design into the structure of a double-deck pipeline with the catheter, the inlayer pipe is ordinary TPU or PVC material, the skin is the antibiotic hydrophilic type TPU of the self-lubricating of thickness less, its permanent self-lubricating nature can effectively help improving the insertion efficiency of catheter, reduce patient's painful sense, simultaneously because the existence of hydrophilic lubricating layer can reduce urine dirt/calculus and at the outer adnexion of pipe, the extension catheter is put into the time, also can reduce the injury to patient when getting the pipe. In addition, because hydrophilic type TPU absorbs moisture after, its volume has certain inflation, this can help reducing the clearance between catheter and the bladder to effectively reduce the overflow of urine (not pass through the catheter, flow along the outer wall of tube), reduce catheter outer wall scale deposit, the life cycle of extension catheter also can effectively reduce patient's misery when drawing the pipe. Meanwhile, after the hydrophilic TPU absorbs moisture, the release efficiency of silver ions can be greatly improved and the release lasts for a long time, so that the infection caused by the placement of the catheter can be greatly reduced, the life quality of a patient is improved, and the treatment effect is improved.

The double-layer medical catheter can be prepared by adopting the traditional PVC and TPU through a co-extrusion process and can be prepared by co-extruding 2 (more) single-screw extruders. The traditional PVC and TPU pipeline bonding modes can also be adopted, such as solvent bonding, UV glue bonding, thermal welding, high-frequency welding and the like.

The double-layer medical catheter of the utility model can be used as an interventional catheter such as a CVC, a PICC, a catheter, a peritoneal dialysis catheter and the like, and the thickness of the outer layer is 10 to 25 percent of the whole pipeline, but is not limited to the proportion. The thickness of the outer layer of the conduit is 0.05-0.50 mm, and preferably 0.08-0.20 mm. The material of the inner layer main pipe is not limited to PVC, TPU and other high molecular polymers with good compatibility.

At present, the total demand of CVC, PICC and urinary catheters in China is about more than 5000 ten thousand sets, wherein materials such as PVC, TPU, silica gel and the like are taken as main materials. The self-lubricating and antibacterial hydrophilic TPU material can be used for the outer layers of PVC and TPU pipe bodies to provide continuous lubricity and antibacterial property, can be completed with the traditional PVC and TPU through a simple co-extrusion process, and can also adopt the traditional PVC and TPU pipeline bonding modes (solvent bonding, UV adhesive bonding, hot welding and high-frequency welding); the thickness of the catheter only needs 10 to 25 percent of the thickness of the whole catheter, and the effects of self-lubrication, high efficiency and continuous antibiosis can be achieved. Effectively solves the clinical pain points and difficulties of high infection rate of the traditional catheter, pain of the patient who puts or pulls the catheter, short service cycle of the pipeline and the like, and has good market prospect. Can be widely popularized on interventional medical instruments such as hemodialysis catheters (CVC), peripheral circulation catheters (PICC), catheters, peritoneal dialysis catheters and the like.

The following is a specific embodiment of the double layer medical catheter of the present invention.

Example 1

All of the following materials are commercially available:

hydrophilic TPU resin (Tecophilic): lumboluo Tecophilic HP-93A-100

Silver ion antibacterial agent: swiss santizied silver ion antibacterial agent BCA21-61

The bond coat formulation is given in the following table:

all the materials in the formula are poured into a mixer to be mixed for 10-15 minutes, wherein the TPU needs to be dried for 4-6 hours by a dehumidifying dryer at 80 ℃ in advance. And melting and extruding the mixed raw materials by a double-screw extruder, and granulating.

The antibacterial TPU/medical TPU double-layer tube is extruded by two single screws in a co-extrusion way, and the structure is as follows with reference to FIG. 1:

a) the outer layer 2 is TPU mixed with antibacterial silver ions, and the thickness is 0.08mm

b) The inner layer 1 is made of TPU (transparent or 20% barium sulfate developer TPU-B20) with the hardness of about 80A-90A and the thickness of 0.40mm

Example 2

All of the following starting materials are commercially available:

hydrophilic TPU resin (Tecophilic): lumboluo Tecophilic HP-93A-100

Silver ion antibacterial agent: switzerland Shanningtai Sanitized silver ion antibacterial agent BCA21-61

The bond coat formulation is given in the following table:

all the materials in the formula are poured into a mixer to be mixed for 10-15 minutes, wherein the TPU needs to be dried for 4-6 hours by a dehumidifying dryer at 80 ℃ in advance. And melting and extruding the mixed raw materials by a double-screw extruder, and granulating.

The antibacterial TPU/medical PVC double-layer pipe is extruded by two single screws in a co-extrusion mode, and the structure is as follows with reference to FIG. 1:

a) the outer layer 2 is TPU mixed with antibacterial silver ions, and the thickness is 0.08mm

b) The inner layer 1 is made of PVC material (transparent or 20% barium sulfate developer PVC-B20) with the hardness of about 80A-90A, and the thickness is 0.40mm

Performance testing

The double layer catheters prepared in examples 1 and 2 were tested for tubing according to GB8368-1998 gravity infusion method using disposable infusion sets. The test results are shown in Table 1.

TABLE 1 TPU/TPU or PVC Dual layer medical catheter Performance test results

The embodiment shows that the double-layer medical catheter has the capability of continuously releasing silver ions, and the concentration of the released silver ions is 8-12 ppm within 24 hours to 30 days. Has strong bacteriostatic action, and can 100% inhibit the growth of staphylococcus aureus, escherichia coli, candida albicans, aspergillus niger and pseudomonas aeruginosa.

Although some specific embodiments of the present invention have been described in detail by way of illustration, it should be understood by those skilled in the art that the above illustration is only for the purpose of illustration and is not intended to limit the scope of the utility model. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the utility model. The scope of the utility model is defined by the appended claims.

Claims (9)

1. The double-layer medical catheter is characterized in that the medical catheter is of a double-layer structure comprising an inner layer and an outer layer, the inner layer of the catheter is made of TPU (thermoplastic polyurethane), the outer layer of the catheter is made of hydrophilic TPU, and the medical catheter is one of CVC (composite chemical vapor deposition), PICC (peripherally inserted central catheter), catheter and peritoneal dialysis catheter.

2. The double layer medical catheter of claim 1, wherein the hydrophilic TPU is Tecophilic TPU with a water absorption between 50% and 150%.

3. The dual layer medical catheter of claim 1, wherein the catheter outer layer has a thickness of 10% to 25% of the entire catheter.

4. The double-layered medical catheter according to claim 1, wherein the catheter outer layer has a thickness of 0.05 to 0.50 mm.

5. The double-layered medical catheter according to claim 4, wherein the catheter outer layer has a thickness of 0.08 to 0.20 mm.

6. The dual layer medical catheter of claim 1, wherein the catheter outer layer is 0.08mm thick and the catheter inner layer is 0.40mm thick.

7. The dual layer medical catheter as set forth in claim 1, wherein the dual layer medical catheter is prepared by a co-extrusion process.

8. The double-layered medical catheter according to claim 1, wherein the double-layered medical catheter is prepared by means of adhesion.

9. The dual layer medical catheter of claim 8, wherein the bonding means is one of solvent bonding, UV glue bonding, thermal welding and high frequency welding.

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