WO2014119987A1

WO2014119987A1 - Intravenous catheter of a polymer compound material with oriented nanoparticles, with low friction coefficient and low microbial adherence

Info

Publication number: WO2014119987A1
Application number: PCT/MX2014/000032
Authority: WO
Inventors: José Antonio Arellano Cabrera; José María Rodriguez Lelis; María Teresa Lucas Jimenez; Alfredo Chalita Vizcarra
Original assignee: Equipos Médicos Vizcarra, S.A.
Priority date: 2013-01-30
Filing date: 2014-01-29
Publication date: 2014-08-07
Also published as: MX2013001220A

Abstract

The invention relates to an intravenous catheter for administering drugs or fluids to the vascular system of a patient, and in particular relates to peripheral intravenous catheters, central intravenous catheters and other types of catheters that are placed in the vascular system of a patient in order to administer or remove fluids. The catheter is formed by a tube (1) made up of a lumen (14) with a lumen wall (13) made of a polymer matrix reinforced with nanoparticles oriented in specific directions and with a low friction coefficient; the lumen wall (13) is coated with a coating (12) made of a compound of a bactericidal material with a low friction coefficient. The catheter of polymer compound material with oriented nanoparticles, with low friction coefficient and low microbial adherence of the invention has the advantages of: a) reducing the forces of resistance or friction of the catheter against the tissue of the patient when the catheter is inserted; b) having compounds of bactericidal material that reduce the adherence of microorganisms on the surface of the catheter and the growth thereof, thus avoiding the generation of infections in the catheterisation areas; and c) the orientation of the reinforcing particles grants the catheter mechanical properties that provide comfort for the patient during the catheterisation procedure and all the related treatment.

Description

INTRAVENOUS CATHETER OF POLYMER COMPOSITE MATERIAL WITH NANOP ORIENTED ARTICLES, LOW COEFFICIENT OF

FRICTION AND LOW MICROBIAL ADHERENCE FIELD OF THE INVENTION

The present invention is related to the hospital instrument manufacturing industry. More specifically it relates to the instrument manufacturing industry for venous canalization and the administration of medications directly into the vascular system. Even more specifically it relates to the manufacturing industry of peripheral, central and other intravenous catheters, which are made of biocompatible composite materials reinforced with nano particles. BACKGROUND OF THE INVENTION

As Rivera et al [1] mention, IV intravenous therapy starts from the need to transfer blood from one human being to another, and dates from approximately 1492. The administration of medications to the vascular system of patients by specific treatments and when the medication It will be supplied with long periods of time, it represents a challenge in the design of medication delivery systems. The device most commonly used to achieve this, are intravenous catheters, which are formed from a pipe with a diameter smaller than the vein where it will be inserted and are made of soft, flexible, waterproof and non-reactive materials to the medications of the selected therapy , in addition to being made of a biocompatible material with living tissues.

The traditional materials used for intravenous catheters are plastic materials such as silicones, polyurethanes, PVC, polytetrafluoroethylene and others; These materials are injected or extruded through a die so that pipes of different diameters are formed according to the required lumen size. In addition, intravenous catheters are typically made with a radiopaque compound used to visualize the catheter during medical procedures such as a PTCA. diagnostic imaging or as security to visualize in specific cases the location of the catheter in the patient's vascular system by means of x-rays and avoid tissue damage. At present, intravenous catheters are used for intravenous administration of a fluid, a disposable needle that passes through the catheter is used; The needle makes a cut in the patient's skin and vein and allows the catheter to enter. Once the assembly placed in the vein is verified by a retrospection of the blood in the needle, the needle is removed leaving the intravenous catheter in place for connection to an intravenous bag or a bottle, or a cap for later use .

In addition to the above, it is sometimes necessary to successively administer intravenous fluids to the patient, which requires that the patient be subjected to a series of several intravenous punctures performed in different periods of time and areas of the body, which results for the patient in A traumatic and painful experience. As a solution to this, a lubricant coating is applied to the catheters on its external surface with the aim of making the puncture and placement of this device as painless as possible to the patient. This lubricant coating is often a type of silicone or hydrophilic gel which becomes lubricant after absorbing water. Patents such as US 7,914,809 B2, US 20080228168A1, US 6,221,461 Bl and others present solutions applying lubricating coatings to catheters. One of the common problems with lubricating coatings that have high lubricity is their poor adhesion to the catheter surface, in addition to catheter characteristics such as strength, flexibility and easy manufacturing. A biocompatible material to provide a low coefficient of friction is polytetrafluoroethylene, however it is a material that due to its low adhesion energies is difficult to adhere to another material and the processing and manufacturing of intravenous catheters results in a very complicated process.

Still another characteristic that catheters should cover are phlebitis complications [2] which may occur in percentages above 75% of hospitalized patients [3], which means a problem in clinical treatment, patient dissatisfaction, continuous catheter replacement and prolonged hospitalization stays that increase the costs of hospitalization services. Health. One of the factors that causes phlebitis is related to the type of medication administered that can irritate the tissues in the catheterization zone. The other factors are related to infectious agents due to the growth of microorganisms between the catheter and the puncture site. In addition to mechanical factors such as the type of catheter material, site size and duration of catheterization.

Oligodynamic metals such as silver in the form of ions and small amounts are very effective as bactericides. For intravenous catheters, a collagen-shaped silver polymeric coating is used which dissolves once the catheter is in the patient's vascular system thus preventing the growth of microorganisms in the puncture site. Other similar solutions can be found in patents US 005759564A, US 006060000A and others. The use of oligodynamic metals in the form of a fluid coating presents the problem that the coating dissolves very quickly and then there is no longer antibacterial protection and in most intravenous catheters their stay in the patient's vascular system is prolonged, In addition to the fact that infections can enter the patient's body through the inside or outside of the catheter and not all catheters are coated in both areas.

As can be inferred in the text, the combination of all these characteristics for the design of intravenous catheters limits the materials available for their elaboration. The patent presented claims solutions to the needs of a) a low friction coefficient intravenous catheter to reduce damage to the patient's tissues during placement and also the sensation of pain, b) a catheter made of materials with antibacterial characteristics that act inside and outside the catheter reducing the possibility of phlebitis, c) a catheter with mechanical properties that facilitate its placement avoiding problems of flourishing and roll-up of the catheter and d) an intravenous catheter with radio-opacity characteristics. OBJECTIVES OF THE INVENTION

The main objective of the invention is to achieve an intravenous catheter that has a low coefficient of friction with the patient's skin and vein so as to minimize tissue damage caused by puncture and placement of the catheter.

Another objective is to achieve an intravenous catheter made of polymer composite material reinforced with nanoparticles oriented in specific directions, which also prevents the growth of bacterial agents causing infections or phlebitis.

Still another objective is an intravenous catheter that presents the mechanical properties necessary to avoid the phenomena of roll up and flourish of the catheter when the puncture is performed and its placement in the vascular system of the patient and has sufficient flexibility to adapt to the shape and movements of the vein during its time of use.

And all those objectives and advantages that will become apparent with the reading accompanied by the drawings that for illustrative purposes, but not limitation, are an integral part of this description.

BRIEF DESCRIPTION OF THE INVENTION

This invention relates to an intravenous catheter for the administration of medications or fluids to a patient's vascular system, particularly it relates to peripheral, central intravenous catheters and other types of catheters that are placed in a patient's vascular system for administration or fluid removal The catheter manufacturing material is composed of a material composed of a polymeric matrix which is reinforced with nanoparticles oriented in specific directions and which is produced by means of the injection and / or extrusion of said material for the formation of a pipe that serves as a base component for catheter fabrication.

This invention relates to a medical device that meets the characteristics of be a catheter for their mechanical and according _c to the type of orientation properties of nanoparticles, avoids phenomena arremangado and flourish of the catheter tip that is inserted into the vein of the patient through the skin by cutting a introducer needle, in addition to being a catheter that due to the composition of the material that forms it has low coefficients of friction between its exterior and the punctured skin when the patient's vascular system is placed.

Likewise, the material from which the catheter is formed has the characteristic of being a material that prevents the growth of infectious agents in the area of catheterization of the patient avoiding the generation of phlebitis and the problems related to this condition.

The polymer composite composite catheter with oriented nanoparticles, low coefficient of friction and low microbial adhesion of this invention is composed of a pipe made of biocompatible polymeric material to which a percentage of biocompatible nano particles that range in ranges are added during processing 10 to 50 percent of the total material processed. The nanoparticles are in ranges of sizes greater than 1 nm and oriented in specific directions, within the polymeric material by physical means, so that the resulting pipe is of a polymeric composite material with nano particles oriented in specific directions.

The pipe that forms the catheter is cut into sections that range in lengths greater than 1 cm, where the distal part of the catheter pipe is formed by physical means in determined geometries according to the type of medical procedure to which it will be applied; while in the anterior part of the catheter a component is attached that allows the coupling with the serum tubes for the administration of medication, with devices for the extraction of fluids and others related to catheterization procedures.

The base pipe for catheter fabrication can be formed in ranges of outside diameter greater than 0.1 mm and can be formed in ranges of internal diameter greater than 0.1 mm. The orientation of the nanoparticles in the polymer composite material meet with two main functions; The first is to provide the catheter with mechanical resistance to flourish and roll up during the puncture and canalization process, in addition to providing the catheter with flexibility to deform depending on the movement of the patient's vein when it has already been placed.

The second main function is that according to the type of nanoparticles selected and the type of orientation they provide the catheter with low coefficients of friction with the patient's skin and vein, in addition to being nanoparticles with bactericidal properties, thus preventing the formation of infectious agents. in the catheterization zone. Even more nanoparticles have radiopacity properties.

BRIEF DESCRIPTION OF FIGURES

Fig. 1 illustrates an isometric view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.

Fig. 2 shows a side sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.

Fig. 3 illustrates a cross-sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions.

Fig. 4 shows a side sectional view of one of the possible configurations of the distal tip of the intravenous catheter made of polymeric composite material reinforced with nanoparticles oriented in specific directions. DETAILED DESCRIPTION OF THE INVENTION

For the detailed description, we will rely on the figures of the preferred embodiment of the present invention. An isometric view of the intravenous catheter made of polymeric composite material reinforced with nanoparticles oriented in specific directions is shown in Figure 1. The pipe (1) made of polymeric composite material reinforced with nanoparticles, is attached to a hub or canopy (2 ) which serves as a coupling to intravenous infusion systems or other devices depending on the particular application of the catheter, in addition the anterior part of the pipe (1) is formed by physical means in specific geometries (1 1) depending on the particular application of the catheter As shown in figure 1 the pipe (1) is placed inside the patient's body in the treatment areas while the pavilion (2) is outside to be coupled to the infusion systems or other medical devices necessary for the specific treatment

The layers that form the intravenous catheter pipe (1) made of polymer composite material reinforced with nanoparticles oriented in specific directions are shown in the side sectional view of Figure 2. Inside the pipe there is a gap or lumen (14 ) where the fluids circulate through the catheter, this lumen (14) can be formed in diameters of ranges greater than 0.1 mm.

The lumen wall (13) is formed of the composite polymeric material reinforced with nanoparticles, which are oriented in directions with orientation angles between 0 and 360 degrees and with a concentration in the polymer matrix with ranges between 10 and 50% of reinforcing particles. On the outer surface of the lumen wall there is a coating (12) made of particles with bactericidal properties and friction coefficients of less than 0.9. The coating (12) is diffused with the surface of the lumen wall (13) formed a second compound representing the surface of the catheter pipe (1).

A cross-sectional view of the intravenous catheter made of polymer composite reinforced with nanoparticles oriented in specific directions is shown in Figure 3. The layers forming the catheter tubing (1) having internal diameters or lumen (14) are indicated. in ranges greater than 0.1 mm and external diameters with ranges greater than 0.1 mm with lumen wall thicknesses (13) greater than 0.01 mm. On the outer surface of the catheter tubing (1) a coating (12) of a compound made of bactericidal materials with low coefficient of friction is applied in order to reduce the resistance to displacement of the catheter through the patient's tissues and besides avoiding the adhesion and microbial growth that can generate infections. The lumen wall (13) is reinforced with nano particles which, through its orientation, increase the resistance of the catheter pipe (1) in the axial direction of the pipe and increase the flexibility in the transverse direction of the catheter pipe ( one). A sectional view of the tip formed of the catheter pipe (1) is shown in Figure 4. The pipe formed by a lumen (14) with a lumen wall (13) coated on its outside by a coating (12) in The anterior part is formed by mechanical or thermal physical means in specific geometries (11) depending on the type of treatment and application of the catheter. A possible specific geometry (1 1) is that shown in Figure 4 which corresponds to a specific geometry (11) characteristic of a peripheral intravenous catheter, in which the different layers that form the catheter tubing can be observed ( 1) made of polymer composite material reinforced with nano particles oriented in specific directions. References

[1.] A. M. Rivera, K. W. Strauss, A. Van Zundert, and E. Mortier, The history of peripheral intravenous catheters: How little plastic tubes revolutionized medicine, Acta Anaesth. Belg., 2005, 56, 271-282.

[2.] Sutariya B, Berk W. Vascular access. In: Tintinally J, Kelen G, Stapczynski S, eds. Emergency Medicine 5th ed. New York: McGraw-Hill, 2000: 103-4.

[3.] Myrianthefs P, Sifaki M, Samara I, Baltopoulos G. The epidemiology of peripheral vein complications: evaluation of the efficiency of differing methods for the maintenance of catheter patency and thrombophlebitis prevention. J Eval Clin Pract 2005; 11: 85-9. The invention has been described sufficiently that a person with average knowledge in the field can reproduce and obtain the results mentioned in the present invention. However, any skilled person in the field of the art that is in charge of the present invention may be able to make modifications not described in the present application, however, if for the application of these modifications in a given structure or in the manufacturing process thereof, the matter claimed in the following claims is required, said structures must be included within the scope of the invention.

Claims

CLAIMS Once the present invention has been described, with a degree of qualification, it is considered as a novelty and therefore is claimed as property, what is contained in the following clauses:

1. A catheter for the administration or extraction of fluids from the vascular system of a patient characterized in that the lumen wall (13) is formed of the composite polymeric material reinforced with nanoparticles, which are oriented in directions at different orientation angles, and with a concentration in the polymer matrix with ranges between 10 and 50% of reinforcing particles; on the outer surface of the lumen wall there is a coating (12) made of particles with bactericidal properties and friction coefficients of less than 0.9; The coating (12) is diffused with the surface of the lumen wall (13) formed a second compound representing the surface of the catheter pipe (1).

2. A catheter for the administration or extraction of fluids from the vascular system of a patient, as claimed in the preceding claim, characterized in that it is made of a polymeric material reinforced with nanoparticles which are oriented in specific directions according to the catheter application and also has a low coefficient of friction with the patient's tissues when placed.

3. An intravenous catheter made of polymer composite material reinforced with nanoparticles oriented in specific directions, as claimed in claim 1, further characterized in that it is formed with an inner diameter or lumen (14) with a size greater than 0.1 mm.

4. An intravenous catheter made of polymer composite material reinforced with nanoparticles oriented in specific directions, as claimed in the preceding claim, further characterized in that the distal end of the catheter tubing (1) is formed in specific geometries (1 1 ) according to the application of the catheter and because at the anterior end a cube or pavilion (2) is attached that it is used for the connection for the administration and extraction systems of fluids or medical devices related to the particular treatment that is applied.