MXPA97009679A - Lubricant transported in water for detef products - Google Patents

Abstract

This invention relates to a new water-soluble lubricant for a medical device, such as a catheter and an introducer needle. Lubricant is a silicon surfactant that is not ionic and is a good lubrication fluid. Preferably the silicon surfactant which is used is a polyalkylene polyalkylene modified polydimethylsiloxane block copolymer. The water is dyed as a solvent for this lubricant. The lubrication solution includes a stabilizer of the lubrication solution including a solution stabilizer to clarify the solution and antimicrobial agents to inhibit the growth of microbes in the water solution or on the coated product. Vitamin E or its derivatives can also be used in the lubrication solution. When the lubrication solution is used to lubricate Teflon products, a small amount of low molecular weight alcohol is added to the lubrication solution to increase the humed

Description

LUBRICANT TRANSPORTED IN WATER FOR TE LON PRODUCTS Background of the Invention This invention relates in general to a novel lubricant for medical devices, in particular catheters / intravenous (IV). IV catheters are generally used in patients to put infusions such as normal purgative salt, glucose solutions and medications in the patient. These catheters are also used to draw blood from the patient for blood gas and other tests.

In order to place a catheter in a patient's vein, a pointed needle should be used to puncture the skin, tissue and wall of the vein to provide a path for placement of the catheter into the vein. Typical IV catheters are catheters "above the needle" where the catheter is placed coaxially over the needle. The tip or distal end of the catheter is located adjacent to the distal tip of the needle and proximal to it. Preferably the tip of the catheter adheres slightly to the tip of the needle to ensure that both the catheter and the needle travel together through the skin, tissue and wall of the vein and into the patient's vein. Adhesion is achieved by making the inside diameter of the catheter tip slightly smaller than the outer diameter of the needle.

The placement of the catheter and the needle inside the patient causes acute pain in the patient. In order to facilitate insertion of the catheter and needle into the vein and minimize discomfort in the patient, both the catheter and the needle should be lubricated. Most IV catheters and needles are lubricated with polydi-ethylsiloxane silicon fluid. However, some IV catheters and needles are not lubricated at all.

The silicon fluid of polydimethylsiloxane can be applied to the surface of the catheter and the needle by rubbing the surfaces with the lubricant. Alternatively, the catheter and the needle can be immersed separately in a solution of lubrication of polydimethylsiloxane silicon fluid and a solvent. This is generally the preferred method for lubricant application because a consistent, controlled and uniform coating can be achieved. The polydimethylsiloxane silicon fluid must be dissolved in an organic solvent because the silicon oil in this compound is hydrophobic. Typically the solution contains 2.5% silicon oil.

Until recently the preferred solvent has been freon because it is flammable and not sparked, ie it evaporates easily after the silicon solution of polydimethylsiloxane has been applied to the catheter and the needle. Although Freon has been preferred, this suffers from some drawbacks. For example, the high rate of evaporation causes the silicon fluid of polydimethylsiloxane to concentrate on the surface of the solution into which the catheter and needle are immersed. Due to this high rate of evaporation, it is difficult to control the solution. Moreover, this solution is expensive due to the large loss of freon during the coating process. In addition, freon is a chlorofluorocarbon (CFC) that is supposed to react and destroy the ozone zone that protects the earth. Thus the manufacture and use of this CFC will finally cease in the near future. As a result, other solvents will have to be used in order for the sicily fluid to be applied to medical devices, such as catheters and needles, to be used as a lubricant. Other solvents include alcohol and hydrocarbons. However, alcohol and hydrocarbons are highly combustible. Therefore, it is very dangerous to use large quantities of these solvents in manufacturing.

Compendium of the Invention Accordingly, an object of this invention is to provide a lubricant for a medical device, such as a catheter and an introducer needle assembly that does not require the use of a solvent such as CFC.

Another object of this invention is to provide a lubricant for a medical device, such as a catheter and an introducer needle assembly that does not require the use of large amounts of flammable material for a solvent.

Still another object of this invention is to provide a lubricating solution for a medical device, such as a catheter and an introducer needle assembly that is inexpensive and easy to control.

Yet another object of this invention is to provide a lubrication solution for a medical device such as a catheter and an introducer needle assembly that is "environmentally friendly".

The lubricant of this invention is a silicon surfactant which is a good lubricating fluid. In addition, the surfactant is preferably non-ionic, because it may have less toxicity than that of the ionic form. Since the silicon surfactants are water soluble, the water can be used as the solvent to provide a lubrication solution for the application of the lubricant on the medical device. If medical devices formed from polytetrafluoroethylene or, that is, Teflon, are to be lubricated, small amounts of alcohol can be used in conjunction with water as the solvent. The alcohol facilitates the wetting of the Teflon surface and allows a uniform coating of the lubricant on the Teflon surface once the water and alcohol evaporate.

The lubrication solution can also include vitamin E or its derivatives to avoid degradation of the lubrication solution and improve lubricant lubricity. In addition, the lubrication solution in which the medical device to be lubricated is immersed, may include a solution stabilizer to clarify the lubrication solution and antimicrobial agents, to inhibit the growth of microbes in the lubrication solution in the medical device coated.

The foregoing and other objects and advantages of the invention will be apparent upon consideration of the following detailed description.

Detailed Description of the Invention Although this invention has been discussed in terms of its application in IV catheters and introducer needles, it will be understood that this invention could be used in other medical devices where a lubricious surface on the device is desired.

A silicon tendectant agent is used as the lubricant since it is a good lubrication fluid. The use of a silicon surfactant is a lubricant for IV catheters and introducer needles also reduce the possibility of poor retrospection through the lumen of the needle. This is due to the fact that the surfactants tend to draw blood through the dressing and do not resist the flow of blood as most silicons do. In addition, the surfactant has a greater affinity with the catheter and the needle. As a result, the tenciactive agent improves the uniformity of the cover and is less likely to come out from between the tip of the catheter and the needle, thereby controlling adhesion between the tip of the catheter and the needle.

Another benefit when using a silicon tenciactive agent is that it is soluble in water and with this it can be applied to the surface to be lubricated in a silicon and water surfactant solution. The use of a needle-soluble lubricant for medical devices reduces some of the problems associated with previous lubrication solutions. For example, this water-based lubrication solution is relatively inexpensive and easier to control than alcohol or freon-based lubrication solutions. In addition, water is "environmentally friendly" compound. When a Teflon surface is to be covered with the lubricant of this invention, a small amount of alcohol must be added to the water to be used as a solvent. The alcohol should have a molecular weight less than or equal to 150 and should have the formula ROH wherein R is any alkyl or a substituted alkyl hydrocarbon group. It is important to use alcohols that have low molecular weight because as the molecular weight increases, the solubility of alcohol in water decreases. In fact, alcohols having a molecular weight at 150 can not be dissolved in water and will not provide a lubrication solution that works in accordance with this invention. Preferably, the isopropyl alcohol is used. The addition of alcohol to water facilitates moisture on the Teflon surface, which is hydrophobic, through the lubrication solution and this produces a uniform layer of lubricant on the Teflon surface once the solvent evaporates.

The alcohol should comprise more than 0% and less than 30% approximately of the lubrication solution. Preferably the alcohol should comprise between 5% and 20% approximately of the lubrication solution. When the alcohol comprises less than 5% of the lubrication solution, the Teflon surface is wetted very poorly with the solution. When the amount of alcohol increases, the humidity increases. However, when the alcohol comprises more than 20% of the lubrication solution, the flammability problems increase significantly, making it difficult to handle the lubrication solution.

The silicon surfactant should comprise from about 0.125% to about 40.%, and preferably from about 2.0% to about 6.0% of the solution. Preferably, the silicon surfactant that is used is a silicon surfactant of Silwet. Silwet is a registered trademark of a -ln-f of a silicon bond that has OPIS (? - -> iblo) In. 'Ett.o,' pp , - euoj nací í vo- < &nt; n < op di rp < io 1 '..) of polydimetilsi loxane modified lixionic oxide are similar to I03 d &g fluids; sackcloth . > I tlü i ll '' X 'opl o u Pi i'.ijii lu do! , \ L p > J '(j' [ni '> l' 'l l' tlio 1 ion «; id na .: Literal • of o .. do of? li J qui Leño do peni ".; t -nci -i"? ionic? For example, the copolymers of Moque poll -? :: i ot i leño) poly i- (oxypropylene) known romo pol j ol -p] u oiii = ¡. The side chains are determined with either hydr "i or low terminal groups in the oxy.One of these \ Ü < ni • > 1 '3p - i p i vu.3, Silwet L7001 has a molecular weight • "? JU II '""' '^ ni ^.' Tn ^ c "Tl i nu j 6n: The option liiu i 'd- l i. »-' ¡< The modified sackcloth or -wheel, also used as a lubricant alone or in confinement, the polyalkylene oxide copolymer modified siloxane block. These tenciactive agents are soluble in a wide variety of solvents such as CFC, alcohol, acetone and water. The plialkylene oxide chains also promote moisture on the polyether urethane surfaces. Polyether urethane is a material used to make IV catheters. The similarity in the chemical structure between these side chains and the soft segment of the polyether urethane promotes the affinity of the tenciactive agent with the surface of the catheter.

Although the surfactants may be irritant or toxic depending on their exposure levels, silwet silicon surfactants are copolymers of two polymeric materials, silicon fluids and polyalkylene oxides, which are low in toxicity. In particular, the Silwet L7001 has a very low order of acute toxicity when swallowing, or penetration into the skin and is minimally irritating to the skin and does not irritate the eyes. This is why there should be no toxicity problems when the lubricant of this invention is used in a patient.

Example No. 1 Initial studies were conducted by separately immersing 20 measuring catheters and insertion needles in 4%, 8% and 32% of Silwet L7001 water solutions and silicon surfactants and then mounting the catheters and needles. The assemblies were tested with a penetration through a thick natural latex film of 13.5 thousand. 4% Silwet L7001 8% Silwet L7001 Needle tip (g) 24.5 (09) 23.3 (2.9) Needle transition (g) 18.5 (2.7) 17.0 (2.2) Needle heel (g) 11.0 (0.7) 10.5 (1.5) Catheter tip (g) 26.0 (3.7) 28.3 (5.3) Catheter guide (g) 15.3 (0.8) 15.0 (3.0) Catheter drag (g) 7.3 (1.9) 4.5 (0.5) 32% Silwet L7001 Needle tip (g) 24.3 (5.8) Needle transition (g) 15.0 (1.0) Needle heel (g) 8.0 (0.0) Catheter tip (g) 25.3 (1.9) Catheter guide (g) 10.3 (0.8) Catheter drag (g) 4.0 (0.0) NOTE: () = standard deviation. Sample size = 4 l or "viLoio- d-? E e >; ? ^ s nt .tri 1 ^ i eai: "Mici .i ou r ittin.j - ???????????????????????????????? These values are comparable to those produc o o? ut '-' i ..- ijp > =? on The actu ili ul ul - Lubi / jido • < C > M fl uido l dimP 1 L'll? and that OH OL, - prodlj 'Lo u loqi or nj are lubricated.This example shows that an agent in a sackcloth works as a pipette lubricant and introducer needle.

The third stage can also include vitamin E or its derivatives.Preference can be used 0.12 to 1.0% vitamin E or its derivatives, vitamin E, which is known as alpha-tocopherol, It is an antioxidant and with this the degradation of the solution is avoided, both vitamin E and its derivative of Vitamin E are products of oil and improve the lubricity of this lubrication system.The molecular structure of Vitamin E It is given below.

Since the lubrication solution is preputed in water, it is highly desirable that a small amount of an effective agent should be used to serve as a liquid. In the absence of antimicrobial agents in the collocation and toxic solution. There are several commercial antimicrobial agents available. These are iodofors, phenols, phenolic compounds such as para-chloro-meta-xyleneol; biguadins such as clojhexidine gluconate and polyhexamethylene biguadine hydrochloride (cosmocil). The cosmocil is used because it is less toxic than other antimicrobial agents and is used as a preservative in cleaning solutions for 15-count lenses. The molecular structure of cosmocil is given below: HCl - NH 2 (Cll 2) - CH 3 NH-C-NH- - (CH 2) 3-r < CH2) 3- NH-C-NH-H NH -HC1 NH The molecular weight of this product is 2100 + -300. The antimicrobial agent should comprise between about 0.001% to about 5.0%, preferably between about 0.002% to about 0.05 of the lubrication solution.

Example No measuring catheters and needles were separately immersed in a solution containing 8% silicon surfactant Silwet L7001, 0.25% vitamin E, 0.5% vitamin E acetate and 0.026% cosmocil. The catheters and needles were then assembled and those mounts passed the penetration test through a natural latex film of a thickness of 13.5 thousand. The results are shown below. Needle tip (g) 18.3 (1.9) Needle transition (g) 14.7 (0.6) Needle heel (g) 7.0 (0.3) Catheter tip (g) 20.2 (2.3) Catheter guide (g) 10.5 (0.6) Catheter drag (g) 3.5 (1.3) NOTE: () = standard deviation. Sample size = 5 It can be seen that the use of vitamin E and / or its derivatives in the solution improves penetration forces.

When the vitamin E and / or its derivatives are included in the lubrication solution, a nebulous solution is obtained indicating that the solution is not homogeneous. If a quaternary ammonium salt is added in a certain concentration, a clear solution is obtained. For example, Sylguard, marketed by Dow Corning, which is a quat and benzalkonium chloride reagent, can be added to the solution. Other quaternary ammonium salts, such as benzaetonium chloride, can also be used. The stabilizer of the solution should comprise between about 0.1% to about 10%, preferably between about 0.2% to about 1.0% of the lubrication solution.

Example No. 3 A solution containing 6.0% of a Silwet L7001 surfactant, 0.36% vitamin E and 1.0% benzalkonium chloride was used as the lubrication solution. In this example, 1.0% of the benzalkonium chloride was in the form of 2.0% of Hya ine 3500. The Hyamina 3500 is a registered trademark of the benzalkonium chloride solution sold by Rohm and Hass and contains 50% of the active ingredient . By way of comparison, a lubrication solution that does not have benzalkonium chloride was also used. 18 measuring catheters and needles were submerged separately and then mounted. These catheter assemblies were penetrated through a dental dam (natural latex film).

Without salt of Quaternary Ammonium Needle tip (g) 24.3 (4.6) Needle transition (g¡ 19.0 (1.0) Needle heel (g) 11.3 (1.2) Catheter tip (g) 19.8 (2.1) Catheter guide (g) 15.5 (0.9) Catheter drag (g) 4.8 (0.5) 1% Benzalkonium Chloride Needle tip (g) 24.0 (3.6) Needle transition (g) 19.3 (1.4) Needle heel (g) 10.0 (0.5) Catheter tip (g) 24.2 (2.3) Catheter guide (g) 17.3 (1.8) Catheter drag (g) 4.9 (0.4) NOTE: () = standard deviation These results indicate that there is no adverse effect on the lubricant caused by using a quaternary ammonium salt in the lubrication solution.

Example No. 4 Since modified amino silicones are lubri- cated when applied to metal surfaces, the following lubrication solutions were prepared.

Lubricant I Lubricant II Tenciactivo agent 4.50 Silicon 4.50 Copolymer of 0.005% electrolyte silicon 0.50 silicon Vitamin E (%) 0.25 0.25 Cosmocil (PPPPM) 50 50 Water Q.S. to 100 100 measurement catheter assemblies were mounted after submerging the catheters and insertion needles separately in the above solutions. The adhesion strength of the tip between the catheter and the needle was measured after maturing at 90 ° C for 2 1/2 days. The results are tabulated below: Adhesion of the tip (lbs) Lubricant I 0.348 (0.11) Lubricant II 0.188 (0.03) NOTE. : () = standard deviation. These test results indicate that the use of amino modified silicone polyether copolymer lubricates the metal surface better than the unmodified silicon surfactant alone. Example No. 5 The following statistical experiments were carried out to optimize the formula of the lubrication solution of this invention. The following table names some of the variations of the composition that were used. Composition A Composition B Tensile Agent 3.0 4.5 Silicon Copolymer of polyether 0.5 0.25 silicon modified amino Vitamin E (%) 0.15 0.13 Cosmocil (PPM) 50 50 Water Q.S. to 100 100 Composition B 6.0 Silicon Tentactive Agent 0.5 amino silicon modified polyether copolymer Vitamin E (%) 0.125 Cosmocil (PPM) 50 Water Q.S. at 100 20 measurement catheter assemblies were mounted after immersing the catheters and inserting needles separately. After maturing the assemblies at 90 ° C for 2 1/2 days, these assemblies were subjected to penetration tests through a thick natural latex film of 86.7 mils thick. The thick latex was used because it is of a thickness closer to that of the mammary skin and because the small difference in penetration force was magnified. The results are tabulated below.

Composition A Composition B Needle tip (g) 156.0 (11.7) 150.4 (13.1) Catheter tip (g) 90.6 (10.3) 87.0 (10.5) Catheter drag (g) 31.6 (2.9) 32.0 (2.3) Composition C Needle tip (g) 155.9 (9.5) Catheter tip (g) 98.3 (7.0) Catheter drag (g) 27.6 (1.8) NOTE: () = standard deviation. Sample size = 8 The previous assemblies were also matured at 90 ° C for two weeks to simulate a shelf life of five years and penetration test through fresh cowhide. The results are tabulated below: Composition A Composition B Needle tip (g) 237.0 (63.7) 226.0 (68.6) Catheter tip (g) 299.0 (53.5) 379.0 (42.7) Catheter guide (g) 320.0 (37.9) 28.0 (34.0) Catheter drag / g) 51.0 (8.0) 46.0 (9.7 = Composition C Needle point (g) 20.9.0 (46.1) Catheter tip (g) 378.0 (41.2) Catheter guide (g) 327.9 (39.4) Catheter guide (g) 42.0 (11.2) NOTE: () = standard deviation. Sample size = 5 These results on the thick latex membrane show that the amount of the silicon surfactant applied to the catheter and the needle has the opposite effects on the penetration of the catheter guide and the tip of the needle. The higher the concentration of the silicon surfactant, the lower is the guide, but at high concentrations of the lubricant the penetration value of the needle tip increases. On fresh cow skin, the penetration value of the needle tip decreases with an increased concentration.

Example No. 6 Catheter Lubricant Agent Tenciactivo 4.75% + -0.25% silicon Copoiimer of polyether of 0.525% + - 0.025% modified silicon of amino Vitamin E (%) 0.263% + - 0.13% Cosmocil 50 ppm Water Q. S. to 100 Needle with Lubricant Agent Tenciactivo 2.38% + - 0.25 of silicon Copolymer of polyether of 0.525% - 0-025 silicon modified of amino Vitamin E (%) 0.263% + - 0.013 Cosmocil 50 ppm Water Q.S. A 100 20 measuring catheters and needles were mounted as before and the penetration test was carried out on a natural latex film of 13.5 mils in thickness. At the same time, 20 commercial Insyte® measuring catheter products were tested under the same conditions for comparison. The results are as follows: Experimental Sample Needle tip (g) 22.6 (8.6) Needle transition (g¡ 17.3 (1.9) Needle heel (g) 10.9 (1.1) Catheter tip (g) 18.1 (3.0) Catheter guide (g) ) 16.2 (2.1) Catheter drag (g) 4.8 (1.9) Commercial Sample Needle tip (g) 19.5 (5.7) Needle transition (g¡ 13.4 (1.2) Needle heel (g) 7.0 (0.6) Catheter tip (g) 16.3 (2.4) Catheter guide (g) ) 10.6 (1.0) Catheter drag (g) 3.0 (0.6) NOTE: = standard deviation Sample size = 10 As is evident, the results are comparable with commercial products and experimental samples. The commercial sample used polydimethylsiloxane silicon fluid as a lubricant.

Example No. 7 22 measuring catheters and needles were assembled as before using the formulas described in Example 6 and penetration was tested through a sheepskin in the hindquarter just below the knee. Penetration forces were measured using sensitive force transducers. The data was collected on a computer for analysis. For comparison, the 22 commercial measuring catheters and needle assemblies used polydimethylsiloxane silicon fluid as the lubricant that was used. The results are given below: Experimental sample Max. Catheter / needle tip (g) 142.5 ^ Max Catheter guide (g) 70.31 Commercial Sample Max. Catheter / needle tip (g) 164. 67 Max. Catheter guide (g. 271 .68 As is evident, the new lubricant is superior to the standard commercial product.

Example No oo The polyurethane tubes were lubricated using the formulas of this invention described in Example 6, as well as the polydimethylsiloxane silicon fluid. These tubes were implanted in the aorta of the rabbits to determine the level of coagulation and embolism formula. After three days the animals were sacrificed and the tubes were examined while they were still in the aorta. The coagulation, if present, was photographed and its size, number and location recorded. The kidneys were also examined for some situation of renal infarction that would indicate that an embolus was formed and that it traveled downstream to lodge in the minor arteries of the kidney. The coagulation resulting from the water-based lubrication solution of the invention was less than the coagulation that resulted from the commercial lubricant. The calculated risk of coagulation was three times lower when the water-based lubrication solution was used against the commercial lubricant.

Example No. 9 The following formulas were tested: Ingredients Needle with Lubricant Tentactive Agent 2.38% + - 0.25% silicon Polyether copolymer of 0.525% + - 0.025% amino modified silicon Vitamin E (%) 0.263% + - 0.013i Cosmocil 50 ppm Isopropyl Alcohol Water Q.S. to 100 Ingredients Catheter with lubricant "A" Tentactive agent 4.75% + - 0.25% silicon Ingredients Catheter with lubricant "A" Polyether copolymer of 0.525% + - 0.025% amino modified silicon Vitamin E (%) 0.263% + - 0.013% Cosmocil 50 ppm Isopropyl alcohol Water Q.S. to 100 Ingredients Catheter with lubricant "B" Agent Tenciactivo 4.75% + - 0.25% of silicon Copolymer of polyether of 0.525% + - 0.015% silicon modified of amino Vitamin E (%) 0.263% + - 0.13% Cosmocil 50 ppm Alcohol of sipropilo Water Q.S. to 100 measuring Teflon catheters and needles were mounted lubricating the needles first with the needle lubricant. The Teflon catheters were lubricated with both the "A" lubrication catheter solution and the "B" catheter lubrication solution. The needles and Teflon catheters were put together, but making sure that the two groups of the Teflon catheters were separated from each other. These assemblies passed the penetration tests through a natural latex film of a thickness of 13.5 mils. At the same time, 20 sets of commercial Teflon measuring catheters were tested under the same conditions for comparison. The results are given below: Commercial Sample Needle tip (g) 15.2 (2.7) Needle transition (g) 12.6 (1.5) Needle heel (g) 5.7 (0.4) Catheter tip (g) 18.5 ( 2.8) Catheter guide (g) 10.8 (1.2) Catheter entrainment (g) 3.9 (0.6) Sample size 20 Lubricant for Catheter Sample; 'A Needle tip (g) 17.8 (4.5 Needle transition (g) 13.4 (1.2) Needle heel (g) 7.1 (0.8) Catheter tip (g) 22.2 (2.6) Catheter guide (g) 25.3 (5.1) Catheter drag (g) 14.0 (6.3) Sample size 10 Catheter lubricant Samples "B" Needle tip (g) 15.5 (2.8) Needle transition (g) 14.1 (1.8) Needle heel (g) 7.8 (0.9) Catheter tip (g) 20.1 (2.1) Catheter guide (g) 15.1 (2.2) Catheter drag (g) 6.1 (2.0) Sample size 20 NOTE: Parentheses () = Standard derivation As can be seen, the results obtained with solution "B" of lubrication for the catheter are comparable with commercial samples. This test indicated that the lubrication solution should contain 10% isopropyl alcohol in addition to the rest of the ingredients, when a Teflon product is to be lubricated.

Also 20 Teflon measuring catheters with the solution "B" lubrication for the catheter was penetrated through the fresh cow skin. At the same time, commercial Teflon catheter assemblies were penetrated through cow skin under similar conditions. The resulting evidence; they are given below: Commercial Sample Needle tip (g) 166.0 (37.9) Catheter tip (g) 230.0 (35.9) Catheter guide (g) 297.5 (45.) Catheter drag (g¡ 77.3 (11.3) Sample size 10 Lubricant for Catheter Samples "B" Needle tip (g) 146.0 (37.6) Catheter tip (g) 220.0 (62.7) Catheter guide (g) 304.0 (68.1) Catheter drag (g¡ 60.3 (12.3) Sample size 10 As can be seen, all the functions of the test products are equal or slightly better than those compared with the commercial product. These results indicate that approximately 10% of the isopropyl alcohol in the lubrication solution provides better lubrication of the surface of the Teflon catheter.

Example No. 10 The surface tension of the "A" lubrication solution for the catheter and the "B" lubrication solution for the catheter was measured using a DuNouy Surface Tensiometer. The results were the following.

Lubricant Dynes / Dyne Surface Tension Lubricant for Catheter "A" 34.3 Catheter Lubricant T'B "29.7 The above results further show that solution "B" of catheter lubrication having a lower surface tension will provide a better surface coating for the Teflon products.

Example No. 11 Twenty sets of Teflon measuring catheters were lubricated with catheter lubrication solution "A" and catheter lubrication solution "B" examined under scanning electron microscope to verify surface morphology. The surface of the catheter lubricated with the "A" solution of catheter lubrication was not smooth and it could be seen that larger spots of the lubricant were visible on the surface. The surface of the catheter lubricated with catheter lubrication solution "B" was considerably softer and the lubricant spread very well on the surface. Again, these results confirm that for Teflon products whose surface is difficult to lubricate, it will be more likely to provide a homogeneous layer of a catheter lubrication solution that has a lower surface tension compared to a lubrication solution that has a higher surface tension value.

Example No. 12 Catheter Lubrication Solution Ingredients I II Tentactive Agent 4.75% 4.75% silicon Polyether copolymer 0.525% 0.525% amino modified silicon Lubrication Solution for Catheter Ingredients II Vitamin E 0.263% 0.263% Cosmocil 50 ppm 50 ppm Isopropyl alcohol 0% 5% Water Q.S. to 100 100 Catheter Lubrication Solution Ingredients III IV Tenciactivo Agent 4.75% 4.75% of silicon Copolymer of polyether 0.525% 0.525% of silicon modified of amino Vitamin E (%) 0.263% 0.263% Cosmocil 50 ppm 50 ppm Isopropyl alcohol 0% 15% Water Q.S. to 100 100 Catheter Lubrication Solution Ingredients V VI Tenciactivo agent 4.75% 4.75% of silicon Copolymer of polyether 0.525% 0.525% of silicon modified of amino Vitamin E (%) 0.263% 0.263% Cosmocil 50 ppm 50 ppm Isopropyl alcohol 20% 30% Water Q.S. 100 100 Lubrication Solution for Catheter Ingredients VII Tentactive agent 4.75% silicon Polyether copolymer 0.525% amino modified silicon Vitamin E (%) 0.263% Cosmocil 50 ppm Isopropyl alcohol 50% Water Q.S. a 100 The surface tension and the flame possibility data of these formulas are given below: Composition Voltage of Flammability Surface (dynes / cm) I 34.3 No II 34.6 No III 29.7 No IV 29.3 No V 28.0 No VI 26.0 Yes VII 24.7 Yes As this information indicates, the surface tension of several solutions improves when alcohol Isopropyl ester comprises a larger portion of the solution. However, once the isopropyl alcohol comprises 30% or more of the lubrication solution it becomes flammable and therefore difficult to handle.

In this way it is observed that the new lubricant is provided without requiring the use of a CFC or large amounts of flammable material for a solvent, and a new, inexpensive and easy to control lubrication solution is provided. In addition, the lubrication solution of this invention is safe, non-toxic and "environmentally friendly".

Claims (9)

1. A lubrication solution for a medical device that includes: a lubricant of silicon surfactant; water and; a low molecular weight alcohol.

2. The lubricant solution of claim 1, wherein the lubricant of silicon surfactant is a modified copolymer polyalkeno oxide polydimethylsiloxane.

3. The lubrication solution of claim 1, wherein the lubricant of the silicon surfactant is a copolymer of amino modified sicilium polyether.

4. The lubrication solution of claim 2, wherein the lubricant of the silicon surfactant also includes an amino-modified silicon polyether copolymer.

5. The lubrication solution of any one of claims 1 to 4, wherein the lubricant of the silicon surfactant comprises between 2% and about 6% of the solution.

6. The lubrication solution of any one of claims 1 to 4, wherein the low molecular weight alcohol comprises about more than 0% and less about 30% of the solution.

7. The lubrication solution of claim 5, wherein the low molecular weight alcohol comprises more than about 0% and less than about 30% of the solution.

8. The lubrication solution of claim 6, wherein the low molecular weight alcohol has a molecular weight less than or equal to 150.

9. The lubrication solution of claim 7, wherein the low molecular weight alcohol has a molecular weight less than or equal to 150.