MXPA97009975A - Neopr copolymer surgery gloves - Google Patents

Abstract

Certain neoprene copolymers make it possible to manufacture surgical gloves, Swanz-Ganz balloons that have improved properties

Description

NEOPRENE COPOLYMER SURGERY GLOVES This invention relates to improved surgical gloves and compositions used in its manufacture BACKGROUND OF THE INVENTION In some cases, natural rubber medical gloves can produce allergic responses in individuals predisposed to develop a reaction. allergic to latex Some of the medical literature has suggested that the allergic response is especially high in rubber gloves in the areas of medicine due to the continuous exposure by health care providers.The resistance to change of natural latex It has always been associated with uncomfortable texture or different from all other synthetic options, including neoprene, and other materials ^ Neoprene surgery gloves now on the market are generally unpopular because they feel tight and inflexible in user's hands, surgical users of these products prefer the soft and flexible texture of a natural rubber glove. The neoprene compound, and the process developed by this invention produces a synthetic glove which has a lower modulus than the prior art. The invention produces a neoprene glove of equal or better softness to the touch than surgical gloves constructed of natural latex. Advantages of the invention The neoprene gloves of the invention are made of synthetic elastomers, still possess the appearance and texture of natural latex gloves. They are basically non-allergic and are free of protein. They can be manufactured using existing glove manufacturing techniques and processes. The gloves of the invention are resistant to solvents and ozone. The gloves can be treated: with conventional lubricating powders. Alternatively, the gloves can be dust-free while still maintaining good mold release and put-on properties. To achieve this effect, conventional halogenation processes can be employed. The physical properties are not materially reduced after undergoing radiation sterilization. The invention comprises gentle surgical gloves or industrial medical gloves that have been constructed in a latex of neoprene copolymer and 2,3-dichloro-l, 3-butadiene, which polymer contains between 25-55%, and preferably 35-45 % chlorine. In a more preferred embodiment, the copolymer contains 40% chlorine. The mild surgical gloves can be further characterized by having a low modulus, a low crystallization ratio, a high wet gel strength and a medium gel content. The invention also comprises compositions useful for producing soft surgical gloves of the types described above. One, general formula used in the preparation of the gloves is disclosed in Table I.

TABLE I INGREDIENTS PARTS PER HUNDRED PERIOD Latex of neoprene copolymer 100.00 Plasticizer stabilizer I 0.25- to 10.00 Emulsifier stabilizer I '• 0.25 to 10.00 Anti-ozone plastifier I 0.25 to 10.00 Stabilizer of sequestered pH 0.10.a 1.50 Stabilizer of pH 0.10 1.50 Activator of vulcanization ', 0.25 to 20.00 Interleaver 0.10 to 3.00 Vulcanization accelerator 0.25 »4.00 Antioxidant 0.10 to 3.00 Pigment white * 0.05.a 3.00 Pigment yellow * 0.05 to 3.00 (Reoblent rubber) 0.001 to 1.0 Emulsifier I wetting agent 0.001 to 1.0 Defoamer 0.001 a 2.0 Rubber softener 0.0 'to 50.0 optional ingredients. Detailed description of the preferred embodiments The neoprene copolymer latex as indicated, this copolymer of 2-chloro-1,3-butadiene and 2,3-dichloro, 3-butadiene contains between 30-50%, preferably 35-45% of chlorine and more preferably 40%. The modulus (elasticity) MPa of these polymers should not be greater than 0.6 to 100%, preferably the modulus > it is approximately 0.4 to 100%. For a more detailed explanation of these values see table II of the DuPónt newsletter, A GUIDE FOR THE SELECTION OF LATEX OF NEOPRENE, by C.H. Gilbert, 1985 (NL-020.1 (Rl)), which is incorporated herein by reference. These latexes have had a solids content between 35-60% by weight. Preferably it is 50%. As indicated, the copolymers useful in the practice of the invention have a slow crystallization rate, a medium gel content and a high wet gel strength. These are preferably anionic latexes. More information about these polymers is available by referring to the C.H. bulletin. Gilbert and the DuPont newsletter, LÁTEX DE NEOPRENO-ITS PREPARATION AND CHARACTERISTICS, by L.L. Harrel'Jr., 1981 (ADH 200.1). This reference is also here for reference. The preferred commercial latex used in the practice of the invention is available from DuPont under the code number 750. This anionic copolymer latex has a chlorine content of 40% and has all the preferred properties described above. The specific details that describe this latex can be found in the C.H. bulletin. Gilbert. Glove Thick The term "surgical gloves", as used herein and in the claims, includes related products such as examination gloves, thimbles and Swanz-Ganz balloons in medical catheters. It is an important feature of the invention that the gloves are thin gloves having an average thickness anywhere of less than 12.7 cm (5"), preferably the thickness will not exceed 1.23 mm (0.009"). A typical glove produced in accordance with the invention has a thickness of 0.142 mm (0.006") and a thickness in the fingers of 0.19 mm (0.0075"). Processes for manufacturing surgical gloves The gloves of the invention are preferably manufactured using well-known immersion technologies. These processes are in most cases well-known processes, for example, straight immersion and coagulant immersion, the latter being the most frequent process comprising the anode process or the Teague process. While any of these coagulation processes can be used in the practice of this invention, the anode process is the most preferred. The descriptions of these processes are described in the publication, TECHNOLOGIES OF IMMERSION OF HULE NATURAL, by R.D. Culp and B. L. Pugh, Symposium on latex as barrier material, April 6 and 7, 1989, University of 'Mary'land. Another document describing latex immersion is • NEOPRENE LATEX AND ITS APPLICATIONS WITH EMPHASIS ON THE MANUFACTURE OF GOOD IMMERSES, by O.H. Gilbert and H. E. Berkheimer, ACS Spring Convention, Rubber Division, Montreal, Quebec, May 27,1987. These documents are incorporated here for reference. Still another reference describes the immersion of neoprene latex is the publication 'LÁTEX DE NEOPRENO Y SU APLICACIONES, F. L. McMillan, ACS. Rubber Division, Toronto, Ontario, May 21-24, 1991. This document provides a good description of various ingredients used in the formulation of neoprene latex and its functions. This document also provides a description of the anode immersion process in the next language: "In the anode process, a form is submerged in a coagulant, withdrawn, and rotated to allow the uniform deposit of the coagulant, after allowing it to partially dry, during which time the coagulant film becomes more viscous, the In this way, it immerses slowly and stably into the latex compound and stays there long enough to allow the film to settle to the desired thickness, then it is removed at a stable rate - slow enough to minimize the flow of the outer layer of the wet compound - in the form ". "When it is in straight immersion, the rotation of the shape after the removal helps in the uniformity of the film.The immersed compound is often followed by another immersion of coagulant to fix the wet film.Due to the deposit reason it is very fast at the beginning but then decreases quickly with the momentary stop time and due to • that; the whole process can be repeated many times, it is often * less expensive and faster to use in multiple dives when producing heavy films. "These last two references are incorporated herein for reference EXAMPLES Using an anode immersion process of the type described and A formula of the type shown in Table I, surgery gloves were made and tested against commercial neoprene gloves.The results of these tests are disclosed in Tables 2 and 3.? TABLE 2 ORIGINAL SURGERY GLOVES ASTM STANDARDS TYPE 1 (NATURAL) TYPE 11 (SYNTHETIC) MODULE 500% 800 lb / in2 (54.44 atm) 1020 lb / in2 (69.41 atm) MAX ELONGATION 750% MIN 650% MIN 00 TRACTION 3500 1b / in2 (238.17 atm) 2470 Ib / in2 (168.08 atm) * NOTE: THE GLOVES GIVE THE INVENTION WERE NOT STERILIZED TABLE 3 SURGERY GLOVES AFTER ACCELERATED AGING AT 70 ° C (158 ° C) - 7 DAYS ASTM TYPE 1 STANDARDS (NATURAL) TYPE 11 (SYNTHETIC) MODULE 500% NONE ELONGATION 560% MIN 490% MIN < - TRACTION 2610 lb / in2 (177.61 atm) 1740 lb / in2 (118.40 atm) MIN * NOTE: THE GLOVES OF INTENTION WERE NOT STERILIZED To illustrate the fact that radiation sterilization does not materially diminish The physical properties of the gloves of the invention, is given in Table 4 to continued TABLE 4 PHYSICAL PROPERTIES BEFORE STERILIZATION Using a similar formula, Swanz-Ganz balloons were prepared. These balloons successfully passed the standard pressure tests. The foregoing descriptions of the preferred embodiments of the present invention have been presented for purposes of illustration and description, are not intended to be exhaustive or to limit the invention to the precise forms discussed, and obviously many modifications and variations are possible to light of the above teachings The modalities were chosen and described in order to better explain the principles of the invention and its practical application, thus enabling others with skill in the art to better utilize the invention and various modalities with various modifications as appropriate. for the particular use contemplated, it is intended the scope of the invention to be defined by the appended claims to the present and their equivalents.

Claims (10)

1. CLAIMS 1. A surgical glove that has been constructed of neoprene latex copolymer and 2,3-dichloro-1,3-butadiene, which copolymer contains between 25-55% chlorine.
2. 2. The surgical glove according to claim 1, wherein the copolymer contains between 35-45% chlorine.
3. 3. The surgical glove according to claim 1, wherein the copolymer contains 40% chlorine.
4. 4. The surgery glove according to claim 1, further characterized in that it has a low modulus, a low crystallization ratio, a low wet gel strength and a medium gel content.
5. 5. A Swanz-Ganz balloon which has been constructed of a copolymer of neoprene latex and 2,3-dichloro-1,3-butadiene, which copolymer contains between 25-55% chlorine.
6. 6. The Swanz-Ganz balloon according to claim 5, wherein the copolymer contains between 35-45% chlorine.
7. 7. The Swanz-Ganz balloon according to claim 5, wherein the copolymer contains 40% chlorine.
8. 8. The Swanz-Ganz balloon according to claim 5, further characterized in that it has a low modulus, a low crystallization ratio, a low wet gel strength and a medium gel content.
9. 9. A composition useful in the production of surgical gloves according to claim 1, comprising: INGREDIENTS PARTS PER HUNDRED PERIOD Latex of neoprene copolymer 100.00 Plasticizer stabilizer I 0.25 to
10. 10.00 Emulsifier stabilizer I 0.25 to 10.00 Anti-ozone plastifier I 0.25 to 10.00 Stabilizer of sequestering pH 0.10 to 1.50 Stabilizer of pH 0.10'a 1.50 Vulcanization activator 0.25"at 20.00 Interleaver 0.10 to 3.00 Vulcanization accelerator 0.25 to 4.00 Antioxidant 0.10 to 3.00 Pigment white * 0.05 to 3.00 Pigment yellow * 0.05 to 3.00 (Reoblent of rubber) 0.001 to 1.0 Emulsifier I of wetting agent 0.00 * 1 to 1.0 Defoamer 0.001 a 2.0 Rubber softener 0.0 i 50.0