MXPA99001064A - Quirérgicos / medical pipe and container for use in transporting medical and similar solutions - Google Patents

Abstract

Plastic articles obtained from a modified ionomeric polyether ether are stored in a receptacle containing cryogenic fluid. Items can be pipes or bags or items of equipment or surgical clothing

Description

PIPING AND SURGICAL / MEDICAL CONTAINERS FOR USE IN TRANSPORTING MEDICAL AND SIMILAR SOLUTIONS Reciprocal Reference to Related Applications This application relates to variations of the inventions disclosed in U.A. Patent No. 5,496,291 and pending applications, Serial No. 803,779, filed on February 24, 1997; Serial No. 790,192, filed on January 30, 1997 and No. serial 1 () 742,046, filed on November 1, 1996.

Background of the Invention Polyvinyl chloride (PVC) is the accepted material for use as pipelines in various medical applications, such as peritoneal dialysis, blood LT processes, chemotherapy and other uses. In these uses, a consumable substance is transported through the pipeline from one location to another. For peritoneal dialysis (CAPD), for example, it is also a practice to replace the used dialysate bag with a new bag. This is achieved by cutting through the PVC pipe, which leads from the used bag, and then welding the pipe from a new bag to the cut portion of the pipe, so that one bag can replace another. PVC is also a generally accepted material for forming bags and other medical containers and is commonly used as a pipeline in the food process, particularly for fluids and semi-solids. In addition, PVC is the material generally used to form sheets and films for the exclusion of bacteria and viruses. Despite its acceptance in the 5 technique, PVC has a number of disadvantages, which it would be convenient to overcome in such uses. For example, conventional PVC includes a plasticizer (DOP), which can be leached into the solutions in the bag. In addition, after the PVC has leached its PDO, large volumes of PVC particles. Other disadvantages will be mentioned later. US Patent No. 5,496,291 and Application Serial No. 08 / 803,779, filed on February 24, 1997, disclose an ionomeric modified polyether ether material, which can be used as a substitute for polyvinyl chloride. Other variations of that material are described in applications Serial No. 08 / 742,046, filed on November 1, 1996 and Serial No. 08 / 790,192, filed on January 30, 1997. ? o Compendium of the Invention An object of this invention is to provide a material that acts as an improved replacement for PVC in conventional PVC applications.

A further object of this invention is to provide such material that can be used: 1) as a pipe for medical applications, 2) as bags and other medical containers, 3) as surgical equipment or clothing, such as gloves, clothing, aprons, boots, gowns and masks for the face, 4) for pipes in food processes and 5) for sheets and films for the exclusion of bacteria and viruses. Still another object of this invention is to provide LO techniques for storing devices made of such material. According to this invention, the material that complies with the above objects includes an ionomeric modified polyether ester, as described in the L5 patent of E. U. A., No. 5,496,291 and in the aforementioned patent application. In the practice of this invention, the various devices made of the material are stored cryogenically. It has been found that such a way of storing the devices increases the possible uses of the 3 devices, without harming their physical characteristics. Thus, for example, the devices can be used in connection with the storage of products, such as semen, blood cells and DNA. It has also been found that by storage cryogenically the devices do not need to include both ionomer with the polyether ester, and in the amounts mentioned in the patent 5,496,291 and in the aforementioned patent applications.

The Drawings Figure 1 is a front elevation view, showing the practice of the invention, in which a device, made with the material of this invention, is cryogenically stored; Figure 2 is a perspective view showing .0 a tube which can be used in the practice of this invention; Figure 3 is a schematic view, showing a bag and tube assembly, according to this invention, used for peritoneal dialysis; -5 Figure 4 is a top plan view of a surgical cover or film, in accordance with this invention; Figure 5 is a top plan view of a surgical glove, in accordance with this invention; ! () Figure 6 is a top plan view of an apron, in accordance with this invention; and Figure 7 is a top plan view of a surgical mask for the face, in accordance with this invention.

Detailed Description The present invention is directed to supplying a material which can be used as a substitute for PVC in conventional uses of this PVC, while having 3 advantages over such PVC material. The material of this invention is an ionomeric modified polyether ester with a small amount of ionomer. The polyether ester is a well known material, generally used to take advantage of its high strength characteristics. Such a material is used, for example, in clothes, generally referred to as polyester clothes. Ordinarily, the resistance of such material would make it unsuitable for use as a substitute of PVC in PVC applications with which this invention relates. However, it has been discovered that L5 the polyether ester material can be modified by the incorporation of a small amount of an ionomer, which will modify the characteristics of the polyether ester giving sufficient brittleness to, for example, allow the material, when used Like a sealed tube, open 0 by pop. The specific amount of the ionomer will depend on the end use. The qualities can also be retained when the material is mixed with a small amount of silica, such as colloidal silica dioxide (amorphous or pharmaceutical grade). The silica can be in the form of silica oil. The present invention is based on variations of the material described in the patent 5,496,291 and in the aforementioned patent applications. All the details of the patent 5,496,291 and the aforementioned patent applications are incorporated herein by reference. In general, these patents and applications disclose an ionomeric modifier, which comprises from 0.5 to 50% by weight, and preferably from 1 to 25% by weight, of the combination that depends on the end use requirement. For example, in pipes, such as for CAPD use, where the material is to be sealed, welded and the lumen will be reopened, the range of the ionomer composition ranges from 2 to 15% by weight, a further range preferred will be from 3 to 10% by weight. An interval of 7 to 10% by weight is ideal. The result is a tube, which is strong, of sufficiently elastic type, and a degree of fracture to make it possible to reopen the sealed tubes by finger pressure. For bags, films and other thin structures, the ionomer will be present in a range of 1 to 50% by weight of the combination, depending on the end use requirements. For food process tubes and aseptic surgical cover procedures, an interval of 10 to 20% by weight is desirable. For implanted catheters and sutures, the preferred range is 0.5 to 1% by weight. The material of the prior invention in the patent application Serial No. 08 / 742,046, is a ') combination of PVC and an ionomeric modified polyether ester, in which the material has from 0.5 to 25% by weight of PVC , from 1 to 50% by weight of the ionomer and from 50 to 99% by weight of the polyether ester with equal mixtures of ionomer and the polyether ester being possible. The material of the prior invention in the patent application Serial No. 08 / 790,192, is a combination of silica and an ionomer modified polyether ester, in which the material has from 5 to 10% by weight of oil of silica or from 1 to 3% by weight of r dioxide) colloidal silica in mixture with 1 to 50% by weight of ionomer and 50 to 99% by weight of the polyether ester with equal mixtures of an ionomer and poly - ether-ester being possible. The components of the basic material are as follows: Poly-ether-ester COPOLYMER OF BLOCK OF POLY -TERTER- STER (polyether-block ester) (co-poly-ester-ester) (polyester elastomer) (polyether- thermoplastic ester, trade names: Hytral, Lomod, Pelprene and others A block copolymer containing both polyether and ether blocks The best-known example is polymethylmethylene-terephthalate-b-polyoxytetramethyl terephthalate.ock. , commercial name: Surlyn, among others. An ethylene copolymer with 1-10% by weight of methacrylic acid, which has been converted to the methacrylate salt, often a sodium, magnesium or zinc salt, by neutralization with the appropriate base. The resulting ionic groups tend to aggregate to form domains that act as physical entanglements for the polyethylene. However, domains break when heated, so the material can be processed in molten form like other thermoplastics. The copolymers are produced by the high pressure ethylene polymerization process and thus are similar to low density polyethylene. The copolymer decreases in crystallinity, but the consequent loss of stiffness is restored by physical entanglements. The material is more transparent than the LDPE and shows better adhesion, which makes it useful as a layer in laminated coextruded packaging films and, therefore, the homogeneous mixture.

Reference is made to the patent of E. U. A., No. ,496,291, all the details thereof are incorporated herein by reference for a further discussion of the ionomeric modified polyether ester component of the material. Poly-ether-esters are valuable materials because they have excellent properties at low temperatures (freezing) and are impervious to chemicals, oils and fabrics. However, they have a disadvantage for many end uses: they stretch 7 times their length with low voltage. For example, a 30 cm long tube will stretch to 2.10 meters before breaking. Industrial products, such as bags, films, tubes, etc., easily buckle in their configuration and become unacceptable as end-use products. The present invention adds an ionomer to the composition to obtain thin, useful products. Ionomers are somewhat similar to polyethylene in that they are useful as films because they are excellent for wrapping food, packing medical and pharmaceutical products and are impervious to most oils and chemicals. Like polyethylene, they are easily perforated and only stretch 3 times before breaking.

A common use is a coating on stronger materials and are often used as coextrusions in nylon and other films to provide heat sealing. The invention makes use of the fact that polyether esters and ionomers can be selected to melt at the same temperature (191 ° C) or at sufficiently close temperatures. Instead of a coating, the invention mixes them together. In this form, the disadvantages of the two materials can be adjusted in a variety of ways to obtain new materials that are stronger than the ionomers, and stretch less than the polyether-esters. By combining the two materials, as described, other major limitations of the polyether-ethers (P.E.E.) are also reduced. They can absorb excessive moisture, depending on temperature and humidity. In the case of using the P.E.E. in autoclaved medical tubing (sterilized with steam), for example, moisture capture makes the tubing unacceptable for further processing. By adding 5 to 7% of the ionomer to the composition, the ability to absorb moisture to less than 1% by weight is reduced. A level comparable to medical grade PVC and well within the required TCD® limits for welding. To form the material of this invention, the following process can be used. The individual materials are fed separately in the form of pellets in a single screw extruder. Other forms of extruders can be used satisfactorily, but that of a single screw is sufficient and easier to control. The materials in the pellet streams are mixed in the required ratios and fed into the extruder. Extrusion rates of 4.54 to 113.4 kilograms per hour are practical at melting temperatures of 180 to 200 ° C, with 191 ° being the ideal temperature. The melt is fed through a sizing die and the liquid is cooled as it leaves the die for accuracy and handling purposes. A heating and mixing profile of a typical extruder will involve feeding the materials, such as pellets, from individual feed hoppers into the extruder, where the feed zone of the extruder is at 149 ° C. The material will then move to a compression zone at 177 ° C. The materials will then pass into a melting zone at 190 ° C. Finally, the material will be extruded in the desired configurations.

Techniques conventionally used for PVC can then be used to form the final products. In general, the portion of the material having the ionomer and the polyether ester can include from 10 to 15% by weight of the ionomer when used for bags (containers), pipes and films for use in medical, surgical or food processes. The range of the ionomer of the portion of the material, which has the ionomer and the polyether ester, can include 5 to 15% of the ionomer when used for surgical equipment and clothing, such as gloves, clothing, aprons, masks for the f boots and coveralls. The present invention is directed to a way of storing articles or devices obtained from such material. It has been found that when the articles or devices are stored cryogenically, it is possible to reduce the amount of the ionomer in the material without detrimentally affecting the desired characteristics. If the amount of the ionomer is relatively large, such as in the upper limits of the various ranges described in the '519 patent and the aforementioned patent applications, the presence of such an amount of ionomer can cause fissure formation. However, when the devices or articles are stored cryogenically, that ionomer squelch can be significantly reduced. For example, when used for tubes, bags and films, the ionomer may be present in the range of 0.05 to 2% by weight of the portion of the material containing the polyether ester and the ionomer. The interval can be increased with some sacrifice of the properties, such as 5% by weight of the ionomer or the range can be decreased to 0.01% and even to the point of elimination of this ionomer. Thus, in the preferred practice of the invention there is no more than 2% by weight of the ionomer in the portion of the material having the polyether ester and any ionomer. The same intervals can be used for final products, such as gloves, clothing, aprons, boots, gowns and fmasks. The material may also include small amounts of silica and / or PVC at the intervals described in the aforementioned patent applications, added to the combined polyether-ester and ionomer. Figure 1 illustrates a practice of the invention, in which a storage container 10, which contains a cryogenic material 12, is used to store a bag or container 14, which has a substance, such as semen, blood cells or DNA, stored in the bag 14. This bag 14 is obtained with the material of this invention. Any suitable cryogenic substance, such as liquid nitrogen, carbon dioxide or helium, can be used. Other types of devices that can be stored include, for example, the pipe 18 of Figure 2, covers or surgical films 20 of Figure 4, gloves 22 of Figure 5, aprons 24 of Figure 6 or masks for the fof Figure 7. Similarly, surgical boots or gowns can be stored. It is convenient to store such devices particularly when storage sterility is preferred, by having the various devices stored in a sterile condition, inside a cryogenic receptacle. The invention can be practiced widely by cryogenically storing any device made of the material of this invention, which is a substrate for such a device that is previously made of PVC. Figure 2 shows the combination of a container or bag 14 used with the line 18 leading to a patient 19 for CAPD use. both the bag and the pipe have been stored cryogenically. A series of cryogenic tests were performed on pipes, such as tube 18 using liquid nitrogen at a temperature of -273 ° C. The material of the pipe has an outer diameter of 5.4 mm and an inner diameter of 3.85 mm. The pipe has a CAPD size that is 30 cm longer and is bent into a U-shape, then immersed in a thermo-bottle of liquid nitrogen. The tube is removed from the Dewar flask and dropped from a meter to a concrete floor. The material does not splinter like most plastics, but remains intact and resilient. A second test was carried out using the same piece of pipe. In the second test, the U-shaped tube was found to straighten this tube. Notably, the tube was flexible enough to straighten it without splintering or cracking. After returning it to room temperature, the integrity of the tube was completely restored. The invention is particularly useful in that it has applicability for the storage of many biological fluids, such as mammalian cell culture processes that require cryogenic storage capacity. Advantageously, the material of this invention is capable of withstanding the rigors of cryogenic temperatures, for example, the temperatures of liquid nitrogen, and still remain flexible. Even with a reduced amount of the ionomer, according to this invention, where the pipe is stored cryogenically, the material of the pipe is capable of being welded to itself to form a seal, which resists the opening at an internal pressure of up to 4.2 kg / cm2, and this seal is able to open by the external pressure of a finger. The pipe is also capable of being welded to a conventional PVC pipe. When the material is used in a container or bag, these can be sterilized. When used for tubing and containers, the invention can be practiced in such assemblies as a peritoneal dialysis assembly (Figure 2), where the container 14 is the dialysis bag mounted at a remote location of the patient and the tubing 18 is mounted at the connection structure of the container, to allow the flow of fluid through the container and the patient 19. The invention can also be practiced in a urinary drainage assembly, where the container is a urinary container and the tubing carries urine from the patient to the recipient. The invention can be practiced in a blood process set, which includes a blood supply needle and a blood collection container, where this container is made in accordance with the material of this invention and the tubing creates the flow communication between the needle and the container.

The invention can also be practiced in a chemotherapy set, where the container is a container of a solution and the tubing leads from the container to a patient, to deliver the solution to the patient and with a drug introduction set communicating with the patient. pipe to introduce a drug into the solution. The invention can be practiced in a parenteral feeding set, wherein the container is a container of liquid nutrient and the tube is inserted into the subclavicular drain of a patient, in flow communication with the container. The invention can be practiced in a cell culture assembly, which includes a reactor with the pipeline leading from the reactor. In addition to the medical-type uses, described above, the invention can also be used in the food process, particularly as a pipe for -fluids and semisolids and as the material for obtaining sheets and films for the extrusion of bacteria and viruses. When used as sheets or films, the sheet can be covered over the patient and the surgeon will cut through the sheet in the patient.

As is evident, the invention can be practiced for PVC substitute articles of any type, wherein the article is stored cryogenically.

Claims (28)

1. Claims 1. In combination, a storage receptacle, a cryogenic fluid within the storage receptacle, a plastic article, disposed within the cryogenic fluid, to be stored within the receptacle, this plastic article is obtained from a plastic material the which is predominantly a polyether ester and which is free of plasticizer.
2. 2. The combination of claim 1, wherein the plastic material is an ionomeric modified polyether ester, containing no more than 5% by weight of the ionomer, and this polyether ester and the ionomer, individually and in combination They are free of plasticizer.
3. 3. The combination of claim 2, wherein this material does not contain more than 2% by weight of the ionomer.
4. 4. The combination of claim 3, wherein the material contains at least 0.01% by weight of the ionomer.
5. 5. The combination of claim 4, wherein the plastic article is a pipe.
6. 6. The combination of claim 4, wherein the plastic article is a container.
7. 7. The combination of claim 6, wherein the container contains human material, selected from the group consisting of semen, blood cells and DNA.
8. 8. The combination of claim 4, wherein the plastic article is a film.
9. 9. The combination of claim 2, wherein the plastic article is an article of surgical equipment or clothing.
10. 10. The combination of claim 9, wherein the surgical equipment or clothing is selected from the group consisting of gloves, clothing, aprons, boots, gowns and face masks.
11. 11. The combination of claim 3, wherein the plastic material contains a minor amount of silica.
12. 12. The combination of claim 3, wherein the plastic material contains a minor amount of PVC.
13. 13. A plastic pipeline for transporting fluids between a first location and a remote container, this pipeline is obtained from an ionomeric modified polyether ether material, which contains no more than 2% by weight of ionomer, this polyether ester is a block copolymer containing both polyether and ester blocks, modified by the ionomer. this ionomer is a copolymer of ethylene with 1 to 10% by weight of methacrylic acid, converted to the methacrylate salt, this polyether ester and the ionomer, both individually and in combination, are free of plasticizer, the pipe is capable of being welded to itself, to form a seal, which resists the opening at an internal pressure of up to 4.2 kg / cm2, and this seal is capable of being opened under the external pressure of a finger.
14. 14. The pipe of claim 13, wherein the material contains at least 0.01% by weight of ionomer.
15. 15. The tubing of claim 14, wherein the material includes a minor amount of silica.
16. 16. The tubing of claim 14, wherein the material includes a minor amount of PVC.
17. 17. A container for medical substances, this container is made of a modified ionomeric polyether ester material, containing no more than 2% by weight of ionomer, this polyether ester is a block copolymer containing both blocks. of poly ether as ester, modified by an ionomer, this ionomer is a copolymer of ethylene with from 1 to 10% by weight of methacrylic acid converted to a meta-plate salt, and the poly-ether-ester and the ionomer, both individually as in combination, they are free of plasticizer, and the recirculator can be sterilized by means of steam.
18. 18. The container of claim 17, wherein this container includes a structure for communication with the pipe.
19. 19. The container of claim 17, wherein the material contains at least 0.01% by weight of the ionomer.
20. 20. The container of claim 19, wherein the material includes a minor amount of silica.
21. 21. The container of claim 19, wherein the material includes a minor amount of PVC.
22. 22. A method for storing plastic articles, which comprises the steps of supplying a storage container, inserting a cryogenic fluid into the storage container, and inserting this plastic article into the cryogenic fluid, where the plastic article is obtained from the material of poly-ether-ester, which is free of plasticizer.
23. 23. The method of claim 22, wherein the plastic article is a modified, ionomeric polyether ester material, containing no more than 2% by weight of ionomer.
24. 24. The method of claim 23, wherein the plastic material contains at least 0.01% by weight of the ionomer.
25. 25. The method of claim 24, wherein the plastic article is selected from the group consisting of containers, pipes, films, gloves, clothing, aprons, boots, gowns and face masks.
26. 26. The method of claim 25, wherein the plastic article is a pipe.
27. 27. The method of claim 25, wherein the plastic article is a container.
28. 28. The method of claim 27, wherein the human substances are inside the container.