MXPA06009326A - Solventless plastic bonding of medical devices and container components through infrared heating - Google Patents

Abstract

The present invention provides a method for preparing solventless bonds between plastic components. The method includes the step of using infrared exposure to create bonds, and more specifically, the step of exposing a first article and/or a second article to a specific portion of the infrared spectrum. The invention further provides medical devices fabricated using infrared exposure.

Description

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UNSUPPLICED PLASTIC UNION OF MEDICAL DEVICES AND CONTAINER COMPONENTS THROUGH HEATING INFRARED CROSS REFERENCE TO RELATED REQUESTS Not applicable.

DEVELOPMENT OR FEDERALLY SPONSORED INVESTIGATION Not applicable.

BACKGROUND OF THE INVENTION The present invention relates to a method for joining plastic components without the need for solvents. The method includes using infrared heat and in some cases precisely absorbing infrared light pigment to create a joint. The method is preferably used to prepare strong bonds, which last longer between various types of medical devices and containers. There are numerous types of medical devices that are made of multiple plastic components. Ordinarily, these components must then be joined together in some way before the device is operable. Currently there are several binding techniques prevalently used including mechanical, thermal, solvent and chemical adhesive. It is a requirement that the joining technique chosen must not only provide a secure connection that satisfies all the parameters of the specific application, but also must not interfere with the function or safety standards of the device. Solvent bonding is a technique that is commonly used to join component parts of medical devices. Some of the advantages of solvent bonding are that it is relatively simple to perform, requires inexpensive materials and is usually quick to perform. However, there has recently been a further movement within the medical device industry away from solvent bonding. Another technique frequently used in the medical device industry is adhesive bonding. Some common adhesives used include epoxies, polyurethanes, silicones and acrylics. However, some of these devices have security risks. For example, polyurethanes may contain toxic heavy metal catalysts that pose serious problems in some applications of the medical device. In addition to safety concerns, another significant limitation of commonly used adhesives is that many can only be used for disposable devices. This limitation is partly due to the fact that many adhesives can not tolerate repeated sterilization. According to the above, there is a need to provide an alternative to the previously used joining techniques that does not suffer from these aforementioned disadvantages.

BRIEF DESCRIPTION OF THE INVENTION A method for assembling a medical device is described herein, including the steps of: providing a first article of a polymeric material; provide a second article of a polymeric material; contact the first article with the second article along an interface area; and exposing the first article and the second article to a specific portion of the infrared spectrum where the polymeric material of the first article and the polymeric material of the second article absorb infrared energy to generate sufficient heat to create a bond between the first article and the second article. In addition, a method for assembling a medical device is hereby established including the steps of: providing a first article of a polymeric material; provide a second article of a polymeric material; join the first article to the second article along an interface area; and exposing either the first or the second article to a specific portion of the infrared spectrum where the polymeric material of the first article or the polymeric material of the second article absorbs infrared energy to generate sufficient heat to create a bond between the first and the second article. Further described herein is a method for assembling a medical device including the steps of: providing a first article of a polymeric material; provide a second article of a polymeric material; applying an infrared light absorbing pigment to one of the first article or the second article to define an interface area; contact the first article with the second article along the surface area; and joining the first article to the second article along the interface area using exposure to infrared light. Further described herein is a method for assembling a medical device including the steps of: providing a first article of a polymeric material, providing a second article of a polymeric material, providing an infrared responsive pigmented film, placing the infrared responsive pigmented film between the first article and the second article to define an interface area and contact the first article with the second article, and apply exposure to infrared light to join the first article and the second article. Further described herein is a medical device assembly including a first article of a polymeric material; a second article of a polymeric material; the first or second article having an infrared absorbing pigment placed thereon to define an interface area, the first article contacting the second article in the interface area; and a protective plate temporarily placed on at least a portion of the interface area, so that when the infrared heat is applied to the interface area a joint is formed between the first article and the second article. There is further described herein a medical device assembly of a first article of a polymeric material; a second article of a polymeric material; the first or second article having an infrared absorbing pigment placed thereon to define an interface area, the first article contacting the second article in the filter area; and a protective plate temporarily placed on at least a portion of the interface area, so that when the infrared heat is applied to the interface area a joint is formed between the first article and the second article. There is further described herein a medical device assembly of a first article of a polymeric material, a second article of a polymeric material, either the first or second article having an infrared absorbing pigment placed thereon to define an area of interface, the first article joining in a fixed manner to the second article in the interface area when applying exposure to infrared light. Additional features and advantages of the present invention are described in, and will be apparent from, the following detailed description of the invention and the figures.

BRIEF DESCRIPTION OF THE FIGURES Figure 1A and Figure 1B are respectively cross-sectional views of a solderable, non-PVC, monolayer tube and a multilayer tube having the monolayer tube as a layer therein for use with the method of the present invention. Figure 2 is a cross-sectional view of a container of flexible material and a passage closure assembly for use with the method of the present invention.

Figure 3A is a cross-sectional view of a closure assembly having a membrane tube and two-layer passage tube for use with the method of the present invention. Figure 3B is a cross-sectional view of one embodiment of a closure assembly of the present invention. Figure 4 is a cross-sectional view of a closure assembly having a membrane tube and a three-layer passage tube for use with the method of the present invention. Figure 5A is a cross-sectional view of a tube assembly in which an inner tube has a layer of infrared-absorbing pigment on an outer surface. Figure 5B is a cross-sectional view of a tube assembly in which an outer tube has a layer of infrared-absorbing pigment on an inner surface. Figure 5C is a cross-sectional view of a tube assembly in which both an outer tube and an inner tube have a layer of infrared-absorbing pigment. Figure 6A and Figure 6B are a schematic plan view and a front perspective view of one embodiment of a protective layer according to principles of the present invention. Figure 7A and Figure 7B are a schematic plan view and a front perspective view of another embodiment of a protective layer according to principles of the present invention. Figure 8A and Figure 8B are a schematic plan view and a front perspective view of yet another embodiment of a protective layer according to principles of the present invention. Figure 9A and Figure 9B are a schematic plan view and a front perspective view of yet another embodiment of a protective layer according to principles of the present invention. Figure 10A and Figure 10B are a schematic plan view and a front perspective view of yet another embodiment of a protective layer according to principles of the present invention. Figure 1 1A and Figure 1 1 B are front plan views showing a method for joining two membrane tubes using the protective layer of the present invention. Figure 12 is a front perspective view showing an annular insert of pigment responsive to infrared light molded in a step with projections. Figure 13 is a schematic plan view of an infrared responsive pigmented film being used to join a passage with projections to a medical film. Fig. 14 is a schematic plan view of a step with protrusions having an infrared absorbing pigment printed on a surface that is to be attached to a surface of a medical film. Fig. 15 is a schematic plan view of a step with protrusions having infrared-absorbing pigment printed on a surface bonding to a surface of a medical film using a protective layer according to the present invention. Figure 16A and Figure 16B are schematic plan views of a method for joining a step with protrusions having infrared light absorbing pigment printed on a bottom surface thereof to a surface of a filled medical container using a protective layer according to the present invention. Figure 17A and Figure 17B are front plan views of a tube assembly before heating and after the infrared heat welding process showing unacceptable distortion. Figure 18 is a front perspective view showing a method for spraying an infrared pigment in a medical device according to the present invention. Figure 19 is a diagram of union strength vs. black smoke of natural gas by mass.

DETAILED DESCRIPTION OF THE INVENTION While this invention is susceptible to mode in many different forms, specific embodiments thereof are shown in the drawings, and will be described in detail herein with the understanding that the present disclosure is to be considered as a exemplification of the principles of the invention and it is not proposed to limit the invention to the specific embodiments illustrated. Figure 1A shows a monolayer tube that is suitable for use with the present invention. The monolayer tube 10 has a side wall 12 made of a polymeric material and more preferably of a non-PVC containing polymer and more preferably of a non-PVC containing polymer that is capable of being heated on exposure to an infrared source ("IR responsive"). "). Figure 1 B shows a two-layer tube 10 having a first layer or contact layer of solution 14 and a second layer 16. At least one of layers 14 or 16 is composed of a polymer not containing PVC that is responsive to IR . In a preferred form, the other layer 14 or 16 will also be a polymer not containing PVC, and more preferably a polymer not containing PVC that is responsive to IR. However, it may also be desirable to have a contact layer of solution 14 that is not IR responsive or does not contain any components that can be leached in solution or react with the solution. Of course, it is contemplated that the tube having more than two layers can be used without departing from the scope of the present invention. The side walls of the tube define a fluid path 18 therebetween. Suitable non-PVC containing polymers include polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene alkyl acrylate copolymers substituted by lower alkyl, copolymers of ethylene vinyl acetate, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers. Suitable polyolefins include homopolymers and copolymers obtained by polymerizing alpha-olefins containing from 2 to 20 carbon atoms, and more preferably from 2 to 10 carbons. Therefore, suitable polyolefins include polymers and copolymers of propylene, ethylene, butene-1, rye-1,4-methyl-1-pentene, hexene-1, septene-1, octene-1, ninth-1 and decene- 1 . More preferably the polyolefin is a propylene homopolymer or copolymer or a polyethylene homopolymer or copolymer. Suitable polypropylene homopolymers can have an amorphous, isotactic, syndiotactic, atactic, hemi-isotactic or stereoblock block stereochemistry. In a more preferred form, the polypropylene will have a low melting heat of about 20 joules / gram to about 220 joules / gram, more preferably from about 60 joules / gram to about 160 joules / gram and more preferably about 80 joules / gram. at approximately 130 joules / gram. It is also desirable, in a preferred form, for the polypropylene homopolymer to have a melting point temperature of less than about 165 ° C and more preferably from about 130 ° C to about 160 ° C, more preferably from about 140 ° C to approximately 150 ° C. In a preferred form of the invention, the polypropylene homopolymer is obtained using a single site catalyst. Suitable propylene copolymers are obtained by polymerizing a propylene monomer with an α-olefin having from 2 to 20 carbons. In a more preferred form of the invention, the propylene is copolymerized with ethylene in a weight amount of from about 1% to about 20%, more preferably from about 1% to about 10% and more preferably from 2% to about 5% by weight of the copolymer. The ethylene and propylene copolymers may be blocking or random copolymers.

The propylene copolymer should have a low melting heat of from about 40 joules / gram to about 140 joules / gram, more preferably from about 60 joules / gram to about 90 joules / gram. In a preferred form of the invention, the propylene copolymer is obtained using a single site catalyst. It is also possible to use a mixture of α-olefin copolymers and polypropylene wherein the polypropylene copolymers can vary by the number of carbons in the α-olefin. For example, the present invention contemplates mixtures of α-olefin and propylene copolymers wherein one copolymer has a 2-carbon α-olefin and another copolymer has a 4-carbon α-olefin. It is also possible to use any combination of α-olefins of 2 to 20 carbons and more preferably 2 to 8 carbons. According to the above, the present invention contemplates mixtures of α-olefin and propylene copolymers wherein a first and second α-olefins have the following combination of carbon numbers: 2 and 6, 2 and 8, 4 and 6, 4 and 8. It is also contemplated to use more than 2 copolymers of α-olefin and polypropylene in the mixture. Suitable polymers can be obtained, for example, by using a cataleation process. It is also desirable to use a polypropylene of high melt strength. The high melt strength polypropylenes may be a polypropylene homopolymer or copolymer having a melt flow index within the range of 10 grams / 10 min to 800 grams / 10 min, more preferably 30 grams / 10 min to 200 grams / 10 min, or any rank or combination of ranges in them. Polypropylenes of high melt strength are known to have long chain free end branches of propylene units. Methods for preparing polypropylenes that exhibit a feature of high melt strength have been described in U.S. Pat. UU Nos. 4,916, 198; 5,047,485 and 5,605,936 which are incorporated herein by reference and form part thereof. Such a method includes irradiating a linear propylene polymer in an environment in which the concentration of active oxygen is about 15% by volume with high energy radiation by ionization of energy at a dose of 1 to 104 megarads per minute for a period of time sufficient for a substantial amount of chain cut of the linear propylene polymer to occur but insufficient to cause the material to become gelatinous. Irradiation results in chain cutting. The subsequent recombination of chain fragments results in the formation of new chains, as well as the joining of chain fragments to chains to form branches. This also results in the desired, non-linear, high molecular weight, branched long chain free end propylene polymer material. The radiation is maintained until a significant amount of long chain branches is formed. The material is then treated to substantially deactivate all free radicals present in the irradiated material. High melt strength polypropylenes can also be obtained as described in U.S. Pat. Do not. ,416, 169, which is hereby incorporated in its entirety for reference and forms part thereof, when a specified organic peroxide (di-2-ethylhexyl peroxydicarbonate) is reacted with a polypropylene under specified conditions, followed by melt-kneading. . Such propylenes are linear, crystalline polypropylenes having a branching coefficient of substantially 1, and, therefore, have no free end long chain branching and will have an intrinsic viscosity of from about 2.5 dl / g to 10 dl / g. Suitable ethylene homopolymers include those having a density greater than 0.915 g / cc and include low density polyethylene (LDPE), medium density polyethylene (MDPE) and high density polyethylene (HDPE). Suitable copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 3 to 20 carbons, more preferably 3-10 carbons and more preferably from 4 to 8 carbons. It is also desirable that the ethylene copolymers have a density as measured by ASTM D-792 of less than about 0.915 g / cc and more preferably less than about 0.910 g / cc and even more preferably less than about 0.900 g / cc. . Such polymers are often referred to as VLDPE (very low density polyethylene) or ULDPE (ultra low density polyethylene). Preferably, the ethylene α-olefin copolymers are produced using a single site catalyst and even more preferably a metallocene catalyst system. Single site catalysts are believed to have a sterically and electronically equivalent catalyst position, unique as opposed to Ziegler-Natta type catalysts which are known to have a mixture of catalyst sites. Such single site catalyzed ethylene α-olefins are sold by Dow under the trademark AFFINITY. DuPont Dow under the trademark ENGAGE® and by Exxon under the trademark EXACT. These copolymers should sometimes be referred to herein as m-ULDPE. Suitable copolymers of ethylene also include copolymers of lower alkyl acrylate and ethylene, copolymers of alkyl acrylate substituted with lower alkyl and ethylene and copolymers of ethylene vinyl acetate having a vinyl acetate content of from about 8% to about 40% by weight. weight of the copolymer. The term "lower alkyl acrylates" refers to comonomers having the formula set forth in Diagram 1: Diagram 1 The group R refers to alkyls having from 1 to 17 carbons. Thus, the term "lower alkyl acrylates" includes but is not limited to methyl acrylate, ethyl acrylate, butyl acrylate, and the like. The term "alkyl acrylates substituted by alkyl" refers to comonomers having the formula set forth in diagram 2: Diagram 2 Ri and R2 are alkyls having 1-17 carbons and may have the same number of carbons or have a different number of carbons. Thus, the term "alkyl acrylates substituted by alkyl" includes but is not limited to methacrylate of methyl, ethyl methacrylate, methyl ethacrylate, ethyl ethacrylate, butyl methacrylate, butyl ethacrylate and the like. Suitable polybutadienes include the products of 1, 2- and 1, 4-addition of 1,3-butadienes (these must collectively be referred to as polybutadienes). In a more preferred form of the invention, the polymer is a 1,2-addition product of 1,3-butadiene (These should be referred to as 1, 2-polybutadienes). In a more preferred form of the invention, the polymer of interest is a syndiotactic 1,2-polybutadiene and even more preferably a syndiotactic 1,2-polybutadiene, of low crystallinity. In a preferred form of the invention, syndiotactic 1, 2-polybutadiene, of low crystallinity will have a crystallinity of less than 50%, more preferably less than about 45%, still more preferably less than about 40%, even more preferably the crystallinity will be from about 13% to about 40%, and more preferably, from about 15% to about 30%. In a preferred form of the invention, the low crystallinity 1,2-polybutadiene syndiotactic will have a melting point temperature measured according to ASTM D 341 8 from about 70 ° C to about 120 ° C. Suitable resins include those sold by JSR (Japanese Synthetic Rubber) under the grade designations: JSR RB 810, JSR RB 820, and JSR RB 830. Suitable polyesters include polycondensation products of di or polycarboxylic acids and di or polyhydroxy alcohols or alkylene oxides. In a preferred form of the invention, the polyester is a polyester ether. Suitable polyester ethers are obtained by reacting 1,4-cyclohexane dimethanol, 1,4-cyclohexane dicarboxylic acid and polytetramethylene glycol ether and should generally be referred to as PCCE. Suitable PCCE's are sold by Eastman under the ECDEL trademark. Suitable polyesters further include polyester elastomers which are block copolymers of a hard crystalline segment of polybutylene terephthalate and a second segment of soft (amorphous) polyether glycols. Such polyester elastomers are sold by DuPont Chemical Company under the trademark HYTREL®. Suitable polyamides include those resulting from an annular opening reaction of lactams having 4-12 carbons. This group of polyamides therefore includes nylon 6, nylon 10 and nylon 12. Acceptable polyamides also include aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, polyamides resulting from the condensation reaction of dimer fatty acids, and amide-containing copolymers. In this way, suitable aliphatic polyamides include, for example, nylon 66, nylon 6, 10 and dimer fatty acid polyamides. The styrene of the hydrocarbon-styrene copolymer includes styrene and the various substituted styrenes including styrene substituted by alkyl and styrene substituted by halogen. The alkyl group may contain from 1 to about 6 carbon atoms. Specific examples of substituted styrenes include alpha-methylstyrene, beta-methylstyrene, vinyltoluene, 3-methylstyrene, 4-methylstyrene, 4-isopropylstyrene, 2,4-dimethystyrene, o-chlorostyrene, p-chlorostyrene, o-bromostyrene, 2-chloro -4-methylstyrene, etc. Styrene is the most preferred. The hydrocarbon portion of the hydrocarbon-styrene copolymer includes conjugated dienes. The conjugated dienes that can be used are those containing from 4 to about 10 carbon atoms and more generally, from 4 to 6 carbon atoms. Examples include 1,3-butadiene, 2-methyl-1,3-butadiene (soprene), 2,3-dimethyl-1,3-butadiene, chloroprene, 1,3-pentadiene, 1,3-hexadiene, etc. Mixtures of these conjugated dienes are also used such as mixtures of butadiene and isoprene. Preferred conjugated dienes are isoprene and 1,3-butadiene. The hydrocarbon and styrene copolymers can be block copolymers including di-block, tri-boc, multi-block and star block. Specific examples of diblock copolymers include styrene-butadiene, styrene-isoprene, and the hydrogenated derivatives thereof. Examples of triblock polymers include styrene-butadiene-styrene, styrene-isoprene-styrene, alpha-methylstyrene-butadiene-alpha-methylstyrene and alpha-methylstyrene-isoprene-alpha-methylstyrene and hydrogenated derivatives thereof. The selective hydrogenation of the above block copolymers can be carried out by a variety of well-known processes including hydrogenation in the presence of such catalysts as Raney nickel, noble metals such as platinum, palladium, etc., and soluble transition metal catalysts. Suitable hydrogenation processes that can be used are those wherein the diene-containing polymer or copolymer is dissolved in an inert hydrocarbon diluent such as cyclohexane and hydrogenated by reaction with hydrogen in the presence of a soluble hydrogenation catalyst. Such procedures are described in U.S. Pat. UU Nos. 3,119,186 and 4,226,952, the descriptions of which are incorporated herein by reference and form a part thereof. Particularly useful hydrogenated block copolymers are the hydrogenated block copolymers of styrene-isoprene-styrene, such as a styrene- (ethylene / propylene) -styrene block polymer. When a polystyrene-polybutadiene-polystyrene block copolymer is hydrogenated, the resulting product looks like a regular copolymer block of ethylene and 1-butene (EB). As noted above, when the conjugated diene employed is isoprene, the resulting hydrogenated product looks like a regular copolymer block of ethylene and propylene (EP). An example of a commercially available selectively hydrogenated block copolymer is KRATON G-1652 which is a hydrogenated SBS triblock comprising 30% styrene end blocks and an equivalent half block is a copolymer of ethylene and 1-butene (EB). This hydrogenated block copolymer often refers to SEBS. Other suitable SIS or SEBS copolymers are sold by Kuraray under the trademark SEPTON® and HYBRAR®. It may also be desirable to use modified graft hydrocarbon and styrene block copolymers when grafting a high, beta-unsaturated dicarboxylic or monocarboxylic acid reagent onto the selectively hydrogenated block copolymers described above. The block copolymers of the conjugated diene and the aromatic vinyl compound are grafted with an alpha-beta-unsaturated dicarboxylic or monocarboxylic acid reagent. Carboxylic acid reagents include carboxylic acids per se and their functional derivatives such as anhydrides, imides, metal salts, esters, etc. , which are capable of being grafted onto the selectively hydrogenated block copolymer. The grafted polymer will usually contain from about 0.1 to about 20%, and preferably from about 0.1 to about 10% by weight based on the total weight of the block copolymer and the carboxylic acid reagent of the grafted carboxylic acid. Specific examples of useful monobasic carboxylic acids include acrylic acid, methacrylic acid, cinnamic acid, protonic acid, acrylic anhydride, sodium acrylate, calcium acrylate and magnesium acrylate, etc. Examples of dicarboxylic acids and useful derivatives thereof include maleic acid, maleic anhydride, fumaric acid, mesaconic acid, itaconic acid, citraconic acid, itaconic anhydride, citraconic anhydride, momomethyl maleate, monoxide maleate, etc. The hydrocarbon block copolymers and styrene can be modified with an oil such as the oil modified SEBS sold by the Shell Chemical Company under the product designation KRATON G2705. In a preferred form of the invention, the tube is composed of a multi-component polymer mixture. The present invention contemplates mixing two or more of any of the polymers set forth above. In a preferred form of the invention, the polymer blend includes a polyolefin mixed with a hydrocarbon-styrene copolymer. In a preferred form of the invention, the polyolefin is a propylene-containing polymer and can be selected from the propylene homopolymers and copolymers described above including high melt strength polypropylenes. It may also be desirable to have three or more components including a hydrocarbon copolymer and styrene with a mixture of several types of polypropylenes. Polypropylene, either alone or in sum, may be present in a weight amount of the mixture of from about 10% to about 50%, more preferably from about 15% to about 45% and more preferably from about 20% to about 40% with the equilibrium of the mixture being the hydrocarbon block copolymer and styrene. When using oil modified SEBS it may be desirable, although not critical, to use a high melt strength polypropylene as a blending component. The mixtures containing SEBS and suitable polypropylene include: (1) precomposed mixtures of PP and SEBS sold by Wittenburg under the trademark CAWITON and particularly grades PR 3670E and PR4977; (2) 90-98% by weight of KRATON G2705 with 2-10% polypropylene of high melt strength Basell PROFAX PF 61 1; (3) 75% KRATON G2705 with 23% random propylene copolymer Basell PROFAX SA 861 and ethylene with 2% Basell PROFAX PF-61 1 which is PP of high resistance to fusion; and (4) PP / SEBS precomposed mix sold by J-Von under grade 70585E. In another preferred form of the invention, the tube will be manufactured from a single m-ULDPE resin or a mixture of m-ULDPE resins. A particularly suitable m-ULDPE resin is sold by DuPont-Dow under the trademark ENGAGE® and even more particularly ENGAGE® 8003 (density 0.885 g / cc). It is also contemplated to mix more than one m-ULDPE resin. Such resins and tubes and films made thereof are more fully set forth in U.S. Pat. No. 6,372,848 which is incorporated herein in its entirety for reference and forms part thereof.

It is also contemplated to manufacture polybutadiene tubes or polybutadiene resin mixtures described above. Although suitable non-PVC containing polymers and polymer blends are typically infrared responsive, to some degree, one may optionally incorporate an infrared responsive component into the polymer or polymer blend. Suitable infrared responsive components include dyes, additives, agents, primers, dyes and / or pigments. In a more preferred form of the invention, the infrared responsive material is a pigment that is responsive to exposure to infrared light at a wavelength, or a narrow range of wavelengths, within a range of wavelengths in the spectrum near infrared and more preferably from about 700 nm to about 1500 nm. In a preferred form of the invention, the pigment is responsive to exposure to infrared light at maximum wavelengths from about 780 nm to about 1000 nm and generates sufficient heat over a short period of time to allow fusion of the polymer blend or polymer not PVC. What is meant by short period of time is less than 8 seconds, more preferably about 6 seconds, and more preferably 2 seconds. The pigments for use with the present invention preferably absorb I R and are chemically inert. The pigments are also preferably thermally stable at temperatures reached during the extrusion processing of the polymer or polymer mixture. Suitable pigments are sold by Lancer Dispersions, Inc. of Akron, Ohio. In another preferred form of the invention, the IR responsive material will be applied to a surface of materials to be joined instead of incorporating the IR responsive material into the mixture. For this purpose, the IR responsive material is dissolved or suspended in a suitable carrier or solvent, and in this form can be applied specifically to selected portions of the surfaces to be joined. The responsive material IR can be applied by immersing the surfaces to be joined in the responsive material IR, or the responsive material IR can be rubbed, sprayed, or printed or the like, as seen in FIG. 17. The present invention further contemplates increasing the IR response of a tube layer by adjusting the crystallinity of a material, orienting the tube or quenching the material during fabrication. The tubes of the present invention may be manufactured by any known polymer processing technique, but, in a preferred form of the invention, it is formed by extrusion, co-extrusion or injection molding. Such tubes are soft, flexible, resistant to bending, have a good tactile sensation (haptic), and are capable of being sterilized by steam sterilization, radiation or by exposure to ethylene oxide (EtO). Figure 2 shows a container of flowable material that is suitable for use with the present invention. The container of flowable material 50 has side walls 52 sealed along peripheral edges to define a chamber 54 therebetween. A closure assembly 56 provides access to the contents of the container. The container 50 is preferably manufactured from a material not containing PVC In a preferred form of the invention, the side walls 52 are made of a multiple component polymer alloy described in detail in U.S. Pat. No. 5,686,527 which is incorporated herein by reference and forms part thereof. A particularly suitable polymer alloy is a mixture of polypropylene, ultra low density polyethylene, a dimer fatty acid polyamide and a hydrocarbon block copolymer and styrene.

The container 50 shown in Figure 2 is particularly suitable for medical applications such as storage and supply of various medical solutions, including but not limited to IV solutions, peritoneal dialysis solutions, blood and pharmaceutical drugs, blood components, and blood substituents. name some. It is contemplated that such a container may also be used to store food products or other consumable products. What is meant by "flowable material" is a material that will flow by the force of gravity. The flowable materials therefore include both liquid articles and granular or powder articles and the like. Figure 3 shows the closure assembly 56. The closure assembly 56 has a passage tube 58 and a membrane tube 60 coaxially mounted therein. A passage of fluid 61 of the membrane tube 60 is sealed by a membrane 62 placed in an intermediate portion of the membrane tube 60. For medical applications, the membrane 62 can be punctured by a puncher of an infusion set to place the contents of the container in fluid communication with, for example, the vascular system of a patient being treated. In a preferred form of the invention, the passage tube 58 is a multilayer structure and more preferably has a first layer 63 and a second layer 64. The first layer 63 must be a non-PVC containing material that is capable of sealing on the side walls 52 of the container 50, using infrared sealing or RF sealing or heat conductive type sealing techniques. In a preferred form of the invention, the first layer 63 is a polymer blend of: (a) from about 25% to about 50% by weight and more preferably from about 30% to about 40% by weight, of the first layer of a first polyolefin selected from the group consisting of polymers containing propylene, (b) from about 0 to about 50% by weight, and more preferably from about 5-40% by weight, from the first layer a second polyolefin from a copolymer or polymer containing α-olefin and more preferably is a copolymer of α-olefin and ethylene; (c) from about 0% to about 40% by weight, and more preferably from about 10% to about 40% by weight, of the first layer a radio-frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers , ethylene methacrylic acid copolymers, polyamides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content of 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with comonomer content of methyl acrylate of 18% -40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content of 15% -70% by mole percent of the copolymer; and (d) from about 0% to about 40% by weight, and more preferably from 10% to about 40% by weight, of the first layer of a thermoplastic elastomer. A particularly suitable mixture for the first pass-pipe layer is a mixture of four components having by weight the following components: from about 10% to about 40% and more preferably 30% of a dimer fatty acid polyamide, of about 0 % to about 50% and more preferably from about 0% to about 10% of an ultra low density polyethylene, from about 25% to about 50% and more preferably from about 30% to about 40% of a polypropylene and from about 10% to about 40% and more preferably 30% styrene-ethylene-butylene-styrene block copolymer with functionality of maleic anhydride. The second layer 64 of the passage tube 58 is of a non-PVC containing material which is capable of being joined in accordance with the present invention to the membrane tube 60. In a preferred form of the invention, the second layer 64 is a mixture of multiple components of the following components by weight: from about 25% to about 55% and more preferably from 33% -52% of a thermoplastic elastomer, from about 20% to about 45% and more preferably from about 25% to about 42% of a polyether-polyester block copolymer, from about 0% to about 15% and more preferably from about 5% to about 12% by weight of the second layer of an ethylene copolymerized with vinyl lower alkyl esters and preferably vinyl acetate, from about 0% to about 10% by weight and more preferably from about 1% to about 5% by weight of the second layer of a polymer containing propylene and from about 0% to about 35% by weight of a polymer selected from the group consisting of acrylonitrile-butadiene-styrene block copolymer (ABS), styrene-ethylene-butylene copolymer, styrene-acrylonitrile copolymer and cyclic olefin polymers containing polycyclic olefin bridging. A particularly suitable mixture of the second layer 64 of the passage tube 58 is a mixture of five components having from about 33% to about 35% SEBS (KRATON® 1660), from about 25% to about 29% of polyester block copolymers -polyether (HYTREL®), from about 5% to about 9% EVA, from about 1% to about 3% polypropylene and from about 28% to 32% ABS. Another suitable mixture of the second layer 64 of the passage tube 58 is a four component mixture having from about 48% to about 52% SEBS, from about 36% to about 42% polyester-polyether block copolymer, of about 8 % to about 12% EVA and from about 1% to about 4% polypropylene. The membrane tube 60 should be made of a material not containing PVC and should be capable of bonding, preferably using solvent-free bonding techniques, to the passage tube 58. In a preferred form of the invention, the membrane tube 60 is a structure multi-layer The membrane tube 60 has an outer layer 65 and an inner layer 66. The outer layer 65 is made of a material selected from the same materials as are established for the second layer 64 of the passage tube. Similarly, the inner layer 66 of the membrane tube 60 is selected from the same materials as the first layer 63 of the passage tube 58. A particularly suitable inner layer 66 of the membrane tube 60 is a mixture of four components by weight of the inner layer 66 that varies slightly from the first most preferred layer of the passage tube. The components are by weight of the inner layer 66 as follows: 40% polypropylene, 40% ultra low density polyethylene, 10% polyamide and 10% SEBS. However, it is to be understood that the inner layer 66 of the membrane tube could also be selected from the same components and weight percentage ranges as set forth above for the first layer of the passage tube. In a preferred form of the invention, the outer layer of the membrane tube should have a thickness of about 15 mils to about 35 mils and more preferably from about 20 mils to about 30 mils. The inner layer of the membrane tube should have a thickness of about 2 mils to about 12 mils and more preferably from about 5 mils to about 10 mils. Figure 4 shows an alternative embodiment of the membrane tube having three layers. In addition to the outer layer 65 and the inner layer 66 shown in Figure 3, Figure 4 shows an intermediary layer 67 interposed therebetween. The intermediate layer 67 is preferably a thermoplastic elastomer and more preferably an oil-modified styrene-ethylene-butylene-styrene block copolymer sold by the Shell Chemical Company under the product designation KRATON G2705. The intermediate layer 67 may also be a blend of from about 99% to about 70% of a thermoplastic elastomer and from about 1% to about 30% of a propylene-containing polymer. In yet another preferred form of the invention (Figure 3B), the passage tube 70 is a multilayer structure and more preferably has a first layer 72 and a second layer 74. The first layer 72 must be of a material that does not contain PVC that is capable of sealing on the side walls 12 and 14 of the container 10. In a preferred form of the invention, the first layer 72 is a polymer blend of: (a) from about 25% to about 50%, more preferably from about 30% to about 40%, by weight of the first layer a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) from about 0% to about 50%, more preferably from about 5% to about 40% % by weight of the first layer a second polyolefin of a copolymer or polymer containing α-olefin and more preferably is a copolymer of α-olefin and ethylene; (c) from about 0% to about 40%, more preferably from about 10% to about 40% of the first layer a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers , polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a content of vinyl acetate comonomer from 12% to 50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate cpmonomer content of 12% by weight 40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content of 12% to 70% by mole percent of the copolymer; Y (d) from about 0% to about 40%, more preferably from about 10% to about 40% by weight of a thermoplastic elastomer of the first layer. The second layer 74 of the passage tube 70 is of a non-PVC containing material which is capable of solvent bonding to the membrane tube. In a preferred form of the invention, the second layer 74 is a thermoplastic elastomer or a blend of a thermoplastic elastomer in an amount by weight of from about 80% to about 100% and a polymer containing propylene of from about 0% to about 20% by weight of the second layer 74. It is also desirable, but optional, that the second layer 74 be slightly softened at autoclave temperatures so that when the passage tube and the membrane tube assembly are steam sterilized, the passage tube adheres more hermetically to the membrane tube. As shown in Figure 3B, the first layer 72 has a greater thickness than the second layer 74. In a preferred form of the invention the first layer will have a thickness of from about 15 mils to about 40 mils and more preferably about 20 mils. mils at approximately 30 mils. The second layer will have a thickness of about 2 mils to about 10 mils and more preferably from about 3 mils to about 7 mils. The membrane tube 76 must be made of a material not containing PVC. In a preferred form of the invention, the membrane tube 76 is a multilayer structure having an outer layer 80, a central layer 82 and an inner layer 84. In a preferred form of the invention, the outer layer 80 is a mixture of polymers of: (a) from about 0% to about 60%, more preferably from about 20% to about 55% and more preferably from about 30% to about 50% by weight of the outer layer of a polyolefin or (b) from about 40% to about 100%, more preferably from about 45% to about 80% and more preferably from about 50% to about 70% by weight of the outer layer of a thermoplastic elastomer. Also, in a preferred form of the invention, the core layer 82 is a polymer blend of: (a) from about 35% to about 100%, more preferably from about 50% to about 90% and more preferably 70% to about 90 % by weight of the middle layer of a thermoplastic elastomer and (b) from about 0% to about 65%, more preferably from about 10% to about 50% and more preferably from about 10% to about 30% by weight of the layer central of a polyolefin. Also, in a preferred form of the invention, the inner layer 84 is a blend of polymers of: (a) from about 25% to about 55%, more preferably from about 25% to about 40% by weight of the inner layer of a polyolefin; (b) from about 0% to about 50%, more preferably from about 0% to about 40% and more preferably 0% to about 20%, by weight of the inner layer of a polyolefin selected from the group consisting of copolymers and polymers containing α-olefin and more preferably is a copolymer of α-olefin and ethylene; (c) from about 0% to about 40% by weight, more preferably from about 15% to about 40%, of the inner layer a radiofrequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, copolymers of methacrylic acid of ethylene, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content of 12% to 50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 12% to 40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content of 12% to 70% by mole percent of the copolymer; and (d) from about 0% to about 40%, more preferably from about 15% to about 40% by weight of the inner layer of a thermoplastic elastomer. In a preferred form of the invention, the outer layer 80 will have a thickness of about 3 mils to about 15 mils and more preferably from about 3 mils to about 10 mils. The core layer 82 will have a thickness of about 10 mils to about 35 mils and more preferably from about 10 mils to about 30 mils. The inner layer 84 will have a thickness of about 3 mils to about 15 mils and more preferably from about 5 mils to about 10 mils. Suitable propylene-containing polymers include homopolymers, copolymers and terpolymers of propylene. Suitable comonomers are one or more α-olefins having 2 to 17 carbons and more preferably ethylene in a weight amount of about 1% to about 8% by weight of the copolymer.

Suitable propylene-containing polymers include those sold by Solvay under the trademark FORTILINE and include from about 1.0% to about 4.0% by weight of ethylene of the copolymer. Suitable α-olefin-containing polymers include homopolymers, copolymers and α-olefin interpolymers having from 2 to 17 carbons. Suitable ethylene α-olefin copolymers have a density, as measured by ASTM D-792, of less than about 0.915 g / cc and are commonly referred to as very low density polyethylene (VLDPE), linear low density polyethylene ( LLDPE), ultra low density polyethylene (ULDPE) and the like. In a preferred form of the invention, the α-olefin and ethylene copolymers are obtained using single site catalysts. Suitable catalyst systems, among others, are those described in U.S. Pat. Nos. 5,783,638 and 5,272,236. The α-olefin and ethylene copolymers include those sold by the Dow Chemical Company under the trademark AFFI NITY, DuPont-Dow under the trademark ENGAGE, Exxon under the trademark EXACT and Phillips Chemical Company under the trademark MARLEX. Suitable polyamides include those selected from a group consisting of: aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a di-acid condensation reaction having a carbon number within a range of 2-13, polyamides resulting from the condensation reaction of dimer fatty acids, and amide-containing copolymers. The polyamides resulting from an annular opening operation of a cyclic amide such as e-caprolactam is also suitable. In a preferred form of the invention, the polyamide is a dimer fatty acid polyamide sold by Henkel under the trademark MACROMELT. Suitable thermoplastic elastomers of the present invention include hydrocarbon and styrene copolymers, and EPDM. Styrene can be substituted or unsubstituted styrene. The hydrocarbon and styrene copolymers can be a block copolymer including di-block, tri-block, star block, it can also be a suitable copolymer and other types of styrene and hydrocarbon copolymers that are known to those skilled in the art. The hydrocarbon and styrene copolymers may also contain various types of the hydrocarbon and styrene copolymers identified above. The hydrocarbon and styrene copolymers can be functionalized by carboxylic acid groups, carboxylic acid anhydrides, carboxylic acid esters, epoxy groups and carbon monoxide. In a preferred form of the invention, the thermoplastic elastomer of the first layer 63 of the passage tube 58 and the inner layer 66 of the membrane tube 60 is a SEB di-block copolymer in mixture and SEBS tri-block. Such a copolymer is sold by Shall Chemical Company under the trademark KRATON® FG1924X. The preferred thermoplastic elastomer of the second layer 64 of the passage tube 58 and the outer layer 65 of the membrane tube 60 is a SEBS copolymer. Such tri-block copolymer is sold by, for example, Shell Chemical Company under the trademark KRATON® 1660. Suitable polyester-polyether block copolymers are sold by DuPont under the trademark HYTREL and particularly HYTREL 4056. The term "esters" Lower vinyl alkyl "includes those having the formula set forth in Diagram 3: Diagram 3 R in Diagram 3 refers to alkanes having 1 to 17 carbons. Thus, the term "vinyl lower alkyl esters" includes but is not limited to vinyl methanoate, vinyl acetate, vinyl propionate, vinyl butyrate and the like. In a preferred form of the invention, the ethylene and vinyl lower alkyl ester of the second layer 24 of the passage tube 18 and the layer outer 26 of membrane tube 20 is a copolymer of vinyl acetate and ethylene having from about 12% to about 40% by weight of copolymer vinyl acetate comonomer. Suitable vinyl acetate and ethylene copolymers are sold by Quantum under the product designations LJE634 and UE697. Suitable ABS copolymers include triblock copolymers of acrylonitrile-butadiene-styrene. The polymers containing polycyclic hydrocarbon bridge or suitable cyclic olefin and mixtures thereof, can be found in U.S. Pat. Copendents Nos. 5,218,049; 5,854,349; 5,863,986; 5,795,945; 5,792,824; 6,297,322; EP 0 291, 208; EP 0 283, 164; and EP 0 497,567 which are hereby incorporated by reference in their entirety and form part thereof. In a preferred form, these homopolymers, copolymers and polymer blends will have a vitreous transition temperature greater than 50 ° C, more preferably from about 70 ° C to about 180 ° C, a density greater than 0.910 g / cc and more preferably from 0.910 g / cc to about 1.3 g / cc and more preferably from 0.980 g / cc to about 1.3 g / cc and have at least about 20 mol% of a cyclic aliphatic or a polycyclic bridge in the structure of the polymer more preferably of about 30-65 mol% and more preferably of about 30-60 mol%. In a preferred form of the polymer blends for use with the present invention, suitable olefin monomers are monocyclic compounds having from 5 to about 10 carbons in the ring. The cyclic olefins can be selected from the group consisting of substituted or unsubstituted cyclopentene, cyclohexene, cycloheptene and cyclooctene. Suitable substituents include lower alkyl, acrylate derivatives and the like. In a preferred form of the polymer blends, suitable bridged polycyclic hydrocarbon monomers have two or more rings and more preferably contain at least 7 carbons. The rings can be replaced or not replaced. Suitable substituents include lower alkyl, aryl, aralkyl, vinyl, allyloxy, (meth) acryloxy and the like. The polycyclic bridging hydrocarbons are selected from the group consisting of those described in the patent applications and patents incorporated. Polymers containing suitable bridged polycyclic hydrocarbon are sold by Ticona under the trademark TOPAS, by Nippon Zeon under the trademark ZEONEX and ZEONOR, by Daikyo Goma Seiko under the trademark resin CZ, and by Mitsui Petrochemical Company under the trademark APEL . Suitable comonomers include α-olefins having 3-10 carbons, aromatic hydrocarbons, other cyclic olefins and polycyclic bridged hydrocarbons. It may also be desirable to have pendant groups associated with the cyclic olefin containing polymers and bridged polycyclic containing hydrocarbons. Pending groups are for compatibilizing cyclic olefin containing polymers and bridging polycyclic hydrocarbon containing polymers with more polar polymers including amine, amide, imide, ester, carboxylic acid and other polar functional groups. Suitable pendant groups include aromatic hydrocarbons, carbon dioxide, monoethylenically unsaturated hydrocarbons, acrylonitriles, vinyl ethers, vinyl esters, vinylamides, vinyl ketones, vinyl halides, epoxies, cyclic esters and cyclic ethers. The monoethylenically unsaturated hydrocarbons include alkyl acrylates and aryl acrylates. The cyclic ester includes maleic anhydride. The passage tube and the membrane tube are preferably manufactured using coextrusion techniques well known to those skilled in the polymer manufacturing art. The membrane tube is attached to the passage tube by joining the membrane tube to the passage tube and exposing the area of the membrane to a specific portion of the infrared spectrum as it is. It deals in detail below. In addition, the infrared light absorbing pigments can be incorporated into the polymer blends for the passage tube and membrane tube to further facilitate bond formation. Referring now to Figures 5A-5C, a medical tube assembly 100 according to the present invention is described. In this example, the tube assembly includes a pair of centrally mounted tubes. The membrane can be mono or multilayer and are preferably manufactured from previously treated polymeric materials. The tubes are designed to interconnect so that there is an inner tube 102 that fits inside an outer tube 1 10. The outer tube 1 10 has an inner layer 1 1 1 and an outer layer 1 12. The inner tube 1 02 also it has an inner layer 103 and an outer layer 104. The tube assemblies of Figures 5A-5C differ in the location of a pigment layer 106. In Figures 5A and 5B, a single pigment layer is used. In Figure 5C, two layers of pigment are present. In Figure 5A, the pigment layer 106 forms an outer layer of inner tube 102. In Figure 5B, the pigment layer 106 forms an inner layer of outer tube 1 10. In Figure 5C, the pigment interface layers shows. The pigment layer 106 can be printed on the tubes 10 and / or 102 after fabrication (FIG. 17) or applied by adding infrared light absorbing pigment (s) directly to the polymer blends used to make the pigments. tubes as discussed in detail below. In cases where the infrared pigment is printed on the tube, it can be printed on a first area at a first concentration and on a second area at a concentration lower than the first concentration. It is further contemplated that the tubes may include non-infrared absorbent pigments. More specifically, where the polymeric materials themselves absorb infrared light, little or no pigment may be necessary. According to the method of the present invention, the inner tube 102 is inserted into the outer tube 1 10 to define an interface area 108. The interface area 108 acts as a joining area to hold the tubes together. Once the inner tube 102 is inserted into the outer tube 1 10, either the inner tube 102 or the outer tube 1 10 is then exposed to a specific portion of the near infrared or infrared spectrum where the pigment layer 106 of either the inner tube 1 08 or the outer tube 1 10 absorbs infrared energy. Exposure to infrared light is designed to generate sufficient heat to create a junction between the inner tube 1 02 and the outer tube 1 10 as the interface area 1 12. In a preferred form of the invention, the infrared energy will be at a length wavelength from about .075 to about 1.0 microns. Alternatively, if both, the inner tube 102 as the outer tube 108 include layers of pigment 106, then both can be exposed to a portion of the near-infrared or infrared spectrum where the pigment layers 106 absorb the infrared energy to generate the necessary heat to create a junction between the inner tube 102 and the outer 1 10. In cases where the pigment layer 106 is provided in different concentrations, the tube assembly 100 can be exposed to a first exposure to infrared light to create a first seal and then a second exhibition to create a second seal. In this regard, a first hybrid joint could be created initially and a higher ultimate strength joint could be created during sterilization. In case where no infrared pigment layer is included in either the outer tube 10 or the inner tube 102, one must select a portion of the infrared or near infrared spectrum where the polymer materials themselves will absorb enough infrared light to generate the necessary heat to create a union. Although the above-mentioned method works effectively with most polymeric materials, some materials can mitigate stress to create unacceptable distortion during the infrared heat welding process as seen in Figures 17A-B. Figure 17A shows a tube assembly before IR welding and Figure 1B shows the assembly after IR welding. In this way it may be desirable to provide a layer 1 14 (Figures 6-10) that can protect a non-union area, while allowing infrared light to reach the bond area 108. In this aspect, the layer limits the bond area , thus helping the components maintain a functional geometry during and after the heating process.

In the illustrated embodiment, the layer 1 14 is tube-shaped and includes a diameter 126 that is longer than the diameter of the inner tube 102 and the outer tube 1 10 of the tube assembly 100 (Figures 1A-B). This allows the layer 1 14 to slide over the tube assembly 100. The diameter 126 of the layer can be varied so that different amounts of infrared energy reach the tube assembly 100, essentially covering some parts and allowing exposure to others. The layer 1 14 is designed so that the main body 16 includes a thick wall section 120 which inhibits some transmission of infrared energy to protect a non-union area and prevents unacceptable distortion. The main body 1 16 further includes a thinner wall section 122 that limits the bonding area 124 while also allowing the infrared transmission to reach the bonding area, thereby generating sufficient heat to create a bond. In still other preferred embodiments (Figures 6A-10B), the layer 1 14 includes a main body 1 16 and also includes a plurality of side windows 1 18. As discussed above, the main body 1 16 of the layer 1 14 protects a non-union area to either reflect far infrared light or inhibit transmission. In contrast, the side windows 1 18 are designed to allow exposure to infrared light to reach the joint area and create a joint. Figures 6A, 6B have two opposite windows 1 18 separated by narrow pillars 127 to allow exposure around more than 90% of the circumference of the tube. Figures 7A, 7B show the window 1 18 having a plurality of circumferentially extending grooves, in curved form 130. The grooves are placed in vertically separate groups 131, each group having a groove or more than one groove having individual grooves in each group separated circumferentially from one another. The grooves are generally narrow, extending from about 10 ° to about 350 °, more preferably about 30 ° to 270 °, and more preferably from about 90 ° to about 180 °. The grooves are generally constant in height across their length and have generally round end sections 132. Figures 9A and 9B are still another embodiment having circumferentially extending grooves in vertically spaced relationship with each groove extending around the total circumference of the groove. layer 1 14. Figures 8A, 8B, 10A, 10B show window 1 18 having a plurality of grooves extending axially and circumferentially spaced apart. The slots are shown spaced at approximately 60 ° intervals but it could be that any of the slots provide a tube assembly that can be effectively sealed with IR exposure. The grooves in Figures 8A, 8B are narrow and have round end sections 132. The grooves in Figures 10A, 10B are generally rectangular in shape. The slots described herein can be installed axially and can have varying inclination and width to provide variable resistance joints, as shown in Figures 9A-B. For this purpose, the formed joints can be either watertight or non-watertight depending on the size and shape of the side windows 1 18. The layer 1 14 can be composed of any material that shows good transmission of infrared light including such materials as glass, or the similar. However, layer 1 14 is more preferably composed of polytetrafluoroethylene, commonly referred to as TEFLON® that is commercially available from DuPont. TEFLON® is an ideal material because it shows good infrared light transmission and it is easy to clear welded components due to its relative lubricity. Referring now generally to Figures 12-16, various methods according to the present invention are provided to join a passage with projections 200 to a medical device. The step with projections 200 is generally made of the polymeric materials discussed in detail above and may or may not include an infrared-absorbing pigment to facilitate bonding. In an example, an infrared responsive pigmented ring 202 is molded by insertion into the base 201 of the passage with projections 200, as seen in Figure 12. Once the infrared pigment is joined to the passage with protrusions 200, the passage with protrusions 200 is joined then to a medical device such as a medical film (not shown) and joined using exposure to infrared light as discussed in detail above. Returning to Figure 13, still another embodiment of the method of the present invention is shown. In this example, an infrared responsive pigmented film 204 is provided to facilitate bonding. The infrared responsive pigmented film 204 is designed to be placed between the passage with protrusions 200 and a second film 206 to which the passage with protrusions 200 is to be welded. The second film 206 is preferably made from any of the polymer blends discussed above. In a preferred embodiment, the second film 206 is a wall of a sterilized container sealed in either a full or empty state as can be seen in Figure 15 and Figures 16A-B. In cases where the second film 206 is a container, it may include any solution, but more preferably a medical solution such as l.V. solutions, peritoneal dialysis solutions, pharmaceutical drugs, blood, blood components, and blood substituents to name a few. The infrared responsive pigmented film 204 is preferably compatible with both the polymeric materials of the projection passage 200 and the second film 206. As mentioned above, the pigment responsive to infrared light can be printed on the film 204 after manufacture or applied when adding infrared light absorbing pigment (s) directly in polymer blends used to make the film 204. Once the infrared responsive pigmented film 204 is placed between the step with protrusions 200 and the second film 206, the step with protrusions 200 is then attached to the second film 206. The total assembly is then exposed to infrared light, and more specifically, to a specific portion of the infrared spectrum where the absorbing pigment (s) of infrared light absorbs (n) ) Energy. This generates sufficient heat to join the passage with projections 200 to the second film 206. Referring now to Figure 14, still another example of a method according to the present invention is provided. In this example, the infrared absorbing pigment 207 is printed on a lower surface 208 of the projecting passage 200. In a particularly preferred example, the pigment is strategically located across several areas of the lower surface 208, thus providing several different binding sites. The passage with protrusions 200 is then attached to a film 206 and exposed to a specific portion of the infrared spectrum where the pigment (s) absorbs energy, generating sufficient heat to create a junction between the passage with protrusions 200. and the film 206. Figure 18 shows another embodiment for applying IR responsive material to a member 60 by spraying. As was the case with polymeric materials treated above for joining medical tubing, some materials for use with the passage with protrusions 200 and the second film 206 may relieve the tension to create unacceptable distortion during the infrared heat welding process. This may be desirable and / or necessary to use an infrared light transmission block 210 such as that observed in Figure 15 and Figures 16A-B. The infrared light transmission block 210 is designed to provide a path to obstruct the light energy as well as pressure to facilitate proper binding. It is contemplated that the infrared light transmission block 210 could be located on either or both sides of the second film 206. In the case where the infrared light transmitting blocks 210 are located on both sides of a full container 212, contacting the two blocks 210 will provide sufficient pressure to express the fluid in the sealing area 214 to create a sealing environment. As in the case with previous examples, the assembly is then exposed to a portion of the infrared spectrum where the infrared pigment (s) absorb energy to create sufficient heat to create a bond. EXAMPLES A passage tube and a membrane tube are used to test the bond strength that can be achieved using the IR sealing techniques described herein. The membrane tube is adjusted by interference in the longer passage tube. The 0.0077 cm thick outer layer of the membrane tube is a SEBS / polypropylene blend. The inner layer of 0.015 thick is 100% SEBS. Adding potential and known infrared light absorbing materials to the outer layer created the variations of the membrane tube used in these examples. The intent was to transmit infrared light through the wall of the passage tube into the doped outer layer of the membrane tube to create a weld. Eleven other mixtures are created to investigate the relative binding strength of different dopants with respect to the natural gas carbon black response. The list of variations is detailed in the following table.

The primary equipment for welding I R consists of a pair of halogen lamps focused on a line in space with parabolic mirrors. The lamps emit 1200 watts each at total power with a primary emission in near infrared of .78 to 1 micron wavelength. Preliminary Feasibility Experiment The closure system when attached to solvent with eumeno and subsequently steam sterilized demonstrates a bond strength of nominally 521 bs of traction. For this study, 3 variations of the membrane tube are created with different amounts of natural gas carbon black charge. The standard membrane tubes are manufactured at the same time. The membrane films are then soldered by radiofrequency at the appropriate average position inside the membrane tubes. The membrane tubes are then assembled in the passage tubes to the depth of the membrane location. The samples are soldered by infrared light at an exposure time of 3 seconds. The samples are allowed to cool to room temperature. All samples are tested by pressure to ensure that the welding process has not damaged the membrane. For each membrane, 25 samples of the tube variation assembly were tested for traction for failure with an administration puncture inserted into the membrane tube to mimic common use. This represents a green resistance of the union prior to terminal steam sterilization. For comparison, 25 samples of each membrane tube assembly are then sterilized by steam. Those samples are similarly tested by traction for failure. The results of these tests are summarized in table 1. Table 1 These data suggest three different aspects of feasibility. The third column shows that charges of natural gas carbon black of 0.046 percent or more of a pigment and source of infrared light welding can be replaced by solvent bonding and achieve the same strength. The last value in the second column suggests that acceptable bond strengths can be obtained without the secondary cure process of the steam sterilization cycle. This could be used for other products that are terminally sterilized by other means. It is also observed that the results sterilized by non-pigmented value are within 20% of the goal of 521b. This is due to the inherent infrared absorbance characteristic of the base resin combined with the heat supplied by the steam sterilization process. This suggests that the development could produce an acceptable process where no pigment is required for infrared welding. Although a seal cycle time of 3.0 seconds is used for this experiment, seal cycle times less than 0.6 seconds have been recorded for specific applications. Bond strength as a natural gas carbon black charge function In this experiment the relative bond strength of the closure assembly as a natural gas carbon black charge function in the outer layer of the membrane tube is examined. A set of experimental conditions is created to reduce variables that act on the created seal and still produce a response over the pigment charge range. Twelve different mass loads are created using a common source of natural gas carbon black and carrier resin. The membrane tubes are assembled in the passage tubes using water as an assembly lubricant. The assemblies are allowed to dry completely before welding. Non-membrane films are added to the assemblies and steam sterilization is not included in the experiment since its effects are examined in preliminary feasibility experiments. The welding equipment is modified to include mirrors to better distribute the infrared energy focused in line over the target area of circular welding.

Welding time of 2.9 seconds is determined experimentally to provide response to all pigment loads. For each load, 25 samples are soldered. As the structures are multilayer co-extrusions, the peel test for failure is always possible. Peel tests generally have lower yields than identical sample shear tests as the peel tests fail the sample sequentially instead of all at once with a shear bond production. The peel tests can be used to provide a relative comparison of solder bond strength.

All welded closure samples are cut in half along the long axis. Each half is then tested by traction for failure with the sum of the results for the halves of each recorded sample. This is done to minimize the effects of sample preparation. A relative seal resistance diagram as a natural gas carbon black charge function is shown in Figure 19. Figure 19 indicates a significant increase in bond strength with rising natural gas carbon black load up to 0.03% for this closing design. After 0.03%, the addition of natural gas carbon black does not significantly change the binding resistance response suggesting that functional saturation is achieved. Comparison of other pigments to natural gas carbon black Natural gas carbon black is generally considered to be an ideal absorber of light energy. The appearance of a medical product inked with natural gas carbon black can find resistance in the market. It is possible that a more striking color that is responsive to infrared light can be used in a design welded by infrared light. Ten other pigments are created and evaluated with the mixtures 1 to 12 that established the characteristic curve shown in Figure 19. The mixtures 13 to 21 are evaluated at a concentration of 0.035 mass%. The mixture 22 is evaluated as a concentration of 0.03% by mass due to the limited amount of pigment available. The pigments of mixtures 14 to 22 are chosen as pigments reflecting color at the blue / violet end of the visible spectrum. Pigment 13 was carbon black from alternative source. The attempt was to compare alternative pigments with the reference natural gas carbon black of Figure 19 to describe their behavior. The resulting bond resistances can be found in the table above. Those joining resistances are then substituted in the equation for the line of Figure 19 to determine their equivalence in natural gas carbon black concentration. Mixtures 15 and 16 were Ultra Violet Violet and were functionally equivalent to a non-pigmented closure assembly. The remaining mixtures between 13 and 21 at 0.035% concentration provided comparable binding strengths with natural gas black carbon concentrations ranging from 0.010 to 0.015%. The mixture 22 is unique in that the pigment is generally not perceived by the human eye but elevated the bonding response above the base resin. This suggests that natural gas carbon black can be replaced by alternative pigments so that infrared light welding is required through a higher concentration. It should be understood that various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its proposed advantages. Therefore, it is proposed that such changes and modifications be covered by the appended claims.

Claims (76)

1. CLAIMS 1. A method for assembling a medical device comprising: providing a first article of a polymeric material; provide a second article of a polymeric material; contact the first article with the second article along an area of interaction; and exposing the first article and the second article to a specific portion of the infrared spectrum where the polymeric material of the first article and the polymeric material of the second article absorb infrared energy to generate sufficient heat to create a bond between the first article and the second article . The method according to claim 1, further comprising the step of: providing a layer that fits over a portion of the interface area, the layer allowing exposure to infrared light to reach the interface area while protecting a non-union area. 3. The method according to claim 2, characterized in that the layer comprises polytetrafluoroethylene. The method according to claim 1, characterized in that the first article is a medical housing and the second article is a medical tube. The method according to claim 1, characterized in that the first article is a medical tube and the second article is a medical tube. 6. The method according to claim 1, characterized in that the first article is a film and the second article is a step with projections. The method according to claim 1, characterized in that the first article is a sealed container and the second article is a step with projections. The method according to claim 7, characterized in that the sealed container is filled with a solution. The method according to claim 8, characterized in that the solution is a medical solution. 10. A medical device produced by the method according to claim 1. eleven . A method for assembling a medical device comprising: providing a first article of a polymeric material; provide a second article of a polymeric material; join the first article to the second article along an interface area; and exposing either the first or the second article to a specific portion of the infrared spectrum wherein the polymeric material of the first article or the polymeric material of the second article absorbs infrared energy to generate sufficient heat to create a bond between the first and second article . The method according to claim 1, further comprising the step of: providing a layer that fits over a portion of the interface area, the layer allowing exposure to infrared light to reach the interface area while protecting a non-union area . The method according to claim 12, characterized in that the layer comprises polytetrafluoroethylene. The method according to claim 1, characterized in that the first article is a medical housing and the second article is a medical tube. The method according to claim 1, characterized in that the first article is a medical tube and the second article is a medical tube. The method according to claim 1, characterized in that the first article is a film and the second article is a step with projections. The method according to claim 1, characterized in that the first article is a sealed container and the second article is a step with projections. 18. The method according to claim 17, characterized in that the sealed container is filled with a solution. The method according to claim 18, characterized in that the solution is a medical solution. 20. A medical device produced by the method according to claim 1 1. A method for assembling a medical device comprising the steps of: providing a first article of a polymeric material; provide a second article of a polymeric material; apply an infrared absorbing light pigment to one of the first article or the second article to define an interface area; contact the first article with the second article throughout the interface area; and joining the first article to the second article along an interface area using exposure to infrared light. 22. The method according to claim 21, characterized in that the infrared absorbing pigment comprises natural gas carbon black. 23. The method according to claim 21, characterized in that the infrared light absorbing pigment comprises activated charcoal. The method according to claim 21, characterized in that the infrared-absorbing pigment is mixed in the polymeric material of the first article or the second article. 25. The method according to claim 21, characterized in that the infrared absorbing pigment is printed on the first article or the second article. The method according to claim 21, characterized in that the infrared absorbing pigment is placed in a first portion of a surface of the first or second article in a first concentration and in a second portion of the surface in a second concentration lower than the first concentration. 27. The method according to claim 26, further comprising the step of applying a first infrared light exposure to the first portion of the surface to create a seal. The method according to claim 27, further comprising the step of applying a second exposure to infrared light higher than the first exposure to infrared light to the second portion of the surface to create a second seal. 29. The method according to claim 21, characterized in that the first article is a medical housing and the second article is a medical tube. 30. The method according to claim 21, characterized in that the first article is a medical tube and the second article is a medical tube. 31. The method according to claim 21, characterized in that the first article is a film and the second article is a step with projections. 32. The method according to claim 21, characterized in that the first article is a sealed container and the second article is a step with projections. 33. The method according to claim 32, characterized in that the sealed container is filled with a solution. 34. The method according to claim 33, characterized in that the solution is a medical solution. 35. The method according to claim 21, further comprising the step of: providing a layer that fits over a portion of the interface area, the layer allowing exposure to infrared light to reach the interface area while protecting a non-union area . 36. The method according to claim 35, characterized in that the layer is made of glass. 37. The method according to claim 35, characterized in that the layer is made of polytetrafluoroethylene. 38. The method according to claim 37, characterized in that the layer includes multiple slots installed along an axis to allow infrared light to reach the interface area and provide multiple sealing areas. 39. The method according to claim 21, characterized in that the joining step is performed using infrared lamps. 40. The method according to claim 21, characterized in that the joining step is performed using a laser. 41 A method for assembling a medical device comprising the steps of: providing a first article of a polymeric material; provide a second article of a polymeric material; applying an absorbent pigment to infrared light to the first article and the second article to define an interface area; contact the first article with the second article throughout the interface area; and joining the first article to the second article along the interface area using exposure to infrared light. 42. The method according to claim 41, characterized in that the first article is a medical tube and the second article is a medical tube. 43. The method according to claim 41, characterized in that the infrared absorbing pigment is mixed with the polymeric material from which the first article and the second article are derived. 44. The method according to claim 41, characterized in that the infrared absorbing pigment is printed on the first and second articles. 45. The method according to claim 41, characterized in that the infrared absorbing pigment is placed in a first portion of a surface of the first or second article in a first concentration and in a second portion of the surface in a second concentration lower than the first concentration. 46. The method according to claim 45, further comprising the step of applying a first infrared light exposure to the first portion of the surface to create a seal. 47. The method according to claim 46, further comprising the step of applying a second exposure to infrared light higher than the first exposure to infrared light to the second portion of the surface to create a second seal. 48. The method according to claim 41, further comprising the step of: providing a layer that fits over a portion of the interface area, the layer allowing exposure to infrared light to reach the interface area while protecting a non-union area. 49. The method according to claim 48, characterized in that the layer is made of polytetrafluoroethylene. 50. The method according to claim 49, characterized in that the layer includes multiple slots installed along an axis to allow infrared light to reach the area of the interface and provide multiple sealing areas. 51. A method for assembling a medical device comprising: providing a first article of a polymeric material; provide a second article of a polymeric material; provide a pigmented film responsive to infrared light; placing the pigmented film responsive to infrared light between the first article and the second article to define an interface area and contact the first article with the second article; and apply exposure to infrared light to join the first article and the second article. 52. The method according to claim 51, characterized in that the first article is a step with projections and the second article is a film. 53. The method according to claim 51, characterized in that the first article is a sealed container and the second article is a step with projections. 54. The method according to claim 53, characterized in that the sealed container is filled with a solution. 55. The method according to claim 54, characterized in that the solution is a medical solution. 56. The method according to claim 51, further comprising the step of providing a protective layer that fits over a portion of the interface area, the layer allowing exposure to infrared light to reach the interface area while protecting a non-union area. . .57. The method according to claim 56, characterized in that the layer is made of polytetrafluoroethylene. 58. The method according to claim 57, characterized in that the layer includes multiple grooves installed along an axis to allow infrared light to reach the filter area and provide multiple sealing areas. 59. A medical device assembly comprising: a first article of a polymeric material; a second article of a polymeric material; the first or second article having an infrared absorbing pigment placed thereon to define an interface area, the first article contacting the second article in the filter area; and a protective layer temporarily placed over at least a portion of the interface area, so that when the infrared heat is applied to the interface area a joint is formed between the first article and the second article. 60. The medical device assembly according to claim 59, characterized in that the first article is a medical tube and the second article is a medical housing. 61 The medical device assembly according to claim 59, characterized in that the first article is a medical tube and the second article is a medical tube. 62. The medical device assembly according to claim 59, characterized in that the first article is a film and the second article is a step with projections. 63. The medical device assembly according to claim 59, characterized in that the first article is a sealed container and the second article is a step with projections. 64. The medical device assembly according to claim 63, characterized in that the sealed container is filled with a solution. 65. The medical device assembly according to claim 64, characterized in that the solution is a medical solution. 66. The medical device assembly according to claim 59, characterized in that the layer is made of polytetrafluoroethylene. 67. The medical device assembly according to claim 66, characterized in that the layer includes multiple slots installed along an axis to allow infrared light to reach the interface area and provide multiple sealing areas. 68. The medical device assembly according to claim 59, characterized in that the infrared absorbing pigment is placed in a first portion of a surface of the first or second article in a first concentration and in a second portion of the surface in a second concentration. lower than the first concentration. 69. The medical device assembly according to claim 59, characterized in that the infrared absorbing pigment comprises natural gas carbon black. 70. The medical device assembly according to claim 59, characterized in that the infrared light absorbing pigment comprises activated charcoal. 71 The medical device assembly according to claim 59, characterized in that the infrared absorbing pigment is mixed with the polymeric material from which the first article and the second article are derived. 72. The medical device assembly according to claim 59, characterized in that the infrared absorbing pigment is printed on the first or second article. 73. A medical device assembly comprising: a first article of a polymeric material; a second article of a polymeric material; the first and second articles having an infrared absorbing pigment placed in it to define an interface area, the first article contacting the second article in the interface area; and a protective layer temporarily placed on at least a portion of the interface area, so that when the infrared heat is applied to the interface area a bond is formed between the first and second article. 74. The medical device assembly according to claim 73, characterized in that the infrared absorbing pigment is mixed with the polymeric material from which the first article and the second article are derived. 75. The medical device assembly according to claim 74, characterized in that the infrared absorbing pigment is printed on the first or second article. 76. A medical device assembly comprising: a first article of a polymeric material; a second article of a polymeric material; either the first or second article having an infrared absorbing pigment placed thereon to define an interface area, the first article being fixedly attached to the second article in the interface area upon exposure to infrared light.