Patent Description:
Many industries utilize sterile connections for the delivery and removal of fluids. Since sterile connections may be used in a variety of industries, such as the medical industry and pharmaceutical industry, thermoplastic and thermoset elastomers are typically used that are non-toxic, flexible, thermally stable, have low chemical reactivity, and can be produced in a variety of sizes. In many instances, it is desirable to connect two different profiles to create a sterile fluid connection. Unfortunately, it is difficult to effectively provide a weld with a thermoset elastomeric material and in many cases, two different materials, such as two different polymeric materials. For instance, a silicone elastomer is a thermoset material that cannot be melted and thus, cannot be welded with conventional high temperature methods. Further, it is a challenge to maintain any sterility, especially when welding two profiles.

Accordingly, an improved sterile connection and method of providing a weld between two profiles is desired.

<CIT> discloses a connection comprising a first profile having a first end, the first profile comprising a first material and a second profile having a second end, the second profile comprising a second material, wherein the first end and the second end are welded at an interface to form a sterile bond.

Subject matter of the present invention is a connection as defined in claim <NUM>, and a method as defined in claim <NUM> of providing a sterile connection. The dependent claims relate to particular embodiments thereof.

The connection according to the present invention includes: a first profile having a first end, the first profile including a first thermoset material; and a second profile having a second end, the second profile including a second thermoset material, wherein the first end and the second end are coincidently bonded without a bonding material at an interface of the first end and the second end via surface activation treatment to form a coincident and sterile bond.

The method according to the present invention of providing a sterile connection includes: providing a first profile having a first end, the first profile including a first thermoset material; providing a second profile having a second end, the second profile including a second thermoset material; providing a surface activation treatment; and contacting the first end directly to the second end to coincidently bond without a bonding material the first end to the second end at an interface via surface activation treatment and provide a sterile connection between a treated surface of the first profile and a treated surface of the second profile.

<FIG> include illustrations of an exemplary connection.

The following description in combination with the figures is provided to assist in understanding the teachings disclosed herein. The following discussion focuses on specific implementations and embodiments of the teachings. This focus is provided to assist in describing the teachings and should not be interpreted as a limitation on the scope or applicability of the teachings.

As used herein, the terms "comprises", "comprising", "includes", "including", "has", "having", or any other variation thereof, are open-ended terms and should be interpreted to mean "including, but not limited to. " These terms encompass the more restrictive terms "consisting essentially of" and "consisting of. " In an embodiment, a method, article, or apparatus that comprises a list of features is not necessarily limited only to those features but may include other features not expressly listed or inherent to such method, article, or apparatus.

This description should be read to include one or at least one and the singular also includes the plural, or vice versa, unless it is clear that it is meant otherwise.

The materials, methods, and examples are illustrative only and not intended to be limiting. To the extent not described herein, many details regarding specific materials and processing acts are conventional and may be found in reference books and other sources within the structural arts and corresponding manufacturing arts. Unless indicated otherwise, all measurements are at about <NUM>. For instance, values for viscosity are at <NUM>, unless indicated otherwise.

The disclosure generally relates to a connection. The connection includes a first profile having a first end, the first profile including a first thermoset material. The sterile connection includes a second profile having a second end, the second profile including a second thermoset material. A connection is provided by coincidentally bonding the first end with the second end at an interface of the first end and the second end. According to the present invention, the coincidental bond is provided via a surface activation treatment, and is provided without a bonding material at the interface.

The surface activation treatment coincidentally and chemically bonds the first end of the first profile to the second end of the second profile when they are placed in direct contact. Any surface activation treatment is envisioned and includes any processing input energy to a surface of the first profile, the second profile, or combination thereof. In an embodiment, the processing input energy is with wave irradiation, particular irradiation, or combination thereof. In an embodiment, the wave irradiation includes any wave irradiation envisioned such as radio waves, microwaves, infrared, visible light, ultraviolet, x-rays, gamma radiation, or combination thereof.

In a particular embodiment, the wave irradiation includes microwaves, ultraviolet, x-rays, gamma radiation, or combination thereof. In an embodiment, the particle irradiation includes alpha radiation, beta radiation, charged ions, neutron radiation, or combination thereof. In another embodiment, the particle irradiation includes corona treatment, ion treatment, plasma treatment, or combination thereof. The surface activation treatment provides an effective weld, and in a particular embodiment, a seal between the two profiles. The efficacy of the seal provides advantageous mechanical and physical properties at the interface of the coincident bond. For instance, the coincident bond withstands a seal integrity pressure test of at least <NUM> kPa (<NUM> psi), such as at least <NUM> kPa (<NUM> psi), such as at least <NUM> kPa (<NUM> psi), such as at least <NUM> kPa (<NUM> psi), or even at least <NUM> kPa (<NUM> psi) air pressure for about <NUM> minutes under dry and wet conditions, as described further in the Examples. In an embodiment, the coincident bond maintains a tensile strength of at least about <NUM>%, such as at least about <NUM>%, such as at least about <NUM>%, or even at least about <NUM>%, compared to a tensile strength of a bulk material of the first profile or a bulk material of the second profile, with the proviso that the comparison is against the bulk material having the lower tensile strength. A measurement of "a bulk material" herein refers to an average measurement obtained over any sampling of the material that is not any portion of the surface that is treated. In a particular embodiment, the coincidental bond has a tensile strength between the first profile and the second profile of at least about <NUM> kPa (<NUM> psi), such as at least about <NUM> kPa (<NUM> psi), or even at least <NUM> MPa (<NUM> psi) via the tensile test described in the Examples. In an example, the coincident bond maintains an elongation at break of at least about <NUM>%, such as at least about <NUM>%, such as at least about <NUM>%, or even at least about <NUM>%, compared to an elongation at break of a bulk material of the first profile or a bulk material of the second profile, with the proviso that the comparison is against the bulk material having the lower elongation at break. Furthermore, the coincident bond has a tear strength of at least about <NUM> N/mm (<NUM> ppi), such as at least about <NUM> N/mm (<NUM> ppi), or even at least about <NUM> N/mm (<NUM> ppi), and even at least about <NUM> N/mm (<NUM> ppi) via the tear test described in the Examples. In yet another embodiment, the coincident bond has an adhesion force at the interface of at least about <NUM> N/mm (<NUM> ppi), such as at least about <NUM> N/mm (<NUM> ppi), or even as at least about <NUM> N/mm (<NUM> ppi) as described via peel test conditions in the Examples.

The surface treatment provides sterility to the surface it treats, i.e. sterilizes the treated surface. A "treated surface" as used herein refers to any surface that is exposed to surface activation treatment. In an embodiment, "providing sterility" includes maintaining sterility for a pre-sterilized first profile and/or a pre-sterilized second profile. The surface activation treatment provides a sterile connection between the first profile and the second profile, such as between a treated surface of the first profile and a treated surface of the second profile.

In an embodiment, any profile is envisioned. In an embodiment, at least one profile has at least one lumen. In a particular embodiment, the profile provides a fluid connection between at least two lumens for fluid to flow through and between the first profile and the second profile. For instance, the profile is any connector, a tube, a port, a hose, a nozzle, a mandrel, a needle, a plug, and the like. The first profile and the second profile may be the same or different. In an embodiment, the first profile and the second profile are both tubes. In another embodiment, the first profile is a tube and the second profile is a plug. In another embodiment, the first profile is a tube and the second profile is a port. In an example, the first profile and/or the second profile may be a single homogenous thermoset material. In an embodiment, the first profile and/or the second profile may be a multi-layered composite material, for example, including more than one distinct polymeric layer.

In an embodiment, the first thermoset material is a thermoset elastomer. Any thermoset elastomer is envisioned. In a particular embodiment, the thermoset elastomer includes a silicone elastomer, a diene elastomer, a butyl rubber, a natural rubber, a polyurethane rubber, an ethylene propylene diene monomer rubber, an isoprene rubber, a nitrile rubber, a styrene butadiene rubber, a blend, or combination thereof. Any rubber for medical/pharmaceutical applications is envisioned. In a particular embodiment, the first thermoset material includes a silicone elastomer.

A typical silicone elastomer includes a silicone matrix component. An exemplary silicone matrix component includes a polyorganosiloxane. Polyorganosiloxanes include a polyalkylsiloxane, a polyarylsiloxane, or combination thereof. Any reasonable polyalkylsiloxane is envisioned. Polyalkylsiloxanes include, for example, silicone polymers formed of a precursor, such as dimethylsiloxane, diethylsiloxane, dipropylsiloxane, methylethylsiloxane, methylpropylsiloxane, or combinations thereof. In a particular embodiment, the polyalkylsiloxane includes a polydialkylsiloxane, such as polydimethylsiloxane (PDMS). In a particular embodiment, the polyalkylsiloxane is a silicone hydride-containing polyalkylsiloxane, such as a silicone hydride-containing polydimethylsiloxane. In a further embodiment, the polyalkylsiloxane is a vinyl-containing polyalkylsiloxane, such as a vinyl-containing polydimethylsiloxane. The vinyl group may be an endblock of the polyalkylsiloxane, on chain of the polyalkylsiloxane, or any combination thereof. In yet another embodiment, the silicone matrix component is a combination of a hydride-containing polyalkylsiloxane and a vinyl-containing polyalkylsiloxane.

In an embodiment, the first thermoset material is a thermoset elastomer and more particularly, a diene elastomer. The diene elastomer may be a copolymer formed from at least one diene monomer. For example, the diene elastomer may be a copolymer of ethylene, propylene and diene monomer (EPDM), a thermoplastic EPDM composite, or combination thereof. An exemplary diene monomer may include a conjugated diene, such as butadiene, isoprene, chloroprene, or the like; a non-conjugated diene including from <NUM> to about <NUM> carbon atoms, such as <NUM>,<NUM>-pentadiene, <NUM>,<NUM>-hexadiene, <NUM>,<NUM>-hexadiene, <NUM>,<NUM>-dimethyl-<NUM>,<NUM>-hexadiene, <NUM>,<NUM>-octadiene, or the like; a cyclic diene, such as cyclopentadiene, cyclohexadiene, cyclooctadiene, dicyclopentadiene, or the like; a vinyl cyclic ene, such as <NUM>-vinyl-<NUM>-cyclopentene, <NUM>-vinyl-<NUM>-cyclohexene, or the like; an alkylbicyclononadiene, such as <NUM>-methylbicyclo-(<NUM>,<NUM>,<NUM>)-nona-<NUM>,<NUM>-diene, or the like; an indene, such as methyl tetrahydroindene, or the like; an alkenyl norbomene, such as <NUM>-ethylidene-<NUM>-norbornene, <NUM>-butylidene-<NUM>-norbornene, <NUM>-methallyl-<NUM>-norbornene, <NUM>-isopropenyl-<NUM>-norbornene, <NUM>-(<NUM>,<NUM>-hexadienyl)-<NUM>-norbornene, <NUM>-(<NUM>,<NUM>-octadienyl)-<NUM>-norbornene, or the like; a tricyclodiene, such as <NUM>-methyltricyclo (<NUM>,<NUM>,<NUM>,<NUM><NUM>,<NUM>)-deca-<NUM>,<NUM>-diene or the like; or any combination thereof.

Depending on the composition of the first thermoset material, the first thermoset material may be formed with any reasonable component such as any precursor with the addition of any reasonable additive. An additional additive includes, but is not limited to, a catalyst, a filler, a plasticizer, a lubricant, an antioxidant, a colorant, an optically transparent conductive additive, an adhesion promoter, heat stabilizer, acid scavenger, UV stabilizer, processing aid, or combination thereof. In a particular embodiment, the precursor, the additional additive such as the catalyst, the filler, plasticizer, lubricant, antioxidant, colorant, an optically transparent conductive additive, an adhesion promoter, heat stabilizer, acid scavenger, UV stabilizer, processing aid, or combination thereof are dependent upon the first thermoset material chosen and final properties desired for the first profile.

Any reasonable catalyst that can initiate crosslinking of the thermoset material is envisioned. Exemplary catalysts include a catalyst that may be heat cured, IR radiation cured, e-beam cured, or combination thereof. The catalyst is dependent upon the thermoset material chosen. The catalyst may or may not be used in combination with a crosslinker promoter, such as triallyl cyanurate (TAC), triallyl isocyanurate (TAIC), or combination thereof. In an embodiment, the additive includes any reasonable adhesion promoter. Any reasonable adhesion promoter that promotes adhesion of adjacent layers is envisioned and is dependent upon the adjacent layers. Exemplary lubricants include silicone oil, waxes, slip aids, antiblock agents, the like, or any combination thereof. Exemplary lubricants further include silicone grafted polyolefin, polyethylene or polypropylene waxes, Oleic acid amide, erucamide, stearate, fatty acid esters, the like, or any combination thereof. Exemplary antioxidants include phenolic, hindered amine antioxidants. Exemplary fillers include calcium carbonate, talc, radio-opaque fillers such as barium sulfate, bismuth oxychloride, any combinations thereof, and the like. In an embodiment, the filler includes a functionalized filler. Exemplary functionalized fillers include, for example, a base filler that has a functional moiety that forms a chemical bond with the second thermoset material. Any reasonable base filler is envisioned such as a silica filler, fumed silica filler, quartz, glass filler, aluminum (AlO(OH)), alumino-silicate, inorganic oxides, resinous filler, carbon black, graphite, graphene, carbon nanotube (CNT), fullerene or combination thereof. In a particular embodiment, the functionalized filler includes a silica filler. Any functional moiety is envisioned that has an adhesive affinity to the second thermoset material. The functionalized moiety is, for example, a silane attached to the base filler, wherein the silane includes an acryl functional group, an epoxy functional group, a chloro functional group, or combination thereof. In an embodiment, any reasonable silane is envisioned and includes, for example, an alkoxysilane such as a trimethoxysilane, a triethoxysilane, or combination thereof. In an embodiment, the functionalized filler is a silicone-hydride attached to the base filler. In a particular embodiment, the silicone-hydride is trimethylsiloxy-terminated. When present as the functional moiety, any reasonable amount of functionalized filler is envisioned to provide an increased adhesive bond between the first thermoset material and the second thermoset material. In an embodiment, the functionalized filler forms a cohesive bond between the first thermoset material and the second thermoset material, i.e. cohesive failure occurs wherein the structural integrity of the first profile and/or the second profile fails before the bond between the two materials fails. In an exemplary embodiment, the functionalized filler is mixed with the thermoset material to form a homogenous mixture of the functionalized filler contained with a matrix of the thermoset material. In an embodiment, the functionalized filler may or may not form a reactive and covalent bond with the thermoset material. In a more particular embodiment, the functionalized filler does not form a reactive and covalent bond with the thermoset material. Exemplary plasticizers include any known plasticizers such as a citrate, a phthalate, a trimellitate, <NUM>,<NUM>-cyclohexane dicarboxylic acid diisonoyl ester (DINCH), an adipate, a polymeric plasticizer, a castor oil, a caster oil derivative, mineral oils, soybean oil, such as epoxidized soybean oil, the like, or any combination thereof.

Typically, the additional additive may be present at an amount of not greater than about <NUM>% by weight of the total weight of the thermoset material, such as not greater than about <NUM>% by weight of the total weight of the thermoset material, such as not greater than about <NUM>% by weight of the total weight of the thermoset material, such as not greater than about <NUM>% by weight of the total weight of the thermoset material, or even not greater than about <NUM>% by weight of the total weight of the thermoset material. In an alternative embodiment, the thermoset material may be substantially free of an additional additive such as a catalyst, lubricant, a filler, a plasticizer, an antioxidant, a colorant, an adhesion promoter, heat stabilizer, acid scavenger, UV stabilizer, processing aid, or combination thereof. "Substantially free" as used herein refers to less than about <NUM>% by weight, or even less than about <NUM>% by weight of the total weight of the thermoset material.

Further included is a second profile. The second profile includes a second thermoset material. In an embodiment, the second polymeric thermoset material includes a thermoset elastomer as described for the first thermoset material. In an embodiment, the first thermoset material and the second thermoset material are the same thermoset material. In another embodiment, the first thermoset material and the second thermoset material are different thermoset materials. For instance, the connection may be between any combination of the first thermoset material and the second thermoset material being: a silicone elastomer. In an embodiment, the first thermoset material and/or the second thermoset material include a silicone elastomer.

<FIG> is a view of a first profile <NUM> and a second profile <NUM> according to an embodiment. Typically, the first profile <NUM> and the second profile <NUM> is any commercially available profile. In a particular embodiment, the first profile <NUM> is in the form of a tube including a body <NUM> having an outside diameter <NUM> and an inner diameter <NUM>. The inner diameter <NUM> can form a hollow bore <NUM> of the body <NUM>. The hollow bore <NUM> defines a central lumen of the tube for fluid flowthrough. In addition, the body <NUM> is illustrated as a single layer, the single layer including the first thermoset material. The body <NUM> can include a wall thickness <NUM> that is measured by the difference between the outside diameter <NUM> and the inner diameter <NUM>.

In a particular embodiment, the outside diameter <NUM> of the body <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the outside diameter <NUM> can be within a range between any of the minimum and maximum values noted above. In an embodiment, the inner diameter <NUM> of the body <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the inner diameter <NUM> can be within a range between any of the minimum and maximum values noted above. The wall thickness <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inch), or even about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the wall thickness <NUM> can be within a range between any of the minimum and maximum values noted above. Although illustrated as a tube, the first profile <NUM> may be any configuration envisioned having a thickness of about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inch), or even about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the thickness can be within a range between any of the minimum and maximum values noted above. Further, the body <NUM> has a first end <NUM>.

Although the cross-section of the inner bore <NUM> perpendicular to an axial direction of the body <NUM> in the illustrative embodiment shown in <FIG> has a circular shape, the cross-section of the inner bore <NUM> perpendicular to the axial direction of the body <NUM> can have any cross-section shape envisioned.

In a particular embodiment, the second profile <NUM> is in the form of a tube and can include a body <NUM> having an outside diameter <NUM> and an inner diameter <NUM>. The inner diameter <NUM> can form a hollow bore <NUM> of the body <NUM>. The hollow bore <NUM> defines a central lumen of the tube for fluid flowthrough. In addition, the body <NUM> is illustrated as a single layer, the single layer including the second thermoset material. The body <NUM> can include a wall thickness <NUM> that is measured by the difference between the outside diameter <NUM> and the inner diameter <NUM>.

In a particular embodiment, the outside diameter <NUM> of the body <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the outside diameter <NUM> can be within a range between any of the minimum and maximum values noted above. In an embodiment, the inner diameter <NUM> of the body <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the inner diameter <NUM> can be within a range between any of the minimum and maximum values noted above. The wall thickness <NUM> is about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inch), or even about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the wall thickness <NUM> can be within a range between any of the minimum and maximum values noted above. Although illustrated as a tube, the second profile <NUM> may be any configuration envisioned having a thickness of about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches), such as about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inch), or even about <NUM> to about <NUM> (about <NUM> inches to about <NUM> inches). It will be appreciated that the thickness can be within a range between any of the minimum and maximum values noted above. Further, the body <NUM> has a second end <NUM>.

Although illustrated as a single layer tube for both the first profile <NUM> and the second profile <NUM>, any number of layers is envisioned. For instance, the first profile and the second profile include one layer, two layers, three layers, or even a greater number of layers. Further, although illustrated as both tubes with substantially the same inner diameter, outer diameter, and thickness, the first profile <NUM> and the second profile <NUM> can have the same or different configurations. Irrespective of the number of layers present, the outside diameter and inner diameter of the first profile <NUM> and the second profile <NUM> can have any values as defined for the single layer tubes <NUM>, <NUM> defined in <FIG>. The number of layers is dependent upon the final properties desired for the sterile connection. Further, although illustrated as a single lumen, i.e. hollow bore <NUM> and <NUM> for both the first profile <NUM> and the second profile <NUM>, any number of lumen is envisioned. For instance, the first profile and/or the second profile include a plurality of lumen.

In an embodiment, the first profile <NUM>, the second profile, <NUM>, or combination thereof may further include other layers. Other layers include, for example, a polymeric layer, a reinforcing layer, an adhesive layer, a barrier layer, a chemically resistant layer, a metal layer, any combination thereof, and the like. Any additional layer is envisioned and is dependent upon the material chosen. In an embodiment, any number of polymeric layers is envisioned.

In an embodiment, a method of providing a connection is provided. The method includes providing the first profile <NUM> having the first end <NUM>. The method further includes providing the second profile <NUM> having the second end <NUM>. In an embodiment, at least the first profile <NUM>, the second profile <NUM>, or combination thereof is cut. In a particular embodiment, the first end <NUM> and the second end <NUM> are coincidently bonded together via a surface activation treatment, the interface of the coincidental bond having an exterior seam <NUM>. For instance, the surface activation treatment is provided to treat a surface of the first end <NUM> and a surface of the second end <NUM> and the first end <NUM> and the second end <NUM> are placed in direct contact to coincidentally bond the first end <NUM> to the second end <NUM>. Typically, a compression force of less than <NUM> Newtons (N) is applied to the abutting first end <NUM> and second end <NUM>. In a particular embodiment, the first end <NUM> has a cross-section across the wall thickness <NUM> that is in full and direct contact with a cross-section across the wall thickness <NUM> of the second end <NUM>. In a particular embodiment, the first profile <NUM>, the second profile <NUM>, or combination thereof has a desirable surface roughness to provide a desirable seal. For instance, the cross-section across the wall thickness <NUM> of the first profile <NUM>, the cross-section across the wall thickness <NUM> of the second profile, or combination thereof has a Ra of less than about <NUM>, such as less than about <NUM>, such as less than about <NUM>, or even less than about <NUM>, as measured by a MarSurf M 300C Mobile Roughness Measuring Instrument. In an example, the surface activation treatment minimally changes a surface roughness of a treated surface. In an embodiment, the surface roughness of a treated surface of the first profile and a surface roughness of a treated surface of the second profile changes by less than about <NUM>%, such as less than about <NUM>%, or even less than about <NUM>%, compared to an untreated surface of the first profile and an untreated surface of the second profile.

The interface has further advantageous physical and chemical properties. In an embodiment, the interface has a mechanical strength of at least <NUM>%, at least <NUM>%, or even at least <NUM>% of a bulk material of the first profile and the second profile, testing conditions as described by the tensile test in the Examples. For instance, the interface has a failure mode of adhesive failure, or even cohesive failure. Although not being bound by theory, a surface activation treatment at least excites an atom at a molecular level to provide the coincident bond. For instance, the interface has an oxygen atomic concentration of greater than about <NUM>%, such as greater than about <NUM>%, such as greater than about <NUM>%, or even greater than about <NUM>%, compared to a bulk material of the first profile and a bulk material of the second profile via XPS. For instance, the interface has a nitrogen atomic concentration of greater than about <NUM>%, such as greater than about <NUM>%, such as greater than about <NUM>%, or even greater than about <NUM>%, compared to a bulk material of the first profile and a bulk material of the second profile via XPS. In a particular embodiment, the interface has a higher valence of an element, compared to a bulk material of the first profile and a bulk material of the second profile. Further, a surface tension at the interface is greater than about <NUM> mN/m (milliNewton per meter), such as greater than about <NUM> mN/m, or even greater than about <NUM> mN/m, as described by the surface energy test in the Examples. For instance, the treated surface has a surface tension of greater than about <NUM> mN/m, such as greater than about <NUM> mN/m, or even greater than about <NUM> mN/m. In particular, a surface tension is increased at a treated interface for connection and/or treated surface for at least about <NUM>/m, at least about <NUM>/m, or even at least than about <NUM>/m, as described by the surface energy test in the Examples.

In an embodiment, the coincidental bond <NUM> is a circumferential seal wherein the bonded ends, <NUM> and <NUM>, are abutted. In a particular embodiment, the bonded ends <NUM> and <NUM> maintain fluid flow through the hollow bore <NUM> and <NUM>. The coincident bond provides an advantageous seal between the first profile <NUM> and the second profile <NUM>. Typically, the interface is substantially free of a bonding material. Any bonding material includes any external adhesive material envisioned such as any added material that provides adhesive properties. Furthermore, the interface is substantially free of any reversible chemistry, such as dynamic covalent chemistry. "Dynamic covalent chemistry" as used herein refers to a chemical reaction that forms a new chemical compound that is different than an original chemical compound. Exemplary chemical reactions include an Aldol reaction, a Diels-Alder reaction, imine formation, aminal formation, and disulfide exchange. Furthermore, the surface activation does not increase a temperature of a treated bulk to exceed the degradation temperature of the bulk material.

In a particular embodiment, a sterile connection is provided between the first profile <NUM> and the second profile <NUM>. In an embodiment, at least the first profile <NUM>, the second profile <NUM>, or combination thereof are sterile prior to the coincident bond. In an embodiment, the surface activation treatment provides a sterile connection between the first profile <NUM> and the second profile <NUM> or at least maintains sterility of a pre-sterilized first profile <NUM> and/or a pre-sterilized second profile <NUM>. In an embodiment, the surface activation treatment provides a sterile connection between the treated surface of the first profile <NUM> and the treated surface of the second profile <NUM> or at least maintains sterility of a treated surface of a pre-sterilized first profile <NUM> and/or a treated surface of a pre-sterilized second profile <NUM>. In an embodiment, the surface activation treatment sterilizes the treated surface of the first profile <NUM>, the treated surface of the second profile <NUM>, or combination thereof. Although not illustrated, the surface activation treatment may be used to provide a visible difference at the interface on a treated area versus non-treated area. The visible difference may be advantageous as a visual indicator that a seal has been achieved or when the seal is no longer present.

As described, the surface activation treatment includes, in an embodiment, corona treatment, plasma treatment, ion treatment, or combination thereof. For instance, the corona treatment ionizes the atmosphere to activate a surface of the first profile and the second profile. In an embodiment, the surface activation treatment includes plasma treatment such as, for example, an inert gas plasma, an oxygen-containing plasma, a nitrogen-containing plasma, a fluorine-containing plasma, or combination thereof. In an embodiment, the surface activation treatment includes plasma treatment which ionizes a gas such as helium, neon, oxygen, argon, nitrogen, compressed air, ammonia, or combination thereof. In an embodiment, the surface activation treatment includes plasma treatment which ionizes a gas such as oxygen, argon, nitrogen, compressed air, ammonia, or combination thereof. Any conditions of the surface activation treatment are envisioned that provides a bond as well as sterile conditions for the first profile <NUM> and the second profile <NUM>. For instance, the plasma treatment is provided for less than <NUM> minutes, such as less than <NUM> minute, such as less than <NUM> seconds, such as less than <NUM> seconds, or even less than <NUM> seconds. In a particular embodiment, an extraction profile of the first profile and the second profile before and after surface activation treatment is substantially identical, indicating that the chemical composition of the first profile and the second profile has not changed before and after surface activation treatment. Furthermore, a change in particulates in the first profile and the second profile before and after surface activation treatment is +/- <NUM>%, such as +/- <NUM>%, or even +/- <NUM>%. In an embodiment, the profiles may be surface treated multiple times. For instance, the method can include disconnecting the coincident bond at the interface, providing an additional surface activation treatment, and contacting the first end directly to the second end to coincidently bond the first end to the second end at the interface.

Since the surface treatment provides sterility to the first profile <NUM> and the second profile <NUM>, a further sterilization process is not required. Further, the surface activation treatment provides an effective seal where the coincidental bond is substantially free of an adhesive, a primer, a chemical treatment, or combination thereof. Any energy, dependent on power and time, is envisioned that activates the surface of the first profile and the second profile. For examples, a power output is about <NUM> Watts for about <NUM> seconds.

In an embodiment, a reinforcement (not illustrated) can be used to reinforce the exterior seam <NUM>. In an embodiment, the reinforcement is a fastening device that surrounds at least a portion of the exterior seam of the coincidental bond. In a particular embodiment, the fastening device that surrounds the entire exterior seam of the coincidental bond. Any fastening device is envisioned such as, for example, a clamp, a polymer tape, an overmolded polymer, a glue, or combination thereof. In a particular embodiment, the fastening device is a polymer tape such as a silicone tape. The silicone tape may be self-adhesive. In another embodiment, a surface between the polymer tape is surface treated to enhance the adhesion of the polymer tape to an exterior surface adjacent to the coincidental bond. For instance, the surface of the polymer tape is treated. In another embodiment, the outer surface of the exterior seam is treated. In a particular embodiment the surface between the polymer tape is surface treated with the surface activation treatment described for the bonding and sterilizing of the first profile and the second profile. Any sequence of surface treating the polymer tape concurrently or subsequently with surface treatment with the surface activation treatment for bonding/welding is envisioned.

In exemplary embodiments, the first profile and the second profile with the coincidental bond can be used in a variety of applications where a bonded connection is desired. According to the present invention, a sterile connection is achieved. Advantageously and in a particular embodiment, the surface activation treatment provides a method of bonding and sterilizing a multitude of polymeric materials not yet before bonded/welded while maintaining a sterilized connection. In particular, the sterile nature of the coincidental bond is useful for any application where sterility is desired. For instance, the coincidental bond of any profiles has potential for FDA, ADCF, USP Class VI, NSF, European Pharmacopoeia compliant, United States Pharmacopoeia (USP) compliant, USP physiochemical compliant, Japanese Pharmacopeia, ISO <NUM> Standard for evaluating biocompatibility of a medical device, and other regulatory approvals. In a particular embodiment, the profile is non-cytotoxic, non-hemolytic, non-pyrogenic, animal-derived component-free, non-mutagenic, non-bacteriostatic, non-fungistatic, or any combination thereof.

In an embodiment, the method of providing a sterile connection may be used in applications such as industrial, medical applications, health care, biopharmaceutical, drinking water, food & beverage applications, dairy applications, laboratory applications, FDA applications, and the like. In an exemplary embodiment, the method of providing a sterile connection may be used in applications such as a fluid transfer tube in food and beverage processing equipment, a fluid transfer tube in medical and health care, biopharmaceutical manufacturing equipment, and peristaltic pump tube for medical, laboratory, and biopharmaceutical applications.

In a particular embodiment, a fluid source, such as a container, reactor, reservoir, tank, or bag, is coupled to the first profile and/or the second profile. The first profile and/or the second profile may engage a pump, fitting, valve, dispenser, or another container, reactor, reservoir, tank, or bag. In an example, the first profile and/or the second profile may be coupled to a water container and may have a dispenser fitting. In another example, the first profile and/or the second profile may be coupled to a fluid bag and coupled to a valve. In a further example, the profile may be coupled to a container, be engaged in a pump, and be coupled to a second container.

The concepts described herein will be further described in the following examples, which do not limit the scope of the disclosure described in the claims. The following examples are provided to better disclose and teach processes and compositions of the present invention. They are for illustrative purposes only, and it must be acknowledged that minor variations and changes can be made without materially affecting the scope of the invention as recited in the claims that follow.

General procedure for welding and burst test:
Welding: place the two tubes under plasma, exposure the cross-sections to plasma for a certain time; then immediately after the treatment, align the tubes and "weld" them by applying gentle compression force (less than 100N but making sure the ends are in full contact).

Post treatment of tubing: the welded tubing are stored in ambient temperature and pressure for certain period before connecting to compression air for burst pressure test.

The pressure is provided via connecting to a compression air line with a regulator to control the pressure during the test. One end of the tested "welded" tubing is connected to the regulator using braid reinforcing silicone tubing with proper fitting. The other end of the "welded" tubing is connected to a pressure gauge. The whole tubing is immersed in water during the test. The fail of the tubing (burst at the joint or burst of tubing) can be easily indicated by the air bubble in the water tank. When test begins, the pressure is increased by controlling the regulator with the rate about <NUM> kPa/s (<NUM> psi/s). The highest pressure during the test is record. The whole process is also recorded by video and confirmed all the reading is correct after test.

Standard Operating Procedure of the test:.

Materials: <NUM> shore A durometer silicone tubing "welding" with same <NUM> shore A durometer silicone tubing (<NUM> ID, <NUM> OD) (<NUM>/<NUM> inch ID, ¾ inch OD). Results can be seen in Table <NUM>.

The following materials are tested: A <NUM> shore A durometer silicone tubing "welding" with the same <NUM> shore A durometer silicone tubing (<NUM> ID, <NUM> OD) (<NUM>/<NUM> inch ID, ¾ inch OD). Results can be seen in Table <NUM>.

The following materials are tested: a silicone tubing "welding" with C-Flex tubing (<NUM> ID, <NUM> OD) (<NUM>/<NUM> inch ID, ¾ inch OD). Shore A durometer of the silicone tubing is seen in Table <NUM>.

Plasma treatment conditions are in Table <NUM> along with max strain, tensile strength, and measured by the following procedure.

Preparation of the sample: for the as-is tubing/control, the tubing is cut with a length ~ <NUM>-<NUM> (~ <NUM>-<NUM> inch); for welded tubing, the tubing after welding is ~ <NUM>-<NUM> (~ <NUM>-<NUM> inch) with the welding line locating at the middle.

Place the tubing in the Instron tensile test machine with both ends into grips. The gas between the grips is set at <NUM> (<NUM> inch), making sure the grips are securely holding the tubing sample.

Pull the sample with the tensile machine at a rate of <NUM> in/min until tubing break, the grips are pulled to <NUM> (<NUM> inches) apart, or until the maximal tensile range of the machine is reached.

Remove the sample from the tensile machine and inspect for visual failure. Calculate the strength based on the ring area of tubing cross-section.

All durometer is shore A. Control samples are tubes un-cut tubes.

The same tensile test conditions are used to determine the tear strength and mechanical strength. Results for tear strength can be seen in Table <NUM>.

Materials: <NUM> duro silicone tubing "welding" with same <NUM> duro silicone tubing (<NUM> ID, <NUM> OD) (<NUM>/<NUM> inch ID, ¾ inch OD).

Burst pressure tests are performed with at least <NUM> hours after welding. Results can be seen in Table <NUM>.

Plasma welding surface energy of C-Flex and silicone tubing after exposure to plasma for welding procedure conditions and results are as follows.

Description of the tested materials is seen in Table <NUM>.

ASTM D7334-<NUM>, "Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement" is followed. This practice deals with the measuring of contact angles to characterize the wettability of surfaces. Two different solvents are used: water and diiodomethane (MI).

The instrument used is a Kruss Mobile Surface Analyzer, which uses an automatic liquid dispenser to place drops of solvent (volume = ~<NUM>µL) on a sample. Drops of water and MI are placed in parallel and allowed to settle on the surface. The values of the two contact angles are determined using drop shape analysis. <NUM>+ drops of each solvent are tested on each sample surface.

For analysis, the Owens-Wendt method is used, which utilizes both the dispersive and polar components of each solvent to determine the surface energy components of the samples. The equation for the method follows: <MAT> Where: cos θ: Cosine of the contact angle of the liquid drop on the sample;.

The equation fits a linear equation y = mx + b. By fitting a linear regression using the mean contact angle of each drop and liquid surface tension components, the surface energy components of the sample is determined.

Contact angle measurements and surface energy calculations are shown in Table <NUM>, Table <NUM>, Table <NUM>, and Table <NUM> below:.

With the silicone plasma weld, using a Sharpie permanent marker, the surface tension is tested. Before the treatment, the surface is not wettable. After the treatment, the surface is wettable.

The adhesion strength is measured by the following procedure. Preparation of the sample: Two silicone slabs with <NUM> (~<NUM>/<NUM> inch) thick are stacked and welded by plasma. The welded silicone slabs is cut into <NUM> (¼ inch) wide pieces. The welded slabs are then placed in the instron with each slab gripped, and peeled with T shape/<NUM> degree peel. The peel force is <NUM> ± <NUM> N/mm (<NUM> ± <NUM> ppi).

Extraction profile is determined as follows: The control silicone tubing and welded silicone tubing are extracted using <NUM>% water and <NUM>% of ethanol for <NUM> hours at <NUM>. Then Gas Chromatograph/Mass Spectrometry is used to analyze the extraction profile. Notably, plasma welding does not substantially change the extraction profile of a material, such as silicone tubing. In an example, when comparing a silicone control and a plasma welded silicone, plasma welding does not increase the extraction of siloxanes.

Claim 1:
A connection comprising:
a first profile (<NUM>) having a first end (<NUM>), the first profile (<NUM>) comprising a first thermoset material; and
a second profile (<NUM>) having a second end (<NUM>), the second profile (<NUM>) comprising a second thermoset material, wherein the first end (<NUM>) and the second end (<NUM>) are coincidently bonded without a bonding material at an interface of the first end (<NUM>) and the second end (<NUM>) via surface activation treatment to form a coincident and sterile bond.