Patent Application
20220160970
N/A
Infusion of medication is often done by infusion pump systems or gravity fed systems and corresponding intravenous (IV) sets. Typical IV sets have infusion components such as drip chambers, check valves, roller clamps, filters and tubing couplers, all connected together by primary and secondary IV tubing. The infusion components and tubing must be primed by placing IV fluid in the infusion components and IV tubing to remove all air prior to attaching the IV tube to the patient. IV tubing is primed to prevent air from entering the circulatory system, thus preventing an air embolism, which is a potential complication of IV therapy. Air embolisms can enter a patient's blood system through cut or unprimed IV tubing, infusion component access ports, and infusion components with too little fluid. Air embolisms can be fatal and deaths have occurred with as little as 10 ml of air. Known solutions to minimize or prevent air bubbles from occurring include using adaptors, sensors and membrane technologies to trap air bubbles in order to minimize bubbles and speed-up priming. However, these solutions require additional devices that increase the complexity of the IV set, while resulting in the need for training users on the correct use of the air bubble removing devices.
It is desirable to provide infusion components and IV tubing having hydrophilic material to prevent air bubbles from sticking to fluid path surfaces, thereby reducing the occurrence of air embolisms, reducing priming time, eliminating the need for additional training and improving manufacturing costs by eliminating the need for additional devices.
The present disclosure provides medical tubing and infusion components having hydrophilic coatings and/or hydrophilic blended base materials, decreasing the water wetting angle to cause air bubbles to slide away quickly or pop off and disappear after contacting the hydrophilic surface, thus reducing both the time required for priming and the risk of an air embolism from fluid delivery of an IV set.
In one or more embodiments, a hydrophilic infusion tube is provided. The hydrophilic infusion tube includes a flexible tube configured to connect a first fluid port and a second fluid port, the flexible tube comprising a base material suitable for fluid infusion and a hydrophilic fluid interfacing surface disposed on an inner surface of the flexible tube wherein the hydrophilic fluid interfacing surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the base material.
In one or more aspects, the base material includes one or more of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM)+polypropylene (PP)), thermoplastic styrenic elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and its blending with polyolefin, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber). In one or more aspects, the hydrophilic fluid interfacing surface comprises a hydrophilic material coated on the base material. In one or more aspects, the hydrophilic material includes Guanidinium copolymer. In one or more aspects, the hydrophilic material provides a lower coefficient of friction than a coefficient of friction provided by the base material. In one or more aspects, the hydrophilic material provides a material wettability that is higher than a material wettability provided by the base material.
In one or more aspects, the hydrophilic fluid interfacing surface comprises a hydrophilic material grafted on the base material. In one or more aspects, the hydrophilic fluid interfacing surface comprises a blend of the base material with a hydrophilic additive. In one or more aspects, the hydrophilic additive includes one or more of polyvinyl pyrrolidone (PVP), polyvinyl alcohol, chitosan (CS), polyamide, polyethylene oxide (PEO), polyethylene glycol (PEG), and polyetheramine. In one or more aspects, the hydrophilic additive includes Guanidinium copolymer. In one or more aspects, the hydrophilic additive is up to 10 percent of the weight of the base material and hydrophilic additive combined. In one or more aspects, the hydrophilic additive is up to 20 percent of the weight of the base material and hydrophilic additive combined.
In one or more embodiments, a hydrophilic infusion component is provided. The hydrophilic infusion component includes a housing. The housing includes a first fluid port, a second fluid port, a base material suitable for fluid infusion and a fluid pathway disposed between the first fluid port and the second fluid port. A hydrophilic fluid interfacing surface is disposed on an inner surface of the fluid pathway. The hydrophilic fluid interfacing surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the base material.
In one or more aspects, the base material includes one or more of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM)+polypropylene (PP)), thermoplastic styrenic elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and its blending with polyolefin, and thermoplastic polyester elastomer (TPEE) (polyether ester) rubber). In one or more aspects, the hydrophilic fluid interfacing surface includes a hydrophilic material coated on the base material. In one or more aspects, the hydrophilic fluid interfacing surface includes a hydrophilic material grafted on the base material. In one or more aspects, the hydrophilic fluid interfacing surface includes a blend of the base material with a hydrophilic additive. In one or more aspects, the hydrophilic additive includes one or more of polyvinyl pyrrolidone (PVP), polyvinyl alcohol, chitosan (CS), polyamide, polyethylene oxide (PEO), polyethylene glycol (PEG), polyetheramine, and Guanidinium copolymer.
In one or more embodiments, an infusion set is provided. The infusion set includes an infusion component and a hydrophilic infusion tube. The hydrophilic infusion tube includes a flexible tube configured to connect a fluid port of the infusion component to a different fluid port, the flexible tube comprising a base material suitable for fluid infusion. The hydrophilic infusion also tube includes a hydrophilic fluid interfacing surface disposed on an inner surface of the flexible tube. The hydrophilic fluid interfacing surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the base material. The flexible tube is configured to provide fluid passage without an accumulation of air bubbles on the inner surface of the flexible tube.
In one or more aspects, the infusion component is a hydrophilic infusion component that includes a housing that includes a first fluid port, a second fluid port, a base material suitable for fluid infusion and a fluid pathway disposed between the first fluid port and the second fluid port, wherein a hydrophilic fluid interfacing surface is disposed on an inner surface of the fluid pathway, and wherein the hydrophilic fluid interfacing surface provides a water wetting contact angle that is less than a water wetting contact angle provided by the base material.
Additional features and advantages of the disclosure will be set forth in the description below and, in part, will be apparent from the description or may be learned by practice of the disclosure. The objectives and other advantages of the disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure as claimed.
The accompanying drawings, which are included to provide further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.
The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided in regard to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology.
It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.
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According to aspects of the disclosure, it is desirable to provide IV sets and IV components having hydrophilic properties that resist stickiness of air bubbles to the fluid interfacing surfaces. In one specific example, a clear need exists for hazardous drug safety products to prevent hazardous drug exposure to health care workers using secondary lines to administer chemotherapy, where typical air mitigation solutions require increased priming time or additional handling of adaptors, sensors or membrane technologies. By using the subject technology having hydrophilic properties, the hazardous drug exposure is minimized, thereby reducing significant health risks (e.g., safety), increasing regulatory and guideline compliance (e.g., regulations) and reducing time required to prime a secondary line filled with hazardous drugs (e.g., workflow).
According to aspects of the disclosure, the subject technology renders hydrophilic surface properties to the materials used for fluid interfacing surfaces of infusion components and IV tubing. These hydrophilic surfaces provide superior lubricity over hydrophobic surfaces, and the hydrophilic surfaces increase the wettability of the material, resulting in that an air bubble will not stick to the surface (e.g., tube wall). Also, a lower coefficient of friction due to the hydrophilic surface may allow air to slide across the surface more quickly. Thus, these hydrophilic surface properties have a bubble terminating feature that causes air bubbles to slide away quickly while disappearing from the hydrophilic surface, preventing sticking of air bubbles to the base material (e.g., fluid interfacing surfaces) of infusion components and IV tubing, thereby improving fluid flow and providing bubble free priming. These hydrophilic material based infusion components and tubing provide improved ease of use to users and eliminates the need for additional user training. In addition, the hydrophilicity of the fluid interfacing surfaces may provide anti-fouling properties to the infusion components and IV tubing, which may provide for longer use of the infusion components/IV tubing/IV sets before needing to be replaced, as well as improve the effectiveness of the fluid delivery.
According to aspects of the disclosure, the subject technology may be used in any medication delivery system that uses plastic components. The subject technology may be utilized at any component of the medication delivery system having a high risk of air bubble formation and/or at critical components. For example, tubing is one place air typically sticks, while a drip chamber is another area where air bubbles may be created during priming and flow regulation or initial flow rate setting steps.
In some aspects of the disclosure, a hydrophilic surface may be provided by coating the desired surfaces of a tube 20 or infusion component, such as a drip chamber 40, for example. Here, hydrophilic chemicals may be coated onto the desired base material. The base material may include any suitable material, such as thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic polyolefin (TPO), soft polyvinyl chloride (PVC), silicone, thermoplastic vulcanizate (TPV) (ethylene propylene diene monomer (EPDM)+polypropylene (PP)), thermoplastic styrenic elastomer (TPS) (styrene-butadiene-styrene (SBS)/styrene-ethylene-butylene-styrene (SEBS)/styrene-isoprene-rubber (SIS)/styrene-ethylene-propylene-styrene (SEPS)) and its blending with polyolefin, thermoplastic polyester elastomer (TPEE) (polyether ester) rubber), and the like. A hydrophilic property of a surface may be provided by coating techniques and/or customized chemistry and synthesis through grafting approaches.
Variables of hydrophilic coating may be selected or controlled to achieve the desired hydrophilic properties. For example, such variables may include the type and chemistry of the coating technique, coating thickness, potential interactions with processing or coating application techniques, and geometry limiting the application process.
In some aspects of the disclosure, a hydrophilic surface may be provided by blending hydrophilic chemicals or additives with the desired base material. The base material may include any suitable material, such as a flexible non-PVC (e.g., s-TPE/TPO/TPU or PVC material blends with hydrophilic additives). For example, polyvinyl pyrrolidone (PVP), polyvinyl alcohol, chitosan (CS), polyamide, polyethylene oxide (PEO), and polyethylene glycol (PEG) may provide effective reduction of contact angles 84 when added up to 10 wt %. Commercially available hydrophilic additives such as Irgasurf HL560 for PP and Elastamine® polyetheramines for polyolefin base materials may be used. Guanidinium copolymer is another hydrophilic chemical that may be either blended or coated. Additives of hydrophilic nature may be blended up to 20 wt % within base polymers to provide different efficiencies.
Variables of hydrophilic blending may be selected or controlled to achieve the desired hydrophilic properties. For example, such variables may include the percentage of the additive(s), types of additives, base material chemistry, processing techniques and the like.
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A super hydrophobic slide 108 is shown in
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Additional approaches to create hydrophilic surface properties of fluid interfacing materials are contemplated, according to aspects of the disclosure. For example, simple coating, coating with chemically reactive hydrophilic polymers, formation of impregnated polymer networks, surface grafting of hydrophilic polymers, blending or complexing of hydrophilic polymers, impregnating polymeric materials with an additive in order to change the surface property to impart hydrophilicity, and surface hydrophilic elastomeric latex (SHEL) film formation on elastomeric, rubbery type material.
It is understood that any specific order or hierarchy of blocks in the methods of processes disclosed is an illustration of example approaches. Based upon design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks be performed. In some implementations, any of the blocks may be performed simultaneously.
The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.
A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.
The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent.
As used herein, the phrase “at least one of” preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrase “at least one of A, B, or C” may refer to: only A, only B, or only C; or any combination of A, B, and C.
A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa.
In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.
It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.
The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.
The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.
