This disclosure relates to devices and methods for obtaining samples of blood or other biological or non biological fluids and suspensions. More particularly, this disclosure relates to devices and methods for obtaining or transporting or separating or diverting samples of blood or other fluids or suspensions with reduced contamination. Even more particularly, this disclosure relates to devices and methods for obtaining a sample of blood, other fluid, or suspension in which a first portion of the sample is different in nature or composition or is contaminated, and the first, contaminated portion is diverted and sequestrated by an absorbent material, based on the nature of its components, with the remaining portion of a sample or other fluid or suspension, being relatively pure or uncontaminated, then being transported further and collected, and processed.
Analysis and processing of samples of biological fluids is an important aspect of diagnosis and evaluation of many disorders and diseases. Generally, a sample of blood or other body fluid is obtained by inserting a needle or similar device into a blood vessel, infected lesion, suspected malignancy or pathological fluid accumulation and withdrawing a sample into a container to be processed, cultured and/or analyzed by various methods.
A sample of fluid or a suspension that is pumped through a conduit has an initial first or priming portion of the sample that may be or become contaminated and is significantly different or from the rest of the sample. This first portion may have to diverted or eliminated or discarded or changed or the characteristics of its composition sensed or analyzed.
I have identified a new problem in the field, namely, that conventional devices and methods for obtaining a sample of blood or other fluid or suspension are inadequate to provide a clean sample. Rather, conventional devices and methods retain a portion of the contaminating skin and its components and with them, microorganisms, their antigens, and their nucleic acids are inadvertently obtained as well and these are usually found in the first portion(s) of the sample.
To solve this problem, I have invented devices and methods where first portion(s) of the sample are absorbed and sequestered and can no longer freely mix with and contaminate the subsequent portions of the sample that will undergo analysis or culture.
These and other aspects and embodiments are described in more detail below, with reference to the attached drawing figures.
This disclosure is made with reference to the figures, in which:
This disclosure relates generally to a biological specimen line or conduit that contains a contaminant-absorbing, linear flow deflecting body.
The following terms are used as herein indicated unless another section of this disclosure provides a different meaning.
The term “about” refers to an average numerical value ±25%.
The term “absorbent” means a material that absorbs a contaminant.
The term “absorbing body” and “absorbent body” means a device sized to fit within a conduit and having an absorbent material attached thereto.
The term “absorbing sequestering body” means a device within a conduit and having an absorbent attached thereto, so that contaminants are sequestered, and decontaminated fluid is not mixed with contaiminants so sequestered. An absorbing sequestering body may be made of stainless steel, biocompatible polymer and can be coated with an absorbent.
The term “conduit” means a tube which can have attachments at one or two ends to permit the conduit to be attached to another tube. The other tube can be an intravenous line, a drip line from an intravenous feeding bag. Attachments can be Luer type devices. A conduit may be made of stainless steel, biocompatible polymer. A conduit may have an internal coating of an absorbent material.
The term “conduit assembly” means a device comprising a conduit with either an absorbent body within the conduit, or a conduit having an absorbent material attached to the internal surface of the conduit.
The term “sequestering” means the act of removing a contaminant from the fluid, so that contaminants are sequestered, and decontaminated fluid is not mixed with contaiminants so sequestered.
In general, the devices and methods of this disclosure include straight, or a tortuous, or winded channel structures within a conduit through which the sample of blood, other fluid, or suspension first passes through a structure containing an absorbent material. A straight or tortuous (twisted) path for the sample changes the the sample's flow dynamics in a way that decreases or prevents the first portion of the sample from being propelled along with the remainder of the sample. Once the first, contaminated portion of the sample is absorbed, the contaminated portion of the sample does not mix with the uncontaminated subsequent portions of the sample. The remaining, uncontaminated portion of the sample will then advance further to be analyzed, or processed, or otherwise used.
It can be desirable for the flow path of a fluid through a conduit assembly to be longer than the straight line distance through the conduit. By providing a longer flow path, the fluid has more opportunities to interact with the absorbent material, and therefore, more contaiminants can be absorbed or sequestered. It can be appreciated that in addition to providing a long flow path, the fluid flow can be turbulent, meaning that there will be increased opportunities for contaminants to make contact with an absorbent material, and be sequestered.
The devices are useful for analysis of cell counts (i.e. in cerebro-spinal fluid or urine), various cultures, nucleic acid sequence determinations, immune stimulation, interferon release assays and many more, whose sensitivity and specificity would be influenced by the presence of material(s) from the skin or in other applications, the tubing within which the fluid or solution to be sampled was contained.
It is to be understood that any of the following aspects may be implemented singly or in any combination.
One aspect includes a conduit assembly comprising:
a hollow conduit, said conduit containing an absorbing sequestering body retained therein, said absorbing sequestering body comprising an absorbent material adhering to said absorbing sequestering body, said absorbent material to absorb, retain and sequester a contaminated portion of a biological fluid or biological suspension flowing through said conduit, thereby permitting a de-contaminated portion of said fluid or suspension to pass through said conduit and collected for analysis.
Another aspect includes a conduit assembly, said absorbing sequestering body having a spiral shape, configured to interfere with flow of the fluid so that the absorbing body absorbs, sequesters and retains a first contaminated portion of the fluid and so that the remainder of the fluid sample is decontaminated.
An additional aspect includes a conduit assembly, said absorbing sequestering body comprising radiating fins or paddles arranged in staircase spiral form filling the interior of said conduit, thereby defining a spiral shaped flow channel to divert the flow of the fluid so that the absorbing sequestering material absorbs, sequesters and retains a first contaminated portion of the sample.
A further aspect includes a conduit assembly, comprising a hollow conduit having a spiral or twisted shape and having an absorptive material adhered to the interior wall of said conduit, absorptive material to provide a surface for flow of a fluid sample through said conduit so that the absorbent material absorbs, sequesters and retains a first contaminated portion of the fluid sample so that the remainder of the fluid sample is decontaminated and can be collected for analysis.
Another aspect includes a conduit assembly, wherein the absorbing sequestering body comprises a plurality of disks, each having one or more triangular or circular holes through them to permit passage of fluid flow and in contact with said absorbent material.
A still further aspect includes a conduit assembly comprising a hollow conduit, said conduit having a spiral shaped or twisted channel therethrough, said absorbent body configured to deflect flow of the fluid sample so that the absorbing body absorbs, sequesters and retains a first contaminated portion of the fluid so that the remainder of said sample is decontaminated.
An additional aspect includes a conduit assembly, where at least some of the absorbing body contains bound pro-coagulants to facilitate the retention of the first, contaminated, sequestered portion of the fluid being blood.
A still further aspect includes a conduit assembly, wherein at least a portion of said absorbing and sequestering body contains anantibody, enzyme, chemical or isotope, whose interaction with an absorbed or sequestered material produces a detectable change in a characteristic of said absorbed sequestered material.
An additional aspect includes a conduit assembly, wherein said conduit or said absorbing body containing a sensor to detect one or more of the fluid sample's temperature, pressure, content, chemical composition, or pH.
A further aspect includes a conduit assembly, wherein said absorbent material comprises one or more of: cellulose, cellulose linten, cellulose acetate, cellulose nitrate, creped cellulose wadding, blotting paper, filter paper, cross-linked carboxymethylcellulose, comminuted wood fibers, bleached wood pulp, cellulitic wood fibers, spaghmum, diatomaceous earth, absorbent cotton, foamed plastic polymers, low-density polyether, polyethylene, collagen hydroxyapatite, chitosan glutamate, low and high molecular weight sericin and glycine, polyvinyl alcohol, vinyl acetate, vinyl acetate ethylene, superabsorbent polymer(s), sodium polyacrylate, polyacrylamide copolymer, ethylene maleic anhydride copolymer, polyvinyl alcohol copolymers, cross-linked polyethylene oxide and starch grafted copolymers of polyacrylonitrile, polysaccharides, proteins, homo polypeptides (i.e. poly(aspartic acid), poly(glutamic acid), and poly(ε-L-lysine)), pectin, xanthan gum, sodium alginate, calcium alginate, particles of an organic noncellulosic substances selected from the group consisting of blood albumin, egg albumin, starches, algin, karaya, tragacanth and guar gums, natural and synthetic gums of polysaccharide character, chemically modified starches, and hydrocolloidal compositions selected from the group consisting of polyacrylamide, alkali metal salts of hydrolyzed polyacrylamides, and free acid or alkali metal salts of polystyrene sulfonates.
A yet further aspect includes a conduit, where said absorbent body has pores with diameters ranging from about 2 μm to about 25 μm.
An additional aspect includes a method for producing a sample of decontaminated biological fluid, comprising the steps:
a) providing a conduit assembly having a hollow conduit, and optionally an absorbent body therein having an absorbent material attached thereto;
b) initiating flow of a sample of biological fluid through said conduit, a portion of said fluid sample making contact with an absorbent material, said absorbent material either adhered to said conduit or adhered to said absorbing sequestering body;
c) permitting a contaminant to adhere to said absorbent material, so that an uncontaminated portion of said fluid sample flows through the remainder of said conduit; and
d) collecting at least a portion of said uncontaminated fluid.
Further aspects include methods for producing a sample of decontaminated fluid from a biological sample, comprising the steps:
a) providing a conduit assembly of any other aspect of this disclosure;
b) initiating flow of a sample of biological fluid through said conduit, a portion of said fluid sample making contact with an absorbent material, said absorbent material either adhered to said conduit or adhered to said absorbing sequestering body;
c) permitting a contaminant to adhere to said absorbent material, so that an uncontaminated portion of said fluid sample flows through the remainder of said conduit; and
d) collecting at least a portion of said uncontaminated fluid.
Yet further aspects include absorbent material comprising one or more of: cellulose, cellulose lintern, cellulose acetate, cellulose nitrate, creped cellulose wadding, blotting paper, filter paper, cross-linked carboxymethylcellulose, comminuted wood fibers, bleached wood pulp, cellulitic wood fibers, spaghmum, diatomaceous earth, absorbent cotton, foamed plastic polymers, low-density polyether, polyethylene, collagen hydroxyapatite, chitosan glutamate, low and high molecular weight sericin and glycine, polyvinyl alcohol, vinyl acetate, vinyl acetate ethylene, superabsorbent polymer(s), sodium polyacrylate, polyacrylamide copolymer, ethylene maleic anhydride copolymer, polyvinyl alcohol copolymers, cross-linked polyethylene oxide and starch grafted copolymers of polyacrylonitrile, polysaccharides, proteins, homo polypeptides (i.e. poly(aspartic acid), poly(glutamic acid), and poly(ε-L-lysine)), pectin, xanthan gum, sodium alginate, calcium alginate, particles of an organic noncellulosic substances selected from the group consisting of blood albumin, egg albumin, starches, algin, karaya, tragacanth and guar gums, natural and synthetic gums of polysaccharide character, chemically modified starches, and hydrocolloidal compositions selected from the group consisting of polyacrylamide, alkali metal salts of hydrolyzed polyacrylamides and free acid or alkali metal salts of polystyrene sulfonates.
To use the conduit assemblies of this disclosure, a fluid or suspension is collected from a source and is introduced into one end of a conduit. Upon introduction of the sample into the conduit, a first portion of the sample makes contact with an absorbent body or absorbent material within the conduit. By slowing the flow of the sample, absorption of a first portion of the sample with its contaminants is facilitated. After making contact with the absorbent material, suspended contaminants are absorbed into or sequestered within the absorbent body, and the remainder of the sample, now being decontaminated, flows through the remainder of the conduit, and can then be collected for analysis.
The material compositions of the absorbing bodies are generally chosen based on the absorptive characteristics, their swelling or non-swelling characteristics, hydrophobic or hydrophilic surfaces, clotting initiation properties and their abilities to be manufactured into desired shapes. Some absorptive materials can have pores to increase the surface area to volume ratio, thereby promoting more efficient absorption. Absorbing material mixtures or layers thereof and the respective dimensions can be chosen depending upon the desired sample(s) to be de-contaminated, the shapes of the conduits, and the non-interference of the absorbent material with the analytes, e.g., specific proteins, lipids, electrolytes, and any organisms or DNA or RNA sequence of interest in the components present in de-contaminated samples. Such organisms of interest are those present in the bloodstream, which may cause fever and/or sepsis, for which identification is of importance to develop organism-specific responses in a patient.
Materials for absorption bodies may be single compositions or combinations, and may be in single or multiple layers. In some embodiments, absorbent materials can have pore diameters ranging from about 2 μm to about 25 μm to sequester particulates, including red and white blood cells, as well as platelets in a sample.
Exemplary absorptive materials include cellulose, cellulose lintens, creped cellulose wadding, cellulose acetate, cellulose nitrate, blotting paper, filter paper, cross-linked carboxymethylcellulose, comminuted wood fibers, bleached wood pulp, cellulitic wood fibers, spaghmum, diatomaceous earth, absorbent cotton, foamed plastic polymers, low-density polyether, polyethylene, collagen hydroxyapatite, chitosan glutamate, low and high molecular weight sericin and glycine, polyvinyl alcohol, vinyl acetate, vinyl acetate ethylene, superabsorbent polymer(s), sodium polyacrylate, polyacrylamide copolymer, ethylene maleic anhydride copolymer, polyvinyl alcohol copolymers, cross-linked polyethylene oxide and starch grafted copolymers of polyacrylonitrile, polysaccharides, proteins, homo polypeptides (i.e. poly(aspartic acid), poly(glutamic acid), and poly(ε-L-lysine)), pectin, xanthan gum, sodium alginate, calcium alginate, particles of an organic noncellulosic substances selected from the group consisting of blood albumin, egg albumin, starches, algin, karaya, tragacanth and guar gums, natural and synthetic gums of polysaccharide character, chemically modified starches, and hydrocolloidal compositions selected from the group consisting of polyacrylamide, alkali metal salts of hydrolyzed polyacrylamides and free acid or alkali metal salts of polystyrene sulfonates.
The foregoing descriptions have broad applications. For example, while examples disclosed herein disclose the absorption and sequestration of first portions of biological samples, this can also be used to clean or alter or signal the chemical composition or property of the initial portion of any fluid or solution that is for the first time pumped or transported through a conduit.
An absorbing body can also function in reverse, in embodiments that are loaded with useful chemical, enzymes or antibodies and there like that change and signal the composition and character of the fluids or suspension that are pumped through them at various speeds and directions. They can also be employed to dampen sudden changes in their composition that which would make them more useful for applications that an ordinary person who is skilled in the art would recognize.
Accordingly, the descriptions herein are meant only to be exemplary and are not intended to suggest that the scope of the disclosure, including the claims, is limited to these embodiments.
Devices and methods of this disclosure for sequestering the first, contaminated portion of a sample is useful in the medical field, including analysis of components of the sample, which is valuable for making diagnosis and/or evaluating therapies.
This United States patent application claims priority to United States Provisional Patent Application No. 62/634,819 filed 24 Feb. 2018 entitled “Devices and Methods to Reduce Contamination of Fluid Collected Through a Conduit by Absorbent Diversion,” Juan Nepomuc Walterspiel, inventor. This application is herewith incorporated fully by reference.
Number | Date | Country | |
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62634819 | Feb 2018 | US |