WO2021260559A1 - Aqueous medium-soluble powder for blood flow simulation - Google Patents

Aqueous medium-soluble powder for blood flow simulation Download PDF

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Publication number
WO2021260559A1
WO2021260559A1 PCT/IB2021/055518 IB2021055518W WO2021260559A1 WO 2021260559 A1 WO2021260559 A1 WO 2021260559A1 IB 2021055518 W IB2021055518 W IB 2021055518W WO 2021260559 A1 WO2021260559 A1 WO 2021260559A1
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Prior art keywords
weight
bmf
composition
present
powder
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PCT/IB2021/055518
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French (fr)
Inventor
Zoé Janusko-Mandin
Hadil NOËL-AL TABCHI
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Biomodex, S.A.S.
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Publication of WO2021260559A1 publication Critical patent/WO2021260559A1/en

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    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30Anatomical models
    • G09B23/303Anatomical models specially adapted to simulate circulation of bodily fluids
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/285Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas

Definitions

  • Medical error is one of the highest causes of death in the United States after heart disease and cancer. Complications during surgery often lead to an increase in cost, and a decrease in the probability of success. Training allows physicians to practice various surgical methods in simulated environments in order to better prepare for surgical complications.
  • BMF Blood Mimicking Fluid
  • a blood mimicking fluid composition includes a mixture.
  • the mixture includes polyethylene glycol (PEG), polysaccharide, and an inorganic salt.
  • PEG polyethylene glycol
  • the PEG has a molecular weight of 3000-4000 Da and is present in about 90-98% by weight
  • the polysaccharide is present in about 0.05-0.15% by weight
  • the inorganic salt is present in 1.95%— 9.85%.
  • the powder is soluble in an aqueous medium
  • a method for preparing a blood mimicking fluid includes providing a BMF powder.
  • the BMF powder includes PEG in about 90-98% by weight, polysaccharide in about 0.05-0.15% by weight, and an inorganic salt in about 1.95%— 9.85%.
  • the BMF powder is combined with an aqueous medium to form a BMF mixture.
  • the BMF mixture is agitated until the BMF powder dissolves in the aqueous medium.
  • the BMF is injected into a training apparatus and a simulated medical procedure is performed using the training apparatus and the BMF.
  • FIG. 1 is a representation of a training apparatus, according to at least one embodiment of the present disclosure
  • FIG. 2 is a flow chart of a method for preparing a blood mimicking fluid, according to at least one embodiment of the present disclosure
  • FIG. 3 is a flow chart of a method for performing a simulated medical procedure, according to at least one embodiment of the present disclosure.
  • a BMF can be created in the form on an aqueous solution formed from an aqueous medium and a powder.
  • a powder may be easier and cheaper to ship than a BMF in liquid form because it is lighter and smaller in volume.
  • a powder may also be easier to store because it has a longer shelf-life than a liquid BMF without the need for preservatives while being immediately available as it can be reconstituted quickly and easily.
  • the reconstituted BMF solution may be useful to simulate various physical and/or rheological properties of blood such as but not limited to density, viscosity, non-Newtonian mechanical response, and electrical conductivity.
  • the solution is meant to be used at the actual temperature of human blood, 37° C, while maintaining one or more physical properties of blood, providing a simulation close to reality.
  • the BMF is safe for the user of a cardiovascular or organ simulation system, or other method implementing the BMF.
  • a method for forming a BMF includes providing a kit containing elements for forming the BMF.
  • the kit may include a vial, packet, or other package of BMF powder.
  • the kit may also include a dissolution bottle.
  • the BMF may be formed by putting a specific volume of BMF powder into the dissolution bottle and adding a specific volume of an aqueous medium.
  • the BMF may be formed by putting a specific volume of an aqueous medium into the dissolution bottle and adding a specific volume of BMF powder.
  • the powder constitutes by weight about 16% of the solution and the aqueous medium constitutes by weight about 84% of the solution.
  • the powder constitutes by weight about 16.0% of the solution and the aqueous medium constitutes by weight about 84.0% of the solution. In some embodiments, the powder constitutes by weight about 16.02% of the solution and the aqueous medium constitutes about 83.98% of the solution. In some embodiments, the powder constitutes by weight about 12% of the solution, and the aqueous medium constitutes by weight about 88% of the solution. In some embodiments, the powder constitutes by weight about 12.2% of the solution, and the aqueous medium constitutes by weight about 87.8% of the solution.
  • the aqueous medium may be water. In some embodiments, the aqueous medium may be distilled water or a physiological serum.
  • the powder is soluble in an aqueous medium.
  • the BMF solution may be formed by agitating the mixture in the dissolution bottle for 30 seconds. In other embodiments, the BMF solution may be formed by agitating the mixture in the dissolution bottle for 60, 90, 120, 150, or 180 seconds. In some embodiments, the BMF solution may be formed by agitating the mixture in the dissolution bottle for less than 30 seconds or more than 180 seconds. In some embodiments, the mixture may be agitated by shaking the dissolution bottle. In other embodiments, the mixture may be agitated by stirring, mixing, blending, beating, spinning, vortexing, or any other method of mixing in order to combine the powder and aqueous medium into one homogeneous solution.
  • the BMF may be transferred from the dissolution bottle into a tank, bottle, or other container for temporary storage.
  • the BMF may be transferred from the dissolution bottle directly to a simulation system, or otherwise transferred from the dissolution bottle to be directly used in a training environment.
  • the BMF may be temporarily stored for up to 24 hours.
  • the BMF may be used for training purposes.
  • the BMF may be used to practice methods of electrolytical detachment of medical devices.
  • the BMF may also be used to simulate blood flow in 3D printed organs, simulate blood flow in vascular, cardiovascular or organ simulations, simulate the consistency of blood, train lifeguards or other safety professionals, or simulate surgical procedures.
  • the BMF powder may be any powder described in the present disclosure.
  • the BMF powder may include polyethylene glycol (PEG), a polysaccharide, and an inorganic salt.
  • PEG polyethylene glycol
  • the PEG having a molecular weight of 3000- 4000 Da, is present in about 94% by weight, the polysaccharide is present in less than 1% by weight, and the inorganic salt is present in about 6% by weight.
  • the PEG is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight.
  • the PEG is present in 93.63% by weight
  • the polysaccharide is present in 0.13% by weight
  • the inorganic salt is present in 6.24% wt.
  • the polyethylene glycol is one of PEG3000 or PEG4000
  • the polysaccharide is one of xanthum gum or dextran
  • the inorganic salt is sodium chloride (NaCl).
  • Each component of the powder may contribute to certain physical and/or rheological properties of the BMF once dissolved to form the solution.
  • one of PEG3000 or PEG4000 may impact such physical properties as viscosity and/or density
  • one of xanthum gum or dextran may cause the BMF to exhibit a non-Newtonian mechanical response
  • sodium chloride may impact the electrical conductivity.
  • other solid PEG’s having different molecular weight e.g., 3350 or 4000 Da
  • other polysaccharides that affect the non- Newtonian behavior of the BMF may be use.
  • other inorganic salt that affects the electrical conductivity may be used.
  • the BMF may be formed by mixing a dry powder and an aqueous medium, such as water.
  • the powder may be formed from a combination of the ingredients discussed herein, including the PEG, the polysaccharide, and the inorganic salt.
  • each of the ingredients discussed herein may be formed from a dry powder.
  • a dry powder may be a powder that includes a weight percentage (wt%) of water or other liquids.
  • the dry powder may include less than 5 wt%, less than 4 wt%, less than 3 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.1 wt%, or any value therebetween of water. In some embodiments, it may be critical that the dry powder is less than 1 wt% liquid to prevent clumping, reduce density, improve storage, and improve the mixing qualities.
  • each ingredient of the BMF powder may be water soluble.
  • each ingredient when added to water in the proportions discussed herein, may be completely soluble in water, such that no precipitate remains after the BMF is mixed. This may help to prevent the BMF from clogging pumps, simulated blood vessels, or other portions of a medical procedure training apparatus.
  • the dry powder may include a homogeneous mixture of the separate ingredients, including the PEG, the polysaccharide, and the inorganic salt.
  • each ingredient in the dry powder may be mixed evenly throughout the dry powder. A homogeneous mixture may allow the manufacturer to prepare large batches of the dry powder and separate the large batch into usable portions.
  • the dry powder may include zones or other regions of higher density of a particular ingredient.
  • each ingredient may be added to the aqueous medium separately.
  • each ingredient in the dry powder may be a separate particle. In some embodiments, multiple particles may be combined or clustered into larger particles.
  • the dry powder has a particle size.
  • the particle size of the dry powder may be selected to improve dissolution of the dry powder in the aqueous medium. In some embodiments, the particle size may be 5 micrometers, 10 micrometers, 25 micrometers, 50 micrometers, 75 micrometers, 100 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, 1 millimeter, 2.5 millimeters, 5 millimeters, or any value therebetween.
  • the particle size of the dry powder is less than 50 micrometers to facilitate dissolution of the dry powder in the aqueous medium or the other fluid.
  • the BMF powder of the present disclosure may be stable.
  • the BMF powder may be mixed, and the individual ingredients may not react with each other, degrade, or otherwise change their properties during storage. This may help to increase the shelf-life of the BMF powder.
  • FIG. 1 is a representation of a training apparatus 100 for medical procedure training, according to at least one embodiment of the present disclosure.
  • the training apparatus may include a housing 102.
  • a vessel port 104 may be defined by the housing.
  • the vessel port 104 may include a hole through or an indentation in the housing 102.
  • a training vessel 106 may be placed in the vessel port 104.
  • the training vessel 106 may include a simulated blood vessel network.
  • the simulated blood vessel network may include a 3-dimensional network of interconnected tubes that represent a series of blood vessels for a patient.
  • the simulated blood vessel network may be a 3D printed blood vessel network of the actual mapped network of a user.
  • the training apparatus 100 includes an input port 108.
  • the input port 108 may be connected to the training vessel 106, including the simulated blood vessel network in the training vessel.
  • fluid may be passed through the input port 108 and into the simulated blood vessel network of the training vessel 106.
  • the fluid passed through the input port may be a BMF. This may allow a medical professional to examine the blood flow through the simulated blood vessel network in the training vessel 106.
  • one or more instruments may be passed through the input port 108.
  • the instruments may perform a simulated medical procedure using the simulated blood vessel network.
  • the BMF may allow the medical professional to analyze the effects of the simulated procedure.
  • the simulated procedure may include the installation of a stent, and the BMF may allow the medical professional to analyze blood flow through the stent.
  • the BMF may have rheological properties that are similar or identical to blood.
  • the movement of blood within blood vessels is affected by the rheological properties of blood.
  • the non-Newtonian nature of blood may be affected by the rheological BMF of the present disclosure.
  • the medical professional may more closely simulate the conditions that may be present in an actual procedure. This type of training may help prepare the medical professional for live medical procedures. A more prepared physician may be more effective and/or make fewer mistakes. In this manner, using a rheological BMF of the present disclosure may help to improve the safety and success rate of medical procedures.
  • the BMF may be mixed and/or pumped through the simulated blood vessel network at the temperature of the human body.
  • the BMF may be mixed and/or pumped through the simulated blood vessel network at 37° C.
  • the BMF may have similar rheological properties as human blood at 37° C.
  • the BMF may be mixed and/or pumped through the simulated blood network at a temperature between 36° C and 40° C.
  • the BMF may have similar rheological properties as human blood at between 36° C and 40° C to account for the range of patient temperatures that may be encountered by medical professionals.
  • FIG. 2 is a representation of a method 210 for preparing a BMF, according to at least one embodiment of the present disclosure.
  • the method 210 may include providing or receiving a powder for a BMF at 212.
  • the powder may be a BMF powder, having proportions of ingredients, including the polyethylene glycol, the sugar, the synthetic polymer, the emulsifier, and the surfactant, as discussed herein.
  • the ingredients of the BMF powder may be mixed into a homogeneous powder.
  • the method 210 may further include combining the BMF powder with an aqueous medium, such as water, at 214.
  • an aqueous medium such as water
  • all of the ingredients of the BMF powder may be added to the fluid simultaneously.
  • the ingredients of the BMF powder may be added separately to each other.
  • the BMF powder and/or the fluid may be combined at a temperature of 37° C. This may allow the resulting BMF to be used and processed at a temperature that approximates the temperature of human blood.
  • the method 210 may further include agitating the combined BMF powder and aqueous medium to form a BMF mixture at 216.
  • the BMF mixture may be mechanically agitated.
  • the BMF mixture may be agitated using a spoon, rotating blade or bar, or other mechanical agitation mechanism.
  • the BMF mixture may be shaken.
  • the user may dump the BMF powder into a bottle.
  • the user may shake the bottle to agitate the BMF mixture .
  • Agitating the BMF powder with the aqueous medium may help to increase the dissolution of the BMF powder in the aqueous medium.
  • the BMF mixture may be agitated until the BMF powder has dissolved in the aqueous medium.
  • the BMF mixture may be agitated for 5 s, 10 s, 20 s, 30 s, 45 s, 60 s, 150 s, 180 s, 240 s, or more before the BMF powder is dissolved.
  • FIG. 3 is a representation of a method 320 for implementing a simulated medical procedure using a BMF, according to at least one embodiment of the present disclosure.
  • the method 320 may include preparing a BMF by mixing a BMF powder with an aqueous medium at 322.
  • the BMF powder may be formed from a mixture of ingredients, including the polyethylene glycol, the sugar, the synthetic polymer, the emulsifier, and the surfactant.
  • the BMF may be injected into a training apparatus at 324, such as the training apparatus 100 shown in FIG. 1.
  • the prepared BMF may have one or more properties that are similar to the physical properties of blood.
  • BMFs according to the present disclosure may have rheological properties that are the same as or similar to the rheological properties of human blood.
  • the BMF may be injected into the training apparatus at 37° C.
  • the training apparatus may include one or more warming portions that may be configured to raise and/or maintain the temperature of the BMF at 37° F.
  • the method 320 may further include performing a simulated medical procedure using the mixed BMF powder in the training apparatus at 326.
  • the method 320 may further include performing a physical measurement of the BMF while the BMF is in the training apparatus.
  • the physical measurement may include a conductivity sensor, a pressure sensor, a viscometer, any other measurement device, and combinations thereof.
  • the health care professional may receive training, practice, or otherwise leam how to perform the medical procedure before performing it on a live patient. This may help to reduce or prevent patient injury and improve the success rate of procedures.
  • the following physical properties will be exhibited by the BMF:
  • a composition comprising: a mixture, the mixture including polyethylene glycol (PEG), a polysaccharide, and an inorganic salt, wherein the PEG, having a molecular weight of 3000-4000 Da, is present in about 90-98% by weight, the polysaccharide is present in 0.05-0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the powder is soluble in an aqueous medium.
  • PEG polyethylene glycol
  • a polysaccharide having a molecular weight of 3000-4000 Da
  • the inorganic salt is present in 1.95-9.85% by weight
  • the powder is soluble in an aqueous medium.
  • composition of section Al wherein the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is one of xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
  • A5. The composition any of sections A1-A4 and an aqueous medium, wherein the mixture constitutes 10-20% by weight of the composition and the aqueous medium constitutes 80-90% by weight of the composition.
  • A6 The composition of any of sections A1-A5, wherein the PEG is PEG 3000, the polysaccharide is xanthum gum, and the inorganic salt is sodium chloride.
  • A7 The composition of any of sections A1-A6, wherein the mixture includes a powder.
  • A12 The composition of any of sections Al-Al l, wherein the composition has a density of 1.03 gem 3 .
  • A15 The composition of any of sections A1-A14, wherein the mixture is homogeneous.
  • a method for forming a blood mimicking fluid comprising: providing a BMF powder, the BMF power including polyethylene glycol (PEG), a polysaccharide, and an inorganic salt, wherein the PEG, having a molecular weight of 3000-4000 Da, is present in about 90-98% by weight, the polysaccharide is present in 0.05-0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the powder is soluble in an aqueous medium.; and agitating the BMF mixture until the BMF powder dissolves in the fluid.
  • PEG polyethylene glycol
  • the inorganic salt is present in 1.95-9.85% by weight
  • the powder is soluble in an aqueous medium.
  • agitating the BMF mixture includes agitating for less than 1 minute.
  • B3. The method of section B1 or B2, wherein the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
  • Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure.
  • a stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result.
  • the stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.
  • any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements.

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Abstract

A blood mimicking fluid (BMF) includes polyethylene glycol (PEG), a polysaccharide, and an inorganic salt. The BMF is prepared as a powder. The BMF is mixed in water prior to use in a simulated medical procedure. The BMF is configured to be used at 37° C. The BMF has the same or similar rheological properties as human blood.

Description

AQUEOUS MEDIUM-SOLUBLE POWDER FOR BLOOD FLOW SIMULATION
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and the benefit of United States Provisional Patent Application No. 63/042,873, filed on June 23, 2020, which are hereby incorporated by reference in its entirety.
BACKGROUND
[0002] Medical error is one of the highest causes of death in the United States after heart disease and cancer. Complications during surgery often lead to an increase in cost, and a decrease in the probability of success. Training allows physicians to practice various surgical methods in simulated environments in order to better prepare for surgical complications.
[0003] To reproduce this physiological environment, cardiovascular and organ simulation systems implement a liquid, such as a Blood Mimicking Fluid (BMF) that circulates throughout the system to simulate blood flow. Depending on the application, various BMF’s are used which exhibit one or more properties of blood for the given training simulation. BMF’s are generally produced in liquid form, which takes several hours to manufacture, and the solutions are generally meant to be used at room temperature.
BRIEF SUMMARY
[0004] In some embodiments, a blood mimicking fluid composition includes a mixture. The mixture includes polyethylene glycol (PEG), polysaccharide, and an inorganic salt. In some embodiments, the PEG has a molecular weight of 3000-4000 Da and is present in about 90-98% by weight, the polysaccharide is present in about 0.05-0.15% by weight, and the inorganic salt is present in 1.95%— 9.85%. In some embodiments, and the powder is soluble in an aqueous medium
[0005] In other embodiments, a method for preparing a blood mimicking fluid includes providing a BMF powder. The BMF powder includes PEG in about 90-98% by weight, polysaccharide in about 0.05-0.15% by weight, and an inorganic salt in about 1.95%— 9.85%. The BMF powder is combined with an aqueous medium to form a BMF mixture. The BMF mixture is agitated until the BMF powder dissolves in the aqueous medium. In some embodiments, the BMF is injected into a training apparatus and a simulated medical procedure is performed using the training apparatus and the BMF.
[0006] This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.
[0007] Additional features and advantages of embodiments of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such embodiments as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS [0008] In order to describe the manner in which the above-recited and other features of the disclosure can be obtained, a more particular description will be rendered by reference to specific implementations thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. While some of the drawings may be schematic or exaggerated representations of concepts, at least some of the drawings may be drawn to scale. Understanding that the drawings depict some example implementations, the implementations will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
[0009] FIG. 1 is a representation of a training apparatus, according to at least one embodiment of the present disclosure;
[0010] FIG. 2 is a flow chart of a method for preparing a blood mimicking fluid, according to at least one embodiment of the present disclosure; and [0011] FIG. 3 is a flow chart of a method for performing a simulated medical procedure, according to at least one embodiment of the present disclosure.
DETAILED DESCRIPTION
[0012] In some embodiments, a BMF can be created in the form on an aqueous solution formed from an aqueous medium and a powder. A powder may be easier and cheaper to ship than a BMF in liquid form because it is lighter and smaller in volume. A powder may also be easier to store because it has a longer shelf-life than a liquid BMF without the need for preservatives while being immediately available as it can be reconstituted quickly and easily.
[0013] In some embodiments, the reconstituted BMF solution may be useful to simulate various physical and/or rheological properties of blood such as but not limited to density, viscosity, non-Newtonian mechanical response, and electrical conductivity. In some embodiments, the solution is meant to be used at the actual temperature of human blood, 37° C, while maintaining one or more physical properties of blood, providing a simulation close to reality. In some embodiments, the BMF is safe for the user of a cardiovascular or organ simulation system, or other method implementing the BMF.
[0014] In some embodiments, a method for forming a BMF includes providing a kit containing elements for forming the BMF. The kit may include a vial, packet, or other package of BMF powder. The kit may also include a dissolution bottle. In some embodiments, the BMF may be formed by putting a specific volume of BMF powder into the dissolution bottle and adding a specific volume of an aqueous medium. In other embodiments, the BMF may be formed by putting a specific volume of an aqueous medium into the dissolution bottle and adding a specific volume of BMF powder. In some embodiments the powder constitutes by weight about 16% of the solution and the aqueous medium constitutes by weight about 84% of the solution. In some embodiments, the powder constitutes by weight about 16.0% of the solution and the aqueous medium constitutes by weight about 84.0% of the solution. In some embodiments, the powder constitutes by weight about 16.02% of the solution and the aqueous medium constitutes about 83.98% of the solution. In some embodiments, the powder constitutes by weight about 12% of the solution, and the aqueous medium constitutes by weight about 88% of the solution. In some embodiments, the powder constitutes by weight about 12.2% of the solution, and the aqueous medium constitutes by weight about 87.8% of the solution. In some embodiments, the aqueous medium may be water. In some embodiments, the aqueous medium may be distilled water or a physiological serum.
[0015] In some embodiments, the powder is soluble in an aqueous medium. In some embodiments, the BMF solution may be formed by agitating the mixture in the dissolution bottle for 30 seconds. In other embodiments, the BMF solution may be formed by agitating the mixture in the dissolution bottle for 60, 90, 120, 150, or 180 seconds. In some embodiments, the BMF solution may be formed by agitating the mixture in the dissolution bottle for less than 30 seconds or more than 180 seconds. In some embodiments, the mixture may be agitated by shaking the dissolution bottle. In other embodiments, the mixture may be agitated by stirring, mixing, blending, beating, spinning, vortexing, or any other method of mixing in order to combine the powder and aqueous medium into one homogeneous solution. [0016] In some embodiments, the BMF may be transferred from the dissolution bottle into a tank, bottle, or other container for temporary storage. In other embodiments, the BMF may be transferred from the dissolution bottle directly to a simulation system, or otherwise transferred from the dissolution bottle to be directly used in a training environment. In some embodiments the BMF may be temporarily stored for up to 24 hours. In some embodiments, the BMF may be used for training purposes. For example, the BMF may be used to practice methods of electrolytical detachment of medical devices. The BMF may also be used to simulate blood flow in 3D printed organs, simulate blood flow in vascular, cardiovascular or organ simulations, simulate the consistency of blood, train lifeguards or other safety professionals, or simulate surgical procedures.
[0017] The BMF powder may be any powder described in the present disclosure. For example, the BMF powder may include polyethylene glycol (PEG), a polysaccharide, and an inorganic salt. In some embodiments, the PEG, having a molecular weight of 3000- 4000 Da, is present in about 94% by weight, the polysaccharide is present in less than 1% by weight, and the inorganic salt is present in about 6% by weight. In some embodiments, the PEG is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight. In some embodiments, the PEG is present in 93.63% by weight, the polysaccharide is present in 0.13% by weight, and the inorganic salt is present in 6.24% wt. In some embodiments, the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is one of xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
[0018] Each component of the powder may contribute to certain physical and/or rheological properties of the BMF once dissolved to form the solution. For example, one of PEG3000 or PEG4000 may impact such physical properties as viscosity and/or density, one of xanthum gum or dextran may cause the BMF to exhibit a non-Newtonian mechanical response, and sodium chloride may impact the electrical conductivity. In other embodiments, other solid PEG’s having different molecular weight (e.g., 3350 or 4000 Da) may be used. In other embodiments, other polysaccharides that affect the non- Newtonian behavior of the BMF may be use. In other embodiments, other inorganic salt that affects the electrical conductivity may be used.
[0019] As discussed herein, the BMF may be formed by mixing a dry powder and an aqueous medium, such as water. In some embodiments, the powder may be formed from a combination of the ingredients discussed herein, including the PEG, the polysaccharide, and the inorganic salt. In some embodiments, each of the ingredients discussed herein may be formed from a dry powder. In some embodiments, a dry powder may be a powder that includes a weight percentage (wt%) of water or other liquids. In some embodiments, the dry powder may include less than 5 wt%, less than 4 wt%, less than 3 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.1 wt%, or any value therebetween of water. In some embodiments, it may be critical that the dry powder is less than 1 wt% liquid to prevent clumping, reduce density, improve storage, and improve the mixing qualities.
[0020] In accordance with embodiments of the present disclosure, each ingredient of the BMF powder may be water soluble. For example, each ingredient, when added to water in the proportions discussed herein, may be completely soluble in water, such that no precipitate remains after the BMF is mixed. This may help to prevent the BMF from clogging pumps, simulated blood vessels, or other portions of a medical procedure training apparatus. [0021] In some embodiments, the dry powder may include a homogeneous mixture of the separate ingredients, including the PEG, the polysaccharide, and the inorganic salt. For example, each ingredient in the dry powder may be mixed evenly throughout the dry powder. A homogeneous mixture may allow the manufacturer to prepare large batches of the dry powder and separate the large batch into usable portions. This may help to ensure that each batch has the appropriate ratio of each ingredient, thereby ensuring that the final mixed BMF has the desired properties. In some embodiments, the dry powder may include zones or other regions of higher density of a particular ingredient. In some embodiments, each ingredient may be added to the aqueous medium separately.
[0022] In some embodiments, each ingredient in the dry powder may be a separate particle. In some embodiments, multiple particles may be combined or clustered into larger particles. The dry powder has a particle size. The particle size of the dry powder may be selected to improve dissolution of the dry powder in the aqueous medium. In some embodiments, the particle size may be 5 micrometers, 10 micrometers, 25 micrometers, 50 micrometers, 75 micrometers, 100 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, 1 millimeter, 2.5 millimeters, 5 millimeters, or any value therebetween. In some embodiments, it may be critical that the particle size of the dry powder is less than 50 micrometers to facilitate dissolution of the dry powder in the aqueous medium or the other fluid. [0023] The BMF powder of the present disclosure may be stable. For example, the BMF powder may be mixed, and the individual ingredients may not react with each other, degrade, or otherwise change their properties during storage. This may help to increase the shelf-life of the BMF powder.
[0024] Referring now to the figures, FIG. 1 is a representation of a training apparatus 100 for medical procedure training, according to at least one embodiment of the present disclosure. The training apparatus may include a housing 102. A vessel port 104 may be defined by the housing. The vessel port 104 may include a hole through or an indentation in the housing 102. A training vessel 106 may be placed in the vessel port 104. The training vessel 106 may include a simulated blood vessel network. The simulated blood vessel network may include a 3-dimensional network of interconnected tubes that represent a series of blood vessels for a patient. In some embodiments, the simulated blood vessel network may be a 3D printed blood vessel network of the actual mapped network of a user.
[0025] The training apparatus 100 includes an input port 108. The input port 108 may be connected to the training vessel 106, including the simulated blood vessel network in the training vessel. In some embodiments, fluid may be passed through the input port 108 and into the simulated blood vessel network of the training vessel 106. In some embodiments, the fluid passed through the input port may be a BMF. This may allow a medical professional to examine the blood flow through the simulated blood vessel network in the training vessel 106.
[0026] In some embodiments, one or more instruments may be passed through the input port 108. The instruments may perform a simulated medical procedure using the simulated blood vessel network. In some embodiments, the BMF may allow the medical professional to analyze the effects of the simulated procedure. For example, the simulated procedure may include the installation of a stent, and the BMF may allow the medical professional to analyze blood flow through the stent.
[0027] In accordance with embodiments of the present disclosure, the BMF may have rheological properties that are similar or identical to blood. The movement of blood within blood vessels is affected by the rheological properties of blood. In particular, the non-Newtonian nature of blood. By using an rheological BMF of the present disclosure, the medical professional may more closely simulate the conditions that may be present in an actual procedure. This type of training may help prepare the medical professional for live medical procedures. A more prepared physician may be more effective and/or make fewer mistakes. In this manner, using a rheological BMF of the present disclosure may help to improve the safety and success rate of medical procedures.
[0028] In some embodiments, to more closely mimic the conditions of a live medical procedure, the BMF may be mixed and/or pumped through the simulated blood vessel network at the temperature of the human body. For example, the BMF may be mixed and/or pumped through the simulated blood vessel network at 37° C. In some embodiments, the BMF may have similar rheological properties as human blood at 37° C. In some embodiments, the BMF may be mixed and/or pumped through the simulated blood network at a temperature between 36° C and 40° C. In some embodiments, the BMF may have similar rheological properties as human blood at between 36° C and 40° C to account for the range of patient temperatures that may be encountered by medical professionals.
[0029] FIG. 2 is a representation of a method 210 for preparing a BMF, according to at least one embodiment of the present disclosure. The method 210 may include providing or receiving a powder for a BMF at 212. The powder may be a BMF powder, having proportions of ingredients, including the polyethylene glycol, the sugar, the synthetic polymer, the emulsifier, and the surfactant, as discussed herein. The ingredients of the BMF powder may be mixed into a homogeneous powder.
[0030] The method 210 may further include combining the BMF powder with an aqueous medium, such as water, at 214. In some embodiments, all of the ingredients of the BMF powder may be added to the fluid simultaneously. In some embodiments, the ingredients of the BMF powder may be added separately to each other. In some embodiments, the BMF powder and/or the fluid may be combined at a temperature of 37° C. This may allow the resulting BMF to be used and processed at a temperature that approximates the temperature of human blood. [0031] The method 210 may further include agitating the combined BMF powder and aqueous medium to form a BMF mixture at 216. In some embodiments, the BMF mixture may be mechanically agitated. For example, the BMF mixture may be agitated using a spoon, rotating blade or bar, or other mechanical agitation mechanism. In some embodiments, the BMF mixture may be shaken. For example, the user may dump the BMF powder into a bottle. The user may shake the bottle to agitate the BMF mixture . Agitating the BMF powder with the aqueous medium may help to increase the dissolution of the BMF powder in the aqueous medium. In some embodiments, the BMF mixture may be agitated until the BMF powder has dissolved in the aqueous medium. In some embodiments, the BMF mixture may be agitated for 5 s, 10 s, 20 s, 30 s, 45 s, 60 s, 150 s, 180 s, 240 s, or more before the BMF powder is dissolved. In some embodiments, it may be critical that the BMF powder dissolves after agitating for less than 30 s (e.g., between 5 s and 30 s, between 10 s and 30 s, between 20 s and 30 s, and so forth) to allow a medical professional to quickly and efficiently begin a simulated medical procedure with minimal setup delay.
[0032] FIG. 3 is a representation of a method 320 for implementing a simulated medical procedure using a BMF, according to at least one embodiment of the present disclosure. The method 320 may include preparing a BMF by mixing a BMF powder with an aqueous medium at 322. As discussed herein, the BMF powder may be formed from a mixture of ingredients, including the polyethylene glycol, the sugar, the synthetic polymer, the emulsifier, and the surfactant.
[0033] In some embodiments, the BMF may be injected into a training apparatus at 324, such as the training apparatus 100 shown in FIG. 1. The prepared BMF may have one or more properties that are similar to the physical properties of blood. For example, BMFs according to the present disclosure may have rheological properties that are the same as or similar to the rheological properties of human blood. In some embodiments, the BMF may be injected into the training apparatus at 37° C. In some embodiments, the training apparatus may include one or more warming portions that may be configured to raise and/or maintain the temperature of the BMF at 37° F. [0034] The method 320 may further include performing a simulated medical procedure using the mixed BMF powder in the training apparatus at 326. In some embodiments, the method 320 may further include performing a physical measurement of the BMF while the BMF is in the training apparatus. In some embodiments, the physical measurement may include a conductivity sensor, a pressure sensor, a viscometer, any other measurement device, and combinations thereof. In this manner, the health care professional may receive training, practice, or otherwise leam how to perform the medical procedure before performing it on a live patient. This may help to reduce or prevent patient injury and improve the success rate of procedures.
[0035] In some embodiments, the following physical properties will be exhibited by the BMF:
Figure imgf000010_0001
[0036] Following are sections according to the present disclosure:
A1. A composition comprising: a mixture, the mixture including polyethylene glycol (PEG), a polysaccharide, and an inorganic salt, wherein the PEG, having a molecular weight of 3000-4000 Da, is present in about 90-98% by weight, the polysaccharide is present in 0.05-0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the powder is soluble in an aqueous medium.
A2. The composition of section Al, wherein the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is one of xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
A3. The composition of section Al or A2, wherein the polyethylene glycol is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight.
A4. The composition of any of sections A1-A3, wherein the polyethylene glycol is present in 93.63% by weight, the polysaccharide is present in 0.13% by weight, and the inorganic salt is present in 6.24% by weight. A5. The composition any of sections A1-A4 and an aqueous medium, wherein the mixture constitutes 10-20% by weight of the composition and the aqueous medium constitutes 80-90% by weight of the composition.
A6. The composition of any of sections A1-A5, wherein the PEG is PEG 3000, the polysaccharide is xanthum gum, and the inorganic salt is sodium chloride. A7. The composition of any of sections A1-A6, wherein the mixture includes a powder.
A8. The composition of any of sections A1-A7, further comprising a fluid, wherein the fluid constitutes about 88% by weight of the composition and the mixture constitutes about 12% by weight of the composition.
A9. The composition of any of sections A1-A8, further comprising a fluid, wherein the fluid constitutes about 84% by weight of the composition and the mixture constitutes about 16% by weight of the composition.
A10. The composition of any of sections A1-A9, further comprising a fluid, wherein the powder constitutes by weight about 16.0% of the solution and the fluid constitutes by weight about 84.0% of the solution.
Al l. The composition of any of sections A1-A10, further comprising a fluid, wherein the powder constitutes by weight about 16.02% of the solution and the fluid constitutes by weight about 83.98% of the solution. A12. The composition of any of sections Al-Al l, wherein the composition has a density of 1.03 gem 3.
A13. The composition of any of sections A1-A12, wherein the composition has a viscosity as a function of shear rate of mo=51.6.103 Pa.s, and m¥=4.4.103 Pa.s.
A14. The composition of an of sections A1-A13, wherein the composition has an electrical conductivity of2.575 Sm 1.
A15. The composition of any of sections A1-A14, wherein the mixture is homogeneous.
B 1. A method for forming a blood mimicking fluid, comprising: providing a BMF powder, the BMF power including polyethylene glycol (PEG), a polysaccharide, and an inorganic salt, wherein the PEG, having a molecular weight of 3000-4000 Da, is present in about 90-98% by weight, the polysaccharide is present in 0.05-0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the powder is soluble in an aqueous medium.; and agitating the BMF mixture until the BMF powder dissolves in the fluid.
B2. The method of section Bl, wherein agitating the BMF mixture includes agitating for less than 1 minute. B3. The method of section B1 or B2, wherein the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
B4. The composition of any of sections B1-B3, wherein the polyethylene glycol is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight.
B5. The composition of any of sections B1-B4, wherein the polyethylene glycol is present in 93.63% by weight, the polysaccharide is present in 0.13% by weight, and the inorganic salt is present in 6.24% by weight. B6. The method of any of sections B 1-B5, wherein the aqueous medium is water.
B7. The method of any of sections B1-B6, wherein the water is distilled water.
B8. The method of any of sections B1-B7, further comprising performing a vascular simulation using the blood mimicking fluid.
B9. The method of section B8, wherein performing the vascular simulation includes performing the vascular simulation at 37° C.
[0037] One or more specific embodiments of the present disclosure are described herein. These described embodiments are examples of the presently disclosed techniques. Additionally, in an effort to provide a concise description of these embodiments, not all features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
[0038] The articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements in the preceding descriptions. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. For example, any element described in relation to an embodiment herein may be combinable with any element of any other embodiment described herein. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure. A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.
[0039] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.
[0040] The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements.
[0041] The present disclosure may be embodied in other specific forms without departing from its spirit or characteristics. The described embodiments are to be considered as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. Changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

What is claimed is:
1. A composition comprising: a mixture, the mixture including polyethylene glycol (PEG), a polysaccharide, and an inorganic salt, wherein the PEG is present in about 90-98% by weight, the polysaccharide is present in 0.05- 0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the mixture is soluble in an aqueous medium.
2. The composition of claim 1, wherein the polyethylene glycol is one of
PEG3000 or PEG4000, the polysaccharide is one of xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
3. The composition of claim 1, wherein the polyethylene glycol is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight.
4. The composition of claim 1, wherein the polyethylene glycol is present in 93.63% by weight, the polysaccharide is present in 0.13% by weight, and the inorganic salt is present in 6.24% by weight.
5. The composition of claim 1, wherein the PEG is PEG 3000, the polysaccharide is xanthum gum, and the inorganic salt is sodium chloride.
6. The composition of claim 1, wherein the mixture includes a powder.
7. The composition of claim 1, further comprising a fluid, wherein the fluid constitutes about 88% by weight of the composition and the mixture constitutes about 12% by weight of the composition.
8. The composition of claim 1, further comprising a fluid, wherein the fluid constitutes about 84% by weight of the composition and the mixture constitutes about 16% by weight of the composition.
9. The composition of claim 1, further comprising a fluid, wherein the mixture constitutes by weight about 16.0% of the composition and the fluid constitutes by weight about 84.0% of the composition.
10. The composition of claim 1, further comprising a fluid, wherein the mixture constitutes by weight about 16.02% of the composition and the fluid constitutes by weight about 83.98% of the composition.
11. The composition of claim 1, wherein the composition has a density of 1.03 gem 3.
12. The composition of claim 1, wherein the composition has a viscosity as a function of shear rate of mo=51.6.103 Pa.s, and m¥=4.4.103 Pa.s.
13. The composition of claim 1, wherein the composition has an electrical conductivity of 2.575 Sm 1.
14. A method for forming a blood mimicking fluid, comprising: providing a BMF powder, the BMF powder including polyethylene glycol
(PEG), a polysaccharide, and an inorganic salt, wherein the PEG, having a molecular weight of 3000-4000 Da, is present in about 90-98% by weight, the polysaccharide is present in 0.05-0.15% by weight, the inorganic salt is present in 1.95-9.85% by weight, and the powder is soluble in an aqueous medium; combining the BMF powder with water to form a BMF mixture; and agitating the BMF mixture until the BMF powder dissolves in the water.
15. The method of claim 14, wherein agitating the BMF mixture includes agitating for less than 1 minute.
16. The method of claim 14, wherein the polyethylene glycol is one of PEG3000 or PEG4000, the polysaccharide is xanthum gum or dextran, and the inorganic salt is sodium chloride (NaCl).
17. The method of claim 14, wherein the polyethylene glycol is present in about 93.6% by weight, the polysaccharide is present in about 0.1% by weight, and the inorganic salt is present in about 16.2% by weight.
18. The method of claim 14, further comprising performing a vascular simulation using the blood mimicking fluid.
19. A method for implementing a simulated medical procedure, comprising: preparing a blood mimicking fluid (BMF) by mixing a BMF powder with water; injecting the BMF into a training apparatus; and performing the simulated medical procedure using the BMF in the training apparatus at 37° C.
20. The method of claim 19, further comprising performing a physical measurement while performing the simulated medical procedure.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002014105A (en) * 2000-06-28 2002-01-18 Amedix:Kk Mimic blood
WO2017108765A1 (en) * 2015-12-21 2017-06-29 Cilag Gmbh International Electrochemical blood mimicking fluid
WO2017155678A1 (en) * 2016-03-10 2017-09-14 Kindheart, Inc Fake blood for use in simulated surgical procedures

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002014105A (en) * 2000-06-28 2002-01-18 Amedix:Kk Mimic blood
WO2017108765A1 (en) * 2015-12-21 2017-06-29 Cilag Gmbh International Electrochemical blood mimicking fluid
WO2017155678A1 (en) * 2016-03-10 2017-09-14 Kindheart, Inc Fake blood for use in simulated surgical procedures

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