Infusion of dissolved oxygen into intravenous fluids to provide short term emergency oxygenation of venous blood for injured patients or trauma patients

Abstract

The present invention relates to a method by which intravenous fluids, blood or artificial blood containing high levels of mechanically infused dissolved oxygen can be used to maintain appropriate oxygen levels in venous blood to provide short term oxygenation support to a compromised patient or trauma patient. In one aspect, a system and method for oxygenating a biological fluid for a compromised subject or trauma subject in need of oxygenation support to maintain the subject at an appropriate oxygen level is provided, the method comprising: supplying oxygen from an oxygen source; and dissolving an amount of the supplied oxygen into the biological fluid to obtain an oxygen enriched biological fluid.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 006,339, filed April 7, 2020, entitled “Infusing Dissolved Oxygen into IV Fluids to Provide Short Term Emergence of Venous Blood for Compromised or Trauma Patients,” which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a system and method for providing short-term oxygenation support to an injured or traumatized patient by infusing oxygen into an intravenous fluid, blood, or artificial blood. In some aspects, the method produces an intravenous fluid, blood, or artificial blood containing a high level of mechanically infused dissolved oxygen to maintain an appropriate oxygen level in the venous blood upon delivery to the injured or traumatized patient. Background Technology

[0004] Long-standing medical issues involve oxygenating the venous blood of injured or traumatized patients. Lung function may be impaired due to diseases that damage lung function, such as pneumonia or viral infections or chronic obstructive pulmonary disease, or due to induced trauma such as through a gunshot wound or car accident, or due to surgery such as during a lung transplant.

[0005] Currently, the methods for providing oxygen to patients include the following:

[0006] • Masks or nasal cannulas with a variable percentage of pure oxygen (80% to 100%)

[0007] • Intubation and connection to a mechanical ventilator / ventilator

[0008] Extracorporeal membrane oxygenation (ECMO) involves taking blood from the patient and passing it through a membrane that allows oxygen to be transferred to the hemoglobin in the blood, and then shunting the oxygenated blood back to the patient.

[0009] Regarding these methods, masks are only effective when the lungs are not severely damaged and there is still sufficient gas exchange in the lungs. Therefore, masks are insufficient for situations involving chest trauma, high lung fluid content, or diaphragmatic / nerve irritation.

[0010] With respect to intubation, it is a high-risk procedure that itself causes lung trauma. Due to this trauma, there is a serious risk of patient death or inability to remove from these machines.

[0011] Finally, it should be noted that ECMO machines are extremely expensive, and are non-portable devices used in a sterile environment such as an operating room, and involve significant time delays due to the implementation process. At the same time, ECMO machines have the potential to temporarily but sufficiently replace lung function by ensuring that proper levels of oxygen are maintained in the blood.

[0012] Accordingly, there is a need for improved systems for blood oxygenation of compromised patients and / or trauma patients, and improved methods for infusing oxygen into intravenous fluids, blood, or artificial blood to provide short-term oxygenation support to compromised patients or trauma patients. SUMMARY

[0013] The present disclosure relates to a system and method of infusing oxygen into intravenous fluids, blood, or artificial blood to provide short-term oxygenation support to compromised patients or trauma patients.

[0014] In some aspects, the method produces intravenous fluids, blood, or artificial blood containing high levels of mechanically infused dissolved oxygen to maintain proper oxygen levels in venous blood when delivered to a compromised patient or trauma patient.

[0015] In one embodiment, the present disclosure relates to a method for oxygenating a biological fluid for a compromised subject or trauma subject in need of oxygenation support to maintain the subject proper oxygen levels, the method comprising:

[0016] supplying oxygen gas from an oxygen source; and

[0017] dissolving an amount of the supplied oxygen into the biological fluid to obtain an oxygen enriched biological fluid.

[0018] In one aspect, the method further comprises the step of removing an amount of a first gas, the amount of the first gas substantially equal to the amount of the supplied oxygen dissolved into the biological fluid.

[0019] In one aspect, the steps of dissolving an amount of the supplied oxygen and removing an amount of the first gas are performed simultaneously to avoid any increase in total gas pressure (TGP) such that when the oxygen enriched biological fluid is introduced into the subject, the formation of gas emboli in the blood stream of the subject is at least reduced or prevented.

[0020] In one aspect, the first gas is nitrogen.

[0021] In one aspect, the method further comprises the step of directing the oxygen enriched biological fluid into a compatible reservoir or the step of delivering the oxygen enriched biological fluid directly into the circulation of the subject.

[0022] In one aspect, the compatible reservoir is an IV bag or bottle.

[0023] In one aspect, the delivering step comprises directly injecting the oxygen- enriched biological fluid into the venous circulation of the subject.

[0024] In one aspect, the oxygen-enriched biological fluid has a high level of dissolved oxygen.

[0025] In one aspect, the oxygen-enriched biological fluid has an oxygen saturation of greater than about 100%.

[0026] In one aspect, the oxygen-enriched biological fluid has an oxygen saturation of at least about 400%.

[0027] In one aspect, the biological fluid is sterile water, intravenous (IV) fluid, blood, or artificial blood.

[0028] In one aspect, the artificial blood is a hemoglobin-based oxygen carrier (HBOC) or perfluorocarbon (PFC).

[0029] In a further aspect, the HBOC is oxyglobin.

[0030] In one aspect, the subject is a human or a non-human animal.

[0031] In one embodiment, the disclosure relates to an oxygen-enriched biological fluid produced according to a method comprising:

[0032] supplying oxygen gas from an oxygen source; and

[0033] dissolving an amount of the supplied oxygen into a biological fluid to obtain an oxygen-enriched biological fluid.

[0034] In one embodiment, the disclosure relates to the use of an oxygen-enriched biological fluid to maintain a subject at an appropriate oxygen level in an impaired subject or a trauma subject in need of oxygenation support.

[0035] In one embodiment, the disclosure relates to a method of oxygenating blood of an impaired patient and / or a trauma patient, comprising administering an oxygen-enriched biological fluid to an impaired subject or a trauma subject in need of oxygenation support to maintain the subject at an appropriate oxygen level.

[0036] In one embodiment, the disclosure relates to a system for administering an oxygen-enriched biological fluid to an impaired subject or a trauma subject in need of oxygenation support to maintain the subject at an appropriate oxygen level, the system comprising:

[0037] an oxygen sensor probe configured to obtain an arterial blood oxygen saturation of the subject and output one or more signals dependent on the obtained arterial blood oxygen saturation level;

[0038] a processor;

[0039] at least one memory device comprising instructions incorporated thereon, wherein the instructions, when executed by the processor, cause the processor to identify one or more signals indicative of an arterial blood oxygen saturation level below a threshold range of appropriate oxygen saturation levels;

[0040] a source of oxygen-enriched biological fluid; and

[0041] a regulator controlled by the processor and configured to deliver an amount of the oxygen-enriched biological fluid to the subject when the processor identifies one or more signals indicative of an arterial blood oxygen saturation level below a threshold range of appropriate oxygen saturation levels.

[0042] In one embodiment, the present disclosure relates to a method of administering an oxygen- enriched biological fluid to an impaired subject or a trauma subject in need of oxygenation support to maintain the subject at an appropriate oxygen level, the method comprising:

[0043] detecting an arterial blood oxygen saturation level of the subject using an oxygen sensor probe; and

[0044] controlling a regulator to increase a rate of delivery of the oxygen-enriched biological fluid if the detected level is below a threshold range of appropriate oxygen levels.

[0045] In one aspect, the regulator comprises an IV drip. BRIEF DESCRIPTION OF DRAWINGS

[0046] Reference will now be made to the drawings in which the example embodiments of the application are shown by way of example, and wherein:

[0047] Figure 1 a schematic diagram of a sterile water oxygenation process is shown;

[0048] Figure 2 an alternative schematic diagram of a sterile water oxygenation process featuring recirculation is shown;

[0049] Figure 3 a schematic diagram of an injection process of intravenous fluid after oxygenation is shown;

[0050] Figure 4 a schematic diagram of a controlled injection process of intravenous fluid after oxygenation is shown;

[0051] Figure 5 a schematic diagram of a process of infusing oxygen into blood via flow-through processing is shown;

[0052] Figure 6 a schematic diagram of a process of infusing oxygen into blood via batch processing is shown; and

[0053] Figure 7 A schematic of the process of oxygen infusion into blood by utilizing recirculation is shown. DETAILED DESCRIPTION

[0054] Reference Figures 1 to 4 A first general embodiment is provided which involves a system and method by which intravenous fluids containing high levels of mechanically infused dissolved oxygen can be used to maintain appropriate oxygen levels in venous blood, thereby providing short term oxygenation support to compromised or trauma patients.

[0055] Pre-packaged commercially available intravenous (IV) fluids are typically composed of:

[0056] • Sterile water

[0057] • Salts, sugars or colloids

[0058] • May contain alkalizing agents to control respiratory acidosis

[0059] • May be combined with additional drug infusions.

[0060] The types of IV fluids or infusions commonly administered to patients intravenously include the following:

[0061] • Lactated ringer’s solutions with or without salt or sugar

[0062] • Isotonic solutions

[0063] o 0.9% NaCl, lactate, 5% dextrose

[0064] • Hypotonic solutions

[0065] o 0.45% NaCl, 0.5% NaCl, 0.33% NaCl

[0066] • Hypertonic solutions

[0067] o 5% dextrose, 10% dextrose, 3% NaCl, 25% albumin, TPN solutions

[0068] • Colloidal solutions

[0069] o Plasma gel, gelofusine, dextron, hetastarch, human plasma protein powder.

[0070] While there are a variety of compositions for IV fluid bags, they are all assembled in a sterile environment from a sterile water pool.

[0071] In one embodiment, the present invention includes a two-stage method:

[0072] AsFigure 1 As shown, the sterile water supply device 10 is in contact with the oxygenation system 12, which includes an oxygen source 13. In the packaging, such as... Figure 3 Before using a commercially available IV bag / bottle 16 with any known IV drip regulator 18, a high level of dissolved oxygen is infused into the sterile water supply device 10 to produce a supply device 14 rich in sterile water.

[0073] like Figure 3 As shown, IV infusion of 18 then delivers the required dissolved oxygen to the hemoglobin in the venous system of subject 2. In some respects, the hemoglobin can be hemoglobin found in natural or artificial blood.

[0074] like Figure 4 As shown, the method can be further enhanced by using an automatic feedback control system 100 including a processor 110 and at least one memory device 112, wherein measurements from one or more arterial oxygen probes 22 and the resulting signals cause the system 100 to actuate the regulator 20 of the IV dripper 18 to mechanically control and regulate the drip rate of the oxygen-enriched biofluid source 16, and thus control and regulate the patient's arterial dissolved oxygen level.

[0075] Specifically, the oxygen sensor probe 22 is configured to acquire the arterial oxygen saturation of the patient / subject 2 and output one or more signals depending on the acquired arterial oxygen saturation level. At least one memory device 110 includes instructions stored thereon, wherein the instructions, when executed by the processor 110, cause the processor 110 to recognize one or more signals indicating that the arterial oxygen saturation level is below a threshold range for an appropriate oxygen saturation level. An oxygen-enriched biofluid source 16 is provided to the system 100, and a regulator 20 controlled by the processor 110 is configured to deliver a quantity of oxygen-enriched biofluid 16 to the patient / subject 2 when the processor 100 recognizes one or more signals indicating that the arterial oxygen saturation level is below a threshold range for an appropriate oxygen saturation level.

[0076] In some respects, the threshold range for an appropriate oxygen saturation level is less than about 100%, less than about 95%, less than about 90%, or less than about 85%.

[0077] One advantage of this invention is that the resulting IV bag / bottle 16 for oxygen delivery is portable, which enables its widespread use in this field. These bags 16 can be used in hospital wards, hospital emergency rooms and operating rooms, ambulances, during epidemics and infectious diseases, armed conflicts, and emergencies declared by the World Health Organization and countries.

[0078] These are some of the techniques used to inject high levels of dissolved oxygen into aquatic environments. For those skilled in the art, oxygen can be injected into water in a variety of ways. For example, this can be achieved through microbubble diffusion, molecular-level delivery, membrane permeation, etc.

[0079] A key issue in intravenous oxygenation is avoiding increasing the dissolved gas pressure to a level that, when injected into the bloodstream, could lead to embolism (i.e., Bends' or Gas Bubble Disease), which can be fatal. Note that this most commonly occurs from nitrogen released from the bloodstream when the victim moves from a high-pressure environment to a low-pressure environment.

[0080] In one aspect, the system and method provide high levels of dissolved oxygen in IV fluids. In some aspects, the system and method provide IV fluids with an oxygen saturation greater than about 100%. In a further aspect, dissolved oxygen in the IV fluid can be increased to more than 400% of saturation without causing embolism when injected into the bloodstream.

[0081] refer to Figures 5 to 7 A second general implementation scheme is provided, which relates to an alternative to an ECMO machine for directly delivering oxygen into the blood.

[0082] like Figure 5 As shown, in this embodiment of the invention, a blood oxygenation system 24 including an oxygen source (13) is used to directly infuse oxygen into blood or artificial blood 26 to produce oxygen-enriched blood or artificial blood 26. The resulting enriched blood or artificial blood 26 can be used as follows: Figure 5 The operating room shown has good ventilation. Alternatively, as... Figure 6 As shown, the blood oxygenation system 24 can be used to infuse oxygen into blood or artificial blood 30 of a given blood type to produce in batches oxygenated blood or artificial blood 32 of a given blood type for storage.

[0083] However, ECMO machines use membrane methods for oxygenation while maintaining dissolved gas pressure, and this implementation uses existing microdiffusion or molecular infusion methods to prevent embolism in the blood or artificial blood while maintaining dissolved gas pressure.

[0084] Regarding the direct oxygenation of blood and artificial blood, this includes all classes of hemoglobin-based oxygen carriers (HBOCs), such as FDA / European-approved blood enhancers for veterinary use and all classes of perfluorocarbons (PFCs).

[0085] according to Figure 2 The illustrated implementation scheme allows for the treatment of the sterile water tank 10 using an oxygenation system 12 to continuously increase and / or replenish the oxygen content of the tank 10. Similarly, as...Figure 7 As shown, the oxygenation system 24 can be used to process a given blood type or artificial blood pool 34 to continuously increase and / or replenish the oxygen content of the pool 34.

[0086] According to the implementation plan, the disclosed system and methods can be widely used in humans and non-human animals.

[0087] The various embodiments presented above are merely examples and are not intended to limit the scope of this disclosure. Many variations of the innovations described herein will be apparent to those skilled in the art who will benefit from the exemplary embodiments, and these variations are within the scope of this disclosure. In particular, features from one or more of the above embodiments can be selected to create alternative embodiments consisting of sub-combinations of features, which may not be explicitly described above. Furthermore, features from one or more of the above embodiments can be selected and combined to create alternative embodiments consisting of combinations of features, which may not be explicitly described above. Features suitable for such combinations and sub-combinations will readily become apparent to those skilled in the art upon reading this disclosure in its entirety. The subject matter described herein is intended to cover and include all suitable variations of the art.

[0088] Certain adjustments and modifications may be made to the described implementation scheme. Therefore, the above implementation scheme is considered illustrative rather than restrictive.

Claims

1. An oxygen enriched biological fluid produced according to a method of oxygenating a biological fluid for use in an impaired subject or a trauma subject in need of oxygenation support to maintain the subject at an appropriate oxygen level, the method comprising: supplying oxygen from an oxygen source; and dissolving an amount of the supplied oxygen into a biological fluid to obtain the oxygen enriched biological fluid; wherein the method further comprises the step of removing an amount of a first gas, the amount of the first gas removed being substantially equal to the amount of the supplied oxygen dissolved into the biological fluid; wherein the steps of dissolving the amount of the supplied oxygen and removing the amount of the first gas are performed simultaneously to avoid any increase in total gas pressure, TGP, such that when the oxygen enriched biological fluid is introduced into the subject, the formation of gas emboli in the blood stream of the subject is at least reduced or prevented; wherein the first gas is nitrogen.

2. The oxygen enriched biological fluid of claim 1, wherein the method further comprises the step of directing the oxygen enriched biological fluid into a compatible reservoir or the step of delivering the oxygen enriched biological fluid directly into the circulation of the subject.

3. The oxygen enriched biological fluid of claim 2, wherein the compatible reservoir is an IV bag or bottle.

4. The oxygen enriched biological fluid of claim 2, wherein the step of delivering comprises directly injecting the oxygen enriched biological fluid into the venous circulation of the subject.

5. The oxygen enriched biological fluid of any one of claims 1 to 4, wherein the oxygen enriched biological fluid has a high level of dissolved oxygen.

6. The oxygen enriched biological fluid of any one of claims 1 to 4, wherein the oxygen saturation of the oxygen enriched biological fluid is greater than 100%.

7. The oxygen enriched biological fluid of any one of claims 1 to 4, wherein the oxygen saturation of the oxygen enriched biological fluid is at least 400%.

8. The oxygen enriched biological fluid of any one of claims 1 to 4, wherein the biological fluid is sterile water, an intravenous, IV, fluid, blood, or artificial blood.

9. The oxygen enriched biological fluid of claim 8, wherein the artificial blood is a hemoglobin-based oxygen carrier, HBOC, or a perfluorocarbon, PFC.

10. The oxygen enriched biological fluid of claim 9, wherein the HBOC is a blood- enhancing agent.

11. The oxygen enriched biological fluid of any one of claims 1 to 4, wherein the subject is a human or a non-human animal.

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