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Title:
CONTAINER FOR FLUID ADMINISTRATION
Document Type and Number:
WIPO Patent Application WO/2020/014147
Kind Code:
A1
Abstract:
A container is provided for the administration of drugs and other fluids to a patient's body. The container is composed of one or more semi-rigid portions, enabling accurate measurement of the volume of fluid remaining in the container while also being easily stored and shipped. The container includes an upper portion having a first cross-sectional area and a first plurality of fluid measurement markings; a lower portion below the upper portion having a second plurality of fluid measurement markings and a smaller cross-sectional area; and at last one port in fluid communication with the lower portion and configured to connect to a line into the patient. One or both of the upper and lower portion may be made of a semi-rigid material, like silicone rubber.

Inventors:
STEWART MARY ELLEN (US)
Application Number:
PCT/US2019/040850
Publication Date:
January 16, 2020
Filing Date:
July 08, 2019
Export Citation:
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Assignee:
UNIV SOUTH ALABAMA (US)
International Classes:
A61J1/10; A61J1/00; A61J1/05; G01F3/36
Domestic Patent References:
WO2009018388A12009-02-05
Foreign References:
US3888126A1975-06-10
US3517450A1970-06-30
US20040118733A12004-06-24
US3961529A1976-06-08
US3888236A1975-06-10
Attorney, Agent or Firm:
LANDAU, Nicholas J. et al. (US)
Download PDF:
Claims:
CLAIMS

I claim:

1. A container for the administration of a fluid to a patient, the container comprising:

(a) an upper portion configured to contain a first quantity of fluid, said upper portion having a first cross-sectional area, and comprising a first plurality of fluid measurement markings;

(b) a lower portion in fluid communication with the upper portion and comprising a second plurality of fluid measurement markings, the lower portion configured to contain a second quantity of fluid, and having a second cross-sectional area that is less than the first cross-sectional area; and

(c) a port in fluid communication with the lower portion and configured to connect to at least one of: an intravenous line and a feeding tube; wherein at least one of the lower portion and the upper portion is a semi-rigid structure.

2. The container of claim 1 , comprising a second port in fluid communication with the lower portion and configured to allow fluid to be added to the container.

3. The container of any one of the claims above, wherein at least one of the upper and the lower portion is a semi-rigid structure that varies in cross-sectional area less than about 20% in an empty state as compared to a state when the container is at least half filled with fluid.

4. The container of any one of the claims above, wherein the upper portion is a rigid structure and the lower portion is a semi-rigid structure.

5. The container of any one of the claims above, wherein the upper portion is a rigid structure and the lower portion is a semi-rigid structure that varies in cross- sectional area less than about 20% in an empty state as compared to a state when the container is at least half filled with fluid.

6. The container of any one of the claims above, wherein at least one of the upper and the lower portion is a semi-rigid structure with sufficient flexibility to be flattened when under net external pressure, but which retains its shape when not under net external pressure.

7. The container of any one of the claims above, wherein the upper portion is a semi-rigid structure and the lower portion is a semi-rigid structure with sufficient flexibility to be flattened when under net external pressure, but which retains its shape when not under net external pressure.

8. The container of any one of the claims above, wherein at least one of the upper and the lower portion is constructed of silicone.

9. The container of any one of the claims above, wherein the upper and the lower portions are constructed of silicone

10. The container of any one of the claims above, wherein at least one of the upper and the lower portions is a rigid structure.

11 . The container of any one of the claims above, wherein the upper portion is a rigid structure and the lower portion is a rigid structure.

12. The container of any one of the claims above, comprising a tapered intermediate portion in fluid communication with the upper portion and in fluid communication with the lower portion.

13. The container of any one of the claims above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing.

14. The container of any one of the claims above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing, and comprising a third plurality of fluid measurement markings.

15. The container of any one of the claims above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing, and comprising a third plurality of fluid measurement markings that each represent volume units of a constant size.

16. The container of any one of the claims above, comprising a tapered intermediate portion between the upper portion and the lower portion, in fluid communication with both of the foregoing, and having a conical shape.

17. The container of any one of the claims above, wherein the first cross-sectional area is approximately constant.

18. The container of any one of the claims above, wherein the second cross- sectional area is approximately constant.

19. The container of any one of the claims above, wherein the first cross-sectional area is constant.

20. The container of any one of the claims above, wherein the second cross- sectional area is constant.

21 . The container of any one of the claims above, wherein the first cross-sectional area is approximately cylindrical.

22. The container of any one of the claims above, wherein the second cross- sectional area is approximately cylindrical.

23. The container of any one of the claims above, wherein the first fluid measurement markings mark a first volume increment, wherein the second fluid measurement markings mark a second volume increment, and wherein the first volume increment is at least 10 times the second volume increment.

24. The container of any one of the claims above, wherein the first fluid measurement markings mark a first volume increment, wherein the second fluid measurement markings mark a second volume increment, and wherein the first volume increment is at least 50 times the second volume increment.

25. The container of any one of the claims above, wherein the container is closed except for one or more ports.

26. The container of any one of the claims above, wherein the first quantity of fluid is greater than the second quantity of fluid.

27. The container of any one of the claims above, wherein the first quantity of fluid is at least twice the second quantity of fluid.

28. The container of any one of the claims above, wherein the first quantity of fluid is at least thrice the second quantity of fluid.

29. The container of any one of the claims above, wherein the container is closed except for two ports.

30. The container of any one of the claims above, wherein: the first plurality of fluid measurement markings represents volume units of a first size; and the second plurality of fluid measurement markings represents volume units of a second size that is less than the first size.

31 . The container of any one of the claims above, wherein the upper portion is configured to contain a greater volume of fluid than the lower fluid-containing portion is configured to contain.

32. The container of any one of the claims above, wherein at least one of the upper portion and the lower portion is at least partially constructed from translucent material.

33. The container of any one of the claims above, wherein at least one of the upper portion and the lower portion is at least partially constructed from tinted translucent material.

34. The container of any one of the claims above, wherein: the upper portion is at least partially constructed from translucent material; and the lower portion is at least partially constructed from translucent material.

35. The container of any one of the claims above, wherein: the upper portion is at least partially constructed from translucent material; and the lower portion is at least partially constructed from tinted translucent material.

36. The container of any one of the claims above, wherein at least one of the upper portion and the lower portion is at least partially constructed from transparent material.

37. The container of any one of the claims above, wherein at least one of the upper portion and the lower portion is at least partially constructed from tinted transparent material.

38. The container of any one of the claims above, wherein: the upper portion is at least partially constructed from transparent material; and the lower portion is at least partially constructed from transparent material.

39. The container of any one of the claims above, wherein: the upper portion is at least partially constructed from tinted transparent material; and the lower portion is at least partially constructed from tinted transparent material.

40. The container of any one of the claims above, wherein at least one of the upper and the lower portion are constructed from glass.

41. The container of any one of the claims above, wherein the upper portion and the lower portion are constructed from glass.

42. The container of any one of the claims above, wherein at least one of the upper and the lower portion is constructed from flexible material that maintains an approximately constant cross-sectional area when fluid is present in said portion.

43. The container of any one of the claims above, wherein: the upper portion is constructed from a flexible material that maintains an approximately constant cross- sectional area when fluid is present in the upper portion; and the lower portion is constructed from flexible material that maintains an approximately constant cross- sectional area when fluid is present in the lower portion.

44. The container of any one of the claims above, constructed from a pharmaceutically compatible material.

45. The container of any one of the claims above, wherein the interior of the container is sterile.

46. The container of any one of the claims above, comprising an intravenous line connected to the first port.

47. The container of any one of the claims above, comprising an intravenous line connected to the first port, said intravenous line terminating in a hypodermic needle.

48. The container of any one of the claims above, comprising an intravenous line connected to the first port, said intravenous line terminating in an intravenous catheter.

49. The container of any one of the claims above, comprising a feeding tube connected to the first port for gastrointeric feeding.

50. The container of any one of the claims above, comprising a feeding tube connected to the first port for percutaneous endoscopic gastrostomy.

51 . The container of any one of the claims above, containing a pharmaceutical selected from one or more of: an anticancer agent, an antibacterial agent, an antiviral agent, an antifungal agent, a hormone replacement agent, a rehydrating agent, an anti-inflammatory agent, a serum, blood plasma, whole blood, platelets, immunoglobulin, and a parenteral nutrition composition.

52. The container of any one of the claims above, containing one or both of an additive and an admixture.

53. The container of any one of the claims above, containing a pharmaceutical composition only in the lower portion.

54. The container of any one of the claims above, containing a pharmaceutical composition only in the lower portion that is an antibacterial agent.

55. The container of any one of the claims above, comprising a connector configured to support the container from an arm of an IV stand.

56. The container of any one of the claims above, comprising a tab configured to support the container from an arm of an IV stand.

57. A container for the administration of a fluid to a patient, the container comprising:

(a) a semi-rigid mostly cylindrical upper portion having a first cross-sectional area, and comprising a first plurality of fluid measurement markings at a first interval;

(b) a semi-rigid conic intermediate portion contiguous with the upper portion and in fluid communication with the upper portion, and comprising a second plurality of fluid measurement markings at about 25% of the first interval; (c) a semi-rigid mostly cylindrical lower portion contiguous with the intermediate portion and in fluid communication with the upper portion and intermediate portion, and comprising a third plurality of fluid measurement markings at about 1 % of the first interval, and having a second cross- sectional area that is less than the first cross-sectional area; and

(d) a port in fluid communication with the lower portion and configured to connect to at least one of: an intravenous line and a feeding tube.

58. A method of intravenously administering a fluid to a patient, the method comprising:

(a) connecting the container of any one of the claims above to an intravenous line;

(b) connecting the intravenous line to a vein of the patient; and

(c) allowing the fluid to flow from the container into the vein of the patient.

59. A method of administering nutrition to a patient, the method comprising:

(a) connecting the container of any one of the claims above to a feeding tube;

(b) inserting the feeding tube into the patient’s gastrointestinal tract; and

(c) allowing the fluid to flow from the container into the patient’s gastrointestinal tract.

60. The method of any one of claims 58-59, comprising:

(a) observing a first volume of fluid in the container at a first point in time, the first volume of fluid determined by a first fluid volume marking closest to the meniscus of the fluid at the first point in time;

(b) observing a second volume of fluid in the container at a second point in time, the second volume of fluid determined by a second fluid volume marking closest to the meniscus of the fluid at the second point in time; (c) comparing the difference in the first and second volume over time to a target rate of volumetric flow from the container; and

(d) changing the volumetric rate of flow of the fluid from the container to achieve said target rate.

61 . The method of claim 60, wherein steps (a)-(d) are initiated only after the meniscus of the fluid drops to the lower portion.

Description:
CONTAINER FOR FLUID ADMINISTRATION

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application cites the benefit of, and is a continuation-in-part of, U.S. Application No. 16/030,604, filed 9 July 2018.

BACKGROUND

FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to containers for the administration of drugs and other substances to the body. Such containers as well as methods for use therewith are provided.

BACKGROUND

[0003] Intravenous (IV) infusions have been performed for over 200 years. Errors and inaccuracies in fluid volume infused can result in serious negative side effects.

[0004] The popular IV container of today is a flexible bag without accurate markings. The lack of a readily visible accurate volumetric marking results in several problems. Many medications and other compositions must be administered at a particular rate of volume per unit time. Although time can be easily measured, the volume administered is more difficult to estimate.

[0005] Flexible bags require repeated checks by the nurse to adjust the rate of infusion of a medication so as to ensure that the medication is flowing into the patient at a target rate needed to ensure that the full amount of medication prescribed by the doctor is administered by a target time. It is common for a nurse to need to repeatedly go back into the patient’s room to adjust the rate of infusion, which results in an inefficient use of the nurse’s time. [0006] Presently, the level of accuracy exhibited when performing IV infusions and administration has not been optimized. A nurse, or other health practitioner, sometimes has to deal with overfilled or under-filled bags. This is because pharmacists often increase the volume of the medication in IV bags when additives are added. This can create perplexing problems for the nurse when attempting to determine the correct rate of administration of a time-sensitive drug, because the starting volume is not known. For many drugs, administration of the entire dosage must occur over a set amount of time or at a set constant rate. The rate of administration must be controlled to accomplish this, but the rate of administration cannot be controlled with any precision unless the volume of fluid in the container can be measured with precision.

[0007] For example, methotrexate is a chemotherapeutic agent that must be administered within a specific period of time (usually about 24 hours). To determine the correct rate of administration of the medication in the IV bag, the nurse must estimate how much solution is in the IV bag that has been prepared and filled by the pharmacist or manufacturer. Accurate measurement of the volume of methoxitrate in the bag (initially and during infusion) facilitates the infusion of the chemotherapeutic agent within the specified amount of time.

[0008] However, due to the shape and lack of accurate volumetric measurement markings on present IV bags, it is difficult for the nurse to determine the volume of medication (or other solution) contained in the bag. Therefore, it is difficult to precisely calculate the amount of time needed for a target quantity of time-sensitive medication to be fully infused by a target time. Consequently, when using present IV bags, careful and repeated monitoring and possible adjustment by the nurse of the rate of infusion is essential, since even the most vigilant nurse is at risk of making inaccurate fluid estimations due to the crude volumetric measurement markings provided on present IV containers.

[0009] Therefore there is a need in the art for rapid and simple means for measuring the volume of fluid administered from IV containers and similar containers.

SUMMARY

[0010] It has been found that the use of rigid and semi-rigid containers for the administration of fluids to a patient greatly enhances the precision of such administration. The container has volumetric measurement markings on each of two distinct sections to allow both rough and fine visual measurements of the volume remaining in the container. The use of rigid and semi-rigid materials, a larger upper portion and a smaller lower portion, the modified shape of the IV container, and volumetric measurement markings enable more precise volumetric measurements than present IV containers when administering time-sensitive medications and quantitative IV nutrition.

[001 1] In a first aspect, container for the administration of a fluid to a patient is provided, the container comprising: an upper portion configured to contain a first quantity of fluid, said upper portion having a first cross-sectional area, and comprising a first plurality of fluid measurement markings; a lower portion in fluid communication with the upper portion and comprising a second plurality of fluid measurement markings, the lower portion configured to contain a second quantity of fluid, and having a second cross-sectional area that is less than the first cross- sectional area; and a port in fluid communication with the lower portion and configured to connect to at least one of an intravenous line and a feeding tube. Either portion may be constructed from a rigid or semi-rigid material. [0012] In a second aspect, a method of intravenously administering a fluid to a patient is provided, the method comprising: connecting the container of the first aspect to an intravenous line; connecting the intravenous line to a vein of the patient; and allowing the fluid to flow from the container into the vein of the patient.

[0013] In a third aspect, a method of administering nutrition to a patient is provided, the method comprising: connecting the container of any one of the claims above to a feeding tube; inserting the feeding tube into the patient’s gastrointestinal tract; and allowing the fluid to flow from the container into the patient’s gastrointestinal tract.

[0014] The foregoing presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key or critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

BRIEF DESCRIPTION OF THE DRAWINGS

[00151 FIG. 1 is a perspective view of a cylindrical embodiment of the container having an upper portion, a tapered intermediate portion, and a lower portion.

[00161 FIG. 2 is a front view of the embodiment of the container shown in FIG. 1 , showing the tab to be held by an IV stand, the tapered intermediate portion between the upper and lower portions, the ports for fluid administration and medication input, and showing more closely spaced markings on the lower portion than on the upper portion.

[00171 FIG. 3 is a side view of an embodiment of the container, showing measurement markings and numbered milliliter markings on the upper, intermediate, and lower portions. [00181 FIG. 4 is a bottom view of the embodiment of the container shown in FIG. 1 having a cylindrical upper fluid-containing portion, an intermediate fluid-containing portion, and a cylindrical lower fluid-containing portion, and the ports for fluid administration and medication input.

G00191 FIG. 5 is a front view of an alternate embodiment of the container, showing a semi-rigid body seamed on the outer perimeter with an upper fluid-containing portion and a lower fluid-containing portion, also showing accurate measurement markings and numbered milliliter markings.

G00201 FIG. 6 is a side view of the embodiment of the semi-rigid container shown in FIG. 5, showing the upper fluid-containing portion and the lower fluid-containing portion.

DETAILED DESCRIPTION

DEFINITIONS

[0021] With reference to the use of the word(s) “comprise” or “comprises” or “comprising” in the foregoing description and/or in the following claims, unless the context requires otherwise, those words are used on the basis and clear understanding that they are to be interpreted inclusively, rather than exclusively, and that each of those words is to be so interpreted in construing the foregoing description and/or the following claims.

[0022] The term “consisting essentially of” means that, in addition to the recited elements, what is claimed may also contain other elements (steps, structures, ingredients, components, etc.) that do not adversely affect the operability of what is claimed for its intended purpose. Such addition of other elements that do not adversely affect the operability of what is claimed for its intended purpose would not constitute a material change in the basic and novel characteristics of what is claimed.

[0023] Terms such as“at least one of A and B” should be understood to mean“only A, only B, or both A and B.” The same construction should be applied to longer list (e.g.,“at least one of A, B, and C”).

[0024] The term “individual”, “subject” or“patient” as used herein refers to any animal, including mammals, such as mice, rats, other rodents, rabbits, dogs, cats, swine, cattle, sheep, horses, or primates, and humans. The term may specify male or female or both, or exclude male or female.

[0025] In this disclosure terms such as“administering” or“administration” include acts such as prescribing, dispensing, giving, or taking a substance such that what is prescribed, dispensed, given, or taken is actually contacts the patient’s body externally or internally (or both). It is specifically contemplated that instructions or a prescription by a medical professional to a subject or patient to take or otherwise self-administer a substance is an act of administration.

[0026] The terms“about” and“approximately” shall generally mean an acceptable degree of error or variation for the quantity measured given the nature or precision of the measurements. Typical, exemplary degrees of error or variation are within 20 percent (%), preferably within 10%, more preferably within 5%, and even more preferably within 1 % of a given value or range of values. Numerical quantities given in this description are approximate unless stated otherwise, meaning that the term “about” or“approximately” can be inferred when not expressly stated. Numerical quantities in the claims are exact unless stated otherwise.

CONTAINER FOR THE ADMINISTRATION OF FLUIDS [0027] A container 100 for the administration of a fluid to a patient is provided. Various features of the container allow for more accurate visual readings of the volume of the fluid remaining in the container. This permits enhanced accuracy of the administration rate of medications and other fluids. These advantages are enhanced when time-sensitive medications are administered, during long periods of administration, and during quantitative IV nutrition.

[0028] A general embodiment of the container 100 comprises an upper portion 102 and a lower portion 104, as shown in FIG. 1. The upper portion 102 is configured to contain a first large volume of fluid. It has a first cross-sectional area and a plurality of fluid measurement markings 302 showing the volume of fluid remaining in the container. Below the upper portion 102 is a lower portion 104 in fluid communication with the upper portion. In the illustrated example the lower portion 104 is below and contiguous with the upper portion 102. The lower portion 104 also has a plurality of fluid measurement markings 304, and configured to contain a second smaller quantity of fluid. The lower portion 104 having a second cross-sectional area that is less than the first cross-sectional area. The smaller cross-sectional area of the lower portion 104 allows more precise measurement of the volume of fluid when the fluid’s meniscus is in the lower portion. The cross-sectional area of both the upper 102 and lower 104 portions must be more or less constant to assure that the volumetric markings are near accurate, as is discussed further below.

[0029] The first quantity of fluid may be greater than the second quantity of fluid (i.e., the upper portion 102 may hold a larger volume than the lower portion 104). Among other advantages, this can allow more precise monitoring of the volume of fluid left in the container as the container nears an empty state. For example, in some embodiments the first quantity of fluid is at least twice the second quantity of fluid. In further embodiments, the first quantity of fluid may be at least thrice the second quantity of fluid. If still further embodiments the first quantity is over thrice the second quantity.

[0030] The container 100 comprises one or more ports 202 in fluid communication with the lower portion 104. One or more of the ports 202 may be configured to connect to a line for delivering the fluid into the patient’s body. For example, the port 202 may be configured to connect to an intravenous line, a vascular catheter, or an esophageal feeding tube. Ports 202 may also be present for the addition of additives to the contents of the container, such as the injection of drugs into the container. In the illustrated embodiments two ports 202 are present: a port that connects to an IV line and a port for the input of drugs or other additives. Some embodiments of the container are closed (no openings to the outside) except for one or more ports 202. A specific embodiment of the container is closed except for two ports 202.

[0031] Either or both of the upper 506 and lower 508 portions of the container 100 may be a semi-rigid structure 400. The semi-rigid structure 400 is one that is flexible under large external net pressures, but which generally retains its shape under low external pressure and under internal pressure. For example, some embodiments of the container 400 have semi-rigid portions 502, 504 in which the cross-sectional area varies by no more than 20% when empty as compared to when loaded. In other embodiments the cross-sectional area varies by no more than about 15%, 10%, 5%, or 1 %. In this context“loaded” means at least half-filled with fluid; in some contexts it can mean at least 75% filled with fluid, or completely filled with fluid. In many embodiments the cross-sectional area of the semi-rigid portion will vary by only a limited amount regardless of how full the container is. The advantage of a semi-rigid portion is that it can be collapsed or flattened when not in use for ease of storage and shipping. Semi-rigid materials may also be more resistant to breakage and shattering than rigid materials (although rigid materials are suitable in some embodiments of the container, as described below). Some embodiments of the container are constructed from a pharmaceutically compatible material. Such pharmaceutically compatible materials may be selected on various bases by persons with the relevant expertise. For example, the pharmaceutically compatible material may be selected based on those that have been approved by a regulatory agency, such as the U.S. Food and Drug Administration, the U.K. Medicines and Healthcare products Regulatory Agency, the Swiss Agency for Therapeutic Products, the Indian Ministry of Health and Family Welfare, and the European Medicines Agency.

[0032] One commonly used semi-rigid material that is suitable in some embodiments of the container 400 is silicone rubber. Silicone is medically compatible, durable, flexible, retains its shape well, and sterilizable by both heat and chemicals. Silicone can also be transparent or translucent. Some embodiments of the container 100 comprise both a silicone upper portion and a silicone lower portion.

[0033] The upper 102 and/or lower 104 portions may also be rigid. Suitable rigid materials include glass and hard plastic. More specific examples are borosilicate glass, tempered soda glass, and polyethylene terephthalate.

[0034] The container 100 may also comprise a tapered intermediate portion 106 in fluid communication with the upper portion 102 and in fluid communication with the lower portion. Such an embodiment is shown in FIGS. 1 , 2, and 3. In that embodiment the tapered intermediate portion 106 is between the upper 102 and the lower 104 portion, connecting them. The intermediate portion 106 may have a plurality of measurement marks 306 showing the volume remaining in the container 100. If the measurement markings denote volume units of constant size, they will appear unevenly spaced, as the intermediate portion narrows in cross-sectional area from top to bottom. In a specific embodiment the intermediate portion 106 is at least approximately conical. In a further embodiment it is conical. The intermediate portion may be constructed of any materials that would be suitable for either or both of the upper and lower portions, including rigid and semi-rigid materials.

[0035] In some embodiments of the container 100 the cross-sectional areas of the upper 102, intermediate 106, and/or lower 104 portions may be approximately constant. In this context “approximately constant” means they do not vary throughout most or all of the length of the portion by more than 20%, in some embodiments by no more than 10%, in further embodiments by no more than 5%, and in particular embodiments by no more than 1 %. The lower portion 104 will in some embodiments come to a sharp taper at the lower end, and that sharp taper is not considered part of the lower portion 104. These constant cross-sectional portions may take the form of prisms or cylinders (as shown in FIGS. 1-3).

[0036] The volumetric markers on the upper 302 and lower 304 portions may mark different increments of volume. For example, each marker on the upper portion 302 may mark a larger amount than does each marker on the lower portion 304. This allows the user to more precisely monitor changes in volume as the total volume in the container drops (i.e. , toward the end of the administration, when the meniscus of the fluid is in the lower portion). Among other things, this enables the user to precisely predict when the container will be empty; this in turn will result in the intravenous line (or other type of line) being removed more promptly, without the need for continuous visual monitoring. It will also enable an empty container to be switched out with a loaded container more promptly when the patient requires constant administration of the fluid. In some embodiments of the container, the first fluid measurement markings 302, 506 mark a first volume increment, and the second fluid measurement markings 304, 508 mark a second volume increment, wherein the first volume increment is at least 10 times the second volume increment. In further embodiments the first volume increment is at least 50 times the second volume increment. Other proportions between the first 302, 506 and second 304, 508 volume increments are possible depending on the relative sizes of the upper and lower portions and the expected rate of administration of the fluid.

[0037] The container may advantageously be transparent or translucent, in whole or in part. At least one advantage of such embodiments is the ability to visually monitor the level of the fluid. In some embodiments of the container at least one of the upper portion 102, 502 and the lower portion 104, 504 is at least partially constructed from translucent material. In some such embodiments the translucent material is tinted to protect the fluid contents from light; this is particularly useful if some of the components of the fluid are photoreactive. However, the level of the fluid can still be visually monitored through tinted translucent material. One or both of the upper portion 102, 502 and the lower portion 104, 504 may also be least partially constructed from transparent material (which may be tinted or untinted). Plastic, glass, and silicone can all be formulated to be translucent, transparent, with or without tinting.

[0038] The container 100, 400 in many cases will be sterile. It may be sterilized during the manufacturing process, or after manufacturing. The container 100, 400 may be made of material that is amenable to sterilization after manufacturing, such as to heat or chemical sterilization. Examples of such materials include silicone, glass, and high-performance plastics. Such containers may be reusable, as they can be sterilized multiple times between uses. Reusable containers have the advantage of reduced cost and waste disposal burden. Alternative embodiments of the container 100, 400 are sterile when manufactured, but cannot be effectively sterilized subsequently; such embodiments are single-use or disposable containers. Disposable container are advantageous in that they eliminate the possibility of cross- contamination between patients if there is a defect in the sterilization process.

[0039] In use, any of various types of lines will connect the container 100, 400 to the patient, generally via one of the ports 202, 510. If the container is used for intravenous administration, it may comprise an intravenous line. The IV line may terminate in an intravenous access device, such as a hypodermic needle or an IV catheter. Alternatively the container may be connected to a different type of line, such as a feeding tube. Suitable feeding tubes includes those used for gastrointeric feeding and those used for percutaneous endoscopic gastrostomy. Specific examples include a nasogastric tube, a nasojejunal tube, a percutaneous jejunostomy tube, and a percutaneous endoscopic gastrotomy tube.

[0040] When loaded, the container 100, 400 may contain a pharmaceutical composition. Suitable examples include: an anticancer agent, an antibacterial agent, an antiviral agent, an antifungal agent, a hormone replacement agent, a rehydrating agent, an anti-inflammatory agent, a serum, blood plasma, whole blood, platelets, immunoglobulin, and a parenteral nutrition composition. The pharmaceutical composition may contain one or more additives and/or admixtures. In some embodiments only the pharmaceutical composition will be present in the container. In some cases a pharmaceutical composition may be of a type that is generally administered in small volumes, such that only the lower portion of the container holds any fluid. One example of such a pharmaceutical that may only be present in the lower portion of the container is an antibacterial agent. [0041] The container 100, 400 may comprise additional structures to allow it to be supported or suspended during use. One example of such a structure is a connector configured to support the container from an arm of an IV stand. Various such connectors may be used. In the embodiment illustrated in FIGS. 1 , 2, 5, and 6 a tab 108, 512 is configured with a hole or a grommet to support the container from an arm of the IV stand.

METHODS OF ADMINISTRATION OF FLUIDS

[0042] The containers 100, 400 described above find use for administering a fluid to a patient. Fluids can be administered to the patient by connecting the container 100, 400 to a line and connecting the line to the patient. In a first general embodiment of the method the container 100, 400 is connected to an intravenous line, and the intravenous line is connected to access a vein of the patient. In a second general embodiment, the container 100, 400 is connected to feeding tube, and the feeding tube is inserted into the gastrointestinal track of the patient. The fluid will be appropriate to the patient’s condition, and the line will be appropriate to the nature of the fluid and the desired method of administration.

[0043] Examples of fluids for administration include an anticancer agent, an antibacterial agent, an antiviral agent, an antifungal agent, a hormone replacement agent, a rehydrating agent, an anti-inflammatory agent, a serum, blood plasma, whole blood, platelets, immunoglobulin, and a parenteral nutrition composition. The pharmaceutical composition may contain one or more additives and/or admixtures. Some embodiments of the method comprise adding a volume of the fluid to the container that is no greater than the volume of the lower portion. As explained above, it is advantageous in some circumstances to administer the fluid only from the lower portion. [0044] One advantage of using the inventive container for fluids administration is the enhanced ability of the user to accurately visually monitor the volume remaining in the container during administration. By observing the fluid level at known time intervals the rate of administration can be calculated. It can then be adjusted if the calculated rate is too low or too high. It can also be used as the basis to predict when the container will be empty. Such an approach might include observing a first volume of fluid by observing the first fluid volume marking closest to the meniscus of the fluid at a first point in time. Then the user may observe a second (presumably lower) volume of fluid in the container at a second point in time. The volumetric flow rate could then be calculated by comparing the difference in the first and second volume over time to a target rate of volumetric flow from the container 100, 400. The volumetric rate of flow of the fluid from the container 100, 400 might then be increased or decreased to achieve said target rate; it may be kept constant if the volumetric flow rate is adequately close to the target rate. In some embodiments of the method the user will start monitoring the volume remaining in the container 100, 400 and calculating the flow rate only after the fluid level has fallen into the lower portion 104, 404 of the container.

EXAMPLES

[0045] A first prophetic example is shown in FIGS. 1 -3. The container 100 shown is a rigid structure constructed of borosilicate glass (such as PYREX), tempered soda glass, or medical grade plastic. The cylindrical upper portion 102 and cylindrical lower portion 104 are connected by a conic tapered portion 106. A tab 108 is provided for suspending the container 100 from an IV stand or other similar structure. Two ports 202 in the lower portion 104 are provided for administration and filling. Volumetric gradation markings 302, 304, and 306 are provided on the upper 102, lower 104, and intermediate 106 portions respectively. The upper portion markings 302 are every 100 ml_; the lower portion markings 304 mark every 10 ml_; and the intermediate portion markings 306 mark every 25 ml_.

[0046] A second prophetic example is shown in FIGS. 5-6. In this example the container 400 comprises a semi-rigid upper portion 502 and a semi-rigid lower portion 504. The upper portion 502 has a set of volumetric markings 506 that mark every 100 ml_ and every 50 ml_ (major and minor gradations, respectively). The lower portion 504 has volumetric markings 508 every 50 ml_ and 10 ml_ (major and minor gradations, respectively). A tab 512 is provided for support, and two ports 510 are provided for filling and emptying the container 400. Although the semi-rigid container 400 maintains a constant cross-sectional area in each of the upper portion 502 and lower portion 504 when in use, it can be collapsed for storage and transport by exerting external pressure on the container 400.

EMBODIMENTS

[0047] In addition to anything described above or currently claimed, it is specifically contemplated that any of the following embodiments may be claimed.

[0048] Emb. 1. A container 100 for the administration of a fluid to a patient, the container 100 comprising: an upper portion 102 configured to contain a first quantity of fluid, said upper portion 102 having a first cross-sectional area, and comprising a first plurality of fluid measurement markings 302; a lower portion 104 in fluid communication with the upper portion 102 and comprising a second plurality of fluid measurement markings 304, the lower portion 104 configured to contain a second quantity of fluid, and having a second cross-sectional area that is less than the first cross-sectional area; and a port 202 in fluid communication with the lower portion 104 and configured to connect to at least one of: an intravenous line and a feeding tube; wherein at least one of the lower portion 104 and the upper portion 102 is a semi-rigid structure.

[0049] Emb. 2. The container of embodiment 1 , comprising a second port 202 in fluid communication with the lower portion 104 and configured to allow fluid to be added to the container.

[0050] Emb. 3. The container 100, 400 of any one of the embodiments above, wherein at least one of the upper 502 and the lower portion 504 is a semi-rigid structure that varies in cross-sectional area less than about 20% in an empty state as compared to a state when the container is at least half filled with fluid.

[0051] Emb. 4. The container 100, 400 of any one of the embodiments above, wherein the upper portion 102 is a rigid structure and the lower portion 504 is a semi- rigid structure.

[0052] Emb. 5. The container of any one of the embodiments above, wherein the upper portion is a rigid structure and the lower portion is a semi-rigid structure that varies in cross-sectional area less than about 20% in an empty state as compared to a state when the container is at least half filled with fluid.

[0053] Emb. 6. The container of any one of the embodiments above, wherein at least one of the upper and the lower portion is a semi-rigid structure with sufficient flexibility to be flattened when under net external pressure, but which retains its shape when not under net external pressure.

[0054] Emb. 7. The container of any one of the embodiments above, wherein the upper portion is a semi-rigid structure and the lower portion is a semi-rigid structure with sufficient flexibility to be flattened when under net external pressure, but which retains its shape when not under net external pressure. [0055] Emb. 8. The container of any one of the embodiments above, wherein at least one of the upper and the lower portion is constructed of silicone.

[0056] Emb. 9. The container of any one of the embodiments above, wherein the upper and the lower portions are constructed of silicone

[0057] Emb. 10. The container of any one of the embodiments above, wherein at least one of the upper and the lower portions is a rigid structure.

[0058] Emb. 1 1. The container of any one of the embodiments above, wherein the upper portion is a rigid structure and the lower portion is a rigid structure.

[0059] Emb. 12. The container of any one of the embodiments above, comprising a tapered intermediate portion in fluid communication with the upper portion and in fluid communication with the lower portion.

[0060] Emb. 13. The container of any one of the embodiments above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing.

[0061] Emb. 14. The container of any one of the embodiments above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing, and comprising a third plurality of fluid measurement markings.

[0062] Emb. 15. The container of any one of the embodiments above, comprising a tapered intermediate portion between the upper portion and the lower portion, and in fluid communication with both of the foregoing, and comprising a third plurality of fluid measurement markings that each represent volume units of a constant size.

[0063] Emb. 16. The container of any one of the embodiments above, comprising a tapered intermediate portion between the upper portion and the lower portion, in fluid communication with both of the foregoing, and having a conical shape. [0064] Emb. 17. The container of any one of the embodiments above, wherein the first cross-sectional area is approximately constant.

[0065] Emb. 18. The container of any one of the embodiments above, wherein the second cross-sectional area is approximately constant.

[0066] Emb. 19. The container of any one of the embodiments above, wherein the first cross-sectional area is constant.

[0067] Emb. 20. The container of any one of the embodiments above, wherein the second cross-sectional area is constant.

[0068] Emb. 21. The container of any one of the embodiments above, wherein the first cross-sectional area is approximately cylindrical.

[0069] Emb. 22. The container of any one of the embodiments above, wherein the second cross-sectional area is approximately cylindrical.

[0070] Emb. 23. The container of any one of the embodiments above, wherein the first fluid measurement markings mark a first volume increment, wherein the second fluid measurement markings mark a second volume increment, and wherein the first volume increment is at least 10 times the second volume increment.

[0071] Emb. 24. The container of any one of the embodiments above, wherein the first fluid measurement markings mark a first volume increment, wherein the second fluid measurement markings mark a second volume increment, and wherein the first volume increment is at least 50 times the second volume increment.

[0072] Emb. 25. The container of any one of the embodiments above, wherein the container is closed except for one or more ports.

[0073] Emb. 26. The container of any one of the embodiments above, wherein the first quantity of fluid is greater than the second quantity of fluid. [0074] Emb. 27. The container of any one of the embodiments above, wherein the first quantity of fluid is at least twice the second quantity of fluid.

[0075] Emb. 28. The container of any one of the embodiments above, wherein the first quantity of fluid is at least thrice the second quantity of fluid.

[0076] Emb. 29. The container of any one of the embodiments above, wherein the container is closed except for two ports.

[0077] Emb. 30. The container of any one of the embodiments above, wherein: the first plurality of fluid measurement markings represents volume units of a first size; and the second plurality of fluid measurement markings represents volume units of a second size that is less than the first size.

[0078] Emb. 31. The container of any one of the embodiments above, wherein the upper portion is configured to contain a greater volume of fluid than the lower fluid- containing portion is configured to contain.

[0079] Emb. 32. The container of any one of the embodiments above, wherein at least one of the upper portion and the lower portion is at least partially constructed from translucent material.

[0080] Emb. 33. The container of any one of the embodiments above, wherein at least one of the upper portion102 and the lower portion 104 is at least partially constructed from tinted translucent material.

[0081] Emb. 34. The container of any one of the embodiments above, wherein: the upper portion 102 is at least partially constructed from translucent material; and the lower portion 104 is at least partially constructed from translucent material.

[0082] Emb. 35. The container of any one of the embodiments above, wherein: the upper portion 102 is at least partially constructed from translucent material; and the lower portion 104 is at least partially constructed from tinted translucent material. [0083] Emb. 36. The container of any one of the embodiments above, wherein at least one of the upper portion and the lower portion is at least partially constructed from transparent material.

[0084] Emb. 37. The container of any one of the embodiments above, wherein at least one of the upper portion 102 and the lower portion 104 is at least partially constructed from tinted transparent material.

[0085] Emb. 38. The container of any one of the embodiments above, wherein: the upper portion 102 is at least partially constructed from transparent material; and the lower portion 104 is at least partially constructed from transparent material.

[0086] Emb. 39. The container of any one of the embodiments above, wherein: the upper portion 102 is at least partially constructed from tinted transparent material; and the lower portion 104 is at least partially constructed from tinted transparent material.

[0087] Emb. 40. The container of any one of the embodiments above, wherein at least one of the upper 102 and the lower 104 portion are constructed from glass.

[0088] Emb. 41. The container 100 of any one of the embodiments above, wherein the upper portion 102 and the lower portion 104 are constructed from glass.

[0089] Emb. 42. The container of any one of the embodiments above, wherein at least one of the upper 102 and the lower 104 portion is constructed from flexible material that maintains an approximately constant cross-sectional area when fluid is present in said portion.

[0090] Emb. 43. The container of any one of the embodiments above, wherein: the upper portion 102 is constructed from a flexible material that maintains an approximately constant cross-sectional area when fluid is present in the upper portion; and the lower portion 104 is constructed from flexible material that maintains an approximately constant cross-sectional area when fluid is present in the lower portion.

[0091] Emb. 44. The container 100, 400 of any one of the embodiments above, constructed from a pharmaceutically compatible material.

[0092] Emb. 45. The container 100, 400 of any one of the embodiments above, wherein the interior of the container is sterile.

[0093] Emb. 46. The container 100, 400 of any one of the embodiments above, comprising an intravenous line connected to the first port 202.

[0094] Emb. 47. The container 100, 400 of any one of the embodiments above, comprising an intravenous line connected to the first port 202, said intravenous line terminating in a hypodermic needle.

[0095] Emb. 48. The container 100, 400 of any one of the embodiments above, comprising an intravenous line connected to the first port 202, said intravenous line terminating in an intravenous catheter.

[0096] Emb. 49. The container 100, 400 of any one of the embodiments above, comprising a feeding tube connected to the first port 202 for gastrointeric feeding.

[0097] Emb. 50. The container 100, 400 of any one of the embodiments above, comprising a feeding tube connected to the first port 202 for percutaneous endoscopic gastrostomy.

[0098] Emb. 51. The container 100, 400 of any one of the embodiments above, containing a pharmaceutical selected from one or more of: an anticancer agent, an antibacterial agent, an antiviral agent, an antifungal agent, a hormone replacement agent, a rehydrating agent, an anti-inflammatory agent, a serum, blood plasma, whole blood, platelets, immunoglobulin, and a parenteral nutrition composition. [0099] Emb. 52. The container 100, 400 of any one of the embodiments above, containing one or both of an additive and an admixture.

[00100] Emb. 53. The container 100, 400 of any one of the embodiments above, containing a pharmaceutical composition only in the lower portion.

[00101 ] Emb. 54. The container 100, 400 of any one of the embodiments above, containing a pharmaceutical composition only in the lower portion that is an antibacterial agent.

[00102] Emb. 55. The container 100, 400 of any one of the embodiments above, comprising a connector configured to support the container from an arm of an IV stand.

[00103] Emb. 56. The container 100, 400 of any one of the embodiments above, comprising a tab 108, 512 configured to support the container from an arm of an IV stand.

[00104] Emb. 57. A container 100 for the administration of a fluid to a patient, the container comprising: a semi-rigid mostly cylindrical upper portion 102 having a first cross-sectional area, and comprising a first plurality of fluid measurement markings 302 at a first interval; a semi-rigid conic intermediate portion 106 contiguous with the upper portion 102 and in fluid communication with the upper portion 102, and comprising a second plurality of fluid measurement markings 306 at about 25% of the first interval; a semi-rigid mostly cylindrical lower portion 104 contiguous with the intermediate portion 106 and in fluid communication with the upper portion 102 and intermediate portion 106, and comprising a third plurality of fluid measurement markings 304 at about 1 % of the first interval, and having a second cross-sectional area that is less than the first cross-sectional area; and a port in fluid communication with the lower portion and configured to connect to at least one of: an intravenous line and a feeding tube.

[00105] Emb. 58. A method of intravenously administering a fluid to a patient, the method comprising: connecting the container of any one of the embodiments above to an intravenous line; connecting the intravenous line to a vein of the patient; and allowing the fluid to flow from the container into the vein of the patient.

[00106] Emb. 59. A method of administering nutrition to a patient, the method comprising: connecting the container of any one of the embodiments above to a feeding tube; inserting the feeding tube into the patient’s gastrointestinal tract; and allowing the fluid to flow from the container into the patient’s gastrointestinal tract.

[00107] Emb. 60. The method of any one of embodiments 58-59, comprising: observing a first volume of fluid in the container at a first point in time, the first volume of fluid determined by a first fluid volume marking closest to the meniscus of the fluid at the first point in time; observing a second volume of fluid in the container at a second point in time, the second volume of fluid determined by a second fluid volume marking closest to the meniscus of the fluid at the second point in time; comparing the difference in the first and second volume over time to a target rate of volumetric flow from the container; and changing the volumetric rate of flow of the fluid from the container to achieve said target rate.

[00108] The method of embodiment 60, wherein the steps are initiated only after the meniscus of the fluid drops to the lower portion.

CONCLUSIONS

[00109] It is to be understood that any given elements of the disclosed embodiments of the invention may be embodied in a single structure, a single step, a single substance, or the like. Similarly, a given element of the disclosed embodiment may be embodied in multiple structures, steps, substances, or the like.

[001 10] The foregoing description illustrates and describes the processes, machines, manufactures, compositions of matter, and other teachings of the present disclosure. Additionally, the disclosure shows and describes only certain embodiments of the processes, machines, manufactures, compositions of matter, and other teachings disclosed, but, as mentioned above, it is to be understood that the teachings of the present disclosure are capable of use in various other combinations, modifications, and environments and is capable of changes or modifications within the scope of the teachings as expressed herein, commensurate with the skill and/or knowledge of a person having ordinary skill in the relevant art. The embodiments described hereinabove are further intended to explain certain best modes known of practicing the processes, machines, manufactures, compositions of matter, and other teachings of the present disclosure and to enable others skilled in the art to utilize the teachings of the present disclosure in such, or other, embodiments and with the various modifications required by the particular applications or uses. Accordingly, the processes, machines, manufactures, compositions of matter, and other teachings of the present disclosure are not intended to limit the exact embodiments and examples disclosed herein. Any section headings herein are provided only for consistency with the suggestions of 37 C.F.R. § 1.77 or otherwise to provide organizational queues. These headings shall not limit or characterize the invention(s) set forth herein.