WO2020181007A1 - Ensemble d'extension iv ou système d'ensemble iv avec collecteur de dérivation - Google Patents

Ensemble d'extension iv ou système d'ensemble iv avec collecteur de dérivation Download PDF

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Publication number
WO2020181007A1
WO2020181007A1 PCT/US2020/021028 US2020021028W WO2020181007A1 WO 2020181007 A1 WO2020181007 A1 WO 2020181007A1 US 2020021028 W US2020021028 W US 2020021028W WO 2020181007 A1 WO2020181007 A1 WO 2020181007A1
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WO
WIPO (PCT)
Prior art keywords
extension
primary
line
flow
flow line
Prior art date
Application number
PCT/US2020/021028
Other languages
English (en)
Inventor
Lucas Reichert
Edwin T. Bulloch
Anthony Clark Harward
Original Assignee
Somnus Medical, LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/417,269 external-priority patent/US11058813B2/en
Application filed by Somnus Medical, LLC filed Critical Somnus Medical, LLC
Publication of WO2020181007A1 publication Critical patent/WO2020181007A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009—Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1083—Tube connectors; Tube couplings having a plurality of female connectors, e.g. Luer connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1088—Tube connectors; Tube couplings having a plurality of male connectors, e.g. Luer connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/28—Clamping means for squeezing flexible tubes, e.g. roller clamps
    • A61M39/286—Wedge clamps, e.g. roller clamps with inclined guides
    • A61M39/287—Wedge formed by a slot having varying width, e.g. slide clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths

Definitions

  • Intravenous (IV) set to access the circulatory system of a patient, enabling the administration of fluids and medications in a controlled, predictable manner.
  • the typical TV set includes a primary fluid flow line of tubular construction with one or more access points. Some of these access points can comprise access ports that allow the
  • a primary ' access point is located at one end of the IV set with a fluid source, such as normal saline or some other carrier fluid.
  • a spike and drip chamber assembly is positioned at a terminus or proximal end of the flow line with means for attachment to a patient injection site on a distal end. Secondary flow lines may be combined with the primary' flow line with similar construction options.
  • the anesthesia provider In the operating room, or during transport to and from the operating room, the anesthesia provider must be prepared and able to quickly modify medication levels as required by hemodynamic changes in the patient’s state of being, as well as anesthesia demands and unexpected em rgencies. Confusion as to the correct identity of a given IV set can be a serious risk to the patient and a great frustration to attending medical personnel. The general absence of standardized labels, standardized positioning requirements along the I V sets, and inadequate IV port or access identification present an ongoing medical risk.
  • Maintaining convenient access to the correct IV set and ensuring proper line identification is the responsibility of each individual attempting to utilize the IV set at the same time. This competition for immediate access by multiple users can add considerable additional stress to an already stressful environment.
  • the various IV sets may be taped together or otherwise generally clipped into a bundle.
  • This grouping of multiple IV sets with intermittent access ports may become very confusing to multiple users of the compilation of IV sets, and is also very' time consuming.
  • Access points allow the various attending personnel to administer medications through a syringe by push or by infusion through an additional IV set. Not only does this additional structure add to the complexity of the compilation of IV sets with respect to possible line entanglement, but it also limits access for the practitioner using a more proximal access port. For example, when a fluid restriction is being observed (e.g., pediatrics, kidney failure, or complex surgery case), pushing a medication through an access point far from the patient becomes a problem. Boluses of fluid must be administered to deliver the medication from the proximal access points to a distal end terminating at the patient.
  • a fluid restriction e.g., pediatrics, kidney failure, or complex surgery case
  • FIG. 1 illustrates a plan view of an IV system in accordance with one exemplar ⁇ embodiment of the present invention
  • FIG. 2a illustrates a partial plan view of the exemplary IV set system of FIG. 1, and particularly one exemplary embodiment of a merging fluid pathway for the IV set system;
  • FIG. 2b illustrates a partial plan view of the exemplary IV set system of FIG. 1, with an alternative merging fluid pathway and access port configuration
  • FIG. 3a illustrates a plan view of an IV set system in accordance with another exemplar ⁇ embodiment of the present invention, the IV set system having several example embodiments of marking indicia;
  • FIG. 3b illustrates a partial plan view of the IV set system of FIG. 3A
  • FIG. 3c illustrates a partial plan view of the IV set system of FIG. 3A
  • FIG. 3d illustrates a partial side view of the IV set system of FIG. 3A
  • FIG. 4a illustrates a partial plan view of an IV set system comprising a plurality of integral inter-attached lines having a strippab!e property, in accordance with one exemplary embodiment of the present invention
  • FIG. 4b illustrates a partial plan view of an IV set system comprising a plurality of integral inter-attached lines having a strippable property, in accordance with another exemplary embodiment
  • FIGS. 5a and 5b illustrate respective cross-sections of the exemplary IV set systems of FIGS. 4a and 4b;
  • FIG. 6a illustrates a cross-sectional view of an TV set system having the secondary ' IV sets oriented and arranged with respect to the primary flow line of the primary IV set of the I set system, in accordance with one exemplary configuration and embodiment of the present invention
  • FIG. 6b illustrates a cross-sectional view of an TV set system having the secondary IV sets oriented and arranged with respect to tire primary' flow line of tire primary' IV set of the IV set system, in accordance with another exemplary ' configuration and embodiment of the present invention
  • FIG. 7a illustrates a partial plan view' of an IV set system having a manifold bypass device in use with a primary flow line of a primary IV set, in accordance with one exemplary' embodiment of the present invention
  • FIG. 7b illustrates a partial plan view of the IV set of FIG. 7A, the IV set comprising a manifold configuration in accordance with an exemplary alternative configuration
  • FIG. 7c illustrates a partial plan view of the IV set of FIG. 7 A, the IV se t comprising a manifold configuration in accordance with still another exemplary alternative configuration
  • FIG. 8 illustrates a partially exploded isometric view' of an IV extension set in support of a bypass manifold in accordance with an example of the present disclosure, the bypass manifold shown exploded from the main tubular flow' line (the extension flow line) of the IV extension set;
  • FIG. 9 illustrates a partially exploded isometric view of the IV extension set of FIG. 8 as connected to an exemplary IV set, such as to form a primary IV set extended by the IV extension set;
  • FIG. 10 illustrates a partial isometric view of an IV extension set, as coupled to an IV set, the IV extension set being in support of a bypass manifold in accordance with an example of the present disclosure, the bypass manifold being removably coupled to the extension flow line of the IV extension set via connectors formed on an incline angle relative to the extension flow line of the IV extension set;
  • FIG. 1 1 illustrates a partial isometric view of an IV extension set, as coupled to an IV set, the I extension set being in support of a bypass manifold in accordance with an example of the present disclosure, the bypass manifold being removably coupled to the extension flow line of the IV extension set via connectors formed on an incline angle relative to tire extension flow 7 line of tire IV extension set;
  • FIG. 12 illustrates a partially exploded isometric view of an IV extension set in support of a bypass manifold and a merging fluid pathway in accordance with an example of the present disclosure, the bypass manifold shown exploded from the main tubular flow' line (the extension flow line) of the IV extension set; and
  • FIG. 13 illustrates a partially exploded isometric view of the IV extension set of FIG. 1 as connected to an exemplary TV set, such as to fonn a primary IV set extended by the IV extension set.
  • the term“substantially” refers to the complete or nearly complete extent or degree of an action, characteri tic, property, state, structure, item, or result.
  • an object that is“substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed.
  • Tire exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained.
  • “adjacent” refers to the proximity of two structures or elements. Particularly, elements that are identified as being“adjacent” may be either abutting or connected. Such elements may also be near or close to each other without necessarily contacting each other. The exact degree of proximity may in some cases depend on the specific context.
  • an IV set is intended to mean a single IV line.
  • An IV set system is intended to mean at least a plurality of IV sets within the IV set system .
  • the IV set system can comprise additional elements or components operable with the IV set, such as a pump interface segment, a merging fluid pathway , a bypass manifold, an extension set, vari ous access points, or any combination of these.
  • An access point is intended to mean any point along the IV set in which access is provided to the fluid flow (or fluid flow path) within the IV set.
  • An access point can include such elements as access ports, spike/drip chambers, patient interconnect structures, fluid interconnect means, etc.
  • An access port is intended to mean a specific type of access point that facilitates access to the fluid flow path and fluid flow 7 within the IV set, for example by push (e.g., using a syrmge), by infusion (e.g., through fluid coupling of another IV set), or others as apparent to those skilled in the art.
  • An IV extension set is intended to mean a type of IV line that is removably coupled to an IV set and which functions to extend the IV set to which it is coupled (i.e., extend the flow line and the fluid flow path) and to provide added functionality and benefit, as explained below.
  • the present IV set technology focuses, without limitation, on meeting fluid delivery requirements, configuring or providing multiple IV sets with indicia to aid in line identification both by fluid type and primary user, configuring one or more IV sets within an I V set system to avoid entanglement of flow lines and to improve user access, adapting an IV set with a manifold bypass component for regulating multiple fluid sources within the same IV set, providing a merging fluid pathway and optimizing the position of this, and expanding the methodology of IV set technology to integrate a multi stage, multi-care venue historical identification aspect.
  • the use of the IV set has been segmented within various progressive stages of the patient experience. For example, at the scene of an accident, paramedics may apply an IV set for temporary relief and application of emergency procedures. Upon arrival at the emergency room, a new IV set may be substituted upon identification of particular needs of the patient. Once the patient is stabilized and an initial diagnosis is made, changes may again be required in the IV set or the now compilation of IV sets. Eventually, the patient may be moved to a hospital ward for further treatment and evaluation. Once again, further modifications may be needed with respect to the patient’s IV. If surger ' is ultimately required, the patient is typically prepared, which preparations can include additional modifications in IV set up as needed for delivery of anesthesia and other required medications.
  • An IV set system in accordance with some exemplary embodiments of the present invention can comprise a primary IV set having a proximal terminus, a distal terminus, and an intermediate tubular length defining a primary flow line and primary fluid flow path of the primar ' IV set.
  • the primary' flow line can include multiple access points along its length that facilitate access to the fluid pathway of the primary IV set, some of winch can comprise access ports.
  • the primary IV set can further comprise a merging fluid pathway proximate to the distal terminus in fluid communication with the fluid flow path and the various access points used to access tire fluid flow path.
  • patient set system can further comprise at least one secondary IV set having a secondary flow line.
  • the secondary ' IV set can be removably and fluidly coupled to the primary- IV set.
  • the secondary ' flow' line can be secured to the primary flow line.
  • the secondary IV set can also include a proximal terminus, a distal terminus, and an intermediate tubular length.
  • the proximal termini of each of the primary' IV set and of the at least one secondary IV set can further include a coupling structure for receiving a fluid source to be coupled to the IV set system for providing at least one fluid medium to a patient through the primary IV set.
  • the distal terminus of the at least one secondary IV set can also include a fluid interconnect of various types and configurations for attaching the distal terminus of the secondary' IV sets(s) to the primary ' IV set, such as via the merging fluid pathway near the distal terminus of the primary IV set.
  • the distal terminus of the primary flow line of the primary IV set can provide a patient interconnect for coupling the primary flow line of the primary IV set to a patient injection site.
  • the respective proximal terminus, access points, and distal terminus of the primary' IV set and each secondary' IV set can have a unique set of marking indicia to distinguish them from one another and other secondary flow lines.
  • the IV set system can further comprise one or more physically connected IV sets.
  • another exemplary aspect of this invention can be to integrally secure at least one secondary IV set to the primary I V set in a parallel relationship in at least a semi- continuous manner substantially along the intermediate tubular length of these. This can function to inhibit line entanglement within the IV set system.
  • at least one secondary ' IV set can be physically removably coupled to the primary IV set, and/or another secondary ' IV set, at one or more locations external to the fluid flow paths of each.
  • the tubular structures making up the respective IV sets and defining the fluid flow paths therein can be physically coupled together along their length.
  • this can be achieved by joining or physically linking the outer surfaces of the respective tubular structures together in a continuous manner. In another aspect, this can be done in a non-continuous manner. Moreover, the physical external connection of two IV sets can be done without interfering with the fluid flow paths of any of the IV sets.
  • the fluid flow paths can he caused to intersect or otherwise merge or come together.
  • the secured tubular lengths or the secured IV sets can be ideally configured for fully or partially peeling or stripping away from one another in a selectable fashion, such as only when needed or desired.
  • one or more secondary IV sets can be fully stripped from the primary IV set and discarded if not needed.
  • secondary IV set(s) can be selectively partially stripped away from the primary IV set as needed or desired to provide variable free lengths of the one or more secondary IV set(s), such as to facilitate fluidly connecting these to the primary IV set and establishing one or more secondary 7 flow 7 lines and corresponding flow paths with respect to the primary flow line and its corresponding flow path.
  • the primary IV set may also include a manifold device positioned proximate to the distal terminus of the primary IV set and mounted externally to the primary flow line, wherein the manifold can be removably coupled to the primary 7 IV set and configured to be in fluid communication with the primary flow line of the primary IV set.
  • the manifold thus functions as an alternate flow line and corresponding flow path configured to selectively bypass a specific segment of the primary flow line and its corresponding flow path.
  • a method for utilizing the same IV set system across various stages of patient care associated with applications of multiple IV procedures can comprise the steps of (a) selecting an IV set system having a primary IV set and one or more secondary IV sets integrally connected with the primary line at one or more positions external to the fluid flow path of each; (b) attaching tire IV set system to a patient during a first stage of medical care and starting IV flow using at least the primary IV set; and (c) optionally progressing through use of at least one successive stages of medical care, wherein at least one secondary IV set is used in each stage and retained, or whose indicia is retained, as part of the IV set system for later identification of the medical care provided during the respective two successive stages.
  • a method for pro viding selective identification of at least one flow line within an intravenous (TV) set system having (i) a primary IV set having a proximal terminus, a distal terminus, and an intermediate tubular length defining a primary flow line of the IV set system, and (ii) at least one secondary IV set defining at least one secondary flow line configured to feed to the primary flow line, the at least one secondary line having a proximal terminus, a distal terminus, and an intemiediate tubular length can comprise providing top-le el marking indicia on the primary IV set; and providing marking indicia on the secondary IV set different from the top-level marking indicia on the primary IV set.
  • the method can further comprise providing second-level marking indicia on the primary IV set, wherein the second-level marking indicia of the primary IV set matches the marking indicia of the secondary IV set providing a set of matching indicia across IV sets; providing additional second-level marking indicia on the primary IV set, wherein the IV set system further comprises an additional secondary IV set operable with the primar ' or secondary' IV sets, the additional secondary IV set comprising marking indicia that differs from the top-level marking indicia of the primary set and the marking indicia on the secondary IV set; matching the marking indicia on the additional secondary ' IV set with the additional second-level marking indicia on the primary' IV set; associating the second-level marking indicia on the primary IV set with an access point of the primary IV set, and associated the second-level marking indicia on the secondary ' IV set with an access poin t of the secondary IV set; and associating the various marking indicia of the primary and secondary IV
  • a method for managing use of an TV set system having a primary' IV set and at least one separably joined secondary IV sets can comprise initiating application of an IV to a patient along a primary IV set; identifying a first secondary IV set of the IV set system for administering a substance to the patient; at least partially stripping an upper end of the first secondary IV set from the IV set system to provide a free, unattached end to facilitate proper access and positioning thereof within the IV set system, while retaining an attached portion of the first secondary IV set, thereby reducing likelihood of entanglement of the primary and secondary ' IV sets; and stripping a lower end of the secondary IV set and coupling it to an access port located proximate a distal terminus of the primary IV set.
  • the method can further comprise completely stripping the secondary IV set from the IV set system following use.
  • a method for bypassing a primary flow path of a primary flow line within a primary IV set can comprise obtaining a primary TV set having a plurality of access points facilitating access to one or more fluid pathways of the primary IV set, at least some of the access points comprising access ports providing fluid access to a primary flow line of the primary IV set; diverting fluid from the primary flow line to a bypass flow line of a manifold removably and externally coupled to the primary IV set via the access ports, the manifold comprising one or more access points that facilitate access to the bypass flow 7 line: and providing, through tire manifold, an alternate primary flow path to a primary flow path through the primary flow 7 line.
  • the method can further comprise selectively actuating a flow control valve operable to selectively occlude fluid flow through the primary flow line of the primary IV set and to divert the fluid through the manifold and the bypass flow line; restoring fluid fl ow 7 through the primasy 7 flow 7 line of the primary IV set.
  • the present disclosure further sets forth an intravenous (TV) set system, comprising a primary IV set (e.g., a gravity or gravity 7 capable pump) having a plurality of access points facilitating access to one or more fluid pathways of the primary IV set, at least some of the access points comprising access ports providing fluid access to a primary flow line of the primary IV set; an IV extension set removably coupled to the primary IV set to form an extended primary IV set, the IV extension set comprising an extension flow line defining an extension flow path, and a plurality of access ports on the extension flow 7 line, at least two of the access ports comprising intermediate access ports located between first and second ends of the IV extension set; and a bypass manifold externally and removably coupled to the extension flow line of the IV extension set via the intermediate access ports on the extension flow line, the bypass manifold comprising a bypass flow 7 line adjacent the extension flow line, and one or more access points that facilitate access to the bypass flow 7 line, wherein the bypass manifold and the bypass flow line are operable
  • the extension flow line of the IV extension set and the primary flow line of the primasy 7 IV set together define an extended primary flow 7 line
  • the extension flow path defined by the extension flow line of the IV extension set and a primary flow path defined by the primary flow line of the primary IV set together define an extended primary flow path of the extended primary IV set
  • the IV set system can further comprise a secondary IV set removably coupleabie wi th the TV extension se t via one of the access points of the IV extension set, the secondary IV set comprising a plurality of access points facilitating access to one or more fluid pathways of the secondary IV set.
  • the present disclosure further sets forth an intravenous (IV) extension set for use with a primary IV set to form an extended primary IV set, the IV extension set comprising an extension flow line defining an extension flow path; a first connector portion secured to a first end of the extension flow line, the first connector portion being configured to releasably couple to a corresponding connector portion of a primary IV set; a second connector portion secured to a second end of the extension flow line; first and second access ports on the extension flow line between the first and second connector portions; and a bypass manifold externally and removably coupleabie to the extension flow line via the first and second access ports of the extension flow line, the bypass manifold comprising a bypass flow line adjacent the extension flow 7 line, and one or more access points that facilitate access to tire bypass flow line, wherein the bypass manifold and the bypass flow line are operable to provide an alternate, bypass flow path through the IV extension set.
  • IV intravenous
  • the present disclosure further sets forth an IV set system, comprising a primary IV set comprising a primary flow 7 line defining a primary flow 7 path, the primary IV set comprising a plurality of access points, at least some of the plurality of access points comprising access ports; an IV extension set removably coupled to the primary IV set to form an extended primary IV set, the IV extension set comprising an extension flow line having a first connector portion supported on a first end of the extension flow line, and a second connector portion supported on a second end of the extension flow line, the extension flow line defining an extension flow 7 path; a plurality of access points, at least some of the plurality 7 of access points comprising first and second access ports in fluid communication with the extension flow path; a bypass manifold externally and removably coupleabie to the extension flow line via the first and second access ports of the extension flow line, the bypass manifold comprising a bypass flow line adjacent the extension flow 7 line, and one or more access points that facilitate access to the bypass flow line, wherein the bypass
  • the present disclosure further sets forth a method for bypassing a primary flow path of a primary flow line within a primary IV set, the method comprising obtaining a primary IV set having a plurality of access points facilitating access to one or more fluid pathways of the primary IV set, at least some of the access points comprising access ports providing fluid access to a primary flow line of the primary IV set: connecting the primary IV set to an IV extension set comprising an extension flow line defining an extension flow path, the primary 7 IV set and the IV extension set forming an extended primary IV set having an extended primary flow line defining an extended primary flow path; diverting fluid from the extension flow line to a bypass flow line of a bypass manifold removably and externally coupled to the extension flow line of the IV extension set via first and second access ports on the extension flow line of the IV extension set, the bypass manifold comprising one or more access points that facilitate access to the bypass flow line and the extension flow line; and providing, through the bypass manifold, a bypass extended primary flow path alternate to the extended primary flow path
  • the present disclosure further sets forth an IV set system comprising a first IV line having a fluid flow line defining a flow path; a second IV line having a fluid flow line defining a flow path, the second IV being removably coupled to the first IV line in an in-line arrangement to form an extended IV line, wherein the fluid flow line of the first IV line and the fluid flow line of the second I V line are in flu id communication with one another; and a bypass manifold operable with and supported by the fluid flow line of the second IV line, wherein the bypass manifold comprises a bypass flow line adjacent the fluid flo line of the second IV line, and one or more access points that facilitate access to the bypass flow line, wherein the bypass manifold and the bypass flow line are operable to provide a bypass flow path alternative to the flow path through the second TV line.
  • the first IV line can comprise a plurality of access points.
  • the second IV line can comprise a first connector portion supported on the fluid flow line of the second IV line proximate a first end of the fluid flow line; and a second connector portion supported on a second end of the fluid flo line of the second IV line, wherein the first IV line comprises a connector portion supported on a second end of the fluid flow line of the first IV line that removably couples with the first connector portion of the second TV fine, and wherein the second connector portion of the second IV line is operable to be coupled to a patient interconnect device at a patient site.
  • the second IV line can comprise a plurality of access points, at least some of the plurality of access points comprising first and second access ports in fluid communication with the fluid flow path of the second IV line, and wherein the bypass manifold is removably coupled to the fluid fl ow line of the second IV line via the fi rst and second access ports.
  • the IV set system can further comprise a merging fluid pathway supported on die fluid flow line of die second IV line, the merging fluid pathway comprising at least one access port facilitating fluid access to the fluid flow line of the second IV line.
  • the present disclosure further sets forth a primary IV set comprising a first flow line segment; a second flow line segment removably coupleable to the first flow' line segment to define a primary' flow line and a primary flow path through the first and second flow line segments; and a bypass manifold removably coupled to the second flow line segment, and defining a bypass flow line, wherein the bypass manifold and the bypass flow line are operable to provide a bypass flow path alternative to the primary flow path through the primary flow line.
  • the present disclosure further sets forth a primary IV set flow 7 line segment operable with another primary 7 IV set flow line segment to form a primary IV set, die primary IV set flow 7 line segment comprising a flow line defining a proximal end, a distal end, and a flow 7 path; a first connector portion supported about the proximal end operable to be coupled to a mating connector portion supported on a distal end of a second primary IV set flow line segment, the first connector portion and the mating connector portions defining a connector facilitating the primary IV set flow line segment to be removably coupled to the second primary IV set flow line segment to form a primar IV set; and a bypass manifold supported by the primary IV set flow line segment, and defining a bypass flow line, wherein the bypass manifold and the bypass flow 7 line are operable to provide a bypass flow 7 path alternative to the flow path through the flow line of the primary IV set flow line segment.
  • Pre-coded IV Sets/Set systems [0063] Some exemplar ⁇ ' embodiments of the present invention represent a change in perspective, endeavoring to actually anticipate and preserve some measure of historical data regarding use of the IV set system as part of the IV structure itself.
  • a multi-set IV set system can be applied which is capable of being adapted for use in subsequent procedures without discarding earlier components and applications of the TV set system.
  • various routine IV procedures can be structurally encoded by incorporating a particular color, shape or appropriate identification to differentiate the various IV sets of the IV set system. These various IV sets can be selectively utilized at sequential stages of medical care of the patient.
  • that secondary IV set can be partially or completely stripped away from the primary ' IV set and discarded. Nevertheless, the identity' of the discarded secondary IV set can be preserved at the primary IV set for future reference by configuring the IV sets, or their various access points, to comprise matching indicia. More specifically, the secondary IV set(s), and/or their access points, can comprise indicia that matches indicia on the primary IV set.
  • the primary' IV set can comprise an access port operable to fluidly couple or interconnect with a corresponding access point on a secondary' IV set.
  • the access port of the primary IV set can comprise indicia that matches indicia on the access poin t of the secondary IV set. Therefore, in the event the secondary IV set is discarded, corresponding or matching indicia present on the remaining primary IV set can indicate the previous presence of the discarded secondary IV set, which indicia can provide useful historical data to medical personnel.
  • Providing pre-coded IV sets within the IV set system itself provides an initial cue to patient information, the details of which are provided on the patient chart. Providing pre-coded IV sets can also speed up the decision process by increasing the awareness of medical personnel with respect to the patient’s treatment history'. Of course, in order to minimize entanglement and confusion, some IV sets can be purposefully adapted to be quickly stripped from the IV set system or rendered unusable when their historical value is nominal.
  • the use of individually distinguishable IV sets having standard unique designations corresponding to standard IV procedures gives medical personnel the ability to quickly select an appropriate IV set from among the various available marked IV sets within the IV set system. For example, the use of a coded IV set specifically reserved for pain medication among the plurality of IV sets within the IV set system provides the medical attendant with an immediate preference of choice in selecting an IV set for administering pain medication.
  • pre-coded IV sets as part of an IV set system provides at least two significant advantages.
  • First, such a practice would assist medical staff in quickly identifying previous procedures applied to the patient, thereby increasing the level of awareness of medical personnel to the patient’s history.
  • having multiple pre-coded IV sets available could simplify the selection of an appropriate line for a current procedure. For example, with a knowledge of a specific, predetermined function of the IV set to be applied, attending personnel can quickly identify the corresponding I V set which has that coded function. Many forms of identification can be applied with respect to the individual sets of an IV set system.
  • These may include, but are not limited to, specific colors, shapes, tactile indicators or indices, tags or other indices that could be respectively allocated and standardized for medications associated with blood, pain medication, anesthesia, etc., as well as any others and/or combinations of these .
  • primary IV sets contain multiple access points that facilitate access to one or more fluid pathways within the IV set.
  • IV sets comprise access points through which fluids (e.g , medications) may be administered. It is standard practice that when an IV is started on a patient that a carrier fluid (normal saline is one example) will be attached and administered. Future medications are administered through the access points along that primary IV set.
  • fluids e.g , medications
  • access points allo medications to be given over multifarious intervals (i.e rapid administration of medications pushed through a syringe by a practitioner, additional IV sets added and medications given at a rate determined by the position of a roller clamp or more specifically by a pump with a set rate, etc.)
  • additional IV sets are used with this primary (carrier) IV set and the growing compilation of IV sets, the potential for miss-identification of access points belonging to the primary IV set increases exponentially. For example, if a primary' IV set contains four access points, an additional or secondary' IV set could also contain two, three, four or more access points. These additional access points may be difficult to distinguish from those of the primary ' IV set.
  • One exemplary' embodiment of the present invention includes the addition of marking indicia on or about (in close proximity to) at least two access points, and alternatively at or about each access point, of the primary- IV set.
  • marking indicia can further be located on or at other locations along the primary' IV set.
  • the marking indicia function to help locate and differentiate the primary IV set and its access points from other secondary I V sets either initially present, or added throughout the healthcare deliver ⁇ process.
  • the primary IV set itself and/or the various access points along the primary IV set can be configured with unique and marking indicia to distinguish it and the access points from other secondary IV sets to facilitate rapid line identification.
  • both the proximal and distal termini, and/or the various access points, of each secondary IV set can also have unique marking indicia different from the primary TV set and other secondary IV sets to distinguish them for rapid identification of priming, connection and disconnection.
  • an IV set system in accordance with an exemplary embodiment of the present invention can include an IV line 100, which in some examples can comprise a primary IV set, having a proximal terminus 102, a distal terminus 104, and an intermediate tubular length 106 defining a primary flow line 108 of the primary IV set 100, such as for providing saline carrier fluid.
  • the primary 7 flow 7 line 108 can have multiple access ports 110 along its length, such as for administering various medications needed by the patient, facilitating coupling of an external manifold to establish a bypass flow line, and others.
  • access ports 110 can be self-sealing, meaning that they are capable of facilitating flow when in use, and prohibiting or sealing off flow when not m use.
  • the access ports 110 can comprise any type or can be used for any purpose as recognized by those skilled in the art.
  • the access ports 110 can he used to couple or removably couple a syringe for pushing fluid into the primary flow line 108, they can be used to couple or removably couple another IV line, such as a secondary IV set to facilitate infusion of a fluid into the primary flow line 108, etc.
  • an IV set system can comprise a first IV line (e.g., a gravity or gravity capable pump IV set) operable with a fluid source, and having a fluid flow line defining a flow path that is operable to be connected to the IV line 100, which can be referred to as a second IV line in this instance.
  • a first IV line e.g., a gravity or gravity capable pump IV set
  • a fluid flow line defining a flow path that is operable to be connected to the IV line 100, which can be referred to as a second IV line in this instance.
  • the first IV line which can be referred to as a primary IV set (e.g , a gravity or gravity capable pump IV set) can be connected to the IV line 100 via the access port 110 located at the proximal fi rst end of the fluid flow line of the IV line 100, the access port comprising connecting portion 1 1 1 operable to removably couple the first IV line to the second IV line in an in line arrangement to form an extended IV line, wherein the fluid flow line of the first IV line and the fluid flow 7 line of the second IV line are in fluid communication with one another.
  • a primary IV set e.g , a gravity or gravity capable pump IV set
  • the second IV line 100 can have a fluid flow line 108 defining a flow path, and a bypass m anifold 140 operable with and supported by the fl uid flow line 108 of the second IV line 100, wherein the bypass manifold 140 comprises a bypass flow line adjacent the fluid flow line 108 of the second IV line 100, and one or more access points that facilitate access to the bypass flow line 108, wherein the bypass manifold 140 and the bypass flow line 108 are operable to provide an alternate, bypass flow path through the second IV line 100.
  • second IV line 100 can instead function as a primary IV set and the access ports 110 can comprise a first connector portion of an interconnect or connector operable to couple with a second connector portion of the interconnect or connector.
  • the access ports 110 each comprise a first connector portion 132 in the form of a female portion of a Luer Lock.
  • Secondary IV sets each comprise a second connector portion 133 in the form of a male portion of a Luer Lock.
  • the TV set system can further comprise at least one secondary TV set (e.g., see secondary IV sets 116, 118, 120) physically and removably coupled to the primary' IV set 100, such as via access ports 110.
  • the one or more secondary IV sets 116, 118 and 120 can further be removably and fluidly coupled to the primary IV set 100 via the one or more access ports 110 of the primary IV set 100, such as via those forming the merging fluid pathway 154, wherein the fluid flow paths of the secondary IV sets 116, 118 and 120 and the primary IV set 100 are in fluid communication with one another, or in other words, come together or merge.
  • the IV set system can further comprise a merging fluid pathway 154 comprised of at least one access port 110 on the second IV line (or the primary IV set) 100.
  • the merging fluid pathway 154 can be positioned on the primary IV set 100 about the primary flow' line 108 proximate to the distal terminus 104 to minimize the amount of fluid in the primary IV set between the merging fluid pathway and the patient interconnect.
  • the access ports 1 10 of the merging fluid pathway 154 can be spaced at a predetermined distance from each other about the primary- TV set 100. In the example shown in FIG. 2A, the access ports 110 can be oriented at a 90- degree orientation relative to the primary flow line 108.
  • FIG. 2B illustrates that the IV set system of FIGS. 1 and 2A can comprise an alternative configuration of a merging fluid pathway.
  • the merging fluid pathway 154' comprises access ports 1 10' oriented on about a 30 degree orientation relative to the primary flow line 108' of the primary IV set 100'.
  • This orientation will likely provide smoother flow transitions of fluids from the secondary IV sets 116', 118', and 120', shown as being fluidly coupled to the primary IV set 100', into the flow path of the primary' IV set 100' over the configuration of the access ports 110 shown in FIGS. 1 and 2A oriented on a 90 degree orientation.
  • the one or more secondary ' IV sets 1 16, 118 and 120 can by physically and separably connected to the primary' TV set and/or one another.
  • the secondary IV sets 116, 118 and 120 can be configured to be stripped or peeled away from tire primary IV set 100 as needed as desired. This concept is discussed in greater detail below .
  • Each secondary IV set can comprise a proximal terminus 122, a distal terminus 124, and an intermediate tubular length 126.
  • the proximal termini of the primar IV set 100 and the one or more secondary lines can be adapted with a coupling structure 130 for receiving a fluid source to be coupled to the IV set for providing at least one fluid medium to a patient through the primary IV set 100.
  • the distal terminus 124 of the one or more secondary line(s) can include fluid interconnect means 132 for attaching the distal terminus 124 of tire one or more secondary lines to one of the access ports 1 10 of the merging fluid pathway 154 near the distal terminus 104 of the primary IV set 100.
  • the distal terminus 104 of the primary IV set 100 can further include a patient interconnect structure 134 for coupling the primary flow line 108 of the IV set to a patient injection site 114.
  • the merging fluid pathway 154 can comprise at least one access port/fluid interconnect in direct fluid communication with the primar flow line 108 of the primary IV set 100.
  • the merging fluid pathway 7 154 can be located anywhere along die primary 7 IV set 100. In one aspect, the merging fluid pathway 154 can be located on the primary IV set 100 below a midpoint of the primary IV set 100. In another aspect, the merging fluid pathway 154 can be located on the primary IV set 100 at or near the distal terminus 104 of the primary IV set 100. In a more specific aspect, the merging fluid pathway 154 can comprise the distal most access ports/fluid interconnects of the primary IV set 100, such as those access ports 110 shown in FIG. 2A.
  • the merging fluid pathway 154 can provide a merging of fluid from the fluid source (e.g., secondary IV set, syringe, etc.) connected to it directly with the fluid of the primary' IV set 100.
  • the merging fluid pathway 154 can provide a final stage of fluid injection or infusion to the primary flow line 108 of the primary' IV set 100 prior to the point of attachment of the primary' IV set 100 to the patient at injection site 114. This final stage may also be followed by a final segment of flow along the distal terminus 104 of the primary IV set 100 to facilitate the merging of fluids within the primary' flow ' line 108 immediately prior to injection into the patient.
  • these benefits can include precise timing of medications, rapid drug response due to location just proximate to IV insertion site, thus avoiding delays in delivery' of medication to the patient, strict control of fluid volume, the ability' to disconnect secondary ' lines leaving minimal amount of medication in the primary' line, and the ability to disconnect and reconnect to the merging fluid pathway 154 during a patients multi-staged care.
  • this configuration provides increased hemodynamic stability independent of change to the rate of flow through the primary flow line 108.
  • This merging fluid pathway 154 may' be arranged in a unilateral orientation (extending in the same direction within a common plane), bilateral (extending in opposing directions) (e.g., see FIG. 2) or circumferential arrangement (extending radially outward). The placement of this merging fluid pathway 154 can provide the caregiver with many options for both fluid management and medication delivery' control.
  • each of the proximal terminus, access points, and distal terminus of the primar IV set 100 can include one or more unique marking indicia to distinguish the primary IV set 100 (an its access points) from one or more secondary IV sets, and to facilitate rapid line identification for each TV set within the IV set system .
  • the marking indicia can be uniform, or configured in accordance with some other arrangement. Any slide clamps, roller clamps, or oilier elements associated with the primary IV set 100 can comprise the same indicia as the other indicia on the primary TV set 100. Similarly, the respective proximal terminus, access points, and distal terminus of any or all secondar IV sets can include one or more unique marking indicia to distinguish it from other secondary IV sets and the primary IV set that may have differing indicia. These too can be uniform or configured in accordance with some other arrangement.
  • the primary IV set 100 can comprise both top-level and second-level marking indicia, wherein the second-level marking indicia matches the marking indicia on a secondary IV set operable with the primary IV set 100.
  • the present description pertaining to coding of the various IV sets within an IV set system is applicable to the IV set system of FIGS. 1 -2B, even if such description is in relation to another embodiment.
  • the IV set system illustrated in FIGS. 1-2B can comprise marking indicia as set forth and described in any of the embodiments discussed herein, as will be recognized and as can he applied by one of ordinary skill in the art.
  • the IV set system of FIGS. 1-2B can further comprise individual IV sets (primary and one or more secondary IV sets) that are physically and separably joined together in at least a semi-continuous manner substantially along their length, such as by attachment members 160, to inhibit entanglement with one another.
  • the IV sets separably joined together in a manner that facilitates partial or full stripping of one IV set from another IV set. It is contemplated herein that the IV set system of FIGS. 1-2B can comprise separably joined IV sets as set forth and described in any of the embodimen ts discussed herein, as will be recognized and as can be applied by one of ordinary skill in the art.
  • the IV set system of FIGS. I-2B can further comprise a manifold 140 externally coupled to the primary IV set via at least some of the access ports of the primary IV set, the manifold comprising a bypass flow line adjacent the primary flow line, and one or more access points that facilitate access to the bypass flow line, wherein the manifold and the bypass flow line provide an alternate primary flow path to a primary flow path through the primary ' flow line.
  • the IV set system of FIGS. 1-2B can comprise a bypass manifold as set forth and described in any of the
  • FIG. 3 A illustrates an IV set system in accordance with another example of the present disclosure.
  • the IV set system in FIG. 3 A is similar in many respects to the IV set system illustrated in FIGS. 1-2B in that it can comprise many of the same elements.
  • the discussion above with respect to the example TV set system of FIGS. 1-2B is applicable to the IV set system of FIG. 3 A unless otherwise noted.
  • the IV set system in FIG. 3A comprises a plurality of secondary IV sets attached to a primary ' IV set 200.
  • the IV set system of FIG. 3 A can further comprise a bypass manifold 240 as set forth and described in any of the embodiments discussed herein, as will be recognized and as can be applied by one of ordinary' skill in the art.
  • the secondary' IV set 216 is shown as being distinguishable from the other secondary' IV set and the primary ' IV set 200 by clearly marked indicia, namely circular rings 238, located at both the proximal and distal termini of the secondary IV set 216.
  • the primary IV set 200 can comprise its own, different marking indicia, as discussed above.
  • the spike structure 230 above the drip chamber 242, as well as the various access ports 210 can have a different set of marking indicia that distinguishes the primary' IV set 200 from any of the secondary IV sets.
  • these marking indicia can form part of the original construction of the respective lines of the IV set, being fabricated as part of the original structure.
  • These marking indicia may include, but are not limited to texture, color and shape.
  • the marking indicia can be manufactured independent of the IV sets, and later applied or otherwise associated with the various primary' and secondary' IV sets of the IV set system subsequent to their initial manufacture.
  • the marking indicia can be associated with the lines in the IV set system, as will be recognized by those skilled in the art.
  • the marking indicia can comprise various objects, indicators, etc.
  • marking indicia may also include color, geometric shape, size and texture, or any other tactile and/or visual element that can enable the attending personnel to quickly and accurately identify a given TV set within the IV set system .
  • each of the IV sets can comprise top-level indicia, identified as top-level indicia“TL,” specific to that particular IV set, yet different from the top-level indicia of surrounding IV sets.
  • each TV set in the IV set system can comprise a different set of top-level indicia, which can be uniform (the same), wherein their primary function is to identify and distinguish each IV set from any other IV set in the IV set system.
  • the primary IV set 200 comprises top-level indicia TLp at the proximal and distal termini .
  • the primary line 200 comprises top-level indicia TLP along its length.
  • the top-level indicia can be uniform about the length of the primary IV set 200.
  • the primary IV set 200 comprises top-level indicia TLp in the form of a plurality of spherical shaped objects 244 located at the proximal and distal termini, as well as at or near the drip chamber 242, and access ports 210.
  • the spherical objects 244 can further comprise additional indicia, such as a textured surface (see pattern of bumps 246 formed thereon). Numerous variations in colors, shapes and textures can be employed.
  • the primary IV set 200 can comprise top-level indicia located directly on each of its access points, such as the access ports 210 (e.g., the access ports 210 comprising a distinguishing color).
  • Tire secondary IV sets 216 and 218 physically and fluidly coupled to the primary IV set 200 can also comprise top-level indicia“TLsr” and“TLs2,” respectively, which can be uniform about the length of the secondary IV sets 216 and 218.
  • secondar ' IV set 216 comprises top-level indicia TLsr in the fonn of circular rings located at the distal termini
  • secondary IV set 218 comprises top-level indicia TLs2 in the form of colored adhesive strips 252.
  • Secondar IV sets 216 and 218 can alternatively comprise top-level indicia directly on each of its access points, such as the interconnects on the proximal and distal termini.
  • the secondary IV sets 216, 218 can he devoid of indicia, wherein if used with the primary IV set 200 these two I V sets will be distinguishable from one another
  • each of the primary and secondar IV sets within the IV set system can each further comprise one or more second-level marking indicia, wherein the second-level marking indicia from one IV set can be configured to match with a corresponding second-level indicia of another IV set, thus providing a set of matching indicia across IV sets.
  • the matching indicia can operate to provide a particular identifying trait or feature pertaining to the associated IV sets.
  • the primary IV set 200 comprises second-level indicia“2Lp” located on a nipple 211 of an access port 210 operable to fluidly and removably couple with an interconnect portion 233 located on tire distal termini of the secondary IV set 218, thus the matching second-level marking indicia is intended to be located on or about or in close proximity to two access points of the primary and secondar TV sets that correspond with or that are intended to correspond with one another (e.g., die fluid coupling of an access point on the secondary IV set with a particular access port on the primary IV set).
  • the secondary IV set 218 is shown as comprising second-level indicia“2Ls2” on the interconnect 233 that couples to the access port 210.
  • the second-level indicia of the primary IV set 200 can be configured to match the second-level indicia of tire secondary IV set 218 at the location where the secondary' IV set 218 couples to the primary IV set 200.
  • the second-level indicia 2Lp and 2Lsz can be colored coded to comprise the same color.
  • the second-level indicia of the primary I V set 200 is concealed, thus maintaining the uniformity of indicia about the primary IV set 200 by way of the top-level indicia thereon.
  • the second- level indicia of the primary IV set 200 will be visible to attending medical personnel.
  • the second-level indicia 2Lp on the primary IV set 200 visible, medical personnel can quickly and easily perform line identification and other tasks, as 'ell as possibly- being provided with historical data pertaining to the use of the IV set system. Matching indicia present on the remaining primary- line can indicate the previous presence of the particular secondary IV set 218. Those skilled in the art will recognize that the second- level indicia 2Ls?. on the secondary IV set 218 can function as a top-level indicia.
  • the secondary- IV set 218 will only comprise only a single level of marking indicia, namely indicia that matches the second-level indicia on the primary TV set 200 .
  • secondary' IV set 216 operable with the primary IV set 200 can also comprise its own top-level and/or second- level indicia different from that of the first secondary IV set, and that matches different second-level indicia on the primary IV set 200, such as that associated with another access port 210.
  • Idle use of multiple or different indicia e.g., including one or more of shape, size, color and texture
  • Vasopressors - indicia type one e.g., purple
  • Narcotics - indicia type three e.g., blue
  • the marking indicia can be further coordinated to represent a group of medical IV procedures corresponding to a particular medical condition or procedure. In this manner, medical specialists can become accustomed to the regular and exclusive use of particular indicia associated with their field of medicine.
  • Such examples can include:
  • Chemotherapy - colored strips or other annular indicia See colored adhesive strips 252).
  • Attending medical personnel can also be assisted in making a correct selection of an IV set in any given procedure based on the IV code identification, rather than merely making random selection of a line from a bundled IV set.
  • An overall advantage of such a system can be to contribute to improved organization and access to the respective IV sets, as well as improved predictability in the administration of an IV. It will be apparent to those skilled in the art that the concepts of unique identification se t forth in this application can be modified in various ways without departing from the invention.
  • IV Sine entanglement is also a major concern in any tertiary care facility. Not only is safety a concern, but time and ease of management for practitioners in tSrese environments is also a worry.
  • benefits associated with the present invention utilizing, for example, color or other indicia coded components, consider a typical experience of a 70 year-old patient arriving at the emergency department with a fracture of the femur. On being admitted, it is determined surgery will be necüy. Suppose the patient has a history of hypertension, coronary artery disease and is a non- insulin dependent diabetic.
  • an appropriate IV set system having physically removably coupled and integrated multiple flow lines having various marking indicia thereon can be selected for the patient.
  • Using a multi-set system with indicia coded lines for the respective potential medications and fluids for this patient provides familiar IV set system choices for each attending medical person.
  • the present disclosure contemplates and the described invention facilitates use of a single IV set system for the length of the stay and across multiple stages of care.
  • the selection process can include an awareness of the patient’s existing co morbidities.
  • a three-set e.g., one primar ' and two secondary IV sets
  • the main or primary IV set can be used for IV fluids and to push medication administration to the patient injection site.
  • the two secondary IV sets can be available for IV drip or medication infusions as needed.
  • Tire patient can then be prepped for the operating room using this single IV set system.
  • the anesthesia provider can quickly visually inspect and interrogate the IV set system and its coded IV sets and corresponding flow lines and identify or determine which line is to be used for administering general anesthesia.
  • the patient becomes hypotensive and a vasoactive medication drip needs to be administered through one of the secondary ' TV sets, one of these components of the IV set system can also already be available for use and easily identifiable with its distinguishable marking indicia.
  • An insulin drip can be on standby 7 and ready for use to be administered through the remaining secondary IV set if needed.
  • the patient stays overnight in the surgical ward, and when the patient stabilizes, it is likely that the insulin and vasoactive medications will no longer be needed.
  • the anesthesia provider can stop the additional infusions and strip away or remove one or more of the two secondary IV sets from the other secondary IV sets and/or the primary IV set, which can remain intact for use on the surgical ward.
  • the use of coded IV sets can avoid the prior known difficulties of selection in the various medical situations encountered.
  • each IV set system can comprise a primary IV set and one or more secondary IV sets joined to the primary IV set and/or an additional secondary IV set. Additionally, each line of each IV set can be properly coded for unique identification.
  • Secondary IV sets can further be appropriately fluidly coupled to the primary IV set, providing a recognizable system for the attending personnel.
  • a manifold coupling system can also he used with the IV set system to simplify multiple stages of patient treatment. If medical staff members are uncertain of the potential procedures to be applied to a patient, an IV set system can be selected which includes physically and separably joined or connected (e.g., integrally separably connected) IV sets for several likely procedures that could arise, enabling attending individuals to have immediate access to an existing I V set coupled to the patient.
  • the versatility of pre-coded IV sets grouped for pre-selection according to the anticipated needs of the patient offers greater convenience, safety, and ultimate cost savings over prior IV set solutions through reduction of errors and risks within the medical care arena.
  • a Total Intravenous Anesthetic or TIVA is the administration of anesthesia utilizing IV medications as opposed to inhaled anesthetics to maintain a general anesthetic.
  • Common medications essential, but not limited, to a TIVA are a
  • the merging fluid pathway can be located on the primary IV set at or near the distal terminus.
  • the MFP can comprise at least one access port/fluid interconnect on the primary flow line in close proximity to the distal terminus of one or more secondary IV set(s) to subsequently be fluidly coupled to the primary IV set.
  • These secondary IV sets can be physically and separably joined (e.g., integrally secured) to the primary IV set in a parallel relationship in at least a semi-continuous manner at least partially along their tubular length to inhibit line entanglement, facilitate rapid line identification and gravity priming (see, for example, the representative methods of attachment between the primary and secondary IV sets illustrated in FIGS. 5 and 6). Attachment between IV sets maintains the respective lines in an orderly array, even when several attending personnel are concurrently making use of the IV system for various procedures. Coding indicators on one or more of these lines enables rapid identification in accordance with the intended purpose for any given line and/or access port.
  • anesthetic agents are often used to facilitate scope and instrument placement and manipulation as well as patient comfort.
  • the present IV set system will allow a secondary IV set that is separably joined to a primary IV set as the means of administrating the sedative/hypnotic agent. Advantages are reduced line entanglement and allowance for rapid onset of any secondary ' medication(s) administered through a secondary' IV set due to the distal location of tire MFP; even with slow primary- flow rates.
  • Anesthesia for a complex patient involves administration of many different medications, often simultaneously, and includes but is not limited to sedatives/hypnotics, narcotics, paralytics, insulin, vasopressors to manipulate blood pressure, and medications to support heart rate, and contractility of the heart.
  • IV access is often limited so all these medications are run via secondary TV sets connected to syringe and infusion pumps into a primary IV set that serves to deliver the carrier fluid. Over fluidization, line entanglement and IV set identification are constant problems encountered during these complex cases. With the limited number of access ports on currently available primary line IV sets, distal connection for these potent and potentially lethal medication lines is an issue.
  • Some embodiments of the present IV set system solve these problems and provide various advantages, such as allowance for rapid onset of any secondary medication(s) administered through a secondar ' line due to the distal location of the MFP (even with slow primary' flow rates), thus reducing total fluid required through the primary IV set limiting over fluidization; reduced line entanglement and identification difficulty related to all secondary' IV sets being separably connected to the primary IV set and having each with its own unique marking indicia to allow for rapid identification of each separate line; the ability to administer medications at a distal location while maintaining hemodynamic stability regardless of flow rate changes in the primary ' flow line; the ability to discontinue one or more secondary' IV sets with minimal residual amounts of medication in the primary flow line, thereby decreasing the risk of an over dose; and others as will be recognized by those skilled in the art.
  • the array of a plurality of secondary ' IV sets integrally connected in combination with a primary IV set avoids the inevitable entanglement of the various lines during patient care IV set positioning remains orderly and predicable throughout the applied procedures by numerous medical personnel. Rapid identification of each IV set with its designated function is facilitated by appropriate marking indicia provided on the TV sets.
  • the present invention provides for separable attachment at least between the secondary IV sets of the IV set system, and also with the primary IV set as well.
  • the present invention incorporates the ability to fully or partially strip one or more separably connected IV sets away from the other IV sets when they are no longer needed or no longer serve a function.
  • the IV set system in some examples, can comprise one or more IV sets (primary, secondary, or both) that are separably connected to one another so as to be fully or partially separable or strippabie. This property of“strip- ability” may be accomplished in several ways and with several types of construction.
  • FIG 3 A illustrates the IV set system as comprising attachment points 260 that physically separably join the primary' IV set 200 to the secondar ' IV sets 216 and 218.
  • Tire IV set system illustrated in FIG. 3A can comprise separably joined IV sets as set forth and described in any of the embodiments discussed herein, as will be recognized and as can be applied by one of ordinar ' skill in the art.
  • FIG. 4b illustrates an IV set system similar to the one shown in FIG. 3.
  • the IV set sy stem of FIG. 4b is shown as comprising a primary' IV set 400 and two secondary' IV sets 416 and 418 that are separably and physically joined together.
  • the IV set system comprises a discontinuous type of attachment of the primary IV set 400 and the secondary lines 416 and 418 at fused locations 460 along the respective tubular flow line structures.
  • discontinuous, isolated attachment members at fused locations 460 function to physically join the IV sets together.
  • attachment members at the various locations 460 are considered to be discontinuous as they are separated by unconnected segments of the tubular flow' Irne structures.
  • Hie isolated points of attachment or fused locations 460 can comprise material integrally formed from the same material as the IV lines, or they can comprise a different material.
  • the attachment members at fused locations 460 can comprise material that can facilitate the joining of one or more IV sets, and the selective separation or peeling away of these.
  • the attachment members can be designed and configured to tear or rip.
  • the attachment m mbers can be designed and configured to separate or pull away from at least one of the IV sets.
  • FIG. 4a illustrates an IV set system comprising a primary' IV set 300 and two secondary IV sets 316 and 318 having a continuous attachment member 362 between the primary I V set 300 and the secondary I V sets 316 and 318 that functions to separably join these together.
  • the attachment member 362 can be comprised of the same material as the primary or secondary lines, and thus be integrally formed, or it can comprise a different material.
  • the attachm nt member 362. can be disposed between one or more joined IV sets in a continuous manner, meaning that the IV sets are joined together without disconnected or disjoined segments within the attachment member 362. This does not necessarily mean that the IV sets are j oined together along their entire length, although they could be.
  • the primary' IV set and/or the secondary IV set(s) may be atached in a continuous manner along at least a portion of their length .
  • the attachment member 362 can he designed and configured to easily tear or rip, or alternatively pull away from one of the lines.
  • Stripping the IV sets from one another can occur as needed or desired, such as when a coded I V set is no longer needed or has already been used and therefore has no value (such as for historical purposes, for administering medication, etc.).
  • a coded I V set is no longer needed or has already been used and therefore has no value (such as for historical purposes, for administering medication, etc.).
  • the presence of any unnecessary IV sets can become a nuisance, interfering with access to still needed or required IV sets, as well as adding unnecessary IV sets that must be distinguished from those still needed by the patient.
  • By stripping away these unnecessary' IV sets the bundle of IV sets within the IV set system is reduced, thus mid-ting the IV set system more manageable.
  • the exemplary primary IV set 300 and secondary TV sets 316 and 318 can be attached in an integral and continuous manner along all or a portion of their lengths.
  • the IV set system can comprise a material portion or attachment member 362 disposed between the IV sets.
  • the material portion 362 can comprise an extension of the same material as that used to form the tubular structures making up the IV sets.
  • the tubular structures of the joined IV sets can be joined during their formation or manufacture.
  • the tubular structures can be configured to comprise an outer wall portion and an inner wall portion that defines the interior bore or lumen of the tubular structure.
  • the tubular structures can further be configured to comprise an extension portion extending from the outer wails between them, the extension portion making up the attachment member 362.
  • the attachment member 362 can be configured to space the tubular structures of the joined IV sets a given distance apart from one another.
  • tire attachment member 362 can be configured to comprise a suitable configuration (c .g . thickness, etc.) that will both maintain a properly joined arrangement during use of the IV set system, while also facilitating selective strip-ability as needed or desired.
  • a continuous joining arrangement will allow the user to precisely control the amount of line to be stripped aw'ay.
  • each secondary IV set having a proximal terminus, a distal terminus, and an intermediate tubular length secured via the attachment member 362 to the primary IV set in a continuous manner substantially along the intermediate tubular length to inhibit line entanglement within the IV set system.
  • This secured attachment along the tubular length is configured in a manner so as to facilitate the peeling away of one or more secondary IV sets 316, 318 from the primary IV set 300 to provide vari able free lengths of the proximal secondary I V sets 316, 318 as needed, such as for establishing secondary flow lines to the primary IV set 300.
  • the at least one secondary IV set 416 may be secured to the primary IV set 400 and/or an adjacent secondary TV set 318 in discontinuous fashion by employing discrete points of attachment460, as illustrated in FIGS. 4b and 5b.
  • the discrete secured segments of the secondary IV sets 416, 418 can be separated by discontinuous, unsecured segments of lengths of the tubular structures making up the IV sets to provide detectable stop points for peeling away the secondary IV sets 416, 418 at predetermined lengths. These stop points provide or define pre-formed lengths of line that can be stripped away upon severing the attachment members, and will allow the user to consciously determine how much of an TV set to strip.
  • each point of attachment releases, allowing the user to choose to partially strip the line or to continue progressively breaking each bond until the line is folly removed.
  • One advantage of a partial release is that attending medical personnel can have a leng th of line now' free from the IV set with another part of the line remaining joined.
  • the now free length can be used for a variety of purposes, such as to connect to an additional saline or fluid bag, a medication infusion source, etc. The length of this free segment can be chosen by the attendant as needed.
  • each attachment member 362 can be bonded or secured at spaced intervals with material that can be easily pulled free from one or more of the joined IV sets, or torn without applying inappropriate breakaway force that could jeopardize the integrity of either of the joined IV sets and/or m aintenance of the I V sets in a secure relationshi p with the patient.
  • the secondary lines 416, 418 may be secured to the primary line 400 in differing discrete segments having differentially secured lengths to provide offset positions for access points along the length of the primary IV set.
  • the IV sets can be configured to break free without undo force so as to not disturb the patient access point.
  • the integrity of the IV sets (leak-free, internal and external wall diameter, longitudinal stretching) can remain unaltered.
  • FIGS. 6a and 6b further illustrate how the at least one secondary IV sets can be aligned in either a planar (linear) or a circumferential arrangement with respect to the primary IV set or other attached secondary' IV sets.
  • secondary IV sets 116, 118 and 120 are shown as being aligned in an exemplary parallel and circumferential arrangement with respect to the primary IV set 100.
  • the primary IV set 100 comprises a larger diameter that facilitates the attachment of the secondary lines 116, 118 and 120 axially around the primary IV set 100 in parallel fashion, such as from proximal to distal termini.
  • the secondary' IV sets 1 16, 118 and 120, and the primary' IV set 100 are shown as being aligned in an exemplary planar or linear arrangement in relation to the primary IV set 100, and in parallel fashion, such as from proximal to distal termini.
  • FIGS. 6a and 6b further illustrate atachment members 162 separably coupling the primary IV set 100 with the one or more secondary IV sets 116, 118, and 120.
  • the present invention includes a m thod for managing use of a primary IV set and multiple, integrally and removably inter-attached secondar TV sets of a bundled IV se t system to minimize entanglement of the lines of the IV sets during use.
  • This method can be generally described by the steps of a) initiating application of the IV set system to a patient in a customary manner using a primal ⁇ flow line of a primary IV set.
  • a second step (b) would be identifying a first secondary IV set of the bundled IV set system for administering a second substance to the patient, such as a medication, and then at least partially stri pping an upper end of the first secondary IV set from the primary IV and or a secondary IV set to provide a free, unattached end of the first secondary IV set.
  • This free end facilitates proper access and positioning of the line with respect to the IV set system in an organized manner, while retaining an attached portion integral with the bundled IV sets to avoid entanglement with other IV sets.
  • a second secondary IV set may also be identified for administering a third substance to the patient, such as a sedating or anesthetizing agent.
  • a third substance such as a sedating or anesthetizing agent.
  • an upper end of this second secondary IV set is at least partially stripped to provide a free, unattached end to facilitate proper access and positioning thereof with respect to the IV set system, while retaining the attached portion of the line integral with the IV set, thereby reducing likelihood of entanglement of this line.
  • a further step (d) involves stripping lower ends of these secondary lines from one or more IV sets within the IV set system, and then coupling them to access ports at the lower distal portion of the primary IV set, such as via the merging fluid patlrway.
  • first and second lines can then be coupled to appropriately administer solutions.
  • each line When marked with unique indicia, each line can be clearly identifiable and quickly accessible to attending medical personnel.
  • the attendant may completely strip at least one of the first or second secondary IV sets free from the IV set system when one or more of those sets are no longer required, thus further simplifying the I V set system and reducing likelihood of entanglement with other lines.
  • indicia matching indicia from that stripped IV set can remain or caused to be visible on the primar ' IV set.
  • an injection port manifold which consists of multiple injection ports organized in close proximity.
  • Standard manifolds are part of the fluid pathway enabling injections to be carried from the injection on the manifold site to the IV patient connection.
  • Manifold injection ports often contain a unidirectional flow apparatus enabling syringes to be left in connection to the port without fluid backflow into the syringe.
  • Manifolds can also be composed of two or more stopcocks permanently attached to one another.
  • the IV set system of the present disclosure can further comprise a manifold design that provides solutions to the problems discussed above.
  • the unique manifold design of the present disclosure overcomes problems of current manifolds by being mounted externally to the primary IV set, thus establishing a bypass flow line to the segment of primary line where it is atached, such as a segment of the primary flow line.
  • This bypass design serves to create an alternate primary flow path to the primary flow line through the manifold and the bypass flow line that is outside of or out of line from the regular primary flow path in the primary flow line, that facilitates administration of multiple boluses through the manifold either by injection or other acceptable means.
  • an IV set system having a primary line 500, a primary flow line 508, and secondary lines 516 and 518, these being similar in form and function to those described above.
  • the IV set system of FIG. 7A can further comprise marking indicia, separably joined IV sets (such as via attachment members 560), and a merging fluid pathway as set forth and described in any of the embodiments discussed herein, as will be recognized and as can be applied by one of ordinary skill in the art.
  • the IV set sy stem further comprises a manifold 540 operable with the primary 7 TV set 500, in accordance with one example of the present disclosure.
  • Access ports 510 on tire primary IV set 500 can be used to removably and externally couple the manifold 540 in a lateral manner relative to the primary IV set 500.
  • the manifold 540 can be prefabricated into or otherwise formed and made operable with the primary flow line 508.
  • Access ports 564 e.g., n number of access ports
  • secondary IV sets and other possible supporting flow lines can be formed or provided in the manifold 540 in a similar manner as the access ports 510 formed in the primary IV set 500.
  • the primary TV set 500 can further comprise access ports 510, some of which can be referred to as manifold access ports, that are operable to removably couple corresponding access points on the manifold 540.
  • access ports 510a and 510b function as the access ports on the primary TV set 500 used to laterally couple the manifold 540.
  • the access points on the manifold 540 can comprise threaded port adaptors or other connector types 544 and 561 that removably couple to the access ports 510a (manifold input access port) and 510b (manifold output access port), respectively.
  • the access points on the manifold 540 can be spaced apart to match the respective positions of the access ports 510a and 510b on the primary IV set 500.
  • the attending medical personnel can make a spontaneous decision to apply a manifold bypass flow line if it is needed.
  • No structural adaptation of the IV set system is required, other than clipping or otherwise coupling the manifold device 540 to the respective access ports 510 on the primary line 500, and particularly the primary flow line 508.
  • the manifold 540 can be disconnected when the bypass flow line is no longer needed: wherein fluid flow through the primary flow line of the primary IV set 500 is restored.
  • the bypass design also eliminates the requirement to“break” or completely disconnect the TV set system, thus reducing tire contamination and infection risk. Accordingly, the adaptation of the primary flow line with a manifold bypass attachment structure greatly enhances both convenience and safety , as compared with prior art practices utilizing an inline manifold configuration .
  • the manifold 540 can be prefabricated.
  • jOI 201 For most patients a hospital encounter is a multi-departmental experience. As a patient travels from one department to another, patient needs and provider focuses change.
  • the present IV set system allows easy transition from one department to the next and adapts to changing patient needs and staff requirements.
  • An important advantage of the present IV set system and its removably coupleable bypass manifold 540 over current manifold systems is the referenced ability to spontaneously add and remove the manifold 540 to/from the IV flow path or fluid pathway without interrupting or interfering with IV function, and particularly the primary flow path, making it readily adaptable to most patient settings. For example, a trauma patient who is transported to the hospital by ambulance may require the ambulance crew to quickly establish IV access using a present IV set system.
  • tire present IV set system Upon arrival at the hospital, tire present IV set system could then be utilized by emergency department personnel to administer medications, and fluids. Up to this point the presence of a manifold may be unnecessary and the added bulk to the line set could increase the risk of the IV becoming caught, tangled or pulled out during patient transfers. However, many patients in die emergency department are transferred directly to the operating department for treatment. For reasons previously described, anesthesia providers often prefer the use of manifolds. With use of the present IV set system, the anesthesia or other provider could simply and quickly couple a present manifold 540 to an IV set as needed or desired, thus creating a bypass flow 7 line that effectively reroutes or diverts the fluid pathway already established, without breaking it.
  • the manifold facilitates diverting of the fluid from the primary flow line through the manifold and the bypass flow line to form an alternate primary fluid flow path, wherein the flow of the fluid is maintained in a continuous manner and not stopped.
  • the IV set system preconfigured with the bypass manifold 540 pre-attached and ready to use. Otherwise, as indicated, upon arrival to die operating department the anesthesia or other provider could attach the externally mountable manifold 540 to the access ports of the IV set system without“breaking” the IV flow-path.
  • the manifold 540 could he utilized during the pre-operative and operative periods, and removed prior to the patient’s transfer to the post-operative, intensive care or medical/surgical unit.
  • a comparative example would be a patient scheduled for an inpatient surgical procedure.
  • the patient upon arrival at the pre-surgical area, could routinely have IV access established.
  • the preoperative nurse could select an IV set system, as described herein, with a manifold 540 pre-attached allowing the manifold 540 to be utilized during induction and maintenance of anesthesia.
  • the manifold 540 could then be safely and easily removed at the end of the operative period, prior to transferring the patient to the designated post-surgical department.
  • the self-sealing access ports 510a and 510b could be used as regular access ports in the absence of the manifold 540.
  • the IV set system can further comprise a flow control valve or device associated with the primary flow line of the primary IV set.
  • the flow control valve can operate to selectively divert fluid flow from the primar flow line to the manifold and through the bypass flow line to form the alternate primary flow path, and then to restore fluid flow through the primary flow line of the primary IV set, such as upon removal of the manifold from the primary TV set.
  • the flow control valve can comprise a clamp, such as a slide clamp, a roller clamp, etc.
  • the flow control valve can comprise a stop cock or a set of stopcocks on a proximal connection point on the primary line.
  • two threaded self-sealing access ports 510a and 510b can be placed continuous and in fluid communication with the primary flow line 508 and the primary flow path.
  • the predetermined distance (as measured between the lower of the access ports connecting tire manifold (e.g., 510b) and the distal most access point of the primary IV set 500) can be, for example, between one and five feet. In one aspect, this distance can he three feet.
  • the access ports 510a, 510b can be spaced at a predetermined distance from each other and, in some examples, can be part of a connector portion oriented at a substantially 90-degree or orthogonal orientation relative to the primary line 500.
  • the access ports 510a and 510b can be part of a connector portion oriented on a 90 degree or orthogonal orientation and can comprise a female portion of a Luer Lock, with the connectors 544 and 561 on the manifold 540 comprising male portions of a Luer Lock formed on a 90 degree orientation relative to the primary flow line and operable to couple to the female portions of the Luer Lock.
  • the manifold 540 can comprise first and second connector portions of tire same type, such as male-male or female-female.
  • the connector portion types on the manifold 540 designed to couple with the access ports on the primary IV set can be the same, each being operable to couple to the access ports in the same manner. This is unlike prior manifold designs that are coupled in an in-line configuration with the primary flow line where the connectors or connector types are alternating.
  • connection systems having angular orientations other than 90 degrees may be employed and used where merited by the circumstances, such as connector portions having angular orientations between 30 and 150 degrees (as measured from the longitudinal axis of the primary' line 500), or even others.
  • FIG. 1 For example, FIG. 1
  • FIG. 7B illustrates access ports 510a' and 510b', each being formed as part of a connector portion oriented on an angle other than 90 degrees relative to the extended primary' flow line 508'
  • access port 510a' forms part of a connector portion oriented in a downward direction on an angle a (e.g., 120 degrees)
  • access port 510b' forms part of a connector portion that is oriented in an upward direction at an angle b (e.g., 30 degrees).
  • FIG. 7C illustrates access ports 510a" and 510b", each being formed as part of a connector portion oriented on an angle other than 90 degrees relative to the extended primary flow line 508".
  • access port 510a" forms part of a connector portion oriented in an upward direction at an angle a (e.g., 30 degrees)
  • access port 510b" forms part of a connector portion that is oriented in downward direction at an angle b (e.g., 120 degrees).
  • angle a e.g. 30 degrees
  • b e.g. 120 degrees
  • the relative degrees of angles a and b of the access ports in the above examples of FIGS. 7A-7C can range anywhere between 0 and 180 degrees).
  • FIGS. 7B and 7C further illustrate the primary line 500 of FIG. 7A as comprising a plurality of tubular flow line segment structures, namely first and second tubular flow line segment structures (referred to as flow line segments hereinafter) or, stated differently, a first IV line and a second IV line removably coupled to one another.
  • first and second tubular flow line segment structures referred to as flow line segments hereinafter
  • first IV line and a second IV line removably coupled to one another.
  • FIG. 7B illustrates the primary IV set 500’ as comprising a first flow line segment or first IV line 569' removably coupled to a second flow line segment or second IV line 570'.
  • Tire first and second flow line segments (or first and second IV lines) 569’ can removably couple together using an interconnect device or connector 536', which in the example shown comprises a Luer lock type of connector, comprising a female connector portion supported on a first, proximal end of the second flow line segment or second IV line 570', and a mating male connector portion supported on a second, distal end of the first flow 7 line segment or first IV line 569'.
  • an interconnect device or connector 536' which in the example shown comprises a Luer lock type of connector, comprising a female connector portion supported on a first, proximal end of the second flow line segment or second IV line 570', and a mating male connector portion supported on a second, distal end of the first flow 7 line segment or first IV line 569'
  • Each of the first and second flow line segments can define, at least in part, a primary flow 7 path through the primary IV set 500'.
  • the bypass manifold 540' can be supported about the second flow line segment or second IV line 570' via access points/ports 510a' and 51 Ob' defined by first and second connectors that facilitate the bypass manifold 540' being removable or removably coupled to the second flow line segment or second IV line 570', similar as taught herein.
  • FIG. 7C illustrates the primary IV set 500" as comprising a first flow line segment or first IV line 569" removably coupled to a second flow line segment or second IV line 570”.
  • the first and second flow line segments (or first and second IV lines) 569" can removably couple together using an interconnect device or connector 536", which in the example shown comprises a Luer lock type of connector, comprising a female connector portion supported on a first, proximal end of the second flow line segment or second IV line 570', and a mating male connector portion supported on a second, distal end of the first flow line segment or first IV line 569".
  • Each of the first and second flow line segments can define, at least in part, a primary flow path through the primary IV set 500".
  • FIGS. 7B and 7C can further illustrate what can be referred to as IV extension set removably coupled to a primary IV set (primary' IV line), wherein the IV extension set is in support of the bypass manifold.
  • FIG. 7B illustrates the second flow line segment or second IV line 570’ of the primary IV set 500 of FIG.
  • second flow line segment or second IV line 570' may be referred to as an IV extension set, removably coupled to the first flow line segment or first IV line 569' of the segmented primary IV set 500' of FIG. 7B (shown via the interconnect device or connector 536') so as to provide an extended primary flow line 508'.
  • a bypass manifold 540' supported on the second flow line segment or second IV line 570' (i.e., IV extension set) and removably coupled to the second flow line segment or second IV Ime 570' via Luer lock type connectors defining access ports 510a’ and 510b'.
  • FIG. 7C illustrates the second flow line segment or second IV line 570” of the primary IV set 500 of FIG. 7A, which second flow line segment or second IV line 570" may be referred to as an IV extension set, removably coupled to the first flow line segment or first IV line 569" of the segmented primary- IV set 500" of FIG. 7C (shown via the interconnect device or connector 536") so as to provide an extended primary flow line 508".
  • a by-pass manifold 540" supported on the second flow line segment or second IV line 570" (i.e., IV extension set) and removably coupled to the second flow line segment or second IV line 570" via Luer lock type connectors defining access ports 510a" and 510b".
  • IV set systems comprising a primary IV set and an IV extension set similar to these are discussed below in greater detail, and are shown in FIGS. 8-13, respectively.
  • a flow control valve or device in the form of a slide style clamp 512 can be placed on the primary line 500 between the two access ports 510a and 510b.
  • a threaded port adapter or other connector 544 on the manifold 540 can be connected to the proximal access port 510a and can be oriented perpendicular or orthogonal to the primary flow line 508.
  • the port adapter 544 can then be connected to a solid 90-degree angle or other angular orientation connector 548 on tire manifold 540, which can divert the flow path through the manifold 540 in a direction parallel to the primary flow line 508 of the primary IV set 500.
  • the flow can continue distal to the 90- degree or other angular orientation connector 548 along a solid manifold or bypass line 552 (e.g., the bypass flow line), which can continue parallel to the primary IV set 500.
  • the solid manifold or bypass line 552 can comprise one or more access ports 564 that function similar to the access ports 510 on the primary IV set 500.
  • Lateral to the distal self-sealing access port 510b can be a second 90-degree or other angular orientation connector 556 on the manifold 540 attached to the primary IV set 500 via a threaded port adaptor or other connector 561 that can be connected to the distal seif-sealing access port 510b of the primary IV set 500.
  • the slide clamp 512 can be closed to occlude the primary flow line 508 in-between the two self-sealing access ports 510a and 510b.
  • any anesthesia specific devices such as the anesthesia manifold
  • any anesthesia specific devices such as the anesthesia manifold
  • the IV Set System Upon leaving the operating room (or OR), any anesthesia specific devices, such as the anesthesia manifold, must be removed from the IV Set System.
  • this is only possible by disconnecting from the patient site, and discarding the entire“in-line” IV set system and replacing it with a new ' IV set system, including costly fluid containers.
  • Significant IV therapy patient cost reduction could be realized by so doing.
  • the present disclosure further sets forth an IV extension set operable with an IV set, such as an existing IV set, wherein a bypass manifold, such as any of tire example configurations discussed herein, is operable with the IV extension set.
  • the bypass manifold can be configured to be removably coupled (i e , coupled in a manner so as to be able to be coupled and then removed, or interchanged with another bypass manifold via an interconnect or connector that is configured to facilitate this, and that comprises self sealing functionality once the bypass manifold is disconnected) to the IV extension set to provide a bypass flow path through the IV extension set.
  • anesthesia manifold can be removed and/or replaced, without breaking the IV set system open.
  • An IV extension set with a bypass manifold can be combined with any gravity or gravity capable IV Pump Set to create a very cost effective anesthesia IV set/manifold system, avoiding the cost and medical waste complications of current anesthesia IV set manifold based systems.
  • the bypass manifold is removably coupled to an IV extension set (similar to the bypass manifold being removably coupled to and supported by the second segment or second IV line of the segmented primary IV line of FIGS. 7B and 7C).
  • the bypass manifold although supported on the IV extension set, is also or further indirectly operable with the primary- IV set upon removably coupling the IV extension set to the primary IV set, namely to provide a bypass of the primary flow path of the primary IV set, as will be discussed in more detail below.
  • the IV extension set as coupled with the primary IV set comprise, at least in pari, an IV set system.
  • providing an IV extension set with a bypass manifold provides the ability to connect the IV extension set to existing IV sets, such as standard or conventional IV sets (e.g., gravity or gravity capable pump IV set), to provide such existing IV sets with all of the functionality and attendant advantages of a bypass manifold even though not initially equipped with such functionality.
  • existing IV sets such as standard or conventional IV sets (e.g., gravity or gravity capable pump IV set)
  • the bypass manifold can be removed without breaking the original IV set system put into place prior to surgery, thus allowing the original IV set system (now without the bypass manifold) to remain in place with the patient.
  • the bypass manifold can function to divert fluid from the extension flow line (i.e., the primary flow line and the extension flow line being referred to herein as die extended primary flow line as these are“in-line” with one another) into the bypass manifold, thus bypassing the extension flow line (and the extended primary flow line).
  • the bypass manifold can be removably coupled to the IV extension set, which can be accomplished without breaking die flow of fluid in the extended primary IV set (which includes the IV extension set).
  • the existing IV set can comprise any of the IV sets discussed herein .
  • the existing IV set can comprise a standard or conventional type of IV set, such as a gravity IV set.
  • the existing IV set can be referred to as a primary IV set, meaning that whatever type of IV set die IV extension set is coupled to can be considered to be a primary IV set relative to the IV extension set.
  • the primary IV set and the TV extension set coupled thereto can be part of an IV set system, which can further comprise one or more secondary IV sets operable to be removably coupled to any one or more of the primary IV set, the IV extension set, the bypass manifold, depending upon the configuration of the IV set system, the particular needs of medical personnel, or other factors. Additional detail pertaining to die above-discussed concepts and features is provided below.
  • FIG. 9 illustrates die IV extension set 670 of FIG. 8 operable for use with an IV set 600 in the form of a conventional gravity IV set (hereinafter referred to as the primary IV set 600), wherein the primary IV set 600 and the TV extension set 670 can comprise part of an IV set system.
  • a fluid source e.g., a gravity -based IV solution bag, a fluid pump set
  • a primary fluid e.g., saline, medication, or others as will be known to those skilled in the art
  • the primary IV set 600 coupled to the fluid source (e.g., via an access point (e.g., an access point in the form of a spiked drip chamber).
  • the IV extension set 670 can comprise a first end defining a proximal terminus 672 (hereinafter proximal terminus 672 or proximal end 672), a second end defining a distal terminus 674 (hereinafter distal terminus 674 or distal end 674), and an extension flow line 678 defining an extension fluid flow' path of the IV extension set 670.
  • the IV extension set 670 can further comprise a plurality of access points 680. At least some of the access points 680 can comprise those supported at the first or proximal end 672 and the second or distal end 674 of the IV extension set 670. These access points can be operable to interface and removably couple with
  • access points 680 can comprise access ports (e.g., see first and second intermediate access ports 682a and 682b, which can be referred to as manifold access ports) located and supported along the length of the extension flow line 678 that are operable to interface and removably couple with corresponding access points on the bypass manifold 640 to removably couple the bypass manifold 640 to the IV extension set 670 in a lateral manner (meaning not in an in-line arrangement with the IV extension set 670).
  • access ports e.g., see first and second intermediate access ports 682a and 682b, which can be referred to as manifold access ports
  • the access point 680 at the first or proximal end 672 can comprise any type of interconnect structure or device or connector as known in the art.
  • the access point 680 at the first end 672 defining the proximal terminus can comprise a connector portion 684 of an interconnect or connector (e.g., a Luer type of connector, swabable, non-swabable, or any other type) operable to interface and removably couple with a corresponding connector portion of the interconnect or connector of the primary IV set 600 (e.g., see the interconnect structure 636 comprising the connector portion 638 on the distal end (i .e., the distal terminus) 604 of the primary IV set 600 and the connector portion 684 on the proximal end 672 of the IV extension set 670 that couple together to j oin the IV extension set 670 to the primary I V set 600).
  • an interconnect or connector e.g., a Luer type of connector, swabable, non-
  • the access point 680 at the second or distal end 674 of the IV extension set 670 can comprise a connector portion 686 of an interconnect or connector (e.g., also a Luer type of connector, swabable, non-swabable, or any oilier type) operable to interface and removably couple with a corresponding connector portion of the interconnect or connector, such as a connector portion as part of a patient interconnect structure for coupling the IV extension set 670 to a patient injection site (e.g., see patient interconnect structure 634 comprising the connector portion 686 of the IV extension set 670 and the connector portion 614 as part of the patient injection site in FIG. 9 that couple together to join the IV extension set 670 to the patient injection site).
  • an interconnect or connector e.g., also a Luer type of connector, swabable, non-swabable, or any oilier type
  • a corresponding connector portion of the interconnect or connector such as a connector portion as part of a patient
  • Additional access points 680 on the extension flow line 678 of the IV extension set 670 can comprise first and second intermediate access ports 682a and 682b spaced at a predetermined distance from each other, and located between the first proximal end 672 and the second distal end 674.
  • the first and second intermediate access ports 682a and 682b can be provided by or in the form of a connector or connector portion used to couple or removably couple a bypass manifold 640 to the IV extension set 670.
  • first and second intermediate access ports 682a and 682b can comprise part of first and second manifold connectors (e.g., Luer type connectors), respectively, supported on or by the extension flo line 678, which manifold connectors can be operable to removably couple the bypass manifold 640 to the extension flow line 678 of the IV extension set 670.
  • the first and second manifold connectors can comprise a Luer connector configuration having a“T” configuration or a‘ ⁇ ” configuration.
  • the first and second manifold connectors comprise a Luer connector having a“T” configuration.
  • the first manifold connector can comprise a connector portion supported on the extension flow line 678 (e.g., see the female connector portion of the Luer connector), which connector portion defines the first intermediate access port 682a.
  • a corresponding connector portion e.g., see the male connector portion of the Luer connector
  • the second manifold connector can comprise a connector portion supported on the extension flow line 678 (e.g., see the female connector portion of the Luer connector), which connector portion defines die second intermediate access port 682b.
  • a corresponding connector portion (e.g., see the male connector portion of the Luer connector) can be supported on the bypass flow line 652 of the bypass manifold 640, which connector portion defines the access port 661 located on lower or second end of the bypass flow line 652 of the bypass manifold 640.
  • the corresponding connector portions of the respecti v e first and second manifold connectors can be operable to interface with and connect with one another to facilitate the removable connection of the bypass manifold 640 to the TV extension set 670. It is noted that the connector portions of the first and second manifold connectors located on the bypass manifold 640 can be of the same type (e.g., both male).
  • the connector portions of the first and second manifold connectors located on the TV extension set 670 can be of the same type (e.g., both female).
  • the access ports 644 and 661 on the bypass manifold 640 can comprise threaded port adaptors or other connector types that removably couple to the access ports 682a (manifold input access port) and 682b (manifold output access port), respectively.
  • the access ports 644 and 661 on the bypass manifold 640 can be spaced apart to match the respective positions of the first and second access ports 682a and 682b on the IV extension set 670.
  • the first and second access ports 682a and 682b on the IV extension set 670 can be self-sealing, meaning that they are capable of facilitating flow when in use, and prohibiting or sealing off flow when not in use.
  • the first and second access ports 682a and 682b can comprise any type or can be used for any purpose as recognized by those skilled in the art (c .g . a threaded Luer type of connector, or others).
  • the extension flow line 678 of the TV extension set 670 can comprise (i.e., be comprised of) a plurality of extension flow' line segments in fluid communication with one another (e.g., see first extension flow' line segments 688, second extension flow line segment 690, and third extension flow- line segment 692).
  • the individual extension flow line segments can be secured together via one or more interconnect structures or connectors supported by the extension flow line segments and the extension flow line.
  • the first extension flow line segment 688 can be coupled to the connector portion 684 and a manifold access port (e.g., first intermediate manifold access port 682a).
  • the second extension flow line segment 690 can be coupled to the connector portion 686 and a manifold access port (e.g., second intermediate manifold access port 682b).
  • the third extension flow line segment 692 can be coupled to the first and second intermediate manifold access ports supported on the extension flow line 678, and can extend between the first and second extension flow' line segments 688 and 690 and the first and second intermediate manifold access ports 682a and 682b.
  • the IV extension set 670 can comprise a length that is relatively small compared to the primary IV set 600.
  • the IV extension set 670 can comprise a length between 12 and 36 inches.
  • the IV extension set 670 can be operable with a patient injection device and to be in place and attached to a patient prior to being coupled to tire primary' IV set 600, wherein the IV extension set 670 is in place to facilitate the admi nistrati on of fluids to the patient upon connection of the primary TV set 600 and any fluid source associated therewith
  • the IV extension set 670 (or the IV set system) can further comprise a flow control valve or de vice associated with die extension flow line of die IV extension set 670.
  • the flow control valve can operate to selectively divert fluid flow from a portion of the extension flow line 678 to the bypass manifold 640 and through the bypass flow line 652 to form an alternate bypass flow path through the IV extension set 670, which can be for purposes similar to those discussed herein.
  • the flow control device can further be operated to restore fluid flow through the extension flow line 678 of the IV extension set 670, such as by deacti vating tire flow control valve or de vice, or by removing the bypass manifold 640 from the IV extension set 670.
  • the flow control valve or device can comprise a clamp, such as the slide clamp 612 shown, a roller clamp, snap clamp, or others.
  • the flow 7 control valve can comprise a stop cock or a set of stopcocks supported on the extension flow line 678. Connection ports 682a and 682b can be stopcocks, which when properly active, will divert fluid flow through the bypass manifold and back into the extension flow path. When stopcocks are used to control direction of fluid flow through the manifold, clamp 612 may not be needed.
  • the bypass manifold 640 can comprise the same or similar features and components or elements as any of the bypass manifolds discussed herein.
  • the bypass manifold 640 can be configured to function and operate with the IV extension set 670 in a similar manner as the other bypass manifolds discussed herein function and operate with the various primary TV sets.
  • the discussion above regarding the bypass manifolds operable with the IV sets is incorporated here, and intended to be supportive of and referenced in understanding the bypass manifold 640 operable with the IV extension set 670, where applicable, and as will be apparent to those skilled in the art Specifically, as shown in the examples illustrated in FIGS.
  • the bypass manifold 640 can be removably coupled to the IV extension set 670, and particularly 7 to the extension flow 7 line 678, thus these components can be individually separable from one another, and can each be part of an IV set system comprising the primary TV set 600, the IV extension set 670 and the bypass manifold 640.
  • the TV set system can further comprise one or more secondary IV sets operable to be removably coupled or coupleable to either the primary IV set 600 or the bypass manifold 640 (as coupled to the IV extension set 670), or both, as taught herein.
  • the bypass manifold 640 can further comprise one or more access ports (e.g., n number of access ports) supported on the bypass flow line 652 that facilitate access to the fluid flow path through the bypass manifold 640.
  • the bypass manifold 640 comprises four access ports 664
  • Tire access ports 664 can be operable or configured for use with syringes, secondary IV sets and other possible supporting flow lines.
  • the access ports 664 can be formed and configured in a similar manner, and can comprise the same or similar types, as the access ports 682a and 682b on the extension flow' line 678 of the IV extension set 670 (as well as access port 610 formed in the primary IV set 600, and/or the access ports 110 of the primary IV set 100 of FIG.
  • the access ports 664 on the bypass manifold 640 can be self-sealing as described elsewhere herein.
  • the access ports 664 can contain check valve mechanisms, which prevent fluid flow from the bypass flow path of the bypass manifold from entering a syringe or other device attached thereto.
  • the IV extension set 670 can be configured to be operable with a primary IV set.
  • the primary IV set 600 can have a first end defining a proximal terminus 602, a second end defining a distal terminus 604, and an intermediate tubular length 606 defining a primar flow line 608 and a primary fluid flow path of the primary IV set 600, such as for conveying saline carrier or other types of fluid through the primary' flow line 608 and ultimately to a patient.
  • the primary flow line 608 can have multiple access points 609, some of which can include one or more access ports 610 along its length that facilitate access to the primary flow line 608 and the primary fluid flow path, such as for selectively administering various medications needed by tire patient, and others. Some of the access ports 610 can be self-sealing, as taught herein.
  • the access ports 610 can comprise any type or can be used for any purpose as recognized by those skilled in the art.
  • one of the access ports 610 can comprise a needleless injection port that can be used to couple or removably couple a syringe for pushing fluid into the primary flow line 608.
  • one of the access ports 610 can comprise a first connection portion of an interconnect device or connector (e.g , a Luer type of connector) operable to couple with a corresponding second connector portion of the interconnect or connector, which second connector portion can be supported on a syringe or a secondary IV set used to facilitate infusion of a fluid into the primary flow line 608 upon removably coupling the syringe or the secondary IV set to the primary IV set 600 via the first connector portion on the primary flow 7 line 608.
  • an interconnect device or connector e.g , a Luer type of connector
  • one of the access ports 610 can comprise a first connector portion in the form of a female portion of a Luer Lock, and one or more secondary I V sets to be removably coupled to the primary IV set 600 can comprise a second or corresponding connector portion in the form of a male portion of a Lner Lock.
  • first connector portion in the form of a female portion of a Luer Lock
  • secondary I V sets to be removably coupled to the primary IV set 600 can comprise a second or corresponding connector portion in the form of a male portion of a Lner Lock.
  • the primary IV set 600 can further comprise access points at the first or proximal end 602 and the second or distal end 604 of the primary flow line 608.
  • the access point at the second or distal end 604 can comprise an access port defined by or comprising a first connector portion of an interconnect or connector operable to removably couple with a corresponding second connector portion of the interconnect or connec tor supported on an IV line to be connected to the primary IV set 600.
  • the primary IV set 600 can have supported on the distal end (i.e., the distal terminus) 604 of its primary flow line 608 the connector portion 638.
  • the IV extension set 670 can have supported on the proximal end 672 of its extension flow line 678 the connector portion 684.
  • the connector portion 638 and the connector portion 684 make up the interconnect device or connector 636, and interface with and removably couple together to removably couple the IV extension set 670 to the primary IV set 600, thus extending the primary IV set 600 and forming what can be referred to as an extended primary IV set.
  • the connector 636 operates to place the primary flow line 608 and the extension flow line 678 in fluid communication with one another, thus essentially extending the primary flow line 608. Indeed, the combined primary flow line 608 and the extension flow line 678 can be referred to as an extended primary flow line.
  • extension flow path defined by the extension flow line 678 of the IV extension set 640 and the primary flow path defined by the primary flow' line 608 of the primary IV set 600 together define what may be referred to as an extended primary flow path of the extended primary IV set.
  • tire primary flow' line comprises both the primary flow' line 608 of the primary IV set 600 and the extension flow line 678 of the IV extension set 670
  • the primary flow path comprises both the primary flow path defined by the primary ' flow' line 608 of the primary IV set 600 and tire extension flow' path defined by the extension flow line 678 of the IV extension set 670.
  • the primary flow line with its primary flow path (and ultimately the fluid flow) are still considered to be“primary” even though these are extended by and through the TV extension set 670.
  • the bypass manifold 640 and the bypass flow path 652 are operable to bypass a portion of the extended primary flow path through the IV extension set. It may simply be said that the primary flow path is bypassed even though it passes through the IV extension set 670.
  • the bypass flow 7 path functions to bypass, at least in part, the extension flow path.
  • bypass manifold 640 operable with the IV extension set 670 and in use with the primary IV set 600, attending medical personnel can make a spontaneous decision to apply a manifold bypass flow line if it is needed.
  • No structural adaptation of the IV set system is required, other than clipping or otherwise coupling the bypass manifold 640 to the respective access ports 682a and 682b on the extension flow line 678 of the IV extension set 670 and actuating the flow 7 control device (e.g., the slide style clamp 612 as shown in FIGS 8 and 9).
  • bypass manifold 640 can be disconnected when the bypass flow line is no longer needed, wherein fluid flow through the primar flow line 608 of the primary IV set 600 and through the extension flow line 678 of the IV extension set 670 is restored by opening the snap or slide clamp 612.
  • the bypass design also eliminates the requirement to“break” or completely disconnect the IV set system, thus reducing the contamination and infection risk. Accordingly, the adaptation of the primary flow path with a lateral bypass function, as provided via the manifold 640 operable with the IV extension set 670, greatly enhances both convenience and safety, as compared with prior art practices utilizing an inline manifold configuration.
  • the IV set system (now comprising the primary IV set 600 and the IV extension set 670, without the bypass manifold 640 attached) can remain in place, attached to the patient site as the patient moves out of the OR into other areas of the care facility 7 . Cost of patient IV therapy care is greatly reduced by not replacing the IV set system with another one, or with several, multiple times during the patient stay in the facility.
  • connection systems having angular orientations other than 90 degrees may be employed and used wliere merited by the circumstances, such as connector portions having angular orientations between 30 and 150 degrees (as measured from the longitudinal axis of the extension flow line 678), or even others.
  • FIG. 10 illustrates an IV extension set 770 comprising access ports 782a and 782b on the extension flow line 778 used to facilitate coupling of a bypass manifold 740 to the extension flow line 778, each of the access ports 782a and 782b being formed as part of a connector portion oriented on an angle other than 90 degrees relative to the primary flow line 708.
  • FIG. 10 further illustrates the bypass manifold 740 as comprising a housing 762 having an interior volume in fluid communication with first and second tubular members 766 and 768 extending from opposing ends of the housing 762, the housing 762 and the first and second tubular members 766 and 768 at least partially defining a bypass flow' line 752.
  • the housing 762 further comprises a plurality of access ports 764 supported about and extending from the housing 762, which access ports 764 facilitate access to the bypass flow line 752 in a similar manner as taught herein.
  • the tubular members 766 and 768 can support one or more interconnect devices or connectors formed on an angle, and operable to couple with the access ports 782a and 782b on the extension flow ' line 778.
  • FIG. 1 1 illustrates an IV extension set 870 comprising access ports 882a and 882b on the extension flow' line 878 used to facilitate coupling of a bypass manifold 840 to the extension flow' line 878, each of the access ports 882a and 882b being formed as part of a connector portion oriented on an angle other than 90 degrees relative to the primary flow line 708.
  • access port 882a forms part of a connector portion oriented in an upward direction on an angle a (e.g., 30 degrees)
  • access port 882b forms part of a connector portion that is oriented in a downward direction at an angle b (e.g., 120 degrees).
  • FIGS 10-1 1 i further illustrates the bypass manifold 840 as comprising a housing 862 having an interior volume in fluid communication with first and second tubular members 866 and 868 extending from opposing ends of the housing 862, the housing 862 and the first and second tubular members 866 and 868 at least partially defining a bypass flow line 852.
  • the housing 862 further comprises a plurality of access ports 864 supported about and extending from the housing 862, which access ports 864 facilitate access to the bypass flow line 852 in a similar manner as taught herein.
  • the tubular members 866 and 868 can support one or more interconnect devices or connectors formed on an angle, and operable to couple with the access ports 882a and 882b on the extension flow line 878.
  • the relati ve degrees of angles a and b of the access ports in tire above examples of FIGS 10-1 1 can range anywhere between 0 and 180 degrees.
  • an IV set system comprising an IV extension set 970 operable to be removably coupled to a primary IV set 900 in a similar manner as discussed above with respect to the IV extension set 670 and the primary TV set 600 of FIGS. 8 and 9.
  • Tire IV extension set 970 and the primary IV set 900 are configured and function similarly as the IV extension set 670 and die primary IV set 600 of FIGS. 8 and 9, except as discussed below.
  • the IV extension set 970 and the primary IV set 900 of FIGS. 12 and 13 are not discussed in detail herein, except to discuss pertinent differences.
  • the disclosure set forth above pertaining to die IV extension set 670 and the primary IV set 600 of FIGS. 8 and 9 is intended to be incorporated here and referenced to understand the IV extension set 970 and the primary IV set 900 of FIGS. 12 and 13, where applicable and where apparent to those skilled in the art.
  • the primary IV set 900 can be the same as die primary IV set 600 shown in FIG. 9, unlike the IV extension set 670 of FIG 8, the IV extension set 970 shown in FIGS. 12 and 13 comprises an additional feature in the form of a merging fluid pathway 954
  • the merging fluid pathway 954 can be configured and can function similarly as discussed above, except in this example, the merging fluid pathway 954 is supported on the IV extension set 970 rather than on the primary IV set 900.
  • the merging fluid pathway 954 can be comprised of at least one access port on the extension flow 7 line 978 of the IV extension set 970.
  • the merging fluid pathway 954 comprises three access ports (e.g., see access ports 985a-c).
  • the merging fluid pathway 954 can be positioned on the TV extension set 900 about the extension flow line 908 proximate to the distal terminus 974 to minimize the amount of fluid in the IV extension set 970 between the merging fluid pathway 954 and a patient interconnect.
  • the access ports 985a-c of the merging fluid pathway 954 can be spaced at a predetermined distance from each other about the extension flow line 978 of the IV extension set 970.
  • the access ports 985a-c can be oriented at a 90-degree orientation relative to the extension flow line 978
  • other angular orientations may be used where merited by the circumstances, such as angular orientations between 30 and 150 degrees (as measured from the longitudinal axis of the extension flow line 978), or even others (e.g., similar to those shown in FIGS 2B).
  • the IV set system can further comprise one or more secondary IV sets (e.g., see secondary IV sets or secondary lines of FIGS. 2a and 2b, and the above discussion) operable to connect to the access ports 985a-c.
  • the distal terminus of the one or more of the secondary IV sets can include an interconnect device or connector for attaching the distal terminus of the one or more secondary IV sets to one of the access ports 985a-c of the merging fluid pathway 954 near the distal terminus 974 of the IV extension set 970.
  • the merging fluid pathway 954 can comprise at least one access port/fluid interconnect in direct fluid communication with the extension flow line 978 of the TV extension set 970.
  • the merging fluid pathway 954 can be located anywhere along the extension flow line 978 of the IV extension set 970.
  • the merging fluid pathway 954 can be located on the extension flow line 978 below a midpoint of the extension flow line 978 and below die access port 982b used to couple the bypass manifold 940 to the extension flow line 978.
  • die merging fluid pathway 954 can be located on the extension flow line 978 at or near the distal terminus 974 of the extension flow line 978.
  • the access ports 985a-c can be configured to couple with the distal termini of the one or more secondary IV sets (e.g., IV sets 116, 118 and 120 of FIG. 2a) to facilitate fluid flow from the one or more secondar IV sets directly into the fluid pathway in the extension flow line 978.
  • the one or more secondary IV sets e.g., IV sets 116, 118 and 120 of FIG. 2a
  • the merging fluid pathway 954 can provide a merging of fluid from the fluid source (e.g., secondary IV set, syringe, etc.) connected to merging fluid pathway 954 directly with the fluid of the IV extension set 970.
  • the fluid source e.g., secondary IV set, syringe, etc.
  • the merging fluid pathway 954 can provide a final stage of fluid injection or infusion into the primary flow path (which comprises the extended primary flow path as facilitated by the IV extension set 970) or the diverted flow path (as provided by the bypass manifold 940 when in use) prior to the point of attachment of the IV extension set 970 to the patient at injection site.
  • This final stage may also be followed by a final segment of flow along the distal terminus 974of the IV extension set 970 to facilitate the merging of fluids within the primary flow path or the diverted flow path immediately prior to injection into the patient.
  • the location of the merging fluid pathway 954 proximate to the patient injection site has many benefits, as taught herein, and as will be recognized by those skilled in the art.
  • the merging fluid pathway 954 can be arranged in a unilateral orientation (extending in the same direction within a common plane), bilateral (extending in opposing directions) (e.g., see FIG. 2) or circumferential arrangement (extending radially outward). The placement of the merging fluid pathway 954 can provide the caregiver with many options for both fluid management and medication delivery control .
  • the IV set systems of FIGS. 8-13 can further comprise marking indicia and separably joined IV sets (such as via attachment members) similarly as set forth and described in any of the example embodiments discussed herein, as will be recognized by those skilled in the art. As such, these are not described in detail here.
  • an IV extension set operable to be removably coupled to a primary IV set can comprise a merging fluid pathway as taught herein without also comprising and/or without also being configured to removably couple with a bypass manifold.
  • the IV extension set 970 of FIG. 13 can comprise only the merging fluid pathway 954, without the bypass manifold 940.
  • Some of these advantages include, but are not limited to, coupling an IV extension set in support of a removable bypass manifold to any IV set (e.g., a gravity or gravity capable IV pump set), thus creating an IV set system, such as those used on an OR bound pabent, thus allowing the original IV set system to remain in place throughout the patient stay; eliminating the need to disconnect and discard multiple IV sets with respect to the same patient during their stay, thus greatly reducing cost of patient IV therapy care and costly medical waste.
  • utilization of the IV extension set with bypass manifold as taught herein can facilitate the use of only a single TV set system instead of two, three or even more.
  • An additional advantage can be that, with an IV extension set with removable bypass manifold in place, bypass manifolds can be removed, added, and removed again, without breaking open the primary line, unlike prior manifold designs where discarding of multiple lines is required due to the inability to add and remove in-line bypass manifolds.
  • an exemplar ⁇ intravenous (IV) set system can comprise, in combination, a primary TV set having a plurality of access points facilitating access to one or more fluid pathways of the primary IV set; an IV extension set removably coupled to the primal ⁇ 7 IV set to extend the primary flow line and the resulting primary flow path .
  • the IV extension set can comprise or be operable with a bypass manifold.
  • the TV extension set can comprise a merging fluid pathway.
  • Tire IV set system can further comprise top-level marking indicia on the primary IV set or on the IV extension set, or both.
  • the IV set system can further comprise a secondary IV set removably coupleable with at least one of the primary' IV set or the IV extension set, or the bypass manifold on the IV extension set via one of the access points of these, the secondary IV set comprising a plurality of access points facilitating access to one or more fluid pathways of the secondary' IV set.
  • the secondary' IV set can comprise marking indicia that differs from the top-level marking indicia, wherein the primary' and secondary IV sets (and/or the IV extension set) are
  • the secondary IV set can further be separably joined to the primary I V set in at least a semi-continuous manner substantially along its length to inhibit entanglement with the primary IV set.
  • the secondary IV set can be at least partially strippable from the primary IV set.
  • the manifold can be operable to externally removably couple to the IV extension set via the plurality of access points on the IV extension set.
  • the manifold can comprise a bypass flow line forming an alternate extension flow path (and ultimately an alternate primar ' flow path) to a fluid pathway of the IV extension set and ultimately the primary' IV set.
  • the merging fluid pathway located about the IV extension set can comprise one or more access ports, wherein the at least one secondary ' IV set is further fluidly coupleable to one of the access ports of the merging fluid pathway, such that a fluid flow path of the secondary IV set merges with an extension flow path of the IV extension set (which extension flow path may alternatively comprise a bypass flow path created by activating the bypass manifold).
  • the IV set system of the present invention as discussed herein provides interactive and synergistic features that offer a significant step forward over prior IV sets or compilations of IV sets. Furthermore, each inventive component as described above can be viewed as a separate invention that can be applied within other fields of use independent of the whole. Several examples of such allocations and procedures have been set forth above and need no further explanation.
  • the method provides selective identification of at least one IV set defining at least one flow line within an IV set system which includes (i) a primary IV set having a proximal terminus, a distal terminus, and an intermediate tubular length defining a primary flow line of the primary IV set; and (ii) an IV extension set configured to be removably coupled to the primary IV set to extend the primary flow line and primal ⁇ ' flow path of the primary ' IV set via an extension flow line defining an extension flow path in-line with the primary' flow line and primary' flow path of the primary IV set, the IV extension set comprising or being operable with a bypass manifold in one example, with a merging fluid pathway in another example, or with a combined bypass manifold and merging fluid pathway in still another example.
  • Tire IV set system can further include (iii) at least one secondary IV set defining at least one secondary flow line configured to feed to the primary' flow line of the primary IV set or to the bypass manifold of the IV extension set, the at least one secondary ' IV set having a proximal terminus, a distal terminus, and an intermediate tubular length.
  • the representative steps of the method can include (a) applying at least one common set of unique marking indicia, which can also be uniform, to at least one of the primary and/or secondar ' IV sets and/or the IV extension set to enable rapid identification thereof with respect to other lines of the IV set system; and (b) allocating or associating the at least one primar ' and/or secondary IV sets and/or IV extension set having the unique marking indicia to/with a primary function or primary user as part of a medical procedure, thereby providing notice to other attending medical personnel of the allocated function for the at least one primary ' IV set and/or secondary IV sets and/or TV extension set.
  • the method may further comprise the steps of (i) applying the unique marking indicia (which may also be uniform) to a plurality of access points/ports positioned along the primary' IV set and/or the IV extension set of the IV set system to identify the primary ' IV set and/or the IV extension set from other lines of the IV set system, and (ii) allocating the primary flow line with the function of providing the IV with a primary carrier fluid flow line.
  • secondary IV sets may also be marked and identified in a similar manner.
  • the method may also include the steps of (i) applying the unique marking indicia (which may also be uniform) to at least one of the secondary IV sets, including at least the distal terminus of the secondary' IV set, for identification thereof from other lines of the IV set system and (ii) allocating the secondary flow line to the function of providing an infusion flow path into the primary flow line (which can further comprise an extended primary' flow line as provided by the extension flow line of the IV extension set, which functions to extend the primary flow' line).
  • the unique marking indicia which may also be uniform
  • a further a general method for providing access for bolus injections and/or secondary IV sets to a primary flow line of a primary IV set (which can comprise an extended primary flow' line as extended by an IV extension set coupled to the primary IV set as taught herein) using an external bypass manifold operable with the IV extension set, the bypass manifold having at least one access port facilitating access to a bypass flow hne and bypass flow path through the bypass manifold.
  • This step can be taken without breaking tire primary fluid flow line of the primary IV set and the fluid flow to a patient, but rather by diverting such primary fluid flow.
  • Hie steps of this procedure can include a) coupling the IV extension set to the primary IV set, such that the primary flow line of the primary IV set and the extension flow line of tire IV extension set are in fluid communication with one another (in an in-line arrangement).
  • the method can further comprise b) coupling a first proximal end of the manifold to a segment of the IV extension set through an access port on the TV extension set that communicates directly with the extension flow line and the primary flow line and tire fluid flow paths tiierein.
  • the method can further comprise c) positioning the manifold adjacent to and aligned with the segment of the IV extension set, and d) coupling the second distal end of the manifold to the segment of the IV extension set through another access port on the IV extension set that also communicates directly with the extension flow line and the primary flow line and the fluid flow paths therein. Laterally coupling the manifold in this manner effectively establishes an bypass flow line external and adjacent to the extension flow line and the primary flow line (e.g., out of line rather than in-line) of the extension IV set and the primary IV set, respectively.
  • the method can further comprise e) blocking flow through the extension flow line within the segment of the I V extension set, thereby diverting fluid flow and the fluid flow path through the bypass flow line created by the manifold.
  • the method can further comprise f) coupling a fluid delivery device, such as a syringe or a secondary line, to an access port of the manifold to enable fluid flow into the bypass flow line, such as to administer fluids (e.g., medication, analgesics, etc.) to the patient.
  • a fluid delivery device such as a syringe or a secondary line

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Abstract

L'invention concerne un ensemble d'extension IV couplé de manière amovible à l'ensemble IV primaire pour former un ensemble IV primaire étendu, l'ensemble d'extension IV comprenant une ligne d'écoulement d'extension délimitant un trajet d'écoulement d'extension, et une pluralité d'orifice d'accès sur la ligne d'écoulement d'extension, au moins deux des orifices d'accès étant situés entre des première et seconde extrémités de l'ensemble d'extension IV. Le système d'ensemble IV comprend en outre un collecteur de dérivation couplé de façon amovible à la ligne d'écoulement d'extension de l'ensemble d'extension IV par l'intermédiaire des orifices d'accès intermédiaires sur la ligne d'écoulement d'extension, le collecteur de dérivation comprenant une ligne d'écoulement de dérivation adjacente à la ligne d'écoulement d'extension, et un ou plusieurs points d'accès qui facilitent l'accès à la ligne d'écoulement de dérivation, le collecteur de dérivation et la ligne d'écoulement de dérivation pouvant être utilisés pour fournir un trajet d'écoulement de dérivation par l'intermédiaire de l'ensemble d'extension IV.
PCT/US2020/021028 2019-03-04 2020-03-04 Ensemble d'extension iv ou système d'ensemble iv avec collecteur de dérivation WO2020181007A1 (fr)

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US201962813748P 2019-03-04 2019-03-04
US62/813,748 2019-03-04
US16/417,269 2019-05-20
US16/417,269 US11058813B2 (en) 2013-08-12 2019-05-20 IV extension set or IV set system with bypass manifold

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