SYSTEMS AND METHODS FOR IMPROVING FLUID FLOW DURING MEDICATION DELIVERY PROCEDURES
20230047546 · 2023-02-16
Inventors
Cpc classification
A61M5/165
HUMAN NECESSITIES
A61M39/28
HUMAN NECESSITIES
International classification
A61M5/168
HUMAN NECESSITIES
A61M39/28
HUMAN NECESSITIES
Abstract
Systems and method for improving fluid flow during medication delivery procedures, such as infusions or pooling, are provided. A spike is punctured though a seal in a container. A liquid substance is drained from said container through a pathway in the spike. The spike includes a channel which permit sliding movement of a snorkel for elevation above the liquid substance to permit air to enter the container from outside without foaming the liquid substance.
Claims
1. A system for improving fluid flow during medication delivery procedures, said system comprising: a snorkel; and a spike configured for selective connection to a container having a liquid substance comprising at least one medication, said spike comprising a drain pathway for said liquid substance and a channel configured to receive, and permit sliding movement of, said snorkel.
2. The system of claim 1 wherein: said channel is configured to permit sliding movement of said snorkel between a retracted position whereby a first end of said snorkel is positioned within said channel and an extended position whereby said first end of said snorkel is locatable above said liquid substance when said spike is connected to said container and said container is oriented for delivery of said liquid substance; and said snorkel has a length sufficient to permit said first end to be elevated above said liquid substance and said second end to be located beyond an entrance to said channel when said snorkel is in said extended position such that ambient gas is ingestible through said second end of said snorkel for travel into said container and out said first end of said snorkel above said liquid solution to permit draining of said liquid substance through said drain pathway.
3. The system of claim 2 wherein: said container is rigid or semi-rigid.
4. The system of claim 2 further comprising: a protective cover attached to the entrance of said channel at a first end of the protective cover and attached to the second end of said snorkel at a second end of the protective cover, wherein said protective cover is selectively collapsible to permit movement of said snorkel between said retracted position and said extended position without removing the protective cover.
5. The system of claim 4 wherein: said protective cover comprises a plastic sheath.
6. The system of claim 3 wherein: said container comprises a bottle comprising a seal located at an otherwise open end of said bottle; and said spike is configured to puncture said seal on said container to provide said connection between the spike and the container.
7. The system of claim 6 wherein: said bottle is rigid or semi-rigid and comprises glass or a polymer.
8. The system of claim 1 further comprising: a fluid control device located at a second end of said snorkel.
9. The system of claim 8 wherein: said fluid control device comprises a one-way valve or a filter for gasses.
10. The system of claim 1 further comprising: said container; and an airflow control device provided at said container at a location above an anticipated fluid line of said liquid substance when said container is oriented for delivery of said liquid substance, wherein said airflow control device is configured to selectively permit air to enter said container.
11. The system of claim 10 further comprising: a needle configured to puncture said airflow control device, wherein said airflow control device is configured to remain sealed until said needle is passed through said airflow control device.
12. The system of claim 2 further comprising: a clamp connected to said spike and configured to selectively secure the position of said snorkel relative to said channel at or between said retracted position and said extended position.
13. The system of claim 2 wherein: said channel comprises a non-linear section; said snorkel comprises a non-linear segment matching said non-linear section; and said channel and said snorkel are configured to provide a sufficiently snug fit such that said snorkel is temporarily securable at or between said extended position and said retracted position.
14. The system of claim 1 wherein: the snorkel is permanently attached to the spike.
15. A method for improving fluid flow during medication delivery procedures, said method comprising the steps of: puncturing a seal of a bottle with at least a portion of a spike, said bottle holding a liquid solution comprising at least one medication for infusion into a patient or transfer to a different container; orienting said bottle for said infusion or said transfer of said liquid solution; extending a snorkel though a channel in said spike such that a first end of said snorkel is elevated above said liquid solution when said bottle is oriented for said infusion or said transfer of said liquid solution and a second end of said snorkel is positioned beyond an entrance of said channel to permit ingestion of ambient gas through said snorkel and into a gaseous pocket located above said liquid solution when said bottle is oriented for said infusion or said transfer of said liquid solution; and draining said liquid solution through a pathway in said spike to perform said infusion or said transfer.
16. The method of claim 15 further comprising the steps of: prior to extending the snorkel though the channel in said spike, closing a fluid control device located at a second end of said snorkel to prevent ingestion of ambient gasses; and after extending the snorkel above the said liquid solution, opening said fluid control device to permit ingestion of the ambient gasses.
17. The method of claim 15 wherein: said snorkel is provided within a collapsible protective sleeve which is collapsed when said snorkel is extended through said channel.
18. The method of claim 15 further comprising the steps of: clamping a clamp about a portion of said snorkel located beyond said entrance and outside of said channel or within said channel to secure said snorkel relative to said channel.
19. The method of claim 15 wherein: orienting said bottle for said infusion or said transfer of said liquid solution comprises orienting said bottle vertically such that said seal faces a ground surface.
20. A system for improving fluid flow during medication delivery procedures, said system comprising: a snorkel having a first open end and a second open end; a spike configured to puncture a seal located at an otherwise open end of a rigid bottle for a liquid solution comprising at least one medication, said spike comprising at least one pathway for draining the liquid solution from the rigid bottle and a channel configured to receive and permit sliding movement of said snorkel within said channel between a retracted position whereby said first open end of said snorkel is positioned within said channel and an extended position whereby said first open end of said snorkel is locatable above a fluid line of the liquid solution when said spike is punctured through said seal and said rigid bottle is inverted for gravitational aided delivery of said liquid solution through said at least one pathway; and a collapsible plastic sheath attached to an entrance area of said channel and the second open end of said snorkel; wherein said snorkel has a length sufficient to permit said first end to be elevated above said fluid line of said liquid substance and said second end to be located beyond said entrance area when said snorkel is in said extended position to establish gaseous communication between an ambient environment and a gaseous pocket located above said fluid line in said rigid bottle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] In addition to the features mentioned above, other aspects of the present invention will be readily apparent from the following descriptions of the drawings and exemplary embodiments, wherein like reference numerals across the several views refer to identical or equivalent features, and wherein:
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)
[0028] Various embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, specific details such as detailed configuration and components are merely provided to assist the overall understanding of these embodiments of the present invention. Therefore, it should be apparent to those skilled in the art that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
[0029] Embodiments of the invention are described herein with reference to illustrations of idealized embodiments (and intermediate structures) of the invention. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, embodiments of the invention should not be construed as limited to the particular shapes of regions illustrated herein but are to include deviations in shapes that result, for example, from manufacturing.
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[0034] The system 100 may be used to delivery any type or kind of substance 124, which is typically provided as a liquid. The substance 124 may comprise any number and type of ingredients. The substance 124 may be provided as a solution, such as a colloid solution, compound, or the like. Typically, at least one medication and at least one inactive carrying fluid are provided in the substance 124, though such is not required. Any type or kind of inactive ingredient, or combination of inactive ingredients, may be utilized. Any type or kind of medication, or combination of medications, may be utilized. The medications may comprise one or more naturally occurring substances, synthesized substances, combinations thereof, or the like. For example, at least one of the medications may comprise one or more proteins or immunoglobulin, such as but not limited to, albumin. These substances may be expensive and/or difficult to obtain. In the example of Immunoglobulin, which is provided without limitation, a single container 122 which is typically administered to a single patient, may be derived from plasma donations from multiple individuals. With the scarcity of available plasma donations, it is readily apparent why discarding even relatively small amounts of remaining substance 124 is undesirable.
[0035] In exemplary embodiments, the container 122 may comprise a bottle or otherwise rigid or semi-rigid container. The container 122 may comprise glass, plastic, or the like. The container 122 may comprise a puncturable seal at an otherwise open end for receiving a spike 112. In other exemplary embodiments, the container 122 may be flexible, such as but not limited to, where the container 122 comprise a bag. Even in the case of such flexible containers, certain amounts of substance 124 may remain in the container 122, such as within creases or air pockets created during administration, transfer, or other delivery. Thus, use of the delivery system 100 may also provide advantages when used with such flexible containers 122.
[0036] The spike 112 may comprise one or more pathways 119 for draining the substance 124 from the container 122.
[0037] As illustrated particularly in
[0038] The channel 126 may be configured to accommodate a snorkel 128. The channel 126 may comprise one or more non-linear section 125, such as but not limited to angular sections, curves, sinuous passages, or the like, though such is not required. For example, in other exemplary embodiments, the channel 126 may extend in an entirely straight line through the spike 112. The snorkel 128 may comprise one or more sufficiently flexible materials to negotiate the non-linear section 125 of the channel 126. Alternatively, or additionally, the snorkel 128 may comprise one or more sufficiently rigid material to remain stiff and upright when inserted into the container 122. The snorkel 128 may comprise a polymer, metal, combinations thereof, or the like. Some or all of the snorkel 128 may be hollow to facilitate the flow of fluids, such as but not limited to air, through the snorkel 128.
[0039] The snorkel 128 may be configured for sliding movement within the channel 126. The snorkel 128 may be moveable between a retracted position (see e.g.,
[0040] In other exemplary embodiments, a securing device 133 may be provided at, or connected to, the spike 112. The securing device 133 may be configured to secure the position of the snorkel 128 relative to the channel 126. The securing device 133 may comprise a strap and/or clamp for compressing the snorkel 128, such as but not limited to a C-clamp, hose clamp, tubing clamp, utility clamp, some combination thereof, or the like. Any type of kind of securing device 133 may be utilized. In exemplary embodiments, the securing device 133 may be positioned at or near the entrance 121 of the channel 126, though any location may be utilized. For example, without limitation, the securing device 133 may be positioned along the channel 126. The securing device 133 may be normally secured, normally unsecured, or the like.
[0041] As illustrated particularly in
[0042] In the retracted position, the first end 127 of the snorkel 128 may reside at least partially within the channel 126. In the extended position, the first end 127 of the snorkel 128 may extend within the container 122. In exemplary embodiments, the snorkel 128 may be of sufficient length to extend through the entire container 122 and the spike 112 when fully inserted (e.g., when in the extended position). At a minimum, the snorkel 128 may be of sufficient length to permit the first end 127 to be elevated above a fluid level of the substance 124 in the container 122 when the snorkel 128 is in the extended position.
[0043] The snorkel 128 may comprise a fluid control device 130 at the second end 129 thereof. The fluid control device 130 may be configured to permit air to enter the snorkel 128 (and thus the container 122) while preventing the substance 124 from exiting the container 122 through the snorkel 128. Alternatively, or additional, the fluid control device 130 may be configured to prevent certain outside contaminants (e.g., dust, pollen, germs, smoke, combinations thereof, or the like) from entering the container 122 while air is ingested. The fluid control device 130 may comprise a filter, cap, valve (e.g., one- or two-way valve, check value), combinations thereof, or the like. In other exemplary embodiments, a fluid control device 130 may not be required and a finger, other appendage, or other blocking member may be placed over the second end 129, which may be otherwise open, to control fluid flow. Any number and type of fluid control devices 130 may be utilized, such as but not limited to, along the snorkel 128, at the first end 127 of the snorkel 128, combinations thereof, or the like. The first end 127 may be otherwise be open.
[0044] The delivery system 100 may comprise a protective cover 132. The protective cover 132 may include one or more adjustable length members extending between the channel 126 and the second end 129 of the snorkel 128. The protective cover 132 may be connected to the spike 112 at a first end of the cover 132. The protective cover 132 may be connected to the fluid control device 130 at a second end of the cover 132. The protective cover 132 may comprise a sheath, sleeve, combinations thereof, or the like which is capable of collapsing. The protective cover 132 may, alternatively or additionally, comprise one or more telescoping member, compressible tubing, combinations thereof, or the like. The protective cover 132 may be configured to cover a portion of the snorkel 128 extending from the channel 126. The protective cover 132 may be configured for collapsing or otherwise reducing to a size which permits the snorkel 128 to be fully extended within the channel 126, and the container 122. The protective cover 132 may be configured for expansion or otherwise increasing to a size which permits the snorkel 128 to be fully retracted from the channel 126, and thus the container 122. The protective cover 132 may permit the snorkel 128 to remain in a sterile environment despite retraction and extension. This may permit the spike 112 and/or the snorkel 128 to be reused. Alternatively, or additionally, this may permit utilization of the snorkel 128 with different size containers 122. For example, the protective cover 132 may provide a sterile environment even where a portion of the snorkel 128 is extended form the channel 126, which may be the case when relatively short containers 122 are used. For example,
[0045] The channel 126 may comprise one or more non-linear sections 125. The snorkel 128 may comprise sufficiently flexible materials to permit the snorkel 128 to negotiate the non-linear sections 125 of the channel 126. The snorkel 128 may comprise materials with sufficient durability and/or memory that the snorkel 128 resumes a linear orientation upon passage beyond the non-linear sections 125.
[0046] Alternatively, or additionally, the snorkel 128 may comprise one or more non-linear segments 131. The non-linear segments 131 may be configured to accommodate some or all of the non-linear sections 125 of the channel 126. For example, the snorkel 128 may be shaped to match the channel 126 when the snorkel 128 is fully inserted within the channel 126, such as when the snorkel 128 is the extended position. The non-linear nature of the sections 125 and/or segments 131 may provide the necessary fiction to temporarily secure the snorkel 128 relative to the channel 126. The snorkel 128 may comprise a sufficiently durable, memory material that normally takes a shape which include the non-linear segments 131, such as but not limited to one or more polymers.
[0047] The first end 127 of the snorkel 128 may be sharpened, blunted, or the like.
[0048]
[0049] The snorkel 228 may comprise one or more non-linear segments 231. The non-linear segments 231 may permit a second end 229 of the snorkel 228 to extend a distance from an outer surface of the spike 212 to facilitate access to said second end 229 when said snorkel 228 is inserted into said container 222. Any shape and number of non-linear segments 231 may be utilized. The second end 229 of the snorkel 228 may be open or the opening may be located a distance from the termination of the second end 229.
[0050] One or more fluid control devices 230 may be provided at the second end 229 of the snorkel 228, along the snorkel 228, at the first end 217, combinations thereof, or the like. The fluid control devices 230 may comprise a valve, filter, combinations thereof, or the like.
[0051] The spike 212 may be vented or unvented. The spike 212 may comprise one or more pathways 219 for draining a substance 224 from said container 222. Stated another way, the spike 212 may not require a separate channel, such as channel 126, for the snorkel 228 as the snorkel 228 may be inserted into the container 222 adjacent to the spike 212. Traditional spikes (vented or non-vented) may be used with the delivery system 200, though such is not required.
[0052] The snorkel 228 may be moveable between a retracted position where said snorkel 228 is located entirely outside of said container 222, and an extended position whereby said first end 217 of said snorkel 228 extends above a fluid line 223 (actual or anticipated) of a substance 224 in said container 222 and into an air pocket 217 (actual or anticipated). The snorkel 228 and/or the seal of the container 222 may comprise one or more materials having sufficient frictional properties that said snorkel 228 is temporarily securable at said extended position, or a position between said retracted position and said extended position. Alternatively, or additionally, a securement device 233, such as but not limited to a clamp, strap, or the like, may be provided at said spike 212 for securing said snorkel 228.
[0053]
[0054] Regardless, the position of the snorkel 128, 228 within the air pocket 117, 217 above the fluid line 123, 223 may permit the introduction of ambient air into the container 122, 222 without the need for the air to bubble directly through the substance 124, 224 once the container 122, 222 is positioned for delivery of the substance 124, 224 and the delivery of the substance 124, 224 has begun, thereby permitting smooth draining of the substance 124, 224 during delivery, which may decrease or eliminate foaming and permit increased or full delivery of the substance 124, 224. Where the fluid control device 130, 230 is utilized, the fluid control device 130, 230 may be closed before the snorkel 128, 228 is raised above the fluid line 123, 223, and opened after the snorkel 128, 228 is raised above the fluid line 123, 223. In other exemplary embodiments, the fluid control device 130, 230 may be configured to automatically prevent the substance 124, 224 from traveling there beyond, but permit ambient air to enter (e.g., one-way value). The position of the snorkel 128, 228 may be secured by the securing device 133, 233.
[0055]
[0056] The airflow control device 334 may comprise a port, cap, stopper, puncturable seal, valve (one-way, two-way, check, combinations thereof, or the like), combinations thereof, or the like. In exemplary embodiments, without limitation, the airflow control device 334 may comprise a rubber stopper. The airflow control device 334 may be positioned at a location of the container 322 within an air pocket 317 (actual or anticipated) located above a fluid line 323 (actual or anticipated) when the container 322 is positioned for administration, transfer, or other removal through a pathway 319. For example, without limitation, the airflow control device 334 may be positioned at or adjacent to a bottom surface, or at bottom portion of the container 322 such that when the spike 312 is inserted and the container 322 is oriented for delivery of the substance 324 (e.g., inverted) the airflow control device 334 is located above the fluid line 323. In this way, the air entering the container 322 does not pass through the substance 324, and thus does not create foaming. Any number of airflow control devices 334 may be utilized or the same or different type at any location on the container 322.
[0057] In exemplary embodiments, the airflow control device 334 may be configured to be remain sealed until a needle 336 or other device is inserted through the airflow control device 334 to permit air to enter the container 322. The airflow control device 334 may be configured to remain closed until certain user interaction is provided, such as but not limited to, opening a cap, removing a stopper, opening a valve, combinations thereof, or the like. Alternatively, the airflow control device 334 may be configured to remain open until certain user interaction is provided. The needle 336 may comprise a filter configured to prevent particulate of a predetermined size from entering said container 322 even when said airflow control device 334 is opened. In this way, contaminants (e.g., dust, pollen, smoke, germs, combinations thereof, or the like) may be prevented from entering the container 322 while the airflow control device 334 is opened or otherwise fully or partially unsealed.
[0058] The delivery system 300 may be used as an alternative to, or in conjunction with, the delivery system 100 and/or the delivery system 200. For example, without limitation, the snorkel 128, 228 and/or spike 112, 212 may be used in combination with the airflow control device 334, though such is not required.
[0059] Traditional spikes (vented or non-vented) may be used with the delivery system 300, though such is not required. The delivery system 300 may be used with rigid or semi-rigid containers 322, such as bottle. In other exemplary embodiments, the delivery system 300 may be used with flexible containers 322, such as bags. Even in the case of flexible containers 322, certain amounts of substance 324 may remain in the container 322, such as within creases or air pockets created during administration, transfer, or other removal. Thus, the delivery system 300 may have applicability to such flexible containers 322.
[0060] Any of the steps shown or described herein may be performed in any order, may omit one or more steps, may repeat one or more steps, or the like.
[0061] Any embodiment of the present invention may include any of the features of the other embodiments of the present invention. The exemplary embodiments herein disclosed are not intended to be exhaustive or to unnecessarily limit the scope of the invention. The exemplary embodiments were chosen and described in order to explain the principles of the present invention so that others skilled in the art may practice the invention. Having shown and described exemplary embodiments of the present invention, those skilled in the art will realize that many variations and modifications may be made to the described invention. Many of those variations and modifications will provide the same result and fall within the spirit of the claimed invention. It is the intention, therefore, to limit the invention only as indicated by the scope of the claims.