Infusion control device for maintaining venous patency

Abstract

To maintain patency of an intravenous (IV) catheter while limiting the risk of occlusion, it can be desirable to use a Keep Vein Open (KVO) infusion flow control device to continuously deliver fluid to a patient's catheter line in a controlled manner. The KVO infusion flow control devices disclosed herein utilize a superabsorbent polymer (SAP) that expands upon contact with water (particularly distilled water) to gradually deliver a steady stream of saline to a patient's catheter line. The KVO infusion flow control device includes a piercing system that can be used to pierce a distilled water chamber and expose the distilled water to the SAP block. As the SAP block expands, the SAP block compresses a flush chamber that is charged with saline and pushes the saline out of the KVO infusion flow control device and into the patient's catheter line.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application No. 19 / 035,523, filed January 23, 2025, entitled “KEEP VEIN OPEN INFUSION CONTROL DEVICE”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to devices for keeping the vein open (KVO) (also known as "keep open" or "TKO"), and more specifically, to KVO devices for administering medical fluids (such as saline, therapeutic agents and / or total parenteral nutrition solutions) to a patient in the form of a continuous, substantially continuous, semi-continuous or intermittent fluid flow. Background Technology

[0004] Medical treatment typically involves infusing medical fluids (such as saline solutions or liquid medications) to a patient using an intravenous (IV) catheter. In cases where a patient may require medication to be received via infusion on a repeated or intermittent basis, it may be desirable to maintain the patency of the IV catheter by preventing venous blockage.

[0005] However, maintaining the patency of unused catheter lumens presents challenges. Over the extended periods between active flows within the lumen, catheter lines can tend to become blocked due to various biological responses within the patient. For example, blood clots may form within the patient's blood vessels, or the catheter line may become clogged with deposits from medications or parenteral nutrition. In addition to inconveniencing caregivers, IV line blockage can increase the patient's risk of bloodstream infections by creating a favorable environment for microbial growth. Summary of the Invention

[0006] Flushing peripheral intravenous catheters (PIVCs) is a common method for maintaining catheter patency. In particular, PIVC flushing is believed to prevent occlusion of the catheter lumen (in addition to reducing the formation of blood clots, bacterial biofilms, and drug deposits). However, existing solutions for preventing IV catheter occlusion are not ideal because even after a patient has received an IV infusion, clinicians must flush unused lumens with saline and / or multiple IV drip bags. Therefore, a KVO infusion flow control device is needed to provide safe and controlled fluid flow. By providing a slow, continuous infusion of fluid (e.g., saline) to the patient, the patient's vein can be kept open while avoiding occlusion in the catheter line.

[0007] Some embodiments of this disclosure relate to an infusion control device for maintaining open vein (KVO) infusion control device comprising: a housing including a tube having a distal end and a puncture system at a proximal portion of the tube; a flushing chamber disposed within the distal portion of the housing and configured to be filled with saline; a superabsorbable polymer (SAP) block disposed within the housing and proximal to the flushing chamber, the SAP block being configured to expand upon contact with distilled water; and a distilled water chamber disposed within the housing adjacent to the puncture system and proximal to the SAP block, the distilled water chamber being configured to be filled with distilled water, wherein the puncture system is configured to facilitate delivery of distilled water to the SAP block, wherein the SAP block is configured to compress the flushing chamber and expel saline distally to the distal end when the SAP block expands.

[0008] In some embodiments, the end is configured to engage with a needleless fluid connector. In some embodiments, the end includes a male Luer lock.

[0009] In some embodiments, the SAP block is generally cylindrical. In some embodiments, the SAP block contains sodium polyacrylate. In some embodiments, the SAP block contains potassium poly(acrylamide-copolyacrylate).

[0010] In some embodiments, the KVO infusion control device further includes a uniform pusher positioned between the SAP block and the flushing chamber. Optionally, the uniform pusher is configured to receive forces from the SAP block as the SAP block expands and apply those forces to the flushing chamber to push the brine distally to the end.

[0011] In some embodiments, the distilled water chamber is configured to be refilled with distilled water via an opening located at the proximal end of the distilled water chamber.

[0012] In some embodiments, the KVO infusion control device further includes a cap attached to the proximal end of the housing, wherein the cap is configured to close the distilled water chamber.

[0013] In some embodiments, the puncture system includes one or more puncture elements located on the inner surface of the housing, each of the puncture elements including a sharp end configured to puncture a distilled water chamber to fluidly connect the distilled water chamber to the housing. Optionally, the puncture system includes one or more puncture elements configured to puncture a distilled water chamber and fluidly connect the distilled water chamber to the SAP block. Optionally, the puncture system is configured to puncture the distilled water chamber and release distilled water into the housing.

[0014] Some embodiments of this disclosure relate to a keep-open vein (KVO) infusion control device comprising: a housing including a tube having a distal end; a flushing chamber disposed within a distal portion of the housing and configured to be filled with saline; a superabsorbent polymer (SAP) block disposed within the housing and proximal to the flushing chamber, the SAP block being configured to expand upon contact with distilled water; a distilled water chamber disposed within the housing and proximal to the SAP block, the distilled water chamber being configured to be filled with distilled water; and a puncture system positioned on an inner surface of the housing and proximal to the distilled water chamber, the puncture system being configured to fluidly connect the distilled water chamber to the housing and facilitate delivery of distilled water to the SAP block, wherein the SAP block is configured to compress the flushing chamber and expel saline distally to the distal end.

[0015] In some embodiments, the KVO infusion control device further includes a cap attached to the proximal end of the housing, wherein the cap is configured to close the distilled water chamber.

[0016] In some embodiments, the puncture system is attached to the cap and configured to puncture the distilled water chamber when the cap is engaged with the proximal end of the housing. Optionally, the puncture system includes one or more puncture elements, each of which includes a distally oriented sharp end configured to puncture the distilled water chamber to fluidly connect the distilled water chamber to the housing.

[0017] Some embodiments of this disclosure relate to a keep-open vein (KVO) infusion control device comprising: a housing including a tube having a distal end and a puncture system at a proximal portion of the tube; a flushing chamber disposed within the distal portion of the housing and configured to be filled with saline, the flushing chamber including a superabsorbent polymer (SAP) tube configured to expand upon contact with distilled water; and a distilled water chamber disposed within the housing adjacent to the puncture system and proximal to the flushing chamber, the distilled water chamber being configured to be filled with distilled water, wherein the puncture system is configured to facilitate delivery of distilled water to the SAP tube, wherein the SAP tube is configured to remove saline from its distal end when the SAP tube expands.

[0018] In some embodiments, the puncture system is configured to puncture the distilled water chamber and release distilled water into the housing, allowing the distilled water to contact the SAP tube.

[0019] In some embodiments, when in contact with distilled water, the SAP tube is configured to expand radially inward and remove brine from its end.

[0020] Further features and advantages of this subject matter will be set forth in the description which follows, and some features and advantages will become apparent from the description or may be learned by practice of the subject matter. The advantages of this subject matter will be realized and obtained through the written description and embodiments, as well as the structures specifically pointed out in the accompanying drawings.

[0021] It should be understood that the general description above and the detailed description below are exemplary and illustrative, and are intended to provide further explanation of the technical subject matter. Attached Figure Description

[0022] Various features of illustrative embodiments of the present invention are described below with reference to the accompanying drawings. The illustrated embodiments are intended to illustrate, not limit, the invention. The drawings include the following figures:

[0023] Figure 1 A KVO infusion control device for use with an IV kit according to some embodiments described herein is shown.

[0024] Figure 2A and Figure 2B Perspective views and cross-sectional perspective views of a KVO infusion control device according to some embodiments described herein are shown.

[0025] Figure 3 shows a cross-sectional view of a KVO infusion control device according to some embodiments disclosed herein and a close-up cross-sectional view of a first embodiment of a puncture system.

[0026] Figure 4A and Figure 4B A cross-sectional view of a KVO infusion control device with a puncture system according to some embodiments disclosed herein is shown.

[0027] Figure 5A and Figure 5B A cross-sectional view of a KVO infusion control device having SAP components, according to some embodiments disclosed herein, is shown.

[0028] Figures 6A-6B The functions of various components of a KVO infusion control device according to some embodiments disclosed herein are illustrated. Detailed Implementation

[0029] In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject matter. The subject matter can be practiced without these specific details. In other instances, well-known structures and techniques are not shown in detail to avoid obscuring the subject matter.

[0030] Furthermore, although this specification sets forth specific details of various embodiments, it should be understood that this specification is illustrative only and should not be construed as restrictive in any way. Moreover, it is conceivable that although specific embodiments of this disclosure may be disclosed or illustrated in the context of IV kits, these embodiments can be used in other fluid delivery systems. Furthermore, various applications and modifications of such embodiments that may occur to those skilled in the art are also included in the general concepts described herein.

[0031] Maintaining the patency of the IV catheter is desirable when patients require medication administration via infusion on a repetitive or intermittent basis. When maintaining IV catheter patency, it is important to take measures to alleviate blockages in the catheter line to avoid both the need for reinsertion of the catheter into the patient's vein and infection in the patient's bloodstream. The following devices and methods offer design modifications to overcome the aforementioned problems.

[0032] Now refer to the attached diagram, Figure 1 A KVO infusion control device for use in conjunction with an IV kit according to some embodiments described herein is illustrated. The IV kit 10 is attached to a patient's arm and includes a catheter 20, a catheter hub 22, catheter wings 24, an extension tube 30, a fluid connector 32 (e.g., a needleless fluid connector or a female Luer element), and a KVO infusion control device 100. The catheter 20 is inserted into a vein in the patient and directly coupled to the catheter hub 22, which is secured to the patient's arm via the catheter wings 24. The extension tube 30 fluidly connects the catheter hub 22 to the needleless fluid connector 32. The needleless fluid connector 32, in turn, is coupled to the KVO infusion control device 100. Thus, the KVO infusion control device 100 is coupled to the patient's vein and delivers a controlled flow of fluid (e.g., saline) when the patient's vein is open to avoid blockage in the catheter line.

[0033] Figure 2A and Figure 2BPerspective and cross-sectional perspective views of a KVO infusion control device according to some embodiments described herein are shown. The KVO infusion control device 100 includes multiple components disposed within a housing 110. Specifically, the housing 110 includes a flushing chamber 130, a superabsorbent polymer (SAP) push block 140, a SAP block 150, and a distilled water chamber 160. At a proximal end, the housing 110 has an opening that can be covered by a cap 170, and at a distal end, the housing 110 has an end 112 that can be coupled to a male Luer lock 120. The housing 110 also has a puncture system 114 configured to puncture the distilled water chamber 160. When the distilled water chamber 160 is punctured, distilled water 162 is released into the housing 110, and the distilled water 162 permeates the SAP block 150. As the SAP block 150 becomes wet, it expands within the housing 110 and compresses the flushing chamber 130. As a result, the saline 132 within the flushing chamber 130 is pushed distally out of the distal end 112 of the housing 110. The KVO infusion control device 100 facilitates a slow, continuous flow of the saline 132 to the patient because the steady flow of distilled water 162 causes a steady expansion of the SAP block 150, and thus allows the saline 132 to be steadily discharged from the distal end 112. As a result, the saline 132 can be infused to the patient over a period of at least 8 hours. In some embodiments, the saline 132 can be infused to the patient over a period of approximately 10 hours.

[0034] The housing 110 is a generally cylindrical tube with an end 112 extending from the distal end of the housing 110. This end 112 is configured to connect with a fluid connector (e.g., Figure 1 The needleless fluid connector 32 shown is used for connection. The end 112 may include a male Luer lock 120, such as a standard male Luer lock with a rotatable collar. Other types of fluid connectors are also possible. The housing 110 also has a puncture system 114 at the proximal portion of the cylindrical tube. As described above, the puncture element 116 of the puncture system 114 is configured to puncture the distilled water chamber 160 and facilitates the delivery of distilled water 162 to the SAP block 150. The structure and function of the puncture system 114 are discussed in more detail below with reference to FIG3. Some embodiments of the KVO infusion control device 100 have a puncture system 114 at the proximal end of the housing 110. This embodiment... Figure 4A and Figure 4B As shown in the figure, and discussed in more detail below.

[0035] The KVO infusion control device 100 also includes a flush chamber 130 disposed in the distal portion of the housing 110 adjacent to end 112. The flush chamber 130 is a generally cylindrical tube filled with saline solution 132. Optionally, the cylindrical tube of the flush chamber 130 is made of plastic or a resilient material. The flush chamber 130 is fitted inside the housing 110 such that the outer surface of the flush chamber 130 is in direct contact with the inner surface of the housing 110.

[0036] In some embodiments, the flushing chamber 130 is configured to be compressed. When the flushing chamber 130 is compressed, the brine 132 within the flushing chamber 130 is pushed distally out of the KVO infusion control device 100 via the distal end 112 of the housing 110.

[0037] In other embodiments, the KVO infusion control device 100 has a flushing area in the distal portion of the housing 110, instead of a flushing chamber 130. In these embodiments, brine 132 fills the distal portion of the housing 110 and is separated from the SAP block 150 by a uniform pusher 140. As the SAP block 150 expands, it displaces the brine 132, and the brine 132 is released from the KVO infusion control device 100 via the distal end 112 of the housing 110.

[0038] The KVO infusion control device 100 also includes a SAP block 150 disposed within the housing 110 and proximal to the flush chamber 130. The SAP block 150 is configured to expand upon contact with a fluid, such as distilled water 162 from the distilled water chamber 160. As the SAP block 150 expands, it pushes the flush chamber 130 distally, causing the brine 132 within the flush chamber 130 to flow out of the KVO infusion control device 100 via the distal end 112 of the housing 110. This effect is driven by osmosis. Because the SAP block 150 contains more ions than the distilled water 162, molecules of distilled water 162 flow into the SAP block 150 to establish an equilibrium between the SAP block 150 and the distilled water 162 within the housing. Specifically, the SAP block 150 is capable of absorbing distilled water 162 at a rate of approximately 500 to 600 grams per gram.

[0039] The volume of SAP block 150 increases due to water, and because SAP block 150 is confined by the inner surface of housing 110 and distilled water chamber 160, SAP block expands distally when wet, pushing brine 132 toward distal end 112. The extent of the volume increase of SAP block 150 is directly related to the amount of distilled water 162 exposed therein. Therefore, the rate at which SAP block 150 pushes brine 132 out of KVO infusion control device 100 can depend on the rate at which distilled water 162 flows into housing 110 and reaches SAP module 150. This will be described in more detail below with reference to FIG3.

[0040] The rate at which the SAP block 150 ejects saline 132 from the KVO infusion control device 100 can also depend on the materials constituting the SAP block 150. This is because the degree of expansion of the SAP block 150 can depend on the crosslinking ability of the polymer constituting the SAP block 150. Some embodiments of the KVO infusion control device 100 have an SAP block 150 made of sodium polyacrylate. Other embodiments have an SAP block 150 made of potassium poly(acrylamide-copolymer-acrylic acid). Both sodium polyacrylate and potassium poly(acrylamide-copolymer-acrylic acid) expand in the range of approximately 270 to 300 grams per gram, which is beneficial for the slow and consistent delivery of saline 132 to the patient.

[0041] SAP block 150 has a generally cylindrical shape and is fitted within housing 110, between rinsing chamber 130 and distilled water chamber 160. SAP block 150 can be fitted tightly within housing 110. Optionally, a gap exists between SAP block 150 and the inner surface of housing 110 (e.g., gap 118 shown in FIG. 3).

[0042] In some embodiments, the KVO infusion control device 100 has a homogenizing actuator 140 positioned between a flushing chamber 130 and a SAP module 150. When the SAP module 150 is exposed to distilled water 162 and expands, the SAP module 150 applies a distal force to the homogenizing actuator 140. The homogenizing actuator 140 then applies a distal force to the flushing chamber 130 to expel brine 132 from the end 112 of the KVO infusion control device 100.

[0043] In some embodiments, the KVO infusion control device 100 has an SAP tube 150' instead of an SAP block 150. The SAP tube 150' is positioned along the inner surface of the flushing chamber 130. This will be referred to below. Figure 5A and Figure 5B To describe in more detail.

[0044] The proximal portion of housing 110 is occupied by a distilled water chamber 160. The distilled water chamber 160 is located proximal to SAP block 150. The proximal end of housing 110 has an opening (not shown). In some embodiments, the distilled water chamber 160, filled with distilled water 162, is inserted into housing 110 through the opening. In other embodiments, the distilled water chamber 160 remains inside housing 110 and is refilled with distilled water 162 by pouring it into the distilled water chamber 160 through the opening. Housing 110 can be closed using a cap 170 that snaps onto the proximal end of housing 110 and the proximal end of distilled water chamber 160.

[0045] The distilled water chamber 160 is also adjacent to the puncture system 114. A caregiver can squeeze or push the housing 110 or cap 170 to puncture the distilled water chamber 160 with the puncture system 114. When the distilled water chamber 160 is punctured, distilled water 162 flows out of the chamber, into the housing 110, and towards the SAP block 150. This will be described in more detail with reference to FIG3.

[0046] Figure 3 shows a cross-sectional view of a KVO infusion control device according to some embodiments disclosed herein and a close-up cross-sectional view of a first embodiment of the puncture system. The KVO infusion control device 100 shown in section A of Figure 3 is configured to release distilled water 162 from the distilled water chamber 160 when the distilled water chamber 160 is punctured or perforated by the puncture system 114. When the distilled water chamber 160 is punctured, the distilled water 162 flows out of the distilled water chamber 160 and into the gap 118 between the outer surface of the distilled water chamber 160 and the inner surface of the housing 110. This is shown in section C of Figure 3. The distilled water 162 flows along the gap 118 and toward the SAP block 150, causing the SAP block 150 to expand. The expansion of the SAP block 150... Figures 6A-6B As shown in the image.

[0047] As shown in section B of Figure 3, the puncture system 114 includes one or more puncture elements 116 located on the inner surface of the housing. The puncture elements 116 protrude from the inner surface of the housing 110 such that their pointed ends point radially inward toward the outer surface of the distillation chamber 160. The puncture elements 116 can be arranged circumferentially around the inner surface of the proximal portion of the housing 110. This is in Figure 2A To best illustrate. For example... Figure 1 As shown, this arrangement of the puncture member 116 may be ideal when the KVO infusion control device 100 is to be placed horizontally on the patient's arm. This is because the circumferential arrangement of the puncture member 116 facilitates the outflow of distilled water 162 from the distilled water chamber 160, regardless of the rotational orientation of the KVO infusion control device 100 relative to the patient's arm. In some embodiments, the puncture member 116 may be circumferentially positioned closer to the SAP block 150 around the inner surface of the housing 110 (i.e., around the distal portion of the distilled water chamber 160). This may be advantageous when the KVO infusion control device 100 is expected to be tilted slightly downward (i.e., toward the ground) with its distal end 112 and a higher infusion rate of saline 132 is desired, as gravity will cause the distilled water 162 to remain in the distal portion of the distilled water chamber 160.

[0048] exist Figure 1In the embodiment shown in Figure 3, a caregiver can puncture the distilled water chamber 160 by squeezing the proximal portion of the housing 110 (i.e., pinching the housing 110 or applying a radially inward force to the housing 110). As shown in section C of Figure 3, the inward force applied to the proximal portion of the housing 110 drives the puncture member 116 into the distilled water chamber 160. The sharp edge of the puncture member 116 pierces the wall of the distilled water chamber 160. When the distilled water chamber 160 is punctured, distilled water 162 flows out of the distilled water chamber 160 through the hole formed by the puncture member 116 and surrounds the puncture member 116.

[0049] The number of puncture points 116 in the puncture system 114 can affect the rate at which distilled water 162 reaches the SAP block 150. Furthermore, the number and location of the puncture points 116 affect the rate of expansion of the SAP block 150, and thus the rate at which saline 132 is delivered to the patient. For example, increasing the number of puncture points 116 increases the rate at which distilled water 162 flows out of the distilled water chamber 160 and into the gap 118 towards the SAP block 150, because it creates more flow paths for the distilled water 162. Therefore, increasing the number of puncture points 116 increases the flow rate of saline 132 as it is delivered to the patient. For the same reason, decreasing the number of puncture points 116 reduces the rate at which distilled water 162 reaches the SAP block 150, and thus reduces the rate at which saline 132 is delivered to the patient.

[0050] Furthermore, the size of the puncture element 116 of the puncture system 114 can affect the rate at which saline 132 is delivered to the patient. A smaller puncture element 116 forms a smaller orifice in the distilled water chamber 160. Therefore, when the puncture element 116 is smaller, the distilled water 162 flows out of the distilled water chamber 160 more slowly, resulting in a slower rate of saline infusion to the patient. Conversely, a larger puncture element pierces a larger orifice in the distilled water chamber 160, thus delivering saline 132 to the patient at a greater rate.

[0051] The size of the gap 118 can limit the impact of the number and size of the puncture elements 116 on the flow rate of saline 132 out of the KVO infusion control device 100. When the gap 118 is smaller, the number and size of the puncture elements 116 have a smaller impact on the flow rate of saline 132 because the smaller gap 118 limits the rate at which distilled water 162 reaches the SAP block 150. On the other hand, when the gap 118 is larger, the number and size of the puncture elements 116 have a greater impact on the flow rate of saline 132. In some embodiments, the thickness of the gap 118 is approximately 5% of the diameter of the housing 110, meaning that approximately 80% of the housing 110 is occupied by the distilled water chamber 160.

[0052] Figure 4A and Figure 4BA cross-sectional view of a KVO infusion control device with a puncture system according to some embodiments disclosed herein is shown. Figure 4A A KVO infusion control device 100 with a housing 110 is shown. The housing has a distal end 112 connected to a galvanic lock 120, a flushing chamber 130 filled with saline 132, a homogenizer 140 adjacent to the flushing chamber 130, a SAP block 150 adjacent to the homogenizer 140, a distilled water chamber 160 filled with distilled water 162 and located proximally adjacent to the SAP block, and a puncture system 114' at the proximal end of the housing 110. The proximal portion of the housing 110 has a gap 118 circumferentially arranged between the inner surface of the housing 110 and the SAP block 150, the distilled water chamber 160, and the puncture system 114'. This gap 118 can be filled with distilled water 162 when the distilled water chamber 160 is punctured by the puncture element 116' of the puncture system 114'.

[0053] The puncture system 114' includes one or more puncture elements 116' located at the proximal end of the housing 110, with the pointed ends of the puncture elements 116' pointing towards the distilled water chamber 160. In the illustrated embodiment, one puncture element 116' is coupled to the cap 170, and when a distal force is applied to the cap 170 (e.g., by a caregiver), the puncture element 116' is driven into the distilled water chamber 160, and distilled water 162 flows toward the SAP block 150. As described above with respect to the first embodiment of the puncture system, the SAP block 150 expands upon contact with water, which pushes the uniform pusher 140 into the flushing chamber 130. The flushing chamber 130 is compressed, and saline 132 is expelled from the distal end 112 of the KVO infusion control device 100. In other embodiments, the puncture element 116' is coupled to the distilled water chamber 160 instead of the cap 170. Alternatively, the puncture element 116' is coupled to the proximal end of the inner surface of the housing 110. An embodiment having a puncture element 116' (or multiple puncture elements 116') at the proximal end of the KVO infusion control device 100 may be particularly useful if the KVO infusion control device 100 is intended to be positioned with the proximal end of the KVO infusion control device 100 facing downward (i.e., cap 170 pointing towards the floor), because gravity will cause distilled water 162 to remain at the proximal end of the distilled water chamber 160, close to the puncture element 116'.

[0054] In some embodiments, the puncture system 114' includes a plurality of puncture elements 116' instead of a single puncture element 116'. The plurality of puncture elements 116' may be arranged near the radial center of the distilled water chamber 160 (i.e., generally in line with the lumen of the distal end 112). The plurality of puncture elements 116' may also be arranged near the inner surface of the distilled water chamber 160. This embodiment is horizontally oriented in the KVO infusion control device 100 (e.g., on the patient's arm, as shown). Figure 1This is particularly useful in the case shown, because gravity will cause the distilled water 162 to remain on the lower part of the inner surface of the distilled water chamber 160 (i.e., closer to the ground).

[0055] In addition to one or more punctures 116' located at the proximal end of the distilled water chamber 160 (e.g., such as...), Figure 4A and Figure 4B As shown in Figure 3, some embodiments of the KVO infusion control device 100 may also include one or more puncture elements 116 (e.g., as shown in Figure 3) surrounding the proximal portion of the inner surface of the housing 110. In embodiments with two puncture elements 116 and 116', a caregiver can puncture the distilled water chamber 160 by applying one or both of a radially inward force to the proximal portion of the KVO infusion control device 100 and a distal force to the proximal end of the KVO infusion control device 100.

[0056] Figure 5A and Figure 5B A cross-sectional view of a KVO infusion control device having SAP components, according to some embodiments disclosed herein, is shown. Figure 5A A KVO infusion control device 100 is shown prior to puncture of the distilled water chamber 160 by the puncture system 114. The KVO infusion control device 100 comprises a housing 110 that holds a flushing chamber 130 filled with saline 132 and a distilled water chamber 160 filled with distilled water 162. In this embodiment, the flushing chamber 130 is adjacent to the distilled water chamber 160. This is because this embodiment has a SAP tube 150' instead of a SAP block 150, as... Figures 1-4B and Figures 6A-6B The SAP block is shown. The SAP tube 150' is made of the same material as the SAP block 150 and has a similar function (i.e., to absorb distilled water 162 and expand to remove brine 132 from the end 112 of the housing 110), even though the SAP tube 150' is a cylindrical tube rather than a disc or cylindrical block.

[0057] In some embodiments, the SAP tube 150' is lined to the inner surface of the flush chamber 130. In other embodiments, the SAP tube 150' is the flush chamber 130, i.e., the inner surface of the flush chamber 130 is made of SAP material. In embodiments where the inner surface of the flush chamber 130 is made of SAP material, the SAP material is surrounded by a membrane permeable to distilled water 162 (i.e., the outer surface of the flush chamber is made of a permeable membrane or material).

[0058] When the distilled water chamber 160 is punctured by the puncture system 114 (or 114'), distilled water 162 enters the gap 118 between the outer surface of the distilled water chamber 160 and the inner surface of the housing 110. The distilled water 162 reaches the flushing chamber 130 and thus the SAP tube 150'. Upon contact with the distilled water 162, the SAP tube 150' expands. Because the SAP tube 150' is confined on its distal side by the housing 110 and on its proximal side by the distilled water chamber 160, the SAP tube 150' expands radially inward. This... Figure 5B As shown in the diagram. As a result, the expanded SAP tubing 150' displaces the saline 132, and the saline 132 is pushed out of the distal end 112 of the housing. When the KVO infusion control device 100 is connected to the conduit line (e.g., via...), Figure 1 When the connector 32 shown is used, saline 132 is delivered to the patient. (It is worth noting that saline 132 does not cause significant expansion of the SAP tube 150' because the ionic difference within the polymer matrix of saline 132 and SAP tube 150' is minimal.)

[0059] This disclosure also includes a method for using a KVO infusion control device. Therefore, Figures 6A-6B The functions of various components of a KVO infusion control device according to some embodiments disclosed herein are illustrated. After the KVO infusion control device 100 is connected to the patient's catheter line (i.e., the male Luer lock 120 is connected to the needleless fluid connector), the caregiver pinches or presses the proximal portion of the housing 110 (e.g., ...). Figure 6A (As indicated by the arrow in the image) to drive the puncture member 116 into the distilled water chamber 160.

[0060] When the puncture element 116 punctures the distilled water chamber 160, distilled water 162 will flow out of the distilled water chamber (via the perforation formed by the puncture element 116) and into the gap 118 between the outer surface of the distilled water chamber 160 and the inner surface of the housing 110. This is in Figure 6B As shown in the image. Figure 6B It is also shown that distilled water 162 flows until it surrounds SAP block 150. When distilled water 162 comes into contact with SAP block 150, it flows into SAP block 150 due to osmosis. SAP block 150 absorbs distilled water 162 and its volume gradually increases. Figure 6BThe arrows in the diagram indicate that the SAP block 150 pushes the homogenizer 140. Because the SAP block 150 is constrained on its proximal side by the distilled water chamber 160, the SAP block 150 applies a distal force to the homogenizer 140 (or, in the absence of the homogenizer 140, directly to the flushing chamber 130). The distal force from the SAP block 150 gradually compresses the flushing chamber 130 and pushes the saline 132 within the flushing chamber 130 distally. As a result, a stable and continuous flow of saline 132 is delivered to the patient, and caregivers can keep the catheter line open while significantly reducing the risk of blockage.

[0061] When the flushing chamber 130 is empty, the KVO infusion control device 100 can be disconnected from the patient's catheter line so that the flushing chamber 130 can be replenished with saline 132.

[0062] When the distilled water chamber 160 is empty, the cap 170 can be removed to expose an opening at the proximal end of the housing 110. In some embodiments, the empty distilled water chamber 160 can be removed from the housing 110 and replaced with a distilled water chamber 160 filled with distilled water 162. In other embodiments, a caregiver can pour distilled water 162 into the distilled water chamber 160 through the opening at the proximal end of the housing 110 (while the distilled water chamber 160 remains inside the housing). After the distilled water chamber 160 has been replaced or refilled with distilled water 162, the caregiver can place the cap 170 back onto the housing 110 and puncture the distilled water chamber 160 with the puncture device 116 to continue delivering saline 132 to the patient.

[0063] Description of this technical topic

[0064] For example, the subject matter technique is illustrated according to the various aspects described below. For convenience, various examples of the various aspects of the subject matter technique are described according to numbered articles (1, 2, 3, etc.). These are provided by way of example only and do not limit the subject matter technique. It should be noted that any subordinate articles can be combined in any combination and placed in corresponding independent articles, such as article 1, article 9, or article 16. Other articles can be presented in a similar manner.

[0065] Item 1. An infusion control device for maintaining open vein (KVO), the KVO infusion control device comprising: a housing including a tube having a distal end at the distal end of the tube and a puncture system at a proximal portion of the tube; a flushing chamber disposed within the distal portion of the housing, the flushing chamber being configured to be filled with saline; a superabsorbent polymer (SAP) block disposed within the housing and proximal to the flushing chamber, the SAP block being configured to expand upon contact with distilled water; and a distilled water chamber disposed within the housing, adjacent to the puncture system and proximal to the SAP block, the distilled water chamber being configured to be filled with distilled water, wherein the puncture system is configured to facilitate delivery of distilled water to the SAP block, wherein the SAP block is configured to compress the flushing chamber and displace saline distally from the distal end when the SAP block expands.

[0066] Clause 2. The KVO infusion control device according to Clause 1, wherein the end is configured to connect to a needleless fluid connector.

[0067] Clause 3. The KVO infusion control device according to Clause 1, wherein the end includes a Luer lock.

[0068] Clause 4. The KVO infusion control device according to Clause 1, wherein the SAP block is generally cylindrical.

[0069] Clause 5. The KVO infusion control device according to Clause 1, wherein the SAP block comprises sodium polyacrylate.

[0070] Clause 6. The KVO infusion control device according to Clause 1, wherein the SAP block comprises potassium poly(acrylamide-copolyacrylate).

[0071] Clause 7. The KVO infusion control device according to Clause 1 further includes a uniform pusher positioned between the SAP block and the flushing chamber.

[0072] Clause 8. The KVO infusion control device according to Clause 7, wherein the uniform pusher is configured to receive a force from the SAP block when the SAP block expands and to apply the force to the flushing chamber to push brine distally to the end.

[0073] Clause 9. The KVO infusion control device according to Clause 1, wherein the distilled water chamber is configured to be refilled with distilled water via an opening located at the proximal end of the distilled water chamber.

[0074] Clause 10. The KVO infusion control device according to Clause 1 further includes a cap coupled to a proximal end of the housing, wherein the cap is configured to close the distilled water chamber.

[0075] Clause 11. The KVO infusion control device according to Clause 1, wherein the puncture system includes one or more puncture elements located on the inner surface of the housing, each of the one or more puncture elements including a sharp end configured to puncture the distilled water chamber to fluidly connect the distilled water chamber to the housing.

[0076] Clause 12. The KVO infusion control device according to Clause 1, wherein the puncture system includes one or more puncture elements configured to puncture the distilled water chamber and fluidly connect the distilled water chamber to the SAP block.

[0077] Clause 13. The KVO infusion control device according to Clause 1, wherein the puncture system is configured to puncture the distilled water chamber and release distilled water into the housing.

[0078] Item 14. An infusion control device for maintaining open vein (KVO), the KVO infusion control device comprising: a housing including a tube having a distal end; a flushing chamber disposed within a distal portion of the housing, the flushing chamber configured to be filled with saline; a superabsorbent polymer (SAP) block disposed within the housing and proximal to the flushing chamber, the SAP block configured to expand upon contact with distilled water; a distilled water chamber disposed within the housing and proximal to the SAP block, the distilled water chamber configured to be filled with the distilled water; and a puncture system positioned on an inner surface of the housing and proximal to the distilled water chamber, the puncture system configured to fluidly connect the distilled water chamber to the housing and facilitate delivery of distilled water to the SAP block, wherein the SAP block is configured to compress the flushing chamber and displace saline distally to the distal end when the SAP block expands.

[0079] Clause 15. The KVO infusion control device according to Clause 14 further includes a cap attached to a proximal end of the housing, wherein the cap is configured to close the distilled water chamber.

[0080] Clause 16. The KVO infusion control device according to Clause 15, wherein the puncture system is attached to the cap and configured to puncture the distilled water chamber when the cap is engaged with the proximal end of the housing.

[0081] Clause 17. The KVO infusion control device according to Clause 14, wherein the puncture system includes one or more puncture elements, each of the one or more puncture elements including a distally oriented sharp end configured to puncture the distilled water chamber to fluidly connect the distilled water chamber to the housing.

[0082] Item 18. An infusion control device for maintaining open vein (KVO), the KVO infusion control device comprising: a housing including a tube having a distal end at the distal end of the tube and a puncture system at a proximal portion of the tube; a flushing chamber disposed within the distal portion of the housing and configured to be filled with saline, the flushing chamber including a superabsorbent polymer (SAP) tube configured to expand upon contact with distilled water; and a distilled water chamber disposed within the housing adjacent to the puncture system and proximal to the flushing chamber, the distilled water chamber configured to be filled with distilled water, wherein the puncture system is configured to facilitate delivery of distilled water to the SAP tube, wherein the SAP tube is configured to remove saline from the distal end when the SAP tube expands.

[0083] Clause 19. The KVO infusion control device according to Clause 18, wherein the puncture system is configured to puncture the distilled water chamber and release the distilled water into the housing, such that the distilled water can contact the SAP tube.

[0084] Clause 20. The KVO infusion control device according to Clause 18, wherein, upon contact with distilled water, the SAP tube is configured to expand radially inward and remove brine from the end.

[0085] Other considerations

[0086] In some embodiments, any of the clauses herein can depend on any of the independent clauses or any of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) can be combined with any other one or more clauses (e.g., dependent or independent clauses). In one aspect, a claim can include some or all of the text (e.g., steps, operations, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, a claim can include some or all of the text recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the text in each of the clauses, sentences, phrases, or paragraphs can be removed. In one aspect, additional text or elements can be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject matter can be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject matter can be implemented using additional components, elements, functions, or operations.

[0087] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter, and the subject matter is not limited to these examples. Numerous modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0088] Unless otherwise stated, the use of the singular form to refer to an element is not intended to mean "one and only one," but rather "one or more." Unless otherwise explicitly stated, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. The use of headings and subheadings (if any) is for convenience only and does not limit this disclosure.

[0089] The term “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” should not be construed as preferred or advantageous to other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0090] For example, phrases like "aspect" do not imply that such an aspect is essential to the present subject matter, or that such an aspect applies to all constructions of the present subject matter. Disclosure relating to an aspect may apply to all constructions or one or more constructions. An aspect may provide one or more examples. For example, the phrase "an aspect" may refer to one or more aspects, and vice versa. For example, phrases like "embodiment" do not imply that such an embodiment is essential to the present subject matter, or that such an embodiment applies to all constructions of the present subject matter. Disclosure relating to an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. For example, the phrase "an embodiment" may refer to one or more embodiments, and vice versa. For example, phrases like "construction" do not imply that such a construction is essential to the present subject matter, or that such a construction applies to all constructions of the present subject matter. Disclosure relating to a construction may apply to all constructions or one or more constructions. A construction may provide one or more examples. The phrase "such a construction" may refer to one or more constructions, and vice versa.

[0091] In one respect, unless otherwise stated, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those in the appended claims, are approximate, not precise. In another respect, they are intended to have a reasonable range consistent with the functions they pertain to and with the custom of the art to which they belong.

[0092] In one respect, the term "linkage" can refer to a direct connection. In another respect, the term "linkage" can refer to an indirect connection.

[0093] For example, the terms “top,” “bottom,” “front,” “rear,” etc., used in this disclosure should be understood to refer to any frame of reference rather than a general gravitational frame of reference. Therefore, the top surface, bottom surface, front surface, and rear surface can extend upward, downward, diagonally, or horizontally in a gravitational frame of reference.

[0094] Various items may be arranged differently (e.g., in different orders or divided in different ways) without departing from the scope of the subject matter. All structural and functional equivalents of the elements throughout the various aspects described in this disclosure are known to or will be known hereafter to those skilled in the art, expressly incorporated herein by reference and intended to be covered by the claims. Furthermore, regardless of whether such disclosure is expressly recited in the claims, the contents disclosed herein are not intended for the public. Unless an element is expressly stated using the phrase “means for…”, or, in the case of a method claim, the element is stated using the phrase “steps for…”, no claim element should be construed as a means or step for performing a particular function without the presence of a structure, material, or action supporting it. Moreover, the scope of the terms “comprising,” “having,” etc., is intended to be inclusive in a manner similar to the term “comprising,” as interpreted when “comprising” is used as a transitional term in the claims.

[0095] The title, background, summary, description of the drawings, and abstract of this disclosure are incorporated herein and are provided as illustrative examples rather than limiting descriptions. This application is filed on the understanding that they are not intended to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be apparent that the description provides illustrative examples, and various features are combined in various embodiments to simplify the disclosure. This approach to disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the appended claims, the inventive subject matter lies in all features of fewer than those in a single disclosed construction or operation. The appended claims are therefore incorporated into the detailed description, each claim being an independent, separately claimed subject matter.

[0096] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language claims and to include all legal equivalents. Nevertheless, none of these claims are intended to cover subject matter that fails to satisfy the patent requirements, nor should they be interpreted in this manner.

Claims

1. An infusion control device for maintaining venous access, the infusion control device for maintaining venous access comprising: A housing comprising a tube having a distal end and a puncture system at a proximal portion of the tube; A flushing chamber, disposed within the distal portion of the housing, is configured to be filled with brine; A superabsorbent polymer block disposed within the housing and located near the flushing chamber, the superabsorbent polymer block being configured to expand upon contact with distilled water; as well as A distilled water chamber, disposed within the housing adjacent to the puncture system and proximal to the superabsorbent polymer block, is configured to be filled with distilled water. The puncture system is configured to facilitate the delivery of distilled water to the superabsorbent polymer block. The superabsorbent polymer block is configured to compress the flushing chamber and push brine to the distal end when the superabsorbent polymer block expands.

2. The infusion control device for maintaining venous access according to claim 1, wherein, The end is configured to connect to a needleless fluid connector.

3. The infusion control device for maintaining venous access according to claim 1, wherein, The end includes a Luer lock.

4. The infusion control device for maintaining venous access according to claim 1, wherein, The superabsorbent polymer block is approximately cylindrical.

5. The infusion control device for maintaining venous access according to claim 1, wherein, The superabsorbent polymer block contains sodium polyacrylate.

6. The infusion control device for maintaining venous access according to claim 1, wherein, The superabsorbent polymer block contains potassium poly(acrylamide-copolymer acrylate).

7. The infusion control device for maintaining venous patency according to claim 1, further comprising a uniform actuator positioned between the superabsorbent polymer block and the flushing chamber.

8. The infusion control device for maintaining venous patency according to claim 7, wherein, The uniform pusher is configured to receive a force from the superabsorbent polymer block as the superabsorbent polymer block expands, and to apply the force to the flushing chamber to push the brine distally to the end.

9. The infusion control device for maintaining venous access according to claim 1, wherein, The distilled water chamber is configured to be refilled with distilled water via an opening located at the proximal end of the distilled water chamber.

10. The infusion control device for maintaining venous patency according to claim 1, further comprising a cap coupled to a proximal end of the housing, wherein, The cap is configured to close the distilled water chamber.

11. The infusion control device for maintaining venous access according to claim 1, wherein, The puncture system includes one or more puncture elements located on the inner surface of the housing, each of the one or more puncture elements including a sharp end configured to puncture the distilled water chamber to fluidly connect the distilled water chamber to the housing.

12. The infusion control device for maintaining venous access according to claim 1, wherein, The puncture system includes one or more puncture elements configured to puncture the distilled water chamber and fluidly connect the distilled water chamber to the superabsorbent polymer block.

13. The infusion control device for maintaining venous access according to claim 1, wherein, The puncture system is configured to puncture the distilled water chamber and release distilled water into the housing.

14. An infusion control device for maintaining venous access, the infusion control device for maintaining venous access comprising: A housing, the housing including a tube having a distal end; A flushing chamber, disposed within the distal portion of the housing, is configured to be filled with brine; A superabsorbent polymer block disposed within the housing and located near the flushing chamber, the superabsorbent polymer block being configured to expand upon contact with distilled water; A distilled water chamber is disposed within the housing and located near the superabsorbent polymer block, the distilled water chamber being configured to be filled with distilled water; as well as A puncture system, positioned on the inner surface of the housing and proximal to the distilled water chamber, is configured to fluidly connect the distilled water chamber to the housing and facilitate the delivery of distilled water to the superabsorbent polymer block. The superabsorbent polymer block is configured to compress the flushing chamber and push brine to the distal end when the superabsorbent polymer block expands.

15. The infusion control device for maintaining venous patency according to claim 14, further comprising a cap coupled to a proximal end of the housing, wherein, The cap is configured to close the distilled water chamber.

16. The infusion control device for maintaining venous access according to claim 15, wherein, The puncture system is attached to the cap and configured to puncture the distilled water chamber when the cap is attached to the proximal end of the housing.

17. The infusion control device for maintaining venous access according to claim 14, wherein, The puncture system includes one or more puncture elements, each of which includes a distally oriented sharp end configured to puncture the distilled water chamber to fluidly connect the distilled water chamber to the housing.

18. An infusion control device for maintaining venous access, the infusion control device for maintaining venous access comprising: A housing comprising a tube having a distal end and a puncture system at a proximal portion of the tube; A flushing chamber, disposed within the distal portion of the housing and configured to be filled with brine, the flushing chamber comprising a superabsorbent polymer tube configured to expand upon contact with distilled water; as well as A distilled water chamber, disposed within the housing adjacent to the puncture system and near the flushing chamber, is configured to be filled with distilled water. The puncture system is configured to facilitate the delivery of distilled water into the superabsorbent polymer tube. The superabsorbent polymer tube is configured to remove brine from its end when the superabsorbent polymer tube expands.

19. The infusion control device for maintaining venous access according to claim 18, wherein, The puncture system is configured to puncture the distilled water chamber and release distilled water into the housing, allowing the distilled water to contact the superabsorbent polymer tube.

20. The infusion control device for maintaining venous access according to claim 18, wherein, When in contact with distilled water, the superabsorbent polymer tube is configured to expand radially inward and remove brine from the end.

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