SYSTEM AND METHOD FOR PREVENTING REFLUSH IN A CATHETER SYSTEM - Patent application

Abstract

The catheter assembly may include a catheter, a catheter hub coupled to the catheter, an injection port on the catheter hub, and an injection port backflow control device. The backflow control device may include a concentric port, a bellows, and a duckbill valve. The injection port backflow control device may include a split septum and a duckbill valve. The injection port backflow control device may include a deformable annular valve disposed around the inner surface of the catheter hub and may occlude an opening in the catheter hub connected to the injection port. The injection port may accept a needleless syringe for administering medication or other fluids. The injection port backflow control device may allow fluid to flow into the catheter hub and may prevent fluid from flowing out of the catheter hub through the injection port.

Description

[Technical field]

[0001] The present invention relates to a system and method for preventing backflow in a catheter system. [Background technology]

[0002] A common type of catheter assembly includes an over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a PIVC extending distally from the catheter hub, and an introducer needle extending through the PIVC. The PIVC and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC and the bevel of the needle faces away (up) from the patient's skin just prior to insertion into the skin. The PIVC and introducer needle are typically inserted at a shallow angle through the skin into the patient's vasculature.

[0003] To verify proper placement of the introducer needle and / or PIVC within the vessel, the clinician may confirm the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once introducer needle placement has been confirmed, the clinician may remove the introducer needle and leave the PIVC in place for future blood collection or transfusion.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in certain environments such as those described above. Rather, this background is provided only to illustrate one example technology area in which some of the embodiments described herein may be practiced. Summary of the Invention

[0005] The present disclosure relates generally to vascular access devices and associated methods. More specifically, the present disclosure relates to catheter assemblies and associated methods. In some embodiments, the catheter assembly may include a catheter, a catheter hub coupled to the catheter, an injection port disposed on the catheter hub, and an injection port backflow control device. In some embodiments, the catheter assembly may include a peripheral venous catheter assembly. In some embodiments, the injection port backflow control device may include a concentric port, a bellows, and a duckbill valve. In some embodiments, the injection port may be configured to accept a needleless syringe for administering medication or other fluids. In some embodiments, the injection port backflow control device may allow fluid to flow into the catheter hub and prevent fluid from flowing out of the catheter hub through the injection port.

[0006] In some embodiments, when the bellows is in an expanded state, the bellows may block the sidewall opening of the concentric port. In some embodiments, the bellows may be vertically compressible from an expanded state to a compressed state. In some embodiments, the bellows may allow fluid to flow into the sidewall opening of the concentric port in the compressed state. In some embodiments, the bellows may surround the concentric port and cover the sidewall opening in the concentric port when the bellows is in an expanded state or uncompressed. In some embodiments, the concentric port may include a vertical opening that may connect the sidewall opening with an opening at the base of the concentric port. In some embodiments, the opening at the base of the concentric port may connect with an opening in the duckbill valve. In some embodiments, the duckbill valve opening may allow fluid to flow into the catheter hub.

[0007] In some embodiments, the fluid pathway in the injection port reflux control device may include a sidewall opening in the concentric port, an annular opening, and a duckbill valve. In some embodiments, a vertical opening may be in the center of the concentric port and may connect the sidewall opening to the top of the duckbill valve. In some embodiments, the duckbill valve may be configured to expand to allow passage of fluid to the catheter hub.

[0008] In some embodiments, the peripheral venous catheter assembly may include a catheter, a catheter hub coupled to the catheter, an injection port on the catheter hub, and an injection port backflow control device. In some embodiments, the injection port backflow control device may include a split septum and a duckbill valve. In some embodiments, the split septum may include multiple leaves. In some embodiments, the injection port may accept a needleless syringe. In some embodiments, the injection port backflow control device may allow fluid to flow into the catheter hub and prevent fluid from flowing out of the catheter hub through the injection port.

[0009] In some embodiments, the duckbill valve may be disposed within the injection port, and the line formed by the meeting of the opposing lips of the duckbill valve may be oriented downward toward the catheter hub. In some embodiments, the split septum may be disposed as a cap over the top opening of the injection port, and the leaves of the split septum may be deformable to open downward toward the catheter hub. In some embodiments, the fluid path into the catheter through the injection port may include an opening in the split septum that may be connected to the opening of the duckbill valve. In some embodiments, the duckbill valve may be configured to expand to allow fluid to flow into the catheter hub and through the catheter hub to the catheter.

[0010] In some embodiments, a peripheral venous catheter assembly may include a catheter, a catheter hub coupled to the catheter, an injection port on the catheter hub, and an injection port backflow control device. In some embodiments, the injection port backflow control device may include a deformable annular valve disposed about an inner surface of the catheter hub and may occlude an opening in the catheter hub connected to the injection port.

[0011] In some embodiments, the injection port may be configured to accept a needleless syringe. In some embodiments, the injection port backflow control device may allow fluid to flow into the catheter hub and may prevent fluid from flowing out of the catheter hub through the injection port.

[0012] In some embodiments, the annular valve may deform longitudinally from fluid pressure of fluid injected into the catheter hub through the injection port. In some embodiments, the annular valve may include a protrusion from an outer sidewall of the annular valve. In some embodiments, the catheter hub may include a notch that corresponds to the protrusion on the annular valve. In some embodiments, the notch and the protrusion may be engaged to secure the annular valve within the catheter hub.

[0013] It is to be understood that both the general description above and the detailed description that follows are exemplary and explanatory and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the figures. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0014] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1] FIG. 1 is a side view of an exemplary peripheral intravenous catheter assembly, according to some embodiments. [Diagram 2] 2 is a top perspective view of the peripheral intravenous catheter assembly of FIG. 1 after insertion into a patient's arm, according to some embodiments. [Diagram 3] 3 is a top perspective view of the peripheral intravenous catheter assembly of FIG. 1 after insertion into a patient's arm, illustrating the injection of fluid into the peripheral intravenous catheter assembly via an exemplary injection port, according to some embodiments. [Figure 4] FIG. 4 is a top perspective view of the proximal end of an exemplary peripheral intravenous catheter assembly having an exemplary injection port reflux control device, according to some embodiments. [Diagram 5] 5 is a cross-sectional view of an injection port reflux control device in the peripheral intravenous catheter assembly of FIG. 4. [Figure 6] FIG. 6 is a top perspective view of an exemplary concentric circular port, according to some embodiments. [Figure 7] FIG. 7 is a bottom perspective view of an exemplary bellows, according to some embodiments. [Figure 8] FIG. 8 is a side view of an exemplary duckbill valve, according to some embodiments. [Figure 9A] 9A is a cross-sectional view of an injection port reflux control device in the peripheral intravenous catheter system of FIG. 4, according to some embodiments. [Figure 9B] FIG. 9B is a cross-sectional view of an injection port backflow control device in the peripheral intravenous catheter system of FIG. 4 according to some embodiments, showing fluid flow from a needleless syringe through an exemplary injection port to the peripheral intravenous catheter system. [Figure 10] FIG. 10 is a top perspective view of an exemplary peripheral intravenous catheter assembly having an exemplary injection port reflux control device, according to some embodiments. [Figure 11] 11 is a cross-sectional view of the peripheral intravenous catheter assembly of FIG. [Figure 12] FIG. 12 is a bottom perspective view of an exemplary split bulkhead, according to some embodiments. [Figure 13] FIG. 13 is a top perspective view of an exemplary duckbill valve, according to some embodiments. [Figure 14] FIG. 14 is a cross-sectional view of the peripheral intravenous catheter assembly of FIG. 10 showing a needleless syringe inserted into the injection port, according to some embodiments. [Figure 15] FIG. 15 is a cross-sectional view of an exemplary injection port backflow control device in an exemplary peripheral intravenous catheter assembly showing fluid entering the peripheral intravenous catheter assembly through an exemplary port, according to some embodiments. [Figure 16] FIG. 16 is a cross-sectional view of an exemplary injection port reflux control device in an exemplary peripheral intravenous catheter assembly, according to some embodiments. [Figure 17A] FIG. 17A is a top perspective view of an exemplary valve, according to some embodiments. [Figure 17B] FIG. 17B is a side view of the valve of FIG. 17A, according to some embodiments. [Figure 18] FIG. 18 is an isometric cross-sectional view of an exemplary injection port reflux control device in an exemplary peripheral intravenous catheter assembly, according to some embodiments. [Figure 19A] FIG. 19A is a left side top perspective view of an exemplary valve, according to some embodiments. [Figure 19B] FIG. 19B is a side view of the valve of FIG. 19A, according to some embodiments. [Figure 19C] FIG. 19C is a right side top perspective view of the valve of FIG. 19A according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The present disclosure relates generally to vascular access devices and associated methods. More specifically, the present disclosure relates to catheter assemblies and associated methods. In some embodiments, the catheter assembly may include a catheter, a catheter hub coupled to the catheter, an injection port on the catheter hub, and an injection port backflow control device. In some embodiments, the backflow control device may include a concentric port, a bellows, and a duckbill valve. In some embodiments, the injection port may accept a needleless syringe for administering medication or other fluids. In some embodiments, the injection port backflow control device may allow fluid to flow into the catheter hub and prevent fluid from flowing out of the catheter hub through the injection port.

[0016] 1-3, in some embodiments, the peripheral intravenous catheter assembly 100 may be configured to deliver fluids to a patient via a peripheral blood vessel. In some embodiments, the peripheral intravenous catheter assembly 100 may include an injection port for injecting fluids into the patient. In some embodiments, the peripheral intravenous catheter assembly 100 may have a catheter 130 at a distal end for insertion into a patient. In some embodiments, the catheter 130 may include a peripheral venous catheter. In some embodiments, the catheter 130 may be connected to a catheter hub 110. In some embodiments, the catheter hub 110 may have a lumen for blood and other fluids to enter and exit the patient. In some embodiments, the proximal end of the catheter hub 110 may have an opening through which a needle may be inserted to facilitate insertion of the catheter 130 into the patient. In some embodiments, the needle may be removed after insertion and an end cap 105 may be attached to the proximal end of the catheter hub 110 to close the proximal end of the catheter hub 110.

[0017] According to some embodiments, the peripheral intravenous catheter assembly 100 may include an injection port disposed on the top of the catheter hub 110. In some embodiments, the port may be covered with an injection port cap 115. In some embodiments, a valve 120 may be disposed within the lumen of the catheter hub 110. In some embodiments, the valve 120 may prevent fluid from exiting the injection port while allowing fluid to flow through the injection port into the catheter hub 110 and catheter 130. In some embodiments, the peripheral intravenous catheter assembly 100 may include wings 125 to stabilize the assembly against the patient's skin.

[0018] In some embodiments, in response to the catheter being placed in the vein, the clinician may observe a flashback of the catheter 130 and / or another portion of the peripheral intravenous catheter assembly 100. The flashback may include blood flowing from the patient into the catheter 130. In some embodiments, the force of the patient's blood flowing into the catheter 130 and then into the catheter hub 110 may push the valve 120 proximally. In some embodiments, after the valve 120 moves proximally, the valve 120 no longer seals the infusion port 145 and the patient's blood may flow up through the infusion port 145 and out of the peripheral intravenous catheter assembly 100. In some embodiments, other fluids or other forces flowing through the peripheral intravenous catheter assembly 100 may displace the valve 120 within the peripheral intravenous catheter assembly 100, causing the valve 120 to malfunction.

[0019] In FIG. 2, a peripheral intravenous catheter assembly 100 according to some embodiments is shown in use after being inserted into a patient's arm. In some embodiments, the catheter 130 may be inserted into the arm of a patient 135. In some embodiments, the wings 125 may be folded downward and secured to the patient's arm 135 by an adhesive tape 140. In some embodiments, the catheter 130 may provide access to the patient's vasculature for administration of fluids, medications, and transfusions. In some embodiments, fluids, medications, and transfusions may be infused into the peripheral intravenous catheter assembly 100 via an infusion port 145.

[0020] 3 shows the peripheral intravenous catheter assembly 100 after it has been inserted into a patient's arm, according to some embodiments. In some embodiments, fluid may be injected into the peripheral intravenous catheter assembly 100 via an injection port 145. In some embodiments, a needleless syringe 150 or another suitable injection device may be used to inject fluid into the injection port 145.

[0021] 4-9, a peripheral intravenous catheter assembly 200 with an injection port reflux control device is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter assembly 200 may be similar or identical to the peripheral intravenous catheter assembly 100 in one or more components and / or operation. For example, as shown in FIG. 4, in some embodiments, the peripheral intravenous catheter assembly 200 may include a catheter hub 110 having a lumen 155 disposed within the catheter hub 110. In some embodiments, the wings 125 may extend longitudinally from the catheter hub 110. In some embodiments, the injection port 145 may extend vertically from the top of the catheter hub 110. In some embodiments, the injection port 145 may be used to inject fluids into the catheter hub 110 and then into the catheter 130 for injection into the patient's body. In some embodiments, the injection port 145 may be used for administration of intravenous fluids, various medications, or blood transfusions.

[0022] According to some embodiments, the injection port reflux control device is shown installed within the injection port 145. In some embodiments, the injection port reflux control device may include multiple parts. According to some embodiments, the injection port 145 may be sealed when the needleless syringe is removed from the injection port 145.

[0023] FIG. 5 shows a cross-sectional view of an injection port backflow control device in a peripheral intravenous catheter assembly 200, according to some embodiments. In some embodiments, the injection port backflow control device may be disposed within the injection port 145. In some embodiments, the injection port backflow control device may include three pieces. In some embodiments, the injection port backflow control device may include a concentric port 210, a bellows 220, and a duckbill valve 230. In some embodiments, the concentric port 210 may be disposed within the bellows 220 such that the bellows surrounds the concentric port 210. In some embodiments, the duckbill valve 230 may be disposed at the base of the concentric port 210. In some embodiments, the opposing lips of the duckbill valve 230 may open to allow fluid to flow from the opening of the concentric port 210 through the opening of the duckbill valve 230. In some embodiments, the duckbill valve 230 may face downward such that when the opposing lips are opened, the opening of the duckbill valve 230 may be fluidly connected to a lumen or opening of the concentric port 210, which may be at the center of the concentric port 210. In some embodiments, the lumen or opening of the concentric port 210 may include a vertical opening. In some embodiments, fluid pressure may open the opposing lips of the duckbill valve 230, allowing fluid to flow into the lumen 155 of the catheter hub 110.

[0024] In some embodiments, the injection port backflow control device may include at least one of a concentric port 210, a bellows 220, and a duckbill valve 230. In some embodiments, the injection port backflow control device may include a concentric port 210 and a bellows 220. In some embodiments, the injection port backflow control device may include a concentric port 210 and a duckbill valve 230. In some embodiments, the injection port backflow control device may include a bellows 220 and a duckbill valve 230. In some embodiments, the injection port backflow control device may include a concentric port 210. In some embodiments, the injection port backflow control device may include a bellows 220. In some embodiments, the injection port backflow control device may include a duckbill valve 230. In some embodiments, the injection port backflow control device may include other components in addition to the concentric port 210, the bellows 220, and the duckbill valve 230.

[0025] In FIG. 6, a concentric port 210 is shown according to some embodiments. In some embodiments, the concentric port 210 may have one or more sidewall openings in the body 250 of the concentric port 210. In some embodiments, the sidewall openings may allow fluid to flow into the lumen of the concentric port 210. In some embodiments, the fluid may then flow down through a lumen that may be in the center of the concentric port 210 and exit the concentric port 210 at an opening in the base 255 of the concentric port 210. In some embodiments, the sidewall openings may include a first sidewall opening 240 and / or a second sidewall opening 245 that may facilitate the flow of fluid through the concentric port 210. In some embodiments, the base 255 of the concentric port 210 may be surrounded by a ring, which provides a stable platform for the concentric port 210. In some embodiments, the bellows 220 may rest on the top of the ring and the duckbill valve 230 engages the bottom of the ring.

[0026] In FIG. 7 , in some embodiments, the bellows 220 may include a compressible body 270 that is cylindrical. In some embodiments, the compressible body 270 may include an accordion shape having a plurality of annular folds. In some embodiments, the bellows 220 may include an upper lip 260 and a lower lip 275. In some embodiments, the bellows 220 may be compressible in a vertical direction. In some embodiments, the bellows 220 may surround an outer surface of the concentric port 210. In some embodiments, the bellows 220 may be disposed between an outer surface of the concentric port 210 and an inner surface of the infusion port 145.

[0027] According to some embodiments, a needleless syringe may be inserted into the injection port 145. In some embodiments, the needleless syringe may contact the top lip 260 of the bellows 220. In some embodiments, the bellows 220 may be pushed vertically down toward the lumen 155 using the needleless syringe 150. In some embodiments, the bellows 220 may be compressed by the needleless syringe, thus exposing the first sidewall opening 240 and the second sidewall port 245. In some embodiments, the needleless syringe may be in fluid contact with the first and second sidewall openings 240 and 245 of the concentric port 210. In some embodiments, a fluid path may be defined or created by compressing the bellows 220, and fluid flows through the first sidewall opening 240 and the second sidewall opening 245 into the central lumen of the concentric port 210. In some embodiments, fluid from the needleless syringe can open the duckbill valve 230 and flow into the lumen 155 of the catheter hub 110.

[0028] 8 illustrates a side view of duckbill valve 230, according to some embodiments. In some embodiments, duckbill valve 230 may include an opening 285 at the top of duckbill valve 230. In some embodiments, opening 285 may be configured to allow fluid to flow through the center of duckbill valve 230. In some embodiments, duckbill valve 230 may include opposing lips 295. In some embodiments, opposing lips 295 may open to allow fluid to flow through duckbill valve 230 from the top to the bottom of duckbill valve 230.

[0029] In some embodiments, the opposing lips 295 facilitate opening the duckbill valve 230 to allow fluid to enter the lumen 155 and closing the duckbill valve 230 to prevent fluid from flowing from the lumen 155 through the injection port 145 in response to fluid pressure from the needleless syringe 150. In some embodiments, the opposing lips 295 may remain in a closed position until fluid pressure forces them open as fluid flows down through the center of the duckbill valve 230. In some embodiments, fluid flowing in the reverse direction from the catheter hub 110 to the injection port 145 is stopped by the opposing lips 295.

[0030] In some embodiments, duckbill valve 230 may further include a ring 290. In some embodiments, ring 290 may be configured to engage base 255 of concentric port 210. In some embodiments, ring 290 may be configured to engage a surface of injection port 145 such that ring 290 rests on the surface of injection port 145. In some embodiments, injection port 145 may have a matching ring configured to receive ring 290 of duckbill valve 230 such that duckbill valve 230 remains seated within injection port 145 during use.

[0031] In FIG. 9A, a cross-sectional view shows the injection port reflux control device fully assembled within the injection port 145. In some embodiments, the top of the injection port 145 may be open. In some embodiments, the injection port reflux control device may be disposed within the opening of the injection port 145. In some embodiments, the concentric port 210 may be disposed at the center of the injection port 145. In some embodiments, the concentric port may be referred to as a "concentric port" because it may be concentric with one or more of the bellows 220, the injection port 145, and the duckbill valve 230. In some embodiments, the first sidewall opening 240 and the second sidewall opening 245 may be disposed longitudinally through the center of the concentric port 210. In some embodiments, the top 235 of the concentric port 210 may be slightly above the top of the injection port 145, may be flush with the injection port 145, or may be slightly below the top of the injection port 145. In some embodiments, the base 255 of the concentric port 210 , which may be annular, may rest on a protrusion in the injection port 145 .

[0032] In some embodiments, the bellows 220 may be disposed between an inner surface of the inlet port 145 and an outer surface of the concentric port 210. The bellows 220 may be configured to compress vertically. An upper lip 260 of the bellows 220 may be flush with an upper surface of the inlet port 145. A lower lip 275 of the bellows 220 may rest on a base 255 of the concentric port 210. In some embodiments, when the bellows 220 is compressed, the first sidewall opening 240 and the second sidewall opening 245 may be exposed.

[0033] In some embodiments, the duckbill valve 230 may be located at the base of the concentric port 210. In some embodiments, the opposing lips 295 of the duckbill valve 230 may open when fluid is infused through the top of the infusion port 145. In some embodiments, the opposing lips 295 of the duckbill valve 230 may be in a default closed position when fluid flows from the catheter hub lumen 155 up through the infusion port 145. In some embodiments, the duckbill valve 230 always remains in a closed position unless there is fluid pressure from fluid flowing into the opening of the infusion port 145.

[0034] FIG. 9B shows a cross-sectional view of an injection port backflow control device in a peripheral intravenous catheter assembly 200, according to some embodiments. In some embodiments, the direction of fluid flow from the needleless syringe 150 through the injection port 145 to the peripheral intravenous catheter assembly 200 is shown by arrow 296, according to some embodiments. In some embodiments, the needleless syringe 150 may compress the bellows 220. In some embodiments, the bellows 220 may completely fill the space between the injection port 145 and the concentric port 210. In some embodiments, the fluid may flow around the top of the concentric port 210 and into the first sidewall opening 240 and the second sidewall opening 245. In some embodiments, the fluid may then flow through a lumen in the concentric port 210 and into the duckbill valve 230. In some embodiments, fluid pressure can open the opposing lips 295 of the duckbill valve 230 and allow fluid to flow from the duckbill valve 230 into the lumen 155 of the catheter hub 110.

[0035] 10-14, a peripheral intravenous catheter assembly 300 with an injection port reflux control device is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter assembly 300 may be similar or identical to the peripheral intravenous catheter assembly 100 and / or the peripheral intravenous catheter assembly 200 in terms of one or more components and / or operation. In some embodiments, the injection port 145 may be configured to accept a needleless syringe 150. The top of the injection port 145 may be covered by a split septum 310. In some embodiments, the injection port 145 may be connected to a catheter hub 110. In some embodiments, the catheter hub 110 may include a lumen 155. In some embodiments, fluid may flow from the needleless syringe 150 into the injection port 145, then into the lumen 155 of the catheter hub 110, and then out through the catheter 130 to the patient.

[0036] FIG. 11 illustrates an injection port backflow control device in a peripheral intravenous catheter assembly 300, according to some embodiments. According to some embodiments, the injection port backflow control device may include a split septum 310 and a duckbill valve 320. In some embodiments, the split septum 310 may be disposed on top of the injection port 145. In some embodiments, the duckbill valve 320 may be disposed within the injection port 145. In some embodiments, the duckbill valve 320 may open when fluid flows into the injection port 145 and remain in a closed position at other times, thus preventing fluid from flowing out of the injection port 145. In some embodiments, the injection port backflow control device may include additional components in addition to the split septum 310 and the duckbill valve 320. In some embodiments, the injection port backflow control device may include only the split septum 310. In some embodiments, the injection port backflow control device may include only the duckbill valve 320.

[0037] In FIG. 12, a split septum 310 is shown, according to some embodiments. In some embodiments, the split septum 310 may include a ring 305 that is located at the top edge of the injection port 145 and surrounds the outside of the top edge of the injection port 145. In some embodiments, the ring 305 may friction fit over the top of the injection port 145 so that the split septum 310 stays in place on the top of the injection port 145 and prevents fluid from leaking out the sides of the split septum 310 or between the split septum 310 and the injection port 145. In some embodiments, the center of the split septum 310 may include multiple leaves 315 that may be deformable downward. In some embodiments, the leaves 315 may deform downward when the needleless syringe 150 is inserted into the injection port 145. In some embodiments, after the needleless syringe 150 is removed from the injection port 145, the leaves 315 of the dividing septum 310 may return to their original position, sealing the injection port 145 and preventing fluid from leaking out of the injection port 145.

[0038] In FIG. 13, a duckbill valve 320 is shown, according to some embodiments. In some embodiments, the duckbill valve 320 may include an opening 335 through the top that passes through the duckbill valve 320 and is connected to a central cavity that is closed by opposing lips 340 of the duckbill valve 320. In some embodiments, the top of the duckbill valve 320 may include a ring 330 that may engage with a structure within the injection port 145. In some embodiments, the ring 330 may position the duckbill valve within the injection port 145 and may maintain the duckbill valve 320 within the injection port 145 as fluid flows through the injection port 145. In some embodiments, the duckbill valve 320 may include a body 325 that is elongated or shortened based on the length of the injection port 145. In some embodiments, the interior of the duckbill valve 320 may include a central cavity. In some embodiments, in a first state, the opposing lips 340 of the duckbill valve 320 may be closed to prevent fluid from exiting the catheter hub 110 into the infusion port 145. In some embodiments, in a second state, the opposing lips 340 of the duckbill valve 320 may be open to allow fluid to flow into the peripheral intravenous catheter assembly 300. In some embodiments, the opposing lips 340 of the duckbill valve 320 remain in the closed position unless acted upon by fluid entering the infusion port 145 through the top opening.

[0039] 14 illustrates an injection port backflow control device in a peripheral intravenous catheter assembly 300, according to some embodiments. In some embodiments, a needleless syringe 150 may be inserted into the top of the injection port 145. In some embodiments, the needleless syringe 150 may be used for insertion of fluid into the peripheral intravenous catheter assembly 300 for administration of the fluid to a patient. In some embodiments, the leaf 315 of the split septum 310 may be deformed downwardly by the needleless syringe 150 into the injection port 145.

[0040] In some embodiments, duckbill valve 320 may be resting within injection port 145. In some embodiments, injection port 145 may have structure corresponding to ring 330 of duckbill valve 320. In some embodiments, this structure may hold duckbill valve 320 in place within injection port 145.

[0041] In some embodiments, fluid may be injected into the peripheral intravenous catheter assembly 300 using a needleless syringe 150 inserted into the injection port 145. In some embodiments, the leaves 315 of the duckbill valve 320 may be opened by the force of the fluid. In some embodiments, the fluid may then flow into the lumen 155 of the catheter hub 110. In some embodiments, the fluid may then flow from the catheter hub 110 into the catheter 130 and into the patient.

[0042] 15, an injection port backflow control device in a peripheral intravenous catheter assembly 400 is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter assembly 400 may be similar or identical to one or more of the peripheral intravenous catheter assembly 100, the peripheral intravenous catheter assembly 200, and the peripheral intravenous catheter assembly 300 in terms of one or more components and / or operation. In some embodiments, the flow of fluid into the peripheral intravenous catheter assembly 400 through the injection port 145, according to some embodiments, is indicated by arrow 410. In some embodiments, the fluid may flow through the injection port 145, and the force of the fluid may elastically deform the valve 120 such that the fluid may flow into the catheter 130 and into the patient. According to some embodiments, the valve 120 may deform downward when the fluid is injected through the injection port 145, and the valve 120 may then return to its original cylindrical shape preventing the fluid from flowing out of the injection port 145. In some embodiments, the peripheral intravenous catheter assembly 400 may include one or more of an injection port cap 115, a catheter hub 110, an end cap 105, and wings 125.

[0043] In some embodiments, the valve 120 may slide circumferentially away from the catheter 130 due to the force of fluid flowing from the patient into the catheter 130 and then from the catheter 130 into the catheter hub 110. In some embodiments, the displaced valve 120 does not cover the injection port 145 and may therefore allow fluid to leak out of the catheter hub 110 and out of the injection port 145. Various methods for preventing displacement of the valve 120 are described herein.

[0044] 16, an injection port backflow control device in a peripheral intravenous catheter assembly 500 is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter assembly 500 may be similar or identical to one or more of the peripheral intravenous catheter assembly 100, the peripheral intravenous catheter assembly 200, the peripheral intravenous catheter assembly 300, and the peripheral intravenous catheter assembly 400 in terms of one or more components and / or operation. In some embodiments, the peripheral intravenous catheter assembly 500 may include one or more of the catheter 130, the catheter hub 110, the lumen 155 in the catheter hub 110, the injection port 145, and the valve 510 having a protrusion. In some embodiments, the protrusion may correspond to an indent in the catheter hub 110. In some embodiments, the protrusion may prevent the valve 510 from being displaced in the catheter hub 110. In some embodiments, the valve 510 may prevent fluid from flowing upward through the injection port 145. In some embodiments, the valve 510 may be compressed to allow fluid to flow from the injection port 145 to the catheter hub 110.

[0045] 16-17, a protrusion 520 is shown, according to some embodiments. In some embodiments, the protrusion 520 may be disposed on the outer surface 505 of the valve 510. In some embodiments, the protrusion 520 may be disposed in the center, off-center, or on a side of the valve 510. In some embodiments, the protrusion 520 may partially or completely surround the valve 510. In some embodiments, the protrusion 520 may have any shape. In some embodiments, the protrusion 520 may include a semi-annular arc shape, which may facilitate insertion of the valve 510 into the catheter hub 110.

[0046] In some embodiments, the valve 510 may include an outer surface 505 that is slightly smaller or the same size as the inner diameter of the lumen 155. In some embodiments, the lumen 155 may have a corresponding indentation that mates with the protrusion 520. In some embodiments, the protrusion 520 mating with the indentation may prevent displacement of the valve 510. In some embodiments, the valve 510 may be held in its position within the lumen 155 by friction.

[0047] 18, an injection port backflow control device in a peripheral intravenous catheter assembly 600 is shown, according to some embodiments. In some embodiments, the peripheral intravenous catheter assembly 600 may be similar or identical in terms of one or more components and / or operation to one or more of the peripheral intravenous catheter assembly 100, the peripheral intravenous catheter assembly 200, the peripheral intravenous catheter assembly 300, the peripheral intravenous catheter assembly 400, and the peripheral intravenous catheter assembly 500. The peripheral intravenous catheter assembly 600 may include one or more of the catheter 130, the catheter hub 110, the lumen 155 in the catheter hub 110, the injection port 145, and the valve 610 having multiple protrusions. The protrusions may correspond to one or more recesses in the catheter hub 110. In some embodiments, the protrusions may prevent the valve 610 from being displaced in the catheter hub 110. In some embodiments, the valve 610 may prevent fluid from flowing upward through the injection port 145. In some embodiments, the valve 610 may be compressed to allow fluid to flow from the injection port 145 to the catheter hub 110.

[0048] 18-19, a valve 610 having a first protrusion 621 and a second protrusion 625 is shown, according to some embodiments. In some embodiments, the first protrusion 621 may include or correspond to the protrusion 620. As shown in FIG. 19A, in some embodiments, the first protrusion 621 and the second protrusion 635 may be disposed on the outer surface 605 of the valve 610. In some embodiments, the first protrusion 621 may be disposed on a first edge of the valve 610. In some embodiments, the second protrusion 625 may be disposed on a second edge of the valve 610. In some embodiments, the first protrusion 621 and the second protrusion 625 may partially or completely surround the valve 610.

[0049] In some embodiments, the first protrusion 621 and the second protrusion 625 may have any suitable shape. In some embodiments, the first protrusion 621 and the second protrusion 625 may include a semi-annular arc shape, which may facilitate insertion of the valve 510 into the catheter hub 110. In some embodiments, the valve 610 may include an outer surface 605 that is slightly smaller than or the same size as the inner diameter of the lumen 155. In some embodiments, the lumen 155 may have one or more corresponding indentations that mate with the first protrusion 621 and / or the second protrusion 625. In some embodiments, the first protrusion 621 and / or the second protrusion 625 mating indentations may prevent displacement of the valve 510. In some embodiments, the valve 610 may be held in its position within the lumen 155 by friction.

[0050] 19B is a side view of valve 610, according to some embodiments. In some embodiments, first protrusion 621 may have a width slightly larger than second protrusion 625. In some embodiments, first protrusion 621 and second protrusion 625 may have the same width. In some embodiments, second protrusion 625 may have a width larger than first protrusion 621. FIG 19C is another view of valve 610 with first protrusion 621 and second protrusion 625, according to some embodiments.

[0051] All examples and conditional language described herein are intended for educational purposes to help the reader understand the present invention and the concepts provided by the inventor to facilitate the present technology, and should be interpreted as not being limited to the specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A peripheral intravenous catheter assembly comprising: A catheter; a catheter hub coupled to the catheter; an injection port disposed on the catheter hub; 1. An injection port reflux control device comprising: Concentric Ports, Bellows, and a duckbill valve; 1. A peripheral intravenous catheter assembly comprising:

2. The peripheral intravenous catheter assembly of claim 1 , wherein the injection port is configured to accept a needleless syringe.

3. 2. The peripheral intravenous catheter assembly of claim 1, wherein the injection port reflux control device is configured to allow fluid to enter the catheter hub and prevent fluid from exiting the catheter hub through the injection port.

4. The peripheral intravenous catheter assembly of claim 1 , wherein the bellows is vertically compressible.

5. 2. The peripheral intravenous catheter assembly of claim 1, wherein said bellows occludes a sidewall opening of said concentric port when said bellows is in an expanded state.

6. The peripheral intravenous catheter assembly of claim 1 , wherein the bellows is compressible to allow fluid to flow into the sidewall opening of the concentric port.

7. 2. The peripheral intravenous catheter assembly of claim 1, wherein the bellows surrounds the concentric port and covers a sidewall opening in the concentric port when the bellows is uncompressed, the concentric port including a vertical opening connecting the sidewall opening with an opening in a base of the concentric port, the opening in the base of the concentric port connecting with an opening in the duckbill valve, the opening in the duckbill valve allowing fluid to flow into the catheter hub.

8. 2. The peripheral intravenous catheter assembly of claim 1, wherein a fluid pathway within the injection port reflux control device is defined by a sidewall opening in the concentric port and a central annular opening of the concentric port connecting the sidewall opening to a top of the duckbill valve, the duckbill valve expanding to allow passage of fluid into the catheter hub.

9. 1. A peripheral intravenous catheter assembly comprising: A catheter; a catheter hub coupled to the catheter; an injection port disposed on the catheter hub; 1. An injection port reflux control device comprising: dividing bulkhead, and a duckbill valve; 1. A peripheral intravenous catheter assembly comprising:

10. The peripheral intravenous catheter assembly of claim 8 , wherein the injection port is configured to accept a needleless syringe.

11. 10. The peripheral intravenous catheter assembly of claim 9, wherein the injection port reflux control device is configured to allow fluid to enter the catheter hub and prevent fluid from exiting the catheter hub through the injection port.

12. 10. The peripheral intravenous catheter assembly of claim 9, wherein the duckbill valve is disposed within the injection port such that a line formed by the convergence of opposing lips of the duckbill valve is oriented downwardly toward the catheter hub.

13. 10. The peripheral intravenous catheter assembly of claim 9, wherein the split septum is positioned as a cap over the upper opening of the injection port, and the leaves of the split septum are deformably configured to open downwardly toward the catheter hub.

14. 10. The peripheral intravenous catheter assembly of claim 9, wherein a fluid path into the catheter through the injection port includes an opening in the split septum connected to an opening in the duckbill valve, the duckbill valve expanding to allow fluid to enter the catheter hub and through the catheter hub into the catheter.

15. 1. A peripheral intravenous catheter assembly comprising: A catheter; a catheter hub coupled to the catheter; an injection port disposed on the catheter hub; an injection port reflux control device including a deformable annular valve disposed about an inner surface of the catheter hub and blocking an opening in the catheter hub connected to the injection port; 1. A peripheral intravenous catheter assembly comprising:

16. The peripheral intravenous catheter assembly of claim 15 , wherein the injection port is configured to accept a needleless syringe.

17. 16. The peripheral intravenous catheter assembly of claim 15, wherein the injection port reflux control device is configured to allow fluid to enter the catheter hub and prevent fluid from exiting the catheter hub through the injection port.

18. 16. The peripheral intravenous catheter assembly of claim 15, wherein the annular valve is configured to deform longitudinally by fluid pressure of fluid injected into the catheter hub through the injection port.

19. The peripheral intravenous catheter assembly of claim 14 , wherein the annular valve further comprises a protrusion from an outer sidewall of the annular valve.

20. 20. The peripheral intravenous catheter assembly of claim 18, wherein the catheter hub includes a notch that corresponds to the protrusion on the annular valve, the notch and the protrusion engaging to secure the annular valve within the catheter hub.

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