IV spikes for use with non-ISO compliant IV containers

Abstract

An intravenous IV spike for administering a medical fluid from a container comprises an elongate body having an upper portion and a lower portion, and a plurality of threads disposed along an outer surface of the lower portion of the elongate body and projecting radially outward from the outer surface. The elongate body is configured to couple to an IV barrel. The outer surface is configured to engage an inner surface of an outlet port of the container in a coupled configuration. In the coupled configuration, edges of the threads grip and engage the inner surface of the outlet port of the container, creating a seal between the lower portion of the elongate body and the outlet port of the container and retaining the body within the outlet port.

Description

[Technical field]

[0001] The present disclosure relates generally to IV set components, and more specifically to an IV spike that pierces and seals membranes on non-ISO compliant IV fluid bags and bottles. [Background technology]

[0002] One of the most widely used methods of medical treatment is the intravenous (IV) infusion of liquid medications and / or nutrients into a patient's bloodstream. A well-known device used in many IV infusion applications is an IV container, such as an IV bag or bottle, which contains the liquid to be infused into the patient.

[0003] When the IV container is a bag or bottle, a hard, hollow, sharp IV spike is pressed into the bag to establish a fluid-communicating passageway through which liquid can flow out of the bag. The spike is usually inserted into the bag through a sealing membrane, commonly called a port. The spike is then coupled to or formed integrally with an inlet port of a small, elongated, transparent, hollow container, commonly called a "drip tube," so that the spike's fluid passageway is in fluid communication with the interior of the drip tube.

[0004] IV containers in the form of bags or bottles discussed above may generally be classified as International Organization for Standardization (ISO) compliant or non-ISO compliant. If an existing IV spike is used to pierce ("spike") a non-ISO compliant container, the non-ISO compliant container will be more prone or at risk of leaking when spiked. Summary of the Invention [Means for solving the problem]

[0005] According to certain embodiments, an intravenous (IV) spike for administering a medical fluid from a container comprises an elongated body having a top and a bottom, the elongated body configured to be coupled to an IV barrel; a spike head disposed on the top of the elongated body, the spike head having a puncturing tip and a puncturing base having a fluid inlet at an upper end, a fluid channel extending from the fluid inlet through the elongated body and into the IV barrel; and a plurality of threads disposed along an outer surface of the bottom of the elongated body and projecting radially outward from the outer surface, the outer surface configured to engage an inner surface of an outlet port of the container in a coupled configuration, and wherein edges of the threads grip and engage the inner surface of the outlet port of the container in the coupled configuration to create a seal between the bottom of the elongated body and the outlet port of the container and retain the body within the outlet port.

[0006] According to some embodiments, an intravenous (IV) drip system can include an IV container that contains a fluid and includes a fluid outlet port having an inner surface, the inner surface being configured without a sealing member; and a spike having an elongated body, the spike including an upper portion, a lower portion, and a plurality of threads disposed along an outer surface of the elongated body and projecting radially outward from the outer surface, the outer surface of the lower portion configured to engage an inner surface of the fluid outlet port of the IV container in a coupled configuration, and in the coupled configuration, the threads at least partially penetrate the inner surface of the outlet port of the IV container to create a seal between the spike and the outlet port of the container and retain the spike in the outlet port.

[0007] According to some embodiments, a method of manufacturing a spike for an intravenous (IV) infusion system includes providing an elongate body having a spike tip at an upper portion and a base at a lower portion, forming a plurality of threads protruding radially outward from an outer surface of the base of the elongate body, and positioning a sealing member between a pair of adjacent threads of the plurality of threads.

[0008] Aspects and features of the models and methods disclosed herein may be provided, omitted, or modified based on the teachings and disclosures herein.

[0009] The following figures are intended to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, permutations, combinations, and equivalents in form and function that will occur to those skilled in the art having the benefit of this disclosure. [Brief description of the drawings]

[0010] [Figure 1A] FIG. 1 is a perspective view of a conventional IV spike. [Figure 1B] FIG. 1B is a cross-sectional view of an IV set including a non-ISO compliant IV container spiked with the conventional IV spike of FIG. 1A. [Figure 1C] FIG. 1C is an enlarged partial cross-sectional view of an IV set with a non-ISO compliant IV container spiked with the conventional IV spike of FIG. 1B. [Figure 2A] FIG. 1 is a perspective view of an IV spike according to some embodiments of the present disclosure. [Figure 2B] FIG. 2B is a cross-sectional view of the IV spike of FIG. 2A according to some embodiments of the present disclosure. [Figure 2C] FIG. 2B is a cross-sectional view of an IV set including a non-ISO compliant IV container spiked with the IV spike of FIG. 2A according to some embodiments of the present disclosure. [Figure 2D] FIG. 2B is an enlarged partial cross-sectional view of an IV set with a non-ISO compliant IV container spiked with the IV spike of FIG. 2A. [Figure 3A] 2B illustrates a method of spiking and sealing a non-ISO compliant IV container using the IV spike of FIG. 2A according to some embodiments of the present disclosure. [Figure 3B] 2B illustrates a method of spiking and sealing a non-ISO compliant IV container using the IV spike of FIG. 2A according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Various embodiments of the present disclosure relate to providing an IV spike that punctures ("spikes") the membranes of non-ISO compliant IV fluid bags and bottles, and the IV spike has improved retention features for retaining the IV spike within the IV container.

[0012] Various embodiments of the present disclosure further relate to providing an IV spike for spike membranes of non-ISO compliant IV fluid bags and bottles, the IV spike having improved sealing capabilities to prevent fluid from inadvertently leaking between the exterior surface of the IV spike and the interior surface of the IV fluid bags and bottles.

[0013] The embodiments disclosed herein are directed to providing an IV spike having improved sealing and retention capabilities as compared to existing IV spikes. According to some embodiments, the IV spike 120 can generally comprise a body having an upper portion and a lower portion or base. The lower portion or base of the IV spike can include a sealing and retention mechanism thereon for sealingly and securely engaging the IV spike at the exit port when spiking a non-ISO compliant IV bag or bottle. Specifically, as shown, the lower portion can include a plurality of threads disposed along and projecting radially outward from an outer surface of the lower portion. In some embodiments, the threads can act as a retention mechanism for anchoring and retaining the body of the IV spike to the non-ISO compliant IV bag or bottle.

[0014] In a mating or "spiked" configuration, where the IV spike is inserted or spiked into the outlet port of the non-ISO compliant IV container, the edge of the threads at least partially penetrates the inner surface of the outlet port and can grip and engage the inner surface of the outlet port 116 of the non-ISO compliant IV container. The penetration of the threads into the inner surface 112 of the outlet port 116 creates a primary seal between the IV spike and the outlet port of the non-ISO compliant IV container. Advantageously, the seal created prevents fluid from inadvertently leaking between the IV spike and the outlet port of the non-ISO compliant IV container 102 when, during, or after spiking.

[0015] In some embodiments, the threads can also act as a retention mechanism that improves the ability of the non-ISO compliant IV container to retain an IV spike inserted or "spiked" into the IV container. Thus, the threads can prevent the IV spike from separating (or otherwise dislodging) from the non-ISO compliant IV container. As the threads 136 rotate and penetrate or otherwise "bite" or "dig" into the inner surface of the outlet port, the material of the inner surface of the outlet port is compressed between the threads 136, which further increases the resistance of the non-ISO compliant IV container to pull-out and shear loads. Thus, advantageously, the threads can function as a structure that increases the friction between the IV spike and the outlet port such that the IV spike cannot be easily dislodged from the non-ISO compliant IV container without departing from the scope of the present disclosure.

[0016] According to various embodiments of the present disclosure, the IV spike may be configured with a sealing member disposed on the bottom of the IV spike body and interposed between a pair of adjacent threads. In the coupled configuration, the sealing member occupies between the inner surface of the outlet port and the outer surface of the bottom of the IV spike body, forming a second seal. As the sealing member 135 advances into the outlet port 116 of the non-ISO compliant IV container 102, the sealing member 135 seals the path created by the penetration of the threads 136. Thus, the IV spike 120 improves upon the deficiencies of the existing IV spike 20 by incorporating a sealing member as a secondary seal on the IV spike, further preventing fluid from inadvertently leaking between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102 in the coupled configuration.

[0017] FIG. 1A shows a perspective view of a conventional IV spike 20. FIG. 1B shows a cross-sectional view of an IV set 10 including an IV container 12 spiked with the conventional IV spike 20 of FIG. 1A. FIG. 1C shows an enlarged partial cross-sectional view of an IV set including an IV container 12 spiked with the conventional IV spike of FIG. 1B. The IV container 12 can be a non-ISO compliant IV fluid bag or bottle. As described herein, a non-ISO compliant IV bag or bottle is one that includes an outlet port, e.g., outlet port 16, that does not include any form of sealing structure or sealing member on the outlet port. In contrast to a non-ISO compliant IV bag or bottle, an ISO compliant IV bag or bottle typically includes some form of sealing element, e.g., in the form of a rubber plug, plug, or stopper, on the outlet port that sealingly couples the outlet port to the conventional IV spike 20 upon spiking. Thus, the sealing element incorporated in the ISO compliant IV bag can minimize leakage of fluid between the inner surface of the outlet port and the outer surface of the body of the conventional IV spike 20.

[0018] As shown, the conventional IV spike 20 may generally include a body 24 having an upper portion 27 and a lower portion 26. The conventional IV spike 20 may be configured to couple to a drip barrel 28. A spike 23 having a puncture tip 29 and a puncture base 31 may be disposed on the upper portion 27 of the body 24. The puncture base 31 may have a fluid inlet 25 at an upper end. As shown, a fluid channel 33 may extend from the puncture base 31 through the body 24 and into the drip barrel 28. The lower portion 26 may function as a base for the IV spike 20 and may have an outer diameter larger than the outer diameter of the upper portion 27 of the elongated body 24. In a coupled configuration in which the IV spike 20 pierces or spikes a non-ISO compliant IV container 12 as shown in FIG. 1B, fluid leakage may occur at a contact point 34 between the base 24 and the inner surface of the outlet port 16 due to the lack of any form of sealing element interposed between the base and the inner surface of the outlet port.

[0019] Therefore, it would be advantageous to have an IV spike that can adequately seal a non-ISO compliant IV bag or bottle to prevent leakage of fluid from the non-ISO compliant IV bag or bottle when spiking, during spiking, and / or after spiking. It would be further advantageous to have an IV spike that has improved retention features over conventional or currently existing IV spikes for retaining the IV spike in the non-ISO compliant IV bag or bottle. Various embodiments of the present disclosure are directed to providing an IV spike that has the aforementioned features that are lacking in conventional or currently existing IV spikes.

[0020] FIG 2A shows a perspective view of an IV spike 120 according to some embodiments of the present disclosure. FIG 2B shows a cross-sectional view of the IV spike 120 of FIG 2A according to some embodiments of the present disclosure. FIG 2C shows a cross-sectional view of an IV set including an IV container 102 spiked with the IV spike 120 of FIG 2A according to some embodiments of the present disclosure. FIG 2D shows an enlarged partial cross-sectional view of an IV set 100 including an IV container 102 spiked with the IV spike 120 of FIG 2A according to some embodiments of the present disclosure.

[0021] As shown in Figures 2C and 2D, the IV container 102 may be a non-ISO compliant IV fluid bag or bottle. As mentioned above, a non-ISO compliant IV bag or bottle is discussed herein as an IV bag or bottle with an outlet port, e.g., outlet port 116, without any form of sealing structure or sealing member on the outlet port. In contrast to a non-ISO compliant IV bag or bottle, an ISO compliant IV bag or bottle typically includes some form of sealing element, e.g., in the form of a rubber plug, plug, or stopper, on the outlet port that sealingly couples the outlet port to the IV spike during spiking. Thus, a sealing element incorporated into the outlet port of an existing ISO compliant IV bag can minimize leakage of fluid between the inner surface of the outlet port and the outer surface of the body of an existing IV spike. In contrast, the lack of any form of sealing member or sealing element incorporated into the outlet port or nozzle of a non-ISO compliant IV bag or bottle may allow fluid to leak from the outlet port during or after spiking.

[0022] Various embodiments of the present disclosure relate to providing an IV spike 120 having improved sealing and retention capabilities as compared to existing IV spikes, such as IV spike 20. Referring back to FIGS. 2A and 2B, IV spike 120 may generally comprise a body 124 having an upper portion 127 and a lower portion or base 126. IV spike 120 may be configured to couple to a drip tube 128. A spike head 123 having a puncturing tip 129 and a puncturing base 131 may be disposed on the upper portion 127 of body 124. According to various embodiments of the present disclosure, lower portion 126, which may also be referred to herein as base portion 126 of IV spike body 124, may have an outer diameter that is greater than an outer diameter of upper portion 27 of elongated body 24. The aforementioned configuration may be advantageous in that a tight interference fit may be formed between base portion 126 of IV spike 120 and inner surface 112 of outlet port 116. The tight interference fit can also aid in retaining the IV spike 120 within a non-ISO compliant IV bag or bottle 102.

[0023] According to various aspects of the present disclosure, the lower portion or base 126 of the IV spike 120 can include a sealing and retention feature thereon for sealingly and securely engaging the IV spike 20 within the exit port 116 when spiking the non-ISO compliant IV bag or bottle 102. Specifically, as shown, the lower portion 126 can include a plurality of threads 136 disposed along and projecting radially outward from an outer surface of the lower portion 126. In some embodiments, the threads 136 can anchor the body 124 of the IV spike 20 within the non-ISO compliant IV bag or bottle 102.

[0024] According to various embodiments, the shape and configuration of the plurality of threads 136 is not limited to any particular configuration. The threads 136 may include a point that is sharp enough to engage and "bite" into the exit port of a non-ISO compliant IV bag or bottle 102. In some embodiments, the pitch of the plurality of threads 136 may vary. For example, the plurality of threads 136 may be formed with a shallow thread pitch, with many turns of the threads 136, with adjacent threads 136 spaced closer together around the exterior surface of the lower portion 126 of the body 124. Alternatively, the plurality of threads 136 may be formed with a steep thread pitch, with fewer turns of the threads 136, with adjacent threads 136 spaced further apart than in a configuration having a steeper pitch. In some embodiments, the height of the threads 136 from the outer surface of the lower portion 126 of the IV spike body 124 to the tip of the threads can extend and protrude radially outwardly a sufficient height to undercut or otherwise cut into the inner surface 112 of the exit port 116. Thus, the outer diameter of each thread can be greater than the inner diameter of the exit port.

[0025] In some embodiments, the threads 136 may be formed at least partially along the lower portion 126 of the body 124. In other embodiments, the threads 136 may be formed entirely along the lower portion 126 of the body 124. As shown in FIG. 2A, the threads 136 may be formed in a helical configuration along the lower portion 126 of the body 124. However, various embodiments of the present disclosure are not limited to such configurations. In some embodiments, the threads 136 may be formed in a series of radial bands along the lower portion 126 of the body 124. In some embodiments, the threads 136 may be spaced apart from one another at regular intervals, e.g., equal intervals. However, in other embodiments, the threads 136 may be spaced apart from one another at irregular intervals, e.g., at varying intervals.

[0026] 2A, the plurality of threads 136 may form a helical spiral around the lower portion 126 of the body 124. The number of threads and the thread pitch are parameters that may vary depending on the material of the outlet port 116 of the IV container 102 into which the IV spike 120 is to be inserted. For example, if the threads 136 are to anchor the IV spike 120 to the outlet port 116, the thread pitch and other thread parameters must be selected so that the threads can withstand large shear and axial loads. If the threads 136 are to be used for other purposes, other factors will dictate the selection of thread design parameters.

[0027] According to various embodiments, the outer surface of the IV spike 120 is configured to engage the inner surface 112 of the outlet port 116 of the container in a mating configuration. As discussed further herein, a mating configuration refers to a configuration in which the IV spike 120 is inserted or spiked into the outlet port 116 of the non-ISO compliant IV container 102. As shown in FIG. 2D, in the mating configuration, at least one edge of the threads 136 at least partially penetrates the inner surface 112 of the outlet port 116 to grip and engage the inner surface 112 of the outlet port 116 of the non-ISO compliant IV container 102. Thus, the threads 136 may be formed with an undercut to sufficiently "bite into," "penetrate," or otherwise engage the inner surface 112 of the outlet port 116. The penetration of the threads 136 into the inner surface 112 of the outlet port 116 creates a seal between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102. Advantageously, the seal created prevents the fluid 140 from inadvertently leaking between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102 .

[0028] In some embodiments, the threads 136 can also act as a retention feature that improves the ability of the non-ISO compliant IV container 102 to retain the IV spike 120 inserted within the IV container in the coupled configuration. The threads 136 can thus prevent the IV spike 120 from separating (or otherwise becoming dislodged) from the non-ISO compliant IV container 102. As the threads 136 rotate and penetrate or otherwise "bite" or "dig" into the inner surface 112 of the outlet port 116, the material of the inner surface 112 of the outlet port 116 is compressed between the threads 136. The pinching of the material of the inner surface 112 of the outlet port 116 between the threads further increases the resistance of the non-ISO compliant IV container 102 to pull-out and shear loads. Thus, advantageously, the threads 136 can be structured to increase friction between the IV spike 120 and the outlet port 116 so that the IV spike 120 cannot easily become dislodged from a non-ISO compliant IV container 102 without departing from the scope of the present disclosure.

[0029] In some embodiments, the threads 136 may be structured as a ramp with a slight undercut configured to penetrate, "bite" or otherwise "dig" into the inner surface 112 of the exit port 116 as the IV spike 120 is inserted or advanced into the non-ISO compliant IV container 102. As the IV spike 120 is pulled and withdrawn from the non-ISO compliant IV container 102, the threads will secure the IV spike 120 within the non-ISO compliant IV container 102. In some embodiments, the upper or undercut portion of the ramp of the threads 136 will dig or grip into the inner surface 112 of the exit port 116 when attempting to withdraw the IV spike 120 from within the non-ISO compliant IV container 102. As a result, advantageously, the pulling force required to remove or otherwise disengage the IV spike 120 from the non-ISO compliant IV container 102 is increased, and thus, the IV spike 120 is better secured to the non-ISO compliant IV container 102.

[0030] It should be noted that the location of the threads on the exterior surface of the IV spike 120 in the figures is merely illustrative and the location of the threads 136 can be varied without departing from the scope of the present disclosure. Additionally, while the figures show multiple threads 136, the multiple threads 136 can be replaced with, for example, lugs and / or barbed features, and the number of threads can be unlimited and can be increased or decreased without departing from the scope of the present disclosure. For example, the multiple lugs can be spaced at regular intervals along the exterior surface of the lower portion 126 of the IV spike body 124. However, in other embodiments, the lugs can be spaced at irregular intervals along the exterior surface of the lower portion 126 of the IV spike body 124. Similarly, the multiple barbed features can be spaced at regular intervals along the exterior surface of the lower portion 126 of the IV spike body 124. However, in other embodiments, the barbed features can be spaced at irregular intervals. The circumferential extent of the barbed features, pointing radially outward from the spike body 124, may be increased or decreased as required by application or design without departing from the scope of this disclosure.

[0031] Thus, the various embodiments of the IV spike 120 described herein provide additional advantages over currently existing IV spikes 20 when coupled to a non-ISO compliant IV container, e.g., containers 12 and 102. Specifically, as shown in Figures 1B and 1C, when currently existing IV spikes 20 are in a coupled configuration and the IV spike 20 pierces or spikes a non-ISO compliant IV container 12, fluid leakage can occur at the contact point 34 between the base 24 and the inner surface 21 of the outlet port 16. As previously discussed, leakage can occur as a result of the lack of a sealing element or mechanism interposed between the base 24 and the inner surface 21 of the outlet port 16. The IV spike 120 of various embodiments described herein improves upon deficiencies of existing IV spikes 20 by incorporating threads 136 on the IV spike as a sealing surface that at least partially penetrates or "digs into" the inner surface 112 of the outlet port 116 when the IV spike 120 is inserted or "spiked" into the outlet port 116 of a non-ISO compliant IV container 102. The threads 136 can cut a helical path into the interior of the outlet port 116 as the IV spike 120 rotates into the outlet port 116. Further advantageously, because the threads 136 rotate and penetrate or otherwise "bite" or "dig" into the inner surface 112 of the outlet port 116, the threads 136 can prevent the IV spike 120 from separating (or otherwise becoming dislodged) from the non-ISO compliant IV container 102. The threads 136 advantageously prevent the IV spike 120 from being axially pulled out of a non-ISO compliant IV container 102 .

[0032] As noted above, a non-ISO compliant IV bag or bottle is discussed herein as an IV bag or bottle with an exit port, e.g., exit port 116, that does not have any form of sealing structure or member on the IV bag or bottle. Thus, according to various embodiments of the present disclosure, the inner surface 112 of the exit port 116 of the IV container 102 (e.g., a non-ISO compliant IV bag or bottle) may be devoid of a sealing member. For example, in contrast to some ISO compliant IV bags and bottles that include a sealing member disposed at the exit port, the IV container 102 may be devoid of or otherwise eliminate a sealing member on the inner surface 112 of the IV container. Thus, when the IV container 12 is spiked with the currently existing IV spike 20, fluid leakage may occur at the contact point 34 between the base 24 and the inner surface 21 of the exit port 16.

[0033] The various embodiments of the IV spike 120 described herein improve upon the deficiencies of existing IV spikes 20 by incorporating a sealing member 135 on the body 124 of the IV spike 120. Specifically, as shown in FIGS. 2A-2D , the sealing member 135 may be disposed on the lower portion 126 of the spike and interposed between a pair of adjacent threads 136. When the sealing member 135 advances into the outlet port 116 of the non-ISO compliant IV container 102, the sealing member 135 seals the path created by the penetration of the threads 136. Thus, the sealing member 135 acts as a secondary seal that further prevents the fluid 140 from inadvertently leaking between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102 in the coupled configuration.

[0034] In some embodiments, the sealing member includes a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof. Furthermore, the sealing member may be made of any chemical type of synthetic material, natural elastomer, and elastomeric compound that may be processed by at least one of injection molding, compression molding, transfer molding, casting, and extrusion techniques, or a combination thereof. Examples of such existing elastomers may be found in FDA 21 CFR 177.2600, although various embodiments of the present disclosure are not limited to this particular regulatory standard.

[0035] According to various aspects of the present disclosure, the puncture base 131 can have a fluid inlet 125 at an upper end. As shown, a fluid channel 133 can extend from the puncture base 131, through the body 124, and into the drip chamber 128. Thus, fluid 140 from the IV container 102 can enter the IV spike 120 at the fluid inlet 125 and flow through the fluid channel 133 into the drip chamber 128.

[0036] 3A and 3B illustrate a method of spiking and sealing an IV container using the IV spike of FIG. 2A according to some embodiments of the present disclosure. As shown in FIG. 3A, the IV spike 120 is inserted into the outlet port 116 of the non-ISO compliant IV bag or bottle 102 with a tight interference fit between the lower portion 126 of the IV spike body 124 and the inner surface 112 of the outlet port 116. The IV spike 120 is then rotated and pushed further up into the outlet port 116 of the non-ISO compliant IV bag or bottle 102. As the IV spike 120 is rotated and advanced further into the non-ISO compliant container 102, the threads 135 may penetrate, "bite" or otherwise "dig" into the inner surface 112 of the outlet port 116. As the IV spike 120 is pulled and withdrawn from the non-ISO compliant IV container 102, the threads 136 will secure the IV spike 120 within the non-ISO compliant IV container 102. As a result, advantageously, the pulling force required to remove or otherwise disengage the IV spike 120 from the non-ISO compliant IV container 102 is increased, and thus the IV spike 120 is better secured within the non-ISO compliant IV container 102.

[0037] Further advantageously, the penetration of the threads 136 into the inner surface 112 of the outlet port 116 creates a primary seal between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102. Advantageously, the seal created prevents fluid 140 from inadvertently leaking between the IV spike 120 and the outlet port 116 of the non-ISO compliant IV container 102.

[0038] As the IV spike 120 advances further into the non-ISO IV container 102, the threads 136 form a recessed path (e.g., a helical path) in the inner surface 112 of the outlet port 116. As the sealing member 135 advances into the outlet port 116 of the non-ISO IV container 102, the sealing member 135 seals the path created by the penetration of the threads 136. Thus, the sealing member 135 acts as a secondary seal that further prevents fluid 140 from inadvertently leaking between the IV spike 120 and the outlet port 116 of the non-ISO IV container 102 in the coupled configuration.

[0039] According to various embodiments of the present disclosure, a method of manufacturing a spike 120 for an intravenous (IV) infusion system 100 can include providing an elongated body 124 with a spike tip 123 at an upper portion and a base 126 at a lower portion. The method can further include forming a plurality of threads 136 projecting radially outward from an outer surface of the base 126 of the elongated body 124. In some embodiments, the outer diameter of the base 126 of the elongated body 124 is greater than the outer diameter of the upper portion 127. The threads 124 can be formed by cutting or removing material from the base 126 of the IV spike to create a series of grooves. Adjacent grooves can define threads 136 between adjacent grooves, and the pitch and size of the threads can vary depending on the needs of the user. In other embodiments, the threads 136 can be formed by adding material in the shape of the threads 136 to the base 126 (also referred to herein as the "lower portion"). In still other embodiments, the threads 136 may be formed by other thread forming processes known in the art.

[0040] According to some embodiments, the method of manufacturing the IV spike 120 may further include positioning a sealing member 135 between a pair of adjacent threads 136 of the plurality of threads 136. The sealing member 135 may be positioned to project radially outward from an outer surface of the base 126 of the elongate body to a greater extent than the plurality of threads projecting radially outward from the outer surface of the base 126 of the elongate body. The sealing member 135 may be coupled, attached, or otherwise joined to the outer surface of the base 126 (or lower portion 126) of the IV spike 120 by any suitable method, including, but not limited to, ultrasonic welding, heat welding, insert molding, adhesive, or other attachment methods. In other embodiments, the sealing member 135 may be coupled, attached, or otherwise joined to the outer surface of the base 126 (or lower portion 126) of the IV spike 120 by a tight interference fit. In some embodiments, the sealing member 135 may be fixedly coupled to the base 126 of the elongate body 124. However, in other embodiments, the sealing member 135 may be removably coupled to the base 126 of the elongate body 124.

[0041] According to some embodiments, the sealing member 135 may be formed of a flexible, resilient material that is fluid impermeable. For example, the sealing member 135 may be made of a silicone material. However, in other embodiments, the valve member 35 may be formed of any non-stick, resilient material, such as natural or synthetic rubber, plastic, or polytetrafluoroethylene (PTFE).

[0042] Various examples of aspects of the present disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the technology. Identification of figures and reference numbers is provided below for illustrative purposes only and the clauses are not intended to be limited by such identification.

[0043] Clause 1 1. An intravenous (IV) spike for administering a medical fluid from a container, the IV spike comprising: an elongated body having an upper portion and a lower portion, the elongated body configured to be coupled to an IV barrel; and a plurality of threads disposed along an outer surface of the lower portion of the elongated body and projecting radially outward from the outer surface, the outer surface configured to engage an inner surface of an outlet port of the container in a coupled configuration, and in the coupled configuration, edges of the threads grip and engage the inner surface of the outlet port of the container to create a seal between the lower portion of the elongated body and the outlet port of the container and retain the body within the outlet port.

[0044] Clause 2 13. The IV spike of claim 1, further comprising a spike head disposed on the top of the elongate body, the spike head comprising a puncturing tip and a puncturing base having a fluid inlet at an upper end, the fluid channel extending from the fluid inlet through the elongate body and into the drip tube.

[0045] Clause 3 13. The IV spike of clause 1, wherein the inner surface of the outlet port is configured without a sealing member.

[0046] Clause 4 The IV spike of clause 3, further comprising a sealing member disposed in the lower portion and interposed between a pair of adjacent threads of the plurality of threads, wherein in the coupled configuration, the sealing member seals between the inner surface of the outlet port and the outer surface of the lower portion of the body to form a seal.

[0047] Clause 5 5. The IV spike of clause 4, wherein the sealing member comprises a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof.

[0048] Clause 6 13. The IV spike of claim 1, wherein in the coupled configuration, at least one edge of the threads penetrates, at least partially, into an inner surface of the exit port.

[0049] Clause 7 An IV spike according to clause 1, in which the outer diameter of each of the threads is greater than the inner diameter of the outlet port.

[0050] Clause 8 2. The IV spike of clause 1, wherein the threads are formed in a series of radial bands spaced apart at regular intervals along at least a portion of the lower portion of the elongated body.

[0051] Clause 9 2. The IV spike of clause 1, wherein the threads are formed in a helical configuration, at least in part, along a bottom portion of the elongate body.

[0052] Clause 10 1. An intravenous (IV) infusion system comprising: an IV container containing a fluid and comprising a fluid outlet port having an inner surface, the inner surface being configured without a sealing member; and an elongated body having an upper portion, a lower portion, and a spike having a plurality of threads disposed along an outer surface of the elongated body and protruding radially outward from the outer surface, the outer surface of the lower portion being configured to engage an inner surface of the fluid outlet port of the IV container in a coupled configuration, and wherein in the coupled configuration, the threads at least partially penetrate the inner surface of the outlet port of the IV container to create a seal between the spike and the outlet port of the container and retain the spike within the outlet port.

[0053] Clause 11 11. The IV drip system of claim 10, wherein the spike further comprises a puncturing base having a puncturing tip and a fluid inlet at the top of the elongate body, and a fluid channel extending from the puncturing base through the elongate body and into the drip barrel.

[0054] Clause 12 The IV drip system of clause 10, further comprising a sealing member disposed on the spike and interposed between a pair of adjacent threads of the plurality of threads, wherein in the coupled configuration, the sealing member forms a seal between an inner surface of the outlet port and an outer surface of the lower portion of the elongated body.

[0055] Clause 13 13. The IV infusion system of clause 12, wherein the sealing member comprises a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof.

[0056] Clause 14 11. The IV infusion system of claim 10, wherein the outer diameter of each of the threads is greater than the inner diameter of the outlet port.

[0057] Clause 15 An IV infusion system of clause 10, including an IV container that is not an International Organization for Standardization (ISO) compliant IV container.

[0058] Clause 16 A method of manufacturing a spike for an intravenous (IV) infusion system, the method comprising: providing an elongate body having a spike tip at an upper portion and a base at a lower portion; forming a plurality of threads protruding radially outward from an outer surface of the base of the elongate body; and positioning a sealing member between a pair of adjacent threads of the plurality of threads.

[0059] Clause 17 17. The method of clause 16, wherein the sealing member projects radially outward from an outer surface of the base of the elongate body to an extent greater than the plurality of threads projecting radially outward from the outer surface of the base of the elongate body.

[0060] Clause 18 17. The method of clause 16, wherein positioning the sealing member includes fixedly coupling the sealing member to a base of the elongate body.

[0061] Clause 19 The method of clause 16, wherein positioning the sealing member includes disposing the sealing member at a base of the elongate body with an interference fit.

[0062] Clause 20 The method of clause 16, wherein an outer diameter of the base of the elongate body is greater than an outer diameter of the upper portion, and forming the plurality of threads includes removing a portion of material of the base to form the threads.

[0063] As used herein, the terms "plumbing," "fluid line," and any variations thereof, refer to medical lines or tubing used to deliver liquids, solvents, or fluids (including gases) to or from a patient receiving medical care. For example, fluid lines (plumbing) may be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, combinations thereof, and the like.

[0064] The foregoing description is presented to enable any person skilled in the art to practice the various aspects described herein. While the foregoing has described what is believed to be the most suitable mode and / or other illustrative examples, it should be understood that various modifications to these aspects will be readily apparent to those skilled in the art, and that the general principles defined herein may be applied to other aspects. Accordingly, the claims are not intended to be limited to the aspects set forth herein, but rather should be given full scope consistent with the claims in language, and references to elements in the singular are intended to mean "one or more" and not "only one" unless otherwise expressly stated. The terms "a set" and "some" refer to one or more, unless otherwise expressly stated. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0065] It is understood that the specific order or hierarchy of steps in the processes disclosed is an example of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes can be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0066] It should be understood that terms such as "top," "bottom," "front," "back," and the like, used in this disclosure refer to an arbitrary coordinate system, rather than the usual gravitational coordinate system. Thus, the top, bottom, front, and back surfaces can extend upward, downward, diagonally, or horizontally in the gravitational coordinate system.

[0067] The use of a phrase such as "an aspect" does not imply that such an aspect is essential to the technology or that such an aspect applies to all configurations of the technology. Disclosure of an aspect may apply to all configurations, or to one or more configurations. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "an embodiment" does not imply that such an embodiment is essential to the technology or that such an embodiment applies to all configurations of the technology. Disclosure of an embodiment may apply to all embodiments, or to one or more embodiments. A phrase such as an embodiment may refer to one or more embodiments, and vice versa.

[0068] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0069] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or that later become known to those of ordinary skill in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. Claim elements are not to be construed under 35 U.S.C. § 112, paragraph 6, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step of." Moreover, to the extent that terms such as "comprises," "comprising," and the like are used in the description or claims, such terms are intended to be inclusive in the same manner as the term "having" is interpreted when "having" is used as a transitional term in the claims.

Claims

1. 1. An intravenous (IV) spike for administering a medical fluid from a container, comprising: an elongated body configured to be coupled to a drip tube, the elongated body having an upper portion and a lower portion, the lower portion having an outer surface defining an outer diameter that is greater than an outer diameter of the upper portion; a plurality of threads disposed along and projecting radially outward from the outer surface of the lower portion of the elongated body, the outer surface is configured to engage an inner surface of an outlet port of the container in a mating configuration; a plurality of threads, in the coupled configuration, where an edge of the threads grips and engages the inner surface of the outlet port of the container to create a seal between the lower portion of the elongated body and the outlet port of the container, retaining the body within the outlet port; IV spike.

2. 2. The IV spike of claim 1, further comprising a spike head disposed on the top of the elongate body, the spike head comprising a puncturing tip and a puncturing base having a fluid inlet at an upper end, a fluid channel extending from the fluid inlet through the elongate body and into the drip tube.

3. 10. The IV spike of claim 1, wherein the inner surface of the exit port is configured without a sealing member.

4. 4. The IV spike of claim 3, further comprising a sealing member disposed on the lower portion and interposed between a pair of adjacent threads of the plurality of threads, wherein in the coupled configuration, the sealing member occupies and forms a seal between the inner surface of the outlet port and the outer surface of the lower portion of the body.

5. 5. The IV spike of claim 4, wherein the sealing member comprises a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof.

6. 2. The IV spike of claim 1, wherein in the coupled configuration, at least one edge of the threads at least partially penetrates the inner surface of the exit port.

7. 2. The IV spike of claim 1, wherein an outer diameter of each of the threads is greater than an inner diameter of the exit port.

8. 2. The IV spike of claim 1, wherein the threads are formed in a series of radial bands spaced apart at regular intervals along at least a portion of the lower portion of the elongate body.

9. The IV spike of claim 1 , wherein the threads are formed at least partially in a helical configuration along the lower portion of the elongate body.

10. an IV container containing a fluid and including a fluid outlet port having an inner surface, the inner surface being configured without a sealing member; 1. A spike comprising: an elongated body configured to be coupled to an IV tube, the elongated body comprising an upper portion and a lower portion, the lower portion having an outer surface defining an outer diameter greater than an outer diameter of the upper portion, the elongated body comprising a plurality of threads disposed along and projecting radially outwardly from the outer surface of the lower portion of the elongated body; the outer surface of the lower portion is configured to engage the inner surface of the fluid exit port of the IV container in a coupled configuration; a spike, wherein in the coupled configuration, the threads at least partially penetrate the inner surface of the outlet port of the IV container to create a seal between the spike and the outlet port of the container and retain the spike within the outlet port; An intravenous (IV) infusion system comprising:

11. The spikes are a piercing base having a piercing tip and a fluid inlet at the top of the elongate body; a fluid channel extending from the puncture base through the elongate body and into a drip tube; 11. The IV infusion system of claim 10, further comprising:

12. 11. The IV infusion system of claim 10, further comprising a sealing member disposed on the lower portion of the elongate body and interposed between a pair of adjacent threads of the plurality of threads, wherein in the coupled configuration, the sealing member forms a seal between the inner surface of the outlet port and the outer surface of the lower portion of the elongate body.

13. 13. The IV infusion system of claim 12, wherein the sealing member comprises a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof.

14. 11. The IV infusion system of claim 10, wherein an outer diameter of each of the threads is greater than an inner diameter of the exit port.

15. 11. The IV infusion system of claim 10, wherein the IV container comprises an IV container that is not International Organization for Standardization (ISO) compliant.

16. 1. A method of manufacturing a spike for an intravenous (IV) infusion system, comprising: providing an elongate body having a spike tip at an upper portion and a base at a lower portion, the lower portion having an outer surface defining an outer diameter greater than an outer diameter of the upper portion; forming a plurality of threads projecting radially outward from an outer surface of the base of the elongate body; positioning a sealing member between a pair of adjacent threads of said plurality of threads; A method comprising:

17. 17. The method of claim 16, wherein the sealing member projects radially outward from the outer surface of the base of the elongate body to a greater extent than the plurality of threads that project radially outward from the outer surface of the base of the elongate body.

18. The method of claim 16 , wherein positioning the sealing member comprises fixedly coupling the sealing member to the base of the elongate body.

19. The method of claim 16 , wherein positioning the sealing member comprises disposing the sealing member on the base of the elongate body with an interference fit.

20. The method of claim 16, wherein forming the plurality of threads includes removing a portion of material of the base to form the threads.

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