Patent Publication Number: US-2020282134-A1

Title: Iv spike for use with non-iso compliant iv container

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to IV set components, and more particularly to IV spikes for puncturing and sealing membranes of non-ISO compliant IV fluid bags and bottles. 
     BACKGROUND 
     One of the most widely used methods of medical therapy is the intravenous (IV) infusion of liquid medicaments and/or nutrients into the bloodstream of a patient. A familiar apparatus that is 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. 
     When the IV container is a bag or bottle, a rigid, hollow, sharpened IV spike is pushed into the bag to establish a pathway for fluid communication through which the liquid can flow out of the bag. The spike is usually inserted into the bag through a sealed membrane, commonly referred to as a port. In turn, the spike is connected to or formed integrally with an inlet port of a small, elongated, transparent hollow container familiarly referred to as a “drip chamber,” with the fluid pathway of the spike in fluid communication with an interior of the drip chamber. 
     IV containers in the form of bags or bottles as discussed above may generally be classified as Intentional Organization for Standardization (ISO) compliant or non-ISO compliant. Where non-ISO compliant containers are pierced (“spiked”) using existing IV spikes, there is a higher tendency or risk for the non-ISO compliant containers to leak upon spiking. 
     SUMMARY 
     In accordance with some embodiments, an intravenous (IV) spike for administering a medicinal fluid from a container includes an elongate body having an upper portion and a lower portion, the elongate body configured to be coupled to a drip chamber; a spike head disposed at the upper portion of the elongate body, the spike head having a puncture tip and a puncture base having a fluid inlet at an upper end thereof, wherein a fluid channel extends from the fluid inlet, through the elongate body, and into the drip chamber; a plurality of screw threads disposed along and protruding radially outward from an outer surface of the lower portion of the elongate body, wherein: the outer surface is configured to engage an internal surface of an outlet port of the container in a coupled configuration; and in the coupled configuration edges of the screw threads grip and engage the internal surface of the outlet port of the container to create a seal between the lower portion of the elongate body and the outlet port of the container and to retain the body in the outlet port. 
     In accordance with some embodiments, an intravenous (IV) drip system may include an IV container containing a fluid and including a fluid outlet port having an internal surface, the internal surface being configured without a sealing member; a spike having an elongate body including an upper portion, a lower portion, and a plurality of screw threads disposed along and protruding radially outward from an outer surface of the elongate body, wherein: the outer surface of the lower portion is configured to engage the internal surface of the fluid outlet port of the IV container in a coupled configuration; and in the coupled configuration, the screw threads penetrate at least partially into the internal surface of the outlet port of the IV container to create a seal between the spike and the outlet port of the container and to retain the spike in the outlet port. 
     In accordance with some embodiments, a method of manufacturing a spike for an intravenous (IV) drip system includes providing an elongate body with a spike tip at an upper portion thereof and a base at a lower portion thereof, forming a plurality of screw 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 screw threads. 
     Aspects and features of the models and methods disclosed herein can be provided, excluded, or modified based on the teachings and disclosure herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following figures are included to illustrate certain aspects of the embodiments, and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure. 
         FIG. 1A  depicts a perspective view of a conventional IV spike. 
         FIG. 1B  is a cross-sectional view of an IV set that includes a non-ISO compliant IV container spiked by the conventional IV spike of  FIG. 1A . 
         FIG. 1C  is an enlarged partial cross-sectional view of the IV set that includes the non-ISO compliant IV container spiked by the conventional IV spike of  FIG. 1B . 
         FIG. 2A  depicts a perspective view of an IV spike, in accordance with some embodiments of the present disclosure. 
         FIG. 2B  depicts a cross-sectional view of the IV spike of  FIG. 2A , in accordance with some embodiments of the present disclosure. 
         FIG. 2C  is a cross-sectional view of an IV set that includes a non-ISO compliant IV container spiked by IV spike of  FIG. 2A , in accordance with some embodiments of the present disclosure. 
         FIG. 2D  is an enlarged partial cross-sectional view of the IV set that includes the non-ISO compliant IV container spiked by the IV spike of  FIG. 2A . 
         FIGS. 3A and 3B  depict a method of spiking and sealing the non-ISO compliant IV container with the IV spike of  FIG. 2A , in accordance with some embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Various embodiments of the present disclosure are directed to providing IV spikes for puncturing (“spiking”) membranes of non-ISO compliant IV fluid bags and bottles, where the IV spikes have improved retention features for retaining the IV spike in the IV container. 
     Various embodiments of the present disclosure are additionally directed to providing IV spikes for spiking membranes of non-ISO compliant IV fluid bags and bottles, where the IV spikes have improved sealing capabilities so as to prevent fluid from inadvertently leaking between external surfaces of the IV spikes and internal surfaces of the IV fluid bags and bottles. 
     Embodiments disclosed herein are directed to providing an IV spike with improved sealing and retention capabilities as compared with existing IV spikes. In accordance with some embodiments, the IV spike  120  may generally include a body having an upper portion and a lower portion or base. The lower portion or base of the IV spike may provide sealing and retention mechanisms thereon for sealingly and securely engaging the IV spike in the outlet port during spiking of the non-ISO compliant IV bag or bottle. In particular, as depicted, the lower portion may include a plurality of screw threads disposed along and protruding radially outward from an outer surface of the lower portion. In some embodiments, the screw threads may act as the retention mechanism to anchor and retain the body of the IV spike in the non-ISO compliant IV bag or bottle. 
     In a coupled or “spiked” configuration where the IV spike is inserted or spiked into the outlet port of the non-ISO compliant IV container, edges of the screw threads may at least partially penetrate the internal surface of the outlet port to grip and engage the internal surface of the outlet port  116  of the non-ISO compliant IV container. Penetration of the screw threads into the internal surface  112  of the outlet port  116  creates a first 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  upon, during, or after spiking. 
     In some embodiments, the screw threads may also act as a retaining mechanism for improving the ability of the non-ISO compliant IV container to retain the IV spike inserted or “spiked” therein. The screw threads may thus prevent the IV spike from separating (or otherwise dislodging) from the non-ISO compliant IV container. As the screw threads  136  rotate and penetrate or otherwise “bite” or “dig” into the internal surface of the outlet port, material of the internal surface of the outlet port is compressed between the screw threads  136 , which further increases the resistance of the non-ISO compliant IV container to pull-out and to shear loads. Advantageously, the screw threads may thus serve as a structure that increases friction between the IV spike and the outlet port such that the IV spike may not be easily dislodged from the non-ISO compliant IV container, without departing from the scope of the disclosure. 
     In accordance with various embodiments of the present disclosure, the IV spike may be configured with a sealing member disposed on the lower portion of the IV spike body, and interposed between a pair of adjacent screw threads. In the coupled configuration the sealing member plugs and forms a second seal between the internal surface of the outlet port and the outer surface of the lower portion of the IV spike body. As the sealing member  135  is advanced 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 screw threads  136 . The IV spike  120  thus remedies the deficiencies of the existing IV spike  20  by incorporating the sealing member thereon as a secondary seal to further prevent 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. 
       FIG. 1A  depicts a perspective view of a conventional IV spike  20 .  FIG. 1B  is a cross-sectional view of an IV set  10  that includes an IV container  12  spiked by the conventional IV spike  20  of  FIG. 1A .  FIG. 1C  is an enlarged partial cross-sectional view of the IV set that includes the IV container  12  spiked by the conventional IV spike of  FIG. 1B . The IV container  12  may be a non-ISO compliant IV fluid bag or bottle. As described herein a non-ISO compliant IV bag or bottle is one having an outlet port, e.g., outlet port  16 , without any form of sealing structure or sealing member thereon. For example, in contrast to non-ISO compliant IV bags or bottles, ISO compliant IV bags or bottles generally include some form of sealing element on the outlet port in the form of a rubber bung, plug, or stopper for sealingly coupling the outlet port and the conventional IV spike  20  during spiking. The sealing elements incorporated into the ISO compliant IV bags thus are capable of minimizing fluid leaks between the internal surface of the outlet port and the outer surface of the body of the conventional IV spike  20 . 
     As depicted, 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 be coupled to a drip chamber  28 . A spike  23  having a puncture tip  29  and a puncture base  31  may be disposed at the upper portion  27  of the body  24 . The puncture base  31  may have a fluid inlet  25  at an upper end thereof. As illustrated, a fluid channel  33  may extend from the puncture base  31 , through the body  24  and into the drip chamber  28 . The lower portion  26  may serve as a base of the IV spike  20  and may have an outer diameter greater than an outer diameter of the upper portion  27  the elongate body  24 . In a coupled configuration, as illustrated in  FIG. 1B , in which the non-ISO compliant IV container  12  is pierced or spiked by the IV spike  20 , fluid leaks may occur at the contact points  34  of the base  24  and the internal surface of the outlet port  16  as a result of the lack of some form of a sealing element interposed therebetween. 
     Therefore, it would be advantageous to have an IV spike capable of sufficiently sealing a non-ISO compliant IV bag or bottle so as to prevent leakage of fluid from the non-ISO compliant IV bag or bottle upon, during, and/or after spiking. It is further advantageous to have an IV spike having improved retention features over conventional or currently existing IV spikes for retaining the IV spike in the non-ISO compliant IV bag or bottle. The various embodiments of the present disclosure are directed to providing an IV spike having the aforementioned features that are lacking in the conventional or currently existing IV spikes. 
       FIG. 2A  depicts a perspective view of an IV spike  120 , in accordance with some embodiments of the present disclosure.  FIG. 2B  depicts a cross-sectional view of the IV spike  120  of  FIG. 2A , in accordance with some embodiments of the present disclosure.  FIG. 2C  is a cross-sectional view of an IV set that includes an IV container  102  spiked by IV spike  120  of  FIG. 2A , in accordance with some embodiments of the present disclosure.  FIG. 2D  is an enlarged partial cross-sectional view of the IV set  100  that includes the IV container  102  spiked by the IV spike  120  of  FIG. 2A . 
     As illustrated in  FIGS. 2C and 2D , the IV container  102  may be a non-ISO compliant IV fluid bag or bottle. As described above, a non-ISO compliant IV bag or bottle is discussed herein as an IV bag or bottle having an outlet port, e.g., outlet port  116 , without any form of sealing structure or sealing member thereon. For example, in contrast to non-ISO compliant IV bags or bottles, ISO compliant IV bags or bottles generally include some form of sealing element on the outlet port in the form of a rubber bung, plug, or stopper for sealingly coupling the outlet port and the IV spike during spiking. The sealing elements incorporated into the outlet ports of existing ISO compliant IV bags thus are capable of minimizing fluid leaks between the internal surface of the outlet port and the outer surface of the body of the existing IV spikes. In contrast, due to a lack of some form of sealing member or element being incorporated onto the outlet port or nozzle of the non-ISO compliant IV bags or bottles, fluid may leak out of the outlet port during, or after spiking. 
     Various embodiments of the present disclosure are directed to providing an IV spike  120  having improved sealing and retention capabilities as compared with existing IV spikes, e.g., IV spike  20 . Referring back to  FIGS. 2A and 2B , the IV spike  120  may generally include a body  124  having an upper portion  127  and a lower portion or base  126 . The IV spike  120  may be configured to be coupled to a drip chamber  128 . A spike head  123  having a puncture tip  129  and a puncture base  131  may be disposed at the upper portion  127  of the body  124 . According to various aspects of the present disclosure, the lower portion  126  may also be referred to herein as a base  126  of the IV spike body  124  and may have an outer diameter greater than an outer diameter of the upper portion  27  the elongate body  24 . The aforementioned configuration may be advantageous in that a tight interference fit may be formed between the base  126  of the IV spike  120  and the internal surface  112  of the outlet port  116 . The tight interference fit may further aid in retention of the IV spike  120  in the non-ISO compliant IV bag or bottle  102 . 
     According to various aspects of the present disclosure, the lower portion or base  126  of the IV spike  120  may provide sealing and retention mechanisms thereon for sealingly and securely engaging the IV spike  20  in the outlet port  116  during spiking of the non-ISO compliant IV bag or bottle  102 . In particular, as depicted, the lower portion  126  may include a plurality of screw threads  136  disposed along and protruding radially outward from an outer surface of the lower portion  126 . In some embodiments, the screw threads  136  may anchor the body  124  of the IV spike  20  into the non-ISO compliant IV bag or bottle  102 . 
     In accordance with various embodiments, the shape and configuration of the plurality of screw threads  136  is not limited to any particular configuration. The screw threads  136  may have an apex having a sharpness sufficient to engage and “bite into the outlet port of the non-ISO compliant IV bag or bottle  102 . In some embodiments, a pitch of the plurality of screw threads  136  can be varied. For example, the plurality of screw threads  136  may be formed with a shallow thread pitch which provides many turns of threads  136  around the outer surface of the lower portion  126  of the body  124  with adjacent threads  136  spaced closely together. Alternatively, the plurality of screw threads  136  may be formed with a steep thread pitch which provides few turns of threads  136  with adjacent threads  136  spaced further apart than the configuration having the steep pitch. In some embodiments, the height of the screw threads  136  from the outer surface of the lower portion  126  of the IV spike body  124  to the apex of the thread may extend and protrude radially outward a sufficient height to dig or otherwise cut into the internal surface  112  of the outlet port  116 . Accordingly, an outer diameter of each of the screw threads may be larger than an internal diameter of the outlet port. 
     In some embodiments, the plurality of screw threads  136  may be formed at least partially along the lower portion  126  of the body  124 . In other embodiments, the plurality of screw threads  136  may be formed completely along the lower portion  126  of the body  124 . As depicted in  FIG. 2A , the plurality of screw threads  136  may be formed in a helical configuration along the lower portion  126  of the body  124 . However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the screw threads  136  are formed in a series of radial bands along the lower portion  126  of the body  124 . In some embodiments, the screw threads  136  may be spaced apart from each other at regular intervals, e.g., equally spaced apart. In other embodiments however, the screw threads  136  may be spaced apart from each other at irregular intervals, e.g., spaced apart at varying intervals. 
     As depicted in  FIG. 2A , the plurality of screw threads  136  may form a helical spiral around the lower portion  126  of the body  124 . The number of threads and thread pitch are parameters that may be varied depending on the material of the outlet port  116  of the IV container  102  in which the IV spike  120  is to be inserted. For example, if the screw threads  136  are to anchor the IV spike  120  in the outlet port  116 , then the thread pitch and other screw parameters should be selected so that the screw can withstand large shearing and axial loads. If the screw threads  136  are to be used for other purposes, then other factors will dictate the selection of screw design parameters. 
     In accordance with various embodiments, the outer surface of the IV spike  120  is configured to engage an internal surface  112  of an outlet port  116  of the container in a coupled configuration. As discussed further herein, a coupled 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 depicted in  FIG. 2D , in the coupled configuration, edges of at least one of the screw threads  136  at least partially penetrate the internal surface  112  of the outlet port  116  to grip and engage the internal surface  112  of the outlet port  116  of the non-ISO compliant IV container  102 . As such, the screw threads  136  may be formed with an undercut so as to sufficiently “bite into,” “penetrate,” or otherwise engage the internal surface  112  of the outlet port  116 . Penetration of the screw threads  136  into the internal 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 fluid  140  from inadvertently leaking between the IV spike  120  and the outlet port  116  of the non-ISO compliant IV container  102 . 
     In some embodiments, the screw threads  136  may also act as a retaining mechanism for improving the ability of the non-ISO compliant IV container  102  to retain the IV spike  120  inserted therein in the coupled configuration. The screw threads  136  may thus prevent the IV spike  120  from separating (or otherwise dislodging) from the non-ISO compliant IV container  102 . As the screw threads  136  rotate and penetrate or otherwise “bite” or “dig” into the internal surface  112  of the outlet port  116 , material of the internal surface  112  of the outlet port  116  is compressed between the screw threads  136 . The pinching of the material of the internal surface  112  of the outlet port  116  between the screw threads further increases the resistance of the non-ISO compliant IV container  102  to pull-out and to shear loads. Advantageously, the screw threads  136  may thus be structure that increases friction between the IV spike  120  and the outlet port  116  such that the IV spike  120  may not be easily dislodged from the non-ISO compliant IV container  102 , without departing from the scope of the disclosure. 
     In some embodiments, the screw threads  136  may be structured as a ramp that has a slight undercut configured to penetrate, “bite into,” or otherwise “dig into” the internal surface  112  of the outlet port  116  as the IV spike  120  is inserted or advanced into the non-ISO compliant IV container  102 . When the IV spike  120  is pulled to be 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 top of the ramp, or the undercut portion of the screw threads  136 , will dig into or grip the internal surface  112  of the outlet port  116  when the IV spike  120  is attempted to be withdrawn from within the non-ISO compliant IV container  102 . Advantageously as a result, the tensile force required to remove or otherwise dislodge the IV spike  120  from the non-ISO compliant IV container  102  is increased and thus the IV spike  120  is better secured in the non-ISO compliant IV container  102 . 
     It should be noted that the locations of the screw threads on the outer surface of the IV spike  120  in the Figures are merely examples, and the location of the screw threads  136  may be changed, without departing from the scope of the disclosure. Further, although the Figures indicate a plurality of screw threads  136 , the plurality of screw threads  136  may be replaced, for example with ledges and/or barbed features, the number of which may not be limited and may be increased or decreased, without departing from the scope of the disclosure. For example, multiple ledges may be disposed at regular intervals along the outer surface of the lower portion  126  of the IV spike body  124 . However, in other embodiments, the ledges may be disposed at irregular intervals along the outer surface of the lower portion  126  of the IV spike body,  124 . Similarly, multiple barbed features may be disposed at regular intervals along the outer surface of the lower portion  126  of the IV spike body,  124 . However, in other embodiments, the barbed features may be disposed at irregular intervals. The circumferential extent of the barbed features radially outward from the spike body  124  may be increased or decreased as required by application or design, and without departing from the scope of the disclosure. 
     The IV spike  120  of the various embodiments described herein thus yields further advantages over the currently existing IV spike  20  when coupled to a non-ISO compliant IV container, e.g., containers  12 , and  102 . In particular, when the currently existing IV spike  20  is in the coupled configuration, as illustrated in  FIGS. 1B and 1C , where the non-ISO compliant IV container  12  is pierced or spiked by the IV spike  20 . fluid leaks may occur at the contact points  34  of the base  24  and the internal surface  21  of the outlet port  16 . As previously discussed, the leaks may occur as a result of lack of a sealing element or mechanism interposed between the base  24  and the internal surface  21  of the outlet port  16 . The IV spike  120  of the various embodiments described herein remedies the deficiencies of the existing IV spike  20  by incorporating the screw threads  136  thereon as a sealing surface which at least partially penetrates or “digs into” the internal surface  112  of the outlet port  116  when the IV spike  120  is inserted or “spiked” into the outlet port  116  of the non-ISO compliant IV container  102 . The screw threads  136  may cut a helical path into the internal of the outlet port  16  as the IV spike  120  rotates into the outlet port  116 . Further advantageously, because the screw threads  136  rotate and penetrate or otherwise “bite” or “dig” into the internal surface  112  of the outlet port  116 , the screw threads  136  may thus prevent the IV spike  120  from separating (or otherwise dislodging) from the non-ISO compliant IV container  102 . The screw threads  136  advantageously keep the IV spike  120  from being axially pulled out of the non-ISO compliant IV container  102 . 
     As described above, a non-ISO compliant IV bag or bottle is discussed herein as an IV bag or bottle having an outlet port, e.g., outlet port  116 , without any form of sealing structure or sealing member thereon. Thus, in accordance with various embodiments of the present disclosure, the internal surface  112  of the outlet 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 having a sealing member disposed on the outlet port, the IV container  102  may lack or otherwise exclude a sealing member on the internal surface  112  thereof. As such, when the IV container  12  is spiked with the currently existing IV spike  20 , fluid leaks may occur at the contact points  34  of the base  24  and the internal surface  21  of the outlet port  16 . 
     The IV spike  120  of the various embodiments described herein remedies the deficiencies of the existing IV spike  20  by incorporating a sealing member  135  on the body  124  of the IV spike  120 . In particular, as illustrated 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 screw threads  136 . As the sealing member  135  is advanced 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 screw threads  136 . Thus the sealing member  135  acts as a secondary seal to further prevent 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. 
     In some embodiments, the sealing member comprises a material selected from the group consisting of rubber, polytetrafluoroethylene (PTFE), silicone, and any combination thereof. Additionally, the sealing member may be made of synthetic and natural elastomers and elastomeric compounds of any chemical type that can be processed by at least one of, or a combination of injection molding, compression molding, transfer molding, casting and extrusion techniques. Examples of such existing elastomers can be found in FDA 21 CFR 177.2600, however the various embodiments of the present disclosure are not limited to this particular regulatory standard. 
     According to various aspects of the present disclosure, the puncture base  131  may have a fluid inlet  125  at an upper end thereof. As illustrated, a fluid channel  133  may extend from the puncture base  131 , through the body  124  and into the drip chamber  128 . As such, fluid  140  from the IV container  102  may enter the IV spike  120  at the fluid inlet  125  and flow through the fluid channel  133  into the drip chamber  128 . 
       FIGS. 3A and 3B  depict a method of spiking and sealing the IV container with the IV spike of  FIG. 2A , in accordance with some embodiments of the present disclosure. As illustrated 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 internal 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 further advanced into the non-ISO compliant container  102 , the screw threads  135  may penetrate, “bite into,” or otherwise “dig into” the internal surface  112  of the outlet port  116 . When the IV spike  120  is pulled to be 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 . Advantageously as a result, the tensile force required to remove or otherwise dislodge the IV spike  120  from the non-ISO compliant IV container  102  is increased and thus the IV spike  120  is better secured in the non-ISO compliant IV container  102 . 
     Further advantageously, the penetration of the screw threads  136  into the internal surface  112  of the outlet port  116  creates a first 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 . 
     As the IV spike  120  is further advanced into the non-ISO compliant IV container  102 , the screw threads  136  form a recessed path (e.g., a helical path) in the internal surface  112  of the outlet port  116 . As the sealing member  135  is advanced 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 screw threads  136 . Thus the sealing member  135  acts as a secondary seal to further prevent 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. 
     According to various embodiments of the present disclosure, a method of manufacturing a spike  120  for an intravenous (IV) drip system  100  may include providing an elongate body  124  with a spike tip  123  at an upper portion thereof and a base  126  at a lower portion thereof. The method may further include forming a plurality of screw threads  136  protruding radially outward from an outer surface of the base  126  of the elongate body  124 . In some embodiments, an outer diameter of the elongate body  124  at the base  126  is larger than that at the upper portion  127 . The screw threads  124  may be formed by cutting out or removing material from the base  126  of the IV spike so as to create a series of grooves. Adjacent grooves may define the screw threads  136  therebetween, a pitch and size of which may be varied based on user&#39;s needs. In other embodiments, the screw threads  136  may be formed by adding material in the shape of the screw threads  136  to the base  126  (also referred to herein as the “lower portion”). In yet other embodiments, the screw threads  136  may be formed through other screw thread formation processes know in the art. 
     In accordance with 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 screw threads  136 . The sealing member  135  may be positioned so as to protrude radially outwards from the outer surface of the base  126  of the elongate body to a greater extent than the plurality of screw threads protrude radially outward from the outer surface of the base  126  of the elongate body. The sealing member  135  may be coupled, attached or otherwise bonded to the outer surface of the base  126  (or lower portion  126 ) of the IV spike  120  through any appropriate methods including, but not limited to ultrasonic welding, heat sealing, insert molding, gluing or other attachment methods. In other embodiments, the sealing member  135  may be coupled, attached or otherwise bonded to the outer surface of the base  126  (or lower portion  126 ) of the IV spike  120  through a tight interference fit. In some embodiments, the sealing member  135  may be fixedly coupled to the base  126  of the elongate body  124 . In other embodiments, however the sealing member  135  may be removably coupled to the base  126  of the elongate body  124 . 
     In accordance with some embodiments, the sealing member  135  may be formed of a flexible, resilient material which is fluid impervious. For example, the sealing member  135  may be made of a silicon material. In other embodiments, however, the valve member  35  may be formed of any non-sticking, resilient material such as natural or synthetic rubber or plastic or polytetrafluoroethylene (PTFE). 
     Various examples of aspects of the disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Identification of the figures and reference numbers are provided below merely as examples for illustrative purposes, and the clauses are not limited by those identifications. 
     Clause 1: An intravenous (IV) spike for administering a medicinal fluid from a container, the IV spike comprising: an elongate body having an upper portion and a lower portion, the elongate body configured to be coupled to a drip chamber; a plurality of screw threads disposed along and protruding radially outward from an outer surface of the lower portion of the elongate body, wherein: the outer surface is configured to engage an internal surface of an outlet port of the container in a coupled configuration; and in the coupled configuration edges of the screw threads grip and engage the internal surface of the outlet port of the container to create a seal between the lower portion of the elongate body and the outlet port of the container and to retain the body in the outlet port. 
     Clause 2: The IV spike of Claim  1 , further comprising a spike head disposed at the upper portion of the elongate body, the spike head having a puncture tip and a puncture base having a fluid inlet at an upper end thereof, wherein a fluid channel extends from the fluid inlet, through the elongate body, and into the drip chamber. 
     Clause 3: The IV spike of Clause 1, wherein the internal surface of the outlet port is configured without a sealing member. 
     Clause 4: The IV spike of Clause 3, further comprising a sealing member disposed on the lower portion and interposed between a pair of adjacent threads of the plurality of screw threads, wherein in the coupled configuration the sealing member plugs and forms a seal between the internal surface of the outlet port and the outer surface of the lower portion of the body. 
     Clause 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. 
     Clause 6: The IV spike of Clause 1, wherein in the coupled configuration edges of at least one of the screw threads at least partially penetrate the internal surface of the outlet port. 
     Clause 7: The IV spike of Clause 1, wherein an outer diameter of each of the screw threads is larger than an internal diameter of the outlet port. 
     Clause 8: The IV spike of Clause 1, wherein the screw threads are formed in a series of radial bands spaced apart from each other at regular intervals along at least a portion of the lower portion of the elongate body. 
     Clause 9: The IV spike of Clause 1, wherein the screw threads are formed in a helical configuration at least partially along the lower portion of the elongate body. 
     Clause 10: An intravenous (IV) drip system comprising: an IV container containing a fluid and including a fluid outlet port having an internal surface, the internal surface being configured without a sealing member; a spike having an elongate body including an upper portion, a lower portion, and a plurality of screw threads disposed along and protruding radially outward from an outer surface of the elongate body, wherein: the outer surface of the lower portion is configured to engage the internal surface of the fluid outlet port of the IV container in a coupled configuration; and in the coupled configuration, the screw threads penetrate at least partially into the internal surface of the outlet port of the IV container to create a seal between the spike and the outlet port of the container and to retain the spike in the outlet port. 
     Clause 11: The IV drip system of Clause 10, wherein the spike further includes: a puncture tip and a puncture base having a fluid inlet at the upper portion of the elongate body; and a fluid channel extending from the puncture base, through the elongate body, and into the drip chamber. 
     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 screw threads, wherein in the coupled configuration the sealing member forms a seal between the internal surface of the outlet port and the outer surface of the lower portion of the elongate body. 
     Clause 13: The IV drip 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. 
     Clause 14: The IV drip system of Clause 10, wherein an outer diameter of each of the screw threads is larger than an internal diameter of the outlet port. 
     Clause 15: The IV drip system of Clause 10, wherein the IV container comprises a non-International Organization for Standardization (ISO) compliant IV container. 
     Clause 16: A method of manufacturing a spike for an intravenous (IV) drip system, the method comprising: providing an elongate body with a spike tip at an upper portion thereof and a base at a lower portion thereof; forming a plurality of screw 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 screw threads. 
     Clause 17: The method of Clause 16, wherein the sealing member protrudes radially outwards from the outer surface of the base of the elongate body to a greater extent than the plurality of screw threads protrude radially outward from the outer surface of the base of the elongate body. 
     Clause 18: The method of Clause 16, wherein positioning the sealing member comprises fixedly coupling the sealing member to the base of the elongate body. 
     Clause 19: The method of Clause 16, wherein positioning the sealing member comprises placing the sealing member on the base of the elongate body with an interference fit. 
     Clause 20: The method of Clause 16, wherein an outer diameter of the elongate body at the base is larger than that at the upper portion, and the forming a plurality of screw threads comprises removing a portion of the base material to form the screw threads. 
     As used herein, the terms “tubing,” “fluid line,” and any variation thereof refers to medical lines or tubes used to deliver liquids, solvents, or fluids (including gas) to or from a patient under medical care. For example, fluid lines (tubing) may be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, a combination thereof, and the like. 
     The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the terms “a set” and “some” refer to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention. 
     It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may 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 meant to be limited to the specific order or hierarchy presented. 
     Terms such as “top,” “bottom.” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference. 
     A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or 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 embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. A phrase such an embodiment may refer to one or more embodiments and vice versa. 
     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. 
     All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, 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 for.” Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.