Safety IV spike with disconnectable mechanism

Abstract

An intravenous IV spike for administering a medical fluid from a container can include a head portion at a proximal end of the IV spike, a base portion at a distal end of the IV spike, and an elongated body portion connecting the head portion and the base portion. The elongated body portion can be configured to be coupled to the container. The IV spike can further include a radial notch extending at least partially along the periphery of an outer surface of the elongated body portion. The radial notch can be recessed radially inward from the outer surface.

Description

[Technical Field]

[0001] The present disclosure relates generally to IV set components, and more particularly to an IV spike having a safety mechanism for disposal after injection use. [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 communication path through which liquid can exit the bag. The spike is typically inserted into the bag through a sealing membrane commonly referred to as a port. The spike is then coupled to or integrally formed with an inlet port of a small, elongated, transparent, hollow container commonly referred to as a "drip chamber," with the spike's fluid path fluidly communicating with the interior of the drip chamber.

[0004] Improper disposal of IV sets after completion of an infusion in a hospital is a potential source of infection that can result from a clinician or other medical professional being injured by the sharp tip of an IV spike. Summary of the Invention [Means for solving the problem]

[0005] According to various embodiments of the present disclosure, an intravenous (IV) spike for administering a medical fluid from a container can include a head portion at a proximal end of the IV spike, a base portion at a distal end of the IV spike, and an elongated body portion connecting the head portion and the base portion. The elongated body can be configured to be coupled to a container. The IV spike can further include a radial notch extending at least partially along the periphery of an outer surface of the elongated body portion. The radial notch can be recessed radially inward from the outer surface.

[0006] According to various embodiments of the present disclosure, an intravenous (IV) spike assembly for administering a medical solution from a container to an IV drip barrel while preventing injury from the spike can include a spike having a head portion, a base portion, and an elongated body portion connecting the head portion and the base portion, and a spike cover. The spike cover can include an elongated body that houses the spike and a base. The base portion of the spike cover and the base portion of the spike can include complementary engagement features that interlock the spike and the spike cover.

[0007] According to various embodiments of the present disclosure, a method of manufacturing a spike for an intravenous (IV) infusion system can include providing an elongate body having a head with a spike tip at a proximal end of the elongate body and a base at a distal end of the elongate body, and can further include forming a radial notch recessed radially inward from an outer surface of the elongate body.

[0008] It should be understood that other configurations of the present technology will be readily apparent to those skilled in the art from the following detailed description, in which various configurations of the present technology are shown and described by way of example. The present technology is capable of other different configurations, as will be recognized, and several details of the present technology are capable of modification in various other respects, all without departing from the scope of the present technology. Accordingly, the drawings and detailed description should be regarded as illustrative in nature, and not as restrictive.

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

[0010] [Figure 1] FIG. 1 is a perspective view of a conventional IV spike. [Figure 2A] FIG. 1 is a perspective view of an IV spike according to some embodiments of the present disclosure. [Figure 2B] 2B is a cross-sectional view of the IV spike of FIG. 2A according to some embodiments of the present disclosure. [Figure 2C] 1A-1C illustrate an IV set with an IV container pierced by an IV spike, according to some embodiments of the present disclosure. [Figure 2D] FIG. 2D is an enlarged, partial perspective view of the IV spike of FIG. 2C. [Figure 3A] 1A-1C illustrate an IV spike assembly including an IV spike and a spike cap for protecting a user from injury from the spike, according to some embodiments of the present disclosure. [Figure 3B] 10A-10C illustrate a method for safely disconnecting an IV spike after an injection is completed, according to some embodiments of the present disclosure. [Figure 3C] 10A-10C illustrate a method for safely disconnecting an IV spike after an injection is completed, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] Various embodiments of the present disclosure are directed to providing an IV spike for puncturing ("spiking") membranes of IV fluid bags and bottles, the IV spike having an improved severable mechanism that helps to more easily sever the IV spike while retaining the sharp portion of the IV spike within the container, such as an IV fluid bag or spike cap.

[0012] According to various embodiments of the present disclosure, an IV spike can include a head portion with a puncture tip, a base portion, and an elongated body portion connecting the head portion and the base portion. The elongated body can be configured to couple to a container, such as an IV fluid bag or bottle. The IV spike can further include a radial notch extending along the periphery of the outer surface of the elongated body portion. The radial notch can be recessed radially inward from the outer surface and define a reduced or diminished cross-sectional area of ​​the IV spike between the elongated body portion and the base portion. The reduced cross-sectional area can create a weak spot, or breakage point, of the IV spike at the location of the radial notch.

[0013] Therefore, when a force is applied to break the IV spike for disposal, stress is concentrated at the break point, allowing the IV spike to be severed using less force than existing IV spikes that do not incorporate radial notches. The IV spikes of the various embodiments described herein can be attached to an IV fluid container, and further advantageously, once the IV spike is broken and severed at the radial notches, the elongated body portion and head portion with the sharp puncture tip can remain safely within the IV fluid container. Therefore, injury to clinicians or other medical personnel that could result from being pierced or otherwise pricked by the sharp puncture tip of the IV spike can be avoided.

[0014] According to various embodiments of the present disclosure, an intravenous (IV) spike assembly for administering a medical solution from a container to an IV drip chamber while preventing injury from the spike can include a spike having a head portion, a base portion, and an elongated body portion connecting the head portion and the base portion. The IV spike assembly can further include a spike cover having an elongated body and a base portion for containing the spike or otherwise protecting the spike from exposure to a user. In some embodiments, the base portion of the spike cover and the base portion of the spike can include complementary engagement mechanisms that interlock the spike and spike cover. Such engagement mechanisms can be advantageous in achieving a secure connection or engagement between the IV spike and the spike cap such that a clinician or other medical personnel can detach or cut the IV spike by applying a cutting force or load to the spike cap rather than having to apply a cutting force directly to the IV spike. Because the IV spike and spike cap are engaged or otherwise interlocked at their bases, application of a cutting force to the spike cap results in a corresponding cutting force being applied to the IV spike such that the IV spike is safely severed or removed within the spike cap, thus avoiding injury to a clinician or other medical personnel that may result from being pierced or otherwise punctured by the sharp puncture tip of the IV spike 220.

[0015] FIG. 1 shows a perspective view of a conventional IV spike 20. The IV container 12 can be an IV fluid bag or bottle 110 (shown in FIG. 2C). As shown, the conventional IV spike 20 can generally include a head portion 25, a base portion 30, and an elongated body portion 35 connecting the head portion 25 and the base portion 30. The conventional IV spike 20 can be configured to couple to an IV barrel 50. A spike 27 including a puncturing tip 29 and a puncturing base 31 can be disposed on the head portion 25. The puncturing base 31 can have a fluid inlet port at an upper end of the puncturing base. As shown, the base portion 26 can have an outer diameter larger than the outer diameter of the elongated body portion. Thus, the base portion 30 can extend radially outward from the elongated body portion.

[0016] A conventional IV spike is coupled to and can pierce an IV fluid bag or container such that, during operation, it fluidly connects the IV fluid container to the dripper 50, allowing IV fluid to be transferred from the IV fluid container and infused into a patient via the dripper and various other fluid lines. After the IV fluid infusion is complete, the IV spike may need to be discarded. Proper disposal of the IV spike after an infusion is critical because the spike 27, which has a sharp puncture tip 29, can puncture a clinician or other medical technician if mishandled, potentially becoming a source of infection. For example, if the spike 27 is discarded with the puncture tip 29 exposed within the IV fluid container, the tip 29 of the spike 27 could pierce the IV fluid container and potentially injure an unaware medical professional.

[0017] Therefore, it would be advantageous to have an IV spike with a structure that allows for easy and safe disposal of the spike without the potential for harm to medical professionals. While current IV spikes may be formed from materials that include glass fiber reinforcement to facilitate cutting the spike after use, current IV spike designs are not optimized to allow clinicians to easily utilize this useful material property. For example, current IV spikes require a greater force than is preferred for a clinician or other medical professional to cut a conventional IV spike 20 for disposal.

[0018] It is further advantageous to have an IV spike cap that fits over the IV spike, the spike cap and IV spike having complementary engagement features that allow the spike cap to engage or otherwise lock onto the IV spike, thereby preventing accidental pricks when the user cuts off the IV spike for disposal.

[0019] Various embodiments of the present disclosure are directed to providing an IV spike with the aforementioned features that are lacking in conventional or existing IV spikes.

[0020] Figure 2A shows a perspective view of an IV spike 120 according to some embodiments of the present disclosure. Figure 2B shows a cross-sectional view of the IV spike 120 of Figure 2A according to some embodiments of the present disclosure. Figure 2C shows an IV set 100 including an IV container 110 pierced by an IV spike 120 according to some embodiments of the present disclosure.

[0021] 2A-2C, according to some embodiments, an IV spike 120 can include a head portion 125 at the proximal end of the IV spike, a base portion 130 at the distal end of the IV spike, and an elongated body portion 135 connecting the head portion 125 and the base portion 130. As shown in FIG. 2C, the elongated body 135 can be configured to couple to a container 110, such as an IV fluid bag or bottle. As further shown in FIG. 2C and with further reference to FIGS. 2A and 2B, the head portion 125 can include a spike head 127 disposed at the proximal end of the IV spike 120. The spike head 127 can include a puncturing tip 129 and a puncturing base 131 having a fluid inlet 132 at its proximal end. A fluid channel 134 can extend from the fluid inlet 132 through the elongated body portion 135 and into the drip barrel 150.

[0022] According to various embodiments of the present disclosure, the IV spike 120 can further include a radial notch 140 extending along the periphery of the outer surface 145 of the elongated body portion 135. The radial notch 140 can be recessed radially inward from the outer surface 145 and define a reduced cross-section of the elongated body portion 135. In some embodiments, the radial notch 140 can be recessed about and extend along the entire periphery of the outer surface 145 of the elongated body portion 135. However, various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the radial notch 140 can extend along only a portion of the outer surface 145 of the elongated body portion 135, or can extend along multiple laterally aligned portions. The radial notch 140 can be, for example, in the form of two or more smaller notches laterally spaced apart from one another around the periphery of the outer surface 145 of the elongated body portion 135. In some embodiments, the radial cutouts 140 may include, for example, a series of discrete notches, indentations, or notches in the outer surface 145 to weaken the material and facilitate and enable cutting by a medical professional.

[0023] In some embodiments, radial notch 140 may extend the entire circumference of outer surface 145, and in some embodiments, radial notch 140 may only extend partially around the circumference of the outer surface and still provide a cutting function. In some embodiments, radial notch 140 may extend, for example, only about three-quarters of the circumference of outer surface 145, and in some embodiments, radial notch 140 may extend only about one-half, one-third, or one-quarter of the circumference of outer surface 145. In some embodiments, radial notch 140 may be located along the inner surface of elongated body portion 135.

[0024] In some embodiments, radial notch 140 may be located in elongate body portion 135 closer to base portion 130 than to head portion 125. In some embodiments, radial notch 140 may be located, for example, between proximal end 133 of base portion 130 and distal end 137 of elongate body portion 135.

[0025] FIG. 2D is an enlarged, partial perspective view of the IV spike 120 of FIG. 2C. Referring to FIG. 2D, in some embodiments, the outer diameter D1 of the base portion 130 can be greater than the outer diameter D2 of the elongated body portion 135. The radial notch 140 can therefore be formed at a location corresponding to the reduction in cross-sectional area of ​​the IV spike 120 at the transition from the elongated body portion 135 to the base portion 130. Furthermore, in some embodiments, the diameter D3 of the radial notch 140 can be less than the outer diameter D2 of the elongated body portion 135. The radial notch 140 therefore achieves a reduced or diminished cross-sectional thickness of the IV spike 120 between the elongated body portion 125 and the base portion 130 compared to the cross-sectional thicknesses of both the elongated body portion 125 and the base portion 130. This reduced cross-sectional thickness creates a weak spot, or breakage point, of the IV spike 120 at the location of the radial notch 140. Thus, when a force is applied to cut the IV spike 120 for disposal, stress is concentrated at the break point, advantageously allowing the IV spike 120 to be cut using less force than existing IV spikes 20 that do not incorporate radial notches. Because the IV spike 120 can be attached to the IV fluid container 110 shown in FIG. 2C , once the IV spike 120 is broken and cut at the radial notch, the elongated body portion 135 and head portion 125 with the sharp puncture tip 129 can remain safely within the IV fluid container 110. Therefore, injury to a clinician that could result from being pierced or otherwise pricked by the sharp puncture tip 129 of the IV spike 120 can be avoided.

[0026] According to some embodiments of the present disclosure, the IV spike 120 may be formed from a thermoplastic or thermoset polymer material. In some embodiments, the IV spike 120 may be formed from, for example, an acrylonitrile butadiene styrene (ABS) material. The IV spike 120 may also be formed from a fiberglass reinforced material. The fiberglass reinforced material may provide the IV spike 120 with a brittle structure. Therefore, the aforementioned structure of the IV spike 120 with the radial notch 140 advantageously takes advantage of the brittleness of the IV spike 120, in that the weak spot or break point created by the radial notch may make the IV spike 120 more easily breakable under a breaking load compared to existing IV spikes. Therefore, the IV spike 120 of the various embodiments described herein can be broken or severed with less load or force, which is advantageous because it reduces the risk of injury or other ergonomic problems typically associated with a clinician having to apply a large amount of force to severe an IV spike.

[0027] 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 elongate body 135 having a spike tip 129 at a proximal end of the elongate body and a base 130 at a distal end of the elongate body. The method can further include forming a radial notch 140 recessed radially inward from an outer surface 145 of the elongate body. In some embodiments, forming the radial notch 140 can include recessing the radial notch 140 to extend along the entire circumference of the outer surface 145. In other embodiments, forming the radial notch 140 can include recessing the radial notch 140 to extend along a portion of the circumference of the outer surface 145. Radial notch 140 may extend along only a portion of outer surface 145 of elongated body portion 135, as described above, or may extend along multiple laterally aligned portions. In these embodiments, radial notch 140 may be in the form of two or more smaller notches spaced laterally from one another around the periphery of outer surface 145 of elongated body portion 135.

[0028] In some embodiments, the method for forming the radial notch can include modifying the way a mold for an existing IV spike 20 is fabricated. The manufacturing method can include, for example, rerouting a parting line of a mold insert so that the insert can create the radial notch 140 without compromising the original functionality of the IV spike. In some embodiments, the IV spike 220 can include upper and lower spike portions that are ultrasonically welded or bonded via adhesive or solvent. In these embodiments, the radial notch 140 can be introduced between the upper and lower spikes so that the radial notch 140 can still form part of the severable feature.

[0029] According to some embodiments, forming the radial notch 140 can include positioning the radial notch 140 in the elongated body portion 135 closer to the base portion 130 than to the head portion 125.

[0030] Figure 3A shows an IV spike assembly including an IV spike 220 and a spike cap 210 for protecting the user from injury from the spike, according to some embodiments of the present disclosure. Figures 3B and 3C show a method for safely disconnecting the IV spike 220 after an injection is completed, according to some embodiments of the present disclosure.

[0031] According to various embodiments of the present disclosure, an intravenous (IV) spike assembly 200 for administering a medical solution from a container to an IV drip tube while preventing injury from the spike can include a spike 220 including a head portion 125, a base portion 230, and an elongated body portion 135 connecting the head portion 125 and the base portion 130. In some embodiments, the spike 220 can have a similar mechanism to the spike 120 but can have a modified mechanism, as described below. However, in other embodiments, the spike 220 can have a similar mechanism to the existing spike 20 but can have a modified mechanism, as described below. The IV spike assembly 200 can include a spike cover 210 having an elongated body 215 for receiving the spike 220, and a base portion 225, as shown in FIGS. 3A-3C . In some embodiments, the base 225 of the spike cover 210 and the base portion 230 of the spike 220 can include complementary engagement features 155, 255 that securely interlock, grip, or otherwise hold the spike 220 and spike cover 210 together without slippage or movement. The base 225 of the spike cover 210 and the base portion 230 of the spike 220 can be specifically designed such that bending / cutting torque from the clinician's hand is transferred to the spike 220, causing the spike 220 to break at the radial notch 140 where stress is concentrated.

[0032] In some embodiments, for example, the base 225 of the spike cover 210 can include a protrusion 255 and the base portion 230 of the spike 220 can include a recess 155 as a complementary engagement feature. In some embodiments, the protrusion 255 of the spike cover 210 can be in the form of a sharp edge or cutter designed to be positioned around the stress concentration feature (e.g., recess 155) to allow a clinician to exert a twisting and / or bending force that safely severs the spike 220 within the spike cover 210. In other embodiments, the base 225 of the spike cover 210 and the base portion 230 of the spike 220 can include complementary threads as a complementary engagement feature.

[0033] The aforementioned engagement mechanism may be advantageous in providing a secure connection or engagement between the IV spike 220 and the spike cap 210 such that a clinician or other medical personnel can detach or cut the IV spike 220 by applying a cutting force or load to the spike cap 210 rather than having to apply a cutting force directly to the IV spike 220. Because the IV spike 220 and spike cap 210 are engaged or otherwise interlocked at their bases, applying a cutting force to the spike cap 210 (as shown in FIG. 3B ) applies a corresponding cutting force to the IV spike 220 such that the IV spike 220 is safely detached or removed within the spike cap 210. Thus, injury to the clinician or other medical personnel as a result of being pierced or otherwise pierced by the sharp puncture tip of the IV spike 220 can be reduced or avoided.

[0034] According to some embodiments, the IV spike 220 may be formed of a thermoplastic polymer material, similar to the IV spike 120 described above. In some embodiments, the IV spike 220 may be formed of, for example, an acrylonitrile butadiene styrene (ABS) material. The IV spike 220 may further be formed of a fiberglass reinforced material to facilitate severing of the spike 220 within the spike cover 210 when a force is applied to the spike cover. The fiberglass reinforced material may provide the IV spike 220 with a fragile structure, as previously described. Therefore, the above-described structure of the IV spike 220 including the spike cap 210 is advantageous in that the fragility of the IV spike 220, combined with the engagement or locking of the base 230 of the IV spike 220 with the base 225 of the spike cap 210, allows for easier and safer severing of the IV spike when subjected to a cutting load, compared to existing IV spikes 20 that do not have a cover that engages with the spike base.

[0035] Various examples of aspects of the present disclosure are described in numbered clauses (1, 2, 3, etc.) for convenience. These are provided by way of example and not as limitations on the technology. Identifying figures and reference numbers are provided below for illustrative purposes only, and the clauses are not limited by such identifying features.

[0036] Clause 1 1. An intravenous (IV) spike for administering a medicinal fluid from a container, the IV spike comprising: a head portion at a proximal end of the IV spike; a base portion at a distal end of the IV spike; an elongated body portion connecting the head portion and the base portion, the elongated body portion configured to be coupled to the container; and a radial notch extending at least partially along the periphery of an outer surface of the elongated body portion, the radial notch being recessed radially inward from the outer surface.

[0037] Clause 2 10. The IV spike of claim 1, wherein the head portion comprises a spike head disposed at a proximal end, the spike head comprising a puncturing tip and a puncturing base having a fluid inlet at an upper end of the puncturing base, and a fluid channel extending from the fluid inlet through the elongated body portion and into the drip tube.

[0038] Clause 3 10. The IV spike of claim 1, wherein the radial notch is located in the elongated body portion closer to the base portion than to the head portion.

[0039] Clause 4 4. The IV spike of clause 3, wherein the radial notch is disposed between the proximal end of the base portion and the distal end of the elongated body portion.

[0040] Clause 5 10. The IV spike of claim 4, wherein the outer diameter of the base portion is greater than the outer diameter of the elongated body portion, and the radial notch is formed at a location corresponding to the reduction in cross-sectional area associated with the transition from the base portion to the elongated body portion.

[0041] Clause 6 10. The IV spike of claim 1, wherein the radial notch extends along the entire periphery of the outer surface of the elongated body portion.

[0042] Clause 7 10. The IV spike of claim 1, wherein the outer diameter of the base portion is greater than the outer diameter of the elongated body portion, and the diameter of the radial notch is less than the outer diameter of the elongated body portion.

[0043] Article 8 10. The IV spike of clause 1, wherein the IV spike comprises a thermoplastic polymer material.

[0044] Article 9 10. The IV spike of claim 8, wherein the thermoplastic polymer material comprises acrylonitrile butadiene styrene (ABS).

[0045] Article 10 9. The IV spike of clause 8, wherein the IV spike further comprises a fiberglass reinforced material that facilitates severing of the elongated body portion within the container because the radial notches create points of stress concentration when a force is applied to the spike.

[0046] Article 11 1. An intravenous (IV) spike assembly for administering a liquid medicine from a container to an IV drip tube while preventing injury from the spike, the IV spike assembly comprising: a spike including a head portion, a base portion, and an elongated body portion connecting the head portion and the base portion; and a spike cover having an elongated body and a base portion that houses the spike, the base portion of the spike cover and the base portion of the spike comprising complementary engagement mechanisms that interlock the spike and the spike cover.

[0047] Article 12 12. The IV spike assembly of claim 11, wherein the base of the spike cover includes a protrusion and the base portion of the spike includes a recess as complementary engagement features.

[0048] Article 13 12. The IV spike assembly of claim 11, wherein the base of the spike cover and the base portion of the spike are provided with complementary threads as the complementary engagement mechanism.

[0049] Article 14 12. The IV spike assembly of claim 11, wherein the spike further includes a puncturing tip, a puncturing base having a fluid inlet at a head portion of the elongated body portion, and a fluid channel extending from the puncturing base through the elongated body and into the drip barrel.

[0050] Article 15 12. The IV spike assembly of claim 11, wherein the spike comprises a thermoplastic polymer material.

[0051] Article 16 16. The IV spike assembly of clause 15, wherein the spike further comprises a fiberglass reinforced material that facilitates severing of the spike within the spike cover.

[0052] Article 17 A method of manufacturing a spike for an intravenous (IV) infusion system, the method comprising the steps of: providing an elongate body having a head with a spike tip at a proximal end of the elongate body and a base at a distal end of the elongate body; and forming a radial notch recessed radially inward from an outer surface of the elongate body.

[0053] Article 18 18. The method of clause 17, wherein forming the radial notch includes recessing the radial notch along a portion of the periphery of the outer surface.

[0054] Article 19 18. The method of clause 17, wherein forming the radial notch includes recessing the radial notch along an entire periphery of the outer surface.

[0055] Article 20 18. The method of clause 17, wherein forming the radial notch includes locating the radial notch in the elongate body closer to the base than to the head.

[0056] As used herein, the terms "plumbing," "fluid conduit," 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. Fluid conduits (tubing) can be used, for example, for intravenous (IV) fluid delivery, fluid drainage, oxygen delivery, combinations thereof, etc.

[0057] 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 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 the full scope consistent with the claims in language is to be accorded, and references to elements in the singular are intended to mean "one or more," rather than "only one," unless expressly stated otherwise. The terms "a set" and "some" refer to one or more, unless expressly stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (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.

[0058] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of sample 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.

[0059] It should be understood that terms such as "top," "bottom," "front," and "back" used in this disclosure refer to any coordinate system, not just the typical gravitational coordinate system. Thus, the top, bottom, front, and back surfaces can extend upward, downward, diagonally, or horizontally in the gravitational coordinate system.

[0060] Use of a phrase such as "aspect" does not imply that such aspect is essential to the technology or that such aspect applies to all structures of the technology. Disclosure of one aspect may apply to all structures, or to one or more structures. A phrase such as "aspect" may refer to one or more aspects, and vice versa. Use of a phrase such as "embodiment" does not imply that such embodiment is essential to the technology or that such embodiment applies to all structures of the technology. Disclosure of one embodiment may apply to all embodiments, or to one or more embodiments. A phrase such as "embodiment" may refer to one or more embodiments, and vice versa.

[0061] 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.

[0062] 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. Furthermore, nothing disclosed herein is intended to be a public offering, regardless of whether such disclosure is expressly recited in the claims. Claimed elements are not to be construed under the provisions of 35 U.S.C. § 112, paragraph 6, unless the elements are expressly recited using the phrase "means for," or, in the case of method claims, the elements are recited using the phrase "step for." Furthermore, to the extent terms such as "comprises," "having," and the like are used in the description or claims, such terms are intended to be inclusive in the same manner as the term "comprising" is interpreted when "comprising" is used as a transitional term in the claims.

Claims

1. 1. An intravenous (IV) spike for administering a medical solution from a container, the IV spike comprising: a head portion at a proximal end of the IV spike, a base portion at a distal end of the IV spike, and an elongated body portion connecting the head portion and the base portion, the base portion having an outer diameter greater than an outer diameter of the elongated body portion, the elongated body portion configured to be coupled to the container; a radial notch extending at least partially along a periphery of an outer surface of the IV spike and disposed between a proximal end of the base portion and a distal end of the elongated body portion, the radial notch being recessed radially inward from the outer surface; An IV spike comprising:

2. 2. The IV spike of claim 1, wherein the head portion comprises a spike head disposed at the proximal end, the spike head comprising a puncturing tip and a puncturing base having a fluid inlet at an upper end of the puncturing base, a fluid channel extending from the fluid inlet through the elongated body portion and into a drip barrel.

3. 2. The IV spike of claim 1, wherein the outer diameter of the base portion is greater than the outer diameter of the elongated body portion, and the radial notch is formed at a location corresponding to the decrease in cross-sectional area transitioning from the base portion to the elongated body portion.

4. 4. The IV spike of claim 1, wherein the radial notch extends along the entire periphery of the outer surface of the elongated body portion.

5. An IV spike as described in any one of claims 1 to 4, wherein the diameter of the radial notch is smaller than the outer diameter of the elongated body portion.

6. 6. The IV spike of claim 1, wherein the IV spike comprises a thermoplastic polymer material.

7. 7. The IV spike of claim 6, wherein the thermoplastic polymer material comprises acrylonitrile butadiene styrene (ABS).

8. 7. The IV spike of claim 6, wherein the IV spike further comprises a fiberglass reinforced material that facilitates severing of the elongated body portion within the container when a force is applied to the spike because the radial notches create points of concentrated stress.

9. 1. An intravenous (IV) spike assembly for administering a medical fluid from a container to an IV dripper while preventing injury from the spike, the IV spike assembly comprising: an IV spike comprising: a head portion at a proximal end of the IV spike; a base portion at a distal end of the IV spike; and an elongated body portion connecting the head portion and the base portion and configured to be coupled to the container, wherein the base portion has an outer diameter greater than an outer diameter of the elongated body portion, and a radial notch extends at least partially along a periphery of an outer surface of the IV spike between the proximal end of the base portion and the distal end of the elongated body portion; a spike cover having an elongated body that houses the IV spike and a base; Equipped with an IV spike assembly, wherein the base of the spike cover and the base portion of the IV spike include complementary engagement features that mate the IV spike and the spike cover;

10. 10. The IV spike assembly of claim 9, wherein the complementary engagement features include a protrusion on the base of the spike cover and a recess on the base portion of the IV spike.

11. 11. The IV spike assembly of claim 9 or 10, wherein the complementary engagement features include complementary threads on the base of the spike cover and the base portion of the IV spike.

12. The IV spike is a puncturing base having a puncturing tip and a fluid inlet at the head portion of the elongated body portion; a fluid channel extending from the puncture base through the elongated body portion and into the drip tube; 12. The IV spike assembly of claim 9, further comprising:

13. 13. The IV spike assembly of claim 9, wherein the IV spike comprises a thermoplastic polymer material.

14. 14. The IV spike assembly of claim 13, wherein the IV spike further comprises a fiberglass reinforcement material that facilitates severing the IV spike within the spike cover.

15. 1. A method of manufacturing a spike for an intravenous (IV) infusion system, said method comprising: providing an elongate body having a head portion with a spike tip at a proximal end of the elongate body and a base portion at a distal end of the elongate body, the base portion having an outer diameter greater than an outer diameter of the elongate body portion; forming a radial notch recessed radially inward from an outer surface of the elongate body, the radial notch being disposed between a proximal end of the base portion and a distal end of the elongate body; A method comprising:

16. The method of claim 15 , wherein forming the radial notch comprises recessing the radial notch along a portion of the periphery of the outer surface.

17. 17. The method of claim 15 or 16, wherein forming the radial notch comprises recessing the radial notch along the entire periphery of the outer surface.

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