Systems and methods for butterfly needle assemblies

Abstract

A butterfly needle assembly (100) is provided that includes a flexible member (102) having a central region (104) with a first side member (106) and a second side member (108) that together provide a substantially flat bottom (110), the central region (104) having an intermediate region (112); an adhesive (114) disposed on the substantially flat bottom (110), the adhesive (114) being protected by a removable cap (116); a needle hub (118) disposed within the central region (104), the needle hub (116) receiving a line of flexible tubes (120) substantially parallel to the substantially planar bottom (110) and providing a needle (122) extending from an intermediate region (112) of the central region (104) substantially orthogonal to the substantially planar bottom (110), the needle (122) extending a first length; a removable needle cap (124) initially disposed around the needle (122), the removable needle cap (124) configured and arranged to removably engage with the needle hub (118); and a closure system (134) constructed and arranged to close the first side member (106) and the second side member (108) of the flexible member (102) around the needle (122). A method of manufacturing a butterfly needle assembly (100) is also provided.

Description

Technical Field

[0001] The present invention generally relates to systems and methods for subcutaneous infusion systems and devices, and more specifically to needle assemblies that provide flexible components for stabilizing and protecting the needle when it is inserted into patient tissue, and systems for reducing the chance of accidental needle pricks before and after use. The assembly also provides ease of assembly with a universal flexible component element for various needle gauges, and ease of sterilization before use. Background Technology

[0002] Infusion systems used to deliver liquid medications are widely used and relied upon by patients and caregivers.

[0003] With a typical injection (often called a "shot"), the patient is rapidly injected with medication from a handheld syringe directly attached to a needle. The caregiver pierces the patient's skin with the needle to reach the desired tissue or structure, presses the plunger of the syringe to inject the medication, and then withdraws the needle. The procedure is usually completed in less than a minute.

[0004] Infusion typically delivers medication over a period of time. A needle is inserted to reach the desired tissue or structure and remains in contact with it for the duration of treatment, which can usually be measured over minutes or hours.

[0005] One form of infusion therapy is immunoglobulin (Ig) therapy, which is frequently used to improve the quality of life for patients with conditions such as primary immunodeficiency (PID), secondary immunodeficiency (SID), chronic inflammatory demyelinating polyradiculopathy (CIPD), and severe combined immunodeficiency (SCID). Historically, Ig therapy has been administered intravenously (IVIg) every 3–4 weeks, which can lead to inconsistent serum levels and a burdensome infusion experience for patients.

[0006] Subcutaneous Ig therapy (SCIg) is a more convenient option, allowing for consistent serum levels and can be performed at home. However, SCIg has its own challenges, such as the need for patients to prepare and administer the infusion themselves, and the potential for site leakage during infusion. The device administers the therapy subcutaneously through one or more injection sites, depending on the prescribed dosage.

[0007] While it is important that infusion needle system components be as simple and straightforward as possible for use in any medical setting, it is especially important for home use.

[0008] To help ensure the needle reaches the desired tissue or structure, infusion needles of a specific length are typically provided. Additionally, to help anchor the needle during the infusion procedure, these needles usually have an anchor from which the needle extends, and once the needle element is inserted into the patient's tissue, the anchor is secured to the patient with tape.

[0009] To further minimize the possibility of interference from the needle, in many cases, a bend to 90 degrees is used. The needle is positioned so that the drug delivery tube is substantially parallel to the patient's skin and can be secured in place with tape when the delivery end of the needle is perpendicular to the skin and at the desired predetermined depth. Manufactured to 90... It is more complex to manufacture than a straight needle, and although this configuration may be ideal for infusion butterfly needles, it usually requires additional costs.

[0010] Two other common problems are maintaining the sterility of the needle before use and avoiding accidental needle pricks before and after use. Various efforts have been made, at least addressing the needle prick problem. Raines' U.S. Patent 6,911,020 teaches a Huber needle with a folding safety wing. The huber needle is mounted such that the horizontal portion of the needle is positioned within the hub, while the vertical portion of the needle extends away from the hub and is primarily located between a pair of folded wings. Although the entire Raines assembly can be supplied in an airtight sealed bag, once opened, all components of the Raines assembly, including the needle, are exposed. Furthermore, because the hub is formed around the horizontal portion of the needle, supplying different needle sizes requires entirely different casting and assembly processes.

[0011] U.S. Patent 5,951,522 to Rosato et al., entitled "Hypodermic Needle Safety Enclosure," teaches a similar device. Here again, 90 The Huber needle is partially surrounded by wing-like structures. When placed on the patient at the insertion site, the wing elements fold and unfold to allow the needle to be exposed and positioned within the patient's body. The wings also provide a generally flat surface over which tape can be applied during infusion to secure the needle assembly. When removed, the wing elements unfold around the needle again. Thus, while Rosato takes precautions to reduce needle sticking before and after use, it remains silent on maintaining the needle's sterility before use.

[0012] Another reference is U.S. Patent Publication 2008 / 0177234 by Keaton et al., entitled "Safety Subcutaneous Infusion Set". Keaton teaches a butterfly anchor consisting of a central body and a pair of folding wings, with the needle extending from the central body. When the wings are folded together around the needle, a locking pin can be inserted into a hole at the distal tip of one wing to lock the wings together. The Keaton abstract states, "[t]hus, the wings can be conveniently folded over the catheter and latched in place to protect the user from pricking after use." Keaton also discloses that the assembly can be held in place by an adhesive strip placed above the assembly. However, like Raines, there is no teaching on how to maintain the sterility of the device, and the problem of preventing needle pricks is a post-use concern.

[0013] Another reference is Lambert's U.S. Patent 8,961,476, entitled "Sharps Protector Device For Protecting A User From A Sharp Tip OF A Medical Needle". As Lambert teaches, a needle extends vertically from a central body portion, and a pair of wings also extend from the central body portion. Mechanical fasteners are provided on at least one of the wings, configured to selectively attach the pair of wings to an intermediate needle positioned therebetween to prevent accidental needlestick injuries. Lambert specifically teaches that the mechanical fastener includes a lip extending along at least a portion of the periphery of at least one of the wings and a mating portion extending along the periphery of at least one other wing of the pair, wherein the mating portion and the lip are configured to align at least one wing relative to at least one other wing in a closed position. Lambert also teaches that the wing may further include a groove to receive at least a portion of the needle when the wing is in the closed position. Therefore, like other references Raines, Rosato, and Keaton, Lambert teaches that the only form of protection against pinpricks is provided by the wings of the component, and there is no teaching on providing sterility before use.

[0014] Furthermore, while all these references may be helpful on a specific issue in themselves, they all suffer from the effects of common problems. For those using 90... The complexity of needle manufacturing necessitates a higher cost compared to straight needles. Furthermore, each component differs for a specific needle specification, requiring a complete inventory for each desired specification in order to offer a range of needle size options—thus necessitating storage space for each option, and potentially leading to shelf-life issues for less frequently used options.

[0015] Furthermore, once the components are positioned for insertion of the needle into the patient, they are attached to the patient via an adhesive strip placed on top of the components. This requires a separate adhesive strip, and if not available, the components need to be released to retrieve the adhesive strip and then reattached. Of course, releasing the components while they are being inserted into the patient before applying the adhesive strip allows for the possibility of moving the components if the patient moves or someone grasps the supply tube.

[0016] Furthermore, many of the aforementioned devices have rigid or relatively rigid components, such as folding wings. Therefore, these rigid components do not readily conform to the patient's skin, and when the components are secured in place with tape, they can indeed press into or even bite into the patient's skin. This can potentially cause patient discomfort.

[0017] Therefore, a method and system are needed to overcome one or more of the above challenges. Summary of the Invention

[0018] This invention addresses the problems of the prior art by providing a novel configurable flow controller, kit, and method of use.

[0019] In particular, and by way of example only, according to one embodiment of the invention, a butterfly needle assembly is provided, comprising: a flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom, the central region having an intermediate region; an adhesive disposed on the generally flat bottom, the adhesive being protected by a removable cap; a needle seat disposed within the central region, the needle seat receiving a flexible tube generally parallel to the generally flat bottom and providing a needle extending from the intermediate region of the central region generally orthogonal to the generally flat bottom, the needle extending a first length; a removable needle cap initially disposed around the needle, the removable needle cap being configured and arranged to removably engage with the needle seat; and a closure system configured and arranged to close the first side member and the second side member of the flexible member around the needle.

[0020] In another embodiment, a butterfly needle assembly is provided, comprising: a flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom; an adhesive disposed on the generally flat bottom, the adhesive being protected by a removable cap; a needle hub frame united with the flexible member, the needle hub frame being opposite the adhesive; a snap-fit ​​needle structure provided by a conduit member having a first end and a second end, the first end being connected to a flexible conduit and the second end being connected to a needle having a first length, the second end being generally orthogonal to the first end, the conduit member being further configured and arranged to snap-fit ​​with the needle hub frame, the needle extending from a central region of the central region generally orthogonal to the generally flat bottom, the flexible conduit being generally parallel to the generally flat bottom near the first end of the conduit member; a removable needle cap initially disposed around the needle, the removable needle cap being configured and arranged to removably engage with the needle hub frame; and a closure system configured and arranged to close the first side member and the second side member of the flexible member around the needle.

[0021] In another embodiment, a butterfly needle assembly is provided, comprising: a flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom; a button disposed on the generally flat bottom near a first distal edge of the first side member; and a through hole disposed near a second distal edge of the second side member, the button and the through hole together providing a closure system configured and arranged to close the first side member and the second side member around the needle; an adhesive disposed on the generally flat bottom and protected by a removable cap; and a needle seat frame connected to the flexible member, the needle seat frame being opposite the adhesive. A snap-fit ​​needle structure is provided by a catheter member having a first end and a second end, the first end being connected to a flexible tubing and the second end being connected to a needle having a first length, the second end being generally orthogonal to the first end, the catheter member being further configured and arranged to snap-fit ​​with a needle hub frame, the needle extending from a central region generally orthogonal to a generally flat bottom, the flexible tubing being generally parallel to the generally flat bottom near the first end of the catheter member; and a removable needle cap initially disposed around the needle, the removable needle cap having a first end disposed in the needle hub frame through the generally flat bottom, the first end having opposing side tabs configured and arranged to be rotatably locked in the needle hub frame.

[0022] Furthermore, in another embodiment, a method of providing a butterfly needle assembly is provided, comprising: providing a flexible member having a central region, the flexible member having a first side member and a second side member that together provide a generally flat bottom, the central region having an intermediate region; providing an adhesive on the generally flat bottom, the adhesive being protected by a removable cap; providing a needle seat disposed within the central region, the needle seat receiving a flexible tubing generally parallel to the generally flat bottom and providing a needle extending from the intermediate region of the central region generally orthogonal to the generally flat bottom, the needle extending a first length; providing a removable needle cap initially disposed around the needle, the removable needle cap being configured and arranged to removably engage with the needle seat; and providing a closure system configured and arranged to close the first side member and the second side member of the flexible member around the needle. Attached Figure Description

[0023] FIG. 1A This is a front upper perspective view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 1B This is a front lower perspective view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 1C This is a side perspective view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 1D This is a front plan view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 1E This is a top plan view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 1F This is an exploded perspective view of the upper part of a butterfly needle assembly according to at least one embodiment of the present invention. FIG. 1G This is a lower perspective exploded view of a butterfly needle assembly according to at least one embodiment of the present invention; FIG. 2A It is according to at least one embodiment of the present invention. FIGS. 1A-1F Front upper perspective view of the flexible component of the butterfly needle assembly shown; FIG. 2B It is according to at least one embodiment of the present invention. FIGS. 1A-1F The lower front perspective view of the flexible component of the butterfly needle assembly shown; FIG. 3A This is a front perspective view of a snap-fit ​​needle assembly disposed in a flexible member of a butterfly needle assembly according to at least one embodiment of the present invention. FIG. 3B This is a rear perspective view of a snap-fit ​​needle assembly disposed in a flexible member of a butterfly needle assembly according to at least one embodiment of the present invention. FIG. 3C Three rear perspective views of different snap-fit ​​needle assemblies according to at least one embodiment of the present invention are presented, the different snap-fit ​​needle assemblies having different needles to be disposed in the flexible members of the butterfly needle assembly; FIG. 4 It is a front perspective sectional view of a butterfly needle assembly, which further depicts, according to at least one embodiment of the invention, the snap-fit ​​needle assembly being disposed in a flexible member to provide the snap-fit ​​function of the butterfly needle assembly. FIG. 5A It is according to at least one embodiment of the present invention. FIG. 1A The front perspective view of the detachable needle cap is shown. FIG. 5B It is according to at least one embodiment of the present invention. FIG. 1A The top view of the detachable needle cap is shown. FIG. 5C It is according to at least one embodiment of the present invention. FIG. 1A The side view of the detachable needle cap is shown. FIG. 5D It is according to at least one embodiment of the present invention. FIG. 1A The front view of the detachable needle cap is shown. FIG. 6A This is a front lower perspective view of a butterfly needle assembly according to at least one embodiment of the present invention, wherein the removable needle cap has now been removed; FIG. 6B This is a front lower perspective view of one embodiment of a butterfly needle assembly according to at least one embodiment of the present invention, wherein the removable cap is removed to expose the adhesive as different layers. FIG. 6C This is a front lower perspective view of another embodiment of a butterfly needle assembly according to at least one embodiment of the present invention, wherein the removable cap is removed to expose the adhesive of the incorporated element as a generally flat bottom, which is a flexible member. FIG. 7A This is a front plan view of a butterfly needle assembly according to at least one embodiment of the present invention, wherein the needle is exposed before the closing system engages around the needle; FIG. 7B This illustrates that, according to at least one embodiment of the invention, when the wing bends downward to surround the needle, the butterfly needle assembly automatically... FIG. 7A Continuing with the front view of the floor plan; FIG. 7C This illustrates that, according to at least one embodiment of the invention, when the closure system is at least partially engaged to surround the needle, it self-... FIG. 7B Continuing with the front view of the floor plan; FIG. 7DThis illustrates that, according to at least one embodiment of the invention, when the closure system is fully engaged and the portions of the wing are pressed together to surround the needle, [the system automatically...]. FIG. 7C Continuing with the front view of the floor plan; FIG. 8 A conceptual schematic diagram illustrating the sterilization of an assembled butterfly needle assembly in a package according to at least one embodiment of the present invention is presented; and FIG. 9 A conceptual schematic diagram of an infusion procedure utilizing at least one butterfly needle assembly according to at least one embodiment of the present invention is presented. Detailed Implementation

[0024] Before proceeding with a detailed description, it should be understood that this teaching is illustrative only and not limiting. The concepts herein are not limited to use or application with the specific systems or methods used to provide butterfly needle assemblies. Therefore, although the tools described herein are for the purpose of facilitating explanation shown and described according to exemplary embodiments, it should be understood and recognized that the principles herein can also be applied to other types of injection or infusion needle assembly systems and methods.

[0025] In the following description, preferred embodiments of the invention are described with reference to the accompanying drawings, wherein the same numerals denote the same or similar elements. Furthermore, regarding the numbering of the same or similar elements, it is understood that the leading value identifies the figure in which the element is first identified and described; for example, element 100 appears in FIG1.

[0026] Now turn to the attached diagram, and more specifically, FIGS. 1A-1G At least one butterfly needle assembly 100, hereinafter referred to as BNA 100, is shown according to at least one embodiment of the present invention. FIG. 1A This presents a top perspective view of the BNA 100, in which... FIG. 1B A bottom perspective view is provided, and FIG. 1C , FIG. 1D and FIG. 1E The perspective side view, front view, and top view of the BNA 100 are provided respectively.

[0027] FIG. 1F and FIG. 1G Combination FIGS. 1A-1E Top and bottom perspective exploded views are provided, which can be understood as aiding in understanding the configuration and placement of components including the BNA 100.

[0028] To facilitate the description of the system and method for implementing BNA 100, as shown in Figure 1, the orientation of BNA 100 is presented in the figure with reference to a coordinate system having three mutually orthogonal axes. The axes intersect each other at the origin of the coordinate system, which is chosen as the center of BNA 100; however, for clarity and ease of illustration, all axes shown in the figure are deviated from their actual orientation.

[0029] As shown in the figure, the BNA 100 is provided by a number of components, the most specific of which is likely the flexible member 102. This provides a one-piece design that allows for easy assembly and improves patient comfort during insertion and throughout the duration of the infusion procedure. The flexible member 102 has a central region 104 with a first side member 106 and a second side member 108 that together provide a generally flat bottom 110. The central region 104 is also understood to have an intermediate region 112. As used herein, the term “flexible” applied to the flexible member 102 is understood and recognized as meaning that the flexible member 102 is relatively flexible and will easily conform to the patient’s skin when the BNA 100 is placed on the patient’s body for treatment.

[0030] In at least one embodiment, the BNA 100 is provided with an adhesive 114 disposed on a generally flat bottom 110, the adhesive 114 being initially protected by a removable cap 116. In different embodiments, the adhesive 114 may be provided to substantially all of the generally flat bottom 110, or a portion of the generally flat bottom 110 typically in the central region 104. The adhesive 114 may be applied to all or part of the generally flat bottom 110 as a spray coating, cut from a roll or sheet, by dipping or other application methods and / or layer development. Furthermore, in at least one embodiment, the generally flat bottom 110 may be textured to provide an increased adhesive surface or adhesive strength for the adhesive 114.

[0031] Furthermore, in different embodiments, adhesive 114 can be understood as an element / component of the generally flat bottom 110, or as an adaptable adhesive dressing attached to the bottom of the flexible member 102, which then provides the generally flat bottom surface of the BNA 100 for placement on a patient. Therefore, as used herein, the term "adhesive" will be understood and recognized to encompass both the development or application of adhesive material layers and more conventional adhesive dressings used and known in the medical field.

[0032] about FIG. 1E and FIG. 1FIn the exploded view, adhesive 114 is shown as a distinct element, essentially a disc-shaped adhesive dressing that substantially conforms to the shape of the central region 104 of the flexible member 102. However, it should be understood and recognized that the depiction was chosen for ease of illustration and discussion and to aid in recognizing the presence of adhesive 114, but is not intended as a limitation on the distinct elements in all embodiments.

[0033] Returning to the most specific FIGS. 1A-1C As shown in the figure, BNA 100 has a needle holder 118 disposed within a central region 104. The needle holder 118 receives a flexible tube 120 generally parallel to a generally flat bottom 110 and provides a needle 122 extending from a central region 112 of the central region 104 generally orthogonal to the generally flat bottom 110. As used herein, the term "flexible" applied to the tube 120 is understood and recognized as referring to the tube 120 being relatively flexible and easily conformable by bending and twisting by an operator. For at least one embodiment, the flexible tube 120 has a Luer connector configured and arranged to connect to a liquid source. Furthermore, for at least one embodiment, the flexible tube 120 is a flow control tube, which may also be referred to as a flow rate control tube.

[0034] As will be further discussed and described below, needle 122 is understood and recognized as having a first length and can be selected from a variety of different needle size options, such as, but not limited to, size options of 24 to 30. This first length will also be understood as essentially the length of the needle protruding beyond the generally flat bottom 110.

[0035] like FIG. 1A As shown, a removable needle cap 124 is initially disposed around the needle 122, and the removable needle cap 124 is configured and arranged to removably engage with the needle seat 118. Furthermore, in at least one embodiment, the removable needle cap 124 has a first end 126, which is configured and arranged to removably engage with the flexible member 102, and more specifically, with the needle seat 118. In at least one embodiment, the first end 126 provides opposing tabs 128 extending radially outward from the removable needle cap 124, such as... FIG. 1A As shown, the tab 128 can be rotated to pass through the side hole 130 of the needle seat 118.

[0036] It should also be understood and recognized that the removable needle cap 124 has an inner cavity 132 that provides a sealed space 132 around the needle 122 when initially engaged with the needle hub 118. Furthermore, the sealed space 132 around the needle 122 can be an airtight space to ensure the needle remains sterile until it is needed for use.

[0037] like FIGS. 1A-1FAs shown, BNA 100 also provides a closure system 134, which is configured and arranged to close the first side member 106 and the second side member 108 around the needle 122. For at least one embodiment, the closure system 134 is provided as a two-part system. More specifically, and as referenced... FIG. 1B As can be more fully understood, for at least one embodiment, the closure system is provided at least in part by a button 136 and a through hole 140, the button 136 being disposed on a generally flat bottom 110 near a first distal edge 138 of the first side member 106, and the through hole 140 being disposed near a second distal edge 142 of the second side member 108.

[0038] Furthermore, it should be understood that the first side member 106 extending away from the needle holder 118 is essentially a first butterfly wing 144, and the second side member 108 extending away from the needle holder 118 in contrast to the first butterfly wing 144 is essentially a second butterfly wing 146. It should be understood that the button 136 and the through-hole 140 are arranged substantially equally opposite to the needle holder 118 such that when the first butterfly wing 144 and the second butterfly wing 146 are folded downwards and around the needle 122, the button 136 is aligned with the through-hole 140. It will also be understood and appreciated that the use of the button 136 and the through-hole 140 provides the user with advantageous visual confirmation that the first butterfly wing 144 and the second butterfly wing 146 are indeed secured around the needle 122—the user can see the button 136 protruding through the through-hole 140. Furthermore, for at least one embodiment, the geometry of the button 136 and the through-hole 140 can be appropriately sized to provide audible and tactile feedback upon proper engagement.

[0039] like FIG. 1B As shown, it should be understood that, for at least one embodiment, button 136 has at least one distal engaging element 148, such as a ridge 150. Since button 136 and / or through-hole 140 are formed of a malleable material, the distal engaging element 148 of button 136 can be compressed, and / or the through-hole 140 can be allowed to expand, allowing the engaging element 148 of button 136 to be squeezed through the through-hole 140. Once through, button 136 and / or through-hole 140 return to their substantially initial state, with the engaging element 148 now positioned on the outside of the through-hole 140, thus joining the first butterfly wing 144 and the second butterfly wing 146 together.

[0040] Of course, it should be understood and recognized that, for at least one alternative implementation, the orientations of the button 136 and the through hole 140 may be reversed, such that the button 136 is closer to the second distal edge 142 and the through hole 140 is closer to the first distal edge 138.

[0041] From at least FIG. 1A and FIG. 1BIt can also be understood that, in at least one embodiment, the flexible member 102 has a plurality of curved grooves 152, which are evenly distributed on both sides of the needle seat 118 and orthogonal to the long axis 154 traveling between the first distal edge 138 and the second distal edge 142. For FIG. 1A The illustrated embodiment has four curved grooves 152, two disposed in the first butterfly wing 144 and two disposed in the second butterfly wing 146. This number was chosen for ease of illustration and discussion and is not intended as a limitation. Furthermore, it should be understood and recognized that the number and arrangement of the curved grooves 152 may vary based on patient demographics and / or other design and manufacturing considerations without departing from the scope and teachings presented herein.

[0042] While the flexible member 102 is indeed understood and recognized as flexible and capable of bending the first butterfly wing 144 and the second butterfly wing 146 downward to engage the closure system 134, the bending groove 152 can further assist this bending process. Although the bending groove 152 is illustrated as being disposed in the generally flat bottom 110, for at least one alternative embodiment, one or more of the bending grooves 152 may be provided in the top surface 156 of the BNA 100, which is opposite to the generally flat bottom 110.

[0043] In at least one embodiment, the BNA 100, and more specifically, the needle holder 118, is provided with a finger gripping portion 158 to assist the user in gripping and holding the BNA 100 when it is placed on the patient for treatment and when it is removed after treatment. In at least one embodiment, the finger gripping portion 158 is provided as an extended rib extending laterally from the upper portion of the needle holder 118. In addition to or as an alternative to the extended rib of the finger gripping portion 158, protrusions, bumps, ribs, or other structures may be provided.

[0044] As described above, the needle holder 118 receives a flexible tube 120 that is generally parallel to a generally flat bottom 110 and provides a needle 122 that extends from a central region 112 of the central region 104 that is generally orthogonal to the generally flat bottom 110. Thus, it will be understood that there is a substantially 90° transition between the tube 120 and the needle 122.

[0045] about FIG. 1F and FIG. 1G The exploded view of the provided BNA 100 will also help to understand that, for at least one embodiment, the needle holder 118 is provided by at least two elements—a needle holder frame 160 and a snap-fit ​​needle structure 162—with the needle holder frame 160 connected to the flexible member 102 and opposite to a generally flat bottom 110 / adhesive 114.

[0046] In at least one embodiment, the snap-fit ​​needle structure 162 is provided by a catheter member 164, which is configured and arranged to connect to the flexible tube 120 at a first end 166 and to the needle 122 at a second end 168, the second end 168 being substantially orthogonal to the first end 166. Furthermore, because the catheter member 164 achieves a substantially approximately 90° transition between the orientation of the first end 166 coupled to the tube 120 and the orientation of the second end 168 coupled to the needle 122, the manufacture of the BNA 100 can advantageously be performed using a straight needle 122. As will be further discussed below, the catheter member 164 is further configured and arranged to snap-fit ​​with the needle hub frame 160.

[0047] FIG. 1F and FIG. 1G The exploded view also provides a conceptual representation of the flexible tube 120, which, as described above for at least one embodiment, is a flow control tube. As shown, for at least one embodiment, tube 120 is coupled to a Luer connector 170, which can be connected to a reservoir or other liquid source. For at least one embodiment, the Luer connector 170 is a flared Luer connector as described in U.S. Patent 10,500,389 entitled “SYSTEM AND METHOD FOR FLARED LUER CONNECTOR FOR MEDICAL TUBING,” which is incorporated herein by reference.

[0048] With respect to the BNA 100 of the present invention, it can be understood and appreciated that the advantages described herein are achieved due to the combination of at least the flexible tube element 120 and the snap-fit ​​needle 162 and their various flow rate characteristics when advantageously combined.

[0049] KORU Medical Systems, Inc., located in Mahwah, New Jersey, is and has been a pioneer in needle kit technology and flow rate control via specially designed flow control tubes. In fact, KORU recognized that different flow rates could be provided by using different combinations of flow rates through flow control tubes, as described in U.S. Patent 10,420,886 entitled "MULTI-FLOW UNIVERSAL TUBING SET" (incorporated herein by reference) and U.S. Patent 10,709,839 entitled "PRECISION VARIABLE FLOW RATE INFUSION SYSTEM AND METHOD" (incorporated herein by reference).

[0050] Furthermore, KORU has developed advantageous infusion systems that allow high flow rates at low pressures, such as those described in U.S. Application 17 / 729,914 entitled "HIGH FLOW AT LOW PRESSURE INFUSION SYSTEM" (US 2022 / 0265923), which is incorporated herein by reference. Additionally, different embodiments of the BNA 100 can incorporate predetermined flow rates of the flexible tubing 120, needle 122, and catheter assembly 164 (and other such elements in needle kits including the BNA 100) to provide one or more BNA 100s as a single or multiple needle kits with predetermined flow rates.

[0051] FIG. 2A and FIG. 2B Top and bottom perspective views of the flexible member 102 are provided. In at least one embodiment, the flexible member 102 is formed at least partially of a medical-grade flexible plastic (e.g., polyethylene, polypropylene, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), silicone, or any other sustainable material). In various embodiments, the flexible member 102 may be provided by casting, molding, stamping, and / or 3D printing, and the flexibility of one region relative to another—e.g., the first butterfly wing 144 and the second butterfly wing 146 relative to the needle holder frame 160—depends at least partially on the thickness of the material comprising the structure. Flexibility can also be adjusted by providing different compounds or mixtures used in one region and another. Furthermore, as discussed further below, a puncture-resistant material may be applied to or disposed on or within portions of the first butterfly wing 144 and the second butterfly wing 146.

[0052] For example, in depicting a top perspective view FIG. 2A As can be understood from this, the needle holder frame 160 can be more fully understood. More specifically, it can be clearly understood that at least one side cavity 130 is constructed and arranged to receive a side tab 128 provided by the first end 126 of the removable needle cap 124 (the tab 128 and the removable needle cap 124 are in...). FIG. 2A or FIG. 2B (Not shown in the image).

[0053] In fact, the stop 200 can be provided as an element of the cavity 130, from which the tab 128 stops against the element of the cavity 130 when the removable needle cap 124 is properly secured in place and temporarily attached to the flexible member 102. In at least one embodiment, the stop 200 can be provided as a thickened section of material from which the needle seat frame 160 is established. In another embodiment, the stop 200 is formed of a harder or denser material, which can be combined with or applied to the material providing the needle seat frame 160.

[0054] likeFIG. 2A As can be appreciated, in at least one embodiment, the lower portion 202 of the side cavity 130 is inclined upward toward the stop 200. Therefore, when the tab 128 of the removable needle cap 124 is rotated into place against the stop 200, the inclined lower portion 202 will further drive and / or snuggly secure the removable needle cap 124 into place. The geometry and dimensions of the tab 128 and the inclined lower portion 202 provide an axial force to prevent separation of the two components.

[0055] A first opening 206 is provided above the cavity 130 in the distal portion 204 of the needle holder frame 160. This first opening 206 is constructed and arranged to receive a snap-fit ​​needle structure 162 (not shown). The finger grip portion 158 can also be more fully perceived on both sides of the first opening 206.

[0056] exist FIG. 2B In this context, the curved groove 152 and the second opening 208 can also be more fully appreciated, from which the needle 122 extends when the snap-fit ​​needle structure 162 is disposed in the first opening 206. The second opening 208 is also constructed and arranged to receive the first end 126 of the removable needle cap 124. FIG. 2B In addition, we can gain a fuller understanding of the connecting element 148, such as the rib 150 of the button 136.

[0057] FIGS. 3A-3C Front and rear perspective views of the snap-fit ​​pin structure 162 are provided. (Example) FIG. 3A and FIG. 3B As can be appreciated, for at least one embodiment, the catheter member 162 is an upper rectangular section 300 receiving the flexible tube 120 and a lower tapered section 302 receiving the needle 122. A rib 304 or edge is provided at the transition between the lower tapered section 302 and the upper rectangular section 300. For at least one embodiment, this rib is a mating surface that, when the snap-fit ​​needle structure 162 is fully disposed in the first opening 206 of the needle holder frame 160, will engage with the internal and opposing ribs within the needle holder frame 160, as will be referred to below. FIG. 4 To have a more comprehensive discussion FIG. 4 A cut-through view is provided of the flexible member 102, the needle holder frame 160, and the snap-fit ​​needle structure 162. (See attached image.) FIG. 3A It will also be appreciated that, in at least one embodiment, the catheter component 164 is provided with a mark 306 to indicate the specification of the needle in the assembled snap-fit ​​needle structure 162.

[0058] like FIG. 3CAs shown, the snap-fit ​​needle structure 162 can be provided with substantially the same conduit member 164, but with significantly different needles, such as needles 122A, 122B, and 122C, which advantageously allows for three different snap-fit ​​needle structures 162A, 162B, and 162C. More specifically, snap-fit ​​needle structure 162A conceptually illustrates a needle 122A having a first specification 308 and a first length 310, snap-fit ​​needle structure 162B conceptually illustrates a needle 122B having a second specification 312 significantly different from the first specification 308, and snap-fit ​​needle structure 162C conceptually illustrates a needle 122C having a first specification 308 but a second length 314 significantly different from the first length 310.

[0059] Furthermore, various BNA100s can be manufactured quickly and easily simply by selecting different snap-fit ​​needle structures 162, each snap-fit ​​needle structure 162 being constructed and arranged to snap into the first opening 206 of the needle seat frame 160 provided by the flexible member 102.

[0060] Go to FIG. 4 A cross-sectional perspective view of BNA 100 is provided, and most specifically, a sectional view of the flexible member 102, the needle seat frame 160, and the snap-fit ​​needle structure 162 fully disposed in the first opening 206 to understand the snap-fit ​​nature. More specifically, and as can be more fully understood in the enlarged ellipse 402, the protruding rib 304 of the snap-fit ​​needle structure 162 is shown engaging with and located below the protruding rib 400 of the needle seat frame 160, such that the snap-fit ​​needle structure 162 is now in a coupled attachment to the needle seat frame 160.

[0061] Furthermore, when the snap-fit ​​needle structure 162 is positioned downward into the first opening 206, the lower tapered section 302 causes the needle holder frame 160 to deflect outward. When the tapered section 302 passes the rib 400, the outward deflection stops, and the elastic material of the needle holder frame 160 returns to its original state; thus, the rib 400 of the needle holder frame is positioned above the rib 304 of the snap-fit ​​needle structure 162.

[0062] FIG. 4It also allows the internal channel 404, constructed and arranged within the catheter assembly 162, to fluidly interconnect the tube 120 and needle 122 and to divert fluid received from the tube 120 to the needle 122. It should be understood and appreciated that, for at least one embodiment, the internal channel 404 is constructed and arranged to smoothly change the direction of fluid flow, for example, by providing smooth, sloping walls to minimize eddies and fluid turbulence. Furthermore, as described in the aforementioned U.S. application 17 / 729,914, for at least one embodiment, the infusion system incorporated into the BNA 100 is constructed and arranged to substantially maintain laminar flow of fluid through the tube 120, catheter assembly 164, and needle 122 in order to deliver fluid to the patient at a high flow rate under low pressure.

[0063] FIGS. 5A to 5D First, use a perspective view (see...) FIG. 5A ), and then with the subsequent top view plan ( FIG. 5B ), side view plan ( FIG. 5C ) and front view plan ( FIG. 5D The detachable needle cap 124 is presented.

[0064] about FIGS. 5A-5D This allows for a more comprehensive understanding of the side convex plate 128. See details for further information. FIG. 5C It can also be recognized that, for at least one embodiment, the tab 128 is angled to align with the inclined lower portion 202 of the first cavity of the pin seat frame 160. FIGS. 5A-5D Not shown in the text, see [link / reference]. FIG. 2A ).

[0065] Furthermore, it is understood that the first end 126 of the removable needle cap 124 provides an opening 500 for an internal hollow cavity 502 within the body 504 of the removable needle cap 124. The opening 500 is configured and arranged to engage with the lower tapered section 302 of the snap-fit ​​needle structure 162. More specifically, when the removable needle cap 124 is positioned through the second opening 208 of the flexible member 102 and twisted to drive the tab 128 to be rotatably locked into the needle seat 118, the opening 500 is press-fitted around at least a portion of the lower tapered section 302 to provide a substantially airtight seal between the removable needle cap 124 and the lower tapered section 302 of the snap-fit ​​needle structure 162.

[0066] It is this airtight seal that achieves the sealed space 132 of the needle 122 in the assembled BNA 100 as described above. In at least one embodiment, at least a portion of the material defining the opening 500 may be a soft and / or elastic or flexible material to further facilitate the formation of an airtight seal with the lower tapered section 302 of the snap-fit ​​needle structure 162.

[0067] Also FIGS. 5A-5DAs shown, in at least one embodiment, the removable needle cap 124 is provided with a grip 506, such as an enlarged knob 508, to facilitate the installation and removal of the removable needle cap 124 from the needle holder 118.

[0068] FIG. 6A A bottom perspective view of BNA 100 is presented, showing that the removable needle cap 124 has been removed, exposing the needle 122. Using the removable needle cap 124, the removable cap 116 protecting the adhesive can also be easily removed, and in at least one embodiment, the removable cap 116 has a predefined tear line 600 that assists the user in easily and completely removing the removable cap 116 to expose the adhesive.

[0069] FIG. 6B and FIG. 6C A basically similar implementation of BNA 100 is provided, wherein FIG. 6B The illustrated embodiment of the BNA 100 has an adhesive 114 as a different pad 602 or material layer. Like the flexible member 102, this adhesive 114 is highly flexible and capable of conforming to the contours of the patient's body. The BNA 100 will be placed on the patient for infusion therapy. The adhesive 114 allows the first butterfly wing 144 and the second butterfly wing 146 to fold downwards and surround the needle 122 after use to prevent accidental needle pricks. As shown, in at least one embodiment, the adhesive pad 602 is provided as a generally circular or elliptical element that conforms to the main portion of the bottom of the flexible member 102 but leaves the closure system 134 unobstructed. Of course, in at least one alternative embodiment, the adhesive pad 602 may substantially conform to the entire bottom of the flexible member 102, including the element surrounding the closure system.

[0070] FIG. 6C Provided with FIG. 6B A view of a basically similar BNA 100, however, here the adhesive 114 is established by spraying, dipping, rolling or other application processes, so that it can be considered as an element of the generally flat bottom 110 itself, denoted as point 604. Furthermore, for FIG. 6C In this embodiment, adhesive 114 / 604 can be described as an adhesive similar to that of conventional adhesive bandages, while FIG. 6B In this context, adhesive 114-602 is an additional layer that can provide additional softness / comfort for the patient, and for at least one embodiment, it can also provide limited absorption properties if extravasation or bleeding is observed during infusion.

[0071] FIGS. 7A-7D A side plan view of BNA 100 is presented to further illustrate the advantageous closure system 134 according to at least one embodiment. Furthermore,FIG. 7A An initial side view of the BNA 100 is presented, allowing for an understanding of the relationship between the first butterfly wing 144 and the second butterfly wing 146 and the needle 122.

[0072] More specifically, such as FIG. 7A As shown, the needle has a first length 700 extending below a generally flat bottom 110. The first side member 106 (also referred to as the first butterfly wing 144) and the second side member 108 (also referred to as the second butterfly wing 146) have substantially the same second length 702 from the central region 104, and as... FIG. 7A As shown, the second length 702 is greater than the first length 700. Therefore, when the first butterfly wing 144 and the second butterfly wing 146 are folded downward around the needle 122, the first butterfly wing 144 and the second butterfly wing 146 will completely surround the distal end of the needle 122.

[0073] FIG. 7B The first butterfly wing 144 and the second butterfly wing 146 are initially folded downwards to eventually surround the needle 122. As described above, the flexible member 102 is intended to be made of a substantially flexible material. However, since the needle holder 118 is an integrated component of the flexible member 102 and therefore provides a thicker area of ​​material, for at least one embodiment, when a force (as indicated by arrow 706) is applied to the first butterfly wing 144 and the second butterfly wing 146, the folding of the first butterfly wing 144 and the second butterfly wing 146 will most easily begin along the side 704 of the needle holder 118.

[0074] In at least one embodiment, when the first butterfly wing 144 and the second butterfly wing 146 are closed, the flexibility of the flexible member 102, and more specifically, the flexibility of the first butterfly wing 144 and the second butterfly wing 146, advantageously allows them to more completely surround the needle 122, which can be achieved if the first wing and the second wing are more ridged structures.

[0075] In fact, such as FIG. 7C As shown, as the first butterfly wing 144 and the second butterfly wing 146 bend further downward, the closure system 134 begins to engage when a force is applied toward the distal end (as indicated by arrow 708). In at least one embodiment, as described above, the closure system is provided at least partially by the button 136 and the through-hole 140. FIG. 7C As shown, if it does not partially pass through the through hole, button 136 is now at least partially located in the through hole 140.

[0076] While this does essentially surround the needle 122, for at least one implementation, a more advantageous closed state can be achieved by simply pressing the first butterfly wing 144 and the second butterfly wing 146 together, as... FIG. 7DAs shown. Furthermore, as... FIG. 7C As shown first, for at least one embodiment, at least a portion of the first butterfly wing 144 and the second butterfly wing 146 may include a cut-resistant / puncture-resistant material 710 (shown as dotted protrusions) to greatly reduce the chance of accidental needle punctures if the first butterfly wing 144 and the second butterfly wing 146 are further bent around the needle.

[0077] In addition, such as can be by FIG. 7D It is recognized that the adhesive 114, which previously aided in anchoring the BNA 100 to the patient's skin, now physically binds the first butterfly wing 144 and the second butterfly wing 146 together around at least a portion of the needle 122, and most importantly around the sharp end of the needle. In this final state, the chance of accidental needle pricks from the used BNA 100 is greatly reduced because the first butterfly wing 144 and the second butterfly wing 146 are mechanically and adhesively bonded together. Furthermore, for at least one embodiment, it is also recognized that the cut-resistant / puncture-resistant material 710 of the first butterfly wing 144 and the second butterfly wing 146 substantially surrounds the orientation of the needle tip within the now-sealed BNA 100.

[0078] To summarize the above description, for at least one embodiment, the present invention provides a BNA 100 comprising: a flexible member 102 having a central region 104 having a first side member 106 and a second side member 108 that together provide a generally flat bottom 110, the central region 104 having an intermediate region 112; an adhesive dressing 114 disposed on the generally flat bottom 110, the adhesive dressing 114 being protected by a removable cap 116; and a needle holder 118 disposed within the central region 104, the needle holder 118 receiving a generally parallel to the generally flat bottom 110. The bottom 110 has a flexible tube 120 line and provides a needle 122 extending from the middle region 112 of the central region 104, which is generally orthogonal to the generally flat bottom 110, the needle 122 extending a first length; a removable needle cap 124 initially disposed around the needle 122, the removable needle cap 124 being configured and arranged to removably engage with a needle seat 118; and a closure system 134 being configured and arranged to close a first side member 106 and a second side member 108 of the flexible member 102 around the needle 122.

[0079] In another embodiment, the present invention provides a BNA 100 comprising: a flexible member 102 having a central region 104 having a first side member 106 and a second side member 108 that together provide a generally flat bottom 110; an adhesive dressing 114 disposed on the generally flat bottom 110, the adhesive dressing 114 being protected by a removable cap 116; a needle seat frame 160 of a needle 122 connected to the flexible member 102, the needle seat frame 160 being opposite the adhesive dressing 114; and a snap-fit ​​needle structure 162 provided by a conduit member 164 having a first end 166 and a second end 168, the first end 166 being connected to a flexible tube 120 and the second end 168 being connected to a needle 12 having a first length. 2. A second end 168 is generally orthogonal to the first end 166. A catheter member 164 is further configured and arranged to snap-fit ​​with a needle hub frame 160. A needle 122 extends from the middle region 112 of the central region 104, generally orthogonal to the generally flat bottom 110. A flexible tube 120 is located near the first end 166 of the catheter member 164, generally parallel to the generally flat bottom 110. A removable needle cap 124 is initially disposed around the needle 122 and is configured and arranged to removably engage with the needle hub frame 160. A closure system 134 is configured and arranged to close the first side member 106 and the second side member 108 of the flexible member 102 around the needle 122.

[0080] A method for providing at least one embodiment of the BNA 100 as described above may be provided by the following steps: providing a flexible member 102 having a central region 104 having a first side member 106 and a second side member 108 that together provide a generally flat bottom 110, the central region 104 having a middle region 112; providing an adhesive dressing 114 on the generally flat bottom 110, the adhesive dressing 114 being protected by a removable cap 116. The method continues with the following steps: providing a needle holder 118 disposed within the central region 104, the needle holder 118 receiving a flexible tube 120 line generally parallel to the generally flat bottom 110, and providing a needle 122 extending from the middle region 112 of the central region 104 generally orthogonal to the generally flat bottom 110, the needle 122 extending a first length. As described above, for at least one embodiment, the needle holder 118 may be provided as a needle holder frame 60, and a particular snap-fit ​​needle structure 162 may be selected that snaps into the needle holder frame 60. The method further includes: providing a removable needle cap 124 initially disposed around the needle 122, the removable needle cap 124 being configured and arranged to removably engage with the needle seat 118; and providing a closure system 134 configured and arranged to close a first side member 106 and a second side member 108 of a flexible member 102 around the needle 122.

[0081] Having described several physical embodiments of BNA 100, it should be further appreciated that, for at least one embodiment, the flexible tube 120, the catheter component 164, and the needle 122 can be joined into an inseparable assembly using ultraviolet (UV) curing adhesive, medical-grade cyanoacrylate adhesive, or other suitable binders.

[0082] To further understand the advantageous applications of BNA 100, FIG. 8 A conceptual diagram of an assembled BNA 100 is presented, housed in a suitable package 800, which is then sterilized by applying radiation 802. As described above, since the removable needle cap 124 surrounds the needle 122 and thus creates a sealed space 132, the sterilization process ensures that the needle is sterilized and will remain sterilized until the removable needle cap 124 is removed before the BNA 100 is inserted into the patient.

[0083] FIG. 9 A conceptual infusion procedure for patient 900 is presented. More specifically, a needle kit 902 incorporating two BNAs 100 (e.g., BNA 100A and BNA 100B) has been placed in the lower body area of ​​patient 900. Because BNAs 100A and 100B have a favorable adhesive 114 on their generally flat bottom 110, no additional tape is required.

[0084] As can be more fully appreciated in the enlarged elliptical section 904, the needle kit 902 is connected to a flow controller 906—this connection can be made via a Luer connector 908, or optionally, the flow controller 906 can be provided as an integral and inseparable component of the needle kit 902. The needle kit 902 is in turn connected to a liquid source or reservoir 910, such as a syringe 912.

[0085] For at least one implementation, it should be understood and appreciated that the needle kit 902 is advantageously constructed and arranged for use with a constant pressure pump 914, such as a Freedom60® syringe infusion pump or a FreedomEdge syringe infusion pump supplied by KORU Medical Systems, Inc., Mova, New Jersey. When combined with the BNA 100, the constant pressure system (such as the constant pressure pump 914), and more specifically, the needle kit (e.g., needle kit 902), may be highly advantageous in preventing accidental and / or unsafe rates of fluid administration from the reservoir 910 to the patient 900.

[0086] With constant flow systems, pressure increases in response to any flow restriction, whether that restriction is in the patient's tissues or in the components of the delivery system. This can result in the administration of fluids at unsafe pressures. Consequently, patients may experience a wide range of symptoms, including but not limited to venous collapse, anaphylactic reactions, overdose, histamine reactions, morbidity, and mortality.

[0087] While the BNA 100 is intended to be placed manually on an infusion patient, it is typically used with a needle insertion device. Therefore, it will be understood and appreciated that different embodiments of the BNA 100 may be provided, wherein the needle hub 118, and more specifically, the needle hub frame 160 and / or the cavity 130, are configured and arranged to engage with embodiments of needle insertion devices taught in U.S. Patent 10,478,569 entitled “NEEDLE INSERTION DEVICE” (incorporated herein by reference), U.S. Patent 10,559,635 entitled “NEEDLE INSERTION DEVICE” (incorporated herein by reference), and U.S. Patent Application 18 / 071,775 entitled “NEEDLE INSERTION DEVICE” (incorporated herein by reference). Furthermore, at least one embodiment of the BNA 100 has, but is not limited to, suitable geometry of the flexible member 102 and / or the needle hub 118 and / or the side cavity 130, to be engaged with one or more needle insertion devices supplied by KORU Medical Systems, Inc., Mova, New Jersey.

[0088] Modifications to the methods, systems, and structures described above may be made without departing from the scope of the methods, systems, and structures described herein. Therefore, it should be noted that the content shown in the above description and / or accompanying drawings should be interpreted as illustrative rather than restrictive. In fact, many other embodiments are feasible and possible, as will be apparent to those skilled in the art. The claims are not limited to the embodiments discussed herein, but only to their terms and the doctrine of equivalents.

Claims

1. A butterfly needle assembly, comprising: A flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom, the central region having an intermediate region; An adhesive, which is disposed on the generally flat bottom, is protected by a removable cap; A needle hub, disposed in the central region, receives a flexible tube substantially parallel to the substantially flat bottom and provides a needle extending substantially orthogonal to the substantially flat bottom from the middle region of the central region, the needle extending a first length. A removable needle cap initially positioned around the needle, the removable needle cap being constructed and arranged to removably engage with the needle hub; and A closure system is constructed and arranged to close the first side member and the second side member of the flexible member around the needle.

2. The butterfly pin assembly of claim 1, wherein the closure system is provided by a button and a through hole, the button being disposed on the generally flat bottom near a first distal edge of the first side member, and the through hole being disposed near a second distal edge of the second side member.

3. The butterfly needle assembly according to claim 1, wherein the first side member and the second side member have substantially the same second length from the central region, the second length being greater than the first length.

4. The butterfly needle assembly of claim 1, wherein the removable needle cap has a first end disposed in the needle seat through the generally flat bottom, the first end having opposing side tabs configured and arranged to be rotatably locked into the needle seat.

5. The butterfly needle assembly of claim 1, wherein the removable needle cap hermetically seals the needle when engaged with the needle seat.

6. The butterfly needle assembly of claim 1, wherein the removable needle cap provides a sealed space around the needle when engaged with the needle hub.

7. The butterfly needle assembly of claim 1, wherein the snap-fit ​​needle structure has opposing side ribs, the side ribs being configured and arranged to snap under the corresponding rib of the needle seat.

8. The butterfly needle assembly of claim 1, wherein the needle hub is provided by at least two elements, namely a needle hub frame and a snap-fit ​​needle structure, the needle hub frame being connected to the flexible member and opposite to the adhesive, the snap-fit ​​needle structure being provided by a catheter member configured and arranged to be connected to the flexible tube at a first end and to a needle at a second end, the second end being substantially orthogonal to the first end, the catheter member being further configured and arranged to snap-fit ​​with the needle hub frame.

9. The butterfly needle assembly according to claim 8, wherein the first butterfly needle assembly is provided by a first snap-fit ​​needle structure, the first snap-fit ​​needle structure providing a first needle having a first specification, and the second butterfly needle assembly is provided by a second snap-fit ​​needle structure, the second snap-fit ​​needle structure providing a second needle having a second specification, the second specification being different from the first specification.

10. The butterfly needle assembly according to claim 1, wherein the needle is a straight needle.

11. The butterfly needle assembly of claim 1, wherein the flexible line is a flow control tube with a Luer connector configured and arranged to connect to a liquid source.

12. The butterfly needle assembly according to claim 1, wherein the flexible member has a plurality of curved grooves evenly disposed on both sides of the needle seat and orthogonal to the needle, the curved grooves facilitating the closure of the first side member and the second side member around the needle.

13. The butterfly needle assembly of claim 1, wherein the butterfly needle assembly is disposed in a sealed package and is irradiated to sterilize the butterfly needle assembly.

14. The butterfly needle assembly of claim 1, wherein the needle hub has a lifting finger grip portion.

15. The butterfly needle assembly of claim 1, wherein the butterfly assembly is configured and arranged to engage with a needle insertion device.

16. A butterfly needle assembly, comprising: A flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom; An adhesive, which is disposed on the generally flat bottom, is protected by a removable cap; A needle holder frame connected to the flexible member, the needle holder frame being opposite to the adhesive; A snap-fit ​​needle structure is provided by a catheter component having a first end and a second end, the first end being connected to a flexible tubing and the second end being connected to a needle having a first length, the second end being generally orthogonal to the first end, the catheter component being further configured and arranged to snap-fit ​​with the needle hub frame, the needle extending from the middle area of ​​the central region generally orthogonal to the generally flat bottom, the flexible tubing being generally parallel to the generally flat bottom near the first end of the catheter component; and A removable needle cap initially positioned around the needle, the removable needle cap being constructed and arranged to removably engage with the needle hub frame; and A closure system is constructed and arranged to close the first side member and the second side member of the flexible member around the needle.

17. The butterfly needle assembly of claim 16, wherein the closure system is provided by a button and a through hole, the button being disposed on the generally flat bottom near a first distal edge of the first side member, and the through hole being disposed near a second distal edge of the second side member.

18. The butterfly needle assembly of claim 16, wherein the first side member and the second side member have substantially the same second length from the central region, the second length being greater than the first length.

19. The butterfly needle assembly of claim 16, wherein the removable needle cap has a first end disposed in the needle seat through the generally flat bottom, the first end having opposing side tabs configured and arranged to be rotatably locked into the needle seat.

20. The butterfly needle assembly of claim 16, wherein the removable needle cap hermetically seals the needle when engaged with the needle seat.

21. The butterfly needle assembly of claim 16, wherein the removable needle cap provides a sealed space around the needle when engaged with the needle hub.

22. The butterfly needle assembly of claim 16, wherein the snap-fit ​​needle structure has opposing side ribs, the side ribs being configured and arranged to snap under the corresponding rib of the needle seat.

23. The butterfly needle assembly of claim 16, wherein the first butterfly needle assembly is provided by a first snap-fit ​​needle structure, the first snap-fit ​​needle structure providing a first needle having a first specification, and the second butterfly needle assembly is provided by a second snap-fit ​​needle structure, the second snap-fit ​​needle structure providing a second needle having a second specification different from the first specification.

24. The butterfly needle assembly of claim 16, wherein the needle is a straight needle.

25. The butterfly needle assembly of claim 16, wherein the flexible line is a flow control tube having a Luer connector configured and arranged to connect to a liquid source.

26. The butterfly needle assembly of claim 16, wherein the flexible member has a plurality of curved grooves evenly disposed on both sides of the needle seat and orthogonal to the needle, the curved grooves facilitating the closure of the first side member and the second side member around the needle.

27. The butterfly needle assembly of claim 16, wherein the butterfly needle assembly is disposed in a sealed package and is irradiated to sterilize the butterfly needle assembly.

28. A butterfly needle assembly, comprising: A flexible member having a central region having a first side member and a second side member that together provide a generally flat bottom, a button disposed on the generally flat bottom near a first distal edge of the first side member, and a through hole disposed near a second distal edge of the second side member, the button and the through hole together providing a closure system configured and arranged to close the first side member and the second side member of the flexible member around the pin; An adhesive, which is disposed on the generally flat bottom, is protected by a removable cap; A needle holder frame connected to the flexible member, the needle holder frame being opposite to the adhesive; A snap-fit ​​needle structure is provided by a catheter component having a first end and a second end, the first end being connected to a flexible tubing and the second end being connected to a needle having a first length, the second end being generally orthogonal to the first end, the catheter component being further configured and arranged to snap-fit ​​with the needle hub frame, the needle extending from the central region generally orthogonal to the generally flat bottom, the flexible tubing being generally parallel to the generally flat bottom near the first end of the catheter component; and A removable needle cap is initially positioned around the needle, the removable needle cap having a first end disposed in the needle hub frame through the generally flat bottom, the first end having opposing side tabs configured and arranged to be rotatably locked in the needle hub frame.

29. The butterfly needle assembly of claim 28, wherein the first side member and the second side member have substantially the same second length from the central region, the second length being greater than the first length.

30. The butterfly needle assembly of claim 28, wherein the first butterfly needle assembly is provided by a first snap-fit ​​needle structure, the first snap-fit ​​needle structure providing a first needle having a first specification, and the second butterfly needle assembly is provided by a second snap-fit ​​needle structure, the second snap-fit ​​needle structure providing a second needle having a second specification different from the first specification.

31. The butterfly needle assembly of claim 28, wherein the needle is a straight needle.

32. The butterfly needle assembly of claim 28, wherein the removable needle cap provides a sealed space around the needle when engaged with the needle hub.

33. The butterfly needle assembly of claim 28, wherein the snap-fit ​​needle structure has opposing side ribs, the side ribs being configured and arranged to snap under the corresponding rib of the needle seat.

34. The butterfly needle assembly of claim 28, wherein the flexible line is a flow control tube having a Luer connector configured and arranged to connect to a liquid source.

35. The butterfly needle assembly of claim 28, wherein the flexible line is a flow control tube having a Luer connector configured and arranged to connect to a liquid source.

36. The butterfly needle assembly of claim 28, wherein the flexible member has a plurality of curved grooves evenly disposed on both sides of the needle seat and orthogonal to the needle, the curved grooves facilitating the closure of the first side member and the second side member around the needle.

37. The butterfly needle assembly of claim 28, wherein the butterfly needle assembly is disposed in a sealed package and is irradiated to sterilize the butterfly needle assembly.

38. A method of providing a butterfly pin assembly, comprising: A flexible member is provided having a central region, the central region having a first side member and a second side member that together provide a generally flat bottom, the central region having an intermediate area; A dressing is provided on the generally flat bottom, and the adhesive is protected by a removable cap; A needle holder is provided in the central region, the needle holder receiving a flexible tube generally parallel to the generally flat bottom, and providing a needle extending from the central region, generally orthogonal to the generally flat bottom, the needle extending a first length. A removable needle cap is provided initially surrounding the needle, the removable needle cap being configured and arranged to removably engage with the needle hub; and A closure system is provided, the closure system being constructed and arranged to close the first side member and the second side member of the flexible member around the needle.

39. The method of claim 38, wherein the closure system is provided by a button and a through hole, the button being disposed on the generally flat bottom near a first distal edge of the first side member, and the through hole being disposed near a second distal edge of the second side member.

40. The method of claim 38, wherein the first side member and the second side member have substantially the same second length from the central region, the second length being greater than the first length.

41. The method of claim 38, wherein the removable needle cap has a first end disposed in the needle seat through the generally flat bottom, the first end having opposing side tabs configured and arranged to be rotatably locked into the needle seat.

42. The method of claim 38, wherein the snap-fit ​​needle structure has opposing side ribs, the side ribs being configured and arranged to snap under the corresponding rib of the needle seat.

43. The method of claim 38, wherein the removable needle cap provides a sealed space around the needle when engaged with the needle hub.

44. The method of claim 38, wherein the needle hub is provided by at least two elements, namely a needle hub frame and a snap-fit ​​needle structure, the needle hub frame being connected to the flexible member and opposite to the adhesive, the snap-fit ​​needle structure being provided by a catheter member configured and arranged to be connected to the flexible tube at a first end and to a needle at a second end, the second end being substantially orthogonal to the first end, the catheter member being further configured and arranged to snap-fit ​​with the needle hub frame.

45. The method of claim 44, wherein the first butterfly needle assembly is provided by a first snap-fit ​​needle structure, the first snap-fit ​​needle structure providing a first needle having a first specification, and the second butterfly needle assembly is provided by a second snap-fit ​​needle structure, the second snap-fit ​​needle structure providing a second needle having a second specification different from the first specification.

46. ​​The method of claim 38, wherein the needle is a straight needle.

47. The method of claim 38, wherein the flexible conduit is a flow control conduit with a Luer connector configured and arranged to connect to a liquid source.

48. The method of claim 38, wherein the flexible member has a plurality of curved grooves evenly disposed on both sides of the needle seat and orthogonal to the needle, the curved grooves facilitating the closure of the first side member and the second side member around the needle.

49. The method of claim 38, wherein the butterfly needle assembly is disposed in a sealed package and is irradiated to sterilize the butterfly needle assembly.

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