Intravenous treatment system and method of manufacturing an intravenous device

Abstract

To provide an intravenous therapy system.SOLUTION: An intravenous therapy system is provided, including: a hub section of which bottom part approaches a patient's skin, when the intravenous therapy system is inserted into the blood vessel, and of which opposite upper part includes a tab extending upwardly; a curved needle of which distal end has a curvature angle between 5 and 15 degrees with regard to the straight proximal end on the hub section side; and a curved catheter through which the curved needle is extending. The curvature angle of the curved needle and curved catheter causes the needle and the catheter to intersect axially with a blood vessel in the patient's body. The curvature angle of the needle and the catheter is between 5 and 15 degrees.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] The present invention relates to an intravenous treatment system for vascular access via a curved needle and a curved catheter. [Background technology]

[0002] Some intravenous treatment systems may include a straight needle and a catheter axially formed around the straight needle. Intravenous treatment systems can be used for a variety of infusion therapies. For example, intravenous treatment systems can be used to infuse fluids, such as saline, various medications, and parenteral nutrition, into a patient. Intravenous treatment systems can also be used to withdraw blood from a patient. To facilitate insertion into the body, the needle of an intravenous treatment system includes a distal tip that includes a bevel that is used to connect with the patient's skin when the bevel faces away from the patient's skin.

[0003] However, some problems arise with intravenous treatment systems that use straight needles. During operation of these intravenous treatment systems, a bevel formed on the distal end of the needle can cause the distal end of the needle to "dive" deeper into the patent even, even though the insertion angle of the intravenous treatment system remains constant. To complete the insertion process of the intravenous treatment system, the clinician can lower the angle of the intravenous treatment system relative to the patient to combat the needle diving further into the patient's body. This can also be done to attempt to position the distal end of the needle in a more parallel position relative to the patient's blood vessel being accessed by the intravenous treatment system.

[0004] However, this manipulation of the intravenous treatment system by the clinician has limited effectiveness with smaller gauge needles and catheters (e.g., 20-gauge, 22-gauge, and 24-gauge) because, as the needle gauge increases, the needle bends relatively easily at lower insertion angles. Second, the distal tip of the needle may be positioned at an approximately 20-degree angle within the vein and may not straighten. Ultrasound images show that the angle of the intravenous treatment system within the patient's blood vessel positions the distal tip of the needle near the inner surface of the vessel, causing the distal tip of the needle to penetrate the posterior wall of the vessel. The penetration of the distal tip of the needle into the posterior wall of the patient's blood vessel can cause vascular trauma, inflammation, and phlebitis, among other conditions. This can also be problematic when drawing blood when a vacuum is generated within the intravenous treatment system, with the distal tip of the needle being drawn into the venous wall. This vacuum generation can further cause the distal tip of the needle to become clogged, thereby preventing fluid from passing through the needle and / or catheter of the intravenous treatment system.

[0005] The subject matter claimed herein is not limited to embodiments that solve any problem or that operate only in environments as described herein. Rather, this background is provided to describe environments in which the embodiments described herein may operate. Summary of the Invention

[0006] FIELD OF THE DISCLOSURE The present disclosure relates generally to intravenous treatment systems and related systems and methods. In some embodiments, the intravenous treatment system provides access to a patient's blood vessel in a manner that avoids additional physical trauma to the patient aside from the initial insertion of the intravenous treatment system into the patient's blood vessel. The intravenous treatment system may include a curved needle.

[0007] In one embodiment, the curved catheter is formed around the outer surface of the curved needle. In one embodiment, the curved catheter is formed coaxially with the curved needle. In one embodiment, the curved catheter can be formed approximately coaxially with the curved needle. When a first length of the curved needle and curved catheter is inserted into a patient's body, the curved angle of the curved needle and curved catheter causes the curved needle and curved catheter to axially intersect with a blood vessel in the patient's body. By creating a curve in the needle and catheter of the intravenous treatment system, when the intravenous treatment system is inserted into a patient, the distal end of the needle runs parallel to and axially with the blood vessel, and the distal end of the needle is not pressed against the inner wall of the patient's blood vessel.

[0008] The present disclosure further relates to methods of manufacturing an intravenous device, which in some embodiments may include introducing heated metal into an extrusion die. In embodiments presented herein, the extrusion die may include an internal spider die that extrudes the heated metal through the extrusion die to form a hollow tube therefrom. In these embodiments, the exit face of the internal spider die is adjusted to be non-orthogonal to the extrusion axis of the spider die to form a curve in the hollow tube.

[0009] The present disclosure further relates to another method of manufacturing an intravenous therapy system. In one embodiment, the method includes introducing heated metal into an extrusion die, where the extrusion die includes an internal spider die. The method may also include extruding the heated metal through the extrusion die to form a hollow tube therefrom and forming a bevel at the distal end of the hollow tube. In these embodiments, the method may include forming a plastic catheter around an outer surface of the curved metal. For example, the method may include forming the plastic catheter coaxially or generally coaxially with the curved metal. In some embodiments, the method may also include bending the hollow tube and catheter using a bending fixture to form a curve in the hollow tube and catheter.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0011] Exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings herein. [Figure 1] FIG. 1 is a side view of a prior art intravenous treatment system. [Figure 2] FIG. 2 is a side view of a prior art intravenous treatment system. [Figure 3] FIG. 3 is a side view of a prior art intravenous treatment system. [Figure 4] FIG. 4 is a side view of a prior art intravenous treatment system. [Figure 5] FIG. 5 is a side cross-sectional view of a prior art extrusion die used to form an intravenous therapeutic system. [Figure 6] FIG. 6 is a side view of an intravenous treatment system according to one embodiment of the present disclosure. [Figure 7] FIG. 7 is a side view of an intravenous treatment system according to one embodiment of the present disclosure. [Figure 8] FIG. 8 is a side view of an intravenous treatment system according to one embodiment of the present disclosure. [Figure 9] FIG. 9 is a side view of an intravenous treatment system according to one embodiment of the present disclosure. [Figure 10] FIG. 10 is a side cross-sectional view of an extrusion die used to manufacture an intravenous treatment system according to one embodiment of the present disclosure. [Figure 11] FIG. 11 is a flowchart illustrating a method of manufacturing an intravenous therapy selection system according to some embodiments of the present disclosure. [Figure 12] FIG. 12 is a flow chart illustrating a method of manufacturing an intravenous treatment system according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] As used herein, the term "proximal" refers to the location on the needle of an intravenous treatment system that is closest to the clinician using the intravenous treatment system and farthest from the patient with whom the device is used during use of the system. Conversely, the term "distal" refers to the location on the needle of an intravenous treatment system that is farthest from the clinician using the intravenous treatment system and closest to the patient with whom the intravenous treatment system is used during use of the system.

[0013] As used herein, the terms "top," "up," or "upward" refer to a position on the needle of an intravenous treatment system that is radially away from the longitudinal axis of the intravenous treatment system and away from the patient's skin during use of the system. Conversely, as used herein, the terms "bottom," "down," or "downward" refer to a position on the needle of an intravenous treatment system that is radially away from the longitudinal axis of the device and toward the patient's skin during use of the system.

[0014] As used herein, the terms "in" or "inwardly" refer to a position on the needle of an intravenous treatment system in a direction toward the inside of the intravenous treatment system during use of the system. Conversely, as used herein, the terms "out" or "outwardly" refer to a position on the needle of an intravenous treatment system in a direction toward the outside of the intravenous treatment system during use of the system.

[0015] The present invention is described herein using like reference numerals to refer to like elements in different embodiments. While the embodiments described herein are used in connection with use as an intravenous treatment system for receiving blood samples or introducing medications into a patient's body, it will be understood that the intravenous treatment system is applicable to other medical devices in which it is desirable to insert a needle and / or catheter into a patient's blood vessel. Furthermore, while the embodiments of the intravenous treatment system may be fulfilled by many different forms of embodiment, within the scope of this disclosure as determined by the appended claims, preferred embodiments of the invention are shown in the drawings and described in detail herein.

[0016] FIG. 1 is a side view of a prior art intravenous treatment system 100. As shown, the intravenous treatment system 100 shows a straight needle 115. The intravenous treatment system 100 may also include a straight catheter 120 formed around the outer surface of the straight needle 115. The straight catheter 120 may be formed coaxially or generally coaxially with the straight needle 115. A hub 125 may be coupled to the straight needle 115 and the straight catheter 120. Once the straight needle 115 and the straight catheter 120 are inserted into a patient's blood vessel, the straight needle 115 may be axially removed from within the straight catheter 120. The prior art intravenous treatment system 100 may also include a barrel 130 coupled to the hub 125.

[0017] Intravenous treatment system 100 may include a proximal end 110 that can be held by a clinician or other health care provider (HCP) to insert intravenous treatment system 100 into a patient. Intravenous treatment system 100 may also include a distal end 105 opposite proximal end 110 at which the tip of a straight needle 115 is disposed. A bevel may be formed at the distal end 105 of straight needle 115. The bevel may be an angled notch formed at the tip of straight needle 115 that creates a sharp edge at the distal-most end 105 of straight needle 115.

[0018] Figure 2 is a side view of a prior art intravenous treatment system 100. Figure 2 shows the intravenous treatment system 100 of Figure 1 inserted into a patient's body 135 with the body including a blood vessel 140. The intravenous treatment system 100 can penetrate the patient's skin at a first angle θ of the intravenous treatment system 100 relative to the patient's body 135.

[0019] FIG. 3 is a side view of a prior art intravenous treatment system 100. FIG. 3 shows the intravenous treatment system 100 after puncturing the wall of a blood vessel 140 within a patient's body 135. As a result of the bevel formed at the distal end 105 of the straight needle 115, the straight needle 115 and straight catheter 120 tend to "dive" into the patient's body at an angle different from the angle θ shown in FIG. 2. To prevent this from occurring, a clinician or other HCP can adjust the approach angle of the intravenous treatment system 100 by reducing the angle of the barrel 130 of the intravenous treatment system 100 to a new, shallower angle θ'. Such a maneuver can cause additional problems associated with inserting the intravenous treatment system 100. For example, particularly with smaller gauge straight needles 115 and straight catheters 120, the straight needles 115 and straight catheters 120 may bend under the pressure created between the patient's skin and the new angle θ' of the barrel 130 relative to the patient's body 135. Furthermore, adjusting the approach angle of the intravenous treatment system 100 relative to the patient's body 135 does not actually prevent the distal end 105 of the straight needle 115 from further diving into the patient's body 135. Instead, further advancement of the straight needle 115 and straight catheter 120 of the intravenous treatment system 100 into the patient's body 135 by the clinician may cause the distal end 105 of the straight needle 115 to puncture the opposite sidewall of the blood vessel 140.

[0020] FIG. 4 is a side view of a prior art intravenous treatment system 100. In FIG. 4, the straight needle 115 formed around the straight catheter 120 has been removed, leaving the straight catheter 120 in place. The straight needle 115 can be formed coaxially or nearly coaxially with the straight catheter 120. The positioning of the straight needle 115 as shown in FIG. 3 positions the distal end 105 of the straight needle 115 next to the wall of the blood vessel 140, so that when the straight needle 115 is removed, the distal end of the straight catheter 120 remains near the wall of the blood vessel 140. Thus, the hollow portion of the straight catheter 120 can prevent the tip of the straight catheter 120 from receiving or passing fluid therethrough because it is blocked by the wall of the blood vessel 140. In the instance where blood is drawn from within the blood vessel 140, the pressure mismatch between the interior of the hollow portion of the straight catheter 120 and the interior of the blood vessel 140 can cause a vacuum to form at the distal end, thereby sucking the straight catheter 120 against the inner surface of the wall of the blood vessel 140.

[0021] Thus, the prior art intravenous treatment system 100 as configured may prevent proper insertion of the intravenous treatment system 100 into the patient's blood vessel 140. Alternatively, such insertion of the intravenous treatment system 100 described in connection with Figures 1-4 may cause venous irritation, phlebitis, and result in inadequate blood collection or infusion.

[0022] 5 is a side cross-sectional view of a prior art extrusion die 200 used to form an intravenous treatment system. The extrusion die 200 can include an extrusion barrel 205 in which a spider die 220 can be positioned. The spider die 220 can be made of a material that can withstand the amount of pressure exerted from behind by a heated metal billet 225 that is forced against the spider die 220 by a ramming device (not shown). As such, the spider die 220 can be made of a hardened metal, such as hardened steel.

[0023] During operation of the extrusion die 200, a heated metal billet 225 is positioned behind the spider die 220 and rammed into and through the spider die 220 by the ramming device described. The amount of pressure applied to the heated metal billet 225 may depend on the temperature of the heated metal billet 225, the volume of the heated metal billet 225, and the pressure applied to the heated metal billet 225 by the ramming device.

[0024] As a result of pressure applied to the heated metal billet 225, the metal of the heated metal billet 225 is forced through the spider die 220 and poured around the central shaft 215 of the spider die 220. The central shaft 215 can be sized to define the inner diameter of the hollow tube formed by the extrusion die 200 (e.g., a precursor form of the straight needle 115 of FIGS. 1-3). The spider die 220 can also include a funnel 210 or other inner surface that defines the outer diameter of the hollow tube formed by the extrusion die 200 (e.g., a precursor form of the straight needle 115 of FIGS. 1-4). As a result of the shape of the spider die 220, a hollow tube can be formed and exit the end of the extrusion die 200, which can serve as a precursor to the straight needle 115 as used in FIGS. 1-4.

[0025] As shown in Figure 5, the exit face of the spider die 220 is perpendicular to the axis of the central shaft 215. This orientation of the central shaft 215 relative to the exit face of the spider die 220 causes the extrusion die 200 to create a straight hollow pipe that is used to form a straight needle during operation. However, as described herein, straight needles such as those shown in Figures 1-4 can cause venous irritation, phlebitis, and result in insufficient blood collection or injection.

[0026] 6 is a side view of an intravenous treatment system 300 according to one embodiment of the present disclosure. The intravenous treatment system 300 described herein may include a distal end 305 and a proximal end 310. In one embodiment, the proximal end 310 may be held by a clinician or other HCP to orient the intravenous treatment system 300 relative to a blood vessel within a patient's body.

[0027] At the proximal end 310 of intravenous treatment system 300, intravenous treatment system 300 may include barrel section 330. In one embodiment, barrel section 330 may be any device that can be coupled to hub section 325 of intravenous treatment system 300. In one embodiment, barrel section 330 may be a blood sample vial for receiving a blood sample from a patient when intravenous treatment system 300 accesses a blood vessel within the patient's body. In another embodiment, barrel section 330 may be a disposable device intended to be temporarily coupled to hub section 325 for easier access by a clinician when inserting intravenous treatment system 300 into a patient's body. While this disclosure provides specific examples of what barrel section 330 may be and its function, these are meant to be non-limiting examples, and this disclosure contemplates that any device may be coupled to hub section 325 to perform a particular purpose or function.

[0028] Hub section 325 may include any type of coupling device that allows hub section 325 to be coupled to any device to receive or provide fluid to hub section 325 via curved needle 315 and curved catheter 320. In one embodiment, hub section 325 may include several threads that can interface with any type of device used to pass fluid through hub section 325.

[0029] In one embodiment, the hub section 325 may be physically coupled to the curved catheter 320. In one embodiment, the curved catheter 320 may comprise a straight or non-curved tube that curves in response to the curved needle 315 being inserted through the tube during assembly or manufacturing. In one embodiment, the curved catheter 320 may be made of any type of elastic material that is elastic for the curved catheter 320 to pinch or collapse upon itself while the curved catheter 320 is within a patient's body. In one embodiment, the curved catheter 320 may be made of a polymer or another suitable material.

[0030] In one embodiment, the intravenous treatment system 300 may include a curved needle 315 formed at the distal end 305 of the intravenous treatment system 300. The curved needle 315 may be formed within the curved catheter 320 and extend around the curved catheter 320 along the entire length of the curved needle 315. The curved needle 315 may be formed within the curved catheter 320 and extend coaxially or nearly coaxially with the curved catheter 320 along the entire length of the curved needle 315. In certain examples, the curved needle 315 is longer than the curved catheter 320 such that the distal end of the curved needle 315 extends a distance beyond the curved catheter 320. The curved needle 315 may also include a bevel formed at the distal end of the curved needle 315. The bevel may be formed to bring the distal end of the curved needle 315 to a sharp point. The sharp tip of the bevel may allow the curved needle 315 to be easily inserted into a patient's body. In one embodiment, the curved needle 315 is made of stainless steel or another type of metal that does not chemically interact with the fluids and tissues in a patient's body. Thus, although a specific example is provided herein that illustrates the curved needle 315 being made of stainless steel, the curved needle 315 may be made of other types of metals suitable for a particular medical purpose.

[0031] The curved catheter 320 and curved needle 315 have a level of curvature that allows for relatively easy insertion and placement of the intravenous treatment system 300 in and within a patient. In contrast to the prior art intravenous treatment systems described in connection with Figures 1-4, the curvature of the curved catheter 320 and curved needle 315 provides that, upon insertion into a patient, the curvature of the curved catheter 320 allows the distal end of the curved needle 315 to track parallel to the blood vessel within the patient.

[0032] 7-9 illustrate the progression of insertion of intravenous treatment system 300 as described in connection with FIG. 6 . FIG. 7 is a side view of an intravenous treatment system according to one embodiment of the present disclosure. As described in connection with FIG. 6 , intravenous treatment system 300 may include barrel section 330 and hub section 325. In one embodiment, barrel section 330 may be any device that can be coupled to hub section 325 of intravenous treatment system 300. In one embodiment, barrel section 330 may be a blood sample vial for receiving a blood sample from a patient when intravenous treatment system 300 accesses a blood vessel within the patient's body. In another embodiment, barrel section 330 may be a disposable device intended to be temporarily coupled to hub section 325 for ease of access by a clinician when inserting intravenous treatment system 300 into a patient's body. While this disclosure provides specific examples of what barrel section 330 is and its function, these are meant to be non-limiting examples, and this disclosure contemplates that any device may be coupled to hub section 325 to perform a specific purpose or function.

[0033] Hub section 325 may include any type of coupling device that allows hub section 325 to be coupled to any device to receive or provide fluid to hub section 325 via curved needle 315 and curved catheter 320. In one embodiment, hub section 325 may include several threads that can interface with any type of device used to pass fluid through hub section 325.

[0034] During operation of intravenous treatment system 300, a clinician may hold intravenous treatment system 300 in the clinician's hand, for example, by barrel section 330 of intravenous treatment system 300. In one embodiment, the clinician may insert intravenous treatment system 300 at a first angle θ″ relative to a patient's body 335. In one embodiment, this angle θ″ may be greater than the insertion angle θ of intravenous treatment system 300 having a straight needle and straight catheter shown in prior art FIG. 2 .

[0035] As a result of this relatively large first angle θ'', the curvature of curved needle 315 and curved catheter 320 can automatically curve to the blood vessel when inserted into the patient's body. This first angle θ'' allows curved needle 315 and curved catheter 320 to follow a trajectory within the patient's body that runs parallel to the patient's blood vessel 340.

[0036] To achieve this insertion, the curvature 355 of the curved catheter 320 and the curved needle 315 may be sufficient such that, upon full insertion into the patient's body, the curved needle 315 and the curved catheter 320 are axially positioned within the target vessel. In one embodiment, the curvature 355 of the curved needle 315 and the curved catheter 320 may have an angle of curvature between 5 and 15 degrees. In one embodiment, the angle of curvature 355 may be measured from the distal end of the curved needle 315 to the axis of the hub section 325.

[0037] The curved needle 315 may also include a bevel formed at the distal end of the curved needle 315. The bevel may be formed to bring the distal end of the curved needle 315 to a sharp point. The sharp tip of the bevel may allow the curved needle 315 to be easily inserted into a patient's body. In one embodiment, the edge of the bevel is formed to face the center point of the curvature 355 so that the bevel faces away from the patient's body during insertion of the intravenous treatment system 300 into the patient's body.

[0038] Figure 8 is a side view of an intravenous treatment system 300 according to one embodiment of the present disclosure. Figure 8 shows the intravenous treatment system 300 fully or nearly fully inserted into a patient's body 335 and blood vessel 340. In Figure 8, the curved needle 315 and curved catheter 320 follow a curve formed by the curved needle 315 and curved catheter 320, similar to what clinicians and other HCPs experience using surgical needles.

[0039] During insertion of intravenous treatment system 300, curved needle 315 and curved catheter 320 can use the bend 355 created by curved needle 315 and curved catheter 320 to pass through a portion of patient's body 335 and enter blood vessel 340, tracing a coaxial direction with blood vessel 340. During insertion into blood vessel 340, the clinician decreases angle θ″ of intravenous treatment system 300 relative to patient's body 335 to use the curved insertion point created by curved needle 315 and curved catheter 320 to insert curved needle 315 further into blood vessel 340 without puncturing the opposite wall of blood vessel 340. Use of intravenous treatment system 300 prevents the distal end of curved needle 315 from continuing through blood vessel 340, thereby damaging the blood vessel and other structures within patient's body 335.

[0040] FIG. 9 is a side view of an intravenous treatment system 300 according to one embodiment of the present disclosure. In FIG. 9, the curved needle 315 and barrel section 330 have been removed, leaving the curved catheter 320 to remain within the patient's blood vessel 340. The curve of the curved catheter 320 may be maintained as a result of a thermal heating process performed on the curved catheter 320 when placed around the curved needle 315. Due to the curvature of the curved needle 315, the distal end of the curved catheter 320 may be coaxial with the longitudinal axis or length of a portion of the blood vessel 340. In this position within the blood vessel 340, the curved catheter 320 may be able to, for example, withdraw a blood sample or administer a medication without being positioned against the wall of the blood vessel 340.

[0041] FIG. 9 shows that the angle θ′″ of the hub section 325 relative to the patient's body 335 has been reduced. This angle θ′″ may be sufficient to attach the hub section 325 to the patient's body 335 to allow for immediate and subsequent blood withdrawal and infusion. The hub section 325 may be affixed to the patient's body 335 using any medical tape, for example, to secure the hub section 325 to the patient's body 335 and maintain the curved catheter 320 within the patient's blood vessel 340. The hub section 325 may include several threads formed on the proximal end of the hub section 325 to accept other medical devices, such as an intravenous lead or a syringe.

[0042] The intravenous treatment system 300 described in connection with Figures 6-9 improves the difficulties associated with and experienced by clinicians using straight needle and straight catheter systems. The presently described intravenous treatment system 300 improves the clinician's success in the initial "stick" or insertion of the intravenous treatment system 300 by automatically steering the intravenous treatment system 300 into the blood vessel 340 in a position more parallel to the blood vessel 340. The intravenous treatment system 300 further reduces trauma to the blood vessel 340, thereby reducing irritation, inflammation, and phlebitis and occlusion of the wall of the blood vessel 340. The intravenous treatment system 300 also increases the likelihood of a successful blood draw from the intravenous treatment system 300 by the clinician or other HCP, reducing the number of attempts to perform a blood draw or medication infusion.

[0043] 10 is a side cross-sectional view of an extrusion die 400 used to manufacture an intravenous treatment system, according to one embodiment of the present disclosure. The extrusion die 400 can include an extrusion barrel 405 in which a spider die 420 can be positioned. The spider die 420 can be made of a material that can withstand the amount of pressure exerted from behind by a heated metal billet 425 that is forced against the spider die 420 by a ramming device (not shown). As such, the spider die 420 is made of a hardened metal, such as hardened steel.

[0044] During operation of the extrusion die 400, a heated metal billet 425 is positioned behind the spider die 420 and rammed into and through the spider die 420 by the ramming device described. The amount of pressure applied to the heated metal billet 425 can depend on the temperature of the heated metal billet 425, the volume of the heated metal billet 425, and the pressure applied to the heated metal billet 425 by the ramming device.

[0045] As a result of applying pressure to the heated metal billet 425, the metal of the heated metal billet 425 is forced through the spider die 420 and poured around the central shaft 415 of the spider die 420. The central shaft 415 can be sized to define the inner diameter of the hollow tube formed by the extrusion die 400 (e.g., the precursor form of the curved needle 315 in FIGS. 6-8). The spider die 420 can also include a funnel portion 410 or other inner surface that defines the outer diameter of the hollow tube formed by the extrusion die 400 (e.g., the precursor form of the curved needle 315 in FIGS. 6-8). During the application of pressure to the heated metal billet 425, the metal of the heated metal billet 425 can be traced, as shown by the arrows, through the orifices formed in the spider die 420 and through the exit orifice of the spider die 420. As a result of the shape of the spider die 420, a hollow tube is formed and can exit the end of the extrusion die 400 which can serve as a precursor to the curved needle 315 as used in FIGS.

[0046] As shown in FIG. 10 , the exit face of the spider die 420 is non-orthogonal to the axis of the central shaft 415. This contrasts with the exit face described in connection with the prior art extrusion die shown in FIG. 5 . This non-orthogonal orientation of the exit face relative to the central shaft 415 of the spider die 420 allows the extrusion die 200 to create a curved hollow pipe that, during operation, is used to form the curved needles 315 described in connection with FIGS. 6-8 . The curvature of the curved needles (355 in FIGS. 7 and 8 ) can depend, among other manufacturing variables, on the angle β of the exit face of the spider die 420 and the extrusion rate of the metal from the extrusion die 400. During operation of the extrusion die 400, as the exit metal passes the lowered edge of the exit face of the spider die 420, the metal may curve along the lines shown in the diagram resulting from the fluid properties of the metal and mechanical stresses applied to that portion of the exit metal relative to the metal still passing the interface between the funnel portion 410 and the axis of the central shaft 415 of the spider die 420. As a result, by forming a hollow pipe, metal passing under the outlet face of spider die 420 will bend away from its lowest part of the outlet face of spider die 420 and towards the higher side of the outlet face.

[0047] In one embodiment, the exit face of the spider die 420 can change orientation as the metal passes through the spider die 420. In this embodiment, the orientation of the funnel portion 410 of the spider die 420 can be enabled, for example, via hydraulic pressure, from a first angle β to an angle perpendicular to the axis of the central shaft 415. In this embodiment, the length and tip of the central shaft 415 can be altered to allow for deformation of the metal according to the operation of the extrusion die 400 in this embodiment. As the metal is extruded from the spider die 420 of the extrusion die 400, the exit face can be maintained at angle β for a certain length of the forming hollow tube. The exit face can then be altered to reduce the angle of the exit face of the spider die 420 so that it is perpendicular to the axis of the central shaft 415. This change in angle β causes the hollow tube to form straight over the length of the forming hollow tube. As a result, a hollow tube can be formed that includes curved and straight portions having a curvature 355.

[0048] In any of the embodiments described herein, a method of manufacturing the curved needle 315 may include forming a catheter over the curved needle 315 to form the curved catheter 320 thereon. The curved catheter 320 may be made of a polymer that can be axially slid around the curved needle 315. To set the curvature of the curved catheter 320, the catheter may be subjected to a thermoforming process such that the curved catheter 320 remains curved when the curved needle 315 is axially removed from the curved catheter 320.

[0049] Additionally, in any embodiment, a bevel may be formed at the distal end of the curved needle 315. The bevel may be formed by a grinding process or any other material removal process. The bevel may be used to create a more comfortable passage point through the patient's body.

[0050] 11 is a flowchart illustrating a method 1100 of manufacturing an intravenous treatment system according to some embodiments of the present disclosure. The method 1100 may include, at block 1105, introducing heated metal into an extrusion die, where the extrusion die includes an internal spider die. As described herein, the spider die includes several extrusion holes that lead to the funnel portion 410. Although the present disclosure describes the extrusion die including a spider die, the present disclosure contemplates that other types of dies can be used to form the curved hollow tubes used to form the curved needles described herein.

[0051] The method 1100 may further include, at block 1110, extruding the heated metal through an extrusion die from which a hollow tube is formed. The heated metal may be extruded through a spider die of the extrusion die using any type of ramming device. Certain parameters of the extrusion process may be controlled to create the curved needle curvature. These parameters may include, among other parameters, the amount of pressure applied to the heated metal billet by the ramming device, the temperature of the heated metal billet, the type of metal being extruded, and the cross-sectional area of ​​the various conduits formed through the spider die and funnel portion of the spider die.

[0052] Method 1100 may further include, at block 1115, adjusting the exit plane of the internal spider die to be non-orthogonal to the extrusion axis of the spider die to form a curve in the hollow tube. As described herein, the angle (angle β in FIG. 10 ) of the exit plane of the spider die (e.g., the exit plane of the funnel portion of the spider die) can be adjusted to create a curvature in the extruded hollow tube. This adjustment of the exit plane, in one embodiment, can be maintained throughout the formation of the curved needle. In another embodiment, the exit plane can be adjusted from a first angle to a second angle that is orthogonal to the axis of the central shaft.

[0053] 12 is a flowchart illustrating a method 1200 of manufacturing an intravenous treatment system according to one embodiment of the present disclosure. The method 1200 may include, at block 1205, introducing heated metal into an extrusion die, where the extrusion die includes an internal spider die. The heated billet may be made of any metal and may be heated to any temperature sufficient to allow the metal to be extruded through the extrusion die.

[0054] The method 1200 may further include extruding the heated metal billet through an extrusion die to form a hollow tube therefrom, at block 1210. In one embodiment, the hollow tube may be a precursor form of a curved needle as described herein.

[0055] The method 1200 may also include forming a bevel at the distal end of the hollow tube at block 1215. The bevel may be created to allow the distal end of the needle to pass through the patient's body and enter a blood vessel (e.g., a vein).

[0056] The method 1200 can proceed at block 1220 by forming a plastic catheter around an outer surface of the metal. In some embodiments, the plastic catheter can be formed around an outer surface of the metal such that the plastic catheter is coaxial with or nearly coaxial with the metal. In one embodiment, the catheter can be physically coupled to a hub section of the intravenous treatment system via sonic welding or any other type of bonding process or device. In certain embodiments, a needle can be fed through the catheter such that the distal end of the curved needle protrudes from the distal end of the catheter.

[0057] The method 1200 may further include bending the hollow tube and catheter to form a curve in the hollow tube and catheter at block 1225. The curvature of the curve formed in the hollow needle and catheter may depend on the type of medical process in which the curved needle and curved catheter are being used. In one embodiment, the curvature 355 of the curved needle 315 and curved catheter 320 may have a curvature angle between 5 and 15 degrees.

[0058] Method 1200, in some embodiments, may include subjecting the installed curved catheter to a thermal heating or thermoforming process, which may be done to ensure that the curved catheter remains curved when the curved needle is axially removed from the curved catheter.

[0059] Embodiments described herein provide an intravenous treatment system including a curved needle. In one embodiment, the curved catheter is formed around the outer surface of the curved needle. In one embodiment, the curved catheter is formed coaxially or generally coaxially with the curved needle. When a first length of the curved needle and curved catheter is inserted into a patient, the angle of curvature of the curved needle and curved catheter causes the curved needle and curved catheter to axially intersect a blood vessel within the patient. By creating a curve in the needle and catheter of the intravenous treatment system, when the intravenous treatment system is inserted into a patient, the distal end of the needle runs parallel to and axially with the blood vessel, preventing the distal end of the needle from being pressed against the inner wall of the patient's blood vessel.

[0060] Again, it will be appreciated that embodiments of the present application may be combined. As an example, the embodiments of Figures 1-12 may be configured to suit a particular application based on the type of operation being performed. For example, if an artery is accessed by a needle, the information processing system may indicate the location of the artery via an indicator system while avoiding veins. This may allow a particular drug to be introduced to a specific location in a patient's body without worrying about the drug distributing throughout the patient's body.

[0061] All examples and conditional language listed herein are intended for educational purposes to help the reader understand the invention and concepts provided by the inventors to facilitate the present technology, and should be construed as not being limited to the specifically listed examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. a hub section including a top portion and a bottom portion opposite the top portion, the bottom portion configured to be adjacent to a patient's skin when the intravenous treatment system is inserted into a blood vessel, the top portion of the hub section including an upwardly extending tab; a curved needle, wherein a distal end portion of the curve comprises a curve spaced apart from a proximal end portion of the curve, the proximal end portion of the curve being adjacent to a straight proximal end portion of the curved needle, the curve being between 5 and 15 degrees relative to the straight proximal end portion of the curved needle, and the curved portion curving upward; a curved catheter through which the curved needle extends; Including, the curved needle is formed so as to be curved immediately from the end point of the distal end of the curved needle and curved throughout the entire distal end portion, and the curved catheter is formed so as to be curved immediately from the end point of the distal end of the curved catheter and curved throughout the entire distal end portion, an intravenous treatment system, wherein upon insertion of the first length of the curved needle and the first length of the curved catheter into the patient, a bend angle of the curved needle and the curved catheter causes the curved needle and the curved catheter to axially intersect a blood vessel within the patient, and the bend angle of the needle and the catheter is between 5 and 15 degrees.

2. The intravenous treatment system of claim 1 , wherein the first length of the curved needle is greater than the first length of the curved catheter.

3. 10. The intravenous therapy system of claim 1, wherein the curved needle further includes a bevel formed at an end point of the distal end of the curved needle, the edge of the bevel being formed to face a center point of the bend of the curved needle.

4. 10. The intravenous treatment system of claim 1, wherein in response to inserting a second length of the curved needle and a second length of the curved catheter into a patient's body, the curved needle and the curved catheter are parallel to the blood vessel.

5. The intravenous treatment system of claim 1 , wherein the curved catheter is made of a polymer and is formed into the shape of the curved needle.

6. 10. The intravenous treatment system of claim 1, wherein the needle bevel is prevented from pressing against the wall of the blood vessel in response to full insertion of the curved needle and curved catheter.

7. A method for manufacturing an intravenous device by fabricating a catheter together with a hollow tube constituting a needle in the intravenous treatment system according to any one of claims 1 to 6, comprising: introducing heated metal into an extrusion die, the extrusion die including an internal spider die, the internal spider die comprising a central shaft and a funnel portion, the central shaft defining an inner diameter of a hollow tube and the funnel portion defining an outer diameter of the hollow tube; adjusting an exit plane of the internal spider die to be non-orthogonal to an extrusion axis of the spider die, the central shaft and the funnel portion defining the exit plane having a high side and a low side such that the exit plane is non-orthogonal to the extrusion axis aligned with the central shaft; extruding the heated metal through an extrusion die to form the hollow tube, wherein as the heated metal is extruded through the extrusion die, the formed hollow tube curves from the lower side toward the higher side to form a curvature in the hollow tube, the curvature in the hollow tube being between 5 and 15 degrees; forming a catheter on the hollow tube to form a curved catheter on the hollow tube, the angle of curvature of the catheter being between 5 and 15 degrees; 1. A method of manufacturing an intravenous device, comprising:

8. The method of claim 7 wherein the metal is stainless steel.

9. The method of claim 7 , further comprising beveling the distal end of the hollow tube to form a sharp tip.

10. A method for manufacturing an intravenous device by fabricating a catheter together with a hollow tube constituting a needle in the intravenous treatment system according to any one of claims 1 to 6, comprising: introducing heated metal into an extrusion die, the extrusion die including an internal spider die, the internal spider die comprising a central shaft and a funnel portion, the central shaft defining an inner diameter of a hollow tube and the funnel portion defining an outer diameter of the hollow tube; extruding the heated metal through the extrusion die to form the hollow tube, wherein the central shaft and the funnel portion define an exit plane perpendicular to an extrusion axis coincident with the central shaft, and the formed hollow tube is straight when the heated metal is extruded through the extrusion die; forming a plastic catheter on the outside of the hollow tube so that the plastic catheter is coaxial with the straight hollow tube; bending the hollow tube and the plastic catheter using a bend fixture to form a curve in the hollow tube and the catheter, the curve in the hollow tube and the plastic catheter being between 5 and 15 degrees; 1. A method of manufacturing an intravenous device, comprising:

11. The method of claim 10 wherein the metal is stainless steel.

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