Hypodermic needle and manufacturing method

Abstract

The hypodermic needle is described as having a proximal end, a distal end having a tissue-piercing tip, and a lumen extending from the proximal end to the distal end. The elongate body may have a channel formed in its outer surface. The channel may be concave or formed in the outer wall. The portion having the channel may maintain a circular lumen, or the lumen may be non-circular or conform to the shape of the channel. Additionally, the elongate body may have a flattened portion along its length. The flattened portion may be at the distal-most portion of the elongate body extending proximally from the distal tip. The elongate body may also include a notch formed in the outer wall to communicate with the lumen or open to the lumen. The opening of the notch may traverse the lumen or be aligned with the lumen.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 387,688, filed December 15, 2022, entitled "HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE," which is incorporated by reference in its entirety.

[0002] Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003]

[0003] The present invention relates generally to hypodermic needles, and more particularly to providing hypodermic needles having one or more flat surfaces along the length of the needle to improve vascular access and intravascular medical procedures. [Background technology]

[0004] Vascular access is a necessary component of medical procedures, from catheter placement and blood withdrawal to fluid and medication delivery. Aside from invasive surgical procedures to access the vascular system, needles were developed in the early 19th century to provide vascular access with minimal physical trauma to the patient. Since then, there has been little innovation beyond the various alloys or compositions of these needles. There has been a significant difference in the amount of innovation in medical devices and instruments coupled to or dependent on needles compared to the needles themselves.

[0005] An example of a common medical procedure requiring a hypodermic needle is venipuncture for vascular access. Venipuncture generally refers to the process of obtaining intravenous access for any of a variety of purposes, including intravenous infusions, medical treatments, blood draws, and the like. In hospitals, for example, venipuncture is commonly used to place small intravenous catheters for intravenous fluid delivery, medication delivery, blood draws, and the like. While venipuncture in relatively healthy patients is a straightforward matter, such access is often necessary in patients who are less healthy and may have small, tortuous, collapsed, fragile, and / or difficult-to-find arteries and / or veins. In such patients, venipuncture or other forms of vascular access can be very difficult, especially for inexperienced phlebotomists, paramedics, nurses, and other healthcare professionals.

[0006]

[0006] Difficult access highlights the need for improved needles to increase the opportunity for additional capabilities of associated medical devices and instruments. Once a blood vessel is accessed, catheter placement may require the use of a guidewire or other type of guiding device to advance the catheter. Current needles require complex and cumbersome procedures of insertion, removal, reinsertion, adjustment, advancement, and retraction of various catheters, guiding devices, etc. Along with all of the instruments and devices, the procedures for their use are complicated and can introduce increased opportunities for error and patient injury. Summary of the Invention [Problem to be solved by the invention]

[0007] For these reasons, it would be desirable to provide improved devices, methods, and systems for improving (e.g., simplifying) vascular access and reducing adverse patient outcomes. It would be particularly desirable to provide improved hypodermic needles that can be configured to improve and expand the functionality and operation of associated instruments and devices during medical procedures. These objectives are achieved, at least in part, by the following various embodiments. [Means for solving the problem]

[0008] In one aspect, a hypodermic needle is provided that includes an elongate body having a proximal end and a distal end, a tissue-piercing tip at the distal end, a lumen extending through the elongate body from the proximal end to the distal end, and a channel formed along the length of the elongate body. In one embodiment, the channel is formed by a press-fit depression in the surface of the elongate body. In another aspect, the lumen adjacent to the channel has a shape complementary to the depression in the surface of the elongate body. In another version, a transition section is included that is positioned between the proximal length of the elongate body and the channel. In yet another aspect, a transition section is included that is positioned at the proximal end of the elongate body, where the channel extending proximally from the transition section is recessed relative to the length of the elongate body proximal to the transition section. Another variation includes a proximal transition section and a distal transition section, where the channel further includes a proximal channel and a distal channel, and the distal transition section is positioned between the proximal and distal channels. In yet another aspect, the elongate body further comprises a proximal region and a distal region, the proximal region and the distal region being separated by a transition section. Optionally, the transition section includes a surface that forms an acute angle with a surface of the channel. In yet another alternative, the channel extends along the entire length of the elongate body. There are other configurations in which a transition section separates the proximal channel from the distal channel, where the distal channel is more recessed than the proximal channel. In one embodiment, the lumen is non-circular, and in another embodiment, the lumen conforms to the shape of an adjacent portion of the channel. Another aspect includes a notch extending through the elongate body into a portion of the lumen. In another variation, the tissue-piercing tip is positioned at the distal end of the elongate body opposite the channel. Additionally or optionally, the channel includes a distal channel and a proximal channel, wherein the distal channel extends between the distal end of the elongate body and the transition section and the proximal channel extends from the transition section to the proximal end of the elongate body, wherein the depth of the distal channel is greater than the depth of the proximal channel. In another variation, the channel is crescent-shaped and is formed in the outer wall of the elongate body, and the lumen has a crescent shape corresponding to the crescent shape of the channel.

[0009] In another embodiment, a hypodermic needle is provided that includes an elongate body having a proximal end and a distal end, a tissue-piercing tip positioned at the distal end, a lumen extending from the proximal end to the distal end, a proximal channel extending along a proximal portion of the elongate body, and a distal channel extending from the distal portion of the elongate body to a transition section separating the proximal channel from the distal channel. In one variation, the distal channel is deeper than the proximal channel relative to the outer wall of the elongate body. In yet another alternative, a proximal transition section is provided at the proximal end of the proximal channel separating the proximal channel from the outer wall of the elongate body. In another configuration, the proximal and distal channels are recessed into the elongate body. Yet another variation has a proximal transition section, a distal transition section, and a ring-shaped proximal portion of the elongate body adjacent the proximal transition section. In another aspect, the proximal channel extends distally from the proximal transition section. In another configuration, the distal channel extends distally from the distal transition section. In yet another configuration, the proximal channel extends distally from the proximal end of the elongate body. Optionally, the proximal channel extends from a transition section positioned distally relative to the proximal end of the elongate body.

[0010] In another embodiment, a hypodermic needle is provided that includes an elongate body having a proximal end and a distal end, a tissue-piercing tip at the distal end, a lumen extending through the elongate body from the proximal end to the distal end, a channel formed along the length of the elongate body, and a notch formed in a wall of the elongate body, the notch forming an opening to the interior of the lumen. In one alternative, the wall of the elongate body has a curved or annular profile. In another aspect, the wall of the elongate body has a flat profile, with the remainder of the elongate body having a curved or annular profile. In one variation, the notch transverses the longitudinal axis of the lumen. In another configuration, the notch is aligned with the longitudinal axis of the lumen. In various alternatives, the shape of the opening formed by the notch is rectangular, curved, V-shaped, or faceted.

[0011] In yet another alternative embodiment, a hypodermic needle is provided comprising an elongate body having a proximal end and a distal end, a tissue-piercing tip at the distal end, a flat portion at the distal end, a lumen extending through the elongate body from the proximal end to the distal end, a channel formed in the outer wall of the elongate body along the length of the elongate body proximal to the flat portion, and at least one notch forming an opening to the interior of the lumen. In one variation, the notch transverses the longitudinal axis of the lumen. In another optional configuration, the notch is aligned with the longitudinal axis of the lumen. In other configurations, the shape of the opening formed by the notch is rectangular, curved, V-shaped, or faceted. Additionally or optionally, the at least one notch comprises a notch on the flat portion and a notch on the channel. In yet another configuration, the elongate body is annular, and the channel forms a concave surface in the elongate body. In yet another variation, the lumen has a circular cross section proximal to the flattened portion.

[0012] The novel features of the invention are set forth with particularity in the following claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1]

[0013] FIG. 1 is a perspective view from the distal end of an embodiment of a hypodermic needle as described herein. [Figure 2]

[0014] FIG. 2A is a side elevational view of the hypodermic needle shown in FIG.

[0015] Figure 2B is an additional view of the hypodermic needle shown in Figure 2A showing details of the distal portion, Figure 2C is an additional view of the hypodermic needle shown in Figure 2A showing details of the distal transition portion, and Figure 2D is an additional view of the hypodermic needle shown in Figure 2A showing details of the proximal transition portion. [Figure 3A]

[0016] FIG. 2 is a perspective view of the distal end of the hypodermic needle shown in FIG. 1. [Figure 3B]

[0017] FIG. 3B is another perspective view of the distal section of the hypodermic needle from FIG. 3A, showing an example of a cutout in the bottom surface of the hypodermic needle. [Figure 4]

[0018] FIG. 2 is a side elevational view of the hypodermic needle from FIG. 1. [Figure 5]

[0019] FIG. 2 is a side view of the distal end of the hypodermic needle shown in FIG. 1. [Figure 6]

[0020] FIG. 6A is a side elevational view of an embodiment of a hypodermic needle described herein.

[0021] FIG. 6B is a detailed view of the proximal portion of the hypodermic needle shown in FIG. 6A. [Figure 7]

[0022] FIG. 7A is a side elevational view of a hypodermic needle described herein.

[0023] FIG. 7B is a detailed view of the distal portion of the hypodermic needle shown in FIG. 7A. [Figure 8]

[0024] 8A and 8B are perspective views of an example distal tip from a hypodermic needle described herein. [Figure 9]

[0025] Figure 9A is a perspective view of an example of a hypodermic needle described herein; Figure 9B is a perspective view of an example of a hypodermic needle described herein; Figure 9C is a perspective view of an example of a hypodermic needle described herein; and Figure 9D is a perspective view of an example of a hypodermic needle described herein. [Figure 10]

[0026] FIG. 10A is a perspective view of an example hypodermic needle described herein.

[0027] FIG. 10B is a perspective view of an example hypodermic needle described herein. [Figure 11]

[0028] FIG. 1 is a perspective view of an example hypodermic needle as described herein, showing details of the needle distal end and tissue-piercing tip. [Figure 12A]

[0029] 1 is a perspective view of a hypodermic needle illustrating an exemplary configuration and arrangement of features described herein. FIG. [Figure 12B]

[0030] FIG. 12B is a detailed perspective view of the hypodermic needle from FIG. 12A showing the distal section. [Figure 12C] FIG. 12B is a detailed perspective view of the hypodermic needle from FIG. 12A showing the proximal section. [Figure 13A]

[0032] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different notch configuration, and a side view of a notch that crosses the needle lumen and has a rectangular shape formed on the flat surface of the needle. [Figure 13B] FIG. 10 is a detailed view of an example of a distal portion of a hypodermic needle described herein with a different cutout configuration, showing a side view of a cutout that traverses the lumen of the needle and has a curved shape formed on the flat surface of the needle. [Figure 13C] FIG. 10 is a detailed view of an example of a distal portion of a hypodermic needle described herein with a different cutout configuration, showing a side view of a cutout that traverses the lumen of the needle and has a V-shape formed on the flat surface of the needle. [Figure 13D] FIG. 10 is a detailed view of an example of a distal portion of a hypodermic needle described herein with a different cutout configuration, showing a side view of a cutout that traverses the lumen of the needle and has a facet shape formed on the flat surface of the needle. [Figure 13E]

[0033] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different cutout configuration, showing a top-down view of a cutout having a rectangular shape along the needle lumen. [Figure 13F]

[0034] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different cutout configuration, showing a top-down view of the circular cutout in the flat surface of the needle. [Figure 13G]

[0035] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different notch configuration, showing a notch that opens into the lumen as in Figure 13A, but the notch is formed in a curved or annular portion of the needle body, or on the surface opposite the flat needle surface. [Figure 13H]13B is a detailed view of an example distal portion of a hypodermic needle described herein with a different cutout configuration, showing a cutout opening into the lumen similar to FIG. 13B, but formed in a curved or annular portion of the needle body, or on the surface opposite the flat needle surface. [Figure 13I] 13C is a detailed view of an example of a distal portion of a hypodermic needle described herein with a different cutout configuration, showing a cutout that opens into the lumen as in FIG. 13C, but the cutout is formed in a curved or annular portion of the needle body, or on the surface opposite the flat needle surface. [Figure 13J] 13D is a detailed view of an example of a distal portion of a hypodermic needle described herein with a different cutout configuration, showing a cutout that opens into the lumen as in FIG. 13D, but the cutout is formed in a curved or annular portion of the needle body, or on the surface opposite the flat needle surface. [Figure 13K]

[0036] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different cutout configuration, where the cutout is formed in the round wall of the needle and has a rectangular shape along the lumen of the needle, and the cutout may be opposite the flat surface of the needle. [Figure 13L]

[0037] A detailed view of an example of the distal portion of a hypodermic needle described in this specification with a different cutout configuration, showing a view from below looking up at a circular cutout in the round wall of the needle, where the cutout may be formed in the round wall portion opposite the flat wall of the needle. DETAILED DESCRIPTION OF THE INVENTION

[0014]

[0038] The needles described herein can have features for use in combination with a guide element or other device adapted to extend along the outer surface of the needle. Generally, the needles have an elongate body or cannula with a lumen extending from the proximal end to the distal end to facilitate fluid flow therethrough. The distal end of the needle can have a tissue-piercing tip adapted to penetrate a patient's tissue during use. The outer surface of the needle can have one or more channels extending along the length of the needle body, extending along the entire length of the elongate body from the proximal end to the distal end. In some examples, the needle can have one or more channels extending along less than the entire length of the elongate body. For example, the needles described herein can have one or more channels extending along a segment of the elongate body.

[0015]

[0039] FIG. 1 shows an example of a needle 100 in a perspective view from the distal end. An elongate body 105 extends between a needle proximal end 110 and a tissue-piercing tip 115 at the needle's most distal end. A lumen 120 extending through the elongate body 105 is shown at its proximal end and can be adapted to direct the flow of fluid (e.g., blood) through the elongate body 105. In this example, a channel 125 is shown along the exterior surface of the needle 100. The channel 125 is generally recessed and is pressed into the needle during manufacturing, thereby modifying the elongate body from a cylindrical cannula to have one or more channels along the exterior of the elongate body 105. A channel distal end 130 is shown in FIG. 1 opposite the tissue-piercing tip 115 and forms a segment of the distal circumference of the lumen 120.

[0016]

[0040] In some examples, the channel may be a concave channel having a uniform depth. The channels described herein may extend along the length of the needle (e.g., the elongate body). For example, the channel may extend along the entire length of the elongate body from the proximal end (e.g., around the proximal lumen) to the distal end (e.g., around the distal lumen). In some examples, the channels described herein may have a uniform depth along the entire length of the channel. In some examples, the channels described herein may have a first depth at the proximal end of the channel and a second depth at the distal end of the channel. For example, the depth of the channel at or near the distal end of the channel may be greater than the depth at or near the proximal end of the channel. In some examples, the depth of the channel at or near the distal end of the channel may be less than the depth at or near the proximal end of the channel. In some examples, the channel may be described in terms of channel segments. In some examples, each channel segment can have the same depth. In some examples, one channel (e.g., channel segment) may have a greater depth than another channel (e.g., channel segment).

[0017]

[0041] 1 illustrates an example of a needle having channel segments separated by transition regions 135 and 140. In this example, proximal transition section 135 is positioned between channel 125 and a proximal portion of the elongate body that extends to proximal end 110. As shown in this example, the elongate body proximal to transition section 135 is generally cylindrical, with transition section 135 being positioned between the cylindrical exterior of the proximal end of elongate body 105 and channel 125 that extends distally from transition section 135.

[0018]

[0042] FIG. 2A shows the needle from FIG. 1 in a side elevation view, having a proximal channel 125b and a distal channel 125a along a segment of the needle's length. In this example, the channel 125 may include two channel segments 125a and 125b. From the elongate body proximal end 110, the proximal transition segment 135 is first pressed into the elongate body to form the transition from the needle proximal portion to the first (e.g., proximal) channel segment 125b. The notch 121 is also visible in this view, positioned generally on the opposite side of the needle from the channel, proximal to the tissue-piercing tip 115. FIG. 2B shows a detailed view of the distal end of the needle from FIG. 2A, detailing how the distal channel 125a transitions to the distal end of the needle and forms a portion of the luminal circumference. FIG. 2C shows details of the transition segment 140 positioned between the distal channel 125a and the proximal channel 125b.

[0019]

[0043] In FIG. 2D , proximal transition section 135 is shown in detail, with channel section 125b extending distally from transition section 135 to distal transition section 140, which is positioned between channel section 125b and channel section 125a, which extends distally from transition section 140. As shown in this example, distal channel section 125a is deeper (e.g., recessed further into the elongate body) than channel section 125b. Varying the depth of the channel or channel section may be adapted to accommodate different sections, features, regions, etc. of a guide element or other device that may extend along the outer surface of the needle during use. For example, as illustrated in FIGS. 2A-2D , distal channel section 125a, which is deeper than proximal section 125b, can be adapted to accommodate a distal portion of a guide element that may be larger than the elongate body of the guide element extending proximally therefrom.

[0020]

[0044] In some examples, the transition sections described herein may be configured to provide a gradual transition of the channel or channel segment along the length of the elongate body. In some examples, the transition section may be adapted to accommodate a guide element or similar device while urging and maintaining the position of the guide element or device along the exterior of the needle. For example, a transition section having a deeper channel extending proximally therefrom may be adapted to prevent a section of the guide element positioned distally relative to the transition section from retracting proximally relative to the transition section. For example, deployment of the guide element in this example may advance the guide element along the channel, deploying a larger distal section of the guide element from the distal channel section.

[0021]

[0045] In some examples, the needles described herein may have a channel adapted to receive a guide element extending along the outer surface of the needle, for example, the channel may be adapted to house a guide element or a guide element segment for routing or providing a path for the guide element.

[0022]

[0046] FIG. 3A shows another perspective view of a needle described herein, viewed from its distal end. Here, the distal end of lumen 120 is shown, and in this perspective view, notch (e.g., flashback feature) 121 can be seen extending through the needle wall (e.g., elongated body) and exposing the lumen to the exterior of the needle. In some examples, needles described herein may have one or more notches (e.g., notch 121) positioned on the needle and adapted to expose the needle lumen so that blood flow through the needle lumen can be confirmed when a portion of blood is viewed through the notch. For example, when blood is viewed through notch 121, the notch can provide a visual indication of successful penetration of a blood vessel. FIG. 3B shows a perspective view of the needle from FIG. 3A, viewed from the bottom side of the distal portion of the needle. The notch 121 is located at the bottom (eg, underside) of the needle and is configured to expose a portion of the needle lumen 120 so that the presence of blood in the needle lumen 120 can be visually confirmed.

[0023]

[0047] Lumen 120 is seen to have a generally crescent-shaped cross-section. Channel segment 125a extends along the distal length of the needle body, compressing lumen 120 from a cylindrical shape to the crescent shape shown in FIG. 3A . In some examples, needles described herein having one or more channels can be manufactured by compressing a concave channel into the interior of a cannula (e.g., the elongate body of the needle) to adapt the lumen to a crescent shape corresponding to the depth of the channel pressed into the elongate body from a generally cylindrical lumen prior to the channel. For example, the crescent-shaped characteristics of the needle lumen can be based on the concave characteristics of the channel (e.g., the channel's depth, width, location, etc.). In some examples, the wall thickness of the elongate body of the needle can be sufficient to allow for the creation of the channel by grinding or removing material from the needle wall to form the channel. In this example, the lumen of a needle described herein can have one or more channels (e.g., channel segments) having a uniform circular cross-section from the distal end of the elongate body to the proximal end of the elongate body.

[0024]

[0048] Referring to FIG. 4, a side elevation view of needle 100 shows examples of needle regions or segments identifiable by different channel segments, features, or characteristics of the elongate body. As described above, distal channel segment 155 is deeper than channel segment 166. In this example, the lumen extending from distal end 150 to the proximal end may have a different diameter along segment 155 than segment 160. In some examples, both segments 155 and 160 may have different diameters relative to a proximal location in a needle lacking a channel segment. The channel may be positioned along any length of the elongate body and may have a length corresponding to a guide element or other device on which the needle is adapted to be housed. For example, channel segment length 155 may be the same as, greater than, or less than channel segment length 160. The example shown in FIG. 4 may be configured to house a guide element having a distal end positionable on the distal channel along length 155 and a guide element proximal end positionable along channel segment length 160. In some instances, the needles described herein may be configured to accommodate guide elements having larger distal sections or include features that benefit from deeper channels in the outer needle surface.

[0025]

[0049] In FIG. 5, needle 100 is shown from a side view looking through lumen 120 at its distal end. Tissue-piercing tip 115 lies about the distal lumen generally opposite channel 125. In this view, it can be appreciated and understood that the width of the channel can be adapted or configured to accommodate a guide element or other instrument therein. For example, if a guide element may have a distal end or distal section that is larger than the elongate body of the guide element, the width of the distal channel section can be larger than the proximal channel section to accommodate a larger portion of the guide element therein. Also visible in FIG. 5 is an example of a crescent shape of lumen 120, having a cross-section that corresponds to the depth of channel 125.

[0026]

[0050] In some examples, the lumen may extend linearly from the distal end to the proximal end of the needle. In some examples, the lumen may be curved or non-linear along its entire length, as changes in channel depth may result in changes in the lumen. For example, the lumen may be crescent-shaped at or near the distal end of the needle and cylindrical at or near the proximal end of the needle, with a transition from the crescent-shaped lumen to a cylindrical lumen. In some examples, the lumens described herein may be coaxial along the entire length of the lumen through the needle. In some examples, the lumen may not be coaxial along the entire length of the needle if there are multiple channel segments and / or cylindrical needle segments. For example, returning to Figure 4, from the needle proximal end to the needle distal end, the lumen may have a first axis from the needle proximal end to a first channel (e.g., length 160), where the lumen axis changes to a second lumen axis along length 160, where the second lumen axis can change to a third lumen axis along length 150. In some examples, the lumen may be coaxial from the needle distal end to the needle proximal end, although the needle may include a channel or multiple channel segments.

[0027]

[0051] In some examples, a needle (e.g., a hypodermic needle, an access needle, a percutaneous needle, a sharp, etc.) has a tissue-piercing end and an engagement element separated by an elongate body having at least one flat surface along the length of the elongate body. A central lumen may extend from the proximal end to the distal end and be configured to direct one or more fluid flows therethrough. The tissue-piercing distal end may be configured to penetrate one or more layers of tissue when advanced into contact with the outer surface of a substrate (e.g., biological tissue). In some examples, the needles described herein may include one or more flat surfaces, one or more channels, or a combination of one or more flat surfaces and one or more channels positioned along the length of the elongate body. For example, the needle may include a channel (e.g., a concave channel) along the length of the elongate body proximal to the flat surface that extends distally beyond the concave channel. In some examples, the needle may include a concave channel extending distally from the flat surface along the length of the elongate body. In some examples, the arrangement of the flat surfaces and concave channels may be in any arrangement along the exterior length of the elongate body.

[0028]

[0052] In some examples, a hypodermic needle as described herein may have one or more flat surfaces that can extend along the length of the needle. In some examples, the needle length may be the distance of the cannula from the proximal end to the tissue-piercing tip. In some examples, the needle length may be the distance from the distal end to the proximal end, which may include one or more engaging elements. For example, the needle length may include the distance from the distal end to the engaging element (e.g., the cannula-cannon junction) configured to engage with the cannon. Considering an example in which the length of a hypodermic needle described herein is defined by the longitudinal distance between the proximal end and the distal end (e.g., the tissue-piercing tip), the flat surfaces may extend longitudinally along the length of the needle. In some examples, the flat surfaces may extend along the entire length of the needle. In some examples, the flat surfaces may extend along a length of the needle (e.g., cannula) that is shorter than the entire length of the needle.

[0029]

[0053] The flat surface can be configured to facilitate passage of one or more instruments along the length of the flat surface during use. In some examples, the hypodermic needles described herein can be operably coupled to one or more medical devices (e.g., instruments). In some examples, the coupled medical devices may rely on the hypodermic needle for penetration and access to tissue, vasculature, cavities, other anatomical structures, or combinations thereof. In some examples, the coupled medical devices may rely on the hypodermic needle for penetration and access through tissue, vasculature, cavities, other anatomical structures, or combinations thereof. The flat surface can be configured to reduce cross-sectional area to limit physical damage to tissue during use.

[0030]

[0054] In some examples, the flat surface may be a seating surface against which one or more instruments may slide and contact. A hypodermic needle as described herein may be configured to engage a medical device. For example, an engaging element may be located at the proximal end of the hypodermic needle, which may be coupled, affixed, adhered, integrated, etc. to the medical device. Some examples of medical devices may be a syringe, a barrel, a tube, a hub, a catheter, an intravascular access device, etc. The engaging element at the proximal end of the hypodermic needle may be configured to engage and hold the needle in operable communication with the medical device. In some examples, the hypodermic needle may be configured to facilitate the transfer, flow, or passage of one or more fluids from the medical device to a patient (e.g., a blood vessel or tissue in which the hypodermic needle is positioned).

[0031]

[0055] Flat surfaces along the needle can be configured to contact or otherwise engage one or more instruments. For example, the hypodermic needles described herein can have one or more flat surfaces along the length of the needle, and each flat surface can be configured to receive, contact, or otherwise engage an instrument. In some examples, the needle can be used in combination with one or more components (e.g., medical devices) during procedures involving tissue penetration. One example of a medical device can be an intravascular access device, which can depend on a needle for initial access to a blood vessel and the introduction of a catheter, introducer, dilator, or the like. In such an example, the needle can be positioned within a catheter lumen at the distal end of the intravascular access device.

[0032]

[0056] The tissue-piercing tip may include a tip configured to penetrate a patient's tissue during use (e.g., a tissue-piercing tip). The tissue-piercing tip may be located at the distal end of a beveled surface extending from one or more flat surfaces along the needle. The tissue-piercing tip may be configured to penetrate one or more tissues. In some examples, the tissue-piercing tip may be the apex of one or more surfaces that may converge to each other at a point (e.g., a tissue-piercing tip). In some examples, the tissue-piercing tip may include the apex of multiple flat surfaces (e.g., a polyhedron). In some examples, the tissue-piercing tip may be the apex of a pyramidal arrangement of three or more surfaces. In some examples, the surfaces converging at the apex (e.g., a tissue-piercing tip) may be quadratic, tertiary, quaternary, etc. beveled surfaces. Multiple beveled surfaces on the tissue-piercing tip may be configured to minimize physical damage to the tissue as the tissue-piercing tip advances through the tissue.

[0033]

[0057] In some examples, the bevel at the distal tip of the needle may be flat or substantially flat. In some examples, the bevel at the distal tip of the needle may include one or more curves, arcs, or other features associated with a non-flat surface. For example, the bevel may be concave from the proximal end of the bevel to the distal end of the bevel (e.g., the tissue-piercing tip). In some examples, the bevel may be convex or otherwise curved outward from the proximal end of the bevel to the distal end of the bevel (e.g., the tissue-piercing tip).

[0034]

[0058] In some examples, the tissue-piercing tip may include a single bevel, multiple bevels, or multiple facet configurations. The tissue-piercing tip may have one or more geometric features of a flat distal configuration along the cannula, as described herein. The geometry of the tissue-piercing tip may be based on the application for which the needle is to be used. Some examples of tissue-piercing tips for hypodermic needles may include one or more elements or geometric features from needle tip configurations such as a diamond needle tip, a Quincke needle tip, a Fransen needle tip, a Whittaker needle tip, a Sprott needle tip, a short bevel needle tip, a Chiba needle tip, a Tuohy needle tip, a Cournan needle tip, a Menghini needle tip, a backcut bevel needle tip, a Dos Santos needle tip, a Seldinger needle tip, a conical tip, a curved tip, a cutting tip, a reverse cutting tip, a tapered, a tapered cutting tip, a micropoint tip, or a spatula tip, as described herein.

[0035]

[0059] In some examples, the central lumen extends through the interior of the needle from the proximal end to the tissue-piercing end. For example, the central lumen may extend from an opening at the proximal end and extend along the central axis to an opening on a bevel at the tissue-piercing end. In some examples, the central lumen may extend from the proximal end to an opening in the needle at one or more locations that can be located proximal to the tissue-piercing end. For example, the central lumen may extend from an opening at the proximal end to an opening at a point along the needle that is proximal to the tissue-piercing end. In some examples, one or more flat surfaces positioned longitudinally along the exterior length of the needle may be coplanar with the axis of the central lumen.

[0036]

[0060] 6A and 6B show an example side elevation view of a hypodermic needle 170 as described herein. A distal end 175 has a tissue-piercing tip 171 at the distal end of the needle 170. The tissue-piercing tip 110 is configured to penetrate tissue during use. For example, the tissue-piercing tip 110 may be configured to penetrate multiple layers of dermal tissue and penetrate into the patient's vascular system. A flat surface 172 extends along the cannula of the needle 170 within a flat surface section 176 between the distal end 175 and an engagement section 177 having an engagement element 173. A detailed close-up of the engagement section 177 near the proximal end of the needle 170 is provided to illustrate an example transition between the flat surface 172 and the engagement element 173 at the indicated area 180.

[0037]

[0061] This transition section, region, feature, etc. may be of any geometric shape (e.g., angled, tapered, curved, etc.). In some examples, the transition from a rounded surface of a needle, as shown in, for example, FIG. 6A, to a flat surface, or a channel, as shown in, for example, FIG. 1, may include a transition section that is curved or angled relative to the flat surface or channel. In some examples, if the transition section is angled, the transition section may form a slope or bevel at an obtuse angle between the transition section and the flat surface or channel. In some examples, if the transition section is angled, the transition section may form a slope or bevel at an acute angle between the transition section and the flat surface or channel. In some examples, if the transition section is angled, the transition section may form a slope or bevel at a right angle between the transition section and the flat surface or channel.

[0038]

[0062] In some examples, the transition between engaging element 173 and flat surface 172 may be configured to facilitate transition of an instrument from the proximal end of needle 170 (e.g., a medical device, an intravascular access device) to the distal end of the needle along flat surface 172. For example, a guidewire or guiding element (not shown) may transition from the intravascular access device along flat surface 172, and transition 180 may facilitate routing of the guiding element along the needle.

[0039]

[0063] The engaging element may be any shape configured to engage an instrument at the proximal end of the needle. In some examples, the flat surface 172 may extend along the entire length of the needle from the distal end to the proximal end such that the cross-sectional geometry of the needle is consistent or uniform along the length of the flat surface. In some examples, the needle may be tapered or may have a non-uniform cross-sectional geometry along the length of the needle. For example, the needle may taper from a larger proximal end to a distal end such that advancing the needle through tissue may enlarge an opening in the tissue.

[0040]

[0064] 7A and 7B show an example hypodermic needle in a detailed, enlarged view near the distal end. Here, a flat surface 210 is seen extending from the proximal end of the needle 205 to the distal end of the needle. A notch 220 is shown intersecting the needle's flat surface. The notch 220 may be positioned anywhere along the length of the needle. In some examples, the needle may have multiple channels oriented at various positions and locations. The notch 220 may be configured to facilitate the flow of fluid (e.g., blood, medication, saline, etc.) while the needle is within a patient. The notch 220 may extend into the needle's cannula to fully expose a central lumen (not shown) extending from the proximal end to the distal end. In some examples, the notch 220 may form a distal opening of the lumen such that the lumen extends from the distal end to the channel.

[0041]

[0065] In some examples, the hypodermic needle may have a beveled surface 216 extending from the flat surface 210 to the tissue-piercing tip 215. FIG. 7B shows an example of an angle 217 between the beveled surface 216 and the flat surface 210. In some examples, the angle 217 may be based on the geometry of the distal tip used and optimized to increase the effectiveness of tissue penetration and limit physical damage to the tissue as the needle is advanced through the tissue. In some examples, an increase in the angle 217 may result in an increase in the size of the distal opening of the needle lumen. In some examples, an increase in the angle 217 may result in a decrease in the size of the distal opening of the needle lumen. In some examples, a decrease in the angle 217 may result in an increase in the size of the distal opening of the needle lumen. In some examples, a decrease in the angle 217 may result in a decrease in the size of the distal opening of the needle lumen.

[0042]

[0066] 8A and 8B, detailed views of the needle distal end are provided to illustrate an example of a tissue-piercing tip 300. The tissue-piercing tip 300 may have an apex that can be the convergence point of multiple surfaces 305 to optimize the surface area at the distal-most point of the tissue-piercing tip 300. The placement of the surfaces may be determined during manufacturing based on the optimal placement to form the most effective tip for penetrating tissue. The needle lumen 310 is shown here opening through the distal end generally through a beveled surface 315. The beveled surface 315 is shown here angled from a flat surface 320 toward the tissue-piercing tip 300. The starting point of the beveled surface 315 at point 321 may be at any angle to optimize the ability of the tissue-piercing tip 300 to penetrate tissue.

[0043]

[0067] In some examples, the flat surface may be positioned along the length of the needle generally opposite the tissue-piercing tip. The example of FIGS. 8A and 8B illustrates this, where a midline may be drawn from the tissue-piercing tip 300 and a midline for the flat surface 320. In this example, each side of the midline may be considered generally symmetrical to the other. In some examples, the flat surface 320 may be positioned such that the needle's midline forms an asymmetrical side. For example, the flat surface may be positioned longitudinally along the needle at any location around the needle's circumference. For example, the needle's central axis may have identifiable radial members extending outward therefrom. The flat surface may be positioned perpendicular to any radial members extending outward from the needle's central axis. In some examples, the flat surface may be more proximal to the tissue-piercing tip than to the opposite end of the diameter of the central lumen.

[0044]

[0068] 8B also shows a detailed view of an exemplary geometry of the distal opening of the needle lumen 310. Here, the example shows a generally oval shape with a distal edge 311 and a proximal edge (e.g., heel of the needle) 312. The length (e.g., major axis) extending between the distal edge 311 and the heel 312 may be based on the angle of the bevel 315. The minor axis is generally perpendicular to the major axis but may have a length related to the diameter of the needle lumen 310. In some examples, the distal opening of the needle lumen has a predetermined geometry such that the bevel 315 can be created at an angle relative to the flat surface 320 to increase or decrease the length of the major axis. The heel 312 may be configured to reduce or prevent coring.

[0045]

[0069] In some examples, a hypodermic needle may have multiple flat surfaces. For example, the needle may have multiple flat surfaces positioned longitudinally along the needle. In some examples, the flat surfaces may be separated by channels such that the flat surface has multiple sections along the same plane. FIG. 9A shows a needle having a first flat surface section 400 and a second flat surface section 405. The first flat surface section 400 is shown extending from the engagement element 403 to the notch 412, and then the second flat surface section 405 extends from the distal side of the notch 412 to the distal end of the needle. FIG. 9B also shows an example of how the flat surfaces of a needle may be separated by notches. In this example, each flat surface section may be flush with one another. FIG. 9C shows another example of a needle having a continuous flat surface 415 extending from the engagement element 403 to the distal end. Yet another example of a notch configuration for a needle described herein is shown in Figure 9D, where notch 417 is positioned on flat surface 416. Here, notch 417 is shown to align with lumen 418 and is configured to exhibit retrograde flow when the tissue-piercing tip is inserted into a blood vessel.

[0046]

[0070] The placement of the flat surface and flat surface segments may be based on the use of the needle and / or the combination of the needle with other medical devices, such as instruments or intravascular access devices. For example, the placement of the flat surface location on the needle may be based on the routing of a guide element or guidewire that extends from a medical device at or near the proximal end of the needle to the distal end of the needle.

[0047]

[0071] 10A and 10B show perspective views of a hypodermic needle showing a central lumen 500 extending from the proximal end to the distal end of the needle through a bevel proximal to the tissue-piercing tip. A channel 510 may be positioned near the distal end of the needle, exposing the central lumen 500 and configured to allow fluid to flow outside the central lumen 500. In some examples, the channel may be configured to allow blood flashback to be visible when the tissue-piercing tip is inserted into a blood vessel. For example, if the needle is used with a catheter, e.g., a catheter coupled to an intravascular access device, the needle may be well inside the central lumen of the catheter. As the needle is advanced into the blood vessel, blood can flow proximally from the opening of the needle lumen 500 into the needle. Visual confirmation of blood vessel insertion may be required for the user to understand needle placement during use. Thus, blood may enter the opening of the needle lumen (e.g., on the bevel at the distal end of the needle) and exit the lumen exposed by the channel 510. Blood exiting the lumen exposed by channel 510 may be retained within the catheter central lumen, but is visible within the channel by the user.

[0048]

[0072] 10A also shows diagrams of exemplary geometries for the transition from the needle proximal end 515 and the flat surface 520. In some examples, this transition 505 can be an angled geometry with a slope from the proximal end 515 to the flat surface 520. Examples of sloped transitions in area 505 can be flat, substantially flat, or curved. In some examples, the geometry can be a vertical or substantially vertical transition. In some examples, the transition 505 can be a tapered transition from the proximal end to the flat surface. The transition 505 can have any geometry for the transition from the proximal end to the flat surface.

[0049]

[0073] The type of transition may be based on the engagement of the proximal end of the needle with an instrument or device, such as a needle carrier for an intravascular access device. In some examples, transition 505 may be configured to facilitate the transition of a guide element (e.g., a guidewire) that can be advanced along the exterior of the needle, such as from the proximal end of the needle along the flat surface and past the distal tip of the needle. In some examples, the guide element may be configured for routing along the exterior of the needle, including routing along the transition from the proximal end to the flat surface.

[0050]

[0074] FIG. 11 shows an exemplary perspective view of a close-up of the distal end of a hypodermic needle as described herein. Flat surface 600 is seen extending along the length of the distal end of the needle, but may be a discontinuous surface with channels 620 cut into the needle. In some examples, the discontinuous flat surface may be flush with each portion or segment of the flat surface along the needle. In some examples, the discontinuous flat surface may not be flush with each portion or segment of the flat surface along the needle. In some examples, each portion or segment of the flat surface may be flush with, non-flush with, or a combination of, one or more portions or segments of other flat surfaces along the needle. Channel 620 is cut to expose needle lumen 610 so that fluid (e.g., blood) can flow from within needle lumen 610 and be visible in the area defined by channel 620. Exposure of blood by channel 620 may be configured to indicate proper placement of the needle within a blood vessel when the needle is in use. For example, a flashback or flush of blood exposed by the channel can indicate that the tissue-piercing tip 625 and needle lumen distal opening 610 are well inside the blood vessel.

[0051]

[0075] Beveled surface 616 extends from flat surface 600 at transition area 605 and angle 617. Angle 617 may be configured to determine the size and geometry of the distal opening of needle lumen 610 on beveled surface 616, where the length of the major axis between distal edge 618 and heel portion 615 may be relative to angle 617 of beveled surface 616. The geometry of the needle lumen distal opening may be configured to facilitate a flow rate of blood or other fluid therethrough. For example, the fluid passing through needle lumen 620 may have one or more attributes (e.g., viscosity, density, heterogeneity, etc.) that enable it to flow through the needle lumen at a more favorable rate based on the distal opening of needle lumen 610.

[0052]

[0076] 12A-12C show another example of a hypodermic needle as described herein. In this example, the needle may be discussed relative to one or more segments. For example, proximal segment 701 may have a length extending distally from the proximal end of the needle to one or more channels 720. Middle segment 702 may include a length extending distally from notch 720 to distal segment 703, which may include a flat surface 705 and a distal tip having a beveled surface 715. A second notch 710 is shown to be located on the flat surface near the distal end of the needle. Here, it extends from proximal end 701 to the proximal end of flat surface 705 along the routing element. As shown here, routing element 700 is an indentation in the needle that can be configured to route, receive, retain, guide, etc., one or more elongated members positioned therein. For example, a guidewire (not shown) may have an elongate body length that can be configured to mount or otherwise engage the deployment element 700. The elongate body of the guidewire may be coupled to a guide element at its distal end configured to contact the flat surface 705 of a hypodermic needle described herein. In some examples, the flat surface of a hypodermic needle described herein may be configured with dimensions corresponding to the dimensions of the guide element at the distal end of the guidewire. For example, the guide element may have a complementary shape to the distal end of the needle such that the guide element has a corresponding flat surface configured to operably contact the flat surface of a hypodermic needle described herein. In some examples, the guide element may be mounted on the flat surface 705 in a ready-to-use configuration once the needle is inserted into a blood vessel. The guide element may advance distally along the flat surface 705 as the guidewire is advanced from the proximal end. In some examples, the transition shape from the needle to the flat surface may correspond to the geometry of the proximal end of the guide element to facilitate engagement of the guide element when mounted on the flat surface 705 of the needle.

[0053]

[0077] In some examples, the guide element may be positioned on the flat surface (e.g., 705) of a hypodermic needle described herein. A notch (e.g., 710) may be cut into the needle sufficiently to expose the needle lumen so that blood can flow from the needle lumen near the channel and between the channel and the surface of the guide element. Any of the notches described herein may be positioned on any surface of the needle and at any location along the length of the needle. For example, the notch may be positioned adjacent to the distal end of the needle. The notch may be positioned between the distal end of the needle and the proximal end of the needle. For example, the notch may be positioned at 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, or more. A needle with multiple notches may include notches positioned at different distances relative to the distal end of the needle (e.g., the tissue-piercing tip) and may be positioned on either surface of the needle relative to the flat, channel, or rounded surface of the needle (e.g., the elongated body).

[0054]

[0078] In some examples, a guide element in operable communication with a hypodermic needle described herein may have a complementary geometry to the needle, such that when the guide element is positioned on the flat surface of the needle, the combination of the guide element and the distal end of the needle (e.g., including the flat surface) may form a generally cylindrical compound cross-sectional geometry. In some examples, the guide element and needle are configured to be operably coupled to one another and configured to be positionable within a catheter lumen. For example, a hypodermic needle and guide element described herein may be positioned within a catheter at the distal end of an intravascular access device.

[0055]

[0079] 12B and 12C, the distal end in FIG. 12B is shown in detail, showing the cutout 710 exposing the needle lumen 721. The beveled surface 715 can be seen with the distal opening of the needle lumen 716 having a major axis whose length can be defined by the angle between the beveled surface 715 and the flat surface 705. The routing element 700 can be seen in both FIGS. 13A and 13B as a longitudinal concave recess into the needle. Considering FIG. 13A, the routing element 700 extends generally collinear with the needle lumen and extends directly through the transition to the flat surface 705. In this manner, a guidewire can extend through the routing element 700 and into a guide element coupled to the distal end of the guidewire. The guide element can then be operably positioned on the flat surface 705 such that the proximal end of the guide element contacts the needle along the flat surface 705, including the proximal transition from the flat surface 705.

[0056]

[0080] Cutout 720, shown in detail in FIG. 13B, is shown exposing needle lumen 721. In some examples, the hypodermic needles described herein may have one or more cutouts along the length of the needle. In some examples, the channel may be located along any arc, side, location, etc. of the needle. One or more of the cutouts may be located perpendicular to the plane of the flat surface, as shown in FIG. 13A. In some examples, one or more cutouts may be positioned or cut at an angle relative to the plane defined by the flat surface of the needle. The location of the one or more cutouts may be configured to provide the most advantageous visibility for viewing blood flowing from the needle lumen at the channel. In some examples, the cutouts may be located on the opposite side of the needle from the flat surface, so that the needle may be inserted with the flat surface facing away from the user, while the cutouts located on the opposite side of the needle may still be visible to the user.

[0057]

[0081] 13A-13L illustrate some examples and variations of needle notch configurations described herein. It should be understood that in some embodiments where the needle is adapted and configured for use with a vascular access device, the notches can be shaped, sized, and positioned relative to the distal tip to aid in blood flow, so-called flashback detection, blood detection, or to indicate that the distal tip and lumen are in a blood vessel. In some embodiments, the notches are sized, shaped, and spaced relative to the distal end to perform a flashback function.

[0058]

[0082] 13A-13D, detailed views of a hypodermic needle distal portion are shown in cross-section to illustrate example geometries of cutouts that create openings through the elongate body (e.g., needle wall) that expose the lumen extending through the needle. For example, in FIG. 13A, cutout 121a is generally square and positioned vertically across the elongate body with sufficient depth to cut away from the needle wall to expose the needle lumen. Similarly, cutouts 121b, 121c, and 121d may all be perpendicular to the needle body. In FIG. 13E, a top plan view of the needle tip portion shows that cutout 121e is generally parallel to the needle lumen and positioned on a flat surface or channel of the needle to expose the needle lumen therethrough. FIG. 13F also shows cutout 121f positioned on a flat surface or channel of the needle with a circular geometry from the top plan view.

[0059]

[0083] Further examples of cutout configurations and locations are shown in Figures 13G-13L, where the cutouts are located on the bottom surface of the needle. Referring to Figures 13G-13J, cutouts extending perpendicular to the needle body are shown in cross-section at the bottom surface of the needle (e.g., the surface adjacent the tissue-piercing tip) with various geometric shapes. In Figures 13K and 13L, the bottom views of these examples show cutout configurations that expose the lumen without extending perpendicular to the needle body.

[0060]

[0084] In any example of a needle described herein, the flat surface may be a flat surface along the length of the needle. In some examples, the flat surface extends from the distal end of the needle to the proximal end of the needle. In some examples, the flat surface may extend along a length or section of the needle from the proximal end of the needle. In some examples, the flat surface may extend along a length or section from the distal end of the needle. In some examples, the flat surface may extend along the length of the needle between the proximal end of the needle and the distal end of the needle. In some examples, the distal end of the needle. In some examples, the distal end of the needle may include a beveled surface. In some examples, the distal end of the needle may be the distal end of the flat surface.

[0061]

[0085] In any example of a needle described herein, the flat surface may be concave along the length of the needle. The concave surface may be concave between the width of the concave surface extending transversely to the needle. In some examples, the concave surface may be concave into the needle material. In some examples, the cross-sectional geometry of the needle may include the needle being generally annular around the needle lumen, with the concave section of the needle being thinner than the remainder of the needle. In some examples, the concave surface extends from the distal end of the needle to the proximal end of the needle. In some examples, the concave surface may extend along a length or section of the needle from the proximal end of the needle. In some examples, the concave surface may extend along a length or section from the distal end of the needle. In some examples, the concave surface may extend along the length of the needle between the proximal end of the needle and the distal end of the needle. In some examples, the distal end of the needle. In some examples, the distal end of the needle may include a beveled surface. In some examples, the distal end of the needle may be the distal end of the concave surface.

[0062]

[0086] In any example of a needle described herein, the flat surface may be convex along the length of the needle. The convex surface may be concave between the width of the convex surface extending transversely to the needle. In some examples, the convex surface may be convex outward from the needle material. In some examples, the cross-sectional geometry of the needle may include the needle being generally annular around the needle lumen, with the convex section of the needle being thicker than the remainder of the needle. In some examples, the convex surface extends from the distal end of the needle to the proximal end of the needle. In some examples, the convex surface may extend along the length or section of the needle from the proximal end of the needle. In some examples, the convex surface may extend along the length or section from the distal end of the needle. In some examples, the convex surface may extend along the length of the needle between the proximal end of the needle and the distal end of the needle. In some examples, the distal end of the needle. In some examples, the distal end of the needle may include a beveled surface. In some examples, the distal end of the needle may be the distal end of the convex surface. In some instances, the needle lumen may have a larger diameter along the length of the needle corresponding to the length of the convex surface, hi some instances, the larger diameter of the needle lumen may be configured to facilitate increased flow (e.g., flow rate) of fluid therethrough.

[0063]

[0087] In some examples, the needles described herein may have a channel extending across (e.g., laterally) the needle at any location along the length of the needle. As described herein, the needles may include one or more channels at any location on the needle. While the images provided herein show examples of channels as elongated portions of the needle that have been removed (e.g., cut away), the channels may include any openings, apertures, depressions, etc. having any geometric configuration. For example, the channels may have one or more circular openings (e.g., holes) extending through the needle from the outer surface to the interior of the needle lumen.

[0064]

[0088] The methods of manufacturing a needle described herein may include determining the location of a flat surface on a cannula (e.g., a needle body). The location of the flat surface may include establishing the longitudinal placement, dimensions, and characteristics of the flat surface. The needle may initially have a generally cylindrical outer surface before removing material at the determined flat surface location. The needle may be positioned in a cassette configured to hold the needle during the removal process. One or more methods for removing material from the needle body at the determined flat surface location may then be applied to the needle. The step of removing material may continue until a flat surface is established along the determined location.

[0065]

[0089] In some examples, the cassette may be configured to hold multiple needles, for example, multiple needles may be processed at once by positioning (e.g., inserting) the needles into or onto the cassette so that the removal method can effectively remove or modify the cannula to provide a flat surface thereon.

[0066]

[0090] In some examples, methods of removing material from the needle surface to form a flat surface may include milling, grinding, laser machining (cutting, welding, marking), burr-free cutting, laser welding, microwelding, micromachining, injection molding, coating, swaging, brazing, forming, bending, electropolishing, electrochemical marking, electro-discharge machining (EDM), swaging, flattening, grinding, etc. In some examples, any milling, machining, physical, electrical, chemical process configured to form a flat surface as described herein may be used.

[0067]

[0091] In some examples, cutting the outer surface of the needle may include removing an arcuate section of the outer surface of the needle. In some examples, the needle may have one or more sections that can be modified, cut, adjusted, or otherwise altered based on the predetermined configuration of the needle. For example, the engagement section at the proximal end may be generally cylindrical or any geometric shape configured for use with an additional instrument or element operably engageable therewith. In some examples, producing a flat surface as described herein may include an extrusion technique in which the needle is passed through one or more dies having a shape configured to modify the exterior of the needle cannula. For example, a generally cylindrical needle may be inserted into an extrusion device and passed through one or more dies configured to modify the cylindrical exterior of the needle into a needle with a flat surface as described herein. In some examples, forming a flat surface as described herein can be achieved using a press or mold, where the needle in a starting configuration having a generally cylindrical cannula along the length of the needle is inserted or operably positioned in or on the press. The mold or die may be applied based on the location and configuration desired for the resulting flat surface or needle surface configuration. Pressure may be applied to modify the shape of the needle according to the determined location of the flat surface provided by the mold or die.

[0068]

[0092] In some examples, the needles described herein may be configured to reduce pain or impact to a patient during use. For example, a tissue-piercing tip, flat surface, or other feature of a needle described herein can reduce the pain experienced by a patient. In some examples, the needles described herein can reduce the amount of pain as determined by a visual analog scale. A visual analog scale is a linear scale used to rate pain using a range of numbers (e.g., 0-10 or 0-100). For example, a lower number may indicate little or no pain, while a higher number may indicate increased pain. In some examples, the needles described herein can be rated on a visual analog scale with lower numbers compared to other needles. In some examples, pain can be determined by a Gracely Box Scale using words corresponding to the numbers. The Gracely Box Scale can be used to detect differences between different regions of the pain scale. Example words used on this scale can be no pain, low pain, mild pain, moderate pain, etc. In some examples, the needles described herein can be described with words on the Gracely Box Scale that indicate less pain than one or more other needles.

[0069]

[0093] In some examples, the needles described herein may be configured to reduce the amount of force required to penetrate or puncture tissue. For example, the needles described herein may have a tissue-piercing tip configured to reduce the amount of force required to penetrate skin by 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, or any percentage in between.

[0070]

[0094] Additional aspects of the construction and operation of catheter placement devices including a housing or handle having a mechanism for advancing a catheter-carrying guiding structure or element, where the handle is adapted to automatically retract both the access needle and the guiding structure or element from the catheter after the placement procedure is complete, as well as a button-activated automatic needle and guide retraction assembly are described in U.S. Patent Publication No. 2008 / 0300574 and U.S. Patent No. 9,522,254, each of which is incorporated herein by reference in its entirety.

[0071]

[0095] Further details of exemplary intravascular catheter insertion devices and methods are described in U.S. Patent Nos. 5,704,914 and 5,800,395, and U.S. Patent Publication Nos. 2010 / 0094310, US2010 / 0210934, and US2012 / 0197200, the entire disclosures of each of which are incorporated herein by reference.

[0072]

[0096] There may be one or more variations, alternatives, constructions, compositions, and / or components described herein that can be used to modify the elements, components, devices, systems, processes, etc. of the guide element, intravascular access device, and / or related structures or processes. Accordingly, any variations, descriptions, examples, elements, components, processes, methods, method steps, etc. described herein can be used as a modification, variation, and / or replacement for any element, device, system, composition, example, component, process, method, method step, etc. described in Provisional Patent Application No. 63 / 328,732, filed April 7, 2022, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," and / or PCT Application No. PCT / US2021 / 54046, filed October 7, 2021, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," which are incorporated herein by reference in their entirety.

[0073]

[0097] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The appended claims define the scope of the invention, and it is therefore intended to cover methods and structures that fall within the scope of these claims and their equivalents.

[0074]

[0098] As used herein, when a feature or element is referred to as being "on" another feature or element, the feature or element can be directly on the other feature or element, and intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. When a feature or element is referred to as being "coupled," "attached," or "coupled" to another feature or element, it is understood that the feature or element can be directly coupled, attached, or coupled to the other feature or element, and there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly coupled," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being disposed "adjacent" another feature may have a portion that overlaps or underlies the adjacent feature.

[0075]

[0099] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprise" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0076]

[0100] Spatially relative terms such as "below," "lower," "below," "above," "upper," and the like may be used herein to describe the relationship of one element or feature to another element or feature shown in the figures for ease of description. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, an element described as being "below" or "directly below" another element or feature would then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an above and below orientation. The device may be oriented in other ways (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, unless specifically indicated otherwise, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only.

[0077]

[0101] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0078]

[0102] Unless the context requires otherwise, throughout this specification and the claims that follow, the word "comprise," as well as variations such as "comprises" and "comprising," mean that various components may be employed together in methods and articles (e.g., compositions and apparatuses, including apparatus and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0079]

[0103] As used herein in the specification and claims, including when used in the examples, and unless expressly specified otherwise, all numbers may be read as if preceded by the word "about" or "approximately," even if the term does not explicitly appear. The terms "about" or "approximately" may be used when describing a size and / or location to indicate that the stated value and / or location falls within an expected reasonable range of values ​​and / or locations. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include that about or approximately value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range stated herein is intended to include all subranges subsumed therein. As will be appreciated by those skilled in the art, when a value is disclosed, it is understood that "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between the values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is understood that throughout this application, data is provided in several different formats, and this data represents endpoints and starting points, as well as ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only values ​​between 10 and 15 are considered to be disclosed, but also values ​​greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than 10 and 15, and equal to 10 and 15. It is also understood that each unit amount between two specific unit amounts is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0080]

[0104] While various exemplary embodiments have been described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0081]

[0105] The examples and illustrations contained herein indicate, for purposes of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized or derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein by the term "invention," either individually or collectively, for mere convenience and without intending to intentionally limit the scope of this application to any single invention or inventive concept if multiple are actually disclosed. Thus, while specific embodiments have been illustrated and described herein, any configurations calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to include any and all modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. an elongate body having a proximal end and a distal end; a tissue-piercing tip at the distal end; a lumen extending through the elongate body from the proximal end to the distal end; a channel formed along the length of the elongate body; A hypodermic needle comprising:

2. the channel is formed by a press-fit depression in a surface of the elongate body; 2. The hypodermic needle of claim 1.

3. the lumen adjacent the channel has a shape complementary to the depression in the surface of the elongate body.

3. The hypodermic needle of claim 2.

4. further comprising a transition section positioned between the proximal length of the elongate body and the channel. A hypodermic injection needle according to any one of claims 1 to 3.

5. further comprising a transition section positioned at a proximal end of the elongate body; the channel extending proximally from the transition section is recessed relative to a length of the elongate body proximal to the transition section; 2. The hypodermic needle of claim 1.

6. further comprising a proximal transition section and a distal transition section; the channel further comprises a proximal channel and a distal channel; The hypodermic needle of claim 1 , wherein the distal transition section is positioned between the proximal channel and the distal channel.

7. The hypodermic needle of claim 1 , wherein the elongate body further comprises a proximal region and a distal region, the proximal region and the distal region being separated by a transition section.

8. the transition section comprises a surface that forms an acute angle with a surface of the channel. A hypodermic needle according to any one of claims 4 to 7.

9. the channel extends along the entire length of the elongate body; 2. The hypodermic needle of claim 1.

10. a transition section separating the proximal channel from the distal channel, the distal channel being recessed relative to the proximal channel; 8. The hypodermic needle of claim 7.

11. the lumen is non-circular; 2. The hypodermic needle of claim 1.

12. further comprising a notch extending through the elongate body into a portion of the lumen.

2. The hypodermic needle of claim 1.

13. the tissue-piercing tip is positioned at the distal end of the elongate body opposite the channel; 2. The hypodermic needle of claim 1.

14. the channel comprises a distal channel and a proximal channel; the distal channel extends between the distal end of the elongate body and a transition section; the proximal channel extends from the transition section to the proximal end of the elongate body; the depth of the distal channel is greater than the depth of the proximal channel; 2. The hypodermic needle of claim 1.

15. the channel is crescent-shaped and formed in an outer wall of the elongate body; the lumen has a crescent shape corresponding to the crescent shape of the channel; 2. The hypodermic needle of claim 1.

16. an elongate body having a proximal end and a distal end; a tissue-piercing tip positioned at the distal end; a lumen extending from the proximal end to the distal end; a proximal channel extending along a proximal portion of the elongate body; a distal channel extending from a distal portion of the elongate body to a transition section separating the proximal channel from the distal channel; A hypodermic needle comprising:

17. the distal channel is deeper than the proximal channel relative to an outer wall of the elongate body; 18. The hypodermic needle of claim 17.

18. a proximal transition section at the proximal end of the proximal channel separating the proximal channel from an outer wall of the elongate body; A hypodermic injection needle according to claim 16 or claim 17.

19. the proximal channel and the distal channel are pressed into the elongate body; 17. The hypodermic needle of claim 16.

20. a proximal transitional segment; a distal transition segment; a ring-shaped proximal portion of the elongate body adjacent the proximal transition section; and Further provided with 17. The hypodermic needle of claim 16.

21. the proximal channel extends distally from the proximal transition section; 19. The hypodermic needle of claim 18.

22. the distal channel extends distally from the distal transition section; 19. The hypodermic needle of claim 18.

23. the proximal channel extends distally from the proximal end of the elongate body; 17. The hypodermic needle of claim 16.

24. the proximal channel extends from a transition section positioned distally relative to the proximal end of the elongate body; 17. The hypodermic needle of claim 16.

25. an elongate body having a proximal end and a distal end; a tissue-piercing tip at the distal end; a lumen extending through the elongate body from the proximal end to the distal end; a channel formed along the length of the elongate body; a notch formed in a wall of the elongate body, the notch forming an opening to the interior of the lumen; A hypodermic needle comprising:

26. the wall of the elongate body has a curved or annular profile; 26. The hypodermic needle of claim 25.

27. the wall of the elongate body has a flat shape; the remainder of the elongate body has a curved or annular profile; 26. The hypodermic needle of claim 25.

28. the notch is transverse to the longitudinal axis of the lumen; 26. The hypodermic needle of claim 25.

29. the notch is aligned with the longitudinal axis of the lumen; 26. The hypodermic needle of claim 25.

30. The shape of the opening formed by the cutout portion is rectangular, curved, V-shaped, or faceted.

30. A hypodermic needle according to any one of claims 25 to 29.

31. an elongate body having a proximal end and a distal end; a tissue-piercing tip at the distal end; a flat portion of the distal end; and a lumen extending through the elongate body from the proximal end to the distal end; a channel formed in an outer wall of the elongate body along a length of the elongate body proximal to the flat portion; at least one notch forming an opening to the interior of the lumen; A hypodermic needle comprising:

32. the notch is transverse to the longitudinal axis of the lumen; 32. The hypodermic needle of claim 31.

33. the notch is aligned with the longitudinal axis of the lumen; 32. The hypodermic needle of claim 31.

34. The shape of the opening formed by the cutout portion is rectangular, curved, V-shaped, or faceted.

34. A hypodermic needle according to any one of claims 31 to 33.

35. the at least one cutout comprises a cutout on the flat portion and a cutout on the channel.

35. The hypodermic needle of claim 34.

36. the elongate body is annular; the channel forms a concave surface in the elongate body; 32. The hypodermic needle of claim 31.

37. the lumen having a circular cross-section proximal to the flat portion; 32. The hypodermic needle of claim 31.

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