WO2025264842A1

WO2025264842A1 - Hypodermic needles and methods of manufacture

Info

Publication number: WO2025264842A1
Application number: PCT/US2025/034230
Authority: WO
Inventors: Raul LEYTE-VIDAL; Amir Belson
Original assignee: Venocare Inc
Current assignee: Venocare Inc
Priority date: 2024-06-18
Filing date: 2025-06-18
Publication date: 2025-12-26
Anticipated expiration: 2026-12-18

Abstract

A die press apparatus and method of operating to fabricate vascular access needles having one or more complex shapes at different locations at or adjacent to or proximal to a tissue penetrating tip along with features along one or more positioned spaced along the body of the needle. In some specific needle configurations, the features are specifically positioned and shaped to cooperate with an article used with the needle such as a handle, catheter, guide element, valve, seal or other component of a vascular access system.

Description

HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63/661,539, titled “HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE,” filed June 18, 2024, which is incorporated by reference in its entirety.

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.

FIELD

[0003] The present invention relates generally to hypodermic needles. More particularly, the present invention provides a hypodermic needle with one or more flat surfaces along a length of the needle to improve vascular access and intravascular medical procedures.

BACKGROUND

[0004] Vascular access is necessary element of medical procedures from catheter placement and blood draws to delivering fluids and drugs. Aside from invasive surgical procedures to access vasculature, needles were developed in the early part of the 19^th century to provide vascular access with the least amount of physical damage to a patient. Since that time, there has been little innovation outside of different alloys or compositions for these needles. There has been a stark difference in the amount of innovation between the medical devices and tools coupled to, or relying on, needles compared to the needles themselves. [0005] Venipuncture is a common procedure requiring hypodermic needles.

Venipuncture refers generally to the process of obtaining intravenous access for any one of a variety of purposes, including intravenous infusion, therapy, blood sampling, and the like. In the hospital, for example, venipuncture is commonly used to place a small intravenous catheter for delivering intravenous fluids, drug delivery, blood sampling and the like. While venipuncture in relatively healthy patients can be a simple matter, such access is often needed in patients who are not healthy and may have small, tortuous, collapsed, fragile, and/or difficult to locate arteries and/or veins. Accordingly, improvements in vascular access devices can benefit from improvements in hypodermic needle form and function. For example, additional capacity of a needle to facilitate the use of catheter assemblies, guide elements, guide wires, or other medical devices can benefit vascular access procedures. Manufacturing these needles, as described herein, can involve one or more steps to produce improved needles to improve medical procedures for which they are employed.

[0006] For these reasons, it would be desirable to provide improved needles and methods of manufacturing the same to improve and expand the function and operation of their use during medical procedures. At least some of these objectives will be met by the various embodiments that follow.

SUMMARY OF THE DISCLOSURE

[0007] Disclosed herein are various embodiments of needles, manufacturing components, and related methods. In general, a hypodermic needle may comprise an elongate body with a tissue penetrating tip at a distal end, a lumen extending through the elongate body, and at least one longitudinal channel pressed into a length of the elongate body.

[0008] In this any other example described herein may further comprise one or more of the following. A first longitudinal channel pressed into a length of the elongate body proximal to a second longitudinal channel pressed into a length of the elongate body. The first and second longitudinal channels can both being parallel to a central axis of the needle. A transition region can be positioned between the first longitudinal channel and the second longitudinal channel. A crimped segment having a diameter less than a cylindrical proximal segment of the elongate body configured to be positioned through a valve of a catheter assembly. A proximal longitudinal channel and a distal longitudinal channel, wherein the distal longitudinal channel may extend between a distal opening of the lumen to the proximal longitudinal channel. The distal longitudinal channel can be deeper than the proximal longitudinal channel. The longitudinal channel may extend along an entire length of the elongate body. A distal longitudinal channel and a proximal longitudinal channel, wherein the distal channel can be configured to receive a guide element distal segment, and the proximal channel can be configured to receive a guide wire extending proximally from the guide element in the distal longitudinal channel. A transition region may separate the proximal longitudinal channel from the distal longitudinal channel, wherein the distal longitudinal channel may be deeper than the proximal longitudinal channel. The lumen may be noncircular along the length of the at least one longitudinal channel. An opening can be through the elongate body configured to expose the lumen to an exterior of the elongate body. A distal longitudinal channel may be adjacent to the tissue penetrating tip and extending proximally along the elongate body to a transition where a proximal channel extends proximally from the transition to a crimped needle segment positioned between the proximal channel and the proximal end of the elongate body. A distal channel and a proximal channel, wherein the distal channel extends between the elongate body distal end and a transition segment, wherein the depth of the distal channel may be greater than the depth of the proximal channel. The elongate body may have a crescent cross-sectional shape along the length of the at least one channel.

[0009] In general, a method of manufacturing a hypodermic needle may comprise the steps of providing a die comprising an upper plate and a lower plate, the upper plate may comprise a longitudinal raised portion configured to contact a needle cannula, the lower plate comprising a recess adapted to receive the needle cannula; positioning a needle cannula in the recess of the lower plate; aligning the upper plate longitudinal raised portion with the needle cannula; contacting the needle cannula with the upper plate; deforming the needle cannula correspondingly with the longitudinal raised portion of the upper plate.

[0010] In this any other example described herein may further comprise one or more of the following. The step of positioning the needle cannula in the recess of the lower plate may further comprise determining a position on the needle cannula for a longitudinal channel, rotating the needle cannula in the lower plate recess until the determined position is superior to the lower plate recess before contacting the needle cannula with the upper plate. The upper plate may comprise a first longitudinal raised portion and a second longitudinal raised portion, wherein the first longitudinal raise portion is proximal to the second longitudinal raised portion. The method may further comprise the step of contacting the needle cannula with the first longitudinal raised portion and the second longitudinal raise portion forming a first longitudinal channel and a second longitudinal channel long the needle cannula. The second longitudinal channel can extend further from the upper plate than the first longitudinal channel. The method may further comprise contacting the needle cannula with the upper plate more than once. The method may further comprise supplying force to the upper plate to contact the needle cannula. The force supplied to the upper plate may be 100 psi or more. The force supplied to the upper plate may be 125 psi, 250 psi, 500 psi, or 1000 psi. The method may further comprise supplying a first force to the upper plate, then supplying a second force to the upper plate. The needle cannula may be 10 gauge to 35 gauge or more or less or any size therebetween. The needle cannula may be between 20 gauge and 25 gauge, less than 20 gauge, or more than 25 gauge. In any example, the needle may have one or more segments of the same gauge, or different gauges. The lower plate comprises a first side and a second side, wherein the method further comprises the step of retaining the needle cannula in the lower plate recess by contacting the needle with the first side and the second side of the lower plate. [0011] In general, the die, press, and/or any other manufacturing component for the needles described herein can be configured and operated to perform any of the methods to manufacture a needle and/or any feature of the same, as described herein.

[0012] In general, needles described herein may comprise an elongate body with an upper surface and a lower surface extending between a proximal end and a distal end. A lumen then extends from the elongate body proximal end to the elongate body distal end. A tissue penetrating tip can be positioned at the distal end of the lower surface. The needle then has at least one deformed portion along the elongate body upper surface. In some examples, there may be a deformed portion (e.g., concave, convex, crimped, or otherwise irregularly shaped compared to a generally cylindrical needle canula).

[0013] In this any other example described herein may further comprise one or more of the following. The at least one deformed portion can be concave towards a center of the lumen. The at least one deformed portion may comprise a first longitudinal channel proximal to a second longitudinal channel, the first and second longitudinal channels can both be parallel to a central axis of the needle; and a transition region can be positioned between the first longitudinal channel and the second longitudinal channel. The at least one deformed portion can comprise a valve segment with a deformed upper surface and a deformed lower surface along the length of valve segment adapted to extend through a valve of a catheter assembly. The at least one deformed portion can comprise a proximal longitudinal channel and a distal longitudinal channel, wherein the distal longitudinal channel extends between a distal opening of the lumen to the proximal longitudinal channel. The distal longitudinal channel can be more concave than the proximal longitudinal channel. The at least one deformed portion may extend along an entire length of the elongate body upper surface. The at least one deformed portion comprising a distal longitudinal channel having a concave curvature adapted to receive a guide element. The at least one deformed portion further comprising a proximal longitudinal channel having a concave curvature adapted to receive a guide wire extending proximally from the guide element in the distal longitudinal channel. A transition region can separate the proximal longitudinal channel from the distal longitudinal channel, wherein the concave curvature of the distal longitudinal channel is greater than the concave curvature of the proximal longitudinal channel. An opening through the elongate body configured to expose the lumen to an exterior of the elongate body. A distal longitudinal channel opposite the tissue penetrating tip and extending proximally along the elongate body to a transition segment where a proximal channel extends between the transition segment and the valve segment. The elongate body lower surface may be generally convex shaped and the at least one deformed portion is concave shaped. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The novel features of the invention are set forth with particularity in the claims that follow. 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 of which:

[0015] FIGS. 1 A and IB illustrate an example of a die configured to be used according to one or more of the methods described herein.

[0016] FIGS. 2 A to FIG. 2C illustrate an example of a die configured to be used according to one or more of the methods described herein.

[0017] FIGS. 3 A to FIG. 3E illustrate an example of a die configured to be used according to one or more of the methods described herein.

[0018] FIG. 4 is a process diagram illustrating an example of a manufacturing process for needles described herein.

[0019] FIG. 5 is another process diagram illustrating additional examples of manufacturing process for needles described herein.

[0020] FIG. 6 is another process diagram illustrating additional examples of manufacturing process for needles described herein.

[0021] FIG. 7 shows various views of a needle cannula from an initial configuration through various steps of methods described herein.

[0022] FIG. 8 is a perspective view of an embodiment of a hypodermic needle from a distal end, as described herein.

[0023] FIG. 9A is a side elevation view of the hypodermic needle shown in FIG. 1.

[0024] FIGS. 9B, 9C, and 9D are additional views of the hypodermic needle shown in FIG. 2A showing details of the distal section, distal transition section, and proximal transition section, respectively.

[0025] FIG. 10 is a perspective view of the hypodermic needle shown in FIG. 1 from the distal end.

[0026] FIG. 11 is profile view from the distal end of the hypodermic needle shown in FIG. 1.

[0027] FIG. 12 is a side elevation view of the hypodermic need from FIG. 1.

[0028] FIG. 13 is a side elevation view of a needle having a crimped section with multiple channel sections provided by the processes described herein.

[0029] FIG. 14 is a detailed view of the crimped segment (e.g., valve segment) from the needle shown in FIG. 9. [0030] FIG. 15A is a distal perspective view of the needle from FIG. 9 with an example of a formed surface along the crimped segment.

[0031] FIG. 15B is a cross sectional view of the needle from FIG. 11 A with the cross section through the crimped segment of the needle to expose the lumen therethrough.

[0032] FIG. 16 is a distal perspective view of a needle having a crimped section with a channel surface as well as additional channel surfaces extending distally from the crimped segment.

[0033] FIGS. 17A and 17B are detailed views of the crimped section from the needle shown in FIG. 16 including a cross section in FIG. 17B to expose the lumen extending therethrough.

[0034] FIG. 18 shows a cross section of a needle illustrating an example the formed needle cannula at the crimped segment of the needle.

[0035] FIG. 19 shows a distal perspective view of a needle with a cross section at a segment of the needle distal to the crimped segment to expose the lumen extending through one of the channel segments.

[0036] FIG. 20 is another perspective view of a distal segment of the hypodermic needle including an examples of a notch in a bottom surface of the hypodermic needle.

DETAILED DESCRIPTION

[0037] Needles described herein can have features for use in combination with guide elements or other tools adapted to extend along the needle exterior surface. Generally, a needle may have an elongate body or cannula with a lumen extending therethrough from a proximal end to a distal end to facilitate a flow of fluid therethrough. The distal end of a needle can have a tissue penetrating tip adapted to penetrate tissue of a patient during use. The exterior surface of the needle is formed or provided with one or more features, elements, segments, regions or otherwise to augment a generally cylindrical cannula to have one or more channels (e.g., grooves), flat surfaces, crimped regions, bleed-back features, or a combination thereof. In some examples, using methods described herein, the needle may have one or more features along a linear section such as one or more channels extending along a length of the elongate body. For example, using one or more forms, molds, dies, or other tools configured to translate pressure to form the needle cannula can provide the channels, crimped regions, flat surfaces, reduce or eliminate a needle heel, or otherwise provide for a needle described herein.

[0038] In some examples, methods of manufacturing needles comprise the use of a die to provide one or more features of the needle such as the irregular needle surface. A die may have one or more portions (e.g., plates) adapted to contact the needle cannula. In some examples, on or more of the die portions maybe adapted to contact the needle cannula and change the cylindrical form of the needle cannula to a needle having an irregular or noncircular cross-sectional geometry along a length of the needle cannula.

[0039] FIG. 1 A to FIG. 3E illustrate examples of die that may be used according to the methods described herein. Referring to FIG. 1 A and IB, this example of a die comprises an upper plate 10 and a lower plate illustrated having two portions 11 and 12 adapted to form a recess 15 in the lower plate configured to receive a needle cannula therein. A raised portion 16 on the upper plate 10 is shown in alignment with the lower plate recess 15 and can be adapted to contact the needle cannula along a length aligned in a superior position along the recess 15. FIG. IB shows the upper plate 10 in operable communication with the lower plate 11 and 12 to form the opening 15 where a needle may be contacted and formed according to the raised feature 16. In the cross-sectional view of FIG. IB, the shape impressed to the needle cannula can be appreciated having a formed crescent or non-circular cross-sectional lumen according to the depression resulting from contact with the raised feature 16.

Although the raised feature 16 appears to have uniform dimensions, there may be a first linear segment of uniform dimension such as the heigh or extend of which feature 16 protrudes from the upper plate. In some examples, there may be more than one linear segment of the raised feature 16 where each linear segment of the raised feature may be dissimilar such that when the raised feature 16 contacts a needle cannula it produces channels along the needle cannula of different depths (e.g., compresses or crushes the needle lumen according to the dimensions of the raised feature of the upper plate).

[0040] FIGS. 2 A to 2C illustrate another example of a die used in the manufacture of needles according to methods described herein. In this example, the die includes an upper casing 20 and a lower casing 21 configured to align and translate pressure to the lower plate 22 and the upper plate having a distal portion 23 and a proximal portion 24. In FIG. 2A, a needle recess 25 can be seen in the lower plate 22 that can be adapted to retain the needle cannula therein. In some examples, the needles described herein may be further manufactured to include a notch that can expose the needle lumen for bleed-back or flash-back confirmation the needle is positioned within a blood vessel during use. Accordingly, the recess 25 can be adapted to allow for formation of the notch in the needle surface.

[0041] Referring to FIG. 2B, the upper plate includes a distal portion 23 and a proximal portion 24. As described herein, the needles may be provided with more than one channel along the needle body to accommodate tools such as guide wire or guide element. For example, a needle may be manufactured according to methods described herein to have a proximal channel adapted to be compatible with a guide wire, while a distal channel can be compatible with a guide element. For example, the proximal channel of a needle described herein may comprise dimensions optimized for accommodating a guide wire therethrough and prevent buckling of the guide wire as it is extended along the needle exterior surface through a catheter during a vascular access procedure. The distal channel may have dimensions to accommodate a guide element positioned therein and may be larger or wider than the proximal channel to accommodate the guide element in the distal channel and the guide wire in the proximal channel.

[0042] The needle cannula 30 can be seen in FIGS. 2 A and 2B with the proximal end of the needle extending beyond the die and ready to be formed according to the methods described herein. The distal side elevation view shown in FIG. 2C of the die from FIG. 2A shows the arrangement of the lower plate 22 and the distal upper plate 23 with the needle 30 positioned therebetween as the upper case 20 is compressed against the lower case 21 to form one or more channels in the needle 30.

[0043] FIGS. 3A to 3E illustrate yet another example of a die having an upper case 35 and a lower case 36 with alignment members 37 and compression member 38 positioned throughout the upper and lower cases to align the upper plate distal portion 40 and the upper plate proximal portion 41 with the lower plate 39, as it may be arranged during use. The views in FIG. 3A to FIG. 3C illustrate the die with some portions (e.g., upper case 35 and lower case 36) substantially transparent to reveal exemplary details of the internal configuration for features and elements.

[0044] Referring to FIGS. 3B and 3C, the die can be seen in transition from an arrangement configuration in FIG. 3B to a compression configuration in FIG. 3C with the upper plate (e.g., distal plate 40) compressed or in contact with the lower plate 39. As described herein, the lower plate 39 may comprise one or more portions that can complement one another to accommodate the needle cannula. In FIG. 3B, the lower plate 39 comprises a first side 39a and a second side or portion 39b that can be adjustable around the needle cannula to retain the cannula in the needle recess of the lower plate for alignment with the upper plate raised feature (e.g., 40a). Also shown in FIG. 3B is an alignment feature 40b of the upper plate 40 that can facilitate proper alignment of the die with the lower plate 39. FIG. 3C shows the alignment and operable communication between the upper plate 40 and the lower plate 39 when in a compressed state as the raised portion 40a of the upper plate 40 is pressed into the needle 45. The detailed views in FIGS. 3D and 3E show the needle 45 already contacted by the upper plate distal portion 40 in FIG. 3D and then with the distal portion 40 removed in FIG. 3E to show contact between the upper plate proximal portion 41 to form the proximal portion or a different proximal channel into the needle 45.

[0045] Some of the methods described herein include aligning the needle cannula in the needle recess of a die plate. For example, methods of manufacturing needles and the resulting needles described herein may have a channel formed at any position along a length of the needle cannula. Accordingly, the needle may be rotated to a position within the die to provide the surface where the channel is to be positioned arranged in a superior position relative to the lower die plate. Referring to FIG. 3E or an example, the tissue penetrating tip 47 is positioned on an opposite side of the needle 45 from where the channel 49 and/or channel 48 are pressed into the needle. Stated differently, the tissue penetrating tip may be at a 6 o’clock position of the needle 45 while the channels are positioned at a 12 o’clock position.

[0046] In the detailed cross section view of FIGS. 3D and 3E, the distal upper plate 40 has the protrusion or raised feature 40a contacting the needle 45 to crush or press the channel 48 into the needle and thereby compress the cannula 46 to a crescent shape. Then, in FIG. 3E, the proximal upper plate 41 has the raised portion 41a to form channel 49 in the needle cannula, visible with the distal plate 40 removed from this view.

[0047] FIG. 4 to FIG. 6 are illustrative examples of manufacturing processes for producing needles that can be configured for use with blood draw devices, catheter placement, administration of medications, facilitate over-the-needle guide wires or medical devices, improve needle function with a valve or other medical device. In some examples, the needles described herein are formed using a die having one or more portions to engage, retain, and form the needle.

[0048] A needle cannula may be initially provided having a generally cylindrical body with a length between a proximal end adapted to couple with a medical device (e.g., vascular access device) and a distal tip adapted to penetrate a patient’s tissue. In some examples, the distal tip may be one of the steps in the processes described herein. For example, an initial needle cannula may be an elongate body having a lumen therethrough. A tissue penetrating tip may be cut or otherwise provided on a distal end of the needle cannula.

[0049] Referring to FIG. 4, an initial needle cannula is positioned in a die at step 100. The needle cannula may have an upper surface and a lower surface. In some examples, the upper surface of the needle cannula (e.g., needle) may be the length of the elongate body extending on an opposite side of the cannula circumference from the tissue penetrating tip. Stated differently, the tissue penetrating tip may mark a point of the cannula circumference at the distal end of the lower portion or distal point of the lower portion of the cannula. In some examples, the lower portion of the needle is positioned in the die with the upper portion exposed an available for contact from another die portion adapted to translate pressure and a pre-determined shape to the needle cannula. At step 200, the lower die portions are brought together and hold the needle in position with the orientation previously described including the needle upper portion exposed and away from the lower die portions. The process illustrated in FIG. 4 shows a single-channel needle. The die or other tooling members may be adapted with pre-determined features such as channels that can be pressed into the needle cannula. In some examples, the needles described herein may have a single channel extending along a length of the needle. For example, a channel extending continuously along the length of the pressed portion of the needle. In other examples, one or more die may be selected for multiple channels having one or more transitions between the channels. For example, a first channel may have a first depth and be positioned proximal along the needle cannula to a second channel having a second depth positioned distal to the first channel. Additional channels may be provided along the length of the needle cannula according to the final form of the needle to be produced.

[0050] At step 110, the upper portion of the die is set for a single-channel needle with the die and channel positioned over the needle cannula. Pressure is then supplied to the upper die portion which translates the pressure as the die contacts the needle surface to impress or otherwise form the channel into the needle at step 115. Once the initial needle cannula has been deformed from the initial cylindrical cannula to the needle having a channel extending along a length of the needle. The upper die may be retracted and the channeled needle may be subjected to additional processing, polishing, etc.

[0051] In some examples, the lower die portions may be two portions configured to interact with one another as well as hold the needle in position while the upper die is pressed to form the channel. In some examples. The lower die portions may also translate pressure along the needle cannula to prevent inadvertent deformation of the needle cannula outside of the channel pressed by the upper die portion.

[0052] In some examples, the formation of a channel or other deformed needle cannula segment may include an upper die having more than one channel feature preset in the die. For example, FIG. 5 illustrates a process similar to FIG. 4 where a needle cannula is initially positioned in a die (e.g., lower ide portions) that are set to hold the initial cannula in position. Then, at step 130, the upper die is pressed into the initial cannula as pressure is supplied to the upper die causing it to contact and deform the initial needle cannula. In this example, the upper die may have more than one channel predetermined into the shape and configuration of the die. Further illustrated in FIG. 7, needles may have more than one channel with transition areas between the channels allowing for different channel depth or characteristics. Accordingly, the upper die portion may have the channel and transition regions predisposed on the die and arranged to translate them to the initial cannula. FIG. 6 illustrates another example of a process to manufacture needles having more than one channel including a first upper die configured to provide a first needle channel at step 150. Subsequent die with additional channel configurations, crimp segment configurations or other needle features may be provided as the process illustrated in FIG. 6 is repeated for the additional of subsequent needle features (e.g., additional channels, etc.). As shown in FIG. 6, after pressure is supplied to the upper die portion to contact and form the needle according to the upper die portion, the process may be repeated at step 150 to provide another upper die portion having a different feature to impress or translate to the needle being manufactured.

[0053] In some examples, the upper die portion comprises more than one upper die portion that may be positioned and used to form the needle simultaneously, sequentially, repeatedly, serially, etc. For example, a die may have two lower portions configured to contact the needle cannula along lateral sides of the needle. In some examples, the upper die portion may be configured to complement and be compatible with the lower die portions. Where there is a single upper die portion, the upper die portion may complement the entire length of the lower die portions and/or the length of the needle being contacted or otherwise acted upon by the upper die portion. In some examples, the upper die portions may comprise more than one die portion (e.g., two upper die portions) that can complement one another and be aligned with different linear regions of the needle cannula. Each of the upper die portions may have the same or different features configured to be imparted onto the needle surface. In some examples, one of the upper die portions may be adapted to provide a first feature onto the needle cannula, while a second die portion can be configured to provide a second feature onto the needle cannula.

[0054] As described herein, the lower die portions may prevent lateral expansion of the needle cannula when the upper die is pressed into the initial cannula. For example, an initial needle cannula may be cylindrical and when the upper die is pressed onto the cannula, there may be a tendency of the cannula to expand laterally to accommodate the pressure and deformation from the upper die. Accordingly, the lower die portions can prevent the lateral expansion and further direct the pressure from the upper die portion to the intended and predetermined deformation of the upper needle surface.

[0055] In any of the examples provided herein, the upper die plate and/or lower die plate may be pressed against the needle cannula to deform the cannula and provide one or more channels along the needle. In some examples, the pressure supplied to the die and translated to the needle may be 1 psi or more. In some examples, the pressure supplied to the die and translated to the needle may be more than 100 psi. For example, the amount of pressure supplied to the needle cannula may be between 200 psi and 500 psi. In some examples, the pressure supplied to the needle cannula via one or more of the die components (e.g., upper plate, lower plate, plate casing, etc.) may be any pressure between 1 psi and 2000 psi. IN any of the examples described herein, the pressure supplied to the needle cannula to form the longitudinal channels may be supplied for a period of time. For example, pressure may be supplied to the needle cannula in the formation of one or more longitudinal channels for 1 second or more. For example, the pressure supplied to the needle cannula to form one or more channels may be 10 seconds or more or less. In some examples, a first pressure is supplied and then a second or subsequent pressure is supplied. In some examples, the first pressure may be great than, less than, or equal to the first pressure. In some examples, the amount of pressure supplied to the needle cannula may be for a first period of time and then for a second or subsequent period of time.

Examples: [0056] In some examples, the needle specifications used may be as provided in the table below with the dimensions provided in inches: [0057] In some examples, the specifications of needles subjected to one or more methods described herein may as follows after subjected to a first press in a die at a pressure of 125 psi. The table below provides dimensions in inches.

[0058] In some examples, the specifications of needles subjected to one or more methods described herein may as follows after subjected to a first press in a die at a pressure of 250 psi. The table below provides dimensions in inches.

[0059] In some examples, the specifications of needles subjected to one or more methods described herein may as follows after subjected to a first press in a die at a pressure of 500 psi. The table below provides dimensions in inches

[0060] In some examples, the specifications of needles subjected to one or more methods described herein may as follows after subjected to a first press in a die at a pressure of 1000 psi. The table below provides dimensions in inches.

[0061] In some examples, the specifications of needles subjected to one or more methods described herein may as follows after subjected to a first press in the die illustrated in FIG.

3 A to FIG. 3E. The table below provides dimensions in inches.

[0062] In any of the examples described herein, the die may be configured to crush or otherwise produce needles having a channel along an entire length of the needle. In some examples, the die may be configured to provide one or more channels along a length of the needle that is positioned within or otherwise in operable communication with the upper and lower plates. In some examples, the needles described herein may be formed using a single press within the die. In some examples, the needles described herein may be formed using more than one press with a die. In some examples, where a die comprises an upper plate with a proximal portion and a distal portion, the different die plate portions may be interchangeable allowing for adaptability in the formation, position, characteristics, dimensions, attributes, or other features of the resulting needle after contact and crushing or compression in a die.

[0063] In FIG. 7, a sequence of changes from a needle cannula 160 are shown. Here, the initial needle cannula 160 is generally cylindrical and comprises a body extending from the tissue penetrating tip 165 to a proximal end 160b. The cross section of the cannula 160 is shown in the lower left and the needle lumen 170 can be seen through the cannula 160. The middle figures illustrate the creation of a first channel 175a and a second channel 175b. The channel 175a comprises different dimensions compared to channel 175b including a more narrow groove or channel into the needle cannula. Accordingly, channel 175a may be an example of a guide wire channel or a proximal channel formed by methods described herein, while the distal channel 175b may be wider and adapted to communicate with a guide element positioned thereon. Of note, the lumen 170 is generally crescent shaped compared to the initial cannula lumen 170 in the figure on the left. Finally, the figure on the right shows a complete needle including the proximal end 160b and the proximal channel 175a then the distal channel 175b looking at the needle from the tissue penetrating tip 165.

[0064] FIG. 8 is a perspective view of an embodiment of a hypodermic needle from a distal end, as described herein. The elongate body 205 extends between the needle proximal end 210 and the tissue penetrating tip 215 at the distal most end of the needle. The proximal end of lumen 220 extending through the elongate body 205 is shown and can be adapted to direct a flow of fluid (e.g., blood) through the elongate body 205. In this example, a channel 225 is shown along an exterior surface of the needle 200. The channel 225 is generally concave and may be pressed into the needle during manufacture such that the elongate body is changed from a cylindrical cannula to having one or more channels along the exterior of the elongate body 205. The channel distal end 230 is shown in FIG. 8 on an opposite side of the tissue penetrating tip 215 and forms a segment of the distal perimeter of the lumen 220. [0065] In some examples, the channel may be a concave channel with a uniform depth. Channels described herein may extend along a length of the needle (e.g., elongate body). For example, a channel may extend along the entire length of the elongate body from the proximal end (e.g., proximal lumen perimeter) to the distal end (e.g., distal lumen perimeter). In some examples, channels described herein may have a uniform depth along an entire length of the channel. In some examples, channels described herein may have a first depth at a proximal end of the channel and second depth at the distal end of the channel. For example, at or near the distal end of a channel, the depth of the channel may be greater than the depth at or near the channel proximal end. In some examples, the at or near the distal end of a channel, the depth of the channel may be less than the depth at or near the channel proximal end. In some examples, the channel may be described in terms of channel segments. In some examples, each channel segment may 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).

[0066] The example shown in FIG. 8 illustrates an example of a needle with channel segments separated by transition regions 235 and 240. In this example, the proximal transition segment 235 is positioned between the channel 225 and a proximal portion of the elongate body extending to the proximal end 210. As illustrated in this example, the elongate body proximal to the transition segment 235 is generally cylindrical and the transition segment 235 is positioned between the cylindrical exterior of the proximal end of the elongate body 205 and the channel 225 extending distally from transition segment 235. [0067] FIG. 9A shows the needle from FIG. 8 in a side elevation view having the proximal channel 225b and distal channel 225a along a segment of the overall needle length. In this example, the channel 225 may comprise two channel segments 225a and 225b. From the elongate body proximal end 210, the proximal transition segment 235 is initially pressed into the elongate body forming a transition from the needle proximal portion to the first (e.g., proximal) channel segment 225b. The notch 121 can also be seen in this view and is generally positioned proximal to the tissue penetrating tip 215 and on the opposite side of the needle from the channel. FIG. 9B shows a detailed view of the distal end of the needle from FIG. 9A to illustrate details of the distal channel 225a transition to the distal end of the needle and forming a portion of the lumen perimeter. In FIG. 9C, details of the transition segment 240 positioned between the distal channel 225a and the proximal channel 225b are illustrated. [0068] In FIG. 9D, the proximal transition segment 235 is detailed whereby channel segment 225b is shown extending distally from transition segment 235 to the distal transition segment 240 positioned between channel segment 225b and 225a that extends distally from transition segment 240. As shown in this example, the distal channel segment 225a is deeper (e.g., pressed further into the elongate body) than channel segment 225b. Changes in the depth of a channel or channel segment may be adapted to accommodate different segments, features, regions, etc. of guide elements or other tools that may be extended along the needle exterior surface during use. For example, as illustrated in FIGS. 9A to 9D, the distal channel segment 225a being deeper than the proximal segment 225b can be adapted to accommodate a distal portion of a guide element that may be larger than the guide element elongate body extending proximally therefrom.

[0069] In some examples, transition segments described herein may be configured to provide a gradual transition of a channel or channel segments along a length of the elongate body. In some examples, transition segments may be adapted to accommodate a guide element or similar tool while motivating and maintain position of the guide element or tool along the needle exterior. For example, a transition segment with a deeper channel extending proximally therefrom may be adapted to prevent a segment of guide element positioned distal to the transition segment from retracting proximally against the transition segment. For example, deployment of a guide element in this example may allow for the guide element to be advanced along the channel to deploy a larger distal segment of the guide element from a distal channel segment. [0070] In some examples, needles described herein may have a channel adapted to receive a guide element extending along the exterior surface of the needle. For example, a channel may be adapted to accommodate a guide element or guide element segment for routing or providing a path for the guide element.

[0071] FIG. 10 shows another perspective view of a needle described herein from the distal end. Here, the distal end of the lumen 220 is shown and in this perspective a notch (e.g., bleed-back feature) 121 can be seen extending through a wall of the needle (e.g., elongate body) to expose 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 such that the flow of blood through the needle lumen can be confirmed when a portion of the blood is visible through the notch. For example, the notch may provide a visual indication of successful penetration of a blood vessel when blood is seen through the notch 121.

[0072] The lumen 220 can be seen having a generally crescent shape cross section. Channel segment 225a extends along a distal length of the needle body and the lumen 220 is compressed from a cylindrical chape to the crescent shape. In some examples, needles described herein with one or more channels may be manufactured by compressing the concave channel into a cannula (e.g., needle elongate body) such that the lumen is adapted from a generally cylindrical lumen before the channel to a crescent shape corresponding to the depth of the channel pressed into the elongate body. For example, the crescent characteristics of a needle lumen may be based on the concave characteristics (e.g., channel depth, width, position, etc.) of the channel. In some examples, the thickness of the walls of a needle elongate body may be sufficient to allow for creation of a channel by grinding or removing material from the needle wall to form the channel. In this example, the lumen of a needle described herein may have one or more channels (e.g., channel segments) with a circular cross section uniform from the distal end of the elongate body to the proximal end of the elongate body.

[0073] In FIG. 11, the needle 200 is shown from a profile view looking through the lumen 220 at the distal end. The tissue penetrating tip 215 is on the distal lumen perimeter generally opposite the channel 225. In this view, the width of a channel can be appreciated and understood as adaptable or configurable to accommodate a guide element or other tool therein. For example, where a guide element may have a distal end or segment that is larger than the guide element elongate body, the width of a distal channel segment may be larger than proximal channel segments to accommodate the larger portion of the guide element therein. Also in FIG. 11, an example of the crescent shape of lumen 220 is visible having a cross section corresponding to the depth of the channel 225.

[0074] Referring to FIG. 12, the side elevation view of the needle 200 shows examples of needle regions or segments distinguishable by different channel segments, features, or characteristics of the elongate body. As described above, the distal channel segment 255 is deeper than the channel segment 166. In this example, the lumen extending from the distal end 250 to the proximal end may have a different diameter along segment 255 compared to segment 260. In some examples, both segments 255 and 260 may have a different diameter relative to the proximal position of a needle without a channel segment. A channel may be positioned along any length of the elongate body and may have a length corresponding to a guide element or other tool for which the needle is adapted to accommodate on an exterior surface. For example, the channel segment length 255 may be the same, greater than, or less than the channel segment length 260. The example illustrated in FIG. 12 may be configured to accommodate a guide element having a distal end positionable on the distal channel along length 255 and a guide element proximal end positionable along channel segment length 260. In some examples, the needles described herein may be configured to accommodate a guide element having a distal segment that is larger or includes features that benefit from a deeper channel in the needle exterior surface.

[0075] Needles, such as those illustrated in FIGS. 8 to 12, comprise one or more channels formed by the methods described herein. Additional features may be provided to needles such as a crimped section (e.g., valve section) or other formation in the needle to accommodate additional needle function. In some examples, the needles described herein may be used with catheter assembly comprising a valve having a septum or slit adapted to receive the needle therethrough. Accordingly, it may be advantageous to provide a reduced diameter segment of a needle along a linear length where the needle may be positioned through the valve. To illustrate, FIGS. 13 to 19 are provided with additional detail of a crimped portion (e.g., valve portion) that may result from suppling pressure to the needle cannula with a die having an upper plate and a lower plate, as described herein, and the upper plate having a raised portion to deform the needle cannula corresponding to the raised portion of the upper plate. In some examples, the lower plates of die described herein may also comprise a raised portion to complement or alternatively provide a deformation of the needle cannula within the die according to the methods described herein.

[0076] FIG. 13 is a side elevation view of a needle 300 with an overall length from a proximal end 355 to a distal end 330 with a tissue penetrating tip 330 and the distal end of the lumen 335a. Various segments of the needle may be adapted for the function of the needle described herein. For example, from the proximal side, segment 305 can be configured to couple with a needle carrier of a vascular access device handle. Moving distally along the needle length, segment 310 can reflect the crimped portion 350 with a length between the crimped portion proximal end 350b and the crimped portion distal end 350a. The length of segment 310, may be any length that is sufficient to be positioned through the valve slit such that the geometry of the crimped portion is adapted to reduce any impact or opening of the valve slit and maintain the integrity of the valve while allowing for flashback and blood flow through the needle lumen 335. Segment 315 may reflect the first (e.g., proximal) channel portion 345 along a length of the needle distal to the crimped portion 350. Transitions may be positioned between the segments of the needle to provide a complementary route for the guide wire that would extend along the needle surface. Segment 320 may be another channel section or distal channel section 340 extending from proximal channel section distal end 345a. The distal channel section 340 can then extend along any length until the distal lumen opening 335a. Accordingly, the needle 300 can be adapted to route a guide element along the needle exterior through the catheter assembly, and into a vessel to position and install the catheter assembly, during use. The die and methods of pressing the various features in the needle, as described herein, may be adapted to press the crimped portion 350, proximal channel 345 and distal channel 340 into/onto the needle while providing for the lumen 335 to extend through the length of the needle.

[0077] FIG. 14 is a detailed side elevation view of the crimp linear segment 350 of the needle 300 highlighting examples of the crimped region that can be provided by the die and methods described herein. Again, the crimped section length 350 may be any length. The crimped portion 350 extends from a proximal end 350b to a distal end 350a and a transition there to the channel section (e.g., proximal channel 340) moving distally along the length of the needle 300. Additional dimensions of the crimped section, such as the height 360d in this view, can be provided based on the configuration of the raised features of the upper and lower plates used to contact and compress the needle cannula to deform the cylindrical cannula to the crimped region 350 and other channel regions. In some examples, the crimped region 350 may also comprise a channel along the crimped region.

[0078] FIG. 15A and FIG. 15B show examples of the needle 300 including crimped section 350 configured with a flat exterior surface 375 along the length of the crimped section 350. In this perspective view, the proximal channel section 345 and distal channel section 340 can be seen extending along different planes relative to one another and a transition or decreasing taper at the proximal channel distal end as indicated by 340b for the distal channel proximal end also referring to the transition between the different channel portions. In some examples, the die may comprise the complementary transition in the raised feature of the upper plate. The lumen 335 can be seen in FIG. 15A adjacent to the tissue penetrating tip 330 at the needle distal end. The needle proximal end 355 is generally cylindrical but also may have any geometry configured to support engagement between the needle 300 and the needle carrier of a vascular access device or other medical device using the needle to penetrate tissue. From the needle proximal end 355, there is a transition to the crimped section 350 which can facilitate the transition for the guide wire from the needle carrier (e.g., guide wire tube) onto the needle exterior surface starting at the crimped section 350. In some examples, the guide wire is routed from the handle to the needle exterior surface proximal to the crimped portion 350 such that the guide element is aligned with the needle in a compact arrangement as the needle and guide element extend or are otherwise positioned through a valve slit in a catheter assembly. FIG. 15B shows a cross section of the needle in FIG. 15A at the crimped section 350 to show an example of the crimp section geometry with a flat surface 375 and the lumen 335 still open and extending through the crimped portion to facilitate the flow of blood through the needle lumen to the proximal end 355.

[0079] FIGS. 16-17B show another example of the needle now having a crimped linear segment 350 including a channel surface 390 along the crimped segment 350 where a guide element can be configured to contact as the guide element and needle extend through another lumen such as that of a catheter during catheter placement. Referring to FIG. 16, the crimped section proximal end 350b has a portion of the channel 390 in the transition from the proximal portion of the needle 355 to the crimped section 350. Accordingly, the channel surface 390 can be configured to compliment the guide wire extending along the needle surface. In some examples, the channel surface 390 may then continue through the proximal channel section 345 then on through the distal channel section 340 where the guide element may be positioned at the distal end of the guide wire and seated adjacent, within, or otherwise at the distal end of the needle. The dies can be adapted to provide the channel 390 and the crimped section 350 in a single press with the needle position in the lower plate and the upper plate having raised features corresponding to the channel and the crimped section such that when the upper plate is pressed into the needle cannula, the crimped section 350 is formed with the channel therethrough or a flat surface or any other surface configuration for the needle.

[0080] FIGS. 17A and 17B show detailed segment views of the crimped section 350 from FIG. 16. In the perspective view in FIG. 17A, the channel surface 390 can be seen positioned along the entire length of the crimped section 350 of the needle. In some examples, the channel surface 390 may be coplanar with the proximal channel section 345. In some examples, there may be a transition between the channel surface 390 and channel section 345. In any example, the guide wire can be configured to extend along the needle exterior surface along the crimped section and to the distal end of the needle. In FIG. 17B, the cross section through the crimped section 350 including the channel surface 390 is shown again to highlight the lumen 335c still extending through the needle with any geometric configuration of the crimped portion 350 such that the lumen 335c is still capable of directing and facilitating a flow of blood through the needle to the needle proximal end 355. The methods described herein can be configured to provide any reduction or deformation of the needle cannula to facilitate the function of the needle for use with guide wires or tools extending along an exterior surface of the needle while still allowing for a flow of blood through the needle lumen.

[0081] Regarding the needle lumen, FIG. 18 and FIG. 19 provide additional cross- sectional views to expose the needle lumen at different points of the needle. Referring to FIG. 18, the cross section is a detailed view from the distal end of the needle at the crimped section 350. The lumen dimensions, e.g., heigh 360 can be configured to allow a fluid to flow therethrough even with the crimped section 350 being more compressed than other sections of the needle. The exterior height 360a in any example of needles described herein can be optimized to reduce the impact and pressure on the valve slit allowing the valve slit to encircle or surround the needle crimped portion 350 and minimize the opening of the valve while maintaining a seal against the needle and guide wire exterior positioned therethrough. The cross section shown in FIG. 19 is taken across the distal channel section 340 and exposes a similarly deformed cross section geometry of the lumen 335. Here, a crescent shape of the lumen 335 is illustrated such that is still configured to allow for a fluid to flow therethrough. Of note, in the view from FIG. 19, the crimped portion 350 is shown to be more compressed (e.g., decreased height) compared to the proximal needle portion or the channel section 345 and 340. In some examples, manufacturing the needles described herein may involve a process of applying pressure ethe a needle having an initially cylindrical or traditional circular cross section. The pressure supplied to the needle can be sufficient to deform the needle and provide for the different crimped or channel sections described herein.

Accordingly, pressing the crimped section 350, the deformation can provide a reduction in the height (e.g., diameter) of the needle cross section at the crimped section 350. In some examples, reducing the diameter or other attribute of the needle may include a reduction in the needle lumen cross section and/or may be accommodated by and increase in the lateral cross section as shown in FIG. 19 with the crimped section 350 being wider than other sections of the needle. [0082] In some examples, the needles provided herein and the methods by which they are manufactured may provide for a notch positioned through the needle cannula to expose the needle lumen. Referring to FIG. 20, a notch 400 is positioned below the distal channel portion of the needle 300. Accordingly, when the tissue penetrating tip 330 is positioned within a blood vessel, a flow of blood through the lumen may be exposed for visual indication of needle position and confirmation that the needle is in position in a vessel. Referring back to FIG. 2B, for example, the recess 26 of the die may be provided to allow for a cutting or other process of removing material from the needle cannula to provide for the flashback or bleed-back opening notch 400 at any position along the length of the needle. [0083] In some examples, the lumen may extend linearly from the distal end of a needle through to the proximal end. In some examples, the lumen may curve or otherwise be nonlinear along its entire length as the changes in channel depth may provide for a change in the lumen. For example, the lumen may be crescent shaped at or near the distal end of the needle and may be cylindrical at or near the proximal end of the needle with a transition from a crescent shaped lumen to a cylindrical lumen. In some examples, a lumen described herein may be coaxial along an entire length of the lumen through a needle. In some examples, a lumen may be coaxial along the entire length of the needle where there are multiple channel segments and/or cylindrical needle segments. In some examples, a lumen of a needle described herein may not be coaxial along the entire length of the needle where there are multiple channel segments and/or cylindrical needle segments. For example, the channel segments may have concave curvatures such that the interior surface of the needle is pressed into the lumen towards a central axis of the lumen and may, in some examples, be pressed to or beyond the central axis of the lumen.

[0084] In some examples, a needle (e.g., hypodermic needle, access needle, transcutaneous needle, sharps, etc.) has a tissue penetrating end and an engagement element separated by an elongate body having at least one flat surface along a length of the elongate body. A central lumen may extend from the proximal end to the distal end and be configured to direct a flow of one or more fluids therethrough. The tissue penetrating distal end can be configured to penetrate one or more layers of tissue when advanced through contact with an exterior surface of a substrate (e.g., biological tissue). In some examples, the needles described herein may comprise 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 a length of the elongate body. For example, a needle may comprise a channel (e.g., concave channel) along a length of the elongate body proximal to a flat surface extending distally beyond the concave channel. In some examples, a needle may comprise a concave channel extending distally along a length of the elongate body from a flat surface. In some examples, the arrangement of a flat surface and a concave channel may be in any arrangement along a length of the exterior of the elongate body. In some examples, the tissue penetrating tip, beveled surface or other features of the needle may be provided with the needle cannula before positioning the needle within a die for channel formation.

[0085] A tissue penetrating end may comprise a tip configured to penetrate tissue of a patient during use (e.g., a tissue penetrating tip). The tissue penetrating tip may me locatable at a distal end of a bevel surface extending from one or more flat surfaces along the needle. The tissue penetrating tip can be configured to penetrate one or more tissues. In some examples, the tissue penetrating tip can be an apex of one or more surfaces that may converge with one another at a point (e.g., tissue penetrating tip). In some examples, the tissue penetrating tip may comprise an apex of a plurality of flat surfaces (e.g., a polyhedron). In some examples, the tissue penetrating tip may be the apex of a pyramidal arrangement of three or more surfaces. In some examples, the surfaces converging to the apex (e.g., tissue penetrating tip) may be secondary, tertiary, quaternary, etc. bevel surfaces. A number of bevel surfaces on the tissue penetrating end may be configured to minimize the physical injury to the tissue as the tissue penetrating tip advances therethrough.

[0086] In some examples, a tissue penetrating tip may comprise a single bevel, multibevel, multi-facet configuration. The tissue penetrating tip may have one or more geometric features of configurations distal of the flat surface along the cannula, as described herein. The geometry of the tissue penetrating tip may be based on the application for which the needle is being used. Some examples of a hypodermic needle tissue penetrating tip, as described herein may include one or more elements or geometric features from needle tip configurations such as a diamond needle tip, franseen needle tip of a quincke needle tip, whitacre needle tip, sprotte needle tip, short bevel needle tip, chiba needle tip, touhy needle tip, cournand needle tip, mengini needle tip, backcut bevel needle tip, dos santos needle tip, seidinger needle tip, conical tip, curved tip, cutting tip, reverse cutting tip, tapered, tapered cutting tip, micro-point tip, spatula tip, etc.

[0087] In some examples, the needle lumen extends through the interior of the needle from the proximal end to the tissue penetrating end. For example, the central lumen may extend from an opening at the proximal end to an opening on the bevel surface of the tissue penetrating end and be adapted to allow a flow of fluid (e.g., blood) through the needle with the channel or crimped depressions along the needle body.

[0088] In some examples, a needle described herein may be an anti -coring needle adapted to reduce or prevent a core of tissue being removed when the needle is inserted. The methods described herein can produce a needle with an anti-coring heel to reduce the impact to the tissue while the needle is being inserted into a vessel.

[0089] Additional aspects of the construction and operation of a catheter placement device which includes a housing or handle having mechanism for advancing a guide structure or guide element which carries the catheter where the handle is adapted to automatically retract both the access needle and the guide structure or guide element from the catheter after the placement procedure is complete, a button activated automatic needle and guide withdrawal assembly are described in U.S. Patent Publication US 2008/0300574 and US Patent 9,522,254, each of which is incorporated herein by reference in their entirety.

[0090] Still other details of representative intravascular catheter insertion devices and methods are described in U.S. Pat. Nos. 5,704,914 and 5,800,395 and in U.S. Patent Publications US 2010/0094310; US 2010/0210934; and US 2012/0197200, the full disclosure of each of these are incorporated herein by reference in their entirety.

[0091] There may be one or more variations, alternatives, constructions, compositions, and/or components described herein that can be used to modify an element, component, device, system, process, etc. of a guide element, intravascular access device and/or an associated structure or process. Additionally, or optionally, the techniques described herein may be applied or modified in order to produce access devices such as those described in U.S. Provisional Patent Application No. 63/387,688, filed December 15, 2022, titled “HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE” along with those in International Patent Application PCT/US2023/084427 entitled, “HYPODERMIC NEEDLES AND METHODS OF MANUFACTURE” filed on December 15, 2023, each of which is incorporated by reference in its entirety for all purposes.

[0092] Still further, in other aspects any variation, description, example, element, component, process, method, method step, etc. described herein can be used as a modification, variation, and/or alternative to any element, device, system, composition, example, component, process, method, method step, etc. described in provisional patent application number 63/328,732 filed on April, 7 2022 entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE”; and/or PCT application number PCT/US21/54046 filed on October 7, 2021 entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE” the entireties of which are incorporated herein.

[0093] While preferred embodiments of the present invention have been shown and described herein, it will be obvious 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. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0094] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also 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. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0095] 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 forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude 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 “/”.

[0096] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0097] 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 feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0098] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device 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.

[0099] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric 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. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0100] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMS What is claimed is:

1. A hypodermic needle comprising: an elongate body comprising a tissue penetrating tip at a distal end, a lumen extending through the elongate body, and at least one longitudinal channel along a length of the elongate body.

2. The hypodermic needle of claim 1, further comprising a first longitudinal channel proximal to a second longitudinal channel, the first and second longitudinal channels both being parallel to a central axis of the needle; and a transition region between the first longitudinal channel and the second longitudinal channel.

3. The hypodermic needle of claim 1, further comprising a deformed segment along a length of the elongate body that extends through a valve of a catheter assembly.

4. The hypodermic needle of claim 1, further comprising a proximal longitudinal channel and a distal longitudinal channel, wherein the distal longitudinal channel extends between a distal opening of the lumen to the proximal longitudinal channel.

5. The hypodermic needle of claim 4, wherein the distal longitudinal channel is deeper than the proximal longitudinal channel.

6. The hypodermic needle of claim 1, wherein the longitudinal channel extends along an entire length of the elongate body.

7. The hypodermic needle of claim 1, comprising a distal longitudinal channel and a proximal longitudinal channel, wherein the distal channel is configured to receive a guide element distal segment, and the proximal channel is configured to receive a guide wire extending proximally from the guide element in the distal longitudinal channel.

8. The hypodermic needle of claim 7, wherein a transition region separates the proximal longitudinal channel from the distal longitudinal channel, wherein the distal longitudinal channel is deeper than the proximal longitudinal channel.

9. The hypodermic needle of claim 1, wherein the lumen is non-circular along the length of the at least one longitudinal channel.

10. The hypodermic needle of any of claims 1 to claim 9, further comprising an opening through the elongate body configured to expose the lumen to an exterior of the elongate body.

11. The hypodermic needle of claim 1, further comprising a distal longitudinal channel adjacent to the tissue penetrating tip and extending proximally along the elongate body to a transition where a proximal channel extends proximally from the transition to a crimped needle segment positioned between the proximal channel and the proximal end of the elongate body.

12. The hypodermic needle of claim 1, further comprising a distal channel and a proximal channel, wherein the distal channel extends between the elongate body distal end and a transition segment, wherein the depth of the distal channel is greater than the depth of the proximal channel.

13. The hypodermic needle of claim 1, wherein the elongate body has a crescent cross- sectional shape along the length of the at least one channel.

14. A method of manufacturing a hypodermic needle comprising: providing a die comprising an upper plate and a lower plate, the upper plate comprising a longitudinal raised portion configured to contact a needle cannula, the lower plate comprising a recess adapted to receive the needle cannula; positioning a needle cannula in the recess of the lower plate; aligning the upper plate longitudinal raised portion with the needle cannula; contacting the needle cannula with the upper plate; deforming the needle cannula correspondingly with the longitudinal raised portion of the upper plate.

15. The method of claim 14, wherein the step of positioning the needle cannula in the recess of the lower plate further comprises determining a position on the needle cannula for a longitudinal channel, rotating the needle cannula in the lower plate recess until the determined position is superior to the lower plate recess before contacting the needle cannula with the upper plate.

16. The method of claim 14, wherein the upper plate further comprises a first longitudinal raised portion and a second longitudinal raised portion, wherein the first longitudinal raise portion is proximal to the second longitudinal raised portion.

17. The method of claim 16, further comprising the step of contacting the needle cannula with the first longitudinal raised portion and the second longitudinal raise portion forming a first longitudinal channel and a second longitudinal channel long the needle cannula.

18. The method of claim 16 or claim 17, wherein the second longitudinal channel extends further from the upper plate than the first longitudinal channel.

19. The method of claim 14, further comprising contacting the needle cannula with the upper plate more than once.

20. The method of claim 14, further comprising supplying force to the upper plate to contact the needle cannula.

21. The method of claim 20, wherein the force supplied to the upper plate is 100 psi or more.

22. The method of claim 20, wherein the force supplied to the upper plate is 125 psi, 250 psi, 500 psi, or 1000 psi.

23. The method of claim 20, further comprising supplying a first force to the upper plate, then supplying a second force to the upper plate.

24. The method of any of claims 14 to 23, wherein the needle cannula is 10 gauge to 35 gauge.

25. The method of any of claims 14 to 23, wherein the needle cannula is between 20 gauge and 25 gauge.

26. The method of any of claims 14 to 25, wherein the lower plate comprises a first side and a second side, wherein the method further comprises the step of retaining the needle cannula in the lower plate recess by contacting the needle with the first side and the second side of the lower plate.

27. A die press machining apparatus as described herein configured and operated to perform any of the methods of claims 14-26 to manufacture a needle according to any of claims 1-13.

28. A needle comprising: an elongate body with an upper surface and a lower surface extending between a proximal end and a distal end; a lumen extending from the elongate body proximal end to the elongate body distal end; a tissue penetrating tip at the distal end of the lower surface; and at least one deformed portion along the elongate body upper surface.

29. The needle of claim 28, wherein the at least one deformed portion is concave towards a center of the lumen.

30. The needle of claim 28 or claim 29, wherein the at least one deformed portion comprises a first longitudinal channel proximal to a second longitudinal channel, the first and second longitudinal channels both being parallel to a central axis of the needle; and a transition region between the first longitudinal channel and the second longitudinal channel.

31. The needle of claim 28, wherein the at least one deformed portion comprises a valve segment with a deformed upper surface and a deformed lower surface along the length of valve segment being adapted to extend through a valve of a catheter assembly.

32. The needle of claim 28, the at least one deformed portion comprising a proximal longitudinal channel and a distal longitudinal channel, wherein the distal longitudinal channel extends between a distal opening of the lumen to the proximal longitudinal channel.

33. The needle of claim 32, wherein the distal longitudinal channel is more concave than the proximal longitudinal channel.

34. The needle of claim 28, wherein the at least one deformed portion extends along an entire length of the elongate body upper surface.

35. The needle of claim 28, the at least one deformed portion comprising a distal longitudinal channel having a concave curvature adapted to receive a guide element.

36. The needle of claim 35, the at least one deformed portion further comprising a proximal longitudinal channel having a concave curvature adapted to receive a guide wire extending proximally from the guide element in the distal longitudinal channel.

37. The needle of claim 36, wherein a transition region separates the proximal longitudinal channel from the distal longitudinal channel, wherein the concave curvature of the distal longitudinal channel is greater than the concave curvature of the proximal longitudinal channel.

38. The needle of any of claims 28 to claim 37, further comprising an opening through the elongate body configured to expose the lumen to an exterior of the elongate body.

39. The needle of claim 31, further comprising a distal longitudinal channel opposite the tissue penetrating tip and extending proximally along the elongate body to a transition segment where a proximal channel extends between the transition segment and the valve segment.

40. The needle of any of claims 28 to 39, wherein the elongate body lower surface is generally convex shaped and the at least one deformed portion is concave shaped.