Introducer needle with notch for improved flashback

The introducer needle with dual notches and a flash chamber in the IV catheter system addresses the challenge of slow flashback in primed systems by facilitating rapid, pressure-driven blood flow for improved vascular penetration confirmation.

JP7796478B2Active Publication Date: 2026-01-09BECTON DICKINSON & CO
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Patent Information

Application Number
JP2020554428
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2018-04-05
Filing Date
2019-03-19
Publication Date
2026-01-09
Estimated Expiration
2039-03-19

AI Technical Summary

Technical Problem

Existing IV catheter systems face challenges in visualizing flashback due to priming with saline, which slows down blood diffusion and makes it difficult to confirm proper placement, especially in integrated systems without ventilated flash chambers.

Method used

An introducer needle with a first and second notch, along with a transparent catheter and a flash chamber, facilitates pressure-driven blood flow through separate pathways for improved flashback visibility, even after priming, using a gas-permeable vent and seal mechanisms to manage fluid flow.

Benefits of technology

Enhances flashback visibility and confirmation of vascular penetration by promoting faster, pressure-driven blood flow, ensuring successful catheter placement and reducing the risk of transfixation errors.

✦ Generated by Eureka AI based on patent content.

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Abstract

The introducer needle may include a proximal end, a distal tip, and a needle lumen extending therebetween. The introducer needle may include a wall defining the needle lumen, a first notch formed through the wall, and a second notch formed through the wall. The catheter system may include a catheter adapter, a catheter extending distally from the distal end of the catheter adapter, a flash chamber coupled to the introducer needle, and the introducer needle, which may extend through the catheter. The first and second notches and the flash chamber may facilitate pressure-driven blood flow into the catheter for improved flashback and penetration fixation detection when the catheter is primed prior to insertion into a patient's vasculature or otherwise.
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Description

[Technical Field]

[0001] Intravenous (IV) catheters are commonly used for various infusion therapies. For example, IV catheters can be used to infuse saline, various medications, or total parenteral nutrition into a patient. IV catheters can also be used to withdraw blood from a patient. [Background technology]

[0002] A common type of IV catheter is the over-the-needle peripheral IV catheter. As the name suggests, an over-the-needle peripheral IV catheter can be attached to an introducer needle with a sharp distal tip. The sharp distal tip can be used to penetrate the patient's skin and vasculature. Insertion of the IV catheter into the vasculature can follow puncture of the vasculature with the introducer needle. The introducer needle and IV catheter are generally inserted at a shallow angle through the skin and into the patient's vasculature, with the bevel of the introducer needle facing away from the patient's skin.

[0003] To confirm proper placement of an introducer needle and / or IV catheter within the vasculature, clinicians typically check for blood flashback, which the clinician can see. In some cases, the introducer needle may include a single notch, and depending on the distal tip of the introducer needle positioned within the vasculature, blood can flow proximally through the needle lumen, exit the needle lumen through the notch, and then travel proximally between the outer surface of the introducer needle and the inner surface of another device (e.g., an IV catheter). Thus, if the other device is at least partially transparent, the clinician can visualize a small amount of blood "flashback," thereby confirming placement of the catheter within the vasculature. The presence of indicators of vasculature entry, such as flashback, can facilitate successful placement of the IV catheter. Once placement of the introducer needle within the vasculature is confirmed, the clinician can temporarily occlude flow within the vasculature and withdraw the introducer needle, leaving the catheter in place for subsequent blood withdrawal and / or fluid injection. Summary of the Invention [Problem to be solved by the invention]

[0004] Priming IV catheters is common practice in some markets. To prime an IV catheter, clinicians can fill the IV catheter with saline or another priming fluid to reduce or eliminate any air pockets located within the IV catheter. The saline can also fill not only distal to the notch, but also a portion of the needle lumen proximal to the notch, all the way to the distal tip of the introducer needle. Therefore, as the distal end of the introducer needle enters the vasculature, flashback may be slowed due to diffusion. Flashback can also be difficult to visualize due to mixing of the flashback with the saline.

[0005] Furthermore, many integrated IV catheter systems with integrated extension tubes do not include a ventilated flash chamber. Examples of integrated IV catheter systems include the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Beckon Dickinson PEGASUS™ Safety Closed IV Catheter System. Therefore, after priming the IV catheter, the IV catheter system may no longer be vented, and blood may only slowly diffuse into the introducer needle as the distal tip of the introducer needle enters the vasculature. Furthermore, because proximal diffusion of blood may continue even when the distal tip is no longer properly positioned within the vasculature, transfixation of the vasculature may not be observed.

[0006] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. [Means for solving the problem]

[0007] The present disclosure generally relates to an introducer needle having a first notch and a second notch, and related devices, systems, and methods. In some embodiments, the introducer needle may include a proximal end, a distal tip, and a needle lumen extending between the proximal end and the distal tip. In some embodiments, the introducer needle may include a wall, which may define the needle lumen. In some embodiments, the first notch may be formed through the wall, and the second notch may be formed through the wall. In some embodiments, the second notch may be proximal to the first notch.

[0008] In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the catheter system may include a catheter, which may include an IV catheter, such as a peripheral IV catheter. In some embodiments, the catheter may extend distally from the distal end of the catheter adapter. In some embodiments, the catheter system may include an introducer needle, which may extend through the catheter and beyond the distal end of the catheter when the introducer needle is in an insertion position for insertion into a patient's vascular system.

[0009] In some embodiments, the first notch of the introducer needle may be positioned within the catheter when the introducer needle is in the insertion position. In some embodiments, at least a portion of the catheter may be transparent. In some embodiments, if the proximal end of the introducer needle is perforated to allow air and / or fluid to move proximally through the introducer needle, the presence of the first and second notches can facilitate pressure-driven blood flow into the catheter for improved flashback and detection of penetration fixation. In some embodiments, the first and second notches can improve the success of the initial needle stick by improving the quality of flashback.

[0010] More specifically, in some embodiments, the catheter system may include a first fluid pathway that may extend between the outer surface of the introducer needle and the inner surface of the catheter wall from a first notch to a second notch, and a second fluid pathway that may extend within the needle lumen from the first notch to the second notch. During flashback, blood may flow through the first fluid pathway and / or the second fluid pathway. In some embodiments, the first fluid pathway may provide pressure-driven flashback even after the catheter system has been primed. In some embodiments, flashback may be faster through the first fluid pathway than through the second fluid pathway. In some embodiments, flashback through the first fluid pathway may be visualized due to the transparency of the catheter.

[0011] In some embodiments, the first fluid path may have a larger volume than the second fluid path, which may promote faster flashback through the first fluid path than through the second fluid path. In some embodiments, a cross section perpendicular to the central axis of the catheter system and through the catheter system between the first notch and the second notch may include a needle lumen region and another region between the outer surface of the introducer needle and the inner surface of the catheter wall. In some embodiments, the another region may be larger than the needle lumen region. In some embodiments, the another region may be larger than the needle lumen region in each cross section through the catheter system perpendicular to the central axis along the entire length between the first notch and the second notch.

[0012] In some embodiments, the catheter system may include a flash chamber, which can facilitate flashback. In some embodiments, the flash chamber may be in fluid communication with the needle lumen. In some embodiments, the flash chamber may include a gas-permeable vent. In some embodiments, the gas-permeable vent of the flash chamber can provide a vent that allows air and / or fluid to move proximally through the introducer needle. In some embodiments, the flash chamber may be located proximal to the proximal end of the introducer needle. In some embodiments, the gas-permeable vent may provide at least some resistance to airflow.

[0013] In some embodiments, the catheter may be primed before inserting the catheter and introducer needle into the patient's vasculature. In some embodiments, the catheter may be primed when the introducer needle is in the insertion position. In some embodiments, to prime the catheter, a user may fill the catheter with a priming fluid, such as saline, to reduce or eliminate any air pockets located within the catheter. In some embodiments, the priming fluid may be located in a first portion of the needle lumen adjacent to the first notch and including the distal tip of the introducer needle. Additionally, in some embodiments, the priming fluid may be located in a second portion of the needle lumen adjacent to the second notch. In some embodiments, if a gas-permeable vent provides resistance, the priming fluid in the first portion may be separated from the priming fluid in the second portion, and air may be located between the first and second portions of the needle lumen.

[0014] In some embodiments, in response to the distal tip of the introducer needle entering the vasculature, blood pressure sends a flashback into the needle. Furthermore, in some embodiments, at least a portion of the flashback may then exit the introducer needle at the first notch and be sent to the catheter. Furthermore, in some embodiments, in response to the distal tip of the introducer needle entering the vasculature, priming fluid outside the introducer needle and within the catheter tube, between the first notch and the second notch, may be sent through the second notch to the introducer needle, and the flashback may eventually reach the flash chamber. In some embodiments, in response to the distal tip of the introducer needle entering the vasculature, blood may also flow proximally through the needle. In some embodiments, pressure-driven blood flow through the first fluid pathway may be faster than diffusion, and the first fluid pathway may initially fill with priming fluid.

[0015] In some embodiments, the flash chamber may comprise a large, non-restrictive volume that can facilitate pressure-driven flow of priming fluid and / or blood toward or into the flash chamber. In some embodiments, the volume of the flash chamber may be large enough to hold priming fluid disposed outside the introducer needle and within the catheter between the first and second notches, and / or priming fluid that may migrate into the flash chamber during priming of the catheter. Additionally, in some embodiments, the volume of the flash chamber may be large enough to hold blood when the distal tip of the introducer needle is positioned within the vasculature.

[0016] In some embodiments, a portion of the introducer needle wall between the first and second notches may be pinched or crimped to prevent fluid, such as blood, from flowing through the needle lumen between the first and second notches. In some embodiments, the crimped portion of the wall can promote rapid flashback through the first fluid pathway.

[0017] In some embodiments, the second notch may be located within the catheter when the needle is in the insertion position. In some embodiments, the second notch may be located within the lumen of the catheter adapter when the needle is in the insertion position. In some embodiments, the distance between the first notch and the second notch may be greater than the length of the catheter, which can facilitate visualization of the transfixation.

[0018] In some embodiments, the catheter system may include a needle hub, which may be coupled to the catheter adapter when the introducer needle is in the insertion position. In some embodiments, the proximal end of the introducer needle may be secured within the needle hub. In some embodiments, a flash chamber may be disposed within the needle hub.

[0019] In some embodiments, the catheter system may include a blood control septum, which may be disposed within the lumen of the catheter adapter. In some embodiments, the septum may divide the lumen of the catheter adapter into a proximal chamber and a distal chamber. In some embodiments, the second notch may be disposed distal to the septum when the introducer needle is in the insertion position.

[0020] In some embodiments, the catheter adapter may include a gas-permeable vent, which may be selectively opened and / or closed. In some embodiments, the gas-permeable vent of the catheter adapter may be positioned distal to the septum such that, when the vent is open, air in the distal chamber can freely flow out of the gas-permeable vent. In some embodiments, the gas-permeable vent of the catheter adapter may be opened during priming of the catheter, thereby preventing priming fluid from being disposed in a first portion of the needle adjacent the first notch and / or a second portion of the needle adjacent the second notch, because the gas-permeable vent of the catheter adapter provides a path of least resistance for the priming fluid.

[0021] In some embodiments, the catheter system may include a seal, which may be secured within the lumen of the catheter adapter. In these and other embodiments, a portion of the introducer needle wall between the first and second notches may be pinched or crimped to prevent fluid from flowing through the needle lumen between the first and second notches. In some embodiments, the introducer needle may be capable of rotating from a priming position to an insertion position and / or from the insertion position to the priming position. In some embodiments, the introducer needle may be positioned in the priming position during priming of the catheter and in the insertion position during insertion into the vasculature.

[0022] In some embodiments, when the introducer needle is in the priming position, the seal can cover or seal the second notch, thereby preventing fluid from flowing through the second notch. In some embodiments, when the introducer needle is in the insertion position, the seal can not cover or seal the second notch, allowing fluid to flow through the second notch. In some embodiments, in response to the second notch not being covered or sealed, a rapid flashback can occur as blood flows into the needle lumen through the second notch. In some embodiments, the seal can include a septum or flapper.

[0023] In some embodiments, the introducer needle may be rotatable about a central axis of the catheter system between the priming position and the insertion position, and the central axis may extend through the needle lumen. In some embodiments, the introducer needle may be rotated by twisting the needle hub. In some embodiments, the introducer needle may be rotated in a first direction and / or a second direction opposite the first direction. In some embodiments, the second notch may be aligned with the seal when the introducer needle is in the priming position and the insertion position. In these and other embodiments, the introducer needle may extend the same distance from the distal tip of the catheter when the introducer needle is in the priming position as when the introducer needle is in the insertion position.

[0024] In some embodiments, the catheter system may include a plug constructed of a dissolvable material, which may be positioned over the second notch to seal the second notch during priming of the catheter system.

[0025] It is to be understood that both the general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as are the claims. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined, or other embodiments may be utilized, and structural changes may be made, unless otherwise stated, without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0026] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0027] [Figure 1] FIG. 1 is a top view of an exemplary catheter system, showing the catheter system in an insertion position, according to some embodiments. [Figure 2A]FIG. 2A is a cross-sectional view of an exemplary introducer needle disposed within an exemplary catheter, showing the introducer needle in an insertion position, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view taken along line 2B-2B of FIG. 2A, according to some embodiments. [Figure 2C] FIG. 2C is a cross-sectional view of the introducer needle of FIG. 2A having an exemplary crimping configuration and positioned within a catheter, showing the introducer needle in an insertion position, according to some embodiments. [Figure 2D] FIG. 2D is a cross-sectional view of the introducer needle of FIG. 2A positioned within a catheter, showing the introducer needle in an inserted position and an exemplary plug comprised of a dissolvable material, according to some embodiments. [Figure 2E] FIG. 2E is a partial cross-sectional view of the introducer needle of FIG. 2A positioned within a catheter, showing the introducer needle in an inserted position and a sleeve element constructed of a dissolvable material, according to some embodiments. [Figure 3A] FIG. 3A is a top view of an exemplary needle assembly, according to some embodiments. [Figure 3B] FIG. 3B is a partial cross-sectional view of the needle assembly of FIG. 3A, according to some embodiments. [Figure 4A] FIG. 4A is a cross-sectional view of the catheter system of FIG. 1A showing the catheter system in an insertion position and an exemplary seal covering an exemplary second notch, according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of the catheter system of FIG. 1A showing the seal removed from the second notch, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present disclosure generally relates to an introducer needle having a first notch and a second notch, and related devices, systems, and methods. Referring to FIG. 1 , in some embodiments, a catheter system 10 may include a catheter adapter 12, which may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the catheter system 10 may include a catheter 14, which may include an IV catheter, such as a peripheral IV catheter. In some embodiments, the catheter 14 may extend distally from the distal end of the catheter adapter 12. In some embodiments, the catheter system 10 may include an introducer needle 16, which may extend through the catheter 14 and beyond the distal end of the catheter 14 when the introducer needle 16 is in an insertion position for insertion into a patient's vascular system.

[0029] In some embodiments, the catheter system 10 may include a needle hub 18, which may be coupled to the catheter adapter 12 when the introducer needle 16 is in the insertion position. In some embodiments, the proximal end of the introducer needle 16 may be secured within the needle hub 18. In some embodiments, the catheter system 10 may include a needle shield 19. In some embodiments, the catheter system 10 may be one-piece or non-one-piece. In some embodiments, the catheter system 10 may include the needle shield 19 or any other type of suitable needle safety mechanism.

[0030] 2A , in some embodiments, introducer needle 16 may include a proximal end, a distal tip 20, and a needle lumen 22 extending between the proximal end and the distal tip 20. In some embodiments, introducer needle 16 may include a wall 24, which may define needle lumen 22. In some embodiments, a first notch 26 may be formed through wall 24, and a second notch 28 may be formed through wall 24. In some embodiments, second notch 28 may be proximal to first notch 26. In some embodiments, wall 24 may include more than two notches.

[0031] In some embodiments, the first notch 26 of the introducer needle 16 may be located within the catheter 14 when the introducer needle 16 is in the insertion position. In some embodiments, at least a portion of the catheter 14 may be transparent. In some embodiments, the presence of the second notch 28 can facilitate pressure-driven blood flow into the catheter 14 for improved flashback and penetration fixation detection. In some embodiments, the second notch 28 can improve the success of the first needle stick by improving the quality of flashback.

[0032] More specifically, in some embodiments, the catheter system 10 may include a first fluid pathway 30 that may extend between the exterior surface of the introducer needle 16 and the interior surface of the catheter wall 32 forming the catheter 14, from a first notch 26 to a second notch 28, and a second fluid pathway 34 that may extend within the needle lumen 22 from the first notch 26 to the second notch 28. In some embodiments, during flashback, blood may flow through the first fluid pathway 30 and / or the second fluid pathway 34. In some embodiments, the first fluid pathway 30 may provide pressure-driven flashback even after the catheter system 10 has been primed. In some embodiments, flashback or proximal blood movement may be faster through the first fluid pathway 30 than through the second fluid pathway 34. In some embodiments, flashback through the first fluid pathway 30 may be visualized due to the transparency of the catheter 14.

[0033] In some embodiments, the second notch 28 may be located within the catheter 14 when the introducer needle 16 is in the insertion position. In some embodiments, the second notch 28 may be located within the lumen of the catheter adapter (e.g., as shown in FIGS. 4A-4B ) when the introducer needle 16 is in the insertion position. In some embodiments, the distance between the first notch 26 and the second notch 28 may be greater than the length of the catheter 14, which can facilitate visualization of the transfixation.

[0034] In some embodiments, the first fluid pathway 30 may have a larger volume than the second fluid pathway 34, which may facilitate faster flashback or proximal movement of blood through the first fluid pathway 30 than through the second fluid pathway 34. Referring to FIG. 2B , in some embodiments, a cross section through the catheter system 10 perpendicular to the central axis 40 of the catheter system 10 between the first notch 26 and the second notch 28 may include a needle lumen region 36 and another region 38 between the outer surface of the introducer needle 16 and the inner surface of the wall 32 of the catheter 14. In some embodiments, the another region 38 may be larger than the needle lumen region 36. In some embodiments, the another region 38 may be larger than the needle lumen region 36 in each cross section through the catheter system 10 perpendicular to the central axis 40 along the entire length between the first notch 26 and the second notch 28.

[0035] 2C, in some embodiments, a portion of introducer needle wall 24 between first notch 26 and second notch 28 may be pinched or crimped to prevent fluid, such as blood, from flowing within needle lumen 22 between first notch 26 and second notch 28. In some embodiments, crimped portion 42 of wall 24 can promote rapid flashback through first fluid pathway 30.

[0036] 2D, in some embodiments, the plug 42 may be comprised of a dissolvable material and may seal the second notch 28 during priming of the catheter 14. In some embodiments, the plug 42 may be dissolved when the catheter system 10 is introduced into the patient's vasculature.

[0037] 2E, in some embodiments, the sleeve 44 may be constructed of a dissolvable material and may seal the second notch 28 during priming of the catheter 14. In some embodiments, the sleeve 44 may be dissolved when the catheter system 10 is introduced into the patient's vasculature.

[0038] 3A-3B, in some embodiments, the catheter system 10 may include a flash chamber 46, which can facilitate flashback. In some embodiments, the flash chamber 46 may be in fluid communication with the needle lumen 22. In some embodiments, the flash chamber 46 may include a gas permeable vent 48. In some embodiments, the flash chamber 46 may be located proximal to the proximal end 49 of the introducer needle 16. In some embodiments, the gas permeable vent 48 may provide at least some resistance to airflow. In some embodiments, the flash chamber 46 may be located within the needle hub 18, for example, as shown in FIG. 3B. FIGS. 3A-3B show a needle assembly with the needle shield 19 removed, according to some embodiments.

[0039] In some embodiments, the catheter 14 may be primed before inserting the catheter 14 and introducer needle 16 into the patient's vascular system. In some embodiments, the catheter 14 may be primed when the introducer needle 16 is in the insertion position. In some embodiments, to prime the catheter 14, a user may fill the catheter with a priming fluid, such as saline, to reduce or eliminate any air pockets located within the catheter. In some embodiments, the priming fluid may be located in a first portion of the needle lumen 22, adjacent to the first notch 26 and including the distal tip 20 of the introducer needle 16. Additionally, in some embodiments, the priming fluid may be located in a second portion of the needle lumen 22, adjacent to the second notch 28. In some embodiments, if the gas permeable vent 48 provides resistance, the priming fluid in the first portion may be separated from the priming fluid in the second portion, and air may be located between the first and second portions of the needle lumen 22.

[0040] In some embodiments, in response to the distal tip 20 of the introducer needle 16 entering the vasculature, blood pressure sends a flashback into the introducer needle 16. Further, in some embodiments, at least a portion of the flashback may then exit the introducer needle 16 at the first notch 26 and be sent into the catheter 14. Further, in some embodiments, in response to the distal tip 20 of the introducer needle 16 entering the vasculature, priming fluid outside the introducer needle 16 and within the catheter 14, between the first notch 26 and the second notch 28, may be sent through the second notch 28 into the introducer needle 16, and the flashback may eventually reach the flash chamber 46. In some embodiments, in response to the distal tip 20 of the introducer needle 16 entering the vasculature, blood may also flow proximally through the introducer needle 16. In some embodiments, pressure-driven blood flow through the first fluid pathway 30 may be faster than diffusion, and the first fluid pathway 30 may initially fill with priming fluid.

[0041] In some embodiments, flash chamber 46 may comprise a large, non-restrictive volume that can facilitate pressure-driven flow of priming fluid and / or blood toward or into flash chamber 46. In some embodiments, the volume of flash chamber 46 may be large enough to hold priming fluid disposed outside introducer needle 16 and within catheter 14, between first notch 26 and second notch 28, and / or priming fluid that may migrate into flash chamber 46 during priming of catheter 14. Additionally, in some embodiments, the volume of flash chamber 46 may be large enough to hold blood when distal tip 20 of introducer needle 16 is disposed within the vasculature.

[0042] 4A-4B, in some embodiments, the catheter system 10 may include a blood control septum 50, which may be disposed within the lumen 52 of the catheter adapter 12. In some embodiments, the septum 50 may divide the lumen 52 of the catheter adapter 12 into a proximal chamber 54 and a distal chamber 56. In some embodiments, the second notch 28 may be disposed distal to the septum 50 when the introducer needle 16 is in the insertion position.

[0043] In some embodiments, the catheter adapter 12 may include a gas permeable vent 57, which may be selectively opened and / or closed. In some embodiments, the gas permeable vent 57 may be disposed through a wall of the catheter adapter 12 and may be disposed distal to the septum 50 such that when the gas permeable vent 57 is open, air within the distal chamber 56 can freely flow out of the gas permeable vent 57. In some embodiments, the gas permeable vent 57 of the catheter adapter 12 may be opened during priming of the catheter 14, thereby preventing priming fluid from being disposed in the first portion of the introducer needle 16 adjacent the first notch 26 and / or the second portion 28 of the introducer needle 16 adjacent the second notch 28.

[0044] In some embodiments, the catheter system 10 may include a seal 58, which may be secured within the lumen of the catheter adapter 12. In these and other embodiments, a portion of the wall of the introducer needle 16 between the first notch 26 and the second notch 28 may be pinched or crimped to prevent fluid from flowing through the needle lumen 22 between the first notch 26 and the second notch 28. In some embodiments, the introducer needle 22 may be rotatable from the priming position to the insertion position and / or from the insertion position to the priming position. FIG. 4A shows the introducer needle 22 in the insertion position, according to some embodiments, and FIG. 4B shows the introducer needle 22 in the priming position, according to some embodiments. In some embodiments, the introducer needle 16 may be positioned in the priming position during priming of the catheter or in the insertion position during insertion into the vasculature. In some embodiments, the catheter system 10 may not include a seal 58, and / or the priming position and the insertion position may be the same.

[0045] In some embodiments, when introducer needle 16 is in the priming position, seal 58 can cover or seal second notch 28, thereby preventing fluid from flowing through second notch 28. In some embodiments, when introducer needle 16 is in the insertion position, seal 58 can not cover or seal second notch 28, allowing fluid to flow through second notch 28. In some embodiments, in response to second notch 28 not being covered or sealed, a rapid flashback may occur as blood flows into needle lumen 22 through second notch 28. In some embodiments, seal 58 can include a septum or flapper.

[0046] In some embodiments, the introducer needle 16 may be rotatable about a central axis 40 of the catheter system 10 between the priming position and the insertion position, and the central axis 40 may extend through the needle lumen 22. In some embodiments, the introducer needle 16 may be rotated by twisting the needle hub 18. In some embodiments, the introducer needle 16 may be rotated in a first direction and / or a second direction opposite the first direction. In some embodiments, the second notch 28 may be aligned with the seal when the introducer needle is in the priming and insertion positions, as shown, for example, in FIGS. 4A-4B . In these and other embodiments, the introducer needle 16 may extend the same distance from the distal tip of the catheter 14 when the introducer needle 16 is in the priming position as when the introducer needle 16 is in the insertion position.

[0047] The present invention may be embodied in other specific forms without departing from its structure, methods, or other essential characteristics broadly described herein and claimed below. The described embodiments and examples are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than by the foregoing specification. All changes that come within the meaning and range of equivalency of the claims are to be embraced within the scope of the invention.

[0048] All examples and conditional language recited herein are intended for educational purposes to aid the reader in understanding the invention and concepts provided by the inventor to further the art, and should not be construed as being limited to such specifically recited examples and conditions. While the implementation of the invention has been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the invention.

Claims

1. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end and a lumen extending therebetween; a catheter extending distally from the distal end of the catheter adapter; an introducer needle including a wall defining a needle lumen of the introducer needle, a first notch formed through the wall, and a second notch formed through the wall; Including, the second notch is more proximal than the first notch; a portion of the wall between the first notch and the second notch is crimped to prevent fluid from flowing through the needle lumen between the first notch and the second notch; the introducer needle extends through the catheter and beyond the distal end of the catheter when the introducer needle is in an insertion position for insertion into a patient; further comprising a seal disposed within the lumen of the catheter adapter, wherein the introducer needle is rotatable between a priming position and the insertion position, wherein the seal covers and seals the second notch when the introducer needle is in the priming position, and wherein the seal does not cover the second notch and fluid can flow through the second notch when the introducer needle is in the insertion position. Catheter system.

2. A catheter system, a catheter adapter including a distal end, a proximal end and a lumen extending therebetween; a catheter extending distally from the distal end of the catheter adapter; an introducer needle including a wall defining a needle lumen of the introducer needle, a first notch formed through the wall, and a second notch formed through the wall; Including, the second notch is more proximal than the first notch; a portion of the wall between the first notch and the second notch is crimped to prevent fluid from flowing through the needle lumen between the first notch and the second notch; the introducer needle extends through the catheter and beyond the distal end of the catheter when the introducer needle is in an insertion position for insertion into a patient; a seal made of a dissolvable material, the seal being disposed over the second notch to seal the second notch; Catheter system.

3. The catheter system of claim 1 or 2, wherein the first notch is located within the catheter when the introducer needle is in the insertion position, and at least a portion of the catheter is transparent.

4. The catheter system of claim 1 or 2, further comprising a flash chamber in fluid communication with the needle lumen, the flash chamber comprising a gas permeable vent.

5. 3. The catheter system of claim 1, wherein the catheter adapter further comprises a gas permeable vent, the gas permeable vent being selectively opened and closed.

6. a first fluid pathway extending from the first notch to the second notch between an outer surface of the introducer needle and an inner surface of the catheter wall; a second fluid path extending within the needle lumen from the first notch to the second notch; 3. The catheter system of claim 1, further comprising: a first fluid path for receiving a first fluid from the catheter; a second fluid path for receiving a second fluid from the catheter;

7. 3. The catheter system of claim 1, wherein a cross section perpendicular to a central axis of the catheter system and passing through the catheter system between the first notch and the second notch includes a needle lumen area and another area between an outer surface of the introducer needle and an inner surface of the wall, the other area being larger than the needle lumen area.

8. The catheter system of claim 1 or 2, wherein the second notch is located within the catheter when the needle is in the insertion position.

9. The catheter system according to claim 1 or 2, wherein the second notch is disposed within the lumen of the catheter adapter when the needle is in the insertion position.

10. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending therebetween; a catheter extending distally from the distal end of the catheter adapter; a blood control septum disposed within the lumen and dividing the lumen into a proximal chamber and a distal chamber; an introducer needle having a wall defining a needle lumen of the introducer needle, a first notch formed through the wall, and a second notch formed through the wall; Including, the second notch is more proximal than the first notch; a portion of the wall between the first notch and the second notch is crimped to prevent fluid from flowing through the needle lumen between the first notch and the second notch; the introducer needle extends through the catheter and beyond the distal end of the catheter when the introducer needle is in an insertion position for insertion into a patient; the first notch is located within the catheter when the introducer needle is in the insertion position; At least a portion of the catheter is transparent; the second notch is located distal to the septum when the introducer needle is in the insertion position. Catheter system.

11. 11. The catheter system of claim 10, further comprising a needle hub connected to the catheter adapter, the proximal end of the introducer needle secured within the needle hub, the needle hub including a flash chamber in fluid communication with the needle lumen and proximal to the proximal end of the introducer needle, the flash chamber including a gas permeable vent.

12. 11. The catheter system of claim 10, wherein the catheter adapter further includes a gas permeable vent extending through a wall of the catheter adapter distal to the septum, the gas permeable vent being selectively open or closed.

13. 11. The catheter system of claim 10, further comprising a seal disposed within the lumen of the catheter adapter distal to the septum, wherein the introducer needle is rotatable between a priming position and the insertion position, wherein the seal covers and seals the second notch when the introducer needle is in the priming position, and wherein the seal does not cover the second notch and allows fluid to flow through the second notch when the introducer needle is in the insertion position.

14. The catheter system of claim 10 , wherein the second notch is located within the catheter when the needle is in the insertion position.

15. The catheter system of claim 10 , wherein the second notch is disposed within the lumen of the catheter adapter when the needle is in the insertion position.

Citation Information

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