Retractable needle catheter delivery apparatus

Abstract

Disclosed herein is a catheter insertion device including a catheter slidably mounted within a retractable needle. The catheter can have multiple features to help a user such as a physician. The catheter can include a magnified optical window to view blood flashback. The catheter can include securement wings to minimize rotation or movement when the catheter is inserted. The catheter can include a countdown prior to automatic needle retraction. The catheter can include a proximal blood valve to minimize blood flow into the proximal end of the catheter.

Description

Attorney Docket No. 56880-707601RETRACTABLE NEEDLE CATHETER DELIVERY APPARATUSCROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 714,070, filed October 30, 2024, which application is incorporated herein by reference in its entirety.

[0002] The subject matter of the present disclosure is related to that of PCT Application No. PCT / US2022 / 013928, filed January 26, 2022, which claims priority to US Provisional Patent No. 63 / 144,258, filed February 1, 2021, and is also related to that of PCT Application No. PCT / US2020 / 061633, which claims priority to US Provisional Patent Applications Nos. 62 / 941,211, filed November 27, 2019, 62 / 941,541, filed November 27, 2019, 62 / 985,182, filed March 4, 2020, and 63 / 023,699, filed May 12, 2020, the full disclosures of which are incorporated herein by reference.BACKGROUND

[0003] The present disclosure relates generally to the field of medical devices and methods. More particularly, the present disclosure relates to catheter insertion devices, through-the- needle catheters, and related methods of their use.

[0004] Catheters can be used in various medical procedures to administer fluids to a patient and / or to withdraw body fluids from a vein of a patient. A needle can be used to access a vein or artery in the body in order to introduce the catheter into a blood vessel. After the needle is in proper position, a catheter can be advanced through the needle and into the vessel. The needle can be then withdrawn from the body, leaving the catheter implanted with the distal end of the catheter located in the vessel. However, the needle cannot be easily removed and disposed of. To solve this, the needle may be made splittable by forming the needle of two longitudinally aligned halves, or by longitudinally scoring or perforating the body of the needle.

[0005] However, even with a splittable needle, the portions of the needle can present a safety / disposal risk. Furthermore, the catheter can be manipulated by an operator while threading the catheter through the lumen of the needle. As a result, catheters may be contaminated by bacteria from the skin of the patient or due to manipulation by the operator.

[0006] It may thus be desirable to provide needle-type catheter insertion tools which do not require splitting or other disassembly of the insertion tool at the time of catheter insertion. It may be further desirable that any such catheter insertion tools be inherently safe and non-Attomey Docket No. 56880-707601 traumatic to the patient in use, and in particular reduce any risk of accidental needle sticks to medical personnel as well as the patient. At least some of these objectives can be met by the present disclosure.SUMMARY

[0007] Disclosed herein is a catheter insertion apparatus. The catheter insertion apparatus can comprise a housing having a longitudinal passage. The catheter insertion apparatus can comprise an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage. The catheter insertion apparatus can comprise a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip. The catheter insertion apparatus can comprise a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector. In some cases, the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle. In some cases, the needle is retractable within the housing.

[0008] Provided herein is a catheter insertion apparatus. The catheter insertion apparatus can comprise a housing having a longitudinal passage. The catheter insertion apparatus can comprise a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip. The catheter insertion apparatus can comprise a needle position indicator disposed within the longitudinal passage of the housing. The catheter insertion apparatus can comprise a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector. In some cases, the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle. In some cases, the needle is retractable within the housing. In some cases, the needle position indicator is configured to incrementally provide audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing.

[0009] Disclosed herein is a catheter insertion apparatus. The catheter insertion apparatus can comprise a housing having a longitudinal passage. The catheter insertion apparatus can comprise one or more securement wings externally attached to the housing. The catheter insertion apparatus can comprise a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-Attorney Docket No. 56880-707601 penetrating distal tip. The catheter insertion apparatus can comprise a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector. The catheter insertion apparatus can comprise one or more longitudinal engagement features between the catheter and the housing. In some cases, the one or more engagement features are configured to prevent the catheter from rotating with respect to the housing. In some cases, the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle. In some cases, the needle is fully retractable within the housing.

[0010] Provided herein is a catheter insertion apparatus. The catheter insertion apparatus can comprise a housing having a longitudinal passage. The catheter insertion apparatus can comprise a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip. The catheter insertion apparatus can comprise a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector. The catheter insertion apparatus can comprise a seal between the catheter and the needle lumen. In some cases, the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle. In some cases, the needle is fully retractable within the housing.

[0011] Disclosed herein is a catheter insertion apparatus. The catheter insertion apparatus can comprise a housing having a longitudinal passage. The catheter insertion apparatus can comprise a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip. The catheter insertion apparatus can comprise a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector. In some cases, the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle. In some cases, the needle is retractable within the housing. In some cases, the catheter insertion apparatus further comprises one or more of: (a) an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage; (b) one or more longitudinal engagement features between the catheter and the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing; (c) a needle position indicator disposed within the longitudinal passage of the housing; or (d) a seal between the catheter and the needle lumen.Attorney Docket No. 56880-707601

[0012] Disclosed herein is a method of inserting a catheter into a subject. The method can comprise advancing a distal tip of a needle coupled to a housing through a skin and into a blood vessel of the subject. In some cases, a catheter is disposed within a lumen of the needle while the distal tip is being advanced. The method can comprise pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel. The method can comprise viewing, via an optical magnification feature mounted within the housing, a longitudinal passage of the housing. The method can comprise retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0013] Provided herein is a method of inserting a catheter into a subject. The method can comprise advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject. In some cases, a catheter is disposed within a lumen of the needle while the distal tip is being advanced. The method can comprise pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel. The method can comprise receiving, via a needle position indicator disposed within a longitudinal passage of the housing, incremental audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing. The method can comprise retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0014] Disclosed herein is a method of inserting a catheter into a subject. The method can comprise advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject. In some cases, a catheter is disposed within a lumen of the needle while the distal tip is being advanced. The method can comprise attaching the housing to a skin of the subject via one or more securement wings externally attached to the housing. The method can comprise pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel. The method can comprise substantially preventing the catheter from rotating with respect to the housing via one or more longitudinal engagement features between the catheter and the housing. The method can comprise retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0015] Provided herein is a method of inserting a catheter into a subject. The method can comprise advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject. In some cases, a catheter is disposed within a lumen of the needle while the distal tip is being advanced. The method can comprise preventing, via a seal between theAttorney Docket No. 56880-707601 catheter and a lumen of the needle, blood from wicking up between the needle lumen and an outer surface of the catheter and into the housing. The method can comprise pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel. The method can comprise retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0016] Disclosed herein is a method of inserting a catheter into a subject. The method can comprise advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject. In some cases, a catheter is disposed within a lumen of the needle while the distal tip is being advanced. The method can comprise pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel. The method can comprise retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel. In some cases, the housing comprises one or more of: an optical magnification feature allowing a user to view into the longitudinal passage; one or more longitudinal engagement features disposed between the catheter and an inner wall of the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing; a needle position indicator disposed within a longitudinal passage of the housing; or a seal between the catheter and the needle lumen.

[0017] Additional aspects and advantages of the present disclosure can become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As can be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.BRIEF DESCRIPTION OF DRAWINGS

[0018] The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure can be obtained by reference to the following detailed description that sets forth illustrativeAttorney Docket No. 56880-707601 embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0019] The disclosure can be understood from the following description of preferred embodiments, taken in conjunction with the accompanying drawings, wherein:

[0020] FIG. 1 shows a perspective view of a top view of a catheter insertion device constructed in accordance with example embodiments described herein.

[0021] FIG. 2 shows a side view of the catheter insertion device of FIG. 1 in accordance with example embodiments described herein.

[0022] FIG. 3 illustrates a venous catheter having an atraumatic distal tip with a laterally offset outlet port that may be delivered using the catheter insertion tools in accordance with example embodiments described herein.

[0023] FIG. 4 shows a detailed view of the distal end of the venous catheter of FIG. 3 in accordance with example embodiments described herein.

[0024] FIG. 5 shows a detailed view of the distal end of the venous catheter of FIG. 5, shown in cross-section, in accordance with example embodiments described herein.

[0025] FIGS. 6A-6C illustrate use of the catheter insertion tools of FIGS. 1 and 2 for delivering a venous catheter into a venous lumen in accordance with example embodiments described herein.

[0026] FIG. 7 shows a perspective view of an integrated catheter insertion apparatus constructed in accordance with example embodiments described herein.

[0027] FIGS. 8A-8C illustrate the integrated catheter insertion apparatus of FIG. 7 showing the steps in deploying a catheter and retracting a needle in accordance with example embodiments described herein.

[0028] FIG. 9 shows an exploded view illustrating the various components of the integrated catheter insertion apparatus of FIG. 7 in accordance with example embodiments described herein.

[0029] FIGS. 10A-10B illustrate details of the spring-loaded needle retraction assembly in accordance with example embodiments described herein.

[0030] FIGS. 11A-11C illustrate the steps of the methods of the present disclosure for advancing the venous access catheter and retracting the venous access needle in accordance with example embodiments described herein.

[0031] FIGS. 12A-12C show cross-sectional views taken along lines 12A-12A, 12B-12B, and 12C-12C, in FIGS. 11A-11C in accordance with example embodiments described herein.Attorney Docket No. 56880-707601

[0032] FIGS. 13A-13B show perspective views of a further embodiment of an integrated catheter insertion apparatus constructed in accordance with example embodiments described herein shown in full view and cross-sectional view, respectively.

[0033] FIG. 14 shows an exploded view illustrating the various components of the integrated catheter insertion apparatus of FIGS. 13A and 13B in accordance with example embodiments described herein.

[0034] FIG. 15 shows a perspective view of a housing of the integrated catheter insertion apparatus of FIGS. 13A and 13B in accordance with example embodiments described herein.

[0035] FIGS. 15A-15B show detailed views of a partial luer fitting incorporated into a proximal end of the housing of FIG. 15 shown in full view and cross-sectional view, respectively, in accordance with example embodiments described herein.

[0036] FIG. 16 shows a perspective view of a cannula of the integrated catheter insertion apparatus of FIGS. 13A and 13B in accordance with example embodiments described herein.

[0037] FIGS. 16A-16C show detailed views of a hub disposed at a proximal end of the cannula illustrated in FIG. 16 in accordance with example embodiments described herein.

[0038] FIGS. 17A-17B show detailed views illustrating how the partial luer fitting incorporated into the proximal end of the housing of FIG. 15 mates with a partial luer fitting incorporated into a proximal end of a catheter assembly to form a complete luer fitting in accordance with example embodiments described herein.

[0039] FIG. 18 shows a cross-sectional view of the housing illustrating channels formed into an internal wall of the housing which receive two arms of the catheter assembly to allow advancement and alignment of the catheter assembly in the housing in accordance with example embodiments described herein.

[0040] FIGS. 19A-19C illustrate method steps for deploying the integrated catheter insertion apparatus of FIGS. 13A and 13B in accordance with example embodiments described herein, shown with the integrated catheter insertion apparatus in a top, cross-sectional view.

[0041] FIGS. 20A-20C illustrate method steps for deploying the integrated catheter insertion apparatus of FIGS. 13A and 13B in accordance with example embodiments described herein, shown with the integrated catheter insertion apparatus in a side, cross-sectional view.

[0042] FIGS. 21A-21D illustrate front (FIG. 21A), side (FIG. 21B), and perspective (FIGS. 21C-21D) views that illustrate the integrated catheter insertion apparatus of FIGS. 13A and 13B after the catheter has been introduced into a vein and the cannula retracted into the housing in accordance with example embodiments described herein.Attomey Docket No. 56880-707601

[0043] FIGS. 22A-22C illustrate an optional blood control valve disposed in the catheter hub which opens from a proximal, closed configuration (FIG. 22A) to a distal, open confirmation (FIG. 22C) as it is distally advanced in a passage of the hub by attachment of an external luer connector in accordance with example embodiments described herein.

[0044] FIG. 23 shows an exploded view illustrating the components of an integrated catheter insertion apparatus similar to that of FIGS. 13A and 13B where the catheter connector hub has a side access port in accordance with example embodiments described herein.

[0045] FIGS. 24A-24B show detailed side views of the catheter connector hub of FIG. 23 shown in full line and cross-section, respectively in accordance with example embodiments described herein.

[0046] FIG. 25 shows a perspective view of an example catheter insertion device with enhanced device feedback features in accordance with example embodiments described herein.

[0047] FIGS. 26A-26C show side (FIG. 26A), front (FIG. 26B), and exploded perspective (FIG. 26C) views of an example catheter insertion device in accordance with example embodiments described herein.

[0048] FIG. 27 shows a blood control needle valve of a catheter insertion device in accordance with example embodiments described herein.DETAILED DESCRIPTION

[0049] Although thousands of catheters are inserted daily, there remains frequent incidence of damage to vessel walls, blood stream infections, and other side effects associated with catheter use. For example, needle insertion, lowering, further advancement, and then catheter insertion uses undue manipulation which leads to error in placement. As skin may not be sterilized and bacteria may persist in underlying skin layers, hair follicles, and sebaceous glands, contamination of the blood with bacteria from the skin can cause infection, and present catheters may not offer protection from bacteria. During insertion, there may be vessel wall skiving and scraping, and infusion deposits can damage the vessel wall. There may also be frequency needle stick injuries from external needles remaining after use and before disposal of a sharp.

[0050] There exists a need for catheter insertion device that minimize damage to vessel walls, are efficient at delivering fluids or other substances, and are safe with minimal chance of inflammation or infection at the site of entry.Attorney Docket No. 56880-707601

[0051] Provided herein are catheter insertion systems comprising both a catheter insertion device and a catheter to be inserted into a patient's venous system using the catheter insertion device. Disclosed herein are methods of using such systems.

[0052] The catheter insertion devices, systems, and methods disclosed herein may comprise needles with a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration.

[0053] The insertion of the catheter can be “through the needle,” which can act as a skin avoidance design. The needle can provide a barrier between the catheter and the skin, minimizing the risk of skin contact which may otherwise cause related bacterial colonization. The catheter insertion device can introduce a catheter into the patient without the catheter ever touching (e.g., contacting, brushing, dragging across) the skin of the patient. Furthermore, the catheter can be introduced into the patient without an operator (e.g., a clinician) ever physically touching the catheter. As a result, the catheter insertion device of the present disclosure can reduce the risk of contaminating the catheter prior to and while introducing the catheter to the patient. Moreover, the catheter insertion device of the present disclosure can reduce the risk of infection, and as a result, can decrease sickness and disease that may be caused by contamination and infection.

[0054] The catheter itself may provide for contoured directional flow that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel. Once the catheter is placed adjacent a wall of the blood vessel, the contoured directional flow can be aimed forward towards the center of the blood vessel, which may minimize chances of damage to the opposite vessel wall.

[0055] Once the devices and systems are used and executed via the methods disclosed herein, the needle may passively retract into the housing as a safety mechanism to avoid post-usage sharps injuries.

[0056] The catheter insertion device can comprise a housing extending along a longitudinal axis and a needle extending distally, for example coaxially, from a distal end of housing. The needle may have a longitudinal passage coaxially aligned with the longitudinal axis of the housing. The catheter may be configured (having a suitable length, diameter, and shaped) to allow the catheter to be advanced from a retracted position within the longitudinal passage in the needle to an extended position beyond a distal tip of the needle. In some cases, from about 25% to about 90% of the catheter length extends beyond the distal end of the needleAttorney Docket No. 56880-707601 when the catheter is in its extended position. In some cases, from about 50% to about 75% of the catheter length extends beyond the distal end of the needle when the catheter is in its extended position. The needle can be configured to be retracted back into the housing after the catheter has been distally advanced through the needle. In this way, the needle can be safely sequestered within the housing, and the housing can be secured to the patient, and may be taped or otherwise secured to a location on the patient’s skin adjacent the catheter entry location.

[0057] In some cases, the catheter insertion tool can further comprise a slider which may be coupled to a proximal end of the needle. The slider maybe mounted on an outer surface of the housing so that a user may manually retract the needle in a proximal direction after the catheter has been advanced through the needle in a distal direction. In some cases, the needle may passively retract into the housing as a safety mechanism. In some cases, the slider may be configured to be retracted through or within an axial slot on the housing. In some cases, the needle and / or the slider can be configured to prevent distal advancement of the needle after the needle has been retracted. In many instances, the catheter of the present disclosure can have an atraumatic distal tip. For example, the catheter may have a bullet tip where a port is formed within or through the bullet tip. This can be done by chamfering a hemispherical or other rounded surface of the bullet tip at an angle to provide a laterally deflected flow from the distal tip of the catheter. For example, the port may be chamfered or otherwise orientated at an angle from about 30° to about 75° relative to a longitudinal axis of the catheter were the distal end period. In some cases, the catheter may have an atraumatic tip, such as a bullet tip and the outlet port may be formed by a chamfer angled on one side of the bullet tip. The chamfering of the bullet tip can provide for contoured directional flow that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel.

[0058] In some cases, the venous or other luminal access catheter has a distal port configured to direct an outlet flow in a lateral direction (relative to the axial direction of the needle). The distal port has a fixed rotational orientation relative to the longitudinal axis of the housing. In this way, a user can readily control a rotational orientation of the distal port of the catheter as the catheter is being advanced from the needle. The user can rotationally orient the catheter insertion device which carries the catheter so that the distal port on the catheter is deployed in a desired rotational orientation in the venous lumen.

[0059] The distal region of the catheter can be advanced against a wall of the venous lumen and the distal port can be oriented to direct fluid flow from the distal port toward the center ofAttorney Docket No. 56880-707601 the venous lumen. Such orientation may be advantageous, as it promotes mixing of the fluid with a greater blood flow.

[0060] In some cases, the present disclosure provides a method for inserting a catheter into a vein. The method can comprise manually advancing a needle extending distally from the housing into the vein. A catheter can be manually advanced from the needle so that a distal port of the catheter lies at a desired location in a venous or other vessel lumen. The needle may then be manually retracted over the catheter and into the housing. After the catheter is thus deployed, the housing may be secured to a skin region of the patient. The housing may be secured adjacent to the catheter insertion site, and a fluid source may be connected to a connecter at a proximal end of the catheter.

[0061] In some cases, the catheter has an atraumatic tip, such as a bullet tip, and the port may be formed by chamfering one side of the bullet tip, for example being oriented at an angle from about 30° to about 75° relative to a longitudinal axis of the catheter near the distal end. The methods may comprise releasing a fluid from a non-longitudinally oriented port in a direction across a blood flow to promote mixing. For example, the distal region of the catheter can be advanced to lie along one side of a venous wall, where the user points the outlet port to direct fluid flow toward a center of the venous lumen, promoting mixing. The chamfering of the bullet tip can provide for contoured directional flow that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel.

[0062] In some cases, the catheter insertion device can comprise an integrated catheter insertion apparatus comprising a housing, a needle, and a venous access catheter. By "integrated," it is meant that the housing, the needle, and the catheter are provided as a single assembly or structure. While various components of the single assembly may be rearranged during use, the components of the integrated apparatus may be used together without disassembly. The apparatus can comprise a luer or other connector for subsequent attachment to external devices and equipment for both venous access for various purposes including delivery of intravenous fluids, drugs, blood transfusions, and the like as well as drawing blood and other treatments.

[0063] Any of these catheter insertion apparatuses may comprise a valve in the luer or other proximal connector where the valve is configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector. For example, the valve in the proximal connector may comprise a split valve that opens whenAttorney Docket No. 56880-707601 advanced distally against a male rod or other fitting in an axial passage in the proximal connector.

[0064] In some cases, the proximal connector of the catheter is oriented and connected at an angle relative to an axis of the catheter and is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing. The angled proximal connector may comprise a luer fitting, and the angle can be in a range from about 30° to about 60°.

[0065] In some cases, the catheter insertion apparatus according to the present disclosure comprise an integrated structure comprising housing having a longitudinal passage. A needle can be slidably mounted within the longitudinal passage of the housing and has an axial lumen extending from a proximal end to a tissue-penetrating distal tip. A catheter can be slidably mounted within the needle lumen and has a distal port and a proximal connector. In an initial configuration of the catheter insertion apparatus, the needle extend can distally of the housing and the catheter is retracted proximally within the needle. The proximal connector of the catheter can be distally advanceable to engage a proximal end of the housing. Such distal advancement can extend the distal port of the catheter distally from the distal tip of the needle, and the needle can be fully retractable over the catheter and within the housing after the catheter has been distally advanced.

[0066] In some cases, the needle may have a length in a range from about 0.5 cm to about 3 cm, often having a length of about 1.5 cm, but sometimes having a length of about 1 cm or shorter. The catheter may have an exposed length (catheter tube length when fully extended distally from the housing) in a range from about 2 cm to about 8 cm. The catheter may have an exposed length from about 3 cm to about 6 cm.

[0067] In some cases, a spring assembly is disposed within the longitudinal passage of the housing and configured to retract the needle after the catheter has been distally advanced from the needle. The spring assembly can be configured to automatically retract the needle after the catheter has been fully distally advanced from the needle. In some cases, the spring assembly comprises a coiled spring disposed coaxially over the needle and a locking mechanism that holds the needle it its distally advanced position with the spring in an axially compressed configuration. Release of the locking mechanism may allow the spring to axially expand, driving the needle proximally to retract the needle fully within the housing. In some cases, the locking mechanism may be configured to automatically release the spring when the catheter is fully advanced and / or when the catheter retraction mechanism is actuated.Attorney Docket No. 56880-707601Alternatively, in some embodiments, the spring assembly may be configured to be manually released, e.g., by a button or other trigger on the housing.

[0068] In some cases, the catheter locks within the housing after the catheter has been fully advanced. In some cases, the housing can be configured to be taped or otherwise secured to the patient after the needle has been retracted. In still further specific instances, the proximal connector of the catheter comprises a luer fitting for attachment to an external structure, such as fluid delivery tubing, used in medical systems.

[0069] In some cases, a catheter insertion apparatus comprises a housing having a longitudinal passage. A needle assembly can be slidably mounted within the longitudinal passage of the housing and has an axial lumen extending from a proximal carriage to a tissuepenetrating distal tip. A needle of the needle assembly can extend distally from a distal end of the housing when the catheter insertion apparatus is in an initial configuration. The apparatus may comprise a catheter assembly including a catheter slidably mounted within the needle lumen. The catheter can comprise a distal port, a proximal connector, and at least one arm extending distally from the proximal connector. The catheter can be retracted proximally within the needle in an initial configuration of the catheter insertion apparatus. The apparatus may further comprise an axially compressed coil spring disposed coaxially over a proximal portion of the needle. The coil spring may have a distal end engaging an interior surface of the longitudinal passage of the housing and a proximal end engaging a distal face of the proximal hub of the needle when the insertion apparatus is in its initial configuration. A locking disc can be configured to hold the coil spring in its axially compressed configuration. The locking disc can be further configured to be engaged by the at least one arm of the catheter assembly when the catheter assembly is distally advanced relative to the housing. Rotation of the catheter assembly after it has been fully advanced can release the locking disc, thus allowing the spring to axially expand to retract the needle. In some cases, prior to rotation of the catheter assembly, the locking disc engages one or more retaining features on an interior surface of the longitudinal passage. Rotation of the catheter assembly can cause the locking disc to rotate and disengage from the one or more retaining feature, thus allowing the coil spring to expand and proximally retract the needle assembly.

[0070] In some cases, a distal end of the at least one arm of the catheter assembly may have a slot which locks with the retaining feature on the interior surface of the longitudinal passage after the catheter assembly has been rotated. Thus, in a single motion of rotating the catheter assembly, the catheter assembly may both lock to the retaining feature and release the needle so that the needle is automatically retracted by expansion of the spring.Attorney Docket No. 56880-707601

[0071] In some cases, once the needle has been fully retracted within the housing and the catheter fully advanced from the housing, the integrated apparatus may be taped to the patient and connected to any fluid or other medicament source. The user can proceed without detaching the needle, and the needle can be fully protected and locked within the housing, thus presenting no safety issues.

[0072] In some cases, the luer or other fitting of the connector of the catheter insertion apparatus may be aligned and / or inserted with an axis of the catheter. In some cases, the luer or other fitting may be oriented and / or inserted at an angle relative to an axis of the catheter. The angle may be in a range from about 30° to about 60°.

[0073] Disclosed herein is a method is provided for inserting a catheter into a vein of a patient. A needle on a housing can be manually advanced into the vein, where the needle and the housing carry a retracted catheter. The catheter can be then manually advanced from the needle into the vein, and the needle is retracted over the catheter into the housing while the catheter remains in the vein. Once the needle is within the housing, the housing may be secured to skin of the patient and is available for connection to a fluid delivery or other medicament system.

[0074] In some cases, the needle remains fully retracted within the housing when the housing is secured to the skin of the patient. The needle may be retracted manually, e.g., where the user retracts the slider on the housing. Alternatively, the needle may be retracted automatically, e.g., by releasing a constrained spring to axially translate the needle relative to the catheter and the housing. This automatic needle retraction can comprise passive retraction into the housing as a safety mechanism.

[0075] In some cases, automatic needle retraction can be affected by mechanically coupling the catheter assembly to the needle, thus accomplishing “automatic” needle retraction while eliminating the use for a spring. For example, a pulley assembly can be provided by attaching a pulling end of one or more tethers to the needle and a driving end of each tether to the catheter, The tether can be passed over a “pulley” feature on the body so that the pulling end of the tethers travels proximally to draw the needle proximally into the housing as the driving ends of the tethers are translated distally as the catheter is pushed forward.

[0076] In some cases, an elastic band or other element may be attached to the needle and the housing and loaded under tension. The tensioned element may then be automatically or manually released to drive the needle proximally into the housing.Attorney Docket No. 56880-707601

[0077] In some cases, an integrated catheter comprises a housing, a needle cannula, a venous access catheter, and a spring configured to automatically retract the needle after the venous access catheter has been advanced through the needle.

[0078] The catheter insertion apparatus may comprise a housing having a longitudinal passage and a cannula or other needle assembly slidably mounted within the longitudinal passage of the housing. The longitudinal passage can extend from a proximal extension to a distal end of the housing, and the needle cannula extends from a proximal hub to a tissuepenetrating distal tip. In an initial configuration, the needle cannula can extend distally from the distal end of the housing, fully exposing the tissue-penetrating distal tip to allow percutaneous introduction to a patient’s venous lumen.

[0079] The venous access catheter can be formed as an assembly including a catheter body or shaft having a distal port and being slidably mounted within the needle lumen, a proximal connector, and at least one arm extending distally from the proximal connector. The catheter shaft can be proximally disposed (e.g., retracted) within the needle lumen when the catheter insertion apparatus is in its initial configuration. The spring can comprise an axially compressed coil spring disposed coaxially over the proximal hub or other portion of the needle cannula, where a distal end of the spring engages an interior surface of the longitudinal passage of the housing and a proximal end of the spring engages a distal face of the proximal hub of the needle when the catheter insertion apparatus is in its initial configuration. A latch on the needle hub can engage a locking feature on an inner surface of the longitudinal passage of the housing to hold the needle in place against the force of the compressed spring, wherein the at least one arm of the catheter assembly can be configured to disengage the latch from the locking feature after the catheter is distally advanced to allow the spring to decompress and retract the needle into the housing.

[0080] In some cases, the needle assembly may comprise a needle hub having at least one spring-loaded latch which engages the locking feature on the inside surface of the longitudinal passage in the housing to hold the needle in place where the at least one arm engages and releases the at least one spring-loaded latch from the locking feature as the catheter is advanced. The at least one spring-loaded latch may comprise a cantilevered hook on the needle hub, and the locking feature may comprise an undercut or other slot formed on the inside surface of the longitudinal passage in the housing. The proximal connector of the catheter can comprise a female luer taper and the proximal extension of the housing can comprise male luer threads, wherein the female luer taper and the male luer threads are joined to form a complete luer fitting when the catheter is fully advanced through the housing. InAttorney Docket No. 56880-707601 some cases, the housing is configured to be taped to a patient after the needle has been retracted.

[0081] In some cases, the present disclosure provides a catheter insertion system which comprises both a catheter insertion device and a catheter to be inserted into a patient's venous system using the catheter insertion device. The catheter insertion device can comprise a housing extending along a longitudinal axis and a needle extending distally, for example coaxially, from a distal end of the housing. The needle can have a longitudinal passage which is coaxially aligned with the longitudinal axis of the housing. The catheter can have a length and be sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position when at least a portion, for example about one- half or more, of the catheter length extends beyond a distal tip of the needle.

[0082] In some cases, the catheter has a distal port configured to direct an outlet flow in a lateral direction (relative to the axial direction of the needle). The distal port may have a fixed rotational orientation relative to the longitudinal axis of the housing. In this way, a user can readily control a rotational orientation of the distal port of the catheter as the catheter is being advanced from the needle. The user can rotationally orient catheter insertion device the which carries the catheter so that the distal port on the catheter is deployed in a desired rotational orientation in the venous lumen. In some cases, the distal region of the catheter can be advanced against a wall of the venous lumen and the distal port can be oriented to direct fluid flow from the distal port toward the center of the venous lumen. Such orientation can be advantageous as it promotes mixing of the fluid with the blood flow.

[0083] In some cases, the housing of the catheter insertion device may have an upper side and the outflow from the distal port of the catheter may be aligned in a direction toward the upper side of the housing. This can allow a user to easily control the direction of the distal port since it can always be aligned with the upper side of the housing which remains visible at all times during catheter deployment.

[0084] In some cases, the catheter may have an advancer (for example, on a proximal hub) which is disposed through a channel in the upper side of the housing so that the advancer is aligned with the outlet flow of the distal port. The needle may be retractable into the housing so that the housing may be secured to a patient without removing the needle. Alternatively, the housing and the needle may both be “splittable” to facilitate removal of the housing and needle from the catheter after the catheter has been introduced into a vein.

[0085] Referring to FIGS. 1 and 2, a catheter insertion tool 10 comprises a housing 12 and a needle 14. The needle can have a sharp distal tip 16 to allow transcutaneous insertion throughAttorney Docket No. 56880-707601 a patient’s skin into a vessel lumen, such as a venous lumen. The sharp distal tip 16 can define an opening 18 at the distal end of a needle lumen through which a catheter can be introduced into the venous or other vessel lumen, as described in more detail below. Opening 18 can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration.

[0086] A slider 20 can be slidably mounted on a surface of the housing 12. The slider 20 can be coupled at or near a proximal end of the needle 14 to allow a user to manually retract the needle into an interior space within the housing, as described further below. In some cases, the slider 20 can be connected through an axial slot 21 or other feature formed in the surface of the housing 12. In some cases, as described above, the needle may be automatically and passively retracted as a safety mechanism.

[0087] A catheter 22 can be slidably mounted within the housing 12. Catheter 22 can have a proximal housing 24. The proximal housing can be or comprise a luer connector. Catheter 22 can have a distal end 30, for example a bullet tip as described in more detail elsewhere herein. Catheter 22 can be free to move within the housing 12 and the needle 14 so that it may be manually advanced by pushing on the catheter, for example pushing in a proximal direction on the proximal 24. To prevent such movement during needle insertion, however, a locking sheath 28 can be provided around a proximal portion of the catheter 22. So long as the locking sheath 28 is in place, as illustrated in FIGS. 1 and 2, the distal tip 30 of the catheter may not be advanced further into the needle than as shown via the broken line.

[0088] Referring now to FIGS. 3, 4, and 5, a bullet-nosed catheter 22 can comprise a flexible shaft 23 having a bullet-shaped distal tip 30 (e.g. having a hemispherical distal end) and a proximal hub 24, such as a luer fitting. As seen in FIGS. 4 and 5, a distal outlet port 32 can be formed in the rounded, bullet tip 30 of the catheter shaft 23 and can be oriented at an angle relative to a longitudinal access of the shaft lumen 25. In some cases, the outlet port 32 can be formed by cutting or "chamfering" a portion of the spherical or domed distal end 32 of the catheter shaft. In some cases, the chamfer can be formed at an angle a in range from about 30° to about 75°, as illustrated in FIG. 5. The chamfering of the bullet tip 30 can provide for contoured directional flow that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel. Other laterally offset outlet ports may also be used. It is desirable that only the outlet port be able to direct fluid from the distal port 32 of the catheter shaft 23 at an angle which is laterally offset orAttorney Docket No. 56880-707601 deflected from the longitudinal access of the shaft, as described in more detail below. This can allow the user to orient the outlet flow of the catheter 100 so that it can be directed across blood flow to promote mixing in the vein.

[0089] In some cases, the length of the needle 14 can be in a range from about 1.5 cm to about 5 cm. The length of needle 14 can be in a range from about 2.5 cm to about 3.5 cm. The catheter shaft 23 may have a length in the range from about 6 cm to about 20 cm. The length of shaft 23 can be from about 8 cm to about 14 cm. In some embodiments, a distal region of the catheter shaft can have a length in the range from about 1.5 cm to about 6 cm. The length of the distal region of the shaft can be from about 2 cm to about 4 cm. The distal region of the catheter shaft can be available to be advanced from the needle and deployed in the patient's vein as described below.

[0090] As shown in FIGS. 6A-6C, the bullet-nose catheter 22 may be deployed in a patient’s venous lumen VL by first choosing a target insertion site T on a patient’s skin S. A sharp tip 18 on the needle 14 can be manually pushed through the skin S at the target site T so that the tip enters the venous lumen VL and may be positioned generally in the middle of the lumen. Opening 18 can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration. The needle can be inserted through the skin S at an angle P relative to the venous lumen VL. The angle can be in the range from about 30° to about 45°, as shown in FIG. 6A.

[0091] Referring now to FIG. 6B, once the distal tip 18 of the needle is in place in the venous lumen VL, the locking sheath 28 can be removed from around the catheter 22, allowing a user to manually push the luer connector 24 or other proximal hub distally so that a distal region of the catheter 22 enters the venous lumen VL. In some cases, the proximal hub can be advanced fully so that it engages a proximal end of the housing 12, as shown in FIG. 6B, but in other instances it may be desirable to only partially advance the catheter, resulting in a shorter length of the catheter being within the vessel. The catheter insertion device can introduce a catheter 22 into the patient without the catheter ever touching (e.g., contacting, brushing, dragging across) the skin of the patient. Furthermore, the catheter can be introduced into the patient without an operator (e.g., a clinician) ever physically touching the catheter. As a result, the catheter insertion device of the present disclosure can reduce the risk of contaminating the catheter prior to and while introducing the catheter to the patient.Attorney Docket No. 56880-707601Moreover, the catheter insertion device can reduce the risk of infection, and as a result, can decrease sickness and disease that may be caused by contamination and infection.

[0092] Referring now to FIG. 6C, once the desired length of the catheter has been introduced into the venous lumen VL, the slider 20 can be manually retracted in a proximal direction to proximally retract the needle 14 fully within an interior space of the housing 12. The proximal fitting 24, such as a luer connector, can be ready to be connected to an external fluid source. The housing 12 may be taped or otherwise secured to the patient’s skin S and the catheter can be considered fully deployed.

[0093] Referring now to FIGS. 7 and 8A-8C, a catheter insertion apparatus 100 may comprise a housing 102, a cannula 104, a needle having a sharpened distal tip 114, and a venous access catheter 106. The catheter can be part of a catheter assembly including a proximal connector 108 at a proximal end of the catheter. The proximal connector 108 may be a luer-type fitting having proximal threads 116 of the type which mate with medical fluid delivery systems. The proximal connector 108 may also have gripping features 118b which eventually line with gripping features 118a at a proximal end of the housing 102, as shown in FIG. 8C

[0094] In an initial configuration (e.g., the configuration used for initial needle penetration into the patient’s vein), the catheter 106 can be fully retracted within the needle 104 and the housing 102, as shown in FIGS. 7 and 8A. Needle 114 can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration. The proximal connector 108 on the catheter assembly can also be proximally spaced from a proximal end of the housing 102 while being slidably attached to the housing by a pair of arms 110. The arms 110 can serve a number of functions, as described below, but as seen in FIGS. 7 and 8A, can act as rails or guides for advancing the catheter assembly into the interior of the housing 102 as the connector 108 is pushed distally by a user.

[0095] The catheter insertion apparatus 100 can comprise a flashback window 112 and a pair of taping wings 120 on the housing 102. Flashback window 112 allows the user to detect when blood flows back into the device after the sharpened distal tip 114 first enters a vein, confirming that access has been achieved. The taping wings can facilitate taping, wrapping, or otherwise securing the housing to the patient after the catheter 106 has been positioned in the target vein.Attorney Docket No. 56880-707601

[0096] After the needle 104 has been introduced into a vein, for example by manual placement, flashback can be observed through the window 112, and the catheter 106 can be distally advanced from the needle 104 by distally advancing the proximal connector 108, as shown in FIG. 8B. At this point, the catheter 106 can be advanced but the needle 104 can still be in place and the catheter has not yet been locked to the housing. Both retracting the needle 104 and locking the catheter 106 may be achieved by rotating the proximal connector 108 until the gripping features 118a and 118b come into axial alignment, as shown in FIG. 8C. While a number of internal mechanisms can be used to bring about this change, for the user can be a simple twist of the connector 108 that both retracts the needle and locks the catheter in place.

[0097] Referring now to FIG. 9, the internal components of the catheter insertion apparatus 100 are identified and described. The needle 104 can have a needle carriage 138 attached to its proximal end. The needle carriage 138 may have a pair of mating wedges 140 projecting radially outwardly from its proximal end. A locking disc 134 can be located on a proximal side on the needle carriage 138 and comprises a pair of locking tabs 136. The arms 110 of the catheter assembly may each have a locking slot 130 formed near their respective distal ends. A coil spring 124 can be disposed between the needle 104 and the housing 102 so that the spring can be compressed between the needle carriage 138 and a forward, interior end (103, FIGS. 10A and 10D) of the housing 102 when the needle 104 is fully advanced relative to the housing, as described in more detail below.

[0098] Referring now to FIGS. 10A and 10B, the details of the internal needle retention and release mechanism are described. In both FIGS. 10A and 10B, the needle 104 can be fully extended in the distal direction and held in place by the locking disc 134 which engages and retains the needle carriage 138. Coil spring 124 can be fully compressed between a distal surface of a retaining flange 135 at a proximal end of the needle carriage 138 and a proximal surface 103 of an internal passage 105 of the housing 102.

[0099] The locking disc 134 can be held in place by an engagement between locking tab 136 which extends radially outwardly from the locking disc and a blocking feature 144 formed on an interior surface of the interior passage 105 of the housing 102. Rotation of the locking disc 134 about a longitudinal axis of the housing 102 (perpendicular to a plane of the locking disk) can disengage the locking tab 136 from the blocking feature 144, allowing the disc to translate proximally propelled by expansion of the spring 124, releasing the needle carriage 138 and spring 124. The mechanisms to rotate the locking disc are described in connection with FIGS. 11A-11C and 12A-12C.Attorney Docket No. 56880-707601

[0100] FIG. 11A illustrates the needle retention and retraction mechanism in the same state as shown in FIGS. 10A and 10B. In addition, FIG. 11 shows one arm 110 of the pair of arms which form part of the catheter assembly shown in FIG. 9. The proximal connector 108 is shown in broken line. All components of the catheter insertion apparatus 100 shown in FIG. 11A are in their initial configuration where the needle is fully advanced and the catheter 106 retracted inside of the needle, as shown in FIGS. 7 and 8A.

[0101] In order to both advance the catheter 106 and release the locking disc 134, the catheter assembly may be distally translated by pushing on the proximal connector 108 to engage a distal surface of the proximal connector against a proximal end of the housing 102, as shown in FIG. 11B. Such axial translation of the connector 108 can fully extend a distal tip of the catheter 106 beyond the sharpened distal tip 114 of the needle 104, as shown in FIG. 8B. At this point, however, as shown in FIG. 11B, the needle 104 may remain distally advanced and the catheter 106 not yet locked in place. In this state, the catheter 106 may be accidentally retracted simply by pulling on the proximal connector 108 and / or pushing on a distal end of the catheter 106 in a proximal direction.

[0102] In order to both lock the catheter 106 to the housing 102 and release the locking disc 134 to allow the needle 104 to retract under the force of spring 124, the proximal connector 108 may be rotated to the position shown in FIGS. 8C and 11C. Such rotation can cause a distal surface 142 of the arm 110 to engage and rotationally displace the locking tab 136 on the locking disc 134. Such rotation may take the locking tab 136 out of axial alignment with the blocking feature 144. When the locking tab is displaced, the locking disc 134 can be free to translate proximally under the force of the spring 124 which is released from compression.

[0103] Simultaneously, as the locking arm 112 rotates, the locking slot 130 on the arm can engage and lock onto the blocking feature 144 on the interior wall of the housing 102, as shown in FIG. 11C. Such engagement and locking can prevent further axial translation of the catheter assembly. As a further safety feature, subsequent rotation of the proximal connector 108 can be prevented by capturing the locking tab 136 on the locking disc 134 between one side of an alignment rail 148 and an opposing surface of the proximal end of the arm 110, as shown in FIG. 11C. It can be appreciated that the alignment rail 148 may act as a guide for the locking tab as it is proximally translated by the expansion of spring 124, thus assuring that the locking tab is positioned between the alignment rail and the arm 110 when the needle is fully retraced and the catheter fully advanced. This safety feature can be of a particular advantage as it prevents accidental release of the needle after the housing has been taped to the patient and connected to the fluid delivery system.Attorney Docket No. 56880-707601

[0104] Positioning of the alignment rails 148 and the arms 110 of catheter assembly during various stages of the operation of the catheter insertion apparatus 100 can be observed in FIGS. 12A-12C which are cross-sectional views taken along lines 12A-12A, 12B-12B, and 12C-12C of FIGS. 11A-11C, respectively.

[0105] Referring now to FIGS. 13A and 13B, a catheter insertion and attachment apparatus 200 can comprise a housing 202, a needle cannula 204, such as a hypotube needle or similar injection device having a sharpened distal tip 214, and a venous access catheter 206. The venous access catheter 206 can be received in an axial passage 203 (FIG. 13B) within the housing 202 and may have a partial (inner) luer fitting 218 at its proximal end. A pair of arms 210 can be attached to the partial luer fitting 218 and extend from the fitting in a distal direction parallel to a longitudinal axis of the venous access catheter 206. A distal end of each arm 210 can terminate in wedge tip 228, which can be configured to release the needle cannula 204 from temporary attachment to the housing 202 as the catheter 206 is distally advanced within the passage 203 of the housing 202. Needle 204 can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration. A second partial (outer) luer fitting 208 can be formed on a proximal extension 234 at a proximal end of the housing 202. The second partial luer fitting can comprise external luer threads 208a, which form the attachment portion of the luer when external tubing is attached to the catheter. In particular, the luer can become functional when the inner luer fitting 218 is inserted into the outer luer fitting 208 as described in greater detail below. In some cases, the housing 202 can comprise a pair of taping or securement wings 216 to facilitate securing the housing 202 to the patient’s skin after catheter insertion and needle retraction

[0106] As further shown in FIGS. 13A and 13B, in the initial configuration of the catheter insertion and attachment apparatus 200, the needle cannula 204 can be fully extended in a distal direction from the housing 202 and the access catheter 206 is fully retracted in a proximal direction within the housing 202. In this configuration, the cannula needle 204 can be ready to be percutaneously inserted into a patient's vein. The sharpened the distal tip 214 can be inserted into a lumen of a target vein, and entry can be confirmed by observing flashback in a window 212 formed in a wall of the housing 202. A complete description of needle insertion, catheter advancement, needle retraction, and external tubing connection is made with reference to FIGS. 19A-19C and FIGS. 20A-20C below.Attorney Docket No. 56880-707601

[0107] Referring now to FIG. 14, each component of the catheter insertion and attachment apparatus 200 is illustrated in isolation. The catheter insertion and advancement apparatus 200 can comprise of four components. In addition to the housing 202, needle cannula 204, and venous access catheter 206 described previously, the apparatus 200 may comprise only a coil or other compression spring 224. It can be a particular advantage that only four separate components are used, substantially simplifying fabrication and assembly of the complete product. As best seen in FIG. 14, the partial luer fitting 218 on the access catheter 206 can comprise a plurality of locking or retention teeth 200a formed on its outer surface. As seen in FIG. 13B, a plurality of locking or retention teeth 220b can be formed on an inner surface of the proximal extension 234 of the housing 202. When the catheter 206 is fully advanced into the housing 202, the locking teeth 220a on the partial luer fitting 218 can engage the locking teeth 218b on the proximal extension of the housing. In this way, the teeth 220a and 220b, which are formed as interlocking ratchets, can engage each other and lock or affix the catheter to the housing to prevent accidental retraction. The venous access catheter 206 can comprise a distal catheter port 226. The distal catheter port 226 may have an upward configuration similar to that described previously.

[0108] As further seen in FIG. 14, the needle cannula 204 may have a hub 238 at its proximal end opposite the sharpened distal tip 214 formed at the distal end. The needle hub 238 can have a pair of engagement hooks or tangs 242 which serve to “releasably” lock the needle cannula in the distally forward configuration prior to retraction of the needle after the catheter has been advanced, as described in greater detail below.

[0109] Referring now to FIGS. 15, 15A, and 15B, the proximal extension 234 of the housing 202 can comprise a pair of semi-cylindrical shell elements 232 having a pair of laterally opposed gaps 230 therebetween. The luer threads 208 may extend around the semi- cylindrical shell elements 238 and over the gap 230, allowing the wedge tips 228 on the arms 210 of the catheter assembly 206 to be advanced beneath the external threads 208 and through channels 250 on an inner wall of the axial passage 203 of the housing 202, as best seen in FIG. 18. In this way, the wedge tips 228 can be advanced to the needle cannula hub 238 as the catheter 206 is being advanced through the needle cannula 204. When the wedge tips 228 reach the needle cannula hub 238, they can disengage the needle cannula hub from the housing wall, as described in more detail below, allowing the compressed spring 224 to decompress and retract the needle proximally over the catheter and into the axial passage 203 of the housing 202.Attorney Docket No. 56880-707601

[0110] Referring now to FIGS. 16 and 16A-16C, the needle cannula assembly 204 can comprise a needle shaft 204a having a sharpened distal tip 215 at its distal end. The cannula hub 238 can be attached to a proximal end of the shaft 204 and comprises a cylindrical wall having a pair of opposed cantilever spring elements 240 formed therein. The cantilever springs can be attached to the wall at their distal ends so that the engagement hooks or tangs 242 at their proximal ends may be resiliently compressed inwardly to release the needle hub from engagement with the housing wall, as can be described below. Each tang or hook 242 can have a beveled surface 244 which is configured to be engaged and compressed by the wedge tips 228 of the arms 210 to effect the desired release. As shown in FIG. 16 C, the spring coil 224 can be maintained in a compressed configuration prior to release of the needle for retraction into the housing. Release of the needle cannula hub 238 from engagement with the housing 202 can allow the spring 228 to decompress and drive the needle cannula assembly 204 proximally so that it fully retracts into the housing prior to attachment of external tubing.

[0111] Referring now to FIGS. 17A and 17B, engagement between the partial luer fitting 218 on the venous access catheter 206 with the partial luer fitting 208 on the housing 202 can be described. In FIG. 17A, the partial luer fitting 218 has been advanced to a point where the locking teeth 220a are just about to enter an interior of the proximal extension 234 of the housing 202. It can be seen that arms 210 are entering the housing 202 through the gaps 230 present in the wall of the proximal extension 234. In particular, the arms 210 may pass beneath the luer threads 208. Once the partial luer fitting 208 on the catheter 206 may be fully advanced into the proximal extension 234, the combination of the partial luer fittings 208 and 218 can form a complete male luer fitting suitable for attachment to a female luer fitting as commonly found on medical tubing. After full insertion of the catheter 206 into the housing 202, the locking teeth 220a on the partial luer fitting 218 can engage the locking teeth 220b (FIG. 15B) on the inner surface of the proximal extension 234. In this way, the catheter can be locked in place within the housing.

[0112] FIG. 18 shows a cross-sectional view of the needle cannula 204 and catheter assembly 206 present in the housing 202. In particular, arms 210 can be advanced through channels 250 formed on the inner wall of the axial passage 203 within the housing 202. As shown in FIG. 18, the venous access catheter 206 may remain within an inner lumen of the needle cannula 204 after the catheter has been advance and the needle catheter retracted.

[0113] Referring now to FIGS. 19A-19C and 20A-20C, stepwise advancement of the catheter assembly 206 into the housing 202 and retraction of the needle cannula 204 into theAttorney Docket No. 56880-707601 housing can be described. As shown in FIG. 19A, the sharpened distal tip 214 of the needle cannula 204 can extend fully distally of the housing 202 and can be ready for insertion through the patient's skin into the venous lumen. At this point, the catheter assembly 206 can be fully retracted in a proximal direction and held in place by engagement of the wedge tips 228 of the arms 210 with the proximal extension 234 of the housing 202. The wedge tips 228 on the distal ends of the arms can be initially located beneath the lower threads 208 and can be disposed in the gap 230.

[0114] After the needle 204 has been advanced into the venous lumen, the catheter 206 can be advanced into the venous lumen by distally pushing the partial luer fitting 218 into the partial luer fitting 208 formed on the proximal extension 234 of the housing, as shown in FIGS. 19B and 20B. The external lower threads 208 can be disposed over the exterior of the partial lower fitting 218 in one orientation (FIG. 19B) and can be attached to the semi- cylindrical elements of the proximal extension in another orientation (FIG. 20B). As the wedge tips 228 are distally advanced, they may engage the engagement hooks or tangs 242 on the needle hub 238. In particular, the inclined surfaces of the wedge tips 228 can engage the beveled surfaces 244 (FIGS. 16A and 16B) of the cantilever springs 240, thereby forcing the springs inwardly and disengaging the engagement hooks or tangs 242 from retention slots 252 formed on the inner wall of the axial passage 203 of the housing 202, as best seen in FIG. 19B. Once the engagement hooks to 42 are released from the engagement slots to 52, the needle hub 238 can be released to translate freely, and the compressed spring to 24 can decompress to translate the needle hub 238 proximally, retracting the needle cannula 204 fully into the housing, as shown and FIGS. 19C and 20C.

[0115] Referring now to FIGS. 21 A and 21B, placement of the catheter 206 into the lumen of a vein V can be accomplished by advancing the needle percutaneously through the patient's skin S, further advancing the catheter into the vein lumen, and then retracting the needle, as just described. In some cases, the distal port 226 of the catheter 206 can be oriented upwardly to provide the advantages described above. FIG. 21A shows a plane at the section view normal to the axis of the catheter. The polar axis of the catheter may be at 12 o-clock, so the fluid flow is delivered at cp = 0°. FIGS. 21C-21D show magnified views of the catheter 206 position in the vein V and the direction of fluid flow. The arrows in FIG. 21A-21D show the direction of fluid flow from the catheter 206.

[0116] The securement wings 216 can facilitate precise in-vessel catheter position via unambiguous extradermal device orientation based on the interaction between the wings and the skin. The wings 216 can be designed to minimize trauma to the vessel and to deliver fluidAttorney Docket No. 56880-707601 into the center of the vessel via careful control of the location and orientation of the catheter tip within the blood vessel. The securement wings 216 on the housing can maintain the correct rotational control and orientation of the skive or chamfered area on the tip of the catheter. The securement wings may allow for consistent relative position of the needle insertion point to the vessel and to the vessel penetration point. The wings can be coupled to the main body of the insertion device. The wings 216 can lie flat against the patient’s skin. Specifically, the wings can allow the skive or chamfered tip to face upwards and have the fluid flow delivered as prescribed. The securement wings can also be called the orientation wings for this reason. In some cases, there may be 1, 2, 3, 4, or more wings. The wings may be longitudinally in a similar area of the catheter insertion device or may be along different longitudinal areas of the insertion device. The average angle of the orientation and securement wings, if at least two, can be + / - 90° (e.g., symmetrical to cp = 180°).

[0117] The axial position of the catheter tube may be parallel but off-axis from the vessel. Even with an off-axis delivery from the catheter tip as shown in FIGS. 21B-D, if the catheter is not positioned and oriented properly, the benefits of reduced chemical phlebitis and improved mixing may not be achieved. The benefits may be achieved when the catheter skive, or chamfer aperture is oriented away from the wall of the vessel and towards the center of the vessel.

[0118] The angular position of the catheter-tip opening in relation to the catheter assembly specifically the catheter arms and wings can be established during manufacture. The angular position of the catheter assembly in relation to the main body can be maintained through the pair of interlocking dovetail arms.

[0119] Memory (e.g., shape memory) of the catheter tube can cause the catheter to lay on the back or bottom wall of the vessel. With the catheter tip so positioned and oriented, delivered fluid can consistently be directed toward the center of the blood vessel. As shown in FIGS. 21C-21D, the delivered fluid can exit the catheter off-axis at angle 9.

[0120] Angle 9 can be from about 10 degrees to about 80 degrees. Angle 9 can be from about 10 degrees to about 20 degrees, about 10 degrees to about 30 degrees, about 10 degrees to about 40 degrees, about 10 degrees to about 50 degrees, about 10 degrees to about 60 degrees, about 10 degrees to about 70 degrees, about 10 degrees to about 80 degrees, about 20 degrees to about 30 degrees, about 20 degrees to about 40 degrees, about 20 degrees to about 50 degrees, about 20 degrees to about 60 degrees, about 20 degrees to about 70 degrees, about 20 degrees to about 80 degrees, about 30 degrees to about 40 degrees, about 30 degrees to about 50 degrees, about 30 degrees to about 60 degrees, about 30 degrees toAttorney Docket No. 56880-707601 about 70 degrees, about 30 degrees to about 80 degrees, about 40 degrees to about 50 degrees, about 40 degrees to about 60 degrees, about 40 degrees to about 70 degrees, about 40 degrees to about 80 degrees, about 50 degrees to about 60 degrees, about 50 degrees to about 70 degrees, about 50 degrees to about 80 degrees, about 60 degrees to about 70 degrees, about 60 degrees to about 80 degrees, or about 70 degrees to about 80 degrees. Angle 9 can be about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, or about 80 degrees. Angle 9 can be at least about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, or about 70 degrees. Angle 9 can be at most about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, or about 80 degrees.

[0121] The catheter may provide for contoured directional flow due to a chamfered tip that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel. Once the catheter is placed adjacent a wall of the blood vessel, the contoured directional flow can be aimed forward towards the center of the blood vessel, which may minimize chances of damage to the opposite vessel wall.

[0122] Referring now to FIGS. 22A to 22C, an alternative inner luer fitting 318 (shown without an outer luer fitting for simplicity of illustration) may be modified by increasing it length (relative to previously illustrated inner luer fitting 218a) and providing a short male fitting 320 defining a blood outlet port 322 on a distal surface 324 of an interior axial passage 330 thereof. A blood control valve 328 having a split valve element 334 may be translatably disposed in the axial passage 330 of the inner luer fitting 318. The blood control valve 328 can be formed from a blood-compatible polymer, such as a silicone polymer, and may have a “top-hat” configuration with a rim 332 formed circumferentially about its proximal end with the split valve element 334 formed in a distal surface thereof. The rim 332 can be configured to act as both a seal and a bearing surface that allows the blood control valve 328 to be advanced from a proximal location, as shown in FIG. 22A, to a distal location, as shown in FIG. 22C. As described in more detail below, the split valve element 334 may be closed as the needle initially penetrates the target vein or other blood vessel to allow blood flashback and gas venting but inhibit blood leakage from the hub. After penetration is confirmed by observing the flashback, an external IV connector 349 or other connector can be attached to the inner luer fitting.

[0123] The external IV connector 340 can be attached to a fluid delivery tube 342 which may be connected to a saline or other fluid delivery bag (not shown). As shown in FIG. 22B, theAttorney Docket No. 56880-707601 external IV connector 340 can have an internal male rod 344 molded into the body of the external IV connector 340 having a central lumen 346 which can receive a fluid flow from the tube 342 when such flow has been initiated. As a needle (e.g. needle 204 in FIG. 16) is inserted distally into a target vein or other patient blood vessel, blood can flow proximally through the needle lumen into the hub 318 which can be transparent or have a transparent window to allow a user to observe blood “flashback” confirming that the needle has entered the blood vessel. The split valve element 334 of the blood control valve 328 can allow gas initially present in the hub 318 to vent while inhibiting blood loss from the hub. To open the valve element to allow infusion, a tip 344a of the male rod 344 can engage the rim 332 of the blood control valve 328 to push the split valve element 334 against the male post 320 which may force the split valve element to open, as shown in FIG. 22C. The silicone or other polymeric material of the valve element can be displaced to fit around the male post inside the catheter assembly hub and can remain there for the remainder of the procedure.

[0124] Referring now to FIG. 23, a catheter insertion and attachment apparatus 400 can comprise a housing 402, a needle cannula 404, such as a hypotube needle or similar injection device having a sharpened distal tip 414, and a venous access catheter 406. The venous access catheter 406 can be slidably received in an axial passage within the housing, and a pair of arms 410 is attached to a catheter hub 412 having a side port 420, such as a luer or other fitting suitable for attaching medical tubing. In contrast to the above, where the tubing connects to the catheter hub in an “in-line” configuration with a direction parallel to a longitudinal axis of the venous access catheter 406, FIG. 23 shows a side port directed laterally outwardly from the connector hub 412, allowing the catheter insertion and attachment apparatus 400 to be used in circumstances where the “in-line” design may not be suitable.

[0125] A distal end of each arm 410 may terminate in wedge tip to 428 which can be configured to release the needle cannula 204 from temporary attachment to the housing 402 as the catheter 406 is distally advanced within the passage of the housing in a manner similar to that described for the catheter insertion and attachment apparatus 200 of FIGS. 13A and 13B. In some cases, the housing 402 can comprise a pair of taping wings 416 (one visible in FIG. 23) to facilitate securing the housing 402 to the patient’s skin after catheter insertion and needle retraction and a flashback window 418. Also analogous to the catheter insertion and attachment apparatus 200, the catheter insertion and advancement apparatus 400 may comprise four components. In addition to the housing 402, needle cannula 404, and venous access catheter 406 described previously, the apparatus 400 may comprise only a coil or otherAttorney Docket No. 56880-707601 compression spring 424. The venous access catheter 406 may comprise a hub 424 and locking tangs 426 as described previously. It can be a particular advantage that only four separate components are used, substantially simplifying fabrication and assembly of the complete product.

[0126] The side port 420 can be shown in more detail in FIGS. 24A and 24B. The side port 420 has a passage 440 which can be oriented along a center line 442 line an angle a relative to a longitudinal axis 444. The angle can be in a range from about 30° to about 60°. The angle can be about 45°. The center line 442 may lie in a plane that passes through the arms 410 so that tubing 436 can be connected to lie over the patient’s body surface adjacent to the connector hub 412.

[0127] FIG. 25 shows a perspective view of catheter insertion device 2500 with enhanced device feedback features. Catheter insertion device 2500 can be similar to the devices 10, 100, 200, and 400 described above. Catheter insertion device 2500 can comprise catheter 2501, needle 2502, magnified flash window 2504, housing 2506, countdown indicators 2508, and side port 2510.

[0128] Needle cannula 2502 can comprise a hypotube needle or similar injection device having a sharpened distal tip. Catheter 2510 can comprise a venous access catheter. The venous access catheter 2510 can be slidably received in an axial passage within the housing, and a pair of arms can be attached to a catheter hub having a side port 2510, such as a luer or other fitting suitable for attaching medical tubing. The side port may be directed laterally outwardly from the connector hub, allowing the catheter insertion and attachment apparatus 2500 to be used in circumstances where an “in-line” design may not be suitable. In some cases, insertion device 2500 can have an in-line port design at the catheter hub while still maintaining magnified flash window 2504 and countdown indicators 2508.

[0129] A distal end of each arm may terminate in a wedge tip configured to release the needle cannula from temporary attachment to the housing 2506 as the catheter 2501 is distally advanced within the passage of the housing in a manner similar to that described for the catheter insertion and attachment apparatus 200 of FIGS. 13A and 13B. In some cases, the housing 2506 can comprise a pair of securement wings to facilitate securing the housing 2506 to the patient’s skin after catheter insertion and needle retraction. The securement wings may be as described above in FIGS. 21A-21B. In contrast to flashback window 418 described above, flashback window 2504 can comprise a magnified version (e.g., a magnified flashback window). The apparatus 2500 can comprise only a coil or other compressionAttorney Docket No. 56880-707601 spring. The venous access catheter can comprise a hub and locking tangs as described previously.

[0130] In the initial configuration of the catheter insertion and attachment apparatus 2600, the needle cannula can be fully extended in a distal direction from the housing and the access catheter can fully retracted in a proximal direction within the housing. The cannula needle can be ready to be percutaneously inserted into a patient's vein. The sharpened the distal tip may be inserted into a lumen of a target vein, and entry can be confirmed by observing flashback in a window formed in a wall of the housing. A complete description of needle insertion, catheter advancement, needle retraction, and external tubing connection is made with reference to FIGS. 19A-19C and FIGS. 20A-20C above.

[0131] In addition to the housing, needle cannula, and venous access catheter, the apparatus 2500 may comprise a coil or other compression spring. The partial luer fitting on the catheter can comprise a plurality of locking or retention teeth formed on its outer surface. A plurality of locking or retention teeth may also be formed on an inner surface of the proximal extension of the housing. When the catheter is fully advanced into the housing, the locking teeth on the partial luer fitting can engage the locking teeth on the proximal extension of the housing. In this way, the teeth can be formed as interlocking ratchets and can engage each other and lock or affix the catheter to the housing to prevent accidental retraction. The venous access catheter can further comprise a distal catheter port.

[0132] The needle cannula may have a hub at its proximal end opposite the sharpened distal tip formed at the distal end. The needle hub can have a pair of engagement hooks or tangs which serve to “releasably” lock the needle cannula in the distally forward configuration prior to retraction of the needle after the catheter has been advanced, as can be described in greater detail below.

[0133] Catheter insertion device 2500 can comprise explicit visual, tactile, and audible cues to a user during use for understanding relative position and state of the device.

[0134] Catheter insertion device 2500 can comprise an optical magnification feature to enhance the apparent size and contrast of visual blood-flash indication so users can discern the blood flash. This can be considered a “magnified flash window” 2504. This magnification feature can comprise a biconvex lens designed to achieve a short-focal length magnification. Other optical designs, such as a convex lens or plano-convex lens, may be utilized to the same effect. The magnified flash window 2504 can be located near the proximal edge of the needle hub in the extended state to also allow the user to visually confirm that the needle has retracted. Upon retraction, the telltale indication can change from red (blood) to grey (needleAttorney Docket No. 56880-707601 lumen). Other colors may be used to demonstrate the change in state (e.g., if the needle lumen is a different color).

[0135] Catheter insertion device 2500 can comprise needle retraction “countdown” indicators 2508 comprising audible and tactile “click” indications notifying the user that needle retraction is imminent with further catheter advancement. These click indications can be actuated via mechanical click detents. FIG. 25 shows three such clicks for a 3-2-1 retraction “countdown.” However, any number of clicks may be utilized to the same effect. There can be 1, 2, 3, 4, 5, 6, or more clicks. This clicking countdown can help a user anticipate when the needle may retract. The clicks can be provided in regular or irregular intervals.

[0136] Needle 2502 can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration.

[0137] The catheter itself may provide for contoured directional flow due to a chamfered tip that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel. Once the catheter is placed adjacent a wall of the blood vessel, the contoured directional flow can be aimed forward towards the center of the blood vessel, which may minimize chances of damage to the opposite vessel wall.

[0138] The catheter insertion device 2500 can introduce a catheter 2501 into the patient without the catheter ever touching (e.g., contacting, brushing, dragging across) the skin of the patient. Furthermore, the catheter can be introduced into the patient without an operator (e.g., a clinician) ever physically touching the catheter. As a result, the catheter insertion device 2500 of the present disclosure can reduce the risk of contaminating the catheter prior to and while introducing the catheter to the patient. Moreover, the catheter insertion device 2500 can reduce the risk of infection, and as a result, can decrease sickness and disease that may be caused by contamination and infection.

[0139] FIGS. 26A-26C show side (FIG. 26A), front (FIG. 26B), and exploded perspective (FIG. 26C) views of a catheter insertion device 2600. Catheter insertion device 2600 can be similar to the devices 10, 100, 200, 400, and 2500 described above. Catheter insertion device 2600 can comprise housing sub-assembly 2602, catheter hub 2604, skin contact site 2606, spring 2610, needle sub-assembly 2612, catheter sub-assembly coupled to venous access catheter 2614, and blood control valve 2616. Catheter hub 2604 shows the catheter hub fully advanced into the housing sub-assembly. The catheter hub can be fully drawn back as shown in 2601 prior to packaging. 2603 shows the valve insertion depth into the catheter hub.Attorney Docket No. 56880-707601

[0140] The needle 2612 can comprise a needle cannula such as a hypotube needle or similar injection device having a sharpened distal tip. Catheter sub-assembly can comprise a venous access catheter 2614 received in an axial passage within the housing and having a partial (inner) luer fitting at its proximal end. A pair of arms can be attached to the partial luer fitting and extend from the fitting in a distal direction parallel to a longitudinal axis of the venous access catheter. A distal end of each arm can terminate in a wedge tip configured to release the needle cannula from temporary attachment to the housing as the catheter is distally advanced within the passage of the housing. The catheter hub arms may slide within receiver channels in the main housing body but may not rotate with respect to the main body. The tolerances between the main body and the catheter hub can allow rotational alignment to be maintained within about 2° to about 4°.

[0141] A second partial (outer) luer fitting can be formed on a proximal extension at a proximal end of the housing. The second partial luer fitting may comprise external luer threads which form the attachment portion of the luer when external tubing is attached to the catheter. The luer may become functional when the inner luer fitting is inserted into the outer luer fitting. In some cases, the housing can comprise a pair of taping or securement wings to facilitate securing the housing to the patient’s skin after catheter insertion and needle retraction. The securement wings can be similar to those described above in FIG. 21A-21B.

[0142] In the initial configuration of the catheter insertion and attachment apparatus 2600, the needle cannula can be fully extended in a distal direction from the housing and the access catheter can fully retracted in a proximal direction within the housing. In this configuration, the cannula needle can be ready to be percutaneously inserted into a patient's vein. The sharpened the distal tip may be inserted into a lumen of a target vein, and entry can be confirmed by observing flashback in a window formed in a wall of the housing. A complete description of needle insertion, catheter advancement, needle retraction, and external tubing connection is made with reference to FIGS. 19A-19C and FIGS. 20A-20C above.

[0143] Referring now to FIG. 26C, each component of the catheter insertion and attachment apparatus 2600 can be illustrated in isolation. In addition to the housing 2602, needle cannula 2612, and venous access catheter and catheter sub-assembly 2614 described previously, the apparatus 2600 may comprise a coil or other compression spring 2610. The partial luer fitting on the catheter can comprise a plurality of locking or retention teeth formed on its outer surface. A plurality of locking or retention teeth may also be formed on an inner surface of the proximal extension of the housing. When the catheter is fully advanced into the housing, the locking teeth on the partial luer fitting can engage the locking teeth on the proximalAttorney Docket No. 56880-707601 extension of the housing. In this way, the teeth can be formed as interlocking ratchets and can engage each other and lock or affix the catheter to the housing to prevent accidental retraction. The venous access catheter can further comprise a distal catheter port.

[0144] The needle cannula 2612 can have a hub at its proximal end opposite the sharpened distal tip formed at the distal end. The needle hub can have a pair of engagement hooks or tangs which serve to “releasably” lock the needle cannula in the distally forward configuration prior to retraction of the needle after the catheter has been advanced, as can be described in greater detail below.

[0145] In some cases, the force to advance the catheter through the introducer needle can be less than about 2 Newtons (N). In some cases, the force to activate the introducer needle’s safety mechanism (e.g., automatic or passive safety mechanism) can be from about 2.5 N to about 6 N.

[0146] Surface 2606 may rest on the patient’s skin and serve as the primary rotational orientation feature for the main body, providing for orientation of less than about + / - 10° with the nominal surface of the skin to stabilize and minimize movement on the skin. The angular position of the skived / beveled catheter can be established during manufacture when the catheter is bonded to the catheter hub. The orientation of the catheter in the vessel at bevel up (as shown in FIGS. 21C-21D) can be about + / - 10° rotationally off-center (e.g., such that the port can direct fluid flow outwardly about + / - 10° rotationally off-center).

[0147] Blood control valve 2616 can prevent blood from exiting the back of the catheter insertion device (e.g., the blood control valve can prevent blood from splashing onto a user after the needle has punctured the vein).

[0148] The needle can comprise a bevel tip and can be inserted into the skin via a bevel only technique. With this technique, the needle may not penetrate past the initial entry which inserts the needle until the proximal end of the bevel. This can improve the likelihood of first attempt success in puncture and reduce the risk of infiltration.

[0149] The catheter itself may provide for contoured directional flow due to a chamfered tip that can atraumatically deliver the catheter and fluids more efficiently while lowering a potential risk of chemical damage to the vessel. Once the catheter is placed adjacent a wall of the blood vessel, the contoured directional flow can be aimed forward towards the center of the blood vessel, which may minimize chances of damage to the opposite vessel wall.

[0150] The catheter insertion device 2600 can introduce a catheter into the patient without the catheter ever touching (e.g., contacting, brushing, dragging across) the skin of the patient. Furthermore, the catheter can be introduced into the patient without an operator (e.g., aAttorney Docket No. 56880-707601 clinician) ever physically touching the catheter. As a result, the catheter insertion device 2600 of the present disclosure can reduce the risk of contaminating the catheter prior to and while introducing the catheter to the patient. Moreover, the catheter insertion device 2600 can reduce the risk of infection, and as a result, can decrease sickness and disease that may be caused by contamination and infection.

[0151] FIG. 27 shows a blood control needle valve of a catheter insertion device as described above. The blood control needle valve 2702 can comprise a small compliant seal that can be molded or secured into the proximal cavity of the needle hub. The inner edge of this seal can interface with the outer surface of the catheter. In some cases, the seal incorporates delicate features to prevent blood from wicking up between the inner diameter of the needle lumen and the outer diameter of the catheter and into the device housing. These delicate features can comprise an elastic, thin material of the valve / seal. The delicate features can comprise two protrusions or flanges disposed on each side of the otherwise rounded valve or seal. These flanges can be used to fit into the needle hub 2704. Unlike blood control feature 2616, which prevents blood exit from the proximal end of the insertion device, blood control needle valve 2702 can prevent blood from entering the housing of the catheter insertion device.Definitions

[0152] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0153] As used herein, the term "vascular catheter" may mean and comprise any catheter that may be used for providing access to the vasculature, such as one or more veins or one or more arteries of a patient, such as a midline catheter, a basilic catheter, a cephalic catheter, a centesis catheter (for deployment in the thoracic or abdominal regions of a patient), or another type of catheter. Vascular catheters described herein may comprise an arterial catheter or a venous catheter.

[0154] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specificallyAttorney Docket No. 56880-707601 disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0155] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like comprises the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein comprise the recited numbers, and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. The term “about” or “approximately” may mean within an acceptable error range for the particular value, which can depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. As used herein, the term “about” a number refers to that number plus or minus 10% of that number. The term “about” a range refers to that range minus 10% of its lowest value and plus 10% of its greatest value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.

[0156] As used in the specification and claims, the singular forms “a”, “an” and “the” comprise plural references unless the context clearly dictates otherwise. For example, the term “a sample” comprises a plurality of samples, including mixtures thereof.

[0157] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0158] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in thatAttorney Docket No. 56880-707601 series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0159] As used herein, the term "substantially" in reference to a given parameter, property, or condition means and comprises to a degree that one of ordinary skill in the art would understand that the given parameter, property, or condition is met with a degree of variance, such as within acceptable manufacturing tolerances. By way of example, depending on the particular parameter, property, or condition that is substantially met, the parameter, property, or condition may be at least 90.0% met, at least 95.0% met, at least 99.0% met, or even at least 99.9% met.

[0160] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. A “subject” can be a biological entity containing expressed genetic materials. The mammal can be a human. The subject may be diagnosed or suspected of being at high risk for a disease. In some cases, the subject is not necessarily diagnosed or suspected of being at high risk for the disease.

[0161] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.Clauses

[0162] 1. A catheter insertion apparatus comprising: a housing having a longitudinal passage; an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissuepenetrating distal tip; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is retractable within the housing.

[0163] 2 The catheter insertion apparatus of clause 1, wherein the optical magnification feature comprises a lens.

[0164] 3 The catheter insertion apparatus of clause 2, wherein the lens comprises one or more of a convex lens, biconvex lens, or a plano-convex lens.

[0165] 4. The catheter insertion apparatus of any one of clauses 1 to 3, wherein the optical magnification feature permits a user to view blood flowing into a catheter tube of the catheter from a blood vessel when the needle is inserted into the blood vessel.Attorney Docket No. 56880-707601

[0166] 5. The catheter insertion apparatus of any one of clauses 1 to 4, wherein the optical magnification feature permits the user to view at least a portion of an interior of the longitudinal passage for a visual cue.

[0167] 6. The catheter insertion apparatus of any one of clauses 1 to 5, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

[0168] 7 The catheter insertion apparatus of any one of clauses 1 to 6, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

[0169] 8. The catheter insertion apparatus of any one of clauses 1 to 7, wherein the needle comprises a bevel tip.

[0170] 9. The catheter insertion apparatus of clause 8, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

[0171] 10. The catheter insertion apparatus of any one of clauses 1 to 9, wherein the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

[0172] 11. The catheter insertion apparatus of clause 10, wherein the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0173] 12. The catheter insertion apparatus of clause 11, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0174] 13. The catheter insertion apparatus of any one of clauses 1 to 12, wherein the catheter comprises a chamfered tip.

[0175] 14. The catheter insertion apparatus of any one of clauses 1 to 13, wherein the needle is configured to be manually retracted.

[0176] 15. The catheter insertion apparatus of any one of clauses 1 to 13, wherein the needle is configured to be automatically retracted.

[0177] 16. The catheter insertion apparatus of clause 15, wherein the automatic retraction comprises a passive retraction.

[0178] 17. A catheter insertion apparatus comprising: a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a needle position indicator disposed within the longitudinal passage of the housing; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end ofAttorney Docket No. 56880-707601 the housing to extend the distal port of the catheter distally from the distal tip of the needle; wherein the needle is retractable within the housing; and wherein the needle position indicator is configured to incrementally provide audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing.

[0179] 18. The catheter insertion apparatus of clause 17, wherein the audible feedback, the tactile feedback, or both is provided as one or more clicks.

[0180] 19. The catheter insertion apparatus of clause 18, wherein the audible feedback, the tactile feedback, or both is provided as a plurality of clicks.

[0181] 20. The catheter insertion apparatus of clause 19, wherein the plurality of clicks is provided in regular intervals.

[0182] 21. The catheter insertion apparatus of clause 19 or 20, wherein the housing comprises a plurality of detents extending at least partially into the longitudinal passage offset from a longitudinal axis thereof to provide the plurality of clicks immediately prior to the needle being retracted within the housing.

[0183] 22. The catheter insertion apparatus of any one of clauses 17 to 21, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

[0184] 23. The catheter insertion apparatus of any one of clauses 17 to 22, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

[0185] 24. The catheter insertion apparatus of any one of clauses 17 to 23, wherein the needle comprises a bevel tip.

[0186] 25. The catheter insertion apparatus of clause 24, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

[0187] 26. The catheter insertion apparatus of any one of clauses 17 to 25, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

[0188] 27. The catheter insertion apparatus of clause 26, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0189] 28. The catheter insertion apparatus of clause 27, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.Attorney Docket No. 56880-707601

[0190] 29. The catheter insertion apparatus of any one of clauses 17 to 28, wherein the catheter comprises a chamfered tip.

[0191] 30. The catheter insertion apparatus of any one of clauses 17 to 29, wherein the needle is configured to be manually retracted.

[0192] 31. The catheter insertion apparatus of any one of clauses 17 to 29, wherein the needle is configured to be automatically retracted.

[0193] 32. The catheter insertion apparatus of clause 31, wherein the automatic retraction comprises a passive retraction.

[0194] 33. A catheter insertion apparatus comprising: a housing having a longitudinal passage; one or more securement wings externally attached to the housing; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; and one or more longitudinal engagement features between the catheter and the housing, wherein the one or more engagement features are configured to prevent the catheter from rotating with respect to the housing; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing.

[0195] 34. The catheter insertion apparatus of clause 33, wherein the one or more securement wings comprise one or more flat wings extending from one or more sides of the housing to orient the catheter insertion apparatus against a flat surface such as skin.

[0196] 35. The catheter insertion apparatus of clause 34, wherein the one or more securement wings comprises a left lateral securement wing extending from a left lateral side of the housing and a right lateral securement wing extending from a right lateral side of the housing.

[0197] 36. The catheter insertion apparatus of any one of clauses 33 to 35, wherein the one or more securement wings are oriented at an angle relative to a longitudinal axis of the housing.

[0198] 37. The catheter insertion apparatus of any one of clauses 33 to 36, wherein the catheter comprises an atraumatic distal tip.

[0199] 38. The catheter insertion apparatus of any one of clauses 33 to 37, wherein the catheter comprises a bullet tip and a port chamfered on one side of the bullet tip.

[0200] 39. The catheter insertion apparatus of clause 38, wherein the port is oriented at an angle from 0° to 90° relative to a longitudinal axis of the catheter near the distal end.Attorney Docket No. 56880-707601

[0201] 40. The catheter insertion apparatus of clause 38 or 39, wherein the port is oriented at an angle from 30° to 75° relative to a longitudinal axis of the catheter near the distal end.

[0202] 41. The catheter insertion apparatus of any one of clauses 33 to 40, wherein a rotational orientation of the catheter when extended within a bodily lumen is established by an orientation of the housing through the one or more securement wings and maintained through the one or more engagement features between the catheter and the housing.

[0203] 42. The catheter insertion apparatus of any one of clauses 33 to 41, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

[0204] 43. The catheter insertion apparatus of any one of clauses 33 to 42, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

[0205] 44. The catheter insertion apparatus of any one of clauses 33 to 43, wherein the one or more engagement features comprise one or more catheter hub arms configured to maintain rotational alignment between the catheter and the housing within about 2 degrees to about 4 degrees.

[0206] 45. The catheter insertion apparatus of any one of clauses 33 to 44, wherein the needle comprises a bevel tip.

[0207] 46. The catheter insertion apparatus of clause 45, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

[0208] 47. The catheter insertion apparatus of any one of clauses 33 to 46, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

[0209] 48. The catheter insertion apparatus of clause 47, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0210] 49. The catheter insertion apparatus of clause 48, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0211] 50. The catheter insertion apparatus of any one of clauses 33 to 49, wherein the needle is configured to be manually retracted.

[0212] 51. The catheter insertion apparatus of any one of clauses 33 to 49, wherein the needle is configured to be automatically retracted.Attorney Docket No. 56880-707601

[0213] 52. The catheter insertion apparatus of clause 51, wherein the automatic retraction comprises a passive retraction.

[0214] 53. A catheter insertion apparatus comprising: a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; and a seal between the catheter and the needle lumen; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing.

[0215] 54. The catheter insertion apparatus of clause 53, wherein the seal is compliant.

[0216] 55. The catheter insertion apparatus of clause 53 or 54, wherein the seal is fixedly attached to a proximal cavity of a hub of the needle with an inner edge of the seal interfacing with an outer surface of the catheter.

[0217] 56. The catheter insertion apparatus of any one of clauses 53 to 55, wherein the seal comprises one or more anti-blood-wicking features to prevent blood from wicking up between an inner surface of the needle and the outer surface of the catheter and into the housing.

[0218] 57. The catheter insertion apparatus of any one of clauses 53 to 56, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

[0219] 58. The catheter insertion apparatus of any one of clauses 53 to 57, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

[0220] 59. The catheter insertion apparatus of any one of clauses 53 to 58, wherein the needle comprises a bevel tip.

[0221] 60. The catheter insertion apparatus of clause 59, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

[0222] 61. The catheter insertion apparatus of clause any one of clauses 53 to 60, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

[0223] 62. The catheter insertion apparatus of clause 61, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.Attorney Docket No. 56880-707601

[0224] 63. The catheter insertion apparatus of clause 62, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0225] 64. The catheter insertion apparatus of any one of clauses 53 to 63, wherein the catheter comprises a chamfered tip.

[0226] 65. The catheter insertion apparatus of any one of clauses 53 to 64, wherein the needle is configured to be manually retracted.

[0227] 66. The catheter insertion apparatus of any one of clauses 53 to 64, wherein the needle is configured to be automatically retracted.

[0228] 67. The catheter insertion apparatus of clause 66, wherein the automatic retraction comprises a passive retraction.

[0229] 68. A catheter insertion apparatus comprising: a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; wherein the needle is retractable within the housing; and wherein the catheter insertion apparatus further comprises one or more of: (a) an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage; (b) one or more longitudinal engagement features between the catheter and the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing; (c) a needle position indicator disposed within the longitudinal passage of the housing; or (d) a seal between the catheter and the needle lumen.

[0230] 69. A method of inserting a catheter into a subject, the method comprising: advancing a distal tip of a needle coupled to a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; viewing, via an optical magnification feature mounted within the housing, a longitudinal passage of the housing; and retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.Attorney Docket No. 56880-707601

[0231] 70. The method of clause 69, further comprising delivering fluid to the subject through the distal tip of the catheter while the housing is secured to the subject.

[0232] 71. The method of clause 69 or 70, wherein viewing the longitudinal passage of the housing comprises viewing the longitudinal passage via one or more of a convex lens, biconvex lens, or a plano-convex lens.

[0233] 72. The method of any one of clauses 69 to 71, wherein viewing the longitudinal passage of the housing comprises viewing blood flowing into a catheter tube of the catheter from the blood vessel when the needle is inserted into the blood vessel.

[0234] 73. The method of any one of clauses 69 to 72, wherein viewing the longitudinal passage of the housing comprises viewing at least a portion of an interior of the longitudinal passage for a visual cue.

[0235] 74. The method of any one of clauses 69 to 73, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

[0236] 75. The method of any one of clauses 69 to 74, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

[0237] 76. The method of clause 75, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0238] 77. The method of clause 76, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0239] 78. The method of any one of clauses 69 to 77, wherein the catheter comprises a chamfered tip.

[0240] 79. The method of any one of clauses 69 to 78, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

[0241] 80. The method of any one of clauses 69 to 78, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

[0242] 81. The method of clause 80, wherein automatically retracting the needle comprises passively retracting the needle.Attorney Docket No. 56880-707601

[0243] 82. The method of any one of clauses 69 to 81, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

[0244] 83. The method of clause 82, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

[0245] 84. The method of clause 82 or 83, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

[0246] 85. The method of clause 84, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

[0247] 86. The method of any one of clauses 69 to 85, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

[0248] 87. The method of any one of clauses 69 to 86, further comprising locking the catheter to the housing after the catheter has been fully advanced.

[0249] 88. A method of inserting a catheter into a subject, the method comprising: advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; receiving, via a needle position indicator disposed within a longitudinal passage of the housing, incremental audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing; and retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0250] 89. The method of clause 88, wherein the audible feedback, the tactile feedback, or both is provided as one or more clicks.

[0251] 90. The method of clause 88 or 89, wherein the audible feedback, the tactile feedback, or both is provided as a plurality of clicks.

[0252] 91. The method of clause 90, wherein the plurality of clicks is provided in regular intervals.

[0253] 92. The method of clause 90 or 91, wherein the housing comprises a plurality of detents extending at least partially into the longitudinal passage offset from a longitudinalAttorney Docket No. 56880-707601 axis thereof to provide the plurality of clicks immediately prior to the needle being retracted within the housing.

[0254] 93. The method of any one of clauses 88 to 92, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

[0255] 94. The method of any one of clauses 88 to 93, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

[0256] 95. The method of clause 94, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0257] 96. The method of clause 95, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0258] 97. The method of any one of clauses 88 to 96, wherein the catheter comprises a chamfered tip.

[0259] 98. The method of any one of clauses 88 to 97, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

[0260] 99. The method of any one of clauses 88 to 97, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

[0261] 100. The method of clause 99, wherein automatically retracting the needle comprises passively retracting the needle.

[0262] 101. The method of any one of clauses 88 to 100, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

[0263] 102. The method of clause 101, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

[0264] 103. The method of clause 101 or 102, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

[0265] 104. The method of clause 103, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises openingAttorney Docket No. 56880-707601 the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

[0266] 105. The method of any one of clauses 88 to 104, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

[0267] 106. The method of any one of clauses 88 to 105, further comprising locking the catheter to the housing after the catheter has been fully advanced.

[0268] 107. A method of inserting a catheter into a subject, the method comprising: advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; attaching the housing to a skin of the subject via one or more securement wings externally attached to the housing; pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; substantially preventing the catheter from rotating with respect to the housing via one or more longitudinal engagement features between the catheter and the housing; and retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0269] 108. The method of clause 107, wherein the one or more securement wings comprise one or more flat wings extending from one or more sides of the housing, wherein attaching the housing to the skin of the subject comprises orienting the housing against the skin via the one or more flat wings.

[0270] 109. The method of clause 107 or 108, wherein the one or more securement wings comprises a left lateral securement wing extending from a left lateral side of the housing and a right lateral securement wing extending from a right lateral side of the housing.

[0271] 110. The method of any one of clauses 107 to 109, wherein the one or more securement wings are oriented at an angle relative to a longitudinal axis of the housing.

[0272] 111. The method of any one of clauses 107 to 110, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

[0273] 112. The method of any one of clauses 107 to 111, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.Attorney Docket No. 56880-707601

[0274] 113. The method of clause 112, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0275] 114. The method of clause 113, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

[0276] 115. The method of any one of clauses 107 to 114, wherein the catheter comprises a chamfered tip.

[0277] 116. The method of any one of clauses 107 to 115, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

[0278] 117. The method of any one of clauses 107 to 115, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

[0279] 118. The method of clause 117, wherein automatically retracting the needle comprises passively retracting the needle.

[0280] 119. The method of any one of clauses 107 to 118, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

[0281] 120. The method of clause 119, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

[0282] 121. The method of clause 119 or 120, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

[0283] 122. The method of clause 121, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

[0284] 123. The method of any one of clauses 107 to 122, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

[0285] 124. The method of any one of clauses 107 to 123, further comprising locking the catheter to the housing after the catheter has been fully advanced.

[0286] 125. The method of any one of clauses 107 to 124, wherein a rotational orientation of the catheter when extended within a bodily lumen is established by an orientation of theAttorney Docket No. 56880-707601 housing through the one or more securement wings and maintained through the one or more engagement features between the catheter and the housing.

[0287] 126. The method of any one of clause 107 to 125, wherein the one or more engagement features comprise one or more catheter hub arms.

[0288] 127. The method of clause 126, further comprising maintaining a rotational alignment between the catheter and the housing within about 2 degrees to about 4 degrees via the one or more catheter hub arms.

[0289] 128. A method of inserting a catheter into a subject, the method comprising: advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; preventing, via a seal between the catheter and a lumen of the needle, blood from wicking up between the needle lumen and an outer surface of the catheter and into the housing; pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; and retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

[0290] 129. The method of clause 128, wherein the seal is compliant.

[0291] 130. The method of clause 128 or 129, wherein the seal is fixedly attached to a proximal cavity of a hub of the needle with an inner edge of the seal interfacing with the outer surface of the catheter.

[0292] 131. The method of any one of clauses 128 to 130, wherein the seal comprises one or more anti-blood-wicking features.

[0293] 132. The method of any one of clauses 128 to 131, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

[0294] 133. The method of any one of clauses 128 to 132, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

[0295] 134. The method of clause 133, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

[0296] 135. The method of clause 134, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.Attorney Docket No. 56880-707601

[0297] 136. The method of any one of clauses 128 to 135, wherein the catheter comprises a chamfered tip.

[0298] 137. The method of any one of clauses 128 to 136, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

[0299] 138. The method of any one of clauses 128 to 136, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

[0300] 139. The method of clause 138, wherein automatically retracting the needle comprises passively retracting the needle.

[0301] 140. The method of any one of clauses 128 to 139, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

[0302] 141. The method of clause 140, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

[0303] 142. The method of clause 140 or 141, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

[0304] 143. The method of clause 142, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

[0305] 144. The method of any one of clauses 128 to 143, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

[0306] 145. The method of any one of clauses 128 to 144, further comprising locking the catheter to the housing after the catheter has been fully advanced.

[0307] 146. A method of inserting a catheter into a subject, the method comprising: advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; and retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel; wherein the housing comprises one or more of: i. an optical magnification feature allowing a user to view into the longitudinal passage; ii. one orAttorney Docket No. 56880-707601 more longitudinal engagement features disposed between the catheter and an inner wall of the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing; iii. a needle position indicator disposed within a longitudinal passage of the housing; or iv. a seal between the catheter and the needle lumen.

[0308] While various embodiments of the present disclosure 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. It is not intended that the disclosure be limited by the specific examples provided within the specification. While the disclosure has been described with reference to the aforementioned specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. Furthermore, it shall be understood that all aspects of the disclosure are not limited to the specific depictions, configurations or relative proportions set forth herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. It is therefore contemplated that the disclosure shall also cover any such alternatives, modifications, variations, or equivalents. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

Attorney Docket No. 56880-707601CLAIMSWHAT IS BEING CLAIMED1. A catheter insertion apparatus comprising: a housing having a longitudinal passage; an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is retractable within the housing.

2. The catheter insertion apparatus of claim 1, wherein the optical magnification feature comprises a lens.

3. The catheter insertion apparatus of claim 2, wherein the lens comprises one or more of a convex lens, biconvex lens, or a plano-convex lens.

4. The catheter insertion apparatus of any one of claims 1 to 3, wherein the optical magnification feature permits a user to view blood flowing into a catheter tube of the catheter from a blood vessel when the needle is inserted into the blood vessel.

5. The catheter insertion apparatus of any one of claims 1 to 4, wherein the optical magnification feature permits the user to view at least a portion of an interior of the longitudinal passage for a visual cue.

6. The catheter insertion apparatus of any one of claims 1 to 5, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

7. The catheter insertion apparatus of any one of claims 1 to 6, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

8. The catheter insertion apparatus of any one of claims 1 to 7, wherein the needle comprises a bevel tip.

9. The catheter insertion apparatus of claim 8, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.Attorney Docket No. 56880-70760110. The catheter insertion apparatus of any one of claims 1 to 9, wherein the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

11. The catheter insertion apparatus of claim 10, wherein the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

12. The catheter insertion apparatus of claim 11, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

13. The catheter insertion apparatus of any one of claims 1 to 12, wherein the catheter comprises a chamfered tip.

14. The catheter insertion apparatus of any one of claims 1 to 13, wherein the needle is configured to be manually retracted.

15. The catheter insertion apparatus of any one of claims 1 to 13, wherein the needle is configured to be automatically retracted.

16. The catheter insertion apparatus of claim 15, wherein the automatic retraction comprises a passive retraction.

17. A catheter insertion apparatus comprising: a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a needle position indicator disposed within the longitudinal passage of the housing; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; wherein the needle is retractable within the housing; and wherein the needle position indicator is configured to incrementally provide audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing.

18. The catheter insertion apparatus of claim 17, wherein the audible feedback, the tactile feedback, or both is provided as one or more clicks.Attorney Docket No. 56880-70760119. The catheter insertion apparatus of claim 18, wherein the audible feedback, the tactile feedback, or both is provided as a plurality of clicks.

20. The catheter insertion apparatus of claim 19, wherein the plurality of clicks is provided in regular intervals.

21. The catheter insertion apparatus of claim 19 or 20, wherein the housing comprises a plurality of detents extending at least partially into the longitudinal passage offset from a longitudinal axis thereof to provide the plurality of clicks immediately prior to the needle being retracted within the housing.

22. The catheter insertion apparatus of any one of claims 17 to 21, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

23. The catheter insertion apparatus of any one of claims 17 to 22, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

24. The catheter insertion apparatus of any one of claims 17 to 23, wherein the needle comprises a bevel tip.

25. The catheter insertion apparatus of claim 24, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

26. The catheter insertion apparatus of any one of claims 17 to 25, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

27. The catheter insertion apparatus of claim 26, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

28. The catheter insertion apparatus of claim 27, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

29. The catheter insertion apparatus of any one of claims 17 to 28, wherein the catheter comprises a chamfered tip.

30. The catheter insertion apparatus of any one of claims 17 to 29, wherein the needle is configured to be manually retracted.

31. The catheter insertion apparatus of any one of claims 17 to 29, wherein the needle is configured to be automatically retracted.Attorney Docket No. 56880-70760132. The catheter insertion apparatus of claim 31, wherein the automatic retraction comprises a passive retraction.

33. A catheter insertion apparatus comprising: a housing having a longitudinal passage; one or more securement wings externally attached to the housing; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; and one or more longitudinal engagement features between the catheter and the housing, wherein the one or more engagement features are configured to prevent the catheter from rotating with respect to the housing; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing.

34. The catheter insertion apparatus of claim 33, wherein the one or more securement wings comprise one or more flat wings extending from one or more sides of the housing to orient the catheter insertion apparatus against a flat surface such as skin.

35. The catheter insertion apparatus of claim 34, wherein the one or more securement wings comprises a left lateral securement wing extending from a left lateral side of the housing and a right lateral securement wing extending from a right lateral side of the housing.

36. The catheter insertion apparatus of any one of claims 33 to 35, wherein the one or more securement wings are oriented at an angle relative to a longitudinal axis of the housing.

37. The catheter insertion apparatus of any one of claims 33 to 36, wherein the catheter comprises an atraumatic distal tip.

38. The catheter insertion apparatus of any one of claims 33 to 37, wherein the catheter comprises a bullet tip and a port chamfered on one side of the bullet tip.

39. The catheter insertion apparatus of claim 38, wherein the port is oriented at an angle from 0° to 90° relative to a longitudinal axis of the catheter near the distal end.

40. The catheter insertion apparatus of claim 38 or 39, wherein the port is oriented at an angle from 30° to 75° relative to a longitudinal axis of the catheter near the distal end.Attorney Docket No. 56880-70760141. The catheter insertion apparatus of any one of claims 33 to 40, wherein a rotational orientation of the catheter when extended within a bodily lumen is established by an orientation of the housing through the one or more securement wings and maintained through the one or more engagement features between the catheter and the housing.

42. The catheter insertion apparatus of any one of claims 33 to 41, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

43. The catheter insertion apparatus of any one of claims 33 to 42, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

44. The catheter insertion apparatus of any one of claims 33 to 43, wherein the one or more engagement features comprise one or more catheter hub arms configured to maintain rotational alignment between the catheter and the housing within about 2 degrees to about 4 degrees.

45. The catheter insertion apparatus of any one of claims 33 to 44, wherein the needle comprises a bevel tip.

46. The catheter insertion apparatus of claim 45, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

47. The catheter insertion apparatus of any one of claims 33 to 46, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

48. The catheter insertion apparatus of claim 47, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

49. The catheter insertion apparatus of claim 48, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

50. The catheter insertion apparatus of any one of claims 33 to 49, wherein the needle is configured to be manually retracted.

51. The catheter insertion apparatus of any one of claims 33 to 49, wherein the needle is configured to be automatically retracted.

52. The catheter insertion apparatus of claim 51, wherein the automatic retraction comprises a passive retraction.

53. A catheter insertion apparatus comprising:Attorney Docket No. 56880-707601 a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; and a seal between the catheter and the needle lumen; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; and wherein the needle is fully retractable within the housing.

54. The catheter insertion apparatus of claim 53, wherein the seal is compliant.

55. The catheter insertion apparatus of claim 53 or 54, wherein the seal is fixedly attached to a proximal cavity of a hub of the needle with an inner edge of the seal interfacing with an outer surface of the catheter.

56. The catheter insertion apparatus of any one of claims 53 to 55, wherein the seal comprises one or more anti-blood-wicking features to prevent blood from wicking up between an inner surface of the needle and the outer surface of the catheter and into the housing.

57. The catheter insertion apparatus of any one of claims 53 to 56, wherein the needle extends distally from a distal end of the housing in an initial configuration of the catheter insertion apparatus and wherein the needle is held in place by a releasable latch.

58. The catheter insertion apparatus of any one of claims 53 to 57, wherein the catheter comprises a catheter tube slidably positioned within the axial lumen of the needle.

59. The catheter insertion apparatus of any one of claims 53 to 58, wherein the needle comprises a bevel tip.

60. The catheter insertion apparatus of claim 59, wherein the needle is configured to be inserted into the skin until the proximal end of the beveled tip.

61. The catheter insertion apparatus of claim any one of claims 53 to 60, wherein a distal end of the catheter is configured to be inserted into a blood vessel of a subject through the needle to reduce a risk of contaminating the catheter prior to and during insertion into the blood vessel.

62. The catheter insertion apparatus of claim 61, wherein the distal end of the catheter is configured to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.Attorney Docket No. 56880-70760163. The catheter insertion apparatus of claim 62, wherein the catheter is configured to direct a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

64. The catheter insertion apparatus of any one of claims 53 to 63, wherein the catheter comprises a chamfered tip.

65. The catheter insertion apparatus of any one of claims 53 to 64, wherein the needle is configured to be manually retracted.

66. The catheter insertion apparatus of any one of claims 53 to 64, wherein the needle is configured to be automatically retracted.

67. The catheter insertion apparatus of claim 66, wherein the automatic retraction comprises a passive retraction.

68. A catheter insertion apparatus comprising: a housing having a longitudinal passage; a needle slidably disposed within the longitudinal passage of the housing and having an axial lumen extending from a proximal end to a tissue-penetrating distal tip; and a catheter slidably disposed within the needle lumen and having a distal port and a proximal connector; wherein the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle; wherein the needle is retractable within the housing; and wherein the catheter insertion apparatus further comprises one or more of:(a) an optical magnification feature mounted within the housing and allowing a user to view into the longitudinal passage;(b) one or more longitudinal engagement features between the catheter and the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing;(c) a needle position indicator disposed within the longitudinal passage of the housing; or(d) a seal between the catheter and the needle lumen.

69. A method of inserting a catheter into a subject, the method comprising:Attorney Docket No. 56880-707601 a. advancing a distal tip of a needle coupled to a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; b. pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; c. viewing, via an optical magnification feature mounted within the housing, a longitudinal passage of the housing; and d. retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

70. The method of claim 69, further comprising delivering fluid to the subject through the distal tip of the catheter while the housing is secured to the subject.

71. The method of claim 69 or 70, wherein viewing the longitudinal passage of the housing comprises viewing the longitudinal passage via one or more of a convex lens, biconvex lens, or a plano-convex lens.

72. The method of any one of claims 69 to 71, wherein viewing the longitudinal passage of the housing comprises viewing blood flowing into a catheter tube of the catheter from the blood vessel when the needle is inserted into the blood vessel.

73. The method of any one of claims 69 to 72, wherein viewing the longitudinal passage of the housing comprises viewing at least a portion of an interior of the longitudinal passage for a visual cue.

74. The method of any one of claims 69 to 73, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

75. The method of any one of claims 69 to 74, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

76. The method of claim 75, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

77. The method of claim 76, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

78. The method of any one of claims 69 to 77, wherein the catheter comprises a chamfered tip.Attorney Docket No. 56880-70760179. The method of any one of claims 69 to 78, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

80. The method of any one of claims 69 to 78, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

81. The method of claim 80, wherein automatically retracting the needle comprises passively retracting the needle.

82. The method of any one of claims 69 to 81, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

83. The method of claim 82, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

84. The method of claim 82 or 83, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

85. The method of claim 84, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

86. The method of any one of claims 69 to 85, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

87. The method of any one of claims 69 to 86, further comprising locking the catheter to the housing after the catheter has been fully advanced.

88. A method of inserting a catheter into a subject, the method comprising: a. advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; b. pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; c. receiving, via a needle position indicator disposed within a longitudinal passage of the housing, incremental audible feedback, tactile feedback, or both immediately prior to the needle being retracted within the housing; andAttorney Docket No. 56880-707601 d. retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

89. The method of claim 88, wherein the audible feedback, the tactile feedback, or both is provided as one or more clicks.

90. The method of claim 88 or 89, wherein the audible feedback, the tactile feedback, or both is provided as a plurality of clicks.

91. The method of claim 90, wherein the plurality of clicks is provided in regular intervals.

92. The method of claim 90 or 91, wherein the housing comprises a plurality of detents extending at least partially into the longitudinal passage offset from a longitudinal axis thereof to provide the plurality of clicks immediately prior to the needle being retracted within the housing.

93. The method of any one of claims 88 to 92, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

94. The method of any one of claims 88 to 93, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

95. The method of claim 94, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

96. The method of claim 95, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

97. The method of any one of claims 88 to 96, wherein the catheter comprises a chamfered tip.

98. The method of any one of claims 88 to 97, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

99. The method of any one of claims 88 to 97, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

100. The method of claim 99, wherein automatically retracting the needle comprises passively retracting the needle.Attorney Docket No. 56880-707601101. The method of any one of claims 88 to 100, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

102. The method of claim 101, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

103. The method of claim 101 or 102, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

104. The method of claim 103, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

105. The method of any one of claims 88 to 104, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

106. The method of any one of claims 88 to 105, further comprising locking the catheter to the housing after the catheter has been fully advanced.

107. A method of inserting a catheter into a subject, the method comprising: a. advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; b. attaching the housing to a skin of the subject via one or more securement wings externally attached to the housing; c. pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; d. substantially preventing the catheter from rotating with respect to the housing via one or more longitudinal engagement features between the catheter and the housing; and e. retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

108. The method of claim 107, wherein the one or more securement wings comprise one or more flat wings extending from one or more sides of the housing, wherein attaching the housing to the skin of the subject comprises orienting the housing against the skin via the one or more flat wings.Attorney Docket No. 56880-707601109. The method of claim 107 or 108, wherein the one or more securement wings comprises a left lateral securement wing extending from a left lateral side of the housing and a right lateral securement wing extending from a right lateral side of the housing.

110. The method of any one of claims 107 to 109, wherein the one or more securement wings are oriented at an angle relative to a longitudinal axis of the housing.

111. The method of any one of claims 107 to 110, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

112. The method of any one of claims 107 to 111, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

113. The method of claim 112, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

114. The method of claim 113, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

115. The method of any one of claims 107 to 114, wherein the catheter comprises a chamfered tip.

116. The method of any one of claims 107 to 115, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

117. The method of any one of claims 107 to 115, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

118. The method of claim 117, wherein automatically retracting the needle comprises passively retracting the needle.

119. The method of any one of claims 107 to 118, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

120. The method of claim 119, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

121. The method of claim 119 or 120, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.Attorney Docket No. 56880-707601122. The method of claim 121, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises opening the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

123. The method of any one of claims 107 to 122, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

124. The method of any one of claims 107 to 123, further comprising locking the catheter to the housing after the catheter has been fully advanced.

125. The method of any one of claims 107 to 124, wherein a rotational orientation of the catheter when extended within a bodily lumen is established by an orientation of the housing through the one or more securement wings and maintained through the one or more engagement features between the catheter and the housing.

126. The method of any one of claim 107 to 125, wherein the one or more engagement features comprise one or more catheter hub arms.

127. The method of claim 126, further comprising maintaining a rotational alignment between the catheter and the housing within about 2 degrees to about 4 degrees via the one or more catheter hub arms.

128. A method of inserting a catheter into a subject, the method comprising: a. advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; b. preventing, via a seal between the catheter and a lumen of the needle, blood from wicking up between the needle lumen and an outer surface of the catheter and into the housing; c. pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; and d. retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel.

129. The method of claim 128, wherein the seal is compliant.

130. The method of claim 128 or 129, wherein the seal is fixedly attached to a proximal cavity of a hub of the needle with an inner edge of the seal interfacing with the outer surface of the catheter.Attorney Docket No. 56880-707601131. The method of any one of claims 128 to 130, wherein the seal comprises one or more anti-blood-wicking features.

132. The method of any one of claims 128 to 131, wherein advancing the distal tip of the needle into the blood vessel comprises advancing a beveled tip of the needle until the proximal end of the beveled tip is disposed in the blood vessel.

133. The method of any one of claims 128 to 132, further comprising reducing a risk of contaminating the catheter prior to and during insertion into the blood vessel via distally advancing the distal tip of the catheter through the needle.

134. The method of claim 133, wherein distally advancing the distal tip of the catheter into the blood vessel comprises advancing the distal tip to rest adjacent to a wall of the blood vessel when inserted into the blood vessel.

135. The method of claim 134, further comprising directing, via the catheter, a fluid flow towards a center of the blood vessel to minimize damage to an opposing wall of the blood vessel.

136. The method of any one of claims 128 to 135, wherein the catheter comprises a chamfered tip.

137. The method of any one of claims 128 to 136, wherein retracting the distal tip of the needle over the catheter and into the housing comprises manually retracting the needle.

138. The method of any one of claims 128 to 136, wherein retracting the distal tip of the needle over the catheter and into the housing comprises automatically retracting the needle.

139. The method of claim 138, wherein automatically retracting the needle comprises passively retracting the needle.

140. The method of any one of claims 128 to 139, further comprises attaching a fluid delivery tube to the proximal connector which is in fluid communication with a lumen of the catheter while the distal tip of the needle remains protected in the housing.

141. The method of claim 140, further comprising delivering a fluid to the patient through the fluid delivery tube while the housing is secured to the patient.

142. The method of claim 140 or 141, further comprising opening a valve in the proximal connector in response to engagement with an external connector on the fluid delivery tube.

143. The method of claim 142, wherein the valve comprises a split valve, wherein opening the valve in response to engagement with the external connector comprises openingAttorney Docket No. 56880-707601 the valve when advanced distally against a male fitting in an axial passage in the proximal connector on the catheter.

144. The method of any one of claims 128 to 143, wherein retracting the distal tip of the needle over the catheter comprises releasing a constrained spring to axially translate the needle relative to the catheter.

145. The method of any one of claims 128 to 144, further comprising locking the catheter to the housing after the catheter has been fully advanced.

146. A method of inserting a catheter into a subject, the method comprising: a. advancing a distal tip of a needle of a housing through a skin and into a blood vessel of the subject, wherein a catheter is disposed within a lumen of the needle while the distal tip is being advanced; b. pushing distally on a proximal connector on the catheter to distally advance a distal tip of the catheter through the needle and into the blood vessel; and c. retracting the distal tip of the needle over the catheter and into the housing while the distal tip of the catheter remains in the blood vessel; d. wherein the housing comprises one or more of i. an optical magnification feature allowing a user to view into the longitudinal passage; ii. one or more longitudinal engagement features disposed between the catheter and an inner wall of the housing, the one or more engagement features configured to prevent the catheter from rotating with respect to the housing, and one or more securement wings externally attached to the housing; iii. a needle position indicator disposed within a longitudinal passage of the housing; or iv. a seal between the catheter and the needle lumen.

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