Catheter delivery devices, systems, and methods

Abstract

A "on-pen" catheter delivery system is provided that includes a stiffening tube concentrically positioned between a needle and a catheter. The needle can include a handle and hub at a proximal end and a distal tip insertable through a sidewall of a patient's blood vessel. The catheter defines a lumen through which the needle extends and includes an engagement surface on an interior thereof. A tubular stiffening member can be positioned within the lumen of the catheter exterior to the needle and can include an engagement surface that can press distally against the engagement surface of the catheter to advance the catheter distally over the needle. The system can also include a stiffening member hub movably coupled to the handle for translation relative thereto. The stiffening member hub can be configured to advance the stiffening member and catheter over the needle and to a target depth.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 511,900, filed May 26, 2017, entitled “CATHETER DELIVERY DEVICES, SYSTEMS, AND METHODS”, filed January 19, 2018, entitled “CATHETER DELIVERY DEVICES, SYSTEMS, AND METHODS”, and U.S. Provisional Patent Application No. 62 / 641,475, filed March 12, 2018, entitled “CATHETER DELIVERY DEVICES, SYSTEMS, AND METHODS”, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] Some of the embodiments described herein relate to catheters in general, while other embodiments relate more specifically to catheter delivery devices, systems, and methods. Background Technology

[0004] Many catheters are introduced into a patient via an insertion needle. Some catheter systems include a catheter positioned above the insertion needle before it is introduced into the patient. At least the distal end of the needle may extend through the distal end of the catheter, and the distal end of the catheter may be angled to have a smaller diameter than the rest of the catheter. The distal end of the needle can be inserted into a patient's blood vessel, and the catheter can pass through an opening created by the needle. Several systems exist for advancing a catheter above the needle and into a blood vessel. However, known devices, systems, and methods have one or more disadvantages that can be addressed, remedied, improved, or avoided by certain embodiments described herein. Attached Figure Description

[0005] This document describes non-limiting and incomplete illustrative embodiments. Referring to some of these illustrative embodiments shown in the figures, wherein:

[0006] Figure 1 This is a top plan view of an embodiment of a catheter delivery system, which includes a catheter, a needle, and stiffeners positioned inside the catheter and outside the needle;

[0007] Figure 2 for Figure 1 An enlarged side front view of the distal portion of a catheter delivery system;

[0008] Figure 3 For along Figure 1A sectional view of the distal portion of the catheter delivery system taken from line of sight 3-3;

[0009] Figure 4A for Figure 1 Another top plan view of the catheter delivery system in an early stage of an illustrative method of using the system, wherein the system is moved consistently to advance the distal end of the needle into the patient's blood vessel;

[0010] Figure 4B For similar Figure 3 The image shows a cross-sectional view of the distal portion of the catheter delivery system at a point in time after the distal end of the needle has been advanced through the patient's insertion site and into the patient's blood vessel.

[0011] Figure 4C For catheter delivery systems in Figure 4B Another top plan view after the time point shown in the figure, which shows the blood flashing through the catheter proximally;

[0012] Figure 4D Another top plan view of the catheter delivery system, demonstrating the deployment of the catheter into the blood vessel above the distal end of the needle;

[0013] Figure 4E Another cross-sectional view of the distal portion of the system after the catheter has been deployed above the distal end of the needle;

[0014] Figure 4F Another top plan view of the catheter delivery system demonstrates the movement of the entire system in the distal direction to further advance the catheter into the blood vessel;

[0015] Figure 4G Another top plan view of the catheter delivery system demonstrates the removal of the needle hub, which is connected to both the needle and the stiffener, from the catheter hub that is attached to the catheter.

[0016] Figure 4H Another top plan view of the catheter delivery system after the needle hub has been removed from the catheter hub, while maintaining the catheter in the proper position within the patient's blood vessel;

[0017] Figure 4I Another cross-sectional view of the distal portion of a catheter used for fluid delivery or aspiration within a patient's blood vessel;

[0018] Figure 4J This is another top plan view of the catheter assembly, showing the medical fluid components connected to the catheter hub;

[0019] Figure 4K Another cross-sectional view of the distal portion of the catheter held within the patient's blood vessel, showing fluid being delivered from the medical fluid component through the catheter and into the patient's blood vessel;

[0020] Figure 5 For example Figure 1 The top plan view of another embodiment of the catheter delivery system shown in the figure defines a significantly larger length;

[0021] Figure 6 The top plan view shows another embodiment of the catheter delivery system, which includes an elongated guide that inhibits lateral deformation of the catheter during deployment within a patient's blood vessel.

[0022] Figure 7A This is a top plan view of another embodiment of a catheter delivery system configured to automatically deploy a catheter above the distal end of a needle, wherein the system is shown in an undeployed state;

[0023] Figure 7B for Figure 7A Another top plan view of the conduit delivery system after the actuator has been actuated, where the system is shown in the deployed state;

[0024] Figure 8A The top plan view is of another embodiment of a catheter delivery system configured to automatically deploy a catheter above the distal end of a needle, wherein the system is shown in an undeployed state, and wherein the system includes a catheter hub disposed outside the housing portion of the needle hub;

[0025] Figure 8B for Figure 8A Another top plan view of the catheter delivery system after the actuator has been actuated, wherein the system is shown in a deployed state, and wherein the system includes another actuator configured to disengage the catheter hub from the needle hub;

[0026] Figure 9 for Figure 8A (It shows a side front view of the distal end of the catheter delivery system of the system, which has a distal end with a single fluid delivery port located at the distal end of the catheter and without a fluid delivery port through its sidewall.)

[0027] Figure 10 for Figure 8A A cross-sectional view of the distal end of the catheter delivery system, showing the elongated adhesion region. Figure 8A The line of sight in the middle is intercepted at 10-10;

[0028] Figure 11 For similar Figure 3 and Figure 10The view shown is a cross-sectional view of another embodiment of the catheter delivery system, which includes an elongated adhesion region and a stiffener, the stiffener having a gripping engagement at its distal end for engaging the distal end of the catheter;

[0029] Figure 12 for Figure 11 An anatomical view of a portion of the catheter delivery system, which also shows the distal end of the stiffener and the gripping joint at the distal end of the catheter;

[0030] Figure 13 For similar Figure 2 and Figure 9 The view shown is a side front view of another embodiment of the catheter delivery system, which includes a catheter tip that extends substantially to the proximal end of the angled distal end of the needle;

[0031] Figure 14 for Figure 13 A cross-sectional view of a catheter delivery system;

[0032] Figure 15A A perspective view of another embodiment of the catheter delivery system;

[0033] Figure 15B for Figure 15A An exploded view of a catheter delivery system;

[0034] Figure 16A To and Figure 15A A perspective view of an embodiment of a handle compatible with a catheter delivery system;

[0035] Figure 16B for Figure 16A A cross-sectional view of the handle, along Figure 16A Line of sight 16B-16B is intercepted;

[0036] Figure 17A To and Figure 15A Perspective view of an embodiment of a stiffening hub compatible with a conduit delivery system;

[0037] Figure 17B for Figure 17A A cross-sectional view of the stiffening hub, along which... Figure 17A Line of sight 17B-17B is intercepted;

[0038] Figure 18A To and Figure 15A Perspective view of an implementation scheme for a catheter hub compatible with a catheter delivery system;

[0039] Figure 18B for Figure 18A A cross-sectional view of the conduit hub core, along Figure 18ALine of sight 18B-18B is intercepted;

[0040] Figure 19A To and Figure 15A A perspective view of an implementation scheme for a catheter connection hub compatible with a catheter delivery system;

[0041] Figure 19B for Figure 19A A cross-sectional view of the conduit connection hub, along which... Figure 19A Line of sight 19B-19B is intercepted;

[0042] Figure 20A for Figure 15A A cross-sectional view of a catheter delivery system in an undeployed state, the cross-section along... Figure 15A Line of sight 20A-20A is intercepted;

[0043] Figure 20B For along Figure 20A An enlarged sectional view of the catheter delivery system taken from view region 20B identified in the image;

[0044] Figure 20C For along Figure 20A Another enlarged cross-sectional view of the catheter delivery system, taken from the view region 20C identified in the image;

[0045] Figure 20D For along Figure 20A Another enlarged cross-sectional view of the catheter delivery system, taken from the 20D view region identified in the image;

[0046] Figure 21A for Figure 15A Another cross-sectional view of the conduit delivery system in a partially deployed state;

[0047] Figure 21B For along Figure 21A An enlarged sectional view of the catheter delivery system taken from view region 21B identified in the image;

[0048] Figure 21C For along Figure 21A Another enlarged sectional view of the catheter delivery system taken from view region 21C identified in the image;

[0049] Figure 21D For along Figure 21A Another enlarged cross-sectional view of the catheter delivery system, taken from view region 21D identified in the image;

[0050] Figure 22A for Figure 15A Another cross-sectional view of the conduit delivery system in a fully deployed state;

[0051] Figure 22B For along Figure 22AAn enlarged sectional view of the catheter delivery system taken from view region 22B identified in the image;

[0052] Figure 23A , Figure 23B and Figure 23C A cross-sectional view of different usage stages of an implementation of a catheter delivery system, which includes a lock to prevent the stiffening hub from returning to the proximal side after catheter deployment;

[0053] Figure 24A A cross-sectional view of another embodiment of a catheter delivery system configured for automated catheter deployment, shown in an undeployed state;

[0054] Figure 24B for Figure 24A Another cross-sectional view of the catheter delivery system in deployment;

[0055] Figure 25 For example Figure 24A A cross-sectional view of a portion of an implementation of a catheter delivery system in an undeployed state, the system including an actuator that releases a latch to allow automated catheter deployment;

[0056] Figure 26A A front view of the distal portion of another embodiment of a catheter deployment system comprising a two-part catheter, the two-part catheter including a catheter body and a separately formed end attached thereto;

[0057] Figure 26B for Figure 26A A cross-sectional view of the distal portion of the catheter deployment system;

[0058] Figure 27 A cross-sectional view of another embodiment of a catheter deployment system, which includes two catheter parts;

[0059] Figure 28 A cross-sectional view of the distal portion of another embodiment of the two-part catheter, the cross-section being taken along a transverse plane passing through the longitudinal axis of the catheter and pointing distally;

[0060] Figure 29 A front view of the distal end of another embodiment of the catheter delivery system;

[0061] Figure 30 A cross-sectional view as part of another embodiment of a catheter delivery system, wherein an engagement member positioned proximal to the catheter hub is configured to push the catheter hub in a distal direction during catheter deployment;

[0062] Figure 31 A perspective view of another embodiment of the catheter delivery system;

[0063] Figure 32 For along Figure 31 The line of sight 32-32 is intercepted Figure 31 A cross-sectional view of a catheter delivery system;

[0064] Figure 33 A perspective view of another embodiment of the catheter delivery system;

[0065] Figure 34 For along Figure 33 The line of sight 34-34 is intercepted Figure 33 A cross-sectional view of a catheter delivery system;

[0066] Figure 35A Perspective view of an embodiment of an upper housing element compatible with a catheter delivery system;

[0067] Figure 35B Its bottom plan;

[0068] Figure 36A Perspective view of an embodiment of a lower housing element compatible with a catheter delivery system;

[0069] Figure 36B Its top plan view;

[0070] Figure 37A Perspective view of an implementation scheme for an upper actuator compatible with a catheter delivery system;

[0071] Figure 37B Its side front view;

[0072] Figure 38A Perspective view of an embodiment of a lower actuator or stiffening hub compatible with a catheter delivery system;

[0073] Figure 38B Another perspective view of it;

[0074] Figure 38C Its sectional view;

[0075] Figure 39 A perspective view of an embodiment of a catheter hub compatible with a catheter delivery system;

[0076] Figure 40 Perspective view of an embodiment of a catheter connection hub compatible with a catheter delivery system;

[0077] Figure 41A A cross-sectional view of a catheter delivery system in a pre-use or pre-actuated state;

[0078] Figure 41B Another cross-sectional view of the catheter delivery system in a partially deployed or initially activated state;

[0079] Figure 41C Another cross-sectional view of the catheter delivery system in a fully deployed or fully activated state;

[0080] Figure 42 A bottom plan view of the conduit delivery system in a fully deployed or fully activated state;

[0081] Figure 43 An enlarged bottom plan view of another embodiment of the catheter delivery system just before full deployment, wherein the catheter delivery system includes a check valve feature that prevents the stiffener from retracting relative to the housing after full deployment is achieved;

[0082] Figure 44 A side front view of an embodiment including a stiffener that enhances flexibility at the distal end;

[0083] Figure 45 A side front view of another embodiment including a stiffener that enhances flexibility at the distal end;

[0084] Figure 46 A perspective view of another embodiment of the catheter delivery system;

[0085] Figure 47 To and Figure 46 A perspective view of an implementation scheme for a catheter connection hub compatible with a catheter delivery system;

[0086] Figure 48 To and Figure 46 A perspective view of an embodiment of an upper housing element compatible with a catheter delivery system;

[0087] Figure 48A For along Figure 48 An enlarged perspective view of a portion of the upper housing element, taken from view area 48A identified in the image;

[0088] Figure 49 To and Figure 46 Perspective view of an embodiment of a stiffening hub compatible with a conduit delivery system;

[0089] Figure 50 To and Figure 46 A perspective view of an implementation scheme for an upper actuator compatible with a catheter delivery system;

[0090] Figure 51A For along Figure 46 Line of sight 51A-51A intercepted Figure 46 A cross-sectional view of a catheter delivery system, showing the catheter delivery system in an undeployed state;

[0091] Figures 51B to 51F for Figure 46 Another cross-sectional view of the catheter delivery system in a different operating state or stage of use;

[0092] Figure 51G This is a cross-sectional view of an embodiment of an insert component that has been removed from an embodiment of a catheter component in a further stage of use of the catheter delivery system.

[0093] Figure 51H This is a cross-sectional view of the catheter delivery system after the insertion component has been removed; and

[0094] Figure 52 This is a front view of an implementation of the kit, which includes an implementation of a catheter delivery system (shown in perspective) and its instructions for use. Detailed Implementation

[0095] This disclosure relates in its entirety to apparatus, systems, and methods for delivering catheters into a patient's vascular system. While specific examples of catheters are described with respect to the accompanying drawings, the description is equally applicable to additional types of catheters that may not be specifically shown or mentioned. For example, while some of the catheters shown in the drawings and described in detail herein may be relatively short, some or all of the features described relative to these shorter catheters may be equally advantageous in certain embodiments with longer catheters, or in other words, those capable of deploying the catheter to relatively deeper depths within a patient's blood vessels.

[0096] Certain known catheter delivery devices, systems, and methods involve catheters on needles. Such systems may include a catheter and a needle extending through a distal end of the catheter. In many cases, the catheter is attached to at least the distal end of the needle. For example, the catheter may be extruded, and then the distal end of the catheter may be “tilted” to provide a rounded and / or narrow distal end that is easier to insert into a blood vessel. The tilting process may be performed by heating the distal end of the catheter and / or by compressing the distal end against a mandrel, which may be slightly smaller than the distal end of the needle. After the catheter is tilted, the needle may be inserted through a distal opening into the tilted catheter, and then the catheter may adhere to the distal end of the needle.

[0097] However, the adhesion strength between the distal end of the catheter and the needle can be difficult to manage. In many cases, adhesion is achieved by using a mandrel with an outer diameter slightly smaller than that of the needle, allowing the distal end of the catheter to grip the distal end of the needle. The adhesion strength can naturally increase over time due to the interaction between the material forming the catheter and the surface of the needle.

[0098] Sufficient adhesion may be desired to allow the distal end of the catheter and the needle to remain attached to each other as the distal end of the catheter passes through the insertion site formed by the distal tip of the needle into the blood vessel. The blood vessel can provide significant resistance to the introduction of the distal end of the catheter. In some cases, if the adhesion strength is insufficient, the distal end of the catheter may be pushed posteriorly (i.e., proximally) a certain distance as the needle is advanced further into the blood vessel (often at an angle relative to the longitudinal axis of the vessel). If the outer surface of the vessel wall pushes the catheter tip proximally too much with each advancement of the needle due to its resistance to catheter entry, the distal end of the needle may eventually pierce the posterior wall of the vessel before the distal end of the catheter finally enters the vessel. In other or additional cases, the skin and tissue may tend to push the distal end of the catheter body posteriorly and resist the advancement of the catheter through it, which can cause the catheter body to wrinkle proximally relative to the needle in an accordion-like or corrugated manner as the needle is advanced distally. Therefore, there may be a danger if there is insufficient adhesion strength.

[0099] However, a less strong adhesion may be desirable, as excessive adhesion can prevent the catheter from separating from the needle at a desired stage—for example, after both the needle tip and the catheter tip have been advanced into the lumen of the vessel—allowing the catheter to be further advanced into the vessel beyond the distal end of the needle. For example, if the adhesion is too strong, causing the catheter tip to remain engaged with the needle as the catheter is advanced distally relative to the needle, the more proximal portion of the catheter can be constricted or compressed in an accordion-like manner, preventing the catheter from being advanced deeper into the vessel and / or potentially damaging it. Furthermore, excessive adhesion may be undesirable, leading to tension buildup during catheter-needle separation until the distal end of the catheter eventually detaches from its adhesion with excessive energy and advances forward to impact the vessel wall, potentially damaging it. In other or additional cases, excessive adhesion can damage, deform, or otherwise undesirably alter the distal end of the catheter and / or damage the vessel wall as the catheter is further advanced into the vessel.

[0100] Therefore, known catheter delivery systems must compete with a narrow window of acceptable adhesion conditions that are neither too weak nor too strong. Failure to meet these conditions can lead to, for example, damage to blood vessels and / or increased patient discomfort, wasted time for both patients and healthcare professionals, and / or wasted costs due to the need to use alternative needle delivery systems to create different insertion sites in the patient.

[0101] Furthermore, known catheter delivery systems can encounter difficulties in addressing the insertion length issue. For example, catheters are often formed from relatively compliant materials, which can make it difficult to advance the catheter itself a significant distance into the vessel. Specifically, the catheter may lack sufficient stiffness or column strength to be independently advanced deep into the vessel, especially when attempting to pass through one or more valves (e.g., in deep vessels). Typically, a compliant catheter folds itself when pushed upward against a valve. Folding or other deformation of the catheter can close it and render it ineffective for fluid delivery and / or collection, can otherwise damage the catheter, and / or damage the vessel. The catheter may also fold itself or otherwise deform in other areas of the vessel. Therefore, in various situations, guidewires or stiffening probes can be used to advance the catheter to the desired depth within the vessel.

[0102] In some systems, a guidewire is introduced into the blood vessel via an introduction needle to help advance the catheter to the target depth within the vessel. While the guidewire can prevent the catheter from bending and / or scraping the inner wall of the vessel in some cases, in many situations, a guidewire-based system may not be reliable. Many guidewire systems can have a number of drawbacks.

[0103] For example, in some cases, a particular guidewire may have minor defects or deformities that could cause it to bend backward, rendering it unusable for catheter advancement and / or potentially damaging the vessel. In other or additional cases, integrated systems that deploy both the guidewire and catheter into the vessel may use only guidewires of limited length. Typically, the length of such guidewires is approximately the length of the catheter deployed by the system—that is, the guidewire length may be substantially the same as or even shorter than the length of the catheter they are intended to guide into the vessel. Attempting to advance the catheter beyond the distal end of such limited-length guidewires, especially when one or more valves are positioned outside the guidewire tip, can result in catheter folding or other undesirable deformation. Therefore, deployment systems typically only work if the guidewire is advanced to the desired or target depth ahead of the catheter, and then the catheter is advanced to the target depth via the guidewire. However, increasing the length of the guidewire in existing systems to achieve greater insertion depths would make the system as complex, expensive, and / or inconvenient as possible. Therefore, deployment systems using guidewires also suffer from insertion length issues.

[0104] In other cases, a stiffening probe is positioned within the lumen of the catheter to increase rigidity and facilitate catheter advancement to the target depth. However, such systems require inserting the dilator and guide into the target vessel to a significant depth (often involving cutting the patient's skin to allow insertion), removing the dilator, and inserting the catheter / probe combination through the guide while the guide remains inserted in the vessel. Relatively speaking, such procedures can increase patient discomfort and / or be longer, more complex, more invasive, and / or generally more strenuous for both the practitioner and the patient.

[0105] In other simple needle-on-catheter systems, the needle can be used to support the catheter during initial insertion into a vessel, or, in some cases, to deliver the catheter to a target depth. Such systems also have significant drawbacks. For example, some of these systems are limited to relatively short catheter lengths for various reasons, such as considerations of needle stability and control. By way of example, in some catheter deployment systems, when the system is in the undeployed state, a needle of a certain length is attached to the catheter, with the distal end of the needle extending just beyond the distal end of the catheter. The needle extends proximally through the catheter and through a catheter hub attached to the proximal end of the catheter, and is secured to the needle hub at the proximal end of the needle. When the system is in the undeployed state, the needle and catheter hub are approximately oriented relative to each other. When using the system, the practitioner holds the needle hub and / or catheter hub and advances the entire system distally, causing the needle and catheter to move in unison, with the needle tip piercing the skin and penetrating the vessel wall. The distal end of the catheter follows the needle's puncture tip through the vessel wall into the lumen of the vessel. Once the catheter tip is inside the blood vessel lumen, the practitioner attempts to stabilize the needle hub while moving it distally to advance the catheter further into the vessel, or in other words, to a deeper depth. Once the catheter is in place, the practitioner stabilizes the catheter hub and pulls it proximally relative to the catheter hub to remove the needle from the system.

[0106] In such systems, the needle must always be longer than the catheter to ensure that the distal end of the needle extends through the catheter hub, through the catheter, and beyond the distal end of the catheter. Therefore, the length of the catheter is limited by the maximum length of the needle. As the needle length increases, controlling the insertion of both the needle and the catheter into the blood vessel becomes increasingly difficult. For example, when one or more of the needle and the catheter hub are held during insertion, small angular movements of the hub cause a significant amount of oscillation at the needle tip, and this oscillation effect increases with needle length (i.e., the same amount of angular movement results in a greater distance traveled by the needle tip), making it difficult to accurately align the insertion site while holding the hub. Furthermore, the needle can be quite flexible (e.g., due to thin walls and / or small diameter), and bending can become more pronounced as the needle length increases.

[0107] The various embodiments disclosed herein can address, remedy, improve, and / or avoid one or more limitations of known catheter delivery devices, systems, and methods (such as those just described), and / or for other or additional reasons, the various embodiments may be advantageous to one or more of these or catheter delivery devices, systems, and methods, as will be apparent from this disclosure. Some embodiments of a catheter delivery system include a catheter, a stiffener, and a needle. In some embodiments, when the needle is first introduced into a patient's blood vessel, the distal end of the catheter and the distal end of the stiffener are positioned proximal to the distal end of the needle. In other or additional embodiments, the distal end of the stiffener and the distal end of the catheter can extend through the outer surface of the needle to a position within the blood vessel distal to the distal end of the needle. The stiffener may help break the adhesion between the distal end of the catheter and the distal end of the needle, and / or may enhance the catheter so that it can be fed or advanced a significant distance or target depth within the blood vessel. The stiffener may advance the catheter all the way to the target site within the blood vessel. Furthermore, in some embodiments, a relatively soft catheter tip can be positioned anterior (e.g., distal) to the distal end of the stiffener throughout deployment, thereby providing a soft and substantially non-invasive guiding tip for insertion. In some cases, the catheter delivery system is able to position the catheter a significant distance within the blood vessel without the use of a guidewire. In other or additional embodiments, a two-piece hub is employed, which in some cases allows the use of a relatively short needle and / or reduces the length of the unsupported needle, increasing stability and control during insertion, and / or providing other or additional advantages. These advantages and / or one or more of the other or additional advantages of the various embodiments will become apparent from the following description.

[0108] refer to Figure 1In some embodiments, the catheter delivery system 100 includes a catheter 102, a needle 104, and a stiffener 106. The catheter 102 includes a proximal end 110 having a proximal end 112 at its distal end, and also includes a distal end 114 having a distal end 116 at its distal end. Similarly, the needle 104 includes a proximal end 120 having a proximal end 122 at its distal end, and also includes a distal end 124 having a distal end 126 at its distal end. Likewise, the stiffener 106 includes a proximal end 130 having a proximal end 132 at its distal end, and also includes a distal end 134 having a distal end 136 at its distal end. In various embodiments, stiffener 106 may also be referred to as, or may have alternative forms, including at least one component, which may be referred to as a support, column, reinforcement, frame, bracket, strut, brace, support, ridge, rod, tube, and / or cannula. For example, in the illustrated embodiment, stiffener 106 may also be referred to as a sheathed cannula, tubular stiffener, etc. In the illustrated embodiment, stiffener 106 is formed of an elongated tube positioned between the outer surface of needle 104 and the inner surface of conduit 102 when system 100 is in an undeployed configuration, such as... Figure 1 As shown below, the tubular stiffener 106 may be flexible in its transverse dimension (e.g., in a direction orthogonal to the longitudinal axis of the tube), but may be substantially rigid or stiff in the axial direction to counteract the axial forces (i.e., longitudinal guiding forces) exerted on the distal portion of the catheter 102 during insertion of the system 100 through the vessel wall and during advancement of the system 100 through the lumen of the vessel.

[0109] System 100 also includes a proximal end 140 and a distal end 142. When system 100 is in an undeployed configuration, the distal ends 114, 124, and 134 of the catheter 102, needle 104, and stiffener 106 are positioned at the distal end 142 of system 100. More specifically, at least a portion of the distal end 124 of needle 104 extends distally beyond the distal end 116 of catheter 102. Furthermore, the distal end 136 of stiffener 106 is positioned proximal to the distal end 116 of catheter 102.

[0110] In the illustrated embodiment, the proximal end 110 of catheter 102 is coupled to catheter hub 146. Catheter hub 146 can be of any suitable form and may include one or more connectors configured to establish one or more fluid connections with any suitable medical fluid device (e.g., syringe, IV line, electric injector, etc.). For example, in some embodiments, catheter hub 146 may include at least one Luer connector through which aspiration and / or injection can be performed after catheter 102 has been positioned within a patient's blood vessel. For example, catheter hub 146 may include a female Luer connector. Catheter 102 may be securely attached to catheter hub 146 in any suitable manner. Catheter 102 and catheter hub 146 may be collectively referred to as a catheter assembly. Catheter hub 146 may also be referred to as catheter connection hub 146. For example, catheter hub 146 may be directly connected to catheter 102 and / or may include connection features for coupling the catheter to other devices (e.g., fluid delivery devices).

[0111] In the illustrated embodiment, the proximal end 120 of the needle 104 is coupled to the needle hub 150. For example, the proximal end 120 of the needle 104 can be securely fixed to the proximal portion of the needle hub 150 in any suitable manner. In the illustrated embodiment, the needle hub 150 includes a housing 152 to which the needle 104 is secured. Other securing arrangements are contemplated. The needle hub 150 may also be referred to as a shank.

[0112] The needle hub 150 may also include an actuator 154 configured to selectively move relative to the housing 152. In an illustrated embodiment, the housing 152 defines a guide or track 156 along which the actuator 154 can move from a proximal position ( Figure 1 As shown, see also Figure 4A and Figure 4C Slide or translate to the distal position (see...) Figure 4D and Figures 4F to 4H Actuation of actuator 154, for example by manually pushing actuator 154 from a proximal position to a distal position in the illustrated embodiment, can change system 100 from a non-deployment configuration to a deployment configuration, as further described below.

[0113] In the illustrated embodiment, the proximal end 130 of the stiffener 106 is fixedly coupled to the actuator 154. The actuator 154 may also be referred to as a stiffener hub. In the illustrated embodiment, the actuator 154 (or stiffener hub) includes an engageable portion (e.g., a button, slider, grip surface) residing on the exterior of the housing 152, a neck (not shown) extending through the track 156, and a container (not shown) inside the housing to which the proximal end of the stiffener 106 is attached. Any suitable fixed attachment between the actuator 154 and the stiffener 106 is contemplated. For example, the stiffener 106 may be glued or otherwise adhered to the actuator 154. In some cases, the actuator 154 includes a generally cylindrical container disposed within the housing 152 of the needle hub 150, and the proximal end of the stiffener 106 is received within the cylindrical portion of the actuator 154. Of course, non-cylindrical geometries are possible and contemplated by this disclosure. Distal movement of actuator 154, such as by pressing forward or distally a portion of actuator 154 positioned outside housing 152 of needle hub 150 (e.g., a button, slider, or other engaging element), achieves a similar distal movement of stiffener 106 relative to housing 152. In the illustrated embodiment, needle hub 150, needle 104, actuator 154, and stiffener 106 may be referred to as an insertion assembly, needle assembly, needle and stiffener assembly, or deployment assembly.

[0114] In the illustrated embodiment, the stiffener 106 extends through the conduit hub 146 and into the interior of the conduit 102. As further described below, the stiffener 106 may be able to move distally alongside the conduit 102, but may be configured to be removed proximally from the conduit 102. Additionally, in the illustrated embodiment, the needle 104 extends through... Figure 1 Each of the stiffener 106 and the catheter 102 is shown in either an operational or undeployed state. Furthermore, the stiffener 106 may be configured to slide relative to the needle 104 or otherwise translate (e.g., freely). In other words, the stiffener 106 may be sized to accommodate the needle 104 within its lumen and to translate freely over the needle 104.

[0115] The catheter hub 146 can be coupled to the actuator 154 in a manner that enables distal movement of both the catheter hub 146 and the catheter 102 relative to the housing 152. Therefore, in some embodiments, distal movement of the actuator 154 enables simultaneous distal movement of the stiffener 106 and the catheter 102. In other words, in some embodiments, the stiffener 106 and the catheter 102 can move distally in a coordinated manner. For example, in some embodiments, the catheter hub 146 is directly attached to the actuator 154 such that movement of the actuator 154 achieves a similar movement to that of the catheter hub 146. The attachment can be selectively released so that the actuator 154 can be easily disengaged from the catheter hub 146 after the catheter 102 has been positioned intravascularly as needed. In other or additional embodiments, the catheter hub 146 is additionally or indirectly connected to the actuator 154 via the catheter 102 and the stiffener 106. Specifically, as further described below, the distal end 114 of the catheter may include a capture region that intersects with the distal end 136 of the stiffener 106 to allow the stiffener 106 to advance the catheter 102 in a distal direction. Thus, in some embodiments, the actuator 154 is directly attached to the stiffener 106, the distal end of which intersects with the distal end 114 of the catheter 102, and the proximal end 110 of the catheter 102 is directly attached to the catheter hub 146. Therefore, the catheter hub 146 is coupled to the actuator 154 such that distal movement of the actuator 154 results in distal movement of both the catheter hub 146 and the catheter 102 relative to the housing 152. Specifically, distal advancement of the actuator 154 relative to the housing 152 causes the distal end 136 of the stiffener 106 to press against the distal end 114 of the catheter 102, thereby forcing the catheter 102 to move distally relative to the housing 152. Because the proximal end 110 of the conduit 102 is attached to the conduit hub 146, the conduit hub 146 is pulled distally relative to the housing 152 by the conduit 102. That is, due to the interaction between the stiffener 106 and the distal end of the conduit 102, pushing the actuator 154 distally causes the conduit hub 146 to be pulled or stretched distally. The distal movements of the actuator 154, stiffener 106, conduit 102, and conduit hub 146 can be substantially simultaneous and / or can be substantially consistent.

[0116] With the needle 104 fixed relative to the housing 152 of the needle hub 150, the stiffener 106 and the guide tube 102 can move distally not only relative to the housing 152 but also relative to the needle 104. Therefore, by pushing the actuator 154 distally, the stiffener 106 and the guide tube 102 can be deployed distally through the distal end 126 of the needle 104, as further described below.

[0117] In some embodiments, the connection between the catheter hub 146 and the actuator 154 is selectively releasable. For example, in some embodiments, it may be desirable to disengage the catheter hub 146 from the actuator 154 at some point after the actuator 154 has been actuated. Such disengagement allows the needle hub 150 to retract proximally from the catheter hub 146. Any suitable selectively releasable mechanical connection between the catheter hub 146 and the actuator 154 is contemplated. For example, in some embodiments, the catheter hub 146 and the actuator 154 are directly attached to each other and held together by one or more resilient arms or latches (not shown), and a recess in the cantilever portion of the arm, button, or any other suitable mechanical linkage can cause the arm to move to a disengagement orientation. In other embodiments, the catheter hub 146 and the actuator 154 are not directly attached to each other, but are connected to each other through the interaction between the distal end of the stiffener 106 and the catheter 102, as previously described. In some such embodiments, the coupling can be released simply by moving the actuator 154 proximally relative to the conduit hub 146, which moves the stiffener 106 proximally relative to the distal end 114 of the conduit 102, and disengaging from the distal end of the conduit. In some cases, after initially advancing distally along the track 156 for conduit deployment, the actuator 154 can be moved proximally within the track 156 to achieve disengagement. In other or additional cases, the conduit hub 146 can be deployed to a position outside the housing 152 while the actuator 154 is advanced distally along the track 156, and disengagement of the conduit hub 146 and housing 152 can be achieved by holding the conduit hub 146 in a fixed position while retracting the housing 152 proximally away from the conduit hub 146. For example, in some cases, the actuator 154 can be positioned at the extremely distal end of the track 156 during conduit 102 deployment and can contact the housing 102 therein. Therefore, due to the interference between the housing 152 and the actuator 154 at the far end of the track 156, moving the housing 152 toward the near side can similarly pull the actuator 152 and the stiffener 106 attached thereto toward the near side.

[0118] Therefore, in various embodiments, the retraction of the needle hub 150 from the conduit hub 146 can retract the stiffener 106 and the needle 104 from the conduit 102 and the conduit hub 146. In addition to the foregoing examples, in some embodiments, the actuator 154 can be configured to lock in a fully actuated orientation in any suitable manner (e.g., by any suitable lock, latch, stop, or other suitable locking system). When the actuator 154 is locked relative to the housing 152 after being actuated in this manner, the stiffener 106 can also be locked relative to the housing 152, such as by being locked without translational movement relative to it. Thus, the stiffener 106 and the needle 102 can be in a locked relationship relative to each other and can therefore be configured to retract from the conduit 102 in a mutually coherent manner, as further described below.

[0119] refer to Figure 1 and Figure 2 (See also) Figure 4K The catheter 102 may define a distal port 160 through which the distal end 124 of the needle 104 passes when the system 100 is in an undeployed configuration. Once the catheter 102 is positioned within a patient's blood vessel, the distal port 160 is used for aspiration and / or infusion. In some embodiments, the catheter 102 may include a plurality of side ports 162, which may also be used for aspiration and / or infusion. In an illustrated embodiment, the catheter 102 includes six side ports 162, which are equiangularly distributed around the circumference of the catheter 102 along a single plane oriented substantially orthogonally to the central longitudinal axis of the catheter 102. Any other suitable size, number, and / or arrangement of the side ports 162 is contemplated. For example, in some embodiments, there are more or fewer side ports 162, and in other or additional embodiments, the side ports 162 may be arranged at different distances from the distal end 116 of the catheter 102.

[0120] Continue to refer to Figure 2 The distal end 124 of the needle 104 can have any suitable configuration. In an illustrated embodiment, the distal end 124 includes a main bevel 127 and a rear bevel 128. The distal tip 126 of the needle 104 is located at the distal intersection of the main bevel 127 and the rear bevel 128. In other embodiments, the needle 104 may have a single bevel or a simple biased abrasive point. The distal tip 126 may be particularly suitable for piercing the skin and penetrating the blood vessel wall.

[0121] Figure 3 It shows along Figure 1 The image shows a cross-sectional view of the distal portion 142 of the catheter delivery system 100, taken from line 3-3. Also in this view, the system 100 is in an undeployed configuration. Dimensions shown are not necessarily drawn to scale.

[0122] The catheter 102 may include an outer surface 170 and an inner surface 171. The inner surface 171 of the catheter 102 may define a catheter lumen 172. The needle 104 may also include an outer surface 173 and an inner surface 174. The inner surface 174 of the needle 104 may define a needle lumen 175. In an illustrated embodiment, the stiffener 106 includes an outer surface 176 and an inner surface 177. The inner surface 177 of the stiffener 106 may define a stiffener lumen 178. In an illustrated embodiment, the needle 104 extends through the proximal end of the catheter lumen 172 (see [link to embodiment]). Figure 1Both the needle 104 and the distal end of the catheter lumen 172. In other words, the needle 104 (e.g., a significant portion of the needle 104) is positioned within the catheter lumen 172 and extends through its entirety. The stiffener 106 is similarly positioned within the catheter lumen 172, but does not extend through its entirety. Specifically, the distal end 134 of the stiffener 106 is positioned within the catheter lumen 172 and engages a portion of the catheter interior, and the stiffener 106 extends proximally through the catheter lumen 172 and extends beyond the proximal end of the catheter lumen 172 (see [link to documentation]). Figure 1 It can be said that the stiffener 106 is outside the needle 104. It can be said that the guide tube 102 is outside the stiffener 106.

[0123] The needle 104 is similarly positioned within the stiffening member cavity 178. In the illustrated embodiment, the needle 104 extends through the proximal end of the stiffening member cavity 178 (see [link]). Figure 1 Both the distal end of the inner cavity 178 of the stiffener and the stiffener.

[0124] In other words, needle 104 (e.g., a prominent portion of needle 104) is positioned within stiffener cavity 178.

[0125] In other words, the needle 104 is nested within the stiffener 106, and the stiffener is nested within the conduit 102. In the illustrated embodiment, the needle 104, stiffener 106, and conduit 102 are coaxial. In other words, each of the needle 104, stiffener 106, and conduit 102 defines its own central longitudinal axis, and each such axis is collinear with the central longitudinal axis of the system 100.

[0126] In some embodiments, the outer surface 173 of the needle 104 is sized to either loosely fit (e.g., closed, but with little or no contact) or tightly fit (e.g., in contact, but with the ability to slide) within the inner surface 177 of the stiffener 106. In some embodiments, the outer surface 176 of the stiffener 106 loosely fits within the inner surface 171 of the conduit 102.

[0127] In the illustrated embodiment, the sidewall of needle 104 defines a port 180 through which blood can flow from the needle lumen 175. The sidewall of stiffener 106 similarly defines a port 182 for allowing blood flow. Ports 180 and 182 together define a passage 186. Ports 180 and 182 can be aligned with each other to form passage 186. In some embodiments, stiffener 106 and needle 104 are rotatably locked relative to each other in the illustrated arrangement, which ensures that ports 180 and 182 remain aligned at least during the insertion phase in methods using system 100.

[0128] For example, refer to again Figure 1As previously described with respect to the illustrated embodiment, the proximal end 120 of the needle 104 is fixedly attached to the needle hub 150, and thus rotatably fixed relative to the housing 152. Furthermore, the stiffener 106 is fixedly attached to the actuator 154, which is positioned within the track 156. Therefore, when the actuator 154 is in the undeployed state, the actuator 154 is constrained by the track 156 and no lateral movement occurs that would rotate the stiffener 106 about the longitudinal axis of the housing 152. Thus, both the needle 104 and the stiffener 106 are rotatably fixed relative to the housing 152 and relative to each other.

[0129] It should also be noted that actuator 154 is constrained to translate along track 156. When track 156 is substantially linear and aligned with the longitudinal axis of system 100, actuator 154 does not rotate about the longitudinal axis of system 100 as it moves along track 152. Therefore, although stiffener 106 can move relative to housing 152, it remains rotatably fixed relative to housing 152 even during deployment of conduit 102 due to the rotational constraint applied to actuator 154.

[0130] Although needle 104 is shown as having an inner lumen in the illustrated embodiment, in other embodiments, needle 104 may not be limited to an inner lumen. For example, in some embodiments, needle 104 may include a solid cannula needle, a pointed rod, etc.

[0131] Refer again Figure 3 The inner surface 171 of catheter 102 can mate with the outer surface 176 of stiffener 106 to define an elongated annular lumen 188 through which blood received from passage 186 can flow proximally through catheter 102. Thus, passage 186 and lumen 188 provide a channel through which blood flash can pass to indicate that the distal end 124 of needle 104 has entered a blood vessel. In some embodiments, the distance between the inner surface 171 of catheter 102 and the outer surface 176 of stiffener 106 is small enough to induce capillary action, which can aspirate or facilitate aspiration of blood flash proximally through lumen 188.

[0132] The distal end 134 of the stiffener 106 can engage the distal end 114 of the conduit 102. The conduit 102 can define a capture region 190 that can intersect with the distal end 136 of the stiffener 106. For example, the capture region 190 can generally be formed as a recess extending distally relative to a portion of the inner surface 171 of the conduit 102 defining the lumen 188 (see also...). Figure 4IIn the illustrated embodiment, the capture region 190 includes an engagement surface, abutment surface, lateral extension, shelf, or flange 191 with a reduced diameter relative to the proximal region of the catheter 102, against which the distal end 136 of the stiffener 106 can apply a distal guiding force. In some embodiments, the distal end 136 of the stiffener 106 and the flange 191 may generally interact with each other only when the stiffener 106 is pushed distally or otherwise pressed against the flange 191, such as during insertion of the catheter 102 into a patient's blood vessel. In the illustrated embodiment, the distal end 136 may also be referred to as an engagement surface, abutment surface, etc. In the illustrated embodiment, the flange 191 defines a planar annulus, and the plane of the annulus is orthogonal to the longitudinal axis of the catheter 102.

[0133] The illustrated capture region 190 also includes a side 192, which in some cases may provide a relatively weak connection between the distal end 134 of the stiffener 106 and the conduit 102. For example, the side 192 of the conduit 102 may be in direct contact with and grip onto the stiffener 106. In some cases, adhesion may be caused by the natural interaction between the materials forming the conduit 102 and the stiffener 106. In some cases, the conduit 102 is inclined on a mandrel that includes a surface at its distal end similar to the outer surface 176 of the stiffener 106, but with a slightly reduced diameter relative to that surface. Thus, when the distal end 134 of the stiffener 106 is inserted into the pre-formed conduit 102, the side 192 of the conduit 102 may press inward against the stiffener 106. In addition to the gripping or frictional forces exerted by this arrangement, an adhesive bond may also form over time due to the interaction between the conduit and stiffener materials. For example, in some embodiments, the stiffener 106 is made of stainless steel, and the conduit 102 is made of a polymer material.

[0134] In other embodiments, little or no engagement between the stiffener 106 and the side 192 of the capture region 190 may be desired. For example, when the stiffener 106 is withdrawn relative to the catheter 102 in a proximal direction, it is generally expected that the stiffener 106 can be easily released from the catheter. That is, once the stiffener 106 has helped to position the catheter 102 within the patient's blood vessel, it is expected that the stiffener 106 can be removed from the catheter 102. Additionally, it is expected that the stiffener 106 can be removed without deforming, significantly deforming, and / or permanently deforming the distal end 114 of the catheter 102 and / or substantially not altering the positioning of the distal end 114 of the catheter 102 within the patient's blood vessel. In some embodiments, the catheter 102 is tilted on a mandrel that includes a surface at its distal end similar to the outer surface 176 of the stiffener 106 and has a diameter substantially the same as or slightly larger than its diameter. In some embodiments, the conduit 102 does not define a side surface 192 and / or contacts the distal end 136 of the stiffener 106 only through the abutment surface 191.

[0135] Regardless of the presence or absence of adhesion between the side 192 of catheter 102 and the stiffener 106, it is expected that the stiffener 106 selectively engages the distal end 114 of catheter 102. Specifically, during insertion of catheter 102 through the vessel wall and during advancement of catheter 102 into the patient's vessel, it is expected that the stiffener 106 applies at least a distal guiding force to the distal end 114 of catheter 102. Furthermore, when the stiffener 106 is withdrawn relative to catheter 102 in the proximal direction, it is expected that the stiffener 106 readily disengages from the distal end 114 of the catheter.

[0136] In some embodiments, the distal end 114 of the conduit 102 may adhere to or otherwise bond to the outer surface 173 of the needle 104. For example, the illustrated capture region 190 includes a side 193 that, in some cases, may provide a relatively strong connection between the conduit 102 and the distal end 124 of the needle 104. For example, the side 193 of the conduit 102 may be in direct contact with the outer surface 173 of the needle 104 and may grip and / or attach to the reinforcement. In some cases, adhesion may be caused by the natural interaction between the materials forming the conduit 102 and the needle 104. In some cases, the conduit 102 is angled on a mandrel that includes a surface at its distal end similar to the outer surface 173 of the needle 104, but with a reduced diameter relative to that surface. Thus, when the distal end 124 of the needle 104 is inserted through the pre-formed conduit 102, the side 193 of the conduit 102 may press inward against the needle 104. In addition to the gripping or frictional forces exerted by this arrangement, an adhesive bond may also form over time due to the interaction between the conduit and stiffening materials. For example, in some embodiments, the needle 104 is made of stainless steel, and the conduit 102 is made of a polymer material.

[0137] The adhesion between the distal end of catheter 102 and needle 104 facilitates insertion of the distal end 114 of catheter 102 through the sidewall of the blood vessel at the insertion site formed by needle 104. For example, strong adhesion between the distal end 114 of catheter 102 and the outer surface 173 of needle 104 reduces the chance of catheter 102 being pushed back by the vessel wall during insertion, which could cause needle 104 to undesirably pass through the posterior wall of the vessel before catheter 102 enters the vessel. Tighter adhesion also reduces the likelihood of other undesirable catheter tip deformations, such as fish-mouth deformation, occurring during insertion through the vessel wall.

[0138] Furthermore, due to the interaction between the stiffener 106 and the catheter 102, a relatively strong adhesive bond can be achieved between the catheter 102 and the needle 104 without concern that the catheter 102 may bunch or deform in an accordion-like manner when attempting to separate it from the needle 104. Specifically, when the stiffener 106 is advanced distally relative to the needle 104 to separate the adhesive bond, the stiffener 106 reinforces, strengthens, supports, engages, or otherwise interacts with the catheter 102. As previously described, in some embodiments, the stiffener 106 and the catheter 102 may be advanced distally relative to the needle 104 simultaneously. The distal end 134 of the stiffener 106 may be pushed distally and provide axial support to the distal end 114 of the catheter 102 to facilitate separation of the catheter 102 from the needle 104. This arrangement also suppresses similar deformation of the catheter 102 that may occur when the catheter 102 passes through the vessel wall and through the insertion site.

[0139] Therefore, some implementations can effectively eliminate adhesion problems in catheter / needle insertion assemblies. As previously mentioned, some prior art systems struggle with adhesion problems because it is difficult to ensure that the adhesion between the catheter and the needle is neither too loose nor too tight. However, the acceptable range of adhesion strength can be expanded by allowing a higher level of adhesion between the catheters to avoid "too loose" and "too tight" scenarios. For example, a stronger adhesion strength can be used, thereby completely avoiding the lower limit of the acceptable strength range. Furthermore, the upper limit of the acceptable strength range can be raised to an insignificant degree. That is, stiffener 106 may be able to facilitate the connection of catheter 102 to needle 104 within this large range of adhesion strength, allowing various manufacturing systems 100 to operate as needed even with fluctuations that may be caused by manufacturing processes, materials, and the length of time spent in storage (which in some cases can increase bond strength).

[0140] In some embodiments, the stiffener 106 may have a bending strength greater than that of the catheter 102. Therefore, the stiffener 106 can facilitate the advancement of the catheter 102 a considerable distance within the blood vessel without the aid of a guidewire. For example, in some embodiments, the catheter 102 may be advanced into the blood vessel to a depth equal to or greater than the depth of the same catheter configuration otherwise achievable using a guidewire. In various embodiments, the bending strength of the stiffener 106 is greater than that of the catheter 102.

[0141] In other or additional embodiments, stiffener 106 may have a bending strength less than that of needle 104. That is, stiffener 106 may be more compliant than needle 104, and therefore may be easier to advance through blood vessels and more easily conform to their natural shape than known needle arrangements.

[0142] In various embodiments, stiffener 106 may comprise superelastic nitinol. In other embodiments, stiffener 106 comprises shape memory nitinol, polycarbonate, or any other suitable material, such as a material that readily allows lateral bending while maintaining sufficient longitudinal stiffness to advance conduit 106 in the manner disclosed herein.

[0143] In various embodiments, needle 104 may comprise stainless steel, such as 304 stainless steel. In various embodiments, the catheter is formed of any suitable biocompatible material such as medical-grade polyurethane. In some embodiments, catheter 102 comprises polyurethane with a Shore A hardness of or not greater than about 91, 93, or 97. In some embodiments, catheter 102 comprises a Shore D hardness of or not greater than about 55.

[0144] Figures 4A to 4K The illustration shows various stages of an exemplary method for using system 100 on patient P. For clarity, some hidden parts or portions thereof may not be shown in some of these figures. However, Figures 1 to 3 The preceding descriptions associated with it should inform the reader about Figures 4A to 4K The relationships between the various components in each stage are shown in the figures, unless such relationships are specifically shown or mentioned. Furthermore, it should be noted that each figure, or in some cases, different parts of a single figure, may not be drawn to scale.

[0145] refer to Figure 4AA portion of the patient's skin 50 may be prepared in any suitable manner to introduce the catheter into the blood vessel 52, such as according to recognized standards of care. The system 100 may then be advanced consistently in a distal direction, as indicated by the right-hand arrow. Thus, as the system 100 is advanced, the distal end 124 of the needle 104 may be inserted through the skin 50 at the skin insertion site 54. As the system 100 is further advanced, the distal end 124 of the needle 104 may be introduced into the blood vessel 52 at the blood vessel insertion site 56.

[0146] exist Figure 4A In the stage shown, only the distal end 124 of the needle 104 has been inserted into the blood vessel 52. Although it has been inserted through the skin insertion site 54, the distal end 116 of the catheter 102 remains outside the blood vessel 52.

[0147] In the illustrated phase, system 100 remains in an undeployed configuration. That is, actuator 154 is not yet actuated (propelled distally relative to housing 152). Furthermore, the duct hub 146, in the illustrated configuration, is coupled to actuator 154 and is also in an undeployed configuration. In the illustrated embodiment, when in the undeployed configuration, duct hub 146 is housed within housing 152 of needle hub 150.

[0148] Figure 4B This is a cross-sectional view of the distal portion of system 100 after the point at which the distal end 126 of needle 104 has just passed through the vessel wall 61 and entered the lumen 63 of vessel 52. Blood, indicated by the arrows, travels proximally through the lumen 175 of needle 104. Blood is also allowed to flow through pathways 186 defined by ports 180 and 182 that pass through the sidewalls of needle 104 and stiffener 106, respectively. Subsequently, blood flows proximally through an annular channel 188 defined by catheter 102 and stiffener 106.

[0149] Figure 4C It shows in Figure 4B The phase shown in the image is shortly after the initial blood flash (indicated by the wavy line) continues to flow proximally through channel 188.

[0150] The catheter 102 may include at least a portion that is sufficiently transparent or translucent to allow observation of blood flash. Blood flash can indicate that the needle 104 is correctly positioned and can indicate that the delivery system 100 is available to deploy the catheter 102 over the needle 104.

[0151] Figure 4D and Figure 4EDifferent views of the same stage of an exemplary method using device 100 are shown. As shown in these figures, actuating actuator 154 deploys the distal end 114 of catheter 102 into blood vessel 52 of patient P. As shown in these figures, actuating actuator 154 deploys the distal end 114 of catheter 102 into blood vessel 52 of patient P. As previously described, this distal movement of actuator 154 uniformly advances both catheter 102 and stiffener 106 in a distal direction (see [reference]). Figure 4E Therefore, the distal ends 114 and 134 of the catheter 102 and the stiffener 106 are advanced into the lumen 63 of the blood vessel 52 through the vascular insertion site 56. The needle hub 150 is kept stable relative to the patient P, and the needle 104 is also kept stable relative to the patient P. Therefore, the catheter 102 and the stiffener 106 are advanced distally above the needle 104, simultaneously advancing into and through the lumen 63 of the blood vessel 52.

[0152] like Figure 4D As shown, in the illustrated embodiment, when system 100 is in a deployment configuration, the conduit hub 146 is advanced to a position outside the housing 152 of the needle hub 150. In some embodiments, moving the conduit hub 146 exposes an actuator 147 thereon, such as a button, switch, lever, or any other suitable release mechanism, which can be actuated to disengage the conduit hub 146 from the needle hub 150. For example, the actuator 147 may be directly mechanically coupled to the actuator 154 of the needle hub 150 via any suitable mechanical linkage, and actuation of the actuator 147 may disengage the actuator 147 from the actuator 154, thus disengaging the conduit hub 146 from the actuator and consequently from the needle hub 150.

[0153] In other embodiments, as previously described, there is no such direct mechanical link between the actuator 154 and the conduit hub 146. In some such embodiments, the actuator 154 (and needle hub 150) can be disengaged from the conduit hub 146 only by retracting the needle hub 150 proximally relative to the conduit hub 146.

[0154] refer to Figure 4E The catheter 102 and stiffener 106 have been positioned above the distal end 126 of the needle 104. Therefore, the stiffener 106 shields or covers the distal end 126. This shielding prevents the needle 104 from damaging the catheter 102 and / or the blood vessel 52 as the system 100 is further advanced into the lumen 63 of the blood vessel 52.

[0155] Figure 4FThe demonstration showed that after system 100 has been deployed to advance catheter 102 into blood vessel 52, the entire system 100 can be moved distally in a consistent manner to further advance catheter 102 into blood vessel 52. As previously described, during this further insertion, catheter 102, needle 104, and stiffener 106 can move substantially simultaneously or substantially concurrently. During this phase, catheter hub 146 can remain engaged with needle hub 150.

[0156] In other implementations (see, for example) Figure 6 (and related descriptions), omitted Figure 4F The advancement phase. For example, in some embodiments, the actuator 154 is advanced along track 156 to advance the catheter 102 to the desired depth within the blood vessel, making further advancement of the entire system 100 undesirable or unnecessary. In some cases, due to one or more of a variety of reasons, it may be desirable for the actuation of the actuator 154 to fully deploy the catheter arrangement. For example, in some cases, fully advancing the catheter 102 in this manner may reduce the risk of trauma to the blood vessel during advancement of the catheter 102 into the blood vessel. This may result in, for example, reduced stiffness, as the stiffness of the combination of catheter 102 and stiffener 106 may be less than the stiffness of the combination of catheter 102, stiffener 106, and needle 104. Such arrangements may also have a relatively short needle 104, which may facilitate the initial insertion of the system 100 into the blood vessel. For example, a shorter needle 104—or more specifically, a shorter effective length of needle, which may be an unsupported portion extending distally from the housing 152—is more easily controlled by manipulating the housing 152.

[0157] However, in some embodiments, the combination of catheter 102, stiffener 106, and needle 104 can still be sufficiently compliant in the lateral direction (i.e., in the direction transverse to the longitudinal axis of the system) to allow a relatively long needle to be advanced a significant distance into the blood vessel before retraction from the needle hub 150. For example, in the following relative to Figure 5 In some embodiments of the system shown and described, the catheter, stiffener, and needle can be sufficiently compliant in the lateral direction to allow their combination to be easily bent at the needle insertion site and advanced a significant distance into the blood vessel when the distal end of the needle is shielded by the tubular stiffener.

[0158] Figure 4G The demonstration illustrates a stage where the needle hub 150 disengages from the conduit hub 146. In the illustrated embodiment, the actuator 147 of the conduit hub 146 is actuated (e.g., pressed down, rotated, or otherwise moved), which releases, for example, the mechanical coupling between the actuator 147 and the actuator 154 of the needle hub 150. Upon release of the mechanical coupling, the needle hub 150 can be withdrawn from the conduit hub 146. For example, as... Figure 4GAs shown, the catheter hub 146 can be stably held in place (e.g., by the hand of a physician), and the needle hub 150 can be moved proximally relative to the catheter hub (e.g., by the other hand of a physician). In other embodiments, the actuator 147 may be omitted, and the catheter hub 146 may be directly coupled to the stiffening actuator 154 in any suitable releasable manner, such as by thread. Thus, the catheter hub 146 can be rotated relative to the stiffening actuator 154 to disengage from the thread and release the catheter hub 146, thereby allowing the needle hub 150, needle 104, stiffening actuator 154, and stiffening 106 to be removed proximally from the catheter 106 and the catheter hub 146. In other embodiments, as previously described, no direct mechanical linkage is provided between the needle hub 150 and the catheter hub 146, so that after the catheter 102 has been positioned intravascularly as needed, the needle hub 150 can be withdrawn proximally from the catheter hub 146 alone.

[0159] As previously described, in some embodiments, once the actuator 154 of the needle hub 150 is actuated, it can be locked in place. This effectively locks the stiffener 106 relative to the needle hub 150. Additionally, in some embodiments, the needle 104 is fixedly attached to the needle hub 150. Therefore, retraction of the needle hub 150 from the guide hub 146 can result in both the needle 104 and the stiffener 106 (see [link to documentation]). Figure 4H The insertion assembly retracts uniformly from catheter 102 and catheter hub 146. In other words, in some embodiments, the insertion assembly can be completely removed from the catheter assembly.

[0160] Figure 4H A needle hub 150 is shown, or more specifically, an assembly that may be referred to as an insertion assembly 109 after it has been fully withdrawn from the catheter hub 146, or more specifically, from the assembly that may be referred to as the catheter assembly 149. In some embodiments, the stiffener 106 is locked in place at its distal end to shield or cover the distal end of the needle 104. This arrangement can advantageously provide protection against accidental needlestick punctures. In other words, the stiffener 106 may cover, surround, conceal, encircle, protect, extend a significant distance beyond, or otherwise shield the distal end of the needle 104 to inhibit or prevent accidental contact with the needle 104. Thus, the stiffener 106 can inhibit, prevent, or avoid sharps injuries and the co-transmission of bloodborne diseases. Therefore, the stiffener 106 may also be referred to as a sheath, shield, puncture-resistant element, etc. It should be noted that although the stiffener 106 may define an opening at its distal end, such that the needle tip can be theoretically observed through the opening, or otherwise exposed to air, sunlight, etc. through the opening, and is therefore not completely "covered" in a sense, the shield 106 provided by the stiffener 106 extending through the distal end and preventing contact with the needle tip may still be referred to herein as "covering" the needle tip.

[0161] Figure 4I The catheter is shown after catheter 102 has been positioned within the lumen 63 of blood vessel 52 and after stiffener 106 and needle 104 have been removed from the catheter. The aforementioned capture area 190, flange 191, side 192, and side 193 are visible in this view. In various embodiments, catheter 102 can be used for any suitable aspiration and / or injection procedure.

[0162] Figure 4J A medical fluid component 197 coupled to a catheter hub 146 is shown. In the illustrated embodiment, coupling is achieved by rotating the medical fluid component 197 relative to the catheter hub 146. For example, in some embodiments, the medical fluid component 197 may include any suitable type of internal connection interface, such as a Luer connector (e.g., a male Luer connector), which can be coupled to a complementary Luer connector (e.g., a female Luer connector) of the catheter hub 146. Any suitable medical fluid component 197 is contemplated, such as a syringe, IV line, electric injector, etc.

[0163] Figure 4K The illustration shows fluid being delivered from a medical fluid component 197 through catheter 102 into the lumen 63 of a patient's blood vessel. In some embodiments, a relatively small needle 104 may be used in system 100. For example, in some cases, stiffener 106 may define an outer diameter substantially the same as that of a needle typically used in known catheter delivery systems. Therefore, the distal port 160 may be relatively smaller than the distal ports of other catheter systems. In other words, the capture region 190 of catheter 102 can reduce the size of the distal port 160 compared to a needle-on-catheter system that does not use stiffener 106 and in which the catheter has the same outer diameter. However, it may be desirable for catheter 102 to produce a flow rate substantially the same as that achieved through other catheter systems. In some embodiments, the flow rate of catheter 102 increases with the presence of the side port 162.

[0164] In various embodiments, the maximum diameter of catheter 102 is no greater than 18G, 20G, or 22G (approximately 1.2 mm, 1.0 mm, and 0.8 mm, respectively) or no greater than 5Fr or 6Fr (approximately 1.67 mm and 2 mm, respectively). In other embodiments, catheter 102 includes only the distal port 160 and is capable of delivering water or water-based fluids (e.g., 0.9% saline at 37°C) at a flow rate of no less than 3, 4, 5, 6, or 7 mL / s without rupture. In various embodiments, the diameter of the distal port 160 is no greater than 55%, 60%, 70%, or 75% of the maximum diameter of catheter 102. For example, in some embodiments, catheter 102 has a maximum diameter of approximately 1.24 mm and the distal port has a diameter of approximately 0.071 mm, while in other embodiments, catheter 102 has a maximum diameter of approximately 1.0 mm and the distal port has a diameter of approximately 0.056 mm.

[0165] In other embodiments where the conduit 102 has a maximum diameter within the aforementioned range, the conduit 102 includes a distal port 160 and a plurality of ports 162. In some embodiments, all ports 160, 162 are capable of delivering water or a water-based fluid (e.g., 0.9% saline at 37°C) together at a flow rate of not less than 3, 4, 5, 6, or 7 ml / s without rupturing.

[0166] Figure 5 This is a top plan view of another embodiment of the catheter delivery system 200. System 200 may be similar in some respects to System 100 described above. Therefore, similar feature structures are designated with similar reference numerals, where the leading numerals increment to "2". Therefore, the relevant disclosures regarding similarly identified feature structures described above will not be repeated below. Furthermore, specific feature structures of System 200 may not be shown or identified by reference numerals in the figures, or may not be specifically described in the following written description. However, such feature structures may be clearly identical or substantially identical to those shown and / or described with respect to such embodiments. Therefore, the relevant descriptions of such feature structures also apply to the feature structures of System 200. Any suitable combination of the same feature structures and variations described with respect to System 100 may be used with System 200, and vice versa. This disclosure pattern also applies to other embodiments shown in the following figures and described below, where the leading numerals may increment further.

[0167] System 200 includes catheter 202, needle 204, and stiffener 206, each defining a length significantly greater than that of catheter 102, needle 104, and stiffener 106, respectively. In various embodiments, system 200 can be used for peripheral venous, midline, PICC, or other applications.

[0168] Figure 6This is a top plan view of another embodiment of the catheter delivery system 300, which includes an elongated guide 399 that inhibits lateral deformation of the catheter 302 during deployment within a blood vessel 52 of the patient P. In the illustrated embodiment, the guide 399 is positioned within an elongated housing 352 of a needle hub 350. The guide 399 can be of any suitable type. For example, in some embodiments, the guide 399 includes sidewalls molded as part of the housing 352. In other or additional embodiments, the guide 399 includes a tube having a sufficiently large lumen to receive the catheter 302 and allow translation of the catheter 302 within the tube.

[0169] System 300 includes stiffeners 306, such as those described above, which facilitate placement of catheter 302 within blood vessel 52. The stiffeners 306 are coupled to actuator 354. Similarly, catheter 302 is attached to catheter hub 346, which is releasably coupled to actuator 354.

[0170] The needle hub 350 may include an actuator 354 and an elongated track 356 that extends substantially along the entire length of the housing 352 and can be coupled to the needle 304. The needle 304 may be fixedly attached to the housing 352 in the manner described above.

[0171] In use, the distal end of the needle 304 is inserted into the blood vessel 52. Once blood flashing is observed, the catheter 302 is deployed via the actuator 354. Specifically, the actuator 354 moves distally, which moves the catheter 302 and the stiffener 306 away from the needle 304. In the illustrated embodiment, the portion of the catheter 302 and the stiffener 306 inserted into the blood vessel is much longer than the portion of the needle 304 inserted into the blood vessel.

[0172] The effective, active, or unsupported length of needle 304 is substantially less than Figure 5 The effective, active, or unsupported length of needle 204 is shown. That is, the length of needle 304 extending distally from housing 352 is substantially less than that from housing 352. Figure 5 The length of the needle 204 extending from the outer shell. As previously mentioned, such as Figure 6 The arrangement shown facilitates the initial insertion of the system 300 into a blood vessel. For example, the needle 304, and specifically its distal end, can be more easily controlled by manipulating the housing 352 and / or is less prone to unexpected or undesirable bending.

[0173] Any suitable length for catheter 302 is envisioned. In various embodiments, the length of catheter 302 is suitable for peripheral veins, midline, PICC, or other applications.

[0174] Figure 7A and Figure 7BAnother embodiment of the catheter delivery system 400 is shown, which is configured to automatically deploy a catheter 402 and a stiffener 406 above the distal end of a needle 404. Figure 7A In the middle, system 400 is in a non-deployed state, and... Figure 7B In the meantime, System 400 has been deployed.

[0175] System 400 may include a needle hub 450 and a conduit hub 446 with similar naming features as described above. However, the needle hub 450 includes an automatic actuator 454. The actuator 454 includes a user engagement 403, such as a pressable button, and a biasing member 407. The user engagement 403 is connected to the biasing member 407 in any suitable manner, such as via a mechanical link 405. Thus, activating the user engagement 403 may cause the biasing member 407 to automatically deploy the conduit 402 and the stiffener 406. In the illustrated embodiment, the biasing member 407 includes a coil spring 409. Any other suitable biasing device is contemplated.

[0176] In the illustrated embodiment, needle 404 is fixedly attached to housing 452, conduit 402 is releasably attached to biasing member 407 via conduit hub 446, and stiffener 406 is fixedly attached to biasing member 407. Therefore, as Figure 7B As shown, when actuator 454 is activated, guide tube 402 and stiffener 406 are automatically deployed above needle 404. Actuator 454 is thus coupled to stiffener 406 and configured to control the movement of stiffener 406. Specifically, actuator 454 is coupled to biasing member 407, which is directly attached to stiffener 406, such that actuation of actuator 454 results in distal advancement of stiffener 406.

[0177] Figure 8A and Figure 8B Another embodiment of the catheter delivery system 500 is shown, which is configured to automatically deploy catheter 502 and stiffener 506 above the distal end of needle 504. Figure 8A System 500 in a non-deployed state is shown, and Figure 8B System 500 in deployment state is shown.

[0178] System 500 includes a conduit hub 546, which is disposed outside or on the exterior of the housing 552 portion of the needle hub 550 when system 500 is in an undeployed state. Figure 8B As shown, the deployment of system 500 moves the conduit hub 546 away from the needle hub 550 to the distal side.

[0179] In some embodiments, either the conduit hub 546 or the stiffener 506 includes an actuator 547 configured to disengage the conduit hub 546 from the stiffener 506. More specifically, the actuator 547 can be actuated to disengage the conduit hub 546 from the needle hub 550. Any suitable actuator arrangement is contemplated, such as those described above. In an illustrated embodiment, the actuator 547 includes a pressure pad actuated by a clamping action on the opposite side of the stiffener 506. Clamping the pressure pad disengages a mechanical linkage through which the conduit hub 546 is connected to the stiffener 506.

[0180] refer to Figure 8A The illustrated conduit hub 546 may include a side port 511 extending at an angle to the longitudinal axis of the system 500. In some embodiments, a fluid connector 513 is disposed at the end of the side port 511. For example, in some embodiments, the fluid connector 513 includes a Luer connector (e.g., a female Luer connector).

[0181] Figure 9 This is a side front view of the distal end of system 500. In the illustrated embodiment, conduit 502 defines only a single fluid delivery port 560 located at the distal end of conduit 502. Conduit 502 has no other fluid delivery ports, such as fluid delivery ports through the sidewalls of conduit 502.

[0182] Figure 10 For along Figure 8A The line of sight 10-10 is intercepted Figure 8A A cross-sectional view of the distal end of the catheter delivery system 500. System 500 includes an adhesion region 521 that is significantly longer than the similar region previously described relative to system 100. The inclusion of a stiffener 506 allows for greater adhesion strength between the catheter and the needle at the distal end of the catheter, as previously described.

[0183] Figure 11 and Figure 12 A cross-sectional view of another embodiment of the distal end of the catheter delivery system 600. (See figure) Figure 11 As shown, system 600 includes an elongated adhesion region 621, such as adhesion region 521. Figure 11 and Figure 12 As shown, system 600 also includes a stiffener 606 having a gripping engagement 631 at its distal end for engaging the distal end 614 of conduit 602. Conduit 602 may define a capture region 690 that intersects with the gripping engagement 631. In the illustrated embodiment, the capture region 690 and the gripping engagement 631 are shaped substantially complementaryly.

[0184] The capture region 690 may include a recess 691 extending distally. In an illustrated embodiment, the recess 691 includes a generally cylindrical outer surface and a generally conical inner surface that engage at the distal end of the recess 691. Similarly, the gripping engagement 631 of the stiffener 606 includes a generally cylindrical surface and a generally conical surface that engage at their distal ends. The recess 690 accommodates the gripping engagement 631 of the stiffener 606. Thus, when the stiffener pushes the conduit 602 in the distal direction, the distal end 614 of the conduit 602 is securely held on the distal end 634 of the stiffener 606. In some cases, the capture region 690 is shaped or otherwise configured to readily allow the gripping engagement 631 of the stiffener 606 to be released from the conduit when the stiffener 606 is withdrawn from the conduit 602 in the proximal direction.

[0185] In some embodiments, the recess 691 is formed via a mandrel during the tilting process prior to the insertion of the stiffener 606 into the catheter 602. In other embodiments, the recess 691 is formed directly via the stiffener 606. For example, the stiffener 606 may serve as a mandrel during tilting, and the distal end of the catheter may be reshaped onto the stiffener 606 to achieve a complementary shape. In some cases, the stiffener 606 may be more easily released from the catheter 602 when the catheter 602 is tilted on a separate mandrel.

[0186] Figure 13 and Figure 14 Another embodiment of a catheter delivery system 700 including a catheter 702 is shown, the catheter having a distal end 716 extending substantially to the proximal end of a main bevel 727 that extends to the distal end 724 of a needle 704. In some cases, this arrangement may facilitate insertion of the catheter 702 through the sidewall of a blood vessel.

[0187] Figure 15A and Figure 15B Another embodiment of the catheter delivery system 800 is shown. System 800 includes many of the feature structures described above with respect to other embodiments of the catheter delivery system. Furthermore, consistent with the foregoing disclosure conventions, it is contemplated that any suitable combination of feature structures or components of other systems disclosed herein may be used in system 800, and any feature structures or components of system 800 may be used as needed with other systems or components disclosed herein.

[0188] As described more fully below, system 800 may include a multi-part catheter hub, the different parts of which may be in a separate orientation and / or spaced apart before catheter deployment and may be assembled together during catheter deployment. In an illustrated embodiment, the catheter hub includes two distinct parts, one of which is secured to a handle (or needle hub) for selective removal therefrom, and the other is fixedly secured to the catheter. As the catheter is advanced distally, the portion attached to the catheter eventually engages with the portion attached to the handle. The handle, along with all components attached thereto, is detachable from and withdrawable from the assembled catheter hub and catheter. In various embodiments, this arrangement may allow the use of relatively long catheters and / or may facilitate at least initial insertion of the catheter into the blood vessel, such as by reducing the effective or unsupported length of the insertion needle initially extending beyond the distal end of the catheter. One or more of these and / or other advantages will become apparent according to this disclosure.

[0189] like Figure 15A and / or Figure 15B As shown, system 800 may include a conduit 802, a needle 804, and a stiffener 806, which may be nested when assembled as described above. System 800 may also include a needle hub or shank 850, which may be securely attached to the needle 804 in any suitable manner, such as by friction fit, adhesion, overmolding, welding, and / or any other suitable technique. System 800 may also include an actuator 854, which may also be referred to as stiffener hub 854. Specifically, stiffener hub 854 includes an integral component comprising a hub portion, or a body and actuator portion, as further described below. Stiffener hub 854 may be securely attached to stiffener 806 in any suitable manner, such as by friction fit, adhesion, overmolding, welding, and / or any other suitable technique. Reference Figure 15B When assembled, the shank 850, needle 804, stiffening hub 854 and stiffening member 806 may be referred to as insertion assembly 809, or as deployment assembly, needle and stiffening assembly, or needle assembly.

[0190] System 800 may also include a catheter assembly 849, which may include a catheter 802 and a multi-part or multi-component catheter hub 846. The catheter hub 846 may include a catheter hub core 841, which may alternatively be referred to as an inner catheter hub component, a catheter hub shuttle, or a first catheter hub member. The catheter hub core 841 may be securely attached to the catheter 802 by any suitable means, such as by adhesion, overmolding, welding, and / or any other suitable technique.

[0191] In some embodiments, the core 841 is coupled to a sealing member 843, such as an O-ring. The core 841 and the sealing member 843 together form a core assembly 844. In an illustrated embodiment, the conduit hub 846 also includes a conduit connection hub 845, which may alternatively be referred to as an external or outer conduit hub component, a conduit hub housing, a conduit hub shell, or a second conduit hub component. As described in further detail below, when the system 800 is in an undeployed state, the core assembly 844 can be detached from the connection hub 845, and the core assembly 844 can be attached to the conduit connection hub 845 when the conduit 802 is deployed.

[0192] The catheter hub 845 can be releasably, removably, or selectively connected to the handle 850 of the insertion assembly 809 in any suitable manner. In an illustrated embodiment, the hub 845 is releasably connected to the distal end of the handle 850. As further described below, in some embodiments, the hub 845 can be detached from the handle 850 once the catheter hub 846 has been assembled, or in other words, during or after the deployment of the catheter 802. The handle 850, along with all components connected thereto—e.g., the needle 804, the stiffener 806, and the stiffener hub 854—can be withdrawn from the catheter assembly 849. In other words, after the catheter 802 has been deployed to the desired depth within the patient's vascular system, the insertion assembly 809 can be detached from and removed from the catheter assembly 849. In an illustrated embodiment, the catheter assembly 849 and the insertion assembly 809 are engaged by a connection interface (e.g., complementary threads) between the hub 845 and the handle 850, respectively, and are detachable from each other.

[0193] Figure 16A and Figure 16B Further details of the handle 850 are described. The handle 850 includes a housing 852, which can be formed in any suitable manner. The housing 852 may define a track 856 through which a portion of the stiffening hub 854 extends, such as... Figure 15A As shown. In the illustrated embodiment, track 856 substantially defines an elongated rectangular window or opening 901 through the sidewall of housing 852.

[0194] The housing 852 may define a cavity 902 within which components or portions of the system 800 may be accommodated. The housing 852 may also define a wall 904 at a proximal end of the cavity 902, from which a connecting protrusion 906 extends distally into the cavity 902. The connecting protrusion 906 may receive a proximal end of a needle 904. The needle 904 may be attached to the connecting protrusion 906 in any suitable manner. In some embodiments, the connecting protrusion 906 is sized to form a frictional fit with the needle 904. In other embodiments, the needle 904 may adhere to the inner sidewall of the protrusion 906. In an illustrated embodiment, the protrusion 906 defines a funnel or conical region 908 that facilitates insertion of the proximal end of the needle 904 into the protrusion 906 during assembly of the system 800.

[0195] The housing 852 may also define a connection interface 910, which may be configured to selectively engage with the connecting hub 845. In an illustrated embodiment, the connection interface 910 is located at the distal end of the housing 852. The illustrated connection interface 910 includes an internal thread 912 that can engage with an external thread on the connecting hub 845. For example, in some embodiments, the thread 912 may be suitable for a quarter-turn connection between the housing 852 and the connecting hub 845. Any other suitable connection interface 910 is contemplated.

[0196] Figure 17A and Figure 17BFurther details of the stiffening hub 854 are shown, which in some cases may alternatively be referred to as an actuator—in the illustrated embodiment, the stiffening hub 854 is formed of a single component including a container portion for engagement with a proximal end of the stiffener 806, and also including an actuator portion that can be engaged by a user to move the container portion relative to the housing 852. Specifically, the stiffening hub 854 may include a body 920 that can be positioned within a cavity 902 of the handle 852, and may also include a protrusion, button, gripper, slider or slide block, bulge, projection, engagement element, or actuator 922 extending laterally from the body 920. When the body 920 is positioned within the cavity 902 of the handle 850, the actuator 922 may extend outwardly through an opening 901 defined by a track 856 of the handle 850. Therefore, in the illustrated embodiment, the actuator 922 of the stiffening hub 854 can be operated at a location outside the handle 850. For example, in some cases, a physician may hold the handle 850 with one hand and may press the actuator 922 distally (e.g., using the fingers of the same or other hand) to advance (e.g., slide) the actuator 854 distally relative to the handle 850. In the illustrated embodiment, the body 920 is substantially cylindrical and can be easily slidable within a cylindrical cavity 902 defined by the housing 852, and the actuator 922 is sized to slide within an opening 901 defined by the track 856. The body 920 can be sized to remain within the cavity 902 even near the track 856. In other words, the body 920 may define a lateral width greater than the width of the track 856 in order to remain within the housing 852 and slide along the track 856. Other arrangements are also contemplated. For example, other complementary shapes are envisioned for the interior of the housing 852 and the outer surface of the actuator body 920, which may facilitate sliding or other relative movements, whether in contact or not.

[0197] Continue to refer to Figure 17A and Figure 17B The body 920 may define a channel 930 that extends through the entire body 920. The channel 930 may have a distal end 932 and a proximal end 934. The distal end 932 may be sized to allow a stiffener 806 to extend through it, and the proximal end 934 may be sized to allow a needle 804 to extend through it. Therefore, when the needle 804 is positioned within the stiffener 806, the needle 804 may extend through the entire channel 930. In contrast, the stiffener 806 may only extend through the distal end 932 of the channel 930.

[0198] Channel 930 may include a recessed region 936, which may have a slightly enlarged inner diameter. The recessed region 936 may be connected to the proximal end of stiffener 806 in any suitable manner (overlay injection molding, adhesion, etc.).

[0199] In some embodiments, the body 920 includes a funnel 938 at the distal end 932 of the channel 930, which can facilitate the assembly of the system 800. For example, in some cases, the proximal end of the stiffener 806 is inserted proximally into the recessed region 936 through the funnel 938 for connection thereto. The funnel 938 can facilitate the insertion of the stiffener 806 into the body 920 by guiding the stiffener 806 into the narrow channel 930.

[0200] Figure 18A and Figure 18B Further details of a conduit hub 841, which may include a body 940, are shown. The body 940 may include a connection region 942 and a sealing region 950. The connection region 942 may be configured to attach the body 940 to a conduit connection hub 845, as further described below. In an illustrated embodiment, the connection region 942 includes a separating nose 944 that extends from a smaller outer diameter to a larger outer diameter in a distal to proximal direction and is configured to force or separate the resilient flexible arms as the hub 841 is advanced distally between the arms. The illustrated separating nose 944 is shaped substantially parabolic, but other shapes and configurations (e.g., conical, hemispherical, etc.) are contemplated.

[0201] The connection region 942 also includes a connection interface 946 configured to interact with a portion of the conduit hub 845 to secure the conduit core 841 to the conduit hub 845. In an illustrated embodiment, the connection region 942 includes a groove 947 in which a portion of the conduit hub 845 is received to lock the conduit core 841 and the conduit hub 845 to each other, as further described below. The groove 947 may include a proximal sidewall 948 and a distal sidewall 949. In some embodiments, the sidewalls 948, 949 are substantially transverse to the longitudinal axis of the conduit core 841. For example, the sidewalls 948, 949 may each define a separate plane extending orthogonally to the longitudinal axis.

[0202] The sealing region 950 may be configured to form or facilitate the formation of one or more of a hermetically sealed, liquid-sealed, or fluid seal between the conduit hub 941 and the conduit connection hub 845. The term "fluid" is used herein in its general sense and includes materials that do not have a fixed shape, readily yield to external pressure, or are flowable, such as gases (e.g., air, nitrogen, etc.) and liquids (e.g., brine, deionized water, etc.). Therefore, a fluid seal may be both a hermetically sealed and a liquid-sealed seal. In an illustrated embodiment, the sealing region 950 includes a channel or groove 952 sized to accommodate a sealing member 843 therein.

[0203] Continue to refer to Figure 18A and Figure 18BThe body 940 may define a channel 960 that extends through the entire body 940. The channel 960 may have a distal end 962 and a proximal end 964. The proximal end 964 may be sized to allow a stiffener 806 to extend through it, and the distal end 962 may be sized to allow a catheter 802 to extend through it. Therefore, when the needle 804, stiffener 806, and catheter 802 are in a nested orientation, such that the needle is positioned within the stiffener 806 and the stiffener 806 is positioned within the catheter 802, the needle 804 and stiffener 806 may extend through the entire channel 960. In contrast, the catheter 802 may only extend through the distal end 962 of the catheter hub 841.

[0204] The channel 960 defined by the catheter hub 841 may include a recessed region 966, which may have a slightly increased inner diameter. The recessed region 966 may be connected to the proximal end of the catheter 802 in any suitable manner (overlay molding, adhesion, etc.). In the illustrated embodiment, the catheter hub 841 is overlaid onto the catheter 802.

[0205] In some embodiments, the body 940 includes a funnel 968 at the proximal end 964 of the channel 960, which facilitates the assembly of the system 800. For example, in some cases, the distal end of the needle 804 and the distal end of the stiffener 806 are inserted distally through the conduit hub 841 and through the conduit 802. The funnel 968 facilitates the insertion of the needle 804 and the stiffener 806 into the body 940 by guiding these components into the narrow channel 960.

[0206] Figure 19A and Figure 19B Further details of the catheter connection hub 845 are shown. Hub 845 includes a body 970 defining a medical interface or medical connector 972, through which the catheter connection hub 845 can be coupled to any suitable medical device, such as any medical fluid component described above with respect to medical fluid assembly 197. In an illustrated embodiment, the medical connector 972 is formed as a female Luer connector 973, which can be coupled, for example, to any medical fluid component including a complementary male Luer connector. Specifically, in an illustrated embodiment, the medical connector 972 may include any suitable connection interface 974, which includes external threads 975. Furthermore, the body 970 may define a fluid-permeable lumen 976. In an illustrated embodiment, a portion of the lumen 976 associated with the connection interface 974 defines a Luer taper 977.

[0207] The body 970 may also define a base 980 at the distal end of the medical connector 972. In some embodiments, the base 980 includes the most distal portion of the medical connector 972. In an illustrated embodiment, the base 980 is a region of the body 970 extending distally from the medical connector 972. The body 970 may define a hub connection interface 982 configured to interact with a connection interface 946 of the catheter hub 841 to secure the catheter hub 845 to the catheter hub 841. In an illustrated embodiment, the connection interface 982 includes a plurality of resilient flexible arms 984 extending distally from the base 980.

[0208] The illustrated embodiment includes four resilient flexible arms 984. Other embodiments include more or fewer arms. Each resilient flexible arm 984 includes an inwardly projecting or snap-fit ​​element 990 configured to directly interact with the connection interface 946 to secure the conduit connection hub 845 to the conduit hub 841. Specifically, the snap-fit ​​element 990 can spring inwardly into a groove 947 defined by the conduit hub 841 to secure the conduit connection hub 845 to the conduit hub 841. Each snap-fit ​​element 990 may each include a proximal side 992 and a distal side 994, which can interact with the proximal sidewall 948 and distal sidewall 949 of the groove 947, respectively, to prevent the hub 841 from moving distally or proximally relative to the connection hub 845 once the snap-fit ​​element 990 has been received in the groove 947.

[0209] It is also conceivable that the conduit hub 841 and the conduit connecting hub 845 can be joined together through other connection interfaces. For example, in some embodiments, the snap-fit ​​and groove configurations may be reversed. For example, the connection interface 946 of the conduit hub 941 may include one or more outwardly guided snap-fits, and the connection interface 982 of the conduit connecting hub 845 may include one or more outwardly guided grooves. The snap-fits may be sized to securely fit within one or more grooves.

[0210] Figures 20A to 20D Various cross-sectional views of component 800 in its assembled and undeployed state. (Reference) Figure 20A In this configuration, the proximal end of the needle 804 is fixedly attached to the shank 850. Specifically, the needle 804 extends through the cavity 902 defined by the housing 852 and adheres to the connecting protrusion 906 defined by the housing 852.

[0211] A stiffening hub 854 is positioned above a needle 804 within a cavity 902 of a housing 852, wherein an actuator 922 of the stiffening hub 854 extends through a track 856 defined by the housing 852. A stiffening member 806 is positioned within and attached to the stiffening hub 854, and is positioned above the needle 804. In other words, the needle 804 is nested within the stiffening member 806. The stiffening member 806 is accessible from... Figure 20A The position shown slides over needle 804 or otherwise translates proximally.

[0212] refer to Figure 20B The core assembly 844 is secured to the conduit 802 for coordinated movement. Specifically, the conduit hub 841 is positioned above the stiffener 806 within the cavity 902 of the housing 852. The conduit 802 is positioned within and attached to the conduit hub 841, and positioned above the needle stiffener 806. In other words, the stiffener 806 and the needle 804 are nested within the conduit 802. The stiffener 806 and the conduit 802 are accessible from... Figure 20B The position shown is translated above needle 804 (e.g., together or consistently). Sealing member 843 is positioned within groove 952 defined by conduit hub 841.

[0213] refer to Figure 20C The conduit hub 845 is secured to the housing 852 and positioned above the needle 804, stiffener 806, and conduit 802. Specifically, the connection interfaces 910 and 974 of the housing 852 and the conduit hub 845 are respectively engaged together. In the illustrated embodiment, this securing is achieved by complementary threads. The conduit 802, stiffener 806, and needle 804 extend through the inner cavity 976 and extend between the resilient arms 984 of the conduit hub 845.

[0214] refer to Figure 20D When the system 800 is in an undeployed state, at least a portion of the distal end 824 of the needle 804 extends distally beyond the distal end 816 of the catheter 802. As with other embodiments described herein, the illustrated needle 804 may include a distal end 826, which may be formed by a main bevel 827 and a rear bevel 828.

[0215] As with other embodiments described herein, the distal end 814 of the catheter 802 may be attached to the needle 804. The attachment may be, for example, a frictional fit and / or physical bond between the materials of the catheter 802 and the needle 804. Specifically, the inner surface 893 of the catheter 802 may be frictionally engaged and / or bonded to the needle 804. The distal end 814 of the catheter 802 may also include a mating surface or abutment surface 891, which can be engaged by the distal end 836 of the stiffener 806 in a manner as described above.

[0216] Needle 804 may define an inner lumen 875 and a port 880. Stiffener 806 may further define a port 882 that can be aligned with port 880 to form a passage 886. The catheter 802 and stiffener 806 may cooperate to define a channel 888.

[0217] When the system 800, in its illustrated undeployed state, is introduced into a blood vessel in the manner described above, the lumen 875, access 886, and channel 888 can expose blood to a physician for flash evaporation. Similarly, the system 800 can maintain port 880, 882 alignment in the manner described above. Specifically, see again... Figure 20A The stiffening hub 854 is rotatably locked relative to the housing 852, which in turn maintains a rotationally locked orientation between the port 882 of the stiffening member 806 and the port 880 of the pin 804. In the illustrated embodiment, the actuator 922 is restricted to any rotation within the track 856 defined by the housing 852, or to only small rotations, thereby achieving rotational locking between the stiffening hub 854 and the housing 852.

[0218] Figures 21A to 21D Various cross-sectional views of system 800 in a partially deployed state. As mentioned earlier, when in... Figures 20A to 20D In the undeployed configuration shown, the distal end of system 800 can be advanced into the patient's blood vessel, and once blood flash is observed, system 800 can be deployed to advance the catheter over the needle to a greater distance into the blood vessel.

[0219] refer to Figure 21A In the illustrated partial deployment configuration, the stiffening hub 854 has been advanced along the track 856 in a forward or distal direction, almost reaching the distal end of the track 856. In some cases, the practitioner may hold the handle 850 with one hand and push the actuator 922 forward with the fingers of the same hand (e.g., index finger or thumb) to advance the stiffening hub 854 distally to the indicated position. For example, in some embodiments, the practitioner may hold the handle 850 between the thumb and one or more fingers (possibly including the index finger) of one hand to insert at least the distal end of the needle 804 and the catheter 802 into a patient's blood vessel. The practitioner may then continue to hold the handle 850 with this hand and may use the index finger of this hand to engage the actuator 922 and advance the stiffening hub 854 distally. For example, in some cases, a practicing physician may curl the index finger and, while straightening the index finger, use at least a portion of the index fingernail (e.g., the surface of the nail) to push the proximal side of the actuator 922 distally.

[0220] Other actuation methods have also been envisioned. For example, in other cases of single-handed deployment, the tip of the index finger could be used instead of the back of the nail. In other cases, the thumb could be used. In other embodiments, the physician could deploy using both hands.

[0221] refer to Figure 21B and Figure 21C The distal advancement of the stiffening hub 854 enables the distal advancement of the guide hub 841. In the illustrated embodiment, the distal advancement of the stiffening hub 854 pushes the stiffening member 806 distally because the stiffening member 806 is fixedly attached to the stiffening hub 854. Figure 21C As shown, the distal end 836 of the stiffener 806 can engage, or in other words, can press distally against the abutment surface 891 of the conduit 802. The force thus applied to the distal end 814 of the conduit 802 can push the conduit 802 distally. This force is sufficient to overcome any friction between the conduit 802 and the needle 804 and / or to break any adhesion, as described above relative to... Figure 20D As stated above.

[0222] refer to Figure 21B Considering that the catheter hub 841 is fixedly attached to the catheter 802, the distal movement of the catheter 802 can simultaneously achieve the distal movement of the catheter hub 841. That is, the stiffener 806 can apply a distal guiding force to the distal end 814 of the catheter 802 (see...). Figure 21C ), which can then pull the conduit hub 841 to the distal side.

[0223] The stiffener 806 can advantageously be substantially rigid or incompressible in its longitudinal dimension or longitudinal direction. Therefore, the stiffener 806 can provide axial support to the catheter 802 or otherwise apply columnar stiffness to it, thereby enabling longitudinal reinforcement of the catheter 802. In other words, the stiffener 806 can be strong in its longitudinal dimension and longitudinally reinforce the catheter 802. Therefore, the stiffener 806 allows the catheter 802 to be advanced distally within the blood vessel. In some cases, the sensation of advancing the catheter 802 within the blood vessel via the internally provided stiffener 806 can be similar to the sensation of advancing a catheter with a similar diameter and composition within the blood vessel via a guidewire, but without the stiffener.

[0224] The stiffener 806 may also advantageously be relatively soft or flexible in its lateral dimensions or lateral directions (e.g., in dimensions orthogonal to the longitudinal axis of the stiffener 806). In other words, the stiffener 806 may advantageously have low bending stiffness in its lateral dimensions. This flexibility allows the stiffener 806 to be easily bent within the blood vessel to facilitate the insertion of the stiffener 806 and catheter 802 into and / or the advancement of the stiffener 806 and catheter 802 within the blood vessel. For example, such flexibility may be desirable to allow the stiffener 806 (and catheter 802) to be advanced through the vascular puncture site into the blood vessel, which typically occurs at an angle relative to the lumen of the vessel, and subsequent initial bending to follow the lumen of the vessel can be easily performed. The stiffener 806 (and catheter 802) may also more easily follow the contour of the blood vessel because the stiffener 806 is advanced to a greater depth within the vessel.

[0225] In various embodiments, the longitudinal stiffness and lateral flexibility characteristics just described can be achieved by adjusting the area moment of inertia of stiffener 806. For example, in some embodiments, stiffener 806 is formed as a thin-walled tube. The thickness of this tube can be adjusted to achieve the desired lateral flexibility. In some cases, the flexibility is substantially the same in all lateral directions, or in other words, stiffener 806 is substantially symmetrically flexible in all dimensions transverse to its longitudinal axis. In some embodiments, it may be desirable that the material typically formed of stiffener 806 and / or stiffener 806 is as flexible as possible while maintaining sufficient column strength to advance catheter 802 to the final target depth within the patient's blood vessel.

[0226] refer to Figure 21D In some embodiments, the stiffener 806 may advantageously be puncture-resistant, such that the distal end 826 of the needle 804 does not penetrate the stiffener 806, such as through the sidewall of the tubular stiffener 806. For example, as previously described, in some embodiments, the stiffener 806 may shield the needle 804 after the catheter 802 has been deployed through the system 800. That is, the stiffener 806 may shield the needle 806 during and after removal of the needle 804 and the stiffener 806 from the catheter 802.

[0227] Any suitable material for stiffener 806 is contemplated. In various embodiments, stiffener 806 may be formed entirely of or comprise a hyperelastic material. For example, in some embodiments, stiffener 806 comprises hyperelastic nitinol, such as hyperelastic nitinol tubing. In other or additional embodiments, stiffener 806 may be formed entirely of or comprise a suitable plastic, such as polycarbonate, engineering thermoplastics, etc. (Purchased from DuPont), shape memory nickel-titanium, etc.

[0228] Refer again Figure 21BIn the illustrated deployment configuration, the conduit hub 841 has been advanced distally until the disengaging nose 944 has contacted the proximal surface of the latch 990 of the flexible arm 984 of the conduit connection hub 845. Upon further distal advancement of the conduit hub 841, the circular disengaging nose 944 will force the latch 990 outward, causing the arm 984 to flex radially outward, thereby allowing the disengaging nose 944 to pass. In other words, the disengaging nose 944 is configured to extend, displace (e.g., radially displace), or extend the arm 984 to allow the disengaging nose 944 to pass.

[0229] Refer again Figure 21D When the system 800 is deployed, the stiffener 806 and catheter 802 are advanced into the blood vessel in a coordinated manner above the needle 804. As previously described, the stiffener 806 provides the desired reinforcement of the catheter 802 to achieve an insertion depth that might not be achievable without the stiffener 806. The stiffener 806 may allow insertion depths that could otherwise be achieved by advancing a similarly constructed catheter solely by a guidewire. Furthermore, during the deployment of the catheter 802 into the blood vessel and / or during the retraction of the stiffener 806 and needle 804 from the catheter 802 after placement, the stiffener 806 protects the catheter 802 from contact with the needle 804, particularly from contact with the distal point 826 of the needle 804.

[0230] Figure 22A and Figure 22B This is a cross-sectional view of system 800 in a fully deployed state. In the illustrated embodiment, stiffening hub 854 is advanced to the distal end near track 856 to fully deploy conduit 802.

[0231] refer to Figure 22B To achieve full deployment of catheter 802, the dissociation nose 944 of catheter hub 841 is advanced distally a sufficient amount to no longer force the flexible arm 984 of catheter hub 845 to disengage. Therefore, upon full advancement of catheter hub 841, the flexible arm 984 rapidly retracts or elastically returns to its natural state, allowing the latching element 990 of arm 984 to enter the groove 947 of catheter hub 841. The proximal side 992 and distal side 994 of latching element 990 then interact (e.g., abut or interfere) with the proximal sidewall 948 and distal sidewall 949 of groove 947, respectively, to suppress or prevent relative translational movement between catheter hub 845 and catheter hub 841. In some embodiments, latching element 990 may adequately grip the bottom wall of groove 947 or otherwise interact with catheter hub 841 to suppress or prevent relative rotational movement between catheter hub 845 and catheter hub 841.

[0232] More specifically, when conduit 802 is fully deployed, the hub connection interface 984 of conduit hub 845 and the connection interface 946 of conduit core 841 interact with each other to engage conduit hub 845 and conduit core 841. In other words, deploying conduit 802 assembles a multi-part conduit hub 846. In other words, when system 800 is in an undeployed state, and when system 800 transitions to a deployed state—or when conduit 802 is deployed—conduit core 841 can be detached from and distanced from conduit hub 845, and is engaged with or directly attached to conduit hub 845. In some embodiments, assembling conduit core 841 and conduit hub 845 into a single hub is irreversible, or in other words, the engagement of conduit core 841 and conduit hub 845 is irreversible (e.g., separation cannot be achieved without tools, or accidental separation is suppressed or prevented).

[0233] When the multi-part conduit hub 846 is assembled, the sealing member 843 can form a seal (e.g., a fluid seal) with the inner surface of the conduit hub 845 and the outer surface of the conduit core 841. Specifically, in the illustrated embodiment, the sealing member 843 includes an elastically deformable O-ring positioned within a groove 952 of the conduit core 841. When the conduit hub 846 is assembled, the sealing member 843 is compressed such that its outer portion seals against the inner surface of the base 980 of the conduit hub 845, and its inner portion seals against the groove 952 defined by the outer surface of the conduit core 841.

[0234] After the system 800 is fully deployed, the handle 850, stiffening hub 854, stiffener 806, and needle 804 can be removed. As previously described, these components removable from the catheter hub 846 and catheter 802 may be referred to as the insertion assembly 809. Specifically, the handle 850 can be disengaged from the catheter connection hub 845, which, in the illustrated embodiment, involves rotating one or more of the housing 850 and the catheter connection hub 845 relative to the other (e.g., a quarter turn) to disengage the complementary threads. The handle 850 and all components connected thereto can then be withdrawn from the catheter hub 846. For example, a physician can hold the catheter connection hub 845 with one hand and use the other hand to retract the handle 850 proximally, thereby pulling the needle 804 and stiffener 806 out of the catheter 802. More specifically, after the catheter 802 is deployed and the catheter hub 846 is assembled simultaneously, the insertion assembly 809 can be removed from the catheter assembly 849.

[0235] In some implementations, once the stiffening hub 854 has been advanced distally to deploy the catheter 802, it is non-reversible relative to the housing 852. In other words, the stiffening hub 854 can be locked relative to the shank 850 when fully deployed, which keeps the stiffening member 806 in a shielded configuration relative to the needle 804. In this configuration, a physician can remove the entire insertion assembly 809 by pulling only proximally on the shank 850. That is, the needle 804 is pulled proximally because it is securely attached to the housing 850, and both the stiffening hub 854 and the stiffening member 806 are pulled proximally simultaneously because the stiffening hub 854 is locked in place relative to the shank 850 (e.g., to maintain a fixed longitudinal orientation).

[0236] After removing the insertion assembly 809 from the catheter hub 846, any suitable medical fluid component 197 (see below) Figure 4J It can be connected to the conduit hub 846 in the manner described above. See also... Figure 22B The seal formed by the sealing member 843 prevents fluid leakage from the multi-part catheter hub 846, such as through passage between the catheter connection hub 845 and the catheter hub core 841. For example, fluid introduced from the medical fluid assembly 197 into the catheter hub 846 for delivery to a blood vessel via the catheter 802 may pass through the lumen 976 defined by the end of the medical connector 972 of the catheter connection hub 845, and then through the proximal end of the channel 960 of the catheter connection hub 845 and into the catheter 802. Any fluid that may pass between the catheter connection hub 845 and the catheter hub core 841 is stopped by the sealing member 843.

[0237] In some embodiments, the sealing member 843 may help maintain a fixed relationship between the conduit hub 845 and the conduit core 841 relative to each other. For example, the sealing member 843 may frictionally engage the surfaces of the two components to suppress relative translational and / or rotational movement between them. In some cases, the suppression of movement provided by the sealing member 843 is complementary to similar suppression of relative translational and / or rotational movement provided by the interaction of the snap-fit ​​member 990 and the groove 947.

[0238] Figures 23A to 23C An exemplary embodiment of a check mechanism or lock 1000 that can be used with a needle assembly such as insertion assembly 809 described herein is shown. Figures 20A to 22B Compared to the views shown in the figures, the sectional views shown in these figures are taken along a plane rotated 90 degrees about the longitudinal axis. The lock 1000 includes a resilient, flexible arm 1002 formed within a housing 852 of the handle 850. For example, in some embodiments, the housing 852 is formed from a single piece of material, and the arm 1002 is formed as an integral part of the housing 852. The arm 1002 may include a latching member 1004 at its distal end. The latching member 1004 may include a ramped surface 1006 and a stop 1008.

[0239] like Figure 23B As shown, when the stiffening hub 856 is advanced distally within the housing 852, the stiffening hub 856 can engage the ramp surface 1006 and cause the flexible arm 1002 to shift outward. Figure 23C As shown, after the stiffening hub 856 has passed through the arm 1002, the flexible arm can automatically return to its unbent state, where the stop 1008 prevents proximal movement of the stiffening hub 856. Any other suitable check mechanism or lock is contemplated.

[0240] Figure 24A Another embodiment of the catheter deployment system 1100 is shown, which may be similar to other systems disclosed herein. System 1100 is configured to automatically deploy catheter 1102. System 1100 includes a handle 1150, at least partially formed by a housing 1152, similar to other embodiments described herein. Housing 1152 may define a track 1156 along which a stiffening hub 1154 may be deployed.

[0241] The stiffening hub 1154 can be releasably engaged with the housing 1152 in any suitable manner in the illustrated retracted or proximal position. Specifically, the actuator 1222 can be mechanically engaged with the housing 1152 in any suitable manner. When the actuator 1222 is actuated to disengage or re-engage the actuator 1222 with the housing 1152, the stiffening hub 1154 is allowed to translate distally relative to the housing 1152.

[0242] In the illustrated embodiment, system 1100 includes a biasing member 1107 that applies a distal guiding force to stiffening hub 1154. Specifically, in the illustrated embodiment, biasing member 1107 includes a helical spring 1109, which is coupled at its proximal end to a connecting protrusion 1206 defined by housing 1152 and at its distal end to stiffening hub 1154. When system 1100 is in an undeployed state, spring 1109 is compressed and stores sufficient potential energy to deploy conduit 1102.

[0243] refer to Figure 24B In the illustrated embodiment, the conduit 1102 can be deployed when the actuator 1222 is actuated. Specifically, actuating the actuator 1222 releases a mechanical coupling that holds the stiffening hub 1154 in a fixed longitudinal position relative to the housing 1152, thereby allowing the compression spring 1109 to decompress and automatically push the stiffening member 1106 distally. The distal movement of the stiffening member 1106 also causes the conduit 1102 to move distally to deploy the conduit 1102 as described above.

[0244] In the illustrated embodiment, actuator 1222 includes a protrusion extending laterally from stiffening hub 1154 through track 1156. In some embodiments, actuator 1222 may also function as a stop to prevent deployment of conduit 1102. Specifically, actuator 1222 may abut the distal end of track 1156 to prevent distal movement of stiffening hub 1154. More specifically, stiffening hub 1154 interacts with housing 1152 to prevent forward movement of stiffening hub 1154. Other arrangements for preventing forward movement of stiffening hub 1154 are also contemplated.

[0245] When system 1100 is in Figure 24B In the fully deployed state shown, spring 1109 can be in a relaxed state, or spring 1109 can remain in a compressed state, although the degree of compression of the spring is less than that when system 1100 is not deployed.

[0246] In other embodiments, spring 1109 is alternatively in a stretched state when in an undeployed state. For example, the distal end of spring 1109 may be coupled to the distal end of housing 1152, and the proximal end of spring 1109 may be coupled to stiffening hub 1154. In either arrangement, when system 1100 is fully deployed, spring 1109 may transition from a displaced state to a less displaced or more relaxed (or even fully relaxed) state when system 1100 is in an undeployed state.

[0247] In some embodiments, system 1100 may be configured to deploy conduit 1102 in a smooth and / or controlled manner. In other words, the deployment rate of the conduit (which may be determined by the translational rate of stiffening hub 1154 relative to housing 1152) may be substantially constant. For example, in various embodiments, the maximum deployment rate of conduit 1102 may differ from the final deployment rate of conduit 1102 (e.g., at a point in time just before deployment is terminated, at which point conduit 1102 no longer advances relative to handle 1150) by no more than 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, or 75%.

[0248] In some implementations, controlled deployment can advantageously reduce the risk of trauma to the patient's blood vessels. For example, in some implementations where the deployment rate of catheter 1102 is not controlled, catheter 1102 may initially accelerate or protrude rapidly in a distal direction upon initial actuation of the automated delivery system and may slow down as deployment progresses. This can result in spring 1109 being at its maximum compression, for example, when the system is in an undeployed state, thus providing maximum force during initial deployment. The deployment force provided by spring 1109 may decrease as spring 1109 relaxes throughout deployment, as the amount of deployment force provided decreases accordingly. Initial bulging or protrusion, as just described, can potentially damage one or more inner layers of the vessel wall (e.g., endothelium), especially during the initial deployment phase where catheter 1102 has just entered the vessel. Typically, catheter 1102 and stiffener 1106 enter the vessel at an angle relative to the longitudinal axis of the vessel, so that catheter 1102 and stiffener 1106 can be rapidly driven into the vessel wall at this insertion angle. The wall allows the catheter 1102 and stiffener 1106 to deflect from the angled insertion trajectory, so that they subsequently follow the contour of the blood vessel. In some cases, the greater the force with which the catheter 1102 contacts the sidewall to be deflected, the greater the likelihood of damage to the sidewall due to the initial deflection and / or subsequent contact with the catheter 1102. For the above and / or other reasons, controlled deployment of the catheter 1102 may be desirable in some cases.

[0249] In various embodiments, damping agents are used to achieve controlled, automated deployment of the conduit 1102. For example, in various embodiments, damping oils, greases, compounds, pastes, and / or coatings are applied to the outer surface of the stiffening hub 1106 and / or the inner surface of the housing 1152. For example, a quantity of silicone-based damping oil may be included in the housing 1152 to achieve controlled deployment. In some embodiments, the damping agent may comprise a viscoelastic material. In various embodiments, the damping agent can provide greater relative motion resistance between the stiffening hub 1154 and the housing 1152 during the initial deployment phase when a greater force is applied to them via the spring 1109, and can provide less relative motion resistance during the later deployment phase as the force provided by the spring 1109 decreases with relaxation of the spring 1109. Thus, the stiffening hub 1154 can achieve a relatively stable rate of movement relative to the housing 1152.

[0250] In some cases, automated catheter delivery 1102 can make catheter delivery more predictable and / or more reliable. For example, in some embodiments, catheter delivery system 1100 can reliably deliver catheter 1102 at rates that never reach or exceed an upper limit. This upper limit may correspond to the rate at which blood vessel damage may occur. In other words, in some cases, multiple automated catheter delivery systems 1100 can be manufactured (e.g., in batches), and each of the systems 1100 can be within a specified tolerance sufficiently below the upper limit to ensure deployment at rates that do not meet or exceed the upper limit. In contrast, some manually deployable embodiments do not limit the rate at which a physician can deploy catheters.

[0251] In some implementations, the automated system 1100 is configured to deploy only when the distal tip of catheter 1102 is positioned within a blood vessel. In other words, the automated system 1100 may not deploy the catheter when its distal tip is not within the blood vessel, such as when the needle has not been sufficiently advanced into the vessel, or when the needle has been accidentally over-advanced through the vessel wall (e.g., a back puncture). In such cases, attempting to deploy catheter 1102 will push the distal tip against the patient's tissue (e.g., fat, muscle) rather than into the lumen of the blood vessel. To advance catheter 1102 in such cases, system 1100 will need to push the distal tip of catheter 1102 through the tissue, which requires greater force than is needed to push the distal tip of catheter 1102 into the vessel to a greater depth after the catheter tip is already positioned within the vessel. Therefore, after the distal end of catheter 1102 is already inside the blood vessel, spring 1109 can provide sufficient force to advance catheter 1102 through the blood vessel to a greater distance or depth inside the vessel, but not enough force to advance the distal end of catheter 1102 through the patient's tissue. In other words, spring 1109 can provide insufficient force to advance the distal end of catheter 1102 through tissue located outside the blood vessel and not previously punctured by the distal end of needle 1104.

[0252] In the illustrated embodiment, an unsuccessful attempt to deploy catheter 1102 may be performed as follows. If the tip of catheter 1102 is not within a blood vessel, the practitioner may activate actuator 1222 to release stiffening hub 1154 from its locking engagement with housing 1152. Spring 1109 applies a distal guiding force to stiffening hub 1154, which is transmitted to the distal end of stiffening 1106, and thus to the distal end of catheter 1102. However, since the catheter tip 1102 is not within a blood vessel, and because the force provided by spring 1109 is insufficient to allow the distal end of catheter 1102 to penetrate the tissue it contacts, stiffening hub 1154 may be substantially held at the proximal end of track 1156, and catheter 1102 may remain in an undeployed state—for example, the distal end of catheter 1102 may be held proximal relative to the distal end of needle 1104. If the physician recognizes that automatic deployment has not occurred, he may then manipulate system 1100 backward, forward, or otherwise until the catheter tip is within the blood vessel and can be deployed.

[0253] For example, in some cases where the tip of needle 1104 may puncture the posterior wall of a blood vessel together with the tip of catheter 1102 (e.g., a dorsal puncture event), system 1100 may retract proximally, such as by pulling the handle 1150 posteriorly, until both the tips of needle 1104 and catheter 1102 are within the lumen of the blood vessel. Once the distal tip of catheter 1102 is within the blood vessel and can be advanced distally above the tip of needle 1104, the distal guiding force of spring 1109 is sufficient to deploy catheter 1102 into the blood vessel, which may occur automatically or spontaneously after system 1104 has been withdrawn to the appropriate position.

[0254] In other cases, before the tip of needle 1104 has penetrated the vessel wall, system 1100 can be advanced distally into the vessel. Once system 1100 has been fully advanced into the vessel, the force of spring 1109 is sufficient to deploy catheter 1102 into the vessel.

[0255] In various implementations, the amount of energy stored in the bias member and the deployment force provided by the bias member 1107 throughout the deployment event are sufficient to: (1) disengage any adhesion that may exist between the distal end of catheter 1102 and the distal end of needle 1104; (2) advance catheter 1102 over the body of needle 1104 through the patient's skin, through the insertion conduit, and into the lumen of the blood vessel when the catheter tip is properly positioned within the vessel; (3) facilitate the connection of catheter hub 1141 to catheter hub 1145 in a manner such as described above (e.g., by separating and deflecting the elastic flexible arms of catheter hub 1145 until they are realigned with the grooves in catheter hub 1141); and / or (4) deploy or otherwise activate a check mechanism to prevent retraction of stiffening hub 1154 (such as the retraction of the stiffening hub 1154 as described above). Figures 23A to 23C (as described above). In other or additional embodiments, the deployment force provided by the biasing member 1107 at any stage of the deployment event may be insufficient to force the distal end of the catheter 1102 and the distal end of the stiffener 1106 through the patient's tissue, thereby puncturing the tissue. In other words, the deployment force may be insufficient to force the distal end of the catheter 1102 through tissue (e.g., fat, muscle) that was not previously punctured by the distal end of the needle 1104.

[0256] The foregoing description of certain embodiments of the automated system 1100 that are designed to prevent catheter 1102 from being deployed above needle 1104 when the needle is not properly positioned within the blood vessel has similar applicability to certain embodiments of manual systems, such as embodiments of system 800. Specifically, the presence of stiffener 1106 can advantageously provide tactile feedback to the practitioner, indicating that the distal end of catheter 1102 cannot be advanced distally, or can only be advanced distally by applying a force significantly greater than that required to deploy catheter 1102 within the blood vessel. This tactile feedback can indicate to the practitioner that the system is not properly positioned for catheter deployment. Such tactile feedback may be superior to prior art systems that only include catheters on needles because the flexibility of the catheter allows it to be easily bundled or accordionized within the patient if the practitioner advances the catheter distally relative to the needle when it is not properly positioned. Due to the relatively low longitudinal stiffness of the catheter, such catheters on needles may not provide any tactile feedback, or may provide tactile feedback that is difficult to detect, when the catheter is deployed prematurely or incorrectly. That is, in some prior art arrangements, the catheter is easily kinked as it is advanced distally relative to the needle, thus providing little or no tactile indication to the user of improper placement, while in some embodiments employing stiffener 1106, stiffener 1106 notifies the physician that the distal end of catheter 1102 has encountered unfavorable advancement conditions and that catheter deployment has not been handled correctly.

[0257] Figure 25An exemplary example of an embodiment of a mechanical coupling 1300 is shown, which selectively secures a stiffening hub 1154 to a housing 1152 of a handle 1150 in an automation system 1100. In the illustrated embodiment, the mechanical coupling 1300 includes a snap-fit ​​member 1302 extending inwardly from the housing 1152. In the illustrated embodiment, the snap-fit ​​member 1302 is integrally formed with the housing 1152.

[0258] The mechanical coupling 1300 also includes an actuator 1222. In an illustrated embodiment, the actuator 1222 includes a resilient flexible arm 1304 that defines a recess 1306 therein, in which the latch 1302 is received when the system 1100 is in an undeployed state. The flexible arm 1304 includes an engagement surface 1308 that a physician can press down to initiate the deployment of the catheter 1102. In an illustrated embodiment, the arm 1304 is integrally formed with the body 1320 of the stiffening hub 1154 and is capable of radially inward deformation.

[0259] To actuate the automatic system 1100, the physician can press inward on the engagement surface 1308, which deflects the arm 1304 inward and disengages it from the latch 1302. Then, under the influence of the bias member 1107, the stiffening hub 1154 can move freely distally as described above.

[0260] Figure 26A and Figure 26B Another embodiment of a catheter deployment system 1400 comprising a multi-part catheter 1402 is shown. Specifically, the catheter 1402 includes a body 1403 and a distal end 1405. In some embodiments, the body 1403 is relatively rigider than the distal end 1405. The distal end 1405 may be much softer than the body 1405, or may be non-invasive to avoid damaging the inner surface of the blood vessel. The relatively rigid body 1403 may be more resistant to bandaging or accordionization. In some embodiments, the body 1403 and the distal end 1405 may be formed of different materials.

[0261] The body 1403 and the end 1405 can be joined together by any suitable means, such as by one or more adhesives, injection molding, welding (e.g., ultrasonic welding or radio frequency welding). In an illustrated embodiment, the end 1405 includes a flange 1407 or a protrusion that extends proximally into the cavity defined by the body 1403 and is secured to the body 1403.

[0262] In other implementations, such as in Figure 2 and Figure 3 In some embodiments of the catheter 102 shown, the relatively soft end, compared to the catheter shaft, can alternatively be achieved by employing a blending gradient during extrusion.

[0263] Figure 27 Another embodiment of the catheter deployment system 1500 includes a multi-part catheter 1502 having a body 1503 and a distal end 1505, and further includes a plurality of side ports 1511 extending through the distal end 1505. Specifically, in the illustrated embodiment, each of the side ports 1511 extends at an angle α relative to the longitudinal axis of the catheter 1502. In various embodiments, the angle α is in the range of about 10 to about 120 degrees, about 15 to about 105 degrees, about 45 to about 90 degrees, or not greater than about 15 degrees, 30 degrees, 45 degrees, 60 degrees, 90 degrees, or 120 degrees. Any suitable number and arrangement of the side ports 1511 is contemplated.

[0264] In some embodiments, the side port 1511 is drilled through the end 1505. In other embodiments, the side port 1511 is formed by a mandrel during molding. Any other suitable techniques for forming the side port 1511 are contemplated.

[0265] In some embodiments, the side port 1511 is symmetrically arranged around the distal end 1505. In some configurations, the side port 1511 can enhance the stability of the distal end of the catheter 1502 during injection, which can reduce trauma to the blood vessel.

[0266] Figure 28 Another embodiment of catheter 1602, similar to catheter 1502, is shown. However, a proximal opening of a side port 1611 extending through one or more of the end 1605 and the body 1603 is located on an abutment surface 1691 defined by the proximal end of the end 1605. This proximal opening may be located directly in the path of fluid flowing distally through the body 1603.

[0267] Figure 29 Another embodiment of a conduit delivery system 1700 with a conduit 1702 is shown, the conduit having a plurality of side ports 1711. In the illustrated embodiment, the side ports 1711 are formed as slits that can be opened to allow fluid to flow through them and can be closed when the pressure difference between the inside and outside of the conduit 1702 is sufficiently small. The illustrated side ports 1711 are essentially formed as slits resembling fish gills. Other suitable arrangements of the side ports 1711 are contemplated.

[0268] Figure 30A portion of another embodiment of the catheter delivery system 1800 is shown, wherein any suitable type of latching or engaging member 1813 is securely attached to a stiffener 1806, which enables or facilitates distal movement of the catheter hub 1841. In the illustrated embodiment, the engaging member 1813 includes a ring securely attached to the stiffener 1806, but any other suitable protrusion or other arrangement is contemplated. The engaging member 1813 may contact the proximal end of the catheter hub 1841 and push the proximal end of the catheter hub forward during forward advance of the stiffener 1806. In some cases, this arrangement may reduce the amount of force exerted by the distal end of the stiffener 1806 on the distal end of the catheter 1802. For example, in some configurations, the distal end of the stiffener 1806 interacts with the distal end of the catheter 1802 primarily to resist proximal accordionization of the catheter tip during insertion into the vessel, to push the catheter away from the needle, and to advance the catheter deeper into the vessel. Such interaction between the distal end of the stiffener 1806 and the distal end of the conduit 1802 can also pull the conduit hub 1841 forward, engaging it with the conduit connection hub, such as relative to... Figure 21B and 22B As shown and described herein. However, the coupling member 1813 may also transfer forces directly from the stiffener 1806 to the hub core 1841 during such assembly of the hub, which may reduce strain on the catheter 1802 and distal end during hub assembly.

[0269] Figure 31 and Figure 32 Another embodiment of the catheter delivery system 2000, similar to other systems disclosed herein, is shown. For example, the catheter delivery system 2000 may be similar in many respects to the system 800 described above, and as previously stated, any suitable combination of the same characteristic structures and variations described relative to system 800, as well as other systems disclosed herein, may be used with system 2000, and vice versa. This disclosure pattern is equally applicable to further embodiments shown in the following figures and described below, wherein the leading numerals may be further incremented.

[0270] The catheter delivery system 2000 includes a shank 2050 or needle hub with an ergonomic profile. In an illustrated embodiment, the shank 2050 is formed of a housing 2052, which includes a top or upper housing element 2052t and a bottom or lower housing element 2052b. An actuator advances a stiffener distally along a longitudinally extending track, the housing 2052 alternatively defining a portion of the stiffener hub 2054 in its intermediate region through a channel or opening 2051 rather than defining the longitudinally extending track. An actuator 2022 can be engaged (e.g., by a user's hand) to advance the stiffener hub 2054 distally relative to the housing 2052 (e.g., which can be held by the user's other hand) to deploy the catheter 2002. As with other embodiments herein, the actuator 2022 can be coupled to the stiffener hub 2054 in any suitable manner. In an illustrated embodiment, the actuator 2022 is integrally formed with the stiffener hub 2054. In some cases, the stiffening hub 2054 may be more generally referred to as an actuator. In other words, the actuator 2022 (which may include an elongated extension projecting longitudinally rearward from the body portion of the stiffening hub 2054) may be pushed into the housing 2052 to advance the stiffening member 2006 coupled thereto to the stiffening hub 2054 in a distal direction, thereby advancing the conduit 2002 in a distal direction. For example... Figure 32 As shown, the main body of the stiffening hub 2054 is positioned within the cavity defined by the housing 2052.

[0271] The actuator 2022 extends downward relative to the top housing element 2052t rather than being positioned on top of the system 2000. This arrangement advantageously allows a physician to hold the handle 2050 with one hand, positioned above the top of the handle 2050 and close to the needle 2004, while simultaneously touching the handle 2050 with the other hand to advance the actuator 2022 forward. By initially positioning it at the rear end of the system 2000 and / or by extending downward, the actuator 2022 is less prone to accidental actuation during the initial introduction of the needle 2004 and catheter 2002 into the patient's blood vessel. In the illustrated embodiment, when the actuator 2022 is in the initial position, or in other words, when the system 2000 is in an undeployed state, the actuator 2022 is located slightly anterior to or distal to the proximal end of the housing 2052.

[0272] System 2000 may also include a catheter hub 2041, a sealing member 2043, and a catheter connection hub 2045, which is substantially similar to the similarly numbered and similarly named components described above (e.g., similarly numbered components 841, 843, 845, 1141, 1145). The catheter 2002, catheter hub 2041, sealing member 2043, and catheter connection hub 2045 may be collectively referred to as catheter assembly 2049. The remaining components of system 2000 may be collectively referred to as insertion assembly 2009. As with other embodiments described herein, catheter assembly 2049 may be assembled during catheter 2002 deployment and may be selectively removed from catheter assembly 2049 after catheter 2002 has been deployed to the desired depth within a patient's blood vessel.

[0273] Figure 33 and Figure 34 Another embodiment of catheter delivery system 2100, similar to other systems disclosed herein, is shown. Specifically, system 2100 may operate in such manners as described with respect to previously disclosed embodiments (e.g., systems 800 and 2000) and may include other or additional feature structures as described below. System 2100 includes an insertion component 2109 that is selectively attached to catheter assembly 2149. As with the other embodiments described above, insertion component 2109 is configured to deploy catheter 2102 to a desired depth within a patient's blood vessel. Thus, insertion component 2109 transforms catheter assembly 2149 from a disassembled state to an assembled state. After deployment of catheter 2102 and after catheter assembly 2149 has been transformed to the assembled state, insertion component 2109 may detach from and withdraw from catheter assembly 2149, thereby holding catheter assembly 2149 in the appropriate position within the patient's vascular system. Deployment of catheter 2102 and transformation of catheter assembly 2149 to the assembled state are at least some of the events that may occur simultaneously. For example, the assembly of the hub portion of the conduit assembly 2149 may be performed during the final stage of the deployment of the conduit 2102 in a manner as described above with respect to system 800.

[0274] The illustrated catheter assembly 2149 is similar to other catheter assemblies described above. Specifically, catheter assembly 2149 includes a catheter 2102, a catheter hub 2141, a sealing member 2143, and a catheter connection hub 2145, each of these components being similarly named and numbered as described above. The catheter hub 2141 is secured to the catheter 2102 (e.g., by injection molding over the proximal end of the catheter 2102). The sealing member 2143 can be engaged with the catheter hub 2141 in any suitable manner, such as by positioning within a groove defined by the catheter hub 2141 as described above. In the illustrated detached state of catheter assembly 2149, corresponding to the undeployed state of system 2100, the catheter hub 2141 is spaced apart from and positioned behind (proximal to) the catheter connection hub 2145, and the catheter 2102 extends through the entire catheter connection hub 2145. The catheter hub 2141, sealing member 2143 and catheter connecting hub 2145 can be assembled together to form catheter hub 2146.

[0275] In an illustrated embodiment, the insertion assembly 2109 includes a handle 2150, which may include a housing 2152. The housing 2152 may be shaped to have an ergonomic profile that can be easily gripped by a user's hand. The illustrated housing 2152 includes a top or upper housing element 2152t and a bottom or lower housing element 2152b. The housing elements 2152t and 2152b may cooperate to define an opening, port, or channel 2154 through which a stiffening hub 2151 extends. The channel 2151 is located in the middle region of the housing 2152.

[0276] exist Figure 33 and Figure 34 In the pre-use, pre-deployment, initial, or packaging states shown, housing 2152 is connected to conduit connection hub 2145 at its distal end. As in other embodiments, conduit connection hub 2145 may be selectively releasable from housing 2152.

[0277] The stiffener 2106, which may be referred to in various other ways such as those mentioned above (e.g., sheathed cannula), is positioned within the catheter 2102 in the manner described above. The stiffener 2106 is fixedly attached to the stiffener hub 2154.

[0278] The insertion needle 2104 is positioned within the stiffener 2106 and extends through the entire conduit 2102 (e.g., extending distally through the front end of the conduit 2102 and proximally through the rear end of the conduit 2102), through the entire stiffener 2106, and through most of the housing 2152. Specifically, the needle 2104 extends through the distal end of the housing 2152, and the proximal end of the needle 2104 is internally attached to the proximal end of the upper housing element 2152t.

[0279] As with other embodiments described herein, stiffener 2106 is secured at its proximal end to stiffener hub 2154, which is movable within and relative to housing 2152. Stiffener hub 2154 may include actuating elements 2222, such as a laterally (e.g., downwardly) extending proximal end of stiffener hub 2154 (e.g., a pushing element), as further described below. Actuating element 2222 may protrude away from housing 2152 to be engaged by a user's hand (e.g., one or more fingers). Stiffener hub 2154 may generally be referred to as an actuator, such as in the illustrated embodiment, where stiffener hub 2154 is rigidly secured to actuating element 2222 (e.g., integrally formed with the actuating element) such that stiffener hub 2154 and actuating element 2222 move coherently as a single entity. Alternatively, the stiffening hub 2154 may be said to be coupled to the actuator (e.g., integrally formed with or otherwise formed with the actuator). Thus, in the illustrated embodiment, the main body portion of the stiffening hub 2154 may be said to be attached to the actuating element 2222. Furthermore, the actuating element 2222 may also be referred to as an actuator, deployment actuator, propulsion actuator, main actuator, first actuator, direct stiffening hub actuator, lower actuator, rear actuator, etc. Moreover, in many cases, reference to the actuator 2222 may be more generally understood as a reference to the stiffening hub 2154 as a whole.

[0280] The insertion assembly 2109 may also include an initiation actuator 2155, which is further described below. The initiation actuator 2155 may also be referred to as an insertion actuator, stabilizing actuator, supplementary actuator, optional actuator, second actuator, indirect stiffening hub actuator, upper actuator, or directional actuator, etc. It should be understood that these terms refer to... (The sentence is incomplete and requires further context to be fully translated). Figure 33 and Figure 34 The positions shown in the views are not limited relative to other arrangements. That is, for convenience, the terms “upper” and “lower” are used illustratively herein, and it should be understood that these terms are readily replaced by other suitable designations for actuators 2222, 2155, such as those described above. For example, in other embodiments, actuators 2222, 2155 are reversed, such that actuator 2222 is accessible at the upper end of housing 2152, and actuator 2155 is accessible at the lower end of housing 2152. In other embodiments, the positions of actuators 2222, 2155 can be completely altered, such as by being located in a lateral position. For example, actuators 2222, 2155 can be positioned on other opposite sides of housing 2152 (e.g., left and right sides), rather than on opposite upper and lower sides of housing 2152.

[0281] The actuating actuator 2155 may selectively engage with the stiffening hub 2154 to move the stiffening hub 2154 forward by an initial amount, as further described below. In the illustrated embodiment, when the system 2100 is in a pre-use or pre-deployment configuration, the actuating actuator 2155 may be adjacent to or engaged with the stiffening hub 2154 (see [link to relevant documentation]). Figure 34 This allows the actuator 2155 to move forward or distally immediately (or almost immediately, such as when the actuator 2155 moves a short distance before engaging the stiffening hub 2154), while simultaneously allowing the stiffening hub 2154 to move forward (thereby allowing the stiffening 2106 and the conduit 2012 to move forward).

[0282] As further described below, system 2100 can operate in a manner similar to those described above with respect to system 800. For example, in some cases, system 2100 can be fully deployed using only the lower actuator 2222. Therefore, Figures 20A to 22B The same deployment phases shown can be achieved using system 2100, with the notable exception that the lower actuator 2222 is actuated below housing 2152, while the actuator 922 of system 800 is actuated along the upper portion of housing 852. However, in other cases, system 2100 can be deployed in two separate phases: first, by advancing the upper actuator 2155 to insert catheter 2102 into a first depth within a patient's blood vessel; and second, by advancing the lower actuator 2222 to further advance catheter 2102 into the blood vessel to a second depth greater than the first depth. In either case, the deployment of catheter 2102 via stiffener 2106 and the assembly of the multi-part catheter hub 2146 are performed substantially as described above with respect to system 800. In fact, during the various phases of use of system 2100, the configuration and relative orientation of the various components of needle 2104, stiffener 2016, and catheter assembly 2149 are relative to... Figure 20B , Figure 20C , Figure 20D , Figure 21B , Figure 21C , Figure 21D and Figure 22B The systems shown in the figures are substantially the same as those in system 800. Therefore, these figures can be referenced in relation to the operation of system 2100.

[0283] More details about the upper housing component 2152t are available in [link / details]. Figure 35A and Figure 35BAs shown in the diagram. In some embodiments, the upper housing element 2152t includes a sliding surface 2201 and a track or guide channel 2302. The guide channel 2302 begins at the rear end of the sliding surface 2201 and terminates toward the distal end of the sliding surface 2201. That is, the distal end 2303 of the guide channel 2302 is located behind the distal end of the sliding surface 2201. In the illustrated embodiment, the sliding surface 2201 is generally located at the front end of the upper housing element 2152t and extends to the front side of the upper housing element 2152t and terminates there. An actuation actuator 2155 can slide over or against the sliding surface 2201, and the path of such sliding can be controlled by the guide channel 2302.

[0284] like Figure 35B As shown, the upper housing element 2152t may also define an inner track 2307, which may be configured to accommodate a portion of the actuation actuator 2155, as further described below. The inner track 2307 may be aligned with (e.g., collinear with) the guide channel 2303. The inner track 2307 extends rearward from the proximal end of the guide channel 2302. The inner track 2307 may be formed as a recess in the sidewall of the upper housing element 2152t.

[0285] The upper housing element 2152t may also define a needle channel 2304, within which a proximal portion of the needle 2104 is received. In an illustrated embodiment, the needle channel 2304 is formed as a groove. The distal end of the needle channel 2304 may define an expanded inlet or tapered region 2308 to facilitate assembly of the system 2100, as previously described with respect to tapered region 908. In some cases, the forward portion of the needle channel 2304 may define a semi-circular profile sized to receive only the upper side (e.g., the upper half or other portion) of the needle 2104. Figure 34 As shown, the rear end of the needle channel 2304 can extend into and terminate within the rear portion 2370 of the upper housing element 2152t. The cross-sectional profile of the needle channel 2304 within the rear portion 2370 can be substantially circular. The rear portion 2370 can be said to completely surround or encircle the proximal end of the needle 2104. The needle 2104 can be secured within the rear portion 2370 in any suitable manner.

[0286] The rear portion 2370 of the upper housing element 2152t may define a stop surface or stop member 2371. In the illustrated embodiment, the stop member 2371 is formed as a substantially flat surface that extends substantially orthogonally relative to the longitudinal axis of the upper housing element 2152t, or more specifically, relative to the longitudinal axis when the system 2100 is in the assembled state. For example, Figure 34As shown, the stop 2371 can interact with the rear end of the lower actuator 2222 to define the rearward movement of the stiffening hub 2154. In some cases, the lower actuator 2222 may also include any suitable type of stop 2372 (see also...). Figure 38B In the illustrated embodiment, stop 2372 is also defined as the substantially flat rear end of actuator 2222, which extends substantially orthogonally relative to the longitudinal axis of assembly system 2100. When system 2100 is in an initial, packaged, or undeployed state, stops 2371, 2372 may be close to each other (e.g., in contact or very close), such as Figure 34 As shown in the image.

[0287] The upper housing element 2102t may define an orientation surface 2373, which facilitates rotational locking between the housing 2152 and the stiffening hub 2154, and thus facilitates rotational locking between the needle 2104 (which is securely fastened to the housing 2152) and the stiffener 2106 (which is securely fastened to the stiffener hub 2154). In other words, the orientation surface 2373 may help maintain a fixed angular orientation between specific components of the system 2100, including the shank 2150, the needle 2104 attached to the shank 2150, the stiffening hub 2154, and the stiffener 2106 attached to the stiffener hub 2154. Maintaining this fixed angular orientation ensures that when the system 2100 is in a pre-deployed state, the openings or ports at the distal ends of the needle 2104 and the stiffener 2106 are aligned to define a continuous pathway through which blood flash can pass, as previously described with respect to system 800 (see [link to previous description]). Figure 20D (Ports 880, 882 and path 886).

[0288] In the illustrated embodiment, the orientation surface 2373 comprises a substantially flat surface. In various embodiments, the plane of the orientation surface 2373 passes through, or is close to and parallel to, the longitudinal axis of the assembly system 2100. As further described below, the orientation surface 2373 may interact with the orientation surface of the stiffening hub 2154 to achieve the aforementioned rotational locking or angular locking.

[0289] refer to Figure 36A and Figure 36BThe lower housing element 2152b may define a curved inner surface 2375 that extends to a proximal end of the lower housing element 2152b. The proximal end of the curved inner surface 2375 may mate with the orientation surface 2372 of the upper housing element 2152t to define a channel 2151 through which the stiffening hub 2154 passes. Thus, the channel 2151 may define a bonding shape. The portion of the stiffening hub 2154 extending through the channel 2151 may be complementary to the channel 2151 or may be otherwise shaped to pass through the channel 2151 only at a single angle. In the illustrated embodiment, the channel 2151 is substantially semi-circular. Other configurations are contemplated.

[0290] refer to Figures 35A to 36B The upper housing element 2152t may include a recess 2102t, which mates with the recess 2102b defined by the lower housing element 2152b to define a cavity 2202 (see reference). Figure 34 Such as the cavity 902 described above. In the illustrated embodiment, cavity 902 includes a generally cylindrical profile along substantially its entire length.

[0291] The upper housing element 2152t may also define connecting elements for connection with the lower housing element 2152b. In an illustrated embodiment, the upper housing element 2152t includes four snaps, latches, or inserts 2305 that are inserted into two containers or slots 2312 defined by the lower housing element 2152b to secure the upper and lower elements together. Additional connecting features include those provided by the upper housing element 2152t ( Figure 35B The two longitudinally extending recesses 2306 defined by the lower housing element 2152b and the lower housing element 2152b Figure 36A and Figure 36B Two complementary, longitudinally extending protrusions 2312 are defined and configured to engage within the recess 2306. The inserts and slots and / or the protrusions and recesses may be reversed and / or other or additional connecting features may be used. In some embodiments, the housing 2102 is assembled without any adhesive.

[0292] like Figure 33 , Figure 34 , Figure 35B and Figure 36BAs shown, the upper housing element 2152t and the lower housing element 2152b may define a connection interface 2210 configured to selectively engage with the conduit connection hub 2145. Specifically, the upper housing element 2152t and the lower housing element 2152b each define connection interface portions 2210t and 2210b, which cooperate to define the connection interface 2210. In the illustrated embodiment, the connection interface 2210 includes an internal thread 2212—specifically, threaded portions 2212t and 2212b—configured to intersect with a complementary external thread on the conduit connection hub 2145. In the illustrated embodiment, the connection interface 2210 is located at the distal end of the housing 2152. Any suitable selective engagement or connection interface is contemplated. For example, in other embodiments, the housing 2152 may define a latching system configured to selectively disengage from the conduit connection hub 2145.

[0293] like Figures 33 to 35B As shown, the upper housing element 2152t may define an elongated, generally semi-conical shape that tapers from its front end to its rear end. The outer surface of the upper housing element 2152t may be circular. Similarly, as Figure 33 , Figure 34 , Figure 36A and Figure 36B As shown, the lower housing element 2152b may define an elongated, generally truncated conical shape. Along at least the side of the lower housing element 2152b, the profile of the lower housing element 2152b substantially or smoothly matches the conical shape of the upper housing element 2152t. The lower housing element 2152b may be significantly shorter than the upper housing element 2152t. The upper housing element 2152t and the lower housing element 2152b may cooperate to define a handle 2150, which can be easily gripped and manipulated by a user with one hand.

[0294] In the illustrated embodiment, the lower housing element 2152b defines a plurality of gripping feature structures 2180 (see...). Figure 33 , Figure 34 , Figure 42 In the illustrated embodiment, the gripping feature 2180 is a laterally extending groove. Any suitable friction-enhancing surface feature, layer, or coating is contemplated.

[0295] In some embodiments, the upper housing element 2152t and the lower housing element 2152b are formed of a blend of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) (i.e., PC / ABS). In other embodiments, the upper housing element 2152t and the lower housing element 2152b are formed of polycarbonate, acetal, etc. Any suitable material is contemplated.

[0296] refer to Figure 37A and Figure 37BThe upper actuator 2155 may include an actuation region 2327, which includes a gripper 2320 and a latching member 2322. The gripper 2320 may include gripping features such as lateral grooves to enhance friction. The gripper 2320 may be sized to be actuated by the tip of a fingertip, such as the index finger or thumb. The gripper 2320 may extend longitudinally to allow the fingertip to flip forward and backward over the gripper 2320 while maintaining contact with it. In other cases, the fingertip may be firmly pressed against the gripper 2320 and held in a substantially fixed orientation relative to it to slide the upper actuator 2155 forward (and / or, in some cases, backward). Any suitable friction-enhancing surface features, layers, or coatings are contemplated for the gripper 2320.

[0297] The latching member 2322 may extend upward at the distal end of the gripper 2320. In some cases, the proximal side of the latching member 2322 may be engaged by a fingernail (e.g., the top surface of the fingernail), and the finger may be moved forward to advance the upper actuator 2155. In some cases, this arrangement is particularly suitable for actuation by flicking the index finger or by more controlled actuation of a curled or semi-curled index finger against the latching member 2322, and in either case, the top surface of the fingernail may press forward against the rear surface of the latching member 2322 to move the actuator 2155 forward. In other cases, the user may use the angle of engagement of the tip of the latching member 3233 to move the upper actuator 2155 forward. Thus, the upper actuator 2155 can be engaged in a variety of ways to achieve its movement.

[0298] The upper actuator 2155 may also include a longitudinal rod 2324 that connects the actuation region 2327 to the engagement protrusion 2325. The rod 2324 may also be referred to as a guide or slider. The engagement protrusion 2325 extending from the rod 2324 may be configured to engage a stiffening hub 2154 within the housing 2152, as further described below. For example, in the illustrated embodiment, the engagement protrusion 2325 includes an engagement surface 2326 that interferes with the surface of the stiffening hub 2154 as the upper actuator 2155 is advanced distally. The illustrated engagement surface 2326 is a substantially flat surface at the distal end of the engagement protrusion 2325 that, when positioned within the assembly system 2100, extends substantially transversely to or orthogonally to the longitudinal axis of the system 2100.

[0299] The dimensions of the longitudinal rod 2324 can be designed (e.g., the width can be defined) to fit into the upper housing element 2152t. Figure 35BWithin the track 2307, the longitudinal rod 2324 can slide or otherwise translate within the track 2307 as the upper actuator 2155 advances or retracts along the guide channel 2302 of the upper housing element 2152t. The track 2307 and / or guide channel 2302 can constrain the movement of the upper actuator 2155, and more specifically, can constrain the movement of the longitudinal rod 2324. For example, the track 2307 and / or guide channel 2302 can suppress or prevent lateral movement of the longitudinal rod 2324.

[0300] like Figure 37B As shown, the longitudinal rod 2324 may define a distal end 2328 and a proximal end 2329. The track 2307 of the upper housing element 2152t may be long enough to accommodate the longitudinal rod 2324 at every position between the fully retracted state (e.g., the closest side state) and the fully advanced state (e.g., the farthest side state) of the upper actuator 2155 (including the fully retracted state and the fully advanced state). In some embodiments, when the upper actuator 2155 is in the fully retracted state, the proximal end 2329 of the longitudinal rod 2324 may be close to (e.g., accessible or adjacent to) the proximal end of the track 2307 (see [link to documentation]). Figure 34 When the upper actuator 2155 is in the fully advanced state, the distal end 2328 of the longitudinal rod 2324 can contact the distal end 2303 of the guide channel 2302 (see...). Figure 34 , Figure 35A , Figure 37B Therefore, the distal end 2328 of the longitudinal rod 2324 can act as a stop to define the forward movement of the upper actuator 2155.

[0301] In some embodiments, the upper actuator 2155 is formed of PC / ABS. In other embodiments, the upper actuator 2155 is formed of polycarbonate, acetal, etc. Any suitable material is contemplated.

[0302] refer to Figure 38A , Figure 38B and Figure 38C The stiffening hub 2154 includes a body 2220, which is similar in many respects to the body 920 described above. For example, as Figure 38C As shown, the body 2220 may define an internal channel 2230, which includes a recessed region 2236 for connection with the stiffener 2106, similar to the channel 930 and recessed region 936 described above.

[0303] However, the main body 2220 may also define a track, guide path, or channel 2230 at its upper end, and an upper actuator 2155 ( Figure 37A , 37BThe engaging protrusion 2325 can pass through the track, guide path, or channel. The dimensions of the engaging protrusion 2325 can be designed to translate unimpeded within the channel 2230. The engaging surface 2326 of the engaging protrusion 2325 ( Figure 37B The upper actuator 2155 may intersect (e.g., interfere with) the engagement surface 2381 at the distal end of the channel 2230 to achieve forward movement of the stiffening hub 2154. For example, in the illustrated embodiment, the engagement surface 2381 defines a substantially flat surface that extends substantially orthogonally relative to the longitudinal axis of the assembly system 2100. Thus, when the upper actuator 2155 is advanced distally, the opposing engagement surfaces 2381, 2326 of the channel 2230 of the stiffening hub 2154 and the engagement protrusion 2325 of the upper actuator 2155 may interfere with each other or selectively engage with each other. When the upper actuator 2155 retracts proximally, the engagement surfaces 2326, 2381 may disengage from each other.

[0304] The stiffening hub 2154 may also include a protrusion 2332 extending distally from the body 2220. The protrusion 2332 may include a tapered end 2334 at its distal end, which engages within a tapered opening 2264 of the guide hub 2141 (see [reference]). Figure 34 and Figure 39 The tapered end 2334 of the stiffening hub 2154 can directly engage the conduit hub 2141 and can be used as (and referred to as) a coupling member, such as the coupling member 1813 described above.

[0305] The stiffening hub 2154 may also include a rod, post, bridge, or extension 2336 extending rearward from the body 2220 to connect the body 2220 to the actuator 2222. The extension 2336 may also be considered a forward extension of the actuator 2222 that transmits forces applied to the actuator 2222 to the body 2220. The extension 2336 may define a portion of a needle channel 2230. In an illustrated embodiment, this portion of the needle channel 2230 defined by the extension 2336 is a groove sized to allow the needle 2104 to pass through easily. In some embodiments, the interaction between the channel 2230 and the needle 2104 may maintain or help maintain the longitudinal axis of the stiffening hub 2154 aligned with the longitudinal axis of the assembly system 2100.

[0306] Extension 2336 may define orientation surface 2382, which is configured to intersect with orientation surface 2373 of upper housing element 2102t to achieve rotational locking. In the illustrated embodiment, orientation surface 2382 substantially defines a plane passing through or near the longitudinal axis of assembly system 2100 and parallel to the longitudinal axis. Orientation surfaces 2382 and 2373 may slide along or through each other to maintain a fixed angular relationship between stiffening hub 2154 and upper housing element 2012t.

[0307] As previously described, the cross-section or outer contour of the extension 2336 may be bonded to the rear channel 2151 defined by the housing 2152 (see above). Figure 34 The shape of the extension 2336. In the illustrated embodiment, the outer contour of the extension 2336 is substantially defined as a semicircle.

[0308] In some embodiments, the stiffening hub 2154 defines angled ribs 2339 that can intersect with the groove 2314 of the lower housing element 2152b (see [link]). Figure 36A , Figure 36B , Figure 42 (c) For example, when the stiffening hub 2154 is advanced to the fully deployed state, the rib 2339 may be accommodated within the groove 2314. In some cases, the rib 2339 may prevent the stiffening hub 2154 from moving forward relative to the housing 2152, as further described below. The rib 2339 may reinforce the actuator 2222 or stabilize the actuator 2222 relative to the extension 2336.

[0309] The body 2220 of the stiffening hub 2154 can be configured to easily pass through the chamber 2202 of the housing 2152. In the illustrated embodiment, the body 2220 defines a generally cylindrical outer surface with the channel 2330 recessed relative to this outer surface. The cylindrical outer surface can be dimensioned to translate (e.g., slide) within a generally cylindrical inner surface of the housing 2152. Any other suitable arrangement for the body 2220 and the chamber 2202 is contemplated. For example, in other embodiments, the body 2220 and the chamber 2202 may not be shaped complementaryly. The chamber 2202 can be said to constrain the movement of the body 2220 therein, such as ensuring a substantially linear path of movement that is substantially aligned with the longitudinal axis of the system 2100.

[0310] In the illustrated embodiment, the body 2220 of the stiffening hub 2154 defines a stop 2384, which may also be referred to as an abutment surface. The illustrated stop 2384 includes a substantially flat surface at a proximal end of the body 2220. The plane of this surface is substantially transverse to or orthogonal to the longitudinal axis of the assembly system 2100. As further described below, the stop 2384 prevents or inhibits the removal of the stiffening hub 2154 from the housing 2152.

[0311] In various implementations, the stiffening hub 2154 is formed from one or more of acetal, polycarbonate, PC / ABS, etc. Any suitable material is contemplated.

[0312] refer to Figure 39 The conduit hub 2141 may be substantially similar to other similarly named and numbered components previously described. For example, the conduit hub 2141 may be comparable to... Figure 18A and Figure 18B The catheter hub 841 shown is substantially the same. As previously described, the tapered orifice 2264 at the proximal end of the catheter hub 2141 can receive and interfere with the tapered end 2334 of the stiffening hub 2154. The stiffening hub 2154 can thus directly transmit force to the catheter hub 2141 (such as during coupling of the catheter hub 2141 to the catheter connection hub 2145). The previous description of the catheter hubs 841, 1141, 1841, 2041 also applies to the catheter hub 2141, as do other similarly named and numbered components within this disclosure.

[0313] In some embodiments, the conduit hub 2141 is made of polyurethane (e.g., from Lubrizol (Wickliffe, Ohio)). Formation. Another illustrative example of a suitable material includes polycarbonate. Any suitable material is contemplated.

[0314] refer to Figure 40 The conduit hub 2145 may be substantially similar to other similarly named and numbered components previously described, and therefore the previous disclosures regarding such components also apply to the conduit hub 2145. For example, the conduit hub 2145 includes a connection interface 2274 configured to selectively engage the conduit hub 2145 to the housing 2152 and selectively disengage the conduit hub 2145 from the housing 2152 in a manner as previously disclosed. In the illustrated embodiment, the connection interface 2274 includes an external thread 2275. In other embodiments, one or more external lugs or protrusions capable of suitably engaging with the thread 2212 of the housing 2142 may be used instead of the thread 2275. Any suitable connection interface 2274 is contemplated.

[0315] In the illustrated embodiment, the catheter hub 2145 may include any suitable type of friction-enhancing feature 6 to facilitate the disengagement of the catheter assembly 2149 from the shank 2150 (specifically, for disengaging the catheter hub 2145). In the illustrated embodiment, the friction-enhancing feature 2362 includes a knurled ring 2360 that facilitates rotation of the catheter hub 2145. Other arrangements are also contemplated.

[0316] In some implementations, the conduit connection hub 2145 is made of polyurethane (e.g., from Lubrizol). Formation. Another illustrative example of a suitable material includes polycarbonate. Any suitable material is contemplated.

[0317] Figures 41A to 41C The various stages of operation of system 2100 are illustrated. In other words, Figures 41A to 41C Various stages or steps of exemplary methods (such as those using system 2100) are shown. Therefore, the following description of these figures discloses operational details of embodiments of system 2100 and exemplary methods (including methods specifically employing embodiments of system 2100).

[0318] Figure 41A System 2100 is shown in an undeployed, pre-used, original packaged, or initial state. For example, system 2100 is shown in a state where system 2100 can be sterilized, packaged, delivered to a user, and / or removed from the package by a user. In other words, in some cases, a user can remove system 2100 from the package in a substantially illustrated configuration.

[0319] In some embodiments, system 2100 includes a top cover (not shown) that covers the distal end of needle 2104 to prevent accidental puncture before intended use. Any suitable mechanism may also be employed to retain the upper actuator 2155 and lower actuator 2222 in their respective retracted states. For example, in some embodiments, the top cover and / or a separate spacer or stop element (not shown) may be configured to retain the upper actuator 2155 in a fully retracted or undeployed orientation. Furthermore, in some embodiments, a separate top cover, spacer or stop element, and / or packaging for system 2100 may prevent actuation of the lower actuator, such as during transport.

[0320] As previously described, the overall arrangement of the conduit 2102, needle 2104, and stiffener 2106 in the illustrated pre-use configuration, and their relationships, are related to... Figures 20A to 20D The catheter 802, needle 804, and stiffener 806 shown and described are substantially the same. In addition, any suitable material (such as those previously described (e.g., relative to catheter 102, needle 104, and stiffener 106)) may be used for catheter 2102, needle 2104, and stiffener 2106.

[0321] In the pre-use configuration, each of the upper actuator 2155 and the lower actuator 2222 is in the fully retracted position. In other words, each of the upper actuator 2155 and the lower actuator 2222 is in the most lateral or fully rearward position. Therefore, the stiffening hub 2154 is also in the fully retracted position. In the illustrated embodiment, a stop 2384 defined by the body 2220 of the stiffening hub 2154 abuts the inner surface of the upper housing element 2152t, which prevents or inhibits the stiffening hub 2154 from being removed from the housing 2152. Similarly, the stop 2372 of the lower actuator 2222 contacts a stop 2371 defined by the proximal portion of the upper housing element 2152t, which also prevents or inhibits the stiffening hub 2154 from being removed from the housing 2152. In other embodiments, when the stiffening hub 2154 retracts (e.g., due to variations within acceptable tolerances), only one of the stops 2372, 2384 of the stiffening hub 2154 can contact the housing element 2152t. Multiple stops 2372, 2384 provide redundancy to ensure that the stiffening hub 2154 remains within the housing 2152 during retraction.

[0322] In the illustrated embodiment, the two components are initially not engaged when both the upper actuator 2155 and the stiffening hub 2154 are in their retracted orientation. Specifically, as Figure 41A As shown, there is a small space or gap between the engagement surface 2326 of the engagement protrusion 2325 of the upper actuator 2155 and the engagement surface 2381 of the stiffening hub 2154. Therefore, the upper actuator 2155 advances forward a short distance to initially engage the stiffening hub 2154.

[0323] In other embodiments, in the pre-use state of system 2100, the mating surface 2326 of the upper actuator 2155 and the mating surface 2381 of the stiffening hub 2154 are in abutment contact, such that forward movement of the upper actuator 2155 immediately causes simultaneous forward movement of the stiffening hub 2154. In some cases, the presence and / or size of any initial gap between the mating surfaces 2326, 2381 may vary within acceptable tolerances between the various systems 2100, such that the upper actuator 2155 does not need to move forward or only moves slightly before engaging the stiffening hub 2154 of any of the system 2100 manufactured to specifications.

[0324] As previously described, the distal end 2334 of the stiffening hub 2154 is complementary to the tapered proximal opening 2264 of the conduit hub 2141 and can fit tightly within the tapered proximal opening to effectively apply deployment force to the stiffening hub 2154 in the distal direction. In the illustrated embodiment, when the system 2100 is in a pre-use or pre-deployment state, the distal end 2334 of the stiffening hub 2154 engages the proximal opening 2264 of the conduit hub 2141. In some cases, it may be desirable to ensure that the stiffening hub 2154 engages the conduit hub 2141 in this initial state of the system 2100 to ensure that the stiffener 2106 and the conduit 2102 move substantially uniformly immediately upon actuation of the stiffening hub 2154. That is, the stiffening hub 2154 immediately transmits force to the conduit hub 2141, causing the two components to move forward uniformly. This arrangement can reduce strain along the length of the conduit 2106, which would otherwise occur without the stiffening hub 2154 pushing the conduit hub 2141 forward.

[0325] For example, as previously described (relative to other embodiments), the advancement of stiffener 2106 causes its distal end to be pushed forward over the distal end of conduit 2102. This not only causes the distal end of conduit 2102 to move forward, but also pulls the rest of conduit 2102 forward due to stress applied along its length. If the forward movement of conduit hub 2141 is impeded, strain along the length of conduit 2102 can increase.

[0326] By pushing the catheter hub 2141 forward (on which the proximal end of catheter 2102 is attached), the stiffening hub 2154 relieves stress along at least a portion of the length of catheter 2102. For some embodiments, this stress relief can be particularly noticeable and useful in the later stages of catheter deployment, where it may be necessary to provide an increased force to the catheter hub 2141 to deploy an elastic arm at the distal end of catheter connecting hub 2145 during coupling of the catheter hub 2141 to catheter connecting hub 2145 (in a manner as previously described). In such cases, all or substantially all of the force required to coupling the catheter hub 2141 to catheter connecting hub 2145 can be directly provided to the catheter hub 2141 via the stiffening hub 2154.

[0327] The strain relief provided to the conduit 2102 by the junction of the stiffening hub 2154 and the conduit hub 2141 can be explained in other words. For example, by ensuring a direct connection between the stiffening hub 2154 and the conduit hub 2141 in the initial pre-use state of the system 2100, the proximal and distal ends of both the conduit 2102 and the stiffening member 2106 move forward at the same rate. In other words, the lengths of the conduit 2102 and the stiffening member 2106 are substantially constant throughout deployment, and furthermore, the conduit 2102 and the stiffening member 2106 move forward in unison.

[0328] In other embodiments, when the system is in initial or pre-use orientation, and possibly in at least some of the subsequent stages of deployment, a space or gap may exist between the distal end 2334 of the stiffening hub 2154 and the tapered proximal opening 2264 of the conduit hub 2141. For example, a small gap may exist due to manufacturing tolerances. In some such cases, the stiffening hub 2154 does not facilitate forward translation of the conduit hub 2141 unless and until the strain on the conduit 2102 is sufficient to elongate the conduit 2102 to contact the stiffening hub 2154. For example, in some such embodiments, the conduit hub 2141 may be pulled distally by the conduit body 2102 until the conduit hub 2141 contacts the resilient arm of the conduit connection hub 2145. Due to the increased resistance to distal movement provided by the conduit hub 2145, the conduit body 2102 can elongate when the stiffener 2106 is pushed distally to the extent that the stiffener hub 2154 engages the proximal end 2334 of the conduit hub 2141. At this time, the stiffener hub 2154 can directly push the conduit hub 2141, thereby supplementing the distal force on the conduit hub 2141, which is also provided to the conduit hub 2141 via an indirect path. Specifically, the stiffener hub 2154 pushes the stiffener 2106 forward, which in turn pushes the distal end of the conduit 2106 forward, which in turn pulls forward the proximal end of the conduit 2016 and the conduit hub 2141 (to which the proximal end is attached).

[0329] Continue to refer to Figure 41AIn the illustrated embodiment, when system 2100 is in a pre-use or non-deployed state, the conduit hub 2141 is spaced apart from the conduit connection hub 2145. Specifically, the conduit hub 2141 is completely separated from the conduit connection hub 2145, does not contact the conduit connection hub, and is located at a considerable distance from the conduit connection hub 2145. The conduit hub 2141 is located behind or near the conduit connection hub 2145. The conduit hub 2141 is located inside the housing 2142, or in other words, is completely contained within the cavity 2202 of the housing 2142. It can be said that the housing 2142 surrounds, encloses, or encloses the conduit hub 2141. Furthermore, in the illustrated embodiment, when system 2100 is in a pre-deployed state, no part of the conduit hub 2141 is surrounded, enclosed, or enclosed by the conduit connection hub 2145.

[0330] In contrast, in the illustrated embodiment, the conduit hub 2145 is coupled to the distal end of the housing 2152 in a manner as previously disclosed. Thus, the conduit hub 2145 is connected to the housing 2152 via a connection interface 2210. Except for the connection interface 2210, substantially the entire outer surface of the conduit hub 2145 is outside the housing 2142. However, the interior of the conduit hub 2145 is in fluid communication with the cavity 2202 of the housing 2142. Additionally, in the illustrated embodiment, except for the proximal portion of the conduit hub 2145 defining the connection interface 2210, a considerable portion or most of the conduit hub 2145 extends distally away from and outside the housing 2142.

[0331] In the initial state of system 2100, the conduit hub 2141 is freely translated within housing 2142 in a manner as previously disclosed (e.g., longitudinally sliding while maintaining rotational locking). In contrast, the conduit connection hub 2145 is selectively fixed relative to housing 2142.

[0332] As further described below, when system 2100 is in an undeployed state, the distal ends of system 2100 (e.g., the distal ends of needle 2104, catheter 2102, and stiffener 2106) can be advanced through the patient's skin to establish an insertion site in the skin (e.g., Figure 4A The insertion site 54 identified in the image), and at least the distal end of the needle 2104 can be further advanced into the patient's blood vessel to establish a vascular insertion site (e.g., Figure 4AThe identified vascular insertion site 56). In some cases, deployment of system 2100 begins only after the tip of needle 2104 has been advanced into the blood vessel. In other cases, the distal tip of catheter 2102 (and in other cases, the distal tip of stiffener 2106) also enters the lumen of the blood vessel relatively little by little through the vascular insertion site when system 2100 is not deployed.

[0333] Once the appropriate portion of the distal end of system 2100 is located within the lumen of a blood vessel (as shown in blood flashing in a manner such as previously disclosed), system 2100 can then be actuated or deployed to insert catheter 2102 into the blood vessel and then advance catheter 2102 to the final or maximum depth within the blood vessel (e.g., initially only the distal end of needle 2104 is inserted into the lumen of the blood vessel) or to advance catheter 2102 to the final depth within the blood vessel (e.g., initially at least the distal end of catheter 2102 is inserted into the lumen of the blood vessel).

[0334] Figure 41B The system 2100 in a subsequent operational state is shown. Specifically, a portion or intermediate amount of the system 2100 has been deployed via the upper actuator 2155. A series of partial or intermediate deployments of the system 2100 can be made via the actuator 2155. In the illustrated phase, the upper actuator 2155 has been advanced to its maximum forward position, which has caused the stiffening hub 2154 to move forward and thus the stiffening member 2106 and the catheter 2102 to move forward simultaneously through a distance D1. In some embodiments, as further described below, the distance D1 may be selected to ensure that the stiffening member 2106 and the catheter 2102 are advanced through the lumen of the blood vessel to a depth sufficient to temporarily hold the catheter 2102 and the stiffening member 2106 within the blood vessel before the catheter 2102 and the stiffening member 2106 are finally advanced to the maximum deployment depth by the lower actuator 2222.

[0335] In other words, as previously described, the upper actuator 2155 can move forward until its surface (specifically, the stop surface at the distal end 2328 of the rod 2324) abuts the distal end 2303 of the track 2302 defined by the housing 2152. Thus, the upper actuator 2155 enables the stiffening hub 2154 to move a distance D1. That is, due to the engagement between the upper actuator 2155 and the lower actuator 2154, the lower actuator 2154 can move synchronously with the upper actuator 2155 for the same or substantially the same distance as the upper actuator 2155. In some cases, in the undeployed state of the system 2100, the upper actuator 2155 and the lower actuator 2222 are already engaged with each other, and the distance traveled by the upper actuator 2155 is equal to D1. If actuators 2155 and 2222 are not engaged in this manner from the outset, the distance traveled by upper actuator 2155 may be less than D1.

[0336] In other words, in Figure 41B In the operational phase shown, the upper actuator 2155 has been advanced along the entire track 2302, and thus along a predetermined distance. This forward movement of the upper actuator 2155 will pull the stiffening hub 2154 forward by a corresponding or approximately corresponding amount. Specifically, when the upper actuator 2155 moves from its fully retracted position to its fully advanced position (as shown), the stiffening hub 2154 also moves a predetermined distance, which may be the same as or substantially the same as the predetermined distance traveled by the upper actuator 2155.

[0337] For reasons further described below, the first deployment distance D1 traveled by the stiffening hub 2154 can also be referred to as the stabilization, anchoring, and / or holding distance, as advancing the catheter 2102 into the blood vessel to this distance helps ensure that the catheter 2102 remains positioned within the blood vessel for at least an intermediate cycle time. This intermediate cycle can begin after the initial deployment phase, achieved by the upper actuator 2155, has ended, and can end once the lower actuator 2222 is activated to achieve the final deployment of the system 2100.

[0338] As previously mentioned, in some cases, the upper actuator 2155 can be conveniently advanced forward in a variety of ways using a single finger of the hand (e.g., the index finger) while the handle 2150 is held in the same hand. In the illustrated embodiment, the upper actuator 2155 is located at the front end of the handle 2150, which facilitates this form of actuation.

[0339] As previously described, the overall arrangement of the conduit 2102, needle 2104, and stiffener 2106, and the relationships between them, at various stages of deployment, can be similar to those illustrated elsewhere in this document. For example, in Figure 41B During the operational phase shown, the relative positions of the distal ends of the catheter 2102, stiffener 2106, and needle tip 2104 can be substantially as follows: Figure 21C and 21D As shown and as described relative to these figures, the difference is that the distance between the needle tip 2104 and the catheter tip 2102 can be larger or smaller depending on the overall length of the catheter 2102.

[0340] Figure 41CThe system 2100 in a subsequent operational state is shown. Specifically, the system 2100 is fully deployed or deployed to its maximum extent. The final actuation has been achieved by the lower actuator 2222. A series of partial or intermediate deployments of the system 2100 can also be performed by the lower actuator 2222. However, in the illustrated stage, the lower actuator 2222 has been advanced to its maximum forward position, which has caused the stiffening hub 2154 to move forward and thus the stiffener 2106 and the conduit 2102 to move forward simultaneously through an additional distance D2. Therefore, the system 2100 (specifically, the stiffening hub 2154 of the system 2100) has been actuated through a total distance D3, which is the sum of D1 (generated by indirect actuation of the stiffening hub 2154 via the upper actuator 2155) and D2 (generated by direct actuation of the stiffening hub 2154 via the lower actuator 2222).

[0341] In other words, after the initial actuation of the system 2100 via the upper actuator 2155, the lower actuator 2222 can be advanced the remainder of the available forward path to complete the deployment of the combined catheter 2102 / neck brace 2106 above the needle 2104. Therefore, the lower actuator 2222 can be advanced any additional distance up to the maximum additional distance of D2.

[0342] In the illustrated embodiment, no further forward movement of the upper actuator 2155 occurs during the direct actuation of the lower actuator 2222. In other words, during the further forward propulsion of the stiffening hub 2154, the upper actuator 2155 can disengage from the stiffening hub 2154 and remain stationary relative to the housing 2152.

[0343] The forward path traveled by stiffening hub 2154 can be defined by conduit connection hub 2145. In other words, engagement of conduit hub 2141 with conduit connection hub 2145 terminates the forward propulsion of stiffening hub 2154. Specifically, in an exemplary embodiment, the lower actuator 2222 is pushed (e.g., pressed) forward to directly propel stiffening hub 2154 forward. As previously described, during part or all of this forward propulsion of stiffening hub 2154, stiffening hub 2154 may engage and press the proximal end of conduit hub 2141, thereby pushing conduit hub 2141 forward. Because the resistance to the forward movement of stiffening hub 2154 can be increased, tactile feedback can be provided to the user that conduit hub 2141 has begun to engage the elastic arm of conduit connection hub 2145. Finally, as described above relative to Figure 21B and Figure 22BMore fully, the conduit hub 2141 is advanced distally a sufficient amount to allow the deflection engagement arm of the conduit connection hub 2145 to snap into and securely hold the conduit hub 2141 in place. Since the conduit connection hub 2145 is securely attached to the housing 2152 and the conduit hub 2141 is securely attached to the conduit connection hub 2145, the user is prevented from advancing the stiffening hub 2154 any further relative to the housing 2152. This significant resistance or complete opposition to further advancement of the stiffening hub 2154 relative to the housing 2152 provides the user with further tactile feedback, this time indicating that deployment is complete and the conduit assembly 2149 is fully assembled.

[0344] In some implementations, the user may also receive auditory feedback indicating deployment completion. For example, the catheter hub 2145 and / or the catheter hub 2141 may generate an auditory signal individually or collaboratively upon connection. In an illustrated implementation, the connection between the catheter hub 2145 and the catheter hub 2141 produces an audible "click" sound indicating connection completion.

[0345] In other or additional cases, the forward path may be defined by direct contact between the stiffening hub 2154 and the lower housing element 2152b. In any case, the stiffening hub 2154 may directly or indirectly cooperate with the housing 2152 to define the forward movement of the stiffening hub 2154, the total distance traveled by the stiffening hub 2154 during the entire actuation process being D3 (i.e., D1+D2).

[0346] As previously described, in some cases, the lower actuator 2222 can be conveniently advanced by the user's other hand when the user holds the housing 2152 with one hand. In some cases, the lower actuator 2222 is positioned behind the lower housing element 2152b, generally behind the upper actuator 2155, and / or generally extending downward relative to the housing 2152, which may provide convenience or other benefits. In some cases, this arrangement can result in a compact system 2100 because the lower actuator 2222 does not extend significantly beyond the lower profile of the lower housing element 2152b. However, the illustrated actuator 2222 is large enough to be easily grasped and / or easily pushed to deploy or further deploy the system 2100. In some cases, this significant rearward position of the lower actuator 2222 allows the handle 2150 to be positioned close to the patient's skin, which may allow for a shallow insertion angle.

[0347] As previously described, the overall arrangement of the conduit 2102, needle 2104, and stiffener 2106, and the relationships between them, at various stages of deployment, can be similar to those illustrated elsewhere in this document. For example, in Figure 41CDuring the operational phase shown, the relative positions of the distal ends of the catheter 2102, stiffener 2106, and needle tip 2104 can be substantially as follows: Figure 21C and 21D As shown and as described relative to these figures, the difference lies in the fact that, depending on the overall length of the catheter 2102, the distance between the needle tip 2104 and the catheter tip 2102 can be larger or smaller, and in any case, with Figure 41B Compared to the previous operation phase, the distance between the needle tip 2104 and the catheter tip 2102 will increase.

[0348] Further reference Figures 41A to 41C The dual-actuator system 2100 and the two-stage deployment process can be advantageous in some cases (as just described). The first stage of actuation (e.g., a flick of the index finger or other advance of the upper actuator 2155) can help initially capture the blood vessel, and the second stage of actuation can subsequently advance the catheter 2102 to its final or full insertion position.

[0349] This can be particularly useful in deep vein placement of catheter 2102. In such placements, the practitioner can use, for example, their non-dominant hand to press against the skin above the blood vessel to provide tension to the area and help locate the vessel and / or align system 2100 with it. Another (e.g., dominant) hand can grasp system 2100 (or any desired portion thereof, such as the handle 2150) and advance the entire system 2100 forward to introduce the needle tip (and possibly the catheter tip at this stage) into the blood vessel until blood flashes are seen.

[0350] At this point, removing the non-dominant hand from the patient's skin before deploying the catheter 2102 into the blood vessel via the needle 2104 may allow sufficient movement of the blood vessel and surrounding tissue, or otherwise destabilize the area and / or allow unintended movement of the dominant hand and the system 2100 that holds the dominant hand relative to the area, to some extent causing the needle 2104 and catheter 2102 to accidentally disengage from the blood vessel. To prevent this, after placing the needle tip into the blood vessel, it may be desirable to advance the catheter 2102 (e.g., via a sheathed cannula 2106) into the blood vessel to, for example, at least 1 Approximately 2 inches is used to prevent accidental removal of the catheter 2102 from the blood vessel when removing the non-dominant hand to actuate the lower actuator 2222. This is achieved by advancing the upper actuator 2155 forward while maintaining a stable position with both hands, such as pressing on the patient with the non-dominant hand and grasping the system 2100 with the dominant hand. After initially capturing the blood vessel and removing the non-dominant hand from the patient's skin in this manner, the non-dominant hand can then be used to advance the lower actuator 2222 to complete advancing the catheter 2012 into the patient to the target depth, or in other words, to the fully deployed position.

[0351] Vascular capture in the manner described above can be referred to in various ways. For example, such vascular capture may also be described as stabilizing or anchoring the system 2100 relative to the blood vessel. That is, despite small or unintended relative movements between the blood vessel and the system 2100, the catheter 2102 is advantageously advanced into the blood vessel, allowing the catheter 2102 to remain in its position within the blood vessel. Thus, the initial distance (e.g., distance D1) by which the catheter 2102 is advanced above the needle within the blood vessel may be referred to as the capture, stabilization, anchoring, or holding distance. Such advancement of the catheter 2102 serves as preparation for the eventual deployment of the catheter 2102 to its final position within the blood vessel, which may also be referred to as indwelling, fully advanced, or lodged position, etc.

[0352] In some cases, positioning the lower actuator 2222 below the handle 2150 allows the dominant hand to maintain continuous contact with the handle 2150 during the initial introduction of the catheter 2102 into the blood vessel and subsequently during the actuation of the system 2100 to further deploy the catheter 2102 to its final depth within the blood vessel. For example, by gripping the handle 2150 with the dominant hand, the fingers can wrap around the housing 2152, but not extend beyond the sliding path along which the lower actuator 2222 slides, or more specifically, along the sliding path along which the stiffening hub 2154 slides. When the dominant hand grips the housing 2152, with the index finger on one side and the other fingers on the other, the non-dominant hand can engage the lower actuator 2222 and move it forward between the thumb and fingers of the dominant hand without disrupting the placement of the thumb and fingers of the dominant hand. In other cases, the roles of the dominant and non-dominant hands can be reversed.

[0353] In the illustrated embodiment, when propelled in a distal direction, the upper actuator 2155 captures or engages the stiffening hub 2154, but does not capture or engage the stiffening hub when pulled in a proximal direction. When moving in a forward direction, the stiffening hub 2154 does not capture or engage the upper actuator 2155, but if the stiffening hub 2154 is pulled in a rearward direction (if the upper actuator 2155 has previously been propelled distally), the stiffening hub 2154 may capture or engage the upper actuator 2155.

[0354] Refer again Figure 41A In some cases, the user may forgo using the upper actuator 2155 and instead choose to deploy the conduit 2102 using only the lower actuator 2222. That is, refer to... Figure 41C The lower actuator 2222 can move the entire deployment distance D3 directly or without using the upper actuator 2155. In the illustrated arrangement, since only the stiffening hub 2154 moves from... Figure 41ADuring the forward movement of the position shown, there is no interaction between the stiffening hub 2154 and the upper actuator 2155, so the upper actuator 2155 can remain in its initial position during this deployment. Therefore, when the system 2100 is in the fully deployed state, the upper actuator 2155 can be positioned in the fully retracted state instead of the fully advanced state. Then, refer to... Figure 41C When the system 2100 is fully deployed in this manner, the actuator 2155 will be positioned in its leftmost orientation rather than its rightmost orientation.

[0355] In some cases, a physician may choose to use this single-stage actuation in contexts such as peripheral placement. For example, in some situations where vascular access is relatively simple, a physician may prefer to deploy catheter 2102 using only the lower actuator 2222. Due to the relative accessibility of peripheral vessels (e.g., due to their shallow location), the physician can insert the tip of needle 2104 (and possibly the tip of the catheter) into the vessel to the desired initial amount (e.g., when system 2100 is in an undeployed state) without using another hand for traction / positioning. Once system 2100 has been inserted into the vessel to an initial depth (which may also be referred to as the introduction depth), the physician can then simply slide the lower actuator 2222 to advance catheter 2102 into the vessel to the final depth or placement depth.

[0356] Therefore, System 2100 can be used in two different deployment modes (i.e., in a two-stage deployment mode or a single-stage deployment mode). Thus, users can select the mode to use based on preferences, the type of blood vessel being accessed, etc.

[0357] The exemplary methods using System 2100 have been described previously. More details of these methods, or some of them, will now be described.

[0358] Users of system 2100 can remove system 2100 from the packaging, at which point system 2100 can be in a state of... Figure 41A The pre-deployment state is shown. The user can prepare the patient's skin (on which the insertion site will be formed) according to standard operating procedures. The user can then insert the distal end of the system 2100 (such as...) in a manner as previously described. Figure 20D(As shown) The catheter 2102 is advanced through the patient's skin and into the blood vessel. Furthermore, as previously described, the stiffener 2106 facilitates and / or reduces or prevents deformation of the distal tip of the catheter 2102 during such insertion through the skin and into the vessel wall. Once the distal tip of the system 2100 has been inserted into the blood vessel to a sufficient extent, blood flashing can be observed, indicating that proper vascular introduction has been achieved. At this point, the tip of the needle 2104 has entered the blood vessel, and possibly the distal tips of the catheter 2102 and the stiffener 2106 may also have entered the blood vessel. The depth to which the catheter 2102 has been inserted into the lumen of the blood vessel at this point can be referred to as the introduction depth, initial depth, preliminary depth, etc.

[0359] After observing the flash evaporation of blood, the user may then deploy the catheter 2102 above the needle 2104 in any of the methods described above. For example, in some methods, the user may first advance the upper actuator 2155 forward relative to the housing 2150 (which may remain substantially stationary, stable, secure, fixed, or immobile relative to the patient and / or relative to the blood vessel) to deploy the catheter 2102 to the capture depth within the blood vessel, and may then advance the lower actuator 2222 forward relative to the housing 2150 (which may again remain substantially stationary, stable, secure, fixed, or immobile relative to the patient and / or relative to the blood vessel) to further deploy the catheter to the final indwelling depth within the blood vessel and assemble the catheter assembly 2149. In other methods, the user uses only the lower actuator 2222 to fully deploy the catheter to the final indwelling depth and assemble the catheter assembly 2149. In either case, the user can be alerted to the indwelling depth by tactile feedback (e.g., difficulty or inability to advance the lower actuator 2222) and / or auditory feedback (e.g., a click when the catheter assembly 2149 is in place).

[0360] Figure 42 The stiffening hub 2154 is shown in the fully advanced position. In many embodiments, the forward movement of the stiffening hub 2154 is not directly defined by the housing 2152, but rather indirectly defined by the housing 2152 due to the interaction and connection between the housing 2152 and the conduit assembly 2149. However, in some cases, the stiffening hub 2154 may directly contact the lower housing element 2152b in an abutment manner in the illustrated operating state, which defines the forward movement of the stiffening hub 2154. In some cases, such contact may only occur within manufacturing tolerance limits. In other or additional cases, it may be desirable to ensure that there is at least some space between any stop surfaces of the housing 2152 and the stiffening hub 2154 when the stiffening hub 2154 is fully advanced, to ensure sufficient passage to allow for complete assembly of the conduit hub.

[0361] As previously described, when the stiffening hub 2154 has been advanced to the fully advanced position, the rib 2339 of the stiffening hub 2154 can be accommodated within the groove 2314 of the lower housing element 2152b. In many embodiments, this interaction between the rib 2339 and the stiffening hub 2154 does not prevent rearward movement of the stiffening hub 2154, or in other words, allows the stiffening hub 2154 to retract relative to the housing 2152. In other embodiments, the stiffening hub 2154 may cooperate with the housing 2152 to remain in the fully advanced position, or more specifically, to remain in the advanced position (e.g., whether fully advanced or partially advanced relative to the final, most distal position). By being confined to this forward position, the stiffening hub 2154 effectively locks the stiffener 2106 above or behind the distal end of the needle 2104, thereby shielding the needle from accidental contact as previously described. In other words, in some implementations (such as some of those described below), the stiffening hub 2154 may mate with the housing 2152 to prevent the stiffening member 2106 from exposing the needle tip after a deployment event. In other words, the stiffening hub 2154 and the attached stiffening member 2106 may be confined to a position that maintains the stiffening member 2106 in a shielded orientation relative to the needle tip with respect to the housing 2154, for example, in a position where the stiffening member 2106 extends distally beyond the distal end of the needle 2104 by an amount sufficient to suppress or prevent accidental contact with the needle tip.

[0362] Figure 43 This is an enlarged bottom plan view of another embodiment of the catheter delivery system 2300, which includes check, locking, shielding, or safety features such as those just described. Specifically, after the system 2300 is fully deployed, the check feature prevents the stiffener of the system 2300 from retracting relative to the housing. The system 2300 is shown just before its full deployment. Specifically, the system 2300 includes a lower housing element 2352b that defines a groove 2414 including a pair of inwardly projecting latching members 2484. The latching members 2484 engage with the proximal surface of a locking protrusion 2482 defined by a rib 2439 of the stiffener hub 2354. Once these features are locked together, the stiffener hub 2354 cannot retract relative to the housing. Thus, the stiffener attached to the lower actuator is held in a fixed, shielded position above the needle tip (e.g., in a similar...). Figure 51G (The shielding location is shown in the figure).

[0363] In the illustrated embodiment, the stiffener is held in the fully deployed position and thus extends a maximum length beyond the needle tip. In other embodiments, the anti-return feature allows a certain amount of proximal movement of the stiffener hub and stiffener relative to the housing after deployment, but prevents the stiffener from fully retracting from above the needle. That is, the system can hold the stiffener at least a certain length beyond the distal end of the needle by an amount sufficient to shield the needle tip from accidental contact. In other words, the system can hold the stiffener in a state of at least partial deployment. Illustrative examples of such systems are further described below.

[0364] Figure 44 This is a side front view of an embodiment of stiffener 2506, compatible with the catheter delivery system described herein and including a flexible, enhanced distal end. In many embodiments, as previously disclosed, stiffener 2506 or sheathed cannula can be very flexible. For example, the sheathed cannula can be formed of a hyperelastic material (e.g., hyperelastic nitinol). To enhance the flexibility (e.g., lateral flexibility) of the sheathed cannula without negatively impacting the longitudinal support it provides (e.g., to a stepped feature at the distal end of the catheter), a series of notches, slits, or other curved features 2511 can be placed in a specific region / orientation at or toward the distal end of the cannula. In some cases, lateral flexibility enhancement features can be positioned in a region near the distal end where significant lateral bending is anticipated, such as during initial angled introduction of the vessel into the lumen defined by the vessel and then by immediate changes in orientation caused by advancement within the lumen of the vessel.

[0365] In other words, a blood vessel may define a lumen extending in a longitudinal direction, or it may define a lumen defining a longitudinal axis. The longitudinal axis may extend longitudinally along and through the center of the blood vessel, and thus may follow the contour of the blood vessel. This contour may be substantially linear in some areas and / or substantially curved in others. Generally, a system such as the system 2100 described above is inserted into a blood vessel along its longitudinal axis, typically aligned with the longitudinal axis of the blood vessel, but at an angle relative to the blood vessel (e.g., an approach angle). Typically, this approach angle is as shallow as possible to facilitate the insertion of a needle (which is typically aligned with the longitudinal axis of the system) and catheter into the blood vessel. However, due to this angle, the catheter / neckpiece pair of the system may enter the blood vessel at an approach angle. When initially advanced above the tip of the needle for intravascular or intraluminal deployment, the catheter / neckpiece pair may approach or contact the inner surface of the blood vessel wall substantially at an approach angle. The catheter / neckpiece pair may then bend to advance substantially along the lumen of the blood vessel, along the inner lumen of the blood vessel, and / or generally in the direction of the longitudinal axis of the blood vessel. This initial bend may also be referred to as an entry bend or initial bend. After the initial bend, the catheter / stiffening assembly can be advanced longitudinally through the blood vessel to a target site or depth within the vessel, which can be relatively far from the insertion site and the initial bend.

[0366] Refer again Figure 44 The curved feature 2511 may facilitate the initial formation of the entry bend of the catheter / stiffening pair, or more specifically, may facilitate the introduction of the catheter / stiffening pair into and / or the initial advancement within the blood vessel. In the illustrated embodiments, the curved feature 2511 (e.g., a notch) may be placed in the alternating pattern shown or in any other suitable pattern or arrangement. The notch 2511 may be formed in any suitable manner (e.g., by laser cutting). In some embodiments, the notch 2511 is positioned no more than about 0.75, 1.0, or 1.5 inches beyond the distal end of the stiffening member 2506. In various embodiments, the depth of each notch 2511 is no greater than about 0.7, 0.8, or 0.9 times the radius of the stiffening member 2506.

[0367] As previously described, implementations of the system may include a rotation-locking feature by which the stiffener 2506 maintains a fixed angular relationship relative to the shank or housing of the system. This rotational locking can be used to ensure the correct orientation of the stiffener 2506 relative to the bending feature 2511. For example, in the illustrated implementation, it may be desirable for the bending feature 2511 to be oriented substantially vertically relative to the longitudinal axis of the system during insertion (e.g., within the vertical planes passing through the upper and lower actuators of a system such as system 2100). In other words, the blood vessel may extend substantially linearly near the insertion site on the patient. In some cases, it may be desirable to align substantially the longitudinal axis of the system (e.g., the longitudinal axis of the needle of the system) with the longitudinal axis of the insertion region portion of the blood vessel. The two longitudinal axes may be substantially coplanar. Figure 44 In the embodiment shown, the upper bending feature structure and the lower bending feature structure 2511 may each intersect the plane, which may facilitate the bending of the stiffener 2506 to align with the longitudinal axis of the blood vessel.

[0368] Figure 45 A side front view of another embodiment of the stiffener 2606 is shown, which is compatible with the catheter delivery system described herein and includes a flexible, enhanced distal end. In this embodiment, a single bending feature 2611 is provided. Specifically, the bending feature 2611 includes an elongated notch in one side of the catheter stiffener 2606. In some embodiments, the bending feature 2611 may be oriented upward using the catheter delivery system such that the forward and rearward ends of the notch are slightly inclined to each other when the stiffener 2606 bends upon entry into a blood vessel (e.g., initially forming a bend within the vessel).

[0369] Figure 46 Another embodiment of catheter delivery system 2700, similar to other systems disclosed herein, is shown. Specifically, system 2700 may operate in the manner described relative to previously disclosed embodiments (e.g., systems 800, 2000, and 2100) and may include other or additional feature structures as described below. All relevant disclosures of the previous embodiments are incorporated herein with necessary modifications relative to system 2700 and in accordance with the previously outlined disclosure requirements. System 2700 includes an insertion component 2709 selectively attached to catheter assembly 2749. As with the other embodiments described above, insertion component 2709 is configured to deploy catheter 2702 to a desired depth within a patient's blood vessel.

[0370] The catheter delivery system 2700 includes a catheter 2702, a needle 2704, and a stiffener 2706. Figure 51G), such as components with similar naming and numbering as previously described. System 2700 includes a check valve feature that holds stiffener hub 2754 in a neutral position to hold stiffener 2706 in a shielded orientation relative to pin 2704. System 2700 may also include a snap-fit ​​feature to prevent upper actuator 2755 from unintentionally disengaging from shank 2750, which may be formed by housing 2752.

[0371] refer to Figure 47 In some embodiments, system 2700 includes a conduit hub 2745 that includes friction-enhancing feature structures 2962 shaped in various ways. Specifically, friction-enhancing feature structure 2962 includes a substantially cubic or parallelepiped-shaped region 2961 that can be easily manipulated by a user. Furthermore, region 2961 may include a plurality of substantially flat surfaces that can be easily printed with markings.

[0372] refer to Figure 48 The upper housing element 2752t may define a track 2902, such as track 2302. Track 2902 may define a first width. The housing element 2752t may also define an inner track 2907, which may have a proximal portion and a distal portion. In some cases, the proximal portion may have a width substantially the same as track 2902. The distal portion of track 2907 may include an enlarged region 2990 defining a larger width. The increased width of region 2990 allows for the accommodation of the latching element of the upper actuator 2755, which will be discussed further below.

[0373] The upper housing element 2752t may include a pair of recesses 2991, which may, for example, reduce the amount of material used in the upper housing element 2752t and reduce manufacturing costs.

[0374] refer to Figure 48A The upper housing element 2752t may define a stop 2992, which prevents the stiffener 2706 from returning, as further described below. The stop 2992 shown includes a pair of ramps 2992, each ramp including a ramp surface 2993 and an adjacent or engaging surface 2994. The stop 2992 may protrude away from a substantially flat orientation surface 2373.

[0375] refer to Figure 49 In some embodiments, the stiffening hub 2754 may include a stop interface 2995, which in an illustrated embodiment includes a cavity 2997 and a ramp 2996. The stop interface 2995 is defined by an extension 2936 (such as the extension 2336 described above).

[0376] refer to Figure 50And as previously described, the upper actuator 2775 may include a pair of latching members 2998 extending outward or laterally from the rod 2974. The latching members 2998 are sized to be accommodated within an enlarged region 2990 of the inner track 2907 defined by the upper housing element 2752t, but extend outward by a sufficient amount to prevent them from fitting through the track 2902 unless the actuator 2775 is twisted to an orientation that would otherwise be suppressed by the presence of the stiffening hub 2757 within the housing 2752.

[0377] Figures 51E to 51H The various stages of operation of system 2700 are shown. Figure 51E The system 2700 is shown in an undeployed state. In this state, the upper actuator 2755 and the stiffening hub 2754 are each in the fully retracted position. The stop 2992, defined by the upper housing element 2752t, is positioned within the cavity 2997 defined by the stiffening hub 2754.

[0378] exist Figure 51B In this configuration, the upper actuator 2755 has been fully advanced to its furthest advancing position. The upper actuator 2755 has pulled the stiffening hub 2754 forward by the same amount, but the stiffening hub 2754 remains only in a partially actuated or partially deployed state. In this operating state, the ramp surface 2993 of the stop 2992 has not yet contacted the ramp surface 2996 of the stiffening hub 2754. Therefore, the additional force exerted when the ramp surfaces 2993 and 2996 interact with each other may not have any effect on the deployment of the upper actuator 2755.

[0379] As shown in Figure 58A, in some embodiments, the ramp surfaces 2993, 2996 may be at shallow angles, such that the interaction of the ramp surfaces 2993, 2996 can create less resistance to the forward movement of the stiffening hub 2754. In the illustrated embodiment, the upper housing element 2752t and the stiffening hub 2754 are formed of a flexible (e.g., elastically flexible) material and also define a long moment arm in the longitudinal direction, and therefore can easily bend slightly away from each other as the ramp surfaces 2993, 2996 travel over each other. Such interaction can occur shortly after the user engages the stiffening hub 2754 to continue deploying the system 2700. The stage in which the ramp surfaces 2993, 2996 interact with the upper housing element 2172t and the stiffening hub 2754 in opposite directions and bend outward (to a slight degree) is not shown.

[0380] Figure 51CThe subsequent stage is shown, in which the stiffening hub 2754 has been advanced just past the stop 2992, and both the housing 2752 and the stiffening hub 2754 have rapidly retracted to an orientation substantially parallel to each other. In some cases, only a faint or inaudible sound may be produced, and / or when this rapid retraction occurs, the user may only detect a slight difference in thrust to avoid confusion about when the fully deployed system 2700 and the conduit hub 2741 audibly and rapidly retract into the conduit connection hub 2745. In fact, in the illustrated embodiment, all interactions between the ramp surfaces 2993, 2996 are completed before the conduit hub 2741 contacts the resilient, flexible gripping arm of the conduit connection hub 2745.

[0381] Figure 51D As shown, the stiffening hub 2754 has been further advanced to contact the inner surface of the gripping arm of the conduit-connected hub 2745. In some cases, the increase in force required to push through the inner protrusion of the arm relative to the force used during all previous deployment phases can be perceptible in order to provide the user with tactile feedback on the construction status of the hub assembly 2149.

[0382] Figure 51E An operational state is shown in which the resilient arm of the catheter connection hub 2745 has rapidly retracted to engage with the catheter hub core 2741. In this embodiment, the fully deployed orientation of the system 2700 is shown.

[0383] Figure 51F Another operational phase is shown, in which the upper actuator 2755 has retracted away from the conduit connection hub 2745. In some cases, moving the upper actuator 2755 in this manner can facilitate the removal of the conduit connection hub 2745 from the housing 2752. The view also shows that as the upper actuator 2755 moves rearward, it does not engage the stiffening hub 2754, thus the stiffening hub 2754 remains in its forward-facing fully deployed position.

[0384] Figure 51G and Figure 51H A later operational phase is shown, in which the insertion component 2709 has been removed from the catheter assembly 2749 while the catheter assembly remains in place to position the catheter at its indwelling location in the blood vessel. For example, in some cases, the user may use one hand to keep the catheter assembly 2749 stable or stationary relative to the patient while using the other hand to withdraw the insertion component 2709 from the catheter assembly 2749.

[0385] like Figure 51GAs shown, in this embodiment, the stiffening hub 2754 is allowed to move proximally relative to the housing 2752 to a certain extent, but is prevented from fully retracting to the starting position by a stop 2992 (specifically, by the engagement surface 2994 of the stop 2992). Thus, the significant length of the stiffening member 2706 extends distally beyond the distal end 2726 of the needle 2704 to protect the needle tip from accidental contact (e.g., preventing accidental needle insertion into the user).

[0386] like Figure 51H As shown, the catheter assembly 2749 that can be retained in the patient's body may include a deployed catheter 2702, a catheter hub 2741, a sealing member 2743, and a catheter connection hub 2745.

[0387] Refer again Figure 51C In some embodiments, system 2700 may be resettable. In other words, the check valve feature or stop 2992 may be selectively covered to allow the device to reset. In an illustrated embodiment, the stiffening hub 2754 can be moved proximally past the stop 2992 and back to the upper housing element 2752t and stiffening hub 2754 by bending the upper housing element 2752t and stiffening hub 2754 away from each other. Figure 51A The device is reset to its initial position. In some cases, even after the adhesive between the catheter tip and the needle has broken, the system 2700 can be used in the reset state to advance the catheter into the blood vessel. For example, in some cases, the support provided by the stiffener 2706 may be sufficient to help push the catheter tip through the vessel wall.

[0388] Figure 52 An embodiment of kit 3000 for deploying a catheter into a patient's blood vessel is shown, or in other words, an embodiment of catheter delivery kit 3000 is shown. Kit 3000 may include any catheter delivery system and / or components thereof disclosed herein, or alternative components thereof. For example, in the illustrated embodiment, kit 3000 includes catheter delivery system 2700.

[0389] Kit 3000 may include instructions for use 3002, which may provide instructions regarding any methods or processes disclosed herein. For example, instructions for use 3002 may describe any methods and / or other parts of this disclosure.

[0390] In various implementations, Kit 3000 (specifically, Instructions for Use 3002) may be approved or authorized by a regulatory authority in a particular jurisdiction. For example, Kit 3000 and its Instructions for Use 3002 may be approved or authorized by the U.S. Food and Drug Administration and / or may comply with the regulations of other jurisdictions, such as CE marking in the European Union. Instructions for Use 3002 and System 2700 may be incorporated into any suitable package 3004.

[0391] Other features and advantages of the various embodiments will now be discussed. In some embodiments, due to the presence of a sheathed cannula, the distal end of the catheter (e.g., in the region distal to the distal end of the sheathed cannula) includes more material. In other words, for a given outer diameter catheter, some embodiments disclosed herein have a smaller opening and also more material in the inclined region compared to a standard needle catheter device. Although, as previously mentioned, flow may be potentially restricted in some of these arrangements, such embodiments can benefit from other advantages.

[0392] For example, in standard needle catheter systems, the catheter wall thickness is substantially constant from the proximal region to the distal end. However, in some embodiments disclosed herein, the catheter includes an internal stepped region at the distal end, resulting in more material at the distal end, i.e., a thicker catheter wall along the longitudinal length of the distal end (e.g., in the transverse direction), which extends posteriorly (in the proximal direction) from a substantially sharp (cross-sectional) end to a transverse sheath cannula engagement flange, where the wall thickness can become substantially constant as with other catheter devices.

[0393] To avoid fish-mouth formation, some standard catheter devices have strong catheter-to-needle adhesion at the distal end. This makes it difficult to push the catheter away from the needle. The practitioner must apply force until the adhesive breaks, thus giving the practitioner poor tactile feedback on what is happening at the distal end of the catheter during the insertion event. For example, during the initial insertion phase of advancing the catheter into the blood vessel, the sudden change in force caused by the breaking of the adhesive used to initiate catheter-needle separation shields other forces.

[0394] Some embodiments disclosed herein do not require strong adhesion to avoid fishmouth formation. That is, the additional material and geometry at the distal ends of at least some of the catheters disclosed herein produce stronger distal ends (with greater crush strength, etc.) that are less prone to deformation (such as fishmouth formation). Therefore, much lower adhesive strength can be used / is present, which can result in smoother deployment or less force fluctuation. This provides practitioners with improved tactile feedback that is less likely to be masked by initial adhesion failure.

[0395] Furthermore, the stronger distal tip is less prone to collapse during aspiration. Even when the catheter is made of a relatively soft material, this additional material and the strength provided by its structure can resist closure of the distal tip during aspiration. However, the effect is far less pronounced than in standard catheter systems in terms of any tendency to collapse.

[0396] Generally speaking, including notched needles in standard needle-passing catheter systems, for example for rapid detection purposes, is disadvantageous because it weakens the needle tip. Standard catheter systems use such small needles, and the weakening effect introduced by such notches allows undesirable movement of the needle tip (e.g., lateral deflection) during placement. This weakening effect can even lead to rupture. Given the toughness of the vessel wall, this effect can be significant.

[0397] However, the embodiments disclosed herein enhance the notched needle for rapid detection. For example, in some embodiments, a sheath cannula surrounds the needle, for instance, in areas both proximal and distal (important) to the notch. Thus, the sheath cannula counteracts forces that might otherwise deflect the notched needle. This results in a stronger, more accurate, and easier-to-use system.

[0398] Some implementations allow the use of extremely flexible catheters. Some implementations are pulled into the blood vessel from their distal end via sheathed cannula, thus achieving any stiffness requirements for advancement into the blood vessel via sheathed cannula rather than catheter, rather than pushing these implementations into the blood vessel with a guidewire, which requires inherent stiffness sufficient for such proximal advancement.

[0399] Certain implementations are well-suited for use as delivery catheters through blood vessels that include one or more valves. In fact, valve penetration can be achieved without prior advancement of a guidewire or other guiding element before the catheter. Catheters reinforced with stiffeners can be rigid enough to penetrate valves without assistance. As previously described, in some implementations, the distal tip of the catheter may be located at the most distal end of the system (e.g., distal to the distal end of the stiffener) throughout the entire time the catheter is deployed to the final target site within the blood vessel via a needle. In some cases, the catheter tip may be relatively flexible and substantially non-invasive.

[0400] Those skilled in the art will understand that changes can be made to the details of the above embodiments without departing from the basic principles presented herein. For example, various embodiments or any suitable combination of their features are contemplated.

[0401] While the foregoing detailed descriptions contain numerous details for illustrative purposes, those skilled in the art will recognize that many modifications and alterations can be made to these details, and such modifications and alterations are considered to be included herein. Therefore, the description of the above embodiments does not diminish the generality of any of the listed claims, nor does it limit any of the listed claims. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0402] Any method disclosed herein includes one or more steps or actions for performing the method. These method steps and / or actions are interchangeable. In other words, the order and / or use of specific steps and / or actions may be modified unless the correct operation of the implementation requires a specific sequence of steps or actions.

[0403] As used in this specification and the appended claims, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include plural references. Thus, for example, reference to “a layer” may include multiple such layers.

[0404] In this disclosure, the terms “comprising,” “including,” “containing,” “having,” etc., may have the meanings described in U.S. Patent Law and may mean “covering,” “containing,” etc., and are generally interpreted as open-ended terms. The terms “composed of” or “consisting of” are closed-ended terms and include only the component structures, steps, etc. specifically listed in conjunction with such terms, as well as those component structures, steps, etc. that comply with U.S. Patent Law.

[0405] In the specification and claims, the terms “first,” “second,” “third,” “fourth,” etc. (if any) are used to distinguish similar elements and are not necessarily used to describe a specific sequence or time order. It should be understood that such terms are interchangeable where appropriate, allowing embodiments described herein to operate, for example, in orders other than those shown or otherwise described herein. Similarly, if a method described herein comprises a series of steps, the order of such steps presented herein is not necessarily the only possible order in which such steps can be performed, and it may be possible to omit some of the steps, and / or to add other steps not described herein to the method.

[0406] In this specification and claims, the terms “left,” “right,” “front,” “back,” “top,” “bottom,” “above,” “below,” etc. (if any) are used for descriptive purposes and are not necessarily used to describe permanent relative positions. It should be understood that the terms thus used are interchangeable where appropriate, such that the embodiments described herein can operate in orientations other than those shown or otherwise described herein. As used herein, the term “connection” is defined as a direct or indirect connection in any suitable manner. Objects described herein as “adjacent” to each other may be in direct contact with each other, close to each other, or in the same general area or region, as applicable to the context in which the phrase is used. The phrases “in one embodiment” or “in one aspect” appearing herein do not necessarily all refer to the same embodiment or aspect.

[0407] As used herein, the term "substantially" refers to the extent or degree of completeness or near-completeness of an action, characteristic, attribute, state, structure, item, or result. For example, a "substantially" closed object would mean that the object is completely or nearly completely closed. In some cases, the exact permissible deviation from absolute completeness may depend on the specific context. However, in general, near-completeness will result in the same overall result as achieving absolute or complete completeness. The use of "substantially" also applies when used in a negative sense, referring to the complete or near-complete absence of an action, characteristic, attribute, state, structure, item, or result. For example, a composition "substantially free of" particles is either completely free of particles or almost completely free of particles; the effect of almost completely free of particles will be the same as the effect of completely free of particles. In other words, a composition "substantially free of a component or element" may still actually contain such an item, provided there is no measurable effect.

[0408] As used herein, the term "about" is used to provide flexibility for the endpoints of a numerical range by assuming that a given value may be "slightly higher" or "slightly lower" than the endpoint. Furthermore, references to approximations, such as those using the terms "about," "approximately," or other terms (used throughout this specification), should be understood that in some embodiments, values, features, or characteristics may be specified without approximations. For example, in the use of modifiers such as "about," "substantially," and "roughly," these terms, within their scope, include words that qualify in the absence of their modifiers. For example, in the use of the term "substantially perpendicular" relative to a feature structure, it should be understood that in other embodiments, the feature structure may have a precisely perpendicular orientation.

[0409] As used herein, for convenience, multiple items, structural elements, components, and / or materials may be presented in a common list. However, these lists should be understood to mean that each member in the list is individually identified as a separate and unique member. Therefore, no individual member in such a list should be construed as substantially equivalent to any other member in the same list solely based on its presentation in a common group, without the contrary indication.

[0410] Concentration, quantity, and other numerical data may be represented or presented in range format herein. It should be understood that this range format is used merely for convenience and brevity, and therefore should be flexibly interpreted to include not only the values ​​explicitly listed as range limits, but also all individual values ​​or subranges covered within that range, as if each value and subrange were explicitly listed. For example, the numerical range “about 1 to about 5” should be interpreted to include not only the explicitly listed values ​​of about 1 to about 5, but also individual values ​​and subranges within the specified range. Thus, the numerical range includes individual values ​​such as 2, 3, and 4; and subranges such as 1 to 3, 2 to 4, and 3 to 5, as well as the individual values ​​1, 2, 3, 4, and 5.

[0411] The same principle applies to ranges where only one value is considered as the minimum or maximum. Furthermore, this interpretation should apply regardless of the breadth of the range or characteristic being described.

[0412] Throughout this specification, the phrase "an example" (if any) means that a specific feature, structure, or characteristic described in connection with that example is included in at least one embodiment. Therefore, the phrase "in an example" appearing throughout this specification does not necessarily refer to the same embodiment.

[0413] Throughout this specification, the references to "an embodiment" or "the embodiment" mean that a specific feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, not all references or variations thereof listed throughout this specification necessarily refer to the same embodiment.

[0414] Similarly, it should be understood that in the foregoing description of the embodiments, for the purpose of simplifying this disclosure, various features may sometimes be combined together in their individual embodiments, drawings, or descriptions. However, this approach of the disclosure should not be construed as reflecting an intention to claim more features than are expressly mentioned in any claim. Rather, aspects of the invention lie in combinations of features fewer than all features of any single embodiment of the foregoing disclosure.

[0415] In the claims, the use of the term "first" in relation to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements specifically described in the means plus function format (if any) are intended to be understood as conforming to 35 U.S.SC §112(f). Elements not presented in the necessary means plus function format (if any) are not intended to be understood as conforming to 35 U.S.SC §112(f). Embodiments of the invention in which proprietary attributes or privileges are claimed are defined as follows.

Claims

1. A catheter delivery system, comprising: Needle hub; A needle fixedly attached to the needle hub, the needle including a distal end configured to be inserted into a patient's blood vessel, the needle defining an outer surface; A conduit connecting hub that can be releasably connected to the needle hub; The catheter includes a distal end and an inner surface, the inner surface defining a lumen therein in which a portion of the needle is positioned, the distal end of the needle being located distal to the distal end of the catheter, the catheter further including a reduced-diameter capture region extending inwardly at the distal end of the catheter; A stiffening hub, which is connected to the needle hub, thereby enabling it to move relative to the needle hub from a retracted position to a forward position; and A longitudinally extending stiffener, fixedly attached to a stiffener hub, allows the stiffener hub, the stiffener, and the catheter to move relative to the needle hub when the catheter connection hub is connected to the needle hub, as the stiffener hub moves from the retracted position to the forward position. The stiffening member is positioned between the outer surface of the needle and the inner surface of the catheter. The stiffener includes a distal end that engages the capture region of the catheter when the catheter and the stiffener are inserted into the patient's blood vessel above the needle. The stiffener is configured to detach from the catheter and translate proximally relative to the catheter to position the catheter within the patient's blood vessel as the stiffener is withdrawn from the catheter in the proximal direction.

2. The system of claim 1, wherein the conduit hub is connected to the needle hub via a connection interface.

3. The system of claim 1, wherein when the conduit connection hub is connected to the needle hub, the stiffening hub is movable from a retracted position to a deployed position.

4. The system of claim 3, wherein the capture region of the conduit includes an inner guide surface that contacts the distal end of the stiffener.

5. The system of claim 4, wherein the capture region defines a distal guide recess, the distal guide recess being sized to accommodate at least a portion of the distal end of the stiffener.

6. The system of claim 1, wherein the capture region of the conduit includes an inner guide surface that contacts the distal end of the stiffener.

7. The system of claim 1, wherein the capture region defines a distal guide recess, the distal guide recess being sized to accommodate at least a portion of the distal end of the stiffener.

8. The system of claim 1, wherein the conduit includes a recess in the distal end, and the distal end of the stiffener is received in the recess.

9. The system of claim 8, wherein the recess is formed by a mandrel during the tilting process performed before the stiffener is inserted into the lumen of the conduit.

10. The system of claim 8, wherein the recess is formed directly by the stiffener when the end of the conduit is reshaped onto the stiffener during tilting.

11. The system of claim 8, wherein the recess is formed directly by the stiffener when the end of the conduit is reshaped onto the stiffener during tilting.

12. The system of claim 1, wherein the catheter defines an end port through which the needle extends when the system is in an undeployed state, and wherein the catheter defines a plurality of side ports that extend through the sidewall of the catheter at the distal end of the catheter.

13. The system of claim 1, wherein the maximum outer diameter of the conduit is not greater than 1.2 mm, the diameter of the end port is not greater than 70% of the maximum outer diameter of the conduit, and wherein the distal end of the conduit is capable of delivering water at a flow rate of not less than 3 ml / s without breaking.

14. The system of claim 1, wherein the catheter and the stiffener cooperate to define an elongated annular lumen through which blood flash can flow proximally when the distal end of the needle is inserted into the patient’s blood vessel, and wherein the passage extends through the sidewalls of the needle and the sidewalls of the stiffener to allow blood to flow from a location within the needle into the elongated annular lumen.

15. The system of claim 14, wherein the needle defines an opening, and the stiffener defines an opening that is aligned to form the passage.

16. The system of claim 1, wherein each of the needle, the catheter, and the stiffener comprises an elongated tube, and wherein all of the tubes are coaxial.

17. The system of claim 16, wherein when the needle and the stiffener are positioned within the conduit, the needle and the stiffener are rotatably locked relative to each other.

18. The system according to claim 1, further comprising: A catheter assembly, the catheter assembly including the catheter and the catheter connection hub; and An insertion assembly, the insertion assembly including a needle hub, the needle, the stiffening hub, and the stiffening member.

19. The system of claim 18, wherein the needle hub is configured to disengage from the catheter connection hub to allow the insertion assembly to be removed from the catheter assembly after the catheter is deployed.

20. The system of claim 1, wherein the stiffening hub includes or is coupled to an actuator, and wherein movement of the actuator enables movement of the stiffening hub and the stiffener relative to the needle.

21. The system of claim 20, wherein distal movement of at least a portion of the actuator enables simultaneous distal movement of the stiffener and the catheter relative to the needle.

22. The system of claim 21, wherein the catheter hub is configured to be released from the actuator after the catheter and the stiffener have been advanced distally over the distal end of the needle, and wherein proximal movement of the needle hub relative to the catheter hub simultaneously moves the needle and the stiffener proximally to remove them from the lumen of the catheter.

23. The system of claim 22, wherein the stiffening hub is configured to be locked in a distal position, and wherein when the stiffening hub is locked in the distal position, the stiffening member is locked relative to the needle hub in a fixed relationship.

24. The system of claim 23, wherein when the stiffening hub is locked in the distal position, the stiffening shields the distal end of the needle.

25. The system of claim 21, wherein the actuator is configured to achieve the distal movement by manual movement of at least a portion of the actuator.

26. The system of claim 25, wherein the needle hub includes a track, and during the manual movement, the at least portion of the actuator is constrained to move distally along the track.

27. The system of claim 21, wherein the actuator includes a biasing member configured to automatically achieve the distal movement when the actuator is actuated.

28. The system of claim 27, wherein the biasing member comprises a spring.

29. The system of claim 20, wherein when the actuator is in an unactuated orientation, the catheter hub is positioned inside the needle hub, and wherein actuation of the actuator moves the catheter hub to a position outside the needle hub.

30. The system of claim 18, wherein the conduit connection hub comprises a Luer connector.

31. The system of claim 18, wherein when the system is in an undeployed state, the conduit extends through the conduit connection hub.

32. The system of claim 18, wherein the catheter includes a side port extending at an angle relative to a central longitudinal axis defined by the catheter.

33. The system of claim 20, wherein the needle hub includes a guide, a portion of the catheter is positioned within the guide, and wherein the guide is configured to inhibit lateral movement of the portion of the catheter when the actuator is activated to advance the catheter into the patient's blood vessel.

34. The system of claim 1, wherein the movement of the stiffening hub from the retracted position to the forward position deploys the distal end of the stiffening member distally past the distal end of the needle to shield the end of the needle.

35. The system of claim 20, wherein actuation of the actuator deploys the distal end of the stiffener to a position distal to the distal end of the needle to shield the end of the needle.

36. The system of claim 35, wherein actuation of the actuator locks the distal end of the stiffener at the position distal to the distal end of the needle.

37. The system of claim 36, wherein when both the needle and the stiffener are removed from the lumen of the catheter, the actuator continues to lock the distal end of the stiffener at the position distal to the distal end of the needle.

38. The system of claim 35, wherein the distal end of the stiffener includes a tube that surrounds the distal end of the needle when the distal end of the stiffener is moved to a position distal to the distal end of the needle.

39. The system of claim 1, wherein the stiffening member has bending strength greater than that of the conduit.

40. The system of claim 39, wherein the bending strength of the stiffener is less than the bending strength of the needle.

41. The system of claim 1, wherein when the catheter is inserted into the patient's blood vessel, the distal end of the stiffener applies a distal guiding force on the distal end of the catheter.

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