EP2571562A1

EP2571562A1 - Integrated vascular delivery system with safety needle

Info

Publication number: EP2571562A1
Application number: EP11784270A
Authority: EP
Inventors: Adrienne R. Harris; Steven B. White; Elyse Kemmerer; Nathan Farrell; Henry J. H. Brown; Ronald D. Duis
Original assignee: Tangent Medical Technologies Inc
Current assignee: Tangent Medical Technologies Inc
Priority date: 2010-05-19
Filing date: 2011-05-19
Publication date: 2013-03-27
Also published as: EP2571562A4

Abstract

An integrated vascular delivery system and safety needle including: a frame having a catheter hub providing a first anchoring point and that receives a catheter that transfers fluid at an insertion site, and a stabilization hub providing a second anchoring point; a fluidic channel coupled to the catheter; a housing; a needle insertable through the frame; and a sheath telescopically engaged with the housing. The sheath couples to the frame such that needle removal from the frame transitions the sheath from a retracted position, in which the sheath exposes the needle, to an extended position in which the sheath surrounds the needle. The frame operates in a folded configuration in which each hub couples to the housing and/or sheath and in an unfolded configuration in which the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

Description

INTEGRATED VASCULAR DELIVERY SYSTEM WITH SAFETY NEEDLE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application number

61/356,776 filed 21-JUN-2010, 61,352,220 filed 07-JUN-2010, 61/407,777 filed 28- OCT-2010, 61/448,132 filed oi-MAR-2011, 61/346,292 filed 19-MAY-2010, 61/407,797 filed 28-OCT-2010, 61/418,349 filed 30-NOV-2010, 61/438,774 filed 02-FEB-2011, 61/418,352 filed 30-NOV-2010, 61/438,778 filed 02-FEB-2011, 61/418,354 filed 30- NOV-2010, 61/438,781 filed 02-FEB-2011, 61/442,456 filed 14-FEB-2011, 61/418,358 filed 30-NOV-2010, 61/438,782 filed 02-FEB-2011, 61/448,318 filed 02-MAR-2011, and 61/448,140 filed oi-MAR-2011. This application also claims the benefit of U.S. Application numbers 13/111,693 filed 19-MAY-2011 and 13/111,716 filed 19-MAY-2011. Each of these 17 provisional applications and 2 nonprovisional applications is incorporated in its entirety by this reference.

TECHNICAL FIELD

[0002] This invention relates generally to the medical field, and more specifically to an improved integrated vascular delivery system with safety needle in the medical field. BACKGROUND

[0003] Patients undergoing medical treatment often require a form of intravenous

(IV) therapy, in which a fluid is administered to the patient through a vein of the patient. IV therapy is among the fastest ways to deliver fluids and medications into the body of the patient. Intravenously infused fluids, which typically include saline, drugs, blood, and antibiotics, are conventionally introduced to the patient through a catheter positioned at any of several venous routes, such as peripheral veins and central veins. Typically, the catheter and associated tubing are secured directly against the skin of the patient with tape or similar catheter stabilization devices (CSDs) such as adhesive stabilizing pads that restrain the catheter body. However, conventional devices and methods for IV therapy have drawbacks. Extension tubing may catch on nearby obstacles during patient movement or caregiver manipulation, which may cause painful vein irritation and compromise the IV. Tape and other existing CSDs are not optimal for stabilization because securing the round, rigid and bulky components against the skin can be difficult and ineffective. Tape and other existing CSDs do not fully prevent the catheter from moving within the vein, which leads to patient-endangering complications including catheter dislodgement, infiltration (fluid entering surrounding tissue instead of the vein), and phlebitis (inflammation of the vein). Adhesive stabilizing pads tend to result in other undesired effects, such as skin irritation and/or breakdown due to prolonged concentrated adhesion to the skin. Furthermore, tape and current CSDs do not prevent the catheter from painfully and dangerously pivoting around the insertion site and moving within the vein.

[0004] Furthermore, the placement of catheter devices typically utilizes needles that are inserted into the patient. By contacting body tissue and fluids such as blood, such needles carry biohazard risks including cross-contamination and transmission of blood-borne diseases, as well as accidental needle punctures inflicted on a user of the medical device.

[0005] Thus, there is a need in the medical field to create an improved vascular delivery system and safety needle that overcomes one or more of the drawbacks of the conventional vascular delivery systems. This invention provides such an improved vascular delivery system with safety needle.

BRIEF DESCRIPTION OF THE FIGURES

[0006] FIGURE l is an overview schematic of the integrated vascular delivery system with safety needle;

[0007] FIGURES 2-5 are variations of the integrated vascular delivery system;

[0008] FIGURES 6-14 are variations of means for coupling the catheter hub and stabilization hub in the integrated vascular delivery system;

[0009] FIGURES 15-21 are variations of a septum in the integrated vascular delivery system with safety needle;

[0010] FIGURES 22-27 are variations of a needle blunter mechanism in the integrated vascular delivery system; [0011] FIGURES 28A and 28B are schematics of the retracted and extended positions, respectively, of the safety needle system of a first preferred embodiment coupled to a catheter hub;

[0012] FIGURES 29-32 are schematics of the housing in the safety needle system of a first preferred embodiment;

[0013] FIGURES 33A-33C are variations of the needle in the safety needle system;

[0014] FIGURES 34A-34F are schematics of the sheath in the safety needle system of a first preferred embodiment;

[0015] FIGURES 35A-35F are schematics of the slider in the safety needle system of a first preferred embodiment;

[0016] FIGURES 36A-36B and 37A-37B are schematics of variations of the sheath in the safety needle system of a first preferred embodiment;

[0017] FIGURES 38A-38C are schematics of the coupling between the sheath, slider, and housing during use of the safety needle system of the first preferred embodiment;

[0018] FIGURES 39 and 40 are schematics of the "closed" and "open" configurations of the jaws in the sheath of a variation of the safety needle system of the first preferred embodiment;

[0019] FIGURES 41A-41F are schematics of the slider of a variation of the safety needle system of the first preferred embodiment; [0020] FIGURES 42A and 42B are schematics of the retracted and extended positions, respectively, of the safety needle system of a second preferred embodiment;

[0021] FIGURES 43A-43C are schematics of the housing of the safety needle system of a second preferred embodiment;

[0022] FIGURES 44-46 are variations of the sheath in the safety needle system of a second preferred embodiment;

[0023] FIGURES 47 and 48 are variations of the locking mechanism in the safety needle system of a second preferred embodiment;

[0024] FIGURES 49-50 are schematics of a method of assembling the safety needle system of a second preferred embodiment;

[0025] FIGURES 51-56 are schematics of a sheath septum in the safety needle system;

[0026] FIGURE 57 is a schematic of a vent chamber in the safety needle system;

[0027] FIGURES 58-60 are schematics of a needle protection cap in the integrated vascular delivery system with safety needle; and

[0028] FIGURES 61-70 are schematics of a method of stabilizing a catheter using the integrated vascular delivery system with safety needle.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The following description of preferred embodiments of the invention is not intended to limit the invention to these preferred embodiments, but rather to enable any person skilled in the art to make and use this invention. [0030] As shown in FIGURE l, the integrated vascular delivery system 100 with safety needle of a preferred embodiment includes: a frame no having a catheter hub 120 configured to receive a catheter 122, a stabilization hub 130, and at least one lateral member 140 extending between the catheter hub and stabilization hub; a fluidic channel 150 that fluidically communicates with the catheter; a housing 310 including a needle mount; a needle 320 having a distal end insertable through the frame and a proximal end coupled to the needle mount; and a sheath telescopically engaged with the housing. The catheter hub 120 preferably provides a first anchoring point 112 on the patient and is configured to receive a catheter 122 insertable in a patient to transfer fluid at an insertion site 102, and the stabilization hub 130 preferably provides a second anchoring point 112' on the patient. The frame 110 preferably operates in a folded configuration 114 in which the catheter and stabilization hubs may be coupled, and in an unfolded configuration 116 in which the first and second anchoring points are distributed around the insertion site 102 to anchor the frame 110 to the patient, thereby stabilizing the catheter. For instance, in a preferred embodiment the first and second anchoring points are on opposite sides of the insertion site, such as proximal and distal to the side, or on opposite lateral sides of the insertion site. The sheath operates in a retracted position in which the sheath exposes the distal end of the needle and an extended position in which the sheath substantially surrounds the distal end of the needle. The sheath is preferably coupleable to the frame such that removal of the needle from the frame draws the sheath over the needle, thereby transitioning the sheath to the extended position. The system 100 preferably includes a catheter 122, such as a catheter embedded in the catheter hub 120, but may the system may alternatively be configured to receive and/or couple to a separate catheter before or after insertion into the patient.

[0031] The integrated vascular delivery system may be used to obtain access to a blood vessel of a patient, such as one undergoing intravenous (IV) therapy. The system may be used to administer drugs, antibiotics, saline, blood, or any suitable fluid to a patient, and/or to remove fluid from the patient. The system may be used to create, stabilize, and maintain an IV line at an insertion site on a peripheral vein or artery such as on the arm, hand, or leg, or for central venous access on the neck, chest, abdomen, or any suitable IV location. However, the system may be used to create, stabilize, and maintain any suitable catheter-based access to a patient, such as catheters for transfer of cerebrospinal fluid. Use of the safety needle may reduce the risk of cross-contamination and infection from bodily fluids and other biohazards, and reduce risk of accidental needle injuries to a user handling the medical device.

1. Integrated vascular delivery system

[0032] The frame 110 of the integrated vascular delivery system functions to stabilize the system and the catheter on the patient. As shown in FIGURES 2-3, the frame 110 preferably includes a catheter hub 120 that provides a first anchoring point 112 on the patient, a stabilization hub 130 that provides a second anchoring point 112' on the patient, and at least one lateral member 140 that extends between the catheter and the stabilization hubs. In alternative embodiments of the frame 110, the frame may include any suitable number of hubs and any suitable number of lateral members, such that the frame forms an enclosed or partial, non-enclosed perimeter of any suitable shape and size around the insertion site 102. The frame preferably allows visualization of the insertion site of the catheter, such as by leaving an open uncovered area around the catheter, although alternatively the system may include a cover that is transparent, translucent, opaque, or any suitable kind of materials, that extends over the frame to cover the insertion site and/or catheter.

[0033] The catheter hub 120 is configured to receive a catheter 122, which may be embedded in the catheter hub and integrally part of the system, or may be a separate catheter that is coupled to the catheter hub 120 before or after insertion into the patient, such as with a snap fit into the catheter hub 120. Alternatively, any suitable portion of the frame may be configured to receive the catheter. The catheter hub 120 preferably includes a channel 124, concentrically aligned with the catheter, that may receive a needle 320 used during insertion of the catheter into the patient. As shown in FIGURE 2D, the catheter hub and/or stabilization hub may include a sensor 126 that measures a biometric parameter such as temperature, blood pressure, or pulse rate of the patient. The sensor 126 may additionally and/or alternatively sense any suitable parameter such as one pertaining to the fluid passing through the catheter, such as pH or flow rate.

[0034] The catheter hub and/or stabilization hub may have a relatively wide and thin profile, which may help distribute forces over a greater area on the skin and decreases the chances of the patient developing skin irritations, sores, and other degradations. The thin profile may help decrease the risk of the risk of the hub catching or snagging on bed equipment or other nearby obstacles that could cause the catheter to move within the vein and cause complications such as catheter dislodgement, infiltration, and phlebitis. However, the catheter and stabilization hubs may have any suitable shape. The catheter and stabilization hubs may include a rigid or semi-rigid plastic or other suitable material, and/or softer material. For example, one or both hubs may include a rigid core overmolded with a softer material such as silicone.

[0035] As shown in FIGURE 2A, the system may further include at least one extension tube 160 and/or a fluid supply adapter 162, coupled to the catheter hub 120 and/or stabilization hub 130, that delivers fluid from a fluid supply to the fluidic channel 150. The extension tube 160, which provides stress relief if the system is jostled (such as from patient movement or caregiver manipulations), is preferably made of flexible tubing such as polymer tubing, but may alternatively be a passageway made of any other suitable material. The extension tube 160 is preferably long enough to provide stress relief if needed, but short enough to reduce the chances of the extension tube catching or snagging on nearby obstacles. In another variation, the fluidic channel 150 and/or extension tube 160 may be coiled like a spring to provide stress relief. The length of the extension tube may alternatively be any suitable length, and may depend on the specific application of the system. Other dimensions of the extension tube, such as outer diameter and inner diameter, may also depend on the specific application of the system. The fluid supply adapter 162 preferably includes a connector that attaches the extension tube to a fluid supply (e.g. pole-mounted IV bag, syringe, or pump that supplies fluid through tubing). The connector may be a standard female luer lock connector (FIGURES 4A and 4B) or Y-connector (FIGURES 4C and 4D) that commonly interfaces with conventional IV bags. Alternatively, the connector may be any suitable male or female connector that is adapted to interface with a fluid supply. Furthermore, the luer lock connector or other fluid supply adapter may be coupled directly to the catheter hub and/or stabilization hub, rather than to an extension tube.

[0036] In alternative versions of the system, the system may include more than one extension tube 160 and/or fluid supply adapter 162, to facilitate delivering fluid from multiple fluid supplies simultaneously to the system. For example, in an embodiment of the system that includes two fluidic channels, the system may include a first extension tube that delivers a first fluid to a first fluidic channel, and a second extension tube that delivers a second fluid to the second fluidic channel. However, two extension tubes may useful in applications involving the administering of two separate fluids through the same fluidic channel 150 and catheter.

[0037] The lateral member 140 functions to provide structural stability to the frame 110 by stabilizing the catheter hub 120 relative to the stabilization hub 130. As shown in FIGURES 2-4, the frame preferably includes two lateral members 140 that, with the catheter and stabilization hubs, form a perimeter around the catheter. The two lateral members may be approximately parallel, or may be in any crossed, non-parallel or other suitable orientation. However, as shown in FIGURE 3, the frame 110 may include only a partial perimeter around the catheter, such as with one lateral member instead of two. Each lateral member 140 may be flexible, such as to allow the catheter and stabilization hubs to move relative to one another with a significant number of degrees of freedom, including displacement in the compression direction (and subsequent displacement in the tension direction) along the axis of the catheter, displacement in both directions along the other two axes, twisting in both directions along the axis of the catheter, and bending in both directions along the other two axes. In particular, the lateral member 140 may be reversibly bendable to allow the frame 110 to be in a folded configuration in which the catheter and stabilization hubs are coupleable. One or more lateral members may be tubular. For example, the lateral member may be a generally straight, soft, and flexible hollow channel like medical tubing, but may be any suitable structure with a lumen.

[0038] The fluidic channel 150 functions to deliver fluid from a fluid supply to the catheter, and in some embodiments, deliver fluid to and from the catheter, such as transferring fluid removed from the patient through the catheter to an external reservoir. As shown in FIGURE 2C, at least a portion of the fluidic channel 150 may be fixed within at least one of the hubs and/or within a tubular lateral member. As shown in FIGURES 5A-5C, at least a portion of the fluidic channel 150 may be additionally and/or alternatively be external to the hubs and lateral members. For instance, at least a portion of the fluidic channel 150 may be molded to an external surface of the catheter hub, the stabilization hub, and/or lateral member. The fluidic channel 150 preferably includes a turnabout portion 152 in which fluid flows in a direction different from that within the catheter 122. In particular, the turnabout portion 152 preferably directs the fluid flow to a direction opposite of that within the catheter, or in an approximately 180- degree turn. The turnabout portion 152 of the fluidic channel 150 may be fixed or embedded within the catheter hub and/or stabilization hub. In one exemplary application of the system, the catheter is inserted in the patient such that its penetrating end points proximally towards the heart of the patient, and the turnabout portion of the fluidic channel 150 allows a stand supporting the IV bag or other fluid supply to be kept near the head of a bed, or otherwise proximal to the insertion site as is typically practiced in patient treatment settings. The internalized fluid flow turn in the turnabout portion 152 of the fluidic channel 150 reduces the number of external structures that can get caught or snagged on nearby obstacles and consequently disturb the catheter and IV setup. Another effect of the turnabout portion is that if external tubing in the IV setup is pulled or caught, the turnabout portion may enable the frame 110 to stabilize the catheter more effectively by causing the catheter to be pulled further into the patient. For example, in a common catheter placement in which the catheter is placed on the forearm with its distal end pointing proximally toward the elbow of the patient, if the external tubing is accidentally pulled posteriorly towards the patient, the tubing will in turn pull the turnabout portion of the fluidic channel 150 and the catheter hub 120 toward the patient, thereby pulling the catheter further into the blood vessel of the patient rather than displacing the catheter from the insertion site.

[0039] In some variations, the system may include one, two, or any suitable number of fluidic channels. For instance, a second fluidic channel 150 may pass through a second lateral member 140. The second fluidic channel 150 preferably receives a second fluid, which may be the same or different from the first fluid supplied to the first fluidic channel 150. As shown in FIGURES 4A-4C, the system may further include a second extension tube 160 that supplies a second fluid to the frame and catheter. However, as shown in FIGURE 4D, the system may include only one extension tube 160 that supplies fluid to one or multiple fluidic channels. The fluidic channels may have separate inlets on the stabilization hub 130 (FIGURES 4 A and 4C), or may share the same inlet on the stabilization hub in which flow may be regulated with valves or other fluid control means (FIGURES 4B and 4D). In one variation, the first and second fluidic channels preferably fluidically communicate with the same catheter in the catheter hub 120, coupled to the catheter at the same point (FIGURES 4A and 4B) or different points (FIGURE 4C) along the length of the catheter or channel. In this variation, the system preferably includes a flow control system 154 that selectively restricts flow of one or both of the fluids to the catheter and therefore to the patient. The flow control system 154 may include one or more valves 156, such as at the extension tubes (FIGURES 4A and 4B), at the junction between the fluidic channel 150 and the catheter (FIGURE 4C and 4D) or any suitable location. The flow control system may additionally and/or alternatively use pressure drops, vents, or any suitable technique for controlling fluid flow among the fluidic channels and catheter. The flow control system may also be present in an embodiment that includes only one fluidic channel 150. In another variation, the first and second fluidic channels preferably fluidically communicate with a catheter with dual lumens, such that one catheter lumen is coupled to the first fluidic channel and another catheter lumen is coupled to a second fluidic channel. In yet another variation, the first and second fluidic channels fluidically communicate with separate catheters. Additional variations expand on these variations with three or more fluidic channels. [0040] As best shown in FIGURE 2D, the frame 110 preferably operates in a folded configuration 114 in which the catheter hub 120 and stabilization hub 130 may be coupled to one another and in an unfolded configuration 116 in which the first and second anchoring points are distributed around the insertion site. To facilitate a folded configuration, the frame 110 preferably allows the catheter hub 120 and stabilization hub 130 to move relative to one another with a significant number of degrees of freedom. In particular, the frame is preferably reversibly bendable or foldable to fold the catheter and stabilization hubs toward each other, or to pass one of the hubs over and/or under the other hub.

[0041] In the folded configuration 114, the catheter hub 120 and stabilization hub 130 may be coupled to one another, thereby securing the frame in a folded configuration. With the catheter and stabilization hubs coupled, the hubs experience the same movement relative to a needle 320 being passed into the catheter hub 120 and catheter, such as during insertion of the catheter in the patient. In a first variation, the catheter hub 120 and stabilization hub 130 may be coupled to one another by interaction of the needle 320 with the catheter hub 120 and/or stabilization hub 130. In one example of this variation, as shown in FIGURES 6A-6D, the stabilization hub 130 includes an extension 132, and the catheter hub 120 may include a slot 128 or other recess that receives the extension 132, although in another example the catheter hub 120 may include the extension 132 and the stabilization hub 130 may include the slot 120. The extension 132 defines a through hole 134, such that when the extension 132 is inserted into the slot 128, the through hole 134 is substantially aligned with a needle- receiving channel 124 of the catheter hub 120. In this variation, the frame 110 may be folded into the folded configuration during catheter insertion into the patient by a user (e.g. medical practitioner) who couples the catheter and stabilization hubs together by passing the needle 320 through the channel 124 of the catheter hub 120 and through the through hole 134 of the extension 132. Alternatively, the frame 110 may be folded and/or the needle 320 may be passed through the extension and slot of the hubs during manufacturing, such as during assembly and/or packaging. When the needle 320 is withdrawn from the hubs, the hubs may be decoupled and the frame 110 may be unfolded into the unfolded configuration. As shown in FIGURES 7A and 7B, the extension 132 may be retractable into the hub when the extension is no longer needed, such as when the frame 110 is in the unfolded configuration and ready for securement to the patient. The catheter hub and stabilization hub may include one, two, or any suitable number of extensions and/or slots. However, the catheter hub 120 and/or stabilization hub 130 may additionally and/or alternatively interact with the needle in any suitable manner (e.g., with a housing that surrounds the needle) to facilitate selective coupling of the catheter and stabilization hubs.

[0042] In a second variation, as shown in FIGURE 9, the catheter hub 120 and stabilization hub 130 may be indirectly coupled to one another by mutually coupling to the housing. For example, as shown in FIGURE 9, in the folded configuration of the frame, the catheter hub may be coupled to the sheath and indirectly to the housing, and the stabilization hub may be coupled to the housing, thereby indirectly coupling the hubs and securing the frame in a folded configuration. [0043] In a third variation, as shown in FIGURES 10-12, the catheter hub 120 and stabilization hub 130 may be indirectly coupled to one another by mutually coupling to the sheath. In a first example, as shown in FIGURES 10A-10D, the catheter hub may be coupled to the sheath, and the stabilization hub may include an extension that is alignable with the catheter hub and/or the sheath, such that the needle passing through the sheath additionally passes through the extension and the catheter hub, thereby coupling the catheter hub and stabilization hub, somewhat similar to the first variation of hub coupling except the extension is received by the sheath. Like in the first variation of hub coupling, the extension may be retractable. In a second example, the stabilization hub may couple to the sheath by being press fit or snapped into an external features of the sheath, thereby indirectly coupling the catheter hub and stabilization hub. For instance, as shown in FIGURE 11A-11B, the sheath may include an indentation having at least a partial outline of the perimeter of the stabilization hub, such as two bumps or pegs between which the stabilization hub fits. To facilitate such a press fit or snap fit, the stabilization hub and/or sheath may include an overmold of a soft, compressible material such as silicone, isoprene, thermoplastic elastomers, or any suitable material. In a third example, as shown in FIGURE 12A-12B, the catheter hub and/or stabilization hub may couple to the sheath with a link. In this example, the stabilization hub has an extension with a through hole that, when the frame is in the folded configuration, may nest within the catheter hub or between the catheter hub and the sheath. The link may be a pin that laterally or longitudinally passes through the catheter hub, the extension in the stabilization hub, and the sheath and/or housing. However, the link may be any suitable user-controlled latch or other link that provides manual coupling for securing the folded configuration of the frame.

[0044] In a fourth variation, the catheter hub, stabilization hub, sheath, and/or housing intercouple with a latching system to secure the frame in the folding configuration and couple the sheath to the frame. For example, each of the catheter hub 120, stabilization hub 130, and sheath 330 includes at least one extension (e.g., tab or arm) or at least one slot to receive an extension of one of the other pieces such that the frame and sheath interlock. For example, as shown in FIGURES 13A-13D, the catheter hub 120 includes a slot 172 on its proximal side, the stabilization hub 130 includes a stabilization hub tab 174 on its distal side and the sheath 330 includes a sheath tab 176 and/or at least one side arm 178 extending from the distal end of the sheath. As shown in FIGURE 14, when the frame is in the folded configuration, the slot, tabs, and/or side arms interlock. In particular, (1) the sheath side arms 178 couple to the proximal end of the catheter hub (FIGURES 14A and 14B) such that the catheter hub is seated within the sheath, (2) the stabilization hub tab 174 on the inverted stabilization hub couples to the catheter hub slot (FIGURE 14C) and (3) the sheath tab 176 on the sheath couples to the stabilization hub slot (FIGURES 14D and 14E). In other examples, different parts of the frame, sheath, and needle housing may include different combinations of intercoupling extensions and slots, snaps, magnets, latches, and/or any suitable fastening mechanism.

[0045] In a fifth variation, the catheter hub 120 and stabilization hub 130 may be coupled to one another by mutually interacting a third structural element, thereby indirectly coupling to one another. For example, as shown in FIGURE 8, a block 136 may couple to both the catheter hub 120 and the stabilization hub 130 when the frame 110 is in the folded configuration. Although the block 136 is shown in FIGURE 8 to have a particular geometry, the block may include a switch, latch, plug, and/or any suitable fastener or other mechanism. Removal of the block 136 may facilitate the decoupling of the catheter hub 120 and stabilization hub, such that frame may be in the unfolded configuration. As another example, the needle 320 may couple to both the catheter hub 120 and the stabilization hub 130 when the frame is in the folded configuration, such as during catheter insertion. Following catheter insertion, removal of the needle may facilitate the decoupling of the catheter hub 120 and stabilization hub.

[0046] In a sixth variation, the catheter hub 120 and stabilization hub 130 may be coupled to one another in a slidable manner. For example, one of the hubs may have side grooves or channels, and the other hub may have side ridges that slidingly engage with the grooves of the other hub when the frame 110 is in the folded configuration. Other examples of this variation may include tabs inserted into slots, or any suitable mechanism.

[0047] In a seventh variation, the catheter hub 120 and stabilization hub 130 may be coupled to one another with snaps, latches, magnets, and/or any suitable fastener when the frame 110 is folded into the folded configuration. The fastener may be a separate piece that is mutually coupled to the catheter and stabilization hubs. Additional variations of the coupling of the catheter hub and stabilization hub include various combinations of the above variations. Furthermore, the catheter hub and stabilization hub may be coupled in any suitable manner, with or without the cooperation of the needle to help secure or lock the coupling of the catheter hub and stabilization hub.

[0048] In the unfolded configuration 116, as shown in FIGURES 2A and 2B, the catheter hub 120 and stabilization hub 130 are decoupled such that the frame 110 may be secured to the patient such that the first and second anchoring points 112 and 112' are distributed around the insertion site 102 of the catheter, thereby stabilizing the catheter. The frame 110 is preferably secured to the patient by securing the catheter hub 120 and stabilization hub 130 to the patient at the first and second anchoring points, respectively. However, the frame 110 may additionally and/or alternatively be secured by securing only the catheter hub 120, only the stabilization hub 130, the lateral members 140 and/or any suitable portion of the frame 110. The frame may alternatively stabilize the catheter at anchoring points located at any suitable locations relative to the catheter insertion site. The frame 110, when secured to the patient, enables the integrated vascular delivery system to stabilize the catheter more effectively than conventional catheter securement devices that stabilize the catheter on only one side of the insertion site, because stabilizing the catheter on two different sides of the insertion site reduces pivoting motions of the catheter that may occur during normal patient movement and/or caregiver manipulates of the IV setup. The frame 110 is preferably secured to the patient with tape, but may additionally and/or alternatively be secured with an adhesive located on the underside of the catheter hub and/or stabilization hub; an elastic strap; a strap fastened with fasteners such as hooks, hook and loop, or magnets; or any suitable securement mechanism. [0049] In one alternative embodiment, as shown in FIGURE 5A-5C, the frame 110 includes one catheter hub, two stabilization hubs located on an opposite side of the frame as the catheter hub, two lateral members each connecting the catheter and a respective stabilization hub, and a fluidic channel. In this variation, each hub provides a respective anchoring point, such that the overall frame 110 includes three anchoring points 112, 112' and 112". In other examples, the frame may include any suitable number of anchoring points distributed equally or unequally around the insertion site 102. As shown in FIGURE 5A, the catheter hub 120, stabilization hubs 130, and lateral members 140 may be integrated in a single piece. The single piece may include a single kind of material, or may include a rigid core of a first material (e.g. a rigid material such as plastic) and an outer layer of a second material (e.g. soft material such as silicone) covering the rigid core.

[0050] Other variations of catheter hub, stabilization hub, and lateral member configurations may be similar to that described in U.S. Application number 12/855,013 entitled "Integrated vascular delivery system", which is incorporated in its entirety by this reference. Furthermore, the frame may include a catheter hub and a stabilization hub, but lack a lateral member; for example, the catheter hub and stabilization hub may be coupled together in a hinged manner such that the frame can operate in folded ("closed hinge") and unfolded ("open hinge") configurations.

1.1 Hub septum [0051] The catheter hub 120 preferably further includes a catheter hub septum 200 that functions to seal the internal channel 124 of the catheter hub 120 after withdrawal of the insertion needle 320 after catheter insertion, to prevent escape or leakage of blood and other potential biohazards or other fluids from the catheter hub 120. The catheter hub septum 200 is preferably coupled to the catheter hub 120, preferably disposed within an internal channel 124 of the catheter hub, and may be concentrically aligned with the catheter. The catheter hub septum 200 is preferably coupled to the catheter hub 120 and includes a primary seal 210 and a secondary seal 212, although a septum 200 may additionally and/or alternatively be coupled to the stabilization hub. The primary seal 210 is an inner seal that functions as a first defense against fluid escaping, and the secondary seal 212 is an outer seal that functions as a second defense against fluid escaping. In some embodiments, the catheter hub septum 200 may include fewer or more seals similar to the primary and secondary seals, which may be suitable for some applications to modify the amount of fluid leakage protection. The catheter hub septum preferably defines a catheter hub septum cavity 214 between the primary and secondary seals that may contain trapped fluid that passes through the primary seal. The catheter hub septum cavity 214 may be larger than the diameter of the needle 320 to reduce frictional force on the needle during needle insertion through the catheter hub septum, thereby increasing the ease of passing the needle through the catheter hub septum. However, the cavity may alternatively be closely fit, and/or may include a material with a lower friction coefficient and/or fluid absorbent material. [0052] The catheter hub septum 200 may include an elastomeric material, and may have a diameter slightly larger than the channel 124 within the catheter hub 120, such that compression of the catheter hub septum 200, when assembled in the channel, seals the annular gap between the outer circumferential edges of the catheter hub septum and the walls of the channel within the catheter hub 120, thereby preventing fluid from escaping through the annular gap, and further maintaining the coupling between the catheter hub septum 200 and the catheter hub 120, similar to a press fit. The catheter hub septum 200 may additionally and/or alternatively include a sealant material applied to the outer edges of the septum to prevent passage of fluid between the septum and catheter hub walls, and/or be temporarily or permanently bonded to the catheter hub such as with sonic welding, chemical welding, or adhesive.

[0053] As shown in FIGURES 15A-15E, in a preferred embodiment, the septum

200 includes a rigid core 222 and a compressible plug 288 coupled to the rigid core. The rigid core is a framework that preferably includes a back wall 224 with aperture 286 and wall members 285 extending from the back wall. The back wall 224 may provide a flange that helps seat the septum 200 within the catheter hub 120. The wall members 285 are preferably substantially parallel, but may be in any suitable relative orientation that defines a gap between the wall members. The compressible plug 228 is coupled partially or wholly around the rigid core, covering or filling the aperture 286 and surrounding the wall members 285 to define a cavity 214 in a central portion of the septum. One end of the compressible plug forms the primary seal 210, and the other end of the compressible plug covering the aperture of the back wall forms the secondary seal 212. The aperture 226 of the back wall allows needle puncture access in and out of the septum cavity (and the catheter). The rigid core 222 is preferably made of a rigid plastic such as polycarbonate, acrylonitrile butadiene styrene (ABS) or other styrene, and the compressible plug 228 preferably includes an elastomeric material such as isoprene or silicone. However, the rigid core and compressible plug may include any suitable materials. The compressible plug is preferably coupled to the rigid core in an overmolding manufacturing process, but may additionally and/or alternatively include other coupling mechanisms or processes such as adhesive.

[0054] In a first variation, as shown in FIGURES 16A-16C, the septum is a split septum 230 that includes a split 232 along a portion of its length. The split longitudinally divides the septum into approximately two halves or other multiple portions. The split may terminate near the inner face of the primary seal 210, such that the split 232 travels along at least half of the length of the septum and is joined near the primary seal, but the split may alternatively be any suitable length, including along the entire length of the septum such that the septum includes two separate portions. As shown in FIGURE 16C, when the septum 230 is assembled into the catheter hub 120, the channel of the catheter hub preferably radially compresses the septum material to close the split, thereby forming the cavity 214 and the secondary seal 212. The split septum may be manufactured through injection molding, such as with a mold having a cavity complementary to the septum shape as shown in FIGURE 16B. In another example of this variation, the split may begin at the inner primary seal and continue towards the secondary seal. In yet another example of this variation, the septum may be split longitudinally along two or more lines, forming three or more split portions.

[0055] In a second variation, as shown in FIGURES 17A and 17B, the septum is a dual grommet septum 240 that includes at least two septum pieces 242 or "grommets" placed serially within the catheter hub 120. One of the septum pieces forms the primary seal 210 and another septum piece forms the secondary seal 212. The septum pieces 242 are preferably immediately adjacent to each other such that part of their interior faces are contacting and form a fluid-tight seal against the catheter hub wall. The interior faces of the septum pieces 242 may be chamfered or radiused to define the septum cavity 214 between the septum pieces, but the septum pieces may alternatively have any suitable geometry. Alternatively, the septum pieces may be separated by a distance, such that the septum cavity is at least partially formed by the walls of the catheter hub 120. In other examples of this variation, the septum may includes three or more septum pieces placed serially within the catheter hub 120, such as to provide three or more seals.

[0056] In a third variation, as shown in FIGURES 18A and 18B, the septum 250 includes at least two separate septum pieces 252 and an inner sleeve 254 disposed between the septum pieces. In this variation, two septum pieces are placed serially within the catheter hub 120, either directly adjacent to each other or separated by a distance. One of the septum pieces forms the primary seal 210 and another septum piece forms the secondary seal 212. The interior faces of the septum pieces 252 are preferably adapted to receive the inner sleeve 254, such as by defining axially aligned recesses. The inner sleeve 254 may be cylindrical and sized to fit within the recesses of the septum pieces, with an inner diameter large enough to form a cavity 214 that accommodates the diameter of the needle 320. The inner sleeve 254 is preferably rigid, and made of a thermoplastic material or any other suitable rigid material, although the inner sleeve may be made of any suitable material. In other examples of this variation, the septum may include more than two septum pieces, such as further including an outer sleeve-like septum part surrounding the inner sleeve.

[0057] In a fourth variation, as shown in FIGURES 19A-19E, the septum 260 includes a housing with first and second housing portions 264 and first and second septum pieces 262. In this variation, as shown in FIGURE 19E, the septum includes a distal half and a proximal half that is substantially a mirrored version of the distal half, with each half including a housing portion 264 and a corresponding septum piece 262. As shown in FIGURES 19A and 19B, each housing piece includes a tapered, hourglass- shaped chamber 266 for receiving a corresponding septum piece. The taper in the chamber 266 helps reduce relative movement such as translational movement between the septum piece 262 and the housing 264. Each housing piece may further include an external annular flange or other protrusion that helps reduce translational movement between the housing and the catheter hub 120. The two housing pieces 264 may be coupled together and/or to the catheter hub 120 through ultrasonic welding, epoxy or other adhesive, threads, and/or any suitable coupling mechanism. As shown in FIGURE 19C and 19D, each septum piece 262 preferably includes a cavity 263 that extends inward from one open end of the septum piece, and the septum pieces are preferably assembled such that the open ends of the septum pieces abut against each other. In this manner, the closed ends of the septum pieces form primary and secondary seals 210 and 212, respectively, of the septum 260, and the joined open ends of the septum pieces form enclosed septum cavity 214. The housing and septum pieces are preferably combined, with a corresponding septum portion nested within (e.g. molded into or pressed into) each housing portion, and the combined housing and septum pieces are preferably mounted within the catheter hub 120.

[0058] In an alternative embodiment, the septum may have only a primary seal.

In a first alternative variation of this embodiment, the septum 200 is made of a flexible material that self-seals to form a hermetic seal on the hub. This self-sealing septum prevents fluid from passing out of the catheter hub 120, contributing to a closed system in which blood and other fluids will not exit the catheter hub. In a second alternative variation, as shown in FIGURES 20 and 21, the septum 200 may be sealed with a plug, such as a stopper or sealant material applied to the septum by a user. Before and during catheter insertion the back end of the channel of the catheter hub may be left open (FIGURES 20A and 21A). After the catheter is inserted in the patient, the user may occlude the blood vessel (such as by applying external direct pressure), withdraw the needle 320 from the catheter and catheter hub 120, place a plug on the back end of the catheter hub 120 to prevent fluid flow out of the hub (FIGURES 20B and 20B), and allow the blood vessel to be in fluid communication with the catheter (such as by releasing external direct pressure on the blood vessel). The plug may include a separate stopped plug applied to the catheter hub (FIGURE 20), a sliding piece that the user slides to gate off the back of the hub (FIGURE 21), a hinged piece that the user swings to the back of the hub, and/or any suitable septum piece. Any of these single seal variations of the septum may be repeated serially to form two seals (primary and secondary) or more seals.

[0059] The septum may be one or more of the embodiments and variations described above, and/or one or more of the embodiments described in U.S. Provisional Applications 61/346,292 filed 19-MAY-2010 and 61/407,797 filed 28-OCT-2010, which is each incorporated in its entirety by this reference. Furthermore, the septum may be any suitable mechanism that helps prevent escape or leakage of fluid from the catheter hub 120.

1.2 Needle shield

[0060] As shown in FIGURES 22-27, the catheter hub 120 and/or stabilization hub 130 may include a needle shield 190. The needle shield 190 functions to blunt, or protect the user from, the distal end of the needle 320 after the needle is withdrawn from the catheter and catheter hub after catheter insertion. The needle shield 190 helps prevent accidental needle sticks to the user and the transfer of biological hazards. The needle shield 190 is preferably coupled to the catheter hub 120 and/or stabilization hub 130, but may additionally and/or alternatively be coupled to any suitable portion of the system. The needle shield 190 is preferably a clip such as a spring clip, but may alternatively include any suitable blunting mechanism such as a cap. In general, during insertion of the catheter into the patient, the needle 320 passes through an inactive needle shield 190 and into the catheter (e.g., FIGURE 22A). After the catheter is placed in the patient, the needle 320 is withdrawn from the catheter in a proximal direction and engages with the needle shield 190, such as due to interaction with a needle catch 106 on the needle 320. After the needle catch 106 engages with the needle shield, the needle shield is triggered to decouple from the catheter hub and/or stabilization hub and cover or blunt the distal end of the needle (e.g., FIGURE 22B). The now active needle shield 190 continues to cover the distal end of the needle 320 as the needle is further withdrawn and removed from the catheter hub 120. The needle catch 106 that triggers decoupling of the needle shield 190 from the hub may be one or more of several variations. In one variation, the needle catch 106 may be an annular structure around the needle body that catches on a portion of the needle shield 190 as the needle is withdrawn from the hub. In another variation, the needle catch 106 may include barbs that allow free passage of the needle through the needle shield 190 when the needle passes into the catheter hub 120, but catch on the needle shield 190 when the needle withdraws from the catheter hub 120. Alternatively, the needle catch 106 may be located on the needle shield 190. However, any suitable variation of the needle catch 106 that facilitates the engagement of the needle and the needle shield 190, and the disengagement of the needle shield from the hub, may be used.

[0061] The needle shield 190 may be configured in one or more of several arrangements. In a first embodiment, the needle shield 190 is coupled to the catheter hub 120. In a first variation of this first embodiment, the needle shield is removably coupled to an internal portion of the catheter hub 120. For example, the needle shield 190 may be coupled to an internal surface of a proximal portion of the catheter hub 120 (FIGURES 22 and 24), a distal portion of the catheter hub 120 or any suitable internal surface of the catheter hub. As shown in FIGURE 22, the needle shield 190 may be coupled to an internal surface of the catheter hub recessed within the catheter hub, or as shown in FIGURE 24, the needle shield 190 may be coupled to an internal surface of the catheter hub approximately flush with an external surface of the catheter hub, such as adjacent to the stabilization hub when the frame is in the folded configuration. As another example, the needle shield 190 may be engaged within the catheter hub 120 proximal to the septum 170 (FIGURE 23A), and/or distal to the septum 170. As another example, the needle shield is engaged within the septum 170 of the catheter hub (FIGURE 23B), such as within the cavity, a slit, or other suitable receptacle within the septum. As yet another example, the needle shield 190 may be adjacent to a flash chamber 192.

[0062] In a second variation of the first embodiment, the needle shield 190 is removably coupled to an external portion of the catheter hub 120. For example, as shown in FIGURES 25A and 25B, the needle shield may interact with the catheter hub 120 and/or the needle 320 at at least three points. The needle shield may couple to the catheter hub 120 at a first point a, such as to the outside of the hub (e.g., FIGURE 25A) or to notches or other receiving features on the proximal portion of the catheter hub 120 (e.g., FIGURE 25B). The needle shield 190 closes around the distal end of the needle 320 at a second point b. The withdrawal of the needle 320 causes disengagement of the needle shield from the catheter hub when needle catch 106 engages the needle shield 190 at a third point c. In this example, the needle shield may be a spring clip configured such that when the needle catch 106 on the needle 320 engages with the needle shield during withdrawal, the engagement simultaneously triggers containment of the needle tip at point b and the disengagement of the needle shield from the catheter hub. The spring clip is preferably dimensioned relative to the needle such that a distance "x", defined as the distance between the distal end of the needle 320 and the needle catch 106, is approximately equal to or less than distance "y", defined as the distance between points b and c, although the spring clip may have any suitable geometry. However, the needle shield may be any suitable mechanism to blunt the needle tip outside the catheter hub.

[0063] In a second embodiment, the needle shield 190 is coupled to the stabilization hub 130. In a first variation of this embodiment, as shown in FIGURES 26A and 26B, the needle shield is removably coupled to an internal portion of the stabilization hub, in a manner similar to that of the first embodiment. For example, the stabilization hub may include a tab that substantially aligns with the catheter hub 120 when the frame 110 is in the folded configuration. The tab may define a recess to which an internal needle shield couples, or an external needle shield may be externally coupled to the tab. During catheter placement, the frame 110 is preferably in the folded configuration and the needle 320 passes through the tab, through the needle shield, and through the catheter hub 120. Upon removal of the needle 320 from the catheter hub 120, the needle shield disengages from the stabilization hub 130 and covers the needle. Following withdrawal of the needle from the catheter hub and disengagement of the needle shield from the stabilization hub, the frame 110 may be unfolded into its unfolded configuration. In a second variation, the needle shield 190 is removably coupled to an external portion of the stabilization hub, particularly when the frame 110 is in the folded configuration, similar to the variation in which the needle shield is coupled to an external portion of the catheter hub.

[0064] Additional alternative embodiments of the needle shield include various combinations of the above variations of the needle shield. In other words, the needle shield may be inside and/or outside the catheter hub 120 and/or stabilization hub. For example, as shown in FIGURE 27, the needle shield 190 may be coupled directly to an internal portion of the catheter hub 120 and indirectly to an external portion of stabilization hub 130. As another example, the needle shield may be partially inside and partially outside the catheter hub, or the three-point contact needle shield of the first embodiment may be coupled to the stabilization hub instead of the catheter hub 120. Further, the needle shield of any of these variations may be coupled to a sheath that covers at least a portion of the needle body, such that the needle blunter and sheath combination contains more than solely the distal end of the needle.

[0065] The needle shield may be one or more of the embodiments and variations described above, and/or one or more of the embodiments described in U.S. Provisional Applications 61/418,358 filed 30-NOV-2010, 61/438,782 filed 02-FEB-2011, and 61/448,318 filed 02-MAR-2011, which are each incorporated in its entirety by this reference. Furthermore, the needle shield may be any suitable mechanism that sufficiently covers and/or blunts the distal end of the needle. 2. Safety needle system

[0066] In a first preferred embodiment, as shown in FIGURES 28A and 28B, the safety needle system 100 operable with the integrated vascular delivery system or other medical device includes: a housing 310 having a needle mount 312; a needle 320 having a distal end insertable through the frame and a proximal end coupled to the needle mount 312; a sheath 330 telescopically engaged with the housing 310 and circumferentially surrounding at least a portion of the needle 320, in which the sheath 330 operates in a retracted position 332 and an extended position 334; and a slider 350 longitudinally engaged with the sheath and/or housing and including a restraint that selectively engages with the sheath. In the retracted position 332 of the sheath, the sheath exposes the distal end of the needle. In the extended position of 334 of the sheath, the sheath substantially surrounds the distal end of the needle. In the retracted position 332 of the sheath, the sheath exposes the distal end of the needle. In the extended position 334 of the sheath, the sheath substantially surrounds the distal end of the needle. The sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position. In a preferred embodiment, the restraint is selectively engaged with the sheath such that (1) the restraint is coupled to the sheath when the sheath is in the retracted position and coupled to the medical device, and the restraint reinforces the coupling of the sheath to the medical device, and (2) the restraint is uncoupled from the sheath when the sheath is in the extended position, and the restraint weakens the coupling of the sheath to the medical device, thereby reducing the force required to uncouple the sheath from the medial device. In other variations, during removal of the needle from the medical device as the sheath is drawn over the needle, the slider automatically triggers the full uncoupling of the sheath and the medical device. Removal of the needle is preferably performed by pulling the needle away from the medical device, but alternatively removal of the needle may be performed by pulling the medical device away from the needle. In other words, to draw the sheath from its retracted position to its extended position and to decouple the safety needle system from the medical device, the user (e.g., medical practitioner) may pull the needle away in a proximal direction (or pull the medical device away in a distal direction away from the safety needle system) thereby allowing the sheath to slide from its retracted position to its extended position to cover the distal end of the needle. In a preferred embodiment, the slider further includes a proximal articulation 364 and a distal articulation 366. When the sheath is in the extended position, the proximal articulation of the slider is coupled to the housing 310 and the distal articulation of the slider is coupled to the sheath, thereby locking the sheath in the extended position; however, the system may include any suitable locking mechanism to lock the sheath in the extended position.

[0067] The housing 310 functions to support the sheath 330 and the slider 350, to support the needle and/or to provide a user interface. As shown in FIGURES 29A-29C, the housing 310 includes a needle mount 312 to which the needle is coupled. The needle mount is preferably on a distal end of the housing and axially centered on the housing, but may alternatively be on any suitable portion of the housing. The needle may be molded into the needle mount such that the distal end of the needle extends out of the distal end of the housing, but the needle may alternatively be coupled to the needle mount with a snap fit, friction fit, threads, epoxy, or in any suitable manner.

[0068] The housing 310 is slidingly or telescopically engaged with the sheath 330 and/or slider 350. The housing 310 includes an inner portion that is contained within the sheath, such that the housing slides within the sheath. However, alternatively the housing may be tubular or otherwise configured such that the sheath slides within the housing. The inner portion of the housing may include a track 314 along which the slider 350 is slidingly engaged. The track is preferably longitudinal along the housing body, and may be a projected track such as a ridge (FIGURES 30A and 30D), and/or a recessed track (FIGURES 30B-30D). In one variation, as shown in FIGURE 29A, the housing includes one or more arches 318 that form an outer framework around the sheath and/or slider, such as brackets.

[0069] The housing 310 preferably includes a housing stop 316 that is configured to abut the proximal articulation of the slider 350 when the sheath is in the extended position. In a preferred embodiment, the abutment of the housing stop 316 against the proximal articulation 364 (or other portion of the slider) functions to fix the relative positions of the housing and slider, thereby contributing to locking the sheath in the extended position. In one variation, as best shown in FIGURES 29C and 32, the housing stop 316 includes a snap lock cantilevered arm whose free end abuts the proximal articulation of the slider. The housing stop 316 may be biased or radially deflected towards the slider such as to allow the slider to pass the housing stop in one direction (e.g. as the slider passes in a distal direction relative to the housing) but to prevent the slider from passing the housing stop in the opposite direction (e.g. as the slider passes in a proximal direction relative to the housing). Alternatively, other housing stop may include a sliding latch, lever, push button, another protrusion of the housing that interacts with the slider, or another suitable mechanism that abuts any suitable portion of the slider. As another alternative, the housing stop may include an aperture that receives the proximal articulation or any suitable portion of the slider. The housing stop is preferably integrally formed with the housing, but may alternatively be a separate piece coupled to the housing during assembly of the safety needle device.

[0070] In some embodiments, as best shown in FIGURE 28, the housing 310 may have one or more handles 311 that a user can grip and manipulate to operate the safety needle system. The handle 311 preferably includes two side grips on opposite sides of the housing that enable secure grasping with one hand. The handle 311 may include features such as ergonomic contours, ridges to improve friction in the grip, cushioning material such as silicone, or any suitable additions. Furthermore, other variations of the handle may include fewer or more grips (such as a single bulbous handle), and may be particular for specific applications. In some embodiments, as shown in FIGURE 33, the handle may further function as a hub cradle, such as for receiving a catheter hub or stabilization hub such as that described in U.S. Patent Application number 12/855,013, or any suitable hub or other portion of a medical device.

[0071] The housing 310 is preferably plastic and may be made of one singular piece, such as by an injection molding that forms the needle mount, arches, and/or handles integrally with the rest of the housing. The housing may alternatively include multiple pieces that are separately manufactured and attached to the tubular portion of the housing in a secondary process such as with adhesive, locking joints, or other fasteners. However, the housing may be in made in any suitable manufacturing process such as milling, turning, or stereolithography, and be made of any suitable material.

[0072] The needle 320 of the safety needle system is preferably a medical grade needle with a cannula, such as those used to aid insertion of catheters. The needle may have a gauge or size that is selected from a group of available needle gauges, such as standard diameter sizes. In one variation, as shown in FIGURE 33A, the needle 320 may include a notch 322 along a portion of the length of the needle. The notch 322 is positioned at a notch extent distance 326 defined as the distance between the distal end of the needle and the proximal edge of the notch. In an exemplary embodiment used with a catheter, during catheter placement within a blood vessel, the needle 320 is typically telescopically engaged within the catheter, forming an annular space between the outer wall of the needle and inner wall of the catheter. When the needle is placed within the blood vessel, blood or other fluids pass along the length of the needle, and the notch in the needle allows a small amount of the fluid (known as "flash") to pass into the annular space between the needle and catheter. This "flash" becomes visible to the user through the catheter, and the appearance of the flash signifies needle placement within the blood vessel.

[0073] In another variation of the needle 320, as shown in FIGURE 33B, the needle may be a substantially solid needle rather than a hollow needle with a cannula. For example, the needle 320 may include a trocar as a catheter introducer. In this variation, the needle may include a sharp distal tip and a groove running from the distal tip of the needle. The groove 324 preferably receives the flash upon needle insertion into the vessel (FIGURE 33C), and the flash may be visible to the user through the catheter tubing and/ or catheter hub.

[0074] The sheath 330 of the safety needle system preferably functions to cover the distal end of the needle 320 after the needle tip is no longer needed, to help protect the user from fluid contamination and accidental needle punctures. The sheath 330 operates in a retracted position 332 and an extended position 334, such that in the retracted position 332 the sheath exposes the distal end of the needle 320, and in the extended position 334 the sheath is extended from the housing and substantially surrounds or covers the distal end of the needle 320. In the extended position, the sheath may cover the entire needle body, or only a portion of the needle body including the distal end.

[0075] As best shown in FIGURE 34F, the sheath 330 preferably includes a set of sheath stops including a first stop 336 and a second stop 337. The first stop 336 is configured to abut the distal articulation of the slider 350 when the restraint 351 is engaged with the split portion 340 of the sheath. The second stop 337 is configured to abut the distal articulation of the slider 350 when the sheath is in the extended position, which prevents substantial relative longitudinal motion of the sheath and housing, thereby contributing to locking the sheath in the extended position. The sheath stops may additionally and/or alternatively abut against any suitable part of the slider. In one variation, as shown in FIGURE 34E, the sheath stops 336 and 337 may include an aperture defined in a side wall of the sheath. The aperture may have a partial perimeter defined by the gap between two or more split portions 340 in a side wall of the sheath. For example, the split portions 340 may be opposing members with each member having an angled or toothed tip 342. The opposing angled tips 342 define an aperture with a surface for abutting the distal articulation of the slider. Alternatively, the aperture may be a hole with an enclosed perimeter defined in the side wall of the sheath. In other variations, the sheath stop may include a projection or other extension, such as one similar to any of the variations of the housing stop, or any suitable portion of the sheath.

[0076] The sheath 330 may include a mating feature that enables the sheath to couple to the frame, or other suitable medical device. In one variation, the distal end of the sheath is adapted to mechanically couple to the medical device. In one preferred embodiment, as shown in FIGURES 34A-34E, the mating feature includes jaws 342 extending longitudinally from a distal end of the sheath 330. The jaws 342 are preferably flexible and couple to corresponding mating features (e.g., external articulations, cutouts or pockets) on the medical device. Each jaw may be coupled to a split portion 340 of the distal end of the sheath, and preferably couples to the restraint tab 351 of the slider. For example, as shown in FIGURE 34F, each split portion or jaw may define a restraint slot 138 that receives a respective restraint tab 351 of the sheath. In one variation, the jaws may have an approximately arcuate profile (FIGURE 34A) to conform to an approximately circular portion of the medical device. In other variations, the jaws may include hooked tips 344 (FIGURES 36A and 36B) and/or platforms 346 (FIGURES 37A and 37B) configured to particular corresponding features on the medical device and/or slider 350. In other variations of mechanically coupling to the medical device, the sheath 330 may extend beyond the distal end of the housing when the sheath is in the retracted position to enable the distal end of the sheath to seat within a channel (e.g. a septum or other receptacle) of the medical device. For example, the medical device may retain the distal end of the sheath. As another example, the distal end of the sheath 330 may include extensions that mate with a corresponding recess in the medical device, or the medical device may include extensions that mate with a corresponding recess on the sheath 330. The distal end of the sheath 330 may include other features for sating within the septum or another receiving portion of the medical device, such as having a slight taper to a narrower diameter that fits within the septum, frictional features like ribs or ridges that may includes retention of the sheath 330 within the septum. The distal end of the sheath may additionally and/or alternatively couple to the medical device with magnets, adhesive, snap locks, fasteners, or any suitable mechanical means.

[0077] In another variation, the distal end of the sheath 330 is adapted to manually couple to the frame. For example, as shown in FIGURE 34A, the sheath may include a holding tab 348 extending from the distal end of the sheath that provides a finger rest for the to press the holding tab against the medical device, thereby manually coupling the sheath and the medical device. The holding tab may extend laterally outwards or be a projection from the sheath extending in any suitable direction. The holding tab 348 may provide assistance for the user to hold the sheath against the medical device as a counterforce while pulling the housing and needle 320 away from the medical device. As shown in FIGURE 34D, the holding tab 348 may include a bridge that connects the split portions of the sheath stop. Alternatively, the sheath may include multiple holding tabs, such as one holding tab 348 extending from each split portion 340 or jaw 342 of the sheath. The holding tab 348 may include features to help the user hold the holding tab against the medical device, such as a lip, ridges that increase friction, or a friction coating such as silicone. The holding tab may include adhesive and/or a mechanical attachment such as a pin, snap or latch that couples the holding tab to the medical device.

[0078] In a preferred embodiment, the slider 350 functions to selectively modulate the coupling force between the sheath and the medical device. The slider 350 may further contribute to locking the sheath 330 in the extended position over the distal end of the needle. The slider 350 longitudinally extends along at least a portion of the sheath 330 and/or housing and is slidingly engaged with the sheath and/or housing, such that the housing, sheath and slider are longitudinally movable relative to one another. As shown in FIGURES 35A-35E, the slider 350 may include a planar portion 352 and a sheath insert portion 346. The planar portion is preferably substantially flat and is slidingly engaged with the track of the housing, although may alternatively be contoured. The planar portion 352 may include a groove 356 (FIGURE 30A) and/or a ridge 358 (FIGURE 30B) complementary to the track 314 of the housing 310, or any suitable profile. The sheath insert portion 354 is preferably located on a distal section of the slider, and is telescopically engaged in the sheath 330. As shown in FIGURE 35D, the sheath insert portion may have an approximately arcuate cross-section profile, or any suitable profile complementary to the cross-sectional profile of the sheath to allow the sheath insert portion to be slidingly engaged with the sheath. The sheath insert portion 354 preferably defines an aperture 362 that allows the needle 320 to pass within the sheath insert. The aperture 362 may be a round hole, a slot, or any suitable opening to allow relative longitudinal translation of the slider 350 and the needle 320. In some embodiments, as shown in FIGURE 41, the slider 350 may include protrusions 356 that interfere with the flexible jaws of the sheath 330, such that when the slider is withdrawn from the medical device the protrusions 368 trigger the jaws into the "open" configuration, thereby automatically decoupling the sheath 330 and the medical device.

[0079] The sheath insert portion 354 preferably includes a restraint that selectively engages with the sheath, such that when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the medical device, and when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the medical device. In a preferred embodiment, as shown in FIGURE 35F, the slider 350, in particular the sheath insert portion 354, may include at least one restraint tab 351 that is insertable into a restraint slot 338 on split portion 340 or jaw 342 of the sheath. In this embodiment, when the sheath is retracted and jaws 342 are surrounding and gripping the medical device, the restraint tabs 351 are coupled to the restraint slots 338 and the restraint tabs substantially prevent the jaws from moving relative to each other, thereby strengthening the grip of flexible jaws 142 on the medical device. When the sheath is extended (e.g. the housing is moved in a proximal direction away from the medical device), the restraint tabs become uncoupled from the restraint slots 338, leaving the flexible jaws 342 to more freely move relative to other, thereby weakening the grip of flexible jaws 342 on the medical device. In other words, the selective coupling of the restraint tabs 351 on the slider to the restraint slots 338 on the sheath effectively modulates the amount of force required to flex the jaws and uncouple the sheath from the medical device.

[0080] The slider 350 preferably includes a proximal articulation 364 that abuts the housing stop and/or a distal articulation 366 that abuts the sheath stop when the sheath 330 is in the extended position. When the sheath 330 is in the extended position, the proximal and distal articulations preferably fix the slide position relative to both the housing and sheath, respectively, which indirectly fixes the sheath 330 relative to the housing, thereby locking the sheath 330 in the extended position. Alternatively, the system may include any suitable locking mechanism to lock the sheath in the extended position. As best shown in FIGURE 35E, the proximal articulation 364 of the slider 350 is preferably on a proximal portion of the slider and is a laterally outward extension, such as a tab, that abuts the housing stop. The proximal articulation 364 may or may not include an aperture similar to the aperture 362 of the sheath insert portion to allow passage of the needle 320 through the proximal articulation. The distal articulation 366 of the slider 350 is preferably an extension, such as a nub or catch on the sheath insert portion that catches in the aperture 336 of the sheath stop. Alternatively, the distal articulation 366 may be on any suitable distal portion of the slider. As shown in FIGURES 49 and 41, the proximal and distal articulations may project towards the bottom of the slider 350, although they may project in any suitable direction corresponding to the locations of the housing stop on the housing and the sheath stop on the sheath. In other variations, the proximal and distal articulations may be in any suitable locations on the slider and may each be an aperture or extension corresponding to the kinds of housing stop on the housing and sheath stop on the sheath.

[0081] Overall in a preferred embodiment, coupling a distal portion of the sheath to the portion of the medical device involves coupling flexible jaws (which are extensions of split portions on the sheath) around the medical device. As shown in FIGURE 38A, the sheath is preferably retracted, and restraint tabs 351 on the slider are inserted in restraint slots 338 on the split portions. While the restraint tabs are inserted the restraint slots, the restraint tabs strengthen or lock the coupling between the jaws and the medical device, by substantially preventing the jaws from moving laterally apart. When the housing and slider are pulled away from the medical device, thereby drawing the sheath over the needle, the distal articulation of the slider temporarily abuts the first sheath stop 336 so that the restraint tabs 351 remain engaged in restraint slots 338 and the sheath remains coupled to the medical device. In this intermediate step, the abutment of the distal articulation of the slider against the first sheath stop is preferably overcomes the shear force due to friction between the housing and slider. As shown in FIGURE 38C, when the housing is further pulled away from the medical device, the housing pulls the slider away from the medical device until the distal articulation 366 overcomes first stop 336 and abuts the second sheath stop 337, while the proximal articulation 364 of the slider abuts the housing stop 316. Furthermore, when the slider overcomes the first stop 336, any other portions of the medical device (e.g. a stabilization hub 130 in the integrated vascular delivery system as described above) may be released and decoupled from the safety needle system. Furthermore, as shown in FIGURE 38B, when the distal articulation abuts the second sheath stop, the restraint tabs 351 disengage from the restraint slots 338, thereby weakening the coupling between the jaws and the medical. For instance, after this final step the user can easily provide enough force to separate the extended sheath (surrounding the needle) and the medical device.

[0082] In an alternative embodiment, as shown in FIGURES 39-41, the slider functions to automatically trigger the decoupling between the sheath 330 and the medical device when the needle is withdrawn from the medical device. In this embodiment, as shown in FIGURE 39, the jaws 342 may be biased into a "closed" configuration 341 in which the jaws tend to grip the mating features on the medical device. As shown in FIGURE 40, the jaws 342 may be manipulated to flex, swing, or otherwise move into an "open" configuration 343 in which the jaws move laterally apart, thereby enabling decoupling of the sheath 330 and medical device 302, such as after the sheath has been drawn into its extended position. The jaws 343 may be manipulated into the "open" configuration automatically when the housing and/or slider 350 is pulled in a proximal direction away from the medical device, thereby automatically decoupling the sheath 330 from the medical device. In this embodiment, as shown in FIGURE 41E, the slider 350 include protrusions 356 that interfere with the flexible jaws of the sheath 330, such that when the slider is withdrawn from the medical device the protrusions 368 trigger the jaws into the "open" configuration, thereby automatically decoupling the sheath 330 and the medical device.

[0083] In a second preferred embodiment, as shown in FIGURES 42A and 42B, the safety needle system 400 includes a housing 410 including a needle mount 412 coupled to a setting 414 that approximately axially centers the needle mount 412 within the housing 410; a needle 412 having a distal end insertable through the frame or other suitable medical device and a proximal end coupled to the needle mount 412; and a sheath 430 telescopically engaged with the housing 410 and having a distal wall 444 defining a needle aperture 446 and a longitudinal track 442 that is slidingly engaged with the setting 414 of the housing 410. The sheath 430 operates in a retracted position 432 in which the sheath exposes the distal end of the needle and an extended position 434 in which the sheath substantially surrounds the distal end of the needle. Like the sheath of the first preferred embodient of the safety needle system, the sheath 430 is preferably coupleable to the medical device such that removal of the needle from the medical device draws the sheath 430 over the needle, thereby transitioning the sheath from the retracted position to the extended position. The safety needle system preferably further includes a locking mechanism 450. In a preferred embodiment of the safety needle system, when the sheath is in the extended position, a proximal portion of the sheath 430 abuts a housing stop or catch in the housing, and the locking mechanism 450 restrains the sheath in the extended position. In one variation, the locking mechanism 450 is a housing stop including a snap lock cantilevered arm with a free end that is configured to abut the proximal portion of the sheath when the sheath is in the extended position. However, any suitable locking mechanism may be used.

[0084] The housing 410 of the second embodiment of the safety needle system functions similarly to the housing of the first embodiment of the system. As shown in FIGURES 43A-43C, the housing 410 is preferably tubular, defining a channel 416 that telescopically engages the sheath 430, and the housing 410 and/or channel 416 is preferably elongated and cylindrical, but may alternatively have any suitable cross- section, such as an oval or an approximate rectangle. Like the housing in the first embodiment, the housing 410 of the second embodiment includes a needle mount 412 to which the needle 420 (which is preferably similar to that of the first embodiment) is coupled. The housing preferably further includes a setting 414 that anchors the needle mount 412 in the housing. The needle mount 412 of the housing is preferably located on a distal end of the housing and is preferably approximately axially centered within the housing. However, the needle mount may alternatively be offset from the center of the housing, or located in any suitable position in or on the housing. The setting is preferably a peg, protrusion, or other inwardly, radially extending feature coupled to an internal wall of the housing. The setting 414 preferably slidingly engages with the sheath 430 to facilitate assembly and/or operability of the sheath in the retracted and extended positions. The setting 414 may have any suitable cross-sectional shape to guide the sliding sheath, such as a square or rectangle. Furthermore, the setting 414 may have a cross-sectional shape that may particularly help reduce lateral movement of the sheath 430 within the housing, such as a dovetail. The housing 410 may also have multiple settings arranged within the channel 416 of the housing that slidingly engage and guide the sheath. For example, the housing may have a first setting on one side of the channel to guide an upper side of the sheath 430, and a second setting on an opposite side of the channel relative to the first setting to guide a lower side of the sheath 430. The needle mount 412 is preferably coupled to the setting 414 such that the setting anchors the needle mount to the housing, but the needle mount and setting may alternatively be independent of one another and located in any suitable position in or on the housing. For example, the setting 414 may be a guide located along the same longitudinal line as the needle mount 412, or on an opposite wall of the needle mount 412, or any suitable location. As shown in FIGURE 44C, the relative dimensions of the needle mount and setting preferably form an overhang that defines an alcove space 415 or recess between the needle mount and the housing. The alcove space 415 is preferably dimensioned to accommodate the thickness of the sheath when the sheath is in the extended mode, without permitting the sheath to wobble extensively within the housing.

[0085] In some embodiments, the housing 410 further includes one or more handles 418 that a user can grip and manipulate to operate the safety needle system. The handle preferably includes two side grips on opposite sides of the housing that enable secure grasping with one hand. The side grips may be relatively short and narrow along the length of the housing (FIGURE 43A) or may be relatively wide and extend along a substantial length of the housing (FIGURE 45A). Like the handle of the first preferred embodiment of the system, the handle 418 may include features such as ergonomic contours, ridges to improve friction in the grip, cushioning material such as silicone, or any suitable additions. Furthermore, other variations of the handle may include fewer or more grips (such as a single bulbous handle), and may be particular for specific applications. In some embodiments, the handle may further function as a hub cradle, such as for receiving the catheter hub 120 or stabilization hub 130 or other suitable portion of a medical device.

[0086] As shown in FIGURE 43C, the distal end of the housing 410 may further include a ledge 417 that helps support the sheath 430 when the sheath is in the extended position. The ledge 417 preferably extends beyond the distal end of the housing, preferably on at least an underside of the housing to support the extended sheath against gravity, and may be flat, curved, or any geometry to support the sheath. The ledge may include additional features such as rubberized grips or teeth, or fasteners such as magnets, clips, or adhesive to help secure or support the extended sheath. Furthermore, the ledge may be hingedly attached to the housing, such as for folding to make the system more compact during storage before and/or after use. However, the ledge may have any other suitable geometry and/or arrangement.

[0087] The sheath 430 of the safety needle system of the second preferred embodiment of the safety needle system functions similarly to the sheath of the first embodiment of the system. As best shown in FIGURE 45A, the sheath 430 is preferably slidably engaged with the housing 410 such that the sheath passes telescopically within the channel of the housing. The sheath 430 is operable in at least one of a retracted position 432 in which the sheath is at least partially retracted within the housing 410 and exposes the distal end of the needle, and an extended position 434 in which the sheath 430 is extended from the housing 410 and substantially surrounds the distal end of the needle. As shown in FIGURES 44-45, the sheath includes a longitudinal track 442 that slidingly engages with the setting or other portion of the housing, and a distal wall 444 that contributes to covering the distal end of the needle when the sheath is in the extended position.

[0088] In one preferred embodiment, the sheath 430 is comprised of two pieces, including a proximal sheath portion 430a and a distal sheath portion 430b. As shown in FIGURES 44A-44E, the proximal sheath portion 430a and the distal sheath portion 430b are assembled to form an integrated sheath body. As shown in FIGURE 44E, the proximal sheath portion 430a preferably includes snap latches 431a and the distal sheath portion preferably includes snap holes 431b that receive snap latches 431a in a snap fit fastening manner. However, additionally and/or alternatively, the distal sheath portion may include snap latches and the proximal sheath portion may include snap holes, or the proximal and distal sheath portions may be attached by threads, an interference fit, magnets, adhesive, or in any suitable manner. The proximal and distal sheath portions are preferably assembled within the housing 410, joined around the setting and/or other internal projections inside the housing. During assembly, the distal sheath portion may enter the housing 410 from the distal end of the housing and the proximal sheath portion may enter the housing from the proximal end of the housing. In another variation, the sheath includes one sheath portion and includes features, preferably in the longitudinal track as described below, that facilitates assembly into the housing. [0089] The longitudinal track 442 of the sheath 430 functions to guide transition of the sheath between the retracted and extended positions. The longitudinal track is preferably a slot, but may alternatively be a groove that slidingly engages the setting, or may include a combination of single or multiple slots and/or grooves. The longitudinal track 442 is preferably substantially parallel to a longitudinal axis of the sheath, from a proximal end of the sheath towards a distal end of the sheath, and slidingly engages with the setting and/or needle mount or another feature of the housing 410.

[0090] As shown in FIGURES 45 and 46, in the one-piece sheath variation, the longitudinal track preferably includes a series of arcuately offset, adjacent slotted portions, and more preferably two such portions that at least partially overlap to form a single track of varying width. In a preferred embodiment, as best shown in the "unwrapped" view of the track in FIGURE 45C, the first track portion 442a runs longitudinally along the sheath 430 from the proximal end of the sheath to a point partially along the length of the sheath. In this embodiment, the second track portion 442b is preferably parallel to and circumferentially offset by an offset angle from the first track portion and runs along substantially the entire length of the sheath 430. Each of the two track portions are preferably approximately as wide, or slightly wider than, the width of the setting of the housing, such that as the sheath 430 telescopically moves within the housing 410 with the setting slidingly engaged with the track 442, the setting 414 freely passes within the longitudinal track. In a preferred embodiment, the first track portion 442a slidingly engages the setting to allow the sheath 430 to pass in a proximal direction up to the end of the first track portion, particularly to at least partially retract the sheath in the housing, such as during assembly of the safety needle system. The second track portion 442b preferably slidingly engages the setting at a different circumferential angle around the sheath 430, to allow the sheath to pass farther in the proximal direction towards the fully retracted position. The second track portion 442b preferably also engages the setting 414 to allow the sheath to pass in a distal direction towards the extended position of the sheath, such as during use of the safety needle system to cover the needle. Although the first and second track portions preferably at least partially share an edge, in other variations the track 442 may include any suitable number of track portions in any suitable arrangement. For example, the first and second track portions may be offset by a relatively large offset angle such that the first and second track portions do not share an edge. Furthermore, as shown in FIGURE 46A, the longitudinal track portions may be joined by a lateral track 442c or other open passageway (such as an open distal end of the sheath as shown in FIGURE 46B) so that rotation of the sheath within the housing enables the setting to travel between the track portions.

[0091] The longitudinal track 442 and/or other portion of the sheath 430 preferably also defines a catch portion 438 at the proximal portion of the sheath that functions to prevent the extended sheath from fully exiting the housing 410. The catch 438 is preferably arranged at the proximal portion of the sheath and abuts the setting and/or needle mount when the sheath is in the extended position. The catch 438 may fit into the alcove space 415 of the housing. Another catch mechanism, such as springs or latches, may additionally and/or alternatively be used to prevent the sheath from fully exiting the housing. In one or more of these variations, the sheath is preferably restrained from sliding beyond a particular point in the extension (distal) direction.

[0092] The distal wall 444 of the sheath 430 functions to substantially cover the distal end of the needle when the sheath is in the extended position, and further functions as a stop against the needle mount and/or setting when the sheath 430 is in the retracted position, to prevent the sheath from fully retracting into the housing 410. The distal wall 444 forms a substantially full or partial face on the distal end of the sheath, and defines a needle aperture 446 or hole large enough to receive and allow passage of at least a portion of the needle. The needle aperture 446 may be an opening in the distal wall of the sheath (FIGURE 46B) or may be in a guide or partial needle covering that extends beyond the distal wall (FIGURE 49). To limit sheath retraction up to a point (such as less than fully retracted within the housing 410, such that the distal end of the sheath is still extending beyond the distal end of the housing), the distal wall 444 may abut the needle mount and/or setting when the sheath is in the retracted position, or additionally and/or alternatively the proximal end of the sheath may butt against a proximal wall or another stop in the housing 410. In at least one of these manners, the sheath is preferably retraining from sliding beyond a particular point in the retraction (proximal) direction.

[0093] The distal end of the sheath 430 is adapted to mechanically and/or manually couple to the medical device, similar to the sheath of the first preferred embodiment of the system. [0094] The locking mechanism 450 of the safety needle system functions to restrain the sheath 430 in the extended position and prevent the sheath from returning from the extended position to the retracted position. In some embodiments, the safety needle system may include two or more locking mechanisms in the sheath 430 and/or housing 410. In one variation, as shown in FIGURES 47A-47D, the locking mechanism 450 may be coupled to the sheath 430 and/or housing 410. For example, the locking mechanism 450 may be a tab 452, coupled to the sheath, that engages a corresponding catch 454 or other stop in the housing 410 such as near the setting and needle mount (or other suitable location in the housing), to substantially lock the sheath in the extended position. In a one-piece sheath, the tab 452 is preferably near the proximal end of the sheath. In a two-piece sheath, the tab may be located on the proximal sheath portion or the distal sheath portion. The tab preferably enables passage of the sheath 430 within the housing 410 in a proximal direction (e.g. only in assembly), while substantially preventing passage of the sheath in the proximal direction when the tab engages the catch when the sheath is in the extended position. For instance, as shown in FIGURE 47B, during assembly when the sheath 430 is passed in the proximal direction into the housing 410, the sheath may be rotated to a particular angle such that the setting and/or needle mount preferably deflect the tab towards the wall of the housing 410, enabling the sheath to free pass in the proximal direction within the housing 410. As shown in FIGURES 47C and 47D, during operation of the safety needle system, when the sheath is drawn out to its extended position, a barbed end of the tab engages and stops on the catch of the housing, thereby substantially preventing movement of the sheath in the proximal direction and restraining the sheath in its extended position.

[0095] In another variation, as shown in FIGURES 48A-48D, the locking mechanism 450 includes a housing stop coupled to the housing 410. In the extended position of the sheath 430, the catch of the sheath preferably abuts the setting or other stop of the housing 410 and the housing stop abuts a proximal face of the catch, thereby trapping the catch between the setting and the housing stop. The housing stop is preferably a snap lock cantilevered arm or tab on a wall of the housing 410 that is radially deflectable inwards (FIGURE 48A) and/or have a projection that extends radially inwards. (FIGURE 48B). In other variations, the locking mechanism 450 may be a sliding latch (FIGURE 48C), lever, (FIGURE 48D), push button, or another suitable mechanism that is engageable to trap the catch of the sheath 430 against the setting of the housing, thereby locking the sheath in the extended position. In further variations, the locking mechanism 450 may additionally and/or alternatively abut a distal portion, central portion, or any suitable portion of the sheath. The locking mechanism is preferably integrally formed with the housing 210, but may alternatively be a separate piece that is coupled to the housing during assembly of the safety needle device.

[0096] Preferably, the locking mechanism 450 is disengaged or otherwise does not interfere with the ability of the sheath 430 to pass in a proximal direction to its retracted position during assembly of the safety needle, or before extended position of the sheath 430 is desired for covering the needle tip. For example, the free end of the cantilever arm may extend into the alcove space 415 adjacent to the setting of the housing 410 out of the assembly path of the sheath, such that during assembly the cantilever arm does not accidentally abut the catch of the sheath 430 and prematurely lock the sheath in the extended position. In other variations, the locking mechanism may be selectively disengaged according to its mechanical nature, such as by sliding a latch or pivoting a lever out of the way of the sheath when the sheath is to be retracted (e.g. during assembly or if the needle is to be uncovered).

[0097] As shown in FIGURES 49A-49D, the method of assembling the safety needle system 500 of the second embodiment includes: inserting a proximal end of the sheath into a distal end of the housing S510; engaging the setting of the housing within the first track portion of the longitudinal track S520; sliding the sheath telescopically to at least a partial retracted position in the housing S530, with the setting of the housing traveling within the first track portion of the longitudinal track; rotating the sheath within the housing by the offset angle S540 to engage the setting of the housing within the second track portion of the longitudinal track; and sliding the sheath into a full retracted position in the housing S550, with the setting of the housing traveling within the second track portion of the longitudinal track. As shown in FIGURE 49E, the method may also include sterilizing the needle and/or placing a protective cap S560 onto a distal end of the needle that helps maintain sterility and protect users from accidental needle pricks during transport and storage. This method may be used to assemble an embodiment of the safety needle system with a one piece sheath, but a variation 500' may similarly be used to assemble a safety needle system with a sheath having two or more pieces. In another variation 500', as shown in FIGURES 50A and 50B, to assemble a two-piece sheath variation of the system, the proximal sheath portion and the distal sheath portion are preferably coupled to one another around the setting or other housing stop of the housing. For instance, method 500' may include inserting the proximal sheath portion into the proximal end of the housing S570, inserting the distal sheath portion into a distal end of the housing S580, and coupling the proximal sheath portion and distal sheath portion to one another S590, preferably around the setting. After assembly, the sheath is preferably approximately concentrically nested within the housing. The safety needle system may be assembled during manufacture and supplied to the user with the sheath in its retracted position, or with the sheath in its extended position. Alternatively, the safety needle system may be assembled by the user prior to use.

2.1 Sheath septum

[0098] In either preferred embodiment, the safety needle system may further include one or more instances of a sheath septum 200' that functions to seal any body fluids, such as blood, or other potential biohazards within the sheath as the sheath passes over the needle into the extended position, as the needle is withdrawn from the medical device. Although the sheath septum is primarily shown with the safety needle system of the first preferred embodiment, the second preferred embodiment of the system may also include a sheath septum 200'. The sheath septum 200' is preferably coupled to the sheath 330 and more preferably within the sheath. The sheath septum 200' in the safety needle system is configured to couple to the catheter hub (or alternatively any suitable medical device) in a fluid-tight manner, to help prevent fluid leakage through the joint between the catheter hub and the safety needle system. For example, the end of the sheath septum may be circumferentially enclosed by the catheter hub, or the catheter hub may be circumferentially enclosed by the safety needle system septum. As another example, the joint between the safety needle system and the medical device may include a fluid-tight butt joint and/or a sealant.

[0099] As shown in FIGURE 51, the sheath septum preferably includes a first seal

210' and a second seal 212'. The first seal 210' is a defense against fluid escaping from one end of the sheath septum, and the second seal 212' functions as a defense against fluid escaping from another end of the sheath septum. In some embodiments, the sheath septum 200' may include fewer or more seals similar to the first and second seals, which may be suitable for some applications to modify the amount of fluid leakage protection. The sheath septum 200' preferably defines a cavity 214' between the first and second seals that may contain trapped fluid. The cavity 214' may be larger than the diameter of the needle to reduce frictional force as the sheath septum passes over the needle. However, the cavity may alternatively be closely fit over the needle, and/or include a material with a lower friction coefficient and/or fluid absorbent material. In some embodiments, the needle may include additional fluid exit points such as multiple notches along its length, and the sheath may include a longer sheath septum or multiple sheath septa to contain the multiple fluid exit points on the needle. The septum 200' may be similar in structure to one or more of the variations of the catheter hub septum, as described above. [00100] As shown in FIGURES 51-53, in one variation, the sheath septum length, and more preferably the sheath septum cavity length, is at least a long as the notch extent distance of the needle and positioned as such that when the sheath is in the extended mode, the notch is fully contained within the sheath septum. As shown in FIGURE 54, in another variation, the catheter hub septum length y and the sheath septum length z sum to a sealing length at least as long as the notch extent distance 326. In this variation, the catheter hub septum 200 and/or the sheath septum 200' may individually be shorter than the notch extent distance, but together the combination the catheter hub septum and the sheath septum is preferably equal to or greater than the notch extent distance, to fully contain the notch extent distance within at least one of the hubs.

[00101 ] As shown in FIGURES 52A and 52B, the safety needle septum 200' may be shorter than the length of the sheath 330, such as near the distal end of the sheath so that when the sheath is in the extended position, the septum contains a portion of the needle body including the distal end of the needle and the notch. Alternatively, the sheath septum may be at least substantially the same length as the sheath. For example, as shown in FIGURES 53A and 53B, the septum may be nearly the same length as the sheath such that when the sheath is in the extended position, the septum contains a large portion needle body. In another example, as shown in FIGURE 54A and 54B, the sheath and septum may be at least as long as the notch extent to contain the notch, but shorter than the overall needle length. [00102] Similar to the catheter hub septum, the sheath septum 200' may include an elastomeric material, and may have a diameter slightly larger than the diameter of the sheath, such that compression of the septum, when assembled in the sheath, seals the annular gap between the outer circumferential edges of the septum and the walls of the sheath, thereby preventing fluid from escaping through the annular gap, and further maintaining the coupling between the septum and the sheath, similar to a press fit. The septum may additionally and/or alternatively include a sealant material applied between the outer surface of the septum and the sheath, and/or be temporarily or permanently bonded to the sheath such as with sonic welding, chemical welding, or adhesive.

[00103] In either preferred embodiment, the safety needle system may further include a catch 480 that helps lock the septum 200' (or alternatively a portion of the sheath 330 without a septum) in place over the notch 122 and/or the distal end of the needle 120. The catch 380 may additionally and/or alternatively fix the sheath in the extended position. As shown in FIGURES 33A and33B, in one variation the catch may be coupled to an internal portion of the septum, such as a spring clip within the septum cavity (or other portion of the septum or sheath) that engages the needle once the sheath is in its extended position. When the spring clip engages the needle, the spring clip prevents movement of the sheath in a proximal direction, thereby locking the septum in place. As also shown in FIGURE 56A and 56B, in another variation the catch is a compressible ring 484 or nub on an external surface of the needle 120 that compresses when the septum 200' passes over the catch in a distal direction, and expands again when the septum covers the notch and/or distal end of the needle, thereby preventing movement of the sheath in a proximal direction and locking the septum in place.

[00104] In either preferred embodiment, as shown in FIGURE 57, the housing 110 may, in addition or an alternative to a sheath septum, include a vent chamber 270 and a vent cap 272 that seals one end of the vent chamber. The vent chamber 270 may be coupled to the needle mount, such that the vent chamber receives blood or other body fluids through the needle. In one variation, the vent chamber includes a recess within the needle mount of the housing, and the proximal end of the needle is inserted into an entrance of the vent chamber to carry fluids into the vent chamber. In this variation, the interface between the needle and the vent chamber is sealed to further guard against release of fluids, such as with a filter, gasket, O-ring, epoxy, or any suitable seal material or mechanism. Furthermore, the housing may include a vent cap 272 that seals one end of the vent chamber to prevent passage of fluid throughout the rest of the housing and safety needle system. The vent cap is preferably hydrophobic, preventing fluid from exiting the vent chamber while allowing air to exit the vent chamber, thereby creating a pressure differential across the needle body due to the difference between vascular and atmospheric pressures. This pressure differential causes the blood in the needle to "flash back" into the vent chamber. In another variation, the proximal end of the needle includes an enlarged needle chamber volume that receives fluids, and the vent chamber of the housing receives the needle chamber. In this variation, the fluids are contained within the needle structure, which is in turn mounted in the housing. 3. Needle protection cap

[00105] The integrated vascular system and/or safety needle system may be coupled to a needle protection cap 460 that protects the folded or bent lateral members prior to insertion of the catheter in the patient, such as during packaging, shipping, and storage of the integrated vascular delivery device and/or the safety needle system. The needle protection cap 460 may further protect a user or other handlers from accidental needle punctures prior to insertion of the needle and/or catheter in the patient. As shown in FIGURE 58, the needle protection cap 460 of a preferred embodiment includes a lumen 462 configured to receive the needle and a recess configured to receive the catheter hub. Alternatively, the protective cap may be a sleeve that surrounds at least a portion of the exposed needle, and/or include a blunt stopper that occludes or blunts the distal end of the needle. However, any other suitable type of cap may be used. Furthermore, the cap may be used to protect only the needle; for example, if the integrated vascular delivery system is packaged and shipped in the unfolded configuration, the cap may primarily function to cover the needle, and be coupled to the needle (additionally and/or alternatively to any suitable part of the integrated vascular delivery device and/or the safety needle system.

[00106] As shown in FIGURES 59A and 59B, the overall body of the needle protection cap 460 is preferably is at least as high and/or at least as wide as the dimensions of at least the folded lateral members and/or the needle, such that the needle protection cap 460 bears forces (e.g., forces lateral to the axis of the needle) that would otherwise be inflicted on features of the integrated vascular delivery device, such as the folded lateral members. In one aspect, the overall body of the needle protection cap is preferably as high as or higher than the height of the folded lateral members, such that the needle protection cap bears overhead forces that would otherwise be inflicted on the folded lateral members. In another aspect, the overall body, and the lumen 462, of the needle protection cap may be as long as or longer than the length of the exposed needle extending beyond the housing. In another aspect, as shown in FIGURE 60A, at least one point, the overall body of the needle protection cap may be as wide or wider than the widest width of the folded lateral members. Furthermore, as shown in FIGURE 60B, in an alternative variation the needle protection cap may further cover some or all of the folded lateral members and/or catheter hub for greater protection. The needle protection cap may further include side walls to bear other forces lateral to the axis of the needle.

[00107] The overall body of the needle protection cap 460 may be made of rigid or semi-rigid plastic, and/or cushioning elastomer such as silicone, although soft plastics or any suitable material may additionally and/or alternatively be used. The needle protection cap may be made of a single unitary piece, or may include multiple coupled pieces.

[00108] The lumen 462 of the needle protection cap functions to receive and cover a needle tip, such as the distal end of a needle of a safety needle system that is coupled to an integrated vascular delivery system. In one variation, the lumen is a through hole that extends from one end of the cap to an opposite end of the cap. In another variation, the lumen is a cavity that is closed on a distal end. In both variations, the lumen is preferably longer than the length of the exposed needle, such that the distal end of the needle is contained within the lumen. Furthermore, the lumen may include a sterilizing gel or other material that sterilizes and/or further protects against contamination of the needle tip prior to insertion in a patient. The lumen may further include "grips" or other internal texture to help secure the needle protection cap over the needle.

[00109] The recess 464 that is configured to receive the catheter hub 120 functions to secure the needle protection cap to the frame. In a preferred embodiment, the recess receives the catheter hub and couples the needle protection cap to the integrated vascular delivery device with a press fit. In an alternative embodiment, the needle protection cap may additionally and/or alternatively include snaps, latches, catches, or any suitable coupling mechanisms to secure the needle protection cap to the integrated vascular delivery device. However, the needle protection cap may additionally and/or alternatively couple to any one or more suitable portions of the frame and/or safety needle system, such as the stabilization hub or the flexible lateral members of the integrated vascular delivery device, or a sheath, or needle housing of the safety needle system.

4. Method for stabilizing a catheter

[00110] In a preferred embodiment, as shown in FIGURES 61-69, a method 600 for stabilizing a catheter around a catheter insertion site on a patient includes: providing a frame S610 including a catheter hub, a catheter coupled to the catheter hub, and stabilization hub; providing a safety needle system S612 including a housing with a needle mount, a needle coupled to the needle mount, and a sheath telescopically engaged with the housing, wherein the sheath operates in a retracted position that exposes a distal end of the needle and an extended position that covers the distal end of the needle; folding the catheter hub and stabilization hub towards one another S620, thereby folding the frame into a folded configuration; coupling the sheath in the retracted position to the catheter hub or other portion of the frame S630; inserting the catheter S640 into the patient at an insertion site; pulling the housing away from the catheter hub S650, thereby drawing the sheath into the extended position S652; decoupling the extended sheath from the catheter hub S660 and locking the sheath in the extended position S662; unfolding the frame S670 such that the frame surrounds the insertion site in an unfolded configuration; and securing the frame to the patient at a plurality of anchoring points S680 distributed around the insertion site, thereby stabilizing the catheter relative to the insertion site.

[00111] The step of folding the catheter hub and stabilization hub towards one another S620 functions to expose the end of the catheter, which may help provide visual and/or physical clearance for the catheter to be positioned at an insertion site. As shown in FIGURE 62, folding the catheter hub and stabilization hub towards one another thereby folds the frame into a folded configuration. The folding step S620 may include passing the stabilization hub towards a relatively stationary catheter hub, passing the catheter hub towards a relatively stationary stabilization hub, or simultaneously passing both the catheter and stabilization hubs towards each other. In one embodiment, the frame may be folded by the user such as a medical practitioner. In one example of the folding step S620, the stabilization hub is positioned to be a proximal portion of the frame (relative to the patient) and the catheter hub is positioned to be a distal portion of the frame. Relative to an insertion site on the forearm of a patient, the stabilization hub is closer to the elbow and the catheter hub is closer to the hand. In this example, the folding step S620 folds the stabilization hub away from the patient towards the catheter hub. In another embodiment, the frame may be folded and/or the needle may be inserted into the catheter prior to use such as during manufacturing (e.g. during assembly or packaging). For example, the frame may be shipped and provided to the user in folded configuration, with the sheath in the retracted position and the needle covered with a needle protection cap that couples to the frame, needle, sheath, housing. The needle cap may further assist in the folding step. In alternative embodiments, the catheter hub and stabilization hub may be moved in any suitable relative motion, such as sliding or twisting relative to each other.

[00112] Folding the catheter hub and stabilization hub S620 may further include coupling the catheter hub and the stabilization hub. The catheter hub and stabilization hub may be directly coupled to one another, or may be indirectly coupled by mutual connection to a third element such as a portion of the safety needle system, the needle protection cap, or other piece. For instance, in one embodiment, the method may include coupling the sheath and/or housing to the stabilization hub, such that in combination with coupling the sheath to the catheter hub, the catheter hub and stabilization hub are indirectly coupled to one another. [00113] Coupling the sheath to the catheter hub S630 may include mechanically coupling the sheath to the catheter hub. In one variation, as shown in FIGURE 63A, mechanically coupling the sheath to the catheter hub includes seating a portion of the medical device within the distal portion of the sheath, such as surrounding or gripping a portion of the medical device with flexible jaws or receiving a feature of the catheter hub in a receptacle of the sheath. In another variation, mechanically coupling the sheath to the medical device includes seating the distal end of the sheath in a receptacle of the medical device S526. In other variations, mechanically coupling the sheath to the medical device includes manipulating snaps, latches, tabs and slots, magnets, or any suitable fastener. Alternatively, as shown in FIGURE 63B, coupling the sheath to the portion of the medical device includes manually coupling a distal portion of the sheath to the medical device S632, which may include manually pressing a holding tab (or other finger rest, extension, or other portion of the sheath) of the sheath over the medical device. In other variations manually coupling the sheath to the medical device may include any suitable manual coupling step.

[00114] Inserting the catheter into the patient S640 preferably includes any suitable steps for particular applications, such as removing a needle protection cap (before or after the folding step), threading the catheter over the needle into a blood vessel, of drawing blood through the needle. These steps are common and are familiar to one skilled in the art, although any suitable insertion step may be used. As shown in FIGURE 64, the step of inserting the needle into the patient may further include inserting the needle through a portion of the medical device, such as the catheter hub. [00115] As shown in FIGURE 65, pulling the housing away from the catheter hub S650 initiates allowing the sheath to slide in a distal direction towards the extended position. Pulling the housing away from the catheter hub includes maintaining the coupling between the sheath and catheter hub, although in a preferred embodiment, the coupling between the sheath and the medical device may be weakened after the sheath is in the extended mode, thereby lowering the required amount of force to separate or decouple the sheath and the medical device. Allowing the sheath to slide in a distal direction towards the extended position includes drawing the sheath into the extended position. In one embodiment, allowing the sheath to slide in a distal direction includes drawing a sheath septum over the needle S652, which allows the sheath to contain fluid leakage from the needle. When the sheath is in the extended position, the septum preferably encloses the distal tip of the needle and the notch (if present). Steps S650 and S652 are preferably performed approximately simultaneously, but may alternatively be performed separately and sequentially.

[00116] As shown in FIGURES 66A and 66B, uncoupling the distal portion of the sheath from the hub S660 includes reversing the mechanical or manual coupling step performed when coupling the distal portion of the sheath to the catheter hub. Uncoupling may include unseating the catheter hub from within the sheath, unseating the sheath from the catheter hub, releasing a manual holding force coupling the catheter hub and sheath, or any suitable step. In some embodiments, the interaction of the sheath, slider, and housing triggers automatic decoupling of the sheath from the catheter hub. Following the uncoupling step, the needle is contained within the extended sheath and the safety needle system is fully disengaged from the catheter hub.

[00117] Locking the sheath in the extended position S662 may be one of more of several variations. In one variation, such as with the safety needle system of the first embodiment as shown in FIGURES 67A-67C, locking the sheath S662 includes longitudinally wedging a slider between the extended sheath and the housing S664. Wedging the slider S664 preferably includes coupling a proximal end of the slider to the housing S666 and coupling a distal end of the slider to the sheath S668, thereby preventing relative longitudinal movement between the sheath and the housing. In another variation locking the sheath includes allowing a locking mechanism to abut a proximal portion of the sheath against a stop. In a third variation, locking the sheath includes allowing the sheath and needle to engage with a catch. The catch may be coupled to the sheath and engage with the needle (e.g., a spring clip within the septum or other portion of the sheath), and/or the catch may be coupled to the needle and engage with the sheath (e.g. a compressible ring around an external surface of the needle). However, locking the sheath in the extended position may include any suitable step.

[00118] Unfolding the frame S670 functions to orient the frame around the insertion site in an unfolded configuration. As shown in FIGURE 68, unfolding the frame S670 preferably reverses the movement performed on the catheter hub and stabilization hub in the step of folding the frame, but may additionally and/or alternatively include other suitable steps such as moving the catheter hub and stabilization hub in another direction, twisting a portion of the frame, or sliding a portion of the frame.

[00119] Securing the frame to the patient S68o at a plurality of anchoring points distributed around the insertion site functions to stabilize the frame, and thereby the catheter, relative to the insertion site. Securing the frame includes securing the catheter hub at a first anchoring point and securing the stabilization hub at a second anchoring point. As shown in FIGURE 69, the first and second anchoring points are distributed around the insertion site, preferably on substantially opposite sides of the insertion site. More preferably, as shown in FIGURE 70, one of the anchoring points is proximal to the insertion site and another anchoring point is distal to the insertion site. However, the first and second anchoring points may be distributed around the insertion site in any suitable manner. In one variation, securing the frame may further include securing the frame at a third anchoring point, such that the first, second and third anchoring points are distributed around the insertion site. The frame may also be secured to the patient at four or more anchoring points. The multiple anchoring points may be approximately equally or unequally distributed around the insertion site. The securing steps may include taping the frame to the patient (e.g. with medical tape or sterile adhesive dressing), adhering the frame to the patient with adhesive, strapping the frame to the patient, or any suitable securing mechanism.

[00120] As shown in FIGURE 69, the method may further include the step of applying a dressing over the insertion site and the frame S690. The step of applying a dressing functions to protect the insertion site against bacteria, viruses, and other pathogens. The dressing is preferably a breathable, sterile dressing. The dressing is preferably transparent to allow visualization of the insertion site, and includes adhesive to attach to the skin of the patient and to provide securement of the frame. The dressing can be used after the frame has been secured to the patient, or the dressing can be used to secure the frame to the patient. However, the dressing can include any suitable device or method to assist in the protection of the insertion site.

[00121] In another embodiment, the method may further include applying a septum plug, preferably to a proximal portion (e.g. needle-receiving channel) of the catheter hub, which functions to help prevent escape or leakage of fluids from the catheter after the catheter insertion. The septum plug may be applied in one or more several manners depending on the nature of the plug, and applying a septum plug may include sliding a septum plug over the catheter hub (e.g. septum is a sliding gate), stopping a channel in the catheter hub (e.g. septum is a stopper), or any suitable steps.

[00122] In another embodiment, the method may further include engaging at least a distal portion of the needle with a needle shield coupled to the catheter hub and/or stabilization hub. The needle shield preferably functions to cover the distal end of the needle and may a spring clip, cap, or any suitable mechanism. The needle shield may be inside or outside the catheter hub, inside or outside the stabilization hub, or coupled to any suitable part of the frame. In this variation, inserting the catheter may further include decoupling the needle shield from the catheter hub and/or stabilization hub before, simultaneously with, or after, withdrawing the needle from the catheter hub. The action of the needle insertion and/or needle withdrawal may trigger the decoupling of the needle shield from the catheter hub and/or stabilization hub. In this manner, the needle may be fully withdrawn from the catheter hub while still being engaged and/or covered with the needle shield.

[00123] As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to the preferred embodiments of the invention without departing from the scope of this invention defined in the following claims.

Claims

We Claim: l. An integrated vascular delivery system with safety needle comprising:

• a frame including:

o a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site; and

o a stabilization hub providing a second anchoring point on the patient; o wherein the frame operates in a folded configuration and in an unfolded configuration;

• a fluidic channel that fluidically communicates with the catheter;

• a housing including a needle mount;

• a needle having a distal end insertable through the frame and a proximal end coupled to the needle mount; and

• a sheath telescopically engaged with the housing, wherein the sheath is coupleable to the frame such that removal of the needle from the frame draws the sheath over the needle, thereby transitioning the sheath from a retracted position in which the sheath exposes the distal end of the needle to an extended position wherein the sheath substantially surrounds the distal end of the needle;

• wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath; and • wherein in the unfolded configuration of the frame, the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

2. The system of Claim l, wherein in the folded configuration of the frame, the stabilization hub couples to the housing.

3. The system of Claim 1, wherein the unfolded configuration of the frame, one of the first and second anchoring points is configured to be proximal to the insertion site and the other one of the first and second anchoring points is configured to be distal to the insertion site, relative to the patient.

4. The system of Claim 1, wherein in the unfolded configuration of the frame, the first anchoring point is configured to be substantially opposite the second anchoring point.

5. The system of Claim 1, further comprising two lateral members extending between the catheter hub and stabilization hub.

6. The system of Claim 5, wherein the first and second lateral members are substantially parallel with the catheter.

7. The system of Claim 5, wherein the fluidic channel is disposed within one of the lateral members.

8. The system of Claim 1, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction substantially opposite from that within the catheter.

9. The system of Claim 8, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter hub and stabilization hub.

10. The system of Claim 1, further comprising a third hub providing a third anchoring point around the insertion site.

11. The system of Claim 1, wherein the catheter hub includes recesses and the sheath includes flexible jaws extending from a distal end of the sheath that mate with the recesses on the catheter hub.

12. The system of Claim 1, further comprising a slider longitudinally engaged with the sheath and the housing.

13. The system of Claim 12, wherein the slider includes a restraint that selectively engages the sheath, wherein: • when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the frame; and

• when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the medical device.

14. The system of Claim 13, wherein the restraint is coupled to the sheath when the sheath is in the retracted position, and the restraint is uncoupled from the sheath when the sheath is in the extended position.

15. The system of Claim 14, wherein the sheath includes flexible jaws extending from a distal end of the sheath and biased to couple to the frame, wherein the restraint of the sheath is coupleable to the flexible jaws.

16. The system of Claim 15, wherein the distal end of the sheath includes two split portions, each split portion including one of the flexible jaws and a slot, and wherein the restraint of the sheath includes two tabs, wherein:

• when the restraint is coupled to the sheath, each tab is engaged with a respective slot, thereby substantially fixing the flexible jaws relative to one another, and

• wherein when the restraint is uncoupled from the sheath, each tab is disengaged from its respective slot, thereby substantially allowing movement of the flexible jaws relative to one another.

17. The system of Claim 12, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.

18. The system of Claim 17, wherein the slider includes a substantially planar portion and a substantially nonplanar sheath insert portion that is telescopically engaged within the sheath.

19. The system of Claim 17, wherein the housing includes a housing stop that is configured to abut the proximal articulation of the slider when the sheath is in the extended position.

20. The system of Claim 19, wherein the housing stop includes a snap lock cantilevered arm and the proximal articulation of the slider is a laterally outward extending tab.

21. The system of Claim 17, wherein the sheath includes a sheath stop that is configured to abut the distal articulation of the slider when the sheath is in the extended position.

22. The system of Claim 21, wherein the sheath stop is an aperture defined in a side wall of the sheath and the distal articulation of the slider is an extension that catches in the aperture when the sheath is in the extended position.

23. The system of Claim 1, wherein the housing includes a setting to which the needle mount is coupled, and wherein sheath includes a longitudinal track that is substantially parallel to a longitudinal axis of the sheath and slidingly engaged with the setting.

24. The system of Claim 23, wherein the longitudinal track includes:

• a first track portion that slidingly engages the setting of the housing to allow the sheath to retract in a proximal direction into the housing up to a first limit; and

• a second track portion, approximately parallel to and circumferentially offset from the first track portion that slidingly engages the setting to allow the sheath to retract in the proximal direction into the housing beyond the first limit and up to a second limit.

25. The system of Claim 24, wherein the second track portion further slidingly engages the setting to allow the sheath to extend in a distal direction towards the extended position of the sheath.

26. The system of Claim 23, wherein when the sheath is in the extended position, a proximal portion of the sheath abuts a stop in the housing, thereby preventing overextension of the sheath in a distal direction beyond the housing.

27. The system of Claim 26, further comprising a locking mechanism configured to lock the sheath in the extended position.

28. The system of Claim 27, wherein the locking mechanism includes a snap lock cantilevered arm, wherein the snap lock cantilevered arm abuts a proximal portion of the sheath against the setting.

29. The system of Claim 23, wherein the sheath includes a proximal sheath piece and a separate distal sheath piece coupled to the proximal sheath piece.

30. The system of Claim 1, wherein the sheath is coupleable to an internal surface of the catheter hub.

31. The system of Claim 1, wherein the sheath is coupleable to an external surface of the catheter hub.

32. The system of Claim 1, wherein the catheter hub includes a hub septum having a hub septum length, a primary seal, a secondary seal, and a hub septum cavity defined between the primary seal and secondary seal.

33. The system of Claim 32, wherein the hub septum includes a rigid core and an elastomeric plug surrounding at least a portion of the core, wherein the rigid core includes a wall defining an aperture and a plurality of members extending from the wall.

34. The system of Claim 33, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the hub septum length is greater than or equal to the notch extent distance.

35. The system of Claim 33, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, and the sheath includes a sheath septum having a sheath septum length, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.

36. The system of Claim 1, further comprising a cap with a lumen that receives and covers the needle when the frame is in the folded configuration and the sheath is in the retracted position.

37. The system of Claim 36, wherein the cap includes a recess that receives and couples to at least one of the housing.

38. The system of Claim 36, wherein the cap includes a recess that receives and couples to the stabilization hub

39. The system of Claim 1, further comprising a cap that couples to the frame in the unfolded configuration and to at least one of the needle, sheath, and housing when the sheath is in the retracted position, wherein the cap includes a lumen that receives and covers the needle

40. An integrated vascular delivery system adapted to be placed on a patient, comprising:

• a frame including:

o a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site;

o a stabilization hub providing a second anchoring point on the patient; and o a flexible lateral member extending between the catheter hub and stabilization hub; and

• a fluidic channel that fluidically communicates with the catheter; • wherein the frame operates in:

o a folded configuration wherein the catheter and stabilization hubs are coupleable to one another; and

o an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

41. The system of Claim 40, wherein one of the catheter hub and stabilization hub includes an extension with an aperture, wherein in the folded configuration of the frame, the aperture is aligned with the other one of the catheter hub and stabilization hub.

42. The system of Claim 41, wherein in the folded configuration of the frame, the needle is insertable through the extension and the catheter hub, thereby coupling the catheter hub and stabilization hub to one another.

43. The system of Claim 40, wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath, thereby indirectly coupling the catheter hub and stabilization hub to one another.

44. The system of Claim 40, further comprising a lateral member extending between the catheter hub and stabilization hub.

45. The system of Claim 44, further comprising a second lateral member.

46. The system of Claim 45, wherein the first and second lateral members are substantially parallel with the catheter.

47. The system of Claim 44, wherein the fluidic channel is disposed within the lateral member.

48. The system of Claim 40, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction different from that within the catheter.

49. The system of Claim 48, wherein the turnabout portion of the fluidic channel directions fluid flow in a direction substantially opposite from that within the catheter.

50. The system of Claim 48, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter hub and stabilization hub.

51. The system of Claim 40, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length.

52. The system of Claim B12, wherein the hub septum includes a primary seal and a secondary seal, wherein the hub septum cavity is defined between the primary and secondary seals.

53. The system of Claim 52, wherein the septum includes a rigid core and an elastomeric plug surrounding at least a portion of the core.

54. The system of Claim 53, wherein the rigid core includes a wall defining an aperture, and a plurality of members extending from the wall.

55. The system of Claim 51, wherein the hub septum includes a spring clip disposed inside the hub septum cavity.

56. The system of Claim 51, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the hub septum length is greater than or equal to the notch extent distance.

57. The system of Claim 40, further comprising a third hub providing a third anchoring point around the insertion site.

58. The system of Claim 57, wherein the first, second, and third anchoring points are distributed approximately equally around the insertion site.

59. The system of Claim 40, further comprising a needle shield, coupled to at least one of the catheter hub and stabilization hub, that engages the distal end of the needle.

60. The system of Claim 59, wherein the needle shield is removably coupled to the catheter hub.

61. The system of Claim 59, wherein the needle shield is removably coupled to the stabilization hub.

62. The system of Claim 59, wherein the needle shield includes a spring clip that engages a distal portion of the needle.

63. The system of Claim 40, further comprising:

• a housing including a needle mount;

• a needle having a distal end insertable through the frame and a proximal end coupled to the needle mount;

• a sheath telescopically engaged with the housing and operating in:

o a retracted position, wherein the sheath exposes the distal end of the needle; and o an extended position, wherein the sheath substantially surrounds the distal end of the needle;

• wherein the sheath is coupleable to the frame such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position.

64. The system of Claim 63, wherein in the folded configuration of the frame, the catheter hub couples to the sheath and the stabilization hub couples to at least one of the sheath and the housing, thereby indirectly coupling the catheter hub and stabilization hub to one another.

65. The system of Claim 63, further including a slider longitudinally engaged with the sheath and the housing.

66. The system of Claim 65, wherein the restraint selectively engages the sheath, wherein:

o when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the frame; and

o when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the frame.

67. The system of Claim 65, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.

68. The system of Claim 63, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length, the sheath includes a sheath septum having a sheath septum length, and the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.

69. The system of Claim 68, wherein the hub septum length is less than the notch extent distance.

70. A system with a safety needle, comprising:

• a housing including a needle mount;

• a needle having a distal end insertable through a medical device and a proximal end coupled to the needle mount;

• a sheath telescopically engaged with the housing and circumferentially surrounding at least a portion of the needle, wherein the sheath operates in: o a retracted position, wherein the sheath exposes the distal end of the needle; and

o an extended position, wherein the sheath substantially surrounds the distal end of the needle;

o wherein the sheath is coupleable to a medical device such that removal of the needle from the medical device draws the sheath over the needle, thereby transitioning the sheath from the retracted position to the extended position; and

• a slider, longitudinally engaged with at least one of the sheath and the housing and including a restraint that selectively engages the sheath, wherein:

o when the restraint is engaged with the sheath, the restraint reinforces the coupling of the sheath to the medical device; and

o when the restraint is disengaged from the sheath, the restraint weakens the coupling of the sheath to the medical device.

71. The system of Claim 70, wherein the restraint is coupled to the sheath when the sheath is in the retracted position, and the restraint is uncoupled from the sheath when the sheath is in the extended position.

72. The system of Claim 70, wherein the housing includes an inner portion that is telescopically engaged within the sheath.

73. The system of Claim 72, wherein the sheath is telescopically engaged around the slider.

74. The system of Claim 73, wherein the housing includes at least one arch that forms an outer framework at least partially around the sheath and slider.

75. The system of Claim 70, wherein the needle has a lumen.

76. The system of Claim 70, wherein the sheath includes a holding tab extending laterally outward from a distal end of the sheath.

77. The system of Claim 70, wherein the slider includes a substantially planar portion and a substantially nonplanar sheath insert portion that is telescopically engaged within the sheath.

78. The system of Claim 77, wherein the housing, sheath, and slider are

longitudinally movable relative to one another.

79. The system of Claim 70, wherein the sheath includes flexible jaws extending from a distal end of the sheath and biased to couple to the medical device.

80. The system of Claim 79, wherein the flexible jaws surround a portion of the medical device.

81. The system of Claim 80, wherein the restraint of the sheath is coupleable to the flexible jaws.

82. The system of Claim 81, wherein the distal end of the sheath includes two split portions, each split portion including one of the flexible jaws and a slot, and wherein the restraint of the sheath includes two tabs, wherein:

83. The system of Claim 79, wherein when the restraint is engaged with the sheath the jaws are in a closed configuration and when the restraint is disengaged from the sheath jaws are in an open configuration.

84. The system of Claim 70, wherein the slider includes a proximal articulation and a distal articulation, wherein when the sheath is in the extended position the proximal articulation is coupled to the housing and the distal articulation is coupled to the sheath, thereby locking the sheath in the extended position.

85. The system of Claim 84, wherein the housing includes a housing stop that is configured to abut the proximal articulation of the slider when the sheath is in the extended position.

86. The system of Claim 85, wherein the housing stop includes a snap lock

cantilevered arm.

87. The system of Claim 86 wherein the proximal articulation of the slider is a laterally outward extending tab.

88. The system of Claim 84, wherein the sheath includes a sheath stop that is configured to abut the distal articulation of the slider when the sheath is in the extended position.

89. The system of Claim 88, wherein the sheath stop is an aperture defined in a side wall of the sheath.

90. The system of Claim 89, wherein the distal articulation of the slider is an extension that catches in the aperture.

91. The system of Claim 70, wherein the sheath includes a sheath septum defining a sheath septum cavity and a sheath septum length.

92. The system of Claim 91, wherein when the sheath is in the extended position, the septum cavity surrounds the distal end of the needle.

93. The system of Claim 92, wherein the needle further includes a needle catch that secures the septum cavity over the distal end of the needle.

94. The system of Claim 92, wherein the septum cavity includes a spring clip that secures the septum cavity over the distal end of the needle.

95. The system of Claim 92, wherein the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch and the sheath septum length is greater than or equal to the notch extent distance.

96. The system of Claim o, further comprising a frame including:

• a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site; and • a stabilization hub providing a second anchoring point on the patient;

• wherein the frame operates in a folded configuration and in an unfolded configuration;

• a fluidic channel that fluidically communicates with the catheter;

• wherein in the folded configuration of the frame, the catheter hub and stabilization hub each couples to at least one of the housing and sheath; and wherein in the unfolded configuration of the frame, the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

97. The system of Claim 96, wherein the unfolded configuration of the frame, one of the first and second anchoring points is configured to be proximal to the insertion site and the other one of the first and second anchoring points is configured to be distal to the insertion site, relative to the patient.

98. The system of Claim 96, wherein the catheter hub includes a hub septum having a hub septum cavity and a hub septum length, the sheath includes a sheath septum having a sheath septum length, and the needle includes a notch positioned at a notch extent distance defined as the distance between the distal end of the needle to the proximal edge of the notch, wherein the sum of the hub septum length and the sheath septum length is greater than or equal to the notch extent distance.

99. The system of Claim 98, wherein the hub septum length is less than the notch extent distance.

100. A method for stabilizing a catheter around a catheter insertion site on a patient, comprising:

• providing a frame including a catheter hub, a catheter coupled to the catheter hub, and a stabilization hub;

• providing a safety needle system including a housing with a needle mount, a needle coupled to the needle mount, and a sheath telescopically engaged with the housing, wherein the sheath operates in a retracted position that exposes a distal end of the needle and an extended position that covers the distal end of the needle;

• folding the catheter hub and stabilization hub towards one another, thereby folding the frame into a folded configuration;

• coupling the sheath in the retracted position to the catheter hub;

• inserting the catheter into the patient at an insertion site;

• pulling the housing away from the catheter hub, thereby drawing the sheath into the extended position;

• uncoupling the extended sheath from the catheter hub and locking the sheath in the extended position;

• unfolding the frame such that the frame surrounds the insertion site in an unfolded configuration; and • securing the frame to the patient at a plurality of anchoring points distributed around the insertion site, thereby stabilizing the catheter relative to the insertion site.

101. The method of Claim 100, wherein folding the catheter hub and stabilization hub further includes coupling the catheter hub and the stabilization hub.

102. The method of Claim 101, wherein coupling the sheath and the stabilization hub includes coupling at least one of the sheath and housing to the stabilization hub.

103. The method of Claim 100, wherein securing the frame includes securing the frame at at least two anchoring points on substantially opposite sides of the insertion site.

104. The method of Claim 103, wherein securing the frame includes securing the one of the catheter hub and stabilization hub at a first anchoring point proximal to the insertion site, and securing the other of the catheter hub and stabilization hub at a second anchoring point distal to the insertion site.

105. A septum in a fluid delivery system adapted to be placed on a patient, comprising:

• a rigid core having a core wall defining an elongated aperture; • two members extending approximately perpendicularly from the core wall, wherein the two members are separated and approximately parallel;

• a cylindrical elastomeric plug circumferentially surrounding the two members and having a distal face opposing the wall of the rigid core and a proximal face occluding the aperture of the core wall;

• wherein a diameter of the elastomeric plug is smaller than a diameter of the core wall, such that the core wall forms a flange;

• wherein the distal face of the elastomeric plug defines a primary seal and the proximal face of the elastomeric plug provides a secondary seal; and

• wherein the two members, the primary seal, and the secondary seal cooperatively define a cavity.