Closed system catheter assembly and intravenous catheter assembly with needle insertion assembly therefor - Patents.com

Abstract

A closed system catheter (CSC) assembly includes a catheter hub assembly and a needle insertion assembly including a needle, a needle housing, and a clip guard housed in a distal compartment of the needle housing. The clip guard has a chamber with a safety clip fixedly enclosed therein. The safety clip has two elongated arms with a distal gripper and a barrier that naturally biases toward one another. When the barriers are biased outwardly away from one another by a needle passing between them, the distal gripper fixedly holds the proximal end of the catheter hub of the catheter hub assembly. When not biased by the needle, the barrier returns to its naturally inwardly biased state causing the distal gripper to release its hold on the catheter hub, so that the clip guard and catheter hub may be separated from one another. The barrier forms a distal stop that prevents the needle from re-exiting the safety clip.

Description

[Technical field]

[0001] The present invention relates to a safety intravenous catheter assembly that includes a closed system catheter (CSC) assembly having a catheter hub with a side port, and a needle insertion assembly connectable to the catheter hub. [Background technology]

[0002] U.S. Patent No. 10,675,440, assigned to the same assignee as the present application, describes a closed system catheter (CSC) assembly having a catheter insertion device coupled to a catheter hub assembly having a catheter hub with a side opening to which an extension tube is connected. The catheter insertion device has a needle housing having a passive release mechanism at its distal end for connection to the proximal end of the catheter hub. The passive release mechanism includes an actuator internally movable relative to an output collar attached to the needle housing. Summary of the Invention

[0003] The needle insertion assembly of the present invention has a passive connection mechanism that does not rely on relative movement of an actuator within a collar to connect to a catheter hub.

[0004] The present invention is directed to a safety intravenous catheter assembly comprising a closed system catheter (CSC) assembly having a catheter hub assembly and a needle insertion assembly. The catheter hub assembly has a catheter hub with a catheter tube extending from its distal end. The needle insertion assembly has a needle housing comprising a needle hub and a safety clip enclosed in a protective housing or clip guard removably housed within a compartment of the distal section of the needle housing. The safety clip within the clip guard securely holds the catheter hub when the CSC assembly is in a ready-to-use position or state, or simply in the ready position. The needle, or needle cannula, is fixedly attached at its proximal, or non-patient, end to a needle hub integrally formed within the needle housing. The needle extends from the needle hub such that its patient end passes through the catheter and its sharply beveled distal tip extends beyond the distal end of the catheter. The proximal end of the needle may be flush with the proximal end of the needle hub or extend slightly beyond the proximal end of the needle hub into the flashback chamber in the proximal section of the needle housing. A flashback plug is attached to the open proximal end of the flashback chamber such that fluid entering the flashback chamber is trapped therein while allowing air within the needle cannula and flashback chamber to pass therethrough.

[0005] The safety clip has two arms extending from a base having an opening through which the needle passes. Each arm has an elongated member extending distally from the base to an elbow where the member is bent substantially perpendicular to the elongated member and forms a central section with curved ends forming a distal gripper. The gripper may be a hook-like finger or jaw. The grippers at the distal ends of the elongated members are movable relative to each other and are adapted to grip a proximal end of a catheter hub in a ready-to-use position. At least one flange or protrusion may be formed on the open proximal end of the catheter hub to facilitate gripping of the catheter hub by the gripper. The elongated members have a natural inward bias to pivot toward each other in a natural state. The arms further have respective barriers proximal to the corresponding elbows that have a natural inward bias toward a longitudinal axis of the safety clip.

[0006] The barriers are biased outwardly away from one another when the needle, or more precisely the needle shaft, passes therebetween such that the distal grippers of the elongate members are forced inward to grip the proximal end of the catheter hub, thus holding the catheter hub securely in the safety clip unless the distal tip of the needle is retracted proximal to the naturally inward biasing barrier of the safety clip, thus preventing exposure of the sharp distal tip of the needle to the environment.

[0007] To further ensure that the needle tip remains protected from the environment, the safety clip is received and fixedly held within a clip guard having a proximal portion that slidably form-fits into an opening in the distal end of the needle hub in the ready-to-use position, while a distal portion of the clip guard that protects the safety clip is received within a similarly configured compartment in the distal section of the needle housing in the ready-to-use position.

[0008] The catheter hub of the CSC assembly has a distal end to which the catheter tube, or simply the proximal end section of the catheter, is attached. An insert may be used to frictionally hold the proximal end section of the catheter to the catheter hub. In the ready position, the needle extends along the interior cavity of the catheter hub and slidably extends along the catheter with its sharp distal tip protruding or extending beyond the distal end of the catheter. The catheter hub has a side opening to an extension integral with the catheter hub to which one end of an extension tube is attached. The other end of the extension tube has a connector mechanism adapted to be connected to a fluid reservoir. A pair of wings are integrally formed on the patient-facing surface of the catheter hub to assist the clinician in positioning and holding the catheter hub assembly on the patient during use. The wings and catheter hub may later be taped to the patient's skin to hold the catheter hub assembly on the patient.

[0009] An internal cavity is formed within the catheter hub between its distal end and the open proximal end. An elastomeric septum forming a side port extension is positioned adjacent the opening in the side wall to prevent fluid from flowing proximally toward the open proximal end of the catheter hub. When the needle is withdrawn from the catheter hub and the septum is resealed, a fluid pathway is established between the patient's vasculature through which the catheter is inserted and the extension tube in the side opening of the catheter hub, and thence to a fluid reservoir which may be connected to the extension tube.

[0010] In an embodiment of the invention, a septum retainer may be inserted distally into the interior cavity of the catheter hub from the open proximal end such that a distal end of the septum retainer abuts a proximal face of the septum. A stop on the inner wall of the catheter hub prevents the septum from moving in a distal direction. The septum is thus held in place within the catheter hub by the stop on the inner wall of the catheter hub and the septum retainer. An opening may be provided at the distal end of the septum retainer to allow passage of a needle into the septum.

[0011] In the ready position, the proximal end of the catheter hub is held to the clip guard by the distal gripper of the safety clip, which is non-removably enclosed within the clip guard. When the needle is withdrawn from the patient and moves past the septum so that its distal tip is proximate the biased barrier and is no longer biased outwardly by the needle, the barrier will return to its natural inwardly biased state such that the distal gripper is released from the flange at the proximal end of the catheter hub. When the needle feature at the distal end of the needle contacts the opening at the base of the safety clip, the opening is sized to prevent the needle feature from passing through, and the clip guard may be detached from the catheter hub. As the needle moves further proximally relative to the catheter hub, the safety clip and the clip guard, which are non-removably attached to it, are separated from the catheter hub assembly. When the needle is removed from the catheter hub, the needle housing is moved proximally relative to the catheter hub to pull the needle away from the catheter hub. Because the safety clip is non-removably encapsulated in the clip guard, the contaminated distal tip of the needle continues to be protected from the environment by the clip guard as the needle is withdrawn from the catheter hub into the safety clip. Thus, the distal tip of the needle is continuously protected from when the CSC assembly is in the ready position to when it is in the safe position by the distal tip of the needle being trapped within the safety clip.

[0012] The present invention provides a closed system catheter assembly, comprising: a catheter hub having a body with a distal end from which a catheter having a distal tip extends in a distal direction, an open proximal end, and a wall extending between the distal and proximal ends and defining an interior cavity, and a side port extending from an opening in the wall between the distal and proximal ends; a needle insertion assembly comprising a needle housing having a needle hub with a proximal end of a needle having a sharp distal tip secured thereto, the needle housing separating a distal section and a proximal section thereof, the needle establishing a fluid passage between the sharp distal tip and the proximal section of the needle housing; Clip guard and a safety clip non-removably housed within a clip guard slidably mounted along the needle, the safety clip having a base having two arms extending distally therefrom, the two arms having respective distal fingers and respective naturally inwardly biasing members; Equipped with The present invention is directed to a closed catheter assembly in which a needle extends through a catheter hub with its distal sharp tip extending beyond the distal end of the catheter, and when the catheter assembly is in the ready position, the proximal end of the catheter hub is held by the distal grippers of two arms of a safety clip and a clip guard is surrounded by the distal section of the needle housing.

[0013] The present invention also provides a needle insertion assembly comprising: a needle having a distal tip and a proximal end; a needle housing having a distal section, a proximal section, and a needle hub sandwiched between the distal and proximal sections, a proximal end of the needle secured to the needle hub, a distal tip of the needle extending away from the needle hub and beyond the distal section, the needle establishing a fluid passageway between the distal tip and an interior cavity of the proximal section of the needle housing; a clip guard removably positioned on the distal section of the needle housing in the ready position; a safety clip non-removably housed within a clip guard slidably mounted along the needle, the safety clip having a base from which extend distally two arms each having a distal gripper and a respective naturally inwardly biasing member; Equipped with The present invention is directed to a needle insertion assembly adapted to be coupled to a catheter hub having a proximal end opening into an internal cavity such that when the needle passes between the inwardly biasing members and extends distally through the internal cavity of the catheter hub, two arms of the safety clip are biased outwardly by the needle to cause the distal gripper to fixedly hold the proximal end of the catheter hub.

[0014] The present invention further provides a method of making a safety catheter assembly, comprising the steps of: providing a catheter hub having a body with a distal end, an open proximal end, and a wall extending between the distal and proximal ends and defining an interior cavity; extending a catheter having a distal tip from a distal end of the catheter hub; providing a needle housing having a distal section, a proximal section, and a needle hub sandwiched between the distal section and the proximal section; attaching a needle having a sharp distal tip and a proximal end to the needle hub to establish a fluid passage between the sharp distal tip and a proximal section of the needle housing; removably positioning a clip guard on a distal section of the needle housing; slidably mounting a safety clip along the needle; non-removably housing within the clip guard a safety clip having a base with two distally extending arms having respective distal grippers and respective naturally inwardly biasing members; extending the needle through the catheter hub and its distal sharp tip beyond the distal end of the catheter such that when the catheter assembly is in the ready position, the proximal end of the catheter hub is fixedly held by the distal grippers of the two arms of the safety clip and the clip guard is enclosed in the distal section of the needle housing; The present invention relates to a method comprising: [Brief description of the drawings]

[0015] The invention will become apparent and the invention itself will be best understood by reference to the following description of the invention taken in conjunction with the accompanying drawings, in which:

[0016] [Figure 1] FIG. 1 is an overall view of a closed system catheter (CSC) assembly of the present invention. [Diagram 2] The CSC assembly of FIG. 1, but with the needle sheath protecting the catheter and needle removed prior to use. [Diagram 3] FIG. 2 is a horizontal cross-sectional view of a CSC assembly of the present invention. [Figure 4] FIG. 13 is a close-up view of the catheter hub and the distal portion of the clip guard and safety clip of the needle insertion assembly. [Diagram 5] FIG. 2 is a perspective view of an exemplary safety clip of the present invention relative to the proximal end of a catheter hub. [Figure 6] 1 is a cutaway view of a proximal portion of an exemplary safety clip non-removably secured to a clip guard. [Figure 7] FIG. 2 is a perspective view of a catheter hub assembly of the CSC assembly of the present invention. [Figure 8] FIG. 8 is an exploded view of the various components of the catheter hub assembly of FIG. [Figure 9] FIG. 9 is a cross-sectional side view of the catheter hub shown in FIGS. [Figure 10] 1 shows the CSC assembly in a ready-to-use position. [Figure 11] 1 shows the CSC assembly with the needle removed from the catheter. [Figure 12] 1 shows the needle substantially separated from the catheter hub, but with the clip guard still positioned against the catheter hub. [Figure 13] 1 shows the needle insertion assembly separated from the catheter hub assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] This application is related to provisional application US63 / 227,508, filed on July 30, 2021, and assigned to the assignee of this application. The disclosure of the '508 application is incorporated by reference in its entirety into the disclosure of this application.

[0018] As shown in Figures 1-4, a closed system catheter (CSC) assembly 2 is comprised of a catheter hub assembly 4 and a needle insertion assembly 6 coaxially positioned along a longitudinal axis 3. The catheter hub assembly 4 has a catheter hub 8 having a distal section 8a to which a catheter tube, or simply a catheter 10, is attached via its proximal end 10a. An insert (Figure 8) may be used to frictionally attach the proximal end 10a of the catheter 10 to the distal section 8a of the catheter hub 8. Alternatively, the proximal end of the catheter may be attached to the distal end of the catheter hub 8 by adhesive, as is well known. A needle 12 extends through the catheter 10 with its beveled sharp distal tip 12a extending beyond the distal end 10b of the catheter 10. A needle feature 12b having a different size or configuration than the shaft 12c of the needle 12 is provided proximal to the sharp distal tip 12a of the needle 12, as best shown in Figure 5.

[0019] The catheter hub 8 has an interior cavity 8b defined by a wall 8c extending from a distal section 8a to an open proximal end 8d. A side opening 8e in the wall 8c connects the interior cavity 8b to a side port extension 8f of the catheter hub 8. For purposes of discussion, the side port extension 8f may simply be referred to as the side port or extension of the catheter hub. One end of an extension tube 14 is fixedly attached to the open end of the extension 8f. The other end of the extension tube 14 is fitted with a connector 28 adapted to connect to a fluid reservoir, such as a syringe, fluid line, pump, or the like, as is well known, from which fluid may be input into the interior cavity 8b of the catheter hub 8. A clamp 26 is slidably mounted along the tube 14 and adapted to tightly close the tube 14 and prevent the flow of fluid along the tube. The catheter hub 8 is shown in more detail in Figures 7-9.

[0020] A septum 16, made of an elastomeric material as is well known, is positioned in the interior cavity 8b proximal to the side opening 8e to prevent fluid from flowing in a proximal direction as indicated by directional arrow 18. The elastomeric septum 16 is penetrable by a needle, such as needle 12, and reseals after the needle is withdrawn. A circumferential shoulder 8g formed on the inner surface of wall 8c prevents distal end 16a of septum 16 from moving in a distal direction as indicated by directional arrow 20.

[0021] 3-4 and 7-9, septum retainer 22 is shown inserted into open proximal end 8d of catheter hub 8 such that distal end 22a, or a surface of the distal end, abuts proximal end 16b of septum 16 to hold septum 16 in place. Septum retainer 22 has a cup-like configuration with its distal end corresponding to the bottom of the cup and a peripheral wall 22d extending therefrom defining an internal cavity 22e for the septum retainer. As best shown in FIG. 9, distal end 22a is provided with an opening 22f sized to allow needle 12 to pass therethrough. Septum retainer 22 may be fixedly held in the proximal section of catheter hub 8 by circumferential projection 22b of the septum retainer mating with inner circumferential groove 8h formed in the inner wall of catheter hub 8. In the illustrated embodiment, septum retainer 22 has a proximal end 22c flush with proximal end 8d of catheter hub 8. However, it should be understood that the proximal end of the septum retainer 22 may extend proximally beyond the proximal end 8d of the catheter hub 8 or distally inwardly from the proximal end 8d. At least one flange may be provided at the proximal end 8d of the catheter hub 8 for receiving a distal gripper of a safety clip, as discussed below.

[0022] Extending from the underside of the catheter hub 8 are two orthogonal wings 8i that can be used to press the catheter hub against the patient's skin when the CSC assembly 2 is in use. As shown in FIGS. 1 and 2, prior to use, the catheter 10 and the needle 12 slidably extending therethrough are protected by a needle sheath 24, which has been removed in FIG. 2. FIGS. 1-2 show the CSC assembly 2 in a ready-to-use position or condition, or simply in a ready position. In FIGS. 7 and 8, the open proximal end 8d of the catheter hub 8 is shown to have a flange 8j that can be used to couple to a distal gripper of a safety clip, discussed below. Although one flange is shown, it should be understood that the flange can be one continuous circumferential flange or multiple partial circumferential flanges that can be grasped by the gripper of a safety clip, such as flanges 8j1 and 8j2 shown in FIG. 5.

[0023] 8 and 9 show an insert 8k press-fit into a passageway 8a' defined by a wall 8c extending through the distal section 8a of the catheter hub 8. The insert 8k is inserted into the passageway 8a' to frictionally hold the proximal end of the catheter 10 against the distal end of the catheter hub 8. When fully seated in the passageway, the tapered proximal end 8k' of the insert 8k contacts the smaller distal section 8b1 of the interior cavity 8b of the catheter hub 8, preventing fluid from passing therethrough.

[0024] 1-3, the needle insertion assembly 6 includes a needle housing 30 having a distal section 30a configured with four walls each tapering outwardly in a distal direction. The needle housing 30 includes a middle section 30b having an integral internal needle hub 30c. The needle hub 30c includes an internal passage 30c1 in which the proximal end 12e of the needle 12 is fixedly attached by adhesion or friction fit as is known. The proximal end 12d of the needle 12 may be flush with the proximal end 30c2 of the needle hub 30c. The proximal end 12d of the needle 12 is fed into an interior or flashback chamber 30d in the proximal section 30e of the needle housing 30. The open proximal end 30e1 of the proximal section 30e includes a flash plug 32 attached thereto, which may be made of an air permeable hydrophilic material that allows air to pass but prevents the passage of fluids, as is known. Air in the flashback chamber 30d is forced through the flush plug 32 by the incoming blood until the blood reaches the hydrophilic material of the flush plug 32 which prevents the blood from passing through.

[0025] A needle tip protector guard, or clip guard 34, is removably received within a compartment defined by the distal section 30a of the needle housing 30. The clip guard 34 is configured to be snugly received within the compartment defined by the distal section 30a. As shown in FIG. 3, the clip guard 34 has an open distal end 34a that tapers proximally inward to a proximal rear end 34b having a proximal extension 34c that fits into an opening 30c3 in the distal end of the needle hub 33 in the ready position. The distal end 34a of the clip guard 34 extends distally from the distal end 30f of the needle housing 30 as shown in the exemplary embodiment of FIGS. 3 and 4. It should be understood that in practice, the distal end 34a of the clip guard 34 may be flush with or adjacent to the distal end 30f of the needle housing 30 in the ready position. It should be noted that the distal end 34a of the clip guard 34 surrounds the distal gripper of a safety clip housed in the clip guard 34 as discussed herein.

[0026] As shown in Figure 3, a needle protection device or safety clip 36 is fixedly enclosed within the internal chamber 34d of the clip guard 34. One embodiment of the safety clip 36 is shown in detail in Figure 5. With reference to Figures 3 and 4, the CSC catheter assembly 2 is shown to have the proximal end 8d of the catheter hub 8 covered by the open distal end 34a of the clip guard 34. The remainder of the clip guard 34 is received in a compartment in the distal section 30a of the needle housing 30.

[0027] 5 illustrates the safety clip 36 in relation to the proximal section of the catheter hub 8. The needle safety clip 36 is shown to have two arms 36c1 and 36c2 extending substantially laterally distally from opposite ends of a base 36a. An opening 36b formed in the base 36a is sized to allow passage of the needle 12 but prevent passage of the needle feature 12b in the proximal direction indicated by directional arrow 18. The respective intermediate sections 36d1 and 36d2 of the arms 36c1 and 36c2 are bent toward the center of the safety clip 36 such that the corresponding bent ends 36d1b and 36d2b are curved to form respective natural inward biasing members or barriers 36d1b and 36d2b.

[0028] 5, the mid-sections 36d1 and 36d2 are bent inwardly from the arms 36c1 and 36c2 to form a slot along the arms 36c1 and 36c2 with parallel rails left by the inward bending of the mid-sections. In particular, the parallel rails 36e1 and 36e2 extend from the mid-section of the arm 36c1 to a cross end 36e3 connecting the rails to define a slot 36e4 of a width to allow passage of the needle 12. As shown, the rails 36e1 and 36e2 extend distally in the same plane for a distance proximal to the proximal end 8d of the catheter hub 8 and are then bent downwardly at a slight angle away from the right angle to form the downward section 36c1'. Similarly, the arm 36c2 is bent in a reverse direction such that the rails 36f1 and 36f2 are bent upwardly slightly off-perpendicular from the longitudinal length of the arm 36c2 to form an upright section 36c2' that defines a slot 36f4 with sufficient space for the needle 12 to pass through. The section 36c2' is formed at a proximal distance from the section 36c1'. The width of the slot 36f4 in the upright section 36c2' is less than the width of the slot 36e4 in the section 36c1', so that the upright section 36c2' is free to move within the slot 36e4. The ends of the rails 36e1 and 36e2 are further bent in a distal direction substantially transverse to the section 36c1' to form a lower jaw 36g adapted to bear against the flange 8j2 of the catheter hub 8, while the distal end of the arm 36c2 is configured as a hook-like finger 36h adapted to grip the flange 8j1 to couple the safety clip 36 to the catheter hub 8.

[0029] In the embodiment shown in Figures 3 and 4, the lower jaw of arm 36c1 is replaced with a hook-like finger, such as 36h. Thus, safety clip 36 may have hook-like fingers at the distal ends of both of its arms, as shown in Figures 3 and 4. Both of the hook fingers shown in Figures 3-4, and the hook finger and jaw combination shown in Figure 5, may be referred to simply as the gripper of safety clip 36.

[0030] As shown in FIG. 5, when the barriers 36d1b and 36d2b are in the safe position, in which they are not biased by the needle 12 and are therefore in their natural inwardly biased position, the barriers stop distal to the distal tip 12a of the needle 12 to prevent the needle 12 from re-emerging distally from the safety clip 36. At the same time, the needle feature 12b prevents the needle 12 from moving further proximally relative to the safety clip 36 through the opening 36b. Thus, the distal end, including the distal tip 12a, of the needle 12 is trapped in the safety clip 36. As shown, the barrier 36d1b is distal to the barrier 36d2b, and the distal tip 12a of the needle 12 is proximal to both the barriers 36d1b and 36d2b. FIG. 5 illustrates the CSC assembly 2 in a safe state or position when the potentially contaminated distal tip 12a of the needle 12 is trapped within the safety clip 36.

[0031] 3 and 5, when the CSC assembly 2 is in the ready position, the barriers 36d1b and 36d2b are biased away from the longitudinal axis 3 of the CSC assembly by the needle 12. The needle 12 also passes through the slots 36f4 and 36e4 of the arms 36c2 and 36c2, respectively, into the catheter hub 8. When the barriers 36d1 and 36d2 are biased outward, the cross sections 36c1' and 36c2' move in opposite directions away from the longitudinal axis 3 such that the hook fingers 36h grip the flange 8j1 and the jaws 36g press against the flange 8j2 of the catheter hub 8, thereby coupling the safety clip 36 and the catheter hub 8 together. Although the embodiment of FIG. 5 shows a hook and jaw combination, it should be understood that in practice the arms may each have a hook finger at its distal end as shown in FIGS. 3-4, or some other finger gripping mechanism that allows the safety clip to securely hold the catheter hub 8. Thus, the proximal end of the catheter hub is fixedly held by the distal gripper of the safety clip in the ready position. It should further be understood that the safety clip 36 described above may be adapted for use with safety catheter assemblies other than the CSC catheter assemblies.

[0032] Figures 3 and 4 show the safety clip 36 and catheter hub 8 coupled together by dual finger hook grippers 36h1 and 36h2 instead of the hook and jaw combination discussed above with reference to Figure 5. Functionally, the finger hook grippers of Figures 3 and 4 operate in the same manner as the grippers discussed with reference to Figure 5, except that opposing flanges 8j1 and 8j2 of the catheter hub 8 are grasped by one of the corresponding grippers 36h1 and 36h2, respectively.

[0033] FIG. 3 shows the safety clip 36 housed or enclosed within the clip guard 34. The clip guard 34 is received in a compartment defined by the distal section 30a of the needle housing 30. The safety clip 36 has the same components as the safety clip described in FIG. 5, except that both distal grippers are hook-type gripper mechanisms. To retain the safety clip 36 within the chamber 34d of the clip guard 34, a pair of opposing protrusions or tangs 36i extending from the base 36a is added to the safety clip 36, as shown in FIG. 6. Opposing inner walls of the clip guard 34 are formed with undercuts 34e or other structures adapted to cooperate with the tangs 36i. When the safety clip 36 is inserted into the chamber 34b, upon contact with the tapered distal surface of the undercut 34e, the tangs 36i will bend inwardly to pass through the undercut. Once past the undercuts, the tangs 36i return to their natural, unbiased state such that each edge 36i1 abuts the proximal rear surface of each undercut 34e to prevent the safety clip 36 from moving distally relative to the clip guard 34. As a result, the safety clip 36 is non-removably enclosed in the chamber 34b of the clip guard 34. Note that opposing tangs 36i extend from opposing sides of a base 36a of the safety clip 36, while arms 36c1 and 36c2 of the safety clip 36 extend from other opposing sides of the base 36a.

[0034] The operation of the safety catheter assembly of the present invention is illustrated in Figures 10-13. In the ready position shown in Figure 10, the catheter hub 8 is coupled to the clip guard 34 by the distal gripper of the safety clip 36 which holds the proximal end 8d of the catheter hub 8 in a fixed manner. After the needle has been inserted into the appropriate vein or artery of the patient, followed by the catheter 10, the clinician will withdraw the needle 12 by moving the needle housing 30 in a proximal direction relative to the catheter hub 8 as indicated by the directional arrow 18, as shown in Figure 11. Further proximal movement of the needle housing 30 relative to the catheter hub 8 brings the needle feature 12b (Figure 5) into contact with the opening 36b in the base 36a of the safety clip 36, positioning the distal tip 12a of the needle 12 proximal to the barriers 36b1 and 36b2. When the bias by the needle 12 is removed, the barriers 36b1 and 36b2 return to their natural inward biased state such that the distal gripper is released from the proximal end 8d of the catheter hub 8. The safety clip 36 is non-removably held by the clip guard 34 such that further proximal movement of the needle housing 30 relative to the catheter hub 8 detaches the clip guard 34 from the catheter hub and seals the safety clip 36 therein, trapping the distal tip 12a of the needle 12 in the safety clip. Figure 13 shows the needle housing assembly 6 and the catheter hub assembly 4 separated from one another.

[0035] 13 may be considered to be in a safe position or state in that the distal tip 12a of the needle 12 is trapped in a safety clip 36 surrounded by a clip guard 34 within the needle housing 30 of the needle insertion assembly 6. Thus, throughout the life of the CSC assembly 2, from shipment to use to disposal, or from the ready position to the safe position, the distal portion of the needle, and more specifically the sharp distal end of the needle, is prevented from being exposed to the environment.

[0036] It is the intention of the inventors that all matters set forth throughout this specification and shown in the accompanying drawings shall be interpreted only as illustrative and not in a limiting sense, and the invention is therefore intended to be limited only by the spirit and scope of the claims appended hereto.

Claims

1. a catheter hub having a body with a distal end from which a catheter having a distal tip extends distally, an open proximal end, and a wall extending between said distal end and said proximal end and defining an interior cavity, a side port extending from an opening in said wall between said distal end and said proximal end; a needle insertion assembly comprising a needle housing having a needle hub having a proximal end of a needle secured thereto, the needle having a sharp distal tip separating a distal section and a proximal section of the needle housing, the needle establishing a fluid passage between the sharp distal tip and the proximal section of the needle housing; Clip guard and a safety clip non-removably housed within the clip guard slidably mounted along the needle, the safety clip having a base having two arms extending distally from the base, the two arms having respective distal fingers and respective natural inward biasing members; A closed system catheter assembly comprising: A closed catheter assembly, wherein the needle extends through the catheter hub with its distal sharp tip extending beyond the distal end of the catheter, the proximal end of the catheter hub is held by the distal grippers of the two arms of the safety clip, and the clip guard is surrounded by the distal section of the needle housing when the catheter assembly is in a ready position.

2. 2. The closed system catheter assembly of claim 1, further comprising an elastomeric septum mounted inside the catheter hub proximal to the opening of the side port, the elastomeric septum adapted to be penetrated by the needle in the ready position and resealed when the needle is removed from the septum.

3. 2. The closed system catheter assembly of claim 1, further comprising a septum retainer non-removably inserted into the open proximal end of the catheter hub, the septum retainer having a distal end abutting a proximal end of the septum mounted inside the catheter hub to prevent proximal movement of the septum.

4. 4. The closed system catheter assembly of claim 3, wherein the septum has a distal end in non-movable contact with an internal wall stop proximal to the opening of the side port to hold the septum in place within the catheter hub such that a fluid communication path is established between the catheter and the side port through the internal cavity of the catheter hub after the needle is withdrawn from the catheter.

5. 4. The closed system catheter assembly of claim 3, wherein the distal end of the septum retainer has an opening through which the needle passes to puncture the septum when the catheter assembly is in the ready position.

6. 2. The closed system catheter assembly of claim 1, wherein the clip guard comprises a proximal section configured to fit snugly into the distal opening of the needle hub and a chamber for enclosing the safety clip, and the clip guard removably form-fits onto the distal section of the needle housing in the ready position.

7. 2. The closed system catheter assembly of claim 1, wherein the two arms are interdependent elongate members each extending longitudinally away from the base to a corresponding elbow where the elongate members bend toward each other at a substantially right angle to form respective bends with the distal gripper, one of the interdependent elongate members having a slot through which the bend of the other interdependent elongate member passes, and wherein the respective natural inward biasing members are provided on the interdependent elongate members proximal to the corresponding elbow, such that when the catheter assembly is in the ready position, the respective natural inward biasing members are biased by the needle passing therebetween to urge the elongate members outwardly to move the respective bends toward each other such that the proximal end of the catheter hub is gripped by the distal gripper.

9. The closed system catheter assembly of claim 1, wherein in a safe position, the distal tip of the needle is withdrawn proximally beyond the biasing member such that the biasing member returns to its natural inner position to provide a stop preventing the distal tip of the needle from re-emerging from the safety clip.

10. 2. The closed system catheter assembly of claim 1, wherein the base of the safety clip is fixedly retained in a proximal portion of the clip guard such that the safety clip is non-removably retained within the clip guard, movable relative to the needle housing.

11. 2. The closed system catheter assembly of claim 1, wherein the proximal section of the needle housing is a flash chamber with a flash plug at the proximal opening of the needle housing that allows air to pass but prevents fluid from exiting the proximal portion.

12. 2. The closed system catheter assembly of claim 1, wherein the catheter hub has side wings extending integrally from the outer wall of the catheter hub and an extension tube connected to the side port.

13. a needle having a distal tip and a proximal end; a needle housing having a distal section, a proximal section, and a needle hub sandwiched between the distal section and the proximal section, the proximal end of the needle being secured to the needle hub, the distal tip of the needle extending past the distal section and away from the needle hub, the needle establishing a fluid passage between the distal tip and an interior cavity of the proximal section of the needle housing; a clip guard removably positioned on the distal section of the needle housing in a ready position; a safety clip non-removably housed within the clip guard slidably mounted along the needle, the safety clip having a base from which extend distally two arms having respective distal grippers and respective natural inward biasing members; 1. A needle insertion assembly comprising:

11. A needle insertion assembly adapted to be coupled to a catheter hub having a proximal end that opens into an internal cavity such that when the needle passes between the inwardly biasing members and extends distally through the internal cavity of the catheter hub, the two arms of the safety clip are biased outwardly by the needle to cause the distal gripper to fixedly hold the proximal end of the catheter hub.

14. 14. The insertion needle assembly of claim 13, wherein the clip guard comprises a proximal section configured to fit snugly into a distal opening of the needle hub and a chamber for enclosing the safety clip, the clip guard releasably form-fitting onto the distal section of the needle housing in the ready position.

15. 14. The insertion needle assembly of claim 13, wherein the two arms are interdependent elongate members each extending longitudinally away from the base to a corresponding elbow where the elongate members bend toward each other at a substantially right angle to form respective bends with the distal gripper, one of the interdependent elongate members having a slot through which the bend of the other of the interdependent elongate members passes, and the respective natural inward biasing members are provided on the interdependent elongate members proximal to the corresponding elbow such that when the catheter assembly is in the ready position, the respective natural inward biasing members are biased by the needle passing therebetween to urge the elongate members outwardly to move the respective bends toward each other such that the proximal end of the catheter hub is gripped by the distal gripper.

16. 14. The insertion needle assembly of claim 13, wherein when the distal sharp tip of the needle is withdrawn proximally past the biasing member, the biasing member will return to its natural inner position to provide a stop to prevent the distal sharp tip of the needle from re-emerging from the safety clip.

17. 1. A method of making a safety catheter assembly, comprising: providing a catheter hub having a body with a distal end, an open proximal end, and a wall extending between the distal end and the proximal end defining an interior cavity; extending a catheter having a distal tip from the distal end of the catheter hub; providing a needle housing having a distal section, a proximal section, and a needle hub sandwiched between the distal section and the proximal section; attaching a needle having a sharp distal tip and a proximal end to the needle hub to establish a fluid passage between the sharp distal tip and the proximal section of the needle housing; removably positioning a clip guard on the distal section of the needle housing; slidably mounting a safety clip along the needle; non-removably housing within the clip guard a safety clip having a base with two distally extending arms having respective distal grippers and respective natural inwardly biasing members; extending the needle through the catheter hub and its distal sharp tip beyond the distal end of the catheter such that when the catheter assembly is in a ready position, the proximal end of the catheter hub is fixedly held by the distal grippers of the two arms of the safety clip and the clip guard is enclosed in the distal section of the needle housing; The method includes:

18. extending a side port from an opening in the wall between the distal end and the proximal end of the catheter hub; mounting an elastomeric septum within the catheter hub proximal to the opening of the side port, the septum adapted to be penetrated by the needle in the ready position and resealed when the needle is removed from the septum; 20. The method of making the safety catheter assembly of claim 17, further comprising:

19. non-removably inserting a septum retainer into the open proximal end of the catheter hub; abutting a distal end of the septum retainer against a proximal end of a septum mounted within the catheter hub to prevent proximal movement of the septum; providing an internal wall stop proximal to the opening of a side port to prevent distal movement of the septum relative to the catheter hub such that the septum is held in place within the catheter hub; 20. The method of making the safety catheter assembly of claim 17, further comprising:

20. 20. The method of making the safety catheter assembly of claim 17, further comprising the step of configuring the clip guard to have a proximal section that is fittable snugly into the distal opening of the needle hub and a chamber for enclosing the safety clip, and to form-fit into the distal section of the needle housing in the ready position.

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