Releasable safety catheter insertion assembly

Abstract

A safety catheter insertion assembly configured to prevent access to a distal tip of a needle cannula prior to release of the catheter insertion assembly from a catheter hub. The safety catheter insertion assembly includes a catheter assembly having an elastomeric blood control valve and a catheter insertion device having a safety clip movable between a deployed configuration in which a portion of the safety clip applies a compression force to a portion of the elastomeric blood control valve and a retracted configuration in which the compression force is reduced and the safety clip can be released from the elastomeric blood control valve.

Description

[0001] This application is a divisional application of Chinese patent application No. 201980023690.3, filed on January 31, 2019, entitled "Releasable Safety Catheter Insertion Assembly".

[0002] Relevant application information

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 624,470 (filed January 31, 2018) and U.S. Provisional Application No. 62 / 643,229 (filed March 15, 2018), the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure relates generally to safety catheters, and more particularly to a safety catheter having a passive release mechanism configured to shield the sharp distal tip of the needle sheath before releasing the catheter interface from the catheter insertion device. Background Technology

[0005] Intravenous (IV) therapy is a universal technique for administering medical fluids to and from patients. IV therapy has been used for a variety of purposes, such as maintaining blood and electrolyte balance, blood transfusions, administering nutritional supplements, chemotherapy, and administering anesthetics and drugs. These fluids (collectively referred to as drugs in this document) can be administered via subcutaneous needle, intravenously by injection, or via infusion using a needle or catheter, either intermittently or continuously. A common intravenous access device used by clinicians is the peripheral intravenous catheter (PIVC).

[0006] PIVCs are made of soft, flexible plastic or silicone and are typically sized 14 to 24. During a routine venipuncture procedure, the catheter is inserted into a vein in the patient's hand, foot, or inner arm, or into any vein in the body from which the IV catheter will be received. To place an IV catheter into a patient's vein, a sharp guide needle is used to puncture the skin, tissue, and vein wall to provide a path for placing the catheter into the vein.

[0007] refer to Figure 1A-B depicts a conventional catheter insertion assembly 50, which includes a catheter insertion device 52 configured for insertion of a catheter 54 "over the needle". The catheter 54 generally includes a catheter portion 56 having a distal end 58 for insertion into a biological site, a proximal end 60, and a flexible wall defining a lumen extending therebetween. Typically, the proximal end 60 of the catheter portion 56 is operatively coupled to the catheter interface 62. The catheter 54 is operatively coupled to the catheter insertion device 52, in part, by coaxially positioning the catheter 54 on the needle cannula 64 of the catheter insertion device 52. The catheter 54, together with the needle cannula 64, then passes through the skin, tissue, and vein wall into the patient's vein.

[0008] Various catheter insertion devices have been developed to provide needles for catheter insertion. One such example of a catheter insertion device is sold by Smiths Medical ASD, Inc. of St. Paul, Minnesota, under the trademarks JELCO and INTUITIV and described in U.S. Patent Nos. 8,257,322 and 2011 / 0319838 and 2017 / 0095617, the contents of which are incorporated herein by reference. In other cases, catheter insertion devices provide safety needle assemblies that function to accommodate the sharp tip of the needle to reduce the likelihood of unintentional needlestick injuries. Examples of this type of catheter insertion device are sold by Smiths Medical ASD, Inc. under the trademarks PROTECTIV and VIAVALVE and described in U.S. Patent Nos. 5,000,740, 7,736,342 and 2016 / 0220791, the contents of which are incorporated herein by reference.

[0009] Once the catheter portion 56 has entered the patient's vein, the needle cannula 64 and catheter 54 are lowered toward the patient's skin to reduce the angle of entry, and the catheter portion 56 is slightly advanced into the vein. The connection between the catheter 54 and the needle cannula 64 is then released, allowing the catheter portion 56 to be advanced further into the vein as needed, and the needle cannula 64 to be withdrawn from the catheter 54.

[0010] In some cases, catheter 54 may include a tip protector through which at least a portion of needle cannula 64 passes. The tip protector may be configured to surround or otherwise shield the sharp distal tip 66 of needle cannula 64 after it has been withdrawn from catheter portion 56. One form of tip protector involves a clip fitted within catheter interface 62. This clip may comprise a thin web of metal or the like, which is curved or otherwise formed to have a rear wall and one or more distally extending walls, which are generally of the same thickness. In the clip-ready position, the shaft of needle cannula 64 passes through an orifice in the rear wall of the clip and abuts against a pair of distally extending arms to enter catheter portion 56. Needle cannula 62 may be pulled proximally relative to the clip to bring the distal tip 66 proximal to the rear wall of the clip, whereby the arms are configured to close to prevent further distal re-emergence of the distal tip 66. Further proximal movement of the needle cannula 64 pulls the tip protector out of the catheter interface 62.

[0011] The catheter interface 62 can be coupled to an applicator or syringe for introducing fluid into and / or withdrawing bodily fluids from a patient. The catheter interface 62 may have an open proximal end 68 adapted to receive a male Luer cone into a cavity defined to form a fluid connection between the patient's vascular system and the Luer cone. The proximal end 68 may also be provided with an external ear 70, etc., to secure the Luer cone in the catheter interface 62, such as when the Luer cone is coupled to a male Luer locking ring of an applicator or syringe.

[0012] Under normal circumstances, after the needle cannula 64 is withdrawn and before the Luhr cone is inserted into the catheter interface 62, blood flows through the catheter section 54 and into the internal cavity of the catheter interface 62. To restrict blood flow, the catheter interface 62 may include a valve or diaphragm that seals the needle cannula path after the needle cannula 64 has been withdrawn from the catheter 54, thereby preventing blood or bodily fluids from the patient from escaping from the catheter 54 into the surrounding environment.

[0013] A catheter insertion device 50 has been created that attempts to lock the catheter 54 to the catheter insertion device 52 during insertion. However, it is possible to improve such a device to consistently enable the smooth release of the catheter interface 62 from the needle cannula 64, particularly in a manner that reduces or eliminates the risk of unintentional needle pricks. Therefore, the applicant of this disclosure has recognized the need for a safety catheter insertion assembly that includes a mechanism for the smooth and passive release of the catheter from the catheter insertion device upon retraction of the needle cannula. Summary of the Invention

[0014] Embodiments of this disclosure provide a safe catheter insertion assembly that includes a mechanism for smoothly and passively releasing the catheter from the catheter insertion device when the needle cannula is withdrawn into a tip protector, thereby improving the catheter insertion process while suppressing the risk of unintentional needlestick injuries.

[0015] One embodiment of this disclosure provides a safety catheter insertion assembly including a catheter assembly, a catheter insertion device, and a passive release mechanism. The catheter assembly includes a catheter interface and a catheter portion extending distally therefrom. The catheter interface may have an open proximal end and a distal end, defining an internal cavity therebetween. The catheter insertion device may include a needle interface and a needle cannula extending distally from the needle interface. The needle cannula may have a sharp distal tip. The passive release mechanism may be configured to couple the catheter interface to the catheter insertion device and may include a compliant sealing member and a safety clip. The compliant sealing member may be disposed within the internal cavity of the catheter interface and may have an open distal end and a proximal end, defining the internal cavity therebetween. The safety clip may be releasably coupled to the compliant sealing member and may be configured to move relative to the needle cannula between a first position and a second position, in which the distal tip extends distally from the safety clip, and in the second position, the distal tip is captured within the safety clip. In the first position, a portion of the safety clip applies a compressive force to a portion of the compliant sealing member. In the second position, reduced compressive force and release of the safety clip from the compliant seal member are achieved, preventing access to the distal tip of the needle cannula before the needle clip is released from the compliant seal member.

[0016] In one embodiment, when the safety clip is in the second position, the needle insertion assembly can be removed from the catheter interface without substantial interference. In one embodiment, the compliant sealing member is a blood control valve. In one embodiment, the safety catheter insertion assembly further includes a rigid actuator extending proximally within an internal cavity of the catheter interface, the free proximal end of the rigid actuator including an enlarged proximal flange. In one embodiment, the compliant sealing member can include an actuator cavity configured to receive the enlarged proximal flange of the rigid actuator, and a membrane defining a valve slit proximal to the actuator cavity, wherein the proximal flange of the rigid actuator is displaceable relative to the compliant sealing member between a first position and a second position, in which the valve slit is closed and in which the valve slit is open. In one embodiment, the safety catheter insertion assembly further includes a proximal cup operatively coupled to a compliance seal member, the proximal cup having an open distal and proximal end and defining a cavity therebetween, the cavity defined by the compliance seal member abutting the cavity defined by the proximal cup to form a cavity configured to receive a safety clip. In one embodiment, the proximal cup further includes a rod extension configured to conform to the outer diameter of the needle cannula to prevent fluid from passing through the cavity of the proximal cup. In one embodiment, the compliance seal member includes a blood control valve and a wiper assembly, the blood control valve being configured to allow selective passage of the needle cannula therethrough, the wiper assembly being positioned distal to the blood control valve and configured to prevent fluid from passing through therethrough. In one embodiment, the safety clip includes a first arm and a second arm biased toward the longitudinal axis of the needle cannula located therebetween. In one embodiment, the first arm includes a first needle cannula guide surface, and the second arm includes a second needle cannula guide surface, such that when the safety clip is in the second position, the first and second needle cannula guide surfaces extend beyond the longitudinal axis of the needle cannula. In another embodiment, the first arm includes a pair of needle cannula guide surfaces that extend beyond the longitudinal axis of the needle cannula when the safety clip is moved to the second position.

[0017] Another embodiment of this disclosure provides a passive safety catheter assembly. The passive safety catheter assembly may include a catheter assembly, a catheter insertion device, and a passive release mechanism. The catheter assembly may include a catheter interface and a catheter portion extending distally therefrom. The catheter insertion device may include a needle interface and a needle sheath extending distally therefrom. The needle sheath may include a sharp distal tip. The passive release mechanism may include a compliant external sealing member received within the catheter interface, and an internal needle clamping member received at least partially within the compliant external sealing member. The needle sheath may be slidably received within the internal clamping member and movable between a first position and a second position, in which the needle sheath forces a portion of the internal needle clamping member into compressive contact with the compliant external sealing member, and in the second position, the distal tip is captured within the internal needle clamping member and the compressive contact is reduced, allowing the insertion needle assembly to be removed from the catheter interface without substantial interference.

[0018] In one embodiment, the internal needle clamp member is configured to capture the distal tip of the needle cannula before releasing the needle clamp from the compliant external seal member. In one embodiment, the compliant external seal member is displaceable between a first position and a second position, in which a blood control valve of the compliant external seal member is closed, and in the second position, the blood control valve is open. In one embodiment, the passive safety catheter assembly further includes a proximal cup operatively coupled to the compliant external seal member, the proximal cup having an open distal end and a proximal end and defining a cavity therebetween, the cavity defined by the compliant external seal member abutting the cavity defined by the proximal cup to form a cavity configured to receive the internal needle clamp member. In one embodiment, the compliant external seal member may include a membrane and a swab assembly, the membrane defining a blood control valve configured to allow selective passage of the needle cannula therethrough, the swab assembly being positioned distal to the blood control valve and configured to prevent bodily fluids from passing through therethrough.

[0019] Another embodiment of this disclosure provides a catheter interface assembly. The catheter interface assembly may include a catheter interface body, a rigid actuator, a compliant sealing member, and a safety clip. The catheter interface body may have an open proximal end and a distal end, defining an internal cavity therebetween. The rigid actuator may extend proximally from the distal end of the catheter interface to a free end within the internal cavity of the catheter interface. The actuator may have an enlarged proximal flange at its free end. The compliant sealing member may be disposed within the internal cavity of the catheter interface. The compliant sealing member may include an actuator cavity configured to receive the enlarged proximal flange of the rigid actuator, and a diaphragm defining a valve orifice location proximal to the actuator cavity, wherein the proximal flange of the rigid actuator is displaceable relative to the compliant sealing member between a first position, in which the valve orifice is biased closed, and in a second position, the valve orifice is biased open. The safety clip may be partially received within the compliant sealing member. The safety clip can be configured to move between a first position and a second position. In the first position, a portion of the safety clip causes a portion of the compliant sealing member to be outwardly biased to interfere with contact with the inner diameter of the inner cavity of the conduit interface. In the second position, the outward bias of the safety clip on the compliant sealing member is eliminated.

[0020] Another embodiment of this disclosure provides a catheter interface assembly. The catheter interface assembly can include a catheter interface body, a compliance sealing member, a proximal cup, and a safety clip. The catheter interface body can have an open proximal end and a distal end, defining an internal cavity therebetween. The compliance sealing member can be disposed within the internal cavity of the catheter interface. The compliance sealing member can have an open distal end and a proximal end, defining a cavity therebetween. The proximal cup can be operatively coupled to the compliance sealing member. The proximal cup can have an open distal end and a proximal end, defining a cavity therebetween. The cavity defined by the compliance member can abut against the cavity defined by the proximal cup to form a safety clip cavity. The safety clip can be received within the safety clip cavity. The safety clip can be configured to move between a first position and a second position, in the first position, a portion of the safety clip outwardly biases a portion of the compliance sealing member to interfere with contact with the inner diameter of the internal cavity of the catheter interface, and in the second position, the outward bias of the safety clip against the compliance sealing member is eliminated.

[0021] Another embodiment of this disclosure provides a catheter interface assembly. The catheter interface assembly can include a catheter interface body and a compliance seal member. The catheter interface body can have an open proximal end and a distal end, defining an internal cavity between the proximal and distal ends. The compliance seal member can be disposed within the internal cavity of the catheter interface. The compliance seal member can include a membrane and a wiper assembly, the membrane defining a valve orifice configured to allow selective passage of a needle cannula through the orifice, the wiper assembly being positioned distal to the membrane, the membrane being configured to fit snugly against the outer diameter of the needle cannula to prevent the passage of bodily fluids therethrough.

[0022] The above overview is not intended to describe every illustrated embodiment or every implementation of this disclosure. The following drawings and detailed description illustrate these embodiments in more detail. Attached Figure Description

[0023] A more complete understanding of this disclosure can be achieved by taking into consideration the following detailed description of various embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0024] Figure 1A It is a three-dimensional diagram depicting a conventional catheter insertion assembly, in which the catheter is coaxially positioned on the catheter insertion device.

[0025] Figure 1B It is a description Figure 1A A perspective view of a standard catheter insertion assembly, in which the catheter is removed from the catheter insertion device.

[0026] Figure 2A This is a perspective view depicting a safety catheter insertion assembly in a first or ready-to-use position according to an embodiment of the present disclosure.

[0027] Figure 2B It depicts a second or safe position according to embodiments of this disclosure. Figure 2A A three-dimensional view of the catheter insertion assembly.

[0028] Figure 3 This is an exploded view depicting a safety catheter insertion assembly according to an embodiment of the present disclosure.

[0029] Figure 4A This is a partial cross-sectional view depicting a catheter assembly and catheter insertion device in a first or ready-to-use position according to an embodiment of the present disclosure.

[0030] Figure 4B It depicts a second or safe position according to embodiments of this disclosure. Figure 4A A partial cross-sectional view of the catheter assembly.

[0031] Figure 5 This is a cross-sectional view depicting an actuator according to an embodiment of the present disclosure.

[0032] Figure 6A This is a cross-sectional view depicting a sealing member according to an embodiment of the present disclosure.

[0033] Figure 6B It is a description Figure 6A A near-end view of the sealing component.

[0034] Figure 7 This is a partial cross-sectional view depicting a catheter assembly according to an embodiment of the present disclosure, the catheter assembly having a sealing member having a wiper and a needle cannula passing through it.

[0035] Figure 8A This is a partial cross-sectional view depicting a catheter assembly and Luer cone according to an embodiment of the present disclosure, wherein the sealing member of the catheter assembly is in the closed position.

[0036] Figure 8B This describes an embodiment according to the present disclosure. Figure 8A A partial cross-sectional view of the conduit assembly and Luer cone, showing the sealing member in the transition between the closed and open positions.

[0037] Figure 8C This describes an embodiment according to the present disclosure. Figure 8B A partial cross-sectional view of the conduit assembly and Luer cone, with the sealing member in the open position.

[0038] Figure 9A This is a partial perspective view depicting a first embodiment of a safety clip and needle cannula according to an embodiment of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0039] Figure 9B This describes an embodiment according to the present disclosure. Figure 9A A partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0040] Figure 9C This describes an embodiment of the present disclosure in a free state. Figure 9B A 3D view of the safety clip.

[0041] Figure 9D It describes a position in a second or safe location. Figure 9B Outline diagram of the safety clip and needle cannula.

[0042] Figure 10A This is a partial perspective view depicting a second embodiment of a safety clip and needle cannula according to an embodiment of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0043] Figure 10B This describes an embodiment according to the present disclosure. Figure 10AA partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0044] Figure 10C It describes a position in a second or safe location. Figure 10B Outline diagram of the safety clip and needle cannula.

[0045] Figure 10D This is a partial perspective view depicting a safety clip and needle cannula having tapered distal sidewalls according to an embodiment of the present disclosure.

[0046] Figure 10E This is a perspective view depicting a safety clip with twisted fangs according to an embodiment of the present disclosure.

[0047] Figure 11A This is a partial perspective view depicting a third embodiment of a safety clip and needle cannula according to embodiments of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0048] Figure 11B This describes an embodiment according to the present disclosure. Figure 11A A partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0049] Figure 11C It describes a position in a second or safe location. Figure 11B Outline diagram of the safety clip and needle cannula.

[0050] Figure 11D It describes the position as the first or ready for use. Figure 11B Cross-sectional end view of the safety clip and needle cannula.

[0051] Figure 12A This is a partial perspective view depicting a fourth embodiment of a safety clip and needle cannula according to embodiments of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0052] Figure 12B This describes an embodiment according to the present disclosure. Figure 12A A partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0053] Figure 12C It describes a position in a second or safe location. Figure 12B Outline diagram of the safety clip and needle cannula.

[0054] Figure 13A This is a partial perspective view depicting a fifth embodiment of a safety clip and needle cannula according to embodiments of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0055] Figure 13BThis describes an embodiment according to the present disclosure. Figure 13A A partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0056] Figure 13C It describes a position in a second or safe location. Figure 13B Outline diagram of the safety clip and needle cannula.

[0057] Figure 13D It describes the position as the first or ready for use. Figure 13B Cross-sectional end view of the safety clip and needle cannula.

[0058] Figure 14A This is a partial perspective view depicting a sixth embodiment of a safety clip and needle cannula according to embodiments of the present disclosure, wherein the safety clip is in a first or ready-to-use position.

[0059] Figure 14B This describes an embodiment according to the present disclosure. Figure 14A A partial 3D view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0060] Figure 15A This is a perspective view depicting a seventh embodiment of a security clip according to embodiments of the present disclosure.

[0061] Figure 15B This describes an embodiment according to the present disclosure. Figure 15A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0062] Figure 15C It depicts a second or safe position according to embodiments of this disclosure. Figure 15B Outline diagram of the safety clip and needle cannula.

[0063] Figure 16A This is a perspective view depicting an eighth embodiment of a security clip according to embodiments of the present disclosure.

[0064] Figure 16B This describes an embodiment according to the present disclosure. Figure 16A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0065] Figure 16C It depicts a second or safe position according to embodiments of this disclosure. Figure 16B Outline diagram of the safety clip and needle cannula.

[0066] Figure 17A This is a perspective view depicting a ninth embodiment of a security clip according to embodiments of the present disclosure.

[0067] Figure 17B This describes an embodiment according to the present disclosure. Figure 17A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0068] Figure 17C It depicts a second or safe position according to embodiments of this disclosure. Figure 17B Outline diagram of the safety clip and needle cannula.

[0069] Figure 18A This is a perspective view depicting a tenth embodiment of a security clip according to embodiments of the present disclosure.

[0070] Figure 18B This describes an embodiment according to the present disclosure. Figure 18A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0071] Figure 18C It depicts a second or safe position according to embodiments of this disclosure. Figure 18B Outline diagram of the safety clip and needle cannula.

[0072] Figure 19A This is a perspective view depicting an eleventh embodiment of a security clip according to embodiments of the present disclosure.

[0073] Figure 19B This describes an embodiment according to the present disclosure. Figure 19A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0074] Figure 19C It depicts a second or safe position according to embodiments of this disclosure. Figure 19B Outline diagram of the safety clip and needle cannula.

[0075] Figure 20A This is a perspective view depicting the twelfth embodiment of the security clip according to embodiments of the present disclosure.

[0076] Figure 20B This describes an embodiment according to the present disclosure. Figure 20A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0077] Figure 20C It depicts a second or safe position according to embodiments of this disclosure. Figure 20B Outline diagram of the safety clip and needle cannula.

[0078] Figure 21A This is a perspective view depicting a thirteenth embodiment of a security clip according to embodiments of the present disclosure.

[0079] Figure 21B This describes an embodiment according to the present disclosure. Figure 21A A three-dimensional view of the safety clip and needle cannula, with the safety clip in the second or safe position.

[0080] Figure 21C It depicts a second or safe position according to embodiments of this disclosure. Figure 21B Outline diagram of the safety clip and needle cannula.

[0081] Figure 22A This is a partial cross-sectional view depicting a safety conduit assembly in a first or ready-to-use position according to an embodiment of the present disclosure.

[0082] Figure 22B According to embodiments of this disclosure Figure 22A A partial cross-sectional view of a safety conduit assembly, wherein the safety conduit assembly is in the transition between a first or ready-to-use position and a second or safe position.

[0083] Figure 22C According to embodiments of this disclosure Figure 22B A partial cross-sectional view of the safety conduit assembly, wherein the safety conduit assembly is in the second door safety position.

[0084] Figure 23A This is a perspective view depicting a proximal cup-shaped body according to an embodiment of the present disclosure.

[0085] Figure 23B This is a partial perspective view depicting the needle cannula, safety clip, and proximal cup body in a second or safe position according to an embodiment of the present disclosure.

[0086] Figure 23C This is a partial perspective view depicting a needle cannula, a safety clip, and a proximal cup-shaped body with a rod extension in a second or safe position according to an embodiment of the present disclosure.

[0087] Figure 23D This is a partial cross-sectional view depicting a safety catheter insertion assembly with a proximal cup-shaped body according to an embodiment of the present disclosure, wherein the safety catheter assembly is in a first or ready-to-use position.

[0088] Figure 23E This describes an embodiment according to the present disclosure. Figure 23D A perspective view of a safety catheter insertion assembly, wherein the safety catheter assembly is in a second or safe position.

[0089] While various modifications and alternatives are possible to the embodiments of this disclosure, the details thereof will be described in detail by way of example in the accompanying drawings. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the subject matter as defined by the claims. Detailed Implementation

[0090] This document describes various exemplary embodiments of catheters for accessing a subject's vein. However, it should be understood that the exemplary embodiments described herein can be alternatively used for accessing a subject's blood vessels at locations other than veins, including, but not limited to, the subject's arteries. Furthermore, it should be understood that the term "clinician" refers to any individual capable of performing a catheter insertion procedure using any of the exemplary embodiments described herein or alternative combinations thereof. Similarly, as used herein, the term "subject" should be understood to refer to the individual or object to whom a catheter is to be inserted, whether human, animal, or inanimate. For convenience, various descriptions of procedures for accessing a subject's vein performed by a clinician are provided herein, but this disclosure is not limited to this aspect.

[0091] It should also be understood that, as used herein, the term “distal” refers to the direction closest to the subject during catheter insertion, along the axis of the needle cannula parallel to the safety catheter assembly. Conversely, as used herein, the term “proximal” refers to the direction opposite to the distal direction, along the axis of the needle cannula parallel to the subject's vein, further away from the subject.

[0092] Reference Exam Figures 1A to 1B The image depicts a conventional catheter insertion assembly 50. Details of the conventional catheter insertion assembly 50 are described in the background section above.

[0093] refer to Figures 2A to 2B A perspective view of a safety catheter insertion assembly 100 according to an embodiment of the present disclosure is depicted. Figure 3An exploded view of a safety catheter insertion assembly 100 according to an embodiment of the present disclosure is depicted. The safety catheter assembly 100 may include a catheter insertion device 102 and a catheter assembly 104. The catheter insertion device 102 may include an insert or needle cannula 106 operatively coupled to a needle interface 108. The needle cannula 106 may include an elongated cylindrical metal structure defining a lumen extending between a sharp distal needle tip 110 and a proximal end 112. The sharp distal needle tip 110 may be configured and arranged to pierce the skin of a subject during catheter insertion. For example, in one embodiment, the sharp distal tip 110 may include a V-point designed to reduce the puncture force required to pierce the needle 106 and a portion of the catheter insertion assembly 104 through the skin, tissue, and vein walls of a subject. In one embodiment, the length of the needle 106 may be extended to aid in the insertion of the catheter assembly 104 into an obese patient.

[0094] The needle cannula 106 may also include a transition portion 114 having a different cross-sectional size and shape than other portions of the needle 106 located proximal to the transition portion 114. The needle transition portion 114 (which may alternatively be referred to as a needle protrusion or cannula protrusion) may be created by crimping opposite sides of the needle cannula 106 or otherwise disrupting the structure of the needle 106, such that, measured from the center of the needle axis, the outer surface of the needle 106 extends to a larger radial position than other portions of the needle cannula 106. According to alternative embodiments, the needle transition portion 114 may be formed differently, such as by adding material to the exterior of the needle.

[0095] The proximal end 112 of the needle cannula 106 is operatively coupled to the needle interface 108. The needle interface 108 may include a gripping portion for manipulation by a clinician. In one embodiment, the catheter insertion device 102 may be configured to provide a flashback visual indication when the sharp distal tip 110 of the needle 106 enters a vein in a subject. In this embodiment, the needle interface 108 includes a flash chamber 116 in fluid communication with the lumen of the needle. When the sharp distal tip 110 enters a vein during catheter insertion, blood or bodily fluid flows from the vein into the needle lumen and proximally through the needle 106 into the flash chamber 116. The flash chamber 116 may be sealed at one end by a flash plug 118. The flash plug 118 may be made of a breathable hydrophilic material that allows air to pass through but prevents liquid from passing through. Therefore, the air residing in the needle lumen and flash chamber 116 is propelled by the incoming blood through the flash stop 118 until the blood reaches the flash stop 118 or otherwise stops. The needle interface 108, or a portion thereof, can be made of a transparent or translucent material configured to allow the clinician to observe the presence of blood within the flash chamber 116. In this respect, the presence of blood in the flash chamber 116 can alert the clinician when the needle has entered the subject's vein.

[0096] In one embodiment, features of the catheter insertion device 102, other than the flash chamber 116, can provide an indication that the sharp distal tip 110 has entered a subject's vein. For example, the needle cannula 106 can include a notch 120. In this embodiment, when the sharp distal tip 110 enters a vein, blood flows into the needle lumen. As blood flows proximally within the needle lumen, some blood passes through the notch 120 and enters the annular space located between the exterior of the needle 106 and the interior of the catheter assembly 104. The presence of blood in the annular space can be observed by a clinician through a transparent or translucent portion of the catheter assembly 104, thus providing an indication that the sharp distal tip 110 is present in a vein.

[0097] like Figure 2A As depicted, the safety catheter insertion assembly 100 can be positioned in a first or ready-to-use position, where the catheter assembly 104 is connected to the catheter insertion device 102. Specifically, the catheter assembly 104 (which may include a catheter interface 122 and a catheter tube portion 124) can be positioned above the needle cannula 106 of the catheter insertion device 102, wherein the sharp distal tip 110 of the needle 106 protrudes from the distal end 126 of the catheter tube portion 124. In some embodiments, the safety catheter assembly 100 can be provided for use in a sterile and assembled state, contained within a sealed package.

[0098] To insert the catheter into the subject's vein, the clinician first removes the safety catheter assembly 100 from the packaging. A needle sheath 125 (as shown) covers the needle cannula 106. Figure 3 The needle cannula 106 (as depicted in the text) can be removed to expose the sharp distal tip 110 of the needle cannula 106. The clinician then uses the sharp distal tip 110 to puncture the identified site on the patient or subject and pushes the needle cannula 106 forward until the sharp distal tip 110 and a portion of the catheter portion 124 enter the subject's vein.

[0099] The catheter assembly 104 can then be moved distally over the needle 106, inserting the catheter assembly 104 into the subject's vein while the catheter insertion device 102 remains stationary. With the catheter assembly 104 positioned as desired, the clinician can withdraw the needle cannula 106 from the patient's vein by pulling the catheter insertion device 102 proximally away from the subject while keeping the catheter assembly 104 substantially stationary relative to the subject. Pulling the catheter insertion device 102 proximally continues until the needle cannula 106 separates from the catheter assembly 104.

[0100] like Figure 2B As depicted, the catheter insertion device 102 can be detached from or removed from the catheter assembly 104 depending on a second or safe position. In some embodiments, to prevent unwanted needle pricks, a safety clip 128 can be operatively coupled to either the catheter assembly 104 or the catheter insertion device 102 and positioned above the sharp distal tip 110 before the catheter insertion device 102 is detached from the catheter assembly 104. In the safe position, the clinician can position the catheter insertion device 102 within the sharp container.

[0101] refer to Figure 4A A partial cross-sectional view of a safety conduit assembly 100 in a first or ready-to-use position according to an embodiment of the present disclosure is depicted. (See also:) Figure 4B This image depicts a partial cross-sectional view of a catheter assembly 104 in a second position according to an embodiment of the present disclosure. The catheter assembly 104 may include a catheter interface 122, a catheter portion 124, a safety clip 128, an actuator 130, and a sealing member 132. In some embodiments, the catheter assembly 104 may also include a wing assembly, an extension tube, an extension tube clamp, a needleless connector, and / or a vent cap (not depicted). Therefore, the catheter assembly 104 may include a blood control feature configured to prevent blood leakage after withdrawal of the needle cannula 106, thereby reducing the risk of exposure of blood or other bodily fluids to clinicians, particularly considering sensitivities in the presence of blood-borne diseases. Additionally, embodiments of the catheter assembly 104 may prevent the introduction of unwanted contaminants into the interior of the catheter assembly 104 prior to connection to an IV fluid supply.

[0102] The catheter portion 124 can extend from the distal tapered end 126 to the proximal end 134, where it can be operatively coupled to the catheter interface 122. The catheter portion 124 can define a lumen 136 configured to provide a fluid pathway between a subject's vein and the catheter interface 122. In one embodiment, the catheter portion 124 can include an opaque barium ray for easy identification during the irradiation process.

[0103] The catheter interface 122 may include a catheter interface body 138 having a distal end 140, a proximal end 142, and an inner wall 144 defining an internal cavity 146 therebetween. The internal cavity may include a proximal portion 148 extending from the proximal end 142 of the opening, and a distal portion 150 closer to the distal end 140. In one embodiment, the distal end 140 of the catheter interface body 138 is operatively coupled to the proximal end 134 of the catheter tubing 124 such that the lumen 136 of the catheter tubing 124 is in fluid communication with the proximal portion 148 of the internal cavity 146. The proximal portion 148 of the internal cavity 146 is shaped according to the Lur cone standard to matingly receive a Lur cone 200 (e.g., Figures 8A-8C (As depicted in the text).

[0104] The actuator 130 can be secured proximally to the distal end 140 of the catheter interface 122 so as to extend axially within the internal cavity 146. In one embodiment, the proximal end 134 of the catheter portion 124 can be secured within the internal cavity 146 of the catheter interface 122 by means of the actuator 130. The sealing member 132 (which may alternatively be referred to as the blood control valve 132) can also be secured within the internal cavity 146 of the catheter interface 122 by means of the actuator 130, such that the sealing member 132 is axially displaceable relative to the actuator 130 between a closed or sealed position and an open or actuated position. Thus, the actuator 130 serves both to secure the catheter portion 124 to the catheter interface 122 and to support the sealing member 132.

[0105] refer to Figure 5The image depicts a cross-sectional view of an actuator 130 according to an embodiment of the present disclosure. The actuator 130 can be generally rigid and can include a generally cylindrical body 152 having a distal end 154, a proximal end 156, and a wall 158 defining an internal cavity 160 therebetween. For example, in one embodiment, the actuator 130 can be formed from medical-grade stainless steel using methods generally known in the art. In one embodiment, the internal cavity 160 is configured to receive a needle cannula 106 passing through it without interfering with a needle transition portion 114. Upon withdrawal of the needle cannula, the internal cavity 160 can be configured to allow bodily fluid to pass through it. In one embodiment, the wall 158 can further define an annular rib 162 that divides the cylindrical body 152 into a distal portion 164 and a proximal portion 166. In some embodiments, the distal end 154 can be tapered, and the proximal end 156 can include a flange 168. In one embodiment, the flange 168 can be formed by bending or folding a portion of the wall 158 at an angle greater than 90°, such that in some embodiments, a portion of the wall 158 is folded back on itself.

[0106] like Figures 4A-4B As depicted, the distal portion 164 of the actuator 130 is frictionally engaged within the proximal end 134 of the catheter portion 124, and also frictionally engaged within the internal cavity 146 of the catheter interface 122, such that the catheter portion 124 extends distally from the distal end 140 of the catheter interface 122. The annular rib 162 enhances the frictional engagement of the actuator 130 within the internal cavity 146 of the catheter interface 122. Therefore, the actuator 130 can be positioned within the catheter interface such that the free proximal portion 166 extends proximally within the internal cavity 146 of the catheter interface 122.

[0107] like Figures 4A-4B As depicted, a sealing member 132 (i.e., a blood control valve) is arranged within the internal cavity 146 of the catheter port 122 and is partially supported therein by the actuator 130 and partially by the inner wall 144 of the catheter port 122, such that the sealing member 132 can be displaced between a closed position and an open position, in which the flow of bodily fluid from the catheter portion 124 to the internal cavity 146 of the catheter port 122 is blocked or restricted, and in the open position, the sealing member 132 is displaced relative to the actuator 130, thereby allowing bodily fluid to flow from the catheter portion 124 into the proximal portion 148 of the internal cavity 146 of the catheter port 122, as will be described in further detail below.

[0108] refer to Figure 6A A cross-sectional view of a sealing member 132 according to an embodiment of the present disclosure is depicted. (See reference...) Figure 6BThe image depicts a proximal view of a sealing member 132 according to an embodiment of the present disclosure. The sealing member 132 can be generally elastic or resilient and can include a generally cylindrical body 170 having a distal end 172, a proximal end 174, and a wall 176 defining an internal cavity 178 therebetween. In one embodiment, the sealing member 132 can be formed from a suitable material (including, for example, silicone or polyisoprene) by methods generally known in the art.

[0109] In one embodiment, wall 176 may further include a membrane 180 dividing the internal cavity 178 into a distal portion 182 and a proximal portion 184. In one embodiment, membrane 180 may extend substantially orthogonally to the central longitudinal axis of the cylindrical body 170. Membrane 180 may define a slit 186 that can be properly biased to close when the sealing member 132 is in a relaxed, uncompressed state. Slit 186 may take several forms recognized in the art and may, for example, be a single straight slit (not shown) passing through membrane 180. Figure 6B As depicted, in one embodiment, slit 186 can have a three-slit configuration that extends to three radially outermost ends 188 to present a generally Y-shaped configuration. Slit 186 defines a plurality of membrane flaps 190, the number of which depends on the specific configuration of slit 186 (e.g., three flaps 190 for a three-slit configuration).

[0110] In one embodiment, the shape and size of the slit 186 can be designed to closely conform to the outer diameter of the needle cannula 106 to prevent leakage, particularly during proximal withdrawal of the needle cannula 106, without increasing the actuation force required to withdraw the needle cannula 106 from the catheter interface 122. For example, in some embodiments, the length of the slit 186 (e.g., its radial range) can be very close to the width of a 14-gauge needle (0.06525 inches), a 16-gauge needle (0.05025 inches), an 18-gauge needle (0.03575 inches), or a 20-gauge needle (0.02825 inches). In some embodiments, the length of the slit 186 can be measured as approximately 0.075 inches, 0.070 inches, 0.060 inches, 0.055 inches, 0.045 inches, 0.040 inches, or 0.035 inches. In addition, the length of the slit 186 is preferably smaller than the cross-sectional dimension (e.g., diameter) of the membrane 180, such that the outermost radial end 188 of the slit 186 is spaced apart from the wall 176 of the cylindrical body 170, and the slit 186 does not penetrate into the wall 176 of the cylindrical body 170.

[0111] At the first or ready-to-use location of the safety conduit assembly 100 (e.g.) Figure 4AAs depicted in [the text], the slit 186 in the membrane 180 and the needle sheath 106 cooperate to prevent or restrict the flow of bodily fluids around the outer diameter of the needle sheath 106 as the needle sheath 106 extends through the membrane 180. In some embodiments, the slit 186 and the needle sheath 106 may not form a fluid-tight seal, but may instead provide significant restriction on the flow of bodily fluids therethrough, such that a small amount of blood may permeate through the slit 196 of the membrane 180 during insertion of the catheter portion 124 into the patient's vascular system. In another embodiment, the sealing member 132 may include a second membrane or wipe 202 configured to further restrict or prevent the flow of bodily fluids and generally improve the seal during advancement.

[0112] refer to Figure 7 The image depicts a partial cross-sectional view of a catheter assembly 104 according to an embodiment of the present disclosure, the catheter assembly 104 having a sealing member 132 with a wiper 202 and a needle cannula 106 passing through therethrough. In one embodiment, the wiper 202 can be configured to define a membrane 204 defining an orifice 206. In one embodiment, the orifice 206 can be circular. In contrast to a slit 186 that is typically able to close biasedly when the needle cannula 106 is removed, the orifice 206 can have a cross-sectional dimension slightly smaller than the outer diameter of the needle cannula 106, and therefore, although it closely conforms to and / or slightly interferes with the outer diameter of the needle cannula 106 when the needle cannula 106 is positioned within the sealing member 132, the orifice 206 can remain open when the needle cannula 106 is removed. In one embodiment, the wiper 202 is positioned distal to the membrane 180 to prevent bodily fluids from flowing into the membrane 180 when the needle cannula 106 is positioned within the sealing member 132. In other embodiments, the wiper 202 can be positioned proximal to the membrane.

[0113] Continue to refer to Figure 6A The distal portion 182 of the internal cavity 178 may include a sealing outlet orifice 192 defined by an annular sealing lip 194 extending inward from the distal end 172, and an actuator cavity 196 between the sealing outlet orifice 192 and the diaphragm 180. See also... Figure 8AThe diagram depicts a cross-sectional view of a conduit assembly 104 according to an embodiment of the present disclosure, wherein the sealing member 132 is in a closed position. A proximal portion 166 of the actuator is received through a sealing outlet port 192 and enters into an actuator cavity 196, wherein a flange 168 is contained within the actuator cavity 196. The actuator cavity 196 may include a narrowing portion 198 that provides an hourglass shape to the actuator cavity 196. In one embodiment, the narrowing portion 196 may be provided by an annular rib that projects generally radially inward from a portion of the wall 176 defining the actuator cavity 196. In one embodiment, the flange 168 is completely contained within the actuator cavity 196. For example, in one embodiment, the truncated conical surface of the flange 168 of the sealing member 132 may engage with the annular rib of the narrowing portion 198. The outermost cross-sectional diameter of the flange 168 can be larger than the cross-sectional diameter of the sealing outlet hole 192, and can be configured such that the sealing outlet hole 192 can slide distally on the flange 168, but restricts the sealing member 132 from moving proximally back onto the flange 168. Therefore, in the closed position (e.g.) Figure 8A At the location depicted in the figure, when the flange 168 is positioned within the actuator cavity 196, the slit 186 of the membrane 180 is naturally biased and closed to prevent fluid from flowing through it.

[0114] like Figures 8B-8C As depicted, upon insertion of the Luer cone 200, the sealing member 132 is distally displaced relative to the actuator 130 to push the flange 168 against the membrane 180, thereby at least partially opening the slit 186 of the membrane 180. The proximal portion 184 of the internal cavity 178 can be generally cylindrical and can extend between the membrane 180 and the opening in the proximal end 174 of the sealing member 132. In one embodiment, the proximal portion 184 can have a generally constant cross-sectional dimension configured such that a standard-sized Luer cone 200 cannot enter the internal cavity 178 of the sealing member 132, but instead will at most impact the proximal end 174 of the sealing member 132.

[0115] As the sealing member 132 is axially displaced within the catheter interface 122, the proximal portion 166 of the actuator 130 contacts the membrane 180 and begins to puncture through the slit 186, causing the flap 190 formed by the slit 186 to hinge or open and slide along the flange 168 (e.g., along its truncated conical surface) to gradually open the slit 186. Continued distal insertion of the Luer cone 200 causes axial displacement of the sealing member 132 until the Luer cone 200 is fully extended into the internal cavity 146 of the catheter interface 122, wherein the distal end 172 of the sealing member 132 moves forward or abuts against the distal portion 150 of the internal cavity 146, thereby defining the open position of the sealing member 132 (e.g., ...). Figure 8C(As depicted in the text). When the sealing member 132 is in the open position, an unobstructed fluid path is formed between the catheter section 124 and the Luer cone 200 via the actuator 130, such as for applying fluid to the patient through the catheter assembly 104 or for aspirating blood or other bodily fluids from the patient through the catheter assembly 104.

[0116] In one embodiment, the membrane 180 has sufficient resilience to allow the flange 168 to pierce the slit 186 without tearing or otherwise damaging the membrane 180. After the flange 168 passes through the actuator 130, the slit 186 can then close rearward around the actuator 130. In another embodiment, the flange 168 can deform, tear, or otherwise damage the membrane 180 when it pierces through the slit 186. Therefore, in one embodiment, the sealing member 132 is a one-time seal. In this respect, after the Luer cone 200 is removed from the conduit interface 122, the sealing member 132 will not move proximally back to the closed position, but will instead remain in the open position. In one embodiment, the flange 168 can be configured to allow the sealing member 132 to move distally, but prevent the sealing member 132 from moving proximally in the opposite direction. Therefore, in one embodiment, the membrane 180 does not automatically retract on the flange 168 to close the formed fluid flow path; instead, a patent fluid flow path is provided between the catheter portion 124 and the proximal end 142 of the opening of the internal cavity 146 and / or the catheter interface 122. In another embodiment, the catheter assembly 104 may be provided with a mechanism, such as a spring, elastic element, or bellows, to provide a driving force for proximal, axial displacement of the sealing member 132 back to a closed position. In one embodiment, the mechanism configured to provide the driving force for proximal, axial displacement of the sealing member 132 back may be integral with the seal.

[0117] The safety clip 128 can reside at least partially within the proximal portion 184 of the sealing member 132 and can be configured in a first or ready-to-use position (e.g. Figure 2A (as depicted in the text) and a second or safe location (such as...) Figure 2B The needle cannula 106 slides axially between the two sides (as depicted in the illustration), with the needle cannula 106 passing through the safety clip 128 in the first or ready-to-use position, and the sharp distal tip 110 being captured within the safety clip 128 in the second or safe position to prevent unwanted needle punctures.

[0118] refer to Figures 9A-9D The first embodiment of the security clip according to the present disclosure is described. Figure 9A The safety clip 128 is depicted in a first or ready-to-use position, with the needle cannula 106 passing through a portion of the safety clip 128. Figure 9BA safety clip 128 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 128.

[0119] In one embodiment, the safety clip 128 may include a proximal sidewall 208 and one or more protective arms 210. The proximal sidewall 208 may define an orifice 212 configured to be positioned around or on the needle cannula 106. In some embodiments, the proximal sidewall 208 and the orifice 212 may be configured to engage the needle transition 114 to prevent the safety clip 128 from advancing distally away from the sharp distal tip 110 of the needle cannula 106. In one embodiment, the surface 214 of the proximal sidewall 208 may be generally orthogonal to the longitudinal axis 216 of the needle cannula 106. In other embodiments, the surface 214 may be positioned at an oblique or acute angle relative to the longitudinal axis 216 of the needle cannula 106.

[0120] One or more protective arms 210 are capable of extending distally from the proximal sidewall 208. In one embodiment, the safety clip 128 may include a pair of protective arms 210A / 210B. The safety clip 128 may be formed of a material that is generally resilient (e.g., medical-grade stainless steel) such that the protective arms 210 have a natural bias toward a free or relaxed state when a portion of the safety clip 128 is deviated from its free state. For example, in one embodiment, the safety clip 128 is in a free state when it is in a second or safe position. Therefore, in this embodiment, when the safety clip 128 is in a first or ready-to-use position, the protective arms 210A-B are biased against the needle cannula 106 because the presence of the needle cannula 106 deviates the protective arms 210A-B from their free state. When the needle cannula 106 is retracted and the sharp distal tip 110 moves proximally between the protective arms 210, the protective arms 210 naturally bias toward their free state, thereby capturing the sharp distal tip 110 therebetween. In some embodiments, further proximal movement of the sharp distal tip 110 is prevented by making the cross-sectional dimension of the needle transition portion 114 larger than the orifice 212 in the proximal wall of the safety clip. In some embodiments, distal movement of the sharp distal tip 110 is prevented by the distal portion of at least one of the arms 210A-B.

[0121] In one embodiment, the first protective arm 210A may include a straight portion 218, a curved portion 220, and a distal sidewall 222. The straight portion 218 may be adjacent to the proximal sidewall 208, such that the straight portion 218 and the proximal sidewall 208 are separated by the curved portion 224. In one embodiment, the curved portion 224 may form an angle of 80-90°, although other angles of the curved portion 224 are also contemplated.

[0122] The curved portion 220 may be adjacent to the straight portion 218. In some embodiments, the curved portion 220 may have a width 226 reduced relative to the width 228 of the straight portion 218, such that the curved portion 220 at least partially conforms to the outer diameter of the needle cannula 106. In one embodiment, the curved portion 220 may further define a needle cannula guide surface or contour cut 230 configured to at least partially conform to the needle cannula 106. Thus, the reduced width 226 and contour cut 230 of the curved portion 220 may be configured to maintain the position of the safety clip 128 along the needle cannula 106, particularly when the needle cannula 106 is retracted relative to the safety clip 128 and when the needle cannula 106 is moved. In one embodiment, when the needle cannula 106 is positioned within the safety clip 218, the apex 231 of the curved portion 220 may extend toward the longitudinal axis 216 of the needle cannula 106. In some embodiments, vertex 231 extends beyond the longitudinal axis 216 of the needle cannula 106 only in a second or safe position, and does not extend beyond the longitudinal axis 216 in a first or ready-to-use position. Therefore, in some embodiments, the protective arms 210A-B are non-intersecting (i.e., the protective arms 210A-B do not cross or intersect each other along the longitudinal axis 216 of the needle cannula 106). Note that non-intersecting protective arms (i.e., protective arms that do not cross or intersect each other along the longitudinal axis of the needle cannula 106) can be applied to any embodiment of the needle clip disclosed herein.

[0123] The distal wall 222 may be adjacent to the curved portion 220. In some embodiments, when the needle cannula 106 is positioned within the safety clip 218, the distal wall 222 may be angled toward the longitudinal axis 216 of the needle cannula 106. In one embodiment, the distal wall 222 may also include a lip or hook 232 at its distal end. In one embodiment, the hook 232 may include a curved surface configured to contact and / or slide along the needle cannula 106 when the needle cannula 106 is positioned within the safety clip 218. In one embodiment, the hook 232 may be configured to prevent the sharp distal tip 110 of the needle cannula 106 from moving distally back past the hook 232 and out of the safety clip 128 once the sharp distal tip 110 of the needle cannula 106 has moved proximally past the hook 232.

[0124] The distal wall may also include one or more tabs 234 positioned on either lateral side of the distal wall 222, such that the one or more tabs 234 can be configured to help keep the sharp distal tip 110 of the needle cannula 106 in a second or safe position. The one or more tabs 234 may additionally contact a portion of the opposing protective arm 210B to maintain alignment of the protective arms 210A-B in the second or safe position.

[0125] In one embodiment, the second protective arm 210B may further include a straight portion 218B, a curved portion 220B, and a distal wall 222B having a configuration similar to that of the first protective arm 210A. In some embodiments, the second protective arm 210B may be slightly shorter than the first protective arm 201A, such that in a second or safe position, the hook 232B of the second protective arm 210B can be positioned proximal to the hook 232 of the first protective arm 210A. Additionally, in some embodiments, the curved portion 220B of the second protective arm 210B may be positioned proximal to the curved portion 220 of the first protective arm 210A, such that in a second or safe position, the protective arms 210A-B do not intersect (i.e., the protective arms 210A-B do not cross or intersect each other along the longitudinal axis 216 of the needle sheath 106). In one embodiment, the width 226 of the curved portion 220B of the second guard arm 210B can be positioned on a lateral side opposite to the width 226 of the curved portion 220A of the first guard arm 210A, so as to prevent the guard arms 210A-B from intersecting at a second or safe position.

[0126] refer to Figures 10A-10C The second embodiment of the security clip 300 according to the present disclosure is described. Figure 10A A safety clip 300 is depicted in a first or ready-to-use position, with a needle cannula 106 passing through a portion of the safety clip 300. Figure 10B A safety clip 300 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 300.

[0127] In one embodiment, the safety clip 300 may include a proximal sidewall 308 and one or more protective arms 310A-B. The protective arm 310 may include a straight portion 318, a curved portion 320, and a distal sidewall 322. In one embodiment, the curved portion 320 of the safety clip 300 may define a needle cannula guiding surface or contour-cut notch 330 between the lateral edges 336, 338 of the protective arm 310A, such that the curved portion 330 forms a pair of curved teeth 340, 342 having a generally reduced width 326A / B compared to the width 328 of the straight portion 318. The contour-cut notch 330 may be configured to maintain the position of the safety clip 300 along the needle cannula 106, particularly when the needle cannula 106 is retracted relative to the safety clip 300 and when the needle cannula 106 is moved. Other portions of the safety clip 300 may have a structure similar to that of other safety clip embodiments disclosed herein.

[0128] refer to Figure 10DIn an alternative configuration, the distal wall 322 of the safety clip 300' can have a reduced width to substantially form a distal cone 350. In this configuration, the distal cone 350 can be used to assist in loading and containing the sharp distal tip 110 of the needle cannula 106.

[0129] refer to Figure 10E In another configuration, the teeth 340, 342 of the safety clip 300” may include a torsion portion or a partial rotation portion relative to the straight portion 318. In this configuration, the teeth 340, 342 can more closely conform to the surface of the needle cannula 106, especially when the needle cannula 106 is retracted relative to the needle clip 300” and the needle cannula 106 is moved, thereby helping to maintain the position of the safety clip 300” along the needle cannula 106.

[0130] refer to Figures 11A-11D The third embodiment of the security clip 400 according to the present disclosure is described. Figure 11A A safety clip 400 is depicted in a first or ready-to-use position, with a needle cannula 106 passing through a portion of the safety clip 400. Figure 11B A safety clip 400 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 400.

[0131] In one embodiment, the safety clip 400 may include a proximal sidewall 408 and one or more protective arms 410A-B. The protective arms 410A-B may include a straight portion 418, a tabbed portion 420, and a distal sidewall 422. The straight portion 418 may be adjacent to the proximal sidewall 408, such that the straight portion 418 and the proximal sidewall 408 are separated by a bend 424. In one embodiment, the bend 424 may form an angle of 70-90°, although other angles of the bend 424 are also contemplated.

[0132] The tabbed portion 420 may be adjacent to the straight portion 418. In some embodiments, the tabbed portion 420 may have a width 426 that is reduced relative to the width 428 of the straight portion 418. In one embodiment, the tabbed portion 420 may include one or more tabs 436. The one or more tabs 436 may be configured to maintain the position of the safety clip 400 along the needle sheath 106, particularly when the needle sheath 106 is retracted relative to the safety clip 400 and the needle sheath 106 is moved. In one embodiment, at a second or safe position, the tabbed portion 420 includes the needle sheath 106. In one embodiment, when the needle sheath 106 is positioned within the safety clip 400, the extending surface 431 of the tabbed portion 420 may extend toward the longitudinal axis 216 of the needle sheath 106. In some embodiments, the extending surface 431 extends beyond the longitudinal axis 216 of the needle sheath 106 only at the second or safe position and does not extend beyond the longitudinal axis 216 at the first or ready-to-use position. Therefore, in some embodiments, the protective arms 410A-B are non-intersecting (i.e., the protective arms 410A-B do not cross or intersect each other along the longitudinal axis 216 of the needle sheath 106).

[0133] like Figure 11D As depicted herein, in one embodiment, the tabbed portion 420B of the second protective arm 410B is alignable with the tabbed portion 420A of the first protective arm 410A, while the tab 436B of the second protective arm 410B is positioned on a lateral side opposite to the tab 436A of the first protective arm 410A to prevent the protective arms 410A-B from intersecting in a second or safe position. Other portions of the safety clip 400 can have structures similar to those in other safety clip embodiments disclosed herein.

[0134] refer to Figures 12A-12C The fourth embodiment of the security clip 500 according to the present disclosure is described. Figure 12A A safety clip 500 is depicted in a first or ready-to-use position, with a needle cannula 106 passing through a portion of the safety clip 500. Figure 12B A safety clip 500 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 500.

[0135] In one embodiment, the safety clip 500 may include a proximal sidewall 508 and one or more protective arms 510A-B. The protective arms 510A-B may include a straight portion 518, a tabbed portion 520, and a distal sidewall 522. In one embodiment, the tabbed portion 520 may be present on both protective arms 510A and 510B. In other embodiments, the tabbed portion 520 may be present on a single protective arm 510A / B. In one embodiment, the tabbed portion 520 of the safety clip 500 may define a needle cannula guide surface or contour cut notch 530 between the lateral edges 536, 538 of the protective arm 510A, such that the tabbed portion 520 forms a pair of teeth 540, 542 having an overall reduced width 526A / B compared to the width 528 of the straight portion 518. The contour-cut notch 530 and / or the tabbed portion 520 can be configured to maintain the position of the safety clip 500 along the needle cannula 106, particularly when the needle cannula 106 is retracted relative to the safety clip 500 and when the needle cannula 106 is moved, and / or when approaching or in a second or safe position. Other portions of the safety clip 500 can be similar in structure to other safety clip embodiments disclosed herein.

[0136] refer to Figure 13A -D depicts a fifth embodiment of the security clip 600 according to this disclosure. Figure 13A A safety clip 600 is depicted in a first or ready-to-use position, wherein a needle cannula 106 passes through a portion of the safety clip 600. Figure 13B A safety clip 600 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 600.

[0137] Similar to the fourth embodiment, the first protective arm 610A may include a tabbed portion 620 defining a needle sheath guide surface or contour-cut notch 630 between the lateral edges 636, 638 of the protective arm 610A, such that the tabbed portion 630 forms a pair of teeth 640, 642. In this embodiment, the pair of tabs 644, 646 may be configured to maintain the position of the safety clip 600 along the needle sheath 106, particularly when the needle sheath 106 is retracted relative to the safety clip 600 and when the needle sheath 106 is moved. In one embodiment, when the needle sheath 106 is positioned within the safety clip 600, the outermost surfaces 645, 647 of the tabs 644, 646 may extend toward the longitudinal axis 216 of the needle sheath 106. In some embodiments, surfaces 645, 647 extend beyond the longitudinal axis 216 of the needle sheath 106 only in a second or safe position, and do not extend beyond the longitudinal axis 216 in a first or ready-to-use position. In some embodiments, the second protective arm 610B does not include any tabs. Therefore, in some embodiments, the protective arms 610A-B are non-intersecting (i.e., the protective arms 610A-B do not cross or intersect each other along the longitudinal axis 216 of the needle sheath 106).

[0138] refer to Figures 14A-14B The sixth embodiment of the security clip 700 according to the present disclosure is described. Figure 14A A safety clip 700 is depicted in a first or ready-to-use position, wherein a needle cannula 106 passes through a portion of the safety clip 700. Figure 14B A safety clip 700 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 700.

[0139] In one embodiment, the safety clip 700 may include a proximal sidewall 708, a pair of protective arms 710A-B, and an elastomeric band 712 positioned around the protective arms 700A-B such that the protective arms 700A-B are biased toward each other. As in the previous embodiments, the proximal arm 708 may define an orifice shaped and sized to allow at least a portion of the needle sheath 106 to pass through, but prevents the needle transition portion 114 from passing through, thereby preventing the safety clip 700 from advancing distally away from the sharp distal tip 110 of the needle sheath 106.

[0140] Protective arms 710A-B can extend distally from the proximal sidewall 708 and can be formed of a generally flexible material, allowing the protective arms 710A-B to pivot generally relative to the proximal sidewall 708. An elastomer band 712 can be positioned around a portion of the protective arms 710A-B, thereby providing bias of the protective arms 710A-B toward each other. Thus, in this embodiment, when the safety clip 128 is in a first or ready-to-use position, the protective arms 710A-B are biased against the needle cannula 106. In one embodiment, one of the protective arms 710B can include a distal sidewall 722 configured to prevent further advance of the needle cannula 106 when the needle cannula 106 is retracted and the protective arms 710A-B are biased toward each other and displaced to a second safe position, thereby securely capturing the sharp distal tip 110 of the needle cannula 106 within the safety clip 700.

[0141] refer to Figures 15A-15C The seventh embodiment of the security clip 800 according to the present disclosure is described. Figure 15A The safety clip 800 is depicted separately or separately from the needle cannula 106. Figures 15B-15C A safety clip 800 and a second or second safe position are depicted, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 800.

[0142] In one embodiment, the safety clip 800 may include a proximal arm 802 and one or more protective arms 804. The proximal arm 802 may define an orifice 806 configured to be positioned around or on the needle cannula 106. In some embodiments, the proximal arm 802 and the orifice 806 may be configured to engage with the needle transition 114 to prevent the safety clip 800 from advancing distally away from the sharp distal tip 110 of the needle cannula 106. In one embodiment, a surface 808 of the proximal sidewall 802 may be substantially orthogonal to the longitudinal axis of the needle cannula 106. In other embodiments, the surface 808 may be positioned at an oblique or acute angle relative to the longitudinal axis of the needle cannula 106.

[0143] One or more protective arms 804 are capable of extending distally from the proximal arm 802. In one embodiment, the safety clip 800 may include a pair of protective arms 804A / 804B. The safety clip 800 may be formed (e.g., stamped) from a material that is generally resilient (e.g., medical-grade stainless steel) such that the protective arms 804 have a natural bias toward a free or relaxed state when a portion of the safety clip 800 is deviated from its free state. For example, in one embodiment, the safety clip 800 is in a free state when it is in a second or safe position. Therefore, in this embodiment, when the safety clip 800 is in a first or ready-to-use position, the protective arms 804A / B are biased against the needle cannula 106 because the presence of the needle cannula 106 deviates the protective arms 804A / B from their free state. When the needle cannula 106 is retracted and the sharp distal tip 110 moves proximally between the protective arms 804A / B, the protective arms 804A / B naturally bias toward their free state, thereby capturing the sharp distal tip 110 therebetween. In some embodiments, further proximal movement of the sharp distal tip 110 is prevented by making the cross-sectional dimension of the needle transition portion 114 larger than the orifice 806 in the proximal wall 802 of the safety clip 800. In some embodiments, distal movement of the sharp distal tip 110 is prevented by the distal portion of at least one of the arms 804A / B.

[0144] In one embodiment, the first protective arm 804A may include a proximal portion 810, a straight portion 812, and a distal sidewall 814. The proximal portion 810 may be adjacent to the proximal sidewall 802, such that the proximal portion 810 and the proximal sidewall 802 are separated by a bend 816. In one embodiment, the bend 816 may form an angle of approximately 60-110°, although other angles of the bend 816 are also contemplated.

[0145] The straight portion 812 can be adjacent to the proximal portion 810, such that the straight portion 812 and the proximal portion 810 are separated by a second bend 818. In one embodiment, the bend 818 can form an angle of approximately 90-180°, although other angles of the bend 818 are also contemplated. In one embodiment, the straight portion 812 can include one or more tabs 820A-D positioned on either lateral side of the straight portion 812, such that the tabs 820A-D are configured to at least partially conform to the outer diameter of the needle cannula 106. Thus, the one or more tabs 820A-D of the straight portion 812 can be configured to maintain the position of the safety clip 800 along the needle cannula 106, particularly when the needle cannula 106 is retracted relative to the safety clip 800 and when the needle cannula 106 is moved.

[0146] The distal wall 814 may be adjacent to the straight portion 812. In some embodiments, when the needle cannula is positioned within the safety clip 800, the distal wall 814 may be angled toward the longitudinal axis of the needle cannula. In one embodiment, the distal wall 814 may also include a lip or hook 822 at its distal end. In one embodiment, the hook 822 may include a curved surface configured to contact and / or slide along the needle cannula 106 when the needle cannula 106 is positioned within the safety clip 800. In one embodiment, the hook 822 may be configured to prevent the sharp distal tip 110 of the needle cannula 106 from moving distally back past the hook 822 and out of the safety clip 800 once the sharp distal tip 110 of the needle cannula 106 has moved proximally past the hook 822.

[0147] In one embodiment, the second protective arm 804B may further include a proximal portion, a straight portion 812B, and a distal sidewall having a configuration similar to that of the first protective arm 804A. In some embodiments, the second protective arm 804B may be slightly longer than the first protective arm 804A, such that in a second or safe position, the hook 822 of the first protective arm 804A can be positioned proximal to the hook of the second protective arm 804B. In one embodiment, the second protective arm 804B may include one or more corresponding tabs 824A-D positioned on either lateral side of the straight portion, such that the tabs 824A-D are configured to at least partially conform to the outer diameter of the needle sheath 106. In one embodiment, one or more tabs 824A-D may be configured to engage with one or more tabs 820A-D of the first protective arm 804A when the safety clip 800 is in the second or safe position.

[0148] refer to Figures 16A-16C Furthermore, an eighth embodiment of the security clip 900 according to this disclosure is described. Figure 16A The safety clip 900 is depicted separately, and it is separate from the needle cannula 106. Figures 16B-16C A safety clip 900 and a second or second safe position are depicted, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 900.

[0149] In one embodiment, the safety clip 900 may share structural similarity with previously discussed safety clips (e.g., safety clip 800). For example, the safety clip 900 may include a proximal sidewall 902 defining an opening 906, and one or more protective arms 904A / B having a proximal portion 910, a straight portion 912, and a distal sidewall 914. In one embodiment, the proximal sidewall 902 may be generally circular in shape or otherwise generally correspond to the shape of the opening 906. In one embodiment, the width 916 of the proximal portion 910 may be approximately equal to the width 918 of the straight portion 912. In other embodiments, the width 916 of the proximal portion 910 may be greater than or less than the width 918 of the straight portion 912.

[0150] refer to Figures 17A-17C Furthermore, a ninth embodiment of the security clip 1000 according to this disclosure is described. Figure 17A The safety clip 1000 is depicted separately, and it is separate from the needle cannula 106. Figures 17B-17C A safety clip 1000 and a second or second safe position are depicted, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1000.

[0151] In one embodiment, the safety clip 1000 can share structural similarity with safety clips previously discussed. For example, the safety clip 1000 can include one or more protective arms 1004A / B having a proximal portion 1010, a straight portion 1012, and a distal wall 1014. In one embodiment, the straight portion 1012 of the first protective arm 1004A can include one or more tabs 1020A-D positioned on either lateral side of the straight portion 1012, such that the tabs 1020A-D are configured to at least partially conform to the outer diameter of the needle cannula 106. In one embodiment, the safety clip 1000 can include four tabs 1020A-D, wherein some tabs (e.g., 1020A and 1020C, and 1020B and 1020D) are spaced apart to face each other on opposite lateral sides of the straight portion 1012. The corresponding tabs 1024A-D on the second protective arm 1004B can be positioned on either lateral side of the corresponding straight portion, such that the tabs 1024A-D are configured to engage with the tabs 1020A-D of the first protective arm 1004 when the safety clamp 1000 is in the second or safe position.

[0152] In one embodiment, the safety clip 1000 may include a tubular sleeve 1030 in place of the proximal sidewall defining the orifice. In one embodiment, the sleeve 1030 may be configured to be positioned around or on the needle cannula 106. In some embodiments, the sleeve 1030 may have an inner diameter configured to engage the needle transition 114 to prevent the safety clip 1000 from advancing distally away from the sharp distal tip 110 of the needle cannula 106.

[0153] refer to Figure 18A -C, and a tenth embodiment of the security clip 1100 according to the present disclosure is described. Figure 18A The safety clip 1000 is depicted separately, and it is separate from the needle cannula 106. Figures 18B-18C A safety clip 1100 and a second or second safe position are depicted, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1100.

[0154] In one embodiment, the safety clip 1100 can share structural similarity with safety clips previously discussed. For example, the safety clip 1100 can include one or more protective arms 1104A / B having a proximal portion 1110, a straight portion 1112, and a distal wall 1114. In one embodiment, in an alternative configuration, the one or more tabs 1120A-D can be positioned on either lateral side of the straight portion 1112 such that each tab 1120A-D of the straight portion 1112 is opposite to another tab 1120A-D of the same straight portion 1112. Corresponding tabs 1124A-D on the second protective arm 1104B can be positioned on either lateral side of the corresponding straight portion such that the tabs 1124A-D are configured to engage with the tabs 1120A-D of the first protective arm 1104 when the safety clip 1100 is in a second or safe position.

[0155] refer to Figures 19A-19C Furthermore, an eleventh embodiment of the security clip 1200 according to this disclosure is described. Figure 19A The safety clip 1200 is depicted separately, and it is separate from the needle cannula 106. Figures 19B-19C A safety clip 1200 and a second or second safe position are depicted, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1200.

[0156] In one embodiment, the safety clip 1200 can share structural similarity with safety clips previously discussed. For example, the safety clip 1200 can include one or more protective arms 1204A / B having a proximal portion 1210, a straight portion 1212, and a distal wall 1214. In one embodiment, in an alternative configuration, the one or more tabs 1220A-D can be positioned on either lateral side of the straight portion 1212 such that each tab 1220A-D of the straight portion 1212 is opposite to another tab 1120A-D of the same straight portion 1212. Corresponding tabs 1224A-D on the second protective arm 1204B can be positioned on either lateral side of the corresponding straight portion such that the tabs 1224A-D are configured to engage with the tabs 1220A-D of the first protective arm 1204 when the safety clip 1200 is in a second or safe position. In one embodiment, portions of the straight portion 1212 and the tabs 1220A-D can define material cutting portions 1230A-B, which are configured to aid in the compliance or resilience of the safety clamp 1200.

[0157] refer to Figures 20A-20C The twelfth embodiment of the security clip 1300 according to the present disclosure is described. Figure 20A The safety clip 1300 is depicted separately, and it is separate from the needle cannula 106. Figures 20B-20C A safety clip 1300 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1300.

[0158] In one embodiment, the safety clip 1300 may include a proximal sleeve 1302 and one or more protective arms 1304. The proximal sleeve 1302 may define a lumen or inner diameter 1306 configured to be positioned around or on the needle cannula 106. In some embodiments, the proximal sleeve 1302 and the inner diameter 1306 may be configured to engage with the needle transition 114 to prevent the safety clip 1300 from advancing distally away from the sharp distal tip 110 of the needle cannula 106.

[0159] One or more protective arms 1304 are capable of extending distally from the proximal sleeve 1302. In one embodiment, the safety clip 1300 may include a pair of protective arms 1304A / B. The safety clip 1300 may be formed (e.g., stamped or laser-cut) from a material that is generally resilient (e.g., medical-grade stainless steel) such that the protective arms 1304 have a natural bias toward the free or relaxed state when a portion of the safety clip 1300 is deviated from its free state. Thus, when the safety clip 1300 is in the first or ready-to-use position, the presence of the needle cannula 106 forces the protective arms 1304A / B to deviate from their free state, thereby biasing the protective arms 1304A / B against the needle cannula 106. When the needle cannula 106 is retracted and the sharp distal tip 110 moves proximally between the protective arms 1304, the protective arms 1304 are naturally biased toward their free state, thereby capturing the sharp distal tip 110 between them. In some embodiments, further proximal movement of the sharp distal tip 110 is prevented by making the cross-sectional dimension of the needle transition portion 114 larger than the inner diameter 1306 of the proximal sleeve 1302. In some embodiments, distal movement of the sharp distal tip 110 is prevented by the distal portion of at least one of the arms 1304A / B.

[0160] In one embodiment, the first protective arm 1304A and the second protective arm 1304B can together form a generally cylindrical shape, which is configured to at least partially surround the needle cannula 106 when the safety clip 1300 is in the second or safe position. For example, each of the first protective arm 1304A and the second protective arm 1304B can include a straight portion 1312 having a semi-circular or other generally arcuate cross-section. The straight portion 1312 can be adjacent to the proximal sleeve 1302 such that the straight portion 1312 and the proximal sleeve 1302 are separated by a joint or pivotable coupling 1316, which in some embodiments can be a movable hinge. A distal wall 1314, similar to that of the previously disclosed embodiments, can be adjacent to the straight portion 1312.

[0161] In one embodiment, the straight portion 1312 may include one or more tabs 1320A-D positioned on either lateral side of the straight portion 1312, such that the tabs 1320A-D are configured to conform to the semi-circular or other generally arcuate cross-section of the protective arm 1304 so as to at least partially conform to the outer diameter of the needle cannula 1306. Therefore, one or more tabs 1320A-D of the straight portion 1312 can be configured to maintain the position of the safety clip 1300 along the needle cannula 106, particularly when the needle cannula 106 is retracted relative to the safety clip 1300 and when the needle cannula 106 is moved.

[0162] In one embodiment, the second protective arm 1304B may further include a straight portion 1312B and a distal sidewall having a configuration similar to that of the first protective arm 1312A. In one embodiment, the second protective arm 1304B may include one or more corresponding tabs 1324A-D positioned on either lateral side of the straight portion, such that the tabs 1324A-D are configured to at least partially conform to the outer diameter of the needle cannula 106. In one embodiment, one or more tabs 1324A-D may be configured to engage with one or more tabs 1320A-D of the first protective arm 1304A when the safety clip 1300 is in a second or safe position. Therefore, in some embodiments, the protective arms 1304A-B are non-intersecting (i.e., the protective arms 1304A-B do not intersect or cross each other along the longitudinal axis of the needle cannula 106).

[0163] refer to Figures 21A-21C The thirteenth embodiment of the security clip 1400 according to this disclosure is described. Figure 21A The safety clip 1400 is depicted separately, and it is separate from the needle cannula 106. Figures 21B-21C A safety clip 1400 is depicted in a second or safe position, wherein the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1400.

[0164] In one embodiment, the safety clip 1400 may share structural similarity with previously discussed safety clips (e.g., safety clip 1300). For example, the safety clip 1400 may include one or more protective arms 1404A / B having a straight portion 1412 and a distal sidewall 1414. In one embodiment, one or more tabs 1420A-D may be positioned on either lateral side of the straight portion 1412. Corresponding tabs 1424A-D on the second protective arm 1404B may be positioned on either lateral side of the corresponding straight portion such that the tabs 1424A-D are configured to engage with the tabs 1420A-D of the first protective arm 1404 when the safety clip 1400 is in a second or safe position. In one embodiment, portions of the straight portion 1412 and the tabs 1420A-D may define material cut portions 1430A-B configured to aid in the compliance or resilience of the safety clip 1400.

[0165] refer to Figures 22A-22CThis illustration depicts partial cross-sectional views of a safety catheter assembly 100 according to embodiments of the present disclosure in a first or ready-to-use position, a transitional position, and a second or safe position. In one embodiment, at least the sealing member 132 and the safety clip 128 cooperatively form a “passive release mechanism.” As used herein, the term “passive release mechanism” is understood to refer to a feature of the catheter insertion assembly 100 that prevents release of the catheter assembly 104 from the needle insertion device 102 until the sharp distal tip 110 of the needle sheath 106 has been captured within the safety clip 128. Some or all of the features of the passive release mechanism can be integrated with other components of the catheter insertion assembly 100. In this respect, the term “passive release mechanism” does not necessarily refer to a component separate from the catheter insertion device 102 and / or the catheter assembly 104. Rather, it should be understood that various components of the catheter insertion device 102 and / or the catheter assembly 104 can form a passive release mechanism.

[0166] In one embodiment, the passive release mechanism can be configured to couple catheter interface 122 to catheter insertion device 102 in a first or ready-to-use position, and release catheter interface 122 from catheter insertion device 102 in a second or safe position. Furthermore, the passive release mechanism prevents release of catheter interface 122 from catheter insertion device 102 until the sharp distal tip 110 of needle sheath 106 is in a safe position, where access to the sharp distal tip 110 is prevented. Release of catheter interface 122 from catheter insertion device 102 can occur during catheter insertion without requiring additional steps other than safe retraction of needle sheath 106. In this respect, clinicians can “passively” release the catheter for passive safety. For example, the catheter can be released as the clinician withdraws needle 106 from catheter assembly 104 when a portion of catheter insertion device 102 is pulled.

[0167] like Figure 22A As depicted, when the safety clip 128 is in the first or ready-to-use position, the protective arms 210A-B are forced apart, which in turn causes a portion of the protective arms 210A-B to exert a compressive force on the wall 176 of the proximal portion 184 of the inner cavity 178 of the sealing member 132, thereby preventing movement of the safety clip 128 relative to the sealing member 132. In one embodiment, the naturally resilient sealing member 132 then transmits at least a portion of this compressive force to the inner wall 144 of the proximal portion 148 of the inner cavity 146 of the catheter interface 122, thereby preventing movement of the safety clip 128 and / or the sealing member 132 relative to the catheter interface 122. Therefore, the compressive force creates frictional interference contact between the components of the passive release mechanism, which prevents release of the catheter interface 122 from the catheter insertion device 102.

[0168] As in Figures 22B-22C As depicted, when the needle cannula 106 is retracted and the sharp distal tip 106 is securely captured by the safety clip 128, the protective arms 210A-B move toward each other, and the compressive force between the safety clip 128 and the sealing member 132 ceases. Thereafter, the safety clip 128 can be removed from the sealing member 132 without substantial interference. Therefore, the release of the catheter interface 122 from the catheter insertion device 102 only occurs after the sharp distal tip 110 of the needle cannula 106 is in a secure position.

[0169] In one embodiment, the safety clip 128 is at least partially residing, receiving, or contained within the proximal portion 184 of the internal cavity 178 of the sealing member 132, and at least partially residing, receiving, or contained within the proximal portion 148 of the internal cavity 146 of the catheter interface 122. In one embodiment, the catheter insertion assembly 100 may further include a proximal cup 1502, within which the proximal portion of the safety clip 128 is at least partially residing, receiving, or contained.

[0170] refer to Figure 23A The present disclosure depicts a proximal cup 1502 according to embodiments thereof. In one embodiment, the proximal cup 1502 may include a proximal end 1504, an open distal end 1506, and a generally cylindrical wall 1508 defining an internal cavity therebetween. In one embodiment, the proximal end 1504 of the proximal cup 1502 may define an orifice 1512, the orifice 1512 being shaped and sized to fit snugly against the outer diameter of the needle cannula 106, so as to prevent leakage of blood or body fluid and / or containment of blood or body fluid from the patient during advancement of the catheter assembly 104 by restricting the outflow of air and / or body fluid from the internal cavity 146 of the catheter interface 122. In some embodiments, the proximal cup 1502 may prevent damage to the safety clip 128 (e.g., before transitioning to a second or safe position). Figure 23B (As depicted in the illustration). In some embodiments, because the proximal cup 1502 can be fixedly or operatively coupled to the safety clip 128 before and after transitioning to the second or safe position, the proximal cup 1502 serves to further stabilize the safety clip 128. In one embodiment, the proximal cup 1502 can be made of metal. In one embodiment, the safety clip 128 and the proximal cup 1502 can be formed as an integral part.

[0171] refer to Figure 23CTo further prevent leakage of blood or bodily fluids during the advancement of the catheter assembly 104, in some embodiments, the proximal cup 1502 may further include a rod extension 1514. The rod extension 1514 may include a generally cylindrical wall 1516 defining an orifice 1518, the shape and size of which are designed to fit snugly against the outer diameter of the needle cannula 106 to prevent leakage of blood or bodily fluids. In one embodiment, the rod extension 1514 may be made of metal. In other embodiments, the rod extension 1514 may be formed of a flexible or resilient material to further aid in fitting the outer diameter of the needle cannula 106. In embodiments where the needle cannula 106 includes a notch 120 to indicate a flashback between the outer diameter of the needle cannula 106 and the inner diameter of the catheter portion 124, the rod extension 1514 may be appropriately sized to extend over the notch 120 to prevent blood or bodily fluids from flowing through the notch 120.

[0172] like Figure 23D The image depicts a partial cross-sectional view of a safety catheter assembly 100 including a proximal cup 1502 according to an embodiment of the present disclosure, wherein the safety catheter assembly is in a first or ready-to-use position. In this embodiment, the proximal portion of the safety clip 128 is at least partially residing in, received in, or included within the proximal cup 1502. Figure 23E The illustration depicts a perspective view of a catheter insertion device 102, a proximal cup 1502, and a safety clip 128 in a second or safe position according to an embodiment of the present disclosure. In this embodiment, the proximal portion of the safety clip 128 is held within the proximal cup 1502.

[0173] It should be understood that the various steps used in the methods of this teaching can be performed in any order and / or simultaneously, as long as the teaching remains operational. Furthermore, it should be understood that the apparatus and methods of this teaching can include any number or all of the described embodiments, as long as the teaching remains operational.

[0174] Various embodiments of the systems, apparatus, and methods have been described herein. These embodiments are given by way of example only and are not intended to limit the scope of the claimed invention. Furthermore, it should be understood that the various features of the described embodiments can be combined in various ways to produce many other embodiments. Moreover, while various materials, sizes, shapes, configurations, and positions have been described for use in the disclosed embodiments, other materials, sizes, shapes, configurations, and positions may be used in addition to those disclosed without departing from the scope of the claimed invention.

[0175] Those skilled in the art will recognize that the subject matter herein may include fewer features than those shown in any of the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive representation of the various ways in which the various features of the subject matter can be combined. Therefore, the embodiments are not mutually exclusive combinations of features; rather, as will be understood by those skilled in the art, various embodiments are capable of including combinations of different individual features selected from different individual embodiments. Moreover, even if not described in other embodiments, elements described with respect to one embodiment may be implemented in such embodiments, unless otherwise stated.

[0176] While dependent claims may refer in the claims to specific combinations with one or more other claims, other embodiments may also include combinations of dependent claims with the subject matter of each other dependent claim, or combinations of one or more features with other dependent or independent claims. Such combinations are presented herein unless it is stated that a particular combination is not desired.

[0177] Any inclusion by reference to the foregoing is limited to not incorporating subject matter contrary to the express disclosure herein. Any inclusion by reference to the foregoing is further limited to not incorporating claims included in the documents. Any inclusion by reference to the foregoing is further limited to not incorporating any limitations provided in the documents unless expressly included herein.

[0178] For the purposes of interpreting the claims, it is expressly intended not to invoke the provisions of Section 112(f) of 35 USC unless the specific terms “means for…” or “steps for…” are stated in the claims.

Claims

1. A safety clip for use with a catheter insertion assembly adapted to be in a ready position and a safe position, comprising: The proximal sidewall has an opening through which the needle passes along the longitudinal axis; At least one upper arm extends distally from a top bend near the proximal sidewall along one longitudinal side of the needle, the upper arm having an upper straight portion and a downward bend having a reduced width relative to the upper straight portion such that the downward bend at least partially conforms to the outer diameter of the needle, the downward bend having an upper proximal end extending distally from the distal end of the upper straight portion and an upper distal end connected to the proximal end of the upper distal sidewall, the upper distal sidewall being angled toward the longitudinal axis; At least one lower arm extends from the bottom bend of the proximal sidewall along another longitudinal side of the needle tip, the lower arm having a lower straight portion and an upward bend having a reduced width relative to the lower straight portion, the upward bend having a lower proximal end extending from the distal end of the lower straight portion and a lower distal end connected to the proximal end of the lower distal sidewall, the lower distal sidewall being angled toward the longitudinal axis. Wherein, the upper arm and the lower arm do not intersect or cross each other along the longitudinal axis; and The upper distal sidewall and the lower distal sidewall each have a distal end. When the safety clip is in the ready position, the corresponding distal ends of the upper distal sidewall and the lower distal sidewall are offset from each other by a needle passing through them.

2. The safety clip according to claim 1, wherein, The reduced width of the downwardly curved portion provides a cutting section configured to maintain the position of the safety clamp along the needle tip.

3. The safety clip according to claim 1, wherein, The respective distal ends of the upper distal wall and the lower distal wall return to their respective unbiased states, thereby surrounding the distal tip of the needle when the distal tip is withdrawn to a position proximal to the distal ends of the upper distal wall and the lower distal wall.

4. The safety clip according to claim 1, wherein, The upper distal sidewall and the lower distal sidewall each have a tab extending laterally from the distal sidewall, the tab being configured to keep the needle in a safe position.

5. The safety clip according to claim 1, wherein, When the upper straight portion of the upper arm and the lower straight portion of the lower arm are in a free or relaxed state, they each form an angle toward the longitudinal axis.

6. The safety clip according to claim 1, wherein, The upper straight portion and the lower straight portion have different lengths, such that one of the reduced width portions is closer to the proximal sidewall than the other of the reduced width portions.

7. The safety clip according to claim 2, wherein, Each curved portion of the upper arm has a width that is reduced relative to the width of its corresponding straight portion, such that each curved portion is adapted to at least partially conform to the outer diameter of the needle.

8. The safety clip according to claim 1, wherein, The reduced width portion above includes two downwardly curved portions, each having a proximal end extending from the distal end of the upper straight portion, and a top notch separating the two downwardly curved portions extending from the distal end of the upper straight portion to the proximal end of the upper distal sidewall to maintain the position of the safety clip along the needle tip. and The reduced width portion below includes an upwardly curved portion; The needle is adapted to be guided by a downwardly curved portion forming a top notch.

9. The safety clip according to claim 1, wherein, The upper distal sidewall includes a hook at its distal end, and the lower distal sidewall includes another hook at its distal end; and The lower arm is slightly shorter than the upper arm, so that the other hook is positioned in a safe position near the first hook.

10. The safety clip according to claim 1, wherein, The upper arm includes a tab portion having opposing lateral edges for forming a pair of upper teeth separated by a notch, the notch being configured to maintain the position of the safety clip along the needle tip.

11. The safety clip according to claim 10, wherein, Each of the upper sharp teeth includes a torsional portion or a partially rotating portion relative to the upper straight section; and The lower arm includes a lower protrusion portion, which has opposing lateral edges for forming another pair of sharp teeth, each of which includes a torsional portion or a partially rotating portion relative to the lower straight portion.

12. The safety clip according to claim 1, wherein, The safety clip is adapted to be positioned in a diaphragm cavity defined by the cylindrical wall of a diaphragm that mates inside the interface cavity of the catheter interface. When the needle passes between the distal end walls in the ready position, the proximal ends of the upper and lower distal walls respectively engage in frictional contact with the wall of the diaphragm to prevent the safety clip from moving relative to the catheter interface.

13. The safety clip according to claim 1, wherein, The safety clamp is formed of a material that is generally resilient, and the upper arm and the lower arm extend from the proximal sidewall to the distal side, such that the upper arm and the lower arm are naturally biased toward a relaxed state.

14. A safety clip for use with a catheter insertion assembly adapted to be in a ready position and a safe position, comprising: The proximal sidewall has an opening through which the needle passes along the longitudinal axis; At least one upper arm extends distally from a top bend near the proximal sidewall along one longitudinal side of the needle, the upper arm having an upper straight portion and a downward bend having a reduced width such that the upper bend is adapted to at least partially conform to the outer diameter of the needle, the downward bend including an upper proximal end extending distally from the distal end of the upper straight portion and an upper distal end connected to the proximal end of the upper distal sidewall, the upper distal sidewall being angled toward the longitudinal axis; At least one lower arm extends from the bottom bend of the proximal sidewall along another longitudinal side of the needle, the lower arm having a lower straight portion and an upward bend having a lower proximal end extending from the distal end of the lower straight portion and a lower distal end connected to the proximal end of the lower distal sidewall, the lower distal sidewall being angled toward the longitudinal axis. Wherein, the upper arm and the lower arm do not intersect; and The upper distal sidewall has a distal end and the lower distal sidewall has a distal end. When the safety clip is in the ready position, the distal ends of the upper distal sidewall and the distal ends of the lower distal sidewall are offset from each other by the needle.

15. The safety clip according to claim 14, wherein, The respective distal ends of the upper distal wall and the lower distal wall return to their respective unbiased states, thereby surrounding the distal tip of the needle when the distal tip is withdrawn to a position proximal to the distal ends of the upper distal wall and the lower distal wall.

16. The safety clip according to claim 14, wherein, The upper distal sidewall and the lower distal sidewall each have a tab extending laterally from the distal sidewall, the tab being configured to keep the needle in a safe position.

17. The safety clip according to claim 14, wherein, When the upper straight portion of the upper arm and the lower straight portion of the lower arm are in a free or relaxed state, they each form an angle toward the longitudinal axis.

18. The safety clip according to claim 14, wherein, The upper straight portion and the lower straight portion have different lengths, such that one of the curved portions is closer to the proximal sidewall than the other of the curved portions.

19. The safety clip according to claim 14, wherein, Each curved portion of the upper arm and the lower arm has a width that is reduced relative to the width of its corresponding straight portion, such that each curved portion is adapted to at least partially conform to the outer diameter of the needle.

20. The safety clip according to claim 14, wherein, The upper distal sidewall includes a hook at its distal end, and the lower distal sidewall includes another hook at its distal end; and The lower arm is slightly shorter than the upper arm, so that the other hook is positioned in a safe position near the first hook.

21. The safety clip according to claim 14, wherein, The safety clip is adapted to be positioned in a diaphragm cavity defined by the cylindrical wall of a diaphragm that mates inside the interface cavity of the catheter interface. When the needle passes between the distal end walls in the ready position, the proximal ends of the upper and lower distal walls respectively engage in frictional contact with the wall of the diaphragm to prevent the safety clip from moving relative to the catheter interface.

Images