Releaseable safety catheter insertion assembly

Abstract

A safety catheter insertion assembly configured to inhibit access to the 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. The safety clip is movable between an expanded configuration in which a portion of the safety clip applies a compressive force to a portion of the elastomeric blood control valve and a collapsed configuration in which the compressive force is reduced, allowing release of the safety clip from the elastomeric blood control valve. [Selected Figure] Figure 1

Description

Technical Field

[0001] Related Application Information This application claims the benefit of U.S. Provisional Application No. 62 / 624,470, filed Jan. 31, 2018, and U.S. Provisional Application No. 62 / 643,229, filed Mar. 15, 2018, the contents of which are hereby incorporated by reference in their entirety.

[0002] The present disclosure generally relates to safety catheters, and more particularly to safety catheters having a passive release mechanism configured to shield a sharp distal tip of a needle cannula before releasing a catheter hub from a catheter insertion device.

Background Art

[0003] Intravenous (IV) therapy is a versatile technique used for the administration of fluids to and removal of fluids from a patient. IV therapy is used for a variety of purposes, such as maintaining blood and electrolyte balance, blood transfusions, administration of nutritional supplements, chemotherapy, and administration of drugs and medications. These fluids, collectively referred to herein as agents, can be administered intravenously by injection through a hypodermic needle or can be administered intermittently or continuously by infusion using a needle or catheter. A common venous access device utilized by clinicians is a peripheral intravenous catheter (PIVC).

[0004] The PIVC is made of soft and flexible plastic or silicone and is generally sized 14 to 24 gauge. In conventional venipuncture methods, a catheter is inserted into a vein in the patient's hand, foot, inner surface of the arm, or veins within the body that will receive the venous catheter. To place an IV catheter within a patient's vein, a sharp introducer needle is used to pierce the skin, tissue, and vein wall, providing a path for placing the catheter within the vein.

[0005] Referring to FIGS. 1A - B, a conventional catheter insertion assembly 50 is shown that includes a catheter insertion device 52 configured to insert an “over the needle” catheter 54. The catheter 54 generally includes a catheter tube 56 having a distal end 58 for insertion into a biological site, a proximal end 60, and a flexible wall that defines a lumen extending therebetween. Often, the proximal end 60 of the catheter tube 56 is operably connected to a catheter hub 62. The catheter 54 can be operably connected to the catheter insertion device 52 by coaxially positioning the catheter 54 over the needle cannula 64 of the catheter insertion device 52. In this way, the catheter 54 rides into the patient's vein along with the needle cannula 64 through the skin, tissue, and vein wall.

[0006] A variety of catheter insertion devices have been developed to provide a needle for catheter insertion. One such example of this type of catheter insertion device is sold under the trademarks JELCO and INTUITIV by Smiths Medical ASD, Inc. of St. Paul, Minnesota, and is described in Patent Document 1 (U.S. Patent No. 8,257,322), Patent Document 2 (U.S. Patent Application Publication No. 2011 / 0319838), and Patent Document 3 (U.S. Patent Application Publication No. 2017 / 0095617), the contents of which are incorporated herein by reference. In other cases, the catheter insertion device provides a safety needle assembly that houses the sharp tip of the needle and functions to reduce the possibility of accidental needle sticks. An example of this type of catheter insertion device is sold by Smiths Medical ASD, Inc. under the trademarks PROTECTIV and VIAVALVE, and is also described in Patent Document 4 (U.S. Patent No. 5,000,740), Patent Document 5 (U.S. Patent No. 7,736,342), and Patent Document 6 (U.S. Patent Application Publication No. 2016 / 0220791), the contents of which are incorporated herein by reference.

[0007] Once the catheter tube 56 has entered the patient's vein, lower the needle cannula 64 and the catheter 54 toward the patient's skin to reduce the entry angle and advance the catheter tube 56 slightly into the vein. Then, by loosening the connection between the catheter 54 and the needle cannula 64, the catheter tube 56 can be further advanced into the vein as desired, and the needle cannula 64 can be withdrawn from the catheter 54.

[0008] In some cases, the catheter 54 can include a tip protector through which at least a portion of the needle cannula 64 passes. The tip protector can be configured to seal or shield the sharp distal tip 66 of the needle cannula 64 after being removed from the catheter tube 56. One formation of the tip protector includes a clip that fits within the catheter hub 62. Such a clip can include a thin web, such as of metal, formed by bending or otherwise having a back wall and one or more distally extending walls, all of which are generally the same thickness. In the ready state of the clip, the shaft of the needle cannula 64 passes through an opening in the back wall of the clip and into the catheter tube 56 against a pair of distally extending arms. The needle cannula 62 can be pulled proximally relative to the clip, such that the distal tip 66 can be brought into the proximal clip within the back wall, where the arms are configured to block the distal reemergence of the distal tip 66. Further proximal movement of the needle cannula 64 pulls the tip protector out of the catheter hub 62.

[0009] The catheter hub 62 can be connected to an administration set or syringe to introduce body fluid into and / or withdraw body fluid from a patient. The catheter hub 62 can have an open proximal end 68 adapted to receive a male luer taper within an internally defined cavity to establish a fluid connection between the patient's vasculature and the luer taper. Also, the proximal end 68 can be provided with an outer ear 70 or the like to secure the luer taper within the catheter hub 62, such as when the luer taper is connected to a male luer lock collar of an administration set or syringe.

[0010] Under normal conditions, after removing the needle cannula 64 and before inserting the Luer taper into the catheter hub 62, blood flows through the catheter tube 54 into the internal cavity of the catheter hub 62. To restrict blood flow, the catheter hub 62 can include a valve or septum that seals the needle cannula path after the needle cannula 64 is withdrawn from the catheter 54, thereby preventing blood or body fluid from the patient from escaping from the catheter 54 into the surrounding environment.

Prior Art Documents

Patent Documents

[0011]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Summary of the Invention

Problems to be Solved by the Invention

[0012] A catheter insertion device 50 has been created that attempts to lock the catheter 54 to the catheter insertion device 52 during insertion. However, such a device can be improved, particularly in a way that reduces or eliminates the risk of accidental needlesticks, to consistently enable smooth release of the catheter hub 62 from the needle cannula 64. Accordingly, the applicant of the present disclosure has recognized the need for 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 retracted.

Means for Solving the Problem

[0013] Embodiments of the present disclosure include a mechanism for smoothly and passively releasing a catheter from a catheter insertion device when withdrawing a needle cannula into a tip protector, thereby providing a safe catheter insertion assembly that improves the catheter insertion process while reducing the risk of inadvertent needle stick.

[0014] One embodiment of the present disclosure provides a safe catheter insertion assembly including a catheter assembly, a catheter insertion device, and a passive release mechanism. The catheter assembly includes a catheter hub and a catheter tube extending distally therefrom. The catheter hub can have an open proximal end and a distal end defining an internal cavity therebetween. The catheter insertion device can include a needle hub and a needle cannula extending distally from the needle hub. The needle cannula can have a sharp distal tip. The passive release mechanism can be configured to couple the catheter hub to the catheter insertion device and can include a compliant seal member and a safety clip. The compliant seal member can be disposed within the internal cavity of the catheter hub and can have an open distal end and a proximal end defining the internal cavity therebetween. The safety clip can be releasably coupled to the compliant seal member and can be configured to move relative to the needle cannula between a first position where the distal tip extends distally from the safety clip and a second position where 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 seal member. In the second position, prior to release of the needle clip from the compliant seal member, a reduction and release of the safety clip from the compliant seal member is enabled such that access to the distal tip of the needle cannula is impeded.

[0015] In one embodiment, when the safety clip is in the second position, the needle insertion assembly can be removed from the catheter hub without substantial interference. In one embodiment, the compliant seal member is a blood control valve. In one embodiment, the safety catheter insertion assembly further includes a rigid actuator extending proximally within the internal cavity of the catheter hub and a free (unrestrained) proximal end of the rigid actuator including an enlarged proximal flange. In one embodiment, the compliant seal 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, and the proximal flange of the rigid actuator is movable relative to the compliant seal member between a first position where the valve slit is closed and a second position where the valve slit is open. In one embodiment, the safety catheter insertion assembly further includes a proximal cup operatively coupled to the compliant seal member, the proximal cup having an open distal end and a proximal end defining a cavity therebetween, the cavity being defined by the proximal cup and the compliant seal member adjacent to the cavity defined by the proximal cup to form a cavity configured to receive the safety clip. In one embodiment, the proximal cup further includes a stem extension configured to match the outer diameter of the needle cannula so as to inhibit the passage of body fluid from within the cavity of the proximal cup. In one embodiment, the compliant seal member includes a blood control valve configured to allow the needle cannula to selectively pass therethrough and a wiper assembly located distal to the blood control valve and configured to inhibit the passage of body fluid passing therethrough. In one embodiment, the safety clip includes a first arm and a second arm deflected in the longitudinal axis direction of the needle cannula disposed 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 one 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.

[0016] Another embodiment of the present disclosure provides a passive safety catheter assembly. The passive safety catheter assembly can include a catheter assembly, a catheter insertion device, and a passive release mechanism. The catheter assembly can include a catheter hub and a catheter tube extending distally therefrom. The catheter insertion device can include a needle hub and a needle cannula extending distally therefrom. The needle cannula can include a sharp distal tip. The passive release mechanism can include a compliant outer seal member received within the catheter hub and an inner needle clip member at least partially received within the compliant outer seal member. The needle cannula can be slidably received within the inner clip member and is movable between a first position in which the needle cannula makes compressive contact with a portion of the inner needle clip member against the compliant outer seal member and a second position in which the distal tip is captured within the inner needle clip member and the compressive contact is reduced, such that the insertion needle assembly can be removed from the catheter hub without substantial interference.

[0017] In one embodiment, the inner needle clip member is configured to capture the distal tip of the needle cannula prior to release of the needle clip from the compliant outer seal member. In one embodiment, the compliant outer seal member is movable between a first position where the blood control valve of the compliant outer seal member is closed and a second position where the blood control valve is opened. In one embodiment, the passive safety catheter assembly further includes a proximal cup operably coupled to the compliant outer seal member, the proximal cup having an open distal end and a proximal end that defines a cavity therebetween, the cavity defined by the compliant outer seal member being adjacent to the cavity defined by the proximal cup and forming a cavity configured to receive the inner needle clip material. In one embodiment, the compliant outer seal member can include a membrane that defines a blood control valve configured to allow the needle cannula to selectively pass therethrough, and a wiper assembly located distal to the blood control valve configured to inhibit passage of body fluid therethrough.

[0018] Another embodiment of the present disclosure provides a catheter hub assembly. The catheter hub assembly can include a catheter hub body, a rigid actuator, a compliant seal member, and a safety clip. The catheter hub body can have an open proximal end and a distal end that defines an internal cavity therebetween. The rigid actuator can extend proximally within the internal cavity of the catheter hub from the distal end of the catheter hub to a free end. The actuator can have an enlarged proximal flange at its free end. The compliant seal member can be disposed within the internal cavity of the catheter hub. The compliant seal member can include an actuator cavity configured to receive the enlarged proximal flange of the rigid actuator and a membrane that defines a valve opening position proximal to the actuator cavity, where the proximal flange of the rigid actuator is movable relative to the compliant seal member between a first position where the valve opening is closed in a first position where the valve opening is purchased and a second position where the valve opening is biased to open. The safety clip can be partially received within the compliant seal member. The safety clip can be configured to move between a first position where a portion of the safety clip outwardly biases a portion of the compliant seal member into interference contact with the inner diameter of the internal cavity of the catheter hub and a second position where the outward biasing of the safety clip relative to the compliant seal member is removed.

[0019] Another embodiment of the present disclosure provides a catheter hub assembly. The catheter hub assembly can include a catheter hub body, a compliant seal member, a proximal cup, and a safety clip. The catheter hub body can have an open proximal end and a distal end that defines an internal cavity therebetween. The compliant seal member can be disposed within the internal cavity of the catheter hub. The compliant seal member can have an open distal end and a proximal end that defines a cavity therebetween. The proximal cup can be operably coupled to the compliant seal member. The proximal cup can have an open distal end and a proximal end that defines a cavity therebetween. The cavity defined by the compliant member can form a safety clip cavity adjacent to the cavity defined by the proximal cup. The safety clip can be housed within the safety clip cavity. The safety clip is configured to move between a first position in which a portion of the safety clip biases a portion of the compliant seal member outwardly into interference contact with the inner diameter of the internal cavity of the catheter hub and a second position in which the outward biasing of the safety clip against the compliant seal member is removed.

[0020] Another embodiment of the present disclosure provides a catheter hub assembly. The catheter hub assembly can include a catheter hub body and a compliant seal member. The catheter hub body can have an open proximal end and a distal end that defines an internal cavity therebetween. The compliant seal member can be disposed within the internal cavity of the catheter hub. The compliant seal member can include a membrane that defines a valve opening configured to allow a needle cannula to selectively pass therethrough and a wiper assembly disposed distally of the membrane configured to closely conform to the outer diameter of the needle cannula so as to inhibit the passage of body fluid therethrough.

[0021] The above summary is not intended to describe every illustrated embodiment or every implementation of the present disclosure. The drawings and detailed description that follow more specifically exemplify these embodiments. The present disclosure can be more fully understood in consideration of the following detailed description of various embodiments of the present disclosure in connection with the accompanying drawings.

Brief Description of the Drawings

[0022]

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[0023] Although various modifications and alternative forms are applicable to the disclosed embodiments, specific examples thereof shown as examples in the figures are described in detail herein. However, the present invention should not be construed as attempting to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives included within the spirit and scope of the subject matter defined by the claims.

DETAILED DESCRIPTION OF THE INVENTION

[0024] Various exemplary embodiments of the catheter are described herein for use in accessing a subject's vein. However, it should be recognized that the exemplary embodiments described herein can alternatively be used to access a subject's blood vessel at a location other than a vein, including but not limited to an artery of the subject. The term "clinician" refers to any individual who can perform a catheter insertion procedure with any one or alternative combination of the examples described herein. Similarly, the term "subject" as used herein should be understood to refer to an individual or object into which a catheter is to be inserted, whether human, animal, or inanimate. For convenience, various descriptions are made herein regarding the procedures performed by a clinician to access a subject's vein, but the disclosure is not limited in this regard.

[0025] As used herein, the term "distal" should also be understood to refer to a direction along an axis parallel to the needle cannula of the safety catheter assembly that is closest to the subject during catheter insertion. Conversely, the term "proximal" as used herein refers to a direction along an axis parallel to the needle cannula that is further away from the subject, opposite to the distal direction, when the catheter is inserted into the vein of the subject.

[0026] Referring to FIGS. 1A - B, a conventional catheter insertion assembly 50 is shown. Details of the conventional catheter insertion assembly 50 are described in the background art section above.

[0027] Referring to FIGS. 2A - B, a perspective view of a safety catheter insertion assembly 100 is shown in accordance with an embodiment of the present disclosure. FIG. 3 shows an exploded view of the safety catheter insertion assembly 100 according to an embodiment of the present disclosure. The safety catheter assembly 100 can include a catheter insertion device 102 and a catheter assembly 104. The catheter insertion device 102 can include an insertion or needle cannula 106 operably coupled to a needle hub 108. The needle cannula 106 can 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 can be configured and arranged to pierce the skin of the subject during catheter insertion. For example, in one embodiment, the sharp distal tip 110 can include a V - point designed to reduce the penetration force used to penetrate the skin, tissue, and vein wall of the subject by the needle 106 and a portion of the catheter insertion assembly 104. In one embodiment, the length of the needle 106 can be extended to assist in the insertion of the catheter assembly 104 into an obese patient.

[0028] The needle cannula 106 can further include a transition 114 having different cross-sectional sizes, which then shapes the other portions of the needle 106 located proximal to the transition 114. The needle transition 114 (alternatively referred to as a needle bump or cannula bump) can be created by crimping the opposing sides of the needle cannula 106 or otherwise disrupting the structure of the needle 106 such that, as 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. The needle transition 114 can, according to other embodiments, be formed in different shapes, inter alia, by adding material to the outside of the needle.

[0029] The proximal end 112 of the needle cannula 106 can be operably coupled to the needle hub 108. The needle hub 108 can include a gripping portion for manipulation by a clinician. In one embodiment, the catheter insertion device 102 can be constructed to provide a visual indicator of flashback when the sharp distal tip 110 of the needle 106 enters the subject's vein. In this embodiment, the needle hub 108 includes a flash chamber 116 that is in fluid communication with the lumen of the needle. When the sharp distal tip 110 enters the vein during catheter insertion, blood or body fluid enters the needle lumen from the vein and flows proximally into the flash chamber 116 through the needle 106. The flash chamber 116 can be sealed at one end by a flash plug 118. The flash plug 118 can be made of an air-permeable hydrophilic material that allows the passage of air but inhibits the passage of liquid. Thus, the air present in the needle lumen and the flash chamber 116 is pushed through the flash plug 118 by the incoming blood until the blood reaches or otherwise stops at the flash plug 118. The needle hub 108, or a portion thereof, can be constructed of a transparent or translucent material configured to allow a clinician to view the presence of blood within the flash chamber 116. In this regard, the presence of blood within the flash chamber 116 can alert the clinician when the needle has entered the subject's vein.

[0030] In one embodiment, the features of the catheter insertion device 102 other than the flash chamber 116 can provide a measure indicating that the sharp distal tip 110 has entered the vein of the subject. For example, the needle cannula 106 can include a notch 120. In this embodiment, when the sharp distal tip 110 enters the vein, blood flow enters the needle lumen. As blood flows close to the needle lumen, some of the blood passes through the notch 120 and enters the annular space between the outside of the needle 106 and the inside of the catheter assembly 104. The presence of blood in the annular space can be observed by the clinician through the transparent or translucent portion of the catheter assembly 104, thereby providing a measure indicating that the sharp distal tip 110 is present within the vein.

[0031] As shown in FIG. 2A, the safety catheter insertion assembly 100 can be provided in a first position or ready-to-use position for use, in which the catheter assembly 104 is connected to the catheter insertion device 102. In particular, the catheter assembly 104, which can include a catheter hub 122 and a catheter tube 124, can be disposed on the needle cannula 106 of the catheter insertion device 102, and the sharp distal tip 110 of the needle 106 protrudes from the distal end 126 of the catheter tube 124. In some embodiments, the safety catheter assembly 100 can be provided in a sterilized and assembled state housed within a sealed package for use.

[0032] To insert the catheter into the vein of the subject, the clinician first removes the safety catheter assembly 100 from the package. The needle sheath 125 covering the needle cannula 106 (as shown in FIG. 3) can be removed to expose the sharp distal tip 110 of the needle cannula 106. Next, the clinician punctures a specified site on the patient or subject having the sharp distal tip 110 and pushes the needle cannula 106 forward until the sharp distal tip 110 and a portion of the catheter tube 124 enter the vein of the subject.

[0033] Next, the catheter assembly 104 can be moved distally over the needle 106, advancing the catheter assembly 104 into the subject's vein as the catheter insertion device 102 is held stationary. Once the catheter assembly 104 is positioned at the desired location, 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 generally holding the catheter assembly 104 stationary relative to the subject. The catheter insertion device 102 is pulled proximally until the needle cannula 106 is separated from the catheter assembly 104.

[0034] As shown in FIG. 2B, the catheter insertion device 102 can be separated or removed from the catheter assembly 104 according to a second position or safety position. In some embodiments, the safety clip 128 is operably coupled to either the catheter assembly 104 and / or the catheter insertion device 102 and can be positioned over the sharp distal tip 110 prior to separating the catheter insertion device 102 from the catheter assembly 104 for the purpose of inhibiting an unwanted needle stick. In the safety position, the clinician can discard the catheter insertion device 102 into a sharps container.

[0035] Referring to FIG. 4A, a partial cross-sectional view of a safety catheter assembly 100 in a first position or ready-to-use position is depicted in accordance with an embodiment of the present disclosure. Referring to FIG. 4B, a partial cross-sectional view of the catheter assembly 104 in a second position is shown in accordance with an embodiment of the present disclosure. The catheter assembly 104 can include a catheter hub 122, a catheter tube 124, a safety clip 128, an actuator 130, and a seal member 132. In some embodiments, the catheter assembly 104 can further include a wing assembly, an extension tube, an extension tube clamp, a needleless connection, and / or a vent cap (not shown). Accordingly, the catheter assembly 104 can include a blood control function configured to inhibit blood leakage after removal of the needle cannula 106, thereby reducing the risk of blood or other body fluids being exposed to the clinician, particularly in consideration of the detection sensitivity when there is a possibility of blood-borne diseases. Further, embodiments of the catheter assembly 104 can inhibit the introduction of unwanted contaminants into the interior of the catheter assembly 104 prior to connection to an intravenous fluid supply.

[0036] The catheter tube 124 can extend from a sharp distal end 126 to a proximal end 134, where the catheter tube 124 can be operably coupled to the catheter hub 122. The catheter tube 124 can define a lumen 136 configured to provide a fluid path between a vein of a subject and the catheter hub 122. In one embodiment, the catheter tube 124 can include a barium radiopaque line to facilitate identification of the catheter tube 124 during a radiation procedure.

[0037] The catheter hub 122 can include a catheter hub body 138 having a distal end 140, a proximal end 142, and an inner wall 144 that defines an internal cavity 146 therebetween. The internal cavity can include a proximal portion 148 that extends from the open proximal end 142 and a distal portion 150 that is proximate to the distal end 140. In one embodiment, the distal end 140 of the catheter hub body 138 is operably coupled to the proximal end 134 of the catheter tube 124 such that the lumen 136 of the catheter tube 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 a luer taper standard so as to snugly receive a luer taper 200 (as shown in FIGS. 8A - C).

[0038] The actuator 130 can be fixed proximal to the distal end 140 of the catheter hub 122 so as to extend axially within the internal cavity 146. In one embodiment, the proximal end 134 of the catheter tube 124 can be fixed within the internal cavity 146 of the catheter hub 122 with the aid of the actuator 130. A seal member 132, alternatively referred to as a blood control valve 132, can also be fixed within the internal cavity 146 of the catheter hub 122 with the aid of the actuator 130 such that the seal member 132 is axially movable relative to the actuator 130 between a closed or sealed position and an open or actuated position. Thus, the actuator 130 functions both to fix the catheter tube 124 to the catheter hub 122 and to support the seal member 132.

[0039] Referring to FIG. 5, a cross-sectional view of an actuator 130 according to one embodiment of the present disclosure is shown. The actuator 130 can generally be rigid and can include a generally cylindrical body 152 having a distal end 154, a proximal end 156, and a wall 158 that defines an internal cavity 160 therebetween. For example, in one embodiment, the actuator 130 can be formed of medical grade stainless steel through processes generally known in the art. In one embodiment, the internal cavity 160 is configured to receive the needle cannula 106 therethrough without interference with the needle translation portion 114. When the needle cannula is withdrawn, the internal cavity 160 can be configured to allow the passage of body fluid therethrough. 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 of 90° or more, such that in some embodiments, a portion of the wall 158 is folded back on itself.

[0040] As shown in FIGS. 4A - B, the distal portion 164 of the actuator 130 can frictionally fit within the proximal end 134 of a catheter tube 124 that can frictionally fit within the internal cavity 146 of the catheter hub 122, such that the catheter tube 124 extends distally from the distal end 140 of the catheter hub 122. The annular rib 162 can serve to enhance the frictional fitting of the actuator 130 within the internal cavity 146 of the catheter hub 122. Thus, the actuator 130 can be disposed within the catheter hub such that the free proximal portion 166 extends proximally within the internal cavity 146 of the catheter hub.

[0041] As shown in FIGS. 4A - B, the seal member 132 (i.e., the blood control valve) is disposed within the internal cavity 146 of the catheter hub 122, is partially supported by the actuator 130, is partially disposed by the internal wall 144 of the catheter hub 122, and is movable between a closed position where the flow of body fluid from the catheter tube 124 into the internal cavity 146 of the catheter hub 122 is inhibited or restricted, and an open position where, as will be described in more detail below, the seal member 132 is moved relative to the actuator 130, thereby enabling the flow of body fluid from the catheter tube 124 to the proximal portion 148 of the internal cavity 146 of the catheter hub 122.

[0042] Referring to FIG. 6A, a cross - sectional view of the seal member 132 is depicted in accordance with an embodiment of the present disclosure. Referring to FIG. 6B, a proximal end view of the seal member 132 is shown in accordance with an embodiment of the present disclosure. The seal member 132 can generally be elastic or resilient and can include a generally cylindrical body 170 having a distal end 172, a proximal end 174, and a wall 176 that defines an internal cavity 178 therebetween. In one embodiment, the seal member 132 can be formed from a suitable material, such as silicon or polyisoprene, by processes generally known in the art.

[0043] In one embodiment, the wall 176 can further include a membrane 180 that divides the interior cavity 178 into a distal portion 182 and a proximal portion 184. In one embodiment, the membrane 180 can extend substantially perpendicular to a central longitudinal axis of the cylinder 170. The membrane 180 can define a slit 186 that can be normally biased closed when the seal member 132 is in a relaxed, uncompressed state. The slit 186 can take several configurations recognized in the art, such as a single linear slit (not shown) through the membrane 180. As shown in FIG. 6B, in one embodiment, the slit 186 can have a tri-slit configuration that extends to three radially outermost ends 188 and assumes a generally Y-shaped configuration. The slit 186 defines a plurality of membrane flaps 190, the number of which depends on the particular configuration of the slit 186 (e.g., three flaps 190 for a tri-slit configuration).

[0044] In one embodiment, the slit 186 can be shaped and sized to closely match the outer diameter of the needle cannula 106 to inhibit leakage, particularly during proximal withdrawal of the needle cannula 106, and without increasing the actuation force required to withdraw the needle cannula 106 from the catheter hub 122. For example, in some embodiments, the length of the slit 186 (e.g., its radial extent) can approximate 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 measure approximately 0.075 inches, 0.070 inches, 0.060 inches, 0.055 inches, 0.045 inches, 0.040 inches, or 0.035 inches. Additionally, the length of slit 186 is preferably less than a cross dimension (e.g., diameter) of membrane 180 such that a radially outermost end 188 of slit 186 is spaced from wall 176 of cylinder 170 and slit 186 does not penetrate therethrough.

[0045] As shown in FIG. 4A, in the first position or ready-for-use position of the safety catheter assembly 100, the membrane 180 and the slit 186 in the needle cannula 106 can cooperate to inhibit or restrict the flow of body fluid around the outer diameter of the needle cannula 106 when the needle cannula 106 extends through the membrane 180. In some embodiments, the slit 186 and the needle cannula 106 do not form a fluid-tight seal, but rather can provide a significant restriction to the flow of body fluid therethrough, such that a minimal amount of blood can exude through the slit 196 of the membrane 180 during insertion of the catheter tube 124 into the patient's vasculature. In another embodiment, the seal member 132 can include a secondary membrane or wiper 202 configured to further restrict or inhibit the flow of body fluid and generally improve the seal during advancement.

[0046] Referring to FIG. 7, a partial cross-sectional view of a catheter assembly 104 having a wiper 202 and a seal member 132 intersecting the needle cannula 106 thereof is shown in accordance with an embodiment of the present disclosure. In one embodiment, the wiper 202 can be configured as a membrane 204 defining an opening 206. In one embodiment, the opening 206 can be circular. In contrast to the slit 186, which can normally be closed when the needle cannula 106 is removed, the opening 206 can have an intersection dimension that is slightly smaller than the outer diameter of the needle cannula 106, such that when the needle cannula 106 is disposed within the seal member 132, it closely conforms to and / or slightly interferes with the outer diameter of the needle cannula 106, but when the needle cannula 106 is removed, the opening 206 can remain open. In one embodiment, the wiper 202 is disposed distal to the membrane 180, thereby inhibiting the flow of body fluid to the membrane 180 when the needle cannula 106 is disposed within the seal member 132. In other embodiments, the wiper 202 can be disposed proximal to the membrane.

[0047] Continuing to refer to FIG. 6A, the distal portion 182 of the internal cavity 178 can include a sealed outlet bore 192 defined by an annular sealing lip 194 extending inwardly from the distal end 172, and an actuator cavity 196 between the sealed outlet bore 192 and the membrane 180. Referring further to FIG. 8A, a cross-sectional view of the catheter assembly 104 with the seal member 132 in the closed position is illustrated in accordance with an embodiment of the present disclosure. The proximal portion 166 of the actuator can be received into the actuator cavity 196 through the sealed outlet bore 192, and the flange 168 is housed within the actuator cavity 196. The actuator cavity 196 can include a constricted portion 198 that gives the actuator cavity 196 an hourglass shape. In one embodiment, the constricted portion 196 can be provided by an annular rib that projects generally radially inwardly from a portion of the wall 176 that defines the actuator cavity 196. In one embodiment, the flange 168 is fully housed within the actuator cavity 196. For example, in one embodiment, the frustoconical surface of the flange 168 of the seal member 132 can engage the annular rib of the constricted portion 198. The flange 168 can have an outermost cross-sectional diameter that is larger than the cross-sectional diameter of the sealed outlet bore 192 and can be configured such that the sealed outlet bore 192 can slide distally over the flange 168, but can limit proximal movement back over the flange 168 of the seal member 132. Thus, in the closed position (as shown in FIG. 8A), at the position of the flange 168 within the actuator cavity 196, the slit 186 in the membrane 180 can naturally close to impede fluid flow therethrough.

[0048] As shown in FIGS. 8B - C, when the luer taper 200 is inserted, the seal member 132 can move distally relative to the actuator 130, such that the flange 168 is pressed against the membrane 180, thereby causing the slit 186 in the membrane 180 to open at least partially. The proximal portion 184 of the internal cavity 178 can be generally cylindrical and can extend between the membrane 180 and the opening of the proximal end 174 of the seal member 132. In one embodiment, the proximal portion 184 can have a generally constant intersection dimension such that a standard - sized luer taper 200 cannot pass into the internal cavity 178 of the seal member 132, but instead is configured to impact, at most, the proximal end 174 of the seal member 132.

[0049] As the seal member 132 moves axially within the catheter hub 122, the proximal portion 166 of the actuator 130 contacts the membrane 180 and begins to penetrate the slit 186, thereby hinging or inflating the flap 190 formed by the slit 186 and sliding along the flange 168 (e.g., along its conical face) to gradually open the slit 186. Continuing the distal insertion of the luer taper 200, the luer taper 200 is fully extended into the internal cavity 146 of the catheter hub 122 and the seal member 132 moves axially until the distal end 172 of the seal member 132 moves forward or moves relative to the distal portion 150 of the internal cavity 146, thereby defining the open position of the seal member 132 (as shown in FIG. 8C). When the seal member 132 is in the open position, an unobstructed fluid path, such as for administering body fluid to a patient or withdrawing blood or other body fluid, through the catheter assembly 104 is established between the catheter tube 124 and the luer taper 200 via the actuator 130.

[0050] In one embodiment, the membrane 180 is sufficiently elastic such that the flange 168 can pass through the slit 186 without aging or otherwise breaking the membrane 180. After the flange 168 has passed through, the slit 186 can then close back around the actuator 130. In another embodiment, as the flange 168 passes through the slit 186, the membrane 180 can be deformed, aged, or otherwise ruptured. Thus, in one embodiment, the seal member 132 is a one-time use seal. In this regard, after removing the luer taper 200 from the catheter hub 122, the seal member 132 will not return proximally towards the closed position but instead will remain in the open position. In one embodiment, the flange 168 can be configured to allow movement of the seal member 132 in the distal direction but to impede movement of the seal member 132 and movement in the opposite proximal direction. Thus, in one embodiment, the membrane 180 does not automatically return over the flange 168 to close the established fluid flow path, but instead provides an unobstructed fluid flow path between the catheter tube 124 and the open proximal end 142 of the internal cavity 146 and / or the catheter hub 122. In another embodiment, the catheter assembly 104 can include a mechanism such as a spring, elastomer, or bellows to provide a driving force to axially return the seal member 132 in the proximal direction, and as a result, shift the seal member 132 to the closed position. In one embodiment, the mechanism configured to provide a driving force to axially shift the seal member 132 in the proximal direction can be integrated with the seal.

[0051] The safety clip 128 can be at least partially present within the proximal portion 184 of the seal member 132 and is configured to slide axially along the needle cannula 106 between a first position or ready-to-use position (as shown in FIG. 2A) where the needle cannula 106 crosses the safety clip 128 and a second position or safety position (as shown in FIG. 2B) where the sharp distal tip 110 is captured within the safety clip 128 for the purpose of preventing accidental needle sticks.

[0052] Referring to FIGS. 9A - D, a first embodiment of the safety clip is shown in accordance with an embodiment of the present disclosure. FIG. 9A shows the safety clip 128 in a first position or ready - to - use position where the needle cannula 106 passes through a portion of the safety clip 128. FIG. 9B shows the safety clip 128 in a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 128.

[0053] In one embodiment, the safety clip 128 can include a proximal wall 208 and one or more guard arms 210. The proximal wall 208 can define an opening 212 configured to be disposed around or over the needle cannula 106. In some embodiments, the proximal wall 208 and the opening 212 can be configured to engage the needle transition portion 114 to inhibit distal advancement of the safety clip 128 away from the sharp distal tip 110 of the needle cannula 106. In one embodiment, the surface 214 of the proximal wall 208 can be substantially orthogonal to the longitudinal axis 216 of the needle cannula 106. In other embodiments, the surface 214 can be positioned at an oblique or acute angle with respect to the longitudinal axis 216 of the needle cannula 106.

[0054] The guard arms 210 above 1 can extend distally from the proximal wall 208. In one embodiment, the safety clip 128 can include a pair of guard arms 210A / 210B. The safety clip 128 can be formed of a generally elastic material such as, for example, medical grade stainless steel, such that the guard arms 210 have a natural bias towards their free or relaxed state when portions of the safety clip 128 are deflected away from their free state. For example, in one embodiment, the safety clip 128 is in its free state when the safety clip 128 is in its second or safe position. Thus, in this embodiment, when the safety clip 128 is in its first position or ready for use, the presence of the needle cannula 106 causes the guard arms 210A-B to deviate from their free state, so the guard arms 210A-B are biased against the needle cannula 106. When the needle cannula 106 is retracted and the sharp distal tip 110 moves proximally between the guard arms 210, the guard arms 210 naturally deflect towards their free state, thereby capturing the sharp distal tip 110 therebetween. In some embodiments, further proximal movement of the sharp distal tip 110 is inhibited by the cross-dimension of the needle transition portion 114 being larger than the opening 212 in the proximal wall of the safety clip. In some embodiments, rapid distal movement of the distal tip 110 is inhibited by the distal portion of at least one of the arms 210A-B.

[0055] In one embodiment, the first guard arm 210A can include a straight portion 218, a curved portion 220, and a distal wall 222. The straight portion 218 can be adjacent to the proximal wall 208 such that the straight portion 218 and the proximal wall 208 are separated by a bend 224. In one embodiment, the bend 224 can form an angle between 8090°, although other angles for the bend 224 are contemplated.

[0056] The curved portion 220 can be adjacent to the straight portion 218. In some embodiments, the curved portion 220 can have a reduced width 226 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 can further define a needle cannula guide surface or profile cutout 230 configured to at least partially conform to the needle cannula 106. Thus, the reduced width 226 and profile cutout 230 of the curved portion 220 can be configured to maintain the position of the safety clip 128 along the needle cannula 106, particularly when the needle cannula 106 is retracted and moved relative to the safety clip 128. In one embodiment, the apex 231 of the bent portion 220 can extend toward the longitudinal axis 216 of the needle cannula 106 when the needle cannula 106 is disposed within the safety clip 218. In some embodiments, the apex 231 extends beyond the longitudinal axis 216 of the needle cannula 106 only in a second or safety position and does not extend beyond the longitudinal axis 216 in a first or ready-to-use position. Thus, in some embodiments, the guard arms 210A-B do not intersect (i.e., the guard arms 210A-B do not cross or intersect each other along the longitudinal axis 216 of the needle cannula 106). Note that non-intersecting guard arms (i.e., guard arms that do not cross or intersect each other along the longitudinal axis of the needle cannula) are applicable to any embodiment of the needle clip disclosed herein.

[0057] The distal wall 222 can be adjacent to the curved portion 220. In some embodiments, the distal wall 222 can be angled toward the longitudinal axis 216 of the needle cannula 106 when disposed within the safety clip 218. In one embodiment, the distal wall 222 can further include a lip or hook 232 at the distal end of the distal wall 222. In one embodiment, the hook 232 can include a curved surface configured to contact and / or slide along the needle cannula 106 when the needle cannula 106 is disposed within the safety clip 218. In one embodiment, when the sharp distal tip 110 of the needle cannula 106 moves proximally beyond the hook 232, the hook 232 can be configured to inhibit the sharp distal tip 110 from moving distally back beyond the hook 232 and out of the safety clip 128.

[0058] The distal wall can further include one or more tabs 234 located on either side of the distal wall 222 such that the one or more tabs 234 can be configured to function as an aid to hold the sharp distal tip 110 of the needle cannula 106 in a second or safe position. The one or more tabs 234 can additionally function to contact a portion of the opposing guard arm 210B for the purpose of maintaining the alignment of the guard arms 210A-B in the second or safe position.

[0059] In the first embodiment, the second guard arm 210B can also include a straight portion 218B, a curved portion 220B, and a distal wall 222B, and can have a configuration similar to that of the first guard arm 210A. In some embodiments, the second guard arm 210B can be made slightly shorter than the first guard arm 201A such that in the second or safe position, the hook 232B of the second guard arm 210B can be positioned proximal to the hook 232 of the first guard arm 210A. Further, in some embodiments, the curved portion 220B of the second guard arm 210B can be arranged to approximate the curved portion 220 of the first guard arm 210A such that in the second or safe position, the guard arms 210A-B do not cross (i.e., such that the guard arms 210A-B do not intersect each other along the longitudinal axis 216 of the needle cannula 106 or do not cross). In one embodiment, the width 226 of the curved portion 220B of the second guard arm 210B can be positioned on the opposite side as the width 226 of the curved portion 220A of the first guard arm 210A to suppress the intersection of the guard arms 210A-B in the second or safe position.

[0060] Referring to FIGS. 10A-C, a second embodiment of the safety clip 300 is shown in accordance with the disclosure. FIG. 10A shows the safety clip 300 in the first or ready-to-use position where the needle cannula 106 passes through a portion of the safety clip 300. FIG. 10B shows the safety clip 300 in the second or safe position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 300.

[0061] In one embodiment, the safety clip 300 can include a proximal wall 308 and one or more guard arms 310A-B. The guard arm 310 can include a straight portion 318, a curved portion 320, and a distal wall 322. In one embodiment, the curved portion 320 of the safety clip 300 defines a needle cannula guide surface or a profile cutout notch 330 between the outer edges 336, 338 of the guard arm 310A such that the curved portion 330 forms a pair of curved tines 340, 342 having an overall reduced width 326A / B as compared to the width 328 of the straight portion 318. The profile cutout notch 330 can be configured to maintain the position of the safety clip 300 along the needle cannula 106, particularly when the needle cannula 106 is retracted and moved relative to the safety clip 300. Other portions of the safety clip 300 can be similar to the structures in other safety clip embodiments disclosed herein.

[0062] Referring to FIG. 10D, in another configuration, the distal wall 322 of the safety clip 300' can have a reduced width so as to generally form a distal cone 350. In this configuration, the distal cone 350 can help load and accommodate the sharp distal tip 110 of the needle cannula 106.

[0063] Referring to FIG. 10E, in yet another configuration, the tines 340, 342 of the safety clip 300'' can include a twist or a partial rotation relative to the straight portion 318, and in this configuration, the tines 340, 342 can conform more closely to the surface of the needle cannula 106, thereby functioning as an aid to maintaining the position of the safety clip 300'' along the needle cannula 106, particularly when the needle cannula 106 is retracted and moved relative to the needle clip 300.

[0064] Referring to FIGS. 11A - D, a third embodiment of the safety clip 400 is shown in accordance with the disclosure. FIG. 11A shows the safety clip 400 in a first position or ready - to - use position where the needle cannula 106 passes through a portion of the safety clip 400. FIG. 11B shows the safety clip 400 in a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 400.

[0065] In one embodiment, the safety clip 400 can include a proximal wall 408 and one or more guard arms 410A - B. The guard arms 410A - B can include a straight portion 418, a tabbed portion 420, and a distal wall 422. The straight portion 418 can be adjacent to the proximal wall 408 such that the straight portion 418 and the proximal wall 408 are separated by a bend 424. In one embodiment, the bend 424 can form an angle of 70 - 90°, although other angles for the bend 424 are contemplated.

[0066] The tabbed portion 420 can be adjacent to the straight portion 418. In some embodiments, the tabbed portion 420 can have a reduced width 426 relative to the width 428 of the straight portion 418. In one embodiment, the tabbed portion 420 can include one or more tabs 436. One or more tabs 436 can be configured to maintain the position of the safety clip 400 along the needle cannula 106, particularly when the needle cannula 106 is retracted and moved relative to the safety clip 400. In one embodiment, the tabbed portion 420 includes the needle cannula 106 in the second or safe position. In one embodiment, when the needle cannula 106 is disposed within the safety clip 400, the extension surface 431 of the tabbed portion 420 can extend toward the longitudinal axis 216 of the needle cannula 106. In some embodiments, the extension surface 431 extends only beyond the longitudinal axis 216 of the needle cannula 106 in the second or safe position and does not extend beyond the longitudinal axis 216 in the first or ready-to-use position. Thus, in some embodiments, the guard arms 410A-B do not intersect (i.e., the guard arms 410A-B do not cross or intersect each other along the longitudinal axis 216 of the needle cannula 106).

[0067] As shown in FIG. 11D, in one embodiment, the tabbed portion 420B of the second guard arm 410B can be aligned with the tabbed portion 420A of the first guard arm 410A, and the tab 436B of the second guard arm 210B can be positioned on the opposite side of the tab 436A of the first guard arm 410A to prevent the intersection of the guard arms 410A-B in the second or safe position. Other portions of the safety clip 400 can be similar in structure to those in other safety clip embodiments disclosed herein.

[0068] Referring to FIGS. 12A - C, a fourth embodiment of the safety clip 500 is shown in accordance with the present disclosure. FIG. 12A shows the safety clip 500 in a first position or ready - to - use position where the needle cannula 106 passes through a portion of the safety clip 500. FIG. 12B shows the safety clip 500 in a second or safe position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 500.

[0069] In one embodiment, the safety clip 500 can include a proximal wall 508 and one or more guard arms 510A - B. The guard arms 510A - B can include a straight portion 518, a tabbed portion 520, and a distal wall 522. In one embodiment, the tabbed portion 520 can be present on both guard arms 510A - B. In other embodiments, the tabbed portion 520 can be present on a single guard arm 510A / B. In one embodiment, the tabbed portion 520 of the safety clip 500 can define a needle cannula guide surface or profile cut - out notch 530 between the outer edges 536, 538 of the guard arm 510A, such that the tabbed portion 520 forms a pair of tines 540, 542 having an overall reduced width 526A / B compared to the width 528 of the straight portion 518. The profile cut - out 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 and moved with respect to the safety clip 500 and / or when approaching the second or safe position. Other portions of the safety clip 500 can be similar to the structures in other safety clip embodiments disclosed herein.

[0070] Referring to FIGS. 13A - D, a fifth embodiment of the safety clip 600 is shown in accordance with the disclosure. FIG. 13A shows the safety clip 600 in a first position or ready - to - use position where the needle cannula 106 passes through a portion of the safety clip 600. FIG. 13B shows the safety clip 600 in a second or safe position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 600.

[0071] Similar to the fourth embodiment, the first guard arm 610A can include a tabbed portion 620 that defines a needle extraction surface or profile cut 630 between the lateral edges 636, 638 of the guard arm 610A, and such a tabbed portion 630 forms a pair of tines 640, 642. In this embodiment, a pair of tabs 644, 646 can be configured to maintain the position of the safety clip 600 along the needle cannula 106, particularly when the needle cannula 106 is paired and retracted and moved within the safety clip 600.

[0072] In one embodiment, when the needle cannula 106 is disposed within the safety clip 600, the outermost surfaces 645, 647 of the tabs 644, 646 can extend toward the longitudinal axis 216 of the needle cannula 106. In some embodiments, the surfaces 645, 647 extend beyond the longitudinal axis 216 of the needle cannula 106 only in the second or safety position and do not extend beyond the longitudinal axis 216 in the first or ready-to-use position. In some embodiments, the second guard arm 610B does not include any tabs. Thus, in some embodiments, the guard arms 610A - B are non-intersecting (i.e., the guard arms 610A - B do not cross or intersect each other along the longitudinal axis 216 of the needle cannula 106).

[0073] Referring to FIGS. 14A - B, a sixth embodiment of the safety clip 700 is shown in accordance with the disclosure. FIG. 14A shows the safety clip 700 in the first or ready-to-use position where the needle cannula 106 passes through a portion of the safety clip 700. FIG. 14B shows the safety clip 700 in the second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 700.

[0074] In one embodiment, the safety clip 700 includes a proximal wall 708, a pair of guard arms 710A-B, and an elastomeric band 712 positioned around the guard arms 700A-B, and can bias the guard arms 700A-B towards each other. As in the previous embodiment, the proximal wall 708 allows at least a portion of the needle cannula 106 to pass through it, but inhibits the passage of the needle transition portion 114 passing through it, thereby defining an opening shape and size to inhibit the distal advancement of the safety clip 700 away from the sharp distal tip 110 of the needle cannula 106.

[0075] The guard arms 710A-B can extend distally from the proximal wall 708 and can generally be composed of a flexible material, such that the guard arms 710A-B are generally pivotable compared to the proximal wall 708. The elastomeric band 712 can be positioned proximally to a portion of the guard arms 710A-B, such that the bias of the guard arms 710A-B can be brought closer to each other. Thus, in this embodiment, when the safety clip 128 is in the first position or ready for use, the guard arms 710A-B are biased against the needle cannula 106. In one embodiment, one of the guard arms 710B can include a distal wall 722 configured to prevent the advancement of the needle cannula 106 when the needle cannula 106 is retracted, and the guard arms 710A-B are biased away from each other and shift to a second safety position, such that the sharp distal tip 110 of the needle cannula 106 within the safety clip 700 can be safely captured.

[0076] Referring to FIGS. 15A-C, a seventh embodiment of the safety clip 800 is shown in accordance with the disclosure. FIG. 15A shows the safety clip 800 alone or separately from the needle cannula 106. FIGS. 15B-C show the safety clip 800 and a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 800.

[0077] In one embodiment, the safety clip 800 can include a proximal wall 802 and one or more guard arms 804. The proximal wall 802 can define an opening 806 configured to be disposed around or over the needle cannula 106. In some embodiments, the proximal wall 802 and the opening 806 can be configured to engage the needle transition portion 114 to inhibit distal advancement of the safety clip 800 away from the sharp distal tip 110 of the needle cannula 106. In one embodiment, the surface 808 of the proximal wall 802 can be substantially orthogonal to the longitudinal axis of the needle cannula 106. In other embodiments, the surface 808 can be positioned at an oblique or acute angle to the longitudinal axis of the needle cannula 106.

[0078] The guard arms 804 or more can extend distally from the proximal wall 802. In one embodiment, the safety clip 800 can include a pair of guard arms 804A / 804B. The safety clip 800 can be formed (e.g., stamped) from a substantially elastic material, such as medical grade stainless steel, such that the guard arms 804 have a natural bias (biasing) towards a free or relaxed state when a portion of the safety clip 800 is deflected away from its free state. For example, in one embodiment, the safety clip 800 is in its free state when the safety clip 800 is in the second or safe position. Thus, in this embodiment, when the safety clip 800 is in the first position or ready for use, the presence of the needle cannula 106 causes the guard arms 804A / B to deviate from their free state, so the guard arms 804A / B are biased against the needle cannula 106. When the needle cannula 106 retracts and the sharp distal tip 110 moves proximally between the guard arms 804A / B, the guard arms 804A / B are naturally biased towards their free state and capture the sharp distal tip 110 therebetween. In some embodiments, further proximal movement of the sharp distal tip 110 is inhibited by the cross-dimension of the needle transition portion 114 being larger than the opening 806 in the proximal wall 802 of the safety clip 800. In some embodiments, distal movement of the sharp distal tip 110 is inhibited by the distal portion of at least one arm 804A / B.

[0079] In one embodiment, the first guard arm 804A can include an approximate portion 810, a straight portion 812, and a distal partition 814. The proximal portion 810 can be adjacent to the proximal wall 802 such that the proximal portion 810 and the proximal wall 802 are separated by a bend 816. In one embodiment, the bend 816 can form an angle of about 60-110°, although other angles for the bend 816 are also contemplated.

[0080] 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 the second bending portion 818. In one embodiment, the bending portion 818 can form an angle of about 90 to 180°, although other angles for the bending portion 818 are contemplated. In one embodiment, the straight portion 812 includes one or more tabs 820A - D positioned on either side of the straight portion 812, and the tabs 820A - D may be configured to at least partially conform to the outer diameter of the needle cannula 106. Accordingly, one or more of the 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 retracts and operates to move in relation to the safety clip 800.

[0081] The distal wall 814 can be adjacent to the straight portion 812. In some embodiments, the distal wall 814 can be angled toward the longitudinal axis of the needle cannula when disposed within the safety clip 800. In one embodiment, the distal wall 814 can further include a lip or hook 822 at the distal end of the distal wall 814. In one embodiment, the hook 822 can include a curved surface configured to contact and / or slide along the needle cannula 106 when the needle cannula 106 is disposed within the safety clip 800. In one embodiment, when the sharp distal tip 110 of the needle cannula 106 moves proximally and passes through the hook 822, the hook 822 can be configured to inhibit the sharp distal tip 110 from moving distally beyond the hook 822 and out of the safety clip 800.

[0082] In one embodiment, the second guard arm 804B can also include an approximation portion, a straight portion 812B, and a distal partition wall having a configuration similar to that of the first guard arm 804A. In some embodiments, the second guard arm 804B can be slightly longer than the first guard arm 804A such that in the second or safe position, the hook 822 of the first guard arm 804A can be positioned proximal to the hook of the second guard arm 804B. In a first embodiment, the second guard arm 804B positions one or more corresponding tabs 824A-D on both sides of the straight portion, such that such tabs 824A-D are configured to at least partially conform to the outer diameter of the needle cannula 106. In one embodiment, when the safety clip 800 is in the second position or safe position, one or more tabs 824A-D can be configured to engage with one or more tabs 820A-D of the first guard arm 804A.

[0083] Referring to FIGS. 16A-C, and an eighth embodiment of the safety clip 900, is depicted in accordance with the present disclosure. FIG. 16A shows the safety clip 900 alone, separate from the needle cannula 106. FIGS. 16B-C show the safety clip 900 and a second or safe position in which the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 900.

[0084] In one embodiment, the safety clip 900 can share structural similarity with the aforementioned safety clips (e.g., safety clip 800). For example, the safety clip 900 can include an approximation wall 902 defining a notch 906, and one or more guard arms 904A / B having an approximation portion 910, a straight portion 912, and a distal partition wall 914. In one embodiment, the proximal wall 902 can generally be 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 can be approximately equal to the width 918 of the straight portion 912. In other embodiments, the width 916 of the proximal portion 910 can be larger or smaller than the width 918 of the straight portion 912.

[0085] Referring to FIGS. 17A - C, and to a ninth embodiment of the safety clip 1000, it is depicted in accordance with the present disclosure. FIG. 17A shows the safety clip 1000 alone, separate from the needle cannula 106. FIGS. 17B - C show the safety clip 1000 and a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1000.

[0086] In one embodiment, the safety clip 1000 can share structural similarities with the safety clips described above. For example, the safety clip 1000 can include one or more guard arms 1004A / B having an approximation portion 1010, a straight portion 1012, and a distal wall 1014. In one embodiment, the straight portion 1012 of the first guard arm 1004A can include one or more tabs 1020A - D located on both sides of the straight portion 1012, and these tabs 1020A - D are configured to at least partially conform to the outer diameter of the needle cannula 106. In one embodiment, the safety cup 1000 can include four tabs 1020A - D, and these tabs (e.g., 1020A & 1020C and 1020B & 1020D) are disposed on opposite sides of the straight portion 1012. The tabs 1024A - D of the corresponding second guard arm 1004B can be located on both sides of the corresponding straight portion, and in this way, the tabs 1024A - D are configured to engage with the tabs 1020A - D of the first guard arm 1004 when the safety clip 1000 is in the second or safety position.

[0087] In one embodiment, the safety clip 1000 can include a tubular cuff 1030 instead of a proximal wall defining an opening. In one embodiment, the cuff 1030 can be configured to be disposed around or over the needle cannula 106. In some embodiments, the cuff 1030 can have an inner diameter configured to engage with the needle transition portion 114 to inhibit the safety clip 1000 from advancing distally from the sharp distal tip 110 of the needle cannula 106.

[0088] Referring to FIGS. 18A - C, a tenth embodiment of the safety clip 1100 is shown in accordance with the present disclosure. FIG. 18A shows the safety clip 1100 alone, separate from the needle cannula 106. FIGS. 18B - C show the safety clip 1100 and a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1100.

[0089] In one embodiment, the safety clip 1100 can share a structural similarity with the safety clips described above. For example, the safety clip 1100 can include one or more guard arms 1104A / B with an approximation portion 1110, a straight portion 1112, and a distal wall 1114. In one embodiment, one or more tabs 1120A - D can be located on both sides of the straight portion 1112, and in an alternating configuration, each tab 1120A - D of the straight portion 1112 is arranged to oppose the other tabs 1120A - D of the same straight portion 1112. The tabs 1124A - D of the corresponding second guard arm 1104B can be positioned on both sides of the corresponding straight portion, such that in this way, the tabs 1124A - D are configured to engage with the tabs 1120A - D of the first guard arm 1104 when the safety clip 1100 is in the second or safety position.

[0090] Referring to FIGS. 19A - C, an eleventh embodiment of the safety clip 1200 is shown in accordance with the present disclosure. FIG. 19A shows the safety clip 1200 alone, separate from the needle cannula 106. FIGS. 19B - C show the safety clip 1200 and a second or safety position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1200.

[0091] In one embodiment, the safety clip 1200 can share a structural similarity with the aforementioned safety clip. For example, the safety clip 1200 can include one or more guard arms 1204A / B with an approximate portion 1210, a straight portion 1212, and a distal wall 1214. In one embodiment, one or more tabs 1220A - D can be arranged on either lateral side of the straight portion 1212 in an alternating configuration such that each tab 1220A - D of the straight portion 1212 faces another tab 1220A - D of the same straight portion 1212. The tabs 1224A - D of the corresponding second guard arm 1204B can be positioned on both sides of the corresponding straight portion such that when the safety clip 1200 is in the second or safe position, the tabs 1224A - D are configured to engage with the tabs 1220A - D of the first guard arm 1204. In one embodiment, the straight portion and parts of the tabs 1220A - D can define material cutouts 1230A - B configured to contribute to the compliance or elasticity of the safety clip 1200.

[0092] Referring to FIGS. 20A - C, a twelfth embodiment of the safety clip 1300 is shown in accordance with the disclosure. FIG. 20A shows the safety clip 1300 alone, separate from the needle cannula 106. FIGS. 20B - C depict the safety clip 1300 in the second or safe position where the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1300.

[0093] In one embodiment, the safety clip 1300 can include a proximal cuff 1302 and one or more guard arms 1304. The proximal cuff 1302 can define a lumen or inner diameter 1306 configured to be disposed around or over the needle cannula 106. In some embodiments, the proximal cuff 1302 and the inner diameter 1306 can be configured to engage the needle transition portion 114 to inhibit distal advancement of the safety clip 1300 away from the sharp distal tip 110 of the needle cannula 106.

[0094] The guard arms 1304 above 1 can extend distally from the proximal cuff 1302. In one embodiment, the safety clip 1300 can include a pair of guard arms 1304A / B. The safety clip 1300 can generally be formed (e.g., stamped or laser cut) from an elastic material, such as medical grade stainless steel, such that when a portion of the safety clip 1300 is deflected away from its free state, the guard arms 1304 have a natural bias towards their free or relaxed state. Thus, when the safety clip 1300 is in the first position or ready for use, the presence of the needle cannula 106 causes the guard arms 1304A / B to bias against the needle cannula 106 in order to prevent the guard arms 1304A / B from deviating from their free state. When the needle cannula 106 is retracted and the sharp distal tip 110 moves proximally between the guard arms 1304, the guard arms 1304 naturally deflect towards their free state, thereby capturing the sharp distal tip 110 therebetween. In some embodiments, further proximal movement of the sharp distal tip 110 is inhibited by a crossed mention of the needle transition portion 114 that is larger than the inner diameter 1306 of the proximal cuff 1302. In some embodiments, distal movement of the sharp distal tip 110 is inhibited by the distal portion of at least one arm 1304A / B.

[0095] In one embodiment, the first guard arm 1304A and the second guard arm 1304B can together assume a circular shape configured to at least partially surround the needle cannula 106 when the safety clip 1300 is in the second or safety position. For example, each of the first guard arm 1304A and the second guard arm 1304B can include a straight portion 1312 having a semi-circle and, otherwise, can generally include an arcuate intersection portion. The straight portion 1312 can be adjacent to the proximal cuff 1302 such that the straight portion 1312 and the proximal cuff 1302 are separated by a joint or pivotable coupling 1316, and in some embodiments, can be a living hinge. A distal wall 1314 similar to previously disclosed embodiments can be adjacent to the straight portion 1312.

[0096] In one embodiment, the straight portion 1312 can 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 a semi-circular or other generally arcuate cross-section of the guard arm 1304 so as to at least partially conform to the outer diameter of the needle cannula 1306. Accordingly, one or more tabs 1320A-D of the straight portion 1312 can be configured to maintain the position of the safety cup 1300 along the needle cannula 106, particularly as the needle cannula 106 retracts and moves with respect to the safety clip 1300.

[0097] In one embodiment, the second guard arm 1304B can also include a distal wall having a configuration similar to that of the first guard arm 1312A and a straight portion 1312B. In one embodiment, the second guard arm 1304B can include one or more corresponding tabs 1324A-D located on both sides of the straight portion, and 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 of the tabs 1324A-D can be configured to engage one or more of the tabs 1320A-D of the first guard arm 1304A when the safety clip 1300 is in the second or safety position. Thus, in some embodiments, the guard arms 1304A-B do not intersect (i.e., the guard arms 1304A-B do not cross or intersect along the longitudinal axis of the needle cannula 106).

[0098] Referring to FIGS. 21A-C, a thirteenth embodiment of the safety clip 1400 is shown in accordance with the present disclosure. FIG. 21A shows the safety clip 1400 alone, apart from the needle cannula 106. FIGS. 21B-C show the safety clip 1400 in the second or safety position, in which case the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 1400.

[0099] In one embodiment, the safety clip 1400 can share structural similarities with the aforementioned safety clip (e.g., safety clip 1300). For example, the safety cup 1400 can include one or more guard arms 1404A / B, which can have a straight portion 1412 and a distal wall 1414. In one embodiment, one or more tabs 1420A-D can be positioned on both sides of the straight portion 1412. The tabs 1424A-D of the corresponding second guard arm 1404B can be positioned on both sides of the corresponding straight portion such that when the safety clip 1400 is in the second or safe position, the tabs 1424A-D are configured to engage with the tabs 1420A-D of the first guard arm 1404. In one embodiment, a portion of the straight portion 1412 and the tabs 1420A-D can define material cutouts 1430A-B configured to assist with the compliance or elasticity of the safety clip 1400.

[0100] Referring to FIGS. 22A - C, partial cross-sectional views of the safety catheter assembly 100 in the first or ready-for-use position, the transition position, and the second or safe position are depicted in accordance with embodiments of the present disclosure. In one embodiment, at least the seal member 132 and the safety clip 128 cooperate to 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 inhibits the release of the catheter assembly 104 from the needle insertion device 102 until the sharp distal tip 110 of the needle cannula 106 is captured within the safety clip 128. Some or all of the features of the passive release mechanism may be integral with other components of the catheter insertion assembly 100. In this regard, 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 recognized that various components of the catheter insertion device 102 and / or the catheter assembly 104 can form the passive release mechanism.

[0101] In one embodiment, the passive release mechanism can be configured to couple the catheter hub 122 to the catheter insertion device 102 in a first position or ready-to-use state and to release the catheter hub 122 from the catheter insertion device 102 in a second position or safe position. Further, the passive release mechanism inhibits the release of the catheter hub 122 from the catheter insertion 102 device until the sharp distal tip 110 of the needle cannula 106 is in a safe position where access to the sharp distal tip 110 is inhibited. The release of the catheter hub 122 from the catheter insertion device 102 can occur during the catheter insertion procedure without the need to perform additional steps other than safely retracting the needle cannula 106. In this regard, the catheter can be “passively” released by the clinician to obtain passive safety. As an example, the catheter can be released when the clinician pulls on a part of the catheter insertion device 102 or when the clinician withdraws the needle 106 from the catheter assembly 104.

[0102] As shown in FIG. 22A, when the safety clip 128 is in the first or ready-to-use position, the guard arms 210A - B are forced apart from each other, whereby a portion of the guard arms 210A - B applies a compressive force to the wall 176 of the proximal portion 184 of the internal cavity 178 of the seal member 132, thereby inhibiting the movement of the safety clip 128 relative to the seal member 132. In one embodiment, the seal member 132 is naturally elastic and then transfers at least a portion of this compressive force to the inner wall 144 of the proximal portion 148 of the internal cavity 146 of the catheter hub 122, thereby inhibiting the movement of the safety clip 128 and / or the seal member 132 relative to the catheter hub 122. Thus, the compressive force creates frictional, interfering contact between the components of the passive release mechanism, which inhibits the release of the catheter hub 122 from the catheter insertion device 102.

[0103] As shown in FIGS. 22B-C, when the needle cannula 106 retracts and the sharp distal tip 106 is safely captured by the safety clip 128, the guard arms 210A-B move towards each other and the compressive force between the safety clip 128 and the seal member 132 stops. Thereafter, the safety clip 128 can be removed from the seal member 132 without substantial interference. Thus, the release of the catheter hub 122 from the catheter insertion device 102 occurs only after the sharp distal tip 110 of the needle cannula 106 is in a safe position.

[0104] In one embodiment, the safety clip 128 may at least partially be present or be received within or be receivable within the proximal portion 184 of the internal cavity 178 of the seal member 132, or at least partially be present or be received within or be receivable within the proximal portion 148 of the internal cavity 146 of the catheter hub 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 present or is received.

[0105] Referring to FIG. 23A, the proximal cup 1502 is shown in accordance with an embodiment of the present disclosure. In one embodiment, the proximal cup 1502 can include a proximal end 1504, an open distal end 1506, and a generally cylindrical wall 1508 that defines an internal cavity therebetween. In one embodiment, the proximal end 1504 of the proximal cup 1502 restricts the outflow of air and / or fluid from the internal cavity 146 of the catheter hub 122 and / or inhibits leakage of blood or fluid during advancement of the catheter assembly 104 by containing blood or fluid from the patient, and can define an opening 1512 shaped and sized to closely conform to the outer diameter of the needle cannula 106. In some embodiments, the proximal cup 1502 can inhibit tampering by the safety clip 128 prior to the safety clip 128 transitioning to a second or safe position (as shown in FIG. 23B). In some embodiments, the proximal cup 1502 can be fixedly or operably coupled to the safety clip 128 before and after transitioning to the second or safe position, such that 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 component.

[0106] Referring to FIG. 23C, in some embodiments, the proximal cup 1502 can further include a stem extension 1514 to further inhibit leakage of blood or body fluid during advancement of the catheter assembly 104. The stem extension 1514 can include a generally cylindrical wall 1516 that defines an opening 1518 shaped and sized to closely conform to the outer diameter of the needle cannula 106 so as to inhibit leakage of blood or body fluid. In one embodiment, the stem extension 1514 can be made of metal. In other embodiments, the stem extension 1514 can be formed of a flexible or elastic material to further assist in conforming to the outer diameter of the needle cannula 106. In embodiments where the needle cannula 106 includes a notch 120 for indicating flashback between the outer diameter of the needle cannula 106 and the inner diameter of the catheter tube 124, the stem extension 1514 can be sized to extend over the notch 120 so as to inhibit flow of blood or body fluid through the notch 120.

[0107] As shown in FIG. 23D, a partial cross-sectional view of the safety catheter assembly 100 including the proximal cup 1502 with the safety catheter assembly in the first or ready-to-use position is shown in accordance with an embodiment of the present disclosure. In this embodiment, the proximal portion of the safety clip 128 is at least partially present within or housed within the proximal cup 1502. As shown in FIG. 23E, a perspective view of the catheter insertion device 102, the proximal cup 1502, and the safety clip 128 in the second or safety position is shown in accordance with an embodiment of the present disclosure. In this embodiment, the proximal portion of the safety clip 128 remains within the proximal cup 1502.

[0108] It should be understood that the individual steps used in the methods of the present teachings can be performed in any order and / or simultaneously as long as the teachings remain operable. Further, it should be understood that the devices and methods of the present teachings can include any number, or all, of the described embodiments as long as the teachings remain operable.

[0109] Various embodiments of systems, devices, and methods are described herein. These embodiments are provided by way of example only and are not intended to limit the technical scope of the claimed invention. Further, it should be recognized that the various features of the described embodiments can be combined in various ways to create numerous additional embodiments. Additionally, various materials, dimensions, shapes, forms, and positions, etc. are described for use with the disclosed embodiments, but those other than the disclosed ones can also be utilized without exceeding the technical scope of the claimed invention.

[0110] Those of ordinary skill in the relevant art will recognize that the subject matter of this specification may include fewer features than are exemplified in any of the individual embodiments described above. The embodiments described herein are not meant to be an exhaustive presentation of all the ways in which the various features of the subject matter of this specification can be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, various embodiments can include combinations of different individual features selected from different individual embodiments, as will be understood by those skilled in the art. Further, elements described with respect to one embodiment can be practiced in other embodiments even if not described in such other embodiments, unless specifically stated otherwise.

[0111] Dependent claims can refer in a claim to a particular combination with one or more other claims, but other embodiments can also include combinations of a dependent claim with the subject matter of the dependent claim mutually, or combinations of one or more features with other dependent claims or independent claims. Such combinations are proposed herein unless it is stated that a particular combination is not intended.

[0112] The incorporation by reference of the above documents is limited so that no subject matter contrary to the explicit disclosure of this specification is incorporated. Any incorporation by reference to the above documents is further limited so that the claims contained in the documents are not incorporated into the standards of this specification. The incorporation by reference to the above documents is further limited so that any definition provided in the documents is not incorporated by reference into this specification unless explicitly included in this specification.

[0113] In the interpretation of claims, it is explicitly intended that the provisions of 35 U.S.C. § 112(f) should not be exercised unless the specific terms "means" or "step" are recited in the claims. Note that the present disclosure also includes the following aspects. 〔Aspect 1〕 An IV therapy device, the IV therapy device comprising: A catheter hub including an inner wall defining a catheter hub cavity; A blood control valve disposed within the catheter hub cavity, the blood control valve including a wall defining a blood control valve cavity; A safety clip at least partially disposed within the blood control valve cavity, the safety clip being selectively fixed to the blood control valve by frictional interference contact with the wall of the blood control valve; A needle including an elongate body and a sharp distal tip, the needle being movable relative to the catheter hub between a ready position and a safety position. In the ready position, the elongate body of the needle passes through at least a portion of the safety clip and the blood control valve. When transitioning to the safety position, the safety clip is configured to capture the sharp distal tip of the needle and release frictional interference contact with the wall of the blood control valve. An IV therapy device. 〔Aspect 2〕 The IV therapy device according to aspect 1, further comprising an actuator extending proximally within the catheter hub cavity, the actuator having a free end adapted to open a membrane provided within the blood control valve when the blood control valve is moved to bias the membrane against the free end. 〔Aspect 3〕 The blood control valve further includes an actuator cavity configured to receive the actuator and a resealable membrane disposed proximal to the actuator cavity, and the blood control valve is movable relative to the free end of the actuator between a first position where the membrane is closed and a second position where the membrane is open. The IV therapy device according to aspect 2. 〔Aspect 4〕 The IV therapy device according to aspect 3, wherein the membrane includes a slit shaped and sized to closely conform to the outer diameter of the elongated body of the needle. 〔Aspect 5〕 The IV therapy device according to aspect 1, further including a proximal cup operably coupled to the blood control valve, the proximal cup having an open distal end and a proximal end that defines a cavity therebetween, and a cavity defined by the blood control valve adjacent to a cavity defined by the proximal cup to form a cavity configured to receive the safety clip. 〔Aspect 6〕 The IV therapy device according to aspect 5, wherein the proximal cup further includes a stem extension having an opening configured to conform to the outer diameter of the elongated body of the needle to suppress fluid leakage from the cavity of the proximal cup during operation of the therapy device. 〔Aspect 7〕 The blood control valve includes a membrane configured to allow selective passage of the elongated body of the needle and a wiper assembly disposed distal to the membrane configured to inhibit passage of body fluid. The IV therapy device according to aspect 1. 〔Aspect 8〕 The safety clip includes a first arm and a second arm biased toward the longitudinal axis of the needle in the ready position, and the first arm includes a pair of needle guide surfaces that extend beyond the longitudinal axis of the needle when the safety clip captures the sharp distal tip of the needle. The IV therapy device according to aspect 1. 〔Aspect 9〕 The first arm includes a first needle guide surface, the second arm includes a second guide surface, and when the safety clip is in the folded configuration, the first and second needle guide surfaces extend beyond the longitudinal axis of the needle. The IV therapy device according to aspect 8. 〔Aspect 10〕 The blood control valve includes a membrane that divides the blood control valve cavity into a distal portion and a proximal portion having an open end, and the safety clip has a distal portion slidably disposed in the proximal portion through the open end. The distal portion of the safety clip is configured such that when the needle extends through the safety clip, it applies a compressive force to at least the wall of the blood control valve to prevent relative movement between the safety clip and the blood control valve, and when the distal tip of the needle is captured by the distal portion, it folds such that the compressive force on the wall of the blood control valve is removed and the distal tip of the safety clip can be removed from the proximal portion, the IV therapy device according to Aspect 1. 〔Aspect 11〕 A catheter assembly including a catheter hub including an inner wall defining a catheter hub cavity and a blood control valve disposed within the catheter hub cavity, the blood control valve including a wall defining a blood control valve cavity, the catheter assembly, A safety clip configured to slide axially along a needle having an elongate body and a sharp distal tip disposed at least partially within the blood control valve cavity, the safety clip being selectively fixed to the blood control valve by frictional interference contact with the wall of the blood control valve, the safety clip, The needle is movable relative to the catheter assembly between a ready position and a safety position, in the ready position, the elongate body of the needle passes through at least a portion of the safety clip and the blood control valve, and when transitioning to the safety position, the safety clip is configured to capture the sharp distal tip of the needle and release frictional interference contact with the wall of the blood control valve. IV therapy device. 〔Aspect 12〕 The safety clip includes a first arm and a second arm biased toward the longitudinal axis of the needle in the ready position, and the first arm includes a pair of needle guide surfaces extending beyond the longitudinal axis of the needle when the safety clip captures the sharp distal tip of the needle, the IV therapy device according to Aspect 11. 〔Aspect 13〕 The first arm includes a first needle guide surface, the second arm includes a second guide surface, and when the safety clip is in a folded configuration, the first and second needle guide surfaces extend beyond the longitudinal axis of the needle, the IV therapy device according to Aspect 12. 〔Aspect 14〕 The blood control valve includes a membrane dividing the blood control valve cavity into a distal portion and a proximal portion having an open end, the safety clip having a distal portion slidably disposed within the proximal portion through the open end. The distal portion of the safety clip is configured such that when the needle extends through the safety clip, it applies a compressive force to at least the wall of the blood control valve to prevent relative movement between the safety clip and the blood control valve, and when the distal tip of the needle is captured by the distal portion, it is folded such that the compressive force on the wall of the blood control valve is removed and the distal tip of the safety clip can be removed from the proximal portion, the IV therapy device according to aspect 11. 〔Aspect 15〕 The catheter assembly further includes an actuator extending proximally within the catheter hub cavity, the actuator having a free end adapted to open the membrane provided within the blood control valve when the blood control valve is moved relative to the free end to bias the membrane within the blood control valve, the IV therapy device according to aspect 11. 〔Aspect 16〕 A catheter hub, a catheter tube extending from the catheter hub, and a blood control valve disposed within the catheter hub cavity configured to have a blood control valve cavity, a catheter assembly including: A safety clip at least partially disposed within the blood control valve cavity, and a catheter insertion device including a needle having an elongated body and a sharp distal tip, A safety catheter assembly comprising: The catheter insertion device is movable relative to the catheter assembly between a ready position and a safety position, In the ready position, a portion of the elongated body of the needle, together with the sharp distal tip of the needle extending from the distal end of the catheter tube, is disposed within the catheter tube, and at least a portion of the safety clip is disposed within the blood control valve cavity in an expanded configuration, In the safety position, the safety clip is in a folded configuration that at least partially surrounds the sharp distal tip of the needle. Safety catheter assembly. 〔Aspect 17〕 The safety clip includes a first arm and a second arm biased toward the longitudinal axis of the needle in the ready position, and the first arm includes a pair of needle guide surfaces extending beyond the longitudinal axis of the needle when the safety clip captures the sharp distal tip of the needle, the safety catheter assembly according to aspect 16. 〔Aspect 18〕 The first arm includes a first needle guide surface, the second arm includes a second guide surface, and when the safety clip is in the folded configuration, the first and second needle guide surfaces extend beyond the longitudinal axis of the needle, the safety catheter assembly according to aspect 17. [Aspect 19] The blood control valve includes a membrane that divides a blood control valve cavity into a distal portion and a proximal portion having an open end, and the safety clip has a distal portion slidably disposed in the proximal portion through the open end. The distal portion of the safety clip is configured such that when the needle extends through the safety clip, it applies at least a compressive force to the wall of the blood control valve to prevent relative movement of the safety clip and the blood control valve, and when the distal tip of the needle is captured by the distal portion, it is folded so that the compressive force on the wall of the blood control valve is removed and the distal tip of the safety clip can be removed from the proximal portion, the safety catheter assembly according to aspect 16. [Aspect 20] The catheter assembly further includes an actuator that extends proximally adjacent to the catheter hub cavity, the actuator having a free end that is adapted to open the membrane when the blood control valve is moved to bias a membrane provided within the blood control valve against the free end, the safety catheter assembly according to aspect 16.

Claims

**Claim 1** An IV therapy device, the IV therapy device comprising: a catheter hub defining an inner wall that defines a catheter hub cavity having a proximal opening and extending along a longitudinal axis; a blood control valve having a cylindrical body disposed within the catheter hub cavity, the cylindrical body having a distal end, the cylindrical wall defining a blood control valve cavity, the blood control valve cavity including a proximal portion having a constant transverse dimension and an open end extending between a resealable membrane extending orthogonally to the longitudinal axis within the blood control valve cavity and the proximal opening of the catheter hub, the membrane dividing the proximal portion from the distal portion of the blood control valve cavity; a safety clip having an arm at least partially disposed within the proximal portion of the blood control valve cavity having the constant transverse dimension, the safety clip being adapted to be fixed to the blood control valve by frictional interference contact with the wall defining the proximal portion of the blood control valve; a needle extending along a longitudinal axis having a sharp distal tip, the needle being movable relative to the catheter hub between a ready position and a safety position; In the ready position, the needle passes through the safety clip, biases the arm of the safety clip, applies a compressive force to the wall defining the proximal portion of the blood control valve, generates frictional interference contact between the safety clip and the blood control valve, and prevents movement of the safety clip relative to the blood control valve; In the safety position, the arm of the safety clip is not in frictional interference contact with the wall of the blood control valve, and the sharp distal tip of the needle is captured by the safety clip; An IV therapy device. **Claim 2** The IV therapy device according to claim 1, further comprising an actuator extending proximally adjacent to the catheter hub cavity distal of the membrane, the actuator having a free end adapted to open the membrane when the membrane is biased against the free end. **Claim 3** The distal portion of the blood control valve is an actuator cavity configured to receive the actuator, the membrane is disposed proximal to the actuator, and the blood control valve is movable relative to the free end of the actuator between a first position where the membrane is closed and a second position where the membrane is open. The IV therapy device according to claim 2.

4. The IV therapy device according to claim 3, wherein the membrane includes a slit having a shape and size that closely conforms to the outer diameter of the needle.

5. The IV therapy device according to claim 1, further comprising a proximal cup operably coupled to the blood control valve, the proximal cup having a proximal cup cavity defined between an open distal end and a proximal end, the open distal end of the proximal cup being adapted to be coupled to the proximal end of the blood control valve, the proximal cup cavity and the blood control valve cavity forming a combined cavity configured to receive the safety clip in the ready position.

6. The IV therapy device according to claim 5, wherein the proximal cup includes a stem extension having an opening configured to conform to the outer diameter of the needle to suppress fluid leakage from the cavity of the proximal cup.

7. The IV therapy device according to claim 1, wherein the membrane is configured to allow the needle to pass therethrough, and a wiper assembly disposed distal to the membrane is configured to suppress the passage of body fluid.

8. The IV therapy device according to claim 1, wherein the arms of the safety clip include a first arm and a second arm biased away from the longitudinal axis of the needle in the ready position, and the first arm includes a pair of needle guide surfaces extending toward the longitudinal axis of the needle when the distal tip of the needle is inside the safety clip.

9. The IV therapy device according to claim 8, wherein the first arm includes a first needle guide surface and the second arm includes a second guide surface, and when the safety clip is in a folded configuration, the first and second needle guide surfaces extend beyond the longitudinal axis of the needle.

10. The safety clip has a distal portion slidably disposed into the cavity of the proximal portion through the open end, The distal portion of the safety clip is configured to apply a compressive force to the wall of the blood control valve to prevent relative movement between the safety clip and the blood control valve when the needle extends through the safety clip, and the distal portion of the safety clip is disposed away from the wall of the blood control valve and toward the longitudinal axis such that the distal portion of the safety clip can be removed from the proximal portion when the distal tip of the needle is inside the safety clip. The IV therapy device according to claim 1.

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