Venous device assembly and vascular access device

Abstract

A venous device assembly includes a catheter adapter and a needle guard positioned within a bore of the catheter adapter. The needle guard can include a needle formed through a bore of the needle guard. The bore of the needle guard can include a first inner diameter along a first bore portion and a second inner diameter along a second bore portion, the second inner diameter being smaller than the first bore portion. A clip can be coupled to an outer surface of the needle guard. The clip can include a first arm that can include a first end guard and a second arm that can include a second end guard. The clip can be slid distally along the outer surface of the needle guard to move from an open configuration to a closed configuration to inhibit distal movement of the needle within the needle guard. A vascular access device is also disclosed. The venous device assembly prevents damage to the needle and injury to the patient's body during withdrawal of the needle from within the catheter adapter of the venous device assembly.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to an intravenous (IV) set assembly and a vascular access device (VAD). BACKGROUND

[0002] Intravenous (IV) set assemblies are one of a variety of types of vascular access devices (VADs). An IV catheter construction can include an over-the-needle IV catheter. As the name implies, an over-the-needle IV catheter can be mounted over an introducer needle having a sharp distal tip. The needle can be a hypodermic needle coupled to a needle assembly to help guide the needle and facilitate its cooperation with the catheter. At least an inner surface of a distal portion of the catheter can engage an outer surface of the needle to prevent the catheter from peeling back, thereby facilitating insertion of the catheter into a blood vessel. The catheter and needle can be assembled such that the distal tip of the needle extends beyond the distal tip of the catheter. Further, the catheter and needle can be assembled such that, during insertion, the bevel of the needle faces upward, away from the patient's skin. The catheter and needle can be inserted through the skin into the blood vessel at a shallow angle.

[0003] To verify proper placement of the needle and / or catheter in the blood vessel, the user can confirm the presence of blood "flashback" into a flashback chamber associated with the needle assembly. Flashback typically results in the appearance of an amount of blood, visible within the needle assembly or between the needle and catheter. In response to confirming that the distal tip of the catheter is properly placed into the blood vessel, the user can apply pressure to the blood vessel by pressing downward on the skin over the blood vessel distal of the needle and catheter. The finger pressure can temporarily occlude the blood vessel, thereby further reducing the flow of blood through the needle and catheter.

[0004] The clinician or other health care provider (HCP) can then withdraw the needle from the catheter and, in some cases, separate the needle assembly from the catheter portion of the catheter assembly. Separation of the needle assembly from the catheter portion of the catheter assembly presents a number of potential hazards to the user and others in the area. There is a risk of accidental needle sticks if the distal tip is not properly secured. Additionally, because the needle has been in contact with blood in the patient's vasculature, blood can be present on the exterior of the needle as well as inside the interior lumen of the needle. When the needle is withdrawn from the catheter, there is a risk that blood will drip from the distal tip or come into contact with other surfaces, thereby exposing people and equipment to blood.

[0005] Additionally, withdrawal of the needle from the catheter assembly can impart energy to various portions of the needle assembly. For example, during introducer withdrawal, bending forces can be (unintentionally or intentionally) imparted to the needle. The bending forces acting on the needle can cause blood to splash or spray from the needle as the needle vibrates and shakes as it is disengaged from the catheter assembly and releases stored energy.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described herein. Rather, this background is provided to describe the environments in which the embodiments currently described can operate. Summary of the Invention

[0007] This disclosure generally relates to a venous (IV) device assembly that provides a fluid path through the venous device assembly while reducing the likelihood of any accidental needlesticking, blood diffusion outside the fluid path, and blood spurting during needle withdrawal from the venous device assembly. In some embodiments, the venous device assembly may include a catheter adapter that may include a distal end, a proximal end, and an adapter orifice formed therein axially. In some embodiments, a needle protector may be disposed within the orifice of the catheter adapter. In some embodiments, the needle protector may include a needle protector orifice formed through the needle protector for receiving a needle passing through it. In some embodiments, the needle protector orifice may include a first inner diameter along a first orifice portion of the needle protector orifice and a second inner diameter along a second orifice portion of the needle protector orifice, the second inner diameter being smaller than the first orifice portion. In some embodiments, the second inner diameter may be small enough to cause the needle to remain within the needle protector.

[0008] In some embodiments, the needle protector may include an outer surface to which a clamp is attached. In some embodiments, the clamp may include a clamp retaining feature that cooperates with a catheter adapter retaining feature of a catheter adapter to retain the needle protector in place within an adapter port. In some embodiments, the clamp may include a first arm and a second arm, the first arm including a first end guard and the second arm including a second end guard. In some embodiments, the clamp may slide distally along the outer surface of the needle protector. In some embodiments, in response to retraction of the needle protector from the adapter port, the clamp may move from an open configuration to a closed configuration, in which the needle is movable distally within the needle protector, and in the closed configuration, at least one of the first and second end guards is positioned to prevent distal movement of the needle within the needle protector.

[0009] In some embodiments, the intravenous device assembly may include a hole formed in a clamp through which the bar of the needle protector selectively passes as the needle protector and clamp pass through the catheter adapter. In some embodiments, the intravenous device assembly may include a stepped shoulder formed within the needle protector, wherein the stepped shoulder prevents a first end protector and a second end protector from contacting the needle. In some embodiments, the intravenous device assembly may include a diaphragm located between the distal end of the catheter adapter and the needle protector for needle puncture and exit from the distal end of the intravenous device assembly. In some embodiments, the IV device may include a ridge formed on the needle for abutting at a second inner diameter with the needle protector orifice and for dragging the needle protector to the proximal end of the intravenous device assembly, and for fitting the beveled end of the needle within the needle protector in response to retraction of the needle protector from the adapter orifice.

[0010] In some embodiments, the intravenous device assembly may include a proximal port formed through a distal end of the needle protector to allow a needle to pass through. In some embodiments, the intravenous device assembly may include a plurality of rails formed on the needle protector for mating with an inner surface of a catheter adapter to limit rotation of the needle protector within the adapter port in response to withdrawal of the needle protector from the adapter port. In some embodiments, the intravenous device assembly may include a stepped channel formed within the needle protector to allow a first arm and a second arm to deform into the needle protector. In some embodiments, the intravenous device assembly may include a central opening into which a first end protector and a second end protector are biased in response to withdrawal of the needle protector from the adapter port, thereby placing the clamp in a closed configuration.

[0011] In some embodiments, this disclosure further describes an intravenous device assembly including a catheter adapter having a distal end, a proximal end, and an adapter bore axially formed therein. In these and other embodiments, a needle protector may be located within the adapter bore of the catheter adapter. In some embodiments, the needle protector may include a needle protector bore formed through the needle protector for receiving a needle passing through it. In some embodiments, the needle protector bore may include a first inner diameter along a first bore portion of the needle protector bore and a second inner diameter along a second bore portion of the needle protector bore, the second inner diameter being smaller than the first bore portion. In some embodiments, the needle protector may include an outer surface. In these and other embodiments, the needle may include a catch shaped to abut against the second inner diameter. In some embodiments, a clamp may be coupled to the outer surface of the needle protector. In some embodiments, the clamp may include a clamp retaining feature that cooperates with a catheter adapter retaining feature of the catheter adapter to urge the needle protector into place within the adapter bore. In some embodiments, the clamp may include a first arm and a second arm, the first arm including a first end guard and the second arm including a second end guard.

[0012] In some embodiments, the second inner diameter may be small enough to cause the needle to remain within the needle protector when the retainer engages the second inner diameter. In some embodiments, in response to retraction of the needle protector from the adapter port, the clamp may slide distally along the outer surface to move from an open configuration to a closed configuration, in which the needle is movable distally within the needle protector, and in the closed configuration, at least one of a first end guard and a second end guard is positioned to prevent distal movement of the needle within the needle protector. In some embodiments, the intravenous device assembly may include a diaphragm located between the distal end of the catheter adapter and the needle protector for needle puncture and exit from the distal end of the intravenous device assembly. In some embodiments, the retainer may be a protrusion on the needle for abutting the needle protector port at the second inner diameter. In some embodiments, the retainer may be a detent on the needle for abutting the protrusion on the needle protector port at the second inner diameter. In some embodiments, the retainer may include both a protrusion and a detent that may cooperate to abut and abut a corresponding structure within the needle protector port at the second inner diameter.

[0013] In some embodiments, this disclosure also describes a vascular access device (VAD) comprising: a catheter adapter including a distal end, a proximal end, and an adapter port axially formed therein; and a needle protector located within the adapter port of the catheter adapter. In some embodiments, the needle protector may include a needle protector port formed through the needle protector for receiving a needle passing through it. In some embodiments, the needle protector port may include a first inner diameter along a first port portion of the needle protector port and a second inner diameter along a second port portion of the needle protector port, the second inner diameter being smaller than the first port portion.

[0014] In some embodiments, the vascular access device may further include a clamp coupled to the outer surface of the needle protector. In some embodiments, the clamp may include a first arm and a second arm, the first arm including a first end guard and the second arm including a second end guard. In these and other embodiments, the second inner diameter may be small enough to retain the needle within the needle protector. Additionally, in this embodiment, the clamp and needle protector may be slidable within an adapter port, and in response to retraction of the needle protector from the adapter port, the clamp may move from an open configuration to a closed configuration, in which the needle and needle protector are capable of distal movement within the needle protector. In some embodiments, in the closed configuration, at least one of the first end guard and the second end guard is located within a central opening formed in the needle protector and across the needle protector port to prevent distal movement of the needle within the needle protector. In some embodiments, the vascular access device may include a hole formed in the clamp through which the rod of the needle protector selectively passes as the needle protector and clamp pass through the catheter adapter.

[0015] In some embodiments, the vascular access device may include a diaphragm located between the distal end of the catheter adapter and the needle guard for needle puncture and exit from the distal end of the vascular access device. In some embodiments, the vascular access device may include a ridge formed on the needle for abutting against a needle guard orifice at a second inner diameter to retract the needle guard from the adapter orifice. In some embodiments, the vascular access device may include a stepped channel formed in the needle guard to allow a first arm and a second arm to deform into the body of the needle guard. A stepped shoulder is formed in the needle guard to prevent the clamp from contacting the needle. In some embodiments, the vascular access device may include a snap-fit ​​portion formed on the needle for engaging with a ridge on the needle guard orifice at a second inner diameter.

[0016] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and are not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the configurations and means shown in the drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0017] The exemplary embodiments will be described and illustrated with additional features and details using the accompanying drawings, wherein:

[0018] Figure 1 This is a perspective view of a vein (IV) device assembly according to an embodiment of the present disclosure.

[0019] Figure 2 This is a side cross-sectional view of a vein device assembly 100 according to an embodiment of the present disclosure.

[0020] Figure 3A This is a perspective view of a needle protector according to an embodiment of the present disclosure.

[0021] Figure 3B This is a side view of a needle protector according to an embodiment of the present disclosure.

[0022] Figure 3C This is a side cross-sectional view of a needle protector according to an embodiment of the present disclosure.

[0023] Figure 3D According to embodiments of this disclosure Figure 3C A side cross-sectional view of the needle protector, in which the needle protector is rotated 90 degrees.

[0024] Figure 4A This is a perspective view of a fixture according to an embodiment of the present disclosure.

[0025] Figure 4B This is a side view of a fixture according to an embodiment of the present disclosure.

[0026] Figure 5 This is a perspective view of a needle according to an embodiment of the present disclosure.

[0027] Figure 6A This is a side cross-sectional view of a vein device assembly according to an embodiment of the present disclosure.

[0028] Figure 6B This is a side cross-sectional view of a vein device assembly according to an embodiment of the present disclosure.

[0029] Figure 6C This is a side cross-sectional view of a vein device assembly according to an embodiment of the present disclosure.

[0030] Figure 6D This is a side cross-sectional view of a vein device assembly according to an embodiment of the present disclosure.

[0031] Figure 7 This is a flowchart illustrating a method for manufacturing a vein device assembly according to an embodiment of the present disclosure. Detailed Implementation

[0032] As used herein, the term "proximal" refers to a location on the described element that is closest to the clinician using the device and furthest from the patient associated with using the device during use. The term "distal" refers to a location on the described element that is furthest from the clinician using the device and closest to the patient associated with using the device during use.

[0033] As used herein, the terms “top,” “upward,” or “upward” refer to the position of the needle on the intravenous therapy system radially away from the longitudinal axis of the intravenous therapy system and away from the patient’s skin during use. As used herein, the terms “bottom,” “downward,” or “downward” refer to the position of the needle on the intravenous therapy system radially away from the longitudinal axis of the device and towards the patient’s skin during use.

[0034] As used herein, the terms “in” or “inward” refer to the position of the needle relative to the intravenous therapy system, which faces inward during use. As used herein, the terms “outward” or “outward” refer to the position of the needle relative to the intravenous therapy system, which faces outward during use.

[0035] Although the embodiments described herein are used in conjunction with an intravenous device assembly for receiving blood samples or delivering medication into a patient, it should be understood that the use of the intravenous device assembly can also be applied to other medical devices.

[0036] Figure 1This is a perspective view of a venous (IV) device assembly 100 according to some embodiments of the present disclosure. In some embodiments, the venous device assembly 100 may include a distal end 126 and a proximal end 124. In some embodiments, at the distal end 126, the venous device assembly 100 may be mechanically and fluidly coupled to an IV catheter (not in...) Figure 1 (as shown in the image). Figure 1 In some embodiments, at the proximal end 124, the venous device assembly 100 may be mechanically and fluidly coupled to, for example, a blood-drawing device, such as a BD device manufactured by Becton, Dickinson and Company of Franklin Lake, New Jersey, USA. LUER-LOK TM Access devices. In some embodiments, these devices may form a fluid pathway for transferring blood from a patient or introducing infusion fluids such as saline solution, various medications, and / or total parenteral nutrition into a patient.

[0037] In some embodiments, the intravenous device assembly 100 may include a catheter adapter 118 that may be positioned between a proximal end 124 and a distal end 126 of the intravenous device assembly 100. In some embodiments, the catheter adapter 118 may include an adapter port formed along the long axis of the catheter adapter 118. In some embodiments, the adapter port may be shaped to accommodate a diaphragm 122 and a needle guard 102 therein. In some embodiments, the diaphragm 122 may be punctured by a needle 120 disposed within the intravenous device assembly 100. In some embodiments, the diaphragm 122 may be made of silicone or rubber, which allows the needle 120 to puncture the diaphragm and allows a fluid seal to be created when the needle 120 is pulled out of the diaphragm 122.

[0038] In some embodiments, the needle protector 102 may also be disposed within the adapter port. In some embodiments, the needle protector 102 may be made of plastic, metal, or other types of resilient material, and as described herein, the needle protector may slide within the adapter port in response to retraction of the needle protector from the adapter port. In some embodiments, the needle protector 102 may be made of a material that produces minimal friction between the outer surface of the needle protector 102 and the inner surface of the port formed through the catheter adapter 118, such that the needle protector 102 may be pulled out through the adapter port when force is applied by a clinician or other HCP.

[0039] In some embodiments, the needle protector 102 may include a needle protector port 116 through which the needle 120 may pass. In some embodiments, the needle 120 may be in a deployed state such that the needle 120 extends from the catheter adapter 118 and into the IV catheter. In some embodiments, the length of the needle 120 may allow it to extend beyond the catheter terminal of the IV catheter mechanically and fluidly coupled to the catheter adapter 118. In some embodiments, in this deployed state, the needle 120 may pass through the needle protector port 116 and the diaphragm 122 and through the length of the catheter adapter 118. In some embodiments, an intravenous device assembly 100 having the needle 120 in this deployed state may be provided to a clinician or other HCP.

[0040] In some embodiments, as described herein, the needle protector 102 may include a clamp 104. The clamp 104 may be made of a resilient material such as metal. In this disclosure and the appended claims, the term "resilient" may be defined as the ability of a material to return to a neutral state after being subjected to a tensile force.

[0041] In some embodiments, the clamp 104 may include a first arm 106 and a second arm 108. In some embodiments, the first arm 106 and the second arm 108 may be disposed along the outer surface of the needle protector 102. In some embodiments, the distal ends of the first arm 106 and the second arm 108 may be elastically biased toward the longitudinal axis of the needle protector 102, such that a force is applied to the outer surface of the needle protector 102.

[0042] In some embodiments, to accommodate the mechanical connection between the clamp 104 and the needle protector 102, the needle protector 102 may include a stepped channel formed therein for mating with the clamp 104 and preventing axial rotation of the clamp 104 relative to the longitudinal axis of the needle protector 102. In some embodiments, the stepped channel may be stepped such that the proximal end 124 of the needle protector 102 is wider at the stepped channel than at a midpoint along the length of the needle protector 102. In some embodiments, the stepped channel may terminate at a location along the longitudinal axis of the needle protector 102, midway between the distal end and the proximal end 124 of the needle protector 102. In some embodiments, the stepped channel may terminate at a stepped shoulder on which a first end protector of the first arm 106 and a second end protector of the second arm 108 rest when the needle 120 is in its deployed state.

[0043] In some embodiments, clamp 104 may include clamp holding feature 112. In some embodiments, clamp holding feature 112 may be a bent portion of a first arm 106, the bent portion being close to a first end guard formed at the distal end of the first arm 106. In some embodiments, clamp holding feature 112 may abut with catheter adapter 118 such that clamp 104 may be held in place relative to catheter adapter 118 when needle 120 is in its deployed state. In some embodiments, clamp holding feature 112 may abut with a window 114 formed through the wall of catheter adapter 118. In some embodiments, clamp holding feature 112 may hold clamp 104 at a specific position along adapter hole until needle 120 moves proximally through catheter adapter 118. In some embodiments, clamp may be pulled or slid within catheter adapter 118 as needle 120 moves proximally through catheter adapter 118.

[0044] In some embodiments, a portion of the clamp 104 at the location where the proximal end of the first arm 106 meets the proximal end of the second arm 108 may include a hole 110 formed therethrough. In some embodiments, the hole 110 may be used to allow a rod of the needle protector 102 to pass through it. In some embodiments, the rod abutting the hole 110 may prevent the clamp 104 from moving orthogonally away from the longitudinal axis formed by the needle protector hole 116. Additionally, in some embodiments, the needle 120 may pass through the rod and the hole 110, such that the needle 120 can be pulled proximally through the needle protector 102, as described herein.

[0045] As described, in some embodiments, the intravenous device assembly 100 may include a needle 120 passing through a needle guard orifice 116 formed through a needle guard 102. In some embodiments, the needle guard orifice 116 may include a first inner diameter along a first hole portion of the needle guard orifice 116 and a second inner diameter along a second hole portion of the needle guard orifice 116, the second hole portion being smaller than the first hole portion. In some embodiments, the second hole portion may be located proximal to the first hole portion along the longitudinal axis of the needle guard 102.

[0046] In some embodiments, the needle 120 may further include a retaining member that engages with a second aperture portion as the needle 120 slides proximally through the needle guard 102. In some embodiments, the retaining member may be a protrusion formed on the needle. In these and other embodiments, the diameter of the protrusion on the needle may be larger than the second inner diameter, such that the protrusion causes the needle 120 to remain within the needle guard 102 as the needle is retracted proximally through the needle guard aperture 116. This can be achieved by abutting the protrusion against the smaller diameter of the needle guard aperture 116 having the second inner diameter. This allows the needle guard 102 to be pulled toward the proximal end 124 of the catheter adapter 118. In some embodiments, the retaining member of the needle 120 may be in the form of a snap-fit ​​portion formed on the needle 120. In these and other embodiments, the needle guard hole 116 may include a protrusion formed on the inner surface of the second hole portion for engaging with the latching portion, such that when the needle 120 is retracted proximally through the needle guard hole 116, the latching portion and the protrusion cause the needle to remain within the needle guard 102. This can cause the needle guard 102 to be pulled toward the proximal end 124 of the catheter adapter 118.

[0047] In some embodiments, the needle protector 102 may further include a central opening into which a first end protector of the first arm 106 and a second end protector of the second arm 108 are biased in response to retraction of the needle protector through the adapter port from the IV catheter and diaphragm 122. In some embodiments, the central opening may be an opening formed through the needle protector 102 such that the central opening extends through the needle protector 102 perpendicular to its longitudinal axis. In some embodiments, the central opening may be positioned along the longitudinal axis of the needle protector 102 such that retraction of the needle 120 into the needle protector 102 causes the needle 120 to move proximally beyond the central opening.

[0048] In some embodiments, the intravenous device assembly 100 may include a component port 128. In some embodiments, the component port 128 may include a hole formed therethrough to form a fluid passage to a catheter mechanically and fluidly coupled to a catheter adapter 118. In some embodiments, the component port 128 may be used to introduce infusion fluids such as saline solution, various medications, and / or total parenteral nutrition into a patient.

[0049] The operation of the intravenous device assembly 100 according to some embodiments will now be described. As described herein, in some embodiments, a clinician or other HCP may receive the intravenous device assembly 100 with the needle 120 deployed and extending through the diaphragm 122 from the catheter adapter 118 and through the terminal of an IV catheter (not shown) mechanically and fluidly coupled to the catheter adapter 118. In some embodiments, the IV catheter may be inserted into the patient by means of the beveled edge of the needle 120. In some embodiments, in response to IV catheter placement, the needle may be withdrawn proximally from the catheter and through the diaphragm 122 and the needle guard 102. In some embodiments, in addition to extending the needle 120 from the catheter adapter 118 and through the terminal of the IV catheter, a clamp holding feature 112 may be secured within a window 114 to hold the clamp 104 in a position within the catheter adapter 118, which may be referred to herein as an open configuration. In some embodiments, the open configuration refers to the configuration of the clamp 104 such that the first end guard of the first arm 106 and the second end guard of the second arm 108 of the clamp 104 are arranged at the greatest distance.

[0050] In some embodiments, after the needle 120 has been inserted into the patient, the needle 120 can be removed from the catheter. To do this, a clinician can pull the needle 120 toward the proximal end 124 of the catheter adapter 118. In some embodiments, as described herein, the needle guard 102 can be dragged toward the proximal end 124 of the catheter adapter 118 in response to engagement of a retainer formed on the needle 120 with the second inner diameter of the needle guard hole 116.

[0051] In some embodiments, movement of the needle protector 102 toward the proximal end 124 of the catheter adapter 118 may initially cause the rod of the needle protector 102 to pass through the hole 110, while the clamping retaining feature 112 of the clamp 104 retains it within the catheter adapter 118. In some embodiments, in response to a retainer formed on the needle 120 pulling the needle protector 102 further through the catheter adapter 118, the first end guard of the first arm 106 and the second end guard of the second arm 108 may be lifted from the stepped shoulder and may follow along the mandrel formed between the stepped shoulder and the central opening. In some embodiments, because the mandrel terminates at the central opening, as the needle protector 102 is pulled further toward the proximal end 124 of the catheter adapter 118, the first end guard of the first arm 106 and the second end guard of the second arm 108 may extend into the central opening such that the first end guard and the second end guard intersect the axis of the needle protector hole 116, thereby again preventing the needle 120 from passing through the needle protector hole 116. In some embodiments, the length of the needle 120 from its terminal to the retainer formed thereon is shorter than the length of either the first arm 106 or the second arm 108.

[0052] Therefore, in some embodiments, operation of the intravenous device assembly 100 as described herein can secure the tip of the needle 120 within the needle protector 102. In some embodiments, the needle protector 102 can be completely removed from the catheter adapter 118, and because the first end protector of the first arm 106 and the second end protector of the second arm 108 prevent the needle 118 from exiting through the distal end of the needle 120 from the needle protector 102, the tip of the needle 120 will remain within the needle protector 102 and be prevented from being exposed through the needle protector hole 116. Additionally, in some embodiments, the first end protector of the first arm 106 and the second end protector of the second arm 108 can be prevented from contacting the outer surface of the needle 120. Thus, the core, stepped shoulder, and remainder of the needle protector 102, and the function of these elements, prevent the needle 120 from bending or breaking due to the pressure exerted on the needle 120 by the first arm 106 and the second arm 108.

[0053] Figure 2 This is a side cross-sectional view of a vein device assembly 100 according to some embodiments of the present disclosure. Figure 2 A clamp 104 in an open configuration according to some embodiments is shown. That is, the first arm 106 and the second arm 108 of the clamp 104 expand with the clamp holding feature 112 held within the window 114 of the conduit adapter 118. Figure 2 In some embodiments, the needle 120 is pulled toward the proximal end 124 of the catheter adapter 118. The needle 120 is pulled toward the proximal end 124 of the catheter adapter 118 such that a protrusion 130 on the needle 120 contacts the second inner diameter of the needle guard hole 116. In some embodiments, in this direction, a first end guard 132 of the first arm 106 may rest on a stepped shoulder, while a second end guard 134 rests against the core surrounding the needle 120.

[0054] In some embodiments, Figure 2During the illustrated operation phase, the needle 120 can be pulled back further to pull the needle guard 102 away from the diaphragm 122. In some embodiments, in response to this, the clamping retaining feature 112 of the clamp 104 holds the clamp 104 in place while the needle guard 102 moves toward the proximal end 124 of the catheter adapter 118. In some embodiments, a rod formed at the proximal end 124 of the catheter adapter 118 can pass through the hole 110, thereby allowing the needle guard 102 to continue through the catheter adapter 118. In some embodiments, in response to the needle 120 being pulled further, the second end guard 134 can fall into the central opening formed above the mandrel due to the elastic bias of the second arm 108 of the clamp 104 toward the longitudinal axis of the catheter adapter 118. In some embodiments, in response to the needle 120 being further pulled toward the proximal end 124 of the needle protector 102, the first end guard 132 of the first arm 106 may fall into the central opening formed above the mandrel due to the resilient bias of the first arm 106 of the clamp 104. Figure 2 As shown, the second end guard 134 can fall into the central opening before the first end guard 132 falls into the central opening. This intersection of the second end guard 134 and the first end guard 132 allows the clamp 104 to be positioned in a second, closed configuration. In some embodiments, in this closed configuration, the second end guard 134 and the first end guard 132 are positioned to prevent the needle 120 from moving toward the distal end of the catheter adapter 118 and the needle protector 102.

[0055] Figure 3A This is a perspective view of a needle protector 102 according to some embodiments of the present disclosure. Figure 3B This is a side view of a needle protector 102 according to some embodiments of the present disclosure. Figure 3A and Figure 3B It shows the absence of binding Figure 1 and Figure 2 The clamp 104 has a needle protector 102. In these figures, according to some embodiments, a stepped shoulder 142 is shown formed between the proximal end of the needle protector 102 and the distal end 136 of the needle protector 102, and a rod 144 is formed at the proximal end of the needle protector 102.

[0056] Figure 3A and Figure 3B Further illustrated, according to some embodiments, a core post 140 is formed between a shoulder 142 and a central opening 138. As described herein, in some embodiments, the shoulder 142 and the core post 140 can cooperate to prevent the first end guard 132 of the first arm 106 and the second end guard 134 of the second arm 108 from contacting the needle disposed within the needle guard hole 116. Figure 3A and Figure 3B(Not shown in the image) Contact. Furthermore, in some embodiments, the core 140, shoulder 142, and the remainder of the cut through the needle guard 102 form a stepped channel into which the first arm 106 and the second arm 108 can deform when the needle guard 102 is pulled toward the proximal end 124 of the catheter adapter 118.

[0057] Figure 3A and Figure 3B Further illustrated, according to some embodiments, the needle protector 102 includes a plurality of guide rails 146 formed on the outer surface of the needle protector 102. In some embodiments, the guide rails 146 may engage with a plurality of channels formed on the inner surface of the catheter adapter 118. In some embodiments, by engaging the guide rails 146 with the channels, movement of the needle protector 102 along a single axis can be maintained, and rotation of the needle protector 102 about the longitudinal axis of the needle protector 102 and the catheter adapter 118 can be prevented.

[0058] Figure 3C This is a side cross-sectional view of a needle protector 102 according to some embodiments of the present disclosure. Figure 3D According to some embodiments of this disclosure Figure 3C The two cross-sectional views show a side view of the needle protector 102, rotated 90 degrees. The two cross-sectional views also show a needle protector aperture 116 according to some embodiments, having a first inner diameter 148 along a first aperture portion and a second inner diameter 150 along a second aperture portion. In some embodiments, the diameter of the second inner diameter 150 may be slightly larger than the minimum diameter of a needle (not shown) disposed within the needle protector aperture 116. Therefore, when the needle is pulled toward the proximal end 124 of the catheter adapter 118 by bringing the ridge 130 abutting against the interface between the second inner diameter 150 and the first inner diameter 148, the ridge 130 formed on the needle can prevent further advance of the needle. Figure 3C and Figure 3D In the illustrated and other embodiments, when the rod 144 extends from the distal end of the needle protector 102, the length of the second hole portion having a second inner diameter 150 may be equal to the length of the rod 144.

[0059] Figure 4A This is a perspective view of a fixture 104 according to some embodiments of the present disclosure. Figure 4B This is a side view of a clamp 104 according to some embodiments of the present disclosure. Figure 4A and Figure 4BEach view shown illustrates a clamp 104 in a closed configuration as described herein. In some embodiments, the first arm 106 and the second arm 108 can be resiliently biased toward each other such that separation of the first arm 106 from the second arm 108 generates a force that resiliently pulls the first arm 106 and the second arm 108 together. In some embodiments, when as Figure 1 and Figure 2 When the clamp 104 is positioned adjacent to the needle protector 102, it can overcome the elastic bias between the first arm 106 and the second arm 108. In some embodiments, when the clamp 104 is pulled to the proximal end 124 of the catheter adapter 118 as described herein, the first arm 106 and the second arm 108 can be brought together again, and the first end protector 132 and the second end protector 134 converge within the central opening 138.

[0060] Figure 4A and Figure 4B A hole 110 formed through the proximal end of the clamp 104 according to some embodiments is also shown. Again, in some embodiments, the hole 110 may be formed such that the rod 144 of the needle protector 102 can pass through it during use of the intravenous device assembly 100.

[0061] although Figure 4A and Figure 4B A clamp holding feature 112 is shown formed on a single arm of the first arm 106 and the second arm 108, but this disclosure contemplates that the clamp holding feature 112 may also be formed on the second arm 108. Again, in some embodiments, the clamp holding feature 112 may be arranged within a window 114 formed through the catheter adapter 118. In these and other embodiments, a clinician's visual inspection of the window 114 may indicate to the clinician whether and when the catheter adapter 118 is in the closed configuration described herein or whether the clinician needs to further pull the needle 120 to further pull the needle guard 102 from the adapter port and disengage the clamp holding feature 112 from within the window 114. Thus, the clinician can know whether the needle 120 is secured within the needle guard 102 so that the catheter adapter 118 can be safely disengaged from the IV catheter mechanically coupled to the intravenous device assembly 100 at the distal end 126 of the intravenous device assembly 100.

[0062] Figure 5 This is a perspective view of a needle 120 according to some embodiments of the present disclosure. Figure 5 A ridge 154 formed along the needle 120 is shown according to some embodiments. As described herein, in some embodiments, the ridge 154 may mate with a second inner diameter 150 of the needle guard orifice 116 to allow selective pulling of the needle guard 102 from an adapter orifice in the catheter adapter 118.

[0063] In some embodiments, the needle 120 may also include a beveled end 152. As described herein, in some embodiments, the beveled end 152 may be used to insert the needle 120 into a patient. In some embodiments, the beveled end 152 may be dangerous if it is not covered by the needle protector 102 after the needle 120 has been used for this purpose.

[0064] In some embodiments, the needle 120 may further include a locking portion 156. In some embodiments, the locking portion 156 may be a notch formed in the needle 120 that engages with a protrusion formed in a second hole portion of the needle guard hole 116. In these and other embodiments, as described herein, the protrusion 154 and the locking portion 156 may be used to prevent movement of the needle 120 relative to the needle guard 102 after the beveled end 152 of the needle 120 has entered the core rod 140.

[0065] Figure 6A This is a cross-sectional side view of a vein device assembly according to some embodiments of the present disclosure. Figure 6B This is a cross-sectional side view of a vein device assembly according to some embodiments of the present disclosure. Figure 6C This is a cross-sectional side view of a vein device assembly according to some embodiments of the present disclosure. Figure 6D This is a cross-sectional side view of a vein device assembly according to some embodiments of the present disclosure. Figures 6A to 6D The diagram illustrates the progression of the intravenous device assembly 100 through different stages as the needle 120 and needle guard 102 advance to the proximal end 124 of the catheter adapter 118, according to some embodiments. As described herein, in some embodiments, operation of the intravenous device assembly 100 secures the beveled end 152 of the needle 120 within the needle guard 102. To initiate this process, in some embodiments, a clinician or other HCP may pull the needle 120 toward the proximal end 124 of the catheter adapter 118. Figure 6A It is shown that, according to some embodiments, the beveled end 152 of the needle 120 has been pulled into the needle protector 102 and just past the distal end of the needle protector 102. In some embodiments, at this stage of operation of the intravenous device assembly 100, the bulge 154 has not yet abutted against the second inner diameter 150 of the needle protector orifice 116, and therefore the needle protector 102 has not moved proximally relative to the catheter adapter 118.

[0066] Figure 6B It is shown that, according to some embodiments, the protrusion 154 on the needle 120 has mated with the second inner diameter 150. In some embodiments, in Figure 6BIn this configuration, the beveled end 152 of the needle 120 has passed below the end of the core rod 140. According to some embodiments, the first end guard 132 of the first arm 106 has not yet moved relative to the stepped shoulder 142, and the second end guard 134 of the second arm 108 has not yet moved from its original position against the core rod 140. Furthermore, according to some embodiments, the clamping feature 112 is held within the window 114 formed through the conduit adapter 118.

[0067] Figure 6C The illustration shows, according to some embodiments, that as the needle 120 has been further pulled by the clinician, the needle protector 102 has moved proximally relative to the clamp 104, which holds the feature 112 in place by means of a clamp located within the window 114. Additionally, the rod 144 has advanced through the hole 110 to allow movement of the needle protector 102 relative to the clamp 104, which, for this figure, remains stationary.

[0068] Figure 6D A venous device assembly 100 according to some embodiments is shown, with clamp 104 in a closed configuration. According to some embodiments, in this figure, the needle 120 has been fully pulled so that the needle protector 102 is mechanically engaged with the clamp 104, such that movement of the needle protector 102 also pulls the clamp 104 together with it toward the proximal end 124 of the catheter adapter 118. According to some embodiments, in the closed configuration, the clamp holding feature 112 has disengaged from within the window 114, and the first arm 106 and the second arm 108 have been allowed into the central opening 138. Again, the resilient biasing of the first arm 106 and the second arm 108 causes the first end protector 132 of the first arm 106 and the second end protector 134 of the second arm 108 to drag against the surface of the stepped channel without contacting the outer surface of the needle 120. In this way, the needle 120 can be secured within the needle protector 102, preventing distal movement of the needle 120.

[0069] Figure 7 This is a flowchart illustrating a method 700 for manufacturing a venous device assembly according to some embodiments of the present disclosure. In some embodiments, method 700 may include, at block 705, axially forming a hole within a catheter adapter. In some embodiments, the hole formation may be accomplished using any type of additive or subtractive manufacturing process.

[0070] Method 700 may include, at block 710, disposing a needle protector within a hole in a catheter adapter. In some embodiments, the needle protector may include a needle protector hole formed through the needle protector for receiving a needle passing through it. In some embodiments, the needle protector hole may include: a first inner diameter passing through the needle protector along a first distance and a second inner diameter passing through the needle protector along a second distance; a stepped shoulder formed within the needle protector; and a rod formed at a proximal end of the needle protector.

[0071] Method 700 may further include, at frame 715, disposing a metal clamp between the inner surface of the catheter adapter and the needle protector. In some embodiments, the metal clamp may include a first arm and a second arm, the first arm including a first end guard and the second arm including a second end guard. Method 700 may further include, at frame 720, forming a ridge on the needle for engaging with the needle protector orifice at a second inner diameter and dragging the needle protector to the proximal end of the intravenous device assembly, and fitting the beveled end of the needle within the needle protector.

[0072] The intravenous device assembly described herein prevents the clamp from contacting the needle. This prevents damage to the needle and harm to the patient during needle withdrawal from the catheter adapter of the intravenous device assembly. In some embodiments, because the clamp is made of metal and the needle protector is made of plastic, friction between these two forces is reduced, allowing a smaller force to be applied to the needle when withdrawing the needle protector from the catheter adapter.

[0073] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the inventors' concepts for advancement in the art, and should be interpreted as not being limited to such specific examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the disclosed embodiments.

Claims

1. A venous (IV) device assembly, comprising: A catheter adapter, the catheter adapter including a distal end, a proximal end, and an adapter hole axially formed in the catheter adapter; Needle; Needle protector, located within the adapter port of the catheter adapter, the needle protector comprising: A needle guard hole formed through the needle guard for receiving the needle passing through it, the needle guard hole comprising: Along the first inner diameter of the first hole portion of the needle guard hole; and The second inner diameter along the second hole portion of the needle protector hole is smaller than the first inner diameter along the first hole portion; and A stepped shoulder, disposed distal to the second inner diameter, wherein the stepped shoulder includes a surface substantially perpendicular to the longitudinal axis of the venous device assembly; and outer surface; and A clamp connected to the outer surface, the clamp comprising: A clamp holding feature that cooperates with a catheter adapter holding feature of the catheter adapter to facilitate the needle protector being held in place within the adapter hole; A first arm, the first arm including a first end guard; and The second arm includes a second end guard; in: The second inner diameter is small enough to cause the needle to remain within the needle guard; and The clamp is slidable distally along the outer surface, wherein, in response to the needle's proximal retraction, the clamp slides from an open configuration to a closed configuration, in which the needle is slidable distally within the needle guard, wherein, in the closed configuration, at least one of the first end guard and the second end guard is positioned to prevent distal movement of the needle within the needle guard. The needle protector includes an elongated slot, wherein, when the clamp is in the open configuration, the first arm extends through the elongated slot, wherein, when the clamp is in the open configuration, the proximal end of the clamp is close to and spaced apart from the proximal end of the needle protector, wherein, in response to the needle being retracted proximally and the clamp moving from the open configuration to the closed configuration, the proximal end of the needle protector contacts the proximal end of the clamp, and the elongated slot moves proximally relative to the clamp such that the proximal end of the elongated slot is substantially aligned with the proximal end of the clamp. The stepped shoulder prevents the first end guard and the second end guard from contacting the needle. In the open configuration, the first end guard is configured to contact the surface of the stepped shoulder when the second end guard contacts the needle guard located distal to the surface of the stepped shoulder.

2. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a hole formed in the clamp, through which the rod of the needle protector selectively passes as the needle protector and the clamp pass through the catheter adapter.

3. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a diaphragm disposed between the distal end of the catheter adapter and the needle protector for the needle to puncture and exit the distal end of the intravenous device assembly.

4. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a ridge formed on the needle for engaging with the needle guard port at the second inner diameter and for dragging the needle guard to the proximal end of the intravenous device assembly, and for fitting the beveled end of the needle into the needle guard in response to the retraction of the needle guard from the adapter port.

5. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a plurality of guide rails formed on the needle protector for mating with the inner surface of the catheter adapter to restrict rotation of the needle protector within the adapter port in response to retraction of the needle protector from the adapter port.

6. The intravenous device assembly according to claim 1, characterized in that, The intravenous device assembly also includes a stepped channel formed within the needle protector to allow the first arm and the second arm to deform into the needle protector.

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