Passage system

Abstract

The present application relates to a access system comprising a needle hub comprising a distal end, a proximal end, an internal lumen extending through the distal end and the proximal end; a needle guard comprising a housing disposed within the internal lumen of the needle hub, and a needle comprising a sharp distal tip, the needle extending through the housing and biasing a first arm and a second arm of the housing outward toward the needle hub to facilitate retention of the housing within the needle hub, the access system configured such that when the sharp distal tip of the needle is withdrawn in a proximal direction beyond a second end of the first arm and a second end of the second arm, a duckbill valve of the access system closes and the first arm and the second arm move inward to facilitate removal of the housing from the needle hub. The technical solution of the present application can shield the sharp tip of the needle to prevent blood splatter and prevent exposure of related personnel to blood and blood-borne pathogens.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a pathway system. Background Technology

[0002] Intravenous catheters are traditionally used to infuse fluids (such as saline solutions), various medications, and / or total parenteral nutrition into patients. These catheters can also be used to draw blood from patients and / or monitor various parameters of a patient's vascular system.

[0003] To introduce an intravenous catheter into a patient, an intravenous catheter (“IV”) can be mounted on a hollow guide needle, which may include a sharp distal tip. The inner surface of the catheter can tightly engage the outer surface of the guide needle to prevent catheter dislodgement and facilitate catheter insertion into a blood vessel. The tip of the guide needle may extend beyond the distal end of the catheter to allow the catheter to be inserted into a blood vessel at a shallow angle through the patient's skin.

[0004] To verify proper placement of the needle and catheter in a blood vessel, clinicians can confirm the presence of "backflow" blood in the reflux chamber associated with the catheter and needle assembly. Once proper placement is confirmed, the clinician can apply pressure to the blood vessel to block it, thereby reducing further blood flow through the guiding needle and catheter. The clinician can then withdraw the needle from the catheter to allow for further insertion into the blood vessel. This process of physically manipulating and disassembling the needle and catheter after they have been properly positioned carries a significant risk of accidental needlestick injury and exposure of individuals to blood and blood-borne pathogens.

[0005] Furthermore, it has been observed that withdrawing the needle from the catheter assembly can apply energy to the needle portion. For example, during withdrawal of the guide needle, bending forces can be applied to the needle (unintentionally or intentionally). When the needle is dislodged from the catheter assembly and vibrates and shakes to release stored energy, the bending forces on the needle may cause blood to splash or spray from the needle. Therefore, there is a need in the art for devices, systems, and methods for catheter assemblies that provide increased needle safety.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the practices described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to a needle protection device, and related apparatus, systems, and methods. According to some embodiments, the needle protection device facilitates securing the device within the needle holder until the needle is withdrawn and the distal tip of the needle's sharp end is shielded or sealed for safe disposal. This reduces the likelihood of injury due to contact with the sharp edge or exposure to residual blood within the needle. Some embodiments of this disclosure also reduce the risk of premature disarming or removal of the needle protection device.

[0008] In some embodiments, the access system may include a needle hub, a needle protection device, and a needle. In some embodiments, the access system may include a catheter system, and the needle hub may include a catheter hub. In some embodiments, the access system may include any suitable vascular access system or any suitable cerebrospinal fluid access system. In some embodiments, the needle hub may include a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends. In some embodiments, the needle protection device may include a housing. In some embodiments, the housing may be disposed within the inner lumen of the needle hub, and in some embodiments, it may be integrally formed as a single unit.

[0009] In some embodiments, the housing may include a tubular portion. In some embodiments, the housing may include a first arm, which may include a first end coupled to the tubular portion, a second end disposed within the tubular portion, and a curved portion disposed between the first end and the second end. In some embodiments, the housing may further include a second arm, which may include a first end coupled to the tubular portion, a second end disposed within the tubular portion, and a curved portion disposed between the first end and the second end of the second arm. In some embodiments, the first end of the first arm and the first end of the second arm may be generally planar and flush with the outer surface of the tubular portion in response to the needle being in a protected position. In some embodiments, the second end of the first arm and the second end of the second arm may form a duckbill valve.

[0010] In some embodiments, the needle may extend through the housing and the first and second arms may be biased outward toward the needle hub. In some embodiments, the needle may thus facilitate holding the housing within the needle hub. In some embodiments, the duckbill valve may close in response to retracting the sharp distal end of the needle beyond the second ends of the first and second arms in the proximal direction. In some embodiments, the first and second arms may move inward in response to retracting the sharp distal end of the needle beyond the second ends of the first and second arms in the proximal direction to facilitate removal of the housing from the needle hub.

[0011] In some embodiments, the tubular portion of the housing may include a distal end and a proximal end. In some embodiments, each of the first ends of the first arm and the first ends of the second arm may be formed by a slit within the tubular portion. In some embodiments, the slit may extend through the distal end of the tubular portion. In some embodiments, in response to the needle protection device being in a protected position, the tubular portion may be closed except where the slit is located.

[0012] In some embodiments, the needle may include a feature portion disposed proximal to the distal tip of the sharp point, and the housing may include a proximal opening. In some embodiments, a washer may be attached to the proximal end of the tubular portion to form the proximal opening. In some embodiments, the diameter of the proximal opening may be smaller than the diameter of the feature portion, thereby preventing the distal tip of the sharp point from retracting proximally through the proximal opening.

[0013] In some embodiments, the needle may further include a notch providing access to the lumen of the needle. In some embodiments, in response to the sharp distal end being retracted beyond the second end of the first arm and the second end of the second arm and the feature contact washer, the notch may be located within the tubular portion, proximal to the duckbill valve.

[0014] In some embodiments, the inner surface of the needle hub may form an inner cavity and may include one or more recesses. In some embodiments, the first arm may include a first interlocking protrusion and / or the second arm may include a second interlocking protrusion. In some embodiments, in response to a needle extending through a duckbill valve, the first interlocking protrusion and / or the second interlocking protrusion may be disposed within the recess. This facilitates retaining the housing within the needle hub. In some embodiments, the duckbill valve may close in response to the distal tip being retracted beyond the second end of the first arm and the second end of the second arm. Additionally, in some embodiments, in response to the distal tip being retracted beyond the second end of the first arm and the second end of the second arm, the first interlocking protrusion and the second interlocking protrusion may be removed from the recess, thereby facilitating removal of the housing from the needle hub.

[0015] In some embodiments, the first interlocking protrusion may include a first curved portion and / or the second interlocking protrusion may include a second curved portion. In other embodiments, the first interlocking protrusion may be located proximal to the first curved portion, and the second interlocking protrusion may be located proximal to the second curved portion.

[0016] In some embodiments, a first friction pad may be coupled to a first arm and / or a second friction pad may be coupled to a second arm. In some embodiments, a needle may extend through the housing and bias the first arm outward toward the needle hub such that the first friction pad contacts the needle hub. In some embodiments, a needle may extend through the housing and bias the second arm outward toward the needle hub such that the second friction pad contacts the needle hub. In some embodiments, in response to the sharp distal end being retracted in the proximal direction beyond the second end of the first arm and the second end of the second arm, the first friction pad and / or the second friction pad may be spaced apart from the needle hub.

[0017] In some embodiments, a friction band may surround the housing. In some embodiments, the needle may extend through the housing and bias the first and second arms outward toward the needle hub, such that the friction band contacts the needle hub. In some embodiments, in response to the sharp distal end being retracted in the proximal direction beyond the second ends of the first and second arms, the friction band may be spaced apart from the needle hub.

[0018] In some embodiments, a housing retaining mechanism may include the first friction pad and / or the second friction pad. In some embodiments, the housing retaining mechanism may include the friction band. In some embodiments, the housing retaining mechanism may include the first interlocking protrusion and / or the second interlocking protrusion.

[0019] In some embodiments, the passage system may include a first spring element disposed near the first curved portion and / or a second spring element disposed near the second curved portion. In some embodiments, in response to a needle extending through the housing and biasing the first and second arms outward toward the needle seat, the first spring element may be biased against the second end of the first arm and the second spring element may be biased against the second end of the second arm.

[0020] It should be understood that the foregoing general description and the following detailed description are illustrative and not intended to limit the claimed embodiments. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments unless so required. Therefore, the following detailed description should not be construed as restrictive. Attached Figure Description

[0021] Example embodiments will be described and explained with additional features and details using the accompanying drawings, in which:

[0022] Figure 1A This is a top perspective view of an existing needle assembly;

[0023] Figure 1B yes Figure 1AAn enlarged upper perspective view of a portion of a prior art needle assembly;

[0024] Figure 2A This is a top perspective view of an example needle protection device according to some embodiments;

[0025] Figure 2B According to some embodiments Figure 2A A lower perspective view of the needle protection device;

[0026] Figure 3A This is a partial cross-sectional view of an exemplary pathway system according to some embodiments, showing the needle in the ready position and Figure 2A Needle protection device;

[0027] Figure 3B According to some embodiments Figure 3A A cross-sectional view of the pathway system, showing the needle in the ready position;

[0028] Figure 3C According to some embodiments Figure 3A A partial cross-sectional view of the pathway system, showing the needle in a protected position;

[0029] Figure 3D According to some embodiments Figure 2A A cross-sectional view of the pathway system, showing the needle in the protected position;

[0030] Figure 4A This is a top perspective view of another exemplary needle protection device according to some embodiments;

[0031] Figure 4B According to some embodiments Figure 4A A lower perspective view of the needle protection device;

[0032] Figure 4C According to some embodiments Figure 4A A cross-sectional view of the needle protection device;

[0033] Figure 5A This is a partial cross-sectional view of an exemplary pathway system according to some embodiments, showing a needle in a ready position and another exemplary needle protection device including a friction pad;

[0034] Figure 5B According to some embodiments Figure 5A A partial cross-sectional view of the pathway system, showing the needle in a protected position;

[0035] Figure 6A This is a partial cross-sectional view of another pathway system according to some embodiments, showing a needle in a ready position and another exemplary needle protection device including a friction band;

[0036] Figure 6B According to some embodiments Figure 6A A partial cross-sectional view of the pathway system, showing the needle in a protected position;

[0037] Figure 7A This is a top perspective view of another example needle protection device including a washer at its proximal end according to some embodiments; and

[0038] Figure 7B According to some embodiments Figure 7A A cross-sectional view of an example needle protection device. Detailed Implementation

[0039] Figure 1A A needle assembly 10, typically used in the medical field, is illustrated. The needle assembly 10 may include a needle hub 12, a needle 14 extending distally from the needle hub 12, and a spring clip 16. In some embodiments, the needle 14 may include means for piercing the skin to obtain intravenous access, such as a guide needle. The spring clip 16... Figure 1B The image is magnified. Needle assembly 10 can be a venous (IV) catheter system. Figures 1A-1B (Not shown) and may provide several functions. For example, when the needle 14 of the needle assembly 10 is in the ready position for insertion into a patient's vein, the flexible arm of the spring clip 16 can be pushed outward and may interfere with a retaining structure on the inner surface of the catheter adapter of the venous catheter system to hold the spring clip 16 in place until the needle 14 is retracted. The catheter adapter may include a medical device that provides fluid communication and mechanical connection between the venous catheter and another vascular access device, such as a needle, syringe, blood collection assembly, infusion assembly, etc.

[0040] In response to the placement of the intravenous catheter of the catheter system into the patient's vein, the needle 14 can be retracted proximally. In response to the needle 14 being retracted proximally beyond the distal end of the spring clip 16, the flexible arm can move inward, which first releases the interference between the spring clip 16 and the retaining feature of the catheter adapter, and then provides a distal barrier for the needle 14 to prevent needlestick injury. Releasing the interference between the spring clip 16 and the retaining feature facilitates the removal of the needle assembly 10 from the catheter adapter.

[0041] The needle assembly 10 and spring clip 16 may pose several hazards. In some embodiments, the spring clip 16 may be made of metal and / or may include one or more sharp edges, which may increase the risk of cuts or scratches to the patient or clinician by the spring clip 16, especially when the needle assembly 10 is removed from the catheter adapter. In some cases, the sharp edges of the spring clip 16 may be exposed to the patient's blood, and this could lead to infection by one or more blood-borne pathogens if a clinician comes into contact with the sharp edges. Moreover, the sharp edges of the spring clip 16 may be caught on clothing, bedding, or other materials, which could cause the spring clip to open, exposing the sharp tip of the needle. Furthermore, the internal lumen of the needle 14 and / or the notch of the needle 14 may be filled with blood, and blood may splash or spray from the needle 14 when the needle assembly 10 is removed from the catheter adapter.

[0042] Now refer to Figures 2A-3D The needle protection device 100 according to various embodiments can overcome the disadvantages of the prior art, as explained in further detail below. In some embodiments, the needle protection device 100 can shield the sharp distal end 104 of the needle 102 after use to protect personnel from blood splashes and exposure. In some embodiments, the needle protection device 100 may also provide a safety mechanism that remains within the needle hub 106 until the needle 102 is withdrawn and automatically closes the sharp distal end 104 for safe disposal. In some embodiments, the needle hub 106 may include a catheter hub or another suitable hub. In some embodiments, a access tube, such as a catheter, may extend distally from the needle hub 106. In some embodiments, the catheter may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter.

[0043] Advantageously, some embodiments provide a needle protector 100 that can be integrally formed into a single unit to reduce the risk of exposure to blood and blood-borne pathogens for relevant personnel. Some embodiments of the needle protector 100 may include smooth features to reduce the risk of injury or damage to clinicians from cuts or scratches that may result from contact with sharp edges. Some embodiments of the needle protector 100 may also provide one or more safety mechanisms that are difficult to manually destroy and also prevent accidental failure due to snagging on bedding, clothing, etc.

[0044] In some embodiments, the needle protection device 100 may include a housing 116 configured to surround the outer periphery of the needle 102. In some embodiments, the housing 116 may include a cylindrical or tubular portion 124. In some embodiments, the housing 116 may include a substantially rigid, durable, and puncture-resistant material, such as a metal, plastic, or a composite thereof. In some embodiments, the housing 116 may include a sheet of metal, such as stainless steel or aluminum. In some embodiments, the sheet of metal may include dimensions sufficient to form the housing 116 to include the tubular portion 124 while preventing the needle 102 from puncturing or otherwise compromising the integrity of the housing 116.

[0045] In some embodiments, the tubular portion 124 may surround the needle 102 about its longitudinal axis. In some embodiments, the tubular portion 124 may include two or more components molded or joined together along their longitudinal edges to form the tubular portion 124. In some embodiments, the two or more components may be joined together by one or more dovetail joints or other forms of joints. In some embodiments, the housing 116 may be integrally formed as a single unit. In some embodiments, the housing 116 may be formed from a single sheet of metal.

[0046] In some embodiments, the housing 116 may further include a first arm 118a and / or a second arm 118b. In some embodiments, each of the first arm 118a and the second arm 118b (which may be referred to herein as "arms") may be integrated with or coupled to the tubular portion 124. For example, in some embodiments, each arm may be formed by means of a pair of slits 142a-142d disposed in the tubular portion 124 of the housing 116.

[0047] In some embodiments, the first arm 118a may include a first end 122a integrated or coupled to the tubular portion 124, a second end 126a disposed within the tubular portion 124, and a hinged or bent portion 128a therebetween. Similarly, in some embodiments, the second arm 118b may include a first end 122b integrated or coupled to the tubular portion 124, a second end 126b disposed within the tubular portion 124, and a hinged or bent portion 128b therebetween. The first ends 122a and 122b may be referred to herein as "first ends," and the second ends 126a and 126b may be referred to herein as "second ends." In some embodiments, the second ends 126a of the first arm 118a and 126b of the second arm 118b may extend substantially at an acute angle into the tubular portion 124 and be oriented such that the second ends 126a and 126b of the first arm 118a and the second arm 118b meet. In some embodiments, the second ends 126a, 126b may form a duckbill valve 136, which may be unidirectional. In one embodiment, the duckbill valve 136 may be substantially centered within the tubular portion 124.

[0048] In some embodiments, the housing 116 may be configured to allow the needle 102 to slide in a distal direction through the distal end 138 of the tubular portion 124 during assembly. In some embodiments, in response to the needle protection device 100 being in a protected position, the tubular portion 124 may be closed except where the slits 142a-142d, which may include narrow spaces, are located. In some embodiments, the slits 142a-142d may each include a cutout without narrow spaces, such that in response to the needle protection device 100 being in the protected position, the opposite sides of each of the slits 142a-142d contact and the tubular portion 124 is completely closed. In this way, some embodiments may limit exposure to any portion of the needle 102, as well as exposure to any associated blood splashes or residual blood.

[0049] As previously described, in some embodiments, the first end 122a of the first arm 118a may be formed by a first pair of slits 142a, 142b extending through the distal end 138 of the tubular portion 124. In some embodiments, the slits 142a, 142b may be formed substantially identically and may have the same length and / or orientation as each other. As shown, for example, the first pair of slits 142a, 142b may extend parallel to the length of the tubular portion 124, such that the first end 122a of the first arm 118a is positioned at less than one-quarter of the length of the housing 116. Similarly, the first end 122b of the second arm 118b may be formed by a second pair of slits 142c, 142d extending through the distal end 138 of the tubular portion 124. In some embodiments, since each of the first arm 118a and the second arm 118b can be formed by the tubular portion 124 itself, in response to the needle 102 being in the ready position, the first end 122a of the first arm 118a and the first end 122b of the second arm 118b can be generally planar and flush with the outer surface of the tubular portion 124.

[0050] like Figures 3A-3D As shown, in some embodiments, the needle hub 106 may include a distal end 108, a proximal end 110, and an inner cavity 112 extending through the distal end 108 and the proximal end 110. In some embodiments, the inner cavity 112 may include an inner diameter at least slightly larger than the outer diameter of the housing 116, such that the housing 116 can be disposed within the inner cavity 112. Furthermore, in some embodiments, the housing 116 may include an inner diameter at least slightly larger than the outer diameter of the needle 102 to allow the needle 102 to slide through.

[0051] In some embodiments, when the needle 102 is in a ready position for insertion into a patient's vein, the needle 102 may be positioned within the needle hub 106. According to some embodiments, the ready position is... Figure 3A As shown in the figure. In some embodiments, the needle 102 can move between a ready position and a retracted position, in which the distal tip 104 is outside the housing 116 and the needle hub 106, and in the retracted position, the distal tip 104 is protected within the cavity 112 of the housing 116 and the needle hub 106. According to some embodiments, in Figure 3C and 3D The position of the retracted needle 102 is shown in the diagram.

[0052] In some embodiments, in the ready position, the needle 102 may extend through the proximal end 140 and distal end 138 of the tubular portion 124, thereby pushing the first arm 118a and the second arm 118b outward toward the needle seat 106. In some embodiments, the first arm 118a and the second arm 118b may be significantly elastic, such that the first arm 118a and the second arm 118b may be biased against the elongated shaft 150 of the needle 102. In some embodiments, the curved portions 128a and 128b of each of the first arm 118a and the second arm 118b may also be pushed outward, such that they protrude from the outer surface of the tubular portion 124.

[0053] In some embodiments, the first arm 118a may include a first interlocking protrusion. In some embodiments, the first curved portion 128a may include or correspond to the first interlocking protrusion, and / or the second curved portion 128b may include or correspond to a second interlocking protrusion. In some embodiments, these interlocking protrusions may automatically secure and retain the housing 116 within the cavity 112 during operation of the needle 102.

[0054] like Figure 3A As shown, in some embodiments, the inner surface or cavity 112 of the needle holder 106 may include one or more recesses, which may include grooves, windows, undercuts, indentations, or other features to automatically interlock with the first curved portion 128a, the second curved portion 128b, or other such interlocking protrusions, thereby facilitating the automatic retention of the housing 116 within the needle holder 106 during use. Additionally, the interlocking protrusions may be integral with or coupled to the duckbill valve 136, such that the needle protection device 100 is not accidentally or intentionally removed before the sharp distal end 104 of the needle 102 is retracted and secured within the housing 116. In some embodiments, as long as the needle 102 extends through the housing 116 such that the first arm 118a and the second arm 118b are biased against the elongated axis of the needle 102, the interlocking protrusions can automatically secure the housing 116 within the needle holder 106 and prevent the needle protection device 100 from being accidentally or intentionally removed. In some embodiments, the inner surface or cavity 112 of the needle holder 106 may include a recess or annular groove, and an interlocking protrusion may be disposed in the recess or annular groove in response to the needle 102 being in a ready position.

[0055] In some embodiments, in response to retracting the needle 102 beyond the second end 126a of the first arm 118a and the second end 126b of the second arm 118b in a proximal direction, the first arm 118a and the second arm 118b can relax, thereby causing the duckbill valve 136 to close. In some embodiments, the interlocking protrusion can further disengage from the recess or other interlocking features of the cavity 112, thereby facilitating removal of the housing 116 from the needle holder 106. In some embodiments, when the housing 116 is removed from the needle holder 106, a feature of the needle guard 100 located at or near the proximal end 140 of the tubular portion 124 securely retains the sharp distal end 104 of the needle 102 within the housing 116.

[0056] In some embodiments, retraction of the needle 102 in the proximal direction can actuate the needle protection device 100 to secure the sharp distal end 104 of the needle 102. Specifically, withdrawing the sharp distal end 104 of the needle 102 beyond the second end 126a of the first arm 118a and the second end 126b of the second arm 118b in the proximal direction can cause the first arm 118a and the second arm 118b, which may be resilient, to snap together, thereby closing the duckbill valve 136.

[0057] In some embodiments, the needle 102 may include a notch 154 providing access to the lumen of the needle 102. In operation, the notch 154 allows for observation of blood return as the distal tip 104 enters the patient's vascular system. In some embodiments, the notch 154 may be positioned within the tubular portion 124 when the needle 102 is withdrawn proximally, causing the duckbill valve 136 to close. This prevents the distal tip 104 from moving distally beyond the duckbill valve 136, thereby preventing re-exposure of the distal tip 104 and any blood that may have been released from the distal tip 104 and / or the notch 154.

[0058] like Figure 3D As shown, according to some embodiments, the needle 102 may include a needle feature 152, such as a bulge, curl, protrusion, or other suitable feature located near the distal end of the needle 102. In some embodiments, the needle feature 152 may be located near a notch 154. In some embodiments, the needle feature 152 may include a diameter larger than the diameter of the opening at the proximal end 141 of the housing 116. In some embodiments, as discussed in more detail below, the proximal end 141 of the housing 116 may include a washer having a diameter smaller than the diameter of the needle feature 152. Retracting the needle 102 in the proximal direction can force the needle feature 152 against the proximal end 141 of the housing 116 or the washer, thereby preventing the sharp distal end 104 and the notch 154 from leaving the needle protection device 100.

[0059] Now refer to Figures 4A-4CIn some embodiments, the needle protection device 100 may include a first spring element 400a and / or a second spring element 400b to generate a biasing force on the second ends 126a, 126b of the first arm 118a and the second arm 118b. The first spring element 400a and the second spring element 400b may be referred to herein as "spring elements". In some embodiments, the first spring element 400a may be formed by a pair of slits 402a, 402b formed within the tubular portion 124. In some embodiments, the second spring element 400b may be formed by a pair of slits 402c, 402d formed within the tubular portion 124. In some embodiments, the narrow portion formed between the pair of slits 402a, 402b may be pushed outward from the tubular portion 124 and bent or otherwise molded or deformed to form a spring element configured to store potential energy.

[0060] In some embodiments, in response to the needle 102 extending through the tubular portion 124 and the duckbill valve 136, the first arm 118a and the second arm 118b can be pushed outward toward the needle seat 106 such that the first spring element 400a can contact the second end 126a of the first arm 118a, and the second spring element 400b can contact the second end 126b of the second arm 118b. In some embodiments, the first spring element 400a can apply a vertical or lateral force relative to the tubular portion 124 to the second end 126a of the first arm 118a. Similarly, in some embodiments, the second spring element 400b can apply a vertical or lateral force to the second end 126b of the second arm 118b in a direction substantially opposite to the force applied by the first spring element 400a. In some embodiments, in response to the retraction of the sharp distal end 104 of the needle 102 beyond the second end 126a of the first arm 118a and the second end 126b of the second arm 118b, the vertical or lateral force can push the second ends 126a of the first arm 118a and the second ends 126b of the second arm 118b toward each other. This thereby creates an effective and reliable mechanism to automatically close the duckbill valve 136 and prevent re-exposure of the sharp distal end 104.

[0061] In some embodiments, the first spring element 400a and / or the second spring element 400b may also provide an interlocking mechanism to secure the housing 116 within the needle holder 106. In some embodiments, the first spring element 400a and the second spring element 400b may include interlocking protrusions, which may include bent portions. In some embodiments, the bent portions may be disposed within one or more recesses in the needle holder 106 in response to the needle 102 being in a ready position. In some embodiments, the first spring element 400a and the second spring element 400b may protrude outward from the housing 116 when the needle 102 extends within the housing 116.

[0062] Specifically, in some embodiments, the elongated shaft 150 of the needle 102 can push each arm outward toward the needle holder 106, such that the first spring element 400a and the second spring element 400b contact the second end of each arm. In some embodiments, each of the first spring element 400a and the second spring element 400b may include a corresponding bent portion 404a, 404b to store potential energy. When the needle 102 presses the first arm 118a, the second arm 118b and the corresponding first spring element 400a and the second spring element 400b outward toward the needle holder 106, the bent portions 404a, 404b may also be pushed outward toward the needle holder 106, such that they protrude from the outer surface of the tubular portion 124. In some embodiments, such bent portions 404a, 404b may interlock with recesses or other features integrated into or coupled to the inner wall of the needle holder 106, thereby retaining the housing 116 within the needle holder 106.

[0063] Retracting the needle 102 from the housing 116 relaxes the first arm 118a and the second arm 118b within the tubular portion 124, thereby allowing the ends of each of the first spring element 400a and the second spring element 400b to extend through corresponding slits or holes in the housing 116. The bent portions 404a and 404b of each of the first spring element 400a and the second spring element 400b can also relax, thereby disengaging from the recess or other features of the needle holder 106. This facilitates the removal of the housing 116 from the needle holder 106.

[0064] Now refer to Figures 5A-6B In other embodiments, the needle protection device 100 may include one or more retaining features or friction elements to hold the housing 116 therein during use as the needle 102 extends through the needle holder 106. In some embodiments, a particular retaining feature or friction element may include a friction pad (such as friction pads 502a, 502b), a friction band 600, a friction shell, or another suitable retaining feature. The retaining feature may be integrated with or coupled to the housing 116 to increase friction between the outer surface of the housing 116 and the inner surface of the needle holder 106, thereby securing the housing 116 within the needle holder 106.

[0065] like Figures 5A-5BAs shown, in some embodiments, one or more friction pads 502a, 502b may be integral with or coupled to the first arm 118a and / or the second arm 118b, extending from the tubular portion 124 of the housing 116. As shown, in some embodiments, the friction pad 502a may be coupled to a first end 122a of the first arm 118a near the distal end 138 of the tubular portion 124. In some embodiments, in response to the elongated shaft 150 of the needle 102 pushing the second end 126a of the first arm 118a outward toward the inner surface of the needle holder 106, the first end 122b of the first arm 118a may also be pushed outward toward the needle holder 106. In this way, the friction pads 502a, 502b may also be pushed outward to contact the inner surface or cavity 112 of the needle holder 106.

[0066] In some embodiments, the friction pads 502a, 502b may include a circular or raised profile such that, although the first arm 118a, the second arm 118b may be substantially flush with the outer surface of the housing 116, the friction pads 502a, 502b may protrude therefrom. In this way, as the needle 102 extends within the housing 116, the friction pads 502a, 502b may contact and interact with the inner surface or cavity 112 of the needle holder 106 to secure the housing 116 within the needle holder 106.

[0067] In some embodiments, friction pads 502a, 502b may comprise an elastic material, such as rubber or plastic or another suitable material, to resist movement of the housing 116 relative to the inner surface or cavity 112 of the needle holder 106. In some embodiments, friction pads 502a, 502b may comprise an outer surface that may be textured to increase friction between the outer surface of the friction pads 502a, 502b and the inner surface or cavity 112 of the needle holder 106. In some embodiments, the inner surface or cavity 112 of the needle holder 106 may further comprise textured features such as protrusions, recesses, corrugations, indentations, ridges, lines, etc., to increase friction between the cavity 112 and the friction pads 502a, 502b.

[0068] Now for reference Figures 6A-6BIn some embodiments, the retaining feature may include a friction band 600 or surround applied to the outer periphery of the housing 116 near its distal end 138. The friction band 600 or surround may include a flexible and / or elastic material, such as rubber, plastic, or other suitable material. In some embodiments, the material may be a thin sheet material that may include dimensions configured to cover at least a portion of the tubular portion 124. In some embodiments, the bottom side of the friction band 600 or surround may be disposed adjacent to the outer surface of the tubular portion 124, while the top side of the friction band 600 or surround may serve as a medium for contact between the tubular portion 124 and the inner surface or cavity 112 of the needle holder 106. In some embodiments, either or both of the top and bottom sides may be textured to increase friction and resistance between the friction band 600 and adjacent surfaces. In this way, the friction band 600 can secure the housing 116 within the needle holder 106.

[0069] In some embodiments, in response to the elongated shaft 150 of the needle 102 extending through the housing 116 in a ready position, the friction band 600 can be pushed outward by the first arm 118a and the second arm 118b of the housing 116. This increased pressure on the friction band 600 in the outward direction can increase the resistance between the friction band 600 and the inner cavity 112 of the needle holder 106, thereby further securing the housing 116 within the needle holder 106.

[0070] Retracting the sharp distal end 104 of needle 102 beyond the second end of each of the first arm 118a and the second arm 118b can cause the first ends of the first arm 118a and the second arm 118b to loosen. This can cause the friction band 600 to loosen and, in some embodiments, contract towards the outer periphery of the tubular portion 124. The resistance between the friction band 600 and the inner cavity 112 can be reduced, and the housing 116 can be spaced apart from the needle hub 106. This facilitates the removal of the housing 116 from the needle hub 106.

[0071] In some embodiments, the friction band 600 may include a sleeve or surround that substantially surrounds the distal end 138 of the housing 116. Furthermore, in some embodiments, the sleeve may include an opening or aperture at its distal end to receive a needle 102 passing through it when it extends through the housing 116 for use. In some embodiments, the opening or aperture may be significantly resilient, such that it automatically closes as the needle 102 exits through it.

[0072] Now refer to Figure 7A and 7BIn some embodiments, the proximal end 141 of the housing 116 may include a washer 700. In some embodiments, the washer 700 may be coupled to the proximal end of the tubular portion 124. For example, the washer 700 may be attached to the proximal end of the tubular portion 124 or integrally formed as a single unit with the tubular portion 124. In some embodiments, the washer 700 may be resilient and / or may include an opening 702 to allow a needle 102 disposed within the housing 116 (e.g., see...). Figures 2A-3D It can slide relative to itself. In some embodiments, the opening 702 may be circular or another suitable opening. In some embodiments, the opening 702 may include a diameter or size smaller than that of a bump, crease, or other needle feature 152 located near the pointed distal end 104 of the needle 102. As described above, the needle feature 152 may be located near a notch 154 that provides access to the lumen 112 of the needle 102. In some embodiments, withdrawing the pointed distal end 104 of the needle 102 in a proximal direction may cause the needle feature 152 to interfere with the opening 702, thereby preventing the withdrawal of the pointed distal end 104 and the notch 154, and preventing re-exposure of the person concerned to any residual blood and blood-borne pathogens that may be present.

[0073] All examples and conditional language described herein are for educational purposes, to aid the reader in understanding the embodiments and concepts described, contributed by the inventors to promote the art, and are to be construed as not being limited to such specific examples and conditions. Although some embodiments 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 various embodiments.

Claims

1. A pathway system, characterized in that, The pathway system includes: A needle hub, the needle hub including a distal end, a proximal end, and an inner cavity extending through the distal end and the proximal end; A needle protection device for protecting the sharp distal end of a needle, the needle protection device comprising a housing disposed within the cavity of the needle hub, wherein the housing comprises a tubular portion, a first arm, and a second arm, wherein the first arm comprises a first end connected to the tubular portion, a second end disposed within the tubular portion, and a first curved portion disposed between the first end and the second end of the first arm, wherein the second arm comprises a first end connected to the tubular portion, a second end disposed within the tubular portion, and a second curved portion disposed between the first end and the second end of the second arm, wherein the second end of the first arm and the second end of the second arm form a duckbill valve; Wherein, when the duckbill valve is closed, the first curved portion and the second curved portion protrude outwards relative to the longitudinal axis of the housing than the tubular portion, and the first curved portion and the second curved portion are close to the second end of the first arm and the second end of the second arm forming the duckbill valve; and A needle, the needle including a sharp distal end, wherein the needle extends through the housing and biases the first arm and the second arm outward toward the needle seat to facilitate holding the housing within the needle seat, wherein the passage system is configured such that when the sharp distal end is retracted in the proximal direction beyond the second end of the first arm and the second end of the second arm, the duckbill valve closes and the first arm and the second arm move inward to facilitate removal of the housing from the needle seat; The tubular portion includes a distal end and a proximal end. The first end of the first arm is formed by a first slit and a second slit within the tubular portion. The first end of the second arm is formed by a third slit and a fourth slit within the tubular portion. The first slit, the second slit, the third slit, and the fourth slit extend through the distal end of the tubular portion and along a portion of the length of the tubular portion, such that the proximal ends of the first slit, the second slit, the third slit, and the fourth slit are spaced apart from the proximal end of the tubular portion.

2. The pathway system according to claim 1, characterized in that, The tubular portion is closed, except for the portion of the housing located between the first slit and the second slit, which includes the first arm, and the other portion of the housing located between the third slit and the fourth slit, which includes the second arm.

3. The pathway system according to claim 1, characterized in that, The needle includes a feature portion disposed proximal to the distal tip of the sharp point, and the housing includes a proximal opening with a diameter smaller than that of the feature portion, thereby preventing the distal tip of the sharp point from retracting proximally through the proximal opening.

4. The pathway system according to claim 3, characterized in that, The access system also includes a gasket connected to the proximal end of the tubular portion, wherein the gasket defines the proximal opening.

5. The pathway system according to claim 4, characterized in that, The needle further includes a notch providing access to the lumen of the needle, wherein the access system is configured such that when the sharp distal end is retracted in the proximal direction beyond the second end of the first arm and the second end of the second arm and the feature portion contacts the washer, the notch is within the tubular portion, proximal to the duckbill valve.

6. The pathway system according to claim 1, characterized in that, The needle hub also includes an inner surface forming the cavity, wherein the inner surface includes a recess, wherein the first arm includes a first interlocking protrusion and the second arm includes a second interlocking protrusion, wherein the passage system is configured such that when the needle extends through the duckbill valve, the first interlocking protrusion and the second interlocking protrusion are disposed within the recess to retain the housing within the needle hub, wherein the passage system is configured such that when the sharp distal end is retracted in the proximal direction beyond the second end of the first arm and the second end of the second arm, the duckbill valve closes and the first interlocking protrusion and the second interlocking protrusion are removed from the recess to remove the housing from the needle hub.

7. The pathway system according to claim 6, characterized in that, The first curved portion includes the first interlocking protrusion, and the second curved portion includes the second interlocking protrusion.

8. The pathway system according to claim 6, wherein, The first interlocking protrusion is disposed near the first curved portion, and the second interlocking protrusion is disposed near the second curved portion.

9. The pathway system according to claim 1, characterized in that, The pathway system also includes a first friction pad coupled to the first arm, wherein the needle extends through the housing and biases the first arm outward toward the needle seat such that the first friction pad contacts the needle seat.

10. The pathway system according to claim 9, characterized in that, The pathway system also includes a second friction pad coupled to the second arm, wherein the needle extends through the housing and biases the second arm outward toward the needle seat such that the second friction pad contacts the needle seat.

11. The pathway system according to claim 10, characterized in that, The pathway system is configured such that when the sharp distal end is retracted in the proximal direction beyond the second end of the first arm and the second end of the second arm, both the first friction pad and the second friction pad are spaced apart from the needle seat.

12. The pathway system according to claim 1, characterized in that, The pathway system also includes a friction band surrounding the housing, wherein the needle extends through the housing and biases the first and second arms outward toward the needle seat such that the friction band contacts the needle seat.

13. The pathway system according to claim 12, characterized in that, The pathway system is configured such that when the sharp distal end is retracted along the proximal direction beyond the second end of the first arm and the second end of the second arm, the friction band is spaced apart from the needle seat.

14. The pathway system according to claim 1, characterized in that, The first end of the first arm and the first end of the second arm are generally planar and flush with the outer surface of the tubular portion.

15. The pathway system according to claim 1, characterized in that, The overall terrain of the shell is defined as a single unit.

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