Needle safety system

Abstract

A tissue access device and methods of use and manufacture thereof are disclosed. The device may have a needle, a housing having a wing, a tube having a flow channel, a first tube extension and a second tube extension, and a torsion spring having a first coil and a second coil. The first coil may have a first coil first arm and a first coil second arm. The first coil first arm may be shorter than the first coil second arm. The second coil may have a second coil first arm and a second coil second arm. The second coil first arm may be shorter than the second coil second arm. The device may have a sensor. When the sensor is in a sensor closed configuration, more energy may be stored in the torsion spring than when the sensor is in a sensor open configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 886,762, filed on August 14, 2019, entitled “Needle Safety Systems XIV,” and U.S. Provisional Application No. 63 / 028,907, filed on May 22, 2020, entitled “Needle Safety Systems XIIIa,” the contents of which are incorporated herein by reference in their entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to vascular connections, and more particularly to detection and interruption of dislodged vascular connections. For example, tissue access devices and methods of use and manufacture thereof are disclosed, and more particularly, tissue access devices capable of detecting and interrupting flow and methods of use and manufacture thereof are disclosed. Background Art

[0004] There are many technologies that provide the following means: by which the wrong flow of fluid caused by the removal of the needle from the vascular connection is detected, and the vascular connection guides the fluid from the outside of the body to the inside of the body. The common point of many of these technologies is the use of continuity sensors, which look for the interruption of energy-based signals or some mechanical connections from the pipeline to the body. Such systems usually use mechanical connectors, small currents, capacitors, magnets or even ultrasound as the means of monitoring the fidelity of the connection between the body and the fluid through the element. Other uses are designed to find the technology of humidity based on the theory that the needle that is removed will leak fluid, and fluid detection can be used as an alternative mark for the needle to move out. By combining an external actuation system connected to a fluid pump, these monitoring / detection systems can automatically signal the machine that pumps the fluid to stop pumping when sensing the interruption of the vascular connection caused by the needle moving out.

[0005] A simple alternative method for identifying whether a condition exists where erroneous flow is caused by a dislodged needle and resulting in a subsequent automatic machine shut down can be explained by using a mechanically based system that detects the presence of a needle on the body surface to determine whether the needle is inserted into the patient during the fluid delivery process. (Here, the presence of the needle on the body surface can be used to assume that the needle may still be inserted into the body.) A spring-loaded pedal secured to the base of the needle is one of several methods of performing this sensing operation.

[0006] There are a variety of spring designs and manufacturing / assembly methods that can be considered to enable the development of a full needle system and improve the needle safety system. One is a coil spring design in which the spring is located under the needle body between the needle body and the pedal. Another is a torsion spring design in which the coil is positioned around the pedal hinge point on the needle body side. Another is a standard butterfly design in which an internal feature can be manipulated as needed to control the amount of pre-tension applied to the torsion spring. By manipulating this feature and changing the resulting pre-tension, a critical adjustment that can achieve the optimal spring force for opening and closing can be provided, thereby improving the overall needle system performance.

[0007] Therefore, there is a need for improved needle safety systems. Summary of the invention

[0008] The present disclosure relates generally to tissue access devices and vascular connections.

[0009] Tissue access devices are disclosed. For example, a tissue access device is disclosed that may have a needle and a housing having a wing. The device may have a tube having a flow channel, a tube first extension, and a tube second extension. The device may have a torsion spring having a first coil and a second coil. The first coil may have a first coil first arm and a first coil second arm. The first coil first arm may be shorter than the first coil second arm. The second coil may have a second coil first arm and a second coil second arm. The second coil first arm may be shorter than the second coil second arm. The device may have a sensor having a first connector, a second connector, and an obturator. The obturator may be connected to the first connector and the second connector. The first connector may have a first connector extension. The second connector may have a second connector extension. The sensor may have a sensor open configuration and a sensor closed configuration. When the device is in a fully assembled configuration, the tube first extension may be in the first connector extension and the first coil. When the device is in a fully assembled configuration, the tube second extension may be in the second connector extension and the second coil. When the device is in a fully assembled configuration and the sensor is in a sensor open configuration, the torsion spring may have a first loading configuration. When the device is in the fully assembled configuration and the sensor is in the sensor closed configuration, the torsion spring may have a second loaded configuration. When the torsion spring is in the second loaded configuration, more energy may be stored in the torsion spring than when the torsion spring is in the first loaded configuration.

[0010] Tissue access devices are disclosed. For example, a tissue access device is disclosed that may have a needle and a housing having wings. The device may have a tube having a flow channel, a first tube extension, and a second tube extension. The device may have a torsion spring having a first coil, a second coil, a first arm, a second arm, and a third arm. The third arm may be longer than the first arm. The third arm may be longer than the second arm. The device may have a sensor having a first hinge, a second hinge, and an obturator. When the device is in a fully assembled configuration, the first tube extension may be in the first hinge. When the device is in a fully assembled configuration, the second tube extension may be in the second hinge. When the device is in a fully assembled configuration and the sensor is in a sensor open configuration, the torsion spring may have a first loaded configuration. When the device is in a fully assembled configuration and the sensor is in a sensor closed configuration, the torsion spring may have a second loaded configuration. When the torsion spring is in the second loaded configuration, more energy may be stored in the torsion spring than when the torsion spring is in the first loaded configuration.

[0011] Tissue access devices are disclosed. For example, a tissue access device is disclosed that may have a needle and a housing having wings. The device may have a tube having a flow channel, a first tube extension, and a second tube extension. The device may have a spring located on a first lateral side of the housing and on a second lateral side of the housing. The device may have a sensor having a first hinge, a second hinge, and an obturator. When the device is in a fully assembled configuration, the tube first extension and the spring may be connected to the first hinge. When the device is in a fully assembled configuration, the tube second extension and the spring may be connected to the second hinge. When the device is in a fully assembled configuration and the sensor is in a sensor open configuration, the torsion spring may have a first loaded configuration. When the device is in a fully assembled configuration and the sensor is in a sensor closed configuration, the torsion spring may have a second loaded configuration. When the spring is in the first loaded configuration, less energy may be stored in the spring than when the spring is in the second loaded configuration.

[0012] Tissue access devices are disclosed. For example, a tissue access device is disclosed that can have a needle, a housing, a tube with a flow channel, a torsion spring, and a sensor.

[0013] Tissue access devices are disclosed. For example, a tissue access device is disclosed that can have a needle, a housing, a tube with a flow channel, a torsion spring, and a preload sensor.

[0014] Tissue access devices are disclosed. For example, a tissue access device is disclosed that can have a needle, a housing, a tube with a flow channel, a preloaded torsion spring, and a sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The drawings shown and described are exemplary embodiments and are not limiting. The same reference numerals throughout refer to the same or functionally equivalent features.

[0016] Figure 1 A perspective view of a variation of a tissue access device with a sensor in an occluded configuration is shown.

[0017] Figure 2A Shows Figure 1 A perspective view of the sensor.

[0018] Figure 2B Shows Figure 2A Side view of the sensor.

[0019] Figure 2C Shows Figure 2A Top view of the sensor.

[0020] Figure 3A Shown in a less occluded configuration Figure 1 Side view of a tissue access device.

[0021] Figure 3B Shown is a view taken along line 3B-3B. Figure 3A A variation of a longitudinal cross-sectional view of a tissue access device.

[0022] Figure 4A Shows Figure 1 Side view of a tissue access device.

[0023] Figure 4B Shown is a view taken along line 4B-4B Figure 4A Side view of a tissue access device.

[0024] Figure 4C yes Figure 4B An enlarged view of the 4C-4C portion of the tissue access device.

[0025] Figure 4D Shows Figure 4B Another variation of the occlusive configuration at the 4C-4C portion of the tissue access device.

[0026] Figure 4E Shows Figure 3B Another variation of the occlusive configuration at the 4C-4C portion of the tissue access device.

[0027] Figure 4F Shows Figure 3B Another variation of the occlusive configuration at the 4C-4C portion of the tissue access device.

[0028] Figure 5 yes Figure 4EAn enlarged perspective view of the tissue access device in an occluded configuration.

[0029] Fig. 6A Side views of variations of tissue access devices are shown being inserted into tissue and being removed from tissue.

[0030] Figure 6B Shown is the insertion of Fig. 6A Tissue access device.

[0031] Figure 7A-Figure 7I Variations in the tissue access device manufacturing process and variations in its components are shown.

[0032] Figure 8A-8C Variations of inserts configured to support flow cessation during removal are shown.

[0033] Figure 9A-9F Variations of tissue access devices and components thereof are shown.

[0034] Fig. 10A A perspective view of a variation of a tissue access device is shown.

[0035] Fig. 10B Shows Fig. 10A Exploded view of the device.

[0036] Fig.11A A perspective view of a variation of a tissue access device is shown.

[0037] Fig. 11B Shows Fig.11A Exploded view of the device.

[0038] Fig. 12A Variations of inserts are shown.

[0039] Fig. 12B Shows Fig. 12A Exploded view of the insert.

[0040] Fig.13A Schematic diagrams showing variations of tissue access devices having a pouch.

[0041] Fig. 13B Shows Fig.13A A variation of the invention in which an obturator is provided in the pocket.

[0042] Fig.14A 1 Variations of methods of assembling a tissue access device are shown.

[0043] Fig.14A 2 According to FIG. 14A 1 Variations of the methods and assemblies of tissue access devices.

[0044] Fig. 14B 1 Variations of methods of assembling a tissue access device are shown.

[0045] Fig. 14B 2 According to FIG. 14B 1 Variations of the methods and assemblies of tissue access devices.

[0046] Fig. 14C 1 Variations of methods of assembling a tissue access device are shown.

[0047] Fig. 14C 2 According to FIG. 14C 1 Variations of the methods and assemblies of tissue access devices.

[0048] Fig.15A 1 Variations of methods of assembling a tissue access device are shown.

[0049] Fig.15A 2 According to FIG. 15A 1 Variations of the methods and assemblies of tissue access devices.

[0050] Fig. 15B 1 Variations of methods of assembling a tissue access device are shown.

[0051] Fig. 15B 2 According to FIG. 15B 1 Variations of the methods and assemblies of tissue access devices.

[0052] Fig.16A Variations of methods of assembling a tissue access device are shown.

[0053] Fig. 16B Shown according to Fig.16A Variations of the methods and assemblies of tissue access devices.

[0054] Fig. 16C Shows the use of Fig. 16B Variations of methods of assembling components of a tissue access device.

[0055] Fig.17A A side view of a variation of a tissue access device is shown.

[0056] Fig. 17B Shows Fig.17A A perspective view of the device.

[0057] Fig. 17C Shows Fig.17A A cross-sectional view of the tissue access device along line 17C-17C.

[0058] Fig.17D Shows Fig. 17C An enlarged view of the portion of the device without the insert.

[0059] Fig.17E Shows Fig.17D A perspective view of the device.

[0060] Fig.18A Variations of the sensor are shown.

[0061] Fig.18B Shows that there is Fig.18A Cross-sectional view of a variation of a sensor tissue access device.

[0062] Fig.19 A side view of a variation of a tissue access device is shown.

[0063] Figure 20A-20C Variations of methods of shielding a needle of a tissue access device are shown.

[0064] Figure 21A-Figure 21C Variations of methods of shielding a needle of a tissue access device are shown.

[0065] Figure 22A-22C Variations of methods of shielding a needle of a tissue access device are shown.

[0066] Fig.23 A variation of a portion of a needle guard is shown.

[0067] Fig.24A A side view of a variation of a tissue access device with a variation of a needle guard is shown.

[0068] Fig. 24B Shown with Fig.24A A variation of the device in which the sensor is engaged by a needle guard.

[0069] Fig.25 A variation of a portion of a needle guard is shown.

[0070] Fig.26A Variations of the graphs showing time and pressure.

[0071] Fig.26B Variations of the graphs showing time and pressure.

[0072] Fig.27A Schematic diagrams showing variations of tissue access devices.

[0073] Fig.27B Schematic diagrams showing variations of tissue access devices.

[0074] Fig.28A A perspective view showing a variation of the spring is shown.

[0075] Fig.28B A perspective view of a variation of the sensor is shown.

[0076] Fig.28C Shows Fig.28A A perspective view of a variation of a spring attached to Fig.28B of sensors.

[0077] Fig.29A Shows Fig.28C A perspective view of a variation of a spring sensor component connected to a variation of a tube.

[0078] Fig.29B Shows Fig.28C A perspective view of a variation of a spring sensor component connected to a variation of a tube.

[0079] Fig.29C Shows Fig.29A Side view of.

[0080] Fig.29D Shows Fig.29B Side view of.

[0081] Fig.29E Shows Figure 29A-Figure 29D A perspective view of a first side of the tube.

[0082] Fig.29F Shows Figure 29A-Figure 29D A perspective view of the second side of the tube.

[0083] Fig. 30A A perspective view of a variation of a tissue access device is shown with the sensor in a closed configuration.

[0084] Fig. 30B Shows Fig. 30A A device in which the sensor is in an open configuration.

[0085] Fig. 30C Shows Fig. 30A Side view of.

[0086] Fig.30D Shows Fig. 30B Side view of.

[0087] Fig.31A Shows Fig. 30A A cross-sectional view of a variation of the device along line 31-31.

[0088] Fig.31B Shows Fig. 30A A cross-sectional view of a variation of the device along line 31-31.

[0089] Fig.31C Shows Fig. 30A A cross-sectional view of a variation of the device along line 31-31.

[0090] Fig.31D A bottom perspective view of a variation of the housing is shown.

[0091] Fig.31E Shows Fig.31D An enlarged view of the housing at section 696.

[0092] Fig.32A A perspective view of a variation of a tissue access device is shown.

[0093] Fig.32B Shows Fig.32A Bottom view of the device.

[0094] Fig.32C Shows Fig.32A A top view of the device.

[0095] Fig.32D Shows Fig.32C Side view and cross-sectional view of the device along line WW.

[0096] Fig.32E Shows Fig.32D An enlarged view of the 32E-32E portion of FIG.

[0097] Fig.32F shows a view taken along line WW when the sensor is in the open configuration. Fig.32C Side view and cross-sectional view of the device.

[0098] Figure 32G Shows Fig.32F An enlarged view of the 32G-32G portion of FIG.

[0099] Fig.33A A perspective view showing a variation of the spring is shown.

[0100] Fig.33B Shows Fig.33A Side view of the spring.

[0101] Fig.33C A perspective view showing a variation of the spring is shown.

[0102] Fig.33D Shows Fig.33C Side view of the spring.

[0103] Fig.33E A perspective view showing a variation of the spring is shown.

[0104] Fig.33F Show Fig.33ESide view of the spring.

[0105] Figure 33G Show Fig.33C Side view of the spring.

[0106] Fig.33H express Fig.33C Top view of the spring.

[0107] Fig.33I Shows Fig.33C End view of the spring.

[0108] Fig.34A A perspective view of a variation of a tissue access device is shown.

[0109] Fig.34B Shows Fig.34A Bottom view of the device in FIG.

[0110] Fig.34C Shows Fig.34A A top view of the device.

[0111] Fig.34D Shows Fig.34C Side view and cross-sectional view of the device along line YY.

[0112] Fig.34E Shows Fig.34D An enlarged view of the 34E-34E portion of FIG.

[0113] Fig.34F shows a view taken along line YY when the sensor is in the open configuration Fig.34C Side view and cross-sectional view of the device.

[0114] Figure 34G Shows Fig.34F An enlarged view of the 34G-34G portion.

[0115] Fig.34H Shows Fig.34B A bottom view of the 34H-34H portion of FIG.

[0116] Fig.34I Shows Fig.34H An enlarged view of the 34I-34I portion of the membrane.

[0117] Fig.34J Shows Fig.34H A variation of the bottom view at portion 34J-34J of FIG.

[0118] Figure 34K express Fig.34J An enlarged view of the 34K-34K portion of FIG.

[0119] Figure 34L Shows Fig.34J A variation of the bottom view.

[0120] Figure 34M Shows Figure 34L An enlarged view of the 34M-34M portion.

[0121] Fig.34N Show Figure 34G Variations of the device.

[0122] Fig.35A A perspective view of a variation of the sensor is shown.

[0123] Fig.35B A perspective view of a variation of the sensor is shown.

[0124] Fig.35C A perspective view of a variation of the sensor is shown.

[0125] Fig.36A A perspective view of a variation of the sensor is shown.

[0126] Fig.37A A perspective view showing a variation of the spring is shown.

[0127] Fig.37B Shows Fig.28A A perspective view of a variation of the spring.

[0128] Fig.37C Shows Fig.33C A perspective view of a variation of the spring.

[0129] Fig.38A Shows Fig.34A A perspective view of the housing with the wings in a folded configuration.

[0130] Fig.38B Shows Fig. 30A A perspective view of the housing with the wings in a folded configuration.

[0131] Fig.39A A front perspective view of the device taped to a patient is shown.

[0132] Fig.39B A side view of the device taped to a patient is shown.

[0133] Fig.40A A perspective view showing a variation of the spring is shown.

[0134] Fig.40B Shows Fig.40A A perspective view of a variation of a spring and a variation of the spring attached to a sensor.

[0135] Fig.40CShows when the spring is loaded onto the sensor Fig.40B Top view of the .

[0136] Fig.40D Shows when the spring is loaded onto the sensor Fig.40B Top view of the .

[0137] Fig.40E Shows Fig.40D Bottom view of .

[0138] Fig.41A Shows Fig.40B A perspective view of a variation of a spring sensor component connected to a variation of a tube.

[0139] Fig.41B Shows Fig.40B A perspective view of a variation of a spring sensor component which is connected to a variation of a tube.

[0140] Fig.41C Shows Fig.41A Side view of.

[0141] Fig.41D Shows Fig.41B Side view of.

[0142] Fig.42A A perspective view of a variation of a tissue access device is shown with the sensor in an open configuration.

[0143] Fig.42B Shows Fig. 30A A device wherein the sensor is in a closed configuration.

[0144] Fig.42C Shows Fig.42A Side view of.

[0145] Fig.42D Shows Fig.42B Side view of. DETAILED DESCRIPTION

[0146] Figure 1-42D The features in can be combined with each other in any combination.

[0147] Tissue access devices (also referred to as fluid access devices, vascular access devices, blood access devices, and needles) are disclosed. The disclosed tissue access devices can directly extract fluid and / or deliver fluid directly to a patient. In hemodialysis, the fluid is blood. In other cases, the fluid can be saline or a medication. Vascular access is typically performed in hospitals, clinics, and other medical settings, as well as at home (e.g., during home hemodialysis). For example, vascular connections are disclosed, and more specifically, systems and methods for detecting removal of a vascular connection, as well as systems and methods for interrupting flow when a vascular connection is removed are disclosed.

[0148] A needle safety system having a contact sensing mechanism configured to be placed on a patient's skin to determine when a needle / tube set has been inserted into and / or removed from the patient's body is disclosed. For example, removal may occur when tape holding a tissue access device or vascular access needle in place fails or a wire connected to the device is pulled out.

[0149] Needle safety systems and methods are disclosed that use a force sensing mechanism within the device to determine if and when a given needle / tube set that has been inserted into a patient has experienced dislodgement. This can occur during medical treatment when tubing leading to a vascular access needle is intentionally or accidentally "pulled" or "dragged". This can also occur when medical tape used to hold an inserted needle in place on the skin becomes loose due to reduced tape adhesion due to excessive hair growth or increased sweating / humidity on the patient.

[0150] A needle safety system having a fluid stop valve configured to automatically deploy to stop fluid flow through the needle / cannula when a needle delivering fluid into the body is accidentally dislodged from a patient during fluid delivery is disclosed.

[0151] A needle safety system is disclosed having a pinch valve configured to be activated by a mechanical linkage to a mechanical "skin sensing" element in the needle system that has been pre-manufactured to include a compressible tubing segment.

[0152] A needle safety system having a pinch valve configured to act to block flow on an internally formed flow path formed within a "butterfly" housing of a conventional needle is disclosed.

[0153] Disclosed are systems and methods for automatic flow termination of fluid delivery, including a housing, and a spring-loaded or fluid-sensitive activation mechanism, the housing being configured to couple a fluid delivery tube to a needle, the needle being configured to deliver fluid subcutaneously (into a vascular system) within tissue of a patient, the spring-loaded or fluid-sensitive activation mechanism having a first orientation, a second orientation, and a third orientation, the first orientation corresponding to a condition in which the housing is disposed substantially adjacent to the tissue and the needle is inserted within the tissue, the second orientation corresponding to a condition in which the housing is disposed away from the tissue or the needle is removed from the tissue, and the third orientation corresponding to a condition in which the housing is substantially adjacent to the tissue but in a position pulled back from the original insertion point, causing the needle to no longer deliver fluid into the vascular system. Disclosed is a flow termination mechanism, coupled to an activation mechanism and having an open configuration and a closed configuration, the open configuration allowing flow from the fluid delivery tube to the needle when the activation mechanism is in the first orientation, and the closed configuration substantially terminating flow from the fluid delivery tube to the needle when the activation mechanism is in the second orientation or the third orientation.

[0154] A special needle is disclosed for protecting a patient from fluid delivery issues during medical treatment. For example, a special needle is disclosed that can have a spring-loaded integrated pedal that, when in a disengaged position (e.g., not adhered to the skin and the needle body is dislodged from the skin), causes a pedal occluding member to move into a device flow channel and block fluid flow through the needle.

[0155] A system and method for automatic flow termination for fluid delivery is disclosed, comprising a housing, a force-sensitive activation mechanism (shown here as a pedal), the housing being configured to couple a fluid delivery tube to a needle configured to deliver fluid subendothelially (into the vascular system) in a patient's tissue, and the force-sensitive activation mechanism having a first flat orientation (e.g., a straight or less-straight orientation) corresponding to allowing fluid delivery through the needle body while using a U-shaped opening to protect the needle access hole, and the force-sensitive activation mechanism having a second orientation corresponding to occluding the fluid tube via a fluid occlusion member of the pedal during needle removal via a spring force provided by a curved element molded into the pedal. When the pedal is formed with a curved end, the device's needle insertion is improved due to reduced friction caused by the curved portion against the skin during insertion. In addition, the curved end of the pedal facilitates mechanical contact with the skin even at very large insertion angles (e.g., up to 50 degrees). This enhances removal detection functionality. The use of a curved center portion on the pedal forms an effective internal hinge point for the occlusion arm, and does not require any external hinge point to be mounted on the needle body itself. This greatly improves the function of the device by removing any possible mechanical portion of the system from potential interference from any overlapping medical tape that is typically used to hold the needle in place during treatment.

[0156] A needle safety system is disclosed that can be efficiently and cost effectively manufactured by using a "molded" spring design for a pedal sensing unit. An effective spring can be manufactured by molding the pedal unit with a curved portion. When the pedal is in a straightened position, the mechanical stress on the curved portion results in an effective spring force, the direction and magnitude of which depends on the mechanical shape and size of the associated accessories. By forming a central "mechanical arm", the spring force can be harnessed for use as an occlusion technique by allowing the end of the arm to move directly into the center of the needle body and block or occlude fluid flow in the center of the needle body.

[0157] A needle safety system is disclosed having a spring-loaded pedal secured to the base of a needle to sense erroneous flow from a dislodged needle. In addition, by bending the distal end of the pedal, an effective system can be formed that provides basic safety and ease of the needle insertion process while also protecting the patient from over-insertion of the needle after initial insertion. The curved end also provides a mechanism by which the needle dislodgment detection function can be made effective even if the needle is inserted at a steep (e.g., up to 45 degrees) insertion angle. The opposite end of the pedal can include an occlusion member that can be pushed into the flow path within the needle body and used to block fluid flow. In addition, by molding a curved portion in the base of the pedal and forming an opposing member within the center portion of the pedal, a "spring" can be formed to assist in the "sensing" operation and engage with the end of the center member to move into the flow path within the needle body and block fluid flow when the needle is removed from the surface of the patient.

[0158] The use of a spring-loaded pedal as a "detector" of the presence of underlying skin to determine if and when a needle inserted for fluid delivery has been removed from a patient is disclosed.

[0159] A system and method for automatic flow termination for fluid delivery is disclosed, comprising a housing configured to couple a fluid delivery tube to a needle configured to deliver fluid subendothelially (into the vascular system) of a patient's tissue, and a force-sensitive activation mechanism having a first orientation and a second orientation, the first orientation corresponding to the fluid delivery tube being pulled axially within the needle body. Clamp The second orientation corresponds to a condition in which the fluid tube is clamped in an external arrangement in any other non-axial pulling direction. The flow termination mechanism may be active in each pulling condition, but otherwise have an open flow configuration that allows flow from the fluid delivery tube to the needle when the tube is not subjected to pulling force or the pulling force is below a certain threshold.

[0160] Needle safety systems and methods of use are disclosed that use a force sensing mechanism within the device to determine if and when a given needle / tube set that has been inserted into a patient experiences a "pull force" that approaches what would reasonably be expected to dislodge the tube from the patient. This may occur during medical treatment, for example, when tubing leading to a vascular access needle is intentionally or accidentally "pulled" or "dragged." This may also occur when medical tape used to hold an inserted needle in place on the skin becomes loose due to reduced adhesion of the tape due to excessive hair growth or increased sweating / humidity on the patient.

[0161] Needle safety systems and tube "tightening" or "clamping" methods are disclosed to stop the flow of fluid through a tube leading to a patient if the force on the tube approaches the force expected to dislodge the needle.

[0162] A needle safety system is disclosed having a device having a mechanically optimized pinch valve on its outer portion, which is configured in such a way that the tube can be pinched by compressing the tube through the optimized pinch point if the tube is pulled out of its normal position in any direction other than axial.

[0163] A needle safety system is disclosed having a device having a mechanically optimized pinch valve on an internal portion thereof, which is configured such that if the tube is pulled in an axial direction with a force above a threshold some time after the needle is inserted and taped, the tube can be clamped by compressing the tube via "clamp arms" within the needle body.

[0164] A needle safety system is disclosed that can override the skin sensing element described herein. The disclosed override system can ensure that the skin sensing element is not activated during the needle insertion process and / or during the insertion of the needle into the patient. During needle insertion, and before the needle is taped, it is critical that fluid flow is able to pass through the needle / tube so that clinical personnel can observe "flashback" of blood from the patient through the needle and into the fluid flow tube. Any needle with a fluid flow blocking mechanism can have the blocking mechanism temporarily disabled during that needle insertion and / or needle insertion. The needle safety device feature that achieves this will be referred to as a "needle lock" in this document.

[0165] A needle safety system is disclosed that has the ability to "lock" a skin sensing mechanism after it has been activated due to sliding or other types of removal from the skin. In this case, when fluid flow is blocked, it may be important for clinical staff to assess the situation and replace the needle for other aspects of treatment delivery. The "lock" feature ensures that after the flow stop mechanism is fully activated, additional and potentially dangerous fluid flow will not be started again.

[0166] A needle safety system is disclosed for sensing skin contact using a button-like sensor that comes out of the bottom of the needle body (e.g., comes out straight), and stopping flow using a blocking technique that involves rotating or sliding an opening within a needle valve from closed to open.

[0167] A needle safety system is disclosed having a contact sensing mechanism on the patient's skin to determine when a given needle / tube set that has been inserted into the patient may become detached from the patient in those situations involving the needle "slipping" out of the vascular system but not necessarily completely "moving out" of the body, away from the skin. This incomplete or partial removal may occur when the tape holding the vascular access needle in place provides sufficient downward pressure to hold the needle against the skin but fails to prevent associated movement of the access needle away from the original insertion point. One form of this type of failure to prevent is the needle sliding out of the blood vessel instead of the skin, referred to in the medical literature as "infiltration." When the needle completely slides out of the skin, this may be defined as "slipping removal." Removal in the present disclosure refers to both partial removal and complete removal.

[0168] A needle safety system for sensing relative movement of a taped needle body in a direction opposite to the path in which the needle was initially inserted is disclosed. One implementation is by using an adhesive on the bottom of the needle or providing an improved surface that enhances frictional contact between the needle body and the skin, and in combination with the following method, which detects when the friction force against the bottom of the needle on the needle body in a direction opposite to the insertion is high enough, indicating that the needle itself has or is moving in this undesirable (for treatment) direction. In this case, any blocking method described herein for stopping the flow in the needle can be initiated.

[0169] A needle safety system is disclosed that is capable of sensing relative movement of a needle in a direction away from an insertion position relative to a tape over the needle that holds the needle in place. This may be accomplished by a mechanism that relies on a combination of position and / or velocity and / or acceleration changes with respect to components located over and in contact with the needle and in contact with the tape. A threshold change in position, velocity or acceleration of the needle in a direction away from its intended insertion point, as determined by a relative difference between the tape component and the needle, will result in triggering one of the flow blocking methods through a connection between a detection system and an integrated flow blocking system.

[0170] The disclosed device may not use electricity and therefore does not require an external power source, battery, or cables, thereby increasing the ability to employ the device in medical workspaces that are complex and require simplified solutions. The disclosed device is fully sterilizable and may be fully disposable. The disclosed device may be inexpensively manufactured using high-volume injection molding processes. The disclosed device advantageously does not require extensive clinical training.

[0171] The disclosed needle safety system can be added to an existing needle / tube.

[0172] Disclosed are systems designed to deliver fluids directly into a patient's body. In hemodialysis, the fluid is blood. In other cases, the fluid may be saline or medication. Vascular access is typically performed in hospitals, clinics, and other medical settings, as well as at home (e.g., during home hemodialysis).

[0173] One aspect of the present disclosure is a 2-shot molded part having a structurally strong and mechanically sound cylindrical tube and a region of mechanically compressible soft material through which an external component can be pushed to block flow through the strong tube.

[0174] Features of the present disclosure provide an important difference in the needle system manufacturing process that enables efficient and cost-effective development of the needle system. In these methods, 2-shot injection molding is used to produce internal components that can quickly and effectively interrupt the internal flow path during needle removal. 2-shot injection molding is used to produce a hard-walled flow tube with good mechanical properties having an integrated mechanically soft and compressible area. The compressible area provides a method by which an external component can be introduced into the flow path to block the flow. This flow obstruction can be temporary. When the component (e.g., a pedal on the bottom of the needle body) is allowed to return to its original position, the flow path becomes unobstructed again.

[0175] Another aspect of the present disclosure is a variation of the soft film portion of the 2-shot molded component that incorporates a self-contained pocket that improves closing and occlusion efficiency during activation of the pedal portion of the safety needle.

[0176] Another feature of the present disclosure is an assembly method and technique that enables the integration of 2-shot molded internals with other components required to manufacture other conventional needle assemblies, including a needle removal safety mechanism. These components include the butterfly wing, needle, tube, and skin sensing element (in this example, a spring-loaded pedal). The use of 2-shot molding allows for an efficient needle manufacturing technique, wherein other needle system components can be appropriately assembled around the 2-shot molded components, thereby producing a final product that balances functionality, cost-effectiveness, and build efficiency. The 2-shot molded components allow these other components to be assembled in a logical sequence, which saves time and reduces the risk of spreading adhesive material onto surfaces, where spreading adhesive material may become a problem for subsequent manufacturing steps or even cause product failure. In some cases (e.g. Fig. 10A and 10B ), the butterfly wings can be slid onto the secondary injection molded part from the rear or from the front in the most appropriate way.

[0177] One aspect of the present disclosure is a modification to the pedal design that enables efficient device assembly / manufacturing. Such modifications to the pedal include the use of U-shaped fittings that enable a snap-fit ​​assembly method, or the use of a ring / ferrule system that allows a press-fit assembly method where the ring / ferrule slides over a 2-shot molded core for system integration. The snap-fit ​​or slide-on techniques may or may not be enhanced with additional bonding methods, including but not limited to gluing or ultrasonic welding.

[0178] Another aspect of the present disclosure is the modification of the butterfly wing component to enable the wing to be effectively integrated onto a 2-shot injection molded internal part component. Such a wing can be modified to include a U-shaped snap feature or a ring / collar system that allows a slide-type assembly method. The slide can be performed from the front or back of the assembly. The snap or slide technology can be enhanced with or without additional bonding methods, including but not limited to gluing or ultrasonic welding.

[0179] One aspect of the present disclosure is a needle safety system or add-on to an existing needle / tube that uses a force sensing mechanism within the device to determine if and when a given needle / tube set that has been inserted into a patient has experienced dislodgement. This can actually occur during medical treatment when the tube leading to the vascular access needle is pulled or dragged, either intentionally or unintentionally. This can also occur when the medical tape used to hold the inserted needle in place on the skin becomes loose due to reduced tape adhesion due to excessive hair growth or increased sweating / humidity in the patient.

[0180] One embodiment of the disclosed system and device is to use a spring-loaded pedal as a detector of the presence of underlying skin to determine if and when a needle inserted for fluid delivery has been removed from a patient.

[0181] Features of the present disclosure provide important design features that enable the use of an appropriate spring to achieve the necessary sensing of the patient's arm beneath the needle. An effective spring can be manufactured using pre-bent metal pieces and integrated into an existing pedal design.

[0182] Another feature of the present disclosure is that by modifying the metal spring, the extension of the spring toward the proximal end of the device can also serve as a stopper that enters the fluid path to cause a flow restriction that results in automatic machine shut down.

[0183] Another feature of the present disclosure is that by incorporating a living hinge during product molding, the needle butterfly assembly and the pedal can be molded simultaneously, thereby improving manufacturing efficiency. In the final product, the pedal folds to a position below the needle body.

[0184] Another feature of the present disclosure is to use a plastic cap to cover the proximal extension of the metal spring of the occluder. By modifying the shape, size or contour of the plastic cap, the fluid flow path dynamics can be adjusted / controlled to improve function.

[0185] Another feature of the present disclosure is a modification of a standard needle cap so that the cap can cover and protect the needle and serve as a means by which the pedal is maintained in a range of positions from fully closed to fully open during shipping and during storage prior to use on a patient.

[0186] Various variants of protective needle guards. The sliding systems all have a common design, namely a plastic component, wherein the plastic component is actively moved into position over the sharp needle during intentional withdrawal from the patient after treatment.

[0187] The present disclosure relates to potential modifications to these existing or other designs that would enable the effective use and configuration of needle guards on needle systems equipped with a pedal or other type of integrated skin sensor that is used as part of an overall safety system to protect a patient from the risk of accidental needle dislodgment during a medical treatment (typically hemodialysis, but any other treatment involving the flow of fluid to or from the patient is possible, where the fluid is blood in hemodialysis and may be saline or medication in other cases).

[0188] One aspect of the present disclosure is a modification to a needle guard safety system for protecting patients and caregivers from accidental needle sticks after treatment.

[0189] One embodiment of this modification is the use of a beveled or chamfered edge that can more easily achieve effective automatic closure of the spring-loaded pedal as the needle guard is actively slid into its protective position during use. The beveled or chamfered edge can reduce the likelihood that the needle guard will get caught or caught on the proximal portion of the pedal as the caregiver slides the needle guard into position. Such a beveled or chamfered edge is Fig.23 Shown in.

[0190] A second embodiment of such a modification is to form a larger angled or chamfered feature in the bottom design of the slidable needle guard. This type of technology can achieve effective closure by mechanically redesigning the bottom aspect of the guard so that the device presents an angled opening to the distal portion of the pedal in the transition area where the pedal slides into the needle into the guard. The redesigned opening feature can be achieved simply by making the downward portion of the transition area at an appropriate angle, extending into the needle guard to a certain appropriate depth. More complex is to form an angled entryway of a certain depth in the needle guard, which will result in an increase in the available space to accommodate the pedal.

[0191] The present disclosure is directed to a method that improves the ability of any given needle guard to be smoothly and effectively placed so that the needle can be effectively covered while the pedal is not obstructed in any way.

[0192] One aspect of the present disclosure is a needle safety system or add-on device to an existing needle / tube that uses a force sensing mechanism within the device to determine if and when a given needle / tube set that has been inserted into a patient has experienced dislodgement. This can actually occur during medical treatment when the tubing leading to the vascular access needle is pulled or dragged, either intentionally or unintentionally. This can also occur when the medical tape used to hold the inserted needle in place on the skin becomes loose due to excessive hair growth or increased sweating / humidity on the patient causing the tape to lose adhesion and become loose.

[0193] Features of the present disclosure provide important protection for the patient during removal by maximizing the device's ability to produce a pressure change in the fluid line that is of sufficient magnitude to cause an automatic machine shutdown based on a pressure-triggered alarm. The present disclosure relates to a process for producing a mechanical interruption within the needle fluid flow path that artificially increases the line pressure in a standard needle set during treatment. In the event that the patient input pressure (venous access pressure or VAP in the case of hemodialysis) is less than the difference between the baseline operating pressure and the machine's lower limit setting for pressure detection, it is very likely that the removal of a standard needle will not be detected by the machine. Features of the present disclosure are a pedal / flow tube configuration that uses a mechanical interruption within the flow path to artificially increase the patient's baseline venous line pressure during treatment. When needle removal occurs, the increased pressure difference between the state of the venous needle set that is mechanically occluded during normal fluid delivery and the needle set during removal will produce a pressure change of significant magnitude to clearly trigger the pressure alarm limit of most machines.

[0194] Figure 1A variation of a tissue access device 10 is shown. The device 10 can extract fluid (e.g., blood, lymph, interstitial fluid) from a tissue or a blood vessel lumen. The device 10 can deliver fluid (e.g., blood, lymph, saline, drugs) to a tissue or a blood vessel lumen. For example, the device 10 can be used in a hemodialysis treatment to extract blood from a blood vessel for filtration and return the filtered blood to the blood vessel. Multiple devices 10 can also be used. For example, for a hemodialysis treatment, a first device 10 can be used to extract unfiltered blood from a blood vessel, and a second device 10 can be used to return the filtered blood to the same or different blood vessel. The number of devices 10 used will depend on the number of access points required, and can range, for example, from 1 to 5 or more, including every 1 device increment within the range. The device 10 can control the delivery and / or extraction of fluids through a channel (also referred to as a device channel and a device flow path) in the device 10. For example, when the device 10 is removed during a removal event, the device 10 can automatically reduce (e.g., partially or completely block) the flow of fluid through the channel.

[0195] The device 10 may have a variety of device configurations. For example, the device 10 may have a non-occlusive configuration and / or one or more occlusive configurations. The occlusive configuration may correspond to a partially occluded configuration, a completely occluded configuration, or any combination thereof. When the device 10 is in a non-occlusive configuration, the fluid may flow through the device channel in a manner that is not restricted by the device 10. When the device 10 is in an occlusive configuration, the fluid flow through the device channel may be reduced or completely blocked by the device 10. The device 10 may limit or terminate the fluid flow through the device channel by reducing the channel cross-sectional area from a first cross-sectional area to a second cross-sectional area that is less than the first cross-sectional area. The second cross-sectional area may be about 1% to about 100% smaller than the first cross-sectional area, including every 1% increment within this range, wherein 100% may correspond to a complete blockage of the channel in one or more channel cross sections. The channel may have a channel longitudinal axis and a channel transverse axis. The channel cross-sectional area may be a transverse cross-sectional area perpendicular to the channel longitudinal axis.

[0196] For example, the device 10 may allow less fluid to flow through the device 10 in an occluded configuration than in a non-occluded configuration as measured over a time interval T (e.g., about 0.25 seconds to about 60.0 seconds). For example, the device 10 may allow less fluid to flow through the device in a first occluded configuration than in a second occluded configuration as measured over a time interval T, wherein the second occluded configuration obstructs more of the device flow path than the first occluded configuration. For example, the device 10 may allow more fluid to flow through the device in a first occluded configuration than in a second occluded configuration as measured over a time interval T, wherein the second occluded configuration obstructs less of the device flow path than the first occluded configuration.

[0197] When the device 10 is inserted or attached to tissue, the device 10 may have a non-occlusive configuration or a partially occlusive configuration. The device 10 may have an occlusive configuration before the device 10 is inserted into tissue, when the device 10 is inserted into tissue, when the device 10 is removed or separated from tissue, or any combination thereof.

[0198] When the device 10 is inserted into the tissue, the device 10 can gradually become less occluded by changing from a more occluded configuration to a less occluded configuration. For example, when the device 10 is inserted into the tissue, the device 10 can change from an occluded configuration to a non-occluded configuration. As another example, when the device 10 is inserted into the tissue, the device 10 can change from a first occluded configuration to a second occluded configuration having a less occluded degree than the first occluded configuration. When the insertion of the tissue is completed, the device 10 can have an insertion configuration. The device 10 can be removably fixed to a non-device 10 surface, such as skin, for example, with tape, glue, elastic band or any combination thereof. When the device 10 is removably fixed to a non-device surface, the device 10 can have an attachment attachment configuration (also referred to as a non-removal configuration). The insertion and attachment configurations can be the same or different from each other. For example, the insertion and attachment configurations can be non-occluded configurations or partially occluded configurations. As another example, the insertion configuration can be an occluded (partially or completely) configuration, and the attachment configuration can be a non-occluded configuration or an occluded configuration having a less occluded degree than the occluded insertion configuration.

[0199] As the device 10 is removed from the non-device surface, the device 10 may gradually become more occluded by transitioning from a less occluded configuration to a more occluded configuration. For example, as the device 10 is removed from the non-device surface, the device 10 may transition from a non-occluded configuration to an occluded configuration. As another example, as the device 10 is removed from the non-device surface, the device 10 may transition from a first occluded configuration to a second occluded configuration that is more occluded than the first occluded configuration. The device 10 may have a removed configuration when one or more portions of the device 10 are removed from the non-device surface by an occlusion threshold distance of about 5 mm to about 25 mm, including every 1 mm increment within the range.

[0200] When the device 10 is removed or detached from the non-device surface, the device 10 may automatically move from the attached configuration to the removed configuration. The device 10 may transition from the attached configuration to the removed configuration in less than 0.10 seconds, 0.25 seconds, 1 second, 5 seconds, 10 seconds, or 60 seconds. For example, the device 10 may automatically move from the attached configuration to the removed configuration in 0.01 seconds to 1.00 seconds, including every 0.01 seconds (e.g., 0.10 seconds) within this range.

[0201] Figure 1 Variations of occluded configurations of the device 10 are shown, such as a partially occluded configuration or a fully occluded configuration. Figure 1It is also shown that the device 10 can have the same configuration before the device 10 is inserted into the tissue and attached to the non-device surface and after the device 10 is removed from the non-device surface. When the device 10 is separated from the non-device surface, the device 10 can remain in the tissue or can also be removed from the tissue. For example, when the device 10 is removed from the non-device surface, the portion of the device 10 that is in the blood vessel (e.g., the needle) can remain in the blood vessel, can be removed from the blood vessel but remain in the tissue adjacent to the blood vessel, or can be removed from the blood vessel and tissue together.

[0202] Figure 1 It is further shown that the device 10 may have a device longitudinal axis A1. The device longitudinal axis A1 may be the central longitudinal axis of the device 10. The device longitudinal axis A1 may be the central longitudinal axis of the flow channel in the device 10. The device longitudinal axis A1 may be straight or curved. The device longitudinal axis A1 may be perpendicular to the device first transverse axis A2. The device longitudinal axis A1 may be perpendicular to the device second transverse axis A3. The device first transverse axis A2 and the device second transverse axis A3 may be perpendicular to each other. The device first and second transverse axes A2, A3 may be straight or curved.

[0203] The device 10 may have a device proximal end 10a and a device distal end 10b. The device 10 may have a device first side 10c and a device second side 10d. The device first side 10c may be the bottom surface of the device 10, and the device second side 10d may be the top surface of the device 10.

[0204] Figure 1 It is also shown that the device 10 may have a needle 12 and a housing 14 (also referred to as a needle body). The needle 12 may be, for example, an AV fistula cannula needle or an arteriovenous (AV) fistula butterfly needle housed in a flexible sheath (not shown). The needle 12 may have a needle proximal end 12a and a needle distal end 12b. The housing 14 may be a butterfly housing. For example, the housing 14 may have a first wing 15a and a second wing 15b. The housing may have a housing proximal end 14a and a housing distal end 14b. A needle hub 13 may connect the needle 12 and the housing 14 together. The device 10 may have a connector 16 configured to connect the tube 8 to the device 10. The connector 16 may be external and / or internal to the housing 14. Additionally or alternatively, the connector 16 may be integrated with the housing 14. When connected to the device 10, the tube 8 may be in fluid communication with the needle 12 via a flow channel in the housing 14 (e.g., via the connector 16). The connector 16 may be a rigid material, a semi-rigid material, or a flexible material. The housing may be made of a rigid material, such as plastic, metal, composite material, or any combination thereof.The tip of the needle 12 may be the distal end of the device along the longitudinal axis A1 of the device.

[0205] Figure 1It is also shown that the device 10 can have a sensor 18. The sensor 18 can be a non-device surface sensor, such as a skin sensor. The sensor 18 can be a mechanical sensor. The sensor 18 can be a valve, such as a pinch valve. One or more portions of the sensor 18 can be elastically movable. For example, one or more portions of the sensor 18 can be biased (e.g., via compression and / or tension) to elastically strain away from a sensor neutral position and unstrain back to a sensor neutral position. When a force is applied to the sensor 18 from a non-device surface (e.g., when the device 10 is inserted and attached to the skin), the sensor 18 can change shape. When the force is removed from the sensor 18 (e.g., when the device 10 is removed from the skin), the sensor 18 can change shape.

[0206] The sensor 18 may include, for example, one or more arms, plates, protrusions, extensions, occluders, openings, channels, springs, spring regions, or any combination thereof. The sensor 18 may be disposed on a first side of the device (e.g., first lateral side, bottom side), a second side of the device (e.g., second lateral side, top side), a third side of the device (e.g., first lateral side, left side), a fourth side of the device (e.g., second lateral side, right side), a fifth side of the device (e.g., first longitudinal side, front side), a sixth side of the device (e.g., second longitudinal side, rear side), or any combination thereof. For example, the sensor 18 may be a base plate (also referred to as a pedal), a top plate, a side plate, a front plate, a back plate, or any combination thereof, such that at least a portion of the sensor 18 may detect contact and loss of contact with a non-device surface and / or may detect contact force and reduction in contact force from a non-device surface. For example, Figure 1 It is shown that the sensor 18 may be a skin sensing pedal (also called a movable pedal).

[0207] The sensor 18 may have a sensor proximal end 18a and a sensor distal end 18b. The sensor proximal end 18a and / or the sensor distal end 18b may be configured to slide over a non-device surface when the needle 12 is inserted into tissue. The sensor distal end 18b may have a sensor distal tip 24. The sensor distal tip 24 may be an edge or a surface.

[0208] Sensor 18 may be connected to device 10 (e.g., housing 14) with or without a hinge. For example, Figure 1 It is shown that the sensor proximal end 18a can be directly or indirectly attached to the housing 14 at the device first side 10c without a hinge. The portion of the sensor 18 that is attached to the housing 14 (e.g., the sensor proximal end 18a) can be attached using glue, welding (e.g., sonic welding), snap fit, friction fit, or any combination thereof.

[0209] The sensor distal end 18b can move relative to the sensor proximal end 18a. For example, the sensor distal end 18b can rotate around a sensor hinge (not shown). The sensor hinge can be attached to or integrated with the sensor 18. The sensor hinge can be a spring. The sensor 18 can have multiple sensor hinges / springs.

[0210] The sensor spring (not shown, also referred to as spring area) can cause the distal end 18b to be positioned a distance away from the needle 12 during removal (and before attachment). The sensor spring can bias the sensor distal end 18b to be in a neutral position a distance away from the needle 12 during removal (and before attachment).

[0211] The sensor distal end 18b can have one or more distal segments, for example, 1 to 10 or more segments, including every 1 segment increment within this range (e.g., 2 segments, 3 segments). One or more distal segments can be straight. One or more distal segments can be curved. The sensor distal segments can be angled relative to each other, for example, from about 0 degrees to about 120 degrees, including every 1 degree increment within this range (e.g., 90 degrees).

[0212] For example, Figure 1 It is shown that the sensor distal end 18b may have a distal first segment 20a, a distal second segment 20b, and a distal third segment 20c between the distal first segment 20a and the distal second segment 20b. Figure 1 It is shown that the first segment 20a and the second segment 20b can be straight and the third segment 20c can have a bend 21. The first segment 20a and the second segment 20b can be at an angle of about 90 degrees relative to each other. The different distal portions can be integrated or attached to each other. For example, the sensor distal end 18b can be a monolithic structure. The sensor 18 can be a monolithic structure.

[0213] A curved sensor distal end (e.g., distal end 18b having bend 21) can make the needle insertion process and / or insertion process easier by reducing friction between the device 10 and non-device contact surfaces during insertion, thereby improving the usability of the device 10 for the caregiver. For example, the bend / curved surface 21 can cause the sensor leading edge (e.g., sensor tip 24) to face or extend away from a non-device surface (e.g., away from a patient's skin surface) during insertion. Having the sensor leading edge 24 facing or extending away from the insertion surface during needle insertion can ensure easier needle insertion by reducing or eliminating the possibility of the sensor leading edge catching on the insertion surface when the needle 12 is inserted.

[0214] The curved distal end 18b can also protect the patient by preventing over-insertion of the needle. For example, the distal second segment 20b can be configured to prevent over-insertion of the needle 12 into the blood vessel by acting as a stopper to prevent the needle 12 from being inserted through the second segment 20b. The curved end provides protection to the patient by "blocking" any forward movement of the needle body into the existing needle entry hole (not shown) in this position. The sensor distal end 18b can have a portion (e.g., segment 20b) extending toward the needle 12, with or without a bend 21 in the sensor distal end 18b, so that the sensor distal end 18b can define a needle over-insertion stopper (e.g., segment 20b) in any variation of the sensor 18. Such a stopper can inhibit or prevent the needle 12 from being over-inserted into the skin, for example, longitudinally and / or transversely relative to the longitudinal axis of the needle 12 and / or relative to the needle insertion hole in the skin.

[0215] The curved distal end 18b enables needle removal detection in a desired manner even when the needle (e.g., needle 12) is inserted at a steep insertion angle, e.g., up to 45 degrees, up to 50 degrees, up to 60 degrees, or more. Under these steep insertion angle conditions, the curved end allows for maximum contact between the skin and the closed sensor 18 (not shown, which may be the configuration of the sensor 18 when the device 10 is in the attached configuration), providing increased device functionality by ensuring that the sensor 18 remains in close proximity to the blocked needle 12 regardless of the insertion angle.

[0216] The sensor distal end 18b may have a sensor opening 22 (also referred to as a sensor slot). The sensor opening 22 may receive a portion of the needle 12. For example, Figure 1 The sensor distal second section 20b is shown to have a sensor opening 22. The sensor opening 22 can be configured to receive at least a portion of the needle 12 when the sensor distal end 18b is pressed toward the needle 12 by a non-device surface, for example, when the device 10 is in an insertion or attachment configuration. The sensor opening 22 can advantageously allow the sensor 18 to be closed (e.g., fully closed) against the needle 12 when the sensor distal end 18b is pressed toward the housing 14 (e.g., against the housing 14). The sensor opening 22 can be, for example, U-shaped, V-shaped, or irregularly shaped. At least a portion of the distal tip 24 can define the sensor opening 22.

[0217] The sensor opening 22 integrated with the sensor distal end 18b can allow an over-insertion barrier (e.g., barrier 20b) to be closed around at least a portion of the needle 12 when the device is in the attached configuration. The sensor opening 22 can allow the barrier 20b to better prevent over-insertion by increasing the surface area of ​​the barrier proximate the needle 12, which can prevent further insertion of the needle 12. The barrier 20b can be positioned between the needle tip and the needle hub 13. The sensor opening 22 can be positioned between the needle tip and the needle hub 13. This arrangement can ensure that the needle 12 is not inadvertently pushed deeper into the patient's body through an existing needle access hole.

[0218] Figure 2A The sensor 18 shown may have one or more sensor springs 26 (also referred to as a spring zone), such as 1 to 10 or more springs 26, including every spring increment within this range (e.g., 1 spring, 2 springs). For example, Figure 2A The sensor 18 is shown to have a first spring 26a and a second spring 26b. When multiple springs 26 are used, the multiple springs 26 (eg, first spring 26a and second spring 26b) may be used together as a single spring.

[0219] The springs 26 (e.g., the first spring 26a and the second spring 26b) can function similar to a leaf spring, a compression spring, a tension spring, a torsion spring, or any combination thereof. Each spring 26 can be, for example, a leaf spring, a compression spring, a tension spring, or a torsion spring. The first spring 26a and the second spring 26b can be springs of the same or different types. For example, the first spring 26a can be a leaf spring and the second spring can be a compression spring. As another example, the first spring 26a and the second spring 26b can both be leaf springs, or function similarly to leaf springs.

[0220] The spring 26 can be integrated with, attached to, or embedded in the sensor 18. For example, the spring 26 can be a molded spring made of the same or different material as the rest of the sensor 18. The molded spring 26 can be manufactured by molding the sensor 18 to have one or more non-straight elastic portions (e.g., first and second spring regions 26A, 26b) that can function as a spring when the shape of the elastic portion changes (e.g., straightens). The non-straight elastic portion can be, for example, a curved, multi-reinforced and / or zigzag structure, member, bar, rod, shaft, sheet, laminate, or any combination thereof. For example, the molded spring design can advantageously reduce the manufacturing costs associated with the sensor 18 compared to attaching or embedding a separate spring 26 into the sensor 18.

[0221] When the spring 26 is in a neutral configuration (e.g., an undeflected configuration, a non-strained configuration, a non-stressed configuration), the spring 26 may have a curved or angled zigzag structure. Figure 2A The spring 26 may have a neutral configuration when the device 10 is in the attached configuration (e.g., the removed configuration) and / or before the device 10 is attached to tissue. The spring 26 may be less bent or angled when the device 10 is in the attached configuration, e.g., when the spring 26 is in a compressed and / or tensioned configuration (e.g., a non-neutral configuration). Figure 2A When the sensor 18 is placed in a straightened or less bent configuration, the mechanical stress on the bent portion (spring regions 26a and 26b) can result in an effective spring force. This spring force can bias the sensor 18 to return to the initial configuration. The direction and magnitude of the spring force can depend on the mechanical shape and size of the associated accessories of the sensor 18 (e.g., flow restrictors, features of the sensor distal end 18b).

[0222] The spring 26 may be a sensor hinge configured to allow the sensor distal end 18b to move (eg, rotate) relative to the sensor proximal end 18a.

[0223] Springs 26 (e.g., springs 26a and 26b) can connect sensor proximal end 18a to sensor distal end 18b. Springs 26 can be in the middle region of sensor 18, and / or on sensor distal end 18b or on sensor proximal end 18a. As another example, springs 26 can extend across all or a portion of both device proximal end 18a and device distal end 18b. For example, Figure 2A The spring 26 is shown to be located on the sensor proximal end 18A, wherein the sensor proximal end 18A and the distal end 18b are shown to be separated by a sensor central transverse axis A4. The sensor transverse axis A4 may be curved or straight.

[0224] Figure 2AIt is also shown that the sensor 18 can have a flow restrictor 28. The flow restrictor 28 can have an obturator arm 30 and an obturator 32. The obturator 32 can be, for example, a protrusion extending away from the obturator arm 30 toward the longitudinal axis A1 of the device. The flow restrictor 28 can be integrated with the sensor 18 or attached to the sensor 18. The obturator 32 can be configured to obstruct the flow path of the device when the device 10 is in the removed configuration. The obturator 32 can be rigid. The obturator 32 can be non-deformable. The obturator 32 can be flexible. The obturator 32 can have a blunt head. The obturator 32 can have a pointed head. The obturator 32 can be straight and / or curved. The obturator 32 can have an irregular shape. The spring area 26 can be located on one or both sides of the flow restrictor 28. The spring 26 can bias the flow restrictor 28 to a default occluded position in an elastic manner. For example, when the device 10 is removed, the spring force of the spring 26 can cause the occluder 32 to move directly into the device flow channel and block or occlude the flow of fluid through the device flow channel. The curved regions 26a and 26b form an internal or integrated hinge point for the flow restrictor 28. The sensor 18 can have a sensor hole 36 that can accommodate the flow restrictor 28 when the sensor is straightened. Alternatively or additionally, all or part of the sensor hole 26 can be a groove in the sensor 18. The flow restrictor 28 can be centered in the hole / groove 36 or offset in the hole / groove 36.

[0225] By using the curved portion of the sensor 18 as a mechanical spring, a conventional hinge is not required, which may be required in situations where the member is tilted from a flat position to an angled position. In addition, by tightly securing a portion of the pedal 18 to the needle body 14 using glue, sonic welding, or any other technique (e.g., friction fit, snap fit), the pedal 18 can be made to sense the underlying skin and act as a mechanism to occlude blood flow in a spring-like manner. The hinge point A5 is integrated into the central occluding member 28 of the pedal at the base of the occluder arm 30 as the point where the central curvature 26 produces a natural bending motion. This design can desirably eliminate the need for a conventional hinged attachment on the needle body 14, thereby allowing the mechanical structure of the device 10 to become less susceptible to interference, for example from standard medical tape, which is typically placed on the needle device 10 to hold them in place.

[0226] The sensor 18 can have one or more attachment areas 34. The attachment areas 34 can allow the sensor 18 to be attached to the housing 14 without a hinge. The attachment areas 34 can be attached to the housing 14. For example, the attachment areas can be glued or welded (e.g., sonic welded) to the housing 14. As another example, the attachment areas 34 can fit into corresponding recesses in the housing 14 by snap fit, friction fit, adhesive fit, or any combination thereof.

[0227] Figure 2BIt is shown that the sensor 18 can have a sensor first longitudinal axis A6 and a sensor second longitudinal axis A7. The sensor first longitudinal axis A6 can be the longitudinal axis of the occluder arm. The sensor first longitudinal axis A6 can be the central longitudinal axis of the occluder arm 30. The sensor first longitudinal axis A6 can be curved or straight. The sensor second longitudinal axis A7 can be the longitudinal axis of the sensor proximal end 18a portion close to the spring portion 26. The sensor second longitudinal axis A6 can be the central longitudinal axis of the sensor proximal end 18a. The sensor second longitudinal axis A7 can be curved or straight. An angle 38 can exist between the sensor first longitudinal axis A6 and the second longitudinal axis A7. When the device 10 is in the removed configuration, the sensor 18 can be in an occluded configuration (also referred to as a sensor closed configuration) such that the angle 38 is about 10 degrees to about 75 degrees, including increments of 1 degree each within this range (e.g., 25 degrees, 30 degrees). When the device 10 is in the attached configuration, the sensor 18 can be in a less occluded configuration than when the device 10 is in the removed configuration (also referred to as the sensor open configuration), such that the angle 38 is about 0 degrees to about 30 degrees, including every 1 degree increment within this range (e.g., 0 degrees, 2 degrees, 5 degrees). The angle 38 between the sensor first longitudinal axis A6 and the sensor second longitudinal axis A7 when the sensor 18 is in the open configuration can be less than the angle 38 between the sensor first longitudinal axis A6 and the sensor second longitudinal axis A7 when the sensor 18 is in the closed configuration, for example, about 10 degrees to about 75 degrees less, including every 1 degree increment within this range.

[0228] Figure 2B It is also shown that the sensor 18 may have a sensor first transverse axis A8 and a sensor second transverse axis A9. The sensor first transverse axis A8 may be an axis of the sensor distal end (e.g., the sensor distal end second section 20b). The sensor first transverse axis A8 may be a central axis of the sensor distal end second section 20b. The sensor first transverse axis A8 may be curved or straight. The sensor second transverse axis A9 may be an axis of the occluder 32. The sensor second transverse axis A9 may be perpendicular to the axis of the occluder arm 30 (e.g., perpendicular to the axis A7). The sensor second transverse axis A9 may be curved or straight. The sensor first transverse axis A8 and the second transverse axis A9 may be parallel or non-parallel to each other. As another example, one or both of the sensor first transverse axis A8 and the second transverse axis A9 may extend at least partially in the longitudinal direction, such as along the axis A6 and / or A7. As yet another example, one or both of the sensor first longitudinal axis A6 and the second longitudinal axis A7 may extend at least partially in a transverse direction, such as along axes A8 and / or A9.

[0229] Figure 2BIt is further shown that the sensor distal end 18b can have a transverse dimension 40 of about 5 mm to about 20 mm measured along the axis A8, including every 1 mm increment (e.g., 8 mm) within this range. The sensor opening transverse dimension 42 can be about 2 mm to about 20 mm, including every 1 mm increment (e.g., 5 mm) within this range. As another example, the sensor opening transverse dimension 42 can be the same as the transverse dimension 40. The sensor opening transverse dimension 42 can be selected so that: when the device 10 is in the attached configuration, the needle 12 is configured to contact or be located above the bottom surface of the sensor opening 22. Selecting the opening transverse dimension 42 so that the needle 12 does not contact the bottom surface of the sensor opening 22 when the device 10 is in the attached configuration can advantageously allow the needle 12 to float within the sensor opening 22 so that the sensor distal end 18b does not push the needle 12 upwardly out of the skin during insertion. Allowing the needle 12 to float in the sensor opening 22 is useful in situations where the user must "fish" the blood vessel during insertion, such that the user changes the angle of the device 10 relative to the patient's skin while a portion of the needle is inserted into the tissue. This is also useful where the angle of the device 10 relative to the skin is atypically low (eg, less than 30 degrees, less than 20 degrees, less than 10 degrees).The angle of the device 10 relative to the skin can be measured between the skin surface and the device longitudinal axis A1.

[0230] Figure 2B The obturator 32 is further shown to have a transverse dimension 44 measured along the axis A9 of about 1 mm to about 15 mm, including every 1 mm increment therein (eg, 4 mm, 5 mm).

[0231] Figure 2B It is also shown that the sensor 18 can have a sensor first contact surface 48 and a sensor second contact surface 50. The sensor first contact surface 48 can be configured to removably contact a non-device surface, such as skin, and is therefore also referred to as skin contact surface 48. The sensor second contact surface 50 can be configured to removably contact a device surface, such as a surface of the housing 14, and is therefore also referred to as housing contact surface 50.

[0232] Figure 2C It is shown that the obturator opening 22 can extend through the second and third sections 20b, 20c of the sensor distal end. The sensor opening longitudinal dimension 46 can be about 0 mm to about 50 mm, including increments of 1 mm (e.g., 5 mm) within this range. Having a sensor opening longitudinal dimension 46 greater than zero can allow the needle 12 to float in the sensor opening 22 during low-angle insertion. A sensor opening longitudinal dimension 46 greater than zero can also desirably reduce the material required to manufacture the sensor 18, thereby reducing manufacturing costs.

[0233] Figure 2CIt is further shown that the sensor 18 may have a dimension 47 measured between the proximal end of the sensor and the distal end of the sensor. This dimension may be, for example, from about 10 mm to about 50 mm or more, including every 1 mm increment within this range. Dimension 47 may be the longitudinal length of the sensor 18 as measured along a straight axis or along a curved axis, when in Figure 2A In the neutral position, the axis of the bend follows the contour of the sensor 18 .

[0234] Figure 1-2C It is shown that the device 10 may have a spring 26, a flow limiter 28, an over-insertion protector (e.g., the sensor distal second section 20b), or any combination thereof. Any combination of the spring 26, the flow limiter 28, and the over-insertion protector may be integrated with each other. For example, the spring 26 and the flow limiter 28 may be integrated with each other. The spring 26, the flow limiter 28, and the over-insertion protector (e.g., the sensor distal end 18b) may be integrated with each other. As another example, the spring 26 may have an integrated flow limiter (e.g., the flow limiter 28). The spring 26 may have an integrated over-insertion protector (e.g., the distal end of the sensor distal end 18b). The spring 26 may have an integrated flow limiter (e.g., the flow limiter 28) and an over-insertion protector (e.g., the distal end of the sensor distal end 18b).

[0235] Additionally or alternatively, the device 10 may have an over-insertion protector attached to or integrated with the housing 14 and / or the needle hub 13 that is different from the over-insertion protector that may be part of the sensor 18. In this variation, the over-insertion protector may be an elongated element (e.g., a rod, a plate) that extends at least partially in a longitudinal direction away from the needle hub 13 and at least partially in a lateral direction toward the needle 12, for example, the over-insertion protector may have the same shape as the sensor distal end 18b, where it is just turned upside down and attached to or integrated with the housing 14 (where "same shape" may be without the sensor proximal end 18a, without the spring 26, and without the flow restrictor 28). The over-insertion protector may have an opening similar to or the same as the opening 22. The over-insertion protector may be on the device second side 10d and / or one of the device lateral sides. In the case where the device 10 has an over-insertion protector that is not attached to or integral with the sensor 18b, but rather has an over-insertion protector attached to the housing 14 and / or the needle hub 13, the sensor distal second section 20b may be positioned relative to the sensor 18b. Figure 1-2C14, and the second insertion protector 20a may be shortened as shown in FIG. 14 so that it does not extend as far toward the needle 12 (e.g., 5 mm to 15 mm shorter), for example, so that the sensor distal second segment 20b does not interfere with the over-insertion protector. As another example, the device 10 may have a first insertion protector attached to or integrated with the sensor 18 and a second insertion protector attached to or integrated with the housing 14 and / or the needle hub 13.

[0236] Another variation of the flow restrictor 28 may be a flow restrictor having an occluder arm 30 but without an occluder 32. In this variation, the occluding portion of the sensor 18 may be the end of a straight rod 30 (e.g., the occluder is positioned on the flow restrictor 28). The occluder arm 30 may be a tapered rod. As another example, the occluder arm 30 may be one or more curved, polyline, and / or multi-segment reinforced polygonal rod segments (e.g., different from the occluder protrusion 32) such that the rod 30 is not occluded. Figures 2A-2C The illustrated case of the occluder 32 can still be used as an occluder.

[0237] The sensor 18 may have a spring 26. For example, another variation of the sensor 18 may be Figure 2A-2C One half of sensor 18 is shown. Although one spring 26 (eg, spring 26a or spring 26b) is used instead of two, such a sensor may still function as described herein. Figure 2C Axis A10 in FIG. 1 shows that the sensor 18 can be sliced ​​to produce a smaller sensor 18. One or two halves of the sensor can be made. As another example, in a single spring sensor, the sensor proximal end 18a can remain unchanged, but the sensor distal end 18b connected to the sensor proximal end 18a can be made of Figure 2C The sensor 18 may be separated into two halves (eg, the left or right side of the sensor 18) by the axis A10 in the middle. Such a single spring sensor 18 may or may not have a sensor opening 22. If there is no opening 22, the sensor distal end 18b may still serve as a stopper to prevent over-insertion.

[0238] Figure 3A and Figure 3B The device 10 is shown in a variation of the attachment configuration. To maintain this attachment configuration, the device 10 can be attached to a non-device surface such as skin. For clarity, Figure 3A and Figure 3B Neither tape nor skin is shown.

[0239] Figure 3A and Figure 3B It is further shown that the device 10 may have an attached configuration when an external force 80 is applied to the device first side 10c by a non-device surface (e.g., skin). Figure 3A and Figure 3B Not shown, the device 10 may be attached to the skin, for example, using tape or glue, to secure the device 10 in the attached configuration.

[0240] Figure 3A It is shown that when the device 10 is in the attached configuration, the housing contact surface 50 can abut the housing 14. When the device 10 is in the attached configuration, all or a portion of the skin contact surface 48 can contact the skin, including, for example, the sensor proximal end 18a, the sensor distal end 18b, the spring area 26, the obturator arm 30, or any combination thereof. For example, for the sensor distal end 18b, when the device 10 is in the attached configuration, the skin contact surface 48 of the sensor distal third segment 20c, the sensor distal second segment 20b, the sensor distal portion between the sensor distal first segment 20a and the sensor proximal end 18a, or any combination thereof can contact the skin. The sensor distal first segment 20a can extend from the sensor distal third segment 20c to the distal proximal end 18a and / or the distal end of the spring 26. The portion of the skin contact surface 48 that contacts the tissue when the device 10 is in the attached configuration will depend on factors such as the insertion angle, the depth of needle insertion, and the location of the tape through the top of the device 10.

[0241] Figure 3A It is also shown that when the device 10 is in the attached configuration, the sensor second longitudinal axis A7 can be parallel to the device longitudinal axis A1. In this variation, Figure 3A It is shown that when the device 10 is in the attached configuration, a portion of the sensor distal end 18b (e.g., the sensor distal first segment 20A) can extend at least partially in the longitudinal direction (e.g., only in the longitudinal direction) toward the device distal end 10b. As another example, when the device 10 is in the attached configuration, the axis A7 can be at an angle of about 0 degrees to about 15 degrees relative to the device longitudinal axis A1, including every 1 degree increment (e.g., 3 degrees) within this range. In the case of a rough skin surface, a non-parallel configuration (e.g., an angle greater than 0 degrees) may occur. The non-parallel configuration of the sensor axis A7 can also be temporary, for example, when the patient moves and the needle 12 and / or housing 14 is slightly lifted away from the skin or moved slightly further away from the skin (e.g., when the device 10 is in the attached configuration, the needle and housing are not in contact with the skin except at the needle insertion hole). The spring 26 can be biased to maintain the sensor 18 in contact with the skin during patient movement so that when the patient moves, the needle 12 and / or housing 14 are temporarily moved beyond 0 degrees. Figure 3A In the device configuration of FIG. 1 , the sensor distal tip 24 moves toward or past (e.g., by rotation) the device longitudinal axis A1. Once the patient has stopped moving (e.g., if the tape remains in place), the sensor axis A7 can return to an orientation parallel to the axis A1. Allowing the sensor 18 to move during patient movement provides flexibility to the device 10 and can make patient movement more comfortable.

[0242] Figure 3A It is also shown that when the device 10 is in the attached configuration, the sensor first transverse axis A8 can be perpendicular to the device longitudinal axis A1 and the sensor second longitudinal axis A7. Figure 3A It is shown that a portion of the sensor distal end 18b (e.g., the sensor distal end second segment 20b) can extend at least partially in the transverse direction (e.g., only in the transverse direction). When the device 10 is in the attached configuration, the sensor distal end second segment 20b can also extend at least partially in the longitudinal direction toward the device distal end 10 and / or toward the device proximal end 10a. For example, when the device 10 is in the attached configuration, the axis A8 can be at an angle of about 0 degrees to about 150 degrees relative to the axis A1 and / or A7, including every 1 degree increment within this range (e.g., 60 degrees, 90 degrees, 120 degrees). An angle less than 90 degrees can correspond to a situation where the sensor distal end 18b extends at least partially in the longitudinal direction away from the needle tip and toward the device proximal end 10a when the device is in the attached configuration. An angle greater than 90 degrees can correspond to a situation where the sensor distal end 18b extends at least partially in the longitudinal direction toward the needle tip and away from the device proximal end 10a when the device 10 is in the attached configuration. The angle between the axes A7 and A8 can be the angle between the sensor distal first segment 20a and the sensor distal second segment 20b, respectively. The angle between the axes A7 and A8 can be fixed so that the angle between the sensor distal first segment 20a and the sensor distal second segment 20b remains constant when the device 10 changes configuration. The portion of the sensor distal end 18b that extends laterally toward the needle 12 can include an over-insertion stop for the device 10.

[0243] Figure 3A It is also shown that when the device 10 is in the attached configuration, the sensor distal end 18b can extend beyond the needle hub 13. For example, the sensor distal end 18b can extend beyond the distal longitudinal distance 58 of the needle hub, as measured to the proximal edge or surface of the sensor distal end 18b. The distance 58 can be, for example, about 1 mm to about 15 mm, including every 1 mm increment within this range (e.g., 1 mm, 2 mm, 3 mm).

[0244] Figure 3AIt is further shown that when the device 10 is in the attached configuration, the sensor distal end 24 can extend beyond the device longitudinal axis A1. For example, the sensor distal end 24 can extend beyond the axis A1 by a lateral distance 60. The distance 60 can be, for example, 1.0 mm to about 7.5 mm, including every 0.1 mm increment therein (e.g., 1.0 mm, 2.0 mm, 3.0 mm, 4.0 mm). The sensor distal end 24 can be a sensor lateral end. The sensor 18 can also have a sensor longitudinal end, which can be, for example, a distal edge or surface of the sensor distal second segment 20b. The sensor distal end 18b can be laterally below, partially adjacent to, and / or laterally beyond the axis of the needle 12 (e.g., relative to the attachment orientation). For example, Figure 3A It is shown that the sensor distal tip 24 may be above the shaft of the needle 12 when the device 10 is in the attached configuration.

[0245] Distances 58 and 60 may be the same or different from each other. For example, Figure 3A It is shown that distance 58 can be smaller than distance 60, for example, about 1 mm or about 2 mm smaller. As another example, distance 58 can be greater than distance 60 (e.g., about 1 mm to about 15 mm).

[0246] Figure 3B It is shown that the device 10 may have an insert 17 (also referred to as a membrane insert). The insert 17 may be positioned in a housing space 51. The housing space 51 may define a housing channel. A portion of the insert 17 may be inside the housing 14, and a portion of the insert 17 may be outside the housing 14. For example, the portion of the insert 17 outside the housing 14 may define a connector 16. As another example, the insert 17 may be completely inside the housing 14. In this variation, the connector 16 may be attached to the housing 14, integrated with the housing 14, attached to the insert 17, or any combination thereof. The insert 17 may have a rib 49 that may clamp the needle 12 to hold it in place. There may be glue in the space between the ribs. The rib 49 may be on the proximal and / or distal ends of the insert 17.

[0247] Insert 17 can be rigid, semi-rigid, flexible, elastic and / or deformable. Insert 17 can be made of the same or different material as shell 14. Insert 17 can be softer, more flexible, more elastic or more deformable than shell 14. Insert 17 can be made of multiple materials. Insert first material can be softer, more flexible, more elastic, more deformable or any combination thereof than insert second material. Insert 17 can have one or more thicknesses. For example, insert 17 can have insert first thickness 17a and insert second thickness 17b less than insert first thickness 17a. Insert first thickness 17a and second thickness 17b can be lateral thickness. Insert first thickness 17a can be in the range of from about 0.5mm to about 3.0mm, including every 0.1mm increment (e.g., about 1.5mm) within this range. The insert second thickness 17b may be in the range from about 0.1 mm to about 2.0 mm, including every 0.1 mm increment therein (eg, about 0.2 mm).

[0248] Figure 3B It is further shown that the device 10 may have an elastic membrane 54 (also known as a deformable membrane and a deflectable membrane). The membrane 54 may be located near the restrictor 28. The membrane 54 may be made of the same or different material as the insert 17. The membrane 54 may be attached to the insert 17 or integrated with the insert 17. A portion of the insert 17 may be the membrane 54. For example, the membrane 54 may be a portion of the insert made of the first material of the insert, the membrane 54 may be a portion of the insert 17 having the second thickness 17b of the insert, the membrane 54 may be a portion of the insert 17 adjacent to the restrictor 28, or any combination thereof. As another example, the membrane 54 may be separate from the insert 17.

[0249] Insert 17 may have an outer surface and an inner surface. The insert outer surface may be attached to or contact the inner surface of the housing 14. The inner surface of the insert inner surface and / or the inner surface of the film 54 may define an insert passage 56 (also referred to as an insert flow passage, housing conduit, and device flow passage). The housing conduit 56 may extend from the housing proximal end 14a to the housing distal end 14b. The housing conduit 56 may be straight or curved. The proximal portion of the needle 12 may be located in the insert passage 56. The insert inner surface may have a circular, elliptical, or polygonal cross section (e.g., in a plane defined by the axes A2 and A3). The insert outer surface may have a circular, elliptical, or polygonal cross section (e.g., in a plane defined by the axes A2 and A3). The film 54 may be in the housing 14. The film 54 may be outside the housing 14. The film 54 may be integrated with the housing or attached to the housing. For example, the non-fluid contact side of the film 54 may form the outer surface and / or inner surface of the housing 14.

[0250] Before the device 10 is inserted into tissue, the elastic membrane 54 can have a deformed shape caused by the spring 26 that forces the obturator 32 to press upward against the membrane and force it into the housing conduit 56. When the device 10 is inserted into tissue, the elastic membrane 54 can be undeformed from the first shape of the membrane (e.g., an occlusive shape) to the second shape of the membrane (e.g., a non-occlusive or less occlusive shape). When the device 10 is removed, the obturator 32 can deform the membrane 54 again into the housing flow channel 56 under the action of the spring 26, thereby reducing the cross-sectional area of ​​the housing flow path 56 in the occluded area to restrict or terminate flow.

[0251] Figure 3B It is further shown that the device 10 may have a device flow channel 62. The device flow channel 62 may include a needle flow channel 64 and one or both of the insert flow channel 56 and the housing channel 51. When the tube 8 is connected to the device 10, the device flow channel 62 may be in fluid communication with the tube flow channel 66. The housing conduit 56 (e.g., the insert flow channel 56) may be parallel to the device longitudinal axis A1. The housing conduit 56 may be concentric with the device longitudinal axis A1 or offset from the device longitudinal axis A1. The needle flow channel 64 may be parallel to the device longitudinal axis A1. The needle flow channel 64 may be concentric with the device longitudinal axis A1 or offset from the device longitudinal axis A1. The needle 12 may be at an angle of about 0 degrees to about 45 degrees relative to the housing conduit 56, so that the needle flow channel 64 may be at an angle of about 0 degrees to about 45 degrees relative to the flow path of the housing conduit 56.

[0252] The device flow channel 62 can have a channel occlusion region 68 (also referred to as a catheter occlusion region). The channel occlusion region 68 of the device flow channel 62 can be at least partially defined by the membrane 54. For example, the membrane 54 can define at least a portion of the perimeter (e.g., circumference) of the cross-section of the device flow channel 62 in the occlusion region 68. The membrane 54 can define, for example, about 10% to about 75% of the circumference, including every 1% increment within this range (e.g., 25% or less, 50% or less, 75% or less). Figure 3BIt is shown that the membrane 54 can define about 25% to about 50% (e.g., 50%) of the circumference, wherein 25% to 50% forms the lower half of the occluded region 68 or is a portion thereof from the proximal end to the distal end of the occluded region 68. As another example, the channel occluded region 68 can be completely or at least partially defined by the insert 17, such that the insert 17 can partially or completely define the circumference (e.g., circumference) of the cross-section of the device flow channel 62 in the occluded region 68. As yet another example, the circumference (e.g., circumference) of the channel occluded region 68 can be partially defined by the membrane 54, at least partially defined by the insert 17, at least partially defined by the housing 14, or any combination thereof, such as about 0% to about 100% of the circumference, depending on the combination, wherein all percentage permutations of these various circumference combinations are disclosed herein.

[0253] The membrane 54 may be opposite to a housing surface, opposite to an insert surface, opposite to a housing protrusion (not shown), opposite to an insert protrusion (not shown), or opposite to any combination thereof. One or more housing and / or insert protrusions may extend at least partially toward a longitudinal center of a device flow channel 62 in the housing 14, such as toward a longitudinal center of a flow path defined by the housing conduit 56. The obturator 32 may be configured to engage with the one or more protrusions when the movable sensor 18 is in the closed configuration.

[0254] Figure 3B It is further shown that the device 10 can have a housing opening 70 (also referred to as a housing window). The housing opening 70 can be located on the first, second, third, fourth, fifth, or sixth side of the device, or any combination thereof. The orientation of these different sides is discussed above with reference to the sensor 18. For example, Figure 3B The housing opening 70 is shown to be on the device first side 10c. For example, the device first side 10c may be the bottom side of the device, with the bottom of the device 10 being the skin contacting side of the device 10 relative to when the device is in the attached configuration.

[0255] The housing opening 70 may have, for example, a circular, polygonal (triangular, rectangular), stadium, or irregular shape. The housing opening 70 may be a hole (also referred to as a channel) in the wall of the housing 14 .

[0256] The housing opening 70 may have a housing opening longitudinal dimension 72 (also referred to as a housing opening first dimension). The housing opening longitudinal dimension 72 may be in the range of from about 2 mm to about 40 mm, including increments of 1 mm (e.g., 10 mm) within the range. The housing opening longitudinal dimension 72 may be the maximum longitudinal dimension of the housing opening 70, for example, along an axis parallel to the device longitudinal axis A1 or at an angle to the device longitudinal axis A1.

[0257] Despite Figure 3B 1, but the housing opening 70 may also have a housing opening first transverse dimension (also referred to as a housing opening second dimension). The housing opening first transverse dimension may be in the range of from about 2 mm to about 40 mm, including increments of 1 mm (e.g., 10 mm) within the range. The housing opening first transverse dimension may be the maximum transverse dimension of the housing opening 70, for example, along an axis parallel to or at an angle to the device second transverse axis A3.

[0258] Despite Figure 3B 1 , but the housing opening 70 may also have a housing opening second transverse dimension (also referred to as a housing opening third dimension). The housing opening second transverse dimension may be in the range of from about 0.5 mm to about 10 mm, including every 0.1 mm increment within the range (e.g., 1.0 mm, 2.0 mm). The housing opening second transverse dimension may be the maximum transverse dimension of the housing opening 70, for example, along an axis parallel to the device first transverse axis A2 or at an angle to the device first transverse axis A2. The housing opening second transverse dimension may correspond to the depth of the hole 70.

[0259] The first, second, and third dimensions of the housing opening may correspond to the length, width, and height dimensions of the housing hole (e.g., hole 70), respectively. As another example, the first and second dimensions of the housing opening may be the housing opening radius dimensions, and the third dimension of the housing opening may be the depth of hole 70 (e.g., where hole 70 is cylindrical).

[0260] The housing opening 70 may have a housing opening surface area. The housing opening surface area may be the area of ​​the void defined by the housing opening 70. For example, the area of ​​the void may be defined by a plane parallel to the plane defined by the axes A1 and A3, or any other combination of the axes A1, A2, and A3. The housing opening surface area may be, for example, 4 mm 2 To about 1,600mm 2 or greater, including every 1mm within this range 2 Increments (e.g., less than 25 mm 2 Less than 50mm 2 Less than 100mm 2 Less than 200mm 2 Less than 500mm 2 ).

[0261] The housing opening surface area may be less than the surface area of ​​the housing surface. For example, the housing opening surface area may be a percentage of the surface area of ​​the housing surface. The percentage may be, for example, in the range of about 1% to about 90%, including every 1% increment within the range (e.g., less than 50%, less than 25%, less than 10%, less than 5%, 20%, 15%, 10%, 5%). The housing surface having an area compared to the area of ​​the housing opening 70 may be on the same side or a different side of the device 10 as the housing opening 70. For example, the housing surface may be on a first side 10c of the device (e.g., the bottom surface of the housing), a second side 10d of the device (e.g., the top surface of the housing), or another device side. When the two areas being calculated are on the same surface (e.g., the bottom housing surface), the surface area of ​​the hole 70 may be ignored or taken into account when calculating the surface area of ​​the housing surface. For example, for a device having a 900 mm 2 The surface area is a square bottom surface and has a 100mm 2 The surface area of ​​the opening of the hole 70, the surface area of ​​the bottom surface can be considered to be 1,000mm 2 (ignore hole 70) or 900mm 2 (note hole 70) such that the housing opening surface area is about 10.0% (ignoring hole 70) or about 11.1% (note hole 70) of the surface area of ​​the bottom surface. Another way to quantify this is by stating that the housing opening surface area may be smaller than the housing surface through which housing opening 70 extends. For example, housing opening 70 extending through the housing surface of device 10 may have a housing opening surface area that is about 100 times smaller or more, or more narrowly about 50 times smaller or more, or more narrowly about 25 times smaller or more, or more narrowly about 10 times smaller (e.g., 14 times smaller, 10 times smaller, 5 times smaller) than the surface area of ​​the housing surface through which housing opening 70 extends.

[0262] The size of the housing opening 70 is smaller than the size of the housing surface (e.g., the bottom surface or skin contact surface of the device 10) through which the housing opening 70 extends, which may desirably allow the housing 14 to have a larger surface area that contacts the tissue, which may be more comfortable for the patient when the device is glued to their skin, because the larger device surface area can more evenly distribute the force of the device 10 against the skin, thereby being less likely to "drill" into the tissue or leave sensitive skin indentations or dents after removal. This is particularly beneficial for patients undergoing hemodialysis treatments, because the device 10 can be attached to their skin for several hours at a time, for example, from about 3 hours to about 6 hours. The small housing opening 70 can also allow the housing 14 to maintain a stronger seal around the device flow path 62 in the housing 14, such as around the housing conduit 56, than if the housing space 51 is exposed by a large hole.

[0263] However, in some variations, the aperture 70 may be larger than the size of the housing surface through which the housing opening 70 extends (e.g., the opposite of the "smaller than" and "smaller" ratios / relationships described above). In such variations, for housing surfaces configured to contact the skin, such as the housing bottom surface, the aperture 70 may be large, such that the housing bottom surface may be an annular flange extending around the perimeter of the housing 14. For larger openings 70, the opening 70 may be a housing recess, such that only a portion of the opening extends through the housing wall and exposes the housing space 51. Having such a "larger" opening aperture 70 size may be used to elevate the housing conduit 56 further away from the skin when attached to a patient. Where the opening 70 forms a large recess, a skin warming or cooling pack may be inserted into the recess and in contact with the patient's skin during treatment to increase the patient's comfort. If controlling vasodilation and vasoconstriction is desired or helpful for the particular patient at hand, such hot and cold packs will assist in such control.

[0264] The housing opening 70 can advantageously allow the flow restrictor 28 to enter the housing conduit 56 while maintaining a fluid tight seal between the tube 8 and the tip of the needle 12. The flow restrictor 28 can move within or through the housing opening 70, for example, to deform the membrane 54 to occlude flow through the housing conduit 56.

[0265] For example, the housing opening 70 can expose the membrane 54 by creating a passage through the housing wall (e.g., a housing wall having an outer surface configured to contact the skin). When the sensor 18 is in the open configuration and the device 10 is attached to the non-device surface, the housing opening 70 can be open toward (e.g., facing) the non-device surface (also referred to as the non-sensor surface and the skin). The membrane 54 can be closer to the device longitudinal axis A1 than the housing opening 70. The membrane 54 can be closer to the longitudinal axis of the device flow path 62 than the housing opening 70. Some or all of the membrane 54 can be in the housing opening 70. At least a portion of the membrane 54 can be attached to or integrated into an edge or surface defining the housing opening 70.

[0266] When the device 10 is in the attached configuration (also referred to as when the sensor 18 is in the open configuration), some or all of the restrictor 28 can be located in the housing opening 70. For example, at least a portion of the restrictor 28 can be in an opening plane defined between edges or surfaces of the housing opening 70. The opening plane can be a plane parallel to a plane defined by, for example, the axes A1 and A3, or any other combination of the axes A1, A2, and A3. For example, Figure 3B It is shown that the obturator 32 can be located within the housing opening 70 when the device 10 is in the attached configuration. Although not shown, a portion of the obturator arm 30 can also extend into the housing opening 70 when the device 10 is in the attached configuration.

[0267] Figure 3B It is also shown that when the device 10 is in the attached configuration, a portion of the obturator 32 (e.g., the tip of the obturator 32) can be within the housing 14 (e.g., within the housing space 51), for example, by extending beyond the housing opening 70 (e.g., beyond the inner opening plane of the opening window 70, where the inner opening plane can be defined between edges or surfaces including an inner edge, surface, or boundary of the housing 14). Although not shown, a portion of the obturator arm 30 can also extend into the housing 14 (e.g., within the housing space 51) when the device 10 is in the attached configuration.

[0268] Figure 3B It is also shown that when the device 10 is in the attached configuration, the tip of the occluder 32 can contact the membrane 54. When the sensor 18 is in the open configuration, contact from the occluder 32 (e.g., the occluder tip) can cause the membrane 54 to deform or not deform. Figure 3B The occluder 32 in FIG. 3 is shown as contacting but not deforming the membrane 54 when the sensor 18 is in the open configuration. However, in other variations, the occluder tip may deform the membrane 54 or may be spaced apart from the membrane 54 by a gap when the sensor 18 is in the open configuration. Such deformation or gap may have a deformation / gap dimension of about 0.5 mm to about 2.5 mm, including increments of 0.1 mm within this range. The deformation / gap dimension may be measured along an axis parallel to the device axis, such as axis A1, A2, or A3, or an axis at an angle to the device axis, such as axis A1, A2, or A3. For example, Figure 3B It is shown that the deformation / gap dimension can be measured along an axis parallel to the first lateral axis A2 of the device.

[0269] In a variation in which the occluder tip deforms the membrane 54 when the sensor 18 is in an open configuration, the inner surface of the membrane 54 that defines the housing conduit 56 can be deformed toward the housing surface opposite the occluder 32, toward the surface of the housing conduit 56 opposite the occluder 32, toward the longitudinal axis A1 of the device, toward the longitudinal axis of the fluid conduit 56, or any combination thereof, by this deformation dimension (e.g., deformation of approximately 0.5 mm to approximately 2.5 mm or more).

[0270] In variations where a gap exists between the obturator tip and the membrane 54 when the sensor 18 is in the open configuration, the gap size (e.g., approximately 0.5 mm to approximately 2.5 mm or greater) can be measured between an outer surface of the membrane 54 (e.g., facing away from the housing space 51) and the obturator tip.

[0271] The occluder 32 may be attached to or integrated with the membrane 54. The occluder 32 may float relative to the membrane 54 such that the occluder 32 is not permanently attached to the membrane 54.

[0272] When the device 10 is in the attached configuration, the obturator arm 30 can be located within or outside the housing space 51. When the device 10 is in the attached configuration, the obturator arm 30 can be located within or outside the housing window 70. For example, Figure 3B The obturator arm 30 is shown to be outside (e.g., below) the housing opening 70 (e.g., below an exterior opening plane of the housing window 70, where the exterior opening plane can be defined between edges or surfaces comprising exterior edges, surfaces or boundaries of the housing 14, e.g., those edges, surfaces or boundaries that are farther from the device longitudinal axis A1 than edges, surfaces or boundaries associated with an interior opening plane of the housing window 70).

[0273] Figure 3B It is also shown that when the device 10 is in the attached configuration, the obturator arm 30 can extend over some or all of the housing opening 70. The obturator arm 30 can extend, for example, along about 10% to about 90% of the housing opening longitudinal dimension 72. For example, where the housing opening longitudinal dimension 72 is 10 mm and the obturator arm 30 extends over 75% of the housing opening longitudinal dimension, when the device 10 is in the attached configuration, the obturator arm 30 can extend 7.5 mm over the housing opening 70 along the housing opening longitudinal dimension 72.

[0274] Figure 3B It is also shown that when the sensor 18 is in the open configuration, the occluder axis A9 can be at an occluder angle of about 30 degrees to about 150 degrees relative to the device longitudinal axis A1. Figure 3B The occluder angle is shown to be 90 degrees, or perpendicular to the device longitudinal axis A1. An occluder angle of less than 90 degrees may correspond to a situation where the occluder 32 extends at least partially in the longitudinal direction toward the device distal end 10b or the sensor distal end 18b when the sensor 18 is in the open configuration. An occluder angle greater than 90 degrees may correspond to a situation where the occluder 32 extends at least partially in the longitudinal direction toward the device proximal end 10a or the sensor proximal end 18a when the sensor 18 is in the open configuration.

[0275] Despite Figure 3B5. Although not shown in the drawings, the flow path defined by the housing conduit 56 may have one or more tapers. For example, the flow path defined by the channel occlusion region 68 may taper from a first cross-sectional area to a second cross-sectional area that is smaller than the first cross-sectional area, for example, such that the tapered area of ​​the channel occlusion region 68 forms a truncated conical flow path. The outer surface of the conduit (e.g., the housing conduit 56) defining the tapered flow path may also or may not have a corresponding taper. The first cross-sectional area may be closer to the proximal end of the device flow channel 62 than the second cross-sectional area. The flow path may be tapered so that the flow path may be blocked by the spring action of the restrictor 28 more easily or with less force. For example, the obturator 32 may be configured to deform the membrane 54 at the position of the second cross-sectional area of ​​the channel occlusion region. As another example, the obturator 32 may be configured to deform the membrane 54 by about 1 mm to about 20 mm in a manner longitudinally away from the second cross-sectional position in a direction toward the distal end of the device flow path 62, including every increase of 1 mm (e.g., 5 mm, 10 mm) within this range. The membrane 54 may define some or all of the tapers. The first cross-sectional area may be within or outside the channel occluding area 68 .

[0276] As another example, the aforementioned taper can be a first taper, and the flow path defined by the housing conduit 56 can have a second taper. For example, the flow path defined by the channel occlusion region 68 can taper from a second cross-sectional area to a third cross-sectional area greater than the second cross-sectional area, for example, so that the tapered area of ​​the channel occlusion region 68 forms a second frustoconical flow path. The first and third cross-sectional areas can have cross-sectional areas that are the same or different from each other. The outer surface of the conduit (e.g., the housing conduit 56) defining the second conical flow path may also or may not have a corresponding taper. The second cross-sectional area may be closer to the proximal end of the device flow channel 62 than the third cross-sectional area. The second frustoconical flow path may be a mirror image of the frustoconical flow path (also referred to as the first frustoconical flow path) between the first and second cross-sectional areas, for example, as reflected through the second cross-sectional area. The first cross-sectional area may be inside or outside the channel occlusion area 68. As yet another example, the second cross-sectional area between the first and third cross-sectional areas can be elongated so that a channel having a constant, less tapered, or more tapered cross-sectional flow path can extend between the first and second tapered flow paths (e.g., between the first and second frustoconical flow paths). This elongated channel can desirably allow the obturator 32 to have a smaller cross-sectional area for partial or complete occlusion.

[0277] Figure 4A and 4B As shown above, Figure 1 The device 10 is described in a variation of being in an occluded configuration.

[0278] Figure 4A and 4B It is further shown that when the external force 80 is reduced or completely removed from the sensor first contact surface 48, such as shown by arrow 82, the device 10 can change from the attached configuration with the sensor 18 in the open position to the occluded configuration with the sensor 18 in the closed position. Figure 4A and 4B External force 80 is also shown to illustrate the change in external force that may be applied to sensor first contact surface 48 of device 10 to change the shape of device 10 from an occluded configuration with sensor 18 in a closed position to an attached configuration with sensor 18 in an open position. Figure 4A and 4B The external force 80 shown in FIG. 1 is not applied to the device 10. In other variations, the force 80 is Figure 4A and 4B is applied to the device 10, but its size is smaller than Figure 3A and 3B The magnitude shown in , for example, is shown in conjunction with a reduction or elimination of force arrow 82 .

[0279] Figure 4A and 4B It is further shown that the pre-attachment and removal configurations of the device 10 may be identical. However, the pre-attachment and removal configurations may also differ from each other.

[0280] Figure 4A and 4B It is further shown that when the external force 80 is reduced (e.g., arrow 82) or eliminated (e.g., arrow 82), the sensor distal end 18b can move away from the device longitudinal axis A1 (e.g., arrow 84). The sensor distal end 18b can rotate and / or translate relative to the device longitudinal axis A1. For example, when the external force 80 is reduced (e.g., arrow 82) or eliminated (e.g., arrow 82), the sensor distal end 18b can rotate (e.g., arrow 84) ​​away from the device longitudinal axis A1.

[0281] Figure 4B It is also shown that the flow restrictor 28 can move toward a housing surface opposite the obturator 32, toward a surface of the housing conduit 56 opposite the obturator 32, toward the device longitudinal axis A1, toward the longitudinal axis of the fluid conduit 56, or any combination thereof (e.g., arrow 86). The flow restrictor 28 can rotate and / or translate relative to any of these features. For example, Figure 4B The obturator 32 is shown to be rotatable (e.g., arrow 86) toward a housing surface opposite the obturator 32, toward a surface of the housing conduit 56 opposite the obturator 32, toward the device longitudinal axis A1, toward the longitudinal axis of the fluid conduit 56, or any combination thereof.

[0282] The obturator 32 may be moved (eg, arrow 86) into the device flow path 62, for example, in the channel occlusion region 68. A portion of the obturator 32 (eg, the tip of the obturator 32) may be rotated past the device longitudinal axis Al. Figure 4B It is shown that the occluder 32 can pierce the membrane 54 and rotate directly into the flow path to partially or completely occlude flow through the device flow channel 62 when the device 10 is in the removed configuration. The membrane 54 can self-seal around the base of the occluder (e.g., the portion of the occluder that is in contact with the membrane) so that fluid does not flow through the opening in the membrane 54. If the occluder 32 is removed from the flow path 62 and the membrane 54, for example, if the device 10 is reattached to the skin, the membrane 54 can reseal to itself.

[0283] Figure 4B It is also shown that when the device 10 is in the non-attached configuration, the sensor second longitudinal axis A7 can be at an angle of about 10 degrees to about 75 degrees relative to the device longitudinal axis A1, including every 1 degree increment within this range (e.g., 30 degrees, 40 degrees, 50 degrees). In this variation, Figure 4B It is shown that when the device 10 is in the non-attached configuration, a portion of the sensor distal end 18b (e.g., the sensor distal end first section 2020a) can extend at least partially in the longitudinal direction toward the device distal end 10b, and at least partially in the transverse direction away from the device longitudinal axis A1. When an external force (e.g., arrow 80) is applied to the sensor 18, the sensor axis A7 can return to an orientation that is parallel or at a smaller angle relative to the axis A1.

[0284] Figure 4B It is also shown that when the device 10 is in the non-attached configuration, the sensor first transverse axis A8 can be at an angle of about 10 degrees to about 75 degrees relative to the device longitudinal axis A1, including every 1 degree increment within this range (e.g., 30 degrees, 40 degrees, 50 degrees). In this variation, Figure 4B It is shown that when the device 10 is in the unattached configuration, a portion of the sensor distal end 18b (e.g., the sensor distal end second segment 2020b) can extend at least partially in the longitudinal direction toward the device distal end 10b and at least partially in the transverse direction toward the device longitudinal axis A1. When the device 10 is in the unattached configuration, the sensor distal end second segment 20b can also extend at least partially in the longitudinal direction toward the device distal end 10 and / or toward the device proximal end 10a. When an external force (e.g., arrow 80) is applied to the sensor 18, the sensor axis A8 can return to an orientation that is perpendicular or at a smaller angle relative to the axis A1.

[0285] Figure 4BIt is also shown that when the sensor 18 is in the closed configuration, the occluder axis A9 can be at an occluder angle of about 30 degrees to about 150 degrees relative to the device longitudinal axis A1. Figure 4B The obturator angle is shown to be about 50 degrees, about 60 degrees, or about 70 degrees relative to the longitudinal axis A1 of the device. In these variations, Figure 4B It is shown that when the device 10 is in the non-attached configuration, the obturator 32 can extend at least partially in the longitudinal direction toward the device distal end 10b and at least partially in the transverse direction away from the device longitudinal axis A1. When an external force (e.g., arrow 80) is applied to the sensor 18, the sensor axis A9 can return to a perpendicular or less angled orientation relative to the axis A1.

[0286] Figure 4B It is further shown that when the sensor 18 is in the closed position, the sensor distal tip 24 can have a dimension 90 away from the device longitudinal axis A1. The dimension 90 can be measured along an axis perpendicular to the device longitudinal axis A1 and can be in the range of about 1 mm to about 30 mm, including every 1 mm increment (e.g., 5 mm, 10 mm, 15 mm) within the range. The dimension 90 can be the maximum dimension of the distal tip 24 from the device longitudinal axis A1 when the sensor 18 is in the closed configuration.

[0287] Figure 4C It is shown that when the sensor 18 is in the closed position, the device 10 can be partially occluded. For example, Figure 4C It is shown that there can be a gap 92 between the obturator 32 and the surface of the housing conduit 56 (e.g., the surface of the insert 17, the surface of the housing 14). The size of the gap 92 can be, for example, about 0.1 mm to about 2.0 mm or more measured along the axis A11 between the obturator 32 and the surface defining the housing conduit 56, for example, including every 0.1 mm increment (e.g., 0.8 mm, 1.0 mm) within this range. The axis A11 can be perpendicular to the device longitudinal axis A1.

[0288] Figure 4C It is also shown that the device 10 can be configured to increase the channel cross-sectional area from a first cross-sectional area (e.g., Figure 3B ) is reduced to a second cross-sectional area that is smaller than the first cross-sectional area (e.g., Figure 4B ) to restrict fluid flow through the device channel 62. The second cross-sectional area can be about 1% to about 100% smaller than the first cross-sectional area, including every 1% increment within this range, where 100% can correspond to complete blockage of the channel in one or more channel cross sections. For example, Figure 3B shows that the first cross-sectional area may be completely non-occluded, Figure 4CIt is shown that the second cross-sectional area can be between about 80% and about 95% smaller than the first cross-sectional area, including every 1% increment within the range (e.g., 90%, 95%). The first cross-sectional area can correspond to the cross-section of the flow path when the device 10 is in the attached configuration, and the second cross-sectional area can correspond to the cross-section of the flow path when the device 10 is in the unattached configuration (e.g., the removed configuration).

[0289] Figure 4C The restrictor configuration in may be the default configuration of the restrictor 28. For example, when no external force (e.g., force 80) is applied to the sensor 18 (e.g., applied to the sensor distal end 18b), the spring 26 may be biased to move the obturator 32 and the obturator arm 30 to the position in which the restrictor 28 is located. Figure 4C In other variations, Figure 4C The restrictor configuration in may correspond to a situation where the external force (e.g., force 80) has been reduced (e.g., arrow 82) but not completely removed from the sensor first contact surface 48. In this partial removal situation, the device 10 may still occlude about 80% to about 95% of the flow path 56 and effectively assist the patient by reducing fluid loss or delivery.

[0290] Figure 4D It is shown that the restrictor 28 may completely occlude the housing conduit 56, for example, by moving the occluder 32 further (via the spring 26) into the flow passage 56 during occlusion of the device 10. In this variation, the second cross-sectional area may be about 100% of the first cross-sectional area.

[0291] Figure 4D The restrictor configuration in may be the default configuration of the restrictor 28. For example, when no external force (e.g., force 80) is applied to the sensor 18 (e.g., applied to the sensor distal end 18b), the spring 26 may be biased to move the occluder 32 and the occluder arm 30 to the position in which the restrictor 28 is located. Figure 4D Position shown.

[0292] Figure 4C and Figure 4D It is shown that when the sensor is in the closed position, the obturator 32 can pierce the membrane 54 and reseal thereabout. The piercing point is shown as element 94.

[0293] Figure 4EIt is shown that the flow restrictor 28 (e.g., the occluder 32 and / or the occluder arm 30) can deflect the membrane 54 into the housing conduit 56 to occlude, for example, flow through the device 10 in a direction away from the window 70. The occluder 32 can deflect the membrane 54 into the housing conduit 56 during occlusion of the device 10. The gap 92 can have a dimension of, for example, about 0.1 mm to about 2.0 mm or more measured along the axis A11 between the occluder 32 and a surface defining the housing conduit 56 (e.g., a surface of the insert 17 and / or a surface of the housing 14), for example, including every 0.1 mm increment (e.g., 0.8 mm, 1.0 mm) within this range. The axis A11 can be perpendicular to the device longitudinal axis A1. For the gap 92, Figure 4E The second cross-sectional area is shown relative to the first cross-sectional area (e.g., Figure 3B ) is between about 80% and about 95%, including every 1% increment within this range (e.g., 90%, 95%).

[0294] Figure 4E The restrictor configuration in may be the default configuration of the restrictor 28. For example, when no external force (e.g., force 80) is applied to the sensor 18 (e.g., applied to the sensor distal end 18b), the spring 26 may be biased to move the obturator 32 and the obturator arm 30 to the position in which the restrictor 28 is located. Figure 4E and deforming the membrane 54 into the housing conduit 56. In other variations, Figure 4E The flow restrictor configuration in may correspond to a situation when the external force (e.g., force 80) has been reduced (e.g., arrow 82) but not completely removed from the sensor first contact surface 48. In the partial removal situation, the device 10 may still occlude about 80% to about 95% of the flow path 56 and effectively assist the patient by reducing fluid loss or delivery.

[0295] Figure 4F It is shown that the flow restrictor 28 (e.g., the obturator 32 and / or the obturator arm 30) can completely occlude the housing conduit 56, for example, by moving the obturator 32 and the membrane 54 further (via the spring 26) into the flow path 56. The membrane 54 and the obturator 32 (e.g., on the proximal side of the sensor 18) are shown as being completely pressed into the flow path 56, for example, via the spring 26. For example, the force pushing the member upward can come from the curved spring area portion of the central portion of the sensor 18. When the sensor 18 is in the closed position, a portion of the membrane 54 in the deformed configuration (e.g., the apex) can contact a surface defining at least a portion of the housing conduit (e.g., a surface of the insert 17 and / or a surface of the housing 14). When the obturator 32 pushes the membrane 54 into contact with another surface, the second cross-sectional area can be approximately 100% smaller than the first cross-sectional area, so that the housing conduit 56 is completely occluded.

[0296] Figure 4F The restrictor configuration in may be the default configuration of the restrictor 28. For example, when no external force (e.g., force 80) is applied to the sensor 18 (e.g., applied to the sensor distal end 18b), the spring 26 may be biased to move the obturator 32 and the obturator arm 30 to the position in which the restrictor 28 is located. Figure 4F The location shown in .

[0297] The spring 26 can have a spring constant k such that the weight of the device 10 is configured to be insufficient to move the sensor 18 from the closed position to the partially open or fully open position. This feature can prevent further fluid loss if the device 10 moves and falls onto a surface (e.g., the floor or the patient's knees) and lands such that the device rests on the flow restrictor 28 (e.g., rests on the sensor distal end 18b).

[0298] Figure 3A and 4A It is shown that the spring 26 can be outside the housing 14 when the sensor is in the open configuration and the closed configuration, respectively. For example, when the device 10 is in the attached configuration, the spring 26 can be located between the housing 14 and the skin, and when the device 10 is in the pre-attached or removed configuration, the spring 26 can be located between the housing and the environment. In other variations, some or all of the springs can be located inside the housing 14 when the device 10 is in the attached configuration and / or when the device 10 is in the pre-attached or removed configuration. Figure 3A and 3B Further shown is a first end of spring 26 (eg, the end of the spring closer to the proximal end 10A of the device) when the device 10 is in the attached configuration (eg, Figure 3A ) than when the device 10 is in a pre-attached or removed configuration (e.g., Figure 4A ) is closer to the longitudinal axis A1 of the device.

[0299] Figure 3A-Figure 4B shows when the device is in the attached configuration (e.g. Figure 3A and Figure 3B ), the sensor distal first segment 20a may extend parallel to the device longitudinal axis A1 when the device 10 is in a pre-attached or removed configuration (e.g., Figure 4A and 4B ), the sensor distal first segment 20a extends away from the device longitudinal axis A1. As another example, the sensor distal first segment 20A can extend further away from the device longitudinal axis A1 when the device 10 is in the pre-attachment or removal configuration than when the device 10 is in the attached configuration (e.g., about 5 degrees to about 60 degrees more, including every 1 degree increment within this range).

[0300] Figure 3A-Figure 4B shows when the device is in the attached configuration (e.g. Figure 3A and 3B), the sensor distal second segment 20b may extend parallel to the device first lateral axis A2 and when the device 10 is in a pre-attached or removed configuration (e.g., Figure 4A and Figure 4B ), the sensor distal second segment 20b extends away from the device first lateral axis A2. As another example, the sensor distal second segment 20b can extend further away from the device first lateral axis A1 when the device 10 is in the pre-attached or detached configuration than when the device 10 is in the attached configuration (e.g., about 5 degrees to about 60 degrees more, including every 1 degree increment within this range).

[0301] Figure 3A-Figure 4B The sensor distal end 18b (eg, the needle on the insertion stop 20B) is shown as being able to be in the attached configuration (eg, Figure 3A and 3B ) than when the device 10 is in a pre-attached or removed configuration (e.g. Figure 4A and 4B ) is closer to the longitudinal entrance of needle 12. Figure 3A-Figure 4B It is also shown that the sensor distal end 18b (eg, the needle is above the insertion stop 20B) can be in the attached configuration (eg, Figure 3A ) than when the device 10 is in a pre-attached or removed configuration (e.g. Figure 4A ) is closer to the tip of the needle 12 or the distal end 10b of the device.

[0302] Figure 3A-Figure 4B The needle over-insertion stop (e.g., section 20b) is shown when the device 10 is in the attached configuration (e.g., Figure 3A and 3B ) than when the device 10 is in a pre-attached or removed configuration (e.g. Figure 4A and 4B ) is closer to the longitudinal entrance of needle 12. Figure 3A-Figure 4B It is also shown that the needle over-insertion stop (e.g., section 2020b) can be used when the device 10 is in the attached configuration (e.g., Figure 3A ) than when the device 10 is in a pre-attached or removed configuration (e.g. Figure 4A ) is closer to the tip of needle 12 or the distal end 10b of the device. Additionally or alternatively, the device 10 may have an over-insertion barrier that remains in a fixed position when the sensor 18 moves between the open configuration and the closed configuration. For example, the device 10 may have an over-insertion barrier attached to or integrated with the housing 14 and / or the needle hub 13 as described above.

[0303] FIG. 3A to FIG. 4BThe sensor 18 (e.g., a movable pedal) is shown having a sensor first configuration when the sensor first contact surface 48 applies a first force to a non-sensor surface (e.g., skin), and having a sensor second configuration when the sensor first contact surface 48 applies a second force less than the first force to the non-sensor surface. The spring 26 can be biased to move the movable sensor 18 from the sensor first configuration to the sensor second configuration when the force applied by the sensor first contact surface 48 on the non-sensor surface changes from the first force to the second force. As another example, the spring 26 can be biased to move the sensor 18 from the sensor first configuration to the sensor second configuration when the first force decreases to the second force. The second force can be 0 Newtons.

[0304] When the movable sensor 18 is in the second sensor configuration, at least a first portion of the occluder 32 can occlude the housing conduit 56. When the movable sensor 18 is in the second sensor configuration, at least a second portion of the occluder 32 can be located within the housing opening 70, and when the movable sensor 18 is in the first sensor configuration, at least a second portion of the occluder 32 can be located outside the housing opening 70.

[0305] The sensor distal end 18b may have a stopper configured to prevent excessive insertion of the needle 12 into tissue (e.g., into a blood vessel). At least a portion of the stopper may be closer to the needle 12 when the movable sensor 18 is in the first sensor configuration than when the movable sensor 18 is in the second sensor configuration. When the movable sensor 18 is in the first sensor configuration, at least a portion of the stopper may abut or be close to one side of the needle 12. At least a portion of the stopper may be closer to the needle 12 when the movable sensor 18 is in the first sensor configuration than when the movable sensor 18 is in the second sensor configuration.

[0306] The sensor distal end 18b may have a curved surface (e.g., curved surface 21) configured to reduce friction with a non-sensor surface when the needle 12 is inserted into tissue (e.g., in a blood vessel). When the movable sensor 18 is in the sensor first configuration, at least a portion of the curved surface may be closer to the needle 12 than when the movable sensor 18 is in the sensor second configuration.

[0307] The occluder 32 may be configured to at least partially occlude the housing conduit 56 when the movable sensor 18 is in the second sensor configuration.

[0308] The flow through the housing conduit 56 can be approximately 1% to approximately 100% less when the movable sensor 18 is in the second sensor configuration than when the movable sensor 18 is in the first sensor configuration, including every 1% increment within this range (e.g., 80%, 90%, 95%, 97%, 100%).

[0309] When the movable sensor moves from the first sensor configuration to the second sensor configuration, the housing conduit cross-sectional area can decrease by about 1% to about 100%, including every 1% increment within this range (e.g., 80%, 90%, 95%, 97%, 100%).

[0310] When the movable sensor 18 is in the second sensor configuration, the occluder 32 may be closer to the surface of the housing conduit 56 opposite the deformable membrane 54 than when the movable sensor is in the first sensor configuration. The spring 26 may be biased to move the occluder 32 closer to the surface of the housing conduit 56 when the movable sensor 18 moves from the first sensor configuration to the second sensor configuration.

[0311] When the movable sensor 18 is in the second sensor configuration, the occluder 32 deforms the deformable membrane 54. When the movable sensor 18 is in the second sensor configuration, the surface of the deformable membrane may be closer to the housing catheter surface than when the movable sensor 18 is in the first sensor configuration.

[0312] The occluder 32 deforms or deflects the deformable membrane 54 less when the movable sensor 18 is in the first sensor configuration than when the movable sensor 18 is in the second sensor configuration.

[0313] When the movable sensor 18 is in the first sensor configuration, the occluder 32 does not deform the deformable membrane 54 .

[0314] When the movable sensor 18 is in the sensor first configuration, the sensor distal end 18b may be closer to the needle 12 and the housing catheter 56 than when the sensor 18 is in the sensor second configuration. The spring 26 may be biased to move the sensor distal end 18b away from the needle 12 and the housing catheter 56 when the movable sensor 18 moves from the sensor first configuration to the sensor second configuration.

[0315] The sensor distal end 18b (e.g., the sensor distal end second section 20b) may have a sensor opening 22. When the movable sensor 18 is in the first sensor configuration, a portion of the needle 12 may be in the sensor opening 22, and when the movable sensor 18 is in the second sensor configuration, a portion of the needle 12 may be outside the sensor opening 22.

[0316] The sensor distal end 18b may have a stop configured to prevent over-insertion of the needle into the blood vessel.

[0317] When the movable sensor is in the first and second sensor configurations, at least a portion of the sensor proximal end 18A may extend in a direction parallel to the device longitudinal axis A1. When the movable sensor 18 is in the first sensor configuration, at least a portion of the sensor distal end 18b may extend in a direction parallel to the device longitudinal axis A1, and when the movable sensor 18 is in the second sensor configuration, at least a portion of the sensor distal end 18b extends in a direction that is angled relative to the device longitudinal axis A1.

[0318] The housing 14 may have a housing first side and a housing second side opposite the housing first side. The housing first side may be closer to the sensor first contact surface than the housing second side. The housing window 70 may be on the housing first side so that when the movable sensor 18 is in the sensor first configuration, the housing window 70 faces the non-sensor surface (e.g., skin).

[0319] The sensor 18 may have a sensor second contact surface 50. The sensor second contact surface 50 may be closer to the housing 14 when the movable sensor 18 is in the sensor first configuration than when the movable sensor 18 is in the sensor second configuration.

[0320] The device distal end 10b can move relative to the device proximal end 10a. For example, the device distal end 10b can move longitudinally and / or laterally relative to the device proximal end 10 along the device longitudinal axis A1.

[0321] The needle 12 may be movable longitudinally and / or laterally along the device longitudinal axis A1.

[0322] Needle 12 can be retracted into housing 14 or into a needle channel adjacent housing 14, so that needle 12 has a non-retracted position and a retracted position. The needle distal end (e.g., tissue cutting tip) is closer to housing proximal end 14a when needle 12 is in the retracted position than when needle 12 is in the non-retracted position.

[0323] At least a portion of needle 12 may be located outside of housing 14 or a needle channel adjacent housing 14 in the non-retracted position and inside of housing 14 or a needle channel adjacent housing 14 in the retracted position.

[0324] The needle distal end (eg, a tissue cutting tip) may be the distal tip of the device 10 when the needle 12 is in at least one of the non-retracted position and the retracted position.

[0325] After the device is initially removed from the attached configuration, the needle 12 may be retracted by the user. A button on the housing 14 may be pr.

[0326] When the device is initially removed from the attached configuration, the needle 12 can be automatically retracted. For example, a sensor can be connected to the needle 12 (e.g., the base of the needle 12). When the sensor changes from the open position to the closed position after the initial insertion of the needle 12, the spring 26 can be biased to retract the needle 12. The spring 26 can be connected to the needle with a connecting rod (not shown).

[0327] Figure 5 It is shown that the housing surface 96 defining the housing window 70 may be tapered to allow the occluder arm 30 to move the occluder 32 therein, thereby deflecting the membrane 54 into the housing conduit 56 to occlude the device 10 .

[0328] Figure 5 It is also shown that the obturator 32 can have an obturator tip 35 having a curved surface configured not to pierce the membrane 54 when the sensor 18 is in the closed configuration.

[0329] Figure 5 It is also shown that the connector 16 may include a fitting 19. The fitting 19 may be integrated with or attached to the insert 17. The tube 8 may be connected to the fitting 19.

[0330] Fig. 6A and Figure 6B Variations of the device 10 being inserted into and removed from tissue 100 are shown. FIG. 6A to FIG. 6B , the device 10 is shown being inserted into tissue 100, wherein the sensor changes from a closed position (also referred to as an occluded position) to an open position (also referred to as a less occluded position). FIG. 6B to FIG. 6A , showing the device 10 being removed from the tissue 100, with the sensor 18 changing from an open position to a closed position.

[0331] Fig. 6A The curved portion 21 (also referred to as the curved distal end) of the sensor 18 is shown to reduce friction against the skin 100 during insertion, thereby enabling the needle 12 to be inserted with less force and less trauma to the patient. The curved end of the sensor 18 (e.g., the sensor distal end 18b) can facilitate a low friction insertion process. The device 10 is shown to be inserted at an insertion angle 102 relative to the patient's skin surface 100. The insertion angle 102 can be, for example, from about 10 degrees to about 60 degrees, including every 1 degree increment within this range. For example, the insertion angle 102 can be a typical insertion angle of about 25 degrees or about 18 degrees to about 32 degrees.

[0332] Fig. 6A It is also shown that the curved distal end 18b (eg, having bend 21) can also reduce friction against the skin 100 during removal.

[0333] Figure 6BThe curved distal end 18b is shown to allow the device 10 to maintain mechanical contact with the skin 10, which can continue to maintain the relative position of the sensor 18 and the housing 14 and / or the needle 12 regardless of the insertion angle 102, thereby enhancing the function of the removal detection system. Figure 6B It is shown that after the needle 12 has been fully inserted, the curved distal end 18B (e.g., having the bend 21) can maintain the sensor 18 in the open position (also known as maintaining the device in the attached configuration), and thus maintain the removal detection function of the sensor 18 even if the insertion angle 102 is as high as 50 degrees. Figure 6B It is shown that for a "typical angle" insertion, the insertion angle may be 25 degrees, while for a "high angle" insertion, the insertion angle may be up to about 50 degrees.

[0334] Figure 6B It is also shown that the curved end of the sensor 18 may abut the needle 12 and / or the needle hub 13 when inserted, with the needle 12 extending through the sensor opening 20 (eg, a U-shaped opening) at the sensor distal end 18B.

[0335] Figure 7A-Figure 7I It is shown that the device 10 can be manufactured using a two-shot molding process having a first injection molded part 190 and a second injection molded part 192 . Fig. 7A A variation of a first injection molded part 190 is shown. The first injection molded part 190 may be molded from a single material or a composite material. The first injection molded part 190 may include the pin wings 15a and 15b and a portion of the center body (eg, a portion of the housing 14). Figure 7B A variation of the second injection molded part 192 is shown. The second injection molded part 192 can be molded with a single material or a composite material. The material of the second injection molded part 192 can be the same or different from the material of the first injection molded part 190. For example, the material of the second injection molded part 192 can be softer, more flexible, more elastic, more deformable, or any combination thereof than the material of the first injection molded part 190. The second injection molded part 192 can be completed inside or outside the needle wing / body unit (for example, in the housing 14 defined by the first injection molded part 190). The second injection molded part 192 can be attached to the first injection molded part 190, for example, using glue, adhesive and / or welding (for example, sonic weld). The second injection molded part 192 can be combined with a compressible membrane (for example, membrane 54). The compressible membrane can be a thin compressible membrane, for example, having a thickness of about 0.5 mm to about 2.0 mm, including every 0.1 mm increment within this range (e.g., 0.5 mm, 1.0 mm). The compressible membrane (e.g., membrane 54) can be the pinch point that the sensor 18 acts upon when the needle 12 is inadvertently withdrawn from the patient. The second injection molded part 192 can be the insert 17.

[0336] Fig. 7AIt is shown that at least a portion of the housing 14 may define a housing conduit 56 . Fig. 7A It is further shown that the first injection molded part 190 can include a protrusion 198. The protrusion 198 can extend at least partially toward the longitudinal center of the device flow channel in the housing 14, for example, toward the longitudinal center of the flow path defined by the housing conduit 56. The obturator 32 can be configured to engage with the housing protrusion 198 when the movable sensor 18 is in the closed configuration (for example, when the device 10 is removed after insertion into the cannula).

[0337] Figure 7B It is shown that at least a portion of the second injection molded part 192 may define the housing conduit 56 . Figure 7B Also shown is a variation of a strap 188 that can be integrated with the device 10. The strap 188 can provide a pin lock. For example, the strap 188 can be configured to force the sensor 18 into an open configuration during pin insertion. When the pin wings 15A and 15B are oriented toward each other (e.g., toward Figure 1 When the device 10 is bent, rotated and / or flexed about the first transverse axis A2 of the device in the needle body, the band 188 can pull the sensor 18 into a position that enables fluid to flow through the needle body. For example, the band 188 can pull the sensor 18 into an open position. In the open position, blood flashback during insertion can be seen by the person inserting the needle and naturally observed, for example, where the device 10 has a visual indicator 186. When the needle is taped in place, fluid can flow (e.g., freely) through the device 10 until the needle 12 is intentionally or accidentally removed from the body and the flow stop mechanism (e.g., sensor 18) is activated. The band 188 can be integrated with or attached to the housing 14 and / or the wings 15a and 15b. The band 188 can be an elastic material. The band 188 can be a non-elastic material. The band 188 can be a strip of material having a flexible shape. The band can bend as the wings 15a and 15b rotate and release rotation.

[0338] Figure 7C A variation is shown in which the sensor 18 is attached (arrow 183 ) to the housing 14 after the second injection molding 192 is completed.

[0339] Fig.7D It is shown that the first injection molded piece 190 and the second injection molded piece 192 can be attached to maintain a fluid tight seal 202. The fluid tight seal 202 can withstand the high flow pressures associated with hemodialysis treatment. Fig.7D It is shown that at least a portion of the first injection molding 190 (eg, housing 14) and at least a portion of the second injection molding 192 (eg, insert 17) may define the housing conduit 56. The first injection molding 190 and the second injection molding 192 may define the housing 14 together.

[0340] Fig. 7E The strap 188 is shown relative to a first injection molded part 190 and a second injection molded part 192 .

[0341] Figure 7F and Figure 7G The first injection molded part 190 ( Figure 7F ) and the second injection molded part 192 ( Figure 7G )'s secondary injection molding manufacturing process 204.

[0342] Figure 7H and Fig.7I A variation of the second injection-molded part 192 is shown. Figure 7H It is shown that the second injection molded part 192 may have a surface 206 that at least partially defines the housing conduit 56 . Figure 7H Also shown are variations of the position of the membrane 54 on the insert 17 (also referred to as the second injection-molded part 192 ). Fig.7I It is shown that the second injection molded part 192 may have a recess 208 for the flow restrictor 28 to move into. For example, the recess 208 may allow the sensor 18 to approach the housing conduit 56 by allowing the obturator 32 to deflect the membrane 54 toward the protrusion 198 when the sensor moves from the open position to the closed position.

[0343] Figure 8A-8C A variation of the insert 17 is shown which is configured to support flow cessation during removal. It uses a molded through path 56 with thin walls 54 to serve as a closure point for a structural component that is part of or connected to the blade skin sensing arm 18. Fig. 8A A device 10 is shown having a male component 241 having a needle (eg, needle 12) and a body connectable to a tube (eg, tube 8). Figure 8B A longitudinal cross-sectional view of the insert 17 is shown in an open configuration. Figure 8C A transverse cross-sectional view of the insert 17 is shown in an open configuration. Figure 8C It is further shown that the through path 56 can be closed by applying a force 249 to the membrane 54 . Figure 8A-8C A vane / baffle system is shown which can stop fluid flow when removed using the removal mechanism described herein.

[0344] Figure 9A-9F A variation of the device 10 is shown having an insert 17 defining a housing conduit 56. A finishing cap 251 may be placed over the proximal end of the spring 26. Fig. 9C The device 10 is shown in an attached configuration. Fig.9DThe device 10 is shown in an occluded configuration, wherein the spring 26 forces the distal end of the sensor 18 away from the flow path 56 and forces the occluder 32 into the membrane 54 to close the flow path.

[0345] Fig. 10A A variation of the device 10 is shown having a needle 12, a housing 14, an insert 17, and a sensor 18 (e.g., a skin sensing component). The housing 14 may have wings 15. For example, when the needle 12 is removed from the patient, the device 10 may protect the patient from the hazards associated with needle removal by preventing or stopping fluid flow through the device flow channel 56 via the sensor 18. Fig. 10A It is also shown that the device 10 may have an integrated feature that allows flow to be stopped during accidental needle removal (in Fig. 10A The integrated feature may be the insert 17, the sensor 18, or both. For example, Fig. 10A The insert 17 and sensor 18 are shown as being attached to the housing 14. The insert 17 can be removably or permanently attached to the housing 14. For example, the insert 17 can be attached to the housing 14 by a snap fit, a friction fit, a magnetic fit, a screw fit, an adhesive fit, or any combination thereof. To attach the insert 17 to the housing 14, the insert 17 can be inserted into the housing channel 51. When the insert 17 is attached to the housing 14 (e.g., when the insert 17 is fully inserted into the housing channel 14, as shown in FIG. 5 ), the insert 17 can be attached to the housing 14. Fig. 10A ), the insert 17 may be the central core of the device 10. The insert 17 may define a device flow channel 56.

[0346] When the device 10 is attached to a person's skin, the pedal (also referred to as the sensor 18) abuts against the needle 12 and allows fluid to flow freely. If the needle 12 is removed, the sensor 18 (e.g., a spring-loaded pedal) will extend outwardly away from the needle (e.g., to Fig. 10A ), resulting in flow obstruction through the device flow channel 56 extending through the housing 14. A mechanical feature on the pedal 18 (e.g., a flow restrictor 28 with an occluder 32) introduced into the flow path (e.g., the device flow channel 56) can cause an obstruction when the occluder 32 is pressed against the membrane 54. For example, when the occluder 32 is pressed against the membrane 54, the obstruction can be caused by permanently or temporarily blocking the device flow channel 56 with the membrane 54.

[0347] Fig. 10B A variation of the device 10 is shown, which is in an exploded state, showing Fig. 10A The device 10 (also referred to as a safety needle system 10 ) is decomposed into a needle 12 , a housing 14 , an insert 17 and a sensor 18 . Fig. 10BIt is also shown that the insert 17 can have a first portion 191 (also referred to as the insert first portion 191) and a second portion 193 (also referred to as the insert second portion 193). The first portion 191 can be harder than the second portion 193. The second portion 193 can be softer than the first portion 191 so that when the obturator 32 is pressed against the second portion 193, the second portion 193 can be compressed by the obturator 32. The first portion 191 can extend the length of the insert 17 and have a compressible area (e.g., the second portion 193) that can be used as an entry point for a flow blocking mechanism (e.g., a flow restrictor 28). The compressible area can have a contact surface for the flow restrictor 28. For example, when the obturator 32 is pressed against the second portion 193, the second portion 193 (e.g., the compressible area of ​​the second portion 193) can be deformed into the flow path 56. The first portion 191 can be a hard structural element. The second portion 193 can have one or more flexible membranes 54 (e.g., 1, 2, 3 or more flexible membranes 54). For example, Fig. 10B The second portion 193 is shown to have a flexible membrane 54. As another example, the second portion 193 can be a flexible membrane 54. The membrane 54 can be a soft, compressible membrane 54. The device 10 can have a flow-blocking configuration and a flow-unblocking configuration. When the device 10 is in the flow-unblocking configuration, the occluder 32 can be in contact with the membrane 54 or not. When the device 10 is in the flow-unblocking configuration, the membrane 54 can have a curved or flat shape. When the device 10 is in the flow-unblocking configuration, the membrane 54 can extend into the device flow channel 56, or it can not extend into the device flow channel 56 (e.g., as Fig. 10A and 10B When the device 10 is in the flow blocking configuration, the occluder 32 can be in contact with the membrane 54. When the device 10 is in the flow blocking configuration, the membrane 54 can be stretched or compressed into the device flow channel 56.

[0348] Fig. 10A and Fig. 10B It is also shown that the insert 17 can be manufactured using a two-shot molding process with a first injection molded part 190 and a second injection molded part 192. The first injection molded part 190 can be the insert first part 191, and the second injection molded part 192 can be the insert second part 193, or vice versa. For example, as described above with reference to Figure 7A-Figure 7I As described above, the first injection molded part 190 may be molded from a single material or a composite material, and the second injection molded part 192 may be molded from a single material or a composite material. Fig. 10BIt is shown that the insert 17 can be an overmolded tube (also referred to as an overmolded core, an overmolded component, and other terms with the term "overmolded" therein) that can provide a needle flow path (also referred to as a device flow channel 56) through the device 10. The needle 12 can define a first portion of the device flow channel 56 and the insert 17 can define a second portion of the device flow channel 56. Fig. 10B It is further shown that when the components of the device 10 are in the Fig. 10B In the orientation shown, the secondary injection molded component (eg, insert 17) may have, for example, a soft, compressible membrane 54 on the underside of the needle body (also referred to as housing 14).

[0349] The insert 17 can be made of materials with different mechanical properties and can be formed when or before the full needle system is assembled. The secondary injection molded tube can then be attached to other system components (e.g., needle 12, housing 14, sensor 18, or any combination thereof) by adhesive or other techniques. The order of attachment can be changed to ensure that the adhesive material is not accidentally spread to unwanted areas due to the assembly process during use. The wing features (e.g., the portion of the device 10 having wings 15) can be slid onto the secondary injection molded tube from the front or back as appropriate. The secondary injection molded parts can be a combination of polycarbonate (PC) and thermoplastic elastomer (TPE). The butterfly and pedals (also called blades) can be made using a variety of possible materials, including, for example, polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), acetal resin (Delrin), or any combination thereof. The pedal (e.g., sensor 18) can be designed to, for example, snap into place on the needle 14, friction fit with the housing 14, magnetically couple to the housing (e.g., couple to another magnet or magnets in the housing 14), be glued to the housing, or any combination thereof. As another example, the sensor 18 can be welded to the housing 14, the insert 17, or both.

[0350] Fig. 10A and Fig. 10B It is further shown that the insert 17 can define a device flow channel 56 (also referred to as an inner tube). Fig. 10A and Fig. 10B It is also shown that the insert 17 may define a flow path through the housing 14 , such as through the housing passage 51 . Fig. 10A and Fig. 10B Also shown is that the first injection molded part 190 and the second injection molded part 192 (e.g., the first part 191 and the second part 193) can be attached to maintain a fluid tight seal 202. The fluid tight seal 202 can withstand the high flow pressures associated with hemodialysis treatment. The second injection molded part 192 can have a compressible area of ​​the insert 17. For example, the second injection molded part 192 can have a membrane 54.

[0351] Fig. 10A and Fig. 10B It is further shown that the insert 17 may have an insert proximal end 17p and an insert distal end 17d. The tube 8 may be attached to the insert proximal end 17p. For example, the tube 8 may be attached (e.g., slid) on the insert proximal end 17p so that the distal end of the tube 8 abuts the housing 14, extends into the space in the housing 14 (e.g., extends into the housing channel 51), or stops not far from the housing 14 so that there is a gap between the housing 14 and the distal end of the tube 8.

[0352] Fig. 10A and Fig. 10B It is further shown that the sensor 18 can be attached to the housing 14 with a snap fit. For example, the housing 14 can have a clip recess 14r, and the sensor 18 can have a clip 18x. The clip 18x can be attached to the housing 14 by sliding the clip 18x into the clip recess 14r. When the clip lip 18y is pushed onto the recess lip 14y, the clip 18x can be locked (e.g., permanently or removably locked) in place.

[0353] Fig.11A and Fig. 11B It is shown that the housing 14 may include the wing 15, the insert 17 and the membrane 54, and the housing 14 may be manufactured using a two-shot molding process having a first injection molding 190 and a second injection molding 192. For example, the first injection molding 190 may include the wing 15 and the insert first portion 191, and the second injection molding 192 may be the insert second portion 193, or vice versa. Fig.11A and Fig. 11B It is shown that the insert 17 may be integrated with the wing 15 (eg, by an overmolding process), rather than being manufactured separately from the wing 15 and then attached to the wing 15 . Fig.11A and Fig. 11B The two-shot molding process is shown to advantageously reduce the amount of material required to manufacture the housing 14, for example, by eliminating the need for Fig. 10A and Fig. 10B The need for the portion of the housing 14 defining the housing channel 51 is eliminated because the wing 15 and the insert first portion 191 can be formed as a first injection molded part 190 as an integral piece.

[0354] As another example, Fig.11A and Fig. 11B It is further shown that the 2-shot injection molded component can be both the housing 14 and the insert 17, for example including the wing 15 (e.g., as Fig.11A and Fig. 11B shown) or does not include wing 15. Fig.11A and Fig. 11BIt is shown that the housing 14 and the insert 17 can be formed together by a 2-shot injection molding process, rather than forming them separately and then attaching them together during assembly (e.g., such as for Fig. 10A and Fig. 10B The device 10 shown). For example, as described above with reference to Figures 7A-7I As described, the first injection molded part 190 can be molded with a single material or a composite material, and the second injection molded part 192 can be molded with a single material or a composite material. The first injection molded part 190 may include the wings 15a and 15b and a portion of the central body (e.g., a portion of the housing 14). The second injection molded part 192 can be completed inside or outside the needle wing / body unit (e.g., inside the housing 14 defined by the first injection molded part 190). The second injection molded part 192 can be attached to the first injection molded part 190, for example, using glue, adhesive and / or welding (e.g., sonic welding). The second injection molded part 192 can be combined with a compressible membrane (e.g., membrane 54). The compressible membrane (e.g., membrane 54) can be a pinch point that the sensor 18 acts on when the needle 12 is inadvertently withdrawn from the patient.

[0355] For example, the housing 14 (e.g., a secondary injection molded component, also referred to as a secondary injection molded tube, a secondary injection molded component) can be made of materials with different mechanical properties and can be produced when or before the full needle system is assembled. The secondary injection molded tube can then be attached to other system components (e.g., needle 12, sensor 18, or any combination thereof) by adhesive or other techniques. The order of attachment can be changed to ensure that, when in use, the adhesive material is not accidentally spread to unwanted areas due to the assembly process. The secondary injection molded component can be a combination of polycarbonate (PC) and thermoplastic elastomer (TPE). The butterfly and pedal (also referred to as a blade) can be made using a variety of possible materials, including, for example, polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), acetal resin (Delrin), or any combination thereof. The pedal (e.g., sensor 18) can be designed to, for example, "snap" into place on the needle, friction fit with the housing 14 (e.g., the first injection molding 190 and / or the second injection molding 192), magnetically coupled to the housing (e.g., to another magnet or magnets in the housing 14), glued to the housing, or any combination thereof. As another example, the sensor 18 can be welded to the housing 14 (e.g., welded to the first injection molding 190 and / or the second injection molding 192).

[0356] Fig.11A and Fig. 11B A variation of device 10 is shown having a needle 12 with a sensor 18 (eg, a skin sensing component) designed to protect the patient from the risks associated with needle dislodgement. Fig.11AIt is also shown that the device 10 may have an integrated feature that allows flow to be stopped during accidental needle removal (in Fig.11A not fully visible in the image). Fig. 11B yes Fig.11A Exploded view of a safety needle system. Here, the secondary injection molded tube defining the device flow channel 56 includes structural aspects (e.g., first injection mold 190) and a soft, compressible region (e.g., second injection mold 192), which in this case also includes a wing-shaped structure. Insert 17 serves as an axial flow path through the body of the needle system. The secondary injection molded components are made of materials with varying mechanical properties and are produced during or before the full needle system is assembled. The secondary injection molded tube with wings is then attached to other system components (e.g., to needle 12, to sensor 18, and to tube 8) by adhesive or other techniques. The order of attachment can be changed to ensure that, when in use, the adhesive material is not accidentally spread to unwanted areas due to the assembly process. Fig. 11B The device 10 is shown in an exploded state, showing Fig.11A The device 10 is shown exploded into the tube 8, the needle 12, the housing 14, the sensor 18 and the connector 302.

[0357] When the device 10 is attached to a person's skin, the pedal (also referred to as the sensor 18) abuts against the needle 12 and allows fluid to flow freely. If the needle 12 is removed, the sensor 18 (e.g., a spring-loaded pedal) will extend outwardly away from the needle (e.g., to Fig.11A ), thereby causing an obstruction of flow through a device flow channel 56 extending through the housing 14. A mechanical feature on the pedal 18 (e.g., a flow restrictor 28 with an occluder 32) introduced into a flow path (e.g., a device flow channel 56) may cause an obstruction when the occluder 32 is pressed against the membrane 54. For example, an obstruction may be caused by permanently or temporarily obstructing the device flow channel 56 with the membrane 54 when the occluder 32 is pressed against the membrane 54.

[0358] Fig.11A and Fig. 11BIt is further shown that the device 10 can have a connector 302 having a connector first end 302A and a connector second end 302B. The connector 302 can have a needle hub 13. When the device 10 is assembled, the connector 302 can be attached to the housing 14, for example, by a rib 304 on the connector 302 and a groove 306 on the integrated insert 17, such as by a snap fit or friction fit to connect with the integrated insert 17. For example, the rib 304 can fit into the groove 306. As another example, the connector 302 can be attached to the overmolded housing 14 with a threaded fit, a magnetic fit, or any combination thereof. The needle 12 can be attached to the connector second end 302b and can extend through the channel in the connector 302 and into the housing channel 51.

[0359] Fig.11A and Fig. 11B A portion of the insert first portion 191 is shown as being transparent so that internal features of the first injection molded part 190 can be seen.

[0360] Fig.11A Also shown is the membrane 54 in a deflected configuration, for example, deflected by the occluder 32 into the device flow channel 56 .

[0361] Fig. 12A and Fig. 12B A single 2-shot molded component (also referred to as insert 17) is shown that may include the axial center of device 10 (e.g., Fig. 10A and Fig. 10B The insert 17 may be a part of the housing 14. The wing 15 may be attached to the insert 17 or integrated with the insert 17. Fig. 12A In FIG. 1 , the insert 17 is shown as it will be manufactured (in FIG. Fig. 12A , the compressible membrane 54 is located on the top side). Fig. 12B In the embodiment, for illustration purposes only, the results of each mold injection molding 19 injection molding 19 (e.g., first injection molding 190 and second injection molding 192) are broken down. The secondary injection molded part (e.g., insert 17) may include the following: Fig.11A and 11B The butterfly wing 15 is shown.

[0362] Fig. 12A and Fig. 12B It is further shown that the inner secondary injection molded part (also referred to as insert 17) achieves effective flow occlusion via a compressible membrane 54 as part of a safety needle system (also referred to as device 10) to protect the patient from the risk of needle dislodgement. Fig. 12AOne form of a 2-shot molded part for assembly into the device 10 is shown. The longer dark material may be polycarbonate or other hard material or other material having a greater hardness than the shorter transparent piece. The shorter transparent insert may be a mechanically soft thermoplastic elastomer. The entire piece (also referred to as insert 17) may be about 0.25 inches to about 1.50 inches long, including every 0.05 inch increment within that range (e.g., 0.75 inches, 1.00 inches, 1.25 inches). Fig. 12B Two work pieces (eg, a first injection molded part 190 and a second injection molded part 192 ) are shown as if they were manufactured separately. Fig. 12A Two workpieces are shown that were made by a 2-shot injection molding process. Fig. 12A and Fig. 12B The two pieces in are placed so that the soft area (e.g., membrane 54) of the insert 16 faces upward. In the final complete configuration of the device 10, the soft area (e.g., membrane 54) may face downward so that when the device 10 is attached to a person, the soft area faces the person's skin.

[0363] Fig. 12A and Fig. 12B It is further shown that the membrane 54 can be curved. For example, the membrane 54 can define a portion of the surface of the device flow channel 56. The membrane 54 can define, for example, a portion of a cylindrical device flow channel 56, a frustoconical device flow channel 56, or both.

[0364] Fig. 12A and Fig. 12B It is also shown that the device flow channel 56 may be defined by a first injection molding 190 and a second injection molding 192 .

[0365] Fig. 12A and Fig. 12B Further shown is the membrane 54 in a non-deflected configuration (also referred to as a relaxed configuration).

[0366] Fig. 12B Also shown is that the second injection molded part 192 can be attached to (e.g., via a 2-shot injection molding process) the first injection molded part 190 to cover the opening 203 in the first injection molded part 190. The opening 203 can be at the proximal end 17p of the insert (e.g., as shown in FIG. Fig. 12A ), at the insert distal end 17d, or at a position between the insert proximal end 17p and the insert distal end 17d. Similarly, the second injection molded part 192 may be at the proximal end of the first injection molded part 190 (e.g., as shown in FIG. Fig. 12A ), is attached to the first injection molding 190 at a distal end of the first injection molding 190 or at a position between the proximal end and the distal end of the first injection molding 190.

[0367] Fig.13A and Fig. 13B A variation of a preformed pocket 208 (also referred to as a recess 208) within a soft, compressible membrane region of a secondary injection molded component (e.g., insert 17) is shown. The pocket 208 can advantageously reduce the closing force required to move the sensor 18 (e.g., pedal) to an occluded position. During pressurized fluid flow, the pocket 208 can extend into the flow path (e.g., as shown in FIG. 1 ). Fig.13A As another example, during the flow of pressurized fluid, the pocket 208 may naturally flip to an open position so that it does not restrict flow (e.g., as shown in FIG. 2 ). Fig.13A During pedal closure, the pocket 208 may be stretched by the sensor 18 to allow internal occlusion of the fluid path (e.g., as shown in FIG. Fig. 13B ).

[0368] Fig.13A It is also shown that the sensor 18 may or may not extend into the pocket 208 during the flow of the pressurized fluid. For example, Fig.13A It is shown that when the pocket 208 (e.g., defined by the solid line 54) extends into the flow path during fluid flow, a portion of the sensor 18 (e.g., the occluder 32) can extend into the pocket 208. As another example, Fig.13A It is shown that when the pocket 208 (e.g., defined by the dashed line 54) is in a relaxed, inverted configuration, a portion of the sensor 18 (e.g., the occluder 32) can extend into the pocket 208. When the pocket 208 (e.g., defined by the dashed line 54) is in a relaxed, inverted configuration, some of the membrane 54 can extend outwardly away from the flow path.

[0369] Fig.13A It is also shown that the sensor 18 may or may not be in contact with the membrane 54 during the flow of the pressurized fluid. For example, Fig.13A It is shown that when the pocket 208 (e.g., defined by the solid line 54) extends into the flow path during fluid flow, a portion of the sensor 18 (e.g., the occluder 32) may or may not contact the membrane 54. As another example, Fig.13A It is shown that when the pocket 208 (eg, defined by the dashed line 54 ) is in a relaxed, inverted configuration, a portion of the sensor 18 (eg, the occluder 32 ) may contact the membrane 54 .

[0370] Fig.13A and Fig. 13B It is further shown that the pocket 208 can be integrated with the compressible portion of the 2-shot molded part. The pre-formed pocket 208 can be used with the outer assembly of the pedal to reduce the closing force required to occlude the internal flow. Fig.13AThe sensor 18 (e.g., pedal) is shown when the device is in a glued position on the patient's arm. The pocket 208 can be held in place (e.g., Fig.13A curved solid line above the dashed line) or become inverted or partially inverted through the normal course of fluid flow (e.g. Fig.13A (shown by the dashed line). Fig. 13B The sensor 18 (e.g., pedal) is shown in an activated position, for example, during the process of needle removal from the skin or after the device 10 has been removed from the skin. When the device 10 is removed from the patient's skin, the occluder 32 (e.g., pedal) can push the soft, compressible bag 208 to occlude fluid flow.

[0371] Figures 10A-13B Details of the manufacturing method and various variations of the device 10 are shown, including: for example: (1) manufacturing and using a double-shot molded core with or without wings 15 as an effective device capable of interrupting fluid flow during removal, wherein a portion of the core is a soft membrane (e.g., membrane 54), (2) a pre-formed pocket 208 within the soft portion of the double-shot molded core to increase efficiency, and (3) assembly techniques, or any combination thereof.

[0372] Fig.14A 1 and Figure 14A 2 A variation of attaching the wing 15 to the insert 17 (also referred to as a 2-shot core) is shown. For example, the wing 15 can be attached to the insert 17 by snap fit (arrow 308), or vice versa. As another example, FIG. 14A 1 and 14A 2 It is shown that the housing 14 (e.g., with wings 15) and the insert 17 can be attached to each other by a snap fit (arrow 308). As another example, the insert 17 can be the housing 14, and the wings 15 can be attached to the housing 14 by a snap fit. For example, FIG. 14A 1 and 14A 2 It is further shown that the wing 15 can have a connector 310 that can be attached to the overmolded core (e.g., insert 17). The connector 310 can be attached to the overmolded core (e.g., via a snap fit). The wing 15 can include a wing core having the connector 310. FIG. 14A 1 and Figure 14A 2 The connector 310 shown may be a clip. For example, FIG. 14A 1 and Figure 14A 2 The connector 310 shown may have, for example, a clamping arm (eg, two clamping arms) that can engage with a secondary injection molded core. The connector 310 may be attached to a distal end of the secondary injection molded core (eg, Fig.14A2), attached to the proximal end of the secondary injection core, or attached to somewhere between the proximal and distal ends of the secondary injection core. As some further examples, FIG. 14A 1 and Figure 14A 2 The butterfly assembly technique is shown. For example, FIG. 14A 1 and Figure 14A 2 A snap-fit ​​U-shaped butterfly wing unit 15 is shown that can be snapped onto a central core body composed of an overmolded part. As another example, FIG. 14A 1 and Figure 14A 2 A snap-fit ​​U-shaped butterfly wing unit is shown that can snap onto a housing 14 having a 2-shot molded component (e.g., having a first shot 190 and a second shot 192). The snap fit of the two components can be further enhanced by using adhesives or welding. The connector 310 can be removably attached to the insert 17.

[0373] Fig. 14B 1 and Figure 14B 2 It is shown that the connector 310 may have a ring or collar with an opening that enables a press fit approach by sliding the wings 15 (arrow 312) onto the central secondary injection molded part (eg, onto the insert 17). FIG. 14B 1 and Figure 14B 2 It is shown that the connector 310 can have a ring or collar with an opening that enables the wing 15 to be attached (arrow 312) to the secondary injection molded core (e.g., to the insert 17) by press fitting. As another example, FIG. 14B 1 and Figure 14B 2 A central wing core opening 310 is shown, which enables a press fit method by sliding (arrow 312) the wing 15 onto the central secondary injection molded component (e.g., onto the insert 17). The press fit attachment of the two components can be further enhanced by using adhesives or welding. The device pin and device pedal are not shown.

[0374] Fig. 14C 1 and Figure 14C 2 It is shown that the connector 310 may have a ring with an opening that enables press-fit access by sliding the wings 15 (arrow 314) onto the central secondary injection molded part (eg, onto the insert 17). FIG. 14C 1 and Figure 14C 2 It is shown that the connector 310 can have a ring or collar with an opening that enables the wing 15 to be attached (arrow 314) to the secondary injection molded core (e.g., insert 17) with a press fit. As another example, FIG. 14C 1 and Figure 14C 2The central wing core opening 310 is shown, which is achieved by sliding the wing 15 (arrow 314) onto the central secondary injection molded part (e.g., onto the insert 17) to achieve a press fit method. The sliding can be from the front (e.g., FIG. 14B 1 and Figure 14B 2 ) or later (e.g., FIG. 14C 1 and Figure 14C 2 ). The press fit attachment of the two components can be further enhanced by using adhesives or welding. The device pins and device pedals are not shown.

[0375] Fig.14A 1 - Figure 14C 2 The butterfly wings of the secondary injection molded part and the device 10 are shown to protect the patient from the impact of the intravenous needle being dislodged. The butterfly wings 15 can be manufactured in a manner that allows a snap-on method of integration with the secondary injection molded part (e.g., as shown in FIG. 14A 1 and 14A2). The wing 15 may be configured with openings to allow the wing workpiece to slide on or over the secondary injection molded part (e.g., as shown in FIG. 14B 1 and Figure 14B 2 and Figure 14C 1 and Figure 14C 2 14A 1 and Figure 14A 2 A snap fit connection is shown. Figure 14B 1 and Figure 14B 2 A press-fit connection is shown, wherein the wings 15 are slid from the distal side. FIG. 14C 1 and Figure 14C 2 A press-fit connection is shown, wherein the wings 15 are slid from the proximal side.

[0376] Fig.15A 1 and Figure 15A 2 An exploded view of the device 10 including the sensor 18 (eg, a spring-loaded pedal) is shown ( FIG. 15A 1 ) and assembly (FIG. 15A 2 ) view. In FIG. 15A 1 and Figure 15A 2 15A shows the needle 12 attached to a secondary injection molded part (also referred to as, for example, an insert 17 and a secondary injection molded core). 1 and Figure 15A 2 It is shown that the sensor 18 (e.g., pedal) may have a connector 315 that enables efficient press fit assembly of the sensor 18 to the secondary injection molded component. The fit of the sensor 18 to the secondary injection molded core may be further enhanced by the use of adhesives or welding. FIG. 15A 1 and Figure 15A 2It is shown that the connector 315 can have a ring or collar with an opening that enables the sensor 18 to be attached (arrow 316) to the secondary injection molded core (e.g., insert 17) in a press fit manner. For example, the connector 15 can be slid over the proximal end 17p of the insert (arrow 316). The sensor 18 (e.g., pedal) can be directly welded or fixed to the underside of the secondary injection molded core. The connector 315 (e.g., ring or collar) can be on one end of the sensor 18 (e.g., sensor proximal end 18a). The ring or collar can be used to achieve efficient device assembly / manufacturing. Figure 15A 1 A variation of an exploded view is shown showing the sensor 18 before it is attached to a 2-shot molded core or after it is removed from the 2-shot molded core. FIG. 15A 2 The device 10 is shown in an assembled configuration, showing a ring or collar of a sensor 18 (eg, a pedal) slid into position over a secondary injection molded component (eg, over insert 17).

[0377] Fig. 15B 1 and Figure 15B 2 An exploded view of the device 10 including a sensor 18 (eg, a spring-loaded pedal) is shown ( FIG. 15B ). 1 ) and assembly (FIG. 15B 2 ) view. Figure 15B 1 and Figure 15B 2 The connector 315 is shown to enable an effective snap-fit ​​assembly. The connector 315 can be a clip (e.g., clip 18x). As another example, FIG. 15B 1 and Figure 15B 2 The connector 315 shown may have a snap-fit ​​U-shaped variation that enables efficient snap-fit ​​assembly. The assembly of the two components may be further enhanced by using adhesives or welding. For example, FIG. 15B 1 and Figure 15B 2 It is shown that the sensor 18 can be attached (arrow 318) to the insert 17 (also called 2-shot core) by a snap fit, and vice versa. The connector 315 can be attached (eg, via a snap fit) to the 2-shot core (eg, insert 17).

[0378] Fig.16A and Fig. 16B The wings 15 and the insert 17 are shown exploded ( Fig.16A ) and assembly ( Fig. 16B )view. Fig.16A and Fig. 16BA 2-shot injection molded tube (e.g., insert 17) is shown as the device core, and a wing unit (e.g., wing 15) is built with a connector 310 and a cover 320 (also referred to as a cover and insert cover) that is used as a method of integrating the two components (e.g., for integrating wing 15 with insert 17). Cover 320 can be, for example, a hinged cover. As another example, Fig.16A and Fig. 16B An exploded view of the housing 14 (eg, with wings 15) and the insert 17 is shown. Fig.16A ) and assembly ( Fig. 16B ) view, where a 2-shot injection molded tube (e.g., insert 17) is used as the device core, and a wing unit (e.g., housing 14) is constructed with a connector 310 and a hinged cover 320, which is used as a method for integrating two components (e.g., for integrating wing 15 with insert 17). The hinged cover 320 may have a first hinge 322. The hinged cover 320 may extend from the first hinge 322. The first hinge 322 may be, for example, a living hinge. The first hinge 322 connects the hinged cover 320 to the needle hub 13 (e.g., as shown in FIG. 1 ). Fig.16A as shown) or connected to connector 310. Although Fig.16A 1, but the wing 15 may have a second hinge 323, for example on the opposite side of the needle hub 13 (for example at Fig. 16C ), when the cover 320 is in the Fig.16A In the open configuration shown, the second hinge connects the needle hub 13 to the housing 14. The second hinge 323 can be, for example, a living hinge. The connector 310 can include the cover 320, the first hinge 322, and / or the second hinge so that when the connector 310 is in the open configuration (e.g., as shown in FIG. 1 ), the second hinge connects the needle hub 13 to the housing 14. The second hinge 323 can be, for example, a living hinge. Fig.16A As shown), the needle hub 13 and / or the cover 320 may have Fig.16A When the cover 320 is closed (e.g., Fig. 16B As shown in FIG. 1 , the hinged wing workpieces surround the core secondary injection molded part. Fig. 16C It is shown that a sensor 18 (eg a pedal) can be integrated into the system by using sliding (arrow 330 ) of the sensor 18 with a connector 315 . Fig. 16C It is also shown that the tube 8 can be integrated into the system via sliding (arrow 330) by sliding the tube 8 onto the insert proximal end 17p. Fig. 16C It is further shown that the connector 315 can have a ring / ring type variation. Adhesion or welding can be used to enhance component interconnection (e.g., between the housing 14 and the insert 17, between the sensor 18 and the housing 14, or any combination thereof). As another example, the connector 310 can have a first hinge 322 instead of a second hinge 323, so that when the cover 320 is in the open configuration, the needle hub 13 can be in a closed position. Fig.16A In Fig. 16BThe configuration shown, and such that when the cover 320 is in the open configuration, the needle hub 13 can be a stop for the inserter 17 , preventing the inserter 17 from being over-inserted into the channel 51 .

[0379] Figure 16A-16C It is further shown that the 2-shot molded component 17 can have a soft compressible membrane 54 on the underside of the needle body, and the wing 15 can be a flexible butterfly wing. One method of integration of these two components is a hinge type method that allows the wing 15 to wrap around the core (e.g., around the insert 17) via a molded cover 320. The sensor 18 (e.g., pedal) can be assembled by a collar / ring type variation (e.g., as shown in FIG. 1 ) that allows sliding assembly. Fig. 16C shown) integrated into this type of structure.

[0380] Figure 16A-16C It is also shown that the insert 17 can have one or more aligners 324 (e.g., 1 to 4 or more aligners 324, including increments of 1 aligner within this range, such as Figure 16A-16C 2 aligners shown). The connector 310 may have an aligner groove 325 into which the aligner may slide when the insert 17 is inserted (arrow 326) into the connector 310. As another example, when the aligner and aligner grooves 324, 325 are aligned, the connector 310 may slide (e.g., arrow 314) over the insert 17 into the chamber 51. The aligner and aligner grooves 324, 325 may advantageously ensure that the membrane 54 is in place when the device 10 is in an assembled state, and may lock the insert 17 in place so that the insert does not translate or rotate when the obturator 32 is pressed against the membrane 54. Figures 16A-16C It is further shown that the connector 310 can be a clip and can have, for example, a clip arm (e.g., two clip arms) that can engage with the cover 320 so that the cover 320 can be snapped into the connector 310 (e.g., as shown in FIG. Fig. 16B As another example, Figures 16A-16C It is shown that the connector 310 may have a cover 320 .

[0381] Fig.14A 1 - Fig. 16C Details of the manufacturing method and various variations of the device 10 are shown, including, for example, (1) variations in the butterfly shape to enable efficient assembly, (2) adding a collar to the sensor 18 (e.g., a pedal) or incorporating a snap-fit ​​feature to enable efficient assembly, and (3) introducing a living hinge to serve as a cover 320 that enables the wing 15 to be effectively incorporated into the device 10.

[0382] Fig.17A and Fig. 17BA variation of the device 10 is shown. The device 10 may be an AV fistula butterfly needle with a tube 8 that may be used for hemodialysis treatment. Fig.17A and Fig. 17B The device 10 is shown in a removed state, wherein the needle body (also referred to as the housing 14) is lifted and away from the patient's skin. The device 10 may also be in a position prior to the device 10 being attached to the patient. Fig.17A and 17B The device 10 may be equipped with a sensor 18 (eg, a skin sensing pedal mechanism).

[0383] Figure 17C-17E It is shown that the pedal body can be attached to a spring 332 (e.g., connected to a preformed metal spring). The spring 332 can have a spring first extension 334a, a spring second extension 334b, and a spring third extension 334c. The spring second extension 334b ​​can be used as an occluding element in the internal flow path 56 (e.g., as an obturator 32) during needle removal. The living hinge 336 can simplify manufacturing, allowing the needle butterfly assembly and the pedal to be molded at the same time (the hinge 336 can allow the pedal to be bent into place after molding). The living hinge 336 can be formed integrally with the housing and can connect the sensor 18 to the housing. The housing 14, the sensor 18, and the living hinge 336 can be made of, for example, the same material, multiple materials, can be formed with a single mold, or any combination thereof. The bent end and U-shaped opening of the pedal can be seen, which allows the needle rod to be completely enclosed. Figure 17A-17E The spring 332 shown may be, for example, a stamped and bent flat metal spring, rather than a Figure 1-6B As another example, Figure 17A to Figure 19 The spring 332 shown may be, for example, a flat metal spring rather than a standard helical metal spring.

[0384] Figure 17A-17E Various cross-sectional and angled views of a specialized needle (also referred to as device 10) for protecting a patient from fluid delivery problems during a medical procedure are shown. Device 10 may have a sensor 18 (e.g., a spring-loaded two-part pedal having a sensor first portion and a sensor second portion) that, in the disengaged position shown (unapplied and with the needle body away from the skin), causes an occluding member (also referred to as an occluder 320 at the rear end of the pedal) to move into and block fluid flow through a fluid flow path 56 of device 10. The sensor first portion may be the portion of sensor 18 connected to housing 14 by a living hinge 336, and the sensor second portion may be a spring 332. The flow path 56 through device 10 is Fig. 17B Shown by dotted lines. Figure 17A-17EIt is also shown that the device 10 can have a spring 332 (e.g., an all-metal preformed spring) integrated with the housing 14 and the sensor 18, and the sensor 18 can be integrally formed with the housing 14 so that the sensor 18 (e.g., the first sensor portion) is an extension of the housing 14. The spring 332 can be integrated into the plastic pedal and needle. For example, Figure 17A-17E It is shown that the spring 332 (e.g., the first extension 334a of the spring) can be embedded in the sensor 18. The second extension 334b ​​of the spring 332 (e.g., made from the same piece of metal) can be used to form the occluder 32, which acts as a member to prevent flow through the interior of the device 10 during removal. To simplify manufacturing, the needle butterfly assembly can be molded at the same time as the pedal, with a living hinge that allows the pedal to be easily placed under the needle body.

[0385] Figure 17A-17E It is further shown that the spring first extension 334A can be embedded in the housing 14. Figure 17A-17E It is further shown that the flow restrictor 28 may be a spring second extension 334b. Figure 17A-17E It is further shown that the spring second extension 334b ​​may include two curved portions. One of the two curved portions may be an obturator 32, such as Figures 17C-17E shown. Figure 17A-17E It is further shown that the third extension 334C of the spring can be positioned between the housing 14 and the insert 17 (e.g., as shown in FIG. Fig. 17C As shown), or the third extension 334C can be embedded in the housing 14. Figure 17A-17E It is further shown that the sensor 18 can be an extension of the housing 14 and the spring 332 can be attached to the housing 14 .

[0386] Fig.18A and Fig.18B A top view and a cross-sectional view of a variation of a spring 332 are shown. The spring 332 may be, for example, a preformed metal spring that supplies a spring force for skin service detection and a force for flow path occlusion by actuating an occluder (e.g., of the occluder 32) upward into the flow path. Fig.18A and Fig.18B Also shown is an occluder (e.g., occluder 32) that can be mated with an occluder cap 338 (also referred to as an occluder cover). The occluder cap 338 can be, for example, a custom-formed plastic cap that allows optimization of the closure to maximize device performance through modification of shape, size, form, contour, or material. For example, Fig.18A and Fig.18B It is shown that the obturator cap 338 can have a wedge shape.

[0387] Fig.18AAlso shown is a top angle view of, for example, a spring 332, with an occluder cap 338 positioned on the occluder 32 (e.g., on the occluding portion of the sensor 18). The spring 332 may be metal, plastic, or both. For example, Fig.18A The spring 332 is shown to be metal. The cover 338 can be metal, plastic, or both. For example, Fig.18A It is shown that the cover 338 can be plastic. The shape, size, form, contour or material of the plastic cover can be modified in any necessary way to improve the occlusive function of the occlusion. Fig.18B Also shown is a cross-sectional view showing the plastic cover 338 in place over the occluder (also referred to as occluder 32) during removal (away from the skin).

[0388] Fig.19 It is shown that the device 10 can have a needle cap 340, a sensor support 342, or both. Fig.19 It is also shown that the needle cap 340 can be transparent so that the needle 12 can be seen inside the needle cap 340. Fig.19 Also shown is a needle cap 340 that can be removably attached to the device 10. Fig.19 It is also shown that when the needle cap 340 is attached to the device 10, the needle 12 can be inside the needle cap 340, for example, as shown in FIG. Fig.19 When the needle cap 340 is removed from the device 10, the needle 12 can be outside the needle cap 340.

[0389] Fig.19 Also shown is a needle cap 340 (also referred to as, for example, a needle cover, a protective cover, and a cap) that can include a sensor support 342. As another example, the sensor support 342 can be separated from the needle cap 340, such that the device 10 can have the needle cap 340, the sensor support 342, or both the needle cap 340 and the sensor support 342. During transport and storage, prior to use on a patient, the sensor support 342 can hold the sensor 18 (e.g., a spring-loaded pedal or a sensor 18 with a spring 332) in a fully closed position (e.g., the sensor 18 rests against the needle body) or in a fully open position (e.g., the sensor 18 is positioned such that the sensor 18 is not in contact with the needle body) and the sensor support 342 is not in contact with the needle body. Fig.19In order to maximize device functionality, it may be advantageous to maintain the sensor 18 (e.g., pedal) fully closed, fully open, or in any physical position between closed and open prior to use by a patient, as different positions may impose different amounts of mechanical stress on device components over time. For example, maintaining the sensor 18 (e.g., pedal) in a fully closed position, a fully open position, or in any physical position between fully closed and fully open prior to use by a patient, such as on the sensor 18, can reduce stress on the membrane 54, the spring of the sensor 18 (e.g., the integrated spring and / or the spring 332), or any combination thereof before the device is attached to the patient, thereby advantageously extending the shelf life of the device 10 prior to use. The needle cap 340 may have a recess 344 having a recess height 344 H The recess 344 allows the recess 344 to be formed based on the height (e.g., the recess height 344 of the recess 344) H , where a smaller height keeps sensor 18 closer to needle 12 and where a larger height keeps sensor 18 farther away from needle 12) to maintain sensor 18 (e.g., pedal) at any planned position. Fig.19 It is further shown that when the sensor 18 is in the recess 344, the sensor 18 can abut the sensor support 342. The sensor support 342 can be integrally formed with the needle cap 340 so that the sensor support 342 and the needle cap 342 are a single-piece workpiece. As another example, the sensor support 342 can be removably attached to the needle cap 340. The needle cap 340 can be tethered or not tethered to the device 10.

[0390] Fig.19 Also shown is, for example, a side view of the device showing a protective cover 340. The cover 340 may include an extended step 342 (also referred to as a sensor support), a recess 344, or both, which allows for standard protection of the needle 12 when secured to the needle body (e.g., to the housing 14), but also allows for stabilization of the sensor 18 (e.g., the pedal) in any selected position based on the height of the recess 344. Controlling the position of the pedal may result in increased life of the device during storage by relieving stress on a spring (e.g., a spring integrated with the sensor 18 or spring 332) and allowing access to the inner membrane (e.g., membrane 54) of the internal flow channel 56 via an occluder (e.g., via the occluder 32). Fig.19 It is further shown that the pedal can be molded alone without a living hinge.

[0391] Figure 17A to Figure 19Details of the manufacturing method and various variations of the device 10 are shown, including, for example, (1) the use of a living hinge to enable efficient part count and assembly, (2) an all-metal pre-formed spring assembly, (3) a small plastic cover (e.g., the obturator cap 338) that can be modified to affect flow in a favorable manner during device actuation, and (4) a needle cover 340 that can hold the pedal in a partially extended state prior to use to help relieve stress on the internal core, thereby helping to extend the shelf life of the product.

[0392] Figures 20A-22C Several known designs of protective needle guards 360 are outlined. The major needle manufacturers each use their own designed technology. Medi-Systems, Nipro, and JMS are among the most commonly available AVF needles for dialysis in the United States. Each has a unique slidable system in which Figures 20A-20C Three different systems for protective needle covers designed to be activated at the end of a dialysis treatment are shown in FIGS. 21A-21C and 22A-22C. Figures 20A-22C Commercially available needle guards are shown. For example, Figure 20A-20C from FIG. 20A to FIG. 20C The needle is shown withdrawn from the patient into the protective cover of a Medi-Systems MasterGuard needle guard 360. As another example, Figure 21A-Figure 21C Zhongcong FIG. 21A to FIG. 21C The travel of the NiproTulip needle guard 360 when sliding from the deflected position to the protected position is shown. As another example, Figure 22A-22C Zhongcong FIG. 22A to FIG. 22C The JMS Wistater system 360 is shown as it moves from the deflection position to the protection position. Figure 21A-Figure 22C The design in the invention needs to be improved to fully accommodate device 10 or any needle system with an integrated pedal or other skin sensing unit designed to help protect the patient from the danger of needle dislodgement. In order to be able to effectively use these types of designs (e.g., Figure 21A-Figure 22C Some modifications will be necessary. The present disclosure relates to improved types of sliding needle guards that can effectively use these types.

[0393] Fig.23A needle guard 360 is shown that can be used to protect the needle 12 of the device 10. The needle guard 360 can have a first part 362, which can have a beveled or chamfered edge 364. The first part 362 can be a bottom part configured to slide against the patient's skin, and it is configured to slide under the sensor 18. The first part 362 can be integrated into, for example, Figure 20A-20C The edge design of the bottom part of the slidable needle guard 360 shown in FIG. Figures 20A-22C The needle guard shown in FIG. 3 may be above the sensor 18 (eg, above the pedal). For devices with a sensor 18, the beveled or chamfered edge 364 can make the transition from the non-protected state to the protected state smoother and easier. Fig.23 An improvement to an existing needle guard 360 (e.g., Figures 20A-22C An example of modification of the bottom edge of the needle guard 360 (such as those shown in ) to enable the needle guard 360 to slide more effectively over a needle equipped with a pedal for skin sensing as part of a system (e.g., sensor 18) to protect the patient from accidental needle removal. Fig.23 It is shown that during sliding, the bottom edge 364 of the needle guard can be processed to be inclined or chamfered at the transition area where the bottom edge meets the sensor 18 (e.g., pedal). This angle enables the guard to slide effectively and smoothly over the needle body and pedal. Arrow 366 shows the sliding direction of the needle 12 protection (e.g., covering).

[0394] Fig.24A and Fig. 24B Shown in detail Figure 20A-20C An improvement on the MasterGuard needle protection design 360 shown in . Fig.24A and Fig. 24B Shows Figure 20A-20C A portion 372 of the flat bottom 374 of the needle guard 360 can be positioned at an angle 370 to the conventional bottom. Portion 372 is also referred to as a needle guard tilt slide, needle guard slide, transition zone, angled portion, and other similar terms. Angle 370 enables the needle guard to move more smoothly over the pedal during operation. Fig.24A and Fig. 24B Shows the Figure 20A-20C Another example of modification to the bottom edge of the needle guard 360 to enable the guard 360 to slide more effectively over a needle equipped with a pedal for skin sensing as part of a system to protect the patient from inadvertent needle removal. Fig.24A and 24BIt is shown that the MasterGuard bottom edge 374 can be modified to have a transition area 372 where the bottom edge intersects the sensor 18 (e.g., pedal) during sliding, with the transition area 372 offset by a distance 375 at an angle 370 to enable the guard to slide effectively and smoothly over the needle body and pedal. The distance 375 can be, for example, from about 8 mm to about 20 mm, including every 1 mm increment within this range (e.g., 15 mm). The modification results in a small portion of the transition zone being placed downward from the bottom of the existing needle guard at an angle 370 of about 10 degrees to about 40 degrees, including every 1 degree increment within this range (e.g., 25 degrees). When the needle guard 360 is fully advanced in direction 366, the needle 12 can be covered by the needle guard 360 and the sensor 18 can be in a partially closed position or a fully closed position, wherein Fig.24A The sensor is shown in the fully open position.

[0395] Fig.25 A variation of a protective needle guard design 360 is shown. Fig.25 The bottom of the guard is shown having a larger angled shape that acts as a funnel 376 (also called an entry channel, pedal funnel, pedal guide, pedal channel) to effectively funnel the pedal into the needle guard 360 during sliding. Fig.25 Shows the Figures 20A-20C Another example of modification of the bottom edge of the needle guard 360 to enable the guard to slide more effectively over a needle equipped with a pedal for skin sensing as part of a system to protect the patient from accidental needle removal. Fig.25 It is shown that the MasterGuard bottom edge 374 can be modified to have a transition area 372 where the bottom edge intersects the sensor 18 (e.g., pedal) during sliding, with the transition area 372 offset by a distance 375 at an angle 370 to enable the guard to slide effectively and smoothly over the needle body and pedal. The modification results in a small portion of the transition area being placed downward from the bottom of the existing needle guard at an angle 370 of about 10 degrees to about 40 degrees, including every 1 degree increment (e.g., 25 degrees) within this range. When the needle guard 360 is fully advanced in direction 366, the needle 12 can be covered by the needle guard 360 and the sensor 18 can be in a partially closed position or a fully closed position, wherein Fig.24A The sensor is shown in the fully open position.

[0396] Figure 23-Figure 25 The modifications of the needle guard shown can be applied to any existing needle guard 360 and can be combined with each other in any combination. Fig.25The transition region 372 shown with the funnel 376 may have a beveled or chamfered edge 364, or may have a non-beveled or non-chamfered edge.

[0397] The techniques illustrated and described herein for modifying the base components of a needle guard 360 are also applicable to guards 360 without distinct base components, such as the NiproTulip, in which case any or all components are modified for effective function.

[0398] Other needle guard modification techniques include modifying the materials of the sensor 18 (e.g., pedal) or the guard 360, or a combination thereof, to achieve a lower friction interface between each other, which enables the guard 360 to slide more effectively over the pedal. As another example, the surface of the sensor 18 (e.g., pedal), the guard 360, or both may be modified to induce low friction sliding.

[0399] Figure 19-Figure 25 Various modifications of the device 10, the existing needle guard 360, or both are shown in detail, for example, various modifications of the existing needle guard 360 are shown so that they can be compatible with the device 10 in the event that the device 10 has a sensor 18 (e.g., a pedal) that needs to be taken into account. The federal government requires that all needles have the guard 360 in place when they are removed from the patient. Figure 19-Figure 25 Various examples of what can be done are shown. For example, Figure 19-Figure 25 Various needle guards 360 are shown that can cover the tip of the needle 12 after use by a patient to reduce subsequent needle stick hazards to personnel or patients. For example, when the needle 12 is removed from the patient or when the needle 12 is removed from the patient, the needle guard can be moved over the needle 12 to cover the tip of the needle 12. The needle guard 360 can have a needle guard body having a needle chamber that can accommodate the needle 12. The needle guard 360 can have a needle guard body having a needle chamber that can protect the needle 12. The needle guard 360 can be slid over the device 10, for example, to cover the needle 12. The needle guard 360 can have a needle guard first position relative to the needle 12 and a needle guard second position relative to the needle 12. When the needle guard 360 is in the needle guard first position, the needle 12 can be opened (also called exposed). When needle guard 360 is in the needle guard second position, needle 12 may be covered such that device 10 may comply with federal mandates requiring needle guards (e.g., needle guard 360). Device 10 may have or be equipped with needle cap 340, needle guard 360, or both).

[0400] For example, Figure 1-Figure 25It is further shown that the device 10 can have 12 needles, a first injection molding 190 and a second injection molding 192. The device 10 can have a needle cap 340, a needle guard 360, or both the needle cap 340 and the needle guard 360. The first injection molding 190 and the second injection molding 192 can define the device flow channel 56. As another example, a tube within the channel defined by the first injection molding 190 and the second injection molding 192 can define the device flow channel 56. The device 10 can have an occluder 32. The occluder 32 can move into and out of the device flow channel 56. As another example, the occluder 32 can move from an occluder first position to an occluder second position, wherein when the occluder 32 is in the occluder first position, the occluder 32 can be outside the device flow channel 56, and when the occluder 32 is in the occluder second position, the occluder 32 can be in the device flow channel 56. As yet another example, when the occluder 32 is in the occluder first position, there are relatively fewer occluders 32 in the device flow channel 56 than when the occluder 32 is in the occluder second position. The occluder 32 can move back and forth between the occluder first position and the occluder second position. As another example, when the occluder 32 moves from the occluder first position to the occluder second position, the occluder 32 can be locked in the occluder second position. The device 10 can have a device closed configuration and a device open configuration. When the device 10 is in the device closed configuration, the occluder 32 can be in the device flow channel 56. When the device 10 is in the device open configuration, the occluder 32 in the device flow channel can be less than when the device is in the device closed configuration. For example, when the device 10 is in the device open configuration, the occluder 32 can be in the occluder first position, and when the device 10 is in the device closed configuration, the occluder 32 can be in the occluder second position. When the device 10 is in the device closed configuration, the occluder 32 can restrict or prevent fluid flow through the device flow channel 56, for example, by causing a portion of the device flow channel 56 to have a smaller cross-sectional area when the device 10 is in the device closed configuration than when the device 10 is in the device open configuration. For example, when the device 10 is changed from the device open configuration to the device closed configuration, the occluder 32 can be forced against a conduit defining the device flow channel 56 to create a kink in the device flow channel 56, thereby partially or completely restricting flow through the device flow channel 56. The conduit can be a channel defined by the first injection molded part 190 and the second injection molded part 192, for example, a wall (or multiple walls) defining the device flow channel 56. When the device 10 changes from the device open configuration to the device closed configuration, the occluder 32 can be forced against the membrane 54, so that the membrane 54, which can define a portion of the device flow channel 56, is pushed into the device flow channel 56, so that the occluder 32 causes the membrane 54 to move into the device flow channel 56, thereby partially or completely occluding the device flow channel 56.When the device 10 is in the device open configuration, the device flow channel 56 can have a first cross-sectional area. When the device 10 is in the device closed configuration, the device flow channel 56 can have a second cross-sectional area, such that the second cross-sectional area is smaller than the first cross-sectional area.

[0401] For example, Figure 1-Figure 25It is further shown that the device 10 can have a needle 12 and a housing 14 (also referred to as a device housing). The device 10 can have a needle cap 340, a needle guard 360, or both the needle cap 340 and the needle guard 360. The housing 14 can define a device flow channel 56. As another example, a tube in the housing 14 can define the device flow channel 56. The device 10 can have an obturator 32. The obturator 32 can move into and out of the device flow channel 56. As another example, the obturator 32 can move from an obturator first position to an obturator second position, wherein when the obturator 32 is in the obturator first position, the obturator 32 can be outside the device flow channel 56, and when the obturator 32 is in the obturator second position, the obturator 32 can be in the device flow channel 56. As yet another example, when the obturator 32 is in the obturator first position, relatively less of the obturator 32 is in the device flow channel 56 than when the obturator 32 is in the obturator second position. The occluder 32 can move back and forth between the occluder first position and the occluder second position. As another example, when the occluder 32 moves from the occluder first position to the occluder second position, the occluder 32 can be locked in the occluder second position. The device 10 can have a device closed configuration and a device open configuration. When the device 10 is in the device closed configuration, the occluder 32 can be in the device flow channel 56. When the device 10 is in the device open configuration, the occluder 32 in the device flow channel can be less than when the device is in the device closed configuration. For example, when the device 10 is in the device open configuration, the occluder 32 can be in the occluder first position, and when the device 10 is in the device closed configuration, the occluder 32 can be in the occluder second position. When the device 10 is in the device closed configuration, the occluder 32 can restrict or prevent fluid from flowing through the device flow channel 56, for example, by making a portion of the device flow channel 56 have a smaller cross-sectional area when the device 10 is in the device closed configuration than when the device 10 is in the device open configuration. For example, when the device 10 changes from the device open configuration to the device closed configuration, the occluder 32 can be forced against the conduit defining the device flow channel 56 to create a kink in the device flow channel 56, thereby partially or completely restricting the flow through the device flow channel 56. The conduit can be a channel defined by the housing 14, a tube extending through the housing channel 51, or both, for example, a wall (or multiple walls) defining the device flow channel 56, when the device 10 changes from the device open configuration to the device closed configuration, the occluder 32 can be forced against the membrane 54, so that the membrane 54, which can define a portion of the device flow channel 56, is pushed into the device flow channel 56, so that the occluder 32 causes the membrane 54 to move into the device flow channel 56, thereby partially or completely occluding the device flow channel 56, when the device 10 is in the device open configuration, the device flow channel 56 can have a first cross-sectional area.When the device 10 is in the device closed configuration, the device flow channel 56 can have a second cross-sectional area such that the second cross-sectional area is smaller than the first cross-sectional area.

[0402] For example, Figure 1-Figure 25It is further shown that the device 10 may have a spring (e.g., any spring disclosed, contemplated, and / or shown herein), wherein the spring may be biased to move the occluder into the device flow channel 56 when the device 10 changes from the device open configuration to the device closed configuration. The spring may be, for example, a coil spring, a leaf spring, or a spring-loaded sensor (e.g., a spring-loaded pedal). The spring may be, for example, at least one of a coil spring, a leaf spring, or a spring-loaded sensor (e.g., a spring-loaded pedal). The spring may be metal, plastic, a composite material, or any combination thereof. For example, the spring may be plastic. As another example, the spring may be plastic. The device 10 may have a sensor 18. The sensor 18 may be spring-loaded or not spring-loaded. For example, the sensor 18 may be a spring-loaded sensor (e.g., may be a spring-loaded pedal). As another example, the sensor 18 (e.g., a pedal) may not be spring-loaded, but may have a spring attached to the sensor 18 (e.g., a pedal). The spring may be attached to the sensor 18 (e.g., a pedal). The spring may be integrally formed with the sensor 18 such that the sensor 18 is a spring. The sensor 18 (e.g., a pedal) may have an occluder 32. The first injection molded part 190 may have a butterfly wing 15. The first injection molded part 190 may have a sensor 18 (e.g., a pedal). The device 10 may have a membrane 54. The membrane 54 is deformable. For example, the membrane 54 may be stretchable, compressible, non-foldable, foldable, or any combination thereof. The second injection molded part 192 may have a membrane 54 (e.g., a deformable membrane). The spring may have an occluder 32. The occluder 32 may be moved by the movement of the spring. The sensor 18 (e.g., a pedal) may have an occluder 32. The occluder 32 may be moved by the movement of the sensor 18 (e.g., a pedal). When the device is in the device closed configuration, the occluder may deform the membrane 54. When the device 10 is in the device closed configuration, the occluder 32 may cause less deformation of the membrane 54 when the device 10 is in the device open configuration than when the device 10 is in the device closed configuration. When the device 10 is in the device open configuration, the device flow channel 56 may have a first cross-sectional area. When the device 10 is in the device closed configuration, the device flow channel 56 may have a second cross-sectional area, wherein the second cross-sectional area may be smaller than the first cross-sectional area. When the device 10 is in the device open configuration, the device flow channel 56 may have a first cross-sectional area. When the device 10 is in the device closed configuration, the device flow channel 56 may have a second cross-sectional area, wherein the second cross-sectional area may be smaller than the first cross-sectional area. The membrane 54 may be reversible. The membrane 54 may define a pocket 208 for the occluder 32, the membrane 54 may be reversible, and may define a pocket 208 for the occluder 32. The occluder 32 may have an occluder cap 338 configured to deform the membrane 54. The sensor 18 (e.g., a pedal) may be moved by the movement of a spring. The device 10 may have an insert 17.Insert 17 may have a first injection molded part 190 and a second injection molded part 192. The first injection molded part 190 and the second injection molded part 192 may be insert 17. Housing 14 may have a connector 310. Connector 210 may be configured to connect to first injection molded part 190. Housing 14 may have a connector 310. Connector 210 may be configured to connect to insert 17. Housing 14 may have a cover 320 configured to cover first injection molded part 190. Housing 14 may have a cover 320 configured to cover insert 17. Cover 320 may be a hinged cover. Cover 320 may be connected to housing 14 with a hinge, for example, via hinge 322, via hinge 323, or via both hinge 322 and hinge 323. The hinge may be a living hinge. Device 10 may have a needle hub 13. The needle hub 13 can be, for example, part of the insert 17, part of the first injection molded part 190, part of the housing 14, or any combination thereof. As another example, the needle hub 13 can be attached to the insert 17, the first injection molded part 190, the housing 14, or any combination thereof. The cover 320 can be connected to the housing 14 with a first hinge 322, and the cover 320 can be connected to the housing 14 with a second hinge 323. The hinges (e.g., hinge 322, hinge 323) can be living hinges. The first hinge 322 can be a living hinge. The second hinge 323 can be a living hinge. The device 10 can have a needle cap 340. The device 10 can have a sensor support 342. The sensor support 342 can be configured to reduce the strain on the spring before the device is attached to the patient. The sensor support 342 can be configured to extend the shelf life of the device. The needle cap 340 can have a needle cap chamber and a sensor support 342. The device 10 can have a needle guard 360. The needle guard 360 can be moved over the needle 12 to cover the needle 12 when the needle 12 is removed from the patient or when the needle 12 is removed from the patient. The needle guard 360 can have a needle guard body having a needle chamber configured to receive the needle 12, and the needle guard 360 can slide over the device 10 to cover the needle 12. The needle guard 360 can have a needle guard first position relative to the needle 12 and a needle guard second position relative to the needle 12. When the needle guard 360 is in the needle guard first position, the needle 12 can be exposed. When the needle guard 360 is in the needle guard second position, the needle 12 can be covered by the needle guard 360. When the needle guard 360 is in the needle guard second position, the needle 12 can be covered so that the device 12 complies with the federal order requiring needle guards. When the needle guard 360 is in the needle guard second position, the needle 12 can be covered so that the device 12 complies with the safety requirements prescribed by law. The needle guard body may have a bottom edge that may slide under the sensor 18 (eg, a pedal) when the device 10 is attached to a patient.The needle guard body may have a bottom edge that is slidable under the sensor 18 (e.g., a pedal) after the device 10 is removed from the patient or after the device 10 is removed from the patient. The needle guard body may have a bottom edge that is slidable under the sensor 18 (e.g., a pedal) after the needle 12 is removed from the patient or after the needle 12 is removed from the patient. When the needle guard 360 moves from the needle guard first position to the needle guard second position, the sensor 18 (e.g., a pedal) may move toward at least one of the housing 14, the insert 17, the first injection molded part 190, and the needle 12 via the needle guard 360. The bottom edge of the needle guard 360 may be a beveled or angled edge. The needle guard body may have a flat bottom and an angled portion that is configured to enable the needle guard 360 to slide more effectively over the needle 12 when the device 10 has the sensor 18 (e.g., a pedal). The needle guard body may have a pedal channel (also referred to as a sensor channel) configured to enable the needle guard 360 to slide more efficiently over the needle 12 by directing a pedal into the needle guard 360 when the device 10 has a sensor 18 (e.g., a pedal). As another example, the needle 12 may be retracted into the device 10, e.g., into the device flow channel 56, into the channel 51, into the housing 14, into the insert 17, into the first injection molded part 190, or any combination thereof. The device 10 may have a needle retraction mechanism, such as a needle retractor (e.g., a retractor spring), which may be activated, for example, when the device 10 is removed from the patient when the needle 12 is removed from the patient. For example, when the sensor 18 senses an accidental or intentional removal event, the needle 12 may be automatically retracted into the device 10. The method of assembling the device 10 may include, for example, attaching the wing 15 to a 2-shot core (e.g., insert 17) having a first injection molding 190 and a second injection molding 192. The first injection molding 190 may have a connector (e.g., insert proximal end 17p) for a tube (e.g., tube 8). The second injection molding 192 may have a membrane 54. The membrane 54 and the first injection molding 190 may define a device flow channel 56. The method of assembling the device 10 may include attaching a sensor 18 (e.g., a movable pedal) having an occluder 32 to the first injection molding 190. The sensor 18 may be movable. For example, the method may include attaching a movable sensor 18 (e.g., a movable pedal) to the first injection molding 190. As another example, the method of assembling the device 10 may include attaching the butterfly wing 15 to a device center core (e.g., insert 17) that defines a device flow channel 56. The insert 17 may be a two-shot mold having, for example, a first injection-molded part 190 and a second injection-molded part 192 .As another example, the insert 17 may not be a 2-shot mold, wherein, for example, the insert 17 has a first portion 191 and wherein the second portion 193 is attachable to the first portion 191. The sensor 18 may be attached to the first portion 191 and / or the second portion 193. The method may include attaching the sensor 18 (e.g., a movable pedal) having an occluder 32 to the device center core (e.g., the insert 17). As yet another example, the method of assembling the device may include attaching a movable sensor 18 (e.g., a movable pedal) having an occluder 32 to the housing 14. The method may include attaching the butterfly wing 15 to the housing 14, the housing 14 (or a portion thereof) may define the device flow channel 56, the method may include attaching the tube 8 to a tube connector. The tube connector may be, for example, the insert proximal end 17p. Attaching the wing 15 to the 2-shot core may include clamping the wing 15 onto the 2-shot core or sliding the wing 15 onto the 2-shot core. The device 10 may be configured to have a device open configuration when the device 10 is attached to a person. The device 10 may be configured to change from the device open configuration to the device closed configuration when the device 10 is removed from the person or when the device 10 is removed from the person. The device 10 may be configured to change from the device open configuration to the device closed configuration when the needle 12 is removed from the human body or when the needle 12 is removed from the human body. As another example, the device 10 may have a needle 12. The device 10 may have a first injection molded part 190 and a second injection molded part 192. The first injection molded part 190 and the second injection molded part 192 may define a device flow channel 56. The device 10 may have an obturator 32. The obturator 32 may be moved into and out of the device flow channel 56. The device 10 may have a device closed configuration and a device open configuration. When the device 10 is in the device closed configuration, the obturator 32 may be in the device flow channel 56. When the device 10 is in the device open configuration, there may be fewer occluders 32 in the device flow channel than when the device 10 is in the device closed configuration. As yet another example, the device 10 may have a needle 12. The device 10 may have a housing 14 having a device flow channel 56. The device 10 may have an occluder 32. The occluder 32 may move into and out of the device flow channel 56. The device 10 may have a device closed configuration and a device open configuration. When the device 10 is in the device closed configuration, the occluder 32 may be in the device flow channel 56. When the device 10 is in the device open configuration, there may be fewer occluders 32 in the device flow channel than when the device 10 is in the device closed configuration.

[0403] Fig.26AA general time vs. time graph 378 is shown that summarizes the nature of the pressure detection problem. The venous line pressure of a hypothetical normal patient experiencing a dislodgement is plotted over time. Graph 378 shows an estimate of how the venous line pressure changes during a dislodgement event. For a patient with a low venous access pressure, the pressure drop due to the dislodgement is typically not sufficient to trigger the preset machine low pressure alarm limits, where "Up Lim" is the high pressure alarm limit of the pump, where "LowLim" is the low pressure alarm limit of the pump, and where "VND OCCURS" indicates where the venous dislodgement event occurred. Fig.26A The relationship between venous line pressure (VLP) and time is shown for a hypothetical venous needle removal during hemodialysis. Fig.26A In the extubation event shown, the pressure change caused by the extubation is not enough to trigger the machine pump high or low pressure alarm limit window settings. In this case, the machine will continue to pump blood, which may endanger the patient's life. Fig.26A For example, the pressure from the first venous line pressure VLP is shown 1 Reduce to second venous line pressure VLP 2 .

[0404] Figure 26B-Figure 27B A variation is shown that shuts off fluid flow in the event of venous removal. Fig.27A and Fig.28B The device 10 is shown to have a sensor 18 (e.g., a pedal) and an occluder 32 (e.g., a membrane clamp) that moves out of the flow path (e.g., out of the device flow channel 56) rather than into it during a dislodgment event. The device 10 may or may not have a spring. When the device 10 does not have a spring, the occluder 32 may fall away from the membrane 54 and the device flow channel 56 during a dislodgment event. In the case where the device 10 has a spring, for example, attached to or integrated with the sensor 18, the spring may be biased to pull the occluder 32 away from the membrane 54 and the device flow channel 56 during a dislodgment event. For example, with or without the use of a spring, Fig.27A and 27B Activation of the device 10 is shown to cause the occluder 32 (e.g., clamp) to move out of the device flow channel 56, thereby causing a drop in line pressure. This drop in pressure can be detected by the hemodialysis machine and cause the machine to shut down, such as Fig.26B shown. Fig.27A and Fig.27B It is shown that the device 10 may be, for example, a springless system.

[0405] Fig.26B Details show the use of Fig.27A and Fig.27B FIG. 380 is an estimated curve 380 of venous pressure variation over time for a hypothetical patient undergoing needle removal using the device 10. If the patient is equipped with Fig.27A and Fig.27B In the case of a device 10, the mechanical interruption of the fluid flow path during normal treatment allows the system to respond more forcefully (i.e., the magnitude of the pressure drop is much greater) upon removal. This violent response is more likely to trigger the pressure alarm limit setting and cause the machine to automatically shut down during removal, such as Fig.26B As shown, “Up Lim” is the high pressure alarm limit of the pump, “Low Lim” is the low pressure alarm limit of the pump, and “VNDOCCURS” indicates the location where the venous outflow event occurs. Fig.26B The venous line pressure (VLP) versus time for venous needle removal during hemodialysis is shown for a hypothetical patient using the present disclosure. Fig.26B In the dislodgement event shown, mechanical intrusion in the flow path has created a pressure higher than the usual intravenous line pressure during standard treatment. In the event of needle dislodgement using any device 10, the lower limit alarm is easily violated because the dislodgement also removes the mechanical flow barrier in the needle body. Exceeding the lower alarm limit can cause an automated machine shutdown and protect the patient from blood loss.

[0406] Fig.27A The needle / pedal features (e.g., housing 14 / sensor 18 features, insert 17 / sensor 18 features, or any combination thereof) are shown as they would appear during treatment. When the device 10 is attached to the skin, the sensor 18 (e.g., pedal member) has a segment (e.g., occluder 32) that can protrude through the center of the needle into the fluid flow path 56 via a thin elastic membrane 54. By varying the size and shape of the protrusion (e.g., occluder 32), the line pressure can be increased for any given constant flow setting. For example, with Fig.27A A large protrusion that nearly blocks the flow path will cause a significantly large line pressure increase compared to the relatively small protrusion shown in FIG. Fig.27A It is shown that when the needle 12 is fully attached to the body and fluid is flowing through the device 10, the sensor 18 can increase the pressure in the device flow channel 56. Fig.27A Also shown is a line occlusion feature (e.g., sensor 18) shown in cross section. In normal treatment delivery conditions (taped to the arm), the occluder 32 (e.g., occlusion member) pushes against the flexible membrane. Based on the size and shape of the occluder, the magnitude of the line pressure increase can be controlled.

[0407] Fig.27BThe occlusion feature is shown in the removal mode. When the needle becomes untapped or is accidentally removed from the vascular access during normal treatment, the pressure-raising protrusion (e.g., occluder 32) is pulled away from the flow path 56, for example via a spring-loaded pedal (e.g., sensor 18). Removing the protrusion from the flow channel will therefore allow a significant pressure drop because the mechanical barrier (e.g., occluder 32) no longer impedes flow. Simple physics determines the magnitude of the pressure reduction produced by this feature during removal. Fig.27A and Fig.27B The device 10 in the embodiment can thus generate a pressure drop which serves as a very reliable and unambiguous signal for the automatic shutdown of the machine due to violation of the low-pressure limit value. Fig.27B Further shown is a pedal / line occlusion feature shown in cross-section during intravenous needle removal (device no longer laid flat against the patient's skin). Removal of an occluding element (e.g., occluder 32) from flow channel 56 causes a proportional drop in line pressure. This drop is used to positively trigger the lower alarm setting of the fluid pump and cause the pump to shut down, thereby protecting the patient. Fig.27A and Fig.27B It is shown that when the device 10 is in the device open configuration, the device flow channel 56 may have a first cross-sectional area, and when the device 10 is in the device closed configuration, the device flow channel 56 may have a second cross-sectional area, and the second cross-sectional area may be greater than the first cross-sectional area.

[0408] Figure 27A-27B The device 10 in may have, for example, Figure 1-Figure 25 Any features shown in and any combination of these features.

[0409] For example, Fig.27A and Fig.27B As further shown, for example, the device 10 can have a needle 12 and a housing 14. The housing 14 can have a device flow channel 56. The device 10 can have an obturator 32. The obturator 32 can move into and out of the device flow channel 56. The device 10 can have a first device open configuration and a second device open configuration. When the device 10 is in the first device open configuration, the obturator 32 can be in the device flow channel 56. When the device 10 is in the second device open configuration, there can be fewer obturators 32 in the device flow channel 56 than when the device 10 is in the first device open configuration. The housing 14 can define the device flow channel 56. As another example, a tube in the housing 14 can define the device flow channel 56. The device 10 can have an obturator 32. The obturator 32 can move into and out of the device flow channel 56. As another example, the occluder 32 can be moved from a first occluder position to a second occluder position, wherein the occluder 32 can block the device flow channel 56 (e.g., Fig.27AAs another example, the occluder 32 can be moved from the first occluder position to the second occluder position, wherein when the occluder 32 is in the first occluder position, the occluder 32 can block the device flow channel 56 (e.g., as shown in FIG. 1 ). Fig.27AThe occluder 32 may partially block the device flow channel 56 when the occluder 32 is in the occluder second position, and when the occluder 32 is in the occluder second position, the occluder 32 may block the device flow channel 56 less than when the occluder 32 is in the occluder first position. As another example, when the occluder 32 is in the occluder first position, more occluders 32 are in the device flow channel 56 than when the occluder 32 is in the occluder second position. The occluder 32 may move back and forth between the occluder first position and the occluder second position. The device 10 may have a device first open configuration and a device second open configuration. When the device 10 is in the device first open configuration, the occluder 32 may be in the device flow channel 56. When the device 10 is in the device second open configuration, the occluder 32 in the device flow channel 56 may be less than when the device 10 is in the device first open configuration. When the device is in the device second open configuration, some or no occluders 32 may block the device flow channel 56. For example, when the device 10 is in the first open configuration of the device, the occluder 32 can be in the occluder first position, and when the device 10 is in the second open configuration of the device, the occluder 32 can be in the occluder second position. When the device 10 is in the first open configuration of the device, the occluder 32 can restrict the flow of fluid through the device flow channel 56, for example, by causing a portion of the device flow channel 56 to have a smaller cross-sectional area when the device 10 is in the first open configuration of the device than when the device 10 is in the second open configuration of the device. For example, when the device 10 changes from the first open configuration of the device to the second open configuration of the device, the occluder 32 can move out of the flow channel, thereby eliminating or reducing a kink in the device flow channel 56 caused by the occluder 32 when the device is in the first open configuration of the device. When the device 10 changes from the first open configuration of the device to the second open configuration of the device, the occluder 32 can cause the membrane 54 to deform less, for example, including no deformation at all. When the device 10 is in the first open configuration of the device, the device flow channel 56 can have a first cross-sectional area. When the device 10 is in the second open configuration of the device, the device flow channel 56 may have a second cross-sectional area such that the second cross-sectional area is greater than the first cross-sectional area. The device 10 may have a spring (e.g., any spring disclosed, contemplated, and / or shown herein), wherein the spring may be biased to move the obturator 32 out of the device flow channel 56 when the device 10 changes from the first open configuration of the device to the second open configuration of the device. The device 10 may be configured to have the first open configuration of the device when the device is attached to a person. The device 10 may be configured to change from the first open configuration of the device to the second open configuration of the device when the device 10 is removed from the person or when the device 10 is removed from the person. The device 10 may be configured to change from the first open configuration of the device to the second open configuration of the device when the needle 12 is removed from the human body or when the needle 12 is removed from the human body.When the device 10 changes from the first device open configuration to the second device open configuration, the pressure drop in the device flow channel can be detected, for example, by a pressure sensor. The pump can have a pressure sensor. The pressure sensor can be part of the pump. The housing 14 can have a first injection molded part 190 and a second injection molded part 192. The first injection molded part 190 and the second injection molded part 192 can define the device flow channel 56, the first injection mold can have a butterfly wing 15, and the second injection molded part 192 can have a membrane 54, and the membrane 54 can be deformed. Compared with when the device 10 is in the first device open configuration, when the device 10 is in the second device open configuration, the obturator 32 can cause less deformation of the membrane 54 (e.g., a deformable membrane) when the device 10 is in the second device open configuration.

[0410] Any device disclosed herein (e.g., device 10) may have any combination of features described, contemplated, and / or illustrated herein. For example, any device disclosed herein (e.g., device 10) may have Figures 1 to 27B any combination of the features or properties shown in any combination of Figures 1 to 27B Any subset of the graph in (e.g., FIG. 10A to FIG. 25 , FIG. 10A to FIG. 27B , FIG. 26A to FIG. 27B , FIG. 10A to FIG. 26A). Each arrangement of the features disclosed, contemplated and / or illustrated herein is thereby disclosed and illustrated, for example, by means of the drawings presented herein and their corresponding descriptions. For example, the housing 14, the insert 17, the first injection molded part 190, and the second injection molded part 192 may be interchangeable with each other in any combination. For example, for a device 10 shown as having a housing 14 without an insert 17, the device 10 may be modified to have an insert 17 with or without the housing 14 (e.g., with or without the first injection molded part 190, and / or with or without the second injection molded part 192). As another example, the device 10 may have a housing 14. The housing 14 may be configured to couple a fluid delivery tube to a needle 12, and the needle 12 may be configured to deliver fluid subcutaneously in patient tissue. The device 10 may have a sensor 18 coupled to the housing. The sensor 18 may be, for example, a spring-loaded activation mechanism, such as a pedal. The sensor 18 can have a first orientation corresponding to a situation where the housing 14 is disposed adjacent to the tissue and the needle 12 is stuck in the tissue. The sensor 18 can have a second orientation corresponding to a situation where the housing 14 is disposed away from the tissue or the needle 12 is removed from the tissue. The device 10 can have an obturator 32. The obturator 32 can be a flow termination mechanism. The obturator 32 can be directly or indirectly coupled to the sensor 18. When the sensor 18 is in the first orientation, the obturator 32 can have an open configuration, an orientation that allows fluid to flow from the fluid delivery tube to the needle 12. When the sensor 18 is in the second orientation, the obturator 32 can have a closed configuration, an orientation that reduces, terminates, or substantially terminates flow from the fluid delivery tube to the needle 12. When the sensor 18 is in the first orientation, the sensor 18 can be disposed adjacent to the patient's skin. The sensor 18 can be hinged relative to the housing 14 to move to the second orientation. When the sensor 18 is in the second orientation, the occluder 32 can be a pinch valve that is oriented to reduce, terminate, or substantially terminate flow from the fluid delivery tube to the needle 12. The occluder 32 can be articulated in response to the articulation of the sensor 18 from the first orientation to the second orientation so as to pinch flow from the fluid delivery tube to the needle 12 when the sensor 18 is in the second orientation. The sensor 18 can be a pinch valve. The pedal can be a pinch valve. The device 10 can have a needle cap 340, a needle guard 360, or both the needle cap 340 and the needle guard 360. The occluder 32 can clamp the device flow path 56, for example, by being pressed against the membrane 54. As another example, the housing 14 can have a compliant tube that couples the fluid delivery tube 8 to the needle 12, and the occluder 32 can be articulated with the compliant tube in the second orientation to reduce, terminate, or substantially terminate flow from the fluid delivery tube 8 to the needle 12. As yet another example, the device 10 can have a device longitudinal axis. The device 10 may have a needle 12 having a needle proximal end and a needle distal end. The device 10 may have a housing 14 having a housing opening and a housing conduit. The housing conduit may extend from the housing proximal end to the housing distal end.The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable pedal having a pedal proximal end, a pedal distal end, a pedal first surface, a spring, and an obturator. The pedal proximal end may be attached to the housing. When the pedal first surface applies a first force to a non-pedal surface, the movable pedal may have a pedal first configuration, and when the pedal first surface applies a second force less than the first force to the non-pedal surface, the movable pedal has a pedal second configuration. When the first force is reduced to the second force, the spring may be biased to move the movable pedal from the pedal first configuration to the pedal second configuration. When the movable pedal is in the pedal second configuration, at least a first portion of the obturator may occlude the housing conduit. When the movable pedal is in the pedal second configuration, at least a second portion of the obturator is located in the housing opening, and when the movable pedal is in the pedal first configuration, at least a second portion of the obturator is located outside the housing opening. As another example, the device 10 may have a device longitudinal axis. The device 10 may have a needle 12 having a needle proximal end and a needle distal end. The device 10 may have a housing 14 having a housing opening and a housing conduit. The housing conduit may extend from the housing proximal end to the housing distal end. The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable pedal having a pedal proximal end, a pedal distal end, a pedal first surface, a spring, and an obturator. The pedal proximal end may be attached to the housing. When the force applied by the pedal first surface against the non-pedal surface changes from a first force to a second force less than the first force, the spring may be biased to move the movable pedal from the pedal first configuration to the pedal second configuration. When the movable pedal is in the pedal second configuration, at least a first portion of the obturator may occlude the housing conduit. The pedal distal end may have a stopper configured to prevent excessive insertion of a needle into a blood vessel. When the movable pedal is in the pedal first configuration, at least a portion of the stopper may be closer to the needle than when the movable pedal is in the pedal second configuration. The device 10 may have a needle cap 340, a needle guard 360, or both the needle cap 340 and the needle guard 360. As another example, the device 10 may have a device longitudinal axis. The device 10 may have a needle 12 having a needle proximal end and a needle distal end. The device 10 may have a housing 14 having a housing opening and a housing conduit. The housing conduit may extend from the housing proximal end to the housing distal end. The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable pedal having a pedal proximal end, a pedal distal end, a pedal first surface, a spring, and an obturator. The pedal proximal end may be attached to the housing. When the force applied by the pedal first surface against the non-pedal surface changes from a first force to a second force less than the first force, the spring may be biased to move the movable pedal from a pedal first configuration to a pedal second configuration.When the movable pedal is in the pedal second configuration, at least a first portion of the occluder can occlude the housing conduit. The pedal distal end can have a curved surface configured to reduce friction with a non-pedal surface when the needle is inserted into a blood vessel. When the movable pedal is in the pedal first configuration, at least a portion of the curved surface can be closer to the needle than when the movable pedal is in the pedal second configuration. The device 10 can have a needle cap 340, a needle guard 360, or both the needle cap 340 and the needle guard 360.

[0411] Presented herein is a method of manufacturing a needle safety system capable of automatic flow termination for fluid delivery, the needle safety system comprising a housing configured for coupling a fluid delivery tube to a needle configured for delivery of fluid subendothelially (into the vascular system) in a patient's tissue, and a force-sensitive activation mechanism (shown here as a pedal), the housing being configured for coupling a fluid delivery tube to a needle configured for delivery of fluid subendothelially (into the vascular system) in a patient's tissue, the force-sensitive activation mechanism having a first "flat" orientation corresponding to a state that allows fluid delivery through the needle body when attached to the patient, and a second "displaced" condition, wherein a spring-loaded pedal is configured to push into a soft region and cause internal flow occlusion. The method includes the use of a 2-shot injection molded component capable of effectively occluding an internal flow path, a variation of the component in which a preformed "pocket" is used to help reduce the total force required to produce flow occlusion, and an effective assembly technique with respect to a multi-piece configuration of the full needle system.

[0412] Device modification / assembly methods are presented herein that enable efficient manufacture of needle safety systems for automatically terminating the flow of fluid delivery during removal. Presented aspects of the present disclosure include the use of U-shaped snap fit or press fit modifications that enable integration of separate system components including butterfly wings into a secondary injection molded core or integration of a pedal into a secondary injection molded core. The system can be assembled in a variety of scenarios (front to back, back to front) that best facilitates efficient assembly.

[0413] A system and method for automatic flow termination for fluid delivery, comprising a housing configured to couple a fluid delivery tube to a needle configured to deliver fluid subendothelially (into the vascular system) in a patient's tissue, and a force-sensitive activation mechanism (shown here as a plastic pedal), the housing being configured to couple a fluid delivery tube to a needle configured to deliver fluid subendothelially (into the vascular system) in a patient's tissue, the force-sensitive activation mechanism having a first "flat" orientation corresponding to a state in which fluid delivery is allowed through the needle body while using a U-shaped opening to protect the needle entry hole, and a second orientation corresponding to a state in which the fluid tube is occluded via a fluid occlusion member of the pedal during needle removal by a spring force provided by a preformed metal spring integrated into the plastic pedal. The spring can be designed to also include a proximal portion that can be used directly as an occluder, or the metal occluder can be covered with a small plastic cap that is mechanically molded into a custom shape and design as needed to enhance device functionality. The plastic pedal can be attached to the needle butterfly assembly using a living hinge, thereby providing a device that can be efficiently manufactured and assembled. Finally, a dedicated protective needle cover can be designed to include an extension with a groove that mates with the distal end of the pedal. By controlling the height of the recess, the pedal can be allowed to rest in any physical position from fully closed to fully open during transport and storage prior to patient use, thereby optimizing performance by varying the mechanical stresses imparted prior to use.

[0414] Systems and methods for automatic flow termination for fluid delivery, including a housing configured to couple a fluid delivery tube to a needle configured to deliver fluid subcutaneously (into the vascular system) within a patient's tissue, and a force-sensitive activation mechanism (shown here as a pedal), the housing being configured to couple a fluid delivery tube to a needle configured to deliver fluid subcutaneously (into the vascular system) within a patient's tissue, the force-sensitive activation mechanism having a first "flat" orientation corresponding to a state that allows unimpeded fluid delivery through the needle body, and a second orientation corresponding to a state in which the fluid tube becomes occluded by spring-loaded activation of the pedal during accidental needle dislodgement. When the pedal is allowed to "pop" into the second orientation, the fluid flow path is blocked, but this also leads to challenges in the subsequent placement of a legally required needle safety device. By controlling the shape, size, material, orientation, or surface properties of the lower portion of the needle guard (or, if desired, the pedal), we present embodiments herein that will enable easier, smoother, and more successful placement of the needle guard in place while accommodating the excess volume of the pedal or other skin sensing mechanism that is part of the overall safety system to help protect the patient from intravenous needle dislodgement.

[0415] A system and method for automatic flow termination for fluid delivery, comprising a housing and a force-sensitive activation mechanism (here shown as a pedal), the housing being configured to couple a fluid delivery tube to a needle configured to deliver fluid subcutaneously (into the vascular system) within the tissue of a patient, the force-sensitive activation mechanism having a first "flat" orientation corresponding to a state in which fluid delivery through the needle is allowed while entering the flow path using a mechanical protrusion that significantly occludes flow and causes a pressure line increase during normal fluid delivery into the patient, and a second orientation corresponding to a state in which the fluid tube becomes unoccluded by a spring-loaded activation of the pedal during needle removal. When the pedal is allowed to "pop" into the second orientation, the protrusion is removed from the flow path and the line pressure is proportionally reduced. By controlling the shape and size of the occluding member, the pressure magnitude can be maximized to ensure that the low pressure setting limit of the fluid pumping machine is violated, resulting in an automatic machine pump shutdown. The machine shutdown is used to effectively protect the patient from the hazards associated with needle removal in a package that is self-contained, relatively inexpensive, and very easy to implement. Another advantage of this anti-dislodgement technique over other techniques is that a relatively weak pedal spring element may be used, resulting in a device that may be comfortably positioned on a patient's arm during several hours of fluid delivery therapy (eg, dialysis).

[0416] Fig.28A The spring 26 shown may be a torsion spring 602. The torsion spring 602 may be biased to move the sensor 18 from the closed configuration to the open configuration. The torsion spring 602 may be used as an energy source for opening the sensor 18 when the device 10 is removed from the body. For example, when the device 10 is removed, the torsion spring 602 may be the only energy source that opens the sensor 18 from the closed configuration to the open configuration, thereby moving the sensor opening 22 away from the flow path and moving the occluder 32 into the flow path. The torsion spring 602 may be an energy source for any of the devices 10 disclosed herein. For example, the torsion spring 602 may be Figures 30A-30D The energy source of the entire device 10 is shown.

[0417] Fig.28A It is shown that the torsion spring 602 can have one or more coils 604, such as a first coil 604a and a second coil 604b. Fig.28AIt is shown that the first coil 604a can be on a first side of the torsion spring 602, and the second coil 604b can be on a second side of the torsion spring 602. For example, the first coil 604a can be on a lateral first side of the torsion spring 602, and the second coil 604b can be on a lateral second side of the torsion spring 602. The first and second lateral sides of the torsion spring 602 can be symmetrical about the torsion spring central longitudinal axis 612. The first coil 604a can be opposite to the second coil 604b. The coil 604 can be the proximal end of the torsion spring 602.

[0418] Fig.28A The torsion spring 602 is shown to have an arm 606 extending from a coil 604. For example, Fig.28A It is shown that a first arm 606s and a second arm 606b can extend from each coil 604. The first arm 606a can be shorter than the second arm 606b, or vice versa. The first arm 606s can be connected to the first arm connector (e.g., Figures 31A-31C ), and the second arm 606b can be engaged with a second arm engager (e.g., Fig.28C The first arm connector may be a surface of the body 14, a surface of the insert 17, or a surface of both. The second arm connector may be a surface of the sensor 18, and the coil 604 may be used as a hinge for the first arm 606a and the second arm 606b.

[0419] Fig.28A The torsion spring 602 is shown to have a bridge 608. The bridge 608 can connect the two second arms 606b to each other. The bridge 608 can be the distal end of the torsion spring 602. The bridge 608 can be a first longitudinal end of the torsion spring 602, and the coil 604 can be a second longitudinal end of the torsion spring. The bridge 608 can be a distance 610 from the coil 604. For example, the distance 610 from the center of the bridge 608 to the center of the coil 604 can be measured, as shown in FIG. Fig.28A The longer the distance 610 between the bridge 608 and the coil 604, the greater the leverage created by the torsion spring 602, thereby allowing for reduced closure forces and reduced impact on the patient's arm during use when the sensor 18 is in a closed configuration against the skin.

[0420] Fig.28A The first arm 606s is shown to have a bend 614. The bend 614 can enable efficient assembly and device function. The bend 614 can be located anywhere on the first arm 606a, for example, at Fig.28AThe position shown. For example, the first arm 606a can have a first arm proximal portion 606ap before the apex of the bend 614 and a first arm distal portion 606ad after the apex of the bend 614. The proximal portion 606ap and the distal portion 606ad of the first arm can be straight and / or curved. Any portion of the first arm 606 (e.g., a straight first arm 606a or a first arm 606a having a bend 614, for example, the first arm proximal portion 606ap, the bend 614 and / or the first arm distal portion 606ad) can be engaged with the first arm connector. As another example, the first arm 606a can be straight without the bend 614. The first arm 606a without the bend 614 can also achieve effective assembly and device function, and can additionally reduce the manufacturing cost of the torsion spring 602, for example relative to the manufacturing cost of the torsion spring 602 having the bend 614.

[0421] Fig.28A The torsion spring 602 is shown in a neutral configuration, a non-loaded configuration. When the torsion spring 602 is in the non-loaded configuration, the coil 604 may have a coil diameter 604D and a coil length 604L. The torsion spring 602 may be loaded with energy by winding the coil 604, for example, by rotating the first arm 606a in a first direction 616 (e.g., in a counterclockwise direction) and / or by rotating the second arm 606b in a second direction 618 (e.g., in a clockwise direction) about the center of the coil 604. Fig.28A As shown, the first direction 616 and the second direction 618 can be opposite to each other. When the coil 604 is rolled up, the coil 604 can be tightened, which can cause the coil length 604L to increase and the coil diameter 604D to decrease. When the torsion spring 602 is in a non-neutral, loaded configuration, the coil length 604L can be greater than Fig.28A The coil length 604L shown in FIG. 6A may be greater than about 1.0 mm to about 5.0 mm, including every 0.1 mm increment within this range, and the coil diameter 604D may be less than about 1.0 mm to about 5.0 mm. Fig.28A The coil diameter 604D shown in FIG. 6 is (e.g., less than about 1.0 mm to about 5.0 mm, including every 0.1 mm increment within this range). When the coil 604 is in the loaded configuration, the first and / or second arms 606a, 606b can be moved from Fig.28A The neutral arm position shown in is moved away.

[0422] When the torsion spring 602 is energized, both the first and second directions 616, 618 can be toward the coil 604 such that the distal end of the first arm 606a is closer to the coil 604 when the first arm 606a is in the loaded configuration than when the first arm 606a is in the unloaded configuration, and / or such that the distal end of the second arm 606b (e.g., where the second arm 606b is attached to the bridge 608) is closer to the coil 604 when the second arm 606b is in the loaded configuration than when the second arm 606b is in the unloaded configuration. As another example, after the torsion spring 602 is energized by moving the first arm 606a in the first direction 616 and / or by moving the second arm 606b in the second direction 618, the first arm 606a and the second arm 606b can be closer to each other.

[0423] The coil 604 can store the loaded energy until the first arm 606a and / or the second arm 606b is allowed to return to Fig.28A When the coil 604 is unwound, the coil 604 can be unwound back to the first arm 606a and / or the second arm 606b. Fig.28A When the first arm 606a is unwound from the loaded position, the first arm 606a can move in the second direction 618. When the second arm 606b is unwound from the loaded position, the second arm 606b can move in the first direction 616.

[0424] For example, by configuring the relative change in position of the first arm 606a (e.g., a straight first arm 606a or a first arm 606a having a bend 614, e.g., the first arm proximal portion 606ap, the bend 614, and / or the first arm distal portion 606ad) before and after the torsion spring 602 is assembled with the device 10 at a mating point (e.g., a first arm adapter), the amount by which the torsion spring 602 can be loaded can be controlled. For example, by configuring the relative change in position of the second arm 606b before and after the torsion spring 602 is assembled with the device 10 at a mating point (e.g., a second arm adapter), the amount by which the torsion spring 602 can be loaded can be controlled.

[0425] The total closing force required to move the sensor 18 from the sensor open configuration (occluded configuration) to the closed configuration (non-occluded configuration) can be controlled via the number of coil turns that the coil 604 has. The greater the number of turns or turns, the greater the closing force can be. The coil 604 can have multiple turns, such as 2 to 10 turns or more, or more narrowly, 2 to 6 turns or more, including every 0.1 turn increment within these ranges. For example, Fig.28A It is shown that the first coil 604a and the second coil 604b can each have 3.0 to 4.0 turns (eg, 3.7 turns). Fig.28AIt is further shown that the number of turns may be the number of helical turns.

[0426] Fig.28A It is shown that the torsion spring 602 can be a single wire, where the proximal end of the wire can be the distal end of one of the first arms 606A, and the distal end of the wire can be the distal end of the other of the first arms 606A.

[0427] As another example, the torsion spring 602 may be viewed as having two first arms 606 a and one U-shaped second arm 606 b , where one U-shaped second arm 606 b may be connected to two coils 604 .

[0428] Fig.28B A variation of the sensor 18 is shown that is designed to accommodate a torsion spring 602. As shown, the sensor 18 may be a pedal. Fig.28B The sensor 18 is shown to have one or more connectors 620. The torsion spring 602 may have, for example, a connector 620 for each coil 604 that the torsion spring 602 has. For example, the sensor 18 may have a first connector 620a for the first coil 604a, and may have a second connector 620b for the second coil 604b.

[0429] Fig.28B It is shown that the connector 620 can have a connector extension 622. The coil 604 can be attached to the connector extension 622. For example, the first coil 604a can be attached to the connector extension 622 of the first connector 620a, and the second coil 604b can be attached to the connector extension 622 of the second connector 620b. The connector extension 622 can be a hinge that can allow or accommodate twisting and untwisting of the coil 604 when the coil 604 is connected to the connector extension 622. The connector extension 622 can have any shape that allows the coil 604 to be attached to the connector extension 622. For example, Fig.28B It is shown that the connector extension 622 can have a cylindrical shape. The connector extension 622 can be, for example, a spindle, hub or shaft having a cylindrical shape. Fig.28B The distal end of the connector extension 622 is shown to have a tapered surface 624. The tapered surface 624 can terminate at the distal end face of the connector extension 622. The tapered surface 624 can advantageously provide space for the first arm 606 to deflect when the coil 604 is twisted, such as when the torsion spring 602 is loaded with energy during attachment to the device 10 (e.g., to the insert 17 and / or the housing 14), during attachment to the patient, or during both attachments. As another example, the connector extension 620 can have no tapered surface 624. Fig.28B The connector extension 622 is shown to have an extension longitudinal length 625. The extension longitudinal length 625 can be as follows: Fig.28B 624. The extension longitudinal length 625 may be measured in the manner shown, for example, between the proximal end of the connector extension 622 and the beginning of the tapered surface 624. For variations in which the connector extension 622 does not have the tapered surface 624, the extension longitudinal length 625 may be measured between the proximal end of the connector extension 622 and the distal end of the connector extension 622.

[0430] Fig.28B The connector 620 is shown to have a connector channel 626. The connector 620 can be attached to an extension on the housing 14, an extension on the insert 17, or an extension on both through the connector channel 626. The connector channel 626 can extend completely or partially through any portion of the connector 620. For example, the connector channel 626 can extend completely or partially through the connector extension 622. For example, Fig.28B It is shown that the connector channel 626 can be a through hole that extends completely through the first and second connectors 620a, 620B. As another example, the connector channel 626 can be a groove in the connector extension 622 that does not extend completely through the first and second connectors 620a, 620b. The connector channel 626 can have a cylindrical shape.

[0431] The connector channel 626 can be centered in the connector extension 622, or can be offset from the center of the connector extension 622. For example, Fig.28B It is shown that the connector extension 622 can have a connector extension central longitudinal axis 628, and the connector channel 626 can have a connector channel central longitudinal axis 630. Axes 628 and 630 can be parallel to each other. Axes 628 and 630 can coincide with each other, or can be vertically and / or horizontally offset from each other. For example, Fig.28B It is shown that the connector channel central longitudinal axis 630 can be vertically offset from the connector extension central longitudinal axis 628 (e.g., closer to the top surface of the connector extension 622). This offset between axes 628 and 630 can advantageously allow the torsion spring 602 to more effectively open the sensor 18 when the device 10 is removed from the patient, compared to a configuration in which both axes 628 and 630 are centered in the connector extension 622.

[0432] Fig.28BThe sensor 18 is shown to have a groove 632 for the second arm 606b and / or for the bridge 608. The groove 632 can be a groove on the surface of the sensor 18. The second arm 606b and the bridge 608 can fit into the groove 632. When the torsion spring 602 is connected to the sensor 18, the second arm 606b and the bridge 608 can be located in the groove. The groove 632 can stop or prevent the second arm 606b and the bridge 608 from sliding out of place when the sensor 18 is opened and closed. The groove 632 can have the same or similar shape as the second arm 606b and the bridge 608. For example, Fig.28B It is shown that the groove 632 can have a longitudinal section 632L for the second arm 606B and a transverse section 632T for the bridge 608.

[0433] Fig.28B It is shown that the first connector 620a can be on a first lateral side of the sensor 18 and the second connector 620B can be on a second lateral side of the sensor 18. The first and second sides of the sensor 18 can be symmetrical about a central longitudinal axis 634 of the sensor.

[0434] Fig.28B It is shown that the occluder 32 may be the proximal end of the sensor 18 , while the opening 22 may be the distal end of the sensor 18 .

[0435] Fig.28C The torsion spring 602 is shown assembled to the sensor 18 and ready to be assembled to the device 10 (eg, to the insert 17 and / or to the housing 14). Fig.28C The assembled spring sensor component shown can be pushed into (e.g., pushed vertically upward) the housing 14, thereby allowing proper mating of the hinge (e.g., the connector extension 622) and the first arm 606a (e.g., a straight first arm 606a or a first arm 606a having a bend 614, e.g., the first arm proximal portion 606ap, the bend 614 and / or the first arm distal portion 606ad).

[0436] Fig.28C A torsion spring 602 is shown attached to the sensor 18 . Fig.28C It is shown that when the torsion spring 602 is attached to the sensor 18, the coil 604 can be attached to the connector extension 622. When the torsion spring 602 is attached to the sensor 18, the second arm 606b and / or the bridge 608 can be in the groove 632. For example, Fig.28C It is shown that the second arm 606b and the bridge 608 can be in the groove 632. When the torsion spring 602 is attached to the sensor 18, the second arm 606b and / or the bridge 608 can contact the surface defining the bottom of the groove 632. For example, Fig.28CIt is shown that the second arm 606b and the bridge 608 can contact the bottom of the groove 632. The bottom of the groove 632 can be a second arm engager. For example, the bottom of the longitudinal section 632L can be a second arm engager. The bottom of the groove 632 can be a bridge engager. For example, the bottom of the transverse section 632T can be a bridge engager. Fig.28C It is shown that when the sensor 18 is opened and closed and / or when the torsion spring 602 is loaded (e.g., wound) and unloaded (e.g., expanded), the groove 632 can inhibit or prevent lateral movement of the second arm 606b and the bridge 608. For example, the longitudinal walls of the groove 632 can inhibit or prevent such lateral movement. The lateral walls of the groove 632 (e.g., the distal end wall of the groove 632) can inhibit or prevent longitudinal movement of the second arm 606b and the bridge 608.

[0437] Fig.28C 18 and before the spring-sensor assembly is attached to the rest of the device 10. Fig.28A Neutral configuration shown.

[0438] Fig.28C It is shown that when the torsion spring 602 is attached to the sensor 18 and the torsion spring 602 is in the neutral configuration, the coil 604 can be fully assembled onto the connector extension 622 so that the coil 604 terminates before the distal end of the connector extension 622. For example, Fig.28C It is shown that when the torsion spring 602 is attached to the sensor 18 and the torsion spring 602 is in the neutral configuration, the coil length 604L can be equal to or less than the extension longitudinal length 625, so that the coil 604 ends before the tapered surface 624. When the torsion spring 602 is in the loaded configuration, the coil length 604L can increase so that the first arm 606a can extend over and / or contact the tapered surface 624. As another example, when the torsion spring 602 is attached to the sensor 18 and the torsion spring 602 is in the neutral configuration, the coil length 604L can be greater than the extension longitudinal length 625, so that the coil 604 extends over the tapered surface 624.

[0439] Fig.28C It is shown that when the torsion spring 602 is attached to the sensor 18, the central longitudinal axis of the coil 604 can coincide with the connector extension central longitudinal axis 628, so that the connector extension central longitudinal axis 628 can also be the coil central longitudinal axis.

[0440] To reiterate, Fig.28A Designed to be used as Figures 30A-30DAn example of a torsion spring 602 of the pedal opening energy source of the entire system shown. The torsion spring 602 can have two separate coil areas (e.g., a first coil 604a and a second coil 604b) that are designed to be located on both sides of the pedal hinge point (e.g., the connecting extension 622). The torsion spring 602 assembly can have a connecting bridge (e.g., bridge 614) that can be placed at a certain distance (e.g., distance 610) away from the hinge coil (e.g., the first coil 604a and the second coil 604b). The longer the distance between the connecting bridge and the side coils, the greater the leverage that can be generated, thereby allowing for a reduced closing force and reduced impact on the patient's arm during use in the pedal closed state. The first arm 606a of the torsion spring 602 can be designed with or without an end bend (e.g., bend 614) to achieve effective assembly and device function. The first arm 606a (e.g., straight first arm 606a, first arm 606a with bend 614) can fit into a corresponding slot on the needle body (e.g., housing 14). The amount of prestress built into the torsion spring 602 can be controlled by configuring the relative change in the physical position of the first arm 606a (e.g., straight first arm 606a, first arm 606a with bend 614) before and after assembly into the needle body at the mating point (e.g., at the first arm connector). The total closing force can be controlled via the number of coil turns that the side coils (e.g., first coil 604a and second coil 604b) have. Fig.28B is designed to accommodate Fig.28A 602 in the torsion spring 602. The pedal 18 may include side hinge points (e.g., connector extensions 622) large enough to accommodate the side coils and precisely placed grooves (e.g., grooves 632) designed to accommodate the connecting bridge (e.g., bridge 608) and the bridge to coil connector area (e.g., second arm 606b). Fig.28C A top / angle view of a torsion spring 602 assembled into the pedal 18 and ready for assembly into the overall assembly. Fig.28C The entire assembly shown can be pushed into (eg, vertically upward or downward) a needle (eg, Figures 30A-30D housing 14 shown) / fluid flow core (e.g., Figures 29A-29D The connector 638 is shown in the figure, thereby allowing proper mating of the hinge point (e.g., the connector extension 622) and the first arm 606a (e.g., the straight first arm 606A, the first arm 606a with the bend 614).

[0441] Fig.29AIt is shown that the device 10 may have a tube 638. The tube 638 may be, for example, an insert 17. The tube 638 may have a tube extension 636 (also referred to as an insert extension 636). The connector 620 and / or the coil 604 may be attached to the tube extension 636. The insert extension 636 may be a hinge that may allow the sensor 18 to rotate when attached to the insert 17, for example, so that the sensor 18 can be opened and closed. For example, the connector extension 622 may rotate on the insert extension 636 when the sensor 18 is opened and closed. The insert extension 636 may have any shape that allows the sensor 18 to pivot about the connector extension 622. The sensor 18 may pivot about the central longitudinal axis 630 of the connector channel. For example, Fig.29A The insert extension 636 is shown to have a cylindrical shape. The insert extension 636 may be, for example, a spindle, hub or shaft having a cylindrical shape.

[0442] Fig.29A Shows when Fig.28C When the spring sensor component is attached to the insert extension 636 , the connector extension 622 and the coil 604 can be attached to the insert extension 636 . Fig.29A Shows when Fig.28C When the spring sensor component of the insert extension 636 is attached to the insert extension 636, the insert extension 636 can extend through the connector channel 626 and through the coil 604. The insert extension 636 can extend completely or partially through any portion of the connector channel 626. For example, Fig.29A The insert extension 636 is shown to extend through the connector channel 626 such that the distal end of the insert extension 636 may be flush with the distal end of the connector extension 622. As another example, the insert extension 636 may extend beyond the distal end of the connector extension 622, e.g., such that the proximal end of the insert extension 636 may extend through a mating channel of the extension 622 (e.g., through the connector channel 626), and such that the distal end of the insert extension 636 may extend through a mating channel on the housing 14.

[0443] The insert 17 may have an insert extension 636 for each coil 604 of the torsion spring 602 and / or for each connector 620 of the sensor 18. For example, Fig.29A It is shown that the insert 17 can have two insert extensions 636, one extension to which the first connector 620A can be attached and one extension to which the second connector 620b can be attached. Fig.29A Shows Fig.28C The spring sensor component is connected to the two insert extensions 636, wherein Fig.29AOne of the insert extensions 636 is blocked from view for illustration purposes only. Fig.29A The insert extension 636 which is obscured from view may be Fig.29A The insert extension 636 shown is identical but is located on the opposite side of the tube 638. For example, Fig.29A It is shown that the tube 638 can be symmetrical about the central longitudinal axis of the tube 638. Fig.29A A first coil 604a is shown attached to an insert extension 636. Fig.29A was blocked.

[0444] Fig.29A It is shown that the insert 17 may have a recess 640 that may contact or engage the housing 14 .

[0445] Fig.29A The sensor 18 is shown in a closed configuration and the torsion spring 602 is shown in a neutral configuration.

[0446] Fig.29B The sensor 18 is shown in an open configuration and the torsion spring 602 is shown in a neutral configuration.

[0447] Fig.29C Shows Fig.29A 10 is a side view of the device 10.

[0448] Fig.29D Shows Fig.29B 10 is a side view of the device 10. For illustration purposes only, Fig.29D The tip of the obturator 32 and the engagement of the obturator 32 with the membrane 54 are shown in a transparent manner. Fig.29D Box 694 in FIG. 1 shows that the occluder 32 and the membrane 54 can be as shown in FIG. Figure 4E As shown or Figure 4F As shown in the figure.

[0449] Figure 29A-Figure 29D Several views of a device 10 designed to protect a patient from the risk of needle dislodgement are shown. Figure 29A-Figure 29D In the embodiment of the present invention, the housing 14 (e.g., an outer shell with butterfly wings) is shown as transparent so that the arrangement of the sensor 18, the torsion spring 602, and the tube 638 (e.g., the insert 17) can be shown. The tube 638 can have a hard section and a soft section. The soft section can be deflected by the occluder 32. For example, Figure 29A-Figure 29D It is shown that the flow channel through the device 10 can extend through the tube 638, and the tube 638 can include a hard portion (e.g., the first portion 191, the first injection molded part 190) and a soft portion (e.g., the membrane 54, the second portion 193, the second injection molded part 192), when the sensor 18 is in the open configuration (e.g., Fig.29B and Fig.29DThe soft portion allows the convex portion of the obturator 32 at the proximal end of the sensor to block fluid flow, thereby generating increased back pressure during needle removal. The increase in back pressure can be high enough to trigger the automatic shutoff mechanism of the fluid pump. Figures 29A-29D In the variation of the device 10 shown, the tube 638 (e.g., the insert 17) can be a fluid flow component, whereby the fluid can flow through the hard portion of the tube 638 and through the soft portion of the tube 638. The tube 638 (e.g., the insert 17) can be produced, for example, using a 2-shot injection molding process. In the case of using a 2-shot injection molding process, the hard portion can be, for example, the first shot molded part 190, and the soft portion can be, for example, the second shot molded part 192.

[0450] Fig.29A The apparatus 10 is shown prior to removal, e.g., after needle insertion, and when it is securely held in place against the skin (e.g., Fig.39A and Fig.39B ), the sensor 18 is in the pedal closed position device 10. Fig.29A In the configuration shown, the applied tape (e.g. Fig.39A and Fig.39B ) from above to the skin surface below (e.g. Fig.39A and Fig.39B ) can compress the torsion spring 602 and prevent the coil 604 of the torsion spring 602 from expanding or unwinding, and can maintain the sensor 18 in the pedal closed position to enable fluid to flow through the flow path extending through the tube 638 (e.g., insert 17).

[0451] Fig.29B The device 10 is shown, wherein after removal, for example, wherein the tape (e.g. Fig.39A and Fig.39B ) does not work, the needle has been removed from the skin (e.g. Fig.39A and Fig.39B ), the sensor 18 is inactive in the pedal-on position, and the sensor 18 has been opened via the energy provided by the expansion or unwinding of the coil 604 of the torsion spring 602, thereby moving the sensor distal end 18d (e.g., the opening 22) a certain distance away from the needle 12 and moving the sensor proximal end 18p (e.g., the occluder 32) into the flow path against the soft portion of the tube 638 (e.g., the membrane 54, the second portion 193, the secondary injection molded part 192), thereby blocking the flow of fluid through the flow path through the tube 638 (e.g., the insert 17).

[0452] exist Figure 29A-Figure 29D , for illustration purposes only, the torsion spring 602 is shown in a neutral configuration. FIG. 29A to FIG. 29D In the example, it is not shown FIG. 28C to FIG. 29DThe spring sensor part in the FIG. 30A to FIG. 30D The torsion spring 602 can generate a mating surface (e.g., a surface of a first arm engager) of the first arm 606a prestressed by pressing against the first arm 606a (e.g., a straight first arm 606a or a first arm 60a having a bend 614) when the housing 14 is shown in FIG. 1 and the pedal 18 is in the open configuration. The mating surface of the first arm 606a can bias the sensor 18 to have a Fig.29B and Fig.29D The pedal is in the open position shown. Since the mating surface of the first arm 606a that determines the prestress level of the torsion spring 602 is Figures 29A-29D is not shown, so Figure 29A-Figure 29D The sensor 18 is shown when it is moved from the pedal closed position (eg Fig.29A and Fig.29C ) to the pedal open position (e.g. Fig.29B and 29D ), the first arm 606a (e.g., a straight first arm 606a or a first arm 60a having a bend 614) is rotated to a new position. However, when the device 10 is fully assembled, for example, when Figures 29A-29D The spring-sensor-tube assembly is shown attached to a housing 14 (eg Figures 30A-30D ), the first arm 606a can engage with one or more mating surfaces (e.g., surfaces of the first arm engager) in the pedal open position and the closed position, so that the first arm 606a can have, for example, a first position when the sensor 18 is in the pedal closed position and a first position when the sensor 18 is in the pedal open position. Fig.29B and Fig.29D Thus, when the device 10 is moved out, the coil 604 can be activated and gradually apply prestress to the torsion spring 602 to move the sensor 18 from the pedal closed position (e.g. Fig.29A and Fig.29C ) to the pedal open position (e.g. Fig.29B and Fig.29D ).

[0453] Fig.29E and Fig.29F Shows Figures 29A-29D The tube 638 shown, wherein Fig.29E Shows Figures 29A-29D The tube extension 636 shown, Fig.29F Shown is shown as blocked Figure 29A-Figure 29D Middle tube extension 636. As shown, the two tube extensions 636 can be mirror images of each other, for example, reflected through the tube center longitudinal axis 642.

[0454] Figures 30A-30D Shown in Figures 29A-29D The housing 14 shown transparently in FIG. Figure 29A-Figure 29D The spring-sensor-tube assembly shown in FIG.

[0455] Fig. 30A and Fig. 30B It is shown that the housing 14 can have a housing core 643. The housing core 643 can be the center of the housing 14. The housing core 643 can have a groove or channel into which the tube 638 can fit. For example, Fig. 30A and 30B The tube 638 is shown to be in a groove or channel of the housing core 643. Fig. 30A and Fig. 30B The housing core 643 may extend over or surround the tube 638 (eg, insert 17 ) when the tube 638 is shown in a recess or channel of the housing core 643 .

[0456] Fig. 30A and Fig. 30B It is shown that the housing 14 can have one or more extensions 644, for example, a first extension 644a and a second extension 644b. The housing 14 can have an extension 644 for each hinge (for example, the connector extension 622 and / or the insert extension 636) that the device 10 has. The extension 644 can extend from the housing 14, for example, the extension 644 can extend from the core 643. The extension 644 can be an extension of the housing 14, for example, the extension 644 can be an extension of the core 643. The extension 644 can have a recess into which the insert extension 636, the connector extension 622, and the coil 604 can be assembled. The extension 644 can surround the insert extension 636, the connector extension 622, and the coil 604. For example, Fig. 30A and 30B It is shown that the first coil 604a, the insert extension 636 on which the first coil 604a extends, and the connector extension 622 on which the first coil 604a extends can all be located in the recess of the first expansion portion 644a. As another example, Fig. 30A and Fig. 30B It is shown that the second coil 604b, the insert extension 636 on which the second coil 604b extends, and the connector extension 622 on which the second coil 604b extends can all be located in the recess of the second extension 644b. For example, when the sensor 18 is opened and closed, the extension 644 can protect the insert extension 636, the connector extension 622, and the coil 604 from foreign matter (e.g., clothing, tape, fingers, skin, hair, sweat, blood, fluids) that interfere with the rotation of the sensor 18 and the winding and unwinding of the coil 604. Therefore, the extension 644 can protect the hinge of the device 10 (e.g., the insert extension 636 and the connector extension 622) from foreign matter.

[0457] Fig. 30A and Fig. 30B It is shown that the housing 14 can have wings 15, such as a first wing 15a and a second wing 15b. The wings 15 can extend from the housing 14, the wings 15 can be an extension of the housing 14, and the wings 15 can have hinges 646 about which the wings 15 can rotate. The hinge 646 can be, for example, an area of ​​reduced thickness of the wing 15 so that the wing 15 can bend around the hinge 646. The hinge 646 can be, for example, a living hinge. The hinge 646 can be a flexible portion of the wing 15, and the hinge 646 can be at the base of the wing 15. Fig. 30A and Fig. 30B As shown, for example, the wing 15 can have a first rigid portion 647a, a flexible portion 647b, and a second rigid portion 647c. The flexible portion 647b can be a hinge 646. The flexible portion 647b can be a living hinge. The flexible section can have multiple thin sections, each connected by a living hinge. During the insertion of the needle 12 into the body, the wing can be rotated (e.g., rotated to Fig.38A and 38B The position shown in the figure makes it easier for the user to hold the device 10 and insert the blood vessel needle. Once the blood vessel is needled, the user can rotate the wings 15 to Fig. 30A and Fig. 30B The device 10 is attached to the body (e.g., Fig.39A and Fig.39B As another example, the wing 15 may not have the hinge 646 so that the wing 15 cannot be moved from Fig. 30A and Fig. 30B Move to the position shown.

[0458] Fig. 30A and Fig. 30B It is shown that the wing 15 can extend from the shell core 643 and the expansion 644. For example, the distal end of the wing can extend from the shell core 643, and the proximal end of the wing 15 can extend from the expansion 643.

[0459] Fig. 30A and Fig. 30B It is shown that the housing 14 may be a unitary structure. Fig. 30A and 30B It is shown that the shell core 643, the expansion portion 644 and the wing 15 can be integrated with each other.

[0460] Fig. 30A and Fig. 30B It is shown that the top edge of the extension 644 can be rounded to allow the wing 15 to reduce or eliminate interference from the extension 644 when the wing is folded or in a folded configuration (e.g., see Fig.38B ).

[0461] Fig. 30A The device 10 is shown with the sensor 18 in a pedal closed configuration.

[0462] Fig. 30B The device 10 is shown with the sensor 18 in a pedal-on configuration.

[0463] Fig. 30C Shows Fig. 30A 10 is a side view of the device 10.

[0464] Fig.30D Shows Fig. 30B 10 is a side view of the device 10.

[0465] Figures 30A-30D The torsion spring 602 can have a first spring loading configuration and a second spring loading configuration. Fig. 30B and Fig.30D The second spring loading configuration is shown in Fig. 30A and Fig. 30C When the sensor 18 is in the pedal opening position (e.g., Fig. 30B and Fig.30D ), the torsion spring 602 may have a first spring loading configuration. When the sensor 18 is in the pedal closed position (e.g., as Fig. 30A and Fig. 30C As shown), the torsion spring 602 can have a second spring loading configuration.

[0466] When the torsion spring 602 is in the first spring loading configuration (eg, Fig. 30B and Fig.30D ), the first arm 606A may be in a first arm loading position (e.g., Figure 31A-Figure 31C ), and the second arm 606B may be in a second arm neutral position (e.g., Fig.28A , Fig.28C , Fig. 30B and Fig.30D For example, by following the Fig.28A and Fig.28C By rotating the first arm 606A in the direction 616 shown, the first arm 606A can be moved to the first arm loading position. The first arm 606 can be held in the first arm loading position by engaging with the first arm engager (e.g., Figure 31A-Figure 31C The first arm loading position may bias the sensor 18 to have a pedal open position (e.g., Fig. 30B and Fig.30D ). Moving the first arms 606a from their neutral position to the first loaded position can wind the coil 604 into a first wound configuration. The first wound configuration can bias the sensor 18 to have Fig. 30B and 30D When the device 10 is assembled, for example, Fig.29A When the spring sensor tube assembly shown in FIG-29D is attached to the housing 14, the first arm 606a can be moved to the first arm loading position. For example, when the spring sensor tube assembly is inserted into the recess of the expansion portion 644, the first arm connector of the expansion portion 644 can press against the first arm 606, thereby pushing the first arm 606A in the first direction 616, which winds the coil 604 into the first winding configuration. The spring first loading configuration can therefore be a pre-loaded or pre-stressed configuration of the torsion spring 602 before the device 10 is attached to the patient.

[0467] When the torsion spring 602 is in the second spring loading configuration (eg, Fig. 30A and Fig. 30C ), the first arm 606a may be in a first arm loading position (eg, Figure 31A-Figure 31C ), and the second arm 606b may be in a second arm loading position (e.g., Fig. 30A and 30C For example, by following the Fig.28A and Fig.28C The second arm 606b can be moved to the second arm loading position by rotating the second arm 606b in the direction 618 shown. For example, during the insertion of the needle 12 into the patient, the second arm 606b can be moved in the direction 618 by moving the sensor 18 from the open configuration to the closed configuration. For example, when the sensor 16 is closed from the open state, the sensor 18 can push the second arm toward the tube 638 in the direction 618. This can further wind the coil 604 from the first winding configuration to the second winding configuration. The second winding configuration can be the maximum load to which the coil 604 can be loaded. For example, when the sensor 18 is closed, the bottom of the groove 632 can rotate the second arm 606b in the direction 618 to further wind the coil 604. The second arm 606b can be held in the second arm loading position via the engagement of the sensor 18 with the skin and via the engagement of the second arm 606b with the base of the groove 632 before being removed. When the needle 12 is removed, the torsion spring 602 can unwind via the coil 604 to move the sensor 18 from the closed configuration to the open configuration, thereby returning the second arm 606b to a neutral or less loaded position.

[0468] When the torsion spring 602 is in the spring first loading configuration and the spring second loading configuration, the first arm 606a can be in the first arm loading position. When the torsion spring 602 is in the spring first loading configuration, the second arm 606b can be in a neutral (e.g., non-wound) position, and when the torsion spring 602 is in the spring second loading configuration, the second arm 606b can be in the second arm loading position. As another example, when the torsion spring 602 is in the spring first loading configuration, the second arm 606a can be in the second arm first loading position, and when the tor...

Claims

1. A tissue access device, comprising: Needle; a housing having wings; a tube having a flow passage, a first tube extension, and a second tube extension; a torsion spring having a first coil and a second coil, wherein the first coil has a first coil first arm and a first coil second arm, wherein the first coil first arm is shorter than the first coil second arm, wherein the second coil has a second coil first arm and a second coil second arm, and wherein the second coil first arm is shorter than the second coil second arm; as well as a sensor having a first connector, a second connector, and an occluder, wherein the occluder is connected to the first connector and the second connector, wherein the first connector has a first connector extension, wherein the second connector has a second connector extension, and wherein the sensor has a sensor open configuration and a sensor closed configuration, wherein the tube first extension is within the first connector extension and the first coil when the tissue access device is in a fully assembled configuration, wherein the tube second extension is disposed within the second connector extension and the second coil when the tissue access device is in the fully assembled configuration, and wherein the torsion spring has a first loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor open configuration, wherein the torsion spring has a second loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor closed configuration, and wherein more energy is stored in the torsion spring when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

2. The tissue access device of claim 1, wherein the first loaded configuration comprises a preloaded configuration that biases the sensor in the sensor open configuration.

3. The tissue access device of claim 1, wherein the sensor comprises a pedal.

4. The tissue access device of claim 1, wherein the housing has a first engager, and wherein the first coil first arm engages with the first engager when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

5. The tissue access device of claim 4, wherein the first adapter comprises a housing surface, a protrusion and / or a slot.

6. The tissue access device of claim 1, wherein the housing has a first expansion portion, the first expansion portion has a first expansion portion recess, and wherein the first adapter is located in the first expansion portion recess.

7. The tissue access device of claim 6, wherein the tube first extension, the first connector extension, and the first coil are in the first expansion portion recess when the tissue access device is in the fully assembled configuration.

8. The tissue access device of claim 4, wherein the housing has a second engager, and wherein the second coil first arm engages with the second engager when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

9. The tissue access device of claim 8, wherein the second adapter comprises a housing surface, a protrusion and / or a slot.

10. The tissue access device of claim 6, wherein the housing has a second expansion portion, the second expansion portion has a second expansion portion recess, and wherein the second adapter is located in the second expansion portion recess.

11. The tissue access device of claim 10, wherein the tube second extension, the second connector extension, and the second coil are in the second expansion recess when the tissue access device is in the fully assembled configuration.

12. A tissue access device according to claim 8, wherein the housing has a third connector, and wherein the first coil second arm and the second coil second arm are engaged with the third connector when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

13. The tissue access device of claim 12, wherein the third adapter is the sensor.

14. The tissue access device of claim 12, wherein the third engager comprises a groove in the sensor.

15. The tissue access device of claim 10, wherein the first expansion is on a first lateral side of the tissue access device and the second expansion is on a second lateral side of the tissue access device.

16. The tissue access device of claim 10, wherein the first expansion portion is opposite to the second expansion portion.

17. The tissue access device of claim 1, further comprising a bridge, wherein the bridge connects the first coil second arm to the second coil second arm.

18. The tissue access device of claim 1, wherein the torsion spring has a bridge, and wherein the first coil second arm and the second coil second arm are connected to the bridge.

19. The tissue access device according to claim 18, wherein: The housing has a first engager, and the first coil first arm engages with the first engager when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration, wherein the housing has a second engager, and wherein the second coil first arm engages with the second engager when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration, and wherein the housing has a third engager, and wherein the first coil second arm, the second coil second arm and the bridge engage with the third engager when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

20. The tissue access device of claim 19, wherein the third adapter has a U-shape.

21. The tissue access device of claim 10, wherein the wing has a base, and wherein the base is distal to the first expansion and the second expansion.

22. The tissue access device of claim 1, wherein the wings are foldable.

23. A tissue access device according to claim 1, wherein when the torsion spring is in the first loading configuration, the first coil has a first coil first loading configuration and the second coil has a second coil second loading configuration, wherein the first coil has a smaller diameter when the first coil is in the first coil second loading configuration than when the first coil is in the first coil first loading configuration, and wherein the second coil has a smaller diameter when the second coil is in the second coil second loading configuration than when the second coil is in the first coil first loading configuration.

24. The tissue access device of claim 1, wherein the first coil second arm is closer to the first coil first arm when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

25. The tissue access device of claim 1, wherein the first coil second arm is closer to the needle when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

26. The tissue access device of claim 24, wherein the second coil second arm is closer to the second coil first arm when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

27. The tissue access device of claim 25, wherein the second arm of the second coil is closer to the needle when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

28. The tissue access device of claim 1, wherein the first coil second arm is movable toward and away from the first coil first arm when the device is in the fully assembled configuration.

29. The tissue access device of claim 28, wherein the second coil second arm is movable toward and away from the second coil first arm when the device is in the fully assembled configuration.

30. The tissue access device of claim 1, wherein the sensor inhibits or prevents skin or hair from contacting the torsion spring when the device is attached to the skin.

31. The tissue access device of claim 1, wherein the first connector extension has a cylindrical shape.

32. The tissue access device of claim 31 , wherein the second connector extension has a cylindrical shape.

33. The tissue access device of claim 1, wherein the first connector extension is tapered.

34. The tissue access device of claim 1, wherein the first connector extension has a non-stepped taper.

35. The tissue access device of claim 1, wherein the first connector extension has a stepped taper.

36. The device of claim 1, wherein the first connector extension has a flat outer surface and a curved outer surface.

37. The tissue access device of claim 1, wherein the first connector extension has two planar outer surfaces and two curved outer surfaces.

38. The tissue access device of claim 33, wherein the second connector extension is tapered.

39. The tissue access device of claim 34, wherein the second connector extension has a non-stepped taper.

40. The tissue access device of claim 35, wherein the second connector extension has a stepped taper.

41. The tissue access device of claim 36, wherein the second connector extension has a flat outer surface and a curved outer surface.

42. The tissue access device of claim 37, wherein the second connector extension has two planar outer surfaces and two curved outer surfaces.

43. The tissue access device of claim 12, wherein the first adapter, the second adapter, and / or the third adapter are rigid.

44. The tissue access device of claim 12, wherein the first adapter, the second adapter, and / or the third adapter are not deformable by the torsion spring.

45. The tissue access device of claim 1, wherein the occluder is movable into and out of the flow channel.

46. ​​A tissue access device according to claim 1, wherein the occluder occludes the flow channel when the sensor is in the sensor open configuration, and wherein less of the flow channel is occluded by the occluder when the sensor is in the sensor closed configuration than when the sensor is in the sensor open configuration.

47. A tissue access device according to claim 1, wherein when the tissue access device is attached to a patient, the sensor is in the sensor closed configuration, and wherein when the tissue access device is removed from the patient, the sensor is capable of moving from the sensor closed configuration to the sensor open configuration via the torsion spring expanding from the second loading configuration to the first loading configuration.

48. A tissue access device, comprising: Needle; a housing having wings; a tube having a flow passage, a first tube extension, and a second tube extension; a torsion spring having a first coil, a second coil, a first arm, a second arm, and a third arm, wherein the third arm is longer than the first arm, and wherein the third arm is longer than the second arm; as well as a sensor having a first hinge, a second hinge and an occluder, wherein the tube first extension is in the first hinge when the tissue access device is in a fully assembled configuration, wherein the tube second extension is in the second hinge when the tissue access device is in the fully assembled configuration, and wherein the torsion spring has a first loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor open configuration, wherein the torsion spring has a second loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor closed configuration, and wherein more energy is stored in the torsion spring when the torsion spring is in the second loading configuration than when the torsion spring is in the first loading configuration.

49. The tissue access device of claim 48, wherein the third arm is connected to the first arm and the second arm.

50. The device of claim 48, wherein the third arm is connected to the first coil and the second coil.

51. The tissue access device of claim 48, wherein the third arm connects the first coil to the second coil.

52. The tissue access device of claim 48, wherein the third arm has a U-shape.

53. The tissue access device of claim 48, wherein the housing has a first coupler, and wherein the first arm engages the first coupler when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

54. The tissue access device of claim 53, wherein the housing has a second coupler, and wherein the second arm engages the second coupler when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

55. The tissue access device of claim 54, wherein the housing has a third coupler, and wherein the third arm engages the third coupler when the sensor is in the sensor open configuration and when the sensor is in the sensor closed configuration.

56. The tissue access device of claim 48, wherein the first arm extends from the first coil.

57. A tissue access device according to claim 56, wherein the second arm extends from the second coil.

58. The tissue access device of claim 57, wherein the third arm extends from the first coil and the second coil.

59. The tissue access device of claim 48, wherein the first coil and the second coil are capable of being wound simultaneously via the sensor.

60. The tissue access device of claim 59, wherein the first coil and the second coil are capable of being unwound simultaneously via the sensor.

61. A tissue access device, comprising: Needle; a housing having wings; a tube having a flow passage, a first tube extension, and a second tube extension; a spring on a first lateral side of the housing and a second lateral side of the housing; as well as a sensor having a first hinge, a second hinge and an occluder, wherein the tube first extension and the spring are connected to the first hinge when the tissue access device is in a fully assembled configuration, wherein the tube second extension and the spring are connected to the second hinge when the tissue access device is in the fully assembled configuration, and wherein the spring has a first loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor open configuration, wherein the spring has a second loading configuration when the tissue access device is in the fully assembled configuration and the sensor is in the sensor closed configuration, and wherein less energy is stored in the spring when the spring is in the first loading configuration than when the spring is in the second loading configuration.

62. A tissue access device according to claim 61, wherein the first hinge includes a first connector having a first connector channel connected to the first extension of the tube, and wherein the second hinge includes a second connector having a second connector channel connected to the second extension of the tube.

63. A tissue access device according to claim 61, wherein the spring comprises a torsion spring having a first coil and a second coil, wherein the first coil has a first coil first arm and a first coil second arm, wherein the first coil first arm is shorter than the first coil second arm, wherein the second coil has a second coil first arm and a second coil second arm, and wherein the second coil first arm is shorter than the second coil second arm.

64. The tissue access device of claim 61, wherein the spring comprises a torsion spring having a first coil, a second coil, a first arm, a second arm, and a third arm, wherein the third arm is longer than the first arm, and wherein the third arm is longer than the second arm.

65. The tissue access device of claim 61, the first loading configuration comprising a non-zero loading.

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