Needle safety system

Abstract

Tissue access devices and methods of using the same are disclosed. A device can have a sensor configured to occlude a flow path by deflecting a membrane into the flow path when the device is dislodged from tissue. The sensor can be configured to partially or completely occlude the flow path. The sensor can have a spring. The spring can be biased to move the sensor from a sensor first configuration to a sensor second configuration when a force exerted by a sensor first surface against a non-sensor surface changes from a first force to a second force that is less than the first force. The membrane can be deflected into the flow path when the sensor is in the sensor second configuration.

Description

[0001] This application is a divisional application of patent application No. 2017800871220, filed on December 21, 2017, entitled "Needle Safety System".

[0002] Cross-reference to related applications

[0003] This application claims priority to the following applications: U.S. Provisional Application No. 62 / 437,096, filed December 21, 2016, entitled "Needle Safety System"; U.S. Provisional Application No. 62 / 458,041, filed February 13, 2017, entitled "Needle Safety System II"; U.S. Provisional Application No. 62 / 504,713, filed May 11, 2017, entitled "Needle Safety System III"; U.S. Provisional Application No. 62 / 576,752, filed October 25, 2017, entitled "Needle Safety System IV"; and U.S. Provisional Application No. 62 / 579,129, filed October 30, 2017, entitled "Needle Safety System V". Each of these applications is incorporated herein by reference in its entirety for all purposes. Technical Field

[0004] A tissue entry device and a method of using the tissue entry device are disclosed. More specifically, a tissue entry device that can automatically block flow when detached from tissue and a method of using the tissue entry device are disclosed. Background Technology

[0005] Many technologies can detect erroneous fluid flow by connecting fluid to blood vessels that guide it from the outside to the inside of the body. These technologies share the common feature of using "continuity sensors" that detect interruptions in energy signals or certain mechanical connections from the tube to the body. Such systems typically use mechanical connectors, small currents, capacitance, magnets, or even ultrasound as a means of monitoring the fidelity of the connection between the body and the fluid through the components. Others use techniques designed to detect "humidity," based on the theory that a dislodged needle would cause fluid leakage, and that fluid detection could serve as a substitute marker for needle dislodgement.

[0006] Therefore, a simple, mechanical system is needed to determine the presence of erroneous flow from a dislodged needle. This system "detects" the needle's presence on the skin and can thus be used to determine whether the needle is inserted into the patient during fluid delivery. Therefore, it is also necessary to prevent needle dislodgement due to external forces pulling on the tubing connected to the needle before it is dislodged. Summary of the Invention

[0007] This disclosure generally relates to tissue access devices and vascular connections.

[0008] More specifically, a tissue entry device that automatically blocks flow upon dislodgement from tissue and a method for using the tissue entry device are disclosed. By blocking fluid flow after the tissue entry device has dislodged, erroneous fluid flow during drug treatment can be reduced or prevented, thereby providing necessary safety for the patient. A tissue entry device that can prevent dislodgement and a method for using the tissue entry device are also disclosed. By blocking fluid flow before the tissue entry device dislodges, erroneous fluid flow during drug treatment can be completely avoided, thereby providing necessary safety for the patient.

[0009] Disclosed are tissue access devices. For example, a vascular access device having a longitudinal axis is disclosed. The device may have a needle having a proximal end and a distal end. The device may have a housing having a housing opening and a housing conduit. The housing conduit may extend from the proximal end of the housing to the distal end of the housing. The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable footplate having a proximal end, a distal end, a first surface, a spring, and an occluder. The proximal end of the footplate may be attached to the housing. The movable footplate may have a first footplate configuration when a first force is applied to a non-footplate surface from the first surface, and a second footplate configuration when a second force less than the first force is applied to the non-footplate surface from the first surface. When the first force decreases to the second force, the spring may be biased to move the movable footplate from the first footplate configuration to the second footplate configuration. When the movable footplate is in the second footplate configuration, at least a first portion of the occluder may occlude the housing conduit. At least a second portion of the plug can be located in the housing opening when the movable base plate is in the second base plate configuration, and outside the housing opening when the movable base plate is in the first base plate configuration.

[0010] Tissue access devices are disclosed. For example, a tissue access device having a longitudinal axis is disclosed. The device may have a needle having a proximal end and a distal end. The device may have a housing having a housing opening and a housing conduit. The housing conduit may extend from the proximal end of the housing to the distal end of the housing. The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable base plate having a proximal end, a distal end, a first surface, a spring, and an occluder. The proximal end of the base plate may be attached to the housing. When the force applied by the first surface of the base plate to a non-base plate surface changes from a first force to a second force less than the first force, the spring may be biased to move the movable base plate from a first configuration to a second configuration. When the movable base plate is in the second configuration, at least a first portion of the occluder may occlude the housing conduit. The distal end of the base plate may have a blocking portion configured to prevent excessive needle insertion into a blood vessel. At least a portion of the blocking part can be closer to the needle when the movable base plate is in the first configuration of the base plate than when the movable base plate is in the second configuration of the base plate.

[0011] Disclosed are tissue access devices. For example, a vascular access device having a longitudinal axis is disclosed. The device may have a needle having a proximal end and a distal end. The device may have a housing having a housing opening and a housing conduit. The housing conduit may extend from the proximal end of the housing to the distal end of the housing. The device may have a deformable membrane. The deformable membrane may define a portion of the housing conduit. The device may have a movable base plate having a proximal end, a distal end, a first surface, a spring, and an occluder. The proximal end of the base plate may be attached to the housing. When the force applied by the first surface of the base plate to a non-base plate surface changes from a first force to a second force less than the first force, the spring may be biased to move the movable base plate from a first configuration to a second configuration. When the movable base plate is in the second configuration, at least a first portion of the occluder may occlude the housing conduit. The distal end of the base plate may have a curved surface configured to reduce friction with the non-base plate surface when the needle is inserted into a blood vessel. When the movable base plate is in the first configuration, at least a portion of the curved surface can be closer to the needle than when the movable base plate is in the second configuration. Attached Figure Description

[0012] The accompanying drawings shown and described are exemplary embodiments and not limiting. The same reference numerals always denote the same or functionally identical features.

[0013] Figure 1 A perspective view showing a variant of a tissue entry device with sensors in a occluded configuration.

[0014] Figure 2A Show Figure 1 A perspective view of the sensor.

[0015] Figure 2B Show Figure 2A A side view of the sensor.

[0016] Figure 2C Show Figure 2A A top view of the sensor.

[0017] Figure 3A Showing configurations with fewer blockages Figure 1 Side view of the tissue entering the device.

[0018] Figure 3B The section cut along line 3B-3B is shown. Figure 3A A variation of the longitudinal cross-sectional view of the tissue entering the device.

[0019] Figure 4A Show Figure 1 Side view of the tissue entering the device.

[0020] Figure 4B The section cut along line 4B-4B is shown. Figure 4A Side view of the tissue entering the device.

[0021] Figure 4C yes Figure 4B An enlarged view of the tissue entry device at section 4C-4C.

[0022] Figure 4D Show Figure 4B Another variation of the tissue entry device with a blocking configuration at section 4C-4C.

[0023] Figure 4E Show Figure 3B Another variation of the tissue entry device with a blocking configuration at section 4C-4C.

[0024] Figure 4F Show Figure 3B Another variation of the tissue entry device with a blocking configuration at section 4C-4C.

[0025] Figure 5 yes Figure 4E Enlarged perspective view of the sealing configuration of the tissue entry device.

[0026] Figure 6A A side view showing a variant of the tissue entry device that is inserted into and withdrawn from the tissue.

[0027] Figure 6B Showing insertion into the tissue Figure 6A The tissue enters the device.

[0028] Figure 7AA perspective view showing a variant of a tissue entry device with a clamping system.

[0029] Figure 7B yes Figure 7A A magnified perspective view of the tissue entering the device.

[0030] Figure 7C The section cut along line 7C-7C is shown. Figure 7A A variation of the transverse cross-sectional view of the tissue entering the device.

[0031] Figure 7D This illustrates a variation of the force classification scheme.

[0032] Figure 8A and Figure 8B A variation of a schematic diagram showing a tissue entry device with multiple flow paths is shown.

[0033] Figure 9A A perspective view showing a variant of the tissue entry device with a flow control system.

[0034] Figure 9B Show Figure 9A The front view of the tissue entering the device.

[0035] Figure 9C Showing the configuration in open Figure 9A The front view of the tissue entering the device.

[0036] Figure 9D Showing a closed configuration Figure 9A The front view of the tissue entering the device.

[0037] Figure 10A A variant of a tissue entry device in an open configuration is shown, featuring a variation of a flow control system.

[0038] Figure 10B Showing a closed configuration Figure 10A The tissue enters the device.

[0039] Figure 11A A perspective view showing a variation of the flow control system.

[0040] Figure 11B Showing the configuration in open Figure 11A A front view of the flow control system.

[0041] Figure 11C Showing a closed configuration Figure 11A A front view of the flow control system.

[0042] Figure 11D Show Figure 11B A side cross-sectional view of the flow control system.

[0043] Figure 11E Show Figure 11C A side cross-sectional view of the flow control system.

[0044] Figure 12A A cross-sectional view of a flow control system in a closed configuration is shown.

[0045] Figure 12B Showing the configuration in open Figure 12A The flow control system.

[0046] Figures 13A to 13E A variation of the flow control mechanism is shown.

[0047] Figure 14A and Figure 14B A variation of the flow control mechanism is shown.

[0048] Figures 15A to 15D A variation of the flow control mechanism is shown.

[0049] Figure 16A and Figure 16B A variation of the flow control mechanism is shown.

[0050] Figure 17A and Figure 17B A variation of the flow control mechanism is shown.

[0051] Figure 18A and Figure 18B A variation of the flow control mechanism is shown.

[0052] Figure 19A and Figure 19B A variation of the visual indicator is shown.

[0053] Figures 20A to 20I A variation of the tissue entry device with buckles is shown.

[0054] Figures 21A to 21I This illustrates variations in the manufacturing process of the tissue entry device and variations in its components.

[0055] Figure 22A and Figure 22B Show Figures 20A to 20G Various views of the sensor.

[0056] Figure 23A and 23B A variation of the tissue entry device is shown.

[0057] Figure 24A and 24B A variation of the tissue entry device is shown.

[0058] Figures 25A to 25D A variation of the current limiter is shown.

[0059] Figure 26 A variation of the current limiter is shown.

[0060] Figure 27 A variation of the current limiter is shown.

[0061] Figures 28A to 28F A variation of the current limiter is shown.

[0062] Figure 29 A variation of the current limiter is shown.

[0063] Figures 30A to 30D A variation of the current limiter is shown.

[0064] Figure 31 This illustrates a variation of a multi-component system.

[0065] Figure 32A and Figure 32B A variation of the tissue entry device is shown.

[0066] Figure 33A and Figure 33B A variation of the tissue entry device is shown.

[0067] Figure 34A and Figure 34B A variation of the sensor is shown.

[0068] Figures 35A to 35C A variation of the current limiter is shown.

[0069] Figure 36A and Figure 36B This shows a variation of the plug-in component.

[0070] Figure 36C A variation of the tissue entry device is shown.

[0071] Figures 37A to 37C A variant of the insert is shown, configured to support flow cessation during disengagement.

[0072] Figures 38A to 38F A variation of the tissue entry device and its components is shown.

[0073] Figures 39A to 39C A variation of the flow control mechanism is shown.

[0074] Figures 40A to 40C A variation of the flow control mechanism is shown.

[0075] Figure 41A and 41B A variation of the flow control mechanism is shown.

[0076] Figures 42A to 42E This shows a variation of the humidity detection system.

[0077] Figures 43A to 43D A variation of the flow control system is shown.

[0078] Figure 44A and Figure 44B A variation of the flow control mechanism is shown.

[0079] Figures 45A to 45C A variation of the sliding detector is shown.

[0080] Figures 46A to 46C A variation of the sliding detector is shown.

[0081] Figure 47A and Figure 47B A variation of the sliding detector is shown.

[0082] Figure 48 A variation of the external flow control system is shown.

[0083] Figures 49A to 49D A variation of the flow control system is shown.

[0084] Figures 50A to 50E A variation of the flow control system is shown.

[0085] Figures 51A to 51F A variation of the flow control system is shown. Detailed Implementation

[0086] Disclosed are tissue access devices (also known as fluid access devices, vascular access devices, blood access devices, and needles). The disclosed tissue access devices can aspirate and / or deliver fluid into a patient. In hemodialysis, the fluid is blood. In other cases, the fluid may be saline or medication. Vascular access is routinely performed in hospitals, clinics, and other medical facilities, as well as at home (e.g., during home hemodialysis). For example, vascular connections are disclosed, and more particularly, systems and methods for detecting dislodged vascular connections are disclosed, as well as systems and methods for interrupting flow when a vascular connection dislodges.

[0087] A needle safety system is disclosed, which has a contact sensing mechanism configured to be placed on a patient's skin to determine when the needle / cannula assembly has been inserted into the patient and / or when the needle / cannula assembly has been dislodged from the patient. For example, dislodging may occur when the tape holding the tissue access device or vascular puncture needle in place fails or when the wire connected to the device is pulled out.

[0088] A needle safety system and method are disclosed, which uses a force-sensing mechanism within the device to determine whether and when a given needle / cannula assembly inserted into a patient has become dislodged. This can occur during drug therapy when the cannula leading to a vascular puncture needle is intentionally or unintentionally "pulled" or "dragged." It can also occur when the adhesive tape used to secure the inserted needle to the skin loses its adhesion due to excessive patient hair or increased sweat / humidity.

[0089] A needle safety system with a fluid shut-off valve is disclosed, which is configured to automatically deploy to stop fluid flow through the needle / tube if the needle delivering fluid into the body is accidentally dislodged from the patient during fluid delivery.

[0090] A needle safety system with a pinch valve is disclosed, which is configured to be activated by a mechanical linkage of a mechanical "skin-sensing" element in the needle system, wherein the mechanical linkage has been pre-manufactured to include a compressible tube segment.

[0091] A needle safety system with a clamping valve configured to block flow on a flow path formed inside the “butterfly” housing of a conventional needle is disclosed.

[0092] A system and method for automatic flow termination of fluid delivery are disclosed. The system includes a housing configured to connect a fluid delivery tube to a needle configured to deliver fluid subepithelially (into the vascular system) in patient tissue; and a spring-loaded or fluid-sensitive activation mechanism having a first direction corresponding to a case where the housing is substantially adjacent to the tissue setting and the needle is stored within the tissue, a second direction corresponding to a case where the housing is away from the tissue setting or the needle is dislodged from the tissue, and a third direction corresponding to a case where the housing is substantially adjacent to the tissue setting but is being pulled back from the original insertion point, thereby preventing the needle from delivering fluid into the vascular system. A flow termination mechanism is also disclosed, coupled to an activation mechanism, and having an open configuration that allows flow from the fluid delivery tube to the needle when the activation mechanism is in the first direction, and a closed configuration that substantially terminates flow from the fluid delivery tube to the needle when the activation mechanism is in the second or third direction.

[0093] Specialized needles for protecting patients from fluid delivery problems during medical treatment are disclosed. For example, a specialized needle is disclosed that may have a spring-loaded, integral base plate that, when in a dislodged position (e.g., not in contact with the skin and the needle body detached from the skin), causes a base plate sealing member to move into the device flow channel and prevent fluid from flowing through the needle.

[0094] A system and method for automatic flow termination of fluid delivery are disclosed. The system includes a housing configured to connect a fluid delivery tube to a needle configured to deliver fluid subepithelially (into the vascular system) in patient tissue; and a force-sensitive activation mechanism (shown herein as a base plate) having a first flattened direction (e.g., straight or non-straight) corresponding to a case where fluid delivery is allowed through the needle body while a U-shaped opening is used to protect the needle entry orifice, and a second direction corresponding to a case where the fluid tube is blocked by a fluid-sealing member of the base plate when the needle dislodges through a spring force provided by a bending element molded into the base plate. When the base plate is generated with a bent end, device insertion is improved due to lower curvature-related frictional forces against the skin during insertion. Furthermore, even at very high insertion angles (e.g., up to 50 degrees), the bent end of the base plate facilitates mechanical contact with the skin. This enhances dislodgement detection. The use of a bent central portion on the base plate provides an effective internal hinge point for the occluder arm, eliminating the need for any external hinge attachments on the needle body itself. This greatly enhances the device's functionality by eliminating any potential interference from medical tape, which is typically used to hold the needle in place during treatment, from any possible mechanical components of the system.

[0095] A needle safety system is disclosed, which can be manufactured efficiently and cost-effectively using a "molded-in" spring design for the baseplate sensing unit. The efficient spring can be manufactured by molding a baseplate unit with a curved portion. When the baseplate is in a straight position, the mechanical stress on the curved portion generates an effective spring force, the direction and magnitude of which depend on the mechanical shape and size of the associated attachment. By forming a central "mechanical arm," the spring force can be utilized as a sealing technique, allowing the end of the arm to directly access and prevent or block fluid flow through the center of the needle body.

[0096] A needle safety system is disclosed, featuring a spring-loaded base plate fixed to the base of the needle to sense erroneous flow from a dislodged needle. Furthermore, by bending the distal end of the base plate, an effective system can be formed that provides basic safety and ease of use during cannulation, while also protecting the patient from excessive needle insertion after initial insertion. The bent end also incorporates a mechanism that effectively enables needle dislodgement detection even when the needle is inserted at a steep angle (e.g., up to 45 degrees). The other end of the base plate may include a blocking member that can be pushed into the flow path within the needle body to obstruct fluid flow. Additionally, by forming a curvature in the base plate base and forming opposing members within the central portion of the base plate, a "spring" can be formed to aid in the "sensing" operation, engaging the end of the central member to enter the flow path within the needle body and blocking fluid flow when the needle is removed from the patient's surface.

[0097] The invention discloses the use of a spring-loaded base plate as a "detector" for the presence of an underlying layer of skin to determine whether and when a needle inserted for fluid delivery has dislodged from the patient's body.

[0098] A system and method for automatic flow termination of fluid delivery are disclosed. The system includes a housing configured to connect a fluid delivery tube to a needle configured to deliver fluid subendothelially (into the vascular system) in patient tissue; and a force-sensitive activation mechanism having a first direction corresponding to the condition where the fluid delivery tube is clamped inside the needle body under axial pull, and a second direction corresponding to the condition where the fluid tube is clamped in an external arrangement in any other non-axial pull direction. The flow termination mechanism can be activated with each pull, but in other cases, when the tube is not subjected to tension or the tension is below a certain threshold, the flow termination mechanism has an open flow configuration that allows flow from the fluid delivery tube to the needle.

[0099] A needle safety system and its usage method are disclosed, which utilizes a force-sensing mechanism within the device to determine whether and when a given needle / cannula assembly inserted into a patient is subjected to a "pulling force" close to that which could be reasonably expected to dislodge the cannula from the patient. This can occur during drug therapy, for example, when the cannula leading to a vascular puncture needle is intentionally or unintentionally "pulled" or "tugged." It can also occur when the adhesive strength of the medical tape used to secure the inserted needle to the skin is reduced due to excessive patient hair or increased sweat / humidity.

[0100] Disclosed are needle safety systems and tube “tightening” or “clamping” methods that prevent fluid from flowing through the tube leading to the patient when the force on the tube is close to the force intended to dislodge the needle.

[0101] A needle safety system is disclosed, which has a device with a mechanically optimized clamping valve on the external part of the device, the device being configured such that clamping of the tube can be achieved by compressing the tube through an optimized clamping point when pulled in any direction other than the axial direction beyond its normal position.

[0102] A needle safety system is disclosed, which has a device with a mechanically optimized clamping valve in the internal part of the device, the device being configured such that if the tube is pulled in the axial direction by a force exceeding a threshold at some point after the needle is inserted and wound, the tube can be clamped inside the needle body by compressing the tube through a "clamping arm".

[0103] A needle safety system that can override the skin sensing element described herein is disclosed. The disclosed alternative system ensures that the skin sensing element is not activated during cannulation and / or while the needle is inserted into the patient. It is crucial that fluid flow be enabled through the needle / tube during cannulation and before the needle is taped in, allowing clinicians to see blood “flashback” from the patient through the needle into the fluid flow tube. Any needle with a fluid flow blocking mechanism can have a blocking mechanism that is temporarily disabled during cannulation and / or needle insertion. The needle safety device feature that achieves this purpose will be referred to in this document as a “cannulation lock.”

[0104] A needle safety system is disclosed that can "lock" the skin sensing mechanism after it has been activated due to slippage or other types of skin dislodgement. In such cases, when fluid flow is blocked, it is also important for clinicians to assess the situation and replace other aspects of the treatment delivery. The "locking" function ensures that no additional and potentially dangerous fluid flow is restarted after the flow-stopping mechanism has been fully activated.

[0105] A needle safety system is disclosed for sensing skin contact using a button-shaped sensor that extends from the bottom of the needle body (e.g., directly from the bottom of the needle body) and for using a blocking technique to stop the flow, wherein the blocking technique involves rotating or sliding an opening within a needle valve from closed to open.

[0106] A needle safety system is disclosed, which has a contact sensing mechanism for the patient's skin to determine when a given needle / cannula assembly inserted into the patient may dislodge from the patient in cases involving the needle "slipping" out of the vascular system but not necessarily completely away from the skin and "dislodging" from the body. Such incomplete or partial dislodging can occur when the tape securing the vascular puncture needle provides sufficient downward pressure to keep the needle pressed against the skin but fails to prevent related movement of the puncture needle away from the original insertion point. One form of this type of accident, where the needle slips out of the blood vessel rather than from the skin, is referred to in the medical literature as "infiltration." When the needle slips completely out of the skin, this can be defined as "dislodgement." Throughout the disclosure, dislodging involves both partial and complete dislodging.

[0107] A needle safety system is disclosed for sensing the relative movement of a needle body secured with tape in the direction opposite to the initial insertion path. One approach to this is to use an adhesive to provide enhanced frictional contact at the base of the needle or on an improved surface between the needle body and the skin, combined with a method for detecting when the frictional force on the needle body is high enough to abut against the base of the needle in the opposite direction of insertion, indicating that the needle itself has moved or is moving in an undesirable (for treatment) direction. In this case, any occlusion method described herein for stopping intraneedle flow can be activated.

[0108] A needle safety system is disclosed that senses the relative movement of a needle body relative to an adhesive tape holding the needle body above it in a direction away from the insertion site. This can be achieved through a mechanism that relies on a combination of changes in position, and / or velocity and / or acceleration of a component located above and in contact with the needle body and the adhesive tape. A threshold change in the position, velocity, or acceleration of the needle body in a direction away from its predetermined insertion point, determined by the relative difference between the component held by the adhesive tape and the needle body, will trigger a method of flow blocking through a link between the detection system and one of the integrated flow blocking systems.

[0109] Because the disclosed device does not require electricity, it eliminates the need for external power sources, batteries, or cables, thereby enhancing its usability in complex medical workspaces where simplified solutions are needed. The disclosed device is fully sterilizable and can be completely disposable. It can be manufactured at low cost using a high-volume injection molding process. Advantageously, it does not require extensive clinical training.

[0110] The disclosed needle safety system can be added to existing needles / tubes.

[0111] Systems, equipment and usage methods

[0112] Figure 1A variation of the tissue entry device 10 is shown. Device 10 can withdraw fluid (e.g., blood, lymph, interstitial fluid) from a tissue or vascular lumen. Device 10 can deliver fluid (e.g., blood, lymph, saline, medication) to a tissue or vascular lumen. For example, device 10 can be used in hemodialysis treatment to draw 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 hemodialysis treatment, a first device 10 can be used to draw unfiltered blood from a blood vessel, and a second device 10 can be used to return the filtered blood to the same or a different blood vessel. The number of devices 10 used will depend on the number of entry points required, for example, it can be in the range of 1 to 5 or more, including the amount of each device increment within this range. Device 10 can control the delivery and / or withdrawal of fluid through channels (also referred to as device channels and device flow paths) in device 10. For example, when device 10 dislodges in a dislodgement event, device 10 can automatically reduce (e.g., partially or completely block) the flow rate of fluid through the channels.

[0113] Device 10 may have multiple device configurations. For example, device 10 may have a non-blocking configuration and / or one or more blocking configurations. A blocking configuration may correspond to a partially blocking configuration, a fully blocking configuration, or any combination thereof. When device 10 is in a non-blocking configuration, fluid can flow through the device channel without being restricted by device 10. When device 10 is in a blocking configuration, the fluid flowing through the device channel can be reduced or completely blocked by device 10. Device 10 can restrict or terminate the flow of fluid through the device channel by reducing the channel cross-sectional area from a first cross-sectional area to a second cross-sectional area smaller 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 increments of 1% within this range, where 100% may correspond to completely blocking the channel at one or more channel cross-sections. The channel may have a longitudinal channel axis and a transverse channel axis. The channel cross-sectional area may be a transverse cross-sectional area perpendicular to the longitudinal channel axis.

[0114] For example, as measured over a time interval T (e.g., from about 0.25 seconds to about 60.0 seconds), device 10 may allow less fluid to flow through it in a blocked configuration compared to its non-blocked configuration. For example, as measured over a time interval T, device 10 may allow less fluid to flow through it in a first blocked configuration compared to its second blocked configuration, wherein the second blocked configuration blocks more flow paths than the first blocked configuration. For example, as measured over a time interval T, device 10 may allow more fluid to flow through it in a first blocked configuration compared to its second blocked configuration, wherein the second blocked configuration blocks fewer flow paths than the first blocked configuration.

[0115] When the device 10 is inserted into 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 being inserted into tissue, and may be inserted into tissue when the device 10 is dislodged or separated from tissue, or any combination thereof.

[0116] When device 10 is inserted into tissue, it can become less blocked by transitioning from a more blocking configuration to a less blocking configuration. For example, when device 10 is inserted into tissue, it can transition from a blocking configuration to a non-blocking configuration. As another example, when device 10 is inserted into tissue, it can transition from a first blocking configuration to a second blocking configuration that is less blocked than the first blocking configuration. When insertion into tissue is complete, device 10 may have an insertion configuration. For example, device 10 may be detachably secured to a non-device surface, such as skin, using tape, glue, elastic band, or any combination thereof. When device 10 is detachably secured to a non-device surface, device 10 may have an attachment configuration (also known as a non-disengagement configuration). Insertion and attachment configurations may be the same as or different from each other. For example, both insertion and attachment configurations may be non-blocking or partially blocking configurations. As another example, the insertion configuration can be a blocking (partial or complete) configuration, and the attachment configuration can be a non-blocking configuration or a blocking configuration with a lower degree of blocking than the blocking insertion configuration.

[0117] When device 10 disengages from a non-device surface, device 10 can progressively become more congested by transitioning from a less congested configuration to a more congested configuration. For example, when device 10 disengages from a non-device surface, device 10 can transition from a non-congested configuration to a congested configuration. As another example, when device 10 disengages from a non-device surface, device 10 can transition from a first congested configuration to a second congested configuration that is more congested than the first congested configuration. Device 10 may have a disengaged configuration when one or more portions of device 10 move away from the non-device surface by a congestion threshold distance comprising approximately 5 mm to approximately 25 mm in increments of 1 mm within that range.

[0118] When device 10 detaches or separates from a non-device surface, device 10 can automatically move from an attached configuration to a detached configuration. Device 10 can switch from an attached configuration to a detached configuration in less than 0.10 seconds, 0.25 seconds, 1 second, 5 seconds, 10 seconds, or 60 seconds. For example, device 10 can automatically move from an attached configuration to a detached configuration in a time interval of 0.01 seconds to 1.00 seconds, which is included in this range (e.g., 0.10 seconds).

[0119] Figure 1 Variations of the blocking configuration of device 10 are shown, such as partial blocking or full blocking configurations. Figure 1Furthermore, the device 10 can have the same configuration before it is inserted into the tissue and attached to the non-device surface, and after it is dislodged from the non-device surface. When the device 10 is separated from the non-device surface, it may remain in the tissue or also be dislodged from the tissue. For example, when the device 10 is dislodged from the non-device surface, a portion of the device 10 (e.g., a needle) in a blood vessel may remain in the blood vessel, may be dislodged from the blood vessel but remain in the tissue adjacent to the blood vessel, or may be completely dislodged from both the blood vessel and the tissue.

[0120] Figure 1 Further illustrating that device 10 may have a longitudinal axis A1. The longitudinal axis A1 may be the central longitudinal axis of device 10. The longitudinal axis A1 may be the central longitudinal axis of the flow channel in device 10. The longitudinal axis A1 may be straight or curved. The longitudinal axis A1 may be perpendicular to the first transverse axis A2 of the device. The longitudinal axis A1 may be perpendicular to the second transverse axis A3 of the device. The first transverse axis A2 and the second transverse axis A3 may be perpendicular to each other. The first transverse axis A2 and the second transverse axis A3 may be straight or curved.

[0121] The device 10 may have a proximal end 10a and a distal end 10b. The device 10 may have a first side 10c and a second side 10d. The first side 10c may be the bottom surface of the device 10, and the second side 10d may be the top surface of the device 10.

[0122] Figure 1 The device 10 is further illustrated as having a needle 12 and a housing 14 (also referred to as a needle body). For example, the needle 12 may be an arteriovenous (AV) fistula butterfly needle or AV fistula cannulation needle located in a flexible sheath (not shown). The needle 12 may have a proximal end 12a and a 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 proximal end 14a and a 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 a tube 8 to the device 10. The connector 16 may be external to and / or internal to the housing 14. Alternatively or additionally, the connector 16 may be integral with the housing 14. When connected to the device 10 (e.g., via the connector 16), the tube 8 may be in fluid communication with the needle 12 through flow channels in the housing 14. The connector 16 may be a rigid, semi-rigid, or flexible material. The housing may be made of a rigid material, such as plastic, metal, composite material, or any combination thereof. The tip of needle 12 may be the distal end of the device along the longitudinal axis A1 of the device.

[0123] Figure 1The device 10 may further include a sensor 18. The sensor 18 may be a non-device surface sensor, such as a skin sensor. The sensor 18 may be a mechanical sensor. The sensor 18 may be a valve, such as a clamping valve. One or more portions of the sensor 18 may be elastically movable. For example, one or more portions of the sensor 18 may be biased (e.g., by compression and / or tension) to cause its elastic strain away from the sensor neutral position and destrain back to the 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 may change shape. When a force is removed from the sensor 18 (e.g., when the device 10 is dislodged from the skin), the sensor 18 may change shape.

[0124] For example, sensor 18 may include one or more arms, plates, protrusions, extensions, plugs, openings, channels, springs, spring regions, or any combination thereof. Sensor 18 may be positioned on a first side of the device (e.g., a first lateral side, bottom side), a second side of the device (e.g., a second lateral side, top side), a third side of the device (e.g., a first sidewall, left side), a fourth side of the device (e.g., a second sidewall, right side), a fifth side of the device (e.g., a first longitudinal side, front side), a sixth side of the device (e.g., a second longitudinal side, rear side), or any combination thereof. For example, sensor 18 may be a bottom plate (also called a base plate), a top plate, a side plate, a front plate, a rear plate, or any combination thereof, such that at least a portion of sensor 18 can detect contact and loss of contact with a non-device surface and / or can detect a decrease in contact force and contact force from a non-device surface. For example, Figure 1 The sensor 18 shown can be a skin-sensing base plate (also known as a movable base plate).

[0125] Sensor 18 may have a proximal sensor end 18a and a distal sensor end 18b. When needle 12 is inserted into tissue, the proximal sensor end 18a and / or the distal sensor end 18b may be configured to slide across a non-device surface. The distal sensor end 18b may have a distal sensor terminal 24. The distal sensor terminal 24 may be an edge or a surface.

[0126] Sensor 18 can be attached to device 10 (e.g., housing 14) with or without a hinge. For example, Figure 1 The sensor proximal end 18a is shown to be directly or indirectly attached to the housing 14 on the first side 10c of the device without a hinge. The portion of the sensor 18 attached to the housing 14 (e.g., the sensor proximal end 18a) can be attached using glue, welding (e.g., acoustic welding), snap-fit, friction fit, or any combination thereof.

[0127] The distal end 18b of the sensor is movable relative to the proximal end 18a of the sensor. For example, the distal end 18b of the sensor is rotatable about a sensor hinge (not shown). The sensor hinge may be attached to or integral with the sensor 18. The sensor hinge may be a spring. The sensor 18 may have multiple sensor hinges / springs.

[0128] A sensor spring (not shown, also referred to as the spring region) allows the distal end 18b to be positioned at a distance from the needle 12 during disengagement (and before attachment). The sensor spring also allows the distal end 18b to be biased at a neutral position at a distance from the needle 12 during disengagement (and before attachment).

[0129] The sensor distal end 18b may have one or more distal sections, such as 1 to 10 or more sections, including the amount of each incremental section within that range (e.g., 2 sections, 3 sections). The one or more distal sections may be straight. The one or more distal sections may be curved. For example, the sensor distal sections may be angled relative to each other, such as from about 0 degrees to about 120 degrees, including the amount of each incremental degree within that range (e.g., 90 degrees).

[0130] For example, Figure 1 The sensor distal end 18b is shown to have a distal first portion 20a, a distal second portion 20b, and a distal third portion 20c between the distal first portion 20a and the distal second portion 20b. Figure 1 The first portion 20a and the second portion 20b can be straight, and the third portion 20c can have a curved portion 21. The first portion 20a and the second portion 20b can be at an angle of approximately 90 degrees relative to each other. The different distal portions can be integral or attached to each other. For example, the sensor distal end 18b can be a single-piece structure. The sensor 18 can be a single-piece structure.

[0131] A curved distal end of the sensor (e.g., distal end 18b with bend 21) can improve caregiver usability of the device 10 by facilitating needle insertion and / or cannulation procedures by reducing friction between the device 10 and non-device contact surfaces during insertion. For example, the bend / curved surface 21 can cause the sensor leading edge (e.g., sensor terminal 24) to extend toward or away from a non-device surface (e.g., a skin surface away from the patient) during insertion. Allowing the sensor leading edge 24 to extend toward or away from the insertion surface during needle insertion can ensure easier cannulation by reducing or eliminating the possibility of the sensor leading edge getting stuck on the insertion surface when the needle 12 is inserted.

[0132] The curved distal end 18b can also protect the patient by preventing over-insertion of the needle. For example, the distal second portion 20b can be configured to prevent over-insertion of the needle 12 into a blood vessel by acting as a stop to prevent the needle 12 from being inserted beyond the second portion 20b. The curved end provides protection to the patient in that position by “preventing” any forward movement of the needle body into the existing needle entry hole (not shown). The sensor distal end 18b may have a portion (e.g., portion 20b) extending toward the needle 12, having or not having the curved portion 21, such that the sensor distal end 18b can define a needle over-insertion stop (e.g., portion 20b) in any variation of the sensor 18. This stop can inhibit or prevent over-insertion of the needle 12 longitudinally and / or laterally, such as relative to the longitudinal axis of the needle 12 and / or relative to the needle's insertion hole in the skin.

[0133] Even when the needle (e.g., needle 12) is inserted at a very steep angle, such as up to 45 degrees, 50 degrees, 60 degrees, or greater, the curved distal end 18b can ideally achieve needle dislodgement detection. Under these very steep insertion angle conditions, the curved end achieves maximum contact between the skin and the closed sensor 18 (not shown, which may be the configuration of sensor 18 when the device 10 is in an attached configuration), increasing the functionality of the device by ensuring that sensor 18 is aligned with needle 12 regardless of the insertion angle.

[0134] The distal end 18b of the sensor may have a sensor opening 22 (also called a sensor slot). The sensor opening 22 may accommodate a portion of the needle 12. For example, Figure 1 The sensor distal end 18b is shown to have a sensor opening 22. When the sensor distal end 18b is pressed against 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 be configured to receive at least a portion of the needle 12. When the sensor distal end 18b is pressed against the housing 14 (e.g., against the housing 14), the sensor opening 22 can advantageously allow the sensor 18b to close against the needle 12 (e.g., fully close). For example, the sensor opening 22 can be U-shaped, V-shaped, or irregularly shaped. At least a portion of the distal terminal 24 can define the sensor opening 22.

[0135] When the device is in an attached configuration, the sensor opening 22, integrated with the distal end 18b of the sensor, allows an over-insertion barrier (e.g., barrier 20b) to close around at least a portion of the needle 12. The sensor opening 22 can further enhance the over-insertion prevention effect of the barrier 20b by increasing the surface area of ​​the barrier near the needle 12, which prevents 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 also be positioned between the needle tip and the needle hub 13. This positioning ensures that the needle 12 is not inadvertently pushed deeper into the patient's body through the existing needle entry port.

[0136] Figure 2A The sensor 18 is shown to have one or more sensor springs 26 (also referred to as spring regions), for example, 1 to 10 or more springs 26, including the amount of each spring increment within that 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 (e.g., the first spring 26a and the second spring 26b) can act together as a single spring.

[0137] The springs 26 (e.g., first spring 26a and second spring 26b) may function similarly to leaf springs, compression springs, tension springs, torsion springs, or any combination thereof. For example, each spring 26 may be a leaf spring, compression spring, tension spring, or torsion spring. The first spring 26a and the second spring 26b may be springs of the same type or different types. For example, the first spring 26a may be a leaf spring, and the second spring may be a compression spring. As another example, both the first spring 26a and the second spring 26b may be leaf springs or have functions similar to leaf springs.

[0138] Spring 26 may be integral with, attached to, or embedded in sensor 18. For example, spring 26 may be a molded spring made of the same or different material as the rest of sensor 18. Molded spring 26 can be manufactured by molding sensor 18 with one or more non-linear elastic portions (e.g., first spring region 26a and second spring region 26b), wherein the non-linear elastic portion can function as a spring when the shape of the elastic portion is changed (e.g., straightened). For example, the non-linear elastic portion may be a curved, multi-arc and / or zigzag structure, component, rod, bar, shaft, sheet, laminate, or any combination thereof. For example, a molded spring design can advantageously reduce manufacturing costs associated with sensor 18 compared to attaching or embedding a separate spring 26 to sensor 18.

[0139] When spring 26 is in a neutral configuration (e.g., no deflection, no strain, no stress), spring 26 can have a bent or angled zigzag structure. When device 10 is in a disengaged configuration (e.g., Figure 2A When the device 10 is in the attachment configuration, such as when the spring 26 is in a compressed and / or tensioned configuration (e.g., a non-neutral configuration), the bending or angle of the spring 26 can be smaller. For example, when the device 10 is in the attachment configuration, such as when the spring 26 is in a compressed and / or tensioned configuration (e.g., a non-neutral configuration), the spring 26 can be in a smaller bending or angle. Figure 2A When sensor 18 is in a straightened or slightly bent configuration, the mechanical stress on the bent portions (spring regions 26a and 26b) can generate an effective spring force. This spring force can bias sensor 18 back to its initial configuration. The direction and magnitude of the spring force can depend on the mechanical shape and size of the associated accessories of sensor 18 (e.g., current limiters, features of the distal end 18b of the sensor).

[0140] Spring 26 may be a sensor hinge configured to allow the distal end 18b of the sensor to move (e.g., rotate) relative to the proximal end 18a of the sensor.

[0141] Springs 26 (e.g., springs 26a and 26b) can connect the sensor proximal end 18a to the sensor distal end 18b. Springs 26 can be located in the middle region of the sensor 18 and / or on the sensor distal end 18b or the sensor proximal end 18a. As another example, springs 26 can extend through all or part of the device proximal end 18a and distal end 18b. For example, Figure 2A Spring 26 is shown to be located on the proximal end 18a of the sensor, where the proximal end 18a and the distal end 18b are shown separated by a transverse axis A4 at the center of the sensor. The transverse axis A4 of the sensor can be curved or straight.

[0142] Figure 2AFurther illustrated, sensor 18 may have a current limiter 28. Current limiter 28 may have a plug arm 30 and a plug 32. The plug 32 may be a protrusion extending away from the plug arm 30, for example, toward the longitudinal axis A1 of the device. Current limiter 28 may be integral with or attached to sensor 18. When device 10 is in a disengaged configuration, plug 32 may be configured to block the flow path of the device. Plug 32 may be rigid. Plug 32 may be non-deformable. Plug 32 may be flexible. Plug 32 may have a blunt tip. Plug 32 may have a sharp tip. Plug 32 may be straight and / or curved. Plug 32 may have an irregular shape. Spring region 26 may be on one or both sides of current limiter 28. Spring 26 may elastically bias current limiter 28 to a default blocking position. For example, when device 10 is disengaged, the spring force of spring 26 allows the plug 32 to directly enter the flow path of the device, preventing or blocking fluid flow through the flow path. Bend regions 26a and 26b create internal or integral hinge points for the flow restrictor 28. Sensor 18 may have a sensor hole 36 that can receive the flow restrictor 28 when the sensor is straightened. Optionally or additionally, all or part of the sensor hole 26 may be a recess in sensor 18. The flow restrictor 28 may be located at the center of the hole / recess 36 or offset within the hole / recess 36.

[0143] By using the curved portion of sensor 18 as a mechanical spring, the typical hinges that might be required to tilt the component from a flat position to an angled position are eliminated. Furthermore, by using adhesive, acoustic welding, or any other technique (e.g., friction fit, snap-fit), a portion of the base plate 18 can be tightly secured to the needle body 14, allowing the base plate 18 to sense the underlying skin like a spring and to act as a mechanism for blocking blood flow. Hinge point A5 is integrated at the base of the occlusion arm 30 into the central occlusion member 28 of the base plate, serving as the point where the central curvature 26 generates natural bending motion. This design ideally eliminates the need for conventional hinge attachments on the needle body 14, thus allowing the mechanics of the device 10 to become less susceptible to interference from, for example, standard medical tape typically placed on the needle device 10 to secure them.

[0144] The sensor 18 may have one or more attachment regions 34. The attachment regions 34 allow the sensor 18 to be attached to the housing 14 without hinges. The attachment regions 34 may be attached to the housing 14. For example, the attachment regions may be glued to or welded to (e.g., acoustically welded to) the housing 14. As another example, the attachment regions 34 may be fitted into corresponding recesses in the housing 14 by snap-fit, friction fit, adhesive fit, or any combination thereof.

[0145] Figure 2BThe sensor 18 is shown to have a first longitudinal axis A6 and a second longitudinal axis A7. The first longitudinal axis A6 may be the longitudinal axis of the occluder arm 30. The first longitudinal axis A6 may be the central longitudinal axis of the occluder arm 30. The first longitudinal axis A6 may be curved or straight. The second longitudinal axis A7 may be the longitudinal axis of the portion of the sensor proximal end 18a adjacent to the spring portion 26. The second longitudinal axis A6 may be the central longitudinal axis of the sensor proximal end 18a. The second longitudinal axis A7 may be curved or straight. An angle 38 may exist between the first longitudinal axis A6 and the second longitudinal axis A7. When the device 10 is in the disengaged configuration, the sensor 18 may be in the occluded configuration (also known as the sensor closed configuration) such that the angle 38 is from about 10 degrees to about 75 degrees, including increments of 1 degree within this range (e.g., 25 degrees, 30 degrees). When device 10 is in the attached configuration, sensor 18 can be in a less blocked configuration (also known as the sensor open configuration) than when device 10 is in the disengaged configuration, such that angle 38 is approximately 0 degrees to approximately 30 degrees, including the amount of each degree increment within this range (e.g., 0 degrees, 2 degrees, 5 degrees). The angle 38 between the first longitudinal axis A6 and the second longitudinal axis A7 of the sensor can be smaller when sensor 18 is in the open configuration than when sensor 18 is in the closed configuration, for example, approximately 10 degrees to approximately 75 degrees, including the amount of each degree increment within this range.

[0146] Figure 2B Further illustrating, sensor 18 may have a first transverse axis A8 and a second transverse axis A9. The first transverse axis A8 may be the axis of the distal end of the sensor (e.g., the distal second portion 20b of the sensor). The first transverse axis A8 may be the central axis of the distal second portion 20b of the sensor. The first transverse axis A8 may be curved or straight. The second transverse axis A9 may be the axis of the occluder 32. The second transverse axis A9 may be the central axis of the occluder 32. The second transverse axis A9 may be perpendicular to the axis of the occluder arm 30 (e.g., perpendicular to axis A7). The second transverse axis A9 may be curved or straight. The 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 first transverse axis A8 and the second transverse axis A9 may extend at least partially in the longitudinal direction, for example, along axes A6 and / or A7. As yet another example, one or both of the sensor’s first longitudinal axis A6 and the sensor’s second longitudinal axis A7 may extend at least partially in the lateral direction, for example, along axes A8 and / or A9.

[0147] Figure 2BFurther illustrated, the distal end 18b of the sensor may have a lateral dimension 40 measured along axis A8, which includes approximately 5 mm to approximately 20 mm (e.g., 8 mm) in increments of 1 mm within this range. The lateral dimension 42 of the sensor opening may include approximately 2 mm to approximately 20 mm (e.g., 5 mm) in increments of 1 mm within this range. As another example, the lateral dimension 42 of the sensor opening may be the same as the lateral dimension 40. When the device 10 is in an attachment configuration, the lateral dimension 42 of the sensor opening can be selected such that the needle 12 is configured not to contact the bottom surface of the sensor opening 22 or to be positioned above the bottom surface of the sensor opening 22. Selecting the lateral dimension 42 of the opening such that the needle 12 does not contact the bottom surface of the sensor opening 22 when the device 10 is in an attachment configuration can advantageously allow the needle 12 to float within the sensor opening 22, so that the distal end 18b of the sensor does not push the needle 12 upwards out of the skin during insertion. Floating the needle 12 within the sensor opening 22 can be useful in situations where the user must "fish" for blood vessels during insertion, allowing the user to change the angle of the device 10 relative to the patient's skin while a portion of the needle is inserted into the tissue. It is also useful when the angle of the device 10 relative to the skin is very low (e.g., 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 longitudinal axis A1 of the device.

[0148] Figure 2B It is further shown that the occluder 32 may have a lateral dimension 44 measured along axis A9, from about 1 mm to about 15 mm (e.g., 4 mm, 5 mm), including the amount of each 1 mm increment within this range.

[0149] Figure 2B The sensor 18 is further shown to have a first sensor contact surface 48 and a second sensor contact surface 50. The first sensor contact surface 48 can be configured to detachably contact a non-device surface, such as skin, and is therefore also referred to as skin contact surface 48. The second sensor contact surface 50 can also be configured to detachably contact a device surface, such as the surface of the housing 14, and is therefore also referred to as housing contact surface 50.

[0150] Figure 2C The occluder opening 22 is shown to extend through the distal second portion 20b and the distal third portion 20c of the sensor. The longitudinal dimension 46 of the sensor opening can be from about 0 mm to about 50 mm (e.g., 5 mm), including an amount for every 1 mm increase within this range. Making the longitudinal dimension 46 of the sensor opening greater than zero allows the needle 12 to float in the sensor opening 22 during low-angle insertion. A longitudinal dimension 46 greater than zero also ideally reduces the material required to manufacture the sensor 18, thereby reducing manufacturing costs.

[0151] Figure 2C Further illustrating that sensor 18 may have a dimension 47 that is measured between the proximal and distal ends of the sensor. For example, this dimension may be from about 10 mm to about 50 mm or larger, including the amount for each 1 mm increase within this range. Dimension 47 may be used when the sensor is... Figure 2A The longitudinal length of sensor 18 is measured when the sensor 18 is in its neutral position along the straight axis or along the curved axis.

[0152] Figures 1 to 2C The device 10 shown may have a spring 26, a current limiter 28, an over-insertion protector (e.g., the second portion 20b of the sensor distal end), or any combination thereof. Any combination of the spring 26, current limiter 28, and over-insertion protector may be integrated with each other. For example, the spring 26 and the current limiter 28 may be integrated with each other. The spring 26, the current 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 current limiter (e.g., current 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 current limiter (e.g., current limiter 28) and an over-insertion protector (e.g., the distal end of the sensor distal end 18b).

[0153] Alternatively or additionally, the device 10 may have an over-insertion protector attached to or integrated with the housing 14 and / or needle holder 13, which differs from an 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, plate) extending at least partially away from the needle holder 13 in the longitudinal direction and at least partially towards the needle 12 in the transverse direction. For example, the over-insertion protector may have the same shape as the distal end 18b of the sensor, wherein it is just flipped over and attached to or integrated with the housing 14 (wherein "same shape" may lack the proximal end 18a of the sensor, the spring 26, and the current limiter 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 second side 10d of the device and / or on one of the lateral sides of the device. In the case where the device 10 has an over-insertion protector that is not attached to or integrated with the sensor 18b, but rather has an over-insertion protector attached to the housing 14 and / or the pin seat 13, the distal second portion 20b of the sensor can be relative to, as Figures 1 to 2CThe distal second portion 20b of the sensor shown is shortened (e.g., 5mm to 15mm shorter) so that it does not extend into the needle 12, for example, so that the distal second portion 20b of the sensor does not interfere with the over-insertion protector. As another example, the device 10 may have both 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 holder 13.

[0154] Another variation of the current limiter 28 can be a current limiter with a plug arm 30 but without a plug 32. In this variation, (e.g., where the plug is positioned on the current limiter 28) the plugging portion of the sensor 18 can be the end of a straight rod 30. The plug arm 30 can be a tapered rod. As another example, the plug arm 30 can be one or more curved, zigzag, and / or multi-arc-shaped rod portions (e.g., different from the plugging protrusion 32), such that the rod 30 can still function as a plug without requiring... Figures 2A to 2C The plug 32 shown in the figure.

[0155] Sensor 18 may have a spring 26. For example, another variation of sensor 18 could be... Figures 2A to 2C Half of the sensor 18 shown. Although one spring 26 (e.g., spring 26a or spring 26b) is used instead of two, this sensor can still function as described herein. Figure 2C Axis A10 in the diagram illustrates a variation where sensor 18 can be split to form a smaller sensor 18. The sensor can be manufactured in half or in two halves. As another example, the proximal end 18a of the sensor can remain unchanged in a single-spring sensor, but the distal end 18b of the sensor, attached to the proximal end 18a, can be made of… Figure 2C The structure is separated by axis A10 (e.g., the left or right side of sensor 18). This single-spring sensor 18 may or may not have a sensor opening 22. If there is no opening 22, the distal end 18b of the sensor can still be used as a stop to prevent over-insertion.

[0156] Figure 3A and Figure 3B The device 10 is shown in a variant of the attachment configuration. To maintain this attachment configuration, the device 10 can be adhered to a non-device surface such as skin. For clarity, Figure 3A and 3B Tape and skin are not shown.

[0157] Figure 3A and Figure 3B Further illustrating that when an external force 80 is applied to the first side 10c of the device via a non-device surface (e.g., skin), the device 10 can have an attachment configuration. Although not shown in Figure 3A and3B As shown, in the attachment configuration, device 10 can be attached to the skin, for example, with tape or glue, to secure device 10.

[0158] Figure 3A This diagram illustrates that when the device 10 is in the attached configuration, the housing contact surface 50 can abut against the housing 14. When the device 10 is in the attached configuration, all or a portion of the skin contact surface 48, including, for example, the sensor proximal end 18a, the sensor distal end 18b, the spring region 26, the occluder arm 30, or any combination thereof, can contact the skin. For example, when the device 10 is in the attached configuration, the skin contact surface 48 of the sensor distal end 18b, the sensor distal end third portion 20c, the sensor distal end second portion 20b, the sensor distal end first portion 20a, the sensor distal portion between the sensor distal end first portion 20a and the sensor proximal end 18a, or any combination thereof, can contact the skin. The sensor distal end first portion 20a can extend from the sensor distal end third portion 20c to the distal end of the proximal end 18a and / or the distal end of the spring 26. When the device 10 is in the attached configuration, the portion of the skin contact surface 48 that contacts the tissue will depend on factors such as the insertion angle, the needle insertion depth, and the position of the tape across the top of the device 10.

[0159] Figure 3A Furthermore, when the device 10 is in an attached configuration, the second longitudinal axis A7 of the sensor can be parallel to the longitudinal axis A1 of the device. In such a variation, Figure 3A This illustrates that when the device 10 is in the attached configuration, a portion of the distal end 18b of the sensor (e.g., the first portion 20a of the distal end of the sensor) may extend at least partially toward the distal end 10b of the device in the longitudinal direction (e.g., only in the longitudinal direction). As another example, when the device 10 is in the attached configuration, axis A7 may be at an angle of about 0 degrees to about 15 degrees relative to the longitudinal axis A1 of the device, including the amount of each 1-degree increment within that range (e.g., 3 degrees). Non-parallel configurations (e.g., angles greater than 0 degrees) may occur in cases where the skin surface is rough. Non-parallel configuration of the sensor axis A7 may also be temporary, such as when the patient moves and the needle 12 and / or housing 14 moves slightly away from or slightly away from the skin (e.g., when the device 10 is in the attached configuration, except where the needle and housing are not in contact with the skin at the needle insertion hole), temporarily moving more than 0 degrees. Spring 26 may be biased to keep sensor 18 in contact with the skin during patient movement, such that... Figure 3A In this device configuration, the distal end 24 of the sensor moves toward or (e.g., by rotation) around the longitudinal axis A1 of the device. Once the patient stops moving (e.g., if the tape remains in place), the sensor axis A7 can return to a direction parallel to axis A1. Allowing the sensor 18 to move during patient movement provides flexibility to the device 10 and can make patient movement more comfortable.

[0160] Figure 3A Further illustrating that when the device 10 is in an attached configuration, the sensor's first lateral axis A8 can be perpendicular to either the device's longitudinal axis A1 or the sensor's second longitudinal axis A7. In this variation, Figure 3A A portion of the distal end 18b of the sensor (e.g., the second distal end portion 20b) may extend at least partially in the lateral direction (e.g., only in the lateral direction). When the device 10 is in the attached configuration, the second distal end portion 20b of the sensor may also extend at least partially in the longitudinal direction toward the distal end 10 of the device and / or toward the proximal end 10a of the device. For example, when the device 10 is in the attached configuration, axis A8 may form an angle (e.g., 60 degrees, 90 degrees, 120 degrees) relative to axes A1 and / or A7, including every 1-degree increment within that range, from about 0 degrees to about 150 degrees. Angles less than 90 degrees may correspond to a location where, when the device is in the attached configuration, the distal end 18b of the sensor extends at least partially in the longitudinal direction away from the needle tip and toward the proximal end 10a of the device. An angle greater than 90 degrees may correspond to a location where, when the device 10 is in the attached configuration, the distal end 18b of the sensor extends in the longitudinal direction toward the needle tip and away from the proximal end 10a of the device. The angle between axes A7 and A8 can be the angle between the first distal portion 20a and the second distal portion 20b of the sensor, respectively. The angle between axes A7 and A8 can be fixed so that the angle between the first distal portion 20a and the second distal portion 20b of the sensor remains constant when the device 10 is reconfigured. The portion of the distal end 18b of the sensor that extends laterally toward the needle 12 may include an over-insertion stop of the device 10.

[0161] Figure 3A Further illustrating that when the device 10 is in an attached configuration, the sensor distal end 18b can extend beyond the needle holder 13. For example, the sensor distal end 18b can extend beyond the distal end of the needle holder by a longitudinal distance 58 measured to the proximal edge or surface of the sensor distal end 18b. For example, the distance 58 can be from about 1 mm to about 15 mm, including amounts increasing by 1 mm within this range (e.g., 1 mm, 2 mm, 3 mm).

[0162] Figure 3AFurther illustrating that when the device 10 is in the attached configuration, the distal end 24 of the sensor can extend beyond the longitudinal axis A1 of the device. For example, the distal end 24 of the sensor can extend laterally beyond axis A1 by a distance 60. For example, the distance 60 can be from 1.0 mm to about 7.5 mm, including amounts in increments of 0.1 mm within this range (e.g., 1.0 mm, 2.0 mm, 3.0 mm, 4.0 mm). The distal end 24 of the sensor can be a lateral end of the sensor. The sensor 18 can also have a longitudinal end of the sensor, for example, which can be the distal edge or surface of the second distal portion 20b of the sensor. The distal end 18b of the sensor can be laterally located below the axis of the needle 12, partially adjacent to the axis of the needle 12, and / or (e.g., laterally outside the axis of the needle 12 relative to the attachment direction). For example, Figure 3A This shows that when the device 10 is in an attached configuration, the sensor's distal terminal 24 can be above the axis of the needle 12.

[0163] Distances 58 and 60 can be the same or different from each other. For example, Figure 3A The distance 58 is shown to be less than the distance 60, for example, about 1 mm or about 2 mm. As another example, the distance 58 can be greater than the distance 60 (for example, from about 1 mm to about 15 mm).

[0164] Figure 3B The device 10 shown may have an insert 17 (also referred to as a membrane insert). The insert 17 may be positioned within 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 may be entirely inside the housing 14. In this variation, the connector 16 may be attached to the housing 14, integral with the housing 14, attached to the insert 17, or any combination thereof. The insert 17 may have ribs 49 that can clamp the needle 12 to hold it in place. Adhesive may be present in the space between the ribs. The ribs 49 may be on the proximal and / or distal ends of the insert 17.

[0165] Insert 17 can be rigid, semi-rigid, flexible, elastic, and / or deformable. Insert 17 can be made of the same or different material as housing 14. Insert 17 can be softer, more flexible, more elastic, or more deformable than housing 14. Insert 17 can be made of a variety of materials. The first material of insert 17 can be softer, more flexible, more elastic, more deformable, or any combination thereof than the second material of insert 17. Insert 17 can have one or more thicknesses. For example, insert 17 can have a first thickness 17a and a second thickness 17b smaller than the first thickness 17a. The first thickness 17a and the second thickness 17b can be lateral thicknesses. The first thickness 17a can range from about 0.5 mm to about 3.0 mm, including increments of 0.1 mm within this range (e.g., about 1.5 mm). The second thickness 17b of the insert can range from about 0.1 mm to about 2.0 mm, including increments of 0.1 mm within this range (e.g., about 0.2 mm).

[0166] Figure 3B Further illustrated, device 10 may have an elastic membrane 54 (also referred to as a deformable membrane and a deflectable membrane). Membrane 54 may be positioned adjacent to the current limiter 28. Membrane 54 may be made of the same or different material as the insert 17. Membrane 54 may be attached to or integral with the insert 17. A portion of the insert 17 may be membrane 54. For example, membrane 54 may be a portion of the insert made of a first insert material, membrane 54 may be a portion of the insert 17 having a second insert thickness 17b, membrane 54 may be a portion of the insert 17 adjacent to the current limiter 28, or any combination thereof. As another example, membrane 54 may be separated from the insert 17.

[0167] Insert 17 may have an outer surface and an inner surface. The outer surface of the insert may be attached to or in contact with the inner surface of housing 14. The inner surface and / or inner surface of the membrane 54 may define an insert channel 56 (also referred to as an insert flow channel and housing conduit). The housing conduit 56 may extend from the proximal end 14a of the housing to the distal end 14b of the housing. The housing conduit 56 may be straight or curved. The proximal portion of needle 12 may be in the insert channel 56. The inner surface of the insert may have a circular, elliptical, or polygonal cross-section (e.g., in the plane defined by axes A2 and A3). The outer surface of the insert may have a circular, elliptical, or polygonal cross-section (e.g., in the plane defined by axes A2 and A3). The membrane 54 may be in housing 14. The membrane 54 may be outside housing 14. The membrane 54 may be integral with or attached to the housing. For example, the non-fluid contact side of the membrane 54 may form the outer surface and / or inner surface of housing 14.

[0168] Before the device 10 is inserted into the tissue, the elastic membrane 54 can have a deformable shape because the spring 26 forces the occluder 32 against the membrane and into the housing conduit 56. When the device 10 is inserted into the tissue, the elastic membrane 54 may not deform from a first membrane shape (e.g., an occluding shape) to a second membrane shape (e.g., a non-occluding or less occluding shape). When the device 10 is dislodged, the occluder 32 can deform the membrane 54 again into the housing flow path 56 by the action of the spring 26, thereby reducing the cross-sectional area of ​​the housing flow path 56 in the occluding region to restrict or terminate the flow.

[0169] Figure 3B The device 10 is further shown to have a device flow channel 62. The device flow channel 62 may include one or both of a needle flow channel 64 and an insertion flow channel 56 and a 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 insertion flow channel 56) may be parallel to the longitudinal axis A1 of the device. The housing conduit 56 may be concentric with or offset from the longitudinal axis A1 of the device. The needle flow channel 64 may be parallel to the longitudinal axis A1 of the device. The needle flow channel 64 may be concentric with or offset from the longitudinal axis A1 of the device. The angle of the needle 12 relative to the housing conduit 56 may be from about 0 degrees to about 45 degrees, such that the flow path of the needle flow channel 64 relative to the housing conduit 56 may be at an angle of about 0 degrees to about 45 degrees.

[0170] The device flow channel 62 may have a channel occlusion region 68 (also referred to as a conduit occlusion region). The channel occlusion region 68 of the device flow channel 62 may be at least partially defined by a membrane 54. For example, the membrane 54 may define at least a portion of the outer periphery (e.g., circumference) of the cross-section of the device flow channel 62 within the occlusion region 68. The membrane 54 may define, for example, from about 10% to about 75% of the outer periphery, including amounts in increments of 1% within this range (e.g., 25% or less, 50% or less, 75% or less). Figure 3B The membrane 54 is shown to define approximately 25% to approximately 50% (e.g., 50%) of the outer periphery, wherein 25% to 50% forms or is part of the lower half of the occlusion region 68 from the proximal end to the distal end of the occlusion region 68. As another example, the channel occlusion region 68 may be wholly or at least partially defined by the insert 17, such that the insert 17 may partially or completely define the outer periphery (e.g., circumference) of the cross-section of the device flow channel 62 in the occlusion region 68. As yet another example, depending on the combination, the outer periphery (e.g., circumference) of the channel occlusion region 68, for example, approximately 0% to approximately 100% of the outer periphery, may 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, wherein all percentage arrangements of these different peripheral combinations are disclosed herein.

[0171] The membrane 54 may be opposite to the housing surface, opposite to the insert surface, opposite to a housing protrusion (not shown), opposite to an insert protrusion (not shown), or any combination thereof. One or more housing and / or insert protrusions may extend at least partially toward the longitudinal center of the device flow channel 62 in the housing 14, for example, toward the longitudinal center of the flow path defined by the housing conduit 56. When the movable sensor 18 is in a closed configuration, the plug 32 may be configured to engage one or more protrusions.

[0172] Figure 3B Further illustrated, device 10 may have a housing opening 70 (also referred to as a housing window). The housing opening 70 may be on a first, second, third, fourth, fifth, or sixth side of the device, or any combination thereof. The orientation of these different sides was discussed above with reference to sensor 18. For example, Figure 3B The housing opening 70 is shown to be on the first side 10c of the device. For example, when the device is in an attached configuration, the first side 10c of the device may be the bottom side of the device, wherein the bottom surface of the device 10 is the skin contact side of the device 10.

[0173] The housing opening 70 can be, for example, circular, polygonal (triangular, rectangular), stadium-shaped, or irregular. The housing opening 70 can also be a hole (also called a passage) in the wall of the housing 14.

[0174] The housing opening 70 may have a housing opening longitudinal dimension 72 (also referred to as the housing opening first dimension). The housing opening longitudinal dimension 72 may range from about 2 mm to about 40 mm, including increments of 1 mm within this range (e.g., 10 mm). For example, the housing opening longitudinal dimension 72 may be the maximum longitudinal dimension of the housing opening 70 along an axis parallel to or at an angle to the longitudinal axis A1 of the device.

[0175] Although not in Figure 3B As shown, however, the housing opening 70 may also have a first lateral dimension (also referred to as a second dimension). The first lateral dimension of the housing opening may range from about 2 mm to about 40 mm, including increments of 1 mm (e.g., 10 mm) within this range. For example, the first lateral dimension of the housing opening may be the maximum lateral dimension of the housing opening 70 along an axis parallel to or at an angle to the second lateral axis A3 of the device.

[0176] Although not in Figure 3BAs shown, however, the housing opening 70 may also have a second lateral dimension (also referred to as a third dimension). The range of the second lateral dimension can be from about 0.5 mm to about 10 mm (e.g., 1.0 mm, 2.0 mm) in increments of 0.1 mm within this range. For example, the second lateral dimension can be the maximum lateral dimension of the housing opening 70 along an axis parallel to or at an angle to the first lateral axis A2 of the device. The second lateral dimension can correspond to the depth of the hole 70.

[0177] The first dimension, second dimension, and third dimension of the housing opening can correspond to the length, width, and height dimensions of the housing hole (e.g., hole 70), respectively. As another example (e.g., in the case that hole 70 is cylindrical), the first dimension and second dimension of the housing opening can be the radius of the housing opening, and the third dimension of the housing opening can be the depth of hole 70.

[0178] The housing opening 70 may have a housing opening surface area. The housing opening surface area can be the area of ​​the aperture defined by the housing opening 70. For example, the area of ​​the aperture can be defined by a plane parallel to the plane defined by axes A1 and A3, or by any other combination of axes A1, A2, and A3. For example, the housing opening surface area can be the area included per 1 mm within this range. 2 Increment of 4mm 2 Approximately 1,600 mm 2 Or larger (e.g., less than 25mm) 2 Less than 50mm 2 Less than 100mm 2 Less than 200mm 2 Less than 500mm 2 ).

[0179] The surface area of ​​the housing opening can be smaller than the surface area of ​​the housing surface. For example, the surface area of ​​the housing opening can be a percentage of the surface area of ​​the housing surface. For example, the percentage range can be from about 1% to about 90% of each 1% increment within that 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 comparable to the area of ​​the housing opening 70 can be located on the same or different side of the device 10 as the housing opening 70. For example, the housing surface can be on the first side 10c of the device (e.g., the bottom surface of the housing), the 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 opening 70 can be ignored or observed when calculating the surface area of ​​the housing surface. For example, for a surface area of ​​900 mm² 2 The square base and the surface area of ​​the opening are 100 mm².2 The surface area of ​​the bottom of the hole 70 can be considered to be 1,000 mm². 2 (Ignore hole 70) or 900mm 2 (Observation of hole 70) such that the surface area of ​​the housing opening is about 10.0% (ignoring hole 70) or about 11.1% (observation of hole 70) of the surface area of ​​the bottom surface. Another way to quantify it is by stating that the surface area of ​​the housing opening can be smaller than the housing surface through which the housing opening 70 extends. For example, the housing opening 70 extending through the housing surface of the device 10 can have a housing opening surface area that is about 100 times or more smaller than the surface area of ​​the housing surface through which the housing opening 70 extends, or more narrowly smaller than about 50 times or more, or more narrowly smaller than about 25 times or more, or more narrowly smaller than about 10 times or more (e.g., 14 times smaller, 10 times smaller, 5 times smaller).

[0180] Because a larger device surface area allows for a more even distribution of the force exerted by the device 10 on the skin, a housing opening 70 smaller than the size of the housing surface (e.g., the bottom surface of the device 10 or the skin contact surface) through which the device is attached to the skin can ideally provide the housing 14 with a larger surface area to contact the tissue. This is more comfortable for the patient and less likely to "penetrate" into the tissue or leave sensitive skin imprints or dents after removal. This is particularly beneficial for patients undergoing hemodialysis because the device 10 can be attached to their skin for several hours at a time, for example, from approximately 3 to approximately 6 hours. A smaller housing opening 70 also allows for a more reliable seal around the device flow path 62 within the housing 14 (e.g., around the housing conduit 56) compared to a housing space 51 with a large opening.

[0181] However, in some variations, the orifice 70 may be larger than the size of the housing surface through which the housing opening 70 extends (e.g., the opposite of the ratio / relationship of "less than" and "smaller" above). In such variations, for a housing surface configured to contact the skin, such as the bottom surface of the housing, the orifice 70 may be large enough that the bottom surface of the housing may be an annular flange extending around the outer periphery of the housing 14. For a larger opening 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" orifice 70 may be more useful for further lifting the housing catheter 56 away from the skin when attached to a patient. In cases where the orifice 70 forms a large recess, a skin warming or cooling pack may be inserted into the recess and come into contact with the patient's skin during treatment to increase patient comfort. Such a warming or cooling pack may also help control vasodilation and vasoconstriction, which should be necessary or helpful for the specific patient at the time of treatment.

[0182] The housing opening 70 advantageously allows the flow restrictor 28 to enter the housing conduit 56 while maintaining a fluid seal between the tip of the tube 8 and the needle 12. For example, the flow restrictor 28 can move within the housing opening or move through the housing opening 70, deforming the membrane 54 to block flow through the housing conduit 56.

[0183] For example, housing opening 70 can expose membrane 54 by creating a passage through housing wall (e.g., housing wall having an outer surface configured to contact skin). When sensor 18 is in an open configuration and device 10 is attached to a non-device surface, housing opening 70 can open toward (e.g., toward) the non-device surface (also referred to as the non-sensor surface and skin). Membrane 54 can be closer to the longitudinal axis A1 of the device than housing opening 70. Membrane 54 can be closer to the longitudinal axis of the device flow path 62 than housing opening 70. Part or all of membrane 54 can be in housing opening 70. At least a portion of membrane 54 can be attached to or integral with the edge or surface defining housing opening 70.

[0184] When device 10 is in the attached configuration (also referred to as when sensor 18 is in the open configuration), some or all of the current limiter 28 may be in the housing opening 70. For example, at least a portion of the current limiter 28 may be in an opening plane defined between the edges or surfaces of the housing opening 70. For example, the opening plane may be a plane parallel to a plane defined by axes A1 and A3 or any other combination of axes A1, A2, and A3. Figure 3B The diagram shows that when the device 10 is in the attached configuration, the plug 32 can be in the housing opening 70. Although not shown, a portion of the plug arm 30 may also extend into the housing opening 70 when the device 10 is in the attached configuration.

[0185] Figure 3B Further illustrating that when the device 10 is in the attached configuration, a portion of the occluder 32 (e.g., the tip of the occluder 32) may be located within the housing 14 (e.g., within the housing space 51) by extending through the housing opening 70 (e.g., through the internal opening plane of the opening window 70, wherein the internal opening plane may be defined between edges or surfaces including the internal edge, surface, or boundary of the housing 14). Although not shown, a portion of the occluder arm 30 may also extend into the housing 14 (e.g., within the housing space 51) when the device 10 is in the attached configuration.

[0186] Figure 3B Further illustrating that when device 10 is in the attached configuration, the tip of the occluder 32 can contact membrane 54. When sensor 18 is in the open configuration, contact from the occluder 32 (e.g., the occluder tip) may or may not deform membrane 54. For example, Figure 3BThe diagram shows that when sensor 18 is in the open configuration, although the occluder 32 contacts membrane 54, it does not deform membrane 54. However, in other variations, when sensor 18 is in the open configuration, the tip of the occluder can deform membrane 54 or space it from membrane 54 by a certain gap. This deformation or gap can have a deformation / gap size ranging from about 0.5 mm to about 2.5 mm in increments of 0.1 mm within this range. The deformation / gap size can be measured along an axis parallel to or at an angle to the axis of the device, such as axes A1, A2, or A3. For example, Figure 3B This shows that the deformation / gap dimension can be measured along an axis parallel to the first transverse axis A2 of the device.

[0187] In a variation where the occluder tip deforms the membrane 54 when the sensor 18 is in the open configuration, the inner surface of the membrane 54 defining the housing conduit 56 may 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 an deformation size (e.g., about 0.5 mm to about 2.5 mm or more).

[0188] In a variant where there is a gap between the plug tip and the membrane 54 when the sensor 18 is in the open configuration, the gap size (e.g., about 0.5 mm to about 2.5 mm or greater) can be measured between the outer surface of the membrane 54 (e.g., outward from the housing space 51) and the plug tip.

[0189] The occluder 32 can be attached to or integrated with the membrane 54. The occluder 32 can be floated relative to the membrane 54, so that the occluder 32 is not permanently attached to the membrane 54.

[0190] When the device 10 is in the attached configuration, the plug arm 30 can be inside or outside the housing space 51. When the device 10 is in the attached configuration, the plug arm 30 can be inside or outside the housing window 70. For example, Figure 3B The occluder arm 30 is shown to be outside (e.g., below) the housing opening 70 (e.g., below the outer opening plane of the housing window 70, wherein the outer opening plane may be defined between edges or surfaces including the outer edge, surface, or boundary of the housing 14, for example, between those edge surfaces or boundaries that are farther from the longitudinal axis A1 of the device than those edges, surfaces, or boundaries associated with the inner opening plane of the housing window 70).

[0191] Figure 3BFurther illustrating that when the device 10 is in the attached configuration, the plug arm 30 may extend beyond part or all of the housing opening 70. The plug arm 30 may extend along, for example, approximately 10% to approximately 90% of the longitudinal dimension 72 of the housing opening. For example, when the longitudinal dimension 72 of the housing opening is 10 mm and the plug arm 30 extends beyond 75% of the longitudinal dimension 72 of the housing opening, the plug arm 30 may extend 7.5 mm beyond the housing opening 70 along the longitudinal dimension 72 of the housing opening when the device 10 is in the attached configuration.

[0192] Figure 3B Further illustrating that when sensor 18 is in the open configuration, the occluder axis A9 can be at an occluder angle of approximately 30 degrees to approximately 150 degrees relative to the longitudinal axis A1 of the device. For example, Figure 3B The occluder angle can be 90 degrees or perpendicular to the longitudinal axis A1 of the device. When the sensor 18 is in the open configuration, an occluder angle less than 90 degrees can correspond to a position where the occluder 32 extends at least partially in the longitudinal direction toward the distal end 10b of the device or the distal end 18b of the sensor. When the sensor 18 is in the open configuration, an occluder angle greater than 90 degrees can correspond to a position where the occluder 32 extends at least partially in the longitudinal direction toward the proximal end 10a of the device or the proximal end 18a of the sensor.

[0193] Although Figure 3B Not shown, but the flow path defined by the housing conduit 56 may have one or more cones. For example, the flow path defined by the channel blocking region 68 may taper from a first cross-sectional area to a second cross-sectional area smaller than the first cross-sectional area, such that the tapered region of the channel blocking region 68 forms a truncated conical flow path. The outer surface of the conduit (e.g., housing conduit 56) defining the tapered flow path may also have or not have a corresponding cone. 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 can be blocked more easily or with less force by the spring action of the flow restrictor 28. For example, the blocker 32 may be configured to deform the membrane 54 at the location of the second cross-section of the channel blocking region. As another example, the blocker 32 may be configured to deform the membrane 54 longitudinally away from the second cross-section in a direction toward the distal end of the device flow path 62, including increments of about 1 mm to about 20 mm (e.g., 5 mm, 10 mm) per 1 mm increment within this range. The membrane 54 may define a partial or complete cone. The first cross-sectional area can be inside or outside the channel blocking area 68.

[0194] As another example, the aforementioned cone can be a first cone, and the flow path defined by the housing conduit 56 can have a second cone. For example, the flow path defined by the channel blocking region 68 can gradually taper from a second cross-sectional area to a third cross-sectional area larger than the second cross-sectional area, such that the cone-shaped region of the channel blocking region 68 forms a second truncated conical flow path. The first and third cross-sectional areas can have the same or different cross-sectional areas. The outer surface of the conduit (e.g., housing conduit 56) defining the second conical flow path can also have or not have a corresponding cone. The second cross-sectional area can be closer to the proximal end of the device flow channel 62 than the third cross-sectional area. The second truncated conical flow path can be a mirror image of the truncated conical flow path (also referred to as the first truncated conical flow path) between the first and second cross-sectional areas, for example, as reflected across the second cross-sectional area. The first cross-sectional area can be inside or outside the channel blocking region 68. As another example, the second cross-sectional area between the first and third cross-sectional areas can be elongated, allowing a channel with a constant, smaller, or larger conical cross-flow path to extend between the first and second conical flow paths (e.g., between the first and second truncated conical flow paths). This elongated channel can ideally allow the plugger 32 to have a smaller cross-sectional area for partial or complete closure.

[0195] Figure 4A and Figure 4B As shown in the above reference Figure 1 Device 10 in the variant of the described sealing configuration.

[0196] Figure 4A and Figure 4B Further illustrating that when the external force 80 is reduced or, for example, completely removed from the sensor's first contact surface 48 as indicated by arrow 82, the device 10 can change from an attachment configuration in which the sensor 18 is in the open position to a blocking configuration in which the sensor 18 is in the closed position. Figure 4A and Figure 4B An external force 80 is also shown to illustrate a variation of the external force that can act on the sensor first contact surface 48 of the device 10, such that the shape of the device 10 changes from a blocking configuration in which the sensor 18 is in a closed position to an attachment configuration in which the sensor 18 is in an open position. Figure 4A and Figure 4B The external force 80 shown does not act on device 10. In other variations, force 80 acts on... Figure 4A and Figure 4B The device 10 in the middle, but its size is smaller than that in the middle. Figure 3A and 3B The magnitude shown, for example as illustrated, is combined with the reduction or elimination of force arrow 82.

[0197] Figure 4A and Figure 4B It is further shown that the pre-attachment configuration and the de-attachment configuration of the device 10 can be the same. However, the pre-attachment configuration and the de-attachment configuration can also be different from each other.

[0198] Figure 4A and Figure 4B Further illustrating that when the external force 80 decreases (e.g., arrow 82) or is eliminated (e.g., arrow 82), the sensor distal end 18b can move away from the longitudinal axis A1 of the device (e.g., arrow 84). The sensor distal end 18b can rotate and / or translate relative to the longitudinal axis A1 of the device. For example, when the external force 80 decreases (e.g., arrow 82) or is eliminated (e.g., arrow 82), the sensor distal end 18b can rotate away from the longitudinal axis A1 of the device (e.g., arrow 84).

[0199] Figure 4B Further illustrating that the flow restrictor 28 can move toward the housing surface opposite to the plug 32, toward the surface of the housing conduit 56 opposite to the plug 32, toward the longitudinal axis A1 of the device, 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 plug 32 is shown to be movable toward the housing surface opposite to the plug 32, toward the surface of the housing conduit 56 opposite to the plug 32, toward the longitudinal axis A1 of the device, toward the longitudinal axis of the fluid conduit 56, or any combination thereof (e.g., arrow 86).

[0200] The plug 32 can be moved (e.g., arrow 86) into the device flow path 62, for example, into the channel blocking region 68. Some plugs 32 (e.g., the tips of plugs 32) can rotate through the longitudinal axis A1 of the device. Figure 4B This illustration shows that when device 10 is in the disengaged configuration, the plug 32 can penetrate membrane 54 and rotate directly into the flow path to partially or completely block fluid flowing through device flow channel 62. Membrane 54 can self-seal around the base of the plug (e.g., the portion of the plug in contact with the membrane), preventing fluid from flowing through openings in membrane 54. If the plug 32 is removed from flow path 62 and membrane 54, for example, if device 10 is reattached to skin, membrane 54 can self-seal.

[0201] Figure 4B Further illustrating that when device 10 is in a non-attached configuration, the angle of the sensor's second longitudinal axis A7 relative to the device's longitudinal axis A1 can be from approximately 10 degrees to approximately 75 degrees (e.g., 30 degrees, 40 degrees, 50 degrees) in increments of 1 degree. In such a variation, Figure 4BThis illustrates that when the device 10 is in a non-attached configuration, a portion of the sensor distal end 18b (e.g., the first portion 20a of the sensor distal end) can extend at least partially longitudinally toward the device distal end 10b and at least partially laterally 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 be restored to a direction parallel to or at a smaller angle to axis A1.

[0202] Figure 4B Further illustrating that when device 10 is in a non-attached configuration, the angle between the sensor's first lateral axis A8 and the device's longitudinal axis A1 can be from approximately 10 degrees to approximately 75 degrees (e.g., 30 degrees, 40 degrees, 50 degrees) in increments of 1 degree within this range. In such a variation, Figure 4B It is shown that when the device 10 is in an unattached configuration, a portion of the sensor distal end 18b (e.g., the second portion 20b of the sensor distal end) can extend at least partially toward the device distal end 10b in the longitudinal direction and at least partially toward the device longitudinal axis A1 in the transverse direction. When the device 10 is in an unattached configuration, the second portion 20b of the sensor distal end can also extend at least partially toward the device distal end 10 and / or toward the device proximal end 10a in the longitudinal direction. When an external force (e.g., arrow 80) is applied to the sensor 18, the sensor axis A8 can return to a direction perpendicular to or at a smaller angle to axis A1.

[0203] Figure 4B Further illustrating that when sensor 18 is in the closed configuration, the occluder axis A9 can form an occluder angle of approximately 30 degrees to approximately 150 degrees with the longitudinal axis A1 of the device. For example, Figure 4B The angle of the plug relative to the longitudinal axis A1 of the device can be approximately 50 degrees, approximately 60 degrees, or approximately 70 degrees. In such a variation, Figure 4B This illustrates that when the device 10 is in a non-attached configuration, the blocker 32 can extend at least partially toward the distal end 10b of the device in the longitudinal direction and at least partially away from the longitudinal axis A1 of the device in the transverse direction. When an external force (e.g., arrow 80) is applied to the sensor 18, the sensor axis A9 can return to a direction perpendicular to or at a smaller angle to axis A1.

[0204] Figure 4B Further illustrating that when sensor 18 is in the closed position, the distal end 24 of the sensor can be spaced 90 mm from the longitudinal axis A1 of the device. This dimension 90 can be measured along an axis perpendicular to the longitudinal axis A1 of the device and can be within a range of approximately 1 mm to approximately 30 mm (e.g., 5 mm, 10 mm, 15 mm) in increments of 1 mm. Dimension 90 can be the maximum distance that the distal end 24 can be from the longitudinal axis A1 of the device when sensor 18 is in the closed configuration.

[0205] Figure 4C This illustrates that when sensor 18 is in the closed position, device 10 can be partially blocked. For example, Figure 4C A gap 92 may exist between the occluder 32 and the surfaces of the housing conduit 56 (e.g., the surface of the insert 17, the surface of the housing 14). For example, the gap 92 may have a dimension of approximately 0.1 mm to approximately 2.0 mm or greater (e.g., 0.8 mm, 1.0 mm) measured along axis A11 between the occluder 32 and the surfaces defining the housing conduit 56, including increments of approximately 0.1 mm within that range. Axis A11 may be perpendicular to the longitudinal axis A1 of the device.

[0206] Figure 4C The device 10 further illustrates that it can reduce the channel cross-sectional area from the first cross-sectional area (e.g., Figure 3B Reduce to a second cross-sectional area smaller than the first cross-sectional area (e.g.) Figure 4B This restricts fluid flow through device channel 62. The second cross-sectional area can be smaller than the first cross-sectional area, ranging from about 1% to about 100% of that range for every 1% increment, where 100% can correspond to complete closure of one or more channel cross-sections. For example, Figure 3B This shows that the first cross-sectional area can be completely unblocked, and Figure 4C The second cross-sectional area can be smaller than the first cross-sectional area by approximately 80% to 95% (e.g., 90%, 95%) in increments of 1%. The first cross-sectional area can correspond to the cross-section of the flow path when the device 10 is in an attached configuration, and the second cross-sectional area can correspond to the device 10 in a non-attached configuration (e.g., a dismounted configuration).

[0207] Figure 4C The current limiter configuration can be the default configuration of current limiter 28. For example, when no external force (e.g., force 80) acts on sensor 18 (e.g., sensor distal end 18b), the bias spring 26 can move the plug 32 and plug arm 30 to... Figure 4C The position shown. In other variations, Figure 4C The flow restrictor configuration in the device can correspond to an external force (e.g., force 80) that has been reduced (e.g., arrow 82) but has not been completely removed from the sensor's first contact surface 48. The device 10 can still block about 80% to about 95% of the flow path 56 and effectively assist the patient in such a partial dislodgement situation by reducing fluid loss or delivery.

[0208] Figure 4DThe flow restrictor 28 is shown to completely block the housing conduit 56, for example, by moving the plug 32 further into the flow path 56 during the blocking device 10 (via the spring 26). In this variation, the second cross-sectional area can be approximately 100% of the first cross-sectional area.

[0209] Figure 4D The current limiter configuration can be the default configuration of current limiter 28. For example, when no external force (e.g., force 80) acts on sensor 18 (e.g., sensor distal end 18b), the bias spring 26 can move the plug 32 and plug arm 30 to... Figure 4D The location shown.

[0210] Figure 4C and Figure 4D This illustrates that when the sensor is in the closed position, the plug 32 can penetrate the membrane 54 and reseal it around the membrane 54. The penetration point is shown as element 94.

[0211] Figure 4E A flow restrictor 28 (e.g., plug 32 and / or plug arm 30) can deflect membrane 54 into housing conduit 56 to block fluid flow through device 10, for example, in a direction away from window 70. During closure of device 10, plug 32 can deflect membrane 54 into housing conduit 56. Gap 92 can have a dimension (e.g., 0.8 mm, 1.0 mm) measured, for example, along axis A11 between plug 32 and the surfaces defining housing conduit 56 (e.g., the surface of insert 17 and / or the surface of housing 14), including increments of about 0.1 mm to about 2.0 mm or larger within this range. Axis A11 can be perpendicular to the longitudinal axis A1 of the device. Using gap 92, Figure 4E The second cross-sectional area can be larger than the first cross-sectional area (e.g., Figure 3B The range includes approximately 80% to approximately 95% (e.g., 90%, 95%) of each 1% increment within that range.

[0212] Figure 4E The current limiter configuration can be the default configuration of current limiter 28. For example, when no external force (e.g., force 80) acts on sensor 18 (e.g., sensor distal end 18b), spring 26 can be biased to move the plug 32 and plug arm 30 to... Figure 4E The position shown causes the membrane 54 to deform and enter the housing conduit 56. In other variations, Figure 4E The flow restrictor configuration in the device can correspond to an external force (e.g., force 80) that has been reduced (e.g., arrow 82) but has not been completely removed from the sensor's first contact surface 48. The device 10 can still block approximately 80% to approximately 95% of the flow path 56 and effectively assist the patient by reducing fluid loss or delivery in partial detachment scenarios.

[0213] Figure 4F The flow restrictor 28 (e.g., plug 32 and / or plug arm 30) is shown to completely seal the housing conduit 56, for example, by moving the plug and membrane 32, 54 further into the flow path 56 via spring 26. The membrane 54 and plug 32 (e.g., on the proximal side of sensor 18) are shown fully pressed into the flow path 56, for example, via spring 26. For example, the upward force 54 pushing the member may originate from a bent spring region portion of the central portion of sensor 18. When sensor 18 is in the closed position, a portion (e.g., the apex) of the membrane 54 in a deformed configuration may contact a surface defining at least a portion of the housing conduit (e.g., the surface of insert 17 and / or the surface of housing 14). When the plug 32 pushes the membrane 54 into contact with another surface, the second cross-sectional area may be approximately 100% smaller than the first cross-sectional area, such that the housing conduit 56 is completely sealed.

[0214] Figure 4F The current limiter configuration can be the default configuration of current limiter 28. For example, when no external force (e.g., force 80) acts on sensor 18 (e.g., sensor distal end 18b), spring 26 can be biased to move the plug 32 and plug arm 30 to... Figure 4F The location shown.

[0215] Spring 26 may have a spring constant k such that the weight of device 10 is configured insufficient to move sensor 18 from the closed position to the partially or fully open position. This feature further prevents fluid loss if device 10 dislodges and falls onto a surface (e.g., the floor or a patient's knee) and lands on the flow restrictor 28 (e.g., on the distal end of the sensor).

[0216] Figure 3A and Figure 4A The diagram shows that when the sensor is in both an open and closed configuration, the spring 26 can be external to the housing 14. For example, when the device 10 is in an attached configuration, the spring 26 can be between the housing 14 and the skin, and when the device 10 is in a pre-attached or dismounted configuration, the spring 26 can be between the housing and the environment. In other variations, when the device 10 is in an attached configuration and / or when the device 10 is in a pre-attached or dismounted configuration, some or all of the spring can be internal to the housing 14. Figure 3A and Figure 3B Further illustrating that when the device 10 is in an attached configuration, the first end of the spring 26 (e.g., the end of the spring closer to the proximal end 10a of the device) may be more open than when the device 10 is in a pre-attached or disengaged configuration (e.g., when the device 10 is in an attached configuration). Figure 4A When closer to the longitudinal axis A1 of the device (e.g.) Figure 3A ).

[0217] Figures 3A to 4BThis shows the situation when the device is in an attached configuration (e.g.) Figure 3A and Figure 3B When the sensor is in a pre-attached or de-attached configuration (e.g., when the device 10 is in a pre-attached or de-attached configuration), the first portion 20a at the distal end can extend parallel to the longitudinal axis A1 of the device, and when the device 10 is in a pre-attached or de-attached configuration (e.g., when the sensor is in a pre-attached or de-attached configuration), the first portion 20a at the distal end can extend parallel to the longitudinal axis Figure 4A and Figure 4B When the device 10 is in a pre-attached or de-attached configuration, the first portion 20a of the sensor at the distal end may extend away from the longitudinal axis A1 of the device. As another example, the first portion 20a of the sensor at the distal end may extend further away from the longitudinal axis A1 of the device when the device 10 is in a pre-attached or de-attached configuration than when the device 10 is in an attached configuration (e.g., including about 5 degrees to about 60 degrees in increments of 1 degree within this range).

[0218] Figures 3A to 4B This shows the situation when the device is in an attached configuration (e.g.) Figure 3A and Figure 3B When the sensor is in a pre-attached or de-attached configuration (e.g., when the device 10 is in a pre-attached or de-attached configuration), the second portion 20b at the distal end can extend parallel to the first transverse axis A2 of the device, and when the device 10 is in a pre-attached or de-attached configuration (e.g., when the sensor is in a pre-attached or de-attached configuration). Figure 4A and Figure 4B The second portion 20b of the sensor distal end may extend away from the first lateral axis A2 of the device. As another example, the second portion 20b of the sensor distal end may extend further away from the first lateral axis A1 of the device when the device 10 is in a pre-attached or dismounted configuration than when the device 10 is in an attached configuration (e.g., by about 5 degrees to about 60 degrees in increments of 1 degree within this range).

[0219] Figures 3A to 4B The sensor distal end 18b (e.g., the needle over-insertion stop 20b) is shown in an attachment configuration of the device 10 (e.g., Figure 3A and Figure 3B When the device 10 is in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration), it can be compared to the device 10 being in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration). Figure 4A and Figure 4B (This is closer to the longitudinal inlet of needle 12.) Figures 3A to 4B Further illustrating the sensor distal end 18b (e.g., the needle over-insertion stop 20b) in the device 10 in an attachment configuration (e.g.) Figure 3A When the device 10 is in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration), it can be compared to the device 10 being in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration). Figure 4A () When closer to the tip of needle 12 or closer to the distal end 10b of the device.

[0220] Figures 3A to 4B This shows the needle over-insertion stop (e.g., portion 20b) in the attachment configuration of the device 10 (e.g. Figure 3A and Figure 3B When the device 10 is in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration), it can be compared to the device 10 being in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration). Figure 4A and Figure 4B (This is closer to the longitudinal inlet of needle 12.) Figures 3A to 4BFurther illustrating the needle over-insertion blocking portion (e.g., portion 20b) in the attachment configuration of device 10 (e.g.) Figure 3A When the device 10 is in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration), it can be compared to the device 10 being in a pre-attached or dismounted configuration (e.g., when it is in a pre-attached or dismounted configuration). Figure 4A When the sensor 18 moves between the open and closed configurations, it may be closer to the tip of the needle 12 or closer to the distal end 10b of the device. Alternatively or additionally, the device 10 may have an over-insertion stop that holds the sensor in a fixed position when the sensor 18 moves between the open and closed configurations. For example, the device 10 may have an over-insertion stop that is attached to or integral with the housing 14 and / or the needle holder 13 as described above.

[0221] Figures 3A to 4B The diagram illustrates a sensor 18 (e.g., a movable base plate) having a first sensor configuration when the sensor's first contact surface 48 applies a first force to a non-sensor surface (e.g., skin), and a second sensor configuration when the sensor's first contact surface 48 applies a second force, less than the first force, to the non-sensor surface. When the force applied by the sensor's first contact surface 48 to the non-sensor surface changes from the first force to the second force, a spring 26 can be biased to move the movable sensor 18 from the first sensor configuration to the second sensor configuration. As another example, when the first force decreases to the second force, the spring 26 can be biased to move the sensor 18 from the first sensor configuration to the second sensor configuration. The second force can be 0 Newtons.

[0222] When the movable sensor 18 is in the second sensor configuration, at least a first portion of the plug 32 can block the housing conduit 56. At least a second portion of the plug 32 can be in the housing opening 70 when the movable sensor 18 is in the second sensor configuration, and can be outside the housing opening 70 when the movable sensor 18 is in the first sensor configuration.

[0223] The distal end 18b of the sensor may have a blocking portion configured to prevent the needle 12 from being over-inserted into tissue (e.g., into a blood vessel). At least a portion of the blocking portion 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 blocking portion may be adjacent to or immediately adjacent to the side of the needle 12. At least a portion of the blocking portion 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.

[0224] The distal end 18b of the sensor may have a curved surface (e.g., curved surface 21) configured to reduce friction with non-sensor surfaces when the needle 12 is inserted into tissue (e.g., into a blood vessel). At least a portion of the curved surface 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.

[0225] When the movable sensor 18 is in the second sensor configuration, the plug 32 can be configured to at least partially block the housing conduit 56.

[0226] The flow rate through the housing conduit 56 when the movable sensor 18 is in the second sensor configuration can be reduced by approximately 1% to approximately 100% (e.g., 80%, 90%, 95%, 97%, 100%) for every 1% increment within this range compared to when the movable sensor 18 is in the first sensor configuration.

[0227] When the movable sensor is moved from the first sensor configuration to the second sensor configuration, the cross-sectional area of ​​the housing conduit can be reduced by approximately 1% to approximately 100% (e.g., 80%, 90%, 95%, 97%, 100%) for every 1% increment within that range.

[0228] When the movable sensor 18 is in the second sensor configuration, the plug 32 can 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. When the movable sensor 18 moves from the first sensor configuration to the second sensor configuration, the spring 26 can be biased to bring the plug 32 closer to the surface of the housing conduit 56.

[0229] When the movable sensor 18 is in the second sensor configuration, the deformable membrane 54 can be deformed by the plug 32. When the movable sensor 18 is in the second sensor configuration, the surface of the deformable membrane can be closer to the surface of the housing conduit than when the movable sensor 18 is in the first sensor configuration.

[0230] When the movable sensor 18 is in the first sensor configuration, the deformable membrane 54 can be deformed or deflected less by the blocker 32 than when the movable sensor 18 is in the second sensor configuration.

[0231] When the movable sensor 18 is in the sensor first configuration, the deformable membrane 54 will not be deformed by the blocker 32.

[0232] When the movable sensor 18 is in the first sensor configuration, the distal end 18b of the sensor can be closer to the needle 12 and the housing guide tube 56 than when the sensor 18 is in the second sensor configuration. When the movable sensor 18 is moved from the first sensor configuration to the second sensor configuration, the spring 26 can be biased to move the distal end 18b of the sensor away from the needle 12 and the housing guide tube 56.

[0233] The sensor distal end 18b (e.g., the sensor distal end second portion 20b) may have a sensor opening 22. When the movable sensor 18 is in the sensor first configuration, a portion of the needle 12 may be in the sensor opening 22, and when the movable sensor 18 is in the sensor second configuration, a portion of the needle 12 may be outside the sensor opening 22.

[0234] The distal end 18b of the sensor may have a blocking portion configured to prevent the needle from being excessively inserted into the blood vessel.

[0235] When the movable sensor is in the first sensor configuration and the second sensor configuration, at least a portion of the sensor proximal end 18a can extend in a direction parallel to the longitudinal axis A1 of the device. When the movable sensor 18 is in the first sensor configuration, at least a portion of the sensor distal end 18b can extend in a direction parallel to the longitudinal axis A1 of the device, and when the movable sensor 18 is in the second sensor configuration, at least a portion of the sensor distal end 18b can extend in a direction angled relative to the longitudinal axis A1 of the device.

[0236] The housing 14 may have a first housing side and a second housing side opposite to the first housing side. The first housing side may be closer to the first contact surface of the sensor than the second housing side. The housing window 70 may be on the first housing side such that when the movable sensor 18 is in the first sensor configuration, the housing window 70 faces a non-sensor surface (e.g., skin).

[0237] Sensor 18 may have a second contact surface 50. When the movable sensor 18 is in the first sensor configuration, the second contact surface 50 may be closer to the housing 14 than when the movable sensor 18 is in the second sensor configuration.

[0238] The distal end 10b of the device is movable relative to the proximal end 10a of the device. For example, the distal end 10b of the device may move longitudinally and / or laterally relative to the proximal end 10a of the device along the longitudinal axis A1 of the device.

[0239] The needle 12 can move longitudinally and / or laterally along the longitudinal axis A1 of the device.

[0240] The needle 12 can be retracted into the housing 14 or into a needle channel adjacent to the housing 14, thus giving the needle 12 a non-retracted position and a retracted position. When the needle 12 is in the retracted position, the distal end of the needle (e.g., the tissue cutting tip) can be closer to the proximal end 14a of the housing than when the needle 12 is in the non-retracted position.

[0241] At least a portion of the needle 12 may be outside the housing 14 or outside the needle channel adjacent to the housing 14 when in the non-retracted position, and inside the housing 14 or inside the needle channel adjacent to the housing 14 when in the retracted position.

[0242] When the needle 12 is in at least one of the non-retracted and retracted positions, the distal end of the needle (e.g., the tissue cutting tip) can be the distal end of the device 10.

[0243] After the device is switched from an attached configuration to a detached configuration, the user can retract the needle 12. This can be done by pressing a button on the housing 14.

[0244] When the device changes from an attached configuration to a dismounted configuration, the needle 12 can retract automatically. For example, a sensor can be attached to the needle 12 (e.g., the base of the needle 12). When the sensor changes from an open position to a closed position after initial insertion of the needle 12, a spring 26 can be biased to retract the needle 12. The spring 26 can be connected to the needle via a linkage (not shown).

[0245] Figure 5 The housing surface 96, which defines the housing window 70, may be tapered to allow the sealing arm 30 to move the sealing device 32 to deflect the membrane 54 into the housing conduit 56 to seal the device 10.

[0246] Figure 5 Further shown, the occluder 32 may have an occluder terminal 35 having a curved surface configured not to penetrate the membrane 54 when the sensor 18 is in a closed configuration.

[0247] Figure 5 The connector 16 may further include a nipple 19. The nipple 19 may be integrated with or attached to the insert 17. The tube 8 may be connected to the nipple 19.

[0248] Figure 6A and Figure 6B A variation of the device 10, which is inserted into and withdrawn from tissue 100, is shown. Figures 6A to 6B The image shows the device 10 being inserted into tissue 100, with the sensor changing from a closed position (also known as an occluded position) to an open position (also known as a less occluded position). From Figures 6B to 6A The device 10 is dislodged from the tissue 100, and the sensor 18 changes from the open position to the closed position.

[0249] Figure 6AThe curved portion 21 of sensor 18 (also referred to as the curved distal end) is shown to reduce friction against the skin 100 during insertion, thereby allowing the needle 12 to be inserted with less force and reducing harm to the patient. The curved end of sensor 18 (e.g., sensor distal end 18b) facilitates a low-friction insertion process. Device 10 is shown inserted relative to the patient's skin surface 100 at an insertion angle 102. For example, insertion angle 102 can be from about 10 degrees to about 60 degrees, including the amount in increments of 1 degree within that range. For example, insertion angle 102 can be a typical insertion angle of about 25 degrees or a typical insertion angle between about 18 degrees and about 32 degrees.

[0250] Figure 6A Further illustrating that the curved distal end 18b (e.g., having a bend 21) can also reduce friction on the skin 100 during dislodgement.

[0251] Figure 6B The curved distal end 18b is shown to allow the device 10 to maintain a mechanical interface with the skin 10, which allows the sensor 18 to continue inspecting the housing 14 and / or the needle 12 regardless of the insertion angle 102, thereby enhancing the functionality of the dislodgement detection system. For example, Figure 6B It is shown that bending the distal end 18b (e.g., having a bend 21) after the needle 12 has been fully inserted can hold the sensor 18 in the open position (also known as holding the device in the attached configuration), so that the sensor 18 can maintain its dislodgement detection function even if the insertion angle 102 is as high as 50 degrees. Figure 6B Note that for "typical angle" insertion, the insertion angle can be 25 degrees, while for "large angle" insertion, the insertion angle can be as high as approximately 50 degrees.

[0252] Figure 6B Further shown is the bent end of sensor 18 which can abut against needle 12 and / or needle seat 13 upon insertion, wherein needle 12 protrudes through sensor opening 20 (e.g., U-shaped opening) on ​​sensor distal end 18b.

[0253] Figure 7A The needle 12 can be retracted into the housing 14, for example, into the housing conduit channel 56.

[0254] Figure 7A The illustrated device 10 may have a pincher system 101. The pincher system 101 may have two or more external pinchers 104, for example, 2 to 8 external pinchers 104, including increments of one pincher within this range (e.g., 2 pinchers, 3 pinchers, 4 pinchers). For example, Figure 7AThe device 10 shown may have an external first clamp 104a, an external second clamp 104b, an external third clamp 104c, or any combination thereof. The external clamp 104 may be located at and / or define the proximal end 10a of the device. The external clamp 104 may be integrated with or attached to the connector 16, or may be separate from the connector 16. The external clamp 104 may be attached to or integrated with the housing 14.

[0255] The clamping system 101 may be fixed. The clamping system 101 may be movable. For example, the movable clamping system 101 may rotate about the longitudinal axis A1 of the device and / or the longitudinal axis of the housing guide tube 56. The clamping system 101 may rotate 360 ​​degrees back and forth or any smaller amount. For example, the clamping system 101 may be relative to... Figure 7A The positions shown are rotated clockwise and counterclockwise by approximately 15 degrees to approximately 45 degrees about the longitudinal axis A1 of the device and / or the longitudinal axis of the housing conduit 56, including increments of 1 degree within this range (e.g., 15 degrees, 30 degrees). The clamping system 101 can be mounted on a rotary joint. Alternatively or additionally, the movable clamping system 101 can be connected to the housing 14 via a flexible neck that can be configured to deflect under non-axial loads (e.g., relative to the longitudinal axis A1 of the device). The flexible neck can be attached to the housing 14 or integrated with the base of the housing 14 and / or the base of the clamping system 101. As another example, the movable clamping system 101 may have external clamps 104 that are flexibly attached to the housing 14 at their base, such that, in addition to or in place of a single flexible slot and / or swivel joint, each external clamp 104 may be flexibly attached to or integrated with the housing 14 at its respective base.

[0256] The external clamps 104 may be radially spaced from the tube 8 along their outer periphery and / or spaced along the outer periphery of the clamp system 101. The outer periphery may extend about the longitudinal axis of the device (e.g., axis A1). For example, the external clamps 104 may be circumferentially spaced about the longitudinal axis A1 of the device. The external clamps 104 may be non-uniformly spaced about the outer periphery of the tube 8 or the clamp system 101. For example, Figure 7B As shown, when measured between the longitudinal centers of clamps 104a and 104b, the first clamp 104a and the second clamp 104b can be spaced approximately 90 degrees apart. When measured between the longitudinal centers of clamps 104a and 104c, the first clamp 104a and the third clamp 104c can be spaced approximately 135 degrees apart. Similarly, when measured between the longitudinal centers of clamps 104b and 104c, the second clamp 104b and the third clamp 104c can be spaced approximately 135 degrees apart.

[0257] As another example, the external clamps 104 may be evenly spaced around the outer periphery of the tube 8 or the clamp system 101. For example, the first external clamp 104a, the second clamp 104b, and the third clamp 104c may be spaced 120 degrees apart around the circumference of the longitudinal axis A1 of the device. When the spacing is equal and the outer periphery is circular, the spacing angle can be determined by dividing 360 degrees by the number of external clamps 104.

[0258] The external clamp 104 can be configured to restrict or prevent fluid flow through the tube 8 in the event of dislodgement after needle insertion. Dislodgement can occur before or after the device 10 is adhered to the patient's skin (e.g., skin 100).

[0259] Figure 7A Further illustrating that the external clamping space 106 (also referred to as the external clamping gap) can be defined between adjacent external clamps 104 (e.g., between each pair of adjacent external clamps 104). For example, the external first clamp 104a, the second clamp 104b, and the third clamp 104c can respectively define the external first clamping space 106ab, the second clamping space 106bc, and the third clamping space 106ca (not shown).

[0260] The external clamping gap 106 may be spaced around the outer periphery of the clamping system 101 at an angle that is the same as or different from that of the external clamp. For example, Figure 7B The first external clamping gap 106ab and the second external clamping gap 106bc are shown to be spaced apart by approximately 90 degrees (or approximately one-quarter of the outer circumference of system 101). The first external clamping gap 106ab and the third external clamping gap 106ca are also shown to be spaced apart by approximately 90 degrees (or approximately one-quarter of the outer circumference of system 101). The second external clamping gap 106bc and the third external clamping gap 106ca are shown to be spaced apart by approximately 180 degrees (or approximately half of the outer circumference of system 101).

[0261] The external clamps 104 can be configured to restrict or prevent fluid flow through the device 10 when the tube 8 is pushed or pulled (individually and collectively referred to as moved) in a non-axial direction, such as in any direction away from the longitudinal axis A1 of the device. When the tube 8 moves in a non-axial direction, the tube 8 can be forced into the external clamping gap 106, such that the tube 8 is partially clamped or completely closed by a pair of external clamps 104. In the case where the tube 8 is pulled in a non-axial direction, the tube 8 can be clamped by optimizing the compression clamping point to clamp the tube 8.

[0262] Figure 7A Further illustrating that the external clamp 104 may have one or more tapered portions 112, for example, to help guide the tube 8 into the external clamping gap 106 and / or to help retain the tube 8 within the external clamping gap. For example, Figure 7A The external clamps 104 are shown to each have a tapered first portion 112a configured to guide the tube 8 into the external clamping gap 106, a tapered second portion 112b configured to retain the tube 8 in the external clamping gap 106, or any combination thereof. A tapered inflection point 112c may be located between the tapered first portion 112a and the tapered second portion 112b. The tapered inflection point 112c may be a change in direction from the first tapered portion 112a to the second tapered portion 112b, or vice versa. At least a portion of the tapered first portion 112a may be on the proximal end of each external clamp 104, and at least a portion of the tapered second portion 112b may be on the distal end of each external clamp 104.

[0263] When the clamping system 101 is rotatable, the outer clamp 104 can also rotate and help guide the tube 8 into the outer clamping gap 106. The rotation function also helps hold the tube 8 within the outer clamping gap 106. For example, because the outer clamp 104 can move in response to a rear clamping movement of the tube 8, the rotatable (capable of rotation) outer clamp 104 can make it more difficult to pull the tube 8 out of the outer clamping gap 106. In this way, the rotatable clamping system 101 can help hold the tube 8 in the clamping configuration when a subsequent force is generated that has already dislodged the tube 8 from the non-rotatable system 101's outer clamping gap 106. As another example, because the outer clamp 104 can move and rotate in response to a rear clamping tube movement to "align" with the tube 8, the rotatable outer clamp 104 can more easily pull the tube 8 out of the outer clamping gap 106, such that the rear clamping tube force is directed perpendicularly to the outer clamping gap 106. As another example, the rotatable external clamp 104 neither makes it difficult nor easy to keep the tube 8 in the external clamping gap 106.

[0264] Because the external clamp 104 can respond to contact movement (e.g., rotation) with the tube 8 and is “misaligned” with the direction of the tube force, a larger total force is required to push the tube 8 into the gap 106 due to the less concentrated force applied in the direction of the gap 106. Therefore, the rotatable clamping system 101 (e.g., relative to the fixed or non-rotatable clamping system 101) can increase the total threshold force required to clamp the tube 8 in the external clamping gap 106. In some variations, the rotatable device may have a stop point such that the tube 8 is configured to be compressed when the clamping system 101 is at the stop point. The stop point may correspond to two rotation limits of the clamping system 101, such as clockwise and counterclockwise angular rotation limits (e.g., 15 degrees) about the longitudinal axis of the device. As another example, because the external clamp 104 can rotate to "align" the tube 8 such that most of the tube force is directed perpendicularly into the external clamping gap 106, a smaller total force is required to push the tube 8 into the gap 106 because the applied force is more concentrated in the direction of the gap. Therefore, the rotatable clamping system 101 (e.g., relative to a fixed or non-rotatable clamping system 101) can reduce the total threshold force required to clamp the tube 8 into the external clamping gap 106. As yet another example, the rotatable external clamp 104 neither increases nor decreases the total threshold force required to clamp the tube 8 into the external clamping gap 106.

[0265] Because the outer clamp 104 can move when the clamping system 101 has a flexible slot and / or a flexible outer clamp base, causing the component of the total force pointing towards or away from the outer clamping gap 106 to become misaligned or misaligned, variations of the flexible slot and flexible outer clamp base can make it more difficult or easier to hold the tube 8 within the outer clamping gap 106. For the same reason, variations of the flexible slot and flexible outer clamp base can also increase or decrease the total threshold force required to clamp the tube 8 in the outer clamping gap 106. As yet another example, variations of the flexible slot and / or flexible outer clamp base may neither increase nor decrease the total threshold force required to clamp the tube 8 into the outer clamping gap 106.

[0266] From proximal to distal, the external clamp 104 may widen and then narrow. The proximal tip of the external clamp 104 may be narrower than the distal base of the external clamp 104. For example, from proximal to distal, the first tapered portion 112a may widen such that the clamp 104 becomes wider from the proximal tip to the inflection point 112c. For example, from proximal to distal, the second tapered portion 112b may narrow such that the clamp 104 becomes narrower from the inflection point 112c to the distal base of the external clamp 104. Figure 7AThe external clamp 104 is shown to define an external clamping gap 106 that narrows from proximal to distal, until an inflection point 112c, after which the external clamping gap 106 widens. For example, the tapered clamping gap 106 may have the cross-sectional shape of two opposing chemical flasks (e.g., two opposing conical flasks), with the smaller of the two flask-shaped portions of the clamping gap 106 closer to the distal end 10b of the device than the other portions. The wider portion of the external gap 106 near the base of the external clamp 104 can help position the tube 8 in the clamping configuration by allowing the inflection point 112c to serve as the point of maximum clamping amplitude between the two adjacent external clamps 104. As another example, the tapered second portion 112b of the external clamp may be non-tapered.

[0267] The external clamp 104 can vary in position, size, shape, and / or profile to provide optimized clamping performance for a range of tube pulling events. For example, lateral or upward pulling may require different threshold clamping forces to restrict or stop flow through the tube 8. Variations in the physical characteristics and relative position of the external clamp 104 can give the device 10 variable closing force characteristics in response to variable pulling forces on the tube 8. The threshold clamping force can be controlled by the position, size, shape, and / or profile of the external clamp 104, such as the location of the inflection point 112c where maximum compression is applied to the tube 8.

[0268] Figure 7B The external clamp 104 is shown to have various shapes and sizes. For example, the first external clamp 104a and the second external clamp 104b can have the same size and shape. The third external clamp 104c can be larger and have a different shape than the first external clamp 104a and the second external clamp 104b. Figure 7B As shown, when the external third clamp 104 is configured to form part of the first side 10c of the device (e.g., the bottom of the device 10) and contacts the patient’s skin when the device 10 is in an attached configuration, the external third clamp 104c can be the largest clamp 104.

[0269] Figure 7B Further illustrating that the tapered first portion 112a and the tapered second portion 112b may taper at least partially in the radial direction, at least partially in the circumferential direction, at least partially in the longitudinal direction, or any combination thereof (e.g., becoming narrower and / or wider toward the longitudinal axis A1 of the device).

[0270] Figure 7B Further illustration shows that tube 8 can be connected to movable shuttle 108. Movable shuttle 108 can be a sliding shuttle. Movable shuttle 108 can be configured to slide longitudinally relative to external clamp 104 (e.g., along the longitudinal axis A1 of the device).

[0271] Figure 7B Furthermore, when tube 8 is pulled non-axially according to arrow 118a (e.g., in the plane defined by the longitudinal axis A1 and the first transverse axis A2 of the device), tube 8 can be forced into the outer first clamping space 106ab. When tube 8 is pulled non-axially according to arrow 118b (e.g., in the plane defined by the longitudinal axis A1 and the second transverse axis A3 of the device), tube 8 can be forced into the outer second clamping space 106bc. When tube 8 is pulled non-axially according to arrow 118c (e.g., in the plane defined by the longitudinal axis A1 and the second transverse axis A3 of the device), tube 8 can be forced into the outer third clamping space 106ca.

[0272] Figure 7B Further shown, the tube 8 may have one or more internal clamps 110, for example, 1 to 8 internal clamps 104, including an amount for each additional clamp within this range (e.g., 2 clamps, 3 clamps, 4 clamps). The shuttle 108 may be configured to slide longitudinally relative to the internal clamps 110 (e.g., along the longitudinal axis A1 of the device).

[0273] Figure 7C The diagram shows that tube 8 can be connected to shuttle 108.

[0274] Figure 7C Further illustrating that the clamping system 101 may have an internal first clamp 110a, an internal second clamp 110b, an internal third clamp 110c, an internal fourth clamp 110d, or any combination thereof. Figure 7C In the diagram, the internal second clamp 110b is shown to be almost completely blocked by the internal first clamp 110a, and the internal fourth clamp 110d is shown to be almost completely blocked by the internal third clamp 110c.

[0275] Each internal clamp 110 may have a clamp arm 111. The clamp arm 111 may have a clamp protrusion 113. For example, Figure 7C The internal first clamp 110a is shown to have an internal first clamp arm 111a and an internal first clamp protrusion 113a. The internal third clamp 110c may have an internal third clamp arm 111c and an internal third clamp protrusion 113c. For clarity, the arms and protrusions of the second internal clamp 110b and the fourth internal clamp 110d are omitted. In other variations, the internal clamp 110 may include an arm 111 without the protrusion 113.

[0276] Figure 7C The shuttle 108 is further shown to have a tapered surface 115. The tapered surface 115 may have, for example, the shape of a truncated cone.

[0277] The internal clamp 110 can be configured to restrict or prevent fluid flow through the tube 8 in the event of dislodgement after needle insertion. Dislodgement can occur before or after the device 10 is adhered to the patient's skin (e.g., skin 100).

[0278] For example, the internal clamp 110 (e.g., via arm 111 and / or protrusion 113) can be configured to restrict or prevent fluid flow through the device 10 when the tube 8 is pulled axially, for example, along the longitudinal axis A1 of the device. As the tube 8 moves axially away from the distal end 10b of the device, the shuttle 108 can move axially along the longitudinal axis A1 away from the distal end 10b of the device. As the shuttle 108 moves, the tube 8 can be forced between the internal clamp 110 and the shuttle surface 115. For example, the tube 8 can be forced into the internal clamp 110 such that the tube 8 is partially clamped or completely closed by the external clamp 110, which presses (e.g., gradually compresses) the tube 8 against the tapered shuttle surface 115. In other variations, the shuttle surface 115 can be straight and not tapered. When the tube 8 is pulled axially, the tube 8 can be clamped by a compression clamping point optimized to clamp the tube 8. The compression clamping point can be defined by the internal clamp 110.

[0279] Figure 7C This further illustrates that when tube 8 is axially pulled according to arrow 119 (e.g., along the longitudinal axis A1 of the device), tube 8 can be forced against shuttle surface 115. For example, Figure 7C The tube 8, shuttle 108, and shuttle surface 115 can have the following characteristics: Figure 7C The solid lines in the text indicate the non-clamping configuration and, as shown in the image, the non-clamping configuration and, Figure 7C The clamping configuration is shown by the dashed line 120. The dashed line 120 shows the clamping configuration where the tube 8 abuts against the shuttle surface 115 when the shuttle 108 is axially pulled via the tube 8 according to the arrow 119.

[0280] Figure 7C Further illustrating that the axial force causing the needle 12 and / or housing 14 away from the needle insertion site due to external forces on the tube 8 can be converted into a shuttle motion away from the needle insertion site in the axial direction. This motion can (e.g., via arm 111 and / or protrusion 113) force the internal clamp 110 into a clamping position against the tube 8 via an inclined portion (e.g., an inclined shuttle surface 115) within the needle body. This inclined portion and surrounding features can be modified to produce any specific threshold closing force required. Due to any set threshold axial and non-axial tension in the tube at any location on the device 10, the internal mechanism for axial clamping (e.g., clamp 110 and shuttle 108) coupled to the external clamping point (e.g., via external clamp 104) allows the system 101 to effectively clamp and stop or restrict fluid flow.

[0281] Figure 7DA variation of a general classification scheme 130 is shown, illustrating the possible forces that movement via tube 8 might generate on an inserted fluid delivery needle 12 in a patient (e.g., forearm). Tube 8 can be pulled intentionally or unintentionally in any direction away from the insertion site. For example, Figure 7D The diagram illustrates a first force classification 130a, a second force classification 130b, a third force classification 130c, and a fourth force classification 130d for tube 8. The first force classification 130a can be axial movement of tube 8 away from the needle insertion point. The second force classification 130b, third force classification 130c, and fourth force classification 130d can correspond to the classifications shown. A combination of external clamping points (e.g., between pairs of external clamps 104) and an internal shuttle mechanism 108 can be used to protect the patient from tube pulling in any of these classification areas. For example, the first force classification 130a can correspond to... Figure 7C Force 119, the second force category 130b can correspond to Figure 7B Force 118a and third force classification 130c can correspond to Figure 7B Force 118b and the fourth force category 130d can correspond to Figure 7B The force in the middle is 118c.

[0282] Figure 8A and Figure 8B A variation of a method is shown that allows for visual observation of blood return during cannulation, for example, using a device 10 with sensor 18. Figure 8A and Figure 8B A variation of valve 132 for cannulation locking is shown (e.g., a one-way check valve). Figure 8A and Figure 8B Two flow paths (e.g., first flow path 134a and second flow path 134b) are shown that can be inside the needle body (e.g., within the housing 14). Figure 8A and Figure 8B Further illustrating that the first flow path 134a can be used to visualize blood return, and the second flow path 134b can be used for treatment (e.g., hemodialysis therapy). The conventional fluid path used to pump blood entering or leaving the body to the hemodialysis machine can be the second flow path 134b.

[0283] Figure 8A The second flow path 134b is shown to have a sensor 18. The sensor 18 can be configured to allow blood flow through the second flow path 134b after cannulation. For example, the second flow path 134b may include a clamping valve 18 to control the cessation of flow during unintentional needle dislodgement.

[0284] Figure 8BThe first flow path 134a may include a one-way check valve 132. The one-way check valve 132 may be configured to allow blood to flow from the patient's body through the needle body (e.g., through the housing 14) at the patient's natural pumping pressure during insertion. For example, the one-way check valve 132 may be configured to allow blood to flow from the patient's body through the needle body (e.g., through the housing 14) only at the patient's natural pumping pressure during insertion. The first flow path 134a may allow blood to appear in a flow tube behind the needle body (e.g., towards the proximal end 10a of the device) during insertion.

[0285] During intubation, fluid can flow through the first flow path 134a but not through the second flow path 134b. During intubation, sensor 18 can block the second flow path 134b. During treatment (e.g., after intubation), fluid can flow through the second flow path 134b but not through the first flow path 134a. One-way check valve 132 can block the first flow path 134a after intubation.

[0286] Figure 8A and Figure 8B The diagram illustrates blood flowing through a first flow path 134a during intubation and blocked by sensor 18 in a second flow path 134b. After intubation (e.g., when device 10 is attached to the patient's skin and sensor changes from a closed configuration to an open configuration), the blood pumped into the body will not pass through the one-way valve 132 of the first flow path 134a, but will instead flow through sensor 18 into the second flow path 134b. For example, one-way check valve 132 may allow fluid to flow in a first direction but not in a second direction opposite to the first direction through the first flow path 134a. The first direction may be away from tissue 100, and the second direction may be towards tissue 100. During intubation, sensor 18 may block the second flow path 134b. After intubation, sensor 18 may move from a closed position to an open position to allow blood to flow through the second flow path 134b.

[0287] Figure 9AA variation of the device 10 with a flow control system 136 is shown. The flow control system 136 may be an intubation control system capable of opening a flow path through the device 10 during intubation. The flow control system 136 may be an intubation locking system (also known as an intubation configuration system). For example, the flow control system 136 may include spring-loaded wings 136a and 136b for providing an intubation lock adapted to allow blood flow through the housing 14 during needle insertion into the patient before the needle 12 is fully secured to the body. During intubation, the intubation lock may be the configuration of the device 10. The device 10 may be “locked” in this position or not, and the device 10 may be biased to return to the non-intubation configuration when the user finishes inputting the device 10 into the intubation configuration. The flow control system 136 may be positioned in the intubation configuration by clamping the needle wings 15a and 15b to an upright position (e.g., by clamping the needle wings 15a and 15b to a first transverse axis A2 of the device). For example, wings 15a and 15b can be clamped by bending and / or rotating the wings. The wings can rotate about their base. This clamping is standard practice when the needle is inserted into the body. Therefore, clamping wings 15a and 15b into an upright position can be done as follows: Figure 9A The spring-loaded wings 136a and 136b are brought together. This movement of the spring-loaded wings 136a and 136b toward the first transverse axis A2 of the device can trigger the opening of a flow path through the device 10, which allows blood to return to the proximal portion of the needle. The flow path can also be open when the wings 15a and 15b are stuck after insertion. For example, the flow path can remain open until the needle 12 is accidentally or intentionally removed from the patient and the flow path is automatically blocked by the sensor 18.

[0288] Figure 9A The cannula locking system 136 is shown to be a wing insert. The wing insert 136 may have a first wing extension 136a and a second wing extension 136b respectively attached to the first wing 15a and the second wing 15b, or a first wing extension 136a and a second wing extension 136b respectively integral with the first wing 15a and the second wing 15b.

[0289] Figure 9A The wings 136a and 136b, partially opened by a spring (e.g., an internal spring), are further shown. This can be the default position of the device 10 with the cannula locking device 136. When the cannula locking system 136 is in the default position, it can prevent flow through the device 10.

[0290] Figure 9B This further illustrates that when the cannulation locking system 136 is in the default position, the wings can be spaced about 65 degrees to about 90 degrees apart. Figure 9B Further shown in Figure 9B In the configuration shown, the springs connected to the spring-loaded wings 136a and 136b can be configured to bias the spring-loaded wings 136a and 136b, thereby closing the flow path through the device.

[0291] Figure 9C As shown by arrow 138, wings 15a and 15b (and spring-loaded wings 136a and 136b) can be clamped during insertion to open a flow path through device 10. Wings 15a and 15b (and spring-loaded wings 136a and 136b) can rotate while clamped (e.g., arrow 138).

[0292] Figure 9D As shown by arrow 140, wings 15a and 15b can be pressed against the skin after cannulation. When wings 15a and 15b are in Figure 9D In the configuration shown, the flow path of device 10 can be opened, which can be the configuration of device 10 when it is being processed.

[0293] Figure 10A and Figure 10B A variation of a device having a flow control system including a latch 142 is shown. The latch 142 can open the flow path of the device 10 during insertion, for example, by moving the device 10 to the cannulation locking position. The latch can be directly or indirectly connected to the first wing 15a and / or the second wing 15b. When the wings 15a and 15b are bent, rotated, and / or bent together in conventional methods for securing the needle 12 for insertion, the latch 142 can be configured to pull upward (e.g., along the first transverse axis A2 of the device) on the skin sensing mechanism 18 (e.g., shown as a blade in this variation of the device 10). This bending / rotation / bending can activate the latch 142 to pull the skin sensing element 18 closer to the housing 14, ensuring, for example, the opening of the blood flow path through the device 10 during insertion. This flow path allows blood to return during insertion. For example, Figure 10B The wings 15a and 15b are shown in a non-clamped configuration. Figure 10A The wings 15a and 15b are shown in a clamping configuration, wherein relative to Figure 10B Lock position in Figure 10A The central latch 142 has pulled the sensor 18 closer to the housing 14. Figure 10A The latch 142 is shown to pull the sensor 18 to the open position. When the device 10 is attached to the patient, the latch 142 may have a mechanical release mechanism that allows it to be moved away from or detached from the sensor 18. Figure 10A and Figure 10B It is further shown that the sensor 18 can be connected to the housing 14 via a hinge (also known as a hinge connection).

[0294] Figures 11A to 11E A variation of the flow control system with rotatable wings 15a and 15b is shown. The flow control system can be an insertion control system that can be configured to open a flow path through the device 10 during insertion. Wings 15a and 15b can rotate about their respective bases, for example, where they are respectively attached to the housing 14. Figures 11A to 11E It is shown that wings 15a and 15b can rotate into an X-shape during insertion. When wings 15a and 15b rotate, for example, relative to the longitudinal axis A1 of the device, wings 15a and 15b can allow and / or exert a torsional effect on the internal flow path (e.g., the flow channel 62 of the device). When the butterfly-shaped wings (e.g., wings 15a and 15b) are bent, rotated, and / or folded into an upright position (e.g., toward the first transverse axis A2 of the device), wings 15a and 15b can act as an insertion lock to prevent flow through the needle 12, as is conventionally used for needle operation during insertion. When rotated in the opposite direction, wings 15a and 15b can generate opposing forces that can act on the flow path. Opposing forces can torsion the closed flow path. For example, Figure 11A The device 10 is shown to have rotatable wings 15a and 15b that can rotate in directions 146a and 146b, respectively, and vice versa. As another example, one or both of the wings 15a and 15b can rotate in directions 146a and / or 146b. When the two wings 15a and 15b can rotate in both directions, the device 10 can form two different “X”s. Figure 11B This shows that the flow path 62 can be opened when the wings 15a and 15b are flat (e.g., against the skin). Figure 11C This illustrates that when wings 15a and 15b rotate to form an X-shape, the flow path 62 can be closed. When the wings rotate in the opposite direction, torsional force can twist the flow path. For example, Figure 11C It is further shown that when the wings 15a and 15b rotate in opposite directions, the flow path 62 can be closed by applying a torsion to the tube that defines the housing conduit 56, thereby causing the tube to twist. Figure 11D This shows that the flow path 62 can be opened when the wings 15a and 15b are parallel to each other or not in the X configuration. Figure 11E It is shown that the flow path 62 can be closed by twisting the tube defining the housing conduit 56 using the wings 15a and 15b.

[0295] Figure 12A and Figure 12BA variation of the flow control system 150 is shown. The flow control system 150 can be an intubation control system. For example, the flow control system 150 can be a ball valve system that can be integrated into the device 10 as a method of controlling flow through the needle 12 during intubation. The ball valve system 150 can be internal to the device 10. The ball valve 150 can be actuated via needle wings that bend, rotate, and / or fold toward the first transverse axis A2 of the device, as is typical when the needle 12 is inserted into the patient, to ensure unobstructed flow during intubation. The ball valve 150 can also be controlled to block flow during needle withdrawal. Figure 12A and Figure 12B The ball valve 150 shown may include a ball 152 and a mechanical link 154 attached to the ball 152. The mechanical link 154 may be directly or indirectly attached to the device wing and / or sensor 18. The path (e.g., in the needle holder 13) may have a tapered portion 156 that can guide the ball 152 into the needle port to block the flow path through the device 10. Figure 12A The ball valve system 150 is shown in a closed configuration (blocking flow through needle 12) and Figure 12B The ball valve system 150 is shown in the open configuration (allowing flow through the needle 12).

[0296] Figures 13A-13E A variation of the flow controller 158 is shown. The flow controller 158 may be an intubation flow controller. The flow controller 158 may be an intubation controller that can be configured to open the flow path through the device 10 during intubation. For example, the flow controller 158 may be a lift-up blade mechanism that can achieve intubation locking during intubation. In this variation, the device 10 is not activated for skin sensing detection until the needle 12 has been inserted into the patient and the needle insertion object (e.g., a person with a needle inserted) activates the skin sensing mechanism 18 by physical action, such as using the lift-up blade mechanism 158 to unlock the skin sensing capability of the device 10. Figure 13A The blade erection mechanism 158 is shown to be attachable to the sensor 18. Figure 13A The device 10 is further shown in the open configuration during intubation. Figure 13B The device 10 is shown in an open configuration, wherein the blade erection mechanism 158 is in an erect position when the needle 12 is inserted into the tissue. Figure 13C The device 10 is shown in a closed configuration, with the blade erection mechanism 158 in a non-erected active position. Figure 13C The blade erection mechanism is further shown, and the flow path is deformed by pushing against the housing 14. Figure 13D and Figure 13E The image shows the upright blade mechanism with the housing 14 and housing guide 56 in two configurations.

[0297] Figure 14A and Figure 14B A variation of the flow control mechanism is shown, which allows a user to control the device 10 to enter an actuated state via a digitally operated slider 160. During intubation, the flow control mechanism can be closed and flow permitted via slider 160. The flow control mechanism may be a sensor 18. For example, Figure 14A The system is shown in the open cannula position. After the flow control mechanism is physically activated by slider 160, device 10 can utilize its ability to determine the fluid flow control state through needle 12 using skin sensing element 18. For example, Figure 14B The slider 160 can be slid backward (e.g., arrow 162) to make the sensor 18 stand up.

[0298] Figures 15A-15D A variation of the flow control mechanism 163 is shown. The flow control mechanism may be a flow orifice shaper 163. The flow control mechanism 163 may include device wings 15a and 15b and an internal orifice 164 (e.g., a flow path orifice of device channel 62). The shape of the internal orifice 164 may be mechanically controlled (e.g., opened and closed) by the wings 15a and 15b. The flow path shape control system 163 may be used during needle 12 insertion into the patient. The mechanically controllable orifice 164 may be configured to allow blood flow through the device 10 when the needle wings 15a and 15b are bent, rotated, and / or folded into an upright position toward the first transverse axis A2 of the device, as is normally done during needle insertion, and when the needle wings 15a and 15b are firmly and flatly adhered to the appropriate position on the patient's skin. As another example, the mechanically controllable orifice 164 can be configured to allow blood flow through the device 10 only when the needle wings 15a and 15b are bent, rotated, and / or folded into an upright position toward the first transverse axis A2 of the device, as is normally done during needle insertion, and only when the needle wings 15a and 15b are firmly and flatly adhered to the appropriate location on the patient's skin. Other conditions (e.g., accidental removal of the needle during treatment) may cause the skin sensing mechanism 18 to act on the orifice 164, thereby ensuring that the orifice is in a closed flow state. Figure 15A The device 10 is shown to be fixed to tissue using tape 166. Figure 15B This shows that when wings 15a and 15b are substantially parallel to each other and are connected by the longitudinal axis A1 and the second transverse axis A3 of the device (see, for example, [reference needed]). Figure 1 When the aperture 164 is above the plane 157 defined by the axis of the device, the aperture 164 may have an open shape such that the wings 15a and 15b are on the first side 10c of the device. Figure 15B The device 10 is further shown to adhere to tissue 100 to maintain the open shape of the orifice 164 after insertion. Figure 15C This shows that when wings 15a and 15b are substantially parallel to each other and are connected by the longitudinal axis A1 and the second transverse axis A3 of the device (see, for example, [reference needed]). Figure 1When the aperture 164 is above the plane 157 defined by the axis of the device, the aperture 164 can have a closed shape, such that the wings 15a and 15b are on the second side 10d of the device. Figure 15D The aperture 164 can have an open shape when the wings 15a and 15b are bent, rotated and / or folded toward each other as shown by arrow 168. Figure 15B and 15D It is shown that when the wings 15a and 15b are adhered to the skin 100 and when they are clamped together, the orifices 15a and 15D can have an open shape.

[0299] Figure 16A and Figure 16B A variation of the flow control mechanism 170 is shown. The flow control mechanism 170 can be a one-way valve mechanism that can be integrated into the device 10 to provide an effective mechanism for achieving unidirectional fluid flow as part of a technique to ensure effective cannulation locking during needle insertion. For example, the one-way valve mechanism 170 can open the flow path of the device 10 during cannulation. The one-way valve 170 can be directly or indirectly connected to the first wing 15a and / or the second wing 15b, such that the hinge of the wings 15a and 15b can (e.g., toward the first transverse axis A2 of the device) compress the first portion of the one-way valve 170. Compressing the first portion of the one-way valve 170 can cause the second portion of the one-way valve 170 to expand, open, or define a flow passage. For example, Figure 16B The diagram shows that when assembly 170 is compressed during insertion (e.g., arrow 172), the front portion of assembly 170 can open to allow fluid to flow through device 10 (e.g., arrow 174). For example, assembly 170 can be compressed when the wings 15a and 15b of device 10 are rotated to ensure an open flow path during needle insertion.

[0300] Figure 17A and Figure 17B A variation of the flow control mechanism 176 is shown. The flow control mechanism 176 may be a pressure valve mechanism, which may be integrated with the device 10 to provide an effective mechanism for enabling unidirectional fluid flow as part of a technique to ensure effective cannulation locking during needle insertion. For example, the pressure valve 176 may open the flow path of the device 10 during cannulation. Figure 17A This illustrates that when blood flow is slow, such as when back pressure is present, blood can flow through pressure valve 176 (e.g., arrow 178). Back pressure can be present in the tubing during cannulation. Back pressure can be present on one side of arrow 178, which has an arrowhead. Figure 17B This shows that when blood flow is high, such as when there is no back pressure, component 176 can have a closed configuration. Figure 17B The blocked flow is shown in Figure 178.

[0301] Figure 18A and Figure 18B A variation of the flow control mechanism 180 is shown. The flow control mechanism 180 may be a rod-type valve 180, which may be integrated with the device 10 to provide an effective mechanism for enabling unidirectional fluid flow as part of a technique to ensure effective cannulation locking during needle insertion. For example, the rod-type valve 180 may open the flow path of the device 10 during cannulation. The rod-type valve 180 may be activated by bending, rotating, and / or folding the wings 15a and 15b (e.g., toward the transverse first axis A2 of the device) to ensure that the flow path is open during needle insertion. Figure 18A The rod valve 180 can be in an open configuration when the wings 15a and 15b are clamped together and / or when the wings 15a and 15b are substantially parallel to each other. Figure 18B This illustrates that when wings 15a and 15b are in their default positions, the boom-type plug arm 182 can rotate (e.g., arrow 184) into the flow path 62 to block the flow.

[0302] Figure 19A and 19B A variation of the visual indicator 186, which can be integrated into the device 10, is shown. The indicator 186 can be used to indicate the return of blood itself to the needle body, and, as in conventional methods, there is no need for a flow path that returns blood to the distal tube during insertion. Figure 19A Indicator 186 indicates no blood or no blood return. Figure 19B The darker indicator 186 indicates blood or the presence of blood return. Figure 19A Indicator 186 is shown before intubation. Figure 19B An indicator 186 is shown after intubation, in which blood return can be seen. The indicator 186 may be a transparent window in the housing 14 that visually exposes the device flow path 62, for example, near the needle hub 13.

[0303] Figures 20A to 20G A variation of the buckle 188, which can be integrated with the device 10, is shown. The buckle 188 can provide cannulation locking. For example, the buckle 188 can be configured to force the sensor 18 into an open configuration during cannulation. Figures 20A to 20GThe buckle 188 can pull the sensor 18 to a position that allows fluid to flow through the needle body when the needle wings 15a and 15b are bent, rotated, and / or folded toward each other during insertion (e.g., toward the first transverse axis A2 of the device). For example, the buckle 188 can pull the sensor 18 to an open position. In this open position, for example, when the device 10 has a visual indicator 186, the person inserting the needle can see and naturally observe blood backflow during insertion. When the needle is in place, fluid can flow through (e.g., freely) the device 10 until the needle 12 is intentionally or unintentionally removed from the body, activating a flow-stopping mechanism (e.g., sensor 18). The buckle 188 can be integral with or attached to the housing 14 and / or the wings 15a and 15b. The buckle 188 can be an elastic material. The buckle 188 can be a non-elastic material. The buckle 188 can be a strip material with a flexible shape. The buckle can bend as the wings 15a and 15b rotate and reverse.

[0304] Figure 20A The sensor 18 can be in a closed position when the wings 15a and 15b are in a non-rotating position. For example, the sensor 18 can be in a closed position when the wings 15a and 15b extend substantially along the second transverse axis A3 of the device. When the wings 15a and 15b are in a non-rotating position, the spring 26 can force the sensor 18 into a closed position. The strap 188 may or may not bias the wings. Figure 20A The configuration shown.

[0305] Figures 20B-20E The wings 15a and 15b are shown to be able to rotate (e.g., arrow 196) during insertion to extend substantially along the first transverse axis A2 of the device. When the wings 15a and 15b are in the rotated position, the buckle 188 can overcome the tension of the spring 26 and force the sensor 18 into the open position, thereby keeping the flow path open during insertion.

[0306] Figure 20E The device can further be shown to have a structure with a housing 14 and an insert 17 as shown in the figure. Figure 20E The membrane 54 is further shown to be opposite the housing protrusion 198. The housing protrusion 198 may extend at least partially toward the longitudinal center of the device flow channel 62 in the housing 14, for example toward the longitudinal center of the flow. When the movable sensor 18 is in a closed configuration (e.g., when the device 10 is dislodged after insertion), the occluder 32 may be configured to engage the housing protrusion 198.

[0307] Figure 20F This illustrates that when the device is dislodged from the tissue, the buckle 188 can switch the sensor 18 to a closed position. Figure 20FIt is further shown that the sensor 18 can be attached to the housing 14 via the hinged connection 144.

[0308] Figure 20G This shows that when the device 10 is in the disengaged configuration, the membrane 54 can be forced against the housing protrusion 198. Figure 20G The device 10 is further shown in a fully sealed configuration. Figure 20G This further illustrates that the distal end 26b of the spring can be integrated with or attached to the distal end 18b of the sensor. Figure 20G It is further shown that the proximal end 26a of the spring can be bent to reduce friction when the proximal end 26a of the spring slides along the surface of the spring guide notch 200.

[0309] Figure 20H Another variation of buckle 188 is shown.

[0310] Figure 20I Another variation of buckle 188 is shown.

[0311] Figures 21A-21I The apparatus 10 can be manufactured using a dual injection molding process having a first injection mold 190 and a second injection mold 192. Figure 21A A variation of the first injection molding die 190 is shown. The first injection molding die 190 can be molded using a single material or a composite material. The first injection molding die 190 may include needle wings 15a and 15b and a portion of a central body (e.g., a portion of the housing 14). Figure 21B A variation of the second injection molding die 192 is shown. The second injection molding die 192 can be molded using a single material or a composite material. The material of the second injection molding die 192 can be the same as or different from the material of the first injection molding die 190. For example, the material of the second injection molding die 192 can be softer, more flexible, more elastic, more deformable, or any combination thereof than the material of the first injection molding die 190. The second injection molding die 192 can be completed inside or outside the needle wing / body unit (e.g., within the housing 14 defined by the first injection molding die 190). For example, the second injection molding die 192 can be attached to the first injection molding die 190 by glue, adhesive, and / or welding (e.g., acoustic welding). The second injection molding die 192 can include a compressible membrane (e.g., membrane 54). The compressible membrane can be a thin compressible membrane, for example, with a thickness of about 0.5 mm to about 2.0 mm, including amounts in increments of 0.1 mm within this range (e.g., 0.5 mm, 1.0 mm). A compressible membrane (e.g., membrane 54) can be a clamping point for the sensor 18 when the needle 12 is unintentionally removed from the patient's body. The second injection molding die 192 can be an insert 17.

[0312] Figure 21AAt least a portion of the housing 14 is shown to define the housing conduit 56. Figure 21A The first injection molding die 190 may include a protrusion 198.

[0313] Figure 21B It is shown that at least a portion of the second injection molding die 192 can define the housing conduit 56.

[0314] Figure 21C A variation of the sensor 18 is shown attached (arrow 183) to the housing 14 after the second injection molding die 192 is completed.

[0315] Figure 21D A first injection molding die 190 and a second injection molding die 192 are shown to be attached to maintain a fluid seal 202. The fluid seal 202 can withstand the high flow pressures associated with hemodialysis treatment. Figure 21D At least a portion of the first injection molding die 190 (e.g., housing 14) and at least a portion of the second injection molding die 192 (e.g., insert 17) may define the housing conduit 56. The first injection molding die 190 and the second injection molding die 192 may together define the housing 14.

[0316] Figure 21E The buckle 188 is shown relative to the first injection mold 190 and the second injection mold 192.

[0317] Figure 21F and Figure 21G The first injection molding die 190 is shown. Figure 21F ) and the second injection molding die 192 ( Figure 21G ) dual injection molding manufacturing process 204.

[0318] Figure 21H and Figure 21I A variation of the second injection molding die 192 is shown. Figure 21H The second injection molding die 192 is shown to have a surface 206 that at least partially defines the housing conduit 56. Figure 21H A variation of the position of the membrane 54 on the insert 17 (also known as the second injection molding die 192) is further shown. Figure 21I The second injection molding die 192 is shown to have a notch 208 for the insertion of the flow restrictor 28. For example, when the sensor moves from the open position to the closed position, the notch 208 can allow the sensor 18 to enter the housing conduit 56 by allowing the plug 32 to deflect the membrane 54 toward the protrusion 198.

[0319] Figure 10A , Figure 10B , Figures 13A to 13E , Figure 14A , Figure 14B , Figures 20A to 20I and Figure 21C The sensor 18 is further shown to have a straight sensor distal end 18b. Figure 10A , Figure 10B , Figures 13A to 13E , Figure 14A , Figure 14B , Figures 20A to 20I and Figure 21C The sensor distal end 18b without the bend 21 is further shown.

[0320] Figure 22A and Figure 22B The sensor 18 is shown to have the features shown.

[0321] Figure 23A and Figure 23B A variation of a spring-loaded member 32 (also called a stopper) is shown, pushed from above by a vane mechanism 18 (also called a sensor), wherein the vane mechanism 18 pivots against the skin in the direction opposite to the direction of fluid flow. A linkage assembly 210 is used to push the member 32 against a compressible tube 17 (labeled 17, as the compressible tube may be an insert) for blocking the flow path through the needle. The spring-loaded member 32 may be a spring that loads a spring 26. Figure 23A The device 10 is shown in a blocking configuration. Figure 23B The device 10 is shown in a non-blocking configuration.

[0322] Figure 24A and Figure 24B A variation of the skin-sensing blade mechanism 18, shown with hinges so that the direction of motion is in the same direction as the flow path, is illustrated. Figure 23A and Figure 23B Similarly, when the skin-sensing blade 18 is permitted to swing open during disengagement, the assembly link pushes a structurally intact member 32 against the compressible inner tube 17 to block flow through the needle. For example, the assembly link may push the member 32 against the compressible inner tube 17 to block flow through the needle if and only if the skin-sensing blade 18 is permitted to swing open during disengagement. Member 32 may be a spring loaded with spring 26. The sensing blade may rotate about the hinged connection 144. Figure 24A and Figure 24B The device 10 is shown in a non-blocking configuration.

[0323] Figures 25A to 25DA variation of a button-type skin-sensing actuator 212 (also commonly referred to as flow restrictor 28) with a central through-hole is shown, the through-hole indicating the flow state based on its position relative to an internal flow path 214. Flow can proceed through the internal flow path 214 when the central piston 212 is aligned (e.g., partially or fully) with the through-hole immediately adjacent to it. The system stops the flow whenever the needle is disengaged. For example, flow occurs only when the central piston 212 is aligned with the through-hole immediately adjacent to the internal flow path. The base of the piston 212 may be a sensor 18. Figure 25B A sensor (e.g., sensor 18) is shown in an open configuration, resting against the skin and actuator 212, with the through-hole of actuator 212 aligned with flow path 214. Figure 25C The sensor is shown in a closed configuration, exiting the skin and actuator 212, wherein the through-hole of actuator 212 is misaligned with flow path 214, causing flow path 214 to be blocked. Figure 25D A variation of the device 10 with actuator 212 is shown. Figure 25D Further illustrating that when device 10 is disengaged and the skin sensor moves away from the bottom surface of the device by dimension 216, actuator 212 can completely block flow path 214. For example, dimension 216 can be from about 5 mm to about 25 mm, including increments of 1 mm within this range (e.g., 8 mm, 10 mm, 15 mm, 15 mm).

[0324] Figure 26 A variation of the current limiter 28 is shown. For example, Figure 26 An internal rotating mechanism 220 is shown, connected to an armature 18 used as a skin sensor. When the skin sensor 18 is positioned against the skin, a compressible tube 214 allows fluid to flow through the needle. For example, the compressible tube 214 only allows fluid to flow through the needle when the skin sensor 18 is positioned against the skin. During withdrawal, a spring 26 rotates the internal flow-blocking mechanism 220 and acts on the compressible tube 214, thereby preventing fluid flow. When the needle is pressed firmly against the skin, the spring member 26 is shown in a "Z" position. This spring straightens during withdrawal, creating a flow blockage. The spring 26 can be located within a channel 218 of the rotating mechanism 220.

[0325] Figure 27 A variant of the cross-sectional side view is shown, illustrating a fluid flow control technique generated by the soft sidewall 214 within an embedded flow path 56 in the compression needle body 14. This flow control mechanism eliminates the need for placing an internal compressible tube during manufacturing. Figure 27 As shown, for example, when device 10 is dislodged from tissue, occluder 32 blocks compressible tube 214.

[0326] Figures 28A to 28FMultiple views are shown of a dual-flow control actuation system that generates a flow blockage or channel based on skin sensor 18, wherein fluid is compressed and blocked from the bottom of hose 214. Using this technique, a secondary actuator is used to stop fluid flow after the primary actuator is triggered due to dislodgement. Figures 28A to 28C Showing the open flow path, Figures 28D-28F The flow path of the blockage is shown.

[0327] Figure 29 A flow control mechanism is shown that stops the flow by an actuation transmitted through the top of the compressible tube 214. In this variant, a sensor 18 for skin sensing is integrated into the body of the needle (e.g., housing 14) to provide mechanical stability and protection.

[0328] Figures 30A to 30D A side cross-sectional view is shown of a diaphragm and pin technology that blocks flow during ejection. The skin sensor blade 18 uses an actuator 26 to press a shaped pin 32 into the flow path 56, thereby blocking flow during ejection. Figure 30A and Figure 30D The actuator 26 is a spring 26 that rises and falls with the skin sensor blade 18. Pin 32 can be integrated with diaphragm valve 222. Valve 222 can be connected to spring 26, causing valve 222 to rise and fall as spring 26 moves. Spring 26 can be anchored to the housing via spring anchor 224.

[0329] Figure 31 This is an internal view showing the inserted hose 226, which is clamped during disengagement via a plug 32 to stop flow via a lever system driven by a spring 26. Insertion-type tubing may reduce manufacturing costs. A needle attachment point 227 for the output flow is further shown.

[0330] Figure 32A and Figure 32B The diagram shows a device 10 that stops flow during dislodgement based on a bottom skin sensing plate 18 that detects the dislodgement and an annular member of a compressed hose via a central helical spring 26.

[0331] Figure 33A and Figure 33B A device 10 is shown, having a leaf-shaped skin sensing system 18 for protection against skin detachment. (And...) Figure 32A and Figure 32B Like the mechanism in the previous one, it uses a central helical spring 26 to block the movement of the coil during disengagement. Figure 33A and Figure 33B It is further shown that the hinge 144 may be a polymer hinge. Figure 33BThe sensor 18 is further shown to be able to rotate an angle 227 away from the bottom of the device. For example, the angle 227 may range from about 10 degrees to about 45 degrees or greater, including the amount of each degree increment within this range (e.g., 15 degrees, 20 degrees, 30 degrees).

[0332] Figure 34A and Figure 34B The diagram shows how to improve the blade to better prepare the blade for certain exit features (e.g., via the scooped side 301 or different lengths). For example, Figure 34A The sensor in the middle is 18 times Figure 34B The sensor in the middle is short 18. Figure 34A and Figure 34B The sensor 18 is shown to have a recessed side / edge 301.

[0333] Figures 35A to 35C The diagram shows a tube clamping system in which the slider 230 and clamping arm 234 are used together to clamp the inner tube 214 upon disengagement. The system may also include a spring 232. Figure 35A An exploded view of the pipe clamping system is shown. Figure 35B It is shown that the spring 232 can push the slider 230 in the direction 235 to force the clamping arm 230 toward the tube 214 to clamp the tube 214. Figure 35B The dashed line in the diagram illustrates this movement. The system also benefits from plug-in components, which facilitates manufacturing and reduces manufacturing costs.

[0334] Figure 36A A hybrid form of insertable assembly 241 is shown, having a needle 12 and a body 240 that can be connected to a tube 8. Figure 36B The component 241 is shown to have a shut-off valve 242. Figure 36C The illustration shows a blade / diaphragm system that is made very similar to an actual needle and, upon disengagement, uses the disengagement mechanism described herein to prevent fluid flow.

[0335] Figures 37A to 37C A variant of the insert 17 is shown, configured to support flow cessation during disengagement. It uses a shaped passage 56 with a thinned wall 54 as the closure point of a structural assembly that is part of or attached to the blade skin sensing arm 18. Figure 37A A device 10 with a plug-in component 241 is shown. Figure 37B A longitudinal cross-sectional view of insert 17 in the open configuration is shown. Figure 37C A cross-sectional view of insert 17 in the open configuration is shown. Figure 37C It is further shown that the passage 56 can be closed by applying force 249 to the membrane 54.

[0336] Figures 38A to 38FA variation of the device 10 is shown, featuring an insert 17 with a defined housing conduit 56. A finishing cap 251 can be placed on the proximal end of the spring 26. Figure 38C The device 10 is shown in an attached configuration. Figure 38D The device 10 is shown in a closure configuration, wherein the spring 26 forces the distal end of the sensor 18 away from the flow path 56 and forces the closure device 32 into the membrane 54 to close the flow path.

[0337] Figures 39A to 39C and Figures 40A-40C Two variations of the manually actuating pin 252, which can be pulled by the user when the needle disengagement mechanism is actively engaged, are shown. The user will first intubate the patient before pulling pin 252. Using pin 252 in device 10, the flow path is always engaged (flow path open). Pin 252 ensures that mechanisms used to block the flow path through the needle cannot be activated, which is useful, for example, during intubation. Pin 252 can snap into, slide into, and / or screw into device 10 and / or snap into, slide into, and / or screw out of device 10. Pin 252 can be positioned anywhere within the structure and can take any number of forms (e.g., pins, plugs, bands, collars, screws). Pulling pin 252 will allow any disengagement mechanism disclosed herein to become effective during fluid delivery therapy. Pin 252 can also take the form of a collar wrapped around a standard tube connected to needle body 14. Such a position will maximize the ability of clinicians to use pin 252 under standard acupuncture therapy. As another example, pin 252 could also take the form of a strip or mechanical component extending beneath the needle body and tube as a device to prevent sticking during insertion. When pin 252 is in device 10, it can prevent sensor 18 from activating, thus ensuring the flow path remains open (e.g., Figure 39A and Figure 40A When pin 252 is removed from device 10, sensor 18 can become active, such that the flow path is opened only when the pin remains attached (e.g., Figure 39B and Figure 40B When pin 252 is removed and the needle is dislodged, sensor 18 can actuate and shut off the flow path (e.g., when pin 252 is removed and the needle is dislodged). Figure 39C and Figure 40C ). Figure 40C The housing 14 is shown to have a pin channel 253 for the pin 252.

[0338] Figure 41A and Figure 41BA multi-magnet system is shown, which provides built-in mechanisms for the needles 12 to automatically ensure fluid flow through the needles 12 whenever the needle wings are bent, as during cannulation or patient insertion. Moving the wings to a bent, upright position aligns a set of magnets 260 embedded in each wing to influence another magnet or magnet 262 within the needle body. This magnetic interaction keeps the fluid flow valve in a flowing state as long as magnets 260 and 262 are properly positioned. Bending the wings deactivates the dislodgement detection mechanism via the interaction between the magnets. Then, when the wings are held down for treatment, any skin-sensing dislodgement mechanism 18 is activated.

[0339] Figures 42A to 42E The device 10 shown may have a humidity detection system 270 (also known as a fluid detection system). Figures 42A to 42E The device 10 shown may have one or more expanders and / or fluid detectors. For example, Figures 42A to 42E A device 10 is shown designed to have an expander (e.g., a material, any material) that functions as an actuation method in response to physical changes upon contact with a liquid. For example, Figures 42A to 42E A humidity detection system 270 is shown. The humidity detection system 270 may have an expander 272. The expander 272 may be a fluid-sensitive material, such as a mass of fluid-sensitive material. The expander 272 may be a occluder, such as an expandable occluder. The humidity detection system 270 may have a fluid detector 274. The device 10 may have one or more expanders 272 (e.g., one, two, three, or more expanders). The device 10 may have one or more fluid detectors 274 (e.g., one, two, three, or more fluid detectors). The expander 272 may be configured to change shape (e.g., expand) upon contact with a fluid. For example, the expander 272 may be configured to change shape upon contact with blood. The expander 272 (e.g., a fluid-sensitive material) may be an actuable flow restrictor (e.g., an actuable flow restrictor 28). The expander 272 may be an actuator configured to block blood flow through the device 10 by blocking all or part of the device flow passage 62 upon contact with a fluid. For example, in Figures 42A to 42EIn the illustrated design, an expander 272, such as a fluid-sensitive material (e.g., hydrogel), serves as an actuator to shut off fluid flow to prevent ejection when the expansion of the material detects leakage of liquid (e.g., blood) from the ejection process. When the expander 272 comes into contact with the fluid, it can protrude / expand into a flow path (e.g., housing conduit 56) to block the flow through the flow path. Alternatively or additionally, when the expander 272 comes into contact with the fluid, it can protrude / expand into an ejection mechanism actuator (i.e., an actuator that activates the ejection mechanism to block the flow through the flow path when engaged by the expander 272), or it can protrude / expand into the ejection mechanism and force it into a blocking position in the flow path.

[0340] Figures 42A to 42EThe expander 272 is shown to be located in a cavity (e.g., in a small cavity) on a needle body (e.g., housing 14 of device 10). A first end of the cavity may be sealed and in contact with the fluid detector 274. A second end of the cavity may open to a flow path in device 10 or have a membrane thereon. The membrane may be a fragile membrane. The membrane may be a deformable membrane. The membrane may be between the expander 272 and the flow path in device 10. For example, the membrane may be at the bottom of the cavity (e.g., near the flow path) such that a first side of the membrane faces the expander 272, or it may be in contact with the expander 272 and a second side of the membrane faces the flow path or defines at least a portion of the device channel 62. The expansion of the expander 272 (e.g., a fluid-sensitive material) upon contact with the fluid (e.g., via the fluid detector 274, such as a capillary member) may exert a force on the membrane to rupture it, and then expand into the flow path to block the flow through device 10. In this variation, the membrane may rupture without initial deformation, or it may rupture after a first partial deformation into the flow path (e.g., about 1 mm to about 3 mm). As another example, the expansion of expander 272 (e.g., a fluid-sensitive material) upon contact with a fluid (e.g., via a fluid detector 274 such as a capillary member) can exert a force on the membrane to deform it into the flow path without damaging it, thereby blocking the flow through device 10, such that after expansion, expander 272 is contained within expander cavity and membrane cavity in flow path. In such a variation, when expander 272 expands, the membrane can fill the flow path like an air bladder. The expansion portion or membrane extension (e.g., the portion of the membrane in the flow path with expanded expander 272) can act as a piston to block the flow through device 10 when expander 272 is actuated. When expander cavity opens to flow path without membrane, cavity can be designed such that fluid flowing through expander cavity does not flow into cavity and contacts expander 272 when device 10 is used and expander 272 is not yet actuated. With and without membrane, expander 272 can block flow path upon expansion. Alternatively or additionally, expander 272 may force a plug into the flow path upon expansion after contact with a fluid. For example, the plug (e.g., a piston, rod) may be located within the expander cavity. When expander 272 (e.g., a fluid-sensitive material) expands, expander 272 may force / push the plug (e.g., a piston, rod) into the flow path to block the flow through device 10. As another example, the plug may be part of the release mechanism disclosed herein. As yet another example, expander 272 may actuate the release mechanism disclosed herein to block the flow path upon expansion after contact with a fluid. When expander 272 is a fluid-sensitive material, a sealing top of the cavity may force the material to expand into the flow path as expander 272 expands.

[0341] To ensure that fluid loss due to needle dislodgement is detected after insertion has occurred, a method is used to ensure the detection and / or delivery of fluid through an expander 272 (e.g., a fluid-sensitive material) embedded in the needle body. This may involve the use of a fluid detector 274. The fluid detector 274 can serve as a conduit (e.g., as a mechanical conduit) for the return from the needle tip to the expander 272 (e.g., a hydrogel or other material) which acts as a flow-stopping actuator. The fluid detector 274 can be configured as a capillary member capable of drawing fluid toward the expander 272. The fluid detector 274 can draw a fluid wick to the expander 272. For example, the fluid detector 274 can draw a fluid wick into the expander 272 within the expander cavity. The fluid detector 274 can be directly or indirectly connected to the expander 272. The fluid detector 274 can be adjacent to the expander 272. The fluid detector 274 can be an extension or a flap. The fluid detector 274 can be a sheath. The fluid detector 274 can be a retractable sheath. The fluid detector 274 may extend at least partially along an axis parallel to the longitudinal axis A1 of the device toward the desired tip. The fluid detector 274 may extend beyond the tip of the needle. Figures 42A to 42D An example is shown where a fluid detector 274 (e.g., a flap) extends above the needle tip. This fluid detector 274 can use capillary action or other techniques to signal the presence of fluid overflowing downwards from the dislodged needle tip into the needle body. An expander 272 (e.g., a hydrogel or other material) then receives this moisture and is activated. When activated, the expander 272 can block the flow path and / or can activate any flow restrictor mechanism disclosed herein to block fluid flowing through the device 10, whether or not it expands into the flow path. The expander 272 may or may not expand into the flow path when it activates the flow restrictor mechanism during expansion. For example, when the expander 272 does not block the flow path itself during expansion, it can actuate a separate plug or flow restrictor (e.g., any plug and flow restrictor mechanism described herein). In addition to or instead of a flap as a fluid detector, a sheath or retractable needle sheath 11 can be used as a conduit to transmit the presence of erroneous fluid to the needle body for actuation upon dislodgement. The sheath 11 can be a fluid detector 274. The sheath 11 can be exposed to, for example... Figure 42EFluid flow at the needle bevel shown. Sheath 11 may be adjacent to fluid-sensing expander 272 (e.g., fluid-sensitive material). Fluid-sensing material 272 (e.g., hydrogel) may be configured to expand into the flow path upon exposure to fluid and / or may expand to activate any flow restrictor mechanism disclosed herein to prevent fluid flow through device 10, regardless of whether it expands into the flow path. Espinning member 274 may be used to wick any fluid that flows from the needle tip during treatment during withdrawal. Devices (e.g., device 10) having fluid detection system 270 (e.g., expander 272 and / or fluid detector 274) may have skin-sensing sensor 18. As another example, devices (e.g., device 10) having fluid detection system 270 (e.g., expander 272 and / or fluid detector 274) may not have skin-sensing sensor 18. For example, it may be omitted from these devices 10. Figures 1 to 51E Sensor 18 in the middle.

[0342] Figures 43A-43D A needle with mechanism 304 is shown, which detects both slippage and complete detachment, and in either case, uses mechanical compression of the inner tube 56 to prevent fluid flow through the needle. Mechanism 304 relies on tape or high friction between the bottom skin sensing element and the skin itself. The physical action of sliding pulls the connecting arm to act on the compression member 32, thereby stopping the flow during slippage. Mechanism 304 can also be activated by the skin sensor during detachment. Mechanism 304 is capable of stopping the flow when the horizontal or lateral position of the button / sensor 18, which is adhered to the skin with adhesive 310, changes. Adhesion to the skin can be achieved by various techniques, some examples of which are tape between the sensor 18 and the skin or magnets between the sensor 18 and a magnetic tape on the skin.

[0343] Figure 43A The device 10 is shown in a spring-loaded state. In the spring-loaded state, section A is spring-loaded. Section A is only in its natural state when flat. When attached to the arm, section A bends upward through section B and is in a compressed state. Figure 43B It is shown that when the device 10 is disengaged from the arm, section A moves to its natural state and closes the fluid path, thereby allowing the plug 32 to enter or push the plug 32 into the flow path to block the flow path. Figure 43C and Figure 43D As shown, when the needle flap is pulled in the opposite direction of the needle, button / sensor 17 remains attached to the skin, and segment A moves relative to segment B via a sliding mechanism. Segment A returns to its natural state and closes the fluid path.

[0344] Figure 44A and Figure 44BThis invention illustrates a needle system designed to stop detachment and slippage within a combined mechanism built into a single needle. Figure 44A This illustrates a system capable of stopping flow when the horizontal or lateral position of a button / sensor 18, which is adhered to the skin (e.g., using adhesive 310), changes. Adhesion to the skin can be achieved through various techniques, some examples of which are adhesive tape between the sensor 18 and the skin or magnets between the sensor 18 and a magnetic tape on the skin. When the needle kit is pulled down from the arm or along (e.g.) Figure 44B When pulled horizontally (as indicated by the two parallel arrows in the figure), button / sensor 18 remains adhered to the skin and device 10 breaks at the breakpoint indicated as "X" in the figure. Once the system breaks at the breakpoint, a preloaded fluid path closing mechanism is triggered to close the fluid path.

[0345] Figures 45A-45C A system is shown that can stop flow when the horizontal or lateral position of a hinged blade 18, which is adhered to the skin (e.g., using adhesive 310), is changed. Adhesion to the skin can be achieved by various techniques, some of which are examples of adhesive tape between the sensor and the skin or magnets between the sensor and a magnetic tape on the skin.

[0346] Figure 45A The device 10 is shown in a spring-loaded state. In the spring-loaded state, the leaf spring 26 is spring-loaded. For example, the leaf spring 26 is in its natural state only when it is flat. The leaf spring 26 does not need to be a leaf spring. It can be non-flat. The flat surface of the spring 26 can be a spring-loaded flat rigid surface. When taped to the arm, the leaf spring 26 bends upward through the notch 29 and is in a compressed state. Figure 45B This shows when the needle's butterfly wings are in the opposite direction to the needle (e.g.) Figure 45B When the button / sensor 18 (indicated by the two parallel arrows on the left) is pulled, it remains attached to the skin, and the rest of the needle section moves a critical horizontal distance, during which the notch 29 disengages from the leaf spring 26. The leaf spring 26 moves to its natural state and closes the fluid path valve, which can be of many different types, such as a diaphragm (e.g., valve 222), a ball or clamp, a valve, or any combination thereof. Figure 45C This illustrates that when device 10 is detached from the arm, the spring-loaded leaf spring 26 moves to its natural position and closes the fluid path valve.

[0347] Figures 46A to 46C A mechanism for detecting slippage is shown. This mechanism can be a roller 315 capable of measuring the relative distance the needle body moves during slippage. A threshold distance traveled by roller 315 can trigger a flow-stopping mechanism (also known as a slippage mechanism). Figure 36B This indicates a slide below a threshold distance. Figure 46C The sliding distance that meets the threshold is shown, causing the spring 26 to force the plug 32 into the flow path.

[0348] Figure 47A and Figure 47B A sliding detection mechanism based on the relative movement of a needle body relative to a band applied to a top member 358 is shown. The relative movement of the band causes mechanical motion, which is converted into a mechanism that prevents flow through the inner tube by a specific shape of the membrane. The relative movement of the top member 358 can engage a hinge member 360 that can move the sensor 18 via an arm 361. Figure 47B The downward movement of sensor 18 (e.g., toward the bottom of the page) causes the plug 32 to block the flow path. A linkage can connect the plug 32 to sensor 18.

[0349] Figure 48 A variation of the additional system is shown. This is an external device that includes a dislodgement detection system for sliding or complete dislodgement, or both. Such a device is applied to a tube (e.g., tube 8) of a standard-inserted AV fistula needle and fastened to the tube and adhered in place. If the needle / tube dislodges in any way, the mechanism detects the dislodgement and immediately applies pressure to the tube, thereby shutting off the flow. For example, the external device may include a valve clamping housing 275. The valve clamping housing 275 may have a spring-loaded contact point 277. The clamping valve 275 can operate when the contact point 277 leaves the skin. The valve clamping housing may clamp onto a tube (e.g., tube 214) outside the housing 14 of the device 10. The valve clamping housing 275 may snap onto the tube 214 behind the needle body.

[0350] Figures 49A to 49D A system 180 with sliding and complete disengagement detection and flow-stopping capability is shown. A sliding shuttle 284 is attached to a hinged blade member 18 serving as a skin-sensing element. In the case of complete disengagement, the blade 18 opens and moves the shuttle 184 such that the internal compressible tube 214 is clamped closed by two cam wedges 284, thereby stopping flow. Guide grooves 282 on the sides of the shuttle 284 can be used to improve the actuation process and result. The clamping mechanism 280 can also be activated if the needle body slides a threshold distance outward from its original insertion point. For example, this sliding motion may be generated by a pull on the proximal end of the tube away from the needle insertion point. If this motion generates a force higher than the threshold force of the spring that holds the shuttle against the needle body in place, it may result in a closing motion of the cam wedges 284 that clamps the tube. The key to this design is the variation of force applied by the sliding motion. A certain force can be applied to the sliding detection mechanism when the device slides, and the system is designed such that an actuation for closing will be triggered only above a certain force. The device 10 may have a clamping locking system 286. Figure 49D The tube 214 is shown being compressed by the cam wedge 284 and the cam wedge 284 is locked in the clamping and locking system 286.

[0351] Figures 50A to 50E Show Figures 49A to 49D Another variation of the design shown is in this version. In this design, a certain threshold distance is required to actuate the closure mechanism. In this type of arrangement, any tube pull exceeding the threshold force limit will cause the needle or needle housing to be removed from the blood vessel—but only if the pull exceeds a certain distance will the closure mechanism be triggered. A cam wedge system is used to trigger closure, and can also be activated by the hinge of the leaf-shaped skin sensing unit (e.g., sensor 18) in the event of complete dislodgement. The cam wedge 284 can be pushed inward toward the tube by the wedge 287. Figure 50A The cam wedge 284 is shown in its intermediate position. Figure 50B As shown Figure 50B The two opposing arrows on the left indicate the cam wedge 284 of the compression tube.

[0352] Figures 51A to 51E The mechanism for generating the slip detection system is shown. In this variant, the blade system 291 can activate a sliding shuttle or bracket 292 whose position is controlled by an internal bracket boss that guides the shuttle to a clamping position upon actuation due to slippage or complete disengagement.

[0353] The disclosed device 10 can be designed to be very similar to a conventional needle.

[0354] All devices disclosed herein (e.g., device 10) may have any combination of the features described herein. For example, all devices disclosed herein (e.g., device 10) may have a release sensor 18 and / or a clamping system 101. All devices disclosed herein (e.g., device 10) may have an external clamping subsystem and / or an internal clamping subsystem. For example, all devices disclosed herein (e.g., device 10) may have two or more external clamps 104, one or more external clamping gaps 106, a movable shuttle 108, one or more internal clamps 110, or any combination thereof. All devices disclosed herein (e.g., device 10) may have cannulation control features. All devices disclosed herein (e.g., device 10) may have a visual indicator. All devices disclosed herein (e.g., device 10) may have any sensor 18 (e.g., sensor 18 may be a blade, blade member, button, button member, base plate, base plate member, and any other sensor skin sensing mechanism or any combination thereof). For example, refer to Figures 1 to 5 The described sensor 18 can be used with reference Figures 20A to 21I The described device is 10 units integrated, and vice versa. As another example, see [reference needed]. Figures 1 to 5 One or more features of the described sensor 18 can be compared with those of the reference sensor 18. Figures 20A to 21IThe described device 10 is incorporated, for example, with the curved distal end 18b of the sensor 18 to facilitate insertion and / or serve as an over-insertion barrier. All devices disclosed herein (e.g., device 10) may have any of the current limiters disclosed herein. All devices disclosed herein (e.g., device 10) may have any of the sliding detectors disclosed herein. All devices (e.g., device 10) may have the humidity detection system 270 disclosed herein. All devices disclosed herein (e.g., device 10) may have... Figures 1 to 22B Any combination of the features disclosed herein. All devices (e.g., device 10) may have Figures 23A to 51E Any combination of features in (e.g., humidity detection system 270). All devices (e.g., device 10) can have Figures 1 to 51E Any combination of features in the system. For example, one or more features of the humidity detection system 270 can be combined with a reference. Figures 1 to 21I The described apparatus 10 is combined. The examples in this paragraph do not limit this disclosure. The examples in this paragraph do not exclude combinations of features not specifically provided herein, as they are examples. Because this document specifically teaches their individual and collective disclosures, all combinations of features, apparatuses, systems, and methods described herein (e.g., ...) are excluded, except for those expressly disclosed herein. Figures 1 to 51E In addition to the features, apparatus, systems and methods shown herein, those skilled in the art will readily understand how to integrate all the features, apparatus, systems and methods disclosed herein.

[0355] Additional variations, features, elements, and methods of use of the needle safety system (e.g., for automatically restricting or terminating flow due to needle dislodgement) are described in PCT patent application No. PCT / US2014 / 072573, filed December 29, 2014; U.S. patent application No. 15 / 286,274, filed October 5, 2016; and U.S. provisional application No. 61 / 978,671, filed April 11, 2014, and may be combined with this disclosure in any form, each of which is incorporated herein by reference in its entirety for all purposes.

[0356] Variations disclosed herein are provided by way of example only. The claims are not limited to the variations shown in the drawings, but may claim any feature disclosed or considered as a whole in this disclosure. Any element described herein as singular may be plural (i.e., any element described as “a” may be more than one). Any element described herein as plural may be singular (i.e., any element described as more than one may be “one”). Any specific element of a class of elements may have the characteristics or elements of any other specific element of that class. For clarity of illustration, some elements may be missing in individual drawings. Variations of the above-described configurations, elements, or complete components and methods and their elements, as well as various aspects of this disclosure, for performing this disclosure may be combined and modified in any combination. All apparatuses, devices, systems, and methods described herein may be used for medical (e.g., diagnostic, therapeutic, or rehabilitative) or non-medical purposes.

Claims

1. A tissue access device having a device longitudinal axis, the tissue access device comprising: a needle having a needle proximal end and a needle distal end; a housing having a housing opening and a housing conduit, wherein the housing conduit extends from a housing proximal end to a housing distal end; a deformable membrane, wherein the deformable membrane defines a portion of the housing conduit; a spring; and a movable floor having a floor proximal end, a floor distal end, a floor surface, and an occluder, wherein the floor proximal end is attached to the housing, wherein the spring is biased to move the movable floor from a floor first configuration to a floor second configuration when a force applied by the floor surface to a non-floor surface changes from a first force to a second force that is less than the first force, wherein at least a first portion of the occluder occludes the housing conduit when the movable floor is in the floor second configuration, wherein the needle retracts into the housing such that the needle has a non-retracted position and a retracted position, and wherein the needle distal end is closer to the housing proximal end when the needle is in the retracted position than when the needle is in the non-retracted position.

2. The tissue access device of claim 1, wherein at least a portion of the needle is located outside of the housing in the non-retracted position and at least a portion of the needle is located inside of the housing in the retracted position.

3. The tissue access device of claim 2, wherein the needle distal end comprises a distal end of the device when the needle is in at least one of the non-retracted position and the retracted position.

4. The tissue access device of claim 1, wherein the floor distal end comprises a stop configured to prevent over-insertion of the needle into a blood vessel, and wherein at least a portion of the stop is closer to the needle when the movable floor is in the floor first configuration than when the movable floor is in the floor second configuration.

5. The tissue access device of claim 1, wherein the floor distal end has a curved surface configured to reduce friction against the non-floor surface when the needle is inserted into a blood vessel, and wherein at least a portion of the curved surface is closer to the needle when the movable floor is in the floor first configuration than when the movable floor is in the floor second configuration. ​

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