A device indicating entry into a body cavity, tube, or blood vessel.

Abstract

A device for indicating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal includes a pressure sensor configured to communicate fluidly with the needle hole of the needle in use, and a selective activation indicator. The device is configured to activate the indicator when the pressure acting on the pressure sensor is greater than or equal to a minimum pressure threshold, which is approximately 25 cmH2O.

Description

Technical Field

[0006]

[0001] The present technology relates to a device for indicating the entry of an invasive device, such as a catheter needle, into a body cavity, duct, or blood vessel of a human or non-human animal, more specifically a blood vessel (e.g., vein or artery). [[ID=...]]

Background Art

[0002] Peripheral venous catheters are the most commonly used invasive devices for purposes such as collecting blood samples and administering drugs, body fluids, and blood products. Both intravenous cannulation and arterial cannulation are procedures in which a vein or artery is punctured with an intravascular needle and then a plastic tube (catheter) is inserted into the vein or artery over the needle. The catheter remains in the vein or artery and the needle is discarded.

[0003] It is not uncommon for multiple punctures to be required to successfully insert a catheter. During cannulation, if the tip of the needle exits the inside of the vein or artery before advancing the catheter, due to patient movement or double puncture of the vein, etc., the catheter cannot be successfully advanced into the vein.

[0004] These successive attempts can cause pain and may delay the start of diagnostic treatment or examination. Furthermore, repeated punctures can deteriorate the blood vessel wall and complicate subsequent procedures. This can lead to serious complications related to vascular access, such as bruising, catheter-related infections, extravasation, bleeding, phlebitis, and sepsis.

[0005] Devices for indicating the position of the needle have been proposed. However, such devices are not considered clinically useful enough to be reliable, and are too costly due to complex parts and structures, and are not suitable for use in high-pressure scenarios such as providing emergency medical treatment when injured in a combat or training environment.

[0006] The purpose of this disclosure is to solve at least one of the above-mentioned problems, or to provide at least a useful alternative to the general public.

[0007] Further aspects and advantages of this disclosure will become apparent from the following description, which is provided only as an example. [Overview of the Initiative]

[0008] According to one aspect of this technology, a device is provided for indicating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal, the device being A pressure sensor configured to communicate with the needle hole of a needle in use, A selective activation indicator, comprising, The device is configured to activate an indicator when the pressure acting on the pressure sensor exceeds a minimum threshold.

[0009] In some examples, the device may be configured to deactivate an indicator when the pressure acting on the pressure sensor is below a minimum threshold.

[0010] Examples of devices of this technology may be configured for use in various body cavities, tubes, or blood vessels of humans or non-human animals. Examples of this technology may also be configured for use in demonstrating needle entry into human blood vessels (e.g., veins or arteries), and it should be understood that the principles of those examples can be adapted for use in other body cavities, tubes, or blood vessels.

[0011] According to another aspect of this technology, a device is provided for indicating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal, the device being A pressure sensor configured to communicate with the needle hole of a needle in use, A selective activation indicator, comprising, The device is configured to activate an indicator when the pressure acting on the pressure sensor is approximately 25 cmH2O or higher.

[0012] In some examples, the device may be configured to activate at least one indicator when the pressure acting on the pressure sensor exceeds approximately 30 cmH2O.

[0013] In some examples, the device may be configured to activate at least one indicator at all pressures from a minimum threshold up to at least 100 cmH2O. In some examples, the device may be configured to activate an indicator at all pressures from a minimum pressure up to at least about 250 cmH / 15 > 2O. In some examples, the device may be configured to activate at least one indicator at all pressures from a minimum threshold up to about 500 cmH2O.

[0014] In some examples, at least one indicator may be configured to output a visual signal when activated. For example, at least one indicator may be configured to output light when activated. In some examples, the indicator may include light configured to output light in the visible spectrum. In some examples, the indicator may include light configured to output light in the non-visible spectrum. In some examples, the indicator may output near-infrared or infrared light when activated.

[0015] In some cases, at least one indicator may be configured to output an audible signal when activated.

[0016] In some examples, the pressure sensor may include at least one diaphragm that is deformable from a first configuration to a second configuration under fluid pressure, in which the indicator is not activated and in which the indicator is activated. In some examples, in the second configuration, the diaphragm closes the switch and activates the indicator.

[0017] In some examples, the device may include at least one flexible printed circuit. In some examples, the device may be configured such that the diaphragm displaces at least the movable portion of the flexible printed circuit to complete the electrical circuit and activate the indicator.

[0018] In some examples, the pressure sensor may include a digital pressure sensor. In some examples, the digital pressure sensor may be configured as a pressure switch, outputting a signal that activates an indicator when the sensed pressure exceeds a minimum threshold. In some examples, the pressure sensor outputs a pressure signal to a controller, which may selectively activate the indicator based on whether the pressure exceeds a minimum threshold.

[0019] In some examples, the device may include a body containing a pressure sensor. In some examples including at least one diaphragm, the body may include a first internal cavity between a first surface of the diaphragm and a fluid port that communicates fluidly with the needle hole of a needle in use. In some examples, the body may include a second internal cavity partially formed by a second surface of the diaphragm opposite the first surface. In some examples, the body may include at least one air port between the second cavity and the outside of the body. In some examples, at least one air port may be provided on an end face of the body distal to the fluid port. In some examples, the body may include a plurality of air ports.

[0020] In some examples, the fluid port may include an inlet on the outside of the body and an outlet in the first internal cavity. In some examples, the inlet and outlet of the fluid port may be axially aligned with the center of the diaphragm.

[0021] In some examples, the device may include at least one battery. In some examples, at least one battery may be an alkaline battery. In some examples, at least one battery may be a button battery. In some examples, the device may include multiple batteries. In some examples, the multiple batteries may be stacked in series. In some examples, the multiple batteries may be arranged along the longitudinal axis between the first end of the body and the second end of the body.

[0022] According to another aspect of the present technology, a device is provided for indicating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal, the device comprising: a pressure sensor configured to be in fluid communication with the needle aperture of the needle in use; at least one selectively activatable indicator, the at least one selectively activatable indicator comprising an indicator having at least a first indicator output and a second indicator output; the device being configured to activate the first indicator output when the pressure acting on the pressure sensor is within a first pressure range, and configured to activate the second indicator output when the pressure acting on the pressure sensor is within a second pressure range, the second pressure range being configured to be greater than the first pressure range.

[0023] In some examples, the first pressure range may indicate a central venous pressure (CVP). In some examples, the second pressure range may indicate non-CVP. In some examples, the first pressure range may be from about 3 cmH2O to about 40 cmH2O, and in some examples, the second pressure range may be about 40 cmH2O or more.

[0024] In some examples, the device includes a first selectively activatable indicator providing the first indicator output and a second selectively activatable indicator providing the second indicator output.

[0025] In some examples, the pressure sensor includes at least two diaphragms, each diaphragm being configured to be deformable from a first configuration to a second configuration in response to fluid pressure. In some examples, the device may be configured such that the first indicator output is activated when the first diaphragm is in the second configuration and the second diaphragm is in the first configuration. In some examples, the device may be configured such that the second indicator output is activated when the first diaphragm is in the second configuration and the second diaphragm is in the second configuration. In some examples, the at least two diaphragms may be arranged in stages.

[0026] In various examples, the device may include at least one flexible printed circuit portion, a first contact portion configured to contact the first diaphragm when the first diaphragm is in the second configuration, and a second contact portion configured to contact the second diaphragm when the second diaphragm is in the second configuration.

[0027] In various examples, the pressure sensor may include a digital pressure sensor. In various examples, the digital pressure sensor may be configured as a pressure switch, output a first signal that activates a first indicator output when the sensed pressure is within a first pressure range, and output a second signal that activates a second indicator output when the sensed pressure is within a second pressure range. In various examples, the pressure sensor outputs a signal indicating the pressure to a controller, and the controller may selectively activate the first indicator output or the second indicator output of at least one indicator based on a determination of whether the pressure is within the first pressure range or the second pressure range.

[0028] In various examples, at least one selectively activated indicator may be a light. In various examples, the first indicator output may be a first color, and the second indicator output may be a second color different from the first color. In various examples, the first color may be green, and the second color may be red.

[0029] According to another aspect of the present technology, a device for indicating the entry of a needle into a human or animal blood vessel or cavity is provided. The device includes a diaphragm deformable from a first configuration to a second configuration under fluid pressure, and an electrical circuit having at least one energizable indicator, when the diaphragm is in the first configuration, power is not supplied to the indicator, when the diaphragm is in the second configuration, the indicator is powered on, when the diaphragm is deformed to the second configuration, the electrical circuit is completed and power is supplied to the indicator.

[0030] By providing a diaphragm that contacts the surface to complete the electrical circuit, it is possible to create a simple and inexpensive display device. Furthermore, by providing a more easily detectable electric indicator compared to conventional indicators, users can concentrate on their task at hand (e.g., cannula insertion) rather than focusing on monitoring whether the indicator is active. Advantageously, powered indicators can operate even in dark conditions such as battlefields and other emergency non-hospital environments. Visual indicators, such as lights (e.g., LEDs), can be observed in the user's peripheral vision. Audible indicators, such as buzzers, may be audible regardless of where the user is looking.

[0031] In some examples, the electrical circuit includes at least one flexible printed circuit portion, and in a second configuration, the diaphragm displaces the movable portion of the flexible printed circuit so that the movable portion makes contact with the surface, completing the electrical circuit and supplying power to the indicator.

[0032] In some cases, the surface may be another part of a flexible printed circuit or the terminals of a battery.

[0033] In some cases, spacers may be provided to determine the travel distance of the movable parts of a flexible printed circuit.

[0034] In some examples, the diaphragm may include a conductive material that connects the electrical circuit when the diaphragm is in a second position. In some examples, the diaphragm may be formed from a substantially conductive elastomer material.

[0035] In some examples, the diaphragm connects the circuit by contacting one contact when in the second position, and connects the circuit by contacting two contacts when the diaphragm is in the second position. In some examples, when the diaphragm is in the second position, the diaphragm contacts and activates a pressure-operated switch, thereby connecting the circuit.

[0036] In some examples, the diaphragm is held on a projection, and the surface of the projection includes an outlet for a fluid that deforms the diaphragm.

[0037] In some cases, the surface of the projection may include a substantially central outlet for the fluid to deform the diaphragm.

[0038] In many cases, the surface of the projection includes at least one recess. Providing at least one recess reduces the possibility of the membrane adhering to the surface of the projection and hindering its movement. For example, the surface of the projection may be concave or funnel-shaped.

[0039] In some examples, the surface of the projection may include at least one groove on the surface extending from the exit, or it may include multiple grooves on the surface extending from the exit.

[0040] In many cases, projections can be substantially circular, and surfaces can be substantially circular.

[0041] In an exemplary embodiment, the diaphragm may be held on the projection by a ring.

[0042] In some cases, the diaphragm deforms into its second configuration under arterial pressure, but may not deform under venous pressure.

[0043] In some cases, the diaphragm can be deformed into a second configuration under venous pressure and changed to a third configuration under arterial pressure, and when the diaphragm is in the third configuration, no power is supplied to the indicator.

[0044] In some cases, the diaphragm ruptures in the third configuration.

[0045] In various examples, the male conduit portion configured to engage with the female recess of the cannula is one or more of the following lengths: at least 5 mm, at least 6 mm, at least 7 mm, and at least 8 mm. By providing a male conduit portion of at least 8 mm in length, the gap formed when the conduit portion engages with a female recess with a depth of 8 mm can be minimized.

[0046] In some examples, the chamber in which the diaphragm deforms can be fluidly communicated with the outside atmosphere through at least one aperture.

[0047] In some cases, the diaphragm can be crimped.

[0048] According to another aspect of the present technology, a component kit is provided which includes the device of any of the above embodiments and a device tester that includes means for pressurizing the air inside the device to deform the diaphragm.

[0049] In some examples, a device tester may include a hollow, deformable portion that deforms under pressure applied by the user during use, pushing air into the device. In some examples, the hollow, deformable portion may be a valve.

[0050] In some embodiments, the device tester may include a plunger. In some examples, the plunger may include a shaft configured to be inserted into an aperture of the device that forms part of a flow path to a pressure sensor. In some examples, the plunger may include a stopper configured to restrict the shaft from moving further into the device beyond a predetermined point.

[0051] In some examples, the device may be releasably fixed to a cannula containing a needle. In some examples, the needle cover of the needle may include a device tester that can pump air into the device through the needle hole of the needle.

[0052] In another aspect of the present technology, a component kit is provided which includes a device substantially described herein, a cannula including a needle, the device being releasably fixed to the cannula, and a needle cover provided at the tip of the needle, the needle cover including a device tester which includes means for pressurizing air inside the device through the needle hole of the needle to activate an indicator.

[0053] In another aspect of the present technology, a component kit is provided which includes substantially the device described herein, a device tester including means for pressurizing air within the device to activate an indicator of the device, and a sealed package housing the device and the device tester, wherein at least a portion of the sealed package is deformable to allow operation of the device within the sealed package.

[0054] In many cases, at least a portion of the sealed package is at least semi-transparent. In many cases, at least a portion of the sealed package is transparent.

[0055] According to another aspect of the present technology, a component kit is provided which includes a device substantially described herein and a holder configured to hold the device in use.

[0056] In some examples, the holder may include a body having a cavity for holding the device by friction fitting.

[0057] In some examples, at least one outer surface of the holder may include at least one gripping function.

[0058] In some examples, at least a portion of the holder may be made of a transparent material. In some examples, the holder includes at least one opening between the outside of the holder and the device.

[0059] According to another aspect of the present technology, a method is provided for indicating whether a needle is positioned in a human or animal blood vessel or body cavity, comprising the step of providing a device fabricated according to any embodiment described herein.

[0060] The above and other features will become apparent from the following description and attached drawings.

[0061] Further aspects of this disclosure will become apparent from the following description, which is provided for illustrative purposes only with reference to the drawings. [Brief explanation of the drawing]

[0062] [Figure 1A] This is a perspective view of another example of a device manufactured according to one aspect of this technology. [Figure 1B] Figure 1A is a top view of the device. [Figure 1C] Figure 1A is a cross-sectional side view of the device. [Figure 1D] Figure 1A is an exploded perspective view of the device. [Figure 1E] Figure 1A is a bottom view of the device. [Figure 2A] This is a top perspective view of an exemplary diaphragm used in a device manufactured according to one aspect of this technology. [Figure 2B] Figure 2A is a bottom view of the diaphragm. [Figure 2C] Figure 2A is a top view of the diaphragm. [Figure 2D] Figure 2A is a side view of the diaphragm. [Figure 2E] Figure 2A is a cross-sectional side view of the diaphragm. [Figure 3A] This is a top perspective view of an exemplary switch component used in a device manufactured according to one aspect of this technology. [Figure 3B] Figure 3A is a side view of the switch component. [Figure 4] This figure shows an example of a device manufactured according to one aspect of this technology. [Figure 5]This figure shows an example of a device manufactured according to one aspect of this technology. [Figure 6A] This is a cross-sectional view of a device holder manufactured according to one aspect of this technology. [Figure 6B] Figure 6A is a plan view of the holder, showing how the device is held inside the holder. [Figure 7A] This is a cross-sectional view of a first device tester manufactured according to one aspect of this technology. [Figure 7B] Figure 7A is a cross-sectional view of the first device tester, showing how it is attached to a device manufactured according to one aspect of this technology. [Figure 8A] This is a cross-sectional view of a second device tester manufactured according to one aspect of this technology. [Figure 8B] Figure 8A is a cross-sectional view of the second device tester, showing how it is attached to a device manufactured according to one aspect of this technology. [Figure 9] This is a side view of an exemplary needle cover including a test unit according to one aspect of this technology. [Figure 10] This is a plan view of the package of an exemplary test unit attached to an exemplary device according to one aspect of this technology. [Figure 11A] This is an exploded view of the components of a device manufactured according to one aspect of this technology. [Figure 11B] Figure 11A is a perspective view of the assembled device. [Figure 12] Figure 11A is a plan view of the conductive switch component of the device. [Figure 13A] Figure 12 is a plan view of the switch component assembled with the battery and spacer. [Figure 13B] Figure 13A is a side view of the assembly. [Figure 14A] A cross-sectional view of the device in Figure 11B attached to a cannula (the top of the device casing is not shown for clarity). [Figure 14B]Figure 14A shows a close-up of the cross-section of the device shown in Figure 11B, which is circled in the image. [Figure 15] This is an exploded view of the components of a device manufactured according to a further embodiment of the present invention. [Figure 16A] This is a cross-sectional view of a device manufactured according to another embodiment of the present technology. [Figure 16B] This is a perspective cross-sectional view of a device manufactured according to a similar principle as the device in Figure 16A. [Modes for carrying out the invention]

[0063] In this embodiment, the device is a device that indicates entry into a blood vessel, but this technology is not limited to detecting blood pressure for the purpose of cannula insertion. In other embodiments, a device embodying this technology can be used to detect the entry of a needle into a blood vessel or lumen containing other fluids in the body, such as the bladder or spinal cord. Some embodiments of this technology may be intended for use with gaseous fluids.

[0064] Therefore, it should be noted that in this specification, the word “fluid” is intended to have the usual meaning of flowing substances such as liquids and gases, and is not intended to be limited to liquids such as blood. Operating parameters

[0065] In arterial and venous cannula use cases, the exemplary device according to aspects of this technology is configured to activate at least one indicator when the pressure acting on a pressure sensor is above a minimum threshold. The exemplary device according to aspects of this technology was developed to provide reliable indication of the correct needle position, taking into account that training and expert advice instruct the use of a tourniquet when inserting a peripheral venous cannula.

[0066] The tourniquet increased peripheral venous pressure (PVP), but the surrounding tissue pressure remained nearly the same. In healthy patients, PVP ranges from approximately 10 cmH2O to 25 cmH2O, but in critically ill patients, it can drop to 2 cmH2O to 3 cmH2O. If the tourniquet is inadequate or applied to patients with very low blood pressure, the minimum PVP can be as low as 25 cmH2O. Subcutaneous tissue pressure ranges from approximately 1 cmH2O to approximately 13.5 cmH2O. Subcutaneous tissue pressure around veins / arteries can reach a maximum of 4 cmH2O without a tourniquet, a maximum of 6 cmH2O with a tourniquet, and a maximum of approximately 13.5 cmH2O in swollen limbs.

[0067] Therefore, an exemplary device of this technology is configured to activate at least one indicator under all pressures that are very likely to indicate that the needle is located in a vein or artery. In some examples, the minimum threshold may be about 25 cmH2O. More preferably, the minimum threshold may be about 30 cmH2O.

[0068] In addition to accuracy regarding pressure magnitude, the response speed of the device—that is, the rate at which the indicator is activated and / or deactivated in response to pressure changes—is considered crucial for clinical utility. The purpose of this device is to provide the user with feedback regarding the correct placement of the intravascular needle. If the indicator is not turned on or off at the appropriate time, the risk of incorrect needle placement increases. Therefore, an exemplary device of this technology may be configured to activate and / or deactivate the indicator within approximately one second after the pressure exceeds or falls below a minimum threshold value. Generally speaking, the smaller the pressure difference between the vein and the tissue, the slower the response time. Therefore, a minimum threshold above 25 cmH2O (e.g., approximately 30 cmH2O) is expected to help achieve the desired response time.

[0069] Another requirement for clinical utility is that the indicator remains active across the expected pressure range from the patient while the needle is in a vein or artery. Failure of the pressure sensor or indicator under such expected conditions reduces the usefulness of the device. It is understood that various examples of devices can be configured to operate at different levels of upper limit operating ranges, depending on the acceptable tolerance for the possibility of not being able to detect the presence of a needle in an abnormal patient's vein or artery. For example, it is estimated that 99% of all patients will fall within a pressure range of approximately 30 cmH2O to approximately 250 cmH2O. Therefore, it is expected that examples of devices can be configured to activate the indicator at all pressures from the minimum pressure up to at least approximately 250 cmH2O.

[0070] For completeness, please understand that alternative configurations are also being considered. For example, it is estimated that 90% of all patients may fall within a pressure range of approximately 30 cmH2O to approximately 100 cmH2O. In some cases, the device may be configured to activate at least one indicator at all pressures from the minimum threshold up to at least 100 cmH2O. As a further example, the device may be configured to activate at least one indicator up to a value exceeding approximately 250 cmH2O from the minimum threshold (e.g., at least 500 cmH2O), which may increase the likelihood that the device will function for any particular individual. This does not preclude embodiments in which the device activates an indicator when this value is exceeded, but rather emphasizes the intention that the device will continue to function at least up to that point. Needle entry indicator device

[0071] Figures 1A to 1E show an exemplary device 100 for demonstrating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal. In this example, the device 100 includes a body 120 which includes a first body 122 and a second body 124. The first body 122 includes a male conduit 126 surrounded by an annular ridge 128 defining an annular recess 130 for receiving a cannula (not shown) so that a Luer taper connection is formed. The fluid port 132 of the male conduit 126 includes an inlet 134 located outside the body 120 and an outlet 136 located in a first internal cavity 138 of the body 120.

[0072] Referring to Figures 1C and 1D, the annular diaphragm retaining member 140 is held inside between the first body portion 122 and the second body portion 124. The diaphragm retaining member 140 tightens the diaphragm 200 against the first body portion 122 and holds it in place. Referring to Figures 2A to 2E, in these examples, the diaphragm 200 includes an outer annular rim 202, a central portion 204, and an annular corrugated shape 206 extending between the annular rim 202 and the central portion 204. A cylindrical projection 208 extends from the central portion 204.

[0073] Referring to Figure 1C, the diaphragm 200 is positioned such that the projection 208 faces away from the fluid port 132. In this example, the inlet 134 and outlet 136 of the fluid port 132 are axially aligned with the central portion 204 of the diaphragm 200. The surface of the diaphragm 200 from which the projection 208 extends faces the second internal cavity 142. The second internal cavity 142 houses the switch unit 300, the battery 400, and the spacer 600.

[0074] Referring to Figures 3A and 3B, the switch unit 300 is fabricated from a flexible circuit board with conductive tracks printed on it. The switch unit 300 includes a first contact portion 302, a second contact portion 304, and a bridge portion 306 between the first contact portion 302 and the second contact portion 304. The second contact portion 304 is provided with an indicator in the form of an LED 500. In some examples, the LED 500 may emit light in the visible light spectrum. However, alternative examples are possible in which the light is in a spectrum other than visible light (such as near-infrared or infrared), such as when used in combination with a night vision device.

[0075] As shown in Figure 1C, two batteries 400 are positioned between the first contact portion 302 and the second contact portion 304. In this example, the batteries 400 are alkaline to facilitate the disposal of the device 100, especially in the case of disposable devices. In this example, the batteries 400 are stacked in series, allowing for a sufficiently high voltage while maintaining a narrow diameter footprint. For example, the batteries 400 may be LR41 button cells, but it should be understood that this does not limit all embodiments of this technology.

[0076] In this example, a spacer 600 made of silicon material is provided between the LED 500 and the distal end of the second internal cavity 142, which helps to achieve the desired positioning of the switch unit 300 relative to the diaphragm 200 and the battery 400.

[0077] During use, when the pressure from the fluid entering the first cavity 138 reaches a minimum threshold, i.e., the activation pressure, this pressure displaces the diaphragm 200, causing the projection 208 to press the first contact portion 302 of the switch unit 300 against the nearby battery 400, completing the circuit and turning on the LED 500. Since the circuit is completed only to activate the LED 500 under target pressure, no power is consumed by the battery 400 when the device 100 is not actively used or when the pressure is below the minimum threshold. This means that the battery life of the device 100 is maintained longer than that of a device that constantly consumes power to monitor pressure. This allows for the use of smaller capacity batteries, which may result in a reduction in the device's footprint, weight, and cost, potentially extending the device's shelf life and avoiding the need for power-saving measures that could increase the device's complexity and cost.

[0078] In the use of arterial and venous cannulas, the device 100 is configured such that the LED 500 turns on when the pressure in the first cavity 138 (i.e., the pressure acting on the diaphragm 200) is in the range of approximately 30 cmH2O to at least 500 cmH2O. For completeness, this configuration means: (1) the LED 500 lights up when the pressure reaches 30 cmH2O; (2) the LED 500 remains lit while the pressure is 30 cmH2O or greater; (3) the LED 500 can remain lit while the pressure is between 30 cmH2O and 500 cmH2O; (4) the LED 500 turns off when the pressure falls below 30 cmH2O.

[0079] In some examples, the second body section 124 includes an air port 144 between the second cavity 142 and the outside of the body 120. The air port 144 equalizes the pressure inside the second cavity 142 to atmospheric pressure, allowing the device 100 to be used at various altitudes and enabling transport at abnormal pressures (e.g., inside an aircraft) without damaging the diaphragm membrane. In this example, the air port 144 is provided through the end wall 146 of the second body section distal to the fluid port 132. Placing the air port 144 in this position ensures that it is away from the weld between the first body section 122 and the second body section 124.

[0080] The outer ridge 148 on the outside of the second main body 124 provides a grip for the user's fingers or a holder, as schematically described with reference to Figures 6A and 6B.

[0081] The devices constructed using the method described above with respect to Figures 1A to 1E were tested to confirm that they function correctly. A hydraulic test fixture was established. This fixture consisted of a cylindrical reservoir containing a dry break valve into which the device was inserted, and the diaphragm was exposed to the pressure within the reservoir. The reservoir was filled with simulated blood up to the filling line and pressurized to the target pressure value in the headspace using a pneumatic pump via a Schrader valve. Three devices were tested at 20 cmH2O and 25 cmH2O, and it was confirmed that the devices would not activate below the design pressure of 30 cmH2O. The test procedure was repeated, and the test pressure was increased by 10 cmH2O increments from 30 cmH2O to 250 cmH2O. After testing at 250 cmH2O, the test pressure was increased by 50 cmH2O increments until it reached the maximum pressure of 500 cmH2O. This was repeated three times for each device. This test procedure was repeated for all three devices.

[0082] Initially, the plan was to record the response time for each test to ensure that the activation / deactivation time was less than one second. However, it was observed that the LEDs lit up almost instantaneously, and the results depended primarily on the test operator's reaction time, leading to misleading results. Instead, it was decided to record only the activation and deactivation, using a pass / fail criterion based on whether the device activated and deactivated immediately in response to the pressure change.

[0083] Overall, all three devices functioned correctly. The LEDs did not illuminate when the pressure was below 30 cmH2O. All devices operated consistently across the entire pressure range from the design pressure of 30 cmH2O to the maximum pressure of 500 cmH2O. All three devices immediately and correctly deactivated when the dry break valve was closed.

[0084] Figure 4 schematically shows another exemplary device 1000 demonstrating the entry of a needle into a blood vessel or body cavity of a human or animal. In this example, device 1000 includes a digital pressure sensor 1100 that is in fluid communication with the needle hole of the needle in use. In this example, the digital pressure sensor 1100 may be configured as a pressure switch and output a signal that activates an indicator 1200 (e.g., an LED) when the sensed pressure is within a target pressure range (e.g., about 30 cmH2O to about 500 cmH2O). In another example, the pressure sensor 1100 outputs a pressure signal to a controller 1300, which may selectively activate the indicator 1200 based on a determination of whether the pressure is between about 30 cmH2O and about 500 cmH2O.

[0085] Figure 5 schematically shows another exemplary device 2000 illustrating the insertion of a needle into a human or animal blood vessel or body cavity during central venous line (or central venous catheter) placement. Complications due to accidental arterial puncture are widely recognized during central venous catheter insertion. In the first embodiment, the device 2000 includes a first pressure sensor arrangement 2100a that is in fluid communication with the needle hole of the needle in use, the first pressure sensor arrangement 2100a includes two diaphragms, each diaphragm configured to be deformable from a first configuration to a second configuration in response to fluid pressure. The first diaphragm is configured to deform to a second configuration when the pressure is within a first pressure range, and the second diaphragm is configured to deform to a second configuration when the pressure is within a second pressure range. In some examples, the first pressure range may represent central venous pressure (CVP). In some examples, the second pressure range may represent non-CVP. In some examples, the first pressure range can be from approximately 3 cmH2O to approximately 40 cmH2O, and in some examples, the second pressure range can be from approximately 40 cmH2O to approximately 500 cmH2O.

[0086] The device 2000 includes a circuit 2200 that selectively controls the operation of an indicator 2300 having a first indicator output 2302a and a second indicator output 2302b, depending on the activation of the first and / or second diaphragm. For example, the indicator 2300 is a multicolor LED capable of selectively emitting green and red light. During use, the green light illuminates when the pressure is within a first range, i.e., when the needle is correctly positioned in the vein. The red light illuminates when the pressure rises to a second range. This indicates that an arterial puncture has occurred and prompts corrective action.

[0087] In other examples, device 2000 includes a second pressure sensor arrangement 2100b in the form of a digital pressure sensor that is in fluid communication with the needle hole of a needle in use. In some examples, the pressure sensor 2100b may output a pressure-indicating signal to a circuit 2200 including a controller, which may selectively activate a first indicator output 2302a or a second indicator output 2302b based on a determination of whether the pressure is within a first pressure range or a second pressure range. Device holder

[0088] Referring to Figures 6A and 6B, a holder 600 for a device 100 manufactured according to the present technology is shown, the holder 600 comprising a body 602 having a cavity 604 configured to snugly accommodate the device 100. The cavity 604 is sized to hold the device 100 by friction fit.

[0089] The body 602 is formed of a transparent material so that the user can observe when the LED of device 100 is activated. The see-through material can be transparent or translucent. In some embodiments, only a portion of the body 602 may be transparent, or a window or opening may be provided to allow the LED to be seen. In other embodiments in which device 100 includes an audible indicator, an opaque material may be used to form the body.

[0090] The main body 602 is ergonomically designed to allow the user to easily operate the device housed inside, even in difficult situations such as on the battlefield. For example, a grip feature in the form of an indentation 606 may be provided on the outside of the holder 606. Device Tester

[0091] Referring to Figures 7A and 7B, the first device tester 700 includes a hollow valve 702 which includes a tubular connector 704 having an inner bore 706 that is fitted snugly into the male conduit portion 126 of the device 100 and adapted to form an airtight fit.

[0092] Before using device 100, the user can attach the device tester 700 to the male conduit 126, squeeze the valve 702 to inject air into device 100, and observe whether its indicator is energized, thereby testing whether device 100 is operational. The valve 702 is sized to inject enough air into device 100 to deform its diaphragm and activate its indicator, without injecting so much air that it damages the diaphragm.

[0093] In some embodiments, the device tester 700 may be attached to the male conduit portion 126 of the device 100 by a destructible connection.

[0094] Figures 8A and 8B show a second device tester in the form of a plunger 800 having a shaft 802, a handle 804, and a stopper 806. The shaft 802 is configured to fit snugly into the male conduit portion 126 of the device 100, thereby injecting air into the device 100 to test the operation of its diaphragm. The shaft 802 is provided with a stopper 806 to prevent excessive pressure from being applied to the diaphragm, which could result in damage to the diaphragm.

[0095] Referring to Figure 9, in some examples, the assembly 3000 includes the device 100 according to the Art, which is releasably fixed to a cannula containing a needle 3200. In these examples, the needle cover 3300 of the needle 3200 includes an integrated device tester 3400 in the shape of a light bulb. The device tester 3400 can be operated to blow air into the device 3100 and test its operation before removing the cover 3300 to expose the needle 3200.

[0096] Referring to Figure 10, the component kit 4000 includes a device 4100 and a device tester 4200 which is removably fixed to the device 4100 and includes means for injecting air into the device 4100 to test its operation. The combination of device 4100 and device tester 4200 is housed in a sealed package 4300. The sealed package 4300 is deformable to allow operation of the device tester 4200 within the sealed package 4300 and is at least translucent to allow viewing of the indicator's operation. For example, the sealed package 4300 may include a base portion 4302 and a translucent or transparent window portion 4304. This allows the device 4100 to be tested before opening the sealed package and allows for easy disposal if the device 4100 fails the test. Further examples of needle entry indicator devices Referring to Figures 11A and 11B, a device 5000 manufactured according to one embodiment of the present technology includes a casing 5002 formed from a lower section 5002a, an intermediate section 5002b, and an upper section 3. The casing 5002 is made of a transparent plastic material.

[0097] The lower section 5002a includes a fluid inlet 5004 located at the free end of an elongated, tapered male conduit section 5006. The conduit section 5006 extends from the side of the lower section 5002a. A cylindrical disc-shaped projection 5010 having a substantially circular upper surface 5012 is positioned on the upper surface 5008 of the lower section 5002a.

[0098] A fluid outlet 5014 is located near the center of the upper surface 5012, which is in fluid communication with the fluid inlet 5004 via an internal conduit 5016. Four grooves 5018a, 5018b, 5018c, and 5018d are formed on the upper surface 5012 of the cylindrical projection 5010, extending from the fluid outlet 5014, with each groove extending radially toward the circular periphery of the upper surface 5012.

[0099] The diaphragm 5020 is configured to accommodate the projection 5010 and further includes a peripheral flange 5022 that is positioned on the upper surface 5008 of the lower part 5002a and extends away from the projection 5010 when the device 5000 is assembled.

[0100] The diaphragm 5020 is positioned on the projection 5010, fits around the projection 5010, and is secured in place by a rubber ring 5024 that rests on the flange 5022 of the diaphragm 5020. As a result, the flange 5022 of the diaphragm 5020 is sandwiched between the rubber ring 5024 and the upper surface 5008 of the lower part 5002a.

[0101] The intermediate portion 5002b of the casing 5002 includes a substantially disc-shaped chamber 5026 configured to house the projection 5010 and the diaphragm 5020, the circular portion of the diaphragm 5020 located on the circular surface 5012 of the projection 5010 being substantially flush with the upper surface 5028 of the intermediate portion 5002b.

[0102] The switch unit 5030, battery 5032, and spacer 5034 assembly are placed on the upper surface 5028 of the intermediate section 5002b and bonded thereto. Referring to Figure 12, the switch unit 5030 is a flexible printed circuit including a first contact 5032, a conductive ring 5034, and a second contact 5036.

[0103] When assembled, the spacer 5034 is positioned between the conductive ring 5034 and the battery 5038, and the second contact 5036 of the switch unit 5030 folds down to contact the top surface of the battery 5032. The spacer 5034 is bonded to the conductive ring 5034.

[0104] The first contact 5032 is located in the plane of the conductive ring 5034 and is therefore spaced apart from the underside of the battery 5032 by the thickness of the spacer 5034. The first contact 5032 is elastic and flexible, substantially elongated, and includes a free end. An LED 5040 is positioned on the conductive ring 5034, but is not covered by the spacer 5034 due to an aperture within the spacer 5034. A foam pad 5042 is provided between the upper part 5002c of the casing 5002 and the second contact 5036 to maintain contact with the upper surface of the battery 5032. When assembled, the lower part 5002a, the middle part 5002b, and the upper part 5002c of the casing 5002 are screwed together at their four corners (screws are not shown).

[0105] Turning to the device 5000 in use, referring to Figure 14A, the device 5000 can be attached to the cannula 5100 by inserting the tapered male conduit portion 5006 into the corresponding frustoconical female recess 5102 on the cannula 5100, thereby forming a Luer taper connection. Thus, the needle 5104 is in fluid communication with the fluid outlet 5014 via the internal conduit 5016.

[0106] The needle 5104 is inserted into the patient's body. If located in a vein or artery, blood enters the conduit 5016 and exits the fluid outlet 5014, deforming the diaphragm 5020 from a first (undeformed) configuration to a second configuration, where the diaphragm 5020 deforms enough to press the first contact 5032, which contacts the underside of the battery 5038 and connects to the circuit illumination LED 5040. The user of device 5000 then knows that the needle 5104 is located in a vein or artery and that cannula insertion may be performed.

[0107] When the needle 5104 is dislodged from the vein or artery, the pressure at the fluid outlet 5014 decreases, the diaphragm 5020 returns to its first configuration, the electrical circuit is disconnected, and the LED 5014 is deactivated. The user then knows that the needle is not in the correct position for cannula insertion.

[0108] During use, grooves 5018a, 5018b, 5018c, and 5018d prevent the diaphragm 5020 from sticking to the upper surface 5012 of the cylindrical projection 5010. It is beneficial that by simply changing the thickness of the spacer 5034, different devices can be adapted to activate at different pressures. Furthermore, by changing the thickness of the rubber ring 5024, the tension of the diaphragm 5020, and therefore the pressure at which the diaphragm 5020 deforms, can be changed. In addition, by changing the thickness and / or length of the first contact 5032 of the switch unit 5030, the pressure at which the LED 5040 is activated can be changed.

[0109] Referring to Figure 14A, it was found that, depending on the dimensions of the male conduit portion 5006 and the female recess portion 5102, an empty space 5106 may be formed in the lure connection portion. This is undesirable because if the space 5106 is filled, the activation of the LED 5040 will be delayed.

[0110] Therefore, it is preferable that the male conduit section 5006 be sized to minimize the empty space 5106. The depth of the female recess is approximately 8 mm, and in order to minimize the empty space, the length of the male conduit section 5106 is approximately 8 mm.

[0111] Advantageously, the diaphragm can be deformed to a second position and configured to power the indicator at a very specific pressure. Thus, in some embodiments, the diaphragm is configured to deform under arterial pressure but not under venous pressure, thereby allowing the user to determine that the needle is positioned in an artery rather than a vein, which can be important when drawing blood for the purpose of blood gas analysis.

[0112] In further embodiments, the diaphragm may be deformable into a second configuration under venous pressure and into a third configuration under arterial pressure, for example by rupture or expansion. In the third configuration, the indicator is not powered. Such an arrangement may cause irreparable damage to the device, but it can prevent undesirable arterial cannula insertion.

[0113] Referring to Figure 15 and another embodiment of a device manufactured according to this technology, device 6000 is substantially identical to device 5000 and has a substantially disc-shaped chamber 6002 in which a diaphragm 6004 is housed.

[0114] The difference between device 6000 and device 5000 is that device 6000 has an aperture 6006 on the side wall of the intermediate section 6008 of its casing, which allows the chamber 6002 to be in fluid communication with the outside of device 6000. It is preferable to provide the aperture 6006 in order to allow the diaphragm 6004 to deform freely. The aperture 6006 also allows device 6000 to be used at different altitudes and different atmospheric pressures.

[0115] Referring to Figures 16A and 16B, and further embodiments of devices manufactured according to the present art, device 7000 has a different diaphragm arrangement including a crimped diaphragm 7002. The diaphragm 7002 is crimped in the sense that it includes an annular corrugation 7004 extending in the direction of the switch of device 7000. The diaphragm 7002 further includes a central ridge portion 7006 extending in the direction of the switch of device 7000, and the switch of device 7000 is operated when device 7000 is used and the diaphragm 7002 is deformed by pneumatic pressure.

[0116] In contrast to the examples in Figures 11A and 15, the diaphragm 7002 is not positioned on a protrusion but is secured by a rubber ring. Instead, the diaphragm 7002 is held in place above the air inlet by the circumferential rib 7008 of the diaphragm 7002 being held between the lower part 7010a of the casing of the device 7000 and the middle part 7010b of the casing of the device 7000. Because the crimped diaphragm can move freely, it is more responsive and less likely to stick to the surface of the device and hinder its movement, so including a crimped diaphragm may be advantageous compared to a planar diaphragm.

[0117] In this embodiment, the diaphragm is formed of a non-conductive material, but in other embodiments, the diaphragm may be formed of a conductive rubber material. For example, the non-conductive diaphragm may be provided with a conductive coating, conductive particles throughout, or a conductive connector.

[0118] In this specification, the phrase “touching the surface” is intended in its broadest sense to include at least both simply coming into contact with the surface (if the diaphragm is conductive) and applying pressure to the surface (if the diaphragm activates a pressure-operated switch).

[0119] All references, including patents or patent applications, cited herein are incorporated herein by reference. No reference is considered to constitute prior art. The discussion of a reference presents the claims of its author, and applicants reserve the right to challenge the accuracy and validity of the cited documents. While numerous prior art documents are referenced herein, it is clear that these references do not constitute an endorsement that any of these documents form part of the common general knowledge of the art in any country of the world.

[0120] Unless otherwise clearly indicated in the context, throughout the description and claims, the words “comprise,” “comprising,” and similar phrases shall be interpreted in a comprehensive sense, that is, “including, but not limited to,” and not in an exclusive or exhaustive sense.

[0121] Broadly speaking, the present invention consists of the parts, elements, and features referred to or shown herein, individually or collectively, or of any combination of two or more or all of the said parts, elements, or features. Where, in the foregoing description, an integer or its equivalent is referred to as a known component, those integers are incorporated herein as if they were individually described.

[0122] Various changes and modifications to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the disclosure and without impairing the advantages associated with the disclosure. Accordingly, such changes and modifications are intended to be included within the scope of the disclosure as defined by the appended claims.

Claims

1. A device for indicating the entry of a needle into a body cavity, tube, or blood vessel of a human or non-human animal, A pressure sensor configured to communicate with the needle hole of a needle in use, A system comprising at least one selective activation indicator, The device is configured to activate an indicator when the pressure acting on the pressure sensor is greater than or equal to a minimum pressure threshold, which is approximately 25 cmH. ２ A device that is O.

2. The minimum pressure threshold is approximately 30 cmH ２ The device according to claim 1, wherein the value is 0 or greater.

3. At least 100 cmH from the minimum threshold. ２ The device according to claim 1 or 2, configured to activate at least one of the indicators at all pressures up to OO.

4. At least 250 cmH from the minimum threshold. ２ The device according to any one of claims 1 to 3, configured to activate at least one of the indicators at all pressures up to 0.

5. At least 500 cmH from the minimum threshold. ２ The device according to any one of claims 1 to 4, configured to activate at least one of the indicators at all pressures up to 0.

6. The device according to any one of claims 1 to 5, wherein the pressure sensor includes at least one diaphragm that is deformable from a first configuration to a second configuration under fluid pressure, wherein in the first configuration the indicator is not activated, and in the second configuration the indicator is activated.

7. The device according to claim 6, wherein the diaphragm closes the switch and activates the indicator in the second configuration.

8. The device according to any one of claims 1 to 6, comprising a body housing the pressure sensor, wherein the body includes a first internal cavity between the first surface of the diaphragm and a fluid port that communicates fluidly with the needle hole of the needle during use.

9. The device according to claim 8, wherein the body includes a second internal cavity partially formed by a second surface of the diaphragm opposite to the first surface, and at least one air port between the second internal cavity and the outside of the body.

10. The device according to claim 9, wherein the at least one air port is provided on the end face of the main body distal to the fluid port.

11. The device according to claim 9 or 10, wherein the main body includes a plurality of air ports.

12. The device according to any one of claims 8 to 11, wherein the fluid port includes an inlet to the outside of the body and an outlet to the first internal cavity, and the inlet and outlet of the fluid port are axially aligned with the central portion of the diaphragm.

13. The device according to any one of claims 1 to 12, comprising a plurality of alkaline batteries stacked in series along the longitudinal axis between the first end and the second end of the main body.

14. The device according to claim 1, wherein the pressure sensor includes a digital pressure sensor.

15. The device according to claim 14, wherein the digital pressure sensor is configured as a pressure switch and outputs a signal to activate an indicator when the sensed pressure exceeds the minimum pressure threshold.

16. The device according to claim 15, wherein the digital pressure sensor is configured to output a pressure signal to a controller, and the controller is configured to selectively activate the indicator based on a determination of whether the pressure exceeds the minimum pressure threshold.

17. The device according to any one of claims 1 to 16, wherein the indicator includes light configured to emit light in the non-visible spectrum.

18. The device according to claim 17, wherein the light is configured to emit near-infrared or infrared light when in operation.

19. It is a parts kit, A device according to any one of claims 1 to 18, A cannula including a needle, wherein the device is releasably fixed to the cannula, and the cannula and A component kit comprising: a needle cover provided on the needle, the needle cover including a device tester which includes means for pressurizing air inside the device through the needle hole of the needle to activate the indicator; and

20. It is a parts kit, A device according to any one of claims 1 to 18, A device tester including means for pressurizing the air inside the device to activate the indicator of the device, A component kit comprising: a sealed package for housing the device and the device tester, wherein at least a portion of the sealed package is deformable, allowing the device tester to operate within the sealed package.

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