DISPOSITIVO DE INDICAÇÃO DE ENTRADA DE CAVIDADE CORPORAL, DUCTO OU VASO

Abstract

A device to indicate entry of a needle into a body cavity, duct, or vessel of a human or non-human animal has a pressure sensor configured to be in fluid communication with a needle bore of the needle in use, and a selectively activated indicator. The device is configured to activate the indicator while pressure acting on the pressure sensor is at or above a minimum pressure threshold, wherein the minimum pressure threshold is about 25 cmH2O.

Description

1 / 44 DEVICE FOR INDICATING ENTRY INTO A BODY CAVITY, DUCT OR VESSEL TECHNICAL FIELD

[001] The present technology relates to a device for indicating when an invasive device, such as a catheter needle, enters a body cavity, duct or vessel of a human or non-human animal - more particularly a blood vessel (e.g., a vein or artery). FUNDAMENTALS

[002] Peripheral intravenous catheters are the most commonly used invasive devices for obtaining blood samples or for administering drugs, fluids, and blood products. Both intravenous and arterial cannulation involve puncturing a vein or artery with an intravascular needle, followed by inserting a plastic tube (catheter) over the needle and into the vein or artery. The catheter remains inside the vein or artery while the needle is discarded.

[003] It is not uncommon for multiple punctures to be required to achieve successful catheterization. If the needle tip comes out of the vein or artery during cannulation, for example, due to patient movement or a double venipuncture, before the catheter is advanced, it becomes impossible to successfully advance the catheter into the vein. Petition 870250101784, dated 06 / 11 / 2025, p. 8 / 69 2 / 44

[004] These successive attempts can cause pain and delay the start of diagnostic treatments or examinations. In addition, repeated punctures can degrade the vascular walls, which complicates subsequent attempts. This can cause serious complications associated with vascular access, such as hematomas, catheter-related infection, extravasation, hemorrhages, phlebitis, and sepsis.

[005] Devices to indicate the position of a needle have been proposed. However, such devices are not considered sufficiently reliable to be clinically useful and / or are prohibitively expensive due to the complexity of the components and construction, and / or are poorly suited for use in high-pressure scenarios, such as when providing emergency medical treatment at a point of injury in a combat or training environment.

[006] The aim of this description is to address at least one of the above problems or, at least, to provide the public with a useful choice.

[007] Other aspects and advantages of the present description will become evident from the following description, which is provided only by way of example. SUMMARY

[008] According to one aspect of the present technology, a device is provided for indicating the entry of a needle into a body cavity, duct or vessel of a human animal. Petition 870250101784, dated 06 / 11 / 2025, page 9 / 69 3 / 44 or non-human, the device comprising: a pressure sensor configured to be in fluidic communication with a needle hole of the needle in use; and at least one selectively activated indicator, wherein the device is configured to activate the indicator while the pressure acting on the pressure sensor is above a minimum limit.

[009] In examples, the device can be configured to disable the indicator while the pressure acting on the pressure sensor is below the minimum limit.

[0010] Examples of the device of the present technology can be configured for use in various body cavities, ducts, or vessels of a human being or non-human animal. Although examples of the present technology can be configured for use in indicating the entry of a needle into a blood vessel of a human being (e.g., a vein or artery), it should be noted that the principles of these examples can be adapted for use in other body cavities, ducts, or vessels.

[0011] According to another aspect of the present technology, a device is provided for indicating the entry of a needle into a body cavity, duct or vessel of a human or non-human animal, the device comprising: a pressure sensor configured to be in Petition 870250101784, dated 06 / 11 / 2025, page 10 / 69 4 / 44 fluidic communication with a needle hole of the needle in use; and at least one selectively activated indicator, wherein the device is configured to activate the indicator while the pressure acting on the pressure sensor is about 25 cmH2O or above.

[0012] In examples, the device can be configured to activate at least one indicator while the pressure acting on the pressure sensor is about 30 cmH2O or above.

[0013] In examples, the device can be configured to activate at least one indicator at all pressures from the minimum limit up to at least 100 cmH2O. In examples, the device can be configured to activate one indicator at all pressures from the minimum pressure up to at least 250 cmH2O. In examples, the device can be configured to activate at least one indicator at all pressures from the minimum limit up to approximately 500 cmH2O.

[0014] In examples, at least one indicator may be configured to emit a visual signal when activated. For example, at least one indicator may be configured to emit light when activated. In examples, the indicator may comprise a light configured to emit light in the visible spectrum. In examples, the indicator may comprise a light configured to emit light in the non-visible spectrum. In Petition 870250101784, dated 06 / 11 / 2025, page 11 / 69 5 / 44 examples, the indicator can emit infrared or near-infrared light when activated.

[0015] In examples, at least one indicator can be configured to emit a sound signal when activated.

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

[0017] In examples, the device may comprise at least one flexible printed circuit board. In examples, the device may be configured in such a way that, in its second configuration, the diaphragm moves at least a movable portion of the flexible printed circuit board to complete an electrical circuit and activate the indicator.

[0018] In examples, the pressure sensor may comprise a digital pressure sensor. In examples, the digital pressure sensor may be configured as a pressure switch, emitting a signal to activate the indicator when the detected pressure is above the minimum limit. In examples, the pressure sensor may emit a pressure indication signal to a controller, and the controller may selectively activate the indicator based on the Petition 870250101784, dated 06 / 11 / 2025, page 12 / 69 6 / 44 determination of whether the pressure is above the minimum limit.

[0019] In examples, the device may comprise a body containing the pressure sensor. In examples comprising at least one diaphragm, the body may comprise a first internal cavity between a first face of the diaphragm and a fluid orifice in fluidic communication with the needle bore in use. In examples, the body may comprise a second internal cavity formed in part by a second face of the diaphragm opposite the first face. In examples, the body may comprise at least one air orifice between the second cavity and an external part of the body. In examples, the at least one air orifice may be provided on an end surface of the body distal to the fluid orifice. In examples, the body comprises a plurality of air orifices.

[0020] In examples, the fluid orifice may comprise an inlet on the outside of the body and an outlet in the first internal cavity. In examples, the inlet and outlet of the fluid orifice may be axially aligned with a central portion of the diaphragm.

[0021] In examples, the device may comprise at least one battery. In examples, at least one battery may be an alkaline battery. In examples, at least one battery may be a button-type battery. In examples, the device may include a plurality of batteries. In Petition 870250101784, dated 06 / 11 / 2025, page 13 / 69 / 44 examples, the plurality of batteries can be stacked in series. In examples, the plurality of batteries can be provided along a longitudinal geometric axis between a first end of the body and a 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, duct or vessel of a human or non-human animal, the device comprising: a pressure sensor configured to be in fluidic communication with a needle hole of the needle in use; and at least one selectively activated indicator, wherein the at least one selectively activated indicator has at least one first indicator output and one second indicator output; where the device is configured to: Activate the first output of the indicator when the pressure acting on the pressure sensor is within a first pressure range; and activate the second output of the indicator when the pressure acting on the pressure sensor is within a second pressure range, where the second pressure range is greater than the first pressure range.

[0023] In examples, the first pressure range can Petition 870250101784, dated 06 / 11 / 2025, page 14 / 69 8 / 44 may be indicative of central venous pressure (CVP). In examples, the second pressure range may be indicative of non-CVP. In examples, the first pressure range may be from about 3 cmH2O to about 40 cmH2O. In examples, the second pressure range may be about 40 cmH2O and above.

[0024] In examples, the device comprises a first selectively activated indicator that provides the first indicator output and a second selectively activated indicator that provides the second indicator output.

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

[0026] In examples, the device may comprise at least one portion of flexible printed circuit board, comprising a first contact portion configured Petition 870250101784, dated 06 / 11 / 2025, page 15 / 69 9 / 44 to contact the first diaphragm when the first diaphragm is in the second setting, and a second contact portion configured to contact the second diaphragm when the second diaphragm is in the second setting.

[0027] In examples, the pressure sensor may comprise a digital pressure sensor. In examples, the digital pressure sensor may be configured as a pressure switch, emitting a first signal to activate the first indicator output when the detected pressure is within the first pressure range and emitting a second signal to activate the second indicator output when the detected pressure is within the second pressure range. In examples, the pressure sensor may emit a pressure indication signal to a controller, and the controller may selectively activate either the first indicator output or the second indicator output, generating at least one indicator based on determining whether the pressure is within the first or second pressure range.

[0028] In examples, at least one selectively activated indicator may be a light. In examples, the first output of the indicator may have a first color and the second output of the indicator may have a second color different from the first color. In examples, the first color may be green and the second color may be red. Petition 870250101784, dated 06 / 11 / 2025, page 16 / 69 10 / 44

[0029] According to another aspect of the present technology, a device is provided for indicating the entry of a needle into a human or animal vessel or cavity, comprising: a diaphragm that is deformable under fluid pressure from a first configuration to a second configuration; an electrical circuit with at least one energizable indicator; wherein when the diaphragm is in its first setting, the indicator is not energized; When the diaphragm is in its second configuration, the indicator is energized, and the deformation of the diaphragm in its second configuration completes the electrical circuit and energizes the indicator.

[0030] By providing a diaphragm that touches a surface so as to complete an electrical circuit, a simple and inexpensive indicator device can be created. Furthermore, by providing an energized indicator that is more easily detectable compared to indicators of the previous technique, the user can concentrate on the task at hand (e.g., cannulation) instead of focusing on monitoring whether an indicator is activated or not. Advantageously, an energized indicator can operate in low-light situations, such as battlefields or other environments. Petition 870250101784, dated 06 / 11 / 2025, page 17 / 69 11 / 44 non-hospital emergencies. A visual indicator, such as a light (like an LED), can be observed by the user's peripheral vision. An audio indicator, such as a buzzer, can be heard by a user regardless of where they are looking.

[0031] In examples, the electrical circuit may comprise at least one portion of flexible printed circuit board and, in its second configuration, the diaphragm displaces a moving part of the flexible printed circuit board so that the moving part touches a surface to complete the electrical circuit and energize the indicator.

[0032] In examples, the surface can be another part of the flexible printed circuit board or a battery terminal.

[0033] In examples, a spacer may be provided to determine the displacement distance of the moving part of the flexible printed circuit board.

[0034] In examples, the diaphragm may comprise a conductive material that connects the electrical circuit when the diaphragm is in its second position. In examples, the diaphragm may be substantially formed of conductive elastomeric material.

[0035] In examples, when the diaphragm is in its second position, it touches a single contact to connect the circuit, or when the diaphragm is in its second position, it touches two contacts to connect the circuit. In examples, Petition 870250101784, dated 06 / 11 / 2025, page 18 / 69 12 / 44 when the diaphragm is in its second position, it touches and activates a pressure-operated switch to connect the circuit.

[0036] In examples, a diaphragm may be retained over a projection, wherein one face of the projection comprises an outlet for the fluid to deform the diaphragm.

[0037] In examples, one face of the projection may comprise a substantially central outlet for the fluid to deform the diaphragm.

[0038] In examples, one projection face comprises at least one notch. The provision of at least one notch can reduce the possibility of a membrane being prevented from moving by adhering to the projection face. For example, one projection face may be concave or funnel-shaped.

[0039] In examples, a projection face may comprise at least one groove on its surface extending from the exit, or comprise a plurality of grooves on its surface extending from the exit.

[0040] In examples, the projection may be substantially circular and the face may be substantially circular.

[0041] In exemplary embodiments, the diaphragm may be retained in projection by a ring.

[0042] In examples, the diaphragm may be deformable in its second configuration under arterial pressure, but not under Petition 870250101784, dated 06 / 11 / 2025, page 19 / 69 13 / 44 venous pressure.

[0043] In examples, the diaphragm may be deformable in its second configuration under venous pressure and changeable to a third configuration under arterial pressure, and when the diaphragm is in its third configuration, the indicator is not energized.

[0044] In examples, in its third configuration, the diaphragm is broken.

[0045] In examples, a male conduit portion configured to couple to the female recess of a cannula has 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 with a length of at least 8 mm, the void space formed when the conduit portion is coupled to an 8 mm deep female recess can be minimized.

[0046] In examples, a chamber in which the diaphragm deforms may be in fluidic communication with the external atmosphere by means of at least one opening.

[0047] In examples, the diaphragm can be crimped.

[0048] According to another aspect of the present technology, a kit of parts comprising the device of any of the above-described embodiments and a device tester comprising means for pressurizing air in the device to deform the diaphragm is provided. Petition 870250101784, dated 06 / 11 / 2025, p. 20 / 69 14 / 44

[0049] In examples, the device tester may comprise a deformable hollow portion that, in use, deforms under pressure applied by a user to displace air into the device. In examples, the deformable hollow portion may be a bulb.

[0050] In some embodiments, the device tester may comprise a plunger. In examples, the plunger may comprise a shaft configured to be inserted into an opening in the device, forming a portion of a flow passage to the pressure sensor. In examples, the plunger may comprise a stop configured to restrict the subsequent movement of the shaft into the device beyond a predetermined point.

[0051] In examples, the device may be releasable attached to a cannula containing the needle. In examples, a needle cap may comprise the device tester, wherein the device tester supplies air into the device through a needle hole in the needle.

[0052] According to another aspect of the present technology, a kit of parts is provided comprising: a device substantially as described herein; a cannula containing a needle, wherein the device is releasably attached to the cannula; and a needle cap provided over the tip of the needle, wherein the needle cap comprises a Petition 870250101784, dated 06 / 11 / 2025, page 21 / 69 15 / 44 device tester comprising means for pressurizing air in the device through a needle hole in the needle to activate the indicator.

[0053] According to another aspect of the present technology, a kit of parts is provided comprising: a device substantially as described herein; a tester for the device comprising means for pressurizing air in the device to activate the device indicator; a sealed package containing the device and the tester for the device, wherein at least a portion of the sealed package is deformable so as to permit operation of the device within the sealed package.

[0054] In examples, at least a portion of the sealed packaging is at least translucent. In examples, at least a portion of the sealed packaging is transparent.

[0055] According to another aspect of the present technology, a kit of parts is provided comprising the device substantially as described herein and a support configured to hold the device in use.

[0056] In examples, the support may comprise a body with a cavity for holding the device by means of a friction fit.

[0057] In examples, at least one external surface of the support may comprise at least one gripping accessory. Petition 870250101784, dated 06 / 11 / 2025, page 22 / 69 16 / 44

[0058] In examples, at least a portion of the support may be made of transparent material. In examples, the support includes at least one opening between the outer part of the support 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 vessel or cavity, comprising the step of providing a device made in accordance with any embodiment described herein.

[0060] The above characteristics and others will become evident from the following description and the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Additional aspects of the present description will become apparent from the following description, which is given only as an example and with reference to the accompanying drawings, in which: Figure 1A is a perspective view of another example of a device made according to an aspect of the present technology.

[0062] Figure 1B is a top view of the device in Figure 1A.

[0063] Figure 1C is a cross-sectional side view of the device in Figure 1A.

[0064] Figure 1D is an exploded perspective view. Petition 870250101784, dated 06 / 11 / 2025, p. 23 / 69 17 / 44 of the device in Figure 1A.

[0065] Figure 1E is a bottom view of the device in Figure 1A.

[0066] Figure 2A is a top perspective view of an exemplary diaphragm used in devices made according to an aspect of the present technology.

[0067] Figure 2B is a bottom view of the diaphragm of Figure 2A.

[0068] Figure 2C is a top view of the diaphragm of Figure 2A.

[0069] Figure 2D is a side view of the diaphragm in Figure 2A.

[0070] Figure 2E is a cross-sectional side view of the diaphragm in Figure 2A.

[0071] Figure 3A is a top perspective view of an exemplary switch component used in devices made according to an aspect of the present technology.

[0072] Figure 3B is a side view of the switch component of Figure 3A.

[0073] Figure 4 is a schematic view of an example of a device made in accordance with an aspect of the present technology.

[0074] Figure 5 is a schematic view of an example of a device made in accordance with an aspect of the present Petition 870250101784, dated 06 / 11 / 2025, page 24 / 69 18 / 44 technology.

[0075] Figure 6A is a side cross-sectional view of a support for a device made according to an aspect of the present technology.

[0076] Figure 6B is a planar cross-sectional view of the support of Figure 6A, illustrating how a device is retained within the support.

[0077] Figure 7A is a cross-section of an early device tester made in accordance with an aspect of the present technology.

[0078] Figure 7B is a cross-section of the first device tester of Figure 7A, illustrating how it attaches to a device made according to an aspect of the present technology.

[0079] Figure 8A is a cross-section of a second device tester made according to an aspect of the present technology.

[0080] Figure 8B is a cross-section of the second device tester in Figure 8A, illustrating how it attaches to a device manufactured according to an aspect of the present technology.

[0081] Figure 9 is a side view of an exemplary needle cap comprising a test unit according to an aspect of the present technology.

[0082] Figure 10 is a plan view of the packaging for Petition 870250101784, dated 06 / 11 / 2025, p. 25 / 69 19 / 44 an exemplary test unit affixed to an exemplary device according to an aspect of the present technology.

[0083] Figure 11A is an exploded view of the components of a device made according to an aspect of the present technology.

[0084] Figure 11B is a perspective view of the device in Figure 11A when assembled.

[0085] Figure 12 is a plan view of a conductive switch component of the device in Figure 11A.

[0086] Figure 13A is a plan view of the switch component of Figure 12 when assembled with a battery and a spacer.

[0087] Figure 13B is a side view of the assembly in Figure 13A.

[0088] Figure 14A is a cross-section of the device in Figure 11B when connected to a cannula (for clarity, an upper portion of the device housing is not shown).

[0089] Figure 14B is a close-up cross-sectional view of the device in Figure 11B, as circled in Figure 14A.

[0090] Figure 15 is an exploded view of the components of a device made according to a further embodiment of the present technological invention. Petition 870250101784, dated 06 / 11 / 2025, page 26 / 69 20 / 44

[0091] Figure 16A is a cross-section of a device made according to another embodiment of the present technology.

[0092] Figure 16B is a perspective cross-section of a device made according to principles similar to those of the device in Figure 16A. DETAILED DESCRIPTION

[0093] Although in the present embodiment the device is an entry indicator device for a blood vessel, the technology is not limited to detecting blood pressure for cannulation purposes. In other embodiments, a device incorporating the technology could be used to detect needle entry into any other fluid-containing vessel or body cavity, such as the bladder or spinal cord. Some embodiments of the technology may be intended for use with gaseous fluids.

[0094] Therefore, it should be noted that, in this descriptive report, the word “fluid” has its normal meaning of a substance in flow, such as a liquid or gas, and is not limited to a liquid such as blood. Operational Parameters

[0095] In the case of arterial and venous cannulas, exemplary devices, according to aspects of the present technology, are configured in such a way that at least one indicator is activated when the pressure acting on the sensor Petition 870250101784, dated 06 / 11 / 2025, page 27 / 69 21 / 44 pressure is at or above a minimum limit. Exemplary devices, according to aspects of the present technology, have been developed to provide a reliable indication of the correct needle placement, considering that training and professional advice guide the use of a tourniquet in performing peripheral venous cannulations.

[0096] A tourniquet increases Peripheral Venous Pressure (PVP), while the pressure of the surrounding tissue remains approximately the same. PVP ranges from approximately 10 to 25 cmH2O in a healthy patient, but can be as low as 2 to 3 cmH2O in a critically ill patient. With a tourniquet applied, even if improperly or in a patient with very low blood pressure, the minimum PVP can be on the order of 25 cmH2O. Subcutaneous tissue pressure can vary from about 1 cmH2O to about 13.5 cmH2O: the subcutaneous tissue pressure around the vein / artery is up to 4 cmH2O without a tourniquet, the subcutaneous tissue pressure is up to 6 cmH2O with a tourniquet, and the subcutaneous tissue pressure is up to about 13.5 cmH2O in a swollen limb.

[0097] Thus, exemplary devices of the present technology have been configured to activate at least one indicator under all pressures that have a very high probability of indicating that the needle is located in a vein or artery. For example, the limit Petition 870250101784, dated 06 / 11 / 2025, p. 28 / 69 22 / 44 minimum can be around 25 cmH2O. More preferably, the minimum limit can be around 30 cmH2O.

[0098] In addition to accuracy regarding pressure magnitude, the device's response rate—that is, the speed at which the indicator is activated and / or deactivated in response to a change in pressure—is considered of great importance for clinical utility. The device's objective is to provide the user with feedback on the correct placement of the intravascular needle. If the indicator is not activated or deactivated in a timely manner, there is a greater risk of the needle being incorrectly positioned. Thus, exemplary devices of the present technology can be configured to activate and / or deactivate the indicator in less than one (1) second after exceeding or falling below the minimum limit pressure value. In general, the smaller the pressure differential between the vein and the tissue, the slower the response time.Therefore, it is predicted that a minimum limit above 25 cmH2O (for example, around 30 cmH2O) may be useful to achieve a desirable response time.

[0099] Another requirement for clinical utility is that the indicator remains activated throughout the expected pressure range for a patient while the needle is located in a vein or artery. If the pressure sensor and / or indicator fails under these expected conditions, the utility of Petition 870250101784, dated 06 / 11 / 2025, page 29 / 69 23 / 44 device decreases. It is important to note that several examples of the device can be configured to operate with different levels of upper operating ranges, depending on the acceptable probability of failure to detect the presence of the needle in a vein or artery of patients with discrepant values. For example, it is estimated that 99% of all patients may be within the pressure range of approximately 30 cmH2O to approximately 250 cmH2O. Thus, it is anticipated that examples of the device can be configured to activate the indicator at all pressures, from the minimum pressure up to at least approximately 250 cmH2O.

[00100] For completeness, it should be considered that alternative configurations are contemplated. For example, it is estimated that 90% of all patients may be within the pressure range of approximately 30 cmH2O to approximately 100 cmH2O. In examples, the device may be configured to activate at least one indicator at all pressures from the minimum limit up to at least 100 cmH2O. As a further example, the device may be configured to activate at least one indicator from the minimum limit up to a value above approximately 250 cmH2O – for example, at least 500 cmH2O – in order to increase the likelihood of the device functioning for any individual. This is not intended to exclude modalities in which the device activates the indicator above this value, but rather to emphasize the intention that the Petition 870250101784, dated 06 / 11 / 2025, page 30 / 69 The 24 / 44 device will continue to function at least until that point. Needle Entry Indicator Device

[00101] Figures 1A to 1E illustrate an exemplary device 100 for indicating the entry of a needle into a body cavity, duct, or vessel of a human or non-human animal. In this example, the device 100 comprises a body 120, comprising a first body portion 122 and a second body portion 124. The first body portion 122 comprises a male conduit portion 126 surrounded by an annular ridge 128 that defines an annular recess 130 for receiving a cannula (not shown) so that a tapered Luer connection is formed. A fluid orifice 132 in the male conduit portion 126 comprises an inlet 134 on the outside of the body 120 and an outlet 136 in the first internal cavity 138 of the body 120.

[00102] Referring to Figures 1C and 1D, an annular diaphragm retaining member 140 is held in place internally between the first body portion 122 and the second body portion 124. The diaphragm retaining member 140, in turn, clamps a diaphragm 200 against the first body portion 122 to hold it in place. Referring to Figures 2A to 2E, in this example, the diaphragm 200 includes an outer annular edge 202, a central portion 204, and an annular corrugation 206 that extends between the annular edge 202 and the central portion 204. A cylindrical protrusion 208 extends to Petition 870250101784, dated 06 / 11 / 2025, p. 31 / 69 25 / 44 of the central portion 204.

[00103] Referring to Figure 1C, the diaphragm 200 is installed so that the protrusion 208 faces away from the fluid orifice 132. In this example, the inlet 134 and outlet 136 of the fluid orifice 132 are axially aligned with the central portion 204 of the diaphragm 200. The surface of the diaphragm 200, from which the protrusion 208 extends, faces a second internal cavity 142. A switching unit 300, batteries 400, and a spacer 600 are provided in the second internal cavity 142.

[00104] Referring to Figures 3A and 3B, the switching unit 300 is made of a flexible circuit board with conductive traces printed on it. The switching 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. An indicator in the form of an LED 500 is provided for the second contact portion 304. In examples, the LED 500 may emit light in the visible light spectrum. However, alternative examples are contemplated in which the light is in the non-visible spectrum (e.g., infrared or near-infrared light) – for example, for use in conjunction with a night vision device.

[00105] As shown in Figure 1C, two 400 batteries Petition 870250101784, dated 06 / 11 / 2025, page 32 / 69 26 / 44 are positioned between the first contact portion 302 and the second contact portion 304. In this example, the 400 batteries are alkaline to facilitate disposal of the device 100, especially in single-use cases. In this example, the 400 batteries are stacked in series, allowing a sufficiently high voltage to be achieved while maintaining a reduced diameter. For example, the 400 batteries could be LR41 button cell batteries – although it is important to note that this is not intended to limit all embodiments of the present technology.

[00106] A spacer 600, in this example made of silicone, is provided between the LED 500 and the distal end of the second internal cavity 142, to assist in obtaining the desired positioning of the switching unit 300 in relation to the diaphragm 200 and the batteries 400.

[00107] In use, when the pressure of the fluid entering the first cavity 138 reaches a minimum limit, or activation pressure, this pressure displaces the diaphragm 200 so that the protrusion 208 presses the first contact portion 302 of the switching unit 300 into contact with the proximal battery 400 and completes the circuit to turn on the LED 500. As the circuit is only completed to activate the LED 500 under specific pressures, there is no power consumption in the batteries 400 while the device 100 is not being actively used or the pressure is below the limit. Petition 870250101784, dated 06 / 11 / 2025, page 33 / 69 27 / 44 minimum. This means that the battery life of the device is preserved for a longer period than that of devices that constantly consume energy to monitor pressure. This may allow the use of lower capacity batteries, potentially reducing the size and / or weight and / or cost of the device, or it may allow for a longer device lifespan, or it may avoid the need for energy-saving measures that would otherwise increase the complexity and cost of the device.

[00108] In the case of use of arterial and venous cannulas, the device 100 is configured so that the LED 500 is lit while the pressure within the first cavity 138 (i.e., acting against the diaphragm 200) is within the range of approximately 30 cmH2O to at least 500 cmH2O. To complete, this configuration means that: (1) the LED 500 is lit when the pressure reaches 30 cmH2O, (2) the LED 500 remains lit while the pressure is at least 30 cmH2O or higher, (3) the device is able to keep the LED 500 lit while the pressure is from 30 cmH2O to at least 500 cmH2O, and (4) the LED 500 is deactivated when the pressure is less than 30 cmH2O.

[00109] In examples, the second portion of the body 124 comprises air holes 144 between the second cavity 142 and the outside of the body 120. The air holes 144 allow the pressure in the second cavity 142 to equalize. Petition 870250101784, dated 06 / 11 / 2025, page 34 / 69 28 / 44 with atmospheric pressure, allowing the use of the device 100 at various altitudes and transport in extreme pressures (e.g., in aircraft) without damaging the diaphragm membrane. In this example, air holes 144 are provided through an end wall 146 of the second body portion distal to the fluid hole 132. The positioning of the air holes 144 in this location ensures that they are away from the welding point between the first body portion 122 and the second body portion 124.

[00110] The external protrusions 148 on the outer part of the second portion of the body 124 provide grip, either by the user's fingers or by a support, as generally described with reference to Figures 6A and 6B.

[00111] The devices constructed as described above in relation to Figures 1A to 1E were tested to ensure correct operation. A hydraulic test device was installed, comprising a cylindrical reservoir with a dry-rupture valve, into which the devices were inserted to expose the diaphragm to the internal pressure of the reservoir. The reservoir was filled to a fill line with simulated blood and pressurized to a desired pressure value using a pneumatic pump via a Schrader valve in a free space. Three devices were tested at 20 cmH2O and 25 cmH2O to ensure that the device would not activate below the pressure. Petition 870250101784, dated 06 / 11 / 2025, pp. 35 / 69 29 / 44 of the design pressure of 30 cmH2O. The test procedure was repeated, with the test pressure increased in increments of 10 cmH2O, from 30 cmH2O to 250 cmH2O. After testing at 250 cmH2O, the test pressure was increased in increments of 50 cmH2O until reaching a maximum pressure of 500 cmH2O. This was repeated three times for each device. This test procedure was then repeated with three devices.

[00112] Initially, the response time would be recorded for each test to ensure that activation / deactivation times were less than one second. However, it was observed that LED activation was almost instantaneous and the results depended mainly on the reaction time of the test operator, which could generate misleading results. The decision was made to record only activation and deactivation using a pass / fail criterion based on the immediate activation and deactivation of the device in response to pressure changes.

[00113] Overall, all three devices functioned correctly. The LED did not activate at pressures below 30 cmH2O. All devices functioned consistently from the design pressure of 30 cmH2O, across the entire pressure range, up to the maximum pressure of 500 cmH2O. All three devices also successfully deactivated instantly when the dry shut-off valve was closed. Petition 870250101784, dated 06 / 11 / 2025, pp. 36 / 69 30 / 44

[00114] Figure 4 schematically illustrates another exemplary device 1000 for indicating the entry of a needle into a human or animal vessel or cavity. In this example, the device 1000 comprises a digital pressure sensor 1100 in fluidic communication with the needle hole in use. In examples, the digital pressure sensor 1100 can be configured as a pressure switch, emitting a signal to activate an indicator 1200 (e.g., an LED) when the detected pressure is within a target pressure range – for example, between about 30 cmH2O and about 500 cmH2O. In an alternative example, the pressure sensor 1100 can emit a pressure-indicating signal to a controller 1300, and the controller can selectively activate the indicator 1200 based on determining whether the pressure is between about 30 cmH2O and about 500 cmH2O.

[00115] Figure 5 schematically illustrates another exemplary device 2000 for indicating the entry of a needle into a human or animal vessel or cavity, more particularly during the placement of a central venous catheter (or central venous catheter). In the placement of a central venous catheter, complications with accidental arterial puncture are widely recognized. In a first embodiment, the device 2000 comprises a first pressure sensor arrangement 2100a in fluidic communication with a needle hole of the needle in use, having two Petition 870250101784, dated 06 / 11 / 2025, pp. 37 / 69 31 / 44 diaphragms, each diaphragm configured to be deformable under fluid pressure from a first configuration to a second configuration. The first diaphragm is configured to deform to the second configuration when the pressure is within a first pressure range, and the second diaphragm is configured to deform to the second configuration when the pressure is within a second pressure range. In examples, the first pressure range may be indicative of central venous pressure (CVP). In examples, the second pressure range may be indicative of non-CVP. In examples, the first pressure range may be from about 3 cmH2O to about 40 cmH2O. In examples, the second pressure range may be from about 40 cmH2O to about 500 cmH2O.

[00116] Device 2000 includes a set of circuits 2200 to selectively control the activation of an indicator 2300, which has a first indicator output 2302a and a second indicator output 2302b, depending on the actuation of the first and / or second diaphragm. For example, the indicator 2300 may be a multicolored LED capable of selectively emitting green and red light. In use, the green light is activated when the pressure is within the first range, i.e., indicating that the needle is correctly positioned in the vein. The red light is activated when the pressure increases to the second range – i.e., indicating that a [missing word] has occurred. Petition 870250101784, dated 06 / 11 / 2025, pp. 38 / 69 32 / 44 arterial puncture, to guide corrective action.

[00117] In an alternative example, device 2000 comprises a second pressure sensor arrangement 2100b in fluidic communication with the needle bore in use, in the form of a digital pressure sensor. In examples, the pressure sensor 2100b may emit a pressure-indicating signal to a circuit assembly 2200 comprising a controller, and the controller 2200 may selectively activate the first output of the indicator 2302a or the second output of the indicator 2302b based on determining whether the pressure is within the first pressure range or the second pressure range. Device Support

[00118] Returning to Figures 6A and 6B, a support 600 for a device 100 manufactured according to the present technology comprises a body 602 with a cavity 604 configured to comfortably house a device 100 inside. The cavity 604 is dimensioned so as to retain the device 100 by means of a friction fit.

[00119] The 602 body is made of a transparent material to allow the user to see when an LED on the device 100 is activated. A transparent material can be transparent or translucent. In some embodiments, only part of the 602 body may be transparent or it may include windows or openings to allow the Petition 870250101784, dated 06 / 11 / 2025, pp. 39 / 69 33 / 44 LED display. In other embodiments, where a device 100 comprises an audible indicator, an opaque material may be used to form a body.

[00120] The body 602 is ergonomically designed to allow the user to easily handle a device housed within it under difficult conditions, for example, on a battlefield. For example, gripping features in the form of notches 606 may be provided on the outside of the support 606. Device Tester

[00121] Observing Figures 7A and 7B, a first device tester 700 comprises a hollow bulb 702 with a tubular connector 704 with an internal hole 706 adapted to fit perfectly and form a hermetic fit with a male conduit portion 126 of a device 100.

[00122] Before using device 100, the user can attach device tester 700 to the male conduit portion 126 and squeeze bulb 702 to inject air into device 100 and observe whether the indicator is energized, thus testing whether device 100 is operational or not. Bulb 702 is sized to inject enough air into device 100 to deform the device 100 diaphragm and operate its indicator, while at the same time injecting insufficient air to damage the diaphragm.

[00123] In some modalities, the tester of Petition 870250101784, dated 06 / 11 / 2025, pp. 40 / 69 34 / 44 device 700 can be attached to a male conduit portion 126 of a device 100 by a breakable connection.

[00124] Figures 8A and 8B illustrate a second device tester in the form of a plunger 800, with a shaft 802, a handle 804 and a stop 806. The shaft 802 is adapted to fit snugly within a male duct portion 126 of a device 100 in order to inject air into the device 100 and test the operation of its diaphragm. A stop 806 is provided on the shaft 802 to prevent excessive pressure on the diaphragm and consequent damage to it.

[00125] Referring to Figure 9, in the examples, an assembly 3000 comprises a device 100, according to the present technology, removablely attached to a cannula comprising a needle 3200. In this example, a needle cap 3300 for the needle 3200 comprises an integrated device tester 3400 in the form of a bulb. The device tester 3400 can be manipulated to dispense air to the device 3100 to test its operation before removing the cap 3300 and exposing the needle 3200.

[00126] Referring to Figure 10, a parts kit 4000 comprises a device 4100 and a device tester 4200 removablely attached to the device 4100 and comprising means for injecting air into the device 4100 to test its operation. The combination of the device 4100 and the device tester 4200 is provided within a Petition 870250101784, dated 06 / 11 / 2025, pp. 41 / 69 35 / 44 Sealed packaging 4300. The sealed packaging 4300 is deformable to allow operation of the device tester 4200 within the sealed packaging 4300 and is at least translucent to allow visualization of the indicator operation. For example, the sealed packaging 4300 may comprise a base portion 4302 and a translucent or transparent window portion 4304. This allows the device 4100 to be tested before opening the sealed packaging – facilitating disposal should the device 4100 fail the test. Other Examples of Needle Entry Indicator Devices Referring to Figures 11A and 11B, a device 5000 manufactured according to an embodiment of the present technology comprises an enclosure 5002 formed by a lower portion 5002a, an intermediate portion 5002b and an upper portion 3. The enclosure 5002 is made of a transparent plastic material.

[00127] The lower portion 5002a comprises a fluid inlet 5004 located at a free end of the elongated conical male conduit portion 5006. The conduit portion 5006 extends from a side of the lower portion 5002a. On an upper face 5008 of the lower portion 5002a, there is a disc-shaped cylindrical projection 5010, which has a substantially circular upper surface 5012. Petition 870250101784, dated 06 / 11 / 2025, pp. 42 / 69 36 / 44

[00128] Located substantially centrally on the upper surface 5012 is the fluid outlet 5014, which establishes fluid communication with the fluid inlet 5004 by means of an internal conduit 5016. On the upper surface 5012 of the cylindrical projection 5010 and extending from the fluid outlet 5014 are four grooves 5018a, 5018b, 5018c and 5018d, each extending radially towards the circular peripheral edge of the upper surface 5012.

[00129] The diaphragm 5020 is configured to house the projection 5010 and further comprises a peripheral flange 5022 that sits on the upper face 5008 of the lower portion 5002a and extends away from the projection 5010 when the device 5000 is mounted.

[00130] The diaphragm 5020 is positioned over the projection 5010 and held in place by means of the rubber ring 5024, which fits around the projection 5010 and rests on the flange 5022 of the diaphragm 5020. The flange 5022 of the diaphragm 5020 is therefore interposed between the rubber ring 5024 and the upper face 5008 of the lower portion 5002a.

[00131] The intermediate portion 5002b of the housing 5002 comprises a substantially disc-shaped chamber 5026, configured to house the projection 5010 and the diaphragm 5020, such that the circular portion of the diaphragm 5020, located on the circular face 5012 of the projection 5010, Petition 870250101784, dated 06 / 11 / 2025, pp. 43 / 69 37 / 44 should be substantially level with the upper surface 5028 of the intermediate portion 5002b.

[00132] Seated on and attached to the upper surface 5028 of the intermediate portion 5002b are the switching unit assembly 5030, the battery 5032 and the spacer 5034. Referring to Figure 12, the switching unit 5030 is a flexible printed circuit board comprising a first contact 5032, a conductive ring 5034 and a second contact 5036.

[00133] When assembled, the spacer 5034 is positioned between the conductive ring 5034 and the battery 5038, and the second contact 5036 of the switching unit 5030 is bent so as to make contact with the upper surface of the battery 5032. The spacer 5034 is adhered to the conductive ring 5034.

[00134] The first contact 5032 is in the plane of the conductive ring 5034 and is therefore spaced from the lower surface of the battery 5032 by the thickness of the spacer 5034. The first contact 5032 is resiliently flexible, substantially elongated, and comprises a free end. Located in the conductive ring 5034 is the LED 5040, which is not covered by the spacer 5034 due to an opening in the spacer. To keep the second contact 5036 in contact with the upper surface of the battery 5032, a foam pad 5042 is provided between the upper portion 5002c of the housing 5002 and the second contact 5036. When Petition 870250101784, dated 06 / 11 / 2025, pp. 44 / 69 38 / 44 assembled, the lower, middle and upper portions 5002a, 5002b and 5002c of the 5002 housing are screwed together at the four corners (screws not shown).

[00135] Returning to the device 5000 in use, and with reference to Figure 14A, the device 5000 can be attached to a cannula 5100 by inserting the conical portion of the male conduit 5006 into a corresponding female frustoconical recess 5102 in the cannula 5100, so that a conical Luer connection is formed. Thus, the needle 5104 is in fluidic communication with the fluid outlet 5014 through the internal conduit 5016.

[00136] Needle 5104 is inserted into a patient. When located in a vein or artery, blood enters the conduit 5016 and exits through the fluid outlet 5014, deforming the diaphragm 5020 from a first (undeformed) configuration to a second configuration, in which it is deformed enough to push the first contact 5032 so that it comes into contact with a lower surface of the battery 5038 and connects a circuit that lights the LED 5040. The user of the device 5000 then knows that needle 5104 is located in the vein or artery and cannulation can occur.

[00137] If the needle 5104 comes out of the vein or artery, the pressure at the fluid outlet 5014 drops and the diaphragm 5020 returns to its initial configuration, resulting in the interruption of the electrical circuit and the deactivation of the LED. Petition 870250101784, dated 06 / 11 / 2025, pp. 45 / 69 39 / 44 5014. The user then knows that the needle is not in a suitable position for cannulation.

[00138] In use, grooves 5018a, 5018b, 5018c and 5018d prevent diaphragm 5020 from sticking to the upper surface 5012 of the cylindrical projection 5010. Different devices can be adapted to be activated at different pressures simply by changing the thickness of the spacer 5034. Furthermore, the tension of diaphragm 5020, and therefore the pressure at which diaphragm 5020 deforms, can be changed by changing the thickness of the rubber ring 5024. Additionally, modifying the thickness and / or length of the first contact 5032 of the switching unit 5030 can change the pressure at which LED 5040 is activated.

[00139] Referring to Figure 14A, it can be observed that, depending on the dimensions of the male conduit portion 5006 and the female recess 5102, an empty space 5106 may be formed in the Luer connection. This is undesirable as it results in a delay in the activation of LED 5040 as the space 5106 is filled.

[00140] Therefore, it is preferable that the male conduit portion 5006 be sized in order to minimize the void space 5106. The female recess is approximately 8 mm deep and, therefore, to minimize the void space, the male conduit portion 5106 is approximately 8 mm long. Petition 870250101784, dated 06 / 11 / 2025, pp. 46 / 69 40 / 44

[00141] Advantageously, a diaphragm can be configured to deform into a second position and feed an indicator at a very specific pressure. Thus, in some embodiments, a diaphragm can be configured to deform under arterial pressure but not under venous pressure, thereby allowing the user to determine that a needle is positioned in an artery and not a vein, which can be important when drawing blood for blood gas analysis purposes.

[00142] In other embodiments, a diaphragm may be deformable in its second configuration under venous pressure and deformable in a third configuration, for example, by rupture or distension, under arterial pressure. In the third configuration, the indicator would not be energized. Although such an arrangement may irreparably damage the device, it would prevent unwanted arterial cannulation.

[00143] Referring to Figure 15 and another embodiment of a device manufactured according to the present technology, device 6000 is largely identical to device 5000 and has a substantially disc-shaped chamber 6002, within which the diaphragm 6004 is housed.

[00144] Device 6000 differs from device 5000 because chamber 6002 is in fluidic communication with the outside of device 6000 by virtue of a side wall. Petition 870250101784, dated 06 / 11 / 2025, pp. 47 / 69 41 / 44 of the intermediate portion 6008 of its casing shall be provided with an opening 6006. The existence of an opening 6006 is preferable to allow the diaphragm 6004 to deform freely. The opening 6006 allows the device 6000 to be used at different altitudes with different atmospheric pressures.

[00145] Returning to Figures 16A and 16B and to another embodiment of a device manufactured according to the present technology, the device 7000 has a different diaphragm arrangement, with a crimped diaphragm 7002. The diaphragm 7002 is crimped in the sense that it comprises an annular corrugation 7004 that extends towards the commutator of the device 7000. The diaphragm 7002 further comprises a raised central portion 7006 that extends towards the commutator of the device 7000 and operates the commutator of the device 7000 when the device 7000 is used and the diaphragm 7002 is deformed by air pressure.

[00146] In contrast to the examples in Figure 11A and Figure 15, the diaphragm 7002 is not positioned over a projection and held in place by means of a rubber ring. Instead, the diaphragm 7002 is held in position over an air inlet by the circumferential rib 7008 of the diaphragm 7002, which is held between a lower portion 7010a of the device housing 7000 and an intermediate portion 7010b of the device housing 7000. The supply of a Petition 870250101784, dated 06 / 11 / 2025, pp. 48 / 69 A 42 / 44 crimped diaphragm can be beneficial compared to a flat diaphragm because a crimped diaphragm is able to move freely, making it more responsive, and is less likely to be impeded from moving by adhering to a device surface.

[00147] Although in the present embodiment the diaphragms are made of non-conductive material, in other embodiments the diaphragms may be made of an electrically conductive rubber material. For example, a non-conductive diaphragm may be provided with a conductive coating, conductive particles throughout its length, or a conductive connector.

[00148] In this descriptive report, the expression “touches a surface” is intended, in its broadest sense, to include both simple contact with a surface (if the diaphragm is conductive) and the application of pressure to it (if the diaphragm activates a pressure-operated switch).

[00149] All references, including any patents or patent applications cited in this descriptive report, are incorporated herein by reference. No reference is admittedly stated as prior art. The discussion of references states what their authors claim, and applicants reserve the right to contest the accuracy and relevance of the documents cited. Petition 870250101784, dated 06 / 11 / 2025, pp. 49 / 69 43 / 44 Of course, although several publications on the state of the art are mentioned here, this reference does not constitute an admission that any of these documents are part of the common general knowledge in the field of activity in any country in the world.

[00150] Unless the context clearly requires otherwise, throughout the description and claims, the words understand, including, and similar terms should be interpreted in an inclusive sense, as opposed to an exclusive or exhaustive sense, that is, in the sense of including but not limited to.

[00151] The present description may also be considered, broadly, as consisting of the parts, elements and characteristics mentioned or indicated in the descriptive report of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or characteristics. Where in the preceding description reference has been made to whole numbers or components with known equivalents, those whole numbers are incorporated herein as if they were presented individually.

[00152] It should be noted that several alterations and modifications to the currently preferred modalities described here will be evident to those skilled in the art. Such alterations and modifications can be made without Petition 870250101784, dated 06 / 11 / 2025, pp. 50 / 69 44 / 44 depart from the spirit and scope of the present description without diminishing its inherent advantages. Therefore, it is intended that such alterations and modifications be incorporated into the present description as defined by the appended claims. Petition 870250101784, dated 06 / 11 / 2025, pp. 51 / 69

Claims

1 / 5 CLAIMS 1. Device for indicating the entry of a needle into a body cavity, duct or vessel of a human or non-human animal, the device characterized in that it comprises: a pressure sensor configured to be in fluidic communication with a needle hole of the needle in use; and at least one selectively activated indicator, wherein the device is configured to activate the indicator while the pressure acting on the pressure sensor is equal to or greater than a minimum pressure limit, wherein the minimum pressure limit is about 25 cmH2O.

2. Device according to claim 1, characterized in that the minimum pressure limit is about 30 cmH2O and above.

3. Device according to claim 1 or claim 2, characterized in that the device is configured to activate at least one indicator at all pressures from the minimum limit up to at least 100 cmH2O.

4. Device according to any one of claims 1 to 3, characterized in that the device is configured to activate at least one indicator at all pressures from the minimum limit up to at least 250 cmH2O. Petition 870250084803, dated 09 / 19 / 2025, p. 24 / 29 2 / 5 5. Device according to any one of claims 1 to 4, characterized in that the device is configured to activate at least one indicator at all pressures from the minimum limit up to at least 500 cmH2O.

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

7. Device according to claim 6, characterized in that in the second configuration the diaphragm closes a switch to activate the indicator.

8. Device according to any one of claims 1 to 6, characterized in that the device comprises a body containing the pressure sensor, wherein the body comprises a first internal cavity between a first face of the diaphragm and a fluid orifice in fluid communication with the needle bore of the needle in use.

9. Device, according to claim 8, characterized in that the body comprises a second internal cavity formed in part by a second face of the diaphragm opposite the first face and at least one air hole between the second internal cavity and an exterior of the body.

10. Device according to claim 9, characterized in that at least one air hole is provided on an end surface of the distal body of the fluid orifice.

11. Device according to claim 9 or claim 10, characterized in that the body comprises a plurality of air holes.

12. Device, according to any one of claims 8 to 11, characterized in that the fluid orifice comprises an inlet on an exterior of the body and an outlet in the first internal cavity, and the inlet and outlet of the fluid orifice are axially aligned with a central portion of the diaphragm.

13. Device, according to any one of claims 1 to 12, characterized in that it comprises a plurality of alkaline batteries stacked in series along a longitudinal geometric axis between a first end of the body and a second end of the body.

14. Device according to claim 1, characterized in that the pressure sensor comprises a digital pressure sensor.

15. Device, according to claim 14, characterized in that the digital pressure sensor Petition 870250084803, dated 09 / 19 / 2025, page 26 / 29 4 / 5 is configured as a pressure switch, emitting a signal to activate the indicator when the detected pressure is above the minimum pressure limit.

16. Device according to claim 15, characterized in that the digital pressure sensor is configured to emit a pressure indication signal to a controller and the controller is configured to selectively activate the indicator based on determining whether the pressure is above the minimum pressure limit.

17. Device according to any one of claims 1 to 16, characterized in that the indicator comprises a light configured to emit light in the non-visible spectrum.

18. Device according to claim 17, characterized in that the light is configured to emit infrared or near-infrared light when activated.

19. Parts kit, characterized in that it comprises: the device, as defined in any one of claims 1 to 18; a cannula comprising a needle, wherein the device is releasably attached to the cannula; and a needle cap provided over the needle, wherein the needle cap comprises a device tester Petition 870250084803, dated 09 / 19 / 2025, page 27 / 29 5 / 5 comprising means for pressurizing air in the device through a needle hole in the needle to activate the indicator.

20. Parts kit, characterized in that it comprises: the device, as defined in any one of claims 1 to 18; a device tester comprising means for pressurizing air in the device to activate the device indicator; a sealed package containing the device and the test device, wherein at least a portion of the sealed package is deformable so as to permit operation of the test device within the sealed package. Petition 870250084803, dated 09 / 19 / 2025, pp. 28 / 29

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