noseclip

Abstract

The present disclosure provides a noseclip (2) for attachment to a nasal septum of a patient to determine a physiologic parameter. The noseclip (2) comprises a body (10) with a pair of arms (14), each having a nasal septum contacting portion. At least one of the nasal septum contacting portions includes a peripheral skirt (20) forming a housing enclosing a volume (22), adapted to create a sealed chamber when contacted to the nasal septum. This nasal septum contacting portion has or is adapted to receive a probe (28) housing a sensor responsive to the physiologic parameter. The arms (14) are resiliently biased towards a centreline (C) that extends longitudinally along an insertion axis (Ainsertion) and positioned centrally between the arms. The resilient bias holds the noseclip in position in use, in a clamping action against the walls of the nasal septum. In embodiments, the body (10) includes an engagement portion (12) adapted to receive a cooperating noseclip insertion tool for separating the nasal septum contacting portions along a separation axis (Aseparation). In embodiments, the noseclip insertion tool (4) is integrally formed with the noseclip (2).

Description

NOSECLIPFIELD OF INVENTION

[0001] The present disclosure relates to a noseclip for attachment to a nasal septum of a patient to determine a physiologic parameter, and to a noseclip insertion tool for use with such a noseclip. The disclosure also relates to an assembly or kit of parts comprising the noseclip and noseclip insertion tool.BACKGROUND

[0002] Sensors for measuring physiological parameters in patients are widely used in medical settings for monitoring and diagnosis. These sensors can provide valuable data on various bodily functions and conditions, allowing healthcare professionals to make informed decisions about patient care. One area of particular interest is the measurement of partial pressure of carbon dioxide (pCO2) in the body, which can provide important information about a patient's respiratory status and metabolic function.

[0003] Traditionally, sensors for measuring physiological parameters have been placed in various locations on or in the body, including the nose and inner cheek. These locations offer relatively easy access and can provide accurate readings for certain parameters. In the case of nasal sensors, placement near the nasal septum has been found to be particularly effective for measuring parameters such as pCO2.

[0004] Challenges associated with current sensor placement methods include reliably positioning the sensor, and also securing the sensor in the desired location for an extended period. This is particularly important for continuous monitoring applications. Many existing devices use metal springs or similar mechanisms to hold the sensor in place against the septum or inner cheek. While these mechanisms can be effective, they may cause discomfort for the patient, especially during prolonged use.

[0005] Another issue with current sensor placement devices is the potential for movement or displacement of the sensor, which can lead to inaccurate readings or loss of data. The nasal environment, in particular, can be challenging due to factors such as breathing, sneezing, and natural mucus production, which may interfere with sensor placement and function.

[0006] Additionally, existing sensor placement devices often lack versatility, being designed for use with specific sensor types or models. This can limit their applicability across different monitoring scenarios and may require healthcare facilities to maintain multiple types of placement devices for various sensor configurations.

[0007] It has been appreciated that a noseclip for holding a sensor is needed that overcomes one or more of these problems.SUMMARY

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description.

[0009] In a first aspect, there is presented a noseclip for attachment to a nasal septum of a patient to determine a physiologic parameter of the patient. The noseclip comprises a body that comprises a pair of arms that each comprise a nasal septum contacting portion. A first arm of the pair of arms comprises: a housing; and a peripheral skirt for contacting the nasal septum and adapted to create a sealed chamber enclosing a volume when contacted to the nasal septum. The housing is adapted to retain a probe for determining the physiologic parameter.

[0010] This configuration allows for secure attachment to the nasal septum while providing a sealed environment for accurate sensing of the physiologic parameter.

[0011] According to various embodiments, the probe may be supplied or sourced separately to the noseclip and fitted later, or may be provided with the noseclip (optionally already fitted into the noseclip), or may be integrally formed with the noseclip (e.g. cured into the noseclip material during manufacture), or may be permanently or non-permanently bonded or welded onto or into the noseclip.

[0012] Embodiments according to the disclosure provide a simple and reliable way to position a sensor within a nasal cavity. A nasal contacting portion of the noseclip has a peripheral skirt that encloses a volume of air within a sealed chamber when contacted to the patient. In use, the peripheral skirt contacts the nasal septum providing a comfortable fit whilst enabling a probe to measure a physiological parameter of the patient within the enclosed volume. The enclosed volume ensures that the reading is accurate and reliable and maintains the cleanliness of the probe.

[0013] The peripheral skirt ensures comfortable positioning against the septum compared to e.g. prior designs with metal springs to hold the sensor in place. Such prior designs with springs are typically designed to be slid into position, which can cause significant discomfort. This discomfort is alleviated by the skirt design herein.

[0014] Optionally, the probe may be provided with the noseclip. Alternatively, the noseclip may be supplied without the probe, which is later attached. Having the option of supplying a probe separately provides flexibility and may allow pre-existing probes to be re-used to save cost and waste.

[0015] Optionally, where the probe is supplied with the noseclip, the probe may be installed within the housing. Providing the noseclip with the probe installed within the housing provides user convenience.

[0016] Optionally, the probe may be integrally formed within the housing. For example, the probe may be integrally formed into the housing during the moulding process. Integrally forming the probe provide a more secure positioning of the probe and prevent the probe and housing from becomingseparated. Furthermore, providing an integrally formed sensor may reduce cost. It may also improve convenience, since there is no need to check or fit a probe into the device prior to use. Optionally, probes and noseclips may be colour-coded for a particular use case, improving operator convenience.

[0017] The probe or sensor may be moulded into the noseclip, for example where moulded polymer is used for the forming of the clip. Such a sensor then becomes an integral part of the moulded noseclip.

[0018] In embodiments, the probe may comprise a semiconductor chip. Such a chip may be well suited to being integrally formed in the housing during a moulding or curing process to form the housing, or it may be fused or welded to or into the housing later.

[0019] Where the probe comprises a semiconductor chip, the probe may comprise a photoplethysmogram (PPG) sensor that is suitable for measuring SpO2, respiratory rate etc., or alternatively it may comprise a pCO2 sensor, that utilizes the semiconductor chip.

[0020] The housing may comprise a probe receiving channel that is in communication with the volume and that is adapted to retain the probe.

[0021] A probe receiving channel enables easy insertion and removal of probes comprising sensors, allowing for flexibility in sensor selection and replacement.

[0022] The provision of a probe receiving channel enables the noseclip to be used with different sensors, and allows easy removal, changing, replacement, and cleaning of the probe.

[0023] Optionally, the noseclip comprises a probe that is positioned in the probe receiving channel where present.

[0024] Including the probe within the probe receiving channel provides a ready-to-use configuration, simplifying the use of the noseclip for healthcare professionals. Such a design enables the device to be tailored to a particular use without the need to add a probe prior to use.

[0025] The probe may be removably positioned within the probe receiving channel. For example, the probe may be a friction fit to allow easy replacement, changing for a sensor of a different type or for cleaning. Alternatively, the sensor may be snap-fit into position, relying on detents and protrusions in the sensor and noseclip respectively (or vice versa) to provide a reliable fixing and audible and tactile confirmation that the probe is positioned correctly.

[0026] There may be multiple probe receiving channels on a single arm, for receiving multiple probes within one noseclip.

[0027] Where there are multiple probe receiving channels, they may be differently sized to accommodate probes of different sizes.

[0028] Optionally, a second arm of the pair of arms may comprise a peripheral skirt for contacting the nasal septum, which skirt may be adapted to create a sealed chamber enclosing a volume whencontacted to the nasal septum. Providing both arms with peripheral skirts may improve user comfort since the skirts ensure that the fitting of the noseclip is comfortable against the septum. Since embodiments may comprise one or two skirts, any reference to a feature of one skirt should be understood to be applicable to both skirts of a two skirt design, and any feature mentioned in relation to the two skirts should be understood as applicable to a single skirt.

[0029] Optionally, the second arm of the pair of arms may comprise: a (second) housing; and a (second) peripheral skirt for contacting the nasal septum and adapted to create a (second) sealed chamber enclosing a volume when contacted to the nasal septum, and wherein the (second) housing is adapted to retain a (second) probe for determining the physiologic parameter.

[0030] The second probe, where present, may be for detecting a same or different physiologic parameter to the first probe.

[0031] The dual arm design allows the noseclip to be reversible in its orientation and, in embodiments comprising a sensor on each arm, allow similar or different sensors to be positioned either side of the septum.

[0032] In embodiments, the arms can easily be separated by a squeezing motion or by otherwise actuating the separation, allowing easy and reliable placement without the discomfort of prior art devices that rely on sliding the device over the nasal septum into the operational position.

[0033] The skirt(s) is / are designed to minimize the discomfort to the patient’s mucosal area by acting as a pressure relief mechanism providing a big, dampened area, thus compensating for the pressure applied by the stiffness and width of the body (which may be typically hoop shaped). The skirt(s) are made without sharp edges to avoid pain and inflammatory responses of the mucosa and the inside edges of the skirt(s) may be polished to ensure optimum smoothness for increased comfort.

[0034] Optionally, where both arms comprise housings, both housings may comprise a probereceiving channel and / or probe. Further optionally, the probe on each arm may be integrally formed with the housing on that arm. Where each housing comprises a probe, the probes may be the same or different, i.e. they may be suitable for measuring the same physiological parameter or for measuring different physiological parameters.

[0035] The arms may be resiliently biased towards a centreline that extends longitudinally along an insertion axis positioned centrally between the arms.

[0036] This resilient bias of the arms towards each other ensures a simple but secure fit on the nasal septum once fitted, improving the stability of the noseclip and maintaining consistent contact for accurate sensing.

[0037] The body may comprise an engagement portion adapted to receive a cooperating noseclip insertion tool for separating the nasal septum contacting portions along a separation axis.

[0038] This feature facilitates easier insertion of the noseclip, by allowing temporary separation of the arms, to allow easy fitting and to reduce discomfort for the patient during application.

[0039] The noseclip may be adapted to be inserted into a nasal cavity along an insertion axis, wherein the separation axis and the insertion axis are substantially orthogonal to each other.

[0040] This orthogonal arrangement of axes allows for intuitive insertion and separation of the noseclip, improving ease of use for healthcare professionals. The arms may be separated from each other in a first direction before moving the noseclip in an orthogonal direction into the nasal cavity.

[0041] A first arm of the arms may comprise a wing adapted to support a lateral vestibule wall surrounding a nostril of the patient to maintain an open airway.

[0042] The wing helps maintain an open airway, ensuring patient comfort and unobstructed breathing while the noseclip is in place.

[0043] The wing is designed to secure the noseclip comfortably in the nasal vestibule and prevent it not only from sliding further up in the nasal cavity, but also from falling out of the nose. It is made without sharp edges to avoid pain and inflammatory responses of the nasal cavity.

[0044] The wing may be made of the same material as the rest of the noseclip. The wing may be made of, for example, a polymer material such as a plastic material.

[0045] The wing geometry is optimized so that the wings are of the optimal size and flexibility to best fit into most noses without irritation and discomfort to the patient.

[0046] The wing may be substantially circular when viewed along the centreline that extends between longitudinally and positioned between the arms.

[0047] Both arms may comprise a wing, each of which may have one or more of the aforementioned features.

[0048] A substantially circular wing shape may provide optimal support for the nostril while minimizing irritation to the surrounding tissue.

[0049] The wing may have an opening at a peripheral portion furthest from the centreline that extends longitudinally between the arms.

[0050] This opening allows for some flexibility in the wing, improving comfort and adaptability to different nostril shapes. It may also help to reduce cost since less material is required.

[0051] The opening may comprise between 10 and 30 percent of the circumference of the wing when viewed along the centreline. Accordingly, when viewed along the centreline, the wing may be an incomplete circle with an opening furthest from the centreline that is between 10 and 30 percent of the circumference of the wing.

[0052] This specific range of opening size balances the support provided by the wing with the flexibility needed for comfort and adaptability.

[0053] A second arm of the arms may comprise a wing adapted to support a lateral vestibule wall surrounding a nostril of the patient to maintain an open airway, and the wings of the first and second arms may extend in opposite directions along the separation axis away from the centreline.

[0054] This dual-wing configuration provides balanced support for both nostrils, ensuring optimal airway maintenance and comfort for the patient.

[0055] Optionally the body comprises separating means for separating the arms. This may be the form of tabs that can be squeezed together to cause the arms to separate, akin to the action of a clothes peg. The structure of the arms may be such that they are resiliently biased towards each other and a squeezing on the separating means overcomes this biasing force and causes the arms to separate.

[0056] Optionally, the separating means comprises an engagement portion adapted to receive a cooperating noseclip insertion tool for separating arms.

[0057] The nasal septum contacting portions may be positioned at distal ends of the arms relative to the separating means.

[0058] Positioning the nasal septum contacting portions at the distal ends of the arms allows for controlled and reliable separating of the arms. It also means the separating of the arms can be controlled from outside of the nasal cavity even when the device is positioned in the nasal cavity.

[0059] The noseclip may comprise a separation means for separating the arms. The separating means may comprise an engagement portion for receiving a noseclip insertion tool. The engagement portion may comprise a recess adapted to receive the noseclip insertion tool.

[0060] Such a recess may provide a secure attachment point for the insertion tool, ensuring controlled and precise application of the noseclip.

[0061] The recess may extend along a recess axis and wherein the recess axis is substantially orthogonal to both the separation axis and the insertion axis.

[0062] This orthogonal arrangement of axes facilitates easy manipulation of the noseclip during insertion and removal, and provides a simple and cost effective design for separating the arms.

[0063] The recess may comprise side walls and wherein the side walls are substantially parallel to each other and extend substantially along the recess axis.

[0064] Parallel side walls in the recess provide a secure fit for the insertion tool, improving control during the insertion process. Parallel walls also permit the insertion tool to be a friction fit within the engagement portion, thereby providing a simple and reliable design.

[0065] The engagement portion may comprise a notch.

[0066] The notch provides an additional feature for secure engagement with the insertion tool, enhancing control and precision during application. It may further increase friction and confidence thatthe insertion tool is correctly positioned. Furthermore, the notch may adapt the resilient bias of the arms towards each other, with a larger notch reducing the resilient bias of the arms towards each other.

[0067] The notch may be positioned at a bottom of the recess.

[0068] This configuration of the notch within the recess provides a secure locking mechanism for the insertion tool, preventing accidental disengagement during use.

[0069] A signal wire may extend from the probe to convey data from the probe to apparatus for reading and interpreting the data.

[0070] The engagement portion may be positioned substantially centrally between the arms and about the centreline.

[0071] Central positioning of the engagement portion ensures balanced force distribution during insertion and removal of the noseclip.

[0072] The arms may be substantially mirrored about a vertical plane extending through the centreline, wherein the vertical plane and centreline both extend substantially orthogonal to the separation axis. That is, the arms may be mirrored about a vertically oriented plane extending vertically between them. Vertical here is with reference to the typical in-use orientation of the device, in which the arms substantially extend along a horizontal plane.

[0073] This mirrored configuration provides symmetrical fit and function, ensuring consistent performance regardless of which nostril the noseclip is applied to. It permits the design to be fully reversible, making it easier to use.

[0074] The body may comprise a central arcuate portion forming a hoop shape.

[0075] The hoop shape provides flexibility and resilience to the noseclip, improving comfort and adaptability to different nasal septum shapes. This shape also enables precise control over the separation of the arms and spreads forces more reliably around the noseclip so that the risk of stress fractures is minimized. The shape ensures minimal interference of the arms and body with the end of the septum since the hoop shape ensures a degree of clearance.

[0076] A separation distance of the arms at the central arcuate portion may be greater than a separation distance of the arms at the distal ends.

[0077] This tapered design allows for easier insertion while maintaining a secure fit at the nasal septum. It helps to prevent the lower edges of the arms, furthest from the nasal contacting portions, from interfering with the nostrils.

[0078] The arms may be arcuate and a separation distance between the arms may reduce towards the distal ends.

[0079] The arcuate shape, with a reducing separation distance towards the end that is inserted into the nostrils, provides a secure and comfortable fit while allowing for easy insertion and removal. Ithelps to prevent the proximal edges of the arms, furthest from the nasal septum contacting portions, from interfering with the nostrils.

[0080] Where both arms comprise peripheral skirts these may substantially face each other about the centreline.

[0081] This orientation of the peripheral skirts may ensure optimal contact with the nasal septum, improving the seal and sensor accuracy. It also ensures that forces are more evenly spread and balanced.

[0082] A plane intersecting a peripheral edge of one of the peripheral skirts may be parallel with the centreline.

[0083] This parallel alignment ensures consistent contact and sealing with the nasal septum, improving sensor reliability, particularly where patients have septum that is uniform in thickness along its length.

[0084] In a slight variation, the peripheral skirts may be slightly angled with respect to the aforementioned plane, to accommodate septums with particular geometrical characteristics where parallel peripheral skirts would not provide an optimal fit. For example, the skirts may taper inwards or outwards at the distal ends, relative to the aforementioned plane.

[0085] At least one of the probe and the probe receiving channel may be adapted to allow repeated insertion and removal of the probe into and from the probe receiving channel.

[0086] This feature allows for easy replacement or maintenance of the sensor, improving the longevity and versatility of the noseclip.

[0087] The sensor in the probe may comprise an analyte and may be adapted to measure pCO2.

[0088] This specific sensor configuration allows for accurate measurement of partial pressure of carbon dioxide, a crucial physiological parameter in many medical scenarios.

[0089] Alternatively, the probe may be adapted to measure or monitor parameters including one or more of blood oxygen levels, spO2, heart rate, respiratory rate, blood pressure, and body temperature. The ability to measure various physiological parameters allows the noseclip to be used in a wide range of medical applications, providing valuable data for patient monitoring and diagnosis.

[0090] The peripheral skirt(s) may comprise a flared skirt edge portion.

[0091] The flared edge improves the seal with the nasal septum, enhancing sensor accuracy and patient comfort. It helps to spread the force applied to the septum over a larger area, thereby improving user comfort.

[0092] The peripheral skirt(s) may comprise a truncated cone shape.

[0093] This shape provides an optimal balance between sealing effectiveness and comfort for the patient. It also provides a design that is easy to manufacture.

[0094] The peripheral skirt(s) may comprise an oval or circular shaped peripheral edge.

[0095] The oval or circular shape ensures even pressure distribution around the sensor, improving accuracy and comfort, and may be more suited to the geometry of the nasal septum.

[0096] The peripheral skirt(s) may comprise a peripheral edge that comprises a flexible material.

[0097] In particular, when measured on the shore 00 hardness scale, the shore hardness of the peripheral edge may be between 0 and 70, or more preferably between 10 and 60 or more preferably between 20 and 50 or more preferably between 30 and 40 on that scale.

[0098] The flexible material improves the seal with the nasal septum while enhancing patient comfort during extended wear. The flexible material results in the edge portion being softer than other parts of the noseclip.

[0099] In a second aspect, a noseclip insertion tool for use with the noseclip of the first aspect is provided. The noseclip insertion tool comprises an engagement portion adapted to cooperate with the engagement portion of the noseclip.

[0100] This dedicated insertion tool improves the ease and precision of noseclip application, reducing patient discomfort and ensuring proper placement. It also reduces the cost of the noseclip, and the overall cost of ownership, particularly since an operator may need fewer insertion tools than the number of noseclips.

[0101] The engagement portion of the noseclip insertion tool may comprise a recess.

[0102] This recess allows for secure attachment to the noseclip, ensuring controlled manipulation during insertion.

[0103] The recess may comprise a stepped side wall.

[0104] The stepped side wall provides additional security in the connection between the insertion tool and the noseclip, preventing accidental disengagement. It also allows for a secure friction fit design, that is simple and robust.

[0105] The noseclip insertion tool may comprise a pair of converging arms and a pair of separating arms, the two pairs extending from opposite sides of a pivot portion.

[0106] This configuration allows for intuitive operation of the insertion tool, with the converging arms controlling the separation of the noseclip arms. The converging arms may be adapted for ergonomic use, by being shaped to accommodate a thumb and index finger pad or knuckle.

[0107] The converging arms and separating arms may rigidly extend from the pivot portion and the noseclip insertion tool may comprise a single piece of resilient homogenous material.

[0108] This single-piece design improves durability and simplifies manufacturing of the insertion tool. Since there are no moving parts, manufacture is cheap and simple, and reliability is improved. Resilient homogenous material means a single material used for the production of the noseclip insertiontools, resulting in an appropriate material resiliency, which can be derived from modelling or simply through empirical trial and error. Plastic may for example be a sensible choice. If metal were to be used, it may be thinner than the equivalent plastic design, due to the increased resiliency of metal compared to plastics in general.

[0109] The separating arms may be adapted to separate when a compressive force is applied to the converging arms.

[0110] This mechanism provides a simple and intuitive way to control the separation of the noseclip arms during insertion. Squeezing is a highly intuitive action.[oni] The separating arms may be adapted to separate the arms of the noseclip when the noseclip insertion tool is attached to the noseclip and when a compressive force is applied to the converging arms. Squeezing to provide a separation is highly intuitive.

[0112] This direct mechanical linkage ensures precise control over the noseclip arms during the insertion process.

[0113] In a third aspect, a noseclip assembly comprising a noseclip according to the first aspect and a noseclip insertion tool according to the second aspect is provided.

[0114] This assembly provides a complete solution for accurate and comfortable physiological parameter sensing in the nasal cavity. Providing the devices as a kit of parts is convenient for the user.

[0115] The noseclip and noseclip insertion tool may be rigidly secured.

[0116] Rigid securing ensures consistent relative positioning between the noseclip and insertion tool, improving ease of use and application accuracy.

[0117] The noseclip and noseclip insertion tool may be integrally formed.

[0118] In a further aspect of the disclosure, there is provided a method of producing a noseclip for attachment to a nasal septum of a patient to determine a physiologic parameter of the patient, the method comprising the steps of: in a moulding step, moulding the noseclip; followed by a probe attachment step comprising fusing, welding or gluing a probe the housing of the noseclip. The moulding step may comprise moulding one or more of the body, arms and housing and skirts of any of the disclosed embodiments herein. Optionally, in further methods, the method may comprise only the moulding step or only the probe attachment step.

[0119] In a further aspect of the disclosure, there is provided a method of producing a noseclip for attachment to a nasal septum of a patient to determine a physiologic parameter of the patient, the method comprising the steps of: in a pre-moulding step, positioning a probe within the mould; in a moulding step, moulding at least the housing of the noseclip, such that the probe is integrally formed with the housing. The moulding step may comprise also moulding one or more of the body, arms and and skirts of any of the disclosed embodiments herein, along with moulding the housing. Optionally, the pre-moulding step may comprise positioning a probe comprising a semiconductor chip in the mould;the semiconductor chip may comprise a photoplethysmogram (PPG) sensor that is suitable for measuring SpO2, respiratory rate etc.; or alternatively the probe may comprise a pCO2 sensor, that utilizes the semiconductor chip.

[0120] Any of the methods disclosed herein may also comprise the step of: in a soft moulding step, moulding of the skirt(s) and / or the skirt edge portion(s) to form one or more skirt edge portion(s) that is / are more flexible than other parts of the noseclip.

[0121] The probe may be integrated into the housing either in the moulding step, or in the soft moulding step where present. The probe may alternatively be integrated into or onto the housing in an additive moulding step that follows one or more moulding step, wherein the additive moulding rigidly integrates the probe into, or affixes the probe onto, the housing. Alternatively again, the probe may be attached to, or attached or embedded into, the housing, permanently or non-permanently, during the probe attachment step outline above.

[0122] Integral formation of the probe within the noseclip and simplifies the design, reducing parts and potentially lowering manufacturing costs while ensuring perfect compatibility between the noseclip and insertion tool.

[0123] The noseclip and / or the noseclip insertion tool may comprise one or more polymer materials, for example a plastic material. Optionally the noseclip may comprise different polymer materials with different properties for different parts of the noseclip. For example, the noseclip may comprise a softer and / or more flexible polymer material for the wing(s) and / or skirt(s) and / or skirt edge portion(s) compared to the polymer material that may be used for other parts of the noseclip.

[0124] It should be noted that whilst the noseclip insertion tool is described in some embodiments as a separate article to the noseclip, this should not be read to imply that the noseclip insertion tool cannot be an integrated component of the noseclip.BRIEF DESCRIPTION OF FIGURES

[0125] Embodiments of the invention will be described, by way of example, with reference to the following drawings, in which:

[0126] Fig. 1 shows a perspective view of a noseclip assembly.

[0127] Fig. 2 shows a perspective view of a noseclip.

[0128] Fig. 3 shows a top view of the noseclip assembly with the noseclip in a closed position.

[0129] Fig. 4 shows a top view of the noseclip assembly with the noseclip in an open position.

[0130] Figs. 5A to 5E show multiple orthogonal views of the noseclip.

[0131] Fig. 6 shows a perspective view of the noseclip from one angle.

[0132] Fig. 7 shows a perspective view of the noseclip from another angle.

[0133] Fig. 8 shows a top view of the noseclip with a probe being inserted.

[0134] Fig. 9 shows a top view of the noseclip with the probe inserted.

[0135] Fig. 10 shows a top view of the noseclip and a sectional view along the A-A of the top view.

[0136] Fig. 11 shows a sectional view of a top portion of the noseclip.

[0137] Fig. 12 shows a cross-sectional view of the end of one arm of the noseclip.

[0138] Fig. 13 shows a side view of the end of one arm of the noseclip shown in Fig. 12.

[0139] Fig. 14 shows a perspective view of the noseclip assembly including the noseclip and noseclip insertion tool.

[0140] Fig. 15 shows a perspective view of the noseclip.

[0141] Fig. 16 shows a perspective view of an alternative embodiment.

[0142] Fig. 17 shows a perspective view of a further alternative embodiment.

[0143] Common reference numerals are used throughout the figures to indicate similar features.

[0144] In the Figures, feint dotted lines with arrows indicate axes (Ax), bold dotted lines with arrows indicate movement (Mx), and bold solid lines with arrows indicate forces (Fx), where x is a relevant descriptive subscript.DETAILED DESCRIPTION

[0145] The present disclosure provides a noseclip device designed for attachment to a nasal septum of a patient. The primary purpose of this device is to determine a physiological parameter of the patient, such as the partial pressure of carbon dioxide (pCO2), within the nasal cavity. The noseclip device comprises a body that includes a pair of arms, each having a nasal septum contacting portion. At least one of the arms has a housing that has a peripheral skirt, which work together to seal a volume of air within the housing when the skirt contacts and seals against the nasal septum. This peripheral skirt may be made of a soft and flexible material and is thus adapted to create a sealed chamber when contacted to the nasal septum, providing an environment ideal for accurate sensing of the physiological parameter. The design of the noseclip device allows for secure attachment to the nasal septum, while providing a sealed environment for accurate sensing of the physiological parameter.

[0146] In embodiments, a first nasal septum contacting portion of the noseclip device includes a probe receiving channel that is in communication with the volume enclosed by housing and the peripheral skirt. This probe receiving channel is adapted to receive a probe that houses a sensor responsive to the physiological parameter. The probe receiving channel enables easy insertion and removal of probes, allowing for flexibility in sensor selection and replacement.

[0147] Fig. 1 shows a perspective view of a noseclip assembly.

[0148] Referring to Fig.l, a noseclip assembly 1 is depicted, which includes the noseclip 2 and the noseclip insertion tool 4. The noseclip 2 comprises a body 10 with two arms 14 extending outward. Each arm 14 has a nasal septum contacting portion 20 at its distal end. The nasal septum contacting portions 20 are designed to make contact with the nasal septum when the noseclip 2 is inserted into a nasal cavity.

[0149] The noseclip insertion tool 4 is connected to the noseclip 2 and allows the distal ends of the arms 14 to be separated, thereby separating the nasal septum contacting portions 20. In use, the end of the noseclip insertion tool 4 is squeezed together, with force Fm, which causes the arms at the other end of the noseclip insertion tool 4 to open, which in turn forces the arms 14 of the noseclip 2 apart causing separation of the cavities formed by each of the nasal septum contacting portions 20. This movement is denoted Mcav and is in an opposite direction to the input force Fm.

[0150] In use, the end of the noseclip insertion tool 4 is urged apart with input force Fm, causing the arms to separate in a first direction along a first axis Aseparation. The noseclip is then inserted into the nasal cavity in a second direction along a second axis Assertion which is orthogonal to the other first axis Aseparation. When the separating force Fmis removed from the insertion tool 4, the arms 14 move back towards each other due to the resilience of the noseclip 2, which naturally wants to return to its original shape. This then moves the nasal septum contacting portions 20 towards eachother, within the nasal cavity, such that they may contact respective sides of the nasal septum. To remove the noseclip, the steps are reversed.

[0151] In particular, in order to remove the device, the operator apply forces again applied to the separation tool this causes the nasal septum contacting portions to be separated again thereby causing the allowing the device to be removed.

[0152] This design allows for the arms 14 of the noseclip 2 to be separated during insertion or removal, facilitating a more comfortable and efficient process for the patient. Once positioned, the noseclip is comfortable as the nasal septum contacting portions spread the load exerted by the arms towards the walls of the nasal septum.

[0153] Fig. 1 shows the noseclip 2 and the noseclip insertion tool 4 are part of the same noseclip assembly 1 but can be separated. In other embodiments, the noseclip insertion tool 4 and noseclip 2 are integrally formed.

[0154] The distal ends of the arms comprise wings 16 which are substantially circular in shape, and which can be used to maintain the airway through the nostrils in use. The wings may have openings 17 which may allow some flexibility to the wings, and which may also reduce costs. The size of the openings 17 may be between 10 and 30 percent of the circumference of the wing 16.

[0155] The noseclip insertion tool 4 has an engagement portion 40, in the form of a recess, designed to cooperate with a recess in the noseclip 2, enabling the two to be attached together andenabling a force applied to the noseclip insertion tool 4 to be applied to separate the arms 14 of the noseclip 2. (The recess in the noseclip will be described in more detail in relation to Fig. 2). In particular, the noseclip insertion tool 4 comprises an engagement portion 40 adapted to cooperate with the engagement portion of the noseclip 2. This engagement mechanism allows the noseclip insertion tool 4 to securely attach to the noseclip 2, facilitating the separation of the arms 14 during insertion or removal of the noseclip from a patient.

[0156] The noseclip insertion tool 4 has converging arms 42 (that converge in use) and separating arms 46 (that separate in use) arranged about pivot portion 44. A force Fmon the converging arms 42 causes the separating arms 46 to separate, which in turn enables the arms 14 of the noseclip 2 to be separated. It should be understood that there is not a need for a mechanical pivot or any moving parts, although, in embodiments, such designs are foreseen. The noseclip insertion tool 4 relies on the resiliency of the tool to transfer the force from the converging arms 42 to the separating arms 46 about the pivot portion 44.

[0157] In some aspects, the noseclip insertion tool 4 comprises a single piece of resilient homogenous material, which may enhance the durability and reliability of the tool 4, and make it simpler and cheaper to manufacture.

[0158] Fig. 2 shows a perspective view of a noseclip.

[0159] With reference to Fig. 2, the body 10 of the noseclip 2 also includes an engagement portion 12, which is positioned substantially centrally between the arms 14 and about a centreline C. The engagement portion 12 is adapted to receive a cooperating noseclip insertion tool 4 for separating the nasal septum contacting portions along a separation axis Aseparation.

[0160] Fig. 2 also shows the probe receiving channel 26, into which a probe may be positioned allowing the noseclip to be used to detect a physiologic parameter. A cable extending from a probe in that channel may exit through the opening 27 on the side of the noseclip 2

[0161] The arms 14 of the noseclip 2 are substantially mirrored about a vertical plane extending through the centreline C, which is substantially orthogonal to the separation axis Aseparation. This symmetrical design ensures that the noseclip 2 can be inserted into either nostril with equal ease and effectiveness. The arms 14 are resiliently biased towards the centreline C, extending longitudinally along an insertion axis Assertion and positioned centrally between the arms.

[0162] The body 10 of the noseclip 2 comprises a central arcuate portion forming a hoop shape. This hoop shape is designed to prevent the body 10 from interfering with the columella, the fleshy outer part that separates the nostrils / nasal openings, by being wider than it.

[0163] In embodiments, the body 10 of the noseclip 2 is designed such that a separation distance of the arms 14 at the central arcuate portion is greater than a separation distance of the arms 14 at the distal ends with the nasal septum contacting portions 20. This design allows the arms 14 to be more easily separated during insertion or removal, facilitating a more comfortable and efficient process forthe patient. It also ensures that forces are evenly distributed and reduces the risk of stress or fatigue on any part of the noseclip 2.

[0164] The noseclip 2 comprises a separating means 11 for separating the arms. In some embodiments herein the separating means are suitable for directly separating the arms (for example, by applying a squeezing force to tabs or protrusions), whereas in other embodiments such as the one shown in Fig. 2 the separating means is adapted to receive a special tool to allow the arms to be easily and controllably separated. As shown in the embodiment in Fig. 2, in some embodiments the separating means 11 comprises a recess 12 having a notch 13 at its bottom, and the recess 12 has parallel sidewalls. The recess extends in a third direction along a third axis Arecess which is substantially orthogonal to the first and second axes already mentioned. This configuration allows an insertion tool 4 to be inserted laterally (e.g. vertically), after which the insertion tool 4 can provide a sideways separating force that causes the nasal septum contacting portions 20 to separate.

[0165] In embodiments, the engagement portion 40 of the noseclip insertion tool 4 comprises a corresponding protrusion or tab to engage with the notch 13 of the recess 12 of the noseclip 2, providing a secure and reliable connection between the two components.

[0166] In embodiments, the recess 12 of the noseclip comprises parallel side walls, allowing the noseclip insertion tool 4 to be sized to fit exactly and held in place by a friction fit.

[0167] Fig. 3 shows a top view of the noseclip assembly with the noseclip in a closed position and Fig. 4 shows atop view of the noseclip assembly with the noseclip in an open position.

[0168] Referring to Fig. 3 and Fig. 4, the operational mechanics of the noseclip assembly 1 are illustrated. The noseclip assembly 1 includes the noseclip 2 and the noseclip insertion tool 4. The noseclip 2 is depicted at the top of each figure, while the noseclip insertion tool 4 is shown below it. The pivot portion 44 of the noseclip insertion tool 4 is visible roughly at its center.

[0169] In Fig. 3, two inward forces (Fm) are shown acting on the converging arms 42 of the noseclip insertion tool 4, while two outward forces (Fout) are depicted acting on the separating arms 46 of the noseclip 2. The inward forces (Fm) are applied by the user to the noseclip insertion tool 4 to cause the noseclip 2 to move to its open position wherein the arms are separated. Applying the inward forces (Fin) causes the noseclip insertion tool 4 to apply, via separating arms 46, outward forces (Fout) to arms of the noseclip 2, thereby causing it to adopt the open position.

[0170] Fig. 4 presents a similar view of the noseclip assembly 1, but instead of force vectors, it shows movement vectors. The movement vectors indicate how the noseclip 2 and the noseclip insertion tool 4 move in reaction to the forces shown in Fig. 3. Movement vectors are indicated at various points on the assembly. Movement MCon-arms the converging arms causes movement Msep-arms of the separating arms which in turns transfers a force to the arms of the noseclip, causing movement Mcav of the cavities at the end of the noseclip arms. These enclosed cavities are defined by the nasal septum contacting portions, which when in contact with the nasal septum create an enclosed volume or cavity.

[0171] The separating arms 46 of the noseclip insertion tool 4 are adapted to separate when a compressive force is applied to the converging arms 42. This design allows the user to easily manipulate the arms 14 of the noseclip 2 during insertion or removal, enhancing the usability of the device. This provides a simple and efficient mechanism for separating the arms 14 of the noseclip 2, facilitating a more comfortable and efficient process for the patient. Additionally, because in embodiment the noseclip 2 and noseclip insertion tool 4 can be separated, the insertion tool can be removed after the noseclip 2 is placed in position on a patient.

[0172] Fig. 5 illustrates multiple orthogonal views of the noseclip 2, providing a comprehensive representation of its structure and key features. The figure includes atop view in Fig. 5A, a far end view in Fig. 5B, a near end view in Fig. 5C, and two side views in Figs. 5D and 5E. “Near end view” means when viewed from the end at the bottom of Fig. 5 A, and “far end view” means when viewed from the end at the bottom of Fig. 5A.

[0173] The front view in Fig. 5A reveals the overall U-shaped structure of the noseclip 2. This view clearly shows two arms extending outward from a central portion, forming a symmetrical arrangement. Each arm terminates in a curved distal end, having a nasal septum contacting portions 20 designed to fit comfortably within the nasal cavity. The wings 16 are visible on either side, extending laterally from the distal ends of the arms 14. The wings 16 are adapted to support a lateral vestibule wall surrounding a nostril of the patient to maintain an open airway, and serve multiple purposes, including stabilizing the device within the nasal cavity, maintaining an open airway, and providing a comfortable interface with the nasal tissue.

[0174] The wings are substantially circular when viewed along the centreline C of Fig 1. This substantially circular shape can be seen in Figs. 5B and 5C.

[0175] Fig. 5A also shows the probe receiving channel 26, that is designed to accommodate a sensor probe for sensing a physiologic parameter. The probe receiving channel 26 is also illustrated in Fig. 5B and Fig. 5D. This channel 26 appears as an opening in the body of the noseclip 2, here positioned on one of the arms 14. In other embodiments, there may be more than one probe receiving channel 26 in each arm, or one or more probe receiving channel 26 on each arm.

[0176] The far end view (Fig. 5B) and near end view (Fig. 5C) provide a view of the noseclip 2 from different ends. These views highlight the curvature of the U-shaped body and the positioning of the wings 16. The wings 16 are seen as curved structures protruding outward from the sides of each arm. The wings 16 assist to prop open the nostrils and provide stability to the noseclip 2 when inserted.

[0177] Fig. 5C illustrates the opening 27 that is on the arm 14 with the probe receiving channel, which opening can be used for signal cable or signal wire routing.

[0178] The wings 16 also have openings 17, which are visible in Figs. 5B, 5C, 5D and 5E. These openings 17 provide flexibility to the wings, resulting in reduced irritation and increased patient comfort. The opening 17 may be found at a peripheral portion furthest from the centreline (C), as seenin Figs. 5B and 5C. In embodiments, the size of the opening 17 is between 10 and 30 percent of the circumference of the wing 16.

[0179] The side view 5D offers a profde perspective of the noseclip 2. Again, this figure illustrates the opening 27 that is on the arm 14 with the probe receiving channel, which opening can be used for signal cable or signal wire routing.

[0180] The side view 5E, along with side view 5D, shows the recess 12, and the opening 17 in each of the wings 16.

[0181] Throughout all views, the noseclip 2 maintains a consistent structure, with the wings 16 and probe receiving channel 26 being notable features across multiple perspectives.

[0182] The smooth, contoured shape of the noseclip 2 is evident particularly from Fig. 5A.

[0183] The U-shaped body of the noseclip 2 is designed to provide a resilient bias, allowing the arms to gently grip the nasal septum when inserted.

[0184] Fig. 6 and Fig. 7 show perspective views of the noseclip from different angles. Again, the wings 16 with openings 17 can be seen, along with the probe receiving channel 26 and adjacent opening 27 in one of the arms 14.

[0185] Fig. 6 and Fig. 7 show the engagement portion 12 for receiving an insertion tool (see Fig.1). The use to separate the arms 14 of the noseclip 2, to allow the noseclip 2 to be positioned within the nasal cavity and removed therefrom. More particularly, the insertion tool enables separation of the nasal septum contacting portions 20 along a separation axis Aseparation, i.e. it allows them to be separated during insertion or removal.

[0186] The engagement portion 12 is positioned substantially centrally between the arms 14 and about the centreline C. This central positioning allows the engagement portion 12 to effectively interface with the noseclip insertion tool 4, facilitating the separation of the arms 14 during insertion or removal. The central positioning of the engagement portion 12 also ensures a balanced distribution of forces during the insertion or removal process, enhancing the comfort and efficiency for the patient.

[0187] The engagement portion 12 includes a small notch 13 at the bottom on one side, which enables the insertion tool to be held more securely. This notch permits the design to be moulded with an open channel. Furthermore, this notch 13 can be used as a guide for the cables from sensors, as an alternative to the opening 27 (see e.g. Fig. 5D). Routing the cables or wires through notch 13 may be particularly useful if the cable is very stiff, rendering it difficult to use an opening in the side, proximal to the probe receiving channel 26, such as opening 27.

[0188] The parallel side walls of the recess 12 provide additional stability and alignment during the engagement process of the insertion tool to the noseclip and enable a friction fit between the two, enhancing the usability of the device and providing a simple and reliable attachment mechanism between the noseclip 2 and the insertion tool.

[0189] In addition to the recess, the engagement portion 12 also comprises a notch 13. The notch 13 is positioned at the bottom of the recess, serving as an additional engagement feature. This notch 13 may provide a secure point of contact for the noseclip insertion tool 4, further enhancing the stability and reliability of the connection.

[0190] Fig. 8 shows a top view of the noseclip with a probe being inserted, and Fig. 9 shows a top view of the noseclip with the probe inserted.

[0191] Referring to Fig. 8, a probe 28 is shown being brought towards the probe receiving channel 26 of the noseclip 2. The probe receiving channel 26 is in communication with the volume 22 enclosed by the peripheral skirts 20 of the nasal septum contacting portion. The probe receiving channel 26 is adapted to receive the probe 28, which houses a sensor responsive to the physiological parameter.

[0192] The direction of movement "Msens" is shown, indicating how the probe 28 moves towards the probe receiving channel 26 when it is being inserted in to the noseclip 2.

[0193] The sensor in the probe 28 comprises an analyte and is adapted to measure the partial pressure of carbon dioxide (pCO2) within the nasal cavity. Alternative sensors may be provided, for example to measure or monitor parameters such as blood oxygen levels, heart rate, or body temperature. The ability to measure various physiological parameters allows the noseclip 2 to be used in a wide range of medical applications, providing valuable data for patient monitoring and diagnosis.

[0194] The probe 28 maybe a friction fit within the probe receiving channel 26. The probe 28 and the probe receiving channel 26 may comprise mechanical means such as indents and protrusions to allow the probe to be secured within the probe receiving channel 26.

[0195] The probe receiving channel 26 and the probe 28 are adapted to allow repeated insertion and removal of the probe 28 into and from the probe receiving channel 26. This feature provides flexibility in the use of the noseclip 2, allowing for easy replacement or adjustment of the probe 28 as needed. The design of the probe receiving channel 26 and the probe 28 facilitates easy insertion and removal, enhancing the usability of the noseclip 2.

[0196] In Fig. 9, the probe 28 is shown fully inserted into the probe receiving channel 26 of the noseclip 2. The probe 28, when inserted into the probe receiving channel 26, is therefore able to perform sensing operations of the nasal cavity. One or more wires extend from the probe 28 to allow sensor data to be collected from the probe 28. The probe 28 optionally extends from the bottom of the channel 26, to aid removal, by leaving a portion of the probe 28 that can be readily gripped by hand or with a suitable tool.

[0197] In embodiments the probe 28 is rigidly secured within the probe receiving channel 26 and cannot be removed. In such instances, the body of the noseclip 2 may be colour coded or otherwise marked to denote a particular probe 28 with a particular sensor, thus indicating a particular use.

[0198] In embodiments, there are noseclips 2 with different sized probe receiving channels 26, which are sized to accommodate different sized probes 28 are designed to fit in different sized probe receiving channels. Accordingly, different noseclips 2 can be adapted to monitor different physiological parameters.

[0199] Fig. 10 shows a top view, and a sectional view along the line A-A of the top view, of an embodiment of the noseclip 2. Fig. 11 shows a sectional view of a top portion of the same noseclip. Dimensions, in mm are shown.

[0200] With reference to Fig. 10, the body 10, arms 14 and wings 14 and recess 12 are shown.

[0201] With reference to Fig. 11, the noseclip 2 comprises peripheral skirts 20 that contain a volume 22. When each arm 14 of the noseclip is contacted to the nasal septum, the volume 22 is fully enclosed by the peripheral skirts 20 and the nasal septum. The peripheral skirts 20 include flared skirt edge portions 24 at their outer edges. The flared skirt edge portions 24 are shown at the outer edges of the peripheral skirts 20, curving slightly outward.

[0202] The peripheral skirts 20 comprise a flared skirt edge portion 24 facing the centreline C, made of soft, flexible material. The flared skirt edge portion 24 provides a comfortable interface with the nasal tissue, enhancing the comfort of the patient during use. The flared skirt edge portion 24 also helps to maintain the seal between the peripheral skirts 20 and the nasal septum, ensuring the accuracy of the sensor readings. The entirety of the skirts may be made from this softer, more flexible material.

[0203] This flexible material allows the peripheral skirts 20 to conform more closely to the shape of the nasal septum, enhancing the seal and improving the accuracy of the sensor readings. The flexible material also enhances the comfort of the patient during use, as it reduces the pressure exerted on the nasal septum by the noseclip 2.

[0204] In embodiments, the peripheral skirts 20 comprises a truncated cone shape. This shape may allow the peripheral skirts 20 to conform more closely to the shape of the nasal septum, enhancing the seal and improving the accuracy of the sensor readings. In other cases, at least one of the peripheral skirts 20 comprises an oval or circular shaped peripheral edge. This shape may provide a more comfortable fit within the nasal cavity, enhancing the comfort of the patient during use.

[0205] With reference to Fig. 10 and Fig. 11, the peripheral skirts 20 substantially face each other about the centreline C of Fig. 1. This design ensures that the peripheral skirts 20 form a sealed chamber when contacted to the nasal septum, providing an environment conducive for accurate sensing of the physiological parameter. The peripheral skirts 20 may be designed to create a sealed chamber when contacted to the nasal septum, providing an environment conducive for accurate sensing of the physiological parameter.

[0206] Fig. 12 shows a cross-sectional view of the end of one arm of the noseclip, and Fig. 13 shows a side view of the end of one arm of the noseclip shown in Fig. 12.

[0207] With reference to Fig. 12 and Fig. 13, the peripheral skirt 20 having a flared skirt edge portion 24 and enclosing volume 22 can be seen. Also seen is the probe 28, positioned within the probe receiving channel and in communication with the volume 22

[0208] With reference to Fig. 12 a plane P intersecting a peripheral edge of one of the peripheral skirts 20 is parallel with the centreline C (seen in Fig 1). Accordingly the nasal septum contacting portions at the end of each arm directly face one another (without any taper). This design ensures that the peripheral skirts 20 are aligned correctly with the nasal septum, enhancing the seal and improving the accuracy of the sensor readings. The alignment of the plane P with the centreline C may also facilitate the insertion and removal of the noseclip 2, enhancing the usability of the device.

[0209] The design of the sensor cavity, formed by the peripheral skirts 20, is based on two principles: firstly, minimization of the distance from sensor to mucosa, and, secondly, minimization of the volume of the sensor cavity. Following these two principles significantly reduces the time needed for stabilization after insertion on the mucosa, and results in reduced drift and instability in the measurements overtime.

[0210] The Sensor Cavity design has been designed such that, when the probe used to measure temperature (for example through the use of the IscAlert TM sensor) the cavity covers the thermistor of the probe in a manner that ensures that the temperature measurement is only affected by the temperature of the mucosa and not by breathing or ambient conditions.

[0211] In embodiments, there may be a taper of the nasal septum contacting portions so that they do not directly face one another, to more comfortably fit to the nasal septum.

[0212] In embodiments, the nasal septum contacting portions may articulate with respect to the arms, allowing for a particularly comfortable fit against the nasal septum.

[0213] Fig. 14 shows a perspective view of the noseclip assembly including the noseclip and noseclip insertion tool, and Fig. 15 shows a perspective view of the noseclip. Fig. 14 and Fig. 15 are substantially the same as Fig. 1 and Fig. 2 except that they focus on the different axes and directions of motion of the noseclip 2 and insertion tool 4.

[0214] With reference to Fig. 14 and Fig. 15, when the noseclip 2 is being inserted and removed, it is generally moved along a first axis Assertion, into and out of the nasal cavity. This axis extends in a first direction. Prior to moving the noseclip 2 into the nasal cavity, the user applies a squeezing force to the insertion tool causing the arms of the noseclip to separate in a second direction, that is substantially orthogonal to the first direction. The second direction extends along a the Aseparation axis.

[0215] With reference to Fig. 15. the direction in which the insertion tool is inserted into the noseclip 2 is shown. The insertion tool is inserted vertically into the engagement portion, in a direction that is substantially orthogonal to the first direction and second direction, along the Arecess axis.

[0216] The noseclip 2 and the noseclip insertion tool 4 are designed to work together as an assembly, with the insertion tool 4 providing a mechanism for separating the arms 14 of the noseclip 2 during insertion or removal. The orthogonal relationship between the insertion axis Assertion, the separation axis Aseparation, and the recess axis Arecess facilitates this process, allowing for a more comfortable and efficient use of the noseclip assembly 1.

[0217] Fig. 16 shows a perspective view of an alternative embodiment. This embodiment comprises integrated separating means (so that no separate tool is required), as well as differently shaped wings 16. Separating means 11, in the form of thumb-shaped tabs, extend directly from the body 10 and are squeezed together to actuate the separating of the nasal septum contacting portions at the far end. Accordingly, in this embodiment, no separate tool is required to separate the arms 14.

[0218] As an optional variation, the wings 16 herein comprise a different cross-sectional shape. Instead of being substantially circular, they comprise a longitudinal indent 16A, which optionally is positioned on the side of the wing furthers from the central axis C shown in Fig 1. This shape of wing 6 is strong and allows some flexibility into the wings, this shape may interfere less with the nasal passage, resulting in improved user comfort.

[0219] The wing shape shown in Fig. 16 may optionally be combined with the features of other embodiments.

[0220] The design shown in Fig. 16 may provide improved flexibility compared to some other embodiments.

[0221] The integrated insertion tool design shown in Fig. 16 may be applied to any other embodiment.

[0222] Fig. 17 shows a perspective view of a further alternative embodiment.

[0223] With reference to Fig. 17, the insertion tool 4 is once again removable and slides into an engagement portion 12 in the body 4 of the noseclip. Optionally, the engagement portion 12 of the noseclip 2 that receives the end of the insertion tool 4 may be hoop shaped, semicircular, or may be substantially square or rectangular.

[0224] Optionally, and as shown in Fig. 17, the engagement portion 12 of the noseclip 2 may be positioned near to the nasal septum engagement portion, at the far end from the body from where the two arms 14 join together. The engagement portion 12 may, as shown, be co-incident with the separation axis Aseparation along which the nasal septum contacting portions move when being separated.

[0225] As shown, the noseclip insertion tool 4 may be comprise a body that is substantially shaped the same as the body of the noseclip 4, but with a wider curvature, such that the noseclip insertion tool 4 surrounds the noseclip 4 without contacting it other than at the engagement portion 12.

[0226] Providing the engagement portion 12 of each arm 14 proximal to the nasal septum contacting portions may provide more optimal control over the separation of the arms 14.

[0227] Optionally the design shown in Fig. 17 may also comprise wings, which may be of the shape shown in Fig. 16. Optionally, the design shown in Fig. 17, where the insertion tool engages with hooped engagement portions 12 on the body may be incorporated into other embodiments.

[0228] In some cases, the noseclip 2 and the noseclip insertion tool 4 may be separate components that can be assembled together. In other cases, the noseclip 2 and the noseclip insertion tool 4 may be integrally formed as a single unit.

[0229] In embodiments, the noseclip 2 may include two sensor cavities or sensors, designed for sensing on opposite sides of a septum. This dual sensor configuration may provide enhanced sensing capabilities, allowing for more accurate and reliable measurements of physiological parameters. The two sensors may be designed to sense the same parameter, providing a means to verify the accuracy of the measurements. Alternatively, the two sensors may be designed to sense different parameters, providing a broader range of physiological data.

[0230] The noseclip 2 is designed to be reversible, allowing it to be inserted in either orientation. This feature enhances the usability of the noseclip 2, as it can be inserted into either nostril with equal ease and effectiveness. The reversibility of the noseclip 2 also ensures that the device can be used effectively regardless of the orientation of the nasal septum or the positioning of the sensors.

[0231] In some embodiments, there is an opening 17 in the wing 16. The size of this opening 17 maybe between 2 % and 75% of the circumference of the wing 16, when viewed in cross-section, more preferably between 5% and 45% and more preferably 10% and 30%. When the opening 17 is large, the wing 16 may be substantially semi-circular in cross-section. When the opening 17 is very large, the wing 16 may be a small arc shape.

[0232] In embodiments, the noseclip 2 and the noseclip insertion tool 4 may be provided as a kit of parts. This kit may include all the components necessary for the assembly and use of the noseclip 2, providing a convenient and comprehensive solution for the user. The kit may include instructions for the assembly and use of the noseclip 2, further enhancing the usability of the device.

[0233] In embodiments, the noseclip 2 and the noseclip insertion tool 4 may be integrally formed. This integral formation may simplify the assembly process and reduce the number of separate components, potentially reducing manufacturing costs and increasing ease of use. The integral formation of the noseclip 2 and the noseclip insertion tool 4 may also enhance the stability and reliability of the assembly, providing a more robust and durable device.

[0234] In embodiments, the sensor may be embedded in the noseclip 2. This configuration may reduce costs or simplify use by eliminating the need for a separate probe. The embedded sensor may be positioned in a cavity bounded by a soft peripheral skirt, which makes the device comfortable to wear. The cavity may improve accuracy or reliability and maintain cleanliness of the sensor. The embedded sensor may be designed to sense a variety of physiological parameters, providing a versatile and effective solution for patient monitoring.

[0235] The order of the steps of the methods described herein is exemplary, but the steps may be carried out in any suitable order, or simultaneously where appropriate. Additionally, steps may be added or substituted in, or individual steps may be deleted from any of the methods without departing from the scope of the subject matter described herein.

[0236] The noseclip 2 as mentioned herein may be adapted to include a probe or sensor that is suitable for measuring a range of physiological parameters. These parameters may include parameters that are typically known as “vital parameters”, such as heart rate, spO2, temperature, respiratory rate. The parameter may include blood pressure. In embodiments, a photoplethysmogram (PPG) sensor may be incorporated into the noseclip.

[0237] Aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples without losing the effect sought.

[0238] In embodiments, the probe is shown as cylindrically shaped. Alternatively, the sensor probe may be a planar sensor, which is optionally moulded into the noseclip.

[0239] In embodiments, one or more of the body 10, arms 14, wing(s) 16 and the skirt(s) 20 of the noseclip 2 are made of a thermoplastic elastomer. This material is useful for its compatibility with injection moulding, various sterilization methods, biocompatibility, flexibility, softness, and its high adhesion to polypropylene. One of more portions of the noseclip may be made by injection moulding a polymer material. The noseclip 2 may be formed in stages by injection moulding two or more different polymer materials with different properties to form different parts.

[0240] All parts of the noseclip 2 and optionally also the noseclip insertion tool 4, where present, may be made from a thermoplastic elastomer (TPE). One or more different thermoplastic elastomers with different properties may be used for different parts. For example, one or more of the softer or more flexible parts, such as the wing(s) (16) and / or the skirt(s) (20) may be made of thermoplastic polyurethane (TPU), with some or all of the rest of the noseclip 2 (and noseclip insertion tool 4 where present) being made from Polypropylene (PP).

[0241] It will be understood that the above description of some preferred embodiments is given by way of example only and that various modifications may be made by those skilled in the art. What has been described above includes examples of one or more embodiments. It is, of course, not possible to describe every conceivable modification and alteration of the above devices or methods for purposes of describing the aforementioned aspects, but one of ordinary skill in the art can recognize that many further modifications and permutations of various aspects are possible. Accordingly, the described aspects are intended to embrace all such alterations, modifications, and variations that fall within the scope of the appended claims.

Claims

24CLAIMS1. A noseclip (2) for atachment to a nasal septum of a patient to determine a physiologic parameter of the patient, the noseclip (2) comprising a body (10) that comprises a pair of arms (14) that each comprise a nasal septum contacting portion, and wherein a first arm of the pair of arms comprises: a housing; and a peripheral skirt (20) for contacting the nasal septum and adapted to create a sealed chamber enclosing a volume (22) when contacted to the nasal septum, and wherein the housing is adapted to retain a probe (28) for determining the physiologic parameter.

2. A noseclip (2) according to claim 1, wherein the housing comprises the probe (28).

3. A noseclip (2) according to claim 2, wherein the probe (28) is integrally formed with the housing.

4. A noseclip (2) according to claim 1 or claim 2, wherein the housing comprises a probe receiving channel (26) that is in communication with the volume (22) and that is adapted to retain the probe (28).

5. A noseclip (2) according to any preceding claim, wherein the first arm comprises a curved wing (16) adapted to support a lateral vestibule wall surrounding a nostril of the patient to maintain an open airway.

6. A noseclip (2) according to claim 5, wherein the wing (16) has an opening (17) at a peripheral portion furthest from a centreline (C) that extends longitudinally between the arms.

7. A noseclip according to any preceding claim, wherein the body (10) comprises separating means (11) for separating the arms (14).

8. A noseclip according to claim 7, wherein the separating means (11) comprises an engagement portion (12) adapted to receive a cooperating noseclip insertion tool (4) for separating the arms.

9. A noseclip (2) according to any preceding claim wherein the sensor in the probe (28) comprises analyte and is adapted to measure pCCK10. A noseclip (2) according to any preceding claim wherein the sensor in the probe (28) is adapted to measure heart rate, spO2, temperature, respiratory rate or blood pressure.

11. A noseclip (2) according to any preceding claim wherein at least one of the peripheral skirts (20) comprises a flared skirt edge portion (24).

12. A noseclip (2) according to any preceding claim wherein at least one of the peripheral skirts comprises a peripheral edge (24) that comprises a flexible material that, when measured on the shore 00 hardness scale, has a shore hardness of between 0 and 70, or more preferably between 10 and 60 or more preferably between 20 and 50 or more preferably between 30 and 40.

13. A noseclip insertion tool (4) for use with the noseclip (2) of any preceding claim, the noseclip insertion tool (4) comprising an engagement portion (40) adapted to cooperate with the engagement portion (12) of the noseclip (2) for separating the arms (14).

14. A noseclip assembly (1) comprising a noseclip (2) according to any of claims 1 to 12 and a noseclip insertion tool (4) according to claim 13.

15. A noseclip assembly (1) according to claim 14 wherein the noseclip (2) and noseclip insertion tool (4) are adapted to be releasably securable together by a friction fit between the noseclip (2) and the noseclip insertion tool (4).

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