Anaesthetic device

Abstract

Herein disclosed is a device operable to administer an anaesthetic, the device comprising: a controller detachably mountable on an ultrasound probe; a syringe; a needle; and a tubing comprising: one end coupled to the syringe and the other end coupled to the needle, and a portion of the tubing, between the syringe and the needle, is housed in the controller; wherein the controller comprises a casing and a member coupled to the casing, wherein the member is rotatable to actuate a roller mechanism housed in the casing for administering the anaesthetic, and wherein the roller mechanism is configured to control (i) flow rate of the anaesthetic in the tubing and (ii) direction which the anaesthetic flow in the tubing.

Description

ANAESTHETIC DEVICECross-Reference to Related Application

[0001] This application claims the benefit of priority of Singapore Patent Application No. 10202403375Y, filed 30 October 2024, the content of it being hereby incorporated by reference in its entirety for all purposes.Technical Field

[0002] The present disclosure relates to a device operable to administer an anaesthetic.Background

[0003] Traditionally, ultrasound-guided regional anaesthesia may routinely utilise a double-operator technique, where the proceduralist may perform the injection whilst an assistant administers local anaesthesia (LA). Single-operator technique may also be used, traditionally, which may have the potential to reduce manpower costs, and allow the proceduralist to detect pressure changes while administering LA. However, both of such techniques may be considerably difficult to master and cumbersome.

[0004] hr more detail, the widespread use of ultrasound has shaped modem regional anaesthetic practices. Anaesthetists routinely perform peripheral nerve blocks (PNBs) for anaesthetic and analgesic purposes. Each year, hundreds of thousands of PNBs may be performed globally for various surgeries and indications. This appears to continue growing with the increased availability of ultrasound machines, and anaesthetic trainees may have to be trained to develop skills in regional anaesthesia.

[0005] The growing number of gerontologic patients in developed countries may inevitably lead to surgery in older patients, where avoidance of general anaesthesia and minimisation of opioid use may be favoured to reduce postoperative cognitive dysfunction and delirium. During the COVID-19 pandemic, regional anaesthesia may have become the preferred modality to avoid aerosolisation of virulent particles during airway manipulation.

[0006] To perform a PNB, the proceduralist may hold the ultrasound probe in the nondominant hand and the needle in the dominant hand. Manipulating both ultrasound and needle may require dexterity and hand-eye coordination, especially around nerves andimportant structures such as blood vessels. A set-up may involve a syringe pre-loaded with local anaesthetic (LA), wherein a syringe may be commonly used as it may accommodate an effective volume for LA infiltration without requiring syringe change.

[0007] In double-operator technique, injection of LA may be performed by an assistant, who may not be experienced enough to detect subtle changes in pressure among the various tissue planes, risking inadvertent nerve injury. Although this may allow the proceduralist to focus on needle manipulation, it requires an additional person. In a busy emergency operating theatre or peripheral nerve block service, the additional personnel requirement then becomes a significant resource consideration, as it increases patient waiting time, delays surgery, and results in underutilisation of theatre time.

[0008] In single-operator technique, the proceduralist may perform the PNB without assistance and detect subtle changes in pressure when administering the LA. However, performing the block alone may be challenging, cumbersome, and time-consuming. In practice, the proceduralist may often release the needle to pick up the syringe for LA injection under ultrasound guidance. This repeated back-and-forth action may cause the needle tip to shift, increasing the risk of needle movement within tissue and potential nerve injury, while prolonging procedural time. Hydrodissection and hydrolocation of the needle tip may also be less effective in this technique, as the needle may not be manipulated during delivery of injectate, often resulting in greater than necessary LA use.

[0009] Another single-operator technique may involve a specialised hand grip in which the needle may be held between the fingers, while the palm cradles the syringe and the thumb pushes and pulls on the plunger. Iterations of such grip may exist, but all appears to suffer poor ergonomics and steep learning curve. Despite reduced manpower and better resource utilisation, these limitations have prevented widespread adoption of the technique.

[0010] A reported single-operator solution uses an electronically actuated syringe driver controlled via a foot pedal or a palm controller. This avoids the need for an assistant to perform the injection. However, there appears to be several drawbacks: (i) movement around the patient may be necessary during the procedure, and the foot pedal location may restrict proceduralist movement, (ii) the proceduralist may not be familiar with foot pedal operation and, as it lies outside the line of sight, may inadvertently stepon the wrong switch, (iii) the non-sterile wire connecting the foot pedal to the syringe driver may be a tripping hazard and may compromise sterility, (iv) the palm controller may require actuation using the middle and ring fingers on the needling hand, which may cause undesired needle movement and may not be ergonomically ideal, (v) lack of a sterile configuration makes the system less suitable for peripheral nerve catheter insertion, and (vi) the electronically actuated switches depend on a power source, which tends to run out after about 200 uses.

[0011] There is thus a need to provide for a solution that addresses one or more of the limitations mentioned above.Summary

[0012] In a first aspect, there is provided for a device operable to administer an anaesthetic, the device comprising: a controller detachably mountable on an ultrasound probe; a syringe; a needle; and a tubing comprising: one end coupled to the syringe and the other end coupled to the needle, and a portion of the tubing, between the syringe and the needle, is housed in the controller; wherein the controller comprises a casing and a member coupled to the casing, wherein the member is rotatable to actuate a roller mechanism housed in the casing for administering the anaesthetic, and wherein the roller mechanism is configured to control (i) flow rate of the anaesthetic in the tubing and (ii) direction which the anaesthetic flow in the tubing.Brief Description of the Drawings

[0013] The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the present disclosure. In the following description, various embodiments of the present disclosure are described with reference to the following drawings, in which:

[0014] FIG. 1 shows a finger driven system of the present disclosure based on a “rolling” mechanism for dispensing and aspirating an injectate. HPP denotes high- pressure point (or high-pressure region). LPP denotes low-pressure point (or low- pressure region). “N” denotes the normal force exerted on the tube via the roller. The top image depicts for a single rollcr / rolling mechanism. The bottom image depicts for a continuous rollers / rolling mechanism.

[0015] FIG. 2A shows the finger driven system replaced by a gear system, but still based on the same “rolling” mechanism for dispensing and aspirating an injectate.

[0016] FIG. 2B is a magnified version of the peristaltic manual driver shown in FIG. 3, which includes the gear system shown in FIG. 2A.

[0017] FIG. 3 show a device of the present disclosure, and the ultrasound probe which the device is mountable to. FIG. 3 shows the peristaltic manual driver for singleoperator injection and aspiration.

[0018] FIG. 4A shows the gear system unassembled, wherein the gear system includes a gear train configuration with 20 teeth x 40 teeth spur gear (5mm thickness), wherein the gear train, i.e., such gear system, is a non-limiting example. Such gear system confers a mechanical advantage of being able to amplify the forces used to control the device, minimizing the amount of force required yet not compromising ergonomics or precision of control. For instance, the gear system having such gear train may amplify the force applied by hand by 2 times.

[0019] FIG. 4B shows an example of the gripping elements and catch elements of the present device.

[0020] FIG. 5 A shows the “Tube Roller Pump” (also referred to as a device of the present disclosure), which can be a single-use (disposable), finger-driven peristaltic module attachable to an ultrasound probe that enables one-handed, sterile, and precise injection or aspiration by rotating the roller wheel to control injectate flow.

[0021] FIG. 5B shows the controller in devices of the present disclosure. The left image shows the present device operable based on the “rolling” mechanism and the right image show's the present device (also operable based on the “rolling” mechanism) configured to include a roller pincher for improved control of anaesthetic flow and direction.

[0022] FIG. 5C shows the side view of the present device, the left and right images correspond to the left and right images of FIG. 5B, respectively.

[0023] FIG. 5D shows another controller configuration of the present device.

[0024] FIG. 6A shows various views of the present device that includes the pinch roller, wherein the controller is configured to have a thumb toggle.

[0025] FIG. 6B shows the device of FIG. 6A mountable on an ultrasound probe using elastic Velcro strap.

[0026] FIG. 6C is a mechanical drawing showing the external configurations and dimensions of the device of FIG. 6 A and FIG. 6B having the thumb toggle.

[0027] FIG. 6D illustrates the operation of the device of FIG. 6A to FIG. 6C having the pinch roller mechanism, wherein the bottom image shows one roller pinching on a section of the tubing.

[0028] FIG. 6E shows the internal schematics of the present device that has a pinch roller with the tubes.

[0029] FIG. 7A illustrates non-limiting examples of the detent pins, and the two states which the one or more detent pins are operable to render. The detent pin may be placed in neutral position. For selecting either a dispensing mode or an aspirating mode, an operator may conveniently use a finger and / or thumb to switch between such modes. When a click (the detent pins are depress-able) is felt it indicates going into the next mode.

[0030] FIG. 7B shows an example of the operational procedure of the device with a pinch roller. The user setup procedure may involve purging of the tubes prior to use.

[0031] FIG. 8A is a mechanical drawing showing the external configurations and dimensions of a dispenser module of the present device.

[0032] FIG. 8B illustrates the operational process of the dispenser module (also referred to as an auto-dispenser or a syringe driver).

[0033] FIG. 8C shows a device of the present disclosure (including the dispenser module) in benchtop test setup. This device is used in both theoretical and experimental flow rate characterizations, wherein the results are shown in FIG. 9A to 9E.

[0034] FIG. 8D shows an example of the dispenser module with a gravity quick release pin and two compression springs.

[0035] FIG. 8E shows a non-limiting example of the moveable element and actuator of the syringe.

[0036] FIG. 9A is a table showing the theoretical flow rate characterization results based on a G22 needle.

[0037] FIG. 9B shows a plot (top plot) of flow rate versus syringe volume and a plot (bottom plot) of pressure versus syringe volume, both based on theoretical flow rate characterization results.

[0038] FIG. 9C is a plot of the flow rate test results conducted with the test setup of FIG. 8D to verify that the system is robust and exhibits reliable and consistent flow behavior across five test runs, which form part of the experimental flow rate characterization results.

[0039] FIG. 9D shows a plot (top plot) of flow rate versus syringe volume (tested using water) and a plot (bottom plot) of time versus the dispensed volume of water, which form part of the experimental flow rate characterization results.

[0040] FIG. 9E shows a plot of the syringe and needle pressure (top plot) and a table indicating the experimental data for current extension of the spring(s), which form part of the experimental flow rate characterization results.

[0041] FIG. 10A shows a non-limiting example of the device which is configured to have a volume adapter to accommodate different volume of fluids in the syringe. The dimensions can also be configured to house different models / types of syringes.

[0042] FIG. 10B shows an overview of a device of the present disclosure, which includes the auto-dispenser (i.e., dispenser module with the syringe), the tubing, the needle, and the controller operable based on the “rolling” mechanism incorporated with a pinch roller mechanism.Detailed Description

[0043] The following detailed description refers to the accompanying drawings that show, by way of illustration, specific details and embodiments in which the present disclosure may be practised.

[0044] Features that are described in the context of an embodiment may correspondingly be applicable to the same or similar features in the other embodiments. Features that are described in the context of an embodiment may correspondingly beapplicable to the other embodiments, even if not explicitly described in these other embodiments. Furthermore, additions and / or combinations and / or alternatives as described for a feature in the context of an embodiment may correspondingly be applicable to the same or similar' feature in the other embodiments.

[0045] The present disclosure relates to a device that can provide cost-effective, accurate, reliable, and safe single-operator administration of local anaesthetic, without the need for an anaesthetist to overcome a steep learning curve associated with existing single -operator techniques. The present disclosure addresses this need by providing a device capable of facilitating consistent, safe, and efficient single-operator administration of LA without altering current clinical practices, thereby promoting better uptake and adoption among practitioners. For brevity, the device of the present disclosure may be referred herein as the “present device”.

[0046] Advantageously, the present device is co-operable with an ultrasound probe and under ultrasound guidance.

[0047] The present device enables a proceduralist (e.g., an anaesthetist) to maintain continuous control of both the ultrasound probe and the needle, while performing injection without releasing the needle or relying on an assistant. This allows precise needle tip manipulation and efficient hydrodissection and hydrolocation during LA delivery.

[0048] Unlike traditional single-operator solutions that require specialised hand grips or electronic actuation, the present device can be mechanically operated, is ergonomic, and intuitive to use. It does not require additional extensive training, energy-consuming power sources, or non-sterile components, thereby maintaining a fully sterile setup suitable for peripheral nerve block procedures and peripheral nerve catheter insertions.

[0049] The present device therefore addresses the limitations of both double-operator and existing single-operator techniques by allowing a single proceduralist to perform PNBs with improved control, safety, and procedural efficiency, without altering established clinical workflow.

[0050] Details of various embodiments of the device, its method of operation and use, and advantages associated with the various embodiments are now described below and / or with reference to the drawings. Where advantages of the embodiments andfeatures are already demonstrated in one or more examples below and / or in the drawings, they shall not be reiterated for brevity.

[0051] In the present disclosure, there is provided for a device. The device may be operable to administer an anaesthetic. The device may comprise a controller detachably mountable on an ultrasound probe, a syringe, a needle, and a tubing comprising one end coupled to the syringe and the other end coupled to the needle, and a portion of the tubing, between the syringe and the needle, may be housed in the controller, wherein the controller may comprise a casing and a member coupled to the casing, wherein the member may be rotatable to actuate a roller mechanism housed in the casing for administering the anaesthetic, and wherein the roller mechanism may be configured to control (i) flow rate of the anaesthetic in the tubing and (ii) direction which the anaesthetic flow in the tubing.

[0052] Advantageously, the present device allows for single-handed, continuous administration and aspiration of LA during a peripheral nerve block (PNB) injection. The device may be involve at least two components - a controller that may be attached to an ultrasound probe, and a syringe (or syringe driver). The left image of FIG. 5A shows one example of the present device, which includes the syringe. The controller is shown in FIG. 5B in both images, the left image shows the present device operable based on the “rolling” mechanism and the right image shows the device, also operable based on the “rolling” mechanism but configured to include a “roller pincher” mechanism (for brevity referred to as “pinch mechanism” or “pinch roller”).

[0053] In various embodiments, the needle may be attached to a tubing that connects to the controller, and the operator is free to manoeuvre the needle. An ergonomic design of the ultrasound probe mounted controller minimises the proceduralist’s need to vary ultrasound manipulation to actuate the delivery trigger.

[0054] FIG. 1 shows the “rolling” mechanism involved in the present device. The top image illustrates for a single “rolling / roller” mechanism. As the roller moves and rotates, it exerts normal force (N) on the surface beneath it. At the HPP, the roller may compress the tube or surface more strongly — pressure is highest under this contact region. As the roller continues to move, the tube relaxes behind the roller, forming the LPP, where the pressure is lower. This pressure difference illustrates the interaction of the rolling motion with the fluid in the tube — illustrating how forces distribute under a movingcontact point, whether in the tube, or even under a mechanical syringe or actuator mechanism. The bottom demonstrates the same “rolling / roller” mechanism, except that two rollers are used to depict for a continuous “rolling / roller” mechanism. FIG. 1 also shows the mechanical roll forward using the finger driven system to dispense and aspirate injcctatc, functioning “like a finger-driven pump.” Continuous or metered delivery may be achieved by clockwise rotation of the tube rollers; aspiration may be achieved by anticlockwise rotation. The configuration provides continuous modulation of flow without changing syringes, without a second operator, and without electronic foot pedals or power sources.

[0055] FIG. 2A shows a gear system (e.g., a peristaltic driver) based on aforesaid “rolling / roller” mechanism. FIG. 2B is a magnified version of the gear' system (e.g., a peristaltic manual driver) involving the “rolling / roller” mechanism. For brevity, the “rolling / roller mechanism” may be referred to as “roller mechanism”.

[0056] In various embodiments, an example of which is shown in FIG. 2B, the roller mechanism may comprise a gear train comprising at least two gears operably coupled together, and a roller module configured to render peristaltic flow of the anaesthetic in the tubing, wherein one of the at least two gears may be coupled to the member and another one of the at least two gears may be coupled to the roller module, and wherein a rotation of the member renders rotation of the at least two gears, which in turn renders rotation of the roller module to render the peristaltic flow.

[0057] In various embodiments, an example of which is shown in FIG. 2B, the at least two gears may comprise a first gear, a second gear and a third gear, wherein the first gear may be coupled to the member, and the third gear may be coupled to the roller module, and the second gear may be coupled to the first gear and the third gear, wherein rotation of the member renders rotation of the first gear, which in turn rotates the second gear and rotation of the second gear renders rotation of the third gear, which in turn renders rotation of the roller module.

[0058] In various embodiments, an example of which is shown in FIG. 2B, each of the at least t 'o gears may comprise an edge having spurs configured circumferentially around the edge.

[0059] In various embodiments, an example of which is shown in FIG. 2B, the roller module may comprise a central element coupled to one of the at least two gear s whichmay be coupled to the roller module, wherein the central element may comprise one or more structural members extending radially therefrom, wherein each of the one or more structural members may have one end coupled to a roller.

[0060] In various embodiments, an example of which is shown in FIG. 2A and FIG. 2B, each of the one or more structural members may comprise a length which is dimensioned to have an edge portion of the roller urged against a section of the tubing to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region may be adjacent to the section, wherein the high pressure region may be upstream of the low pressure region, which defines a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

[0061] hi various embodiments, an example of which is shown in FIG. 2B, the roller of one structural member may cooperate with another roller of another structural member to render the peristaltic flow when the central element is rotated by the one of the at least two gears which the roller module is coupled to.

[0062] FIG. 3 illustrates for various embodiments of the present device. FIG. 3 show's that the device can include a mechanical, finger-driven peristaltic driver positioned inline between a syringe and a needle. It enables a single operator to dispense or aspirate injectate by rolling a contoured finger track clock 'ise or anticlockwise, without releasing the block needle or the ultrasound probe. The layout is shown adjacent to an ultrasound probe to illustrate ergonomic alignment. The ultrasound probe may include a handheld transducer with ergonomic grip and probe head. The alignment guide lines indicate its relative position to the driver so both can be fitted together to be ergonomically operable. The peristaltic manual driver (with the internal gear system shown) may have a rectangular- housing with a crescent / three-lobe roller cluster mounted on a rotating hub. A removable cover with a sinusoidal finger track allow's direct finger purchase for bi-directional rotation. Two tubing ports (inlet / outlet) are shown. A flexible tubing may be used, forming a peristaltic loop routed around the internal rollers and exits via the ports. The loop may be compressively occluded by the rollers to generate flow without exposing the fluid to moving parts. There may be a syringe (upstream) connected to an upper port, which may serves as the reservoir for local anaesthetic (injectate) and as a visual volume indicator. There may be a needle(downstream) connected to the lower port, which may a block needle or catheter line. The motion arrows depicts for dispense (curved arrow over the finger track - clockwise rotation example that advances the roller train to deliver fluid toward the needle) and aspirate (curved arrow returning under the driver): counter-clockwise rotation example that draws fluid back from the needle side (useful for safety aspiration and for hydrolocation checks). Operationally, for the peristaltic action, as the operator sweeps a finger along the contoured track, the roller cluster (gears) rotates, sequentially compressing the tube against the housing raceway. This occlusion wave moves along the tube, transporting fluid in the chosen direction. Advantageously, no clutch, valves, or electronics are required for the bi-directional operation. The present device offers a single -operator workflow, that is to say, the ultrasound probe can remain in the nondominant hand for continuous image visualisation, wherein the dominant hand may manipulate the block needle while any finger of either hand can advance the driver to inject or aspirate in short, precise increments. The alignment guide lines in FIG. 3 identifies a positioning of the driver within the same ergonomic zone as the probe for minimal hand travel and stable needle control. The present device offers a sterile fluid path, i.e., only the tubing segment is in contact with the injectate, the rollers act externally, supporting sterility and easy tubing replacement. Also, there can be tactile feedback because peristaltic pumping creates resistance proportional to downstream pressure, the operator perceives subtle pressure changes through finger force, aiding safe injection near nerves and vessels. The above are in turn advantageous for use in hydrolocation / hydrodissection wherein fine, incremental dispense while maintaining real-time probe and needle control. In all, the present device is ergonomic (finger-track drive eliminates awkward syringe-in-palm grips), operable with a stable needle tip (no need to release the needle to operate a plunger), may be cost effective and power-free (can be purely mechanical; no cables, pedals, or batteries), and operable with a sterile path (fluid confined to disposable tubing; driver remains non-fluid-contact).

[0063] In various embodiments, the casing may comprise a concave well adapted to receive the portion of the tubing conformably housed therein in a manner which may allow the roller to urge against the section of the tubing. An example of this is shown in FIG. 4A. In various embodiments, each of the at least two gears may comprise an aperture which is centrally configured.

[0064] FIG. 4A also shows the supporting gear structures. In various embodiments, the casing may comprise a first part and a second part, wherein the first part and the second part fitted together define the casing, wherein the first part and / or the second part each may comprise a wall having one or more supporting gear structures extending orthogonally from the wall, and wherein each of the one or more supporting gear structures may be adapted to receive one of the at least two gears through the aperture and have the one of the at least two gears rotatably mounted thereon.

[0065] In various embodiments, the member may comprise gripping elements shaped to aid a user in rotating the member. An example of this is shown in FIG. 4B (also see leftmost image of FIG. 4A). In various embodiments, the member may be rotatably coupled to the casing in a manner which allows clockwise and anti-clockwise rotation of the member. In various embodiments, the member may be removably secured to the casing by a screw.

[0066] In various embodiments, the casing may comprise an edge having depressions circumferentially configured around the edge and the member may comprise an edge having claw elements circumferentially configured around the edge, wherein each claw element may be adapted to engage one depression in a manner which allows rotational movement of the member on the casing. An example of this is shown in FIG. 5D.

[0067] hi various embodiments, the present device may be configured to include a “roller pincher” mechanism (e.g., pinch mechanism that further aids in aspiration and administration of LA). This may involve a single pinch roller pin with a torsion spring, and a detent pin (i.e., lever) to indicate between apiration or dispense mode. The autoshut mechanism with the torsion spring confers a controlled intermittent flow, further improving for hydrodissection and hydrolocation procedures. An example of such device is shown, for instance, in right image of FIG. 5B and FIG. 6A to FIG. 6D.

[0068] hi various embodiments, the configuration (e.g., sec FIG. 7B) may involve the use of a finger driven single pin roller system, that may perform a small volume mechanical aspirate of fluid. The same pinch roller upon rotating an angle of 22 degrees to a hard stop against a toggle spring may render opening of the tube valve. Once this happens, the pressurized syringe in the auto-dispenser (e.g., a dispenser module of the present device) may perform auto-dispensing of LA. On releasing the fingers, the toggle spring may automatically close the tube valve stopping the dispense action. In variousembodiments, the rotational angle to dispense (clockwise) may be about 22 degrees as mentioned above, the rotational angle to aspirate (counterclockwise) may be about 48 degrees. The torsion spring used may be 37 N mm stainless steel.

[0069] Various embodiments involving the pinch roller mechanism may introduce multiple ergonomic and operational improvements to enhance control, safety, and usability during single-operator administration of local anaesthetic (LA). The refinement brings the paddle closer to the operator’s fingers, providing a closer reach and better accessibility through the use of extended paddles, thereby minimizing or eliminating the need for finger repositioning or adjustment during operation. An auto shut-off mechanism, implemented via a torsion spring, prevents unintended loss of LA by automatically halting fluid flow when not actively engaged. This mechanism also provides tactile feedback, allowing the operator to feel active pressure changes during dispensing for more precise control. The design supports single-finger operation using a single paddle, which offers better thumb and finger support for improved stability and minimal learning requirements, enabling intuitive and efficient one-handed use. To enhance stability, a localized elastic strap with Velcro serves as an active restraint that secures the probe or device during use, preventing tin wanted movement. Additionally, a colour code system on the handles, achieved with coloured shrink tubes, clearly differentiates between dispensing and aspiration functions for ease of identification. The tubing length has been fine-tuned through four prototype iterations to achieve more desirable handling, improving ease of operation while maintaining ergonomic efficiency. Overall, this refined single paddle model may be configured to meet 80%- 90% of anticipated use cases effectively, with provisions to address more complex or challenging procedural scenarios.

[0070] In various embodiments, as shown in FIG. 6D and FIG. 6E, the roller mechanism may comprise a roller module configured to control flow of the anaesthetic in the tubing, wherein the roller module may comprise a pinch roller and is operably coupled to the member, wherein the pinch roller may comprise a plurality of rounded sections and each rounded section extends radially from a central element engageable with a supporting gear structure of the casing which allows rotation of the pinch roller when fitted on the supporting gear structure, wherein the plurality of rounded sections may comprise two rounded sections engaged to one roller, wherein rotation of themember may render the one roller of the pinch roller to urge against a section of the tubing so as to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region may be adjacent to the section, wherein the high pressure region may be upstream of the low pressure region, which defines a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

[0071] In various embodiments, the roller mechanism may comprise a torsion spring, which returns the member to an original position, wherein the original position may comprise a state which the pin roller is not urged against the section of the tubing.

[0072] In various embodiments, the device may further comprise one or more detent pins configured on the casing, wherein the one or more detent pins may be operably configured to engage the member in a first state which prevents rotational movement of the member and in a second state which allows rotational movement of the member so as to render the anaesthetic dispensable and / or aspirable (see FIG. 6A, FIG. 7A and FIG. 7B).

[0073] In various embodiments, the member may comprise a thumb toggle and / or a paddle, wherein the thumb toggle and the paddle (for the finger) may be positionally adapted to suit the hand of a user in rotating the member (e.g., see FIG. 7A).

[0074] hi various embodiments, the thumb toggle and / or the paddle may be operable to render the pinch roller to be in a position which: (i) dispenses the anaesthetic in the tubing into the needle; or (ii) aspirates the anaesthetic; or (iii) have the anaesthetic in the tubing reverse-aspirated; or (iii) stops the flow of the anaesthetic in the tubing.

[0075] In various embodiments, the casing may comprise one or more pairs of catch elements (see right image of FIG. 4B), wherein each of the one or more pairs of catch elements is securable with a strap configured to detachably mount the controller on the ultrasound probe; or a pair of holes which correspond in position to a pair of holes on a catch component, wherein the casing and the catch component may be securable together to have the controller detachably mounted on the ultrasound probe.

[0076] In various embodiments, the casing may have an inlet and an outlet, wherein the inlet may be configured to receive a part of the tubing which facilitates fluid communication of the anaesthetic between the syringe and the controller, and the outletmay be configured to receive another part of the tubing which facilitates fluid communication of the anaesthetic between the controller and the needle.

[0077] FIG. 8A to FIG. 8D provide an overview of the device that includes the dispenser module in various embodiments. In various embodiments, the device may further comprise a dispenser module which may be adapted to have the syringe operably coupled thereto. Such dispenser module may be called herein a syringe driver. In various embodiments, the dispenser module may comprise a safety plug which prevents operation of the dispenser module (and the syringe). In various embodiments, the dispenser may comprise a moveable element operably coupled to an actuator of the syringe, and one or more springs which may be held in tension and release of the tension renders the one or more springs to have the moveable element act on the actuator to drive the anaesthetic out of the syringe.

[0078] As shown in FIG. 8E, in various embodiments, the moveable element may be coupled to a quick release pin (also see FIG. 8C) which holds the moveable element in a position and prevents movement of the moveable element.

[0079] In various embodiments, the syringe driver may utilise a spring mechanism to drive the syringe plunger. Rate of deliver}' has been bench tested and can be varied based on spring tension. There may be a mechanism that allows for quick loading and engagement of the syringe.

[0080] In various embodiments, as shown in FIG. 8C, the dispenser module may include two compression spring to mechanically pressurize the syringe holding the LA. A gravity quick release pin may be used to lock and unlock using a single-handed operation. The theoretical calculation of the flow rate was derived using both Hooke’s Law, and the Poiseuille’s Equation to characterize the pressure and flow behaviour of the system.

[0081] To study the system behaviour against theoretical calculations and its repeatability, prototypes of the design were fabricated and tested to obtain 5 sets of experimental data to verify the actual flow performance in terms of flow rate and dispensed volume, while the pressure characteristic data was also collected during the experiments. Both the theoretical and experimental results are demonstrated in the examples section further below.

[0082] The word “substantially” does not exclude “completely” e.g. a composition which is “substantially free” from Y may be completely free from Y. Where necessary, the word “substantially” may be omitted from the definition of the present disclosure.

[0083] In the context of various embodiments, the articles “a”, “an” and “the” as used with regard to a feature or clement include a reference to one or more of the features or elements.

[0084] In the context of various embodiments, the tilde symbol the term “about”, and the term “approximately”, as applied to a numeric value encompasses the exact value and a reasonable variance. The variance may be ±20%, ±10%, ±5%, ±1%, ±0.5%, ±0.1%, etc.

[0085] As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0086] Unless specified otherwise, the terms "comprising" and "comprise", and grammatical variants thereof, are intended to represent "open" or "inclusive" language such that they include recited elements but also permit inclusion of additional, unrecited elements.Examples

[0087] The device, and its method of operation and use, are described in further details, by way of non-limiting examples, as set forth below.

[0088] In various examples, there is provided a device operable to administer an anaesthetic. The device may comprise a controller detachably mountable on an ultrasound probe, a syringe, a needle, and a tubing that may comprise one end coupled to the syringe and the other end coupled to the needle, and a portion of the tubing, between the syringe and the needle, is housed in the controller, wherein the controller comprises a casing and a member coupled to the casing, wherein the member may be rotatable to actuate a roller mechanism housed in the casing for administering the anaesthetic, and wherein the roller mechanism may be configured to control (i) flow rate of the anaesthetic in the tubing and (ii) direction which the anaesthetic flow in the tubing.

[0089] Example 2 may include the device of example 1 and / or any other example(s) disclosed herein, wherein the roller mechanism may comprise a gear train that maycomprise at least two gears operably coupled together, and a roller module configured to render peristaltic flow of the anaesthetic in the tubing, wherein one of the at least two gears may be coupled to the member and another one of the at least two gears may be coupled to the roller module, and wherein a rotation of the member may render rotation of the at least two gears, which in turn may render rotation of the roller module to render the peristaltic flow.

[0090] Example 3 may include the device of any other example(s) disclosed herein, wherein the at least two gears may comprise a first gear, a second gear and a third gear, wherein the first gear may be coupled to the member, and the third gear may be coupled to the roller module, and the second gear may be coupled to the first gear and the third gear', wherein rotation of the member may render rotation of the first gear, which in turn may rotate the second gear and rotation of the second gear may render rotation of the third gear, which in turn may render rotation of the roller module.

[0091] Example 4 may include the device of any other example(s) disclosed herein, wherein each of the at least two gears may comprise an edge having spurs configured circumferentially around the edge.

[0092] Example 5 may include the device of any other example(s) disclosed herein, wherein the roller module may comprise a central element coupled to one of the at least two gears which may be coupled to the roller module, wherein the central element may comprise one or more structural members extending radially therefrom, wherein each of the one or more structural members may have one end coupled to a roller.

[0093] Example 6 may include the device of any other example(s) disclosed herein, wherein each of the one or more structural members may comprise a length which may be dimensioned to have an edge portion of the roller urged against a section of the tubing to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region may be adjacent to the section, wherein the high pressure region may be upstream of the low pressure region, which may define a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

[0094] Example 7 may include the device of any other example(s) disclosed herein, wherein the roller of one structural member may cooperate with another roller of another structural member to render the peristaltic flow when the central element maybe rotated by the one of the at least two gears which the roller module may be coupled to.

[0095] Example 8 may include the device of any other example(s) disclosed herein, wherein the casing may comprise a concave well adapted to receive the portion of the tubing conformably housed therein in a manner which may allow the roller to urge against the section of the tubing.

[0096] Example 9 may include the device of any other example(s) disclosed herein, wherein each of the at least two gears may comprise an aperture which may be centrally configured.

[0097] Example 10 may include the device of any other example! s) disclosed herein, wherein the casing may comprise a first pail and a second pail, wherein the first pail and the second part fitted together define the casing, wherein the first part and / or the second part each may comprise a wall having one or more supporting gear structures extending orthogonally from the wall, and wherein each of the one or more supporting gear structures may be adapted to receive one of the at least two gears through the aperture and have the one of the at least two gears rotatably mounted thereon.

[0098] Example 11 may include the device of any other example(s) disclosed herein, wherein the member may comprise gripping elements shaped to aid a user in rotating the member.

[0099] Example 12 may include the device of any other example(s) disclosed herein, wherein the member may be rotatably coupled to the casing in a manner which may allow clockwise and anti -clockwise rotation of the member.

[0100] Example 13 may include the device of any other examp le(s) disclosed herein, wherein the member may be removably secured to the casing by a screw.

[0101] Example 14 may include the device of any other example(s) disclosed herein, wherein the roller mechanism may comprise a roller module configured to control flow of the anaesthetic in the tubing, wherein the roller module may comprise a pinch roller and may be operably coupled to the member, wherein the pinch roller may comprise a plurality of rounded sections and each rounded section extends radially from a central element engageable with a supporting gear structure of the casing which allows rotation of the pinch roller when fitted on the supporting gear structure, wherein the plurality of rounded sections may comprise two rounded sections engaged to one roller, whereinrotation of the member may render the one roller of the pinch roller to urge against a section of the tubing so as to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region are adjacent to the section, wherein the high pressure region is upstream of the low pressure region, which defines a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

[0102] Example 15 may include the device of any other examp le(s) disclosed herein, wherein the casing may comprise an edge having depressions circumferentially configured around the edge and the member may comprise an edge having claw elements circumferentially configured around the edge, wherein each claw element may be adapted to engage one depression in a manner which allows rotational movement of the member on the casing.

[0103] Example 16 may include the device of any other example(s) disclosed herein, wherein the roller mechanism may comprise a torsion spring, which returns the member to an original position, wherein the original position may comprise a state which the pin roller is not urged against the section of the tubing.

[0104] Example 17 may include the device of any other example(s) disclosed herein, which may further comprise one or more detent pins configured on the casing, wherein the one or more detent pins may be operably configured to engage the member in a first state which prevents rotational movement of the member and in a second state which allows rotational movement of the member so as to render the anaesthetic dispensable and / or aspirable.

[0105] Example 18 may include the device of any other examp le(s) disclosed herein, wherein the member may comprise a thumb toggle and / or a paddle, wherein the thumb toggle and the paddle may be positionally adapted to suit the hand of a user in rotating the member.

[0106] Example 19 may include the device of any other example(s) disclosed herein, wherein the thumb toggle and / or the paddle may be operable to render the pinch roller to be in a position which: (i) dispenses the anaesthetic in the tubing into the needle; or (ii) aspirates the anaesthetic; or (iii) have the anaesthetic in the tubing reverse-aspirated; or (iii) stops the flow of the anaesthetic in the tubing.

[0107] Example 20 may include the device of any other example(s) disclosed herein, wherein the casing may comprise: one or more pairs of catch elements, wherein each of the one or more pairs of catch elements may be securable with a strap configured to detachably mount the controller on the ultrasound probe; or a pah- of holes which correspond in position to a pair of holes on a catch component, wherein the casing and the catch component may be securable together to have the controller detachably mounted on the ultrasound probe.

[0108] Example 21 may include the device of any other example(s) disclosed herein, wherein the casing may have an inlet and an outlet, wherein the inlet may be configured to receive a part of the tubing which facilitates fluid communication of the anaesthetic between the syringe and the controller, and the outlet may be configured to receive another part of the tubing which facilitates fluid communication of the anaesthetic between the controller and the needle.

[0109] Example 22 may include the device of any other example(s) disclosed herein, which may further comprise a dispenser module which may be adapted to have the syringe operably coupled thereto, wherein the dispenser module may comprise a safety plug which prevents operation of the dispenser module.

[0110] Example 23 may include the device of any other example(s) disclosed herein, wherein the dispenser module may comprise a moveable element operably coupled to an actuator of the syringe, and one or more springs which may be held in tension and release of the tension renders the one or more springs to have the moveable element act on the actuator to drive the anaesthetic out of the syringe. Said differently, the one or more springs may compress against the syringe, i.e., pressurizes the syringe. While the pinch roller may be holding the pressure due to anaesthetic driven into the tubing by the syringe, on release of the pinch roller the fluid may then be dispensed.

[0111] Example 24 may include the device of any other cxamplc(s) disclosed herein, wherein the moveable element may be coupled to a quick release pin which holds the moveable element in a position and prevents movement of the moveable element.

[0112] Example A: Theoretical Flow Characterization with Dispenser Module

[0113] In various examples used for the theoretical flow characterization, the dispenser module (see FIG. 8C) may include two compression spring to mechanically pressurize the syringe holding the LA. A gravity quick release pin may be used to lockand unlock using a single-handed operation. The calculation of the follow rate was derived using both Hooke’s Law, and the Poiseuille’s Equation to characterize the pressure and flow behaviour of the system (see FIG. 9A and FIG. 9B).

[0114] Example B: Experimental Flow Characterization with Dispenser Module

[0115] The same dispenser module of example A was used in this study of the system behaviour against theoretical calculations and its repeatability, prototypes of the design were fabricated and tested to obtain five sets of experimental data to verify the actual flow performance in terms of flow rate and dispensed volume, while the pressure characteristic data was also collected during the experiments. On average the flow rate starts from 0.36 ml / s at full 20 ml syringe volume and end at 0.19 ml / s at 0 ml syringe volume. Graphical trend is approximately linear (see FIG. 9C to FIG. 9E).

[0116] Example C: Advantages and Commercial Applications

[0117] Various embodiments and examples of the present device are advantageous for a proceduralist to conduct a safe and effective block includes the following:

[0118] a. The proceduralist solely controlling the ultrasound (abbreviated as US) probe in the non-dominant hand and the block needle in the dominant hand (for most operators).

[0119] b. The ability to deliver LA instantly when the needle reaches the area of interest - in traditional practice this tends to be achieved by instructing another anaesthetist or assistant to push on the plunger of the LA syringe. With the present device, the LA can be instantly delivered with the push of a trigger without compromising the grip on the needle.

[0120] c. Minimal disruption to the ultrasound image - this is achieved with stabilisation of the ultrasound probe and the needle. In a traditional single-operator syringe technique, the needle may move when the operator lets go of the needle to retrieve and manipulate the syringe. With the present device, the needle is less likely to move as the operator does not need to let go of the needle or manipulate the syringe. Moreover, the ergonomic design and small footprint of the controller on the ultrasound probe allows for easy delivery of LA with minimal movement of the ultrasound probe.

[0121] The present device enables a single operator to administer local anaesthetic (LA) without the need for an additional assistant, thereby freeing the additional person for other important tasks such as documentation or patient monitoring. In terms of timeand cost efficiency, it is estimated that approximately five minutes are saved per procedure, translating to around USD $58 in savings per procedure when compared to standard two-operator techniques, as supported by Medovate’s and SAFIRA’s health economic report on time saved by SAFIRA. The present device may be expected to deliver even greater cost savings due to its reduced operating overheads. Furthermore, the sterile setup allows the same syringe to be re-used if more LA is required, while the absence of electronic components lowers overall costs and reduces barriers to adoption in resource-scarce practices.

[0122] From a patient safety perspective, the ergonomics of the device may enable the proceduralist to maintain familiar ultrasound grips while actuating the delivery of LA. This helps reduce the need for excessive needle manipulation and consequently lowers the risk of nerve injury. Accurate hydrodissection ensures that less LA is delivered, reducing the risk of LA toxicity. High pressures may automatically prevent further LA administration due to the increased resistance against the spring mechanism, with the springs calibrated to allow optimal flow while maintaining safe injectate pressures. The device may also be used in conjunction with off-the-shelf high-pressure systems. Being a single-use, sterile item, it reduces the risk of infection, and the sterile setup further makes it desirable for peripheral nerve catheter insertion.

[0123] In terms of productivity, the proceduralist may precisely and easily administer LA without losing focus on the ultrasound screen, which may reduce procedural time.

[0124] Regarding environmental impact, the device may contain no electronic components, thereby reducing production costs as well as disposal costs associated with electronic waste.

[0125] While the present disclosure has been particularly shown and described with reference to specific embodiments, it should be understood by those skilled in the ait that various changes in form and detail may be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims. The scope of the present disclosure is thus indicated by the appended claims and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced.

Claims

CLAIMS1. A device operable to administer an anaesthetic, the device comprising: a controller detachably mountable on an ultrasound probe; a syringe; a needle; and a tubing comprising: one end coupled to the syringe and the other end coupled to the needle, and a portion of the tubing, between the syringe and the needle, is housed in the controller; wherein the controller comprises a casing and a member coupled to the casing, wherein the member is rotatable to actuate a roller mechanism housed in the casing for administering the anaesthetic, and wherein the roller mechanism is configured to control (i) flow rate of the anaesthetic in the tubing and (ii) direction which the anaesthetic flow in the tubing.

2. The device of claim 1, wherein the roller mechanism comprises: a gear train comprising at least two gears operably coupled together; and a roller module configured to render peristaltic flow of the anaesthetic in the tubing, wherein one of the at least two gears is coupled to the member and another one of the at least two gears is coupled to the roller module, and wherein a rotation of the member renders rotation of the at least two gears, which in turn renders rotation of the roller module to render the peristaltic flow.

3. The device of claim 2, wherein the at least two gears comprise a first gear, a second gear and a third gear, wherein the first gear is coupled to the member, and the third gear is coupled to the roller module, and the second gear is coupled to the first gear and the third gear, wherein rotation of the member renders rotation of the first gear, which in turn rotates the second gear and rotation of the second gear renders rotation of the third gear, which in turn renders rotation of the roller module.

4. The device of claim 2 or 3, wherein each of the at least two gears comprise an edge having spurs configured circumferentially around the edge.

5. The device of any one of claims 2 to 4, wherein the roller module comprises a central element coupled to one of the at least two gears which is coupled to the roller module, wherein the central element comprises one or more structural members extending radially therefrom, wherein each of the one or more structural members has one end coupled to a roller.

6. The device of claim 5, wherein each of the one or more structural members comprises a length which is dimensioned to have an edge portion of the roller urged against a section of the tubing to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region are adjacent to the section, wherein the high pressure region is upstream of the low pressure region, which defines a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

7. The device of claim 5 or 6, wherein the roller of one structural member cooperates with another roller of another structural member to render the peristaltic flow when the central element is rotated by the one of the at least two gears which the roller module is coupled to.

8. The device of claim 6 or 7, wherein the casing comprises a concave well adapted to receive the portion of the tubing conformably housed therein in a manner which allows the roller to urge against the section of the tubing.

9. The device of any one of claims 2 to 7, wherein each of the at least two gears comprise an aperture which is centrally configured.

10. The device of claim 9, wherein the casing comprises a first part and a second part, wherein the first part and the second part fitted together define the casing, whereinthe first part and / or the second part each comprises a wall having one or more supporting gear structures extending orthogonally from the wall, and wherein each of the one or more supporting gear structures are adapted to receive one of the at least two gear s through the aperture and have the one of the at least two gears rotatably mounted thereon.

11. The device of any one of claims 1 to 10, wherein the member comprises gripping elements shaped to aid a user in rotating the member.

12. The device of any one of claims 1 to 11, wherein the member is rotatably coupled to the casing in a manner which allows clockwise and anti-clockwise rotation of the member.

13. The device of claim 12, wherein the member is removably secured to the casing by a screw.

14. The device of claim 1, wherein the roller mechanism comprises a roller module configured to control flow of the anaesthetic in the tubing, wherein the roller module comprises a pinch roller and is operably coupled to the member, wherein the pinch roller comprises a plurality of rounded sections and each rounded section extends radially from a central element engageable with a supporting gear structure of the casing which allows rotation of the pinch roller when fitted on the supporting gear structure, wherein the plurality of rounded sections comprise two rounded sections engaged to one roller, wherein rotation of the member renders the one roller of the pinch roller to urge against a section of the tubing so as to render a high pressure region and low pressure region, wherein the high pressure region and the low pressure region arc adjacent to the section, wherein the high pressure region is upstream of the low pressure region, which defines a direction the anaesthetic flows in the tubing from the high pressure region to the low pressure region.

15. The device of claim 1 or 14, wherein the casing comprises an edge having depressions circumferentially configured around the edge and the member comprisesan edge having claw elements circumferentially configured around the edge, wherein each claw element is adapted to engage one depression in a manner which allows rotational movement of the member on the casing.

16. The device of any one of claims 1 and 14 to 15, wherein the roller mechanism comprises a torsion spring, which returns the member to an original position, wherein the original position comprises a state which the pin roller is not urged against the section of the tubing.

17. The device of any one of claims 1 and 14 to 16, further comprising one or more detent pins configured on the casing, wherein the one or more detent pins are operably configured to engage the member in a first state which prevents rotational movement of the member and in a second state which allows rotational movement of the member so as to render the anaesthetic dispensable and / or aspirable.

18. The device of any one of claims 1 and 14 to 17, wherein the member comprises a thumb toggle and / or a paddle, wherein the thumb toggle and the paddle are positionally adapted to suit the hand of a user in rotating the member.

19. The device of claim 18, wherein the thumb toggle and / or the paddle are operable to render the pinch roller to be in a position which:(i) dispenses the anaesthetic in the tubing into the needle; or(ii) aspirates the anaesthetic; or(iii) have the anaesthetic in the tubing reverse-aspirated; or(iii) stops the flow of the anaesthetic in the tubing.

20. The device of any one of claims 1 to 19, wherein the casing comprises: one or more pairs of catch elements, wherein each of the one or more pairs of catch elements is securable with a strap configured to detachably mount the controller on the ultrasound probe; ora pair of holes which correspond in position to a pair of holes on a catch component, wherein the casing and the catch component is securable together to have the controller detachably mounted on the ultrasound probe.

21. The device of any one of claims 1 to 20, wherein the casing has an inlet and an outlet, wherein the inlet is configured to receive a part of the tubing which facilitates fluid communication of the anaesthetic between the syringe and the controller, and the outlet is configured to receive another part of the tubing which facilitates fluid communication of the anaesthetic between the controller and the needle.

22. The device of any one of claims 1 and 14 to 21, further comprising a dispenser module which is adapted to have the syringe operably coupled thereto, wherein the dispenser module comprises a safety plug which prevents operation of the dispenser module.

23. The device of claim 22, wherein the dispenser module comprises: a moveable element operably coupled to an actuator of the syringe; and one or more springs which are held in tension and release of the tension renders the one or more springs to have the moveable element act on the actuator to drive the anaesthetic out of the syringe.With regard to claim 23, it may be said differently that the one or more springs compresses against the syringe, i.e., pressurizes the syringe. While the pinch roller may be holding the pressure due to anaesthetic driven into the tubing by the syringe, on release of the pinch roller the fluid may then be dispensed.

24. The device of claim 22 or 23, wherein the moveable element is coupled to a quick release pin which holds the moveable element in a position and prevents movement of the moveable element.

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