Sensor array

Abstract

The present invention relates to a sensing device, a method for using a sensing device, and a method for manufacturing a sensing device. Embodiments are generally configured as a sensor array for detecting pressure changes in an infusion line to pre-empt or detect line blockage in the administration of medical infusions. Generally, embodiments include a support component having a support surface for mounting one or more electrically connected switches thereon, and a section of an expandable tube for passing a fluid and fixed to the support surface and in physical contact with the electrically connected switch. The one or more electrically connected switches form a sensor array adapted to sense expansion of the expandable tube, which indicates a pressure change caused by a line blockage.

Description

Technical Field

[0001] The present invention relates to a sensing device for a single-use medical device, a method of using the sensing device, and a method of manufacturing the sensing device. Embodiments are generally configured as a sensor array to detect pressure changes within a section of expandable tubing (e.g., an infusion line) to preempt or detect line blockage during fluid administration during fluid treatment (e.g., medical infusion). The sensor array is generally adapted to sense expansion of the expandable tubing, which indicates a pressure change caused by a line blockage. Background Art

[0002] Medical infusion sets are used to introduce medical fluids into a patient's circulatory system. Infusion sets deliver medical fluids from an infusion bag to a patient's venous system via a patient's administration set; typically including an infusion line connected to the patient via a vascular access device (e.g., a catheter or needle). Medical infusion sets are used to draw fluids from an infusion bag through a patient's administration set to a patient.

[0003] Operational faults that occur during the use of infusion pumps are often caused by blockages in the infusion line. Such errors pose serious health risks and may result in the death of the patient. To prevent such faults, regulators require that medical infusion devices include mechanisms to detect and signal occlusion events. However, the occlusion sensors that have been developed to date and have been adopted in commercially available infusion devices have several disadvantages.

[0004] An occlusion is a blockage in the flow of an infused medical fluid caused by a clog in the infusion line. An occlusion usually occurs if there is some physical obstruction in the infusion line, such as if the patient inadvertently compresses the infusion line, or if the medical fluid undergoes a chemical change. For example, larger molecules such as proteins may be sensitive to physical changes, such as changes in pH or temperature, which may sometimes fluctuate, causing protein aggregates to form, which in turn block the infusion line.

[0005] Blockages can occur upstream or downstream of the infusion pump. Upstream blockages occur in the infusion line connected between the infusion bag and the pump. Upstream blockages are usually caused by mechanical failures in the use of the line, such as when the doctor fails to loosen the clamp after starting the infusion pump or when the infusion line is kinked (for example, if the line is stuck under the patient or under the patient's bed). When an upstream blockage occurs, the upstream pressure decreases and a vacuum is created in the infusion line causing the line to constrict. The constriction in the infusion line hinders the flow of medical fluid to the patient.

[0006] Downstream obstruction occurs in the portion of the line that connects the pump to the patient. Downstream obstruction is usually caused by fluid accumulation in the infusion line, which is suddenly released, causing a large amount of fluid to move through the infusion line toward the patient. In the event of an obstruction in the line, continued operation of the infusion pump increases the pressure of the fluid in the infusion line. The increase in pressure causes the infusion line to swell or bulge. Once the downstream obstruction is released (by force applied by pressure accumulation or other displacement methods), the increased dose of medical fluid will usually be released and delivered to the patient as a bolus.

[0007] Commercially available smart infusion pumps attempt to detect occlusions by presetting an occlusion pressure threshold. Such smart infusion pumps can detect an occlusion once the pressure within the infusion line connected to the patient exceeds a preset limit; the higher the preset limit, the longer it takes to detect an occlusion. In order to detect a downstream occlusion in the infusion line, the pressure in the infusion line must exceed the preset limit. When a downstream occlusion is detected, a large mass has already formed within the infusion line. In addition, the preset limit of the pump is always higher than the upstream occlusion pressure. Since an upstream occlusion causes a vacuum or drop in the infusion line pressure, an upstream occlusion is typically not detected. Therefore, smart infusion pumps are typically unable to detect upstream occlusions and can only detect downstream occlusions caused by a significant pressure increase in the infusion line.

[0008] To overcome the recurring problem of obstructed smart sensing, engineers have deployed various types of sensors to sense restrictions in fluid flow through a patient's infusion line. Sensing systems that attempt to overcome these problems include complex devices such as optoelectronic droplet sensors, pressure sensors, force sensors, and more.

[0009] When combined with a drip chamber, the optical drop sensor is used to detect upstream occlusions in infusion systems using peristaltic pumps. The drop sensor automatically detects upstream occlusions (such as those caused by a clamp or kink in the upstream line) by detecting the lack of drops. However, movement of the IV administration set, if severe enough, can cause additional drops to fall from the drip chamber or may interrupt the drop, resulting in false counts and false alarms. Ambient light can also interfere with the optical drop sensor and cause sensor inaccuracies.

[0010] Another approach for detecting occlusions is to incorporate a pressure sensor into the pumping mechanism of the infusion pump itself. In one example, a pressure transducer is placed in the middle of the pumping area, allowing direct measurement of the pressure in the infusion line segment, which indicates the line pressure. However, this can have an adverse effect on flow uniformity and may require extensive modifications to the pumping mechanism.

[0011] Pressure sensors are typically placed at the proximal (upstream side) and distal (downstream side) ends of an infusion pump to determine when fluid flow upstream and downstream of the infusion line is blocked. When the measured pressure indicates that fluid flow is blocked, an alarm is activated to notify medical staff of the blockage. Alternatively, the pressure sensor can be placed inside the pump to monitor and measure the pressure of the fluid in the line. Pressure sensors are also available as board-mounted sensors, where the sensor is typically mounted on a printed circuit board.

[0012] Alternatively, a force sensor can be used to measure the force from fluid buildup within an infusion line. The force sensor is placed on the outside of the pump, close to the line running between the pump and the patient. An obstruction causes the line to expand, which exerts a force on the force sensor. If an expansion of the infusion line is detected, the sensor can trigger an alarm to alert the user. These sensors can only trigger on one pressure change, and are typically only used for downstream obstructions. Therefore, they can only sense a buildup of pressure, and the pressure must rise significantly, above a predetermined threshold, before the sensor is triggered.

[0013] Many pressure measurement systems, especially those developed for smart infusion pumps or smart medical devices, must come into contact with the fluid path to detect pressure changes within the infusion line. For medical infusions, these sensors must be placed in the line in contact with the medical fluid to sense pressure changes. However, placing components within the medical fluid path can compromise the fluid path. Once foreign components are placed in contact with medical fluids, regulatory and health issues arise; for example, the biocompatibility of the materials used in constructing the components must be determined, and the sterility of the fluid must be maintained.

[0014] Conventional occlusion sensors can only operate either upstream or downstream, but not both, as they do not provide sufficient sensitivity and can only detect a single pressure change. They are usually arranged to detect a pressure change exceeding a preset threshold pressure value to activate an occlusion alarm. Therefore, an occlusion that occurs at a pressure value below the threshold amount will remain undetected. These sensors also remain unable to pre-empt possible occlusions, as they cannot detect multiple pressures and are simply not sensitive enough to detect the minute pressure changes that would indicate the possibility of an impending occlusion.

[0015] Occlusion sensors tend to be complex and therefore are often prone to malfunction. Such complex sensors are expensive and therefore are often out of reach for many patients.

[0016] Furthermore, the increasing complexity of medical treatments and the development of highly sensitive drugs (e.g., complex proteins or immunoglobulins) often require complex dosing regimens, creating a need for more precise drug dosing and, in turn, more precise detection of errors. Therefore, there is a need for sensing devices that are less complex, more cost-effective, and sensitive enough to detect smaller pressure increases or decreases.

[0017] Furthermore, existing occlusion sensors are not suitable for inclusion in single-use medical devices. Sensors included in disposable, single-use devices must be simple in structure to keep manufacturing costs low without sacrificing detection sensitivity. They must have low environmental impact to meet consumer acceptance and regulatory requirements for electronic waste, preferably reducing or completely eliminating the use of heavy metals and other environmentally recalcitrant materials typically used in complex optical sensors or delicate electronics, or simply be constructed primarily of recyclable materials.

[0018] Various further aspects and features of the disclosure are described below. Summary of the invention

[0019] In a first broad aspect, an embodiment of the present invention relates to a sensing device for a disposable medical device, comprising: a support component having a support surface for mounting one or more electrically connected switches thereon, the switches being configured to actuate at a first preconfigured pressure and at a second preconfigured pressure, and a section of expandable tube for allowing fluid to pass, the expandable tube being fixed to the support surface by a fixing device and being in physical contact with the electrically connected switch, wherein the one or more electrically connected switches form a sensor array suitable for sensing the expansion of the expandable tube.

[0020] A sensing device according to an embodiment of the present invention may include one or more electrically connected switches, the electrically connected switches including one or more pressure switches having two or more pressure actuation thresholds, the pressure switches being configured to actuate at a first preconfigured pressure and a second preconfigured pressure, and the first preconfigured pressure and the second preconfigured pressure of the sensor array being capable of providing a stepped output at the two or more pressure actuation thresholds when the expandable tube is expanded.

[0021] A sensing device according to an embodiment of the present invention may include a pressure switch having two or more pressure actuation thresholds, the pressure switch being configured to actuate at a first preconfigured pressure and at a second preconfigured pressure.

[0022] A sensing device according to an embodiment of the present invention may include a first pressure switch, a second pressure switch, and a pressure concentrator located between the second pressure switch and a portion of a section of an expandable tube, the pressure concentrator having an upper surface in physical contact with the section of the expandable tube and a lower surface in physical contact with the second pressure switch, the pressure concentrator being shaped to concentrate pressure from the expansion of the expandable tube to the second pressure switch, wherein the concentrator is configured to adjust a pressure actuation threshold of the second pressure switch to a second preconfigured pressure.

[0023] A sensing device according to an embodiment of the present invention may include a pressure concentrator holder configured to maintain placement of the pressure concentrator in physical contact with a second pressure switch or a length of expandable tubing.

[0024] The sensing device according to an embodiment of the present invention may include a first pressure switch and a second pressure switch, wherein either the first pressure switch or the second pressure switch has two or more pressure actuation thresholds and is configured to actuate at a third preconfigured pressure.

[0025] Preferably, the pressure switch may have a third pressure actuation threshold and may be configured to actuate at a fourth preconfigured pressure. The pressure switch may also include any number of pressure actuation thresholds, the pressure actuation thresholds being configured to actuate at preconfigured pressures.

[0026] Preferably, the sensor array may include any number of electrically connected switches having any number of pressure actuation thresholds, the electrically connected switches being configured to actuate at preconfigured pressures.

[0027] A sensing device according to an embodiment of the present invention may include at least one additional electrically connected switch having a pressure de-actuation threshold and configured to de-actuate at an additional pre-configured pressure upon contraction of the expandable tube.

[0028] A sensing device according to an embodiment of the present invention may include a pressure concentrator holder, wherein the support component includes a printed circuit board, the support surface is provided by a surface of the printed circuit board, and the pressure concentrator holder is formed integrally with the printed circuit board.

[0029] A sensing device according to an embodiment of the present invention may include a fixing device, which further includes a tube housing (which defines a cavity for placing at least a section of expandable tube therein) and a fastener or adhesive for fixing the tube housing to a supporting surface, the fastener or adhesive maintaining a portion of a section of expandable tube in physical contact with one or more electrical connection switches.

[0030] A sensing device according to an embodiment of the present invention may include a fixing device, wherein the tube housing includes; a wall having an outer surface and an inner surface, the wall extending longitudinally, wherein the inner surface of the wall defines a longitudinal cavity for longitudinally placing at least a portion of a section of an expandable tube therein, the wall terminates at opposite ends of the longitudinal cavity in an opening, the opening being configured to allow the expandable tube to pass therethrough, the wall having at least one protrusion along the length of two opposite longitudinal edges of the wall, wherein a portion of the inner surface of the wall at the protrusion contacts and is fixed to a support surface.

[0031] In the second major aspect, an embodiment of the present invention relates to a method for detecting pressure changes in a medical infusion line of a disposable medical device, comprising the following steps: obtaining a sensing device according to the first aspect, connecting the medical infusion line to a section of expandable tubing, passing fluid through the medical infusion line and the section of expandable tubing, changing the pressure of the fluid in the medical infusion line, expanding or contracting the expandable tube, applying pressure to an electrically connected switch through the expandable tube, applying sufficient pressure to reach a pressure actuation or de-actuation threshold, actuating or de-actuating at a preconfigured pressure, and outputting actuation or de-actuation at the pressure actuation or de-actuation threshold.

[0032] According to an embodiment of the present invention, a method for detecting pressure changes within a medical infusion line of a disposable medical device may include additional steps; applying sufficient pressure to reach an additional pressure actuation threshold, actuating at an additional preconfigured pressure, and outputting additional actuation at the additional pressure actuation threshold to provide a stepped output.

[0033] According to an embodiment of the present invention, the method for detecting pressure changes in a medical infusion line of a disposable medical device may include an additional step of eliminating blockage in the medical infusion line in advance.

[0034] In a third broad aspect, an embodiment of the present invention relates to a method for manufacturing a sensing device according to the first aspect, comprising the following steps: obtaining a support component having one or more electrically connected switches mounted thereon, a section of expandable tubing, and a fixing device, maintaining physical contact between the section of expandable tubing and the one or more electrically connected switches, and fixing the section of expandable tubing to the support component by fixing the fixing device to a supporting surface.

[0035] The sensing device according to an embodiment of the present invention may include one or more pressure concentrators that are in contact with the one or more electrical connection switches and can concentrate pressure applied to the one or more electrical connection switches.

[0036] According to an embodiment of the present invention, a sensing device may include one or more switches and one or more pressure concentrators; the one or more pressure concentrators may include a substantially flat surface larger than the surface area of ​​the one or more switches; the one or more concentrators may also be in contact with the one or more switches to sense pressure changes on the substantially flat surface and concentrate pressure on the one or more switches.

[0037] Certain sensing devices may be contained within an infusion pump housing that is used to secure and retain the sensing device therein. Suitable infusion pump housings include those described in US Patent Application No. 16 / 034,301, the entire description of which is incorporated herein by reference.

[0038] The sensing device according to an embodiment of the present invention can be packaged in a sensing device housing connected to a medical infusion line, wherein the sensing device can contact the infusion line to detect two or more pressure changes and can provide compatible accessories for commercially available infusion pumps.

[0039] The sensing device according to an embodiment of the present invention may be integrally formed in a pump head, wherein the pump head may include a pump head housing adapted to accommodate a medical infusion line. They may also include an attachment arrangement corresponding to any one of a number of commercially available infusion pumps.

[0040] The support surface can be formed of any material that provides structural rigidity to support any component fixed thereto. In addition, it can be formed of a surface coated to provide a support surface compatible with a suitable attachment mode of the fixture. For example, the support surface must be capable of physical connection by using a fixture (e.g., a fastener or adhesive). Suitable fixtures for fixing the tube to the support surface are well known to those skilled in the art and can be easily selected by such persons. Suitable structural materials or surface coatings for selected fixtures are well known to those skilled in the art.

[0041] In addition to the surface coating selected to provide a suitable support surface to attach the fixture thereto, the support component can be surface coated to functionalize the surface. For example, a surface coating can be applied to the support surface for electrical conductivity, for example it can be etched with a conductive material to transmit electrical signals from one or more electrical connection switches.

[0042] The sensing device according to an embodiment of the present invention may be attached to or mounted on a printed circuit board. The printed circuit board is preferably miniaturized, i.e., it preferably includes a layout that minimizes the overall size of the printed circuit board. The printed circuit board may support electrical connections formed between components of the sensing device and may support one or more components thereon. One or more sensing device components are preferably attached to the printed circuit board.

[0043] In some embodiments, the printed circuit board may include a hole therethrough. The hole may be a cutout in the circuit board that is shaped to fit a component of the sensing device. The printed circuit board may be formed of a material that prevents charge within the sensing device from escaping.

[0044] Materials used to make components of the sensing device can be selected from those that meet regulatory requirements for medical infusion devices or requirements for disposal in accordance with environmentally sustainable practices. Suitable materials are expected to be familiar to those skilled in the art.

[0045] The expandable tube according to an embodiment of the present invention can be formed of a flexible material, such as silicon, rubber, plastic, or a composite thereof. The thickness or composition of the flexible material can be selected to allow the tube to expand or contract when the pressure in the infusion line changes. In some embodiments, the expandable tube can expand only at a portion of the tube, or it can include a local weakened area. This may help to focus the pressure changes in the pipeline to a specific point in the expandable tube that is aligned with the location of one or more electrically connected switches. Thus, the expandable tube can expand radially, or it can expand at a portion of the circumference of the expandable tube so as to produce a bulge when pressure is applied within a section of the expandable tube.

[0046] Preferably, the infusion line is connected to an infusion bag containing a medical fluid at one end and to a patient at the other end. The infusion line may be directly connected to the patient and / or the infusion bag, or it may be connected to a terminal end of another line, which in turn is connected to the patient and / or the infusion bag.

[0047] Depending on the material of the infusion line, its thickness, its lumen diameter, and the viscosity of the fluid passing therethrough, the infusion line may have a baseline pressure at which the line pressure is neutral during normal flow of the fluid, that is, in a situation where no unusual forces are applied outwardly and no unusual vacuum is created internally. Deviations from the baseline pressure are preferably sensed by a sensing device.

[0048] The one or more pressure switches may be formed of a flexible or tactile material, such as a thin metal film, a plastic sheet, or other flexible material that is flexible but resistant to the application of pressure. The one or more pressure switches may be at least partially formed within the printed circuit board to be integral with the printed circuit board. The flexibility and resistance of the material may allow the one or more pressure switches to be depressed and released when the infusion line is blocked. The infusion line may be in direct or indirect contact with the one or more pressure switches.

[0049] One or more pressure switches according to an embodiment may be actuated at two or more pressure thresholds. In certain embodiments, a single pressure switch may be actuated at two or more pressure thresholds, or, two or more pressure switches may be actuated at a single pressure threshold. In a preferred embodiment, the two or more pressure switches may include a pressure switch actuated at one pressure threshold and a pressure switch actuated at two or more pressure thresholds. A preferred embodiment includes an upstream pressure switch actuated at one pressure threshold and one or more downstream switches actuated at two or more pressure thresholds. In particular, a preferred embodiment includes an upstream pressure switch actuated at one pressure threshold and two or more downstream switches actuated at two pressure thresholds.

[0050] Preferably, the one or more pressure switches may include one or more switches that are actuated at one or more pressure thresholds. Preferably, the one or more pressure switches are actuated at one or more pressure thresholds. The one or more pressure switches may be simple electronic switches or flexible plastic shell switches or dome switches that are configurable to actuate at a precise pressure within the infusion line.

[0051] Preferably, one or more of the pressure switches may include two or more actuators. The two or more actuators enable a single switch to actuate at two or more preconfigured pressures caused by pressure changes in the infusion line. The pressure thresholds of the two or more actuators may be selected to indicate partial and complete blockages. Each may signal the need for a different response, for example, a partial blockage may precede a complete blockage and may signal the need for blockage avoidance intervention, while a complete blockage may signal the need to remove and replace or flush the line. Actuation at two or more preconfigured pressures may enable quantification of the pressure accumulated in the line.

[0052] Preferably, one or more switches providing two or more actuators define a downstream occlusion sensor.

[0053] The one or more pressure sensors may be an upstream pressure sensor or a downstream pressure sensor. Depending on an upstream or downstream obstruction, a pressure change in the infusion line may cause the infusion line to contract or expand. For example, an upstream obstruction may cause a portion of the infusion line to contract. In response to a physical change in the infusion line, the upstream pressure sensor may release an actuator for detecting a pressure change in the infusion line. Preferably, the upstream pressure sensor may be electrically connected to an upstream electrical contact, wherein the upstream electrical contact may be closed when the upstream actuator is released, thereby completing a circuit across the upstream pressure sensor.

[0054] When a downstream occlusion occurs, the pressure in the infusion line may increase and cause the infusion line to expand. The expanded portion of the infusion line may exert a force on the downstream switch, thereby depressing the switch to engage the actuator. In the case where the pressure switch includes two or more actuators, a small increase in pressure in the infusion line may cause the downstream switch to partially depress the first actuator, and a further increase in pressure may cause the downstream switch to depress the first actuator and the second actuator. Additional actuators may be provided in the switch, which may enhance the pressure sensitivity of the sensor.

[0055] Preferably, when the downstream actuator is engaged, the downstream pressure sensor may be electrically connected to the downstream electrical contacts, thereby completing an electrical circuit within the sensor.Preferably, the electrical contacts are formed on a support surface of the support member.

[0056] Preferably, the sensing device may include one or more downstream sensors for sensing two or more pressures at two or more pressure thresholds.

[0057] Preferably, an upstream portion of the upstream pressure sensor is in direct contact with the infusion line, and a portion of the downstream pressure sensor is in indirect contact with the infusion line.

[0058] In certain embodiments, one or more pressure concentrators may be located between the infusion line and one or more downstream pressure sensors. One or more pressure concentrators may be formed of a substantially rigid material. The pressure concentrators may be configured to collect and concentrate forces, and configured to direct the forces to one or more downstream pressure sensors.

[0059] In some embodiments, the pressure concentrator is external to the outer surface of the expandable tube. Preferably, the sensor array is external to the outer surface of the expandable tube. Preferably, one or more electrical connections are in physical contact with the exterior of a section of the expandable tube. The physical contact may be direct contact or indirect contact through the pressure concentrator between the electrical connection and the expandable tube.

[0060] The one or more pressure concentrators preferably include a pressure member and a retaining portion. The pressure member is preferably located between the pressure sensor and the expandable tube. The retaining portion preferably retains the pressure member in a desired position to collect and concentrate the force and direct the force to the one or more downstream pressure sensors. The retaining portion may include a pressure member connector connected to the pressure member and a circuit board fixture for securing the pressure concentrator to the circuit board.

[0061] Alternatively, the pressure piece may be fixed to a spiral or coil-shaped retaining portion for retaining the one or more pressure concentrators in place. Preferably, however, the pressure piece and the retaining portion may be formed as a single piece.

[0062] Preferably, the pressure piece connector is a spiral structure connector with a central terminal end connected to the pressure piece and an outermost end connected to a circuit board fixture, whereby the fixture can be a plate that can be screwed, adhered or otherwise attached to the circuit board. In a preferred form, the pressure concentrator is a one-piece piece, preferably formed from a flexible but rigid sheet, with a spiral portion cut out to form a central pressure member, a spiral pressure piece connector surrounding the pressure piece, and a circuit board fixture surrounding the spiral pressure piece connector.

[0063] The pressure concentrator can thus be secured by placing the pressure piece on the switch and securing the circuit board fixture to the circuit board below.

[0064] A preferred pressure concentrator may include two or more pressure pieces and / or two or more retaining pieces, wherein the pressure concentrator is in contact with two or more pressure sensors. A first pressure piece may have a smaller surface area than a second or further pressure piece to customize the sensitivity or pressure threshold of two or more downstream pressure sensors. In such an embodiment, a single type of downstream pressure sensor may be used, whereby the pressure threshold that triggers each sensor is determined by the size, density, weight or surface area of ​​the pressure piece.

[0065] In some embodiments, the pressure concentrator can be configured so that two or more pressure pieces have different sizes and are arranged so that the pressure piece with a larger surface area is located closer to the pump head and / or the pressure piece with a smaller surface area is located farther away from the pump head. Such placement enables the pressure sensor array to sense a gradually increasing pressure gradient, which can indicate a minor blockage or preempt an impending blockage.

[0066] In certain embodiments, the concentrator block or concentrator block holder may be integrated or bonded or secured to a printed circuit board and may be manufactured integrally or as multiple components.

[0067] In some embodiments, the sensing device may include a housing for fixing or holding one or more pressure sensors, infusion lines, one or more pressure concentrators, or pump heads. The shape of the housing may correspond to the shape of each component fixed in the housing. The housing may be formed as an integral piece for fixing one or more pressure sensors, infusion lines, pressure concentrators, or pump components in the housing.

[0068] Alternatively, the housing may be formed as one or more parts for separately fixing one or more pressure sensors, infusion lines, intermediate concentrators or pump assemblies. Preferably, the sensing device includes a series of three housings, wherein the first housing may be an upstream pressure sensor housing for fixing an upstream pressure sensor therein, the second housing may be a pump head housing configured for fixing a roller assembly and a pump motor of a pump head therein, and the third housing may be a downstream pressure sensor housing for fixing a pressure concentrator and a downstream pressure sensor therein.

[0069] The housing may include one or more apertures for passing and securing an infusion line therethrough. The aperture may be formed so that a portion of a length of expandable tubing may pass through and directly or indirectly contact an upstream sensor or a downstream pressure sensor. A length of expandable tubing may form a connection with the infusion line, which in turn may be wrapped around the roller assembly and positioned so that movement of the roller assembly may squeeze the infusion line and draw fluid from the infusion bag.

[0070] In an alternative embodiment, one or more pressure sensors may be disposed in a pump head that includes a roller assembly, a pump motor, and one or more housings. The pump assembly may be electrically connected to the circuit board. One or more pressure sensors may be embedded in the pump head. The pump head may also include one or more pressure concentrators.

[0071] Embodiments in which the sensing device is disposed within the pump head may include three housing pieces, wherein a first housing piece may secure a portion of a roller assembly of the pump head to prevent any contamination of the pump head, a second housing piece may secure the roller assembly, a portion of a length of expandable tubing, or one or more pressure sensors, and a third housing piece may be configured to secure the pump motor therein. The shape of the housing may correspond to the shape of the roller assembly or the pump motor to secure or retain the components therein.

[0072] The second housing member may also include one or more apertures for allowing a portion of a length of expandable tubing to enter and exit therethrough. One or more pressure sensors may be disposed in the second housing member for sensing baseline pressure changes in the infusion line.

[0073] One or more pressure sensors may be connected to an alarm for signaling an upstream or downstream occlusion to a medical practitioner. Alternatively, one or more pressure sensors may be connected to a device having a display (e.g., a computer, keyboard, touch screen, or phone) for displaying detected pressure changes in the infusion line.

[0074] The present invention will now be described with reference to the accompanying drawings together with the embodiments and preferred embodiments disclosed in the detailed description. The present invention may be embodied in many different forms and should not be construed as limited to the embodiments described herein. These embodiments are provided by way of illustration only so that this disclosure will be thorough, complete and will convey the full scope and breadth of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] Figure 1 A sensing device including a printed circuit board, a concentrator and three dome switches according to an embodiment of the present invention is shown.

[0076] Figure 2 A side view of a sensing device according to an embodiment of the present invention is provided.

[0077] FIG. 3 shows an exploded sensing device according to an embodiment of the present invention; wherein Figure 3a Provides a perspective view of the upstream and downstream switches of the sensing device, Figure 3b A perspective view of a concentrator of a sensing device according to an embodiment of the present invention is provided.

[0078] Figure 4 A sensing device including an infusion line according to an embodiment of the present invention is provided.

[0079] Figure 5 An upstream housing, a pump head housing and a concentrator housing of a sensing device according to an embodiment of the present invention are provided.

[0080] Figure 6 A pump head according to an embodiment of the present invention is provided, which includes a roller assembly, a motor (not shown), and a top housing, a middle housing, and a bottom housing of the pump head. DETAILED DESCRIPTION

[0081] Several embodiments are described in detail below with reference to the accompanying drawings. The exemplary embodiments are described to illustrate certain aspects and embodiments of the present invention, but not to limit the scope thereof, which is defined by the claims. Those of ordinary skill in the art will recognize that multiple equivalent variations of the various features provided in the following description are possible.

[0082] Figure 1 A preferred embodiment of a sensing device 500 including a printed circuit board 200 and a concentrator 400 is shown. The printed circuit board 200 is configured to accommodate components of the sensing device 500 thereon and provide electrical connections therebetween. The printed circuit board 200 further includes an upstream dome switch 210a, a near downstream dome switch 210b, and a far downstream dome switch 210c (not shown). A portion of the printed circuit board 200 includes a cutout 220 shaped to accommodate a pump head 300 and a pump head housing 240 (not shown) therein. The cutout 220 is disposed between the upstream switch 210a and the downstream switches 210b, 210c.

[0083] The downstream switches 210b, 210c are configured to sense a downstream occlusion in a section of tubing provided by the infusion line 100 (not shown), while the upstream switch 210a is configured to sense an upstream occlusion in the infusion line 100. The infusion line 100 is in contact with the upstream switch 210a and the downstream switches 210b and 210c, and terminates at either end with a connector for connecting a patient's drug delivery device at one end and an additional section of infusion line at the other end. The upstream switch 210a is depressed when the upstream occlusion sensor is normal, and is released in the event of a vacuum in the infusion line caused by an upstream occlusion.

[0084] However, the downstream switches 210b and 210c are released when the downstream occlusion sensor is normal, and are pressed in the case of a bulge in the infusion line 100 caused by pressure accumulation in the line. The concentrator 400 is located above the downstream switches 210b, 210c to collect force from the bulging infusion line and concentrate the force on the downstream switch 210b or 210c, thereby improving the sensitivity of the downstream switch 210b or 210c to detect an increase in a slight pressure in the pipeline 100.

[0085] Figure 2 A side view of the sensing device 500 is shown, wherein the upstream dome switches 210b and 210c are sandwiched between the hub 400 and the printed circuit board 110. While the upstream dome switch 210a is in direct contact with the infusion line 100 (not shown), the downstream dome switches 210b and 210c are in contact with the hub 400, which in turn is in contact with the infusion line 100 (not shown).

[0086] Figure 3a A perspective view of the upstream switch 210a and the downstream switches 210b and 210c of the sensing device 500 is provided. The upstream switch 210a and the downstream switches 210b and 210c are formed of a flexible material commonly used to produce dome switches, so that the upstream switch 210a and the downstream switches 210b, 210c can be released or depressed in response to a decrease or increase in pressure in the infusion line 100, respectively.

[0087] Downstream switches 210b and 210c are installed near the distal end of the incision 220 to detect downstream occlusion, and upstream switch 120a is installed near the proximal end of the incision 220 to detect upstream occlusion. Switches 210a, 210b, and 210c each have an actuator that is configured to be triggered at different pressures to sense slight pressure changes when downstream or upstream occlusion occurs in the infusion line.

[0088] The upstream switch 210a has a single actuator and is simply triggered as a release switch at a single predetermined pressure drop corresponding to the threshold pressure expected in the event of an upstream occlusion. However, the downstream switches 210b and 210c are dual pressure switches that can be partially depressed to trigger the actuator at a first preconfigured pressure, or can be fully depressed to trigger the actuator at a second preconfigured pressure, thereby detecting two pressure thresholds in the event of a downstream occlusion.

[0089] The array of downstream switches 210b and 210c can thus sense four pressure thresholds, which can be analyzed to monitor gradient changes in pressure, for example to determine whether an obstruction is increasing severely and therefore there is a risk of completely obstructing the line. Alternatively, different pressure thresholds can signal different events or interventions. For example, if a first actuator triggers a first pressure threshold, the alarm can signal a nurse to monitor the patient for the next five minutes, while a fourth pressure threshold triggered by a fourth actuator can signal a nurse or doctor to immediately remove and flush the line.

[0090] The actuators of downstream switches 210b and 210c are the same switches and are triggered at the same pressure threshold. However, a concentrator 400 (not shown) changes the preconfigured pressures that trigger the first and second actuators of switches 210b and 210c. Downstream switches 210a and 210b are in direct contact with concentrator 400, which collects pressure and concentrates it on downstream dome switches 210a or 210b. Concentrator 400 includes a small concentrator block 410a and a large concentrator block 410b, as well as a block holder 420. The relative sizes of concentrator blocks 410a and 410b determine the relative difference in preconfigured pressures of 210b and 210c. For example, when 410b is twice the size of 410a, the first and second actuators of switch 210c are triggered at a pressure threshold that is twice the pressure threshold of the first and second actuators of switch 210b.

[0091] Figure 3b A perspective view of a concentrator 400 of a sensing device 500 is provided. The concentrator 400 is formed as a single piece and includes two blocks 410a and 410b and a block holder 420, the block holder 420 further including a small block holder 420a and a large block holder 420b; wherein the blocks 410a and 410b are positioned so that each of their lower surfaces is in direct contact with downstream switches 210b and 210c, respectively. The blocks 410a and 410b each collect force from their upper surfaces and concentrate the force on each corresponding switch below. The switches 210b and 210c disposed below the concentrator blocks 410a and 410b are more sensitive to pressure increases within the infusion line, thereby providing more accurate detection of pressure changes within the infusion line 100.

[0092] The pressure sensitivity of the downstream switch can be adjusted by changing the pressure threshold of the actuator or by changing the surface area of ​​the block in contact with it. Downstream pressure switches 210b and 210c are the same type of dome switches, however, blocks 410a and 410b have different surface areas to change the effective pressure threshold of the actuator of each switch. Block 410a has a larger surface area than block 410b to sense lower pressure thresholds in the infusion line 100, and block 410b has a smaller surface area to sense higher pressure thresholds.

[0093] In a preferred embodiment of the concentrator 400, the blocks 410a and 410b are each held in place by a block holder 420a and 420b. The block holders 420a and 420b are spiral cutouts connected at one end to the blocks 410a and 410b, respectively, and at the other end to the concentrator 400, which in turn is secured to the printed circuit board 200 to secure each block in place. The concentrator 400 and block holders 420a and 420b are arranged to uniformly depress the downstream switches 210b and 210c to their partial or full depression points without sliding or moving away from the switches 210b and 210c.

[0094] Figure 4 A sensing device 500 is shown that includes an infusion line 100. The line 100 is positioned so that a first end of the line 100 is connected to an infusion bag containing a medical fluid, and a second end of the line 100 is connected to a patient to allow fluid to flow from the infusion bag to the patient. The line 100 is positioned to make and maintain contact with the upstream switch 210a of the sensing device 500 and blocks 410a, 410b.

[0095] In operation of the sensing device 500, the monitored pump is set to run at a known flow rate. The baseline pressure of the infusion line 100 for a physical parameter of the administered fluid (e.g., viscosity) at a given flow rate is set as the baseline pressure. Any obstruction in the infusion line 100 will cause the baseline pressure of the infusion line 100 to change. As the infusion line 100 shrinks or contracts, the upstream obstruction causes the baseline pressure to decrease. Since the infusion line 100 is in direct contact with the upstream switch 210a, the contraction of the infusion line 100 causes the upstream switch 210a to release and record a negative pressure change, thereby signaling an upstream obstruction.

[0096] Since a downstream obstruction in the infusion line 100 causes the infusion line 100 to expand or bulge, it will cause an increase in the baseline pressure. As the infusion line 100 expands, it exerts a force on the block 410a, which is collected on the surface area of ​​the block and concentrated on the downstream switch 210b, thereby depressing the switch 210b to trigger one or both of its actuators, thereby signaling the presence of a downstream obstruction in the line 100 or preempting a downstream obstruction in the line 100. If only the pressure switch 210b is triggered, a further increase in the baseline pressure will cause the block 410b and switch 210c to be depressed and trigger one or both of the actuators of the switch 210c.

[0097] As described above, the sensing device 500 can detect four pressure thresholds in the pipeline 100 by triggering any of four different actuators. These four pressure thresholds can effectively provide a quantitative measurement of pressure relative to a baseline pressure relative to each other, and further, quantitative changes in pressure can be sensed over time. This sensing can provide an advance indication of the likelihood of an obstruction or the severity of the impact of an obstruction on a patient.

[0098] Figure 5 Several housing components are shown that hold the infusion line 100 in position for upstream and downstream occlusion sensing. The upstream housing 230 is shaped to accommodate the infusion line 100 and is secured to the printed circuit board 200 upstream of the pump to hold the line 100 in position on the upstream pressure switch 210a (not shown). The pump head housing 240 and the concentrator housing 250 are shaped to accommodate the infusion line 100 and are secured to the printed circuit board 200 to hold the line 100 in position within the pump head and in position on the downstream pressure switches 210b and 210c (not shown) downstream of the pump. The concentrator housing 250 is configured to secure the concentrator blocks 410a, 410b and the block holder 420a below the housing and on the downstream pressure switches 210b and 210c.

[0099] In some embodiments, the housing pieces 230, 240, and 250 may be replaced with alternative means for securing the infusion line 100, including but not limited to mounting plates, brackets, supports, and adhesives, which may be located external to or integrated with the printed circuit board or housing. These pieces may be formed separately or as a single piece to replace any combination or all of the housing pieces 230, 240, and 250.

[0100] The upstream housing 230 includes an inlet aperture 230a and an outlet aperture 230b at opposite ends of the housing. The inlet aperture 230a is configured to allow the pipeline 100 to be placed at a desired location within the sensing device 500. The pipeline 100 can pass through the first aperture 230a and pass through the upstream switch 210a and then exit through the outlet aperture 230b.

[0101] The pump head housing 240 is mounted in the cutout 220 of the circuit board 200. The pump head housing 240 includes a roller assembly holder 241 shaped to receive and fix the roller assembly 310 therein. The roller assembly holder 241 includes an opening 241a for receiving the roller assembly 310 therein and a cutout portion including a ridge for fixing the roller assembly 310 therein. The roller assembly 310 of the pump head 300 squeezes the tubing containing the medical fluid, draws it out of the infusion bag, pinches off the captured liquid, and delivers it through the discharge end of the tubing 100.

[0102] The roller assembly holder 241 is fixed to the motor holder 242 for fixing the pump motor 320 of the pump head 300 therein. The motor holder 242 is formed so that the bottom surface of the motor holder 242 is also the top surface of the roller assembly holder 241. A hole is formed through the bottom portion of the motor holder 242 to allow the shaft to pass through the hole of the roller assembly 310 connecting the motor and the pump head therein.

[0103] The roller assembly holder 310 further includes an inlet hole 310a and an outlet hole 310b, wherein the inlet hole 310a is configured to receive the infusion line 100, which then extends through the roller assembly 310. The line 100 extends around the roller assembly 310, where it is squeezed to draw out and pinch off the medical fluid from the infusion bag to deliver the fluid to the patient. The line 100 eventually passes through the outlet hole 310b.

[0104] The concentrator housing 250 is configured to fix the blocks 410a and 410b, the block holder 420a of the concentrator 400, the downstream switches 210b, 210c, and the infusion line 100 therein. The concentrator housing 250 includes an inlet hole 250a and an outlet hole 250b, wherein the inlet hole 250a is configured to accommodate the infusion line 100 exiting from the roller assembly outlet hole 310b. Once the pipeline 100 enters the inlet hole 250a, the pipeline 100 passes through the concentrator 400 so that the pipeline 100 is in direct contact with the blocks 410a and 410b. The pipeline 100 is then allowed to exit through the outlet hole 250b. The outlet hole 250b is the discharge end of the pipeline 100 connected to the patient.

[0105] An infusion bag containing medical fluid is connected to one end of the tubing 100. The other end of the tubing 100 passes through the inlet hole 230a of the upstream switch housing 230 and is placed in contact with the upstream switch 210a. It passes through the upstream switch housing outlet hole 230b and enters the roller assembly 310 through the roller assembly inlet hole 310a. The tubing 100 is wrapped around the roller assembly 310 so that the movement of the roller can draw the medical fluid through the tubing 100. The tubing 100 then passes through the roller assembly outlet hole 310b and is placed in the concentrator housing 250 through the concentrator housing inlet hole 250a. The tubing 100 is positioned on blocks 410a and 410b and passes through the concentrator housing outlet hole 250b (where the other end of the tubing is connected to the patient).

[0106] When the pump is running, the pump motor 320 rotates the roller assembly 310 at a known speed. The rotation of the roller assembly 310 squeezes the tubing 100, thereby creating a pressure differential in the tubing 100 to draw medical fluid from the infusion bag and move it to the patient.

[0107] If the tubing 100 extending between the pump head 300 and the fluid container is blocked, operation of the pump will cause a vacuum to appear in the tubing, which becomes apparent by a drop in the baseline pressure in the tubing 100. The change in pressure causes the tubing 100 to contract, releasing the upstream switch 210a. When the upstream switch 210a is released, it signals an upstream blockage in the tubing 100.

[0108] If the tubing 100 extending between the pump head 300 and the patient is occluded, the baseline pressure within the tubing 100 increases, causing the tubing 100 to swell or bulge. The swollen portion of the tubing 100 exerts pressure on the block 410a, which is concentrated on the downstream switch 210b to press the downstream switch 210b down to its first actuator. A further increase in the baseline pressure further presses the downstream switch 210b down to its second actuator. If the baseline pressure increases even further, the expansion in the tubing 100 increases further, causing the block 410b to exert pressure on the downstream switch 210c to its first actuator. A further increase in the baseline pressure presses the downstream switch 210c to its second actuator, thereby signaling a further change in the downstream occlusion.

[0109] Once the switch 210b or 210c is pressed to its first actuator or second actuator, it makes electrical contact with the circuit board 200 to close the circuit. A signal is then sent through an audible alarm indicating that there may be a blockage in the pipeline 100.

[0110] Figure 6 A pump head 300 is shown, which includes a roller assembly 310, a motor 320 (not shown), and a top housing 301, a middle housing 302, and a bottom housing 303. The roller assembly 310 further includes three rollers 340, which are rotated to move the medical fluid from one end of the infusion line 100 to the other end. The rotation of the rollers is controlled by the motor 320, and the three rollers are connected to the motor 320 through a shaft. The roller assembly 310 and the motor 320 are both enclosed in the pump head housing.

[0111] The pump head housing is provided as three separate pieces, wherein the first piece forms a top housing 301 which provides a cover for the top of the roller assembly 310. The top housing 301 is shaped to fit into the middle housing 302.

[0112] The second workpiece forms an intermediate housing 302 for holding and securing therein the roller assembly 310. The intermediate housing 302 includes two holes (entry hole 302a and exit hole 302b), wherein the entry hole 302a is shaped to receive the pipeline 100 into the roller assembly 310, and the exit hole 302b is shaped to allow the pipeline to exit therethrough.

[0113] A dome switch 330 is disposed within the intermediate housing 302 for sensing an obstruction in the pipeline 100. The dome switch 330 functions as a tactile sensor having two actuators, each of which is set at a different pressure value for detecting different pressure thresholds in the pipeline 100. When the pipeline enters the intermediate housing access hole 302a, the pipeline is positioned around the roller assembly 310, thereby making direct contact with the dome switch 330. A circuit board 305 is disposed outside the intermediate housing for providing electrical connection to the pump head.

[0114] The third piece forming the bottom housing 303 is provided for fixing the motor 320 therein. The bottom housing 303 is fixed to the bottom surface of the middle housing 302. The top surface of the bottom housing 303 includes a hole for receiving the shaft from the middle housing 302 and retaining it therein. The motor 320 is further connected to the shaft, which allows the roller assembly 310 to rotate when in operation.

[0115] In operation, the motor in the bottom housing 303 rotates the roller assembly 310 of the middle housing 302. Each roller squeezes the tubing 100 to extract and move the medical fluid from the container. The medical fluid is then allowed to pass through the tubing 100 to the patient. If an occlusion occurs, the change in baseline pressure causes the tubing 100 to contract or expand, thereby signaling an occlusion event, as described in the above embodiments of the present invention.

[0116] Once the pump pressure switch 330 is triggered, the pump pressure switch 330 makes electrical contact with the circuit board 305 to close the circuit. A signal is then sent as an audible alarm, indicating that there may be a blockage in the pipeline 100.

[0117] It should be understood that use of the term "switch" or its plural forms or variations such as "swithces", or derivative terms such as "pressure switch" will be understood to include any component that makes or breaks one or more electrical circuit connections.

[0118] In particular, it should be understood that use of the term "pressure switch" or its plural forms or derivatives includes any switch wherein the actuation criteria of the switch includes an increase or decrease in pressure thereon exceeding one or more pressure thresholds.

[0119] It will be understood that the use of the term "actuation threshold" or its plural form or variations such as "actuation thresholds" or derived terms as used herein with respect to a pressure switch will be understood to refer to a physical characteristic of the pressure switch that defines the pressure applied when the switch is actuated. This physical characteristic is determined by the structure of the pressure switch, such as a combination of the material composition, physical shape, thickness or density of the material, etc. of the pressure switch.

[0120] In this specification, the word "comprise" or variations such as "comprises" or "comprising" will be understood to imply the inclusion of stated elements, integers or steps, or groups of elements, integers or steps, but not the exclusion of any other elements, integers or steps, or groups of elements, integers or steps.

[0121] It should be appreciated that a particular connection or attachment mechanism or method used to connect two particular components of a sensing device, as described herein, can be used to connect other components of a sensing device as desired.

[0122] The various components described herein can be made of any of a variety of materials, including, for example, plastics, plastic resins (e.g., polyethylene, polypropylene, nylon, composite materials, or rubber), or any other material desired. For example, the sensing device of the present disclosure can be manufactured from a plastic resin (e.g., polyethylene) by injection molding. However, it should be understood that in the case where the sensing device of the present disclosure is used with a medical device, safety material considerations should be considered. The sensing device of the present invention can be used with any other closed fluid system to detect any restriction in fluid flow.

[0123] A variety of production techniques can be used to manufacture the devices and components described herein. For example, suitable injection molding and other molding techniques and other manufacturing techniques can be used. In addition, as desired, particularly when using molded construction techniques, the various components of the device can be integrally formed. In addition, the various components of the device can be formed into workpieces and connected together in some manner, such as using a suitable adhesive.

[0124] As described herein, various devices and components of devices can be provided in various sizes and / or dimensions as required. Suitable sizes and / or dimensions will vary according to the specifications or fields of use of the connecting components, which can be selected by those skilled in the art.

[0125] It should be understood that the features, elements and / or characteristics described in one embodiment of the present disclosure can be used together with other embodiments of the present invention as needed. It should also be understood that the effects of the present disclosure are not limited to the above effects, and those skilled in the art will understand other effects not mentioned herein from the present disclosure and the appended claims.

[0126] Although the preferred embodiments of the present disclosure have been disclosed for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the disclosure and the accompanying claims.

[0127] It should be understood that when an element or layer is referred to as being "on," "contacting," "physically contacting," or "within" another element or layer, the element or layer can be directly on or within another element or layer or intervening elements or layers. In contrast, when an element is referred to as being "directly on," "directly contacting," "directly in physical contact," or "directly within" another element or layer, there are no intervening elements or layers present.

[0128] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0129] It should be understood that although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and / or parts, these elements, components, regions, layers and / or parts should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or part from another region, layer or part. Therefore, without departing from the teachings of the present disclosure, a first element, component, region, layer or part may be referred to as a second element, component, region, layer or part.

[0130] Spatially relative terms, such as "lower", "upper", "top", "bottom", "left", "right", etc., may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figure for ease of description. Spatially related terms, such as those provided above, may be used herein to define the spatially defined relationship of one feature relative to another feature. It should be understood that the spatially relative terms are intended to cover different orientations of the structure in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is turned over, an element described as "lower" relative to other elements or features would then be oriented "higher" relative to the other elements or features. Thus, the exemplary term "lower" can include both above and below orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein should be interpreted accordingly.

[0131] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present disclosure. As used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise. It will be further understood that the terms "including", "comprises", and / or "comprising", when used in this specification, specify the presence of the features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0132] The embodiments of the specification are described herein with reference to figures and / or cross-sectional views, which are, for example, schematic illustrations of preferred embodiments (and intermediate structures) of the specification. As such, variations from the shapes of the illustrations due to, for example, manufacturing techniques and / or tolerances, are to be expected. Thus, the described embodiments should not be construed as limited to the particular shapes of the components shown herein, but rather include deviations in shapes that result, for example, from manufacturing.

[0133] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by ordinary technicians in the field to which this specification belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, unless explicitly defined herein, should be interpreted as having a meaning consistent with its meaning in the context of the relevant field, and will not be interpreted in an idealized or overly formal sense.

[0134] Any reference in this specification to "one embodiment," "an embodiment," "an example embodiment," etc., means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the specification. Such phrases appearing in different places in the specification do not necessarily all refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in connection with any embodiment, it is within the capabilities of those skilled in the art to implement and / or use such feature, structure, or characteristic in connection with other embodiments. Embodiment.

[0135] Embodiments are also intended to include or otherwise encompass methods and methods of manufacture using any or all of the elements described above.

[0136] Although the present invention has been described above according to specific embodiments, it should be understood that the present invention is not limited to these disclosed embodiments. After reading the teachings of this disclosure, many modifications and other embodiments of the present invention will occur to those skilled in the art to which the present invention belongs, and this disclosure and the appended claims are intended to and are covered by this disclosure and the appended claims.

[0137] All publications referred to in this specification are incorporated herein by reference. Any discussion of documents, acts, materials, devices, articles and the like that has been included in this specification is for the purpose of providing a context for the present invention only. It is not to be taken as an admission that any or all of these matters form part of the prior art baseline or are common general knowledge in the field relevant to the present invention as it existed in Australia or elsewhere before the priority date of each claim of this application.

[0138] Indeed, the scope of the present invention is intended to be determined by proper interpretation and construction of the appended claims and their legal equivalents, as will be understood by those skilled in the art from the disclosure in this specification and the drawings.

Claims

1. A sensing device for detecting pressure changes in a medical infusion line of a disposable medical device, comprising a support component having a support surface, the support component having one or more electrical connection switches mounted thereon, the electrical connection switches being configured to be actuated under a first preconfigured pressure and a second preconfigured pressure; a section of expandable and contractible elastic tube for allowing fluid to pass therethrough, the section of expandable and contractible elastic tube being fixed to the support surface by a fixing device; wherein, One or more electrically connected switches include a first pressure switch, and one or more electrically connected switches form a sensor array, wherein the sensor array is suitable for sensing the expansion or contraction of the expandable and contractible elastic tube; wherein the sensing device includes: A pressure concentrator comprises a pressure piece and a pressure concentrator holder; the pressure piece is arranged between a first pressure switch and a portion of the expandable and contractible elastic tube, the pressure piece has an upper surface in physical contact with the portion of the expandable and contractible elastic tube and a lower surface in physical contact with the first pressure switch; the pressure concentrator holder is spiral or coil-shaped, the pressure piece is fixedly connected to the central terminal of the pressure concentrator holder, and is used to keep the pressure piece in a desired position to collect and concentrate the pressure of the expansion of the expandable and contractible elastic tube to the first pressure switch, wherein the concentrator is configured to adjust the pressure actuation threshold of the first pressure switch to a first preconfigured pressure.

2. The sensing device according to claim 1, wherein: One or more electrically connected switches include one or more pressure switches having two or more pressure actuation thresholds or pressure de-actuation thresholds, the pressure switches being configured to actuate or de-actuate under a preconfigured pressure, and the preconfigured pressure of the sensor array being able to provide a stepped output at two or more pressure actuation thresholds or pressure de-actuation thresholds when the expandable and contractible elastic tube expands or contracts.

3. The sensing device of claim 1, wherein the first pressure switch has two or more pressure actuation thresholds, the first pressure switch being configured to actuate at a first preconfigured pressure and a second preconfigured pressure.

4. The sensing device according to claim 1, wherein the pressure concentrator holder is configured to maintain the pressure concentrator in contact with the first pressure switch or a portion of the expandable and contractible elastic tube, and wherein, The support member includes a printed circuit board, the support surface is provided by a surface of the printed circuit board, and the pressure concentrator holder is formed integrally with the printed circuit board.

5. The sensing device of claim 1, comprising a second pressure switch having one or more pressure actuation thresholds, wherein: The first pressure switch has two or more pressure actuation thresholds and the second pressure switch has one or more pressure actuation thresholds and is configured to actuate at a third preconfigured pressure.

6. The sensing device according to claim 1 comprises at least one additional electrically connected switch having a pressure de-actuation threshold and configured to be de-actuated at an additional pre-configured pressure when the expandable and contractible elastic tube is contracted.

7. The sensing device according to claim 6, wherein: At least one additional electrical connection switch includes: a first additional pressure switch, and A pressure concentrator is located between the first additional pressure switch and a portion of the section of expandable and contractible elastic tube, the pressure concentrator has an upper surface in physical contact with the portion of the section of expandable and contractible elastic tube and a lower surface in physical contact with the first additional pressure switch, the pressure concentrator is shaped to concentrate pressure from the contraction of the expandable and contractible elastic tube to the first additional pressure switch, wherein the concentrator is configured to adjust the pressure actuation threshold of the first additional pressure switch to an additional preconfigured pressure.

8. The sensing device according to claim 1, wherein: The fixing device includes a tube housing defining a cavity for placing at least a portion of the section of expandable and contractible elastic tube therein, and the fixing device also includes a fastener or adhesive for fixing the tube housing to a supporting surface to maintain the placement of a portion of the section of expandable and contractible elastic tube in contact with one or more electrical connection switches.

9. The sensing device of claim 8, wherein the tube housing comprises; a wall having an outer surface and an inner surface, The wall extends longitudinally, wherein The inner surface of the wall defines a longitudinal cavity for longitudinally placing at least a portion of the length of expandable and contractible elastic tube therein, The wall terminates at opposite ends of the longitudinal cavity in an opening configured to allow the expandable and contractible elastic tube to pass therethrough, The wall has at least one protrusion along the length of two opposing longitudinal edges of the wall, A portion of the inner surface of the wall at the protrusion contacts and is secured to the support surface.

10. A method of manufacturing a sensing device according to claim 1, comprising the steps of: get; a support member having one or more electrical connection switches mounted thereon, a section of expandable and contractible elastic tube, and Fixtures, maintaining the section of expandable and contractible elastic tube in physical contact with one or more electrical connection switches, and The length of expandable and contractible elastic tube is secured to the support member by securing a securing device to the support surface.

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