Conduit Fixation Device with Force Sensor - Patent application

Abstract

A conduit fixation device (50) comprising a support (52), at least one first elastically stretchable strap (54) coupled to the support (52) and including a portion (54) configured to be attached around a first region of a conduit, at least one force sensor (74) attached to a sensor portion (68) of the device (50), the at least one force sensor (74) configured to sense a force applied to the device (50) as a result of a force applied to the conduit, generate a force signal representative of the force applied to the device, determine when the force signal meets at least one or more threshold values ​​and generate an alarm signal, and an alarm in communication with the force sensor (74) and configured to receive the alarm signal and generate an alarm. A medical system is also provided comprising the conduit fixation device and at least one conduit secured to the device.

Description

[Technical field]

[0001] The present invention relates to conduit fixation devices, and in particular, but not exclusively, to devices for fixating a conduit to a patient in a clinical environment, the devices having a force sensor for sensing forces applied to the device. [Background technology]

[0002] Medical treatments commonly involve infusing or withdrawing fluids from a patient by connecting conduits, such as cannulas, needles, fluid lines, etc., to the patient's body cavities, such as the thoracic, abdominal, cranial, vein, artery, spinal, urethra, intestine, etc. For example, intravenous (IV) fluid lines may be used to administer medications, administer or replace plasma, administer hydration fluids, while fluids may be removed via urinary or intestinal catheters, and surgical drains may be required during or after surgery.

[0003] While the conduits that make up the fluid lines are attached, the patient or body part remains relatively mobile, and the patient may forget or be unaware of the fluid lines, especially during extended treatments or when regaining consciousness. Additionally, clinical settings may be crowded with additional fluid lines and medical equipment, and clinicians may need to frequently work in close proximity to the fluid lines. Thus, unplanned removal of lines from patients is a common problem and can lead to poor quality of care and adverse clinical outcomes.

[0004] Adhesives or tapes can be used to secure the conduit to the patient. This method can be easily adapted to different types or diameters of conduit. However, hair, sweat or other fluids can weaken the adhesion of the conduit to the patient's skin, and at best only limited pulling resistance of the conduit can be achieved. Adhesive tapes can also be uncomfortable for the patient.

[0005] Dialysis lines (among many others) are a specific example of the use of conduits in a clinical environment. Dislodging of such lines has a significant impact on patient morbidity and mortality. Patients are increasingly undergoing dialysis at home, at night, or away from the hospital. This improves the patient experience, but also increases the risk of dialysis lines becoming dislodged. For example, when a patient turns over in bed, this puts stress on the dialysis line, which can cause it to become dislodged.

[0006] The current market standard in dialysis is the use of urine collection pads. These pads provide a patient warning if they become saturated with the patient's blood after the dialysis line becomes disconnected. This is not ideal, and therefore a need remains to address one or more deficiencies in existing conduit / fluid line fixation and patient warning. In other fields, there are situations where conduits are attached to devices and it is undesirable for such conduits to be subjected to stress or to become disconnected. For example, an electrical signal cable may be attached to a monitoring device. If the cable is subjected to stress or becomes disconnected, the signal from the monitoring device may be lost or stopped. In such situations, it is desirable for the operator of the monitoring device to be aware that a stress is being applied to the electrical cable. Summary of the Invention [Means for solving the problem]

[0007] According to a first aspect of the present invention there is provided a conduit fixation device comprising a support portion, at least one first elastically stretchable strap coupled to the support portion and having a portion configured to be attached around a first region of the conduit, at least one force sensor attached to a sensor portion of the device configured to sense a force applied to the device as a result of a force applied to the conduit, generate a force signal representative of the force applied to the device, determine when the force signal meets at least one or more threshold values ​​and generate an alarm signal, and an alarm in communication with the force sensor and configured to receive the alarm signal and generate an alarm.

[0008] The conduit may be a rigid conduit. The rigid conduit may be a cannula or a needle. The conduit may be a flexible conduit. The flexible conduit may be a fluid line, a dialysis line, a catheter, a drain, an electrical signal cable, an optical signal cable, or a wire.

[0009] The first strap may be coupled to the support to hold the conduit in any orientation relative to the support.

[0010] The conduit fixation device may further comprise a second elastically stretchable strap coupled to the support, the second strap including a portion configured to be attached around a second region of the flexible conduit, the first strap and the second strap being positioned on the support at a linearly offset position such that the first region of the flexible conduit is linearly offset from the second region of the flexible conduit and the flexible conduit is urged into a path across the device.

[0011] The second strap may be attached to the first strap. The first strap may be attached to the second strap, thereby coupling the first strap to the support.

[0012] The first strap or the second strap can be coupled to the support by any of a hinge structure, a living hinge, a hook-and-loop fastener, a snap-fit ​​fastener, an eyelet-pin fastener, a hook-and-eyelet fastener, a button-and-eyelet fastener, a popper fastener, a hole-and-link fastener, a slider fastener, a clasp, a squeeze buckle, a D-ring fastener, a magnetic snap fastener, a cam buckle, a ratchet buckle, a slide buckle, a side release buckle, a tie buckle, a ratchet tooth-and-pole fastener, a latch, a lever, and a latch set / release button.

[0013] The conduit fixation device may further comprise two elastically stretchable second straps coupled to the support and each comprising a portion configured to be attached around the second and third regions of the flexible conduit, respectively, the first strap and the second strap being positioned on the support at linearly offset positions such that the first region of the flexible conduit is between and linearly offset from the second and third regions of the flexible conduit, such that the flexible conduit is forced into a curved or convoluted path across the device.

[0014] In use, a portion of the first strap and, if present, a portion of the one or more second straps are attached (e.g., wrapped) around the conduit to secure the conduit to the device. Static friction between the first strap and, if present, the second strap, and the conduit provides some resistance, i.e., resistance to movement of the conduit relative to the fixation device. This tensile resistance is enhanced by the curved or convoluted path, if present. The first strap and, if present, the second strap, resist the transfer of a force applied to one side of the conduit to the other side of the conduit.

[0015] A force applied longitudinally to the conduit (i.e., a force with at least one component of the force applied along the length of the conduit) acts to pull the conduit through a portion of the first strap proximal or distal to the fixation device. A force applied longitudinally to the conduit proximal or distal to the fixation device may act to pull the conduit through a portion of the or each portion of the second strap(s), if present, to straighten the path of the conduit. As the conduit is pulled, the first strap and, if present, the second strap(s) elastically stretch (or further elastically stretch), increasing static friction with the conduit and resisting longitudinal displacement of the conduit. In effect, the fixation device isolates the conduit extending distally from the device from forces applied between the fixation device and the conduit extending proximally from the device, and vice versa. The fixation device thereby reduces the risk of breaking the end of the conduit attached to a patient or to an apparatus, such as a medical device or any other type of device. Furthermore, the elastically deformable straps can deform to accommodate lateral movement or bending of the conduit proximal or distal to the device, reducing the risk of bending or crushing the conduit.

[0016] In some embodiments, all or each of the straps are elastically extensible. In other embodiments, at least a portion of at least one first strap and at least a portion of at least one second strap, if present, are elastically extensible. A portion of at least one first strap and a portion of at least one second strap, if present, are elastically extensible and may comprise loops configured to be attached to the first region of the conduit, the second region of the conduit, and the third region of the conduit, respectively.

[0017] The conduit fixation device may further comprise an external attachment for attaching the device to a patient or to a structure such as a medical device, machine, trolley, bed, dialysis machine, infusion machine, incubator, etc. The external attachment may comprise, for example, a band. It may be attached around a part of the patient's body such as a limb, torso, shoulder, neck, foot, head, waist, etc., or around a part of a structure. The external attachment may comprise a releasable fastener such as a clip or hook and loop fastener component. The external attachment may comprise a garment or part of a garment such as a vest, underwear, limb cover, etc. The external attachment may comprise an adhesive portion, for example in the form of a tape or an adhesive patch or strip. It may be applied to a part of the patient's body such as a limb, torso, shoulder, neck, foot, head, waist, patient's clothing, etc., or to a structure such as a medical device, furniture, machine, incubator, trolley, etc.

[0018] The force sensor may be configured to sense a force applied to the device as a result of a force applied to the conduit due to compression, tension, bending, movement, vibration, or elongation of the conduit.

[0019] The force sensor may be configured to sense one or more of a strain force, a shear force, a pressure force, a dynamic force applied to the conduit fixation device.

[0020] The force sensor may comprise one or more of a strain force sensor, a pressure force sensor, a dynamic force sensor, and a rotational force sensor.

[0021] The force sensor may process the force signal to quantify the force. The force sensor may dynamically process the force signal to quantify the force. The force sensor may process the force signal in real time to quantify the force. The force sensor may process the force signal to determine the direction of the force. The force sensor may process the force signal to add one or more timestamps. The one or more timestamps may record and log either treatment time events, adverse events, which can be verified or reviewed by a care provider in real time or retrospectively, for example for treatment, research or audit purposes.

[0022] The force sensor may process the force signal to determine when the force signal meets at least a force magnitude threshold and generate an alarm signal. The force sensor may process the force signal to determine when the force signal meets at least a force magnitude threshold and at least a force duration threshold and generate an alarm signal. The force magnitude threshold may be 10N, 20N, 30N, 40N, 60N, 100N, 140N. The force magnitude threshold may be adjustable by a user of the conduit fixation device. The force duration threshold may be 0.1 seconds, 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 10 seconds, 20 seconds. The force duration threshold may be adjustable by a user of the conduit fixation device. If the conduit is, for example, a fluid line for a patient, such duration of such force magnitude on the fixation device resulting from forces on the conduit may ultimately lead to dislodging of the fluid line conduit from the patient. These forces may also impede flow through the conduit, which should be avoided. The force sensor may process the force signal to monitor trends in the force signal. The force sensor may generate an alarm signal when one or more of the particular trends are detected.

[0023] The force sensor can include a force sensing element and a signal processing unit in communication with the force sensing element. The force sensing element can sense a force applied to the conduit fixation device, generate a force signal representative of the force, and output the force signal to the signal processing unit. The signal processing unit can determine when the force signal meets at least one or more thresholds and generate an alarm signal.

[0024] The force sensing element may be disposed in a sensor portion of the conduit fixation device constituting a first position of the conduit fixation device, and the signal processing unit may be disposed in a second position of the conduit fixation device. The force sensing element may be disposed in a first housing of the force sensor, and the signal processing unit may be disposed in a second housing of the force sensor. The force sensing element may be in wireless communication with the signal processing unit. The force sensing element may be in wired communication with the signal processing unit.

[0025] The force sensing element and the signal processing unit may be substantially collocated with a sensor portion of the conduit fixation device.The force sensing element and the signal processing unit may be disposed within a housing of the force sensor.

[0026] The signal processing unit may be separate from the conduit fixation device. The signal processing unit may be provided on a computing device separate from the conduit fixation device. The force sensing element may be in wireless communication with the signal processing unit. The force sensing element may be in wired communication with the signal processing unit. This allows processing of the force signal to be performed remotely on a computing device, such as a computer or phone, separate from the conduit fixation device, e.g., a care provider's computing device.

[0027] The force sensing element may be attached to a sensor portion of the conduit fixation device. The force sensing element may be molded into the sensor portion of the conduit fixation device. The sensor portion of the conduit fixation device may comprise any of a central area of ​​a support of the device, an underside of a support of the device, a portion of a first strap configured to be attached around a first region of the conduit, a portion of one of two or more second straps configured to be attached around a region of the conduit, an attachment device for either the one or more first straps or the two or more second straps or a further strap configured to attach the strap to the support.

[0028] The signal processing unit may include at least one processor. The processor may be configured to receive a force signal representative of a force applied to the conduit fixation device from the force sensing element. The processor may be configured to receive a plurality of force signals representative of the forces applied to the conduit fixation device from the force sensing element. The plurality of force signals may be received at regular time intervals, for example at 10 Hz intervals.

[0029] The signal processing unit may include at least one memory unit. The memory unit may be configured to store force sensor data. The force sensor data may include one or more magnitudes of one or more force signals representative of forces applied to the conduit fixation device, one or more time points at which the force signals meet at least one threshold, one or more time points at which an alarm signal is generated, the magnitude of the force signal that meets at least one threshold, or the duration of the force signal that meets at least one threshold. The memory unit may store one or more force magnitude thresholds. The memory unit may store one or more force duration thresholds. The memory unit may store one or more time stamps. The memory unit may store other information, such as operational data.

[0030] The signal processing unit may include at least one transceiver. The transceiver may output the force sensor data to one or more computing devices. The force sensor data may be output via one or more wired connections to one or more computing devices, such as one or more USB connections. The force sensor data may be output via one or more wireless connections to one or more computing devices, such as one or more Bluetooth connections and / or one or more Wi-Fi connections and / or one or more SMS connections. The force sensor data may be output via a combination of one or more wired connections and one or more wireless connections to one or more computing devices.

[0031] The one or more computing devices may comprise a device located in proximity to a patient using the conduit fixation device. Additionally or alternatively, the one or more computing devices may comprise a device located at a patient care facility and configured to receive the force sensor data and generate an alert to care personnel that a force is being applied to the conduit. The force sensor data may be continuously received by the care personnel. The force sensor data may be received on a monitoring screen or platform. The force sensor data may be accessed remotely, for example, via a website or smartphone application. Additionally or alternatively, the one or more computing devices may comprise a device located with one or more care personnel and configured to receive the force sensor data and generate an alert to care personnel that a force is being applied to the conduit. The device located with one or more care personnel may comprise, for example, a smartphone, tablet, laptop, with software, such as application software, configured to receive the force sensor data and generate an alert to care personnel, such as a notification, text message, phone call, etc. Additionally or alternatively, the one or more computing devices may comprise a device connected to the conduit, configured to receive the force sensor data and generate an alert for the device that a force is being applied to the conduit. The device may be configured to use the alert to initiate a change or attenuation of the flow of fluid to the conduit. The device may be, for example, an infusion pump and / or a dialysis machine, and may be configured to slow or stop the infusion / dialysis. The one or more computing devices may be configured to display the force sensor data, for example using a SerialPlot.

[0032] The force sensor may include at least one power source, which may be a battery or may be thermal energy from a patient wearing the conduit fixation device.

[0033] The alarm may comprise an audible alert element configured to receive the alarm signal and emit an audible alert. The audible alert element may be a piezo sounder. Additionally or alternatively, the alarm may comprise a visual alert element configured to receive the alarm signal and emit a visual alert. The visual alert element may be configured to use visual alerts of different colors and / or durations to indicate different alarm states of the alarm. The visual alert element may be configured to emit a visual alert comprising an SMS. The visual alert element may be an RGB LED. The alarm may comprise an audiovisual alert element configured to receive the alarm signal and emit an audiovisual alert. The audiovisual alert element may comprise a display screen. Additionally or alternatively, the alarm may comprise a tactile alert element configured to receive the alarm signal and emit a tactile alert.

[0034] The alarm may comprise an alarm deactivation device that deactivates the alarm when activated. The alarm deactivation device may comprise a push button that deactivates the alarm when pressed. Thus, if the alarm is activated, a patient using the conduit securement device can change position to relieve forces on the conduit and then deactivate the alarm. The alarm may comprise an alarm operation device configured to enable a patient using the conduit securement device to activate the alarm.

[0035] The force sensor may comprise a strain sensor configured to sense a strain force applied to the conduit fixation device, generate a strain signal representative of the strain force, and determine when the strain signal meets at least one or more thresholds and generate an alarm signal.

[0036] The strain sensor may process the strain signal to determine when the force signal meets at least a strain magnitude threshold and generate an alarm signal. The strain sensor may process the strain signal to determine when the strain signal meets at least a strain magnitude threshold and at least a duration threshold and generate an alarm signal.

[0037] The strain sensor may include a strain sensing element and a signal processing unit in communication with the strain sensing element. The strain sensing element may sense a strain applied to the conduit fixation device, generate a strain signal representative of the strain, and output the strain signal to the signal processing unit. The signal processing unit may determine when the strain signal meets one or more thresholds and generate an alarm signal.

[0038] The strain sensing element may comprise a strain gauge. The strain gauge may comprise a strain sensitive cord. The strain gauge may comprise a printed mesh. The strain gauge may be disposed on a base of the strain sensor. The base may be made of a flexible sheet material. The flexible material may be more flexible than a thin metal sheet and less flexible than a silicone sheet. The base may provide strain relief to protect the strain gauge.

[0039] The strain sensing element may comprise a strain sensitive material that senses strain forces through a change in the electrical state of the material. The strain sensitive material may sense strain forces upon bending, e.g., stretching, of the material. The strain sensitive material may be in the form of one or more strips of material. The strain sensitive material may comprise a carbon impregnated polyethylene strain sensitive material. An example of a carbon impregnated polyethylene strain sensitive material is the Velostat (RTM) strain sensitive material.

[0040] The strain sensing element is attached to or molded into a sensor portion of the conduit fixation device that constitutes a central region of the support of the device. This region of the device deforms when a force is applied to the conduit fixed to the device. This region of the device is relatively fixed and does not experience repeated excessive bending during connection and disconnection of the first strap and, if present, the second strap. In this region of the device, the strain sensing element is desirably independent of the size of the conduit.

[0041] The strain sensing element is attached to or molded into a sensor portion that forms the underside of the support of the conduit fixation device.

[0042] In one embodiment, the strain sensing element may be attached to or molded into a sensor portion of the conduit fixation device that constitutes a portion of a first strap configured to be attached around a first region of the conduit. In one embodiment, the strain sensing element may be attached to or molded into a sensor portion of the conduit fixation device that constitutes a portion of one of two or more second straps configured to be attached around a region of the conduit. This portion of the device provides a better location for the strain gauge strain sensing element, which may be very sensitive. In one embodiment, the strain sensing element may be attached to or molded into a sensor portion of the conduit fixation device that comprises a strut of either the one or more first straps or the two or more second straps.

[0043] The force sensor may comprise a pressure sensor configured to sense a pressure force applied to the conduit fixation device, generate a pressure signal representative of the pressure force, determine when the pressure signal meets at least one or more thresholds, and generate an alarm signal.

[0044] The pressure sensor may process the pressure signal to determine when the pressure signal meets at least a pressure magnitude threshold and generate an alarm signal. The pressure sensor may process the pressure signal to determine when the pressure signal meets at least a pressure magnitude threshold and at least a duration threshold and generate an alarm signal.

[0045] The pressure sensor may include a pressure sensing element and a signal processing unit in communication with the pressure sensing element. The pressure sensing element may sense a pressure force applied to the conduit fixation device, generate a pressure signal representative of the pressure force, and output the pressure signal to the signal processing unit. The signal processing unit may determine when the pressure signal meets at least one or more thresholds and generate an alarm signal.

[0046] The pressure sensitive element may comprise a pressure sensitive material that senses pressure forces by a change in the electrical state of the material. The pressure sensitive element may comprise a pressure sensitive conductive material. The pressure sensitive element may comprise a pressure sensitive conductive fabric material. The pressure sensitive element may comprise a carbon impregnated polyethylene pressure sensitive conductive material. An example of a carbon impregnated polyethylene pressure sensitive conductive material is Velostat (RTM) carbon impregnated polyethylene pressure sensitive conductive material. The pressure sensitive element may comprise one or more sheets of pressure sensitive conductive material. The pressure sensitive element may comprise one or more strips of pressure sensitive conductive material.

[0047] The pressure sensitive material may comprise a pressure sensitive rubber material. The rubber pressure sensitive material may be in the form of one or more strips of material or one or more pills of material.

[0048] The pressure sensitive material may comprise a pressure sensitive quantum tunnelling composite (QTC) material. The pressure sensitive QTC material may be in the form of a film.

[0049] The pressure sensing element is attached to or molded into a sensor portion of the conduit fixation device that forms a portion of a first strap configured to be attached around a first region of the conduit. The pressure sensing element may be attached to or molded inside an inner surface of a portion of the first strap. The pressure sensing element may be attached to or molded inside an inner surface of a portion of the first strap such that it wraps around the first region of the conduit. When a force is applied to the conduit, for example by pulling on the conduit, a pressure force is applied to the pressure sensing element.

[0050] The pressure sensing element may be attached to or molded into a sensor portion of the conduit fixation device that constitutes a portion of one or more second straps configured to be attached around a region of the conduit. The pressure sensing element may be attached to or molded inside an inner surface of a portion of the one or more second straps. The pressure sensing element may be attached to or molded inside an inner surface of a portion of the one or more second straps to be wrapped around a region of the conduit.

[0051] The pressure sensing element may be attached to or molded into a sensor portion of the conduit fixation device that forms the underside of the support of the apparatus. The pressure sensing element may be attached to or molded into a sensor portion of the conduit fixation device that comprises a post of either a portion of the first strap or two or more of the second straps.

[0052] The force sensor may comprise a composite force sensor configured to sense pressure and strain forces applied to the conduit fixation device. The composite force sensor may generate a pressure force signal representative of the pressure force and a strain force signal representative of the strain force, determine when either or both of the pressure force signal and the strain force signal meet at least one or more thresholds, and generate an alarm signal. The composite force sensor may comprise a pressure-sensitive conductive material for sensing the pressure force. The composite force sensor may comprise a strain gauge for sensing the strain force. The strain gauge may be attached to the pressure-sensitive conductive material.

[0053] The force sensor may comprise a dynamic force sensor configured to sense a dynamic force applied to the conduit fixation device, generate a dynamic force signal representative of the dynamic force, determine when the dynamic force signal meets at least one or more threshold values, and generate an alarm signal.

[0054] The dynamic force applied to the conduit fixation device may result from dynamic movement of the conduit in any direction, such as pulling, bending, cantilevering, etc. Dynamic movement of the conduit may result, for example, from a short stretch of the conduit caused by it being caught on clothing or the like.

[0055] The dynamic force sensor may process the dynamic force signal to determine when the dynamic force signal meets at least a dynamic magnitude threshold and generate an alarm signal.

[0056] The dynamic force sensor may include a dynamic force sensing element and a signal processing unit in communication with the dynamic force sensing element. The dynamic force sensing element may sense a dynamic force applied to the conduit fixation device, generate a dynamic force signal representative of the dynamic force, and output the dynamic force signal to the signal processing unit. The signal processing unit may determine when the dynamic force signal meets at least one or more thresholds and generate an alarm signal.

[0057] The dynamic force sensing element may comprise a piezoelectric material. The piezoelectric material may be in the form of a ribbon of piezoelectric material. The piezoelectric material may comprise a piezoresistive material. The piezoresistive material may provide a cantilever type motion sensing element.

[0058] The dynamic force sensing element may be attached to a sensor portion of the conduit fixation device that comprises a portion of one or more first straps configured to be attached around a region of the conduit The dynamic force sensing element may be attached to an inner surface of a portion of the one or more first straps.

[0059] The dynamic force sensing element may be attached to a sensor portion of the conduit fixation device that comprises a portion of one or more second straps configured to be attached around a region of the conduit The dynamic force sensing element may be attached to an inner surface of a portion of the one or more second straps.

[0060] The dynamic force sensor may be used in conjunction with one or more other force sensors, such as a strain force sensor and / or a pressure force sensor.

[0061] The force sensor may comprise a rotational force sensor for sensing rotation caused by a force applied to one or more portions of the conduit fixation device. The rotational force sensor may sense rotation caused by a force applied to the first strap when the conduit is subjected to the force. The rotation of the first strap may occur about a post by which the first strap is coupled to a support structure of the conduit fixation device.

[0062] The rotational force sensor may include a rotational sensing element and a signal processing unit in communication with the rotational sensing element. The rotational sensing element may sense rotation caused by a force applied to one or more portions of the conduit fixation device, generate a rotational signal representative of the rotational force, and output the rotational signal to the signal processing unit. The signal processing unit may determine when the rotational signal meets at least one or more thresholds and generate an alarm signal.

[0063] The rotation sensing element may comprise a capacitor. The capacitor may comprise at least one first conductive plate and at least one second conductive plate separated by a dielectric, such as air, and / or one or more insulators. In one embodiment, the at least one first conductive plate and / or the at least one second conductive plate may be formed of a conductive ribbon, a conductive foil, or a conductive cloth. The at least one first conductive plate may be attached to a portion of the support structure below the first strap, and the at least one second conductive plate may be attached to the first strap.

[0064] In another embodiment, the at least one first conductive plate and / or the at least one second conductive plate may be formed of a carbon impregnated elastomeric material, a silicone material, or a carbon impregnated ink. The at least one first conductive plate may be embedded in a portion of the support structure beneath the first strap, and the at least one second conductive plate may be embedded in the first strap.

[0065] The capacitor may comprise a variable capacitor having a first conductive plate located in a portion of the support area under the first strap and a plurality of interconnected second conductive plates of increasing area located under the first strap. The plurality of second conductive plates may comprise either three conductive plates or four conductive plates.

[0066] The variable capacitor may include a variable overlap area between the first conductive plate and the plurality of second conductive plates. The variable capacitor may have a variable capacitance proportional to the variable overlap area between the first conductive plate and the plurality of second conductive plates. The variable overlap area between the first conductive plate and the plurality of second conductive plates may vary depending on a rotation angle of the first strap. The variable capacitor may have a variable capacitance proportional to a rotation angle of the first strap.

[0067] The variable capacitor may be part of a relaxation oscillator connected to a microprocessor unit (MCU). The MCU may generate a signal and input the signal to the oscillator. The oscillator outputs a frequency modulated signal to the MCU. The MCU measures the frequency of the frequency modulated signal over a period of time. The measured frequency may be inversely proportional to the capacitance of the variable capacitor and inversely proportional to the angle of rotation of the first strap.

[0068] The variable capacitor may be part of an RC circuit connected to a microprocessor unit. The MCU may generate a square wave signal and input the square wave signal to the RC circuit. The RC circuit may output a modulated square wave signal to the MCU. The MCU may use a rise time of the modulated square wave of the modulated square wave signal to determine the capacitance of the variable capacitor and the rotation angle of the first strap.

[0069] The rotation sensing element may include a first conductive plate having a plurality of insulated conductive strips and a second conductive plate. In one embodiment, the first conductive plate may be formed of alternating areas of conductive foil or cloth, and the second conductive plate may be formed of conductive ribbon or conductive foil. The first conductive plate may be attached to a portion of the support structure below the first strap, and the second conductive plate may be attached to the first strap, and the position of the second conductive plate may vary with the angle of rotation of the first strap. In another embodiment, the first conductive plate may be formed of alternating areas of conductive ink, and the second conductive plate may be formed of carbon impregnated silicone. The first conductive plate may be embedded in a portion of the support structure below the first strap, and the second conductive plate may be embedded in the first strap, and the position of the second conductive plate may vary with the angle of rotation of the first strap.

[0070] A first conductive plate having a plurality of insulated conductive strips may be connected to an MCU. The MCU may provide a voltage signal to each pair of adjacent conductive strips. Rotation of the first strap may position the second conductive strip adjacent at least one pair of adjacent conductive strips to form a short circuit between the second conductive plate and at least one pair of adjacent conductive strips. The MCU may detect the short circuit and determine the position of the second conductive strip and the rotation of the first strap.

[0071] The rotation sensing element may comprise a zebra strip. The zebra strip may comprise an elastomeric material having alternating conductive and insulating stripes and detecting shorts in the stripes to determine rotation. The zebra strip may be attached to a sensor portion of the conduit fixation device that forms a portion of the first strap. The zebra strip may be attached to an inner surface of a portion of the first strap.

[0072] The rotational force sensor may be used in conjunction with one or more other force sensors, such as a strain force sensor and / or a pressure force sensor.

[0073] The force sensor may comprise a stretch sensor. The stretch sensor may be a capacitive stretch sensor. The stretch sensor may be a resistive stretch sensor. The stretch sensor may comprise a conductive material attached to, printed on, or impregnated in a section of the conduit fixation device, such as the first strap or one of the two or more second straps. The stretch sensor may be coupled to the stretchable electronics.

[0074] The conduit fixation device may further comprise an accelerometer. The accelerometer may sense general movement and vibrations of the conduit fixation device. The accelerometer may measure general movement of a patient wearing the conduit fixation device, which may indicate the patient's activity and posture. The time or times at which the alarm signal is generated may be correlated with one or more measurements from the accelerometer. This may be used to identify the patient's activity at the time or times, allowing the cause of the alarm to be determined and mitigated, for example by changing the patient's position.

[0075] The conduit fixation device may further comprise a sensor for monitoring the contents passing through the conduit. The sensor for monitoring the contents passing through the conduit may comprise a detector that contacts the contents or a detector that does not contact the contents. The sensor for monitoring the contents passing through the conduit may comprise an ultrasonic detector, an infrared detector, a light detector, an electrical detector, or a chemical detector. The sensor for monitoring the contents passing through the conduit may measure flow rate, flow rate, color, a biochemical property, air bubbles in the contents, or oxygen level in the contents.

[0076] According to a second aspect of the invention, there is provided a medical system comprising a conduit fixation device according to the first aspect of the invention and at least one conduit secured to the apparatus.

[0077] It will be understood that the further and optional features of each aspect of the invention correspond to the further and optional features of the other aspects of the invention.

[0078] Exemplary embodiments will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0079] [Figure 1] FIG. 1 shows a first embodiment of a conduit fixation device according to a first aspect of the invention. [Figure 2a-2b] Figures 2a and 2b show a second embodiment of a conduit fixation device according to a first aspect of the invention in a closed and an open position. [Diagram 2] FIG. 3 shows a third embodiment of a conduit fixation device according to the first aspect of the invention. [Diagram 3] FIG. 4 shows a fourth embodiment of a conduit fixation device according to the first aspect of the invention. [Figure 4] FIG. 5 shows an embodiment of a conduit fixation device according to a first aspect of the invention attached to a patient's arm. [Diagram 5] FIG. 6 shows an embodiment of a conduit fixation device according to a first aspect of the invention attached to a patient's torso. [Figure 6] FIG. 7 shows a first embodiment of a conduit fixation device according to a first aspect of the invention attached to the neck of a patient. [Figure 7] FIG. 8 shows a second embodiment of a conduit fixation device according to the first aspect of the invention attached to the neck of a patient. [Figure 8] FIG. 9 shows a strain sensor of a conduit fixation device according to a first embodiment of the present invention. [Figure 9] FIG. 10 shows a pressure sensor of a conduit fixation device according to a first embodiment of the present invention. [Figure 10] FIG. 11 shows a rotational force sensor of a conduit fixation device according to a first embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0080] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 1, a representation of a first embodiment of a conduit fixation device 10 includes a support 12 and an elastically extensible first strap 14. The first strap 14 is releasably coupled at free ends 16, 18 to the support 12 of the device 10 by bands 20 attached to the support 12.

[0081] A portion 22 of the first strap 14 between the free ends 16, 18 is configured to be attached around a first region of the conduit 24. The portion 22 defines a channel across the support 12. The conduit 24 is disposed within the channel and the portion 22 of the first strap 14 is wrapped around the first region of the conduit 24 to secure the conduit 24 to the conduit fixation device 10.

[0082] When a force is applied between the conduit fixation device 10 and the secured conduit 24, either proximal or distal to the device 10, at least one component of the force acts along the conduit 24 which acts to pull the conduit 24 through the portion 22 of the first strap 14. This causes the first strap 14 to elastically stretch or further elastically stretch, thereby increasing the static friction between the strap 14 and the conduit 24 and resisting longitudinal displacement of the conduit 24 relative to the fixation device 10.

[0083] The conduit fixation device 10 includes a force sensor 26 attached to a sensor portion of the device 10 that constitutes portion 22 of the first strap 14. The force sensor 26 is configured to sense a force applied to the device 10 as a result of a force applied to the conduit 24, generate a force signal representative of the force, determine when the force signal meets at least one or more threshold values, and generate an alarm signal. The conduit fixation device 10 further includes an alarm (not shown) in communication with the force sensor and configured to receive the alarm signal and generate an alarm. The alarm may be disposed within the force sensor 26.

[0084] 2a and 2b, a representation of a second embodiment of a conduit fixation device 30 includes a support portion 32 and an elastically stretchable first strap 34. The first strap 34 is coupled at an end 36 to the support portion 32 of the device 30 by a hinge 38.

[0085] A portion 40 of the first strap 34 is configured to be attached around a first region of a conduit (not shown). The portion 40 is substantially U-shaped and defines a channel across the support 32. The first strap 34 pivots about a hinge 38 away from the support 32 so that the conduit can be placed within the channel of the portion 40 (FIG. 2b). The first strap 34 with the conduit then pivots about the hinge 38 towards the support 32, securing the conduit between the first strap 34 and the support 32 (FIG. 2a). The first strap 34 and the support 32 are secured together with a releasable locking mechanism 42.

[0086] When a force is applied between the conduit fixation device 30 and a conduit secured proximally or distally to the device 30, at least one component of the force acts along the conduit which acts to pull the conduit through the U-shaped portion 40 of the first strap 34. This causes the first strap 34 to elastically stretch or further stretch, thereby increasing the static friction between the strap 34 and the conduit and resisting longitudinal displacement of the conduit relative to the fixation device 30.

[0087] The conduit fixation device 30 comprises a force sensor 44 attached to a sensor portion of the device 30 comprising portion 40 of the first strap 34. The force sensor 44 is configured to sense a force applied to the device 30 as a result of a force applied to the conduit, generate a force signal representative of the force, determine when the force signal meets at least one or more threshold values ​​and generate an alarm signal. The conduit fixation device 30 further comprises an alarm (not shown) in communication with the force sensor and configured to receive the alarm signal and generate an alarm.

[0088] 3 shows a conduit fixation device 50 comprising a support 52 and an elastically stretchable first strap 54. The first strap 54 is formed from an elastomeric material and is releasably attached to the support 52 of the device 50 at free ends 56, 58. The releasable attachment is provided by openings 60, 62 through the free ends 56, 58 through which hooks 64, 66 are introduced. The hooks and openings together form a releasable fixation. It will be understood that alternative embodiments of the fixation may be used.

[0089] A portion 68 of the first strap 54 between the free ends 56, 58 is configured to form a loop that defines a channel 70 across the support 52. A conduit (not shown) is placed within the channel 70 and the portion 68 of the first strap 54 is wrapped around a region of the conduit to secure the conduit to the conduit fixation device 50.

[0090] The conduit fixation device 50 further includes an external attachment that, in the illustrated embodiment, comprises an adjustable wristband 72 extending from the support 52, which is used to attach the conduit fixation device 50 to a patient or structure.

[0091] When a force is applied between the conduit fixation device 50 and a portion of the conduit fixed proximally or distally to the device 50, at least one component of that force acts along the conduit, tending to pull the conduit through the loop portion 68 of the first strap 54. This causes the first strap 54 to elastically stretch, or further stretch, increasing the static friction between the strap and the conduit and resisting longitudinal displacement of the conduit relative to the fixation device 50.

[0092] The conduit fixation device 50 includes a force sensor 74 attached to a sensor portion of the device 50 that constitutes portion 68 of the first strap 54. The force sensor 74 is configured to sense a force applied to the conduit fixation device 50, generate a force signal representative of the force, determine when the force signal meets at least one or more threshold values ​​and generate an alarm signal. The conduit fixation device 50 further includes an alarm (not shown) in communication with the force sensor and configured to receive the alarm signal and generate an alarm.

[0093] FIG. 4 shows a conduit fixation device 80 comprising a support 82, a first elastically extensible strap 84, and two second elastically extensible straps 86,88.

[0094] Portion 90 of first strap 84 is configured to be attached around a first region of conduits 92, 94. Respective portions 96, 98 of second straps 86, 88 are adapted to be attached to longitudinally adjacent second and third regions of conduits 92, 94.

[0095] When the first strap 84 and second straps 86, 88 are attached around longitudinally adjacent first, second and third regions of the flexible conduits 92, 94, the conduits 92, 94 are biased into a curved or convoluted path as shown. It will be appreciated that in alternative embodiments, the conduit fixation device may be comprised of a different number of straps and the conduits may be biased into alternative curved or convoluted paths.

[0096] The first strap 84 and the second strap 86, 88 are formed from an elastomeric material and are releasably attached at their respective free ends to the support 82 of the device 80. The releasable attachment is provided by openings through the free ends into which buttons 102, 104, 106 are introduced. Together the buttons and openings form a releasable fastener. It will be appreciated that alternative embodiments of the fastener may be used.

[0097] A portion 90 of the first strap 84 is wrapped around a first region of the conduits 92, 94. A portion 96, 98 of the second strap 86, 88 is wrapped in the opposite direction around second and third regions of the conduits 92, 94. The portions 90, 96, 98 each define a channel which, in the illustrated embodiment, extend generally contiguously with one another and together define, at least in part, a curved or convoluted path of the conduits 92, 94.

[0098] The conduit fixation device 80 is configured such that the portions 90, 96, 98 of the first strap 84 and the second strap 86, 88 form channels that are laterally offset from one another (i.e., offset in a direction generally perpendicular to the direction of the channels). Thus, when the portions 90, 96, 98 of the first strap 84 and the second strap 86, 88 are attached around the regions of the conduits 92, 94, the portions 90, 96, 98 elastically stretch. The first strap 84 applies a first force and the second straps 86, 88 apply a generally opposing second force to the conduits 92, 94, respectively, biasing the conduits 92, 94 into a curved / convoluted path.

[0099] When a force is applied between the conduit fixation device 80 and the conduits 92, 94 proximal or distal to the fixation device 80, at least one component of the force acts longitudinally along the conduits 92, 94. This acts to straighten the convoluted path and further elastically stretch the first strap 84 and the second strap 86, 88. This increases the static friction between the straps and the conduits, resisting longitudinal displacement of the conduits 92, 94 relative to the fixation device 80. Clinically sensitive areas, particularly at least one entry point of the conduit to the patient, may thereby be isolated from such forces applied to the conduits.

[0100] The inherent resiliency of the first strap 84 and the second strap 86, 88 also allows the conduit fixation device 80 to accommodate forces applied in other directions between the fixation device 80 and the conduits 92, 94. In the illustrated embodiment, the portions 90, 96, 98 are not attached to the support 82 and can be lifted away therefrom, further reducing the risk of the conduits 92, 94 bending or kinking where they exit the channel. When used with fluid line conduits, the resiliency of the straps 84, 86, 88 or strap portions 90, 96, 98 can be selected such that the straps will elastically stretch or deform at a force less than that required to compress the fluid line conduits.

[0101] The fixation device 80 further includes an external attachment extending from the support 82, in the illustrated embodiment an adjustable band 108, which is used to attach the conduit fixation device to a patient or structure.

[0102] The curved or convoluted paths of the conduits of the aspects and embodiments disclosed herein isolate conduits extending from either side of the fixation device from forces applied to conduits extending from the other side of the device. Symmetric curved or convoluted paths may be even more beneficial in this regard. Thus, the fixation device may be attached in either orientation, for example, to the upper or lower extremities, torso, lower back, head, neck, etc. of the patient.

[0103] The conduit fixation device 80 includes a force sensor 110 attached to a sensor portion of the device 80 forming a central portion of the support 82. The force sensor 110 is configured to sense a force applied to the device 80 as a result of a force applied to the flexible conduits 92, 94 or each of the flexible conduits 92, 94, generate a force signal representative of the force, determine when the force signal meets one or more threshold values ​​and generate an alarm signal. The conduit fixation device 80 includes an alarm (not shown) in communication with the force sensor 110 and configured to receive the alarm signal and generate an alarm.

[0104] The force sensor 26, 44, 74, 110 of the conduit fixation device 10, 30, 50, 80 may comprise a strain force sensor, a pressure force sensor, a dynamic force sensor, or a rotational force sensor and is configured to sense a force applied to the device 10, 30, 50, 80 as a result of a force applied to the conduit resulting from pulling, bending, moving, vibrating, or stretching the conduit.

[0105] The force sensor 26, 44, 74, 110 generates a force signal representative of the force applied to the device 10, 30, 50, 80 and processes the force signal to quantify the force. The force sensor 26, 44, 74, 110 may further process the force signal to determine the direction of the force. The force sensor 26, 44, 74, 110 processes the force signal to determine when the force signal meets at least a force magnitude threshold and at least a force duration threshold and generates an alarm signal. The force magnitude threshold may be 10N, 20N, 30N, 40N, 60N, 100N, 140N. The force duration threshold may be 0.1 seconds, 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 10 seconds, 20 seconds.

[0106] Each of the force sensors 26, 44, 74, 110 includes a force sensing element and a signal processing unit in communication with the force sensing element. The force sensing element detects a force applied to the conduit fixation device 10, 30, 50, 80, generates a force signal representative of the force, and outputs the force signal to the signal processing unit. The signal processing unit determines when the force signal meets at least one or more thresholds and generates an alarm signal.

[0107] The force sensing element is located on the sensor portion 22, 40, 68, 82 of the conduit fixation device 10, 30, 50, 80. The signal processing unit may be located at the same location as the force sensing element or at another location on the conduit fixation device. The force sensing element may communicate with the signal processing unit wirelessly or by wire. The force sensing element may be attached to or molded into the sensor portion 22, 40, 68, 82 of the conduit fixation device 10, 30, 50, 80.

[0108] Each of the signal processing units comprises at least one processor and is configured to receive a force signal representative of the force applied to the conduit fixation device 10, 30, 50, 80 from the force sensing element. Each of the signal processing units comprises at least one memory unit configured to store the force sensor data, one or more force magnitude thresholds, and one or more force duration thresholds. Each of the signal processing units comprises at least one transceiver that outputs the force sensor data to one or more computing devices, such as a device located in proximity to a patient using the conduit fixation device, a device located at a patient care facility, or a device located with one or more care personnel.

[0109] The force sensing element may continuously monitor the force applied to the conduit fixation device 10, 30, 50, 80 as a result of the force applied to the conduit and continuously generate a force signal representative of the force applied to the device. The force sensing element may continuously output the force signal to a signal processing unit. The signal processing unit may store the force signal and may push or report the force signal to one or more computing devices. The force signal may be continuously captured by one or more computing devices. The force signal may be continuously displayed by one or more computing devices.

[0110] The alarm of the conduit fixation devices 10, 30, 50, 80 may comprise an audible, visual or tactile alarm element configured to receive an alarm signal and generate an audible, visual or tactile alarm, respectively.

[0111] Referring to Figure 5, there is shown an embodiment of a conduit fixation device 120 attached to a patient's arm 122. The conduit fixation device 120 is of the type shown in Figures 2a and 2b. The conduit fixation device 120 includes an external attachment in the form of an adhesive strip 124 that attaches the device 120 to the patient's arm 122. It will be appreciated that the conduit fixation device embodiments shown in Figures 1, 3 and 4 may also be attached to a patient's arm.

[0112] Referring to Figure 6, there is shown an embodiment of a conduit fixation device 130 attached to a patient's torso 132. The conduit fixation device 130 is of the type shown in Figure 1. The conduit fixation device 130 includes an external attachment in the form of a band 134 which passes across the torso 132 and around the patient's shoulders to attach the device 130 to the patient's torso 132, as shown. It will be appreciated that the conduit fixation device embodiments shown in Figures 2, 3 and 4 may also be attached to the patient's torso.

[0113] Referring to Figure 7, there is shown one embodiment of a conduit fixation device 140 attached to a patient's shoulder 142. The conduit fixation device 140 is of the type shown in Figure 1. The conduit fixation device 140 includes external attachments in the form of a first band 144 and a second band 146 that pass over the patient's shoulder and under the patient's arm to attach the device 140 to the patient's shoulder 142, as shown. It will be appreciated that the conduit fixation device embodiments shown in Figures 2, 3 and 4 may also be attached to the patient's shoulder.

[0114] Referring to Figure 8, there is shown one embodiment of a conduit fixation device 150 attached to a patient's neck 152. The conduit fixation device 150 is of the type shown in Figure 1. The conduit fixation device 150 includes an external attachment portion in the form of an adhesive strip (not shown) below the device 150 that attaches the device 150 to the patient's neck 152. It will be appreciated that the conduit fixation device embodiments shown in Figures 2, 3 and 4 may also be attached to the patient's neck.

[0115] Referring to FIG. 9, a force sensor is shown comprising a strain sensor 200 configured to sense a strain force applied to a conduit fixation device, generate a strain signal representative of the strain force, determine when the strain signal meets at least one or more thresholds, and generate an alarm signal.

[0116] The strain sensor 200 processes the strain signal to determine when the strain signal meets at least a strain magnitude threshold and generates an alarm signal. The strain sensor may also process the strain signal to determine when the strain signal meets at least a strain magnitude threshold and at least a duration threshold and generate an alarm signal. If the conduit being secured is, for example, a fluid line for a patient, such a duration of force on the conduit securing device resulting from the force on the conduit may cause one or more of the fluid line conduits to become dislodged from the patient.

[0117] The strain sensor 200 comprises a strain sensing element 202 and a signal processing unit (not shown) in communication with the strain sensing element 202. The strain sensing element 202 senses a strain applied to the conduit fixation device, generates a strain signal representative of the strain, and outputs the strain signal to the signal processing unit. The signal processing unit determines when the strain signal meets at least one or more thresholds and generates an alarm signal.

[0118] The strain sensing element 202 includes a first strain gauge 204 and a second strain gauge 206. The strain gauges 204, 206 are disposed on opposite sides of a base 208 of the strain sensor 200. The base 208 is made of a sheet metal material that is hardened to retain a bridge-like shape. The base 208 may provide strain relief to protect the strain gauges 204, 206.

[0119] The strain gauges 204, 206 comprise a strain sensitive material that senses strain forces by changing the resistance of the material when the material is bent. The strain sensitive material may include, for example, a carbon impregnated polyethylene strain sensitive material. The carbon impregnated polyethylene strain sensitive material may include a Velostat (RTM) strain sensitive material. The Velostat (RTM) strain sensitive material may sense strain forces by changing the resistance of the material.

[0120] The strain sensing element 202 is attached to the sensor portion of the conduit fixation device which constitutes the central section of the support of the device. This central section of the device stretches visibly when a conduit fixed to the device is pulled. This stretches the strain gauges 204, 206, causing a change in the resistance of the gauges. This is detected as a strain force applied to the conduit fixation device and a strain signal representative of the strain force is generated.

[0121] The signal processing unit may be co-located with the strain sensing element 202 and housed within a housing. The housing further contains an alarm (not shown). The housing also contains a power source (not shown) for the strain sensing element 202, the signal processing unit, and the alarm.

[0122] The signal processing unit comprises an interface for the strain sensing element 202, which may consist of a Wheatstone bridge (not shown). The Wheatstone bridge may be connected to an ADC (not shown). This may be a dual channel 24-bit ADC with programmable gain etc. The ADC is connected to a control unit (not shown), such as a multipoint control unit, e.g. an Arduino Teensy 2.0 control unit, with the necessary inputs, outputs, power connectors etc. The signal processing unit 208 may for example be approximately 30 mm x 25 mm in size. The power source is a coin cell (not shown), e.g. a CR2032 coin cell.

[0123] 10, there is shown a force sensor comprising a pressure sensor 220 comprising a pressure sensing element 222 molded into a sensor portion 224 of a first strap 226 of the conduit fixation device, and a signal processing unit (not shown) attached to the support of the device. The pressure sensing element 222 comprises a strip of pressure sensitive material that senses pressure forces by changes in resistance of a material, in this embodiment a conductive fabric pressure sensitive material.

[0124] The sensor portion 224 of the first strap 226 is configured to loop around a region of the conduit when secured to the device. When a force is applied to the conduit, for example by pulling on the conduit, the first strap 226 elastically stretches or further elastically stretches to apply a pressure force to the first strap 226 and the pressure sensing element 222 attached to the first strap 226. The pressure sensing element 222 senses the pressure force, generates a pressure signal representative of the pressure force, and outputs the pressure signal to a signal processing unit. The signal processing unit is wirelessly connected to the pressure sensing element 222. The signal processing unit comprises at least one processor (not shown) that determines when the pressure signal meets at least one or more thresholds and generates an alarm signal.

[0125] The signal processing unit of the pressure sensor 220 may process the pressure signal to determine when the pressure signal meets at least a pressure magnitude threshold and generate an alarm signal. The signal processing unit may process the pressure signal to determine when the pressure signal meets at least a pressure magnitude threshold and at least a duration threshold and generate an alarm signal.

[0126] The signal processing unit communicates with the pressure sensor 220 and sends a signal to an alarm (not shown) configured to receive the alarm signal and generate an alarm. The alarm may be located within the signal processing unit.

[0127] Referring to FIG. 11, a force sensor is shown comprising a rotational sensor 270 configured to sense a rotational force applied to a first strap of a conduit fixation device, generate a rotational signal representative of the rotational force, determine when the rotational signal meets at least one or more threshold values, and generate an alarm signal.

[0128] The rotation sensor 270 processes the rotation signal to determine when the rotation signal meets at least a threshold rotation magnitude and generates an alarm signal. The strain sensor can also process the rotation signal to determine when the rotation signal meets at least a threshold rotation magnitude and at least a threshold duration and generate an alarm signal.

[0129] The rotation sensor 270 comprises a rotation sensing element 272 and a signal processing unit (not shown) in communication with the rotation sensing element 272. The rotation sensing element 272 senses a rotation applied to the first strap of the conduit fixation device, generates a rotation signal representative of the rotation, and outputs the rotation signal to the signal processing unit. The signal processing unit determines when the rotation signal meets at least one or more thresholds and generates an alarm signal.

[0130] The rotation sensing element 272 comprises a first plate 274 and a second plate 276. The first plate 274 is disposed on a support 278 of the conduit fixation device. The second plate 276 is attached to a first strap 280 of the device. The first plate 274 and the second plate 276 are made of conductive sheet material and together form a capacitor. When the conduit is pulled, the first strap 280 rotates, changing the amount of overlap area between the capacitor plates 274, 276, thereby generating a rotational signal representative of the rotational force applied to the strap 280.

[0131] The signal processing unit may be co-located with the rotational sensing element 272 and housed within a housing. The housing may further include an alarm (not shown). The housing may also include a power source (not shown) for the rotational sensing element 272, the signal processing unit, and the alarm.

[0132] While the present invention has been described in conjunction with the exemplary embodiments above, those skilled in the art can make various modifications, additions and variations to the present invention without departing from the scope of the claims.

Claims

1. A conduit fixing device, Support part and A first elastically stretchable strap comprising a portion connected to the support and configured to be attached around a first region of the conduit, At least one force sensor attached to the sensor portion of the conduit fixing device, the force sensor being used to detect the force applied to the conduit fixing device as a result of the force applied to the conduit, the force signal being used to generate a force signal representing the force applied to the conduit fixing device, the force signal being used to determine when one or more thresholds are met, and the force sensor being used to generate an alarm signal, An alarm device configured to communicate with the force sensor, receive the alarm signal, and issue an alarm, A conduit fixing device comprising the above features.

2. The conduit fixing device according to claim 1, wherein the force sensor comprises one or more of the strain force sensor, pressure force sensor, dynamic force sensor, and rotational force sensor.

3. The conduit fixing device according to claim 1 or 2, wherein the force sensor processes the force signal to determine when the force signal satisfies at least a magnitude threshold and generates an alarm signal.

4. The conduit fixing device according to claim 1 or 2, wherein the force sensor processes the force signal to determine when the force signal satisfies at least a magnitude threshold and at least a duration threshold, and generates an alarm signal.

5. The conduit fixing device according to claim 1 or 2, wherein the force sensor comprises a force sensing element and a signal processing unit that communicates with the force sensing element, the force sensing element senses a force applied to the conduit fixing device, generates a force signal representing the force, outputs the force signal to the signal processing unit, and the signal processing unit determines when the force signal satisfies at least one or more thresholds and generates an alarm signal.

6. The conduit fixing device according to claim 5, wherein the signal processing unit comprises at least one memory unit configured to store force sensor data including the magnitude of one or more force signals representing the force applied to the conduit fixing device, one or more time points in time when the force signal satisfies at least one threshold, one or more time points in time when an alarm signal is generated, the magnitude of the force signal satisfying at least one threshold, the duration of the force signal satisfying at least one threshold, one or more thresholds for the magnitude of the force, and one or more thresholds for the duration of the force.

7. The conduit fixing device according to claim 5, wherein the signal processing unit includes a transceiver that outputs force sensor data to one or more computing devices.

8. The conduit fixing device according to claim 1 or 2, further comprising: a strain sensor, the strain sensor configured to sense a strain force applied to the conduit fixing device, generate a strain signal representing the strain force, determine when the strain signal satisfies at least one or more thresholds, and generate an alarm signal.

9. The conduit fixing device according to claim 8, wherein the strain sensor comprises a strain sensing element, and the strain sensing element is attached to a sensor portion that constitutes the central area of ​​the support portion of the conduit fixing device.

10. The conduit fixing device according to claim 1 or 2, wherein the force sensor is a pressure sensor configured to sense the pressure force applied to the conduit fixing device, generate a pressure signal representing the pressure force, determine when the pressure signal satisfies at least one or more thresholds, and generate an alarm signal.

11. The pressure sensor comprises a pressure sensing element. The conduit fixing device according to claim 10, wherein the pressure sensing element is attached to a sensor portion of the conduit fixing device which constitutes part of the first strap configured to be mounted around a first region of the conduit, and / or is attached to a sensor portion of the conduit fixing device which constitutes part of one or more second straps configured to be mounted around a region of the conduit.

12. The conduit fixing device according to claim 1 or 2, wherein the force sensor is a rotational force sensor for sensing rotation caused by a force applied to one or more parts of the conduit fixing device, such as the first strap, when the conduit is pulled.

13. The conduit fixing device according to claim 1 or 2, wherein the force sensor is a dynamic force sensor configured to sense a dynamic force applied to the conduit fixing device, generate a dynamic force signal representing the dynamic force, determine when the dynamic force signal satisfies at least one or more thresholds, and generate an alarm signal.

14. The dynamic force sensor comprises a dynamic force sensing element including a piezoelectric material, The conduit fixing device according to claim 13, wherein the dynamic force sensing element is attached to a sensor portion of the conduit fixing device which constitutes part of one or more second straps configured to be attached around the area of ​​the conduit.

15. The conduit fixing device according to claim 1 or 2, wherein the force sensor comprises a telescopic sensor, a resistive telescopic sensor, and a conductive material attached to, printed on, or impregnated in a portion of the conduit fixing device.

16. The conduit fixation device according to claim 1 or 2, further comprising an accelerometer for measuring the general movement of a patient wearing the conduit fixation device.

17. The conduit fixing device according to claim 16, wherein one or more time points in time when an alarm signal is generated are correlated with one or more measurements from the accelerometer, and the patient's activity at one or more time points in time is identified in order to determine the cause of the alarm.

18. A medical system comprising a conduit fixing device according to claim 1 or 2, and at least one conduit fixed to the conduit fixing device.

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