US20100211032A1 - Aspiration system for removing urine discharged by the human body, and liquid sensor therefor - Google Patents
Aspiration system for removing urine discharged by the human body, and liquid sensor therefor Download PDFInfo
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- US20100211032A1 US20100211032A1 US12/738,322 US73832208A US2010211032A1 US 20100211032 A1 US20100211032 A1 US 20100211032A1 US 73832208 A US73832208 A US 73832208A US 2010211032 A1 US2010211032 A1 US 2010211032A1
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- aspiration system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
- A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
- A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/4404—Details or parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/73—Suction drainage systems comprising sensors or indicators for physical values
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
- A61M1/87—Details of the aspiration tip, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00365—Plasters use
- A61F2013/00536—Plasters use for draining or irrigating wounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0496—Urine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M2205/3386—Low level detectors
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- the present invention relates to an aspiration system for use in an aspiration system for removing liquids, discharged by the human body. Aspects of the invention are particularly directed to the problems of urine removal.
- Urinary management is of critical need in the acute and long term care settings. Urinary issues are generally grouped into two primary categories: failure to drain; and failure to contain. In the case of failure to drain, the patient cannot spontaneously drain urine from the bladder. The general solution to this problem is to catheterize the patient. In the case of failure to contain, the patient cannot contain the urine within their body until a convenient and expedient time. When patients are not conscious or cognizant, they are typically catheterized. Patients who are aware but non-ambulatory often utilize a manual collector for assistance, such as a bedpan, a male urinal, or an adult diaper. These can be cumbersome to use, and sometimes result in spills on or around the patient. Also, such manual collectors may require frequent changes, placing additional burden on caregivers. When it is desired to monitor the urine output, very often medical staff catheterize a patient even when catheterization is not otherwise required. Catheterization provides a means by which urine can be monitored more easily than with a manual collector.
- UTIs catheter-related urinary tract infections
- U.S. Pat. Nos. 5,002,541, 4,747,166 and 4,631,061 describe human urine aspiration systems.
- the urine aspiration systems include an electric pump for applying suction to a urinal.
- the urinal includes a liquid sensor for automatically activating the pump when the presence of liquid urine is detected.
- the three patents all describe liquid-contact sensors in the form of electrodes forming a normally open circuit that is closed by electrical conduction through liquid, when the sensor is contacted by liquid.
- the sensor is necessarily used in close proximity to the sensitive genital area, increasing the concerns of leakage of current that is applied by the electrodes.
- optical fibres are expensive items, and integrating these into the urinal or tubing increases the cost of the urinal or tubing, which are preferably disposable for hygiene reasons.
- electro-optic part is remote from the urinal, and has to be connected by delicate and expensive optical fibres, making the system delicate and expensive as a whole.
- FIG. 1 is a schematic block diagram of a first embodiment of aspiration system for collecting and removing liquid discharged by the human body.
- FIG. 2 is a schematic plan view of a pair of briefs as an overgarment.
- FIG. 3 is a schematic side view of a second embodiment showing an implementation of a capacitive, ultrasonic or piezo-electric non-contact liquid sensor.
- FIG. 4 is a schematic side view of a third embodiment showing an implementation of an electro-optic non-contact liquid sensor.
- FIG. 5 is a schematic side view of a fourth embodiment showing an implementation of a temperature, non-contact liquid sensor.
- an aspiration system 10 for removing body liquid discharged by the human body generally comprises an aspiration unit 12 and a body interface device 14 coupled to the aspiration unit 12 by means of a flexible conduit 16 .
- the flexible conduit 16 may be regarded as part of the aspiration unit 12 and/or part of the body interface device 14 .
- the body interface device 14 is configured for fitting to the body at, or around, the site of discharge of the body liquid desired to be collected.
- the body interface device 14 is preferably attachable to the body by means of an adhesive pad 15 that surrounds the site of discharge.
- the body interface device 14 is configured to fit at the genital region of a male or female wearer, or a surgical urostomy.
- the body interface device 14 is in the form of a snug-fitting urinal (as illustrated herein).
- the body interface device 14 is in the form of a male urinal or a condom (not illustrated).
- the body interface device 14 is in the form of a stoma fitment (not illustrated).
- the present embodiment is especially suitable for removing urine, since urine removal is most challenging in terms of the volume of the liquid to be removed and the speed of liquid discharge. This can distance the field of urine removal from other liquid collection systems.
- the speed of response of the aspiration system 10 to detect and remove the liquid is a significant factor in the ability of the aspiration system 10 to manage a urine discharge. Also, there are significant challenges in terms of cost versus hygiene of the aspiration system 10 .
- the aspiration system 10 includes a liquid sensor 18 for detecting the presence of liquid discharged by the body and collected at the body interface device 14 .
- the liquid sensor 18 is preferably a non-contact sensor that is able to detect the presence or proximity of liquid without contact with the liquid.
- the liquid sensor 18 generates an electrical output signal responsive to proximity of detected liquid.
- the electrical signal is communicated to the aspiration unit 12 by means of an electrical connector 20 .
- the electrical connector 20 may be integrated with, or separate from, the flexible conduit 16 .
- the electrical connector 20 also supplies power from the aspiration unit 12 to power the liquid sensor 18 .
- the feature of the liquid sensor 18 being a non-contact sensor provides significant advantages because: (i) the non-contact approach automatically avoids the concerns about passing an electrical current through the liquid in contact with the skin. Instead, there is no direct contact between the liquid sensor 18 and the liquid; (ii) the non-contact approach means that the liquid sensor 18 is not contaminated by touching the liquid. This allows the liquid sensor 18 easily to be reused with a different body interface device 14 ; and (iii) the non-contact approach means that the liquid sensor 18 does not itself have to be in a sterile condition before use, thus avoiding the difficulty of, or risk of damage when, sterilizing the aspiration system 10 that does interface intimately with the body.
- the feature of the liquid sensor 18 being coupled to the aspiration unit 12 by an electrical connector 20 avoids the expense and fragility associated with using an optical fiber connection.
- a preferred feature of the invention is that the liquid sensor 18 is separate from, or at least separable from, the body interface device 14 .
- the body interface device 14 is a disposable item that may be manufactured inexpensively, and disposed of after a single use, or a limited number of uses, according to the specific body interface device 14 .
- the liquid sensor 18 is more expensive, but is intended to be used plural times, preferably, with a sequence of different body interface devices 14 . This enables the aspiration system 10 to be produced and used very cost efficiently, since the disposable components are generally low cost. The higher cost components may be used multiple times, and may require infrequent replacement.
- the liquid sensor 18 is a universal device that may be used with any of a plurality of different types of body interface devices 14 , such as a female urinal, a male condom, a urostomy body fitment, or a catheter.
- the liquid sensor 18 can be permanently attached to the body interface device 14 .
- the liquid sensor 18 can take a variety of different forms.
- the liquid sensor 18 is selected from: a capacitance sensor; an ultrasonic sensor; and a piezo-electric (or piezo-resonant) sensor.
- a capacitance sensor detects proximity of liquid according to changes in the dielectric effect of liquid proximity, compared to air proximity. The dielectric effect affects the electric field in the active zone around the sensor, and thus, the effective capacitance in the sensor.
- the capacitance is monitored by any suitable capacitance sensing circuit (not shown), such as an RC oscillator whose oscillation frequency and/or whether oscillation occurs, is dependent on the value of a resistor in combination with the effective capacitance of the sensor.
- the oscillation in turn triggers an output stage, coupled to an output amplifier, to generate an output signal indicative of liquid presence.
- the capacitance sensing circuit is preferably disposed near or at the liquid sensor 18 (e.g., as part of the liquid sensor 18 itself), or the capacitance sensing circuit can be disposed at the aspiration unit 12 , or at a point along electrical connector 20 .
- a suitable capacitance sensor and capacitance sensing circuit are described in U.S. Pat. No. 5,576,619, the contents of which are hereby incorporated by reference.
- the invention has been tested using a capacitance “smart” sensor from SIE Sensors.
- the sensor of dimension 35 mm (length) ⁇ 22 mm (width) ⁇ 10 mm (height) was affixed to the external wall of a body interface device 14 .
- the sensor detected the presence of two test liquids, water and saline solution, as soon as the liquid was introduced, and provided an activation signal to the aspiration unit 12 within milliseconds.
- the electric field from the sensor is able to penetrate a wide variety of plastic components (e.g., polyethylene (PE), polypropylene (PP) and acrylics), either transparent or opaque, with great sensitivity.
- An ultrasonic sensor works using the principle of sonar at the ultrasonic frequency range.
- a transducer is resonated at a set frequency to convert electric energy into ultrasonic frequency range acoustic energy.
- the ultrasonic acoustic waves are emitted towards a liquid collection region.
- Energy is reflected either from the walls if the region is empty of liquid, or from liquid if present in the region.
- An example of ultrasonic liquid sensor is described in U.S. Pat. No. 3,960,007, the content of which is incorporated herein by reference.
- a commercially available ultrasonic sensor is made available by ZEVEX Inc.
- a piezo-electric or piezo-resonant sensor also uses high frequency, e.g., ultrasonic energy or acoustic signal, in a similar way to the ultrasonic sensor described above.
- the ultrasonic or acoustic signal could penetrate either transparent or opaque plastic walls.
- An example of piezo-electric sensor is described in U.S. Pat. No. 3,948,098, the content of which is incorporated herein by reference.
- the invention has been tested with a piezo-resonant sensor obtained from GEMS Sensors.
- the sensor of diameter 40 mm was attached to the external wall of the body interface device 14 , and detected the presence of liquid as soon as introduced.
- the liquid sensor 18 is disposed outside the body interface device 14 , or at least outside a liquid collection region 14 a of the body interface device 14 .
- the body interface device 14 is typically made of plastics, through which the sensing electric field can pass in the case of a capacitance sensor, or through which an ultrasonic vibration can pass in the case of an ultrasonic and/or piezo-electric sensor.
- the wall of the body interface device 14 is made suitably thin to provide the sensor with the desired sensitivity to liquid within the body interface device.
- the body interface device 14 may include a window portion made of material through which the electric field or ultrasonic vibration can pass easily if the entire body interface device 14 is not made of such a material.
- FIG. 1 the alternative embodiment illustrated in FIG.
- the housing of the body interface device 14 can be shaped into a pocket 26 , with or without membrane 24 , for receiving and retaining a capacitive, ultrasonic or piezo-electric non-contact liquid sensor 18 .
- Such a design also increases the interface area between the sensor 18 and the liquid collection region 14 a of the body interface device 14 .
- the body interface device 14 is configured for use with an electro-optical sensor.
- the body interface device 14 comprises a window region 22 made of material that is transparent to the optical radiation used by the electro-optical sensor.
- the optical radiation may be in the infra-red range, and/or the visible range, and/or ultra-violet range.
- the term “optical” as used herein means that the radiation lies in a frequency range that obeys substantially the laws of optics.
- the electro-optical sensor comprises an electro-optical emitter, an electro-optical receiver, and sensing circuitry for detecting the presence of liquid according to the electrical output of the electro-optical receiver.
- the sensing circuitry is preferably disposed at the liquid sensor 18 (e.g., as part of the liquid sensor 18 ), or the sensing circuitry is disposed at the aspiration unit 12 , or at a point along electrical connector 20 .
- An example electro-optical liquid sensor is described in U.S. Pat. No. 4,354,180, the content of which is incorporated herein by reference.
- the body interface device 14 is configured for use with a temperature sensor as the liquid sensor 18 .
- the body interface device 14 comprises a liquid impermeable membrane 24 for allowing the temperature sensor 18 to be exposed to an increase in temperature should liquid discharged by the body (in the current case, urine) come into contact with the membrane 24 .
- the membrane 24 prevents the sensor 18 from coming into physical contact with the liquid.
- the membrane 24 may be made of a heat conductive material, or it may be made of other material that is thin enough (e.g., a film) so as not to provide substantial heat insulation.
- a temperature sensor 18 can provide a reliable and quick indication of body liquid exiting the body, without requiring the sensor to be dispersed over a large area.
- the presence of liquid may be detected by detecting (i) a rapid change in temperature, such as an increase of 1° C. within two seconds and/or (ii) a temperature rise above a threshold, such as above 36° C.
- the membrane 24 is shaped like a sock defining a pocket 26 for receiving and retaining the sensor 18 .
- a design also increases the interface area between the sensor 18 and the liquid collection region 14 a of the body interface device 14 .
- the membrane 24 could be a simple window in the wall of the body interface device 14 , similar to the window 22 , if desired.
- FIGS. 3-5 may be intermixed, or used with different liquid sensors, as desired.
- the liquid sensor 18 is separate from, or at least separable from, the body interface device 14 .
- the liquid sensor 18 may be held in an operative position with respect to the body interface device 14 by a variety of possible arrangements:
- a detachable attachment device may be used for releasably attaching the liquid sensor 18 to the body interface device 14 .
- the detachable attachment device could comprise a peelable adhesive, or a peelable mechanical fastener, such as Velcro, or a mechanical coupling based on interference fitting, or other mechanical means.
- the senor could be held in position permanently using a an adhesive, or a mechanical coupling.
- the liquid sensor 18 may be held in the operative position by an overgarment ( FIG. 2 ), such as a pair of briefs 30 .
- the briefs 30 include a retainer 32 for retaining the liquid sensor 18 in position.
- the retainer 32 comprises, for example, a detachable attachment device for attaching the liquid sensor 18 to the briefs 30 , or a pocket or sling for receiving the liquid sensor 18 .
- the briefs 30 might not include a dedicated retainer, but may instead embrace the body interface device 14 to hold the liquid sensor 18 in a recess 26 of the body interface device 14 ( FIG. 5 ).
- the aspiration unit 12 comprises a power supply 40 , an electronic control unit 42 , and a suction source 44 .
- the power supply 40 is selected as one or more of: a replaceable battery, a rechargeable battery, radiation collection panels, and a mains power supply.
- the power supply 40 includes a combination of a rechargeable battery and a mains power supply; such a combination allows portable operation when the aspiration system 10 is not connected to a mains power supply, as well as automatic recharging of the battery when the aspiration system 10 is coupled to a mains power supply.
- the power supply 40 includes radiation collection panels, such as photovoltaic panels or cells for generating electricity from ambient light, which can improve autonomy of operation or for charging the rechargeable battery.
- the power supply 40 provides power for the electronic control unit 42 , the liquid sensor 18 (if needed), and any power needed by the suction source 44 .
- the electric control unit 42 and the liquid sensor 18 could have a separate power supply from the suction source 44 .
- the suction source 44 is an electric pump 44 a that operates under control of the electronic control unit 42 , responsive to detection of liquid by the liquid sensor 18 .
- the pump 44 a could be a suction device based on diaphragm, peristaltic, volume displacement, spring, gravity, siphon, heat-recoverable metal drive, or an in-line pump.
- the flexible conduit 16 is coupled through the pump 44 a to a liquid collection chamber 46 .
- the liquid collection chamber 46 may either be separate from the aspiration unit 12 and coupled thereto with a suitable connector, or the liquid collection chamber 46 may be integral with and/or housed in the aspiration unit 12 .
- the control unit 42 controls the pump 44 a in a quiescent state. Either the pump 44 a is deactivated to generate no suction, or the pump 44 a is operated periodically or at a slow speed to produce low suction (which may encourage the body interface device 14 to hug against the skin, and produce a better seal against the skin).
- the control unit 42 activates the pump 44 a to generate suction through the flexible conduit 16 to draw the liquid from the body interface device 14 into the liquid collection chamber 46 .
- the control unit 42 may operate the pump 44 a for as long as liquid continues to be detected by the liquid sensor 18 , or for a predetermined time interval after liquid detection has finished. Once collected by the liquid collection chamber 46 , the volume of liquid output may be measured, or the liquid may be inspected visually, or sent for biochemical testing or analysis.
- the suction source 44 may comprise a vacuum chamber charged with a low pressure vacuum, and an electronically controlled valve for controlling application of suction from the vacuum chamber to the flexible conduit 16 .
- a pump may be provided for charging the vacuum chamber with the vacuum.
- the liquid sensor 18 When it is desired to replace the body interface device 14 , either for the same patient or for fitting to a new patient, the liquid sensor 18 is separated from a current body interface device 14 and/or briefs 30 .
- the current body interface device 14 and/or briefs 30 are disposed of, and the same liquid sensor 18 is available to be used with a replacement body interface device 14 and/or replacement briefs 30 .
- a quick connector along electrical connector 20 and flexible conduit 16 is equipped to allow for the replacement of body interface device 14 .
- the aspiration system 10 as described herein provides significant advantages compared to the prior art, and can address or mitigate many of the drawbacks of the prior art, especially in terms of efficient detection of liquid without electrical contact with the body liquid.
- the aspiration system 10 is also extremely versatile, and a single aspiration system 10 or different embodiments can have a wide variety of applications.
- the invention is usable in acute care, home care, and long term care situations or facilities.
- the invention is usable with wheelchairs, and with bed-bound patients, as well as being able to be implemented as a fully portable device.
- the invention enables the aspiration system 10 to be discrete, thereby preserving the patient's dignity and privacy.
- the invention may also be used with catheters, either for detecting liquid (urine) presence in a catheter, or for collecting urine from a short catheter that projects a short distance from the body into the body interface device 14 . While the invention as described is especially suitable for removing urine, the invention may find use for removal of other body fluids and secretions.
Abstract
Description
- The present invention relates to an aspiration system for use in an aspiration system for removing liquids, discharged by the human body. Aspects of the invention are particularly directed to the problems of urine removal.
- Urinary management is of critical need in the acute and long term care settings. Urinary issues are generally grouped into two primary categories: failure to drain; and failure to contain. In the case of failure to drain, the patient cannot spontaneously drain urine from the bladder. The general solution to this problem is to catheterize the patient. In the case of failure to contain, the patient cannot contain the urine within their body until a convenient and expedient time. When patients are not conscious or cognizant, they are typically catheterized. Patients who are aware but non-ambulatory often utilize a manual collector for assistance, such as a bedpan, a male urinal, or an adult diaper. These can be cumbersome to use, and sometimes result in spills on or around the patient. Also, such manual collectors may require frequent changes, placing additional burden on caregivers. When it is desired to monitor the urine output, very often medical staff catheterize a patient even when catheterization is not otherwise required. Catheterization provides a means by which urine can be monitored more easily than with a manual collector.
- There is a growing problem with nosocomial infections and a high incidence of catheter-related urinary tract infections (UTIs). Catheter associated UTI is the most common nosocomial infection in hospitals and nursing homes, accounting for up to 40% of all institutionally acquired infections, or more than 1 million infections in US hospitals each year. There is considerable pressure on the healthcare and nursing profession to reduce such infection.
- U.S. Pat. Nos. 5,002,541, 4,747,166 and 4,631,061 describe human urine aspiration systems. The urine aspiration systems include an electric pump for applying suction to a urinal. The urinal includes a liquid sensor for automatically activating the pump when the presence of liquid urine is detected. The three patents all describe liquid-contact sensors in the form of electrodes forming a normally open circuit that is closed by electrical conduction through liquid, when the sensor is contacted by liquid. However, there are obvious concerns about the possibility of electrical current leaking from the electrodes, through the conductive urine, to the skin. Moreover, the sensor is necessarily used in close proximity to the sensitive genital area, increasing the concerns of leakage of current that is applied by the electrodes.
- The last mentioned patent, U.S. Pat. No. 4,631,061, also suggests the possibility of using at least one pair of optical elements, formed by opposed optical fibres integrated into the liquid passage of the urinal or collection tube to sense the liquid. This is said to avoid electrical currents applied to the urinal. However, the design is very expensive and impractical commercially. It requires at least one pair of optical elements that are optically aligned in a pad with a beam of light passing between the pair of optical elements to sense the presence of liquid. It also needs an optically transparent window to allow the beam of light to pass through. Any residues or moisture condensation could easily cloud the window and falsely trigger the pump to turn on. The optical fibres are expensive items, and integrating these into the urinal or tubing increases the cost of the urinal or tubing, which are preferably disposable for hygiene reasons. Moreover, the electro-optic part is remote from the urinal, and has to be connected by delicate and expensive optical fibres, making the system delicate and expensive as a whole.
- It would be desirable to improve on prior art designs of aspirated liquid removal systems, especially in terms of urine detection, in order to satisfy commercial need and improve customer acceptance.
-
FIG. 1 is a schematic block diagram of a first embodiment of aspiration system for collecting and removing liquid discharged by the human body. -
FIG. 2 is a schematic plan view of a pair of briefs as an overgarment. -
FIG. 3 is a schematic side view of a second embodiment showing an implementation of a capacitive, ultrasonic or piezo-electric non-contact liquid sensor. -
FIG. 4 is a schematic side view of a third embodiment showing an implementation of an electro-optic non-contact liquid sensor. -
FIG. 5 is a schematic side view of a fourth embodiment showing an implementation of a temperature, non-contact liquid sensor. - Preferred embodiments of the invention are now described with reference to the drawings. The same reference numerals are used to depict the same or equivalent features in each embodiment.
- Referring to
FIG. 1 , anaspiration system 10 for removing body liquid discharged by the human body generally comprises anaspiration unit 12 and abody interface device 14 coupled to theaspiration unit 12 by means of aflexible conduit 16. Theflexible conduit 16 may be regarded as part of theaspiration unit 12 and/or part of thebody interface device 14. Thebody interface device 14 is configured for fitting to the body at, or around, the site of discharge of the body liquid desired to be collected. Thebody interface device 14 is preferably attachable to the body by means of anadhesive pad 15 that surrounds the site of discharge. - In the case of urine removal, the
body interface device 14 is configured to fit at the genital region of a male or female wearer, or a surgical urostomy. For females, thebody interface device 14 is in the form of a snug-fitting urinal (as illustrated herein). For males, thebody interface device 14 is in the form of a male urinal or a condom (not illustrated). For urostomates, thebody interface device 14 is in the form of a stoma fitment (not illustrated). The present embodiment is especially suitable for removing urine, since urine removal is most challenging in terms of the volume of the liquid to be removed and the speed of liquid discharge. This can distance the field of urine removal from other liquid collection systems. The speed of response of theaspiration system 10 to detect and remove the liquid is a significant factor in the ability of theaspiration system 10 to manage a urine discharge. Also, there are significant challenges in terms of cost versus hygiene of theaspiration system 10. - The
aspiration system 10 includes aliquid sensor 18 for detecting the presence of liquid discharged by the body and collected at thebody interface device 14. Theliquid sensor 18 is preferably a non-contact sensor that is able to detect the presence or proximity of liquid without contact with the liquid. Theliquid sensor 18 generates an electrical output signal responsive to proximity of detected liquid. The electrical signal is communicated to theaspiration unit 12 by means of anelectrical connector 20. Theelectrical connector 20 may be integrated with, or separate from, theflexible conduit 16. Theelectrical connector 20 also supplies power from theaspiration unit 12 to power theliquid sensor 18. - The feature of the
liquid sensor 18 being a non-contact sensor provides significant advantages because: (i) the non-contact approach automatically avoids the concerns about passing an electrical current through the liquid in contact with the skin. Instead, there is no direct contact between theliquid sensor 18 and the liquid; (ii) the non-contact approach means that theliquid sensor 18 is not contaminated by touching the liquid. This allows theliquid sensor 18 easily to be reused with a differentbody interface device 14; and (iii) the non-contact approach means that theliquid sensor 18 does not itself have to be in a sterile condition before use, thus avoiding the difficulty of, or risk of damage when, sterilizing theaspiration system 10 that does interface intimately with the body. The feature of theliquid sensor 18 being coupled to theaspiration unit 12 by anelectrical connector 20 avoids the expense and fragility associated with using an optical fiber connection. - A preferred feature of the invention is that the
liquid sensor 18 is separate from, or at least separable from, thebody interface device 14. Thebody interface device 14 is a disposable item that may be manufactured inexpensively, and disposed of after a single use, or a limited number of uses, according to the specificbody interface device 14. Theliquid sensor 18 is more expensive, but is intended to be used plural times, preferably, with a sequence of differentbody interface devices 14. This enables theaspiration system 10 to be produced and used very cost efficiently, since the disposable components are generally low cost. The higher cost components may be used multiple times, and may require infrequent replacement. In one form, theliquid sensor 18 is a universal device that may be used with any of a plurality of different types ofbody interface devices 14, such as a female urinal, a male condom, a urostomy body fitment, or a catheter. Optionally, theliquid sensor 18 can be permanently attached to thebody interface device 14. - The
liquid sensor 18 can take a variety of different forms. - In the embodiment illustrated in
FIG. 3 , theliquid sensor 18 is selected from: a capacitance sensor; an ultrasonic sensor; and a piezo-electric (or piezo-resonant) sensor. A capacitance sensor detects proximity of liquid according to changes in the dielectric effect of liquid proximity, compared to air proximity. The dielectric effect affects the electric field in the active zone around the sensor, and thus, the effective capacitance in the sensor. The capacitance is monitored by any suitable capacitance sensing circuit (not shown), such as an RC oscillator whose oscillation frequency and/or whether oscillation occurs, is dependent on the value of a resistor in combination with the effective capacitance of the sensor. The oscillation in turn triggers an output stage, coupled to an output amplifier, to generate an output signal indicative of liquid presence. The capacitance sensing circuit is preferably disposed near or at the liquid sensor 18 (e.g., as part of theliquid sensor 18 itself), or the capacitance sensing circuit can be disposed at theaspiration unit 12, or at a point alongelectrical connector 20. A suitable capacitance sensor and capacitance sensing circuit are described in U.S. Pat. No. 5,576,619, the contents of which are hereby incorporated by reference. - The invention has been tested using a capacitance “smart” sensor from SIE Sensors. The sensor of dimension 35 mm (length)×22 mm (width)×10 mm (height) was affixed to the external wall of a
body interface device 14. The sensor detected the presence of two test liquids, water and saline solution, as soon as the liquid was introduced, and provided an activation signal to theaspiration unit 12 within milliseconds. The electric field from the sensor is able to penetrate a wide variety of plastic components (e.g., polyethylene (PE), polypropylene (PP) and acrylics), either transparent or opaque, with great sensitivity. - An ultrasonic sensor works using the principle of sonar at the ultrasonic frequency range. A transducer is resonated at a set frequency to convert electric energy into ultrasonic frequency range acoustic energy. The ultrasonic acoustic waves are emitted towards a liquid collection region. Energy is reflected either from the walls if the region is empty of liquid, or from liquid if present in the region. By measuring the time delay for reflected waves to arrive, and comparing this to one or more pre-calibrated time delays taken when the liquid collection region is empty, the presence of liquid can be reliably and quickly detected. An example of ultrasonic liquid sensor is described in U.S. Pat. No. 3,960,007, the content of which is incorporated herein by reference. A commercially available ultrasonic sensor is made available by ZEVEX Inc.
- A piezo-electric or piezo-resonant sensor also uses high frequency, e.g., ultrasonic energy or acoustic signal, in a similar way to the ultrasonic sensor described above. The ultrasonic or acoustic signal could penetrate either transparent or opaque plastic walls. An example of piezo-electric sensor is described in U.S. Pat. No. 3,948,098, the content of which is incorporated herein by reference.
- The invention has been tested with a piezo-resonant sensor obtained from GEMS Sensors. The sensor of
diameter 40 mm was attached to the external wall of thebody interface device 14, and detected the presence of liquid as soon as introduced. - With the arrangement illustrated in
FIG. 3 , theliquid sensor 18 is disposed outside thebody interface device 14, or at least outside aliquid collection region 14 a of thebody interface device 14. Thebody interface device 14 is typically made of plastics, through which the sensing electric field can pass in the case of a capacitance sensor, or through which an ultrasonic vibration can pass in the case of an ultrasonic and/or piezo-electric sensor. The wall of thebody interface device 14 is made suitably thin to provide the sensor with the desired sensitivity to liquid within the body interface device. Alternatively, thebody interface device 14 may include a window portion made of material through which the electric field or ultrasonic vibration can pass easily if the entirebody interface device 14 is not made of such a material. In the alternative embodiment illustrated inFIG. 5 , the housing of thebody interface device 14 can be shaped into apocket 26, with or withoutmembrane 24, for receiving and retaining a capacitive, ultrasonic or piezo-electric non-contactliquid sensor 18. Such a design also increases the interface area between thesensor 18 and theliquid collection region 14 a of thebody interface device 14. - In the alternative embodiment illustrated in
FIG. 4 , thebody interface device 14 is configured for use with an electro-optical sensor. Thebody interface device 14 comprises awindow region 22 made of material that is transparent to the optical radiation used by the electro-optical sensor. For example, the optical radiation may be in the infra-red range, and/or the visible range, and/or ultra-violet range. The term “optical” as used herein means that the radiation lies in a frequency range that obeys substantially the laws of optics. The electro-optical sensor comprises an electro-optical emitter, an electro-optical receiver, and sensing circuitry for detecting the presence of liquid according to the electrical output of the electro-optical receiver. The sensing circuitry is preferably disposed at the liquid sensor 18 (e.g., as part of the liquid sensor 18), or the sensing circuitry is disposed at theaspiration unit 12, or at a point alongelectrical connector 20. An example electro-optical liquid sensor is described in U.S. Pat. No. 4,354,180, the content of which is incorporated herein by reference. - In the further alternative embodiment illustrated in
FIG. 5 , thebody interface device 14 is configured for use with a temperature sensor as theliquid sensor 18. Thebody interface device 14 comprises a liquidimpermeable membrane 24 for allowing thetemperature sensor 18 to be exposed to an increase in temperature should liquid discharged by the body (in the current case, urine) come into contact with themembrane 24. At the same time, themembrane 24 prevents thesensor 18 from coming into physical contact with the liquid. Themembrane 24 may be made of a heat conductive material, or it may be made of other material that is thin enough (e.g., a film) so as not to provide substantial heat insulation. The use of atemperature sensor 18 can provide a reliable and quick indication of body liquid exiting the body, without requiring the sensor to be dispersed over a large area. Liquid, such as urine, exits the body at a temperature of about 37° C., which is notably higher than ambient room temperature (typically about 23° C.), and also higher than the ambient temperature of a sensor positioned close to the human skin (typically about 32° C.). - The presence of liquid may be detected by detecting (i) a rapid change in temperature, such as an increase of 1° C. within two seconds and/or (ii) a temperature rise above a threshold, such as above 36° C.
- In the present embodiment, the
membrane 24 is shaped like a sock defining apocket 26 for receiving and retaining thesensor 18. Such a design also increases the interface area between thesensor 18 and theliquid collection region 14 a of thebody interface device 14. However, themembrane 24 could be a simple window in the wall of thebody interface device 14, similar to thewindow 22, if desired. - It will be appreciated that the different configurations illustrated in
FIGS. 3-5 may be intermixed, or used with different liquid sensors, as desired. - In all of the preceding embodiments, the
liquid sensor 18 is separate from, or at least separable from, thebody interface device 14. Theliquid sensor 18 may be held in an operative position with respect to thebody interface device 14 by a variety of possible arrangements: - (a) In one form, a detachable attachment device (not shown) may be used for releasably attaching the
liquid sensor 18 to thebody interface device 14. For example, the detachable attachment device could comprise a peelable adhesive, or a peelable mechanical fastener, such as Velcro, or a mechanical coupling based on interference fitting, or other mechanical means. - (b) In another form, the sensor could be held in position permanently using a an adhesive, or a mechanical coupling.
- (c) In another form, the
liquid sensor 18 may be held in the operative position by an overgarment (FIG. 2 ), such as a pair ofbriefs 30. In the illustrated form, thebriefs 30 include aretainer 32 for retaining theliquid sensor 18 in position. Theretainer 32 comprises, for example, a detachable attachment device for attaching theliquid sensor 18 to thebriefs 30, or a pocket or sling for receiving theliquid sensor 18. In an alternative form, thebriefs 30 might not include a dedicated retainer, but may instead embrace thebody interface device 14 to hold theliquid sensor 18 in arecess 26 of the body interface device 14 (FIG. 5 ). - The
aspiration unit 12 comprises apower supply 40, anelectronic control unit 42, and asuction source 44. Thepower supply 40 is selected as one or more of: a replaceable battery, a rechargeable battery, radiation collection panels, and a mains power supply. Preferably, thepower supply 40 includes a combination of a rechargeable battery and a mains power supply; such a combination allows portable operation when theaspiration system 10 is not connected to a mains power supply, as well as automatic recharging of the battery when theaspiration system 10 is coupled to a mains power supply. Additionally or alternatively, thepower supply 40 includes radiation collection panels, such as photovoltaic panels or cells for generating electricity from ambient light, which can improve autonomy of operation or for charging the rechargeable battery. Thepower supply 40 provides power for theelectronic control unit 42, the liquid sensor 18 (if needed), and any power needed by thesuction source 44. Theelectric control unit 42 and theliquid sensor 18 could have a separate power supply from thesuction source 44. In the present embodiment, thesuction source 44 is anelectric pump 44 a that operates under control of theelectronic control unit 42, responsive to detection of liquid by theliquid sensor 18. Thepump 44 a could be a suction device based on diaphragm, peristaltic, volume displacement, spring, gravity, siphon, heat-recoverable metal drive, or an in-line pump. Theflexible conduit 16 is coupled through thepump 44 a to aliquid collection chamber 46. Theliquid collection chamber 46 may either be separate from theaspiration unit 12 and coupled thereto with a suitable connector, or theliquid collection chamber 46 may be integral with and/or housed in theaspiration unit 12. - When the
liquid sensor 18 indicates that no liquid is detected, thecontrol unit 42 controls thepump 44 a in a quiescent state. Either thepump 44 a is deactivated to generate no suction, or thepump 44 a is operated periodically or at a slow speed to produce low suction (which may encourage thebody interface device 14 to hug against the skin, and produce a better seal against the skin). - When the
liquid sensor 18 detects the presence of discharged liquid, thecontrol unit 42 activates thepump 44 a to generate suction through theflexible conduit 16 to draw the liquid from thebody interface device 14 into theliquid collection chamber 46. Thecontrol unit 42 may operate thepump 44 a for as long as liquid continues to be detected by theliquid sensor 18, or for a predetermined time interval after liquid detection has finished. Once collected by theliquid collection chamber 46, the volume of liquid output may be measured, or the liquid may be inspected visually, or sent for biochemical testing or analysis. - In an alternative form, instead of a
pump 44 a directly applying suction to theflexible conduit 16, thesuction source 44 may comprise a vacuum chamber charged with a low pressure vacuum, and an electronically controlled valve for controlling application of suction from the vacuum chamber to theflexible conduit 16. A pump may be provided for charging the vacuum chamber with the vacuum. - When it is desired to replace the
body interface device 14, either for the same patient or for fitting to a new patient, theliquid sensor 18 is separated from a currentbody interface device 14 and/orbriefs 30. The currentbody interface device 14 and/orbriefs 30 are disposed of, and thesame liquid sensor 18 is available to be used with a replacementbody interface device 14 and/orreplacement briefs 30. In the case where the non-contact liquid sensor is permanently attached to thebody interface device 14, a quick connector alongelectrical connector 20 andflexible conduit 16 is equipped to allow for the replacement ofbody interface device 14. - It will be appreciated that the
aspiration system 10 as described herein provides significant advantages compared to the prior art, and can address or mitigate many of the drawbacks of the prior art, especially in terms of efficient detection of liquid without electrical contact with the body liquid. The disposability of the body interface device, and reusability of theliquid sensor 18 without contact with the discharged liquid, make theaspiration system 10 very hygienic and cost efficient. Theaspiration system 10 is also extremely versatile, and asingle aspiration system 10 or different embodiments can have a wide variety of applications. For example, the invention is usable in acute care, home care, and long term care situations or facilities. The invention is usable with wheelchairs, and with bed-bound patients, as well as being able to be implemented as a fully portable device. The invention enables theaspiration system 10 to be discrete, thereby preserving the patient's dignity and privacy. The invention may also be used with catheters, either for detecting liquid (urine) presence in a catheter, or for collecting urine from a short catheter that projects a short distance from the body into thebody interface device 14. While the invention as described is especially suitable for removing urine, the invention may find use for removal of other body fluids and secretions. - Many modifications, improvements and equivalents to the present invention may be made without departing from the spirit and/or scope of the invention as claimed.
Claims (31)
Priority Applications (1)
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US12/738,322 US20100211032A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing urine discharged by the human body, and liquid sensor therefor |
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US98090807P | 2007-10-18 | 2007-10-18 | |
PCT/US2008/080503 WO2009052496A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing liquid discharged by the human body, and liquid sensor therefor |
US12/738,322 US20100211032A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing urine discharged by the human body, and liquid sensor therefor |
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US12/738,332 Abandoned US20100211029A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing liquid other than urine discharged by the human body |
US12/738,322 Abandoned US20100211032A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing urine discharged by the human body, and liquid sensor therefor |
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US12/738,332 Abandoned US20100211029A1 (en) | 2007-10-18 | 2008-10-20 | Aspiration system for removing liquid other than urine discharged by the human body |
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