WO2006002313A1 - Dispositif et techniques d'evaluation de pressions de cavite anatomique - Google Patents

Dispositif et techniques d'evaluation de pressions de cavite anatomique Download PDF

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Publication number
WO2006002313A1
WO2006002313A1 PCT/US2005/022258 US2005022258W WO2006002313A1 WO 2006002313 A1 WO2006002313 A1 WO 2006002313A1 US 2005022258 W US2005022258 W US 2005022258W WO 2006002313 A1 WO2006002313 A1 WO 2006002313A1
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WO
WIPO (PCT)
Prior art keywords
pressure
pressure sensor
pressure sensors
sleeve
flexible material
Prior art date
Application number
PCT/US2005/022258
Other languages
English (en)
Inventor
Adil E. Bharucha
Original Assignee
Mayo Foundation For Medical Education And Research
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mayo Foundation For Medical Education And Research filed Critical Mayo Foundation For Medical Education And Research
Publication of WO2006002313A1 publication Critical patent/WO2006002313A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A61B5/6806—Gloves

Definitions

  • the present invention relates to the assessment of pressure within a body cavity. More particularly, the present invention relates to devices and methods for objective assessment of body cavity pressures (such as, e.g., anorectal pressures).
  • the anal canal is responsible for maintaining continence, i.e., preventing stool from leaking under normal circumstances.
  • the anal canal is surrounded by sphincters made of muscles that are responsible for keeping the canal closed at rest. The sphincters are also preferably capable of contracting further to maintain continence when defecation is inconvenient.
  • anal pressures may be reduced due to disease, injury, etc.
  • anal pressures may be increased causing constipation.
  • Anal pressures may be subjectively assessed by practitioners using a finger or digit inserted into the anal canal of the patient. The subjective nature of such assessments may, however, lead to inconsistent diagnoses, particularly with less-experienced practitioners.
  • Systems for the objective measurement of anorectal pressures have been developed. Anal pressures are measured in such systems use solid-state or water-perfused sensors attached to a catheter inserted in the anal canal. The testing must typically be conducted with the assistance of specially-trained technicians, require 30 to 45 minutes to complete and can be costly, e.g., $350 to $1000. Those factors effectively preclude the use of the tests in pharmaceutical trials, epidemiological studies, etc. where the objective results would be useful.
  • the present invention provides a pressure measurement devices and methods that can be used to obtain objective pressure measurements using one or more pressure sensors that, in some embodiments, are mounted on a sleeve that has a generally cylindrical shape adapted to fit over one or more of a practitioner's digits (i.e., fingers) or a cylindrical device such as, e.g., a catheter, endoscope, etc.
  • the one or more pressure sensors may be mounted on a cylindrical body, e.g., a catheter, endoscope, etc., that is adapted for insertion into the anal canal of a patient.
  • the pressure sensors may preferably be adapted to connect or be connected to a system capable of providing objective pressure measurements.
  • the sleeves on which the pressure sensors are mounted form a finger or digit connected to a glove.
  • Providing two or more pressure sensors in an annular ring may provide the ability, as described herein, to obtain pressures in different sectors about the longitudinal axis of the sleeve/body.
  • the pressure sensors on sleeves or cylindrical bodies of the present invention may be arranged to measure pressures at more than one location along the length or longitudinal axis of the sleeve/body (in place of or in addition to using pressure sensors arranged in an annular ring at one location along the longitudinal axis).
  • Such an arrangement may be useful for measuring pressure at different locations along, e.g., the length of a sphincter muscle (or other anatomical feature) without requiring any repositioning of the sleeve/body during data acquisition.
  • the sleeve forms part of a glove, it may be preferred that at least one of the pressure sensors be located on an anterior surface of the sleeve, such that the pressure sensor is located proximate the anterior surface of a practitioner's digit when that digit is located within the glove.
  • the present invention provides a pressure detection device that includes a glove having a body and one or more finger sleeves extending from the body, wherein each finger sleeve of the one or more finger sleeves has a generally cylindrical surface defining a longitudinal axis, a distal end, and a proximal end, wherein the body and the one or more finger sleeves are constructed of a flexible material; a pressure sensor mounted on at least one of the one or more finger sleeves; and one or more leads attached to the pressure sensor, the one or more leads extending from the pressure sensor in the proximal direction.
  • the present invention provides a digital pressure detection device that includes a finger sleeve having a generally cylindrical surface defining a longitudinal axis, a distal end, and a proximal end, wherein the finger sleeve is constructed of a flexible material; a pressure sensor mounted on the finger sleeve; and one or more leads attached to the pressure sensor, the one or more leads extending from the pressure sensor in the proximal direction.
  • the present invention provides a digital pressure detection system that includes a digital pressure detection device according to the invention and a controller attached to the one or more leads, wherein the controller is capable of receiving a pressure signal from the pressure sensor.
  • the present invention provides a pressure detection device that includes a body having a generally cylindrical surface defining a longitudinal axis, a distal end, and a proximal end; a pressure sensor mounted on an exterior surface of the body; and one or more leads attached to the pressure sensor, the one or more leads extending from the pressure sensor in the proximal direction.
  • the present invention provides a method of measuring anal sphincter pressure, the method including donning a pressure detection device according to the present invention on at least one digit of a practitioner, wherein the pressure detection device includes one or more pressure sensors; advancing the pressure detection device into the anal cavity of a subject by advancing the at least one digit of the practitioner into anal cavity through the subject's anus; and measuring the pressure exerted on the one or more pressure sensors by an anal sphincter when the pressure sensors and the at least one digit are located in the anal cavity.
  • FIG. 1 is a perspective view of one exemplary embodiment of glove including a sleeve and pressure sensor according to the present invention.
  • FIG. 2 is a cross-sectional view of one finger sleeve of the glove of FIG. 1 taken along line 2-2 in FIG. 1.
  • FIG. 3 is a perspective view of a portion of a finger sleeve or other cylindrical body according to the present invention.
  • FIG. 4 is a cross-sectional view of the device of FIG. 3 taken along line 4-4 in FIG. 3.
  • FIG. 5 depicts a device including elongated pressure sensors on a body.
  • FIG. 6 is a diagram of sectors in which pressure may be monitored using the devices and methods of the present invention.
  • FIG. 7 is a schematic block diagram of one exemplary pressure measurement system according to the present invention.
  • FIG. 8 is a schematic diagram of another exemplary pressure measurement system according to the present invention.
  • FIG. 1 One exemplary embodiment of a pressure measurement device according to the present invention is depicted in FIG. 1.
  • the device 10 depicted in FIG. 1 is in the form of a glove that includes a glove body 11, finger sleeves 12a-12d (referred to in common as "finger sleeves 12"), and a thumb sleeve 14.
  • the glove body 11 is preferably sized to extend towards the wrist of a wearer.
  • the device 10 may be provided in a variety of sizes to accommodate a variety of different hand sizes.
  • the finger sleeves 12a-12d are depicted as having closed distal ends 13a-13d (respectively), the distal ends 13a- 13d are not required to be closed.
  • the finger sleeves 12 are depicted as sized to receive one digit of a wearer, in some instances, one or more finger sleeves may be sized to receive two or more digits of a wearer. It may be preferred that glove 10 be constructed of flexible materials, more preferably flexible materials that exhibit some elasticity such that the finger sleeves 12 conform to the shape of a wearer's digits.
  • Suitable flexible materials such as, e.g., latex or latex-free substitutes such as are known to those of skill in the art. It may be preferred that the flexible material used to construct the glove (or at least the finger sleeves 12) be impervious to liquids such as, e.g., the body fluids, lubricants, etc. that are likely to be encountered in use of the device 10. The use of liquid impermeable materials in the glove may assist in hygienic use of the glove.
  • the finger sleeve 12a on glove 10 includes a pressure sensor 20 as seen in FIG. 1.
  • the pressure sensor 20 is preferably connected to one or more leads 22 that extend proximally, i.e., in the direction of the opening 15 of the glove body 11.
  • the pressure sensor 20 be located within the interior of the finger sleeve 12a (see FIG. 2) such that the pressure sensor 20 is protected from contact with body fluids, lubricants, etc.
  • some pressure sensors that may be used in connection with the present invention may be of designs that are suitable for direct exposure to bodily fluids, lubricants, etc.
  • the pressure sensor 20 present a relatively low profile (i.e., thickness as measured radially within the cylindrical finger sleeve 12a) to enhance patient comfort and/or reduce trauma to internal body tissues during insertion and/or removal of the finger sleeve 12a from a body cavity.
  • the pressure sensor 20 may take a variety of different forms.
  • Examples of some potentially suitable pressure sensing constructions may include, but are not limited to, piezoresistive sensors (in which, e.g., deflection of a structure can be transformed into electric signals using piezoresistive materials); resonance sensors (in which, e.g., the resonant frequency of a structure changes upon deflection and that frequency change can be used to determine pressure); capacitance sensors (in which, e.g., capacitance changes in response to deformation with the capacitance change is used to determine pressure); Mach- Zehnder interferometer sensors (in which, e.g., waveguide deformation is used to optically sense pressure); etc.
  • Other pressure sensors may rely on fluid pressure changes within a bladder located in or on the sleeve.
  • the leads 22 may be electrical leads (e.g., wires), optical leads (e.g., optical fibers); or fluidic leads (e.g., fluid filled channels) depending on the mechanism used by the sensor 20 to detect pressure.
  • the leads 22 are depicted in the form of wires capable of carrying electrical signals/power.
  • Appropriate connectors may be located at the proximal end of the leads 22 to connected the pressure sensor 20 to a system capable of processing the signals received from the pressure sensor 20 and providing an objective indication of pressure. It may be preferred that the pressure sensor 20 be located on the palmar side of the finger sleeve 12a.
  • the pressure sensor be located elsewhere such as, e.g., over the nail bed (to provide a firmer base for the pressure sensor), over a joint (also to provide a firmer base for the pressure sensor), etc.
  • the finger sleeves 12 includes a pressure sensor in the glove depicted in FIG. 1, it should be understood that in some instances, it may be preferred to provide one or more pressure sensors on two or more of the finger sleeves 12.
  • the pressure sensors on the different finger sleeves 12 may be of the same or different constructions, in the same or different locations, etc.
  • FIGS. 3 & 4 An alternative exemplary embodiment of a pressure measurement device according to the present invention is depicted in FIGS. 3 & 4.
  • the device is in the form of a body 110 that preferably has a generally cylindrical shape similar to that seen in FIG. 2.
  • the term "cylindrical” should not be limited to circular cylinders, but should be construed broadly to include cylinders having any suitable cross-sectional shape, e.g., oval, elliptical, hexagonal, octagonal, etc.
  • the body 1 10 is provided in a hollow form, i.e., a sleeve, adapted to fit over one or more of a practitioner's digits, it may preferably not form part of a glove as in the embodiment of FIG. 1.
  • Such a sleeve may, however, be used in connection with a glove where the finger sleeve may be located underneath a separate glove worn by a practitioner or over a separate glove worn by a practitioner.
  • the sleeve may be adapted to fit over an existing cylindrical body, e.g., catheter, endoscope, etc.
  • the body 110 is depicted as having a closed distal end 113, the distal end 113 may not required to be closed. If provided as a hollow body adapted to fit on a practitioner, the body 110 may preferably be sized to receive only one digit of a wearer.
  • such a hollow body 110 may be sized to receive two or more digits of a wearer (or capable of being stretched to accept two or more digits).
  • the body 110 includes multiple pressure sensors 120.
  • the pressure sensors 120 are, in the depicted embodiment, located in an annular ring 130 defined about the generally cylindrical body 110. It may be preferred that at least two of the pressure sensors 120 be located in two generally diametrically opposed positions as seen in FIG. 4.
  • Another optional feature depicted in FIGS. 3 & 4 are pressure sensors 140 located in a different position along the longitudinal axis 111 defined by the length of the generally cylindrical shaped body 110.
  • pressure sensors 120 and 140 may be of any suitable construction such as those described in connection with pressure sensor 20 in the embodiment of FIGS. 1 & 2.
  • the leads 122 and 142 depicted in FIGS. 3 & 4 may be of any suitable construction for the pressure sensor to which they are attached.
  • FIG. 5 depicts one such construction in which a body 210 in the form of a sleeve includes multiple elongated fluid- filled bladders 220, each of which is segmented into separate sections 220a, 220b, 220c, 22Od to enable the practitioner to obtain pressure readings along the length of the body 210 as well as in different sectors around the longitudinal axis 211.
  • the body in devices of the present invention be constructed of flexible materials if it is to be used as a sleeve over a practitioner's digits or an existing device, more preferably flexible materials that exhibit some elasticity such that the body is capable of conforming to the shape of a wearer's digit (or digits) or existing device and can be securely retained thereon during use.
  • Suitable flexible materials such as, e.g., latex or latex-free substitutes such as are known to those of skill in the art. It may be preferred that the flexible material used to construct such a sleeve be impervious to liquids such as, e.g., the body fluids, lubricants, etc.
  • devices according to the present invention may use telemetry for communication of signal information to and/or from the pressure sensor(s).
  • Another potential feature may include the transmission of power by telemetry (e.g., RF energy) to the pressure sensors.
  • Methods of using the devices may include, e.g., donning a glove with a finger sleeve that includes one or more pressure sensors or donning finger sleeve such as that depicted in FIGS.
  • 3-5 connecting the pressure sensor(s) to a controller, inserting the finger sleeve with pressure sensor(s) into a body (e.g., the anal cavity, vagina, etc.), and measuring the pressure within the cavity using the pressure sensor(s).
  • a body e.g., the anal cavity, vagina, etc.
  • the present invention may be useful for measuring pressure generated by anal sphincters.
  • a practitioner may don a pressure detection device of the invention on one or more of their digits, wherein the pressure detection device includes one or more pressure sensors.
  • the practitioner may use a cylindrical body having pressure sensors mounted thereon as described herein.
  • the practitioner may then advance the pressure detection device into the anal cavity of a subject by advancing one or more of their digits or the cylindrical body into anal cavity through the subject's anus.
  • the pressure exerted on the pressure sensors of the device by an anal sphincter can be measured while the practitioner's digit or the cylindrical body is located in the anal cavity.
  • multiple pressure sensors are distributed around the perimeter of a device (e.g., as pressure sensors 120 and 140 are distributed about sleeve 110) it may be possible to measure pressures generated on the device in selected sectors about a longitudinal axis (where the longitudinal axis is defined by, e.g., the rectum of subject when anal sphincter pressures are being measured).
  • FIG. 6 is a diagram of one set of sectors 152, 154, 156, 158 in which pressure measurements may be generated using the devices and methods of the present invention.
  • the sectors 152, 154, 156, 158 are depicted as being essentially equal in size, pressure measurement sectors identified in connection with the present invention may or may not be equal in size.
  • the number of sectors in which pressure measurements can be obtained may match the number of pressure sensors used in the device/method, although in some instances the measurements from two or more pressure sensors may be combined to provide a pressure reading for one sector. In another alternative, the number of sectors in which pressure measurements may be ob obtained can be greater than the number of pressure sensors where, e.g., the device is rotated or moved between readings.
  • a single pressure sensor can be used to obtain pressure measurements for more than one sector.
  • the methods of use may be performed using a system such as that depicted in FIG. 7.
  • the system includes a pressure measurement device 310 that may, for example, be in the form of one of the embodiments described herein.
  • the system also includes a controller 350 and connectors 360 adapted to connect to the leads from the pressure sensor(s) on the device 310.
  • the controller 350 may take any suitable form and may include, e.g., a power source, user interface (e.g., pushbuttons, keyboard, touchscreen, microphone, etc.).
  • the controller 350 may also preferably include a sensor analyzer that obtains data from the pressure sensor(s) and a processor to interpret the output of the pressure sensor(s).
  • sensor analyzer may receive output from the pressure sensor(s) and provide input to a processor so that the output of the pressure sensor(s) can be interpreted.
  • the processor may be housed in the same unit as the sensor analyzer or may be part of a separate unit or separate computer.
  • the processor may also be coupled to memory which can store one or more different data analysis techniques, measurements, etc.
  • any desired data analysis techniques may be designed as, e.g., hardware, within the processor.
  • processor may preferably execute any data analysis techniques to determine pressure measured by the pressure sensor(s).
  • the processor may be a general-purpose microprocessor that executes software stored in memory.
  • the processor may be housed in a specifically designed computer, a general purpose personal computer, workstation, handheld computer, laptop computer, or the like.
  • the processor may be an application specific integrated circuit (ASIC) or other specifically designed processor.
  • ASIC application specific integrated circuit
  • the processor preferably executes any desired data analysis technique or techniques.
  • Any memory associated with the processor may be, e.g., any computer readable medium that stores processor executable software instructions that can be applied by the processor.
  • suitable memory may be random access memory (RAM), read-only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read- only memory (EEPROM), flash memory, or the like.
  • FIG. 8 is a schematic diagram of another system that may be used in connection with the present invention.
  • the system may include, e.g., a pressure measurement device 410 in the form of a sleeve, glove or other device as discussed herein.
  • the device 410 may preferably include one or more discrete pressure sensors 420 distributed in or on device 410 as described herein.
  • Each of the pressure sensors 420 is connected to a data acquisition device 450 by a lead 422.
  • the data acquisition device 450 may include a power supply; pressure transducers capable of converting the readings obtained from the pressure sensors 420 into a form suitable for communication, storage, etc.; and a communication device capable of communication with a controller 450.
  • the pressure sensors 420 may be in the form of fluid filled channels with the leads 422 transmitting the fluid pressure in each sensor 420 to pressure transducers located in the data acquisition device 450.
  • the pressure transducers may preferably convert the fluid pressure into a digital form (although an analog signal could alternatively be generated).
  • the data acquisition device 450 is, in the depicted system, in communication with a controller 470 that is not directly physically connected to the data acquisition device 450.
  • the data acquisition device 450 may preferably be in wireless communication with the controller 470.
  • the data acquisition device 450 and the controller 470 may communicate using BLUETOOTH wireless technology, etc.
  • the data generated using the pressure sensors 420 on device 410 may preferably be transmitted to the controller 470 using the data acquisition device 450.
  • Potential advantages of the system depicted in FIG. 8 may include, e.g., the ability to provide a data acquisition device 450 and connected pressure measurement device 410 that may be worn on the practitioner taking the measurements.
  • the pressure measurement device 410 may take the form of a sleeve or glove and the data acquisition device 450 may be attached to, e.g., the practitioner's forearm or some other suitable body location.
  • the practitioner is not encumbered by leads, wires, etc. extending to another device (such as, e.g., data acquisition device 470). This may be more convenient and practical for clinical use.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Physiology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

La présente invention concerne des dispositifs et des procédés de mesure de pression (10) qui peut être utilisé pour obtenir des mesures de pression objectives au moyen d'un ou de plusieurs capteurs de pression (20) montés sur un manchon (12a- 12d) ou un autre dispositif qui possède une forme généralement cylindrique. Ces capteurs de pression (20) peuvent de préférence être conçus pour connecter ou être connectés à un système capable de fournir des mesures de pression objectives. Les corps sur lesquels ces capteurs de pression (20) sont montés peuvent, dans certains cas, former un manchon (12) conçu pour s'adapter sur un doit sur un doigt de gant (11).
PCT/US2005/022258 2004-06-22 2005-06-22 Dispositif et techniques d'evaluation de pressions de cavite anatomique WO2006002313A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US58192704P 2004-06-22 2004-06-22
US60/581,927 2004-06-22

Publications (1)

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WO2006002313A1 true WO2006002313A1 (fr) 2006-01-05

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8182434B2 (en) 2008-05-28 2012-05-22 Roland Alois Thaler Equine locomotor flexion algometry device (ELFA)
WO2013090681A3 (fr) * 2011-12-16 2013-08-15 The Regents Of The University Of Michigan Dispositif de capteur apte à être monté sur un doigt, pour manométrie numérique
CN106933336A (zh) * 2015-12-31 2017-07-07 博世汽车部件(苏州)有限公司 智能手套的制造方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4823619A (en) * 1986-02-28 1989-04-25 Antonio Nicholas F D Sensor and transducer apparatus
US20010043847A1 (en) * 1990-02-02 2001-11-22 James Kramer Force feedback and texture simulating interface device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4823619A (en) * 1986-02-28 1989-04-25 Antonio Nicholas F D Sensor and transducer apparatus
US20010043847A1 (en) * 1990-02-02 2001-11-22 James Kramer Force feedback and texture simulating interface device

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8182434B2 (en) 2008-05-28 2012-05-22 Roland Alois Thaler Equine locomotor flexion algometry device (ELFA)
WO2013090681A3 (fr) * 2011-12-16 2013-08-15 The Regents Of The University Of Michigan Dispositif de capteur apte à être monté sur un doigt, pour manométrie numérique
US9743857B2 (en) 2011-12-16 2017-08-29 The Regents Of The University Of California Digital manometry finger-mountable sensor device
CN106933336A (zh) * 2015-12-31 2017-07-07 博世汽车部件(苏州)有限公司 智能手套的制造方法

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