Apparatus and methods for monitoring subjects
First Claim
1. An apparatus for monitoring a subject comprising:
- a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, and at least one sensor of acceleration within the housing.
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Accused Products
Abstract
This invention provides a device, and method and system for its use, for monitoring participants in clinical trials so that participant self-reporting, which is known to be notoriously inaccurate, can be minimized or eliminated. In preferred embodiments, the device is self-contained and self-powered, resides on or in a body cavity of the participant, collects data monitoring medically relevant aspects of the participant'"'"'s behavior and of the local device environment, and stores data in a memory on-board the device. An accompanying external station reads stored data and prepares it for use. Devices may include electrically-active sensors and non-electrical active sampling sensors. A preferred embodiment of the device is in clinical trials of microbicides inhibiting transmission of the HIV virus.
92 Citations
86 Claims
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1. An apparatus for monitoring a subject comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, and at least one sensor of acceleration within the housing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An apparatus for monitoring a female subject comprising:
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a housing adapted to reside in the subject'"'"'s vagina, the housing having no external physical connection, and one or more sensors within the housing comprising at least one sensor selected from the group consisting of a sensor of acceleration, a sensor of pH, a sensor of temperature, a sensor of the occurrence of menstruation, a sensor of the proximity of magnetic materials, and a sensor of the proximity of a target object. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. An apparatus for monitoring a subject comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, and at least one sensor of the proximity of magnetic materials within the housing. - View Dependent Claims (29, 30, 31, 32)
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33. An apparatus for monitoring a subject comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, and at least one sensor of the proximity of a target object within the housing. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41)
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42. An apparatus for monitoring a subject comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, and a sampling sensor for sampling components of the external environment of the apparatus, the sampling sensor comprising;
an absorbent material disposed in a cavity in the housing, and one or more pores through which components of the external environment have access to the absorbent material, wherein components are sampled by being absorbed by the absorbent material after passing though the pores from the external environment. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51)
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52. An apparatus for monitoring a female subject'"'"'s sexual activity comprising:
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a housing adapted to reside in the subject'"'"'s vagina, the housing having no external physical connection, one or more sensors within the housing, a computer-readable memory within the housing, a controller within the housing, and a program for awakening periodically from a low power sleep state in order to determine from sensor measurements whether or not the subject is likely to be engaging in sexual activity, retrieving measurements from at least one sensor and storing the retrieved measurements in the memory during a period in which the subject is determined as likely to be engaging in sexual activity, and switching back to the low power sleep state if the subject is determined as not likely to be engaging in sexual activity. - View Dependent Claims (53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 82, 83, 84)
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63. An apparatus for subject monitoring and drug delivery comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection;
the housing comprising an embedded pharmaceutical agent that diffuses from the housing into the anatomic cavity, andone or more sensors within the housing. - View Dependent Claims (64, 65, 66, 67, 68, 69, 85, 86)
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70. An apparatus for subject monitoring and drug delivery comprising:
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a housing adapted to reside in an anatomic cavity of the subject'"'"'s body, the housing having no external physical connection, a reservoir of a pharmaceutical agent within the housing, and one or more sensors within the housing, a controller within the housing, and a program for retrieving measurements from at least one sensor and determining whether or not a condition is satisfied in dependence on the retrieved measurements, and if the condition is determined to be satisfied, signaling that an amount of the pharmaceutical agent is to be released in the anatomic cavity. - View Dependent Claims (71, 72, 73, 74)
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75. A computer readable memory with a program for:
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awakening periodically from a low power sleep state in order to determine from acceleration measurements whether or not the subject is likely to be engaging in sexual activity, retrieving measurements from at least one sensor and storing the retrieved measurements in the memory during a period in which the subject is determined as likely to be engaging in sexual activity, and switching back to the low power sleep state if the subject is determined as not likely to be engaging in sexual activity.
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76. A system from monitoring female subjects comprising:
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a monitoring apparatus comprising a housing adapted to reside in the subject'"'"'s vagina, the housing having no external physical connection, and one or more sensors within the housing comprising at least one sensor selected from the group consisting of a sensor of acceleration, a sensor of pH, a sensor of temperature, a sensor of the occurrence of menstruation, a sensor of the proximity of magnetic materials, and a sensor of the proximity of a target object, a computer-readable memory within the housing, and a controller within the housing that retrieves measurements from at least one sensor and stores the retrieved measurements in the memory, and a computer for reading measurements stored in the memory of the monitoring apparatus during a prior period of residence in the subject.
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77. A method of conducting clinical trials using a plurality of subjects comprising:
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providing to at least one subject a monitoring apparatus comprising a housing adapted to reside in the subject'"'"'s vagina, the housing having no external physical connection, and one or more sensors within the housing comprising at least one sensor selected from the group consisting of a sensor of acceleration, a sensor of pH, a sensor of temperature, a sensor of the occurrence of menstruation, a sensor of the proximity of magnetic materials, and a sensor of the proximity of a target object, a computer-readable memory within the housing, and a controller within the housing that retrieves measurements from at least one sensor and stores the retrieved measurements in the memory, reading measurements stored in the memory of the monitoring apparatus after a period of subject use, and transmitting the measurements read for analysis.
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78. A pharmaceutical preparation comprising:
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one or more pharmaceutical agents; and
embedded magnetic materials sufficient to permit a sensor for magnetic materials to sense the proximity of the pharmaceutical preparation.
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79. An apparatus for monitoring a female subject'"'"'s sexual activity comprising:
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a housing adapted to reside in the subject'"'"'s vagina, the housing having no external physical connection, one or more sensors including at least one sensor of acceleration within the housing, a controller within the housing that determines whether or not the subject is likely to be engaging in sexual activity, or is not likely to be engaging in sexual activity, by comparing characteristics of the acceleration signals with characteristics expected if the subject is actually engaging in a sexual activity. - View Dependent Claims (80, 81)
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Specification