초록 ▼

A method and device performing the method for estimation of cell count, such as sperm cell count, is disclosed. The device may be a kit including a cartridge configured to hold fluid, such as seminal fluid, and an instrument configured to centrifuge the cartridge. The cartridge and instrument are co

A method and device performing the method for estimation of cell count, such as sperm cell count, is disclosed. The device may be a kit including a cartridge configured to hold fluid, such as seminal fluid, and an instrument configured to centrifuge the cartridge. The cartridge and instrument are configured such that, during operation or centrifugation, they are securely attached to each other. The cartridge has a component with a defined cross-sectional volume. The defined cross-sectional volume is used to mark the component with markings, allowing a user of the device to read the markings and estimate cell volume and, thus, concentration. Various embodiments of the device are disclosed.

대표청구항 ▼

1. An apparatus comprising: a cartridge having a first end, a second end, an underside, and a connecting mate on the underside, the cartridge having a length that is longer than a width of the cartridge, the cartridge configured to be rotated about a rotational axis of the cartridge to cause sedimen

1. An apparatus comprising: a cartridge having a first end, a second end, an underside, and a connecting mate on the underside, the cartridge having a length that is longer than a width of the cartridge, the cartridge configured to be rotated about a rotational axis of the cartridge to cause sedimentation of particulates or cells in a received sample, wherein the rotational axis is aligned with the connecting mate of the cartridge, and the rotational axis is located between the first end and the second end of the cartridge, the connecting mate configured to connect the cartridge to a connecting mechanism of an instrument for rotation of the cartridge, the cartridge comprising: a central cavity configured to hold the received sample;a sedimentation column configured to be in fluid communication with the central cavity, the sedimentation column comprising: a channel or a second cavity with a cross-sectional area that is less than a cross-sectional area of the central cavity; anda sample directing cavity comprising a first opening connected to the central cavity and a second opening connected to the sedimentation column, the first opening comprising a first cross-sectional area and the second opening comprising a second cross-sectional area that is less than the first cross-sectional area, the sample directing cavity configured to hold a defined volume of the received sample and configured to direct cells into the sedimentation column during rotation of the cartridge. 2. The apparatus of claim 1, further comprising an instrument configured to receive and rotate the cartridge during an operating mode, the instrument comprising: a motor;a connecting mechanism configured to mate the instrument with the cartridge at least during the operating mode; anda controller configured to control amount of power provided to the motor. 3. The apparatus of claim 2, wherein the controller is further configured to control any from a group consisting of: spin rate of the motor, direction or spin of the motor, duration of spin of the motor, and any combination thereof. 4. The apparatus of claim 2, further comprising a plurality of emitters coupled to the controller. 5. The apparatus of claim 4, wherein the controller is further configured to control amount of light emitted by the emitters. 6. The apparatus of claim 2, wherein the controller is further configured to detect a state of the instrument, the state selected from a group consisting of: whether or not a lid of the instrument is opened or closed, voltage of a battery in the instrument, whether or not the cartridge is attached to the instrument, and rate of rotation of the cartridge. 7. The apparatus of claim 2 wherein the instrument further comprises a plurality of reference points, each reference point comprising a voltage value, and wherein the controller is further configured to: measure a difference in voltage value at the plurality of reference points in the instrument at a plurality of specified moments of time when the motor is spinning; andcontrol the spin rate, or duration of spin of the motor by providing power, wherein the power provided is based on the difference in voltage at the plurality of reference points. 8. The apparatus of claim 2, wherein the instrument further comprises a plurality of reference points, each reference point comprising a voltage value, and wherein the controller is further configured to detect whether or not the cartridge is attached to the motor by providing power to the motor and measuring the voltage value at the plurality of reference points. 9. The apparatus of claim 2, wherein the motor further comprises a motor terminal, the instrument comprises one or more reference voltages, and the controller is further configured to detect whether or not the cartridge is attached to the motor by providing power to the motor for a first interval of time, stopping providing power to the motor for a second interval of time, and measuring a voltage difference across the motor terminal and the one of the one or more reference voltage or the voltage difference across a battery of the instrument. 10. The apparatus of claim 2, wherein the instrument further comprises a magnet and a sensor configured to detect magnetic fields. 11. The apparatus of claim 10, wherein the instrument further comprises a lid, the magnet is incorporated into the lid of the instrument, and the sensor is incorporated into the instrument such that, when the instrument lid is closed, a first distance between the magnet and the sensor allows the sensor to detect magnetic fields from the magnet. 12. The apparatus of claim 11, wherein the sensor is coupled to the controller and the controller is further configured to detect a change in magnetic field through the sensor, the change in magnetic field corresponding to whether or not the first distance between the magnet and sensor is less than a threshold distance indicative of a closed lid. 13. The apparatus of claim 12, wherein the controller is further configured to stop powering the motor if the distance between the magnet and the sensor is greater than the threshold distance. 14. The apparatus of claim 1, wherein the connecting mate of the cartridge is configured to attach to an in-built shaft of the connecting mechanism. 15. The apparatus of claim 1, wherein the sample directing cavity is configured to receive a specified volume of the received sample from the central cavity upon rotation of the cartridge at a first rate. 16. The apparatus of claim 15, wherein the sample directing cavity is integrated in the cartridge at a slope configured to direct cells into the sedimentation column when the cartridge is rotated at a second rate, the second rate faster than the first rate. 17. The apparatus of claim 16, wherein the cartridge further comprises shallow channels connecting the first opening of the sample directing cavity to the central cavity such that the received sample can move from the central cavity to the sample directing cavity only through the shallow channels, the shallow channels comprising a third cross-sectional area configured to prevent the received sample from moving from the central cavity to the sample directing cavity when the cartridge is not being rotated. 18. The apparatus of claim 17, wherein the cartridge further comprises additional channels connected to the central cavity or shallow connecting channels, configured to receive particulates or cells from the received sample in the cavity that were not directed to the sample directing cavity upon rotation at the first rate. 19. The apparatus of claim 17, wherein the cartridge further comprises an overflow chamber connected to the central cavity by channels comprising a fourth cross-sectional area substantially smaller than a fifth cross-sectional area of the central cavity, the channels configured to prevent the received sample from moving from the central cavity to the overflow chamber during the first rate of rotation and to allow the received sample to move from the cavity to the overflow chamber during the second rate of rotation. 20. The apparatus of claim 16, wherein the cartridge further comprises an overflow chamber connected to the central cavity, and wherein the overflow chamber is configured such that the overflow chamber and the sample directing cavity equally distribute mass around the center of the cavity and balance the cartridge upon rotation. 21. The apparatus of claim 16, wherein the central cavity is configured such that particulates or cells from the received sample not inside the sample directing cavity and the sedimentation column after rotation at the first rate form a pellet outside of the sedimentation column upon rotation at the second rate. 22. The apparatus of claim 16, wherein the sedimentation column is further configured to sediment a pellet of cells comprising visible borders to an unaided human eye during the second rotation rate. 23. The apparatus of claim 1, further comprising a cylindrical lens incorporated into a polymer structure above the sedimentation column configured to optically magnify a width of a pellet of the sedimented cells and to aid in visualization of the pellet. 24. The apparatus of claim 1, further comprising a cell label included in an enclosure integrated in the cartridge. 25. The apparatus of claim 24, wherein the cell label is acrinidine orange. 26. The apparatus of claim 1, further comprising a fluid label or water soluble label included in an enclosure integrated in the cartridge. 27. The apparatus of claim 26, wherein the fluid label or water soluble label is configured to enhance contrast between the cells and the sample. 28. The apparatus of claim 26, wherein the fluid label or water soluble label is configured to enhance contrast between living and dead cells. 29. The apparatus of claim 28, wherein the fluid label is trypan blue. 30. The apparatus of claim 1, wherein the cartridge further comprises formed polymer layers containing selective light absorbing pigments. 31. The apparatus of claim 30, wherein the pigments within a polymer layer of the cartridge are configured to selectively absorb illumination wavelengths allowing visual fluorescent identification of a height of a pellet of the sedimented cells. 32. The apparatus of claim 1, wherein the cartridge is coated with selective light reflecting dichroic layers. 33. The apparatus of claim 1, further comprising an instrument configured to receive the cartridge and to provide illumination of the sedimentation column from below to cause fluorescent emission by a cell label of the cells. 34. The apparatus of claim 1, wherein a lower element of the cartridge is pigmented and an upper element of the cartridge is transparent such that illumination of the sedimentation column from above causes light to be scattered off of the cells in the sedimentation column and absorbed by the pigmented lower element of the cartridge in locations along the sedimentation column corresponding to an absence of cells, aiding in visualizing a pellet of the sedimented cells. 35. The apparatus of claim 1, wherein a lower element of the cartridge is opaque and an upper element and side elements of the cartridge are transparent such that illumination of the sedimentation column from a side of the cartridge causes light to scatter off of the cells in the sedimentation column and enhances contrast. 36. The apparatus of claim 1, wherein the received sample is semen and the cells are sperm cells. 37. The apparatus of claim 1, further comprising one or more density media in the sedimentation column, in the central cavity, or in the sample directing cavity. 38. The apparatus of claim 37, wherein the cartridge further comprises an evaporation barrier and the cavity, the sedimentation column, and the sample directing cavity are configured to hold the density media. 39. The apparatus of claim 37, wherein the one or more density media comprise a density higher than density of seminal plasma and lower than density of sperm cells, the one or more density media configured to separate sedimented sperm cells from seminal fluid and other particulates in the received sample within the sedimentation column. 40. The apparatus of claim 37, wherein the one or more density media comprise a density higher than density of immotile sperm cells and lower than density of motile sperm cells the one or more density media configured separate motile cells from seminal fluid, immotile cells, and other particulates within the sedimentation column. 41. The apparatus of claim 37, wherein the one or more density media comprise a density higher than density of dead cells and lower than density of live cells, the one or more density media configured separate live cells from seminal fluid, dead cells, and other particulates within the sedimentation column. 42. The apparatus of claim 1, wherein the apparatus further comprises one or more additional sedimentation columns and one or more respective sample directing cavities. 43. The apparatus of claim 42, wherein the apparatus further comprises one or more density media in the one or more sedimentation columns, in the central cavity, or in the one or more sample directing cavities. 44. The apparatus of claim 1, wherein the apparatus further comprises one or more colored or fluorescent polymer floats in the sedimentation column, in the central cavity, or in the sample directing cavity. 45. The apparatus of claim 44, wherein the received sample comprises a first cell type with a first density and a second cell type with a second density, wherein the first density is higher than the second density and one of the one or more floats comprise a density less than the first density and higher than the second density. 46. The apparatus of claim 44, wherein the float comprises a first density higher than a second density of seminal plasma and lower than a third density of sperm cells, the float configured to mark a boundary between sedimented sperm cells and seminal plasma within the sedimentation column. 47. The apparatus of claim 44, wherein the float is selected from a group consisting of: fluorescent polystyrene beads, colored polystyrene beads, and chips of polystyrene. 48. The apparatus of claim 1, wherein the sedimentation column further comprises at least one marking configured for allowing an estimate of cell concentration to be visually ascertained from a volume of the sedimented cells within the sedimentation column. 49. The apparatus of claim 1, wherein the sedimentation column further comprises a plurality of portions, each portion comprising a cross-sectional area different than another cross-sectional area of another portion in the plurality of portions. 50. The apparatus of claim 49, wherein the sedimentation column further comprises a plurality of markings configured to aid a user in estimating cell concentration of the sedimented cells within the sedimentation column and the plurality of portions of the sedimentation column comprises varying cross-sectional areas configured to further aid a user in measuring cell concentration of the sedimented cells. 51. The apparatus of claim 1, wherein the cartridge comprises dense solid objects configured to assist in agitation of the received sample upon rotation. 52. The apparatus of claim 1, wherein at least a portion of the sedimentation column comprises material that is transparent. 53. The apparatus of claim 1, wherein the length of the cartridge is more than twice the width of the cartridge. 54. The apparatus of claim 1, wherein the central cavity further comprises a diameter, wherein the diameter is not more than half the length of the cartridge. 55. The apparatus of claim 1, wherein the sample directing cavity extends radially outward from the cavity and radially inward from the sedimentation column. 56. A kit comprising: the cartridge of claim 1;an instrument comprising a connecting mechanism to securely mate the instrument with the cartridge, the instrument configured to rotate the cartridge;a transfer device; anda sample collection cup. 57. The kit of claim 56, wherein the transfer device further comprises one or more metering lines. 58. The kit of claim 56, wherein the sample collection cup further comprises a material configured to reduce viscosity of a received sample. 59. The kit of claim 58, wherein the received sample is semen and the material is an enzyme configured to break down proteins in semen. 60. The kit of claim 58, wherein the kit further comprises an imaging device configured to assist in quantifying sedimented cell pellets in a sedimentation column of the cartridge. 61. The kit of claim 56, wherein the kit further comprises a density medium. 62. The apparatus of claim 1, wherein the rotational axis of the cartridge is centered at a rotation center of the central cavity. 63. The apparatus of claim 1, wherein the central cavity, the sedimentation column, and the sample directing cavity are aligned along a radial axis directed radially outward from the central cavity. 64. The apparatus of claim 1, wherein a surface of the central cavity, a surface of the sedimentation column, and a surface of the sample directing cavity are coplanar. 65. The apparatus of claim 1, wherein a cross-sectional area of the sample directing cavity and the sedimentation column together form a funnel shape.