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US 9,282,950 B2Granted
Cervical cell tissue self-sampling device
AssigneeGyneConcepts, Inc.
InventorPhilip Klein
Life of this patent
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Abstract
A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.
Claims20
A device for collecting a cervical tissue sample from a patient comprising:
- (a) an elongated insertion tube shaped for insertion into the vagina of the patient and having a proximal end, a distal end, an exterior surface and an interior surface extending therethrough defining a passage;
- (b) an elongated cervical aligning tool shaped for insertion within the passage of the insertion tube and having a proximal end with a handle thereon, a distal end with a cervical aligning probe thereon and a body therebetween, wherein the aligning tool handle is disposed outside the proximal passage of the insertion tube and is movable between a first position for insertion wherein the distal cervical aligning probe is contained within the passage of the insertion tube, and a second position for cervical cap alignment wherein the distal cervical aligning probe extends distally from the passage of the insertion tube to engage the cervical fornix of the patient;
- and
- (c) an elongated cellular sampling tool shaped for insertion within the passage of the insertion tube, and having a proximal end with an advancing handle thereon, a distal end with a cellular adhesion surface thereon, wherein the advancing handle extends from the proximal passage of the insertion tube, and is movable between a first position for insertion wherein the distal cellular adhesion surface is contained within the passage of the insertion tube, and a second position for cervical cell tissue sampling wherein the distal cellular adhesion surface extends distally from the passage of the insertion tube.
1 more element
A method of collecting a cervical tissue sample from a patient comprising:
- (a) inserting into the vagina of the patient a device comprising:
- (i) an elongated insertion tube shaped for insertion into the vagina and having a proximal end, a distal end, an exterior surface and a passage extending therethrough defining an interior surface;
- (ii) an elongated cervical aligning tool shaped for insertion within the passage of the insertion tube and having a proximal end with an advancing handle thereon, a distal end with a cervical aligning probe thereon and a body therebetween, wherein the advancing handle extends from the proximal passage of the insertion tube and is movable between a first position for insertion wherein the distal cervical aligning probe is contained within the passage of the insertion tube, and a second position for cervical cap alignment wherein the distal cervical aligning probe extends distally from the passage of the insertion tube;
- and
- (iii) an elongated cellular sampling tool shaped for insertion within the passage of the insertion tube, and having a proximal end with an advancing handle thereon, a distal end with a cellular adhesion surface thereon, wherein the advancing handle extends from the proximal passage of the insertion tube, and is movable between a first position for insertion wherein the distal cellular adhesion surface is contained within the passage of the insertion tube, and a second position for cervical cell tissue sampling wherein the distal cellular adhesion surface extends distally from the passage of the insertion tube;
- (b) advancing the handle of the cervical aligning tool distally from within the insertion tube in the first position to the second position for cervical cap alignment to engage the cervical fornix of the patient;
- (c) moving the elongated cellular sampling tool distally from the first position to the second position for cervical cell tissue sampling;
- (d) rotating the cellular sampling tool to capture cervical tissue at the patient's os on the cellular adhesion surface;
- (e) moving the elongated cellular sampling tool proximally from the second position to the first position to shield the cervical tissue sample within the insertion tube;
- and
- (f) withdrawing the device from the vagina of the patient.
8 more elements
Dependencies are inferred from the claim text.