DEVICE FOR COLLECTING A BIOLOGICAL SAMPLE

1 . A system for collection of a sample within a patient, the system comprising:

a collection portion sized and shaped to be swallowed by the patient, the collection portion including a first axial end and a second axial end, the second axial end having tissue collecting projections thereon;

a support member fluidly connected to the first axial end of the collection portion, the support member being generally tubular having a lumen extending therethrough for conducting a fluid to the collection portion, the support member being rigid to resist collapse when a vacuum is applied to the support member and the support member is flexible; and

a fluid control in fluid communication with the support member and configured to apply and retain a pressure, with the fluid, through the support member to the collection portion to actuate the second axial end to one of a collapsed configuration or an expanded configuration.

2 . A system for collection of a sample within a patient as set forth in claim 1 , wherein the support member has sufficient material strength to prevent axial deformation when under an axial force.

3 . A system for collection of a sample within a patient as set forth in claim 1 , wherein the support member is configured to position the collection portion within the patient for swallowing of the collection portion.

4 . A system for collection of a sample within a patient as set forth in claim 1 , wherein the support member includes a plurality of depth markings.

5 . A system for collection of a sample within a patient as set forth in claim 1 , wherein the support member is a catheter.

6 . A system for collection of a sample within a patient as set forth in claim 1 , wherein the support member is affixed to the collection portion to permit the support member to remove the collection portion from the patient upon application of a proximal force.

7 . A system for collection a sample within a patient as set forth in claim 1 , wherein the support member is integrally connected to the first axial end.

8 . A system for collection a sample within a patient as set forth in claim 1 , wherein the expanded configuration of the second axial end includes a first expanded configuration and a second expanded configuration.

9 . A system for collection a sample within a patient as set forth in claim 8 , wherein the second axial end moves in an axial direction relative to the first axial end when the second axial end moves between the collapsed configuration and one of the first and second expanded configurations.

10 . A system for collection a sample within a patient as set forth in claim 9 , wherein the second axial end extends axially at least partially into the first axial end and has a concave shape when the second axial end is in the collapsed configuration.

11 . A system for collection a sample within a patient as set forth in claim 9 , wherein the second axial end has an outer surface facing radially outwardly when the second axial end is in one of the first and second expanded configurations, the outer surface facing radially inwardly when the second axial end is in the collapsed configuration.

12 . A method for collecting a biological sample from a collection site in a patient, the method comprising:

moving a collection portion of a device, with a support member, into the patient with the collection portion maintained in a collapsed position, the support member being rigid to resist collapse when a vacuum is applied to the support member and the support member is radially flexible;

conducting a volume of fluid, with a fluid controller, through a support member to the collection portion to expand the collection portion from the collapsed position into an expanded position and retaining the collection portion in the expanded position with the fluid controller;

collecting a biological sample with the collection portion in the expanded position;

releasing the fluid from the collection portion with the fluid controller and applying a vacuum pressure to the collection portion, through the support member, to move the collection portion from the expanded position into the collapsed position; and

removing the device from the patient.

13 . A method for collecting a biological sample from a collection site as set forth in claim 12 wherein the step of collecting a biological sample includes collecting at least one of cells, DNA, and/or RNA.

14 . A method for collecting a biological sample from a collection site as set forth in claim 12 ,

wherein the step of removing the device from the patient includes applying an axial force on the support member, and

wherein the support member resists axial deformation during the step of removing the device.

15 . A method for collecting a biological sample from a collection site as set forth in claim 12 wherein the step of conducting a volume of fluid includes moving a portion of the collection portion from a concave shape to a convex shape.

16 . A method for collecting a biological sample from a collection site as set forth in claim 12 wherein the step of moving the collection portion of the device into the patient includes swallowing the collection portion.

17 . A method for collecting a biological sample from a collection site as set forth in claim 12 further including providing the collection portion with a plurality of tissue collecting projections.

18 . A method for collecting a biological sample from a collection site as set forth in claim 12 wherein the step of removing the device from the patient includes preventing at least a portion of the collection portion from engaging the patient at an area different from the collection site.

19 . A method for collecting a biological sample from a collection site as set forth in claim 12 further comprising removing the collection portion from the support member after the step of removing the device from the patient.

20 . A kit for collecting a sample from a collection site within a patient, the kit comprising,

a support member being substantially tubular having an interior lumen extending from a proximal end to a distal end, the interior lumen being configured to conduct a fluid from the proximal end to the distal end and the support member being configured to resist collapse when a vacuum is applied to the support member;

a sample collection device having a first axial end and a second axial end, the first axial end being configured to be fluidly connected to the distal end of the support member;

a fluid control in fluid communication with the support member and configured to apply and retain a pressure, with the fluid, through the support member to the sample collection device to actuate the second axial end to one of a collapsed configuration or an expanded configuration, the second axial end configured to move in an axial direction relative to the first axial end between the collapsed configuration and the expanded configuration.

21 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member is integrally connected to the first axial end.

22 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member is affixed to the sample collection device to permit the support member to remove the sample collection device from the patient upon application of a proximal force.

23 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member includes depth markings to determine a depth of the sample collection device within the patient.

24 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member has sufficient material strength to prevent axial deformation when under an axial force.

25 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member is configured to position the sample collection device within the patient for swallowing of the sample collection device.

26 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the support member is a catheter.

27 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the second axial end includes a plurality of tissue collecting projections.

28 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the second axial end moves in an axial direction relative to the first axial end when the second axial end moves between the collapsed configuration and one of the first and second expanded configurations.

29 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the second axial end extends axially at least partially into the first axial end and has a concave shape when the second axial end is in the collapsed configuration.

30 . A kit for collecting a sample from a collection site as set forth in claim 20 , wherein the second axial end has an outer surface facing radially outwardly when the second axial end is in one of the first and second expanded configurations, the outer surface facing radially inwardly when the second axial end is in the collapsed configuration.