DEVICE FOR COLLECTING A BIOLOGICAL SAMPLE

1 . A device for collecting a biological sample in a patient, the device comprising

a collection portion sufficiently dimensioned to be swallowed by the patient, the collection portion having a first axial end portion and a second axial end portion; and

the first axial end portion having a first radius, and the second axial end portion having a collapsed position having a second radius and an expanded position having a third radius; and wherein the first radius is larger than the second radius, and the first radius is smaller than the third radius.

2 . A device for collecting a biological sample as set forth in claim 1 wherein upon application of a pressurized fluid to the collection portion, the second axial end portion is configured to be actuated from the collapsed position having the second radius to the expanded position having the third radius.

3 . A device for collecting a biological sample as set forth in claim 2 , wherein the first axial end portion is rigid such that the first axial end portion maintains the first radius upon application of the pressurized fluid to the collection portion.

4 . A device for collecting a biological sample as set forth in claim 2 , wherein upon application of a vacuum pressure to the collection portion, the second axial end portion is configured to be actuated from the expanded position having the third radius to the collapsed position having the second radius.

5 . A device for collecting a biological sample as set forth in claim 4 , wherein the first axial end portion is rigid such that the first axial end portion maintains the first radius upon application of the vacuum pressure to the collection portion.

6 . A device for collecting a biological sample as set forth in claim 2 ,

wherein the second axial end portion has an additional expanded configuration having a fourth radius, and

wherein the fourth radius is different than the third radius.

7 . A device for collecting a biological sample as set forth in claim 1 , wherein the second axial end portion is inverted at least partially within the first axial end portion in the collapsed position.

8 . A device for collecting a biological sample as set forth in claim 1 wherein the second axial end portion includes a plurality of tissue collecting projections.

9 . A device for collecting a biological sample as set forth in claim 8 wherein at least one of the plurality of tissue collecting projections has a V-shape.

10 . A device for collecting a biological sample as set forth in claim 9 wherein the at least one of the plurality of tissue collecting projections has first and second sides extending from an intersection at an angle to each other, the first and second sides extending toward the first axial end portion from the intersection when the second axial end portion is in the expanded position.

11 . A device for collecting a biological sample as set forth in claim 8 wherein the plurality of tissue collecting projections includes at least one circumferentially extending rib.

12 . A device for collecting a biological sample as set forth in claim 8 wherein the plurality of tissue collecting projections includes at least one radially extending cylindrical projection.

13 . A device for collecting a biological sample as set forth in claim 8 wherein the plurality of tissue collecting projections includes at least one bi-directional curved shaped projection.

14 . A device for collecting a biological sample as set forth in claim 1 wherein the first and second axial end portions are integrally formed as one-piece.

15 . A device for collecting a biological sample as set forth in claim 1 wherein the first and second axial end portions are formed as separate pieces and connected together.

16 . A device for collecting a biological sample as set forth in claim 1 wherein the first and second axial end portions are connected by a circumferentially extending hinge.

17 . A device for collecting a biological sample as set forth in claim 1 wherein the second axial end portion is held in the collapsed position by a cap or cover that falls off, pops off, or dissolves when the collection portion reaches a collection site.

18 . A method for collecting a biological sample from a collection site of a lumen of a patient, the method comprising:

moving a collection portion of a device having a first axial end portion, the first axial end portion having a first radius, and a second axial end portion into a lumen of a patient with the second axial end portion in a collapsed position, the second axial end portion having a second radius in the collapsed position, the first radius is larger than the second radius;

moving the second axial end portion relative to the first axial end portion from the collapsed position into an expanded position, the second axial end portion having a third radius in the expanded position, the third radius is larger than the first radius;

collecting a biological sample with the second axial end portion in the expanded position;

moving the second axial end portion into the first axial end portion from the expanded position into the collapsed position; and

removing the device from the lumen of the patient.

19 . A method for collecting a biological sample from a lumen as set forth in claim 18 wherein the step of collecting a biological sample includes collecting at least one of cells, DNA and/or RNA.

20 . A method for collecting a biological sample from a lumen as set forth in claim 18 further comprising expanding the second axial end portion to an additional expanded position, wherein the second axial end portion has a different geometry in the additional expanded position than in the expanded position.

21 . A method for collecting a biological sample from a lumen as set forth in claim 18 wherein the step of moving the second axial end portion from the collapsed position into the expanded position includes moving the second axial end portion from a concave shape to a convex shape.

22 . A method for collecting a biological sample from a lumen as set forth in claim 18 wherein the step of moving the second axial end portion from the expanded position into the collapsed position includes moving the second axial end portion from a convex shape to a concave shape.

23 . A method for collecting a biological sample from a lumen as set forth in claim 18

wherein the lumen is an esophagus of the patient, and

wherein the step of moving the collection portion of the device into the esophagus includes at least one of swallowing the collection portion and intubating the collection portion.

24 . A method for collecting a biological sample from a lumen as set forth in claim 18 wherein the step of moving the second axial end portion from the collapsed position into the expanded position includes applying pressurized air to the second axial end portion and the step of moving the second axial end portion from the expanded position into the collapsed position includes applying a vacuum to the collection portion.

25 . A device for placing a collection portion at a site of interest in a lumen for collecting a sample in a patient, the device comprising

a collection portion provided with a size and shape sufficiently dimensioned to be swallowed by the patient, the collection portion having a first axial end portion and a second axial end portion,

wherein the first axial end portion has a fixed radius, and the second axial end portion is expandable and collapsible to have a variable radius.

26 . A device for placing a collection portion at a site of interest in a lumen as set forth in claim 25 wherein upon application of a pressurized fluid to the collection portion, the second axial end portion is configured to be actuated from a collapsed position having a first radius to an expanded position having a second radius.

27 . A device for placing a collection portion at a site of interest in a lumen as set forth in claim 26 , wherein upon application of a vacuum pressure to the collection portion, the second axial end portion is configured to be actuated from the expanded position having the second radius to the collapsed position having the first radius.

28 . A device for placing a collection portion at a site of interest in a lumen as set forth in claim 26 ,

wherein the first radius is less than the fixed radius of the first axial end portion, and

wherein the second radius is larger than the fixed radius of the first axial end portion.

29 . A device for placing a collection portion at a site of interest in a lumen as set forth in claim 26 , wherein the second axial end portion is inverted at least partially within the first axial end portion in the collapsed position.

30 . A device for placing a collection portion at a site of interest in a lumen as set forth in claim 26 , wherein the second axial end portion includes a plurality of tissue collecting projections.