Device for collecting a biological sample

• US 10,660,621 B2
• Filed: 12/12/2014
• Issued: 05/26/2020
• Est. Priority Date: 12/12/2013
• Status: Active Grant

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Markowitz, Sanford, Chak, Amitabh, Willis, Joseph, Taggart, Jeffrey Silver, Blice, Rebecca, Secrest, Dean, Siedlak, Dennis
• Primary Examiner(s): Hindenburg, Max F
• Application Number:
  US15/103,638
• Publication Number:
  US 20160317132A1
• Time in Patent Office: 1,992 Days
• Field of Search: 600569, 600570, 600572
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2010/0225 for taking multiple samples

Abstract

A device for collecting a biological sample in a patient includes a collection portion having a first axial end portion and a second axial end portion. The second axial end portion has a collapsed position and an expanded position. The second axial end portion moves in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position. The second axial end portion extends axially into the first axial end portion and has a concave shape when in the collapsed position. The second axial end portion is convex when in the expanded position.

Claims

1. A device for collecting a biological sample in a patient, the device comprising a collection portion provided with a size and shape sufficiently dimensioned to be swallowed by a patient, the collection portion having a first axial end portion and a second axial end portion, the second axial end portion having a collapsed position and an expanded position, the second axial end portion moving in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position.

2. A device for collecting a biological sample as set forth in claim 1 wherein the second axial end portion extends axially into the first axial end portion and has a concave shape when the second axial end portion is in the collapsed position.

3. A device for collecting a biological sample as set forth in claim 1 wherein the second axial end portion has an outer surface facing radially outwardly when the second axial end portion is in the expanded condition, the outer surface facing radially inwardly when the second axial end portion is in the collapsed position.

4. 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.

5. A device for collecting a biological sample as set forth in claim 4 wherein at least one of the tissue collecting projections has a V-shape.

6. A device for collecting a biological sample as set forth in claim 5 wherein the at least one of the 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.

7. A device for collecting a biological sample as set forth in claim 4 wherein circumferentially extending ribs extend between adjacent tissue collecting projections.

8. A device for collecting a biological sample as set forth in claim 4 wherein side walls of the tissue collecting projections taper toward each other as the side walls extend radially outward from the distal end portion.

9. A device for collecting a biological sample as set forth in claim 4 wherein the plurality of tissue collecting projections includes at least one circumferentially extending rib.

10. A device for collecting a biological sample as set forth in claim 4 wherein the plurality of tissue collecting projections includes at least one radially extending cylindrical projection.

11. A device for collecting a biological sample as set forth in claim 4 wherein the plurality of tissue collecting projections includes at least one bi-directional curved shaped projection.

12. A device for collecting a biological sample as set forth in claim 11 wherein the at least one bi-directional curved shaped projection includes a support portion extending radially outward from the second axial end portion and a bi-directional curve shaped portion having a cross-section larger than the support portion.

13. A device for collecting a biological sample as set forth in claim 4 wherein the plurality of tissue collecting projections includes at least one X-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 portion 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.

27. A device for collecting a biological sample as set forth in claim 1 wherein the distal 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 the collection site.

17. A method for collecting a biological sample from a collection site of an esophagus of a patient, the method comprising:

moving a collection portion of a device having a first axial end portion and a second axial end portion into the esophagus with the second axial end portion in a collapsed position extending axially into the first axial end portion;

axially moving the second axial end portion relative to the first axial end portion from the collapsed position into an expanded position;

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

axially 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 esophagus of the patient.

18. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of collecting a biological sample includes collecting cells.

19. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of collecting a biological sample includes collecting DNA and/or RNA.

20. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of axially 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.

21. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of axially 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.

22. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of axially moving the second axial end portion from the expanded position into the collapsed position includes causing an outer surface of the second axial end portion facing radially outwardly when the second axial end portion is in the expanded condition to face radially inwardly when the second axial end portion is in the collapsed position.

23. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of moving the collection portion of the device into the esophagus includes swallowing the collection portion.

24. A method for collecting a biological sample from an esophagus as set forth in claim 17 further including providing the second axial end portion with a plurality of tissue collecting projections.

25. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of removing the device from the esophagus includes preventing the second end portion of the collection portion from engaging the esophagus at an area different from the collection site.

26. A method for collecting a biological sample from an esophagus as set forth in claim 17 wherein the step of axially 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 axially moving the second axial end portion from the expanded position into the collapsed position includes applying a vacuum to the collection portion.