Granted Patent B2

US 12,376,837 · App. 17/643,335 · Granted Aug 5, 2025

Inventors: Sanford Markowitz (Cleveland, OH); Amitabh Chak (Cleveland, OH); Joseph Willis (Cleveland, OH); Jeffrey Silver Taggart (Cleveland, OH); Rebecca Blice (Cleveland, OH); Dean Secrest (Cleveland, OH); Dennis Siedlak (Cleveland, OH)

Assignee: Case Western Reserve University

A61B10/02A61B2010/0216A61B2010/0225

Abstract

Claims (37)

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

a support through which fluid can be directed from a source;

a collection portion in fluid communication with the support and being integral therewith, the collection portion having a first rigid axial end portion, a second expandable axial end portion, and a circumference relatively larger than that of the support while being sized to be swallowed by the patient,

a first set of projections positioned on the second axial end portion in spaced relation to one another and being arranged in rows, each of the projections respectively defining a proximally facing cup having sidewalls to collect, receive, and hold the biological sample when the device is moved axially in a proximal direction along a site of interest; and

circumferentially extending ribs which extend between adjacent rows of the rows of the first set of projections.

2. A device for collecting a biological sample as set forth in claim 1 , wherein the second axial end portion includes a collapsed position and an expanded position, the second axial end portion being capable of 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, each of the projections being designed to collect, receive, and hold the biological sample when the device is in the expanded position and is moved axially in the proximal direction along the site of interest.

3. A device for collecting a biological sample as set forth in claim 2 wherein each of the first set of projections respectively define the proximally facing cup when in the expanded position and a distally facing cup when in the collapsed position.

4. A device for collecting a biological sample as set forth in claim 1 wherein the sidewalls of the proximally facing cup, of each projection of the first set of projections, converge to form a V-shape.

5. A device for collecting a biological sample as set forth in claim 1 wherein the sidewalls of the projections of the first set of projections taper toward each other as the sidewalls extend radially outward from the collection portion.

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

providing a support through which fluid can be directed from a source and a collection portion in fluid communication with the support and being integral therewith, the collection portion having a circumference relatively larger than that of the support, a first rigid axial end portion, and a second expandable axial end portion having a collapsed position extending axially into the first axial end portion, the second axial end portion including a first set of tissue collecting projections, in spaced relation to one another and being arranged in rows, and circumferentially extending ribs which extend between adjacent rows of the rows of the first set of projections;

moving the support and the collection portion into the lumen of the patient, by swallowing of the collection portion, the second axial end portion is advanced into the lumen of the patient in the collapsed position;

axially moving the second axial end portion relative to the first axial end portion from the collapsed position into an expanded position to expose the first set of tissue collecting projections, each of the projections respectively defining a proximally facing cup having sidewalls to collect, receive, and hold the biological sample while in the expanded position;

collecting the biological sample with the first set of tissue collecting projections of the second axial end portion when the second axial end portion is in the expanded position;

collapsing the second axial end portion into the first axial end portion; and

withdrawing the collection portion from the lumen of the patient.

7. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the first set of tissue collecting projections engage a surface of the collection site of the lumen of the patient to collect the biological sample.

8. A method for collecting a biological sample from a lumen as set forth in claim 7 wherein the step of collapsing the second axial end portion into the first axial end portion includes cupping the collected biological sample with the first set of tissue collecting projections.

9. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of collecting the biological sample includes collecting cells.

10. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of collecting the biological sample includes collecting DNA and/or RNA.

11. A method for collecting a biological sample from a lumen as set forth in claim 6 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.

12. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of collapsing the second axial end portion includes moving the second axial end portion from a convex shape to a concave shape.

13. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of collapsing the second axial end portion includes causing the first set of tissue collecting projections of the second axial end portion facing radially outwardly when the second axial end portion is in the expanded position to face radially inwardly when the second axial end portion is in the collapsed position.

14. A method for collecting a biological sample from a lumen as set forth in claim 6 ,

wherein the lumen is an esophagus of the patient.

15. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of withdrawing the collection portion from the lumen of the patient includes preventing the second axial end portion of the collection portion from engaging the lumen at an area different from the collection site.

16. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein the step of collapsing the second axial end portion into the first axial end portion includes applying a vacuum to the second axial end portion and the step of axially moving the second axial end portion relative to the first axial end portion from the collapsed position into the expanded position includes applying pressurized air to the collection portion.

17. A method for collecting a biological sample from a lumen as set forth in claim 6 wherein each of the first set of tissue collecting projections respectively define a distally facing cup when in the collapsed position.

18. A sample collection device for collecting a sample in a patient, the device comprising

a support through which fluid can be directed from a source;

a collection portion in fluid communication with the support and being integral therewith, the collection portion having a first rigid axial end portion, a second expandable axial end portion, and a circumference relatively larger than that of the support while being configured to be swallowed by the patient;

a first set of projections and a second set of projections each positioned on the second axial end portion, the first set of projections in spaced relation to one another and being arranged in rows, the first set of projections and the second set of projections having different shapes, each of the first set of projections respectively defining a proximally facing cup having sidewalls to collect, receive and hold the sample when the device is moved axially in a proximal direction within the patient; and

circumferentially extending ribs which extend between adjacent rows of the rows of the first set of projections.

19. A sample collection device for collecting a sample as set forth in claim 18 , wherein the second axial end portion includes a collapsed position and an expanded position, the second axial end portion being capable of 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.

20. A sample collection device for collecting a sample as set forth in claim 19 , wherein each of the second set of projections respectively define a proximally facing cup when in the expanded position and a distally facing cup when in the collapsed position.

21. A sample collection device for collecting a sample as set forth in claim 18 , wherein the first set of projections in a row adjacent to the second set of projections are offset from one another on the second axial end portion.

22. A sample collection device for collecting a sample as set forth in claim 18 , wherein the second set of projections is a plurality of sets of projections and each respective set of projections of the second set of projections is axially aligned at different axial locations on the second axial end portion.

Assignments (3)

Continuity (4)

References Cited (118)