FRICTIONAL TRANS-EPITHELIAL TISSUE DISRUPTION COLLECTION APPARATUS AND METHOD OF INDUCING AN IMMUNE RESPONSE

• US 20110172557A1
• Filed: 03/28/2011
• Published: 07/14/2011
• Est. Priority Date: 07/17/2007
• Status: Active Grant

• Current Assignee: Histologics LLC
• Original Assignee: Histologics LLC
• Inventors: Lonky, Neal M., Lonky, Martin L.
• Granted Patent: US 8,795,197 B2
• Time in Patent Office: Days
• US Class Current: 600/569
• 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 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2017/320008 Scrapers

Abstract

In an embodiment of the invention, a frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain tissue biopsy samples. A frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device is narrow and pointed with a hybrid pear shaped diamond facet. Abrasive material can be adhered to the facet.

Claims

1. A device for obtaining a biopsy tissue sample comprising:

(a) a handle including a proximal end and a distal end, wherein the handle has a first principal axis of rotation, wherein the principal axis of rotation bisects the proximal end of the handle and the distal end of the handle;

(b) a head with a proximal end and a distal end, wherein the proximal end of the head is attached to the distal end of the handle;

(c) at least a first facet associated with the head; and

(d) an abrasive material, wherein the abrasive material is attached to at least the first facet.

2. The device of claim 1, wherein the abrasive material includes a plurality of loops to frictionally abrade tissue.

3. The device of claim 2, wherein the length of the plurality of loops are between:

a lower limit of approximately 3.1 mm; and

an upper limit of approximately 25 mm.

4. The device of claim 2, wherein the distance from the top of the loop to the bottom of the hook relative to the length of the loop is between:

a lower limit of approximately 10%; and

an upper limit of approximately 20%.

5. The device of claim 1, wherein the first facet has a top position and a bottom position, wherein the top position is closest to the proximal end of the head and the bottom position is closest to the distal end of the head, wherein the first facet has a second principal axis of rotation, wherein the second principal axis of rotation intersects the top position and the bottom position.

6. The device of claim 5, wherein the second principal axis of rotation is at an angle relative to the first principal axis of rotation of the handle of between:

a lower limit of approximately 2 degrees; and

an upper limit of approximately 30 degrees.

7. The device of claim 5, wherein the second principal axis of rotation is at an angle relative to the first principal axis of rotation of the handle of between:

a lower limit of approximately 3 degrees; and

an upper limit of approximately 9 degrees.

8. The device of claim 5, wherein the second principal axis of rotation is parallel with the first principal axis of rotation of the handle.

9. The device of claim 5, wherein the second principal axis of rotation is coincident with the first principal axis of rotation.

10. The device of claim 1, wherein at least the first facet has a shape selected from the group consisting of pear-shaped, triangular, diamond and hybrid diamond-pear-shape.

11. The device of claim 1, wherein the radius of curvature of the head is between:

a lower limit of approximately 5×

10<sup>−

4</sup> m; and

an upper limit of approximately 5×

10<sup>−

3</sup> m.

12. The device of claim 1, wherein the head has a perimeter at the distal end and a perimeter at the proximal end, wherein the perimeter at the distal end of the head is smaller than the perimeter at the proximal end of the head.

13. The device of claim 5, wherein the distance between the top position and the bottom position is between:

a lower limit of approximately 4×

10<sup>−

3</sup> m; and

an upper limit of approximately 3×

10<sup>−

2</sup> m.

14. The device of claim 5, wherein the top position is coincident with the distal end of the head.

15. A method of obtaining a biopsy sample in a fixing solution comprising:

(a) selecting a Frictional Tissue Sampling and Collection (FTSC) head with an associated facet, wherein the FTSC head is received in a handle, wherein the handle has an axis of rotation, wherein one or more of the FTSC head size, FTSC head shape, facet size and facet shape are selected based on the nature of the biopsy sampling location to be sampled;

(b) placing the head of the FTSC device on a biopsy sampling location;

(c) rotating around the axis of rotation in a first direction one or both the handle and the FTSC head to frictionally abrade the biopsy sampling location;

(d) removing the FTSC head from the biopsy sampling location;

(e) using a comb to remove tissue obtained from the biopsy sampling location, wherein the tissue is removed by brushing the head in a second direction, wherein the second direction is opposite of the first direction; and

(f) depositing the tissue removed from combing the head in step (e) in a fixing solution.

16. The method of claim 15, wherein the two or more facets are associated with the FTSC head.

17. A device for obtaining a biopsy tissue sample comprising:

(a) a head including a proximal end and a distal end, wherein the head has a first maximum diameter;

(b) a facet extending from the head, wherein the facet has a second maximum diameter, wherein the second maximum diameter is at least 1 mm less than the first maximum diameter;

(b) a handle with a proximal and a distal end, wherein the proximal end of the head is connected to the distal end of the handle; and

(c) an abrasive material, wherein the abrasive material is attached to the facet.

18. The device of claim 17, further comprising two or more facets extending from the head, wherein at least one facet extends from the distal end of the head.

19. The device of claim 18, further comprising the abrasive material attached to the at least one facet extending from the distal end of the head.

20. The device of claim 18, wherein the abrasive material is affixed to at least two facets.