Excisional biopsy devices and methods

• US 6,689,145 B2
• Filed: 01/31/2002
• Issued: 02/10/2004
• Est. Priority Date: 09/03/1998
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Vetter, James W., Lee, Roberta, Chernomorsky, Ary S.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/066,428
• Publication Number:
  US 20020099399A1
• Time in Patent Office: 740 Days
• Field of Search: 606/159, 606/167, 606/170, 606/169, 600/562, 600/564-567
• US Class Current: 606/159
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• 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 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

An excisional biopsy system includes a tubular member that has a proximal end and a distal end in which one or more windows are defined. A first removable probe has a proximal portion that includes a cutting tool extender and a distal portion that includes a cutting tool. The first removable probe may be configured to fit at least partially within the tubular member to enable the cutting tool to selectively bow out of and to retract within one of the windows when the cutting tool extender is activated. A second removable probe has a proximal section that includes a tissue collection device extender and a distal section that includes a tissue collection device. The second removable probe may also be configured to fit at least partially within the tubular member to enable the tissue collection device to extend out of and to retract within one of the windows when the tissue collection device extender is activated. A third removable probe may also be provided. The third removable probe may also be configured to fit at least partially within the tubular member and may include an imaging device, such as an ultrasound transducer, mounted therein. By selectively activating the cutting tool and the tissue collection device while rotating the excisional device, a tissue specimen may be cut from the surrounding tissue and collected for later analysis.

Claims

1. A method of cutting and removing a specimen of breast tissue, comprising the steps of:

providing an excisional device that includes a shaft, a cutting element coupled to the shaft and a tissue collection element coupled to the shaft, the tissue collection element being independently movable relative to the cutting element, both the cutting element and the tissue collection element being movable from a retracted position to an expanded position;

introducing the excisional device into the breast tissue with the tissue collection and cutting elements both in the retracted position;

expanding the cutting element to the expanded position after the introducing step;

moving the cutting element to cut the specimen from the breast tissue;

encapsulating the cut specimen with the tissue collection element while maintaining the cut specimen intact; and

removing the excisional device from the breast tissue while the specimen remains encapsulated within the tissue collection element.

2. The method of claim 1, wherein the expanding step is carried out by expanding the cutting element without expanding the tissue collection element.

3. The method of claim 1, wherein the encapsulating step includes a step of returning the tissue collection element to the retracted position while maintaining the cut specimen intact and encapsulated.

4. The method of claim 1, wherein the encapsulating step is carried out with the tissue collection element following a path traveled by the cutting element during the moving step.

5. The method of claim 1, wherein the tissue collection element and the cutting element are expanded and retracted together.

6. The method of claim 1, wherein the tissue collection element and the cutting element are expanded and retracted independently.

7. The method of claim 1, wherein the providing step is carried out with the excisional device including a first actuator for actuating the cutting element and a second actuator for actuating the tissue collection element.

8. The method of claim 1, wherein the providing step is carried out with the cutting element including a flexible element and wherein the expanding step is carried out with the cutting element bowing away from the shaft.

9. The method of claim 1, wherein the moving step includes rotating the shaft.

10. The method of claim 1, wherein the moving step is carried out with the cutting element moving along an arc.

11. The method of claim 10, wherein the moving step is carried out by moving the cutting element toward the collapsed position after the cutting element moves along the arc.

12. The method of claim 1, wherein the encapsulating step is carried out with the tissue collection element including a bag.

13. The method of claim 1, wherein the encapsulating step is carried out with the tissue collection element including a thin, flexible membrane.

14. The method of claim 13, wherein the encapsulating step is carried out with the thin, flexible membrane being non-porous and preventing fluid and cell leakage to insure isolation of the cut tissue specimen from the surrounding breast tissue.

15. The method of claim 1, wherein the expanding and moving steps are carried out with the cutting element being energized.

16. The method of claim 15, wherein the expanding and moving steps are carried out with the cutting element being energized with RF energy.

17. The method of claim 1, wherein the encapsulating step is carried out to isolate the specimen of the breast tissue from contact with the surrounding tissue.

18. The method of claim 1, wherein the encapsulating step is carried out with the tissue collection element expanding to a size at least equal to the size of the specimen of the breast tissue.

19. The method of claim 1, wherein the shaft defines a longitudinal axis and wherein:

the introducing step includes positioning the shaft along side of the specimen to be cut; and

the moving step includes rotating the shaft about the longitudinal axis so that the cutting element cuts the specimen the breast tissue as the shaft rotates.

20. A excisional device for cutting and removing a specimen of breast tissue, comprising:

a shaft;

a cutting element coupled to the shaft and configured to cut the specimen of breast tissue from surrounding breast tissue;

a tissue collection element coupled to the shaft, the tissue collection element being configured to encapsulate the cut specimen, isolate the cut specimen from the surrounding breast tissue, and maintain the encapsulated specimen intact, the tissue collection element being independently movable relative to the cutting element, both the cutting element and the tissue collection element being movable from a refracted position to an expanded position.

21. The device of claim 20, wherein the cutting element is configured to move to the expanded position while the tissue collection device remains in the retracted position or is in the expanded position.

22. The device of claim 20, further including a first actuator for actuating the cutting element and a second actuator for actuating the tissue collection element.

23. The device of claim 20, wherein the tissue collection element and the cutting element are configured to expand and retract together.

24. The device of claim 20, wherein the tissue collection element and the cutting element are configured to independently expand and retract.

25. The device of claim 20, wherein the cutting element including a flexible element and wherein the flexible element is bowed away from the shaft when the cutting element is in the expanded position.

26. The device of claim 20, wherein the cutting element includes a bag, the bag being open when the tissue collection element is in the expanded position and closed when the tissue collection element is in the retracted position.

27. The device of claim 20, wherein the tissue collection device includes a thin, flexible membrane.

28. The device of claim 20, wherein the thin, flexible membrane is non-porous and prevents fluid and cell leakage to insure isolation of the cut tissue specimen from the surrounding breast tissue.

29. The device of claim 20, wherein the tissue collection element is configured to expand to a size that is at least equal to a size of the cut specimen.