Excisional biopsy devices and methods

• US 6,440,147 B1
• Filed: 05/04/2000
• Issued: 08/27/2002
• Est. Priority Date: 09/03/1998
• Status: Expired due to Term

• 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:
  US09/565,611
• Time in Patent Office: 845 Days
• Field of Search: 606/159, 606/170, 606/169, 606/180, 606/167, 604/22, 600/564, 600/565, 600/566, 600/567
• 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 removing a piece of breast tissue, comprising the steps of:

providing a breast tissue removal device having a shaft and a cutting element coupled to the shaft the breast tissue removal device also having a tissue collection element;

introducing the breast tissue removal device into a breast with the cutting element in a collapsed condition;

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

moving the cutting element to cut a portion of the breast tissue from surrounding breast tissue;

expanding the tissue collection element to surround the portion of breast tissue and isolate the portion of the breast tissue from contact with the surrounding breast tissue; and

removing the portion of the breast tissue while the portion of the breast tissue is contained within the tissue collection element and isolated from the surrounding breast tissue.

2. The method of claim 1, wherein:

the providing step is carried out with the tissue collection element being coupled to the cutting element.

3. The method of claim 1, wherein:

the providing step is carried out with the tissue collection element being independently movable relative to the cutting element.

4. The method of claim 1, wherein:

the providing step is carried out with the cutting element being a flexible element; and

the expanding step is carried out with the cutting element bowing outward.

5. The method of claim 1, wherein:

the moving step is carried out by rotating the shaft.

6. The method of claim 1, wherein:

the moving step is carried out with the cutting element moving along an arc.

7. The method of claim 6, wherein:

the moving step includes the step moving the cutting element toward a collapsed position after the cutting element moves along the arc.

8. The method of claim 1, wherein:

the encapsulating step is carried out with the tissue collection element being a bag.

9. The method of claim 1, wherein:

the encapsulating step is carried out with the tissue collection element being a flexible membrane.

10. The method of claim 1, wherein:

the expanding and moving steps are carried out with the cutting element being energized.

11. The method of claim 10, wherein:

the expanding and moving steps are carried out with the cutting element being energized with RF energy.

12. The method of claim 1, wherein:

the encapsulating step is carried out with the tissue collection element expanding to a size substantially equal to the size of the portion of the breast tissue.

13. The method of claim 1, wherein:

the introducing step is carried out with the shaft having a longitudinal axis, wherein the portion of the breast tissue to be cut is positioned along a side of the shaft; and

the moving step is carried out by rotating the shaft so that the cutting element moves along an arc to cut the portion of the breast tissue for removal.