Excisional biopsy devices and methods

• US 6,863,676 B2
• Filed: 01/31/2002
• Issued: 03/08/2005
• 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:
  US10/066,353
• Publication Number:
  US 20020077648A1
• Time in Patent Office: 1,132 Days
• Field of Search: 606/159, 606/170, 606/180, 606/114, 606/127, 600564-567
• 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 specimen of breast tissue that is cut from surrounding breast tissue, comprising the steps of:

providing a device that includes a shaft and a tissue collection element coupled to the shaft, the tissue collection clement including a thin flexible membrane and being movable between a retracted position to an expanded position;

introducing the device into the breast tissue with the tissue collection element in the retracted position;

expanding the tissue collection element to the expanded position after the introducing step;

moving the tissue collection element to capture the cut specimen;

encapsulating the cut specimen with the thin flexible membrane while maintaining the cut specimen intact and isolating the captured specimen from contact with the surrounding breast tissue and returning the tissue collection element to the refracted position while maintaining the cut specimen intact and encapsulated;

removing the device from the breast tissue while the specimen remains encapsulated within the thin flexible membrane of the retracted tissue collection element.

2. The method of claim 1, wherein the providing step is carried out with the tissue collection element including a flexible element to which the thin flexible membrane is attached and wherein the expanding step is carried out with the tissue collection element bowing away from the shaft.

3. The method of claim 2, wherein the encapsulating step is carried out with the thin flexible membrane forming a bag.

4. The method of claim 3, wherein the bag is configured to selectively open to capture the cut specimen and close to encapsulate the cut specimen as the tissue collection element bows away from and back toward the shaft, respectively.

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

6. The method of claim 1, wherein the moving step is carried out with the tissue collection element moving along an arc.

7. 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 cut specimen.

8. 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 cut specimen; and

the moving step includes rotating the shaft about the longitudinal axis while moving the tissue collection element from the retracted position to the expanded and back to the retracted position to capture and encapsulate the cut specimen as the shaft rotates.