Breast biopsy system and method

• US 6,331,166 B1
• Filed: 04/08/1998
• Issued: 12/18/2001
• Est. Priority Date: 03/03/1998
• Status: Expired due to Term

• Current Assignee: Biopsolation Medical, Inc.
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Jones, Michael L., Burbank, Fred H., Lubock, Paul
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/057,303
• Time in Patent Office: 1,350 Days
• Field of Search: 600/564-567, 606/45-52
• US Class Current: 600/567
• 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 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• 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 2018/162 : located on the probe body
• CPC Class Codes: A61B 2090/3908 : Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/17 : for soft tissue, e.g. breast-holding devices
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

An apparatus and method are provided for precisely isolating a target lesion in a patient'"'"'s body tissue, resulting in a high likelihood of “clean” margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to both diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizing the risk of migration of possibly cancerous cells from the lesion to surrounding tissue or the bloodstream. In particular, the apparatus comprises a biopsy instrument having a distal end adapted for entry into the patient'"'"'s body, a longitudinal shaft, and a cutting element disposed along the shaft. The cutting element is actuatable between a radially retracted position and a radially extended position. Advantageously, the instrument is rotatable about its axis in the radially extended position to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about the tissue specimen. Once the tissue specimen is isolated, it may be segmented by further manipulation of the cutting element, after which the tissue segments are preferably individually removed from the patient'"'"'s body through a cannula or the like. Alternatively, the specimen may be encapsulated and removed as an intact piece.

Claims

1. A biopsy instrument for isolating body tissue, comprising:

an elongate shaft having a longitudinal axis and a distal end;

an electrosurgical tissue cutting element having a curvilinear cutting surface secured to the distal end of the shaft; and

a proximal tissue cutting, element disposed on the elongate shaft proximal of the distal tissue cutting element which is radially extendable from a radially retracted position to a radially extended position, relative to the longitudinal axis, having an arcuate shape and being movable in said radially extended position and arcuate shape to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen.

2. The biopsy instrument as recited in claim 1, wherein the proximal tissue cutting element is rotatable about the longitudinal axis while in the radially extended position to isolate said desired tissue specimen.

3. The biopsy instrument as recited in claim 1, wherein the proximal tissue cutting element can be actuated to cut tissue independent of the distal tissue cutting element.

4. The biopsy instrument as recited in claim 1, wherein the electrosurgical distal tissue cutting element comprises a monopolar electrode.

5. The biopsy instrument as recited in claim 1, wherein the proximal tissue cutting element comprises an electrosurgical cutting element.

6. The biopsy instrument as recited in claim 5, wherein the electrosurgical proximal tissue cutting element comprises a monopolar electrode.

7. The biopsy instrument as recited in claim 5, wherein the electrosurgical proximal tissue cutting element comprises a bipolar electrode.

8. The biopsy instrument as recited in claim 7, wherein a portion of said shaft comprises a return electrode of the bipolar instrument.

9. The biopsy instrument as recited in claim 1, and further comprising a sheath which is axially movable between distal and proximal positions for selectively covering and uncovering the proximal tissue cutting element.

10. The biopsy instrument as recited in claim 9, and further comprising a proximal driver unit for controlling radial expansion and retraction of the proximal tissue cutting element and rotation of the proximal tissue cutting element about the longitudinal axis.

11. The biopsy instrument as recited in claim 10, wherein the proximal driver unit further controls axial movement of said shaft and axial movement of said sheath.

12. The biopsy instrument as recited in claim 5, wherein the electrosurgical proximal tissue cutting element is configured to be manipulated to segment said tissue specimen after it has been isolated from the surrounding tissue.

13. The biopsy instrument as recited in claim 12, wherein the electrosurgical proximal tissue cutting element is configured to segment the tissue specimen as it is being retracted from said radially extended position to said radially retracted position.

14. The biopsy instrument as recited in claim 13, wherein said radially extended position comprises a first radially extended position, and said electrosurgical proximal tissue cutting element is further actuatable to a plurality of additional radially extended positions, said electrosurgical proximal tissue cutting element being rotatable about the longitudinal axis in each of said radially extended positions to selectively peripherally segment said tissue specimen.

15. The biopsy instrument as recited in claim 12, and further comprising a cannula having a lumen for providing a passageway into the patient'"'"'s body, the segments of said tissue specimen being removable from the patient'"'"'s body through said cannula.

16. A method for isolating a tissue specimen in a patient'"'"'s body, comprising:

a) inserting into the patient'"'"'s body a biopsy instrument for isolating body tissue, comprising;

an elongate shaft having a longitudinal axis and a distal end;

an electrosurgical tissue cutting element having a curvilinear cutting surface secured to the distal end of the shaft; and

a proximal tissue cutting element disposed on the elongated shaft proximal of the distal tissue cutting element which is radially extendable from a radially retracted position to a radially extended position, relative to the longitudinal axis, having an arcuate shape and being movable in said radially extended position and arcuate shape to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen;

b) advancing the biopsy instrument in the patient'"'"'s body until the distal end is disposed in a tissue region from which the tissue specimen is to be isolated;

c) energizing the proximal tissue cutting element with RF energy and radially extending said proximal tissue cutting element so that an arcuate portion thereof is radially outwardly spaced from the longitudinal axis of said shaft; and

d) rotating said proximal tissue cutting element about the longitudinal axis to cut said tissue and create a peripheral boundary about said tissue specimen, to isolate the tissue specimen from surrounding tissue in the tissue region.

17. The method as recited in claim 16, and further comprising segmenting said tissue specimen.

18. The method as recited in claim 17, and further comprising withdrawing each segment of said tissue specimen through a cannula lumen.

19. The method as recited in claim 17, wherein segmenting said tissue specimen includes radially retracting said proximal tissue cutting element so that the tissue specimen is segmented radially.

20. The method as recited in claim 17, wherein segmenting said tissue specimen includes partially radially retracting said proximal tissue cutting element from its fully radially expanded position and rotating the instrument about the longitudinal axis to cut said tissue and create a circumferential tissue segment.

21. The method as recited in claim 20, wherein segmenting is repeated at differing partially radially expanded positions of the proximal tissue cutting element, so that a plurality of circumferential tissue segments are created.

22. The method as recited in claim 16, and further comprising simultaneously moving the proximal tissue cutting element axially as it is rotated about said longitudinal axis to cut said tissue.

23. The method of claim 16 further comprising retrieving the tissue specimen from the patient'"'"'s body after it has been isolated.

24. A biopsy instrument for isolating body tissue, comprising:

an elongate shaft having a longitudinal axis and a distal end;

a distal tissue cutting element having a linear cutting surface disposed on the distal end of the shaft; and

an electrosurgical proximal tissue cutting element disposed on the elongate shaft proximal of the distal tissue cutting element which is radially extendable from a radially retracted position to a radially extended position, relative to the longitudinal axis, having an arcuate shape and being movable in said radially extended position and arcuate shape to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen.

25. The biopsy instrument as recited in claim 24, wherein the electrosurgical proximal tissue cutting element can be actuated to cut tissue independent of the distal tissue cutting element.

26. The biopsy instrument as recited in claim 24, wherein the electrosurgical proximal tissue cutting element comprises a monopolar electrode.

27. A method for isolating a tissue specimen in a patient'"'"'s body, comprising:

a) inserting into the patient'"'"'s body a biopsy instrument for isolating body tissue, comprising;

an elongate shaft having a longitudinal axis and a distal end;

a distal tissue cutting element having a curvilinear cutting surface disposed on the distal end of the shaft; and

an electrosurgical proximal tissue cutting element disposed on the elongate shaft proximal of the distal tissue cutting element which is radially extendable from a radially retracted position to a radially extended position, relative to the longitudinal axis, and being movable in said radially extended position to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen;

b) advancing the biopsy instrument in the patient'"'"'s body until the distal end is disposed in a tissue region from which the tissue specimen is to be isolated;

c) energizing the proximal tissue cutting element with RF energy and radially extending said proximal tissue cutting element so that an arcuate portion thereof is radially outwardly spaced from the longitudinal axis of said shaft; and

d) rotating said proximal tissue cutting element about the longitudinal axis to cut said tissue and create a peripheral boundary about said tissue specimen, to isolate the tissue specimen from surrounding tissue in the tissue region.

28. The method as recited in claim 27, and further comprising segmenting said tissue specimen.

29. The method as recited in claim 28, and further comprising withdrawing each segment of said tissue specimen through a cannula lumen.

30. The method as recited in claim 28, wherein segmenting said tissue specimen includes radially retracting said electrosurgical proximal tissue cutting element so that the tissue specimen is segmented radially.

31. The method as recited in claim 28, wherein segmenting said tissue specimen includes partially radially retracting said electrosurgical proximal tissue cutting element from its fully radially expanded position and rotating the instrument about the longitudinal axis cut said tissue and create a circumferential tissue segment.

32. The method as recited in claim 31, wherein segmenting is repeated at differing partially radially expanded positions of the electrosurgical proximal tissue cutting element, so that a plurality of circumferential tissue segments are created.

33. The method as recited in claim 27, and further comprising simultaneously moving the proximal tissue cutting element axially as it is rotated about said longitudinal axis to cut said tissue.