Breast biopsy system and methods

• US 20020072688A1
• Filed: 08/13/2001
• Published: 06/13/2002
• Est. Priority Date: 03/03/1998
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Jones, Michael L., Burbank, Fred H., Lubock, Paul
• Granted Patent: US 7,322,938 B2
• Time in Patent Office: Days
• 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 retrieving body tissue, having a longitudinal axis and comprising:

a distal end adapted for entry into a patient'"'"'s body; and

a cutting element disposed on said instrument, said cutting element being actuatable between a radially retracted position and a radially extended position, relative to said 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.

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

3. The biopsy instrument as recited in claim 1, wherein said cutting element is movable axially in said radially extended position to isolate said desired tissue specimen.

4. The biopsy instrument as recited in claim 1, said distal end comprising an electrosurgical cutting element for cutting tissue and facilitating advancement of said instrument into the patient'"'"'s body.

5. The biopsy instrument as recited in claim 2, and further comprising a shaft disposed along said axis.

6. The biopsy instrument as recited in claim 5, wherein said cutting element comprises an electrosurgical cutting element.

7. The biopsy instrument as recited in claim 5, said instrument comprising a monopolar instrument wherein the electrosurgical cutting element comprises an active electrode thereof.

8. The biopsy instrument as recited in claim 5, said instrument comprising a bipolar instrument wherein the electrosurgical cutting element comprises an active electrode thereof.

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

10. The biopsy instrument as recited in claim 5, and further comprising a sheath which is axially movable between distal and proximal positions for selectively covering and uncovering the cutting element.

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

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

13. The biopsy instrument as recited in claim 5, wherein said cutting element