Excisional biopsy devices and methods

• US 7,303,531 B2
• Filed: 03/08/2004
• Issued: 12/04/2007
• 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
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/796,328
• Publication Number:
  US 20040176789A1
• Time in Patent Office: 1,366 Days
• Field of Search: 606/159, 606/170, 606/167, 606/169, 606/180, 600/564, 600/565, 600/566, 600/567, 600/562, 128/898
• US Class Current: 600/564
• 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 10/0275 with sample notch, e.g. on the side of inner stylet
• 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 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2018/00011 with fluids
• 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
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/461 Displaying means of special interest

Abstract

An excisional biopsy device includes a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed. An excision al biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer may be disposed within a removable transducer core adapted to fit within the tubular member.

Claims

1. A method of removing a tissue specimen from a patient, comprising the steps of:

providing a device that includes a shaft having an outer surface that defines an outer perimeter, the device further including a tissue collection element coupled to the shaft;

introducing the device into the patient;

moving the tissue collection element to collect and encapsulate the tissue specimen such that the collected and encapsulated tissue specimen is disposed along the shaft and outside of the outer perimeter of the shaft, and

removing the device from the breast tissue with the collected specimen.

2. The method of claim 1, wherein the providing step is carried out such that the tissue collection element is configured to isolate the collected tissue specimen from the patient.

3. The method of claim 1, wherein the providing step is carried out such that the shaft defines a longitudinal shaft axis and wherein the longitudinal shaft axis does not intersect the collected tissue specimen.

4. The method of claim 1, wherein the providing step is carried out such that the device further includes a cutting element that is configured to cut the tissue specimen from the patient.