Excisional biopsy devices and methods

• US 6,022,362 A
• Filed: 09/03/1998
• Issued: 02/08/2000
• 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
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/146,743
• Time in Patent Office: 523 Days
• Field of Search: 606/159, 606/170, 606/171, 606/167, 606/180, 600/564, 600/565, 600/566, 600/567, 128/898
• US Class Current: 606/159
• 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 excisional 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. An excisional biopsy device, comprising:

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 severed by the cutting tool as the biopsy device is rotated and the cutting tool is bowed.

2. The excisional biopsy device of claim 1, wherein the distal portion of the cutting tool comprises a thin ribbon sharpened on a leading edge thereof.

3. The excisional biopsy device of claim 2, wherein the leading edge of the thin ribbon is serrated.

4. The excisional biopsy device of claim 1, wherein the tubular member comprises an internal guide allowing a proximal portion of the cutting tool to slide therein when a proximal end of the cutting tool is pushed in a distal direction or pulled in a proximal direction.

5. The excisional biopsy device of claim 1, wherein the cutting tool further comprises:

an interior lumen; and

a plurality of through holes in the distal portion thereof, the through holes being in fluid communication with the interior lumen.

6. The excisional biopsy device of claim 1, wherein the tissue collection device comprises a bag within which the severed tissue is collected.

7. The excisional biopsy device of claim 6, wherein an opening of the bag is at least co-extensive with the window in the tubular member.

8. The excisional biopsy device of claim 1, wherein the tissue collection device is configured to open and to close as the cutting tool is selectively bowed and retracted, respectively.

9. The excisional biopsy device of claim 8, wherein the tissue collection device comprises a bag attached to the tubular member and to a trailing edge of the distal portion of the cutting tool, the bag opening and closing as the cutting tool is bowed and retracted, respectively.

10. The excisional biopsy device of claim 1, further comprising an ultrasound sensor mounted within a distal portion of the tubular member, the ultrasound sensor being disposed within the tubular member so as to image tissue about to be cut by the cutting tool as the biopsy device is rotated.

11. The excisional biopsy device of claim 10, wherein the ultrasound sensor is electrically connected to at least one data processing and display device to allow one of a real time and near real time graphical representation of the tissue to be cut.

12. The excisional biopsy device of claim 1, wherein the distal portion of the cutting tool is electrically connected to an RF power source.

13. The excisional biopsy device of claim 12, wherein the distal portion of the cutting tool comprises a thin wire.

14. An excisional biopsy device, comprising:

a tubular member having a first and a second window near a distal tip thereof;

a cutting tool configured to selectively bow out of the first window and to retract within the first window; and

a removable transducer core, the transducer core including an active transducer element configured to face out of the second window when the removable transducer core is fitted within the tubular member.

15. The device of claim 14, wherein the removable core is adapted to snap fit within the tubular member.

16. The device of claim 14, wherein the active transducer element includes an ultrasound transducer.

17. The device of claim 14, wherein the removable transducer core comprises a tapered distal tip configured to readily penetrate soft tissue.

18. The device of claim 14, further comprising an external tissue collection device attached at least to the cutting tool.

19. The device of claim 18, wherein the tubular member further comprises a recessed section adjacent a trailing edge of the cutting tool, the recessed section being adapted to receive the external tissue collection device.

20. The device of claim 14, further comprising an expandable sheath, the expandable sheath being adapted to receive the removable transducer core and the tubular member.

21. An excisional biopsy device, comprising:

a single use disposable tubular member having a window near a distal tip thereof, the tubular member including 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 single use disposable tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue severed by the cutting tool as the biopsy device is rotated and the cutting tool is bowed.

22. An excisional biopsy device, comprising:

a single use disposable tubular member having a first and a second window near a distal tip thereof, the tubular member including a cutting tool configured to selectively bow out of the first window and to retract within the first window; and

a removable transducer core, the transducer core including an active transducer element configured to face out of the second window when the removable transducer core is fitted within the tubular member.