Excisional biopsy device and methods

• US 6,849,080 B2
• Filed: 01/31/2002
• Issued: 02/01/2005
• 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
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/066,437
• Publication Number:
  US 20020123762A1
• Time in Patent Office: 1,097 Days
• Field of Search: 606/159, 606/167, 606/170, 606/180, 600564-567
• 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. A breast tissue treatment device, comprising:

a shaft having a window near a distal tip thereof;

a tissue cutting tool, the cutting tool being attached near the distal tip of the shalt, the cutting tool being configured to selectively bow out of the window and to retract within the window; and

a tissue collection and isolation device, the tissue collection and isolation device being configured to collect tissue cut by the tissue cutting tool and to physically isolate the collected tissue from a surrounding tissue.

2. The device of claim 1, wherein the tissue cutting tool is configured to be energized by an RF energy source.

3. The device of claim 1, wherein the tissue collection device includes a thin flexible membrane.

4. The device of claim 3, wherein the thin flexible membrane is impermeable.

5. The device of claim 3, wherein the thin flexible membrane includes a polymer.

6. The device of claim 3, wherein the thin flexible membrane is shaped like a bag.

7. The device of claim 1, wherein the tissue collection and isolation device is configured to selectively open and close.

8. The device of claim 1, wherein the tissue collection and isolation device is configured to selectively bow out away from the shalt and to retract back toward the shaft.

9. The device of claim 8, wherein the tissue collection and isolation device is further configured to lay substantially flat against the shaft when in a retracted position.

10. The device of claim 1, wherein the shaft includes a first portion that is configured to remain outside the tissue and a second portion that is configured to penetrate the tissue, the first portion having a greater diameter than the second portion.

11. The device of claim 1, wherein the tissue collection device includes a thin flexible membrane configured to surround the collected tissue.

12. A method of retrieving a specimen from a mass of tissue, including the steps of:

inserting an instrument that includes a cutting clement and a tissue collection and isolation element into the mass of tissue, the cutting element being configured to cut the specimen from the mass of tissue and the tissue collection and isolation element being configured to collect the specimen and to physically isolate the specimen from the mass of tissue;

cutting the specimen, and

collecting the cut specimen and physically isolating the specimen from the mass of tissue.

13. The method of claim 12, wherein the collecting and isolating step includes steps of:

sequentially extending the tissue collection and isolation element to collect the specimen, and

retracting the tissue collection and isolation element to isolate the collected specimen from the mass of issue.

14. The method of claim 12, wherein isolating step includes a step of drawing a flexible membrane around the cut specimen.

15. The method of claim 14, wherein the flexible membrane includes at least one of plastic and nylon.

16. The method of claim 14, wherein the flexible membrane is shaped like a bag.

17. The method of claim 12, wherein the specimen includes a lesion and wherein the cutting step cuts a margin of healthy tissue around the specimen.

18. The method of claim 12, wherein the cutting and collecting and isolating steps preserves a tissue architecture of the collected and isolated specimen.

19. A tissue treatment device, comprising:

a shaft defining a proximal and a distal end;

a tissue treatment assembly attached near the distal end of the shaft and including a first tool configured to cut the tissue and a second tool configured to collect the cut tissue and to isolate the collected tissue from a surrounding tissue, the first tool being configured to selectively extend away from the shaft and to refract toward the shaft, the second tool being configured to open so as to collect the cut tissue and close so as to isolate the collected tissue as the first tool is selectively extended and retracted, respectively.

20. The device of claim 19, wherein the first tool defines a leading edge adapted to cut tissue and a trailing edge, the second tool being attached to the trailing edge of the first tool.

21. The device of claim 20, wherein the second tool is also attached to the shaft.

22. The device claim 19, wherein the second tool includes a flexible membrane.

23. The device of claim 22, wherein the flexible membrane forms a bag shape.

24. The device of claim 19, wherein the tissue includes breast tissue.

25. The device of claim 19, wherein the second tool is configured to lay substantially flat against an outer surface of the shaft when the first tool is fully retracted.

26. The device of claim 19, wherein the first tool is configured to be energized by RF energy.