Excisional biopsy devices and methods

• US 6,423,081 B1
• Filed: 10/13/1999
• Issued: 07/23/2002
• 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): TRUONG, KEVIN THAO
• Application Number:
  US09/417,520
• Time in Patent Office: 1,014 Days
• Field of Search: 606/159, 606/170, 606/169, 606/180, 606/167, 604/22, 600/564, 600/565, 600/566, 600/567
• 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. An invasive interventional device for soft biological tissue, comprising:

a rotatable tubular member having a distal tip adapted to penetrate the tissue;

a work element disposed near the distal tip of the tubular member, the work element acting upon the tissue coming into contact therewith as the tubular member rotates;

an ultrasound transducer disposed near the distal tip of the tubular member and away from the work element, so that the transducer sweeps a plane within the tissue ahead of the work element as the tubular member rotates; and

means for controlling an operation of the work element based upon information gathered from the ultrasound transducer.

2. The device of claim 1, wherein the ultrasound transducer is tuned within a range from about 7.5 MHz to about 20 MHz.

3. The device of claim 1, wherein the ultrasound transducer is disposed within the tubular member at an angle α

relative to the work element, the angle α

being no smaller than that necessary to effectively control the operation of the work element in response to the information gathered from the transducer as the tubular member rotates.

4. The device of claim 3, wherein the angle α

is less than about 180 degrees.

5. The device of claim 1, wherein the work element comprises at least one device selected from the group consisting of:

an abrasive device, a reciprocating cutting device, a bowing cutting device, an electrosurgical device, a laser device and a vibrating device.

6. The device of claim 1, wherein the ultrasonic transducer is connected to at least one data processing and display device to allow an operator of the device to ascertain a structure of the tissue and to control the operation of the work element before the tissue comes into contact with the work element as the device rotates.

7. The device of claim 1, wherein the work element comprises 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 a window in the tubular member and to retract within the window.

8. The device of claim 7, wherein the controlling means include means for selectively bowing and retracting the cutting tool.

9. The device of claim 8, wherein the controlling means includes one of a manually operable push knob and a manually operable turn knob.

10. An excisional device for soft tissue, comprising:

a rotatable tubular member including a distal tip adapted to penetrate the tissue;

an RF work element disposed near the distal tip of the tubular member; and

an imaging device disposed near the distal tip of the tubular member and away from the RF work element, the imaging device being configured to image the tissue ahead of the work element as the tubular member is rotated.

11. The excisional device of claim 10, wherein the RF work element is coupled to an external variable RF energy source.

12. The excisional device of claim 11, wherein the variable RF energy source is configured to enable an RF power applied to the RF work element to be varied to enable selective cutting and coagulating of the tissue.

13. The excisional device of claim 11, wherein the RF work element includes two bipolar electrodes coupled to the external variable RF energy source.

14. The excisional device of claim 10, wherein the imaging device is configured to be removable from the tubular member while the tubular member remains in the tissue.

15. The excisional device of claim 10, wherein the imaging device includes an ultrasound transducer tuned within a range from about 5 MHz to about 20 MHz.

16. The excisional device of claim 11, wherein the imaging device is disposed within the tubular member at an angle α

relative to the work element, the angle α

being no smaller than that necessary to effectively control the operation of the work element in response to the information gathered from the imaging device as the tubular member rotates.

17. The excisional device of claim 16, wherein the angle α

is less than 60 degrees.

18. The excisional device of claim 10, wherein the imaging device is connected to at least one data processing and display device to allow an operator of the excisional device to ascertain structural characteristics of the tissue and to control the operation of the RF work element before the tissue comes into contact with the RF work element as the device rotates.

19. The excisional device of claim 10, wherein the RF work element comprises 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 a window in the tubular member and to retract within the window.