Biopsy apparatus

• US 8,109,886 B2
• Filed: 08/12/2003
• Issued: 02/07/2012
• Est. Priority Date: 11/06/2000
• Status: Expired due to Fees

• Current Assignee: Suros Surgical Systems Incorporated (Hologic Incorporated)
• Original Assignee: Suros Surgical Systems Incorporated (Hologic Incorporated)
• Inventors: Miller, Michael E., Mark, Joseph L., Butcher, Charles, Hancock, John Phillip
• Primary Examiner(s): Szmal, Brian
• Application Number:
  US10/639,569
• Publication Number:
  US 20040049128A1
• Time in Patent Office: 3,101 Days
• Field of Search: 600562-568, 604/19, 604/164.01, 604/22, 604/164.02, 604/27, 604/164.11, 604/30, 604/166.01, 604/34, 604/167.03, 604/35, 606/159, 606/161, 606/79, 606/166, 606/167, 606/170, 606/171, 606176-180
• US Class Current: 600/567
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A disposable tissue removal device comprises a “tube within a tube” cutting element mounted to a handpiece. The inner cannula of the cutting element defines an inner lumen and terminates in an inwardly beveled, razor-sharp cutting edge. The inner cannula is driven by both a rotary motor and a reciprocating motor. At the end of its stroke, the inner cannula makes contact with the cutting board to completely sever the tissue. An aspiration vacuum is applied to the inner lumen to aspirate excised tissue through the inner cannula and into a collection trap that is removably mounted to the handpiece. The rotary and reciprocating motors are hydraulically powered through a foot pedal operated hydraulic circuit. The entire biopsy device is configured to be disposable. In one embodiment, the cutting element includes a cannula hub that can be connected to a fluid source, such as a valve-controlled saline bag.

Claims

1. A method of operating a biopsy device, comprising the steps of:

providing an outer cannula comprising a proximal end, a distal end, a tissue receiving opening adjacent the distal end, and an outer cannula hub including a fitting member formed on the proximal end;

providing a tissue biopsy device comprising a tissue biopsy handpiece and an inner cannula, wherein the inner cannula has a longitudinal axis and wherein, the tissue biopsy handpiece comprises a proximal end, a distal end, a first rotary motor disposed within the handpiece, and a second reciprocating motor disposed within the handpiece, wherein operation of the first rotary motor rotates the inner cannula about the inner cannula longitudinal axis, and operation of the second reciprocating motor reciprocates the first rotary motor along the inner cannula longitudinal axis and reciprocates the inner cannula along the inner cannula longitudinal axis;

detachably connecting and rotatively engaging the fitting member of the outer cannula hub with an integral mating fitting disposed on an outer surface of the distal end of the tissue biopsy handpiece;

providing fluid to the outer cannula hub, through the outer cannula and to the tissue receiving opening while bypassing the tissue biopsy handpiece; and

operating the first rotary motor and the second reciprocating motor such that the inner cannula is inserted into the outer cannula and the inner cannula is moved such that tissue received in the tissue receiving opening of the outer cannula is excised.

2. The method of claim 1, wherein the inner cannula has a proximal end and a distal end, and the method further comprises aspirating the excised tissue from the distal end of the inner cannula to the proximal end of the inner cannula.

3. The method of claim 1, further comprising aspirating the excised tissue from the distal end of the handpiece to the proximal end of the handpiece.

4. The method of claim 1, further comprising aspirating the excised tissue through at least one of the first rotary motor and the second reciprocating motor.

5. The method of claim 4, wherein the least one of the first rotary motor and the second reciprocating motor is both the first rotary motor and the second reciprocating motor.

6. The method of claim 1, wherein the first rotary motor is hydraulically powered.

7. The method of claim 1, further comprising venting the outer cannula through a leak path between the outer cannula hub and the tissue biopsy handpiece, while retracting the inner cannula from a cutting board.

8. A method of operating a biopsy device at a sample site within a patient, comprising the steps of:

providing a tissue biopsy device comprising a tissue biopsy handpiece, an outer cannula, and an inner cannula moveably disposed in the outer cannula, wherein the tissue biopsy handpiece has a proximal end and a distal end, the outer cannula has a proximal end, a distal end, a tissue receiving opening adjacent the distal end, and an outer cannula hub including a fitting member formed on the proximal end, the inner cannula has a longitudinal axis, the tissue biopsy handpiece has a proximal end, a distal end, a mating fitting disposed on an outer surface of the distal end, a first rotary motor disposed within the handpiece, a second reciprocating motor disposed within the handpiece, and the fitting member of the outer cannula hub is detachably connected and rotatively engaged to the integral mating fitting disposed on the distal end of the handpiece, and wherein operation of the first rotary motor rotates the inner cannula about the inner cannula longitudinal axis, and operation of the second reciprocating motor reciprocates the first rotary motor along the inner cannula longitudinal axis and reciprocates the inner cannula along the inner cannula longitudinal axis;

providing fluid to the outer cannula hub, through the outer cannula and to the tissue receiving opening while bypassing the tissue biopsy handpiece; and

operating the first rotary motor and the second reciprocating motor to excise tissue received in the tissue receiving opening of the outer cannula.

9. The method of claim 8, wherein the inner cannula has a proximal end and a distal end, and the method further comprises aspirating the excised tissue from the distal end of the inner cannula to the proximal end of the inner cannula.

10. The method of claim 8, further comprising aspirating the excised tissue from the distal end of the handpiece to the proximal end of the handpiece.

11. The method of claim 8, further comprising aspirating the excised tissue through at least one of the first rotary motor and the second reciprocating motor.

12. The method of claim 11, wherein the at least one of the first rotary motor and the second reciprocating motor is both the first rotary motor and the second reciprocating motor.

13. The method of claim 8, wherein the first rotary motor is hydraulically powered.

14. The method of claim 8, further comprising fluidly connecting the outer cannula through a leak path positioned between the outer cannula hub and the tissue biopsy handpiece.