Manually rotatable piercer

• US 7,648,466 B2
• Filed: 10/24/2007
• Issued: 01/19/2010
• Est. Priority Date: 10/13/2000
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Garrison, William A., Stephens, Randy R.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/877,940
• Publication Number:
  US 20080132804A1
• Time in Patent Office: 818 Days
• Field of Search: 600562-568, 606/167, 606/170, 606/171
• US Class Current: 600/566
• 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 10/0283 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy

Abstract

The present application is directed to an image-guided, vacuum assisted, percutaneous, coring, cable driven breast biopsy instrument which may be conveniently mounted to an x-ray machine wherein the biopsy instrument incorporates a rotation knob at the proximal end of the instrument to manually rotate the distal end of the probe, thus allowing the clinician to conveniently position the tissue port next to the tissue to be sampled.

Claims

1. A biopsy device comprising:

an elongated piercer having a closed distal end, a proximal end, a lateral tissue receiving port spaced proximally of the distal end, and a cutter lumen, wherein the piercer is supported for rotation about a longitudinal axis of the elongated piercer; and

a hollow cutter adapted to rotate and translate within the cutter lumen to sever tissue received in the tissue receiving port;

wherein the elongated piercer is manually rotatable with respect to at least one other portion of the biopsy device from a position spaced proximally from the proximal end of the piercer.

2. The biopsy device of claim 1 comprising a thumbwheel, wherein the elongated piercer is manually rotatable with the thumbwheel from a position on a proximal portion of the biopsy device.

3. The biopsy device of claim 1 wherein the biopsy device comprises a housing having a proximal end and a distal end, wherein the piercer extends distally from the housing;

and wherein the elongated piercer is manually rotatable from a position proximal of the distal end of the housing.

4. The biopsy device of claim 1 comprising at least one fluid seal disposed within the biopsy device, and wherein the elongated piercer is manually rotatable from a position proximal of the seal.

5. The biopsy device of claim 4 comprising at least two fluid seals, and wherein the elongated piercer is manually rotatable from a position proximal of the at least two seals.

6. The biopsy device of claim 1 comprising at least one o-ring received in an o-ring groove, wherein the elongated piercer is rotatable from a position proximal of the o-ring groove, and wherein the o-ring groove is disposed radially outwardly of the longitudinal axis about which the elongated piercer rotates.

7. The biopsy device of claim 6 wherein at least one o-ring groove is disposed distally of the proximal end of the elongated piercer.

8. The biopsy device of claim 1 comprising at least one fluid seal disposed distally of the proximal end of the elongated piercer.

9. The biopsy device of claim 8 comprising at least one o-ring.

10. The biopsy device of claim 1 comprising a member for communicating rotary motion to the elongated piercer.

11. The biopsy device of claim 10 wherein the member comprises a solid rod.

12. The biopsy device of claim 10 wherein the member comprises a metal.

13. The biopsy device of claim 11 wherein the member is laterally offset from an axis about which the elongated piercer rotates.

14. The biopsy device of claim 1 wherein the biopsy device is a breast biopsy device.

15. A biopsy device comprising:

an elongated piercer having a closed distal end, a proximal end, a lateral tissue receiving port spaced proximally of the distal end, and a cutter lumen, wherein the piercer is supported for rotation about a longitudinal axis with respect to a stationary portion of the biopsy device;

a hollow cutter adapted to rotate and translate within the cutter lumen to sever tissue received in the tissue receiving port;

at least one fluid seal disposed in the biopsy device;

wherein the elongated piercer is manually rotatable from a position proximal of the at least one fluid seal.

16. The biopsy device of claim 15 wherein the fluid seal comprises an o-ring.

17. The biopsy device of claim 15 wherein the biopsy device is a breast biopsy device.

18. A method of obtaining biopsy samples comprising the steps of:

obtaining a biopsy device comprising;

a piercer extending from a distal end of the biopsy device, the piercer having a closed distal end and a lateral tissue receiving port spaced proximally of the distal end; and

a hollow cutter adapted to rotate and translate within the piercer to sever tissue received in the lateral tissue receiving port;

directing the piercer into a tissue mass;

receiving tissue into the lateral tissue receiving port of the piercer;

severing a tissue sample from the tissue received in the port with the cutter;

transporting the first tissue sample through the piercer; and

without removing the piercer from the tissue mass, manually rotating the piercer about a longitudinal axis of the piercer from a position associated with a proximal portion of the biopsy device spaced from a proximal end of the piercer.

19. The method of claim 18 wherein the hollow cutter has an distal end, and wherein the step of manually rotating the piercer comprises rotating the piercer relative to the hollow cutter.

20. The method of claim 18 further comprising the step of providing fluid communication with a portion of the biopsy device distal of the position from which the piercer is manually rotated.

21. The method of claim 20 wherein the step of providing fluid communication comprises communicating a gas with a portion of the biopsy device distal of the position from which the piercer is manually rotated.

22. The method of claim 21 wherein the step of providing fluid communication comprises communicating vacuum.

23. The method of claim 18 wherein the step of directing the piercer comprises directing the piercer into breast tissue.

24. A biopsy device comprising:

an elongated piercer having a closed distal end, a proximal end, a lateral tissue receiving port spaced proximally of the distal end, and a cutter lumen, wherein the piercer is supported for rotation about a longitudinal axis of the elongated piercer;

a hollow cutter having an open end adapted to rotate and translate within the cutter lumen to sever tissue received in the tissue receiving port;

a rotatable member, wherein at least a portion of the rotatable member extends proximally of the proximal end of the piercer, and wherein rotation of the rotatable member provides rotation of the piercer.

25. The device of claim 24 wherein the rotatable member comprises a shaft.

26. The device of claim 24 further comprising a thumbwheel operatively associated with a proximal end of the rotatable member, wherein rotation of the thumbwheel provides rotation of the piercer.

27. The device of claim 24 wherein the rotatable member has a longitudinal axis extending in substantially the same direction as the longitudinal axis of the piercer.

28. The device of claim 27 where the longitudinal axis of the rotatable member is offset from the longitudinal axis of the piercer.

29. The device of claim 24 further comprising at least one fluid seal, and wherein a proximal end of the rotatable member is disposed proximally of the at least one fluid seal.

30. The device of claim 24 further comprising at least two fluid seals, and wherein a proximal portion of the rotatable member is operatively associated with a thumbwheel positioned proximally of the at least two seals.

31. A biopsy device comprising:

an elongated piercer having a closed distal end, a proximal end, a lateral tissue receiving port spaced proximally of the distal end, and a cutter lumen, wherein the piercer is supported for rotation about a longitudinal axis of the elongated piercer;

a hollow cutter having an open end adapted to rotate and translate within the cutter lumen to sever tissue received in the tissue receiving port;

a manual rotation feature spaced proximally from the proximal end of the piercer; and

a rotatable member extending through at least a portion of the biopsy device for transmitting rotational motion from the manual rotation feature to the piercer.

32. The biopsy device of claim 31 wherein the rotatable member has a proximal end operatively associated with the manual rotation feature and a distal end operatively associated with the piercer.

33. The biopsy device of claim 31 wherein the manual rotation feature comprises a thumbwheel.

34. The biopsy device of claim 33 wherein the manual rotation feature is disposed on a proximal end of the biopsy device.

35. The biopsy device of claim 31 wherein rotatable member comprises an elongated shaft having a longitudinal axis extending in substantially the same direction as the longitudinal axis of the piercer.

36. The biopsy device of claim 35 wherein the elongated shaft comprises a solid rod.

37. The biopsy device of claim 35 wherein the longitudinal axis of the shaft is offset from the longitudinal axis of the piercer.