VACUUM ASSISTED BIOPSY DEVICE

• US 20080200833A1
• Filed: 02/28/2008
• Published: 08/21/2008
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Promex Technologies LLC
• Original Assignee: Suros Surgical Systems Incorporated (Hologic Incorporated)
• Inventors: Miller, Michael E., Mark, Joseph L., Nicoson, Zachary R., Hardin, Terry D., Hodge, William O.
• Granted Patent: US 7,988,642 B2
• Time in Patent Office: Days
• US Class Current: 600/566
• 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

Abstract

A biopsy device is disclosed that comprises a cutting element mounted to a handpiece and a vacuum chamber. The cutting element comprises a stylet assembly and an outer cannula assembly. The stylet assembly includes a stylet that includes an open proximal end and a tissue opening at a distal end thereof. The tissue receiving opening is in communication with a lumen extending through the stylet. The outer cannula assembly includes an outer cannula that is slidably mounted over the stylet and has an open distal end with a cutting edge formed thereon. The vacuum chamber is in communication with the lumen of the stylet. The stylet is selectively advanced distally outwardly with respect to outer cannula to expose the tissue opening to targeted tissue. The outer cannula is selectively advanced over the tissue opening to sever tissue, while vacuum is generated in the vacuum chamber and delivered to the tissue opening through the lumen. The vacuum causes tissue to be drawn into and maintained in the tissue opening while the outer cannula severs tissue to obtain a biopsy core.

Claims

1. A biopsy device, comprising:

a cutting element mounted to a handpiece, said cutting element comprising;

a stylet assembly having a stylet that includes an open proximal end and a tissue opening at a distal end thereof, wherein the tissue receiving opening is in communication with a lumen extending through the stylet; and

an outer cannula assembly including an outer cannula that is slidably mounted over the stylet and having an open distal end with a cutting edge formed thereon; and

a vacuum chamber in communication with the lumen;

wherein the stylet is selectively advanced distally outwardly with respect to outer cannula to open the tissue opening to targeted tissue;

wherein the outer cannula is selectively advanced over the tissue opening to sever tissue after a slight delay in which vacuum is generated in the vacuum chamber and delivered to the tissue opening through the lumen, the vacuum causing tissue to be drawn into and maintained in the tissue opening while the cutting cannula severs tissue to obtain a biopsy core.

2. The biopsy device of claim 1, further comprising a pickup carriage that operates to selectively move the stylet assembly and the outer cannula assembly between a biopsy ready and a fired position.

3. The biopsy device of claim 2, wherein the pickup carriage further includes a moveable cam member disposed on a bottom surface of the pickup carriage.

4. The biopsy device of claim 2, further comprising an actuation lever that is operatively connected to the pickup carriage by a resilient bridge member.

5. The biopsy device of claim 1, wherein the stylet assembly further comprises a first arm sub-assembly that is fixedly attached to the stylet and a second sub-assembly that is movably attached to the stylet.

6. The biopsy device of claim 5, wherein the first arm sub-assembly includes a leg member and a carrier member.

7. The biopsy device of claim 5, wherein the second arm sub-assembly includes a first leg member and a second leg member that are connected together by a carrier member.

8. The biopsy device of claim 1, wherein the vacuum chamber comprises first and second seal members and a cylinder disposed over the first and second seal members;

wherein the first seal member is operatively connected to a moveable portion of the stylet assembly and the second seal member is fixedly attached to a portion of the stylet proximal to the first seal member;

wherein the stylet further includes a notch that is in communication with the lumen; and

wherein the notch is positioned between the first and second seal members.

9. The biopsy device of claim 8, further comprising a vacuum valve that selective covers the notch.

10. The biopsy device of claim 1, further comprising a normally closed valve disposed on a proximal end of the stylet.

11. The biopsy device of claim 10, wherein the normally closed valve further comprises a body and a flap member that selective opens in response to positive pressure.

12. The biopsy device of claim 1, wherein the handpiece further comprises a stylet firing member and an outer cannula firing member, wherein the stylet firing member releases the stylet from a biopsy ready position to a fired position;

and wherein the outer cannula firing member release the outer cannula from a biopsy ready position to a fired position.

13. The biopsy device of claim 12, wherein at least one of the stylet firing member and the outer cannula firing member includes an indicator that differentiates between the stylet firing member and the outer cannula firing member.

14. The biopsy device of claim 1, wherein the handpieece further comprises an indicator that informs a user when the biopsy device is in a biopsy ready position.

15. The biopsy device of claim 1, wherein the outer cannula assembly further comprises an outer cannula hub that is fixedly connected to the outer cannula;

wherein the outer cannula hub includes a retaining member that serves to selectively retain the outer cannula assembly in a biopsy ready position within the handpiece.

16. The biopsy device of claim 15, further comprising a support rib, wherein the support rib is slidingly received on the stylet, proximal to the outer cannula hub.

17. The biopsy device of claim 16, wherein a biasing member is positioned between the support rib and the outer cannula hub.

18. The biopsy device of claim 1, further comprising an introducer assembly that is selectively engagable with the biopsy device, wherein the introducer assembly comprises an introducer cannula that is configured to be slidingly disposed over the outer cannula and sized such that a portion of the outer cannula is positioned distally of a distal end of the introducer cannula.

19. The biopsy device of claim 18, wherein the introducer assembly includes a latch member that cooperates with a portion of the handpiece of the biopsy device to selectively fix the introducer cannula to the biopsy device.

20. A method of using a biopsy device, comprising:

placing the biopsy device into a biopsy ready position by;

retracting a vacuum chamber;

retracting a cutting cannula;

retracting a stylet;

firing the stylet into a target site and exposing a tissue opening formed in a distal end of the stylet;

firing the cutting cannula, thereby generating vacuum which draws in and maintains tissue within the tissue opening of the stylet;

wherein the cutting cannula slides over the tissue opening, thereby severing tissue so as to leave a biopsy core within the tissue opening.

21. The method of claim 20, wherein the step of placing the biopsy ready position further comprises:

actuating a latch member to release an actuating lever;

depressing the actuating lever a first time to retract the vacuum chamber;

depressing the actuating lever a second time to retract the cutting cannula; and

depressing the actuating lever a third time to retract the stylet.

22. The method of claim 21, wherein depressing the actuating lever moves a pickup carriage, wherein a moveable cam member disposed on the pickup carriage contacts an arm assembly that is slidably attached to the stylet assembly so as to retract the vacuum chamber when the actuating lever is depressed the first time;

wherein the moveable cam member contacts a portion of the cutting cannula so as to retract the cutting cannula when the actuating lever is depressed the second time; and

wherein the moveable cam member contacts a portion of the stylet so as to retract the stylet when the actuating lever is depressed the third time.

23. The method of claim 20, wherein after the cutting cannula is fired, the cutting cannula is retracted again so as to expose the biopsy core retained within the tissue opening.

24. The method of claim 20, further comprising attaching an introducer assembly over the cutting cannula prior to firing the stylet assembly.