BIOPSY DEVICE TISSUE SAMPLE HOLDER WITH REMOVABLE TRAY

• US 20120065542A1
• Filed: 09/07/2011
• Published: 03/15/2012
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Hibner, John A., Ehlert, John S., McCrea, James A.
• Granted Patent: US 9,999,406 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• 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 2010/0225 for taking multiple samples

Abstract

A biopsy device comprises a body, a needle, a cutter, and a tissue sample holder. The tissue sample holder comprises an outer cup and a cap. A tray retains severed tissue samples from a biopsy procedure. In some versions, the tray is selectively detachable from the cap in a one-handed operation by the user. The tray may be ejected into a sample container, such as a formalin cup. The cap may include a threaded portion that is configured to engage a complementary threaded portion of a sample container to seal the sample container once the tissue samples have been transferred to the sample container from the tissue sample holder of the biopsy device. One or more ports may be provided in the cap to manage excess fluid within the outer cup of the tissue sample holder, and/or to provide integrated access for a marker delivery device.

Claims

1. A device for use in a biopsy procedure, wherein the device comprises:

a. a body portion;

b. a needle, wherein the needle extends distally from the body portion, wherein the needle comprises;

i. an outer cannula defining an inner lumen,

ii. a tip, and

iii. a lateral aperture configured to receive tissue, wherein the lateral aperture is proximal to the tip;

c. a cutter, wherein the cutter is operably configured to translate relative to the needle to sever a tissue specimen from tissue received within the lateral aperture; and

d. a tissue sample holder, wherein the tissue sample holder is configured to receive tissue specimens severed by the cutter, wherein the tissue sample holder comprises;

i. an outer cup, wherein the outer cup defines an interior space,

ii. a cap, wherein the cap is selectively coupled with the outer cup, and

iii. a tray, wherein the tray is configured to hold the severed tissue specimens, wherein the tray is selectively coupled with the cap.

2. The device of claim 1, wherein the tray comprises a proximal end, and wherein the cap comprises a receiving member, wherein configurations of the proximal end of the tray and the receiving member complement one another to provide an interference fitting between the proximal end of the tray and the receiving member.

3. The device of claim 1, wherein the cap comprises a handle and an inner recess extending proximally into the handle, wherein the tray comprises a post, and wherein the post is insertable into the inner recess of the cap.

4. The device of claim 3, wherein the cross-sectional area of the inner recess is greater than the cross-sectional area of the post.

5. The device of claim 4, wherein the handle comprises a deformable material.

6. The device of claim 1, wherein the cap comprises a push release button, wherein the tray comprises a post, and wherein the post is insertable into an inner region defined by one or more distal extensions from the push release button.

7. The device of claim 6, wherein the push release button comprises a flexible button, wherein the post is selectively releasable from the push release button by depressing the flexible button.

8. The device of claim 6, further comprising a locking adapter coupled to the push release button and selectively coupleable to the outer cup.

9. The device of claim 1, wherein the tray comprises a sample surface, a proximal end, and a pair of side portions, wherein the sample surface extends distally from the proximal end between the pair of side portions, wherein the sample surface includes a plurality of openings configured to drain fluid from the tray.

10. The device of claim 9, wherein the tray comprises a transparent plastic material.

11. The device of claim 1, wherein the cap is selectively coupled with the outer cup by one or more latches, and wherein the cap comprises a threaded portion configured to engage a complementary threaded portion of a separate sample container.

12. The device of claim 1, wherein the cap includes a port providing selective fluid communication through the cap.

13. A device for use in a biopsy procedure, wherein the device comprises:

a. a body portion;

b. a needle, wherein the needle extends distally from the body portion, wherein the needle comprises;

i. an outer cannula defining an inner lumen,

ii. a tip, and

iii. a lateral aperture configured to receive tissue, wherein the lateral aperture is proximal to the tip;

c. a cutter, wherein the cutter is operably configured to translate relative to the needle to sever a tissue specimen from tissue received within the lateral aperture; and

d. a tissue sample holder, wherein the tissue sample holder is configured to receive tissue specimens severed by the cutter, wherein the tissue sample holder comprises;

i. an outer cup, wherein the outer cup defines an interior space,

ii. a tissue tray removably received in the interior space of the cup, and

iii. a deformable cap removably secured relative to the outer cup, wherein the cap is operable to selectively engage the tissue tray.

14. The device of claim 13, wherein the cap is deformable to selectively engage the tissue tray.

15. The device of claim 13, wherein the cap is deformable to selectively engage the outer cup.

16. The device of claim 13, wherein the tissue tray and cap are removable together from the outer cup as an assembly.

17. A method of operating a biopsy device, wherein the biopsy device includes a cannula, a cutter, and a tissue sample holder, wherein the cannula includes a transverse tissue receiving aperture, wherein the cutter is configured to sever samples from tissue received through the transverse tissue receiving aperture, wherein the tissue sample holder is configured to receive one or more tissue samples severed by the cutter, wherein the tissue sample holder comprises a chamber, a tray disposed in the chamber, and a cap releasably engageable with the tray, the method comprising:

(a) actuating the cutter to sever at least one tissue sample;

(b) communicating the at least one tissue sample to the tray of the tissue sample holder;

(c) removing the cap, the tray, and the at least one tissue sample together from the chamber; and

(d) releasing the tray from the cap.

18. The method of claim 17, wherein the cap includes a handle defining an inner recess, wherein the tray includes a protrusion disposed in the inner recess,

wherein the act of removing the cap, the tray, and the at least one tissue sample comprises pinching the handle to deform the inner recess, thereby grasping the protrusion,

wherein the act of releasing the tray from the cap comprises relieving pressure on the handle to un-deform the inner recess, thereby releasing the protrusion.

19. The method of claim 17, wherein the act of releasing the tray from the cap is performed with a single hand, without grasping the tray with another hand.

20. The method of claim 17, further comprising:

(a) inserting a plug into the chamber after the cap, the tray, and the at least one tissue sample are removed from the chamber, wherein the plug defines a lumen aligned with the cutter; and

(b) inserting an instrument through the lumen of the plug and into the cutter.