Biopsy device tissue sample holder with removable tray

• US 9,999,406 B2
• Filed: 09/07/2011
• Issued: 06/19/2018
• 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.
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US13/226,660
• Publication Number:
  US 20120065542A1
• Time in Patent Office: 2,477 Days
• Field of Search: 600562-568
• 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 includes;

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 includes;

i. an outer cup, wherein the outer cup defines an interior space, wherein the outer cup has a distal end and a proximal end, wherein the outer cup further includes a vacuum port located at the distal end, wherein the vacuum port is configured to couple with a vacuum source,

ii. a cap, wherein the cap is selectively coupled with the proximal end of the outer cup, wherein the cap has at least one ejection feature, wherein the at least one ejection feature extends proximally from the cap when the tray is disposed in the outer cup, wherein a proximal end of the cap is closed by the at least one ejection feature, and

iii. a tray, wherein the tray is configured to hold the severed tissue specimens, wherein the tray is selectively coupled with the cap by an interior receiving member of the cap, wherein the tray includes a pair of resilient latches and a post disposed between the resilient latches, wherein the interior receiving member of the cap is configured to grip the resilient latches, wherein the tray is configured to be ejected distally from the cap when the post of the tray is acted upon by the at least one ejection feature of the cap to thereby release the pair of resilient latches from the grip of the interior receiving member.

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

3. The device of claim 1, wherein the cap further includes a button, wherein the interior receiving member extends proximally into the button, and wherein the post is insertable into the interior receiving member of the cap.

4. The device of claim 3, wherein the cross-sectional area of the interior receiving member is greater than the cross-sectional area of the post.

5. The device of claim 4, wherein the button has a deformable material.

6. The device of claim 1, wherein the cap further includes a push release button defining the at least one ejection feature and the interior receiving member, 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 is 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 including 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 has 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 is a transparent plastic material.

11. The device of claim 1, wherein the cap is selectively coupled with the outer cup by a cover including one or more ledge members, and wherein the cap has one or more locking nubs configured to engage a complementary recess of the cover.

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 includes;

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 includes;

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, wherein the tissue tray includes a release member extending proximally from the tissue tray, wherein the release member has a pair of resilient latches and a cross member extending between the resilient latches, and

iii. a deformable cap removably secured relative to the outer cup, wherein the cap has a flexible button portion, wherein the flexible button portion is configured to close a proximal end of the cap, wherein the flexible button portion fully encompasses a portion of the resilient latches, wherein the flexible button portion is operable to actuate the release member of the tissue tray to selectively release the tissue tray from the deformable cap.

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

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

16. 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 includes a chamber, a tray disposed in the chamber, wherein the tray has a pair of resilient latches and a cross member extending between the resilient latches, and a cap releasably engageable with the tray, wherein the cap includes a flexible portion, wherein the flexible portion defines an inner region, 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, wherein the proximal end of the tissue sample holder is closed by the cap during the act of communicating the at least one tissue sample to the tray;

(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 by pressing distally on the flexible portion of the cap to thereby force the tray distally away from the cap, wherein the act of pressing distally on the flexible portion deforms the cross member of the tray to disengage the resilient latches of the tray from the inner region of the flexible portion.

17. The method of claim 16, wherein the act of releasing the tray from the cap is performed with a single hand, without grasping the tray with another hand.

18. The method of claim 16, further including:

(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.