Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister

• US 9,757,100 B2
• Filed: 09/15/2016
• Issued: 09/12/2017
• Est. Priority Date: 09/29/2004
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Hibner, John A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US15/266,500
• Publication Number:
  US 20170000468A1
• Time in Patent Office: 362 Days
• 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 2010/0225 for taking multiple samples

Abstract

A biopsy device includes a body, a probe cannula, a cutter, a vacuum source, a tissue sample holder, and a flexible tube. The probe cannula extends distally from the body and defines an internal passage with a side aperture. The cutter is translatable relative to the probe cannula to sever a tissue sample received in the probe cannula. The vacuum source is in communication with the cutter. The tissue sample holder includes a vacuum port on the exterior surface to communicate with the vacuum source and a removable portion to hold solid tissue samples. The removable portion is selectively removable from the tissue sample holder and includes a straining member to separate fluids from solids. The flexible tube couples the tissue sample holder with the body such that the tissue sample holder is flexibly spaced away from the body.

Claims

1. A biopsy device comprising:

(a) a probe cannula defining an internal passage and having a side aperture;

(b) a cutter translatable relative to the probe cannula to sever a tissue sample received in the probe cannula;

(c) a vacuum source in communication with the cutter;

(d) a container, wherein the container includes a tissue sample holder located in the container, wherein the tissue sample holder is configured to capture solid tissue samples while allowing fluid to escape the tissue sample holder, wherein the tissue sample holder is configured to hold the solid tissue samples within the container; and

(e) a conduit, wherein the conduit is configured to provide fluid communication between the container and a proximal end of the cutter, wherein the conduit is further configured to communicate solid tissue samples from the cutter to the tissue sample holder, wherein at least a portion of the conduit includes a flexible tube coupling the container with the probe cannula such that the probe cannula is movable relative to the container, wherein the conduit is positioned above a horizontal plane defined by the tissue sample holder and terminates at an end within the container.

2. The biopsy device of claim 1, wherein the conduit is proximally held relative to the probe cannula by a tube guide.

3. The biopsy device of claim 1, wherein the conduit defines at least a portion of a fluid passageway.

4. The biopsy device of claim 3, further comprising a second fluid passageway, wherein the tissue sample holder includes a straining member, wherein the straining member defines the horizontal plane of the tissue sample holder, wherein the second fluid passageway passes through the plane defined by the straining member and terminates at a free end within the container.

5. The biopsy device of claim 3, further comprising a vacuum lumen communicating to a distal end of the probe cannula and a second conduit between the container and the vacuum lumen, wherein the second conduit is configured to communicate vacuum with the vacuum lumen, wherein the tissue sample holder includes a straining member, wherein the horizontal plane of the tissue sample holder is defined by the straining member.

6. The biopsy device of claim 5, wherein the second conduit passes through the plane defined by the straining member and terminates at a free end within the container.

7. The biopsy device of claim 5, wherein the second conduit is positioned above the plane defined by the straining member and terminates at a free end within the tissue sample holder.

8. The biopsy device of claim 6, further comprising a pneumatic switching assembly responsive to the cutter, wherein the pneumatic switching assembly is operatively configured to expose both the cutter and the vacuum lumen from the vacuum source in response to the cutter being retracted to prolapse tissue into the side aperture, wherein the pneumatic switching assembly is responsive to the cutter being distally positioned to expose the vacuum lumen to an increased pressure to effect retraction of severed tissue to the container via the conduit.

9. The biopsy device of claim 1, wherein the container defines a fluid reservoir, wherein at least a portion of the fluid reservoir is defined by the tissue sample holder.

10. The biopsy device of claim 9, wherein the tissue sample holder is configured to hold solid tissue samples separately from the fluid reservoir.

11. The biopsy device of claim 10, wherein the tissue sample holder includes a removable portion, wherein the removable portion of the tissue sample holder includes a basket.

12. The biopsy device of claim 11, wherein the basket is configured to hold solid tissue samples while permitting fluid to flow through the basket.

13. The biopsy device of claim 11, wherein the removable portion includes a straining member, wherein a vacuum port is positioned above the straining member.

14. The biopsy device of claim 1, further comprising a motor assembly operatively configured to translate the cutter to sever a tissue sample.

15. A biopsy system comprising:

(a) a biopsy device including;

(i) a body,

(ii) a cannula defining an internal passage and having a side aperture, and

(iii) a cutter translatable relative to the probe cannula to sever a tissue sample received in the probe cannula;

(b) a sample collection assembly including;

(i) a tissue sample holder extending entirely around an inner perimeter of a container such that the tissue sample holder is configured to separate solid tissue samples from fluid as vacuum is communicated through the container, wherein the tissue sample holder is further configured to hold tissue samples severed by the cutter; and

(ii) a conduit extending from the tissue sample holder to the biopsy device;

wherein the conduit is configured to communicate tissue samples from the biopsy device to the tissue sample holder, wherein at least a portion of the conduit includes a flexible tube coupling the sample collection assembly with the cannula such that the cannula is movable relative to the sample collection assembly;

wherein at least a portion of the conduit includes an elbow portion, wherein the elbow portion is configured to direct tissue samples toward the tissue sample holder.

16. The biopsy system of claim 15, wherein the tissue sample holder further includes a lid, wherein the conduit is configured to engage the lid.

17. The biopsy system of claim 15, wherein the conduit terminates at a proximal end located above at least a portion of the tissue sample holder.

18. The biopsy system of claim 15, wherein the tissue sample holder includes a straining member, wherein the straining member includes a perforated portion.

19. The biopsy system of claim 15, further comprising a tube guide, wherein the tube guide is configured to hold at least a portion of the conduit proximally relative to at least a portion of the biopsy device.

20. The biopsy system of claim 15, further comprising a vacuum conduit, wherein the tissue sample holder includes a strainer, wherein the strainer defines a straining plane, wherein the vacuum conduit includes a proximal end that is disposed below the straining plane such that the vacuum conduit is configured to draw fluid through the strainer of the tissue sample holder.

21. The biopsy system of claim 15, wherein the container defines a fluid reservoir, wherein at least a portion of the fluid reservoir is defined by the tissue sample holder.

22. The biopsy system of claim 21, wherein the tissue sample holder is configured to hold solid tissue samples separately from the fluid reservoir.

23. The biopsy system of claim 15, wherein the tissue sample holder includes a removable portion, wherein the removable portion of the tissue sample holder includes a basket, wherein the basket is configured to hold solid tissue samples while permitting fluid to flow through the basket.

24. The biopsy system of claim 23, wherein the basket defines a strainer, wherein the basket is configured for removal from the container and for insertion into a formalin container.

25. The biopsy system of claim 15, wherein the tissue sample holder further includes a lid and a strainer, wherein the conduit is configured to engage the lid, wherein the straining member includes a perforated portion.

26. The biopsy system of claim 15, wherein the tissue sample holder further includes a lid and a removable portion, wherein the conduit is configured to engage the lid, wherein the removable portion includes a basket, wherein the basket includes a strainer such that the basket is configured to hold solid tissue samples while permitting fluid to flow through the basket, wherein the basket is configured for removal from the container and for insertion into a formalin container.

27. The biopsy system of claim 15, wherein the tissue sample holder further includes a lid and a removable portion, wherein the conduit is configured to engage the lid, wherein the removable portion includes a basket, wherein the basket includes a strainer such that the basket is configured to hold solid tissue samples while permitting fluid to flow through the basket, wherein the basket is configured for removal from the container and for insertion into a formalin container, wherein the container defines a fluid reservoir, wherein at least a portion of the fluid reservoir is defined by the tissue sample holder, the basket is configured to hold solid tissue samples separately from the fluid reservoir.