Revolving tissue sample holder for biopsy device

• US 8,251,916 B2
• Filed: 11/20/2007
• Issued: 08/28/2012
• Est. Priority Date: 12/13/2006
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Speeg, Trevor W. V., Monson, Gavin M., Moore, Kyle P., Hibner, John A., Rhad, Edward A., Parihar, Shailendra K., Haberstich, Wells D., Hogue, Kenneth E., D'Arcangelo, Michele, Weikel, Robert F. Jr.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/942,785
• Publication Number:
  US 20080195066A1
• Time in Patent Office: 1,743 Days
• Field of Search: 600562-568
• US Class Current: 600/565
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• 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
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable

Abstract

A biopsy device includes a cutter defining a cutter lumen and a tissue sample holder for collecting tissue samples. In one example, the tissue sample holder has a rotatable manifold that is configured to redirect fluid from one axial direction to an opposite axial direction. The tissue sample holder also has a plurality of tissue sample trays through which fluid may be communicated. The tissue sample trays define chambers that are each configured to separately hold tissue samples. The tissue sample trays are removable relative to the manifold. A cup is configured to cover the manifold and trays. A tissue sample holder rotation mechanism is operable to rotate the manifold to successively index each chamber of the tissue sample trays with the cutter lumen. A feature may prevent rotation of the manifold when one part of the biopsy device is separated from another part of the biopsy device.

Claims

1. A tissue sample holder for collecting tissue samples obtained using a biopsy device, wherein the biopsy device has a cutter extending distally from the biopsy device and defining a cutter lumen along an axis, wherein the tissue sample holder comprises:

(a) a rotatable manifold, wherein the manifold is in fluid communication with a conduit, wherein the manifold is configured to redirect fluid, wherein the manifold is configured to communicate a vacuum from the conduit to the cutter lumen, wherein the rotatable manifold comprises one or more distal openings on a distal end of the rotatable manifold, wherein the vacuum is communicated from the conduit, through at least one of the distal openings, and to the cutter lumen only through the distal end of the rotatable manifold;

(b) a plurality of discrete tissue sample chambers associated with the manifold, wherein each distal opening of the rotatable manifold is substantially parallel to and in communication with an associated one or more of the discrete tissue sample chambers, wherein each of the tissue sample chambers is configured to receive at least one tissue sample communicated through the cutter lumen;

(c) a cover member configured to removably cover the manifold and the tissue sample chambers, wherein the manifold and tissue sample chambers are configured to rotate within the cover member; and

(d) a tissue sample holder rotation mechanism, wherein the tissue sample holder rotation mechanism is operable to rotate the manifold to successively index the tissue sample chambers relative to the cutter lumen.

2. The tissue sample holder of claim 1, further comprising one or more tissue sample trays removably engaged with the rotatable manifold, wherein the one or more tissue sample trays comprise walls defining the plurality of tissue sample chambers.

3. The tissue sample holder of claim 2, wherein the rotatable manifold comprises a plurality of radially extending fins, wherein the one or more tissue sample trays are engaged with the fins.

4. The tissue sample holder of claim 3, wherein the one or more tissue sample trays comprise a plurality of bottom portions extending between corresponding fins of the rotatable manifold.

5. The tissue sample holder of claim 4, wherein each of the bottom portions has at least one opening formed therethrough, wherein the one or more tissue sample trays are in fluid communication with the manifold via each of the at least one openings.

6. The tissue sample holder of claim 2, wherein the one or more tissue sample trays further comprise a proximal wall portion defining a proximal boundary for each corresponding tissue sample chamber.

7. The tissue sample holder of claim 2, wherein the one or more tissue sample trays further include unique indicia associated with each of the tissue sample chambers.

8. The tissue sample holder of claim 7, wherein the unique indicia include one or more radiographic markers on or near each tissue sample chamber.

9. The tissue sample holder of claim 1, wherein the tissue sample holder rotation mechanism is operable to rotate the manifold to successively index the tissue sample chambers into coaxial alignment with the cutter lumen.

10. The tissue sample holder of claim 1, wherein the manifold is configured to redirect fluid from a first axial direction to a lateral direction and back to a second axial direction, substantially opposite to the first axial direction.

11. The tissue sample holder of claim 1, wherein the conduit extends from the biopsy device to a vacuum source external to the biopsy device.

12. The tissue sample holder of claim 1, wherein the tissue sample holder rotation mechanism includes a retention member configured to selectively prevent rotation of the manifold when a first portion of the biopsy device is separated from a second portion of the biopsy device.

13. The tissue sample holder of claim 12, further comprising a gear extending integrally from the rotatable manifold, wherein the retention member comprises a resilient pawl biased to engage the gear.

14. The tissue sample holder of claim 13, wherein the second portion of the biopsy device comprises a boss configured to engage the pawl, wherein the boss is configured to disengage the pawl from the gear when the boss is engaged with the pawl.

15. The tissue sample holder of claim 1, wherein the tissue sample holder rotation mechanism comprises an electric motor.

16. A tissue sample holder for collecting tissue samples obtained using a biopsy device, wherein the biopsy device has a conduit and a cutter defining a cutter lumen along an axis, wherein the tissue sample holder comprises:

(a) a rotatable manifold, wherein the manifold is in fluid communication with the conduit, wherein the manifold is configured to redirect fluid from the cutter lumen along a first axial direction to a lateral direction and back to a second axial direction, substantially opposite to the first axial direction, wherein the rotatable manifold comprises one or more distal openings on a distal end of the rotatable manifold, wherein the one or more distal openings are configured to selectively communicate with the conduit, wherein the fluid in the first axial direction proximally enters the rotatable manifold at the distal end of the rotatable manifold, wherein the fluid in the second axial direction distally exits the manifold at the distal end of the rotatable manifold;

(b) a plurality of discrete tissue sample chambers associated with the manifold, wherein each of the tissue sample chambers is configured to receive at least one tissue sample communicated through the cutter lumen, wherein at least one of the one or more distal openings on the distal end of the rotatable manifold are substantially parallel to and in communication with one or more of the discrete tissue sample chambers; and

(c) a tissue sample holder rotation mechanism, wherein the tissue sample holder rotation mechanism is operable to rotate the manifold to successively index the tissue sample chambers relative to the cutter lumen.

17. The tissue sample holder of claim 16, wherein the rotatable manifold comprises a central hub portion, wherein at least some of the one or more distal openings are formed through the central hub portion, wherein the tissue sample holder rotation mechanism is further configured to successively index the one or more distal openings relative to the conduit.

18. The tissue sample holder of claim 16, further comprising a plurality of tissue sample trays engaged with the rotatable manifold, wherein the tissue sample trays comprise walls defining the plurality of discrete tissue sample chambers.

19. A tissue sample holder for collecting tissue samples obtained using a biopsy device, wherein the biopsy device has a conduit and a cutter defining a cutter lumen along an axis, wherein the tissue sample holder comprises:

(a) a rotatable manifold defining a longitudinal axis, wherein the rotatable manifold is rotatable about the longitudinal axis, wherein the rotatable manifold comprises a plurality of tissue sample chambers, wherein the tissue sample chambers are radially spaced from the longitudinal axis and are angularly spaced from each other about the longitudinal axis, wherein the tissue sample chambers are oriented substantially parallel to the longitudinal axis;

(b) a longitudinal passage disposed substantially parallel to and radially offset from the plurality of tissue sample chambers; and

(c) a tissue sample holder rotation mechanism, wherein the tissue sample holder rotation mechanism is operable to rotate the manifold about the longitudinal axis to successively index the tissue sample chambers relative to the cutter lumen;

wherein the cutter lumen, the longitudinal passage, and at least one of the tissue sample chambers are in fluid communication such that the cutter lumen, the longitudinal passage, and the at least one of the tissue sample chambers together define a pneumatic path; and

wherein the at least one of the tissue sample chambers is positioned in the pneumatic path between the cutter lumen and the longitudinal passage.

20. The tissue sample holder of claim 19, further comprising one or more tissue sample trays insertable into one or more of the tissue sample chambers of the rotatable manifold, wherein the tissue sample trays comprise a plurality of base portions and a plurality of wall portions.

21. A tissue sample assembly for collecting tissue samples obtained using a biopsy device having a translatable tissue sample cutter defining a cutter lumen extending along an axis, wherein the tissue sample assembly comprises:

(a) a manifold rotatable about a manifold axis, the manifold axis being substantially parallel to and offset from the axis of the cutter lumen, and the rotatable manifold comprising a plurality of chambers, wherein the chambers are radially spaced from the manifold axis and angularly spaced from each other about the longitudinal axis, wherein the manifold is configured to redirect fluid from the cutter lumen along a first axial direction to a lateral direction and back to a second axial direction, substantially opposite to the first axial direction, wherein the rotatable manifold comprises one or more distal openings on a distal end of the rotatable manifold, wherein the fluid in the first axial direction proximally enters the rotatable manifold at the distal end of the rotatable manifold, wherein the fluid in the second axial direction distally exits the manifold at the distal end of the rotatable manifold; and

(b) a plurality of tissue sample receiving members releasably carried by the rotatable manifold, each tissue sample receiving member having a plurality of tissue sample compartments, each tissue sample compartment for receiving and holding a tissue sample, and each tissue sample compartment having a plurality of vacuum openings extending therethrough;

wherein the number of chambers exceeds the number of tissue sample receiving members, and wherein the cutter lumen and the at least one of the chambers together define a pneumatic path for providing vacuum through the vacuum openings in one of the tissue sample compartments.