Soft tissue coring biopsy devices and methods

Patent metadata

Field	Value
Publication number	US-9456807-B2
Application number	US-201314052727-A
Country	US
Kind code	B2
Filing date	Oct 12, 2013
Priority date	Aug 22, 2013
Publication date	Oct 4, 2016
Grant date	Oct 4, 2016

Abstract

An excisional device for either handheld or stereotactic table use may comprise an outer sheath that may comprise a distal trough shape configured to penetrate and/or cut tissue independently or in concert with work element(s). The articulable work element(s) may comprise articulable beak(s) and may be configured to translate and/or rotate at a first rate and to cut tissue in a direction implied by placement of the trough shaped outer sheath. A first helical element or equivalent assembly may be configured to transport tissue cut by the work element(s) and/or trough, may be co-axially disposed relative to the work element(s) and may be operative to rotate at a second rotation rate that is different than the first rate. A proximal sheath may be co-axially disposed relative to the work element(s) and the first helical element, and may be configured to rotate and actuate the work element(s).

First claim

What is claimed is:

1. A method, comprising:
inserting a biopsy device having a long axis into a biopsy site, the biopsy device comprising an articulable beak that is biased open and that comprises a living hinge, the articulable beak comprising, on one side of the living hinge, a first tendon and a first wedge-shaped cutout and, on another side of the living hinge, a second tendon and a second wedge-shaped cutout, being configured to core generally cylindrical tissue specimens centered around the long axis and to sever the generally cylindrical specimens from biopsy site;
while advancing the biopsy device through the biopsy site, rotating and selectively acting upon the first and second tendons to flex the living hinge and selectively open and close the articulable beak, thereby coring and severing a first generally cylindrical tissue specimen from the biopsy site along the long axis of the biopsy device;
drawing the first generally cylindrical tissue specimen away from the biopsy site along the long axis of the biopsy device;
storing the first generally cylindrical tissue specimen in a first removable specimen magazine along the long axis, the first removable tissue specimen magazine comprising a closed proximal end and an open distal end; and
continuing to core, draw and store subsequent generally cylindrical tissue specimens centered along the long axis such that the first generally cylindrical tissue specimen is disposed near the proximal end and the subsequent generally cylindrical specimens are disposed end-to end, aligned along the long axis of the biopsy device, closer to the distal end of the first removable specimen magazine.

2. The method of claim 1 , further comprising:
removing the first specimen magazine from the biopsy device;
coupling a fluid delivery element to the proximal end of the first specimen magazine; and
causing a release of a fluid from the fluid delivery element to the stored tissue specimen within the specimen magazine.

3. The method of claim 2 , wherein the fluid delivery element comprises a fluid ampule and wherein causing comprises breaching the fluid ampule.

4. The method of claim 2 , wherein the first removable specimen magazine comprises a hinge and a latch and wherein the method further comprises actuating the latch and opening the hinged specimen magazine to enable access to the stored tissue specimen.

5. The method of claim 1 , wherein drawing comprises applying a vacuum to the tissue specimen.

6. The method of claim 1 , wherein drawing comprises mechanically drawing the tissue specimen away from the biopsy site.

7. The method of claim 1 , wherein storing comprises storing tissue specimen sequentially such that stored tissue specimen closer to the proximal end were cored and severed before tissue specimen stored closer to the distal end of the biopsy device.

8. The method of claim 1 , further comprising holding each stored tissue specimen in place within the specimen magazine.

9. The method of claim 1 , further comprising coupling a second removable specimen magazine to the biopsy device.

10. The method of claim 9 , further comprising coring, severing, drawing, and storing tissue specimens in the second removable specimen magazine.

11. The method of claim 9 , further comprising delivering a therapeutic agent to the biopsy site before coupling the second removable specimen magazine to the biopsy device.

12. A method, comprising:
providing a biopsy device comprising a tubular coring and transport assembly that defines a long axis and that comprises tissue cutting elements, the tissue cutting elements comprising an articulable beak that is biased open and that comprises a living hinge, the articulable beak comprising, on one side of the living hinge, a first tendon and a first wedge-shaped cutout and, on another side of the living hinge, a second tendon and a second wedge-shaped cutout, the biopsy device being configured to core generally cylindrical tissue specimens centered around the long axis and to sever the generally cylindrical specimens from biopsy site;
while advancing the biopsy device through a biopsy site, rotating and selectively acting upon the first and second tendons to flex the living hinge to selectively open and close the articulable beak, to core and sever generally cylindrical tissue specimens from a biopsy site along the long axis;
transporting the cut generally cylindrical tissue specimen along the long axis within the tubular coring and transport assembly;
storing the cut generally cylindrical tissue specimens in a first specimen magazine coupled to the biopsy device as a first serial train of tissue specimens aligned along the long axis of the biopsy device; and
without removing the biopsy device from the biopsy site;
uncoupling the first specimen magazine from the biopsy device;
coupling a second specimen magazine to the biopsy device; and
continuing to cut generally cylindrical tissue specimens from the biopsy site along the long axis and storing the cut generally cylindrical specimen in the second specimen magazine as a second serial train of generally cylindrical tissue specimens aligned along the long axis of the biopsy device.

13. The method of claim 12 , wherein at least the first specimen magazine stores and maintains the cut tissue specimens in an order in which the tissue specimen were cut from the biopsy site.

14. The method of claim 12 , further comprising carrying out another beneficial action while the biopsy device is within the biopsy site, between uncoupling the first specimen magazine and coupling the second specimen magazine the biopsy device.

Assignees

• Transmed7 Llc

Inventors

• Vetter James W
• Vetter Eugene H
• Clark Daniel E
• Vetter Alisen E

Classifications

• A61B10/0266 Primary

  means for severing sample · CPC title

• A61B10/0283

  with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence) · CPC title

• A61B2010/0208

  Biopsy devices with actuators, e.g. with triggered spring mechanisms · CPC title

• A61B2010/0225

  for taking multiple samples · CPC title

• A61B2017/320064

  with tissue or sample retaining means · CPC title