Soft tissue coring biopsy devices and methods

Patent metadata

Field	Value
Publication number	US-10070884-B2
Application number	US-201414491348-A
Country	US
Kind code	B2
Filing date	Sep 19, 2014
Priority date	Sep 12, 2013
Publication date	Sep 11, 2018
Grant date	Sep 11, 2018

Abstract

An excisional device for either handheld or stereotactic table/MRI use may comprise a work element configured to rotate at a first rotation rate and comprising at least one articulable beak configured to cut tissue in a longitudinal direction. Helical elements or equivalent assemblies may be configured to transport tissue cut by a work element and may be co-axially disposed relative to the work element and may be operative to rotate at rotation rates that may be different from the work element rotation rate. Flush and vacuum tissue transport mechanisms may be incorporated in replacement of or in conjunction with helical elements. A proximal sheath and a distal sheath may be co-axially disposed relative to a work element and may be configured to rotate a work element and to actuate a beak or beaks. A simplified embodiment of this device may be applicable to field use where power sources for actuation may be limited.

First claim

The invention claimed is:

1. An excisional device, comprising:
a proximal sheath;
a distal sheath;
a handle portion comprising a distal end and a proximal end, the handle portion comprising, disposed therein, a cam gear, a proximal sheath cam coupled to the cam gear and to the proximal sheath and a distal sheath cam coupled to the cam gear and at least to the distal sheath;
a cutting assembly comprising at least a first articulable beak, the cutting assembly being coupled to the distal end of the handle portion and configured to rotate, penetrate, core, part-off and at least one of transporting and containing parted-off tissue, the cutting assembly being configured to at least have a fully open configuration and a closed configuration, and to at least fit within the distal sheath in the fully open configuration and to extend out of the distal sheath in the closed configuration;
a tissue storing magazine coupled to the proximal end of the handle portion and configured to receive and store the parted-off tissue,
wherein the cam gear is configured to rotate, so that one rotation of the cam gear causes the proximal sheath to move distally relative to the distal sheath from a resting position and then causes the proximal sheath to return to the resting position while the cutting assembly, over the course of the one rotation of the cam gear:
rotates while advancing distally to at least partially extend out of the distal sheath;
cores tissue while rotating and advancing, parts-off a piece of tissue of a length determined by an amount of distal excursion of the cutting assembly within tissue,
rotates while retracting proximally to a position at least partially withdrawn into the distal sheath; and transports the parted-off piece of tissue toward the tissue storing magazine.

2. The excisional device of claim 1 , wherein parted-off tissue contained in the cutting assembly are configured to be pushed into the tissue storing magazine by a push rod inserted axially within the cutting assembly.

3. The excisional device of claim 1 , further comprising a manual part-off actuator, configured to cause the cutting assembly to part-off cored tissue from surrounding tissue.

4. The excisional device of claim 1 , wherein the cutting assembly is configured to rotate under power from a mechanical wind-up motor within the handle portion.

5. The excisional device of claim 1 , wherein cutting assembly is configured to rotate under power from an electrical motor within the handle portion.

6. The excisional device of claim 1 , wherein the first
articulable beak is configured to have the fully open configuration that is suitable for coring and the closed configuration that is suitable for at least one of parting-off pieces of tissue, penetrating tissue and for tissue dissection.

7. The excisional device of claim 1 , wherein the cutting assembly comprises a single hypo tube in which cuts are made to form at least one articulable cutting element.

8. The excisional device of claim 7 , wherein the at least one articulable cutting element is actuable to assume the fully open configuration and the closed configuration.

9. The excisional device of claim 1 , wherein the handle portion comprises a lower portion and a detachable upper portion.

10. The excisional device of claim 9 , wherein the detachable upper portion is pivotably coupled to the lower portion.

11. The excisional device of claim 1 , wherein the cutting assembly is detachable from the handle portion.

12. The excisional device of claim 1 , wherein the tissue storing magazine is detachable from the handle portion.

13. The excisional device of claim 1 , further comprising a flush port provided in the handle portion through which at least liquids may be delivered and evacuated.

14. A method of excising tissue, comprising:
providing an excisional device comprising a proximal sheath; a distal sheath; a handle portion, the handle portion comprising, disposed therein, a cam gear, a proximal sheath cam coupled to the cam gear and to the proximal sheath and a distal sheath cam coupled to the cam gear and at least to the distal sheath; a cutting assembly comprising at least a first articulable beak, the cutting assembly being coupled to one end of the handle portion and configured to rotate, penetrate, core, part-off and transport or contain parted-off, the cutting assembly being configured to at least have a fully open configuration and a closed configuration, and to at least fit within the distal sheath in the fully open configuration and to extend out of the distal sheath in the closed configuration; and
a tissue storing magazine coupled to another end of the handle portion and configured to receive and store the parted-off tissue,
inserting at least the cutting assembly of the provided excisional device into tissue;
rotating the cam gear over one whole rotation and, during the course of the one whole rotation of the cam gear, sequentially:
causing the proximal sheath to move distally relative to the distal sheath from a resting position while the cutting assembly extends at least partially extend out of the distal sheath while rotating, advancing and coring through the tissue;
causing the proximal sheath to return to the resting position while parting-off a piece of tissue of a length determined by an amount of distal excursion of the cutting assembly within the tissue, and retracting the cutting assembly proximally to a position at least partially withdrawn into the distal sheath while rotating and transporting the parted-off piece of tissue toward the tissue storing magazine.

15. The method of excising tissue of claim 14 , further comprising axially inserting and pushing a push rod within the cutting assembly to push the parted-off piece of tissue contained in the cutting assembly into the tissue storing magazine.

16. The method of excising tissue of claim 14 , further comprising actuating a manual part-off actuator configured to cause the cutting assembly to part-off cored tissue from surrounding tissue.

17. The method of excising tissue of claim 14 , further comprising winding up a mechanical wind-up motor within the handle portion to power the cutting assembly.

18. The method of excising tissue of claim 14 , further comprising applying electrical energy to an electrical motor within the handle portion to power at least the cutting assembly.

19. The method of excising tissue of claim 14 , wherein
the providing step is carried out with the first articulable beak configured to have the fully open configuration that is suitable for coring and the closed configuration that is suitable for at least one of parting-off tissue and penetrating tissue.

20. The method of excising tissue of claim 14 , wherein the providing step is carried out with the cutting assembly comprising single hypo tube in which cuts are made to form at least one articulable cutting element.

21. The method of excising tissue of claim 14 , wherein
the providing step is carried out with the at least one articulable cutting element being actuable to assume the fully open configuration and the closed configuration.

22. The method of excising tissue of claim 14 , the providing step is carried out with wherein the handle portion comprising a lower portion and a detachable upper portion.

23. The method of excising tissue of claim 14 , wherein the providing step is carried out with the detachable upper portion being pivotably coupled to the lower portion.

Assignees

• Transmed7 Llc

Inventors

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

Classifications

• A61B2217/007

  with irrigation system · CPC title

• A61B10/0266 Primary

  means for severing sample · CPC title

• A61B2010/0225

  for taking multiple samples · CPC title

• A61B17/3205 Primary

  Excision instruments · CPC title

• A61B2017/00473

  Distal part, e.g. tip or head (A61B2017/00464 takes precedence) · CPC title