Automated, selectable, soft tissue excision biopsy devices and methods

Patent metadata

Field	Value
Publication number	US-2017333010-A1
Application number	US-201514938155-A
Country	US
Kind code	A1
Filing date	Nov 11, 2015
Priority date	Dec 24, 2012
Publication date	Nov 23, 2017
Grant date	—

Abstract

An excisional biopsy and delivery device may comprise one or more rotating, penetrating and cutting rod elements. The rod elements may be configured to advance from a stored and confined first position and rotate about an axis, while being simultaneously revolved about a central axis. The rod elements may then assume a second released and expanded configuration that is operative to cut around and surround target tissue. In this manner, the rod elements are operative to move through the surrounding tissue to create a volume of revolution and to sever and capture the target tissue contained within the volume of revolution from the surrounding tissue. The severed and captured volume of revolution containing the target issue may then be removed.

First claim

What is claimed is:

1 . A method comprising:
inserting a distal end of a device into tissue, the device comprising one or a plurality of rod elements, each comprising a curved and unattached free end portion that is biased against an internal surface of the distal end of the device to assume a first radius of curvature; deploying the one or plurality of rod elements from the distal end of the device, the curved and unattached free end portion of each of the plurality of rod elements being configured to assume a second radius of curvature when deployed outside of the distal end of the device, the second radius of curvature being smaller than the first radius of curvature; capturing and parting-off a portion of tissue within a volume delimited by the curved and unattached free end portions of the deployed rod element or plurality of rod elements; and collecting the captured and parted-off tissue portion.

2 . The method of claim 1 , wherein capturing comprises at least one of immobilizing and isolating the portion of tissue.

3 . The method of claim 1 , wherein collecting comprises retrieving the parted-off tissue portion.

4 . The method of claim 1 , further comprising rotating at least the distal end of the device concurrently at least with deploying and capturing.

5 . The method of claim 4 , further comprising causing the curved and unattached free end portion of the rod element or of each of the plurality of rod elements to describe a spiral path while deploying from the distal end of the device.

6 . The method of claim 1 , further comprising providing a separate tube chamber for the rod element or for each of the plurality of rod elements and wherein deploying comprises imposing a distally-directed movement on each rod element within each tube chamber.

7 . The method of claim 1 , further comprising advancing a locating wire from the distal end of the device to a desired target region within the tissue.

8 . The method of claim 1 , further comprising advancing a central tube from the distal end of the device to near a desired target region within the tissue.

9 . The method of claim 1 , wherein collecting comprises retracting the device with its deployed rod element or plurality of rod elements while maintaining the captured and parted-off portion of tissue within the volume delimited by the curved and unattached free end portion of the deployed rod element or by the curved and unattached free end portions of the deployed plurality of rod elements.

10 . The method of claim 1 , further comprising isolating the captured and parted-off portion of tissue within the volume delimited by the curved and unattached free end portion or portions of the deployed rod element or plurality of rod elements from surrounding tissue.

11 . The method of claim 1 , wherein at least one of deploying and capturing comprises applying RF energy to the rod element or to the plurality of rod elements.

12 . The method of claim 10 , wherein isolating comprises deploying a sleeve over the captured and parted-off portion.

13 . The method of claim 12 , wherein deploying the sleeve comprised causing the sleeve to turn itself inside out during collecting.

14 . A device, comprising:
a tube, the tube defining a proximal end and a distal end configured for insertion into tissue; a rod element disposed within the tube, comprising a curved and unattached free end portion that is biased against an internal surface within the device to assume a first radius of curvature; wherein the rod element is configured for deployment from the distal end of the device, the curved and unattached free end portion of the rod element being configured to assume a second radius of curvature when deployed outside of the distal end of the device, the second radius of curvature being smaller than the first radius of curvature; and wherein the curved and unattached end portion of the deployed rod element is configured to delimit a volume and/or to capture a portion of tissue within the volume.

15 . The device of claim 14 , wherein the rod element is configured to rotate.

16 . The device of claim 15 , wherein the curved and unattached free end portion of the rod element is configured to describe a spiral path while deploying from the distal end of the device.

17 . The device of claim 14 , further comprising a separate tube chamber for the rod element and wherein the device is further configured to impose a distally-directed movement on the rod element within the tube chamber.

18 . The device of claim 14 , further comprising a locating wire within the tube, the locating wire being configured to be advanced from the distal end of the device to a desired target region within the tissue.

19 . The device of claim 14 , further comprising a central tube being configured to be placed into, advanced or retracted from the distal end of the device to a desired target region within the tissue, and through which may be advanced at least one of a locating wire and materials to be provided to the target tissue, the central tube being further configured to carry a vacuum for withdrawal of materials from the target region.

20 . The device of claim 14 , further comprising a locating tube within which the distal end of the device may be advanced to the desired target region within the tissue.

21 . The device of claim 14 , wherein the curved and unattached free end portion of the deployed rod element is configured to be retracted along with the device while maintaining the volume delimited by the curved and unattached free end portion of the deployed rod element.

22 . The device of claim 14 , wherein the curved and unattached end portion of the deployed rod element is configured to be retracted into the distal end of the device after having circumscribed and parted-off a volume of tissue.

23 . The device of claim 14 , further comprising a sleeve that is configured to deploy over the volume delimited by the curved and unattached end portion of the deployed rod element.

24 . The device of claim 23 , wherein the sleeve is configured to turn itself inside out to thereby envelop the volume formed by the curved and unattached free end portion of the deployed rod element.

25 . The device of claim 14 , comprising a plurality of rod elements disposed within the tube, the curved and unattached free end portion of each being biased against a respective internal surface within the device to assume the first radius of curvature;
wherein each of the plurality of rod elements is configured for deployment from the distal end of the device, the curved and unattached free end portion of each of the plurality of rod elements being configured to assume the second radius of curvature when deployed outside of the distal end of the device; and wherein the curved and unattached end portions of the plurality of deployed rod elements are configured to collectively delimit a volume and/or to capture a portion of tissue within the volume.

Assignees

• Transmed7 Llc

Inventors

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

Classifications

• A61B18/149

  bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers · CPC title

• A61B2010/0208

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

• A61B17/32056

  Surgical snare instruments (for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26) · CPC title

• A61B10/025

  for taking bone, bone marrow or cartilage samples · 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