IP Library Granted Patent US 12,594,064
Granted Patent B2
US 12,594,064 · App. 18/503,468 · Granted Apr 7, 2026

Dual movable blade biopsy tool with stylet

Inventors: Robert M. Clements (Issaquah, WA); Andrew R. Face (Issaquah, WA)
A61B10/04A61B10/0266A61B2010/0093A61B2010/0225A61B10/0283A61B10/06A61B2090/033A61B2090/062
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Quick Facts
Patent No.
US 12,594,064
App. No.
18/503,468
Granted
Apr 7, 2026
Kind
B2
Abstract

A biopsy device comprises a sheath equipped with a removable stylet. The sheath including a terminus with a distal chamber configured with a forward facing cutting edge comprising a plurality of movable blades. The plurality of movable blades including two counter rotating blades configured perpendicular or beveled relative to a long axis of the distal chamber, each counter rotating blade configured to pivot from a separate axis. The biopsy device further comprises a manipulation end controllable by a user to plunge the forward facing cutting edge at a sampling locus after removal of the removable stylet at a depth and to engage a cutting action by the plurality of movable blades at the depth selected to acquire at least one specimen storable in the distal chamber.

Claims (28)

1 . A biopsy device, comprising:

a sheath equipped with a removable stylet, the sheath comprising a terminus with a distal chamber configured with a forward facing cutting edge comprising a plurality of movable blades, the plurality of movable blades including two counter rotating blades configured perpendicular or beveled relative to a long axis of the distal chamber; and

a manipulation end controllable by a user to plunge the forward facing cutting edge at a sampling locus after removal of the removable stylet at a depth selected by the user and to engage a cutting action by the plurality of movable blades at the depth selected to acquire a plurality of specimens storable in the distal chamber.

2 . The biopsy device of claim 1 , wherein additional specimens are acquired at deeper depths at the sampling locus.

3 . The biopsy device of claim 1 , wherein the forward facing cutting edge includes a wire spanning across middle of the forward facing cutting edge.

4 . The biopsy device of claim 3 , wherein the forward facing cutting edge further includes a plate beneath the wire, and wherein the plurality of specimens is cut along the long axis to form a plurality of specimen half pairs, the specimen half pair kept separated by the plate.

5 . The biopsy device of claim 1 , wherein at least one movable blade of the plurality of movable blades is initiated to pivot by a pulling action from the manipulation end.

6 . The biopsy device of claim 1 , wherein at least one movable blade of the plurality of movable blades is initiated to pivot by a pushing action from the manipulation end.

7 . The biopsy device of claim 1 , wherein the distal chamber comprises a fluid passageway for removal of the plurality of specimens from the distal chamber with preservation of specimen order and orientation.

8 . The biopsy device of claim 1 , wherein the sheath comprises at least a rigid sheath portion or a flexible sheath portion.

9 . The biopsy device of claim 1 , wherein the sheath further comprises a plurality of depth markings.

10 . The biopsy device of claim 9 , wherein the plurality of depth markings is visible to an image-guided system.

11 . The biopsy device of claim 9 , wherein the depth is selected by the user based on the depth markings.

12 . The biopsy device of claim 1 , further comprising a proximal chamber in fluid communication with the distal chamber, the proximal chamber configured to receive the plurality of specimens in an order and orientations as acquired.

13 . The biopsy device of claim 1 , further comprising a proximal chamber in fluid communication with the distal chamber, the proximal chamber configured to receive the plurality of specimens in an order and orientations as acquired upon exposure of the plurality of specimens to a fluid or suction conveyed through the sheath.

14 . A biopsy device, comprising:

a sheath equipped with a removable stylet, the sheath comprising a terminus with a distal chamber configured with a forward facing cutting edge comprising a plurality of movable blades, the plurality of movable blades including two counter rotating blades configured perpendicular or beveled relative to a long axis of the distal chamber; and

a manipulation end controllable by a user to plunge the forward facing cutting edge at a sampling locus after removal of the removable stylet at a depth selected by the user and to engage a cutting action by the plurality of movable blades at the depth selected to acquire at least one specimen storable in the distal chamber, wherein the distal chamber comprises a fluid passageway for removal of the at least one specimen from the distal chamber.

15 . The biopsy device of claim 14 , further comprising a proximal chamber in fluid communication with the distal chamber.

16 . The biopsy device of claim 14 , further comprising a proximal chamber in fluid communication with the distal chamber, the proximal chamber configured to receive the at least one specimen upon exposure to a fluid or suction conveyed through the sheath.

17 . A method comprising:

inserting a flexible sheath fitted with a specimen chamber fitted with a forward facing cutting edge through and beyond a terminus of a biopsy channel to place the specimen chamber near a region-of-interest of a patient;

manipulating the specimen chamber via a handle in mechanical contact with the specimen chamber to extend the specimen chamber beyond the terminus of the flexible sheath at a set or selected distance by a user;

plunging the specimen chamber forward facing cutting edge into tissue occupying the region-of-interest to the set or selected distance;

acquiring and storing a plurality of specimens in the specimen chamber; and

procuring the plurality of specimens from the specimen chamber in an order and orientation acquired.

18 . The method of claim 17 , further comprising:

inserting the specimen chamber into an additional location at the tissue to an insertion depth such that a movable blade at the terminus of the specimen chamber partially separates an additional specimen from the tissue, and such that the additional specimen is stored in the specimen chamber and pushes the plurality of specimens further into the specimen chamber.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 7, 2023
From: CLEMENTS, ROBERT M.; FACE, ANDREW R.
To: CRUX MEDICAL INNOVATIONS, INC.
Reel/Frame 065484/0203 →
Continuity (5)
Continuation 17348269 · Jun 15, 2021
Division 15727362 · Oct 6, 2017
Division 12954584 · Nov 24, 2010
Provisional Application 61264628 · Nov 25, 2009
Related Publication 20240065678A1 · Feb 29, 2024
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