Sample management for core needle biopsy device
A core needle biopsy device includes a needle assembly, a drive assembly, and a tissue sample holder. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximal to the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch of the piercer. The drive assembly is configured to selectively move the piercer and the cutter. The tissue sample holder has a sample chamber and a wiper. The wiper is movable relative to the piercer and cutter to manipulate a severed tissue sample into the sample chamber.
1 . A core needle biopsy device, comprising:
(a) a needle assembly including a piercer and a hollow cutter, the piercer being solid and defining a longitudinal piercer axis, the piercer including a sharp distal tip and defining a notch proximal to the distal tip, the notch being a cutout laterally disposed along a solid portion of the needle such that the solid portion extends an entire length of the notch, the piercer being slidably disposed within the cutter to sever a tissue sample into the notch of the piercer;
(b) a drive assembly configured to selectively move the piercer and the cutter; and
(c) a tissue sample holder having a sample chamber and a wiper, the wiper defining a tissue manipulation portion, the wiper being flexible, the wiper being movable about a wiper axis and relative to the piercer and cutter to manipulate a severed tissue sample into the sample chamber, the wiper being configured to sweep the tissue manipulation portion across the entire length of the notch and to move within the sample chamber to push the severed tissue sample out of the notch and into the sample chamber, the longitudinal piercer axis and the wiper axis being parallel.
2 . The core needle biopsy device of claim 1 , the tissue sample holder including a rotatable shaft, the wiper being secured to the shaft such that rotation of the shaft is configured to rotate the wiper relative to the piercer to thereby manipulate a severed tissue sample into the sample chamber.
3 . The core needle biopsy device of claim 2 , the tissue sample holder including a plurality of wipers, which includes the wiper, each wiper of the plurality of wipers being secured to the shaft such that each wiper of the plurality of wipers extends radially outwardly from the shaft.
4 . The core needle biopsy device of claim 2 , wherein the wiper is a single wiper extending radially outward from the shaft.
5 . The core needle biopsy device of claim 1 , the tissue sample holder further including a base, the base including a plurality of sidewalls and a floor defining the sample chamber, the wiper being secured to the base, the base being configured to translate relative to the piercer to translate the wiper relative to the piercer and thereby manipulate a severed tissue sample into the tissue sample chamber.
6 . The core needle biopsy device of claim 5 , the base further including a manipulator, the manipulator being in communication with the drive assembly such that the drive assembly is configured to drive translation of the base relative to the piercer.
7 . The core needle biopsy device of claim 6 , the manipulator including a plurality of wedge-shaped manipulators.
8 . The core needle biopsy device of claim 6 , the manipulator including a plurality of gear teeth arranged in a plurality of discrete groups.
9 . The core needle biopsy device of claim 6 , the manipulator including a plurality of gear teeth arranged in a plurality of discrete groups, the drive assembly including a gear having an intermittent gear portion, the intermittent gear portion being configured to engage the plurality of gear teeth to translate the base intermittently in response to continuous rotation of the gear.
10 . The core needle biopsy device of claim 1 , further comprising a sample tray configured for receipt within a portion of the tissue sample holder, the sample tray being configured to engage the wiper to manipulate a severed tissue sample from the wiper and into an interior space defined by the sample tray.
11 . The core needle biopsy device of claim 10 , the sample tray including a collection tooth, the collection tooth being configured to engage the wiper to manipulate a severed tissue sample from the wiper and into the interior space defined by the sample tray.
12 . The core needle biopsy device of claim 1 , the wiper including a material having a durometer of 30 to 80.
13 . The core needle biopsy device of claim 1 , the wiper defining a thin rectangular shape.
14 . The core needle biopsy device of claim 1 , the wiper defining a curved edge configured to atraumatically engage tissue.
15 . The core needle biopsy device claim 1 , further comprising a body having a distal end, the needle assembly extending distally from the distal end of the body, the tissue sample holder being disposed on the distal end of the body.
16 . A tissue sample holder for use with a core needle biopsy device, the core needle biopsy device including a piercer having a sample notch and a cutter movable relative to the sample notch to sever a tissue sample, the tissue sample holder comprising:
(a) a body defining a sample chamber; and
(b) at least one wiper movable through the sample chamber of the tissue sample holder to manipulate a severed tissue sample from the sample notch of the piercer and into the sample chamber of the body.
17 . The tissue sample holder of claim 16 , further comprising a rotatable shaft, the at least one wiper extending radially outwardly from the shaft, the body including a cylindrical inner wall defining the sample chamber, the at least one wiper being configured to slide along the inner wall of the body to move a severed tissue sample within the sample chamber.
18 . The tissue sample holder of claim 17 , the at least one wiper defining a curved portion, the curved portion defining a curvature oriented in a direction corresponding to a rotation direction of the shaft.
19 . The tissue sample holder of claim 17 , the at least one wiper being secured to the body such that the body is configured to move the at least one wiper relative to the piercer.
20 . A method for using a biopsy device, the method comprising:
(a) retracting a sample notch defined by a piercer proximally into a tissue sample holder;
(b) rotating a wiper relative to the sample notch and within the tissue sample holder to thereby sweep the wiper across the sample notch; and
(c) after rotating the wiper to thereby sweep the wiper across the sample notch, moving the wiper away from the sample notch and towards a sample chamber.