Core needle biopsy device
The present disclosure provides a biopsy device for performing soft tissue biopsy on any major organ through the venous system, and a method for using the biopsy device. The biopsy device of the present disclosure is a system that is sufficiently flexible such that the system can be guided manually and with existing tools i.e., fluoroscopy for visualisation and simple guidewires. Once in place, the biopsy device of the present disclosure can generate enough force and can transmit that force to the distal cutting end of the system to penetrate the organ and obtain a biopsy.
1 . A biopsy device for acquiring a biopsy sample of a target organ in a subject, the biopsy device comprising:
a housing;
an elongated tube with a first proximal end and a first distal end, wherein the first distal end is positioned at a biopsy site of the target organ, and wherein the first proximal end comprises a first locking mechanism having a swivel disposed around the elongated tube and a bayonet externally coupled to the swivel, said bayonet attached to an external portion of the housing; and
a biopsy needle with a second proximal end and a second distal end, the biopsy needle is positioned within the elongated tube for navigation to the biopsy site and is configured to exit the first distal end of the elongated tube for penetration into tissue of the target organ at the biopsy site, and to acquire a biopsy sample of the target organ at the biopsy site,
wherein the second proximal end of the biopsy needle having a second locking mechanism comprising a cartridge and a stylet lug disposed around the biopsy needle, the cartridge and the stylet lug each coupled to and enclosed within the housing.
2 . The biopsy device according to claim 1 , wherein the first locking mechanism comprises opposing extensions configured to engage with an opening in the housing.
3 . The biopsy device according to claim 2 , wherein each of the opposing extensions comprise a shoulder configured to engage with the opening in the housing.
4 . The biopsy device according to claim 1 , wherein the first locking mechanism is freely rotatable around the elongated tube.
5 . The biopsy device according to claim 1 , wherein the biopsy needle comprises a coring needle and a stylet needle.
6 . The biopsy device according to claim 5 , wherein the coring needle comprises one or more spiral cuts extending circumferentially around and longitudinally along the coring needle.
7 . The biopsy device according to claim 6 , wherein the one or more spiral cuts has a constant pitch.
8 . The biopsy device according to claim 6 , wherein the one or more spiral cuts has a variable pitch.
9 . The biopsy device according to claim 5 , wherein the stylet needle comprises notches along its circumference longitudinally along the stylet needle.
10 . The biopsy device according to claim 9 , wherein the notches are diametrically opposed.
11 . The biopsy device according to claim 9 , wherein the notches are of a depth of not more than 30% of the stylet needle diameter.
12 . The biopsy device according to claim 9 , wherein the notches are rotated 90 degrees axially.
13 . The biopsy device according to claim 5 , wherein the housing further comprises:
an advancing mechanism, configured to advance the stylet needle for penetration into tissue of the target organ at the biopsy site; and
a firing mechanism, configured to fire the coring needle for penetration into tissue of the target organ at the biopsy site, thereby obtaining the biopsy sample of the target organ at the biopsy site.
14 . The biopsy device according to claim 13 , wherein the advancing mechanism is actuated by rotation.
15 . The biopsy device according to claim 13 , wherein the firing mechanism is configured to fire the coring needle only when the stylet needle is fully advanced.
16 . The biopsy device according to claim 5 , wherein the stylet needle comprises an indentation at a third distal end of the stylet needle.
17 . A method for acquiring a biopsy sample of a target organ in a subject using a biopsy device, the method including:
providing a biopsy device, the biopsy device comprising:
a housing;
an elongated tube with a first proximal end and a first distal end, wherein the first distal end is positioned at a biopsy site of the target organ, and wherein the first proximal end comprises a first locking mechanism having a swivel disposed around the elongated tube and a bayonet externally coupled to the swivel, said bayonet attached to an external portion of the housing; and
a biopsy needle with a second proximal end and a second distal end, the biopsy needle is positioned within the elongated tube for navigation to the biopsy site and is configured to exit the first distal end of the elongated tube for penetration into tissue of the target organ at the biopsy site, and to acquire a biopsy sample of the target organ at the biopsy site, and wherein the second proximal end of the biopsy needle comprises a second locking mechanism, said second locking mechanism comprising a cartridge and a stylet lug disposed around the biopsy needle, the cartridge and the stylet lug each coupled to and enclosed within the housing
wherein the second proximal end of the biopsy needle having a second locking mechanism comprising a cartridge and a stylet lug disposed around the biopsy needle, the cartridge and the stylet lug each coupled to and enclosed within the housing;
percutaneously inserting the elongated tube into a first blood vessel of a limb of a subject; and
navigating the first distal end of the elongated tube from the first blood vessel through a vascular system of the subject and into a second blood vessel of the target organ near the biopsy site.
18 . The method according to claim 17 , wherein the first locking mechanism comprises opposing extensions configured to engage with an opening in the housing.
19 . The method according to claim 18 , wherein coupling the elongated tube to the housing with the first locking mechanism comprises:
compressing the opposing extensions; and
inserting the compressed opposing extensions into the opening in the housing.
20 . The method according to claim 17 , wherein the biopsy needle comprises a coring needle and a stylet needle.
21 . The method according to claim 20 , further comprising:
pushing the stylet needle into the target organ at the biopsy site until the stylet needle is fully advanced; and
pushing the coring needle into the target organ at the biopsy site.