Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister
View Patent ↗A biopsy device is provided for obtaining a tissue sample, such as a breast tissue biopsy sample. The biopsy device includes a disposable probe assembly with an outer cannula having a distal piercing tip, a cutter lumen, and a cutter tube that rotates and translates past a side aperture in the outer cannula to sever a tissue sample. The biopsy device also includes a reusable handpiece with an integral motor and power source to make a convenient, untethered control for use with ultrasonic imaging. The reusable handpiece incorporates a probe oscillation mode to assist when inserting the distal piercing tip into tissue. An integral vacuum motor assists prolapsing tissue for effective severing as well as facilitating withdrawal of the tissue samples and bodily fluids from the biopsy site into a detachable,self-contained canister for transporting the separated biopsy samples and fluid for pathology assessment, avoiding biohazards in a clinical setting.
1. A biopsy device, comprising:
a. a probe cannula defining an internal passage and having a side aperture;
b. a cutter tube reciprocally received by the probe cannula to sever a tissue sample received in the probe cannula;
c. a vacuum lumen communicating to a distal end of the probe cannula;
d. a vacuum source in communication with the vacuum lumen and cutter tube;
e. a motor assembly operatively configured to translate the cutter tube to sever a tissue sample;
f. a pneumatically sealed container at a reduced pneumatic pressure, wherein the container further comprises:
i. a fluid reservoir, wherein the fluid reservoir is configured to hold fluid,
ii. a filter positioned above the fluid reservoir, wherein the filter is configured to separate fluids from solids,
iii. a tissue sample holder defined by the fluid reservoir and the filter, wherein the tissue sample holder is configured to hold solid tissue samples severed by the cutter tube, wherein the tissue sample holder is located in the container, such that the tissue sample holder holds solid tissue samples within the container, and
iv. a vacuum port positioned on an exterior surface of the container at a location above a level of the fluid held within the fluid reservoir and above the filter, wherein the vacuum port communicates with the vacuum source;
g. a sample retraction conduit communicating between the container and a proximal end of the cutter tube, wherein the sample retraction conduit passes through a plane defined by the filter and terminates at a free end located within the fluid reservoir below the filter and below the vacuum port, wherein the sample retraction conduit is configured to communicate solid tissue samples out through the free end and into the tissue sample holder; and
h. a pneumatic switching assembly responsive to the cutter tube, wherein the pneumatic switching assembly is operatively configured to expose both the cutter tube and the vacuum lumen to vacuum from the vacuum source in response to the cutter tube being retracted to prolapse tissue into the side aperture, wherein the pneumatic switching assembly is responsive to the cutter tube being distally positioned to expose the vacuum lumen to an increased pressure to effect retraction of severed tissue to the container via the sample retraction conduit.
2. The biopsy device of claim 1 , further comprising a handle attached to the probe cannula and containing the motor assembly and the pneumatic switching assembly.
3. The biopsy device of claim 2 , wherein the handle further comprises a vacuum pump for providing a vacuum source to the container and to the pneumatic switching assembly.
4. The biopsy device of claim 2 , further comprising at least one detachable pneumatic connection between the handle and the container and a pneumatic closure to seal the container for transport.
5. The biopsy device of claim 1 , wherein the tissue sample holder comprises a basket.
6. The biopsy device of claim 5 , wherein the basket is configured to hold solid tissue samples while permitting fluid to flow through the basket.
7. The biopsy device of claim 1 , wherein the container further comprises a lid, wherein the sample retraction conduit is engaged with the lid.
8. The biopsy device of claim 1 , wherein the tissue sample holder is removable from the container.
9. The biopsy device of claim 1 , wherein the container is coupled with the remainder of the biopsy device only by one or more conduits, wherein the one or more conduits include the sample retraction conduit.
10. A biopsy device, comprising:
a. a probe cannula defining an internal passage and having a side aperture;
b. a cutter tube reciprocally received by the probe cannula to sever a tissue sample received in the probe cannula;
c. a vacuum lumen communicating to a distal end of the probe cannula;
d. a vacuum source in communication with the vacuum lumen and cutter tube;
e. a motor assembly operatively configured to translate the cutter tube to sever a tissue sample;
f. a container at a reduced pneumatic pressure, wherein the container further comprises:
i. a fluid reservoir, wherein the fluid reservoir is configured to hold fluid,
ii. a tissue sample holder, wherein the tissue sample holder comprises a basket having a top member defining a first horizontal plane and a second member defining a second horizontal plane, wherein the second horizontal plane is below the first horizontal plane, wherein the second member comprises a perforated disk and a filter disk, wherein the perforated disk includes a top surface and a bottom surface beneath the top surface, wherein the filter disk is adhered to the bottom surface of the perforated disk, wherein the tissue sample is captured on the top surface of the perforated disk,
iii. a vacuum port in communication with the vacuum source, wherein the vacuum port terminates above the first horizontal plane;
g. a sample retraction conduit communicating between the container and a proximal end of the cutter tube, wherein the sample retraction conduit terminates at a free end located between the first horizontal plane and the second horizontal plane and below the vacuum port, wherein the sample retraction conduit is configured to communicate tissue samples out through the free end and into the tissue sample holder; and
h. a pneumatic switching assembly responsive to the cutter tube operatively configured to expose both the cutter tube and the vacuum lumen to vacuum from the vacuum source in response to the cutter tube being retracted to prolapse tissue into the side aperture and responsive to the cutter tube being distally positioned to effect retraction of severed tissue to the container.
11. The biopsy device of claim 10 , wherein the basket is fully enclosed.
12. The biopsy device of claim 10 , wherein the tissue sample is held on the perforated disk, separate from fluids collected in the fluid reservoir.