Biopsy device with selectable tissue receiving aperture orientation and site illumination

A tissue biopsy system for collecting at least one tissue specimen from a target site within a patient and delivering at least one marker to the target site after the at least one tissue specimen has been removed from the site, comprising:

• a. a disposable elongated probe component comprising
• i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, and a proximal extremity configured to be secured to a driver unit, and
• ii. an elongated tubular tissue cutting member which has at least one tissue cutting edge at a distal end, which has an opening at a proximal end, which has a tissue specimen receiving opening in the distal end and which has an inner lumen extending therein between the tissue specimen receiving opening and the opening in the proximal end;
• b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which is configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which is configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof;
• and
• c. a marker delivery component for delivery of at least one marker bodies through the tubular tissue cutting member, including:
• i. an elongated marker delivery shaft which has an inner lumen, a discharge opening in a distal portion of the elongated marker delivery shaft, an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component and a handle on a proximal portion of the shaft having a stopping shoulder to stop the proximal end of the tissue cutting member with respect to the elongated marker delivery shaft;
• ii. at least one marker body which is disposed within the inner lumen of the elongated marker delivery shaft;
• iii. a pusher element which is slidably disposed within the marker delivery component and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated marker delivery shaft and the tissue specimen receiving opening in the tissue cutting member;
• and
• iv. a guide member which is slidably disposed on the elongated marker delivery shaft of the marker delivery component, which has an inner distally oriented, outwardly flared surface having a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated marker delivery shaft of the marker delivery component into communication with the proximal end of the tubular cutting member and to allow the elongated marker delivery shaft to advance within an inner lumen of the tubular cutting member.

A method for collecting one or more tissue specimens from a target site within a patient and delivering at least one marker body to the target site, comprising:

• a. providing a biopsy device having:
• i. a disposable elongated probe component comprising:
• an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an distal portion proximal to the penetrating distal tip having a tissue receiving aperture configured to receive tissue from the target site, and
• an elongated tissue cutting member which is slidably disposed within the elongated tubular section, which has a distal end and a proximal end, which has at least one tissue cutting edge on the distal end, which has a tissue specimen receiving aperture, which has an inner lumen extending between the proximal and distal end and which is disposed within the tubular tissue cutting member with the cutting edge distal to the tissue receiving aperture opening so as to close the opening;
• and
• ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal portion of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member;
• b. advancing the probe component at least partially into or adjacent to tissue at the target site with the tissue receiving aperture closed by the tissue cutter;
• c. rotating the tubular section of the probe component about its longitudinal axis to provide a desired orientation to the tissue receiving aperture;
• d. withdrawing the tissue cutter proximally to open a desired length of the tissue receiving aperture;
• e. applying a vacuum within the tubular section to draw tissue at the tissue site through the tissue receiving aperture of the tubular section into the interior thereof;
• f. advancing the tissue cutting member distally within the tubular section of the probe member to cut a tissue specimen from the tissue extending into the tubular section;
• g. transporting a cut tissue specimen through the inner lumen of the tissue cutting member and out a discharge opening in the proximal end thereof;
• h. providing a marker delivery device for delivery of at least one marker bodies through the tubular tissue cutting member, including:
• i. an elongated marker delivery shaft which has an inner lumen, a discharge opening in a distal portion of the elongated marker delivery shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component and a proximal portion with a handle having a stopping shoulder for stopping movement of the proximal end of the tissue cutting member with respect to the elongated marker delivery shaft;
• ii. at least one marker body which is disposed within the inner lumen of the elongated marker delivery shaft;
• iii. a pusher element which is slidably disposed within the elongated marker delivery shaft and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated marker delivery shaft;
• and
• iv. a distally oriented, outwardly flared guide member which is slidably disposed on the elongated marker delivery shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated marker delivery shaft into the proximal end of the tubular cutting member;
• i. advancing the marker delivery device toward the proximal end of the tubular tissue cutting member of the probe component until the distal end of the flared guide member surrounds the proximal end of the tubular tissue cutting member;
• j. further advancing the marker delivery device so the elongated marker delivery shaft thereof extends into the inner lumen of the tubular tissue cutting member until the proximal end of the tissue cutting member engages the stopping shoulder of the handle while the distally flared guide member slides along the elongated marker delivery shaft and the discharge opening in the elongated marker delivery shaft of the marker delivery device is aligned with the tissue receiving aperture of the elongated tubular section;
• and
• k. pressing the pusher element of the marker delivery device to eject at least one marker body through the discharge opening in the marker delivery device, through the tissue receiving aperture and into the target site.