Biopsy device with selectable tissue receiving aperature orientation and site illumination

• US 9,044,215 B2
• Filed: 08/25/2008
• Issued: 06/02/2015
• Est. Priority Date: 02/24/2003
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Shabaz, Martin V., Quick, Richard L., Louw, Frank R., Lubock, Paul, Safabash, Jason H.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): Kremer, Matthew
• Application Number:
  US12/229,545
• Publication Number:
  US 20080319468A1
• Time in Patent Office: 2,472 Days
• Field of Search: 600/564, 600/567, 600/568, 606/185, 606/167, 606/187
• US Class Current: 1/1
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: B23Q 17/2404 Arrangements for improving direct observation of the working space, e.g. using mirrors or lamps structural combinations of lighting devices with other articles, not otherwise provided for, F21V33/00
• CPC Class Codes: F21V 33/0068 Medical equipment

Abstract

The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component with an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The device also has a driver component to which the probe component is releasably secured. The driver has a drive member for adjusting the orientation of the tubular section and thus the aperture therein and one or more drive members for moving the tissue cutting member within the tubular section to sever a tissue specimen from tissue extending into the interior of the tubular section through the aperture. The motion imparted to the tissue cutter is at least longitudinal and preferably is also oscillation and/or rotational to effectively separate a tissue specimen from tissue extending through the aperture in the tubular section.

Claims

1. 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 a distal portion proximal to the penetrating distal tip and having a tissue receiving aperture configured to receive tissue from the target site, and

an elongated tissue cutting member which is disposed within the elongated tubular section, which has a distal end having at least one tissue cutting edge, which has an inner lumen extending therein and which is disposed within the elongated tissue cutting member with the cutting edge distal to the tissue receiving aperture so as to close the aperture, and having a proximal end opposite the distal end; and

ii. a driver component which is configured to receive a proximal portion of the elongated probe component in an operational relationship, which has a first driver unit configured to rotate the elongated tubular section of the elongated probe component to orient the tissue receiving aperture of the elongated tubular section and which has a second driver unit configured to drive the elongated tissue cutting member longitudinally within the elongated tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular section;

b. advancing the elongated probe component at least partially into or adjacent to tissue at the target site with the tissue receiving aperture closed by the elongated tissue cutting member;

c. rotating the elongated tubular section of the elongated probe component about the longitudinal axis to provide a desired orientation of the tissue receiving aperture;

d. withdrawing the elongated tissue cutting member distally to open a desired length of the tissue receiving aperture;

e. applying a vacuum within the elongated tubular section to draw the tissue at the tissue site through the tissue receiving aperture of the elongated tubular section into an interior thereof;

f. advancing the elongated tissue cutting member distally within the elongated tubular section of the elongated probe member to cut the tissue specimen from the tissue extending into the elongated tubular section;

g. applying a vacuum for transporting a cut tissue specimen through the inner lumen of the elongated tissue cutting member and out a discharge opening in the proximal end of the tissue cutting member and into a tissue specimen receiving cartridge;

h. providing a marker delivery device for delivery of the at least one marker body through the elongated tissue cutting member, including;

i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the inner lumen of the elongated tissue cutting member of the elongated probe component;

ii. the at least one marker body which is disposed within the inner lumen of the elongated shaft;

iii. a pusher element which is slidably disposed within the marker delivery device and which is configured to urge the at least one marker body out the discharge opening in the distal portion of the elongated shaft; and

iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the elongated tissue cutting member and which is configured to guide the distal portion of the elongated shaft into a proximal end of the inner lumen of the elongated tissue cutting member;

i. removing at least a portion of the tissue specimen receiving cartridge to expose the proximal end of the elongated tissue cutting member and advancing the marker delivery device toward the proximal end of the elongated tissue cutting member of the elongated probe component until a distal end of the flared guide surrounds the proximal end of the elongated tissue cutting member;

j. further advancing the marker delivery device so the elongated shaft thereof extends into the inner lumen of the elongated tissue cutting member and the discharge opening in the elongated shaft of the marker delivery device is aligned with the tissue receiving aperture of the elongated tubular section of the biopsy device; and

k. pressing the pusher element of the marker delivery device to eject the at least one marker body through the discharge opening in the marker delivery device, through the tissue receiving aperture of the elongated tubular section of the biopsy device, and into the target site.

2. The method of claim 1, wherein the vacuum is applied to a tissue collection device that carries the tissue specimen receiving cartridge.