Biopsy device with selectable tissue receiving aperture orientation and site illumination

• US 8,282,573 B2
• Filed: 08/03/2004
• Issued: 10/09/2012
• 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, Brain
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US10/911,106
• Publication Number:
  US 20050065453A1
• Time in Patent Office: 2,989 Days
• Field of Search: 600/564, 600/568, 600/566, 600/567, 606/167, 606/170.01, 606/185
• US Class Current: 600/564
• 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 2017/00486 Adaptors for coupling parts with incompatible geometries
• 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 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• 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: A61M 1/92 : with liquid supply means
• 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 device for delivery of one or more marker bodies through a tubular cutter member of a biopsy device, comprising:

a. an elongated marker delivery shaft having an exterior, an inner lumen, a discharge opening in a distal portion of the elongated shaft and a handle on a proximal portion of the elongated shaft;

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

c. a guide member which is slidably disposed on the exterior of the elongated marker delivery shaft and which has an inner distally oriented, outwardly flared surface configured to guide the distal portion of the elongated marker delivery shaft into a proximal end of the tubular cutter member of the biopsy device and to allow the elongated marker delivery shaft to advance within an inner lumen of the tubular cutter member;

d. the handle having a stopping shoulder proximal to the guide member that is configured to stop the proximal end of the tubular cutting member of the biopsy device with respect to the elongated marker delivery shaft; and

e. a plunger slidably disposed within the inner lumen of the elongated marker delivery shaft which is long enough to discharge the at least one marker body through the discharge opening in the elongated marker delivery shaft and a tissue receiving aperture in the tubular cutting member when the proximal end of the tubular cutting member engages the stopping shoulder.

2. The device of claim 1 including a pusher element which is slidably disposed within the delivery device 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.

3. 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.

4. 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.