Biopsy device with selectable tissue receiving aperature orientation and site illumination

• US 10,335,127 B2
• Filed: 04/30/2015
• Issued: 07/02/2019
• 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): Kremer, Matthew
• Application Number:
  US14/700,574
• Publication Number:
  US 20150230778A1
• Time in Patent Office: 1,524 Days
• Field of Search: None
• 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

A method for collecting a tissue specimen from a target site within a patient includes rotating an elongated tubular section about a longitudinal axis to provide a desired aperture orientation of a tissue receiving aperture; applying a vacuum within the elongated tubular section to draw tissue at the tissue site through the tissue receiving aperture of the elongated tubular section into the interior thereof; advancing an elongated tissue cutting member longitudinally within the elongated tubular section to cut a tissue specimen from the tissue extending into the elongated tubular section; and applying a vacuum to the proximal end of the elongated tissue cutting member for transporting a cut tissue specimen through the inner lumen of the elongated tissue cutting member to discharge the cut tissue specimen directly from the proximal end of the elongated tissue cutting member into a tissue collection device.

Claims

1. A method for collecting one or more tissue specimens from a target site within a patient, 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 tissue receiving aperture proximal to the penetrating distal tip configured to receive tissue from the target site,

a first driven gear coupled to the elongated tubular section and configured to rotate, to in turn rotate the elongated tubular section around the longitudinal axis,

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 and which has an inner lumen extending therein, the elongated tissue cutting member having a proximal end opposite the distal end, and

a second driven gear coupled to the elongated tissue cutting member and configured to rotate to longitudinally move the elongated tissue cutting member relative to the elongated tubular section along the longitudinal axis,

the first driven gear and the second driven gear being arranged coaxially and adjacent each other on the longitudinal axis;

ii. a driver component configured to receive a proximal portion of the disposable elongated probe component in an operational relationship, the driver component having;

a first driver unit configured to rotate the elongated tubular section of the disposable elongated probe component to orient the tissue receiving aperture of the elongated tubular section, the first driver unit having a first drive gear, and

a second driver unit configured to drive the elongated tissue cutting member longitudinally within the elongated tubular section to cut a tissue specimen from the tissue received in the tissue receiving aperture of the elongated tubular section, the second driver unit having a second drive gear positioned adjacent the first drive gear,

the first drive gear and the second drive gear of the driver component configured to respectively drivably engage the first driven gear and the second driven gear that are arranged coaxially and adjacent to each other on the longitudinal axis; and

iii. a tissue collection device located at the proximal end of the elongated tissue cutting member, a portion of the elongated tissue cutting member being positioned inside the tissue collection device;

b. advancing the disposable elongated probe component at least partially into or adjacent to tissue at the target site;

c. rotating the elongated tubular section about the longitudinal axis by the first driver unit to a predetermined aperture orientation of the tissue receiving aperture;

d. 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;

e. advancing the elongated tissue cutting member longitudinally within the elongated tubular section by the second driver unit to cut the tissue specimen from the tissue extending into the elongated tubular section; and

f. applying a vacuum to the proximal end of the elongated tissue cutting member for transporting the cut tissue specimen through the inner lumen of the elongated tissue cutting member to discharge the cut tissue specimen directly from the proximal end of the elongated tissue cutting member into the tissue collection device.

2. The method of claim 1, comprising:

providing the disposable elongated probe component with a third driven gear coupled to the elongated tissue cutting member, the third driven gear being arranged on the longitudinal axis such that the third driven gear is coaxial with the first driven gear and the second driven gear on the longitudinal axis;

providing the driver component with a third driver unit having a third drive gear configured to drivably engage the third driven gear, the third drive gear positioned adjacent the second drive gear; and

driving the third driven gear with the third drive gear simultaneously with driving the second driven gear with the second drive gear, such that the act of advancing the elongated tissue cutting member longitudinally is achieved by driving the second driven gear and the act of advancing the elongated tissue cutting member longitudinally is accompanied by a rotational or oscillation motion of the elongated tissue cutting member about the longitudinal axis by driving the third driven gear.

3. The method of claim 1, comprising rotating the first driven gear in discrete rotational increments to in turn rotate the elongated tubular section about the longitudinal axis in discrete rotational increments.

4. The method of claim 3, wherein the discrete rotational increments are increments of 30 degrees.

5. The method of claim 3, wherein the discrete rotational increments are multiples of 30 degrees.

6. A method for collecting a tissue specimen from a target site within a patient, 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 tissue receiving aperture proximal to the penetrating distal tip configured to receive tissue from the target site,

a first driven gear coupled to the elongated tubular section,

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 and which has an inner lumen extending therein, the elongated tissue cutting member having a proximal end opposite the distal end,

a second driven gear coupled to the elongated tissue cutting member, and

a third driven gear coupled to the elongated tissue cutting member, wherein the first driven gear, the second driven gear, and the third driven gear are coaxial with each other on the longitudinal axis;

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, the first driver unit having a first drive gear configured to drivably engage the first driven gear of the elongated tubular section for rotating the elongated tubular section to position the tissue receiving aperture,

a second driver unit configured to drive the elongated tissue cutting member longitudinally within the elongated tubular section to cut the tissue specimen from the tissue received in the tissue receiving aperture of the elongated tubular section, the second driver unit having a second drive gear positioned adjacent the first drive gear, the second drive gear configured to drivably engage the second driven gear for longitudinally moving the elongated tissue cutting member relative to the elongated tubular section, and

a third driver unit configured to drive the elongated tissue cutting member in rotational or oscillation motion, the third driver unit having a third drive gear positioned adjacent the second drive gear, and configured to drivably engage the third driven gear for moving the elongated tissue cutting member in the rotational or oscillation motion; and

iii. a tissue collection device located at the proximal end of the elongated tissue cutting member;

b. advancing the elongated probe component at least partially into the patient at the target site;

c. rotating the elongated tubular section about the longitudinal axis to a predetermined aperture orientation of the tissue receiving aperture by the first driver unit;

d. applying a first 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;

e. advancing the elongated tissue cutting member longitudinally within the elongated tubular section by the second driver unit, and rotating or oscillating the elongated tissue cutting member within the elongated tubular section by the third driver unit, to cut the tissue specimen from the tissue drawn into the elongated tubular section; and

f. applying a second vacuum to the proximal end of the elongated tissue cutting member for transporting the tissue specimen through the inner lumen of the elongated tissue cutting member to discharge the cut tissue specimen directly from the proximal end of the elongated tissue cutting member into the tissue collection device.

7. A method of operating a biopsy device, comprising:

a. providing a biopsy device having;

i. a disposable elongated probe component including;

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 tissue receiving aperture proximal to the penetrating distal tip configured to receive tissue from a 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 and which has an inner lumen extending therein, the elongated tissue cutting member having a proximal end opposite the distal end;

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,

a second driver unit configured to drive the elongated tissue cutting member longitudinally within the elongated tubular section to cut a tissue specimen from the tissue received in the tissue receiving aperture of the elongated tubular section,

a third driver unit configured to drive the elongated tissue cutting member in rotational or oscillation motion; and

iii. a first driven gear coupled to the elongated tubular section;

iv. a second driven gear coupled to the elongated tissue cutting member;

v. a third driven gear coupled to the elongated tissue cutting member, wherein the first driven gear, the second driven gear, and the third driven gear are coaxial with each other on the longitudinal axis;

vi. the first driver unit having a first drive gear configured to drivably engage the first driven gear of the elongated tubular section for rotating the elongated tubular section to position the tissue receiving aperture;

vii. the second driver unit having a second drive gear positioned adjacent the first drive gear, the second drive gear configured to drivably engage the second driven gear for longitudinally moving the elongated tissue cutting member relative to the elongated tubular section; and

viii. the third driver unit having a third drive gear positioned adjacent the second drive gear, and configured to drivably engage the third driven gear for moving the elongated tissue cutting member in the rotational or oscillation motion;

b. rotating the elongated tubular section about the longitudinal axis to a predetermined aperture orientation of the tissue receiving aperture by the first driver unit;

c. advancing the elongated tissue cutting member longitudinally within the elongated tubular section by the second driver unit; and

d. rotating or oscillating the elongated tissue cutting member within the elongated tubular section by the third driver unit.

8. The method of claim 7, comprising driving the first driven gear in discrete rotational increments to in turn rotate the elongated tubular section about the longitudinal axis in discrete rotational increments.

9. The method of claim 8, wherein the discrete rotational increments are increments of 30 degrees.

10. The method of claim 8, wherein the discrete rotational increments are multiples of 30 degrees.

11. The method of claim 7, wherein a driving of the third driven gear is simultaneous with a driving of the second driven gear.