Biopsy device with selectable tissue receiving aperture orientation and site illumination

• US 9,204,866 B2
• Filed: 06/04/2010
• Issued: 12/08/2015
• Est. Priority Date: 02/24/2003
• Status: Expired due to Term

• 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): HENSON, DEVIN B
• Application Number:
  US12/794,480
• Publication Number:
  US 20100268117A1
• Time in Patent Office: 2,013 Days
• Field of Search: 600/180, 600/181, 600/178, 600/445, 600/461, 600/462, 600/464, 600562-567
• 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
• 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 biopsy device for obtaining a tissue sample from a patient, the device comprising:

a driver component having a housing that contains an electrical motor, the housing having a distal housing portion;

a probe component including an elongated probe member having a tissue penetrating distal tip and a proximal end, the proximal end of the probe component being secured to the housing of the driver component, the driver component being configured to drivably engage the probe component, with the elongated probe member configured to extend from the distal housing portion of the driver component;

an elongated tissue cutting member disposed coaxial with the elongated probe member and off-axis from the driver component, the electrical motor being drivably coupled to the elongated tissue cutting member to move the elongated tissue cutting member relative to the elongated probe member; and

a light source located in the distal housing portion of the housing of the driver component, the light source being located and configured to project light through the air, with the projected light being external to the biopsy device and in a distal direction toward the tissue penetrating distal tip to provide localized illumination of an operating site on an externally exposed portion of the patient, wherein the driver component is configured to automatically activate the light source to provide the localized illumination when the probe component is installed on the driver component.

2. A biopsy device for obtaining a tissue sample from a patient, the device comprising:

a handle including a driver component having a housing, the housing having a distal housing portion having a front face;

a probe component including an elongated probe member having a tissue penetrating distal tip and a proximal end secured to the handle, the driver component being configured to drivably engage the probe component; and

a light source located in the distal housing portion of the driver component, the light source being radially spaced from the elongated probe member and configured to project light external to the handle from the front face of the distal housing portion of the driver component toward the tissue penetrating distal tip to provide localized illumination of an operating site on an externally exposed portion of the patient, wherein the driver component is configured to automatically activate the light source to provide the localized illumination when the probe component is installed on the driver component,

wherein the light source is a light emitting diode.

3. The biopsy device of claim 2 wherein the driver component has two light sources radially spaced from the elongated probe member, the two light sources being mounted in a recessed cavity in the front face of the distal housing portion of the driver component from which external light is projected.

4. A biopsy device for obtaining a tissue sample from a patient, the device comprising:

a handle including a driver component having a housing, the housing having a distal housing portion having a distal front face, the distal housing portion configured to have a recessed cavity in the distal front face of the housing of the driver component;

a probe component including an elongated probe member having a tissue penetrating distal tip and a proximal end secured to the handle, the driver component being configured to drivably engage the probe component, the elongated probe member configured to extend distally with respect to the distal front face; and

a light source mounted in the recessed cavity in the distal front face of the distal housing portion of the housing of the driver component, the light source being located and configured to project light from the recessed cavity in the distal front face, with the projected light being external to the biopsy device and in a distal direction from the distal front face of the housing of the driver component toward the tissue penetrating distal tip to provide localized illumination of an operating site on an externally exposed portion of the patient, wherein the driver component is configured to automatically activate the light source to provide the localized illumination when the probe component is installed on the driver component.

5. The biopsy device of claim 4 wherein the probe component comprises:

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 a targeted site, a proximal extremity configured to be secured to the driver component, and

an elongated tissue cutting member which is disposed within the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein.

6. The biopsy device of claim 5 wherein the driver component includes in the housing:

a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture to one of a plurality of discrete rotational positions for obtaining the tissue sample; and

a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture.

7. The biopsy device of claim 6 wherein the driver component has a third driver motor configured to rotate the tissue cutting member within the tubular section.

8. The biopsy device of claim 7 wherein the third driver motor rotates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.

9. The biopsy device of claim 6 wherein the driver component has a third driver motor configured to oscillate the tissue cutting member within the tubular section.

10. The biopsy device of claim 9 wherein the third driver motor oscillates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.

11. The biopsy device of claim 6 wherein at least one of the driving motors are electrically powered.

12. The biopsy device of claim 6 wherein at least one of the driving motors are hydraulically powered.

13. The biopsy device of claim 6 wherein at least one of the driving motors are pneumatically powered.

14. The biopsy device of claim 6 including a control module which has an electrical source and a vacuum source.

15. The biopsy device of claim 12 wherein the control module controls the rotation of the tubular section.

16. The biopsy device of claim 6 wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.

17. The biopsy device of claim 5 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member to withdraw tissue therethrough.

18. The biopsy device of claim 17 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member configured to receive tissue withdrawn through the tissue cutting member.

19. The biopsy device of claim 18 wherein the tissue collector is located between the tissue cutting member and the vacuum source.

20. The biopsy device of claim 5 comprising a first driving motor configured to rotate the tubular section in discrete steps about the longitudinal axis thereof.

21. The biopsy device of claim 20 wherein the first driving motor is configured to rotate the tubular section in increments of about 15°

to about 45°

.

22. The biopsy device of claim 20 wherein the first driving motor is configured to rotate the tubular section in increments of about 30°

.

23. The biopsy device of claim 5 wherein a distal extremity of the tubular section of the probe component has a circular transverse cross-section.