Biopsy device with selectable tissue receiving aperture orientation and site illumination

• US 10,172,595 B2
• Filed: 08/25/2008
• Issued: 01/08/2019
• 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): Henson, Devin B
• Application Number:
  US12/229,553
• Publication Number:
  US 20080319342A1
• Time in Patent Office: 3,788 Days
• Field of Search: 600567, 600547, 600573, 600582, 600587, 606167, 606170
• 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 tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component including a distal shaft portion and an elongated tissue cutting member, the distal shaft portion having a tubular section and a tissue receiving aperture in the tubular section, the elongated tissue cutting member being disposed within the tubular section;

b. a driver component having a distal portion with a distal end, the driver component configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver unit configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the tubular section and which has a second driver unit configured to drive the tissue cutting member within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture thereof; and

c. at least one illuminating element located in the distal portion of the driver component and configured to project light from the distal end of the distal portion of the driver component to provide localized illumination of an operating site on the patient.

2. The system of claim 1 wherein each of the at least one illuminating element is a light emitting diode.

3. The system of claim 1 wherein the driver component has two illuminating elements.

4. The system of claim 1 further comprising a manually operable switch positioned to extend distally from the distal end of the distal portion of the driver component, the manually operable switch configured to activate the at least one illuminating element.

5. The tissue biopsy system of claim 1, wherein the at least one illuminating element is radially offset from a longitudinal axis of the disposable elongated probe component and is configured to be parallel to the longitudinal axis of the disposable elongated probe component.

6. A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component comprising

i. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and

ii. an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is configured to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular section;

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

c. at least one light source located in the distal portion of the driver component configured to project light from the distal end of the distal portion of the driver component to provide localized illumination at an operation site on the patient, the driver component being configured to automatically activate the at least one light source when the disposable elongated probe component is installed on the driver component.

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

8. The biopsy system of claim 6 wherein the driver component has a third driving motor configured to rotate the tissue cutting member.

9. The biopsy system of claim 8 wherein the third driving motor is configured to rotate the tissue cutting member as the member is moved longitudinally within the tubular section.

10. The system of claim 6 wherein the at least one light source has two illuminating elements.

11. The system of claim 6 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member.

12. The system of claim 11 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member.

13. The system of claim 12 wherein the tissue collector is located between the tissue cutting member and the vacuum source.

14. The tissue biopsy system of claim 6, wherein the at least one light source is radially offset from the longitudinal axis of the elongated tubular section and is configured to be parallel to the longitudinal axis of the elongated tubular section.

15. A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, 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, a proximal extremity configured to be secured to a driver unit, and

ii. 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;

iii. a probe housing for mounting the distal shaft portion and the elongated tissue cutting member, the probe housing having a distal end; and

b. a driver component having a distal face, the driver component configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver unit configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the tubular section and which has a second driver unit 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 thereof;

c. an orientation indicator secured to the tubular section adjacent the distal end of the probe housing and positioned to project in a direction away from the distal face of the driver component, the orientation indicator configured to provide a visual indication to a user of the orientation of the aperture in the tubular section as the tubular section is rotated by the first driver unit of the driver component; and

d. at least one illuminating element located in the distal face of the driver component and configured to project light from the distal face of the driver component to provide localized illumination of an operating site on the patient.

16. The tissue biopsy system of claim 15, wherein the orientation indicator is configured as an orientation arrow.

17. The tissue biopsy system of claim 15, wherein the at least one illuminating element is radially offset from a longitudinal axis of the disposable elongated probe component and is configured to be parallel to the longitudinal axis of the disposable elongated probe component.