Biopsy device with inner cutting member

• US 7,819,819 B2
• Filed: 08/15/2003
• Issued: 10/26/2010
• Est. Priority Date: 02/24/2003
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Louw, Frank R., Quick, Richard L., Lubock, Paul, Shabaz, Martin V.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US10/642,406
• Publication Number:
  US 20040167428A1
• Time in Patent Office: 2,629 Days
• Field of Search: 600/568, 600/566, 600/567, 600/564, 606 14- 16, 606/170, 606/171
• 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 2017/3405 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 devices and methods for separating and collecting a tissue specimen from a patient'"'"'s target site. The device includes a probe member with a penetrating distal tip and a tissue receiving aperture, and a tissue cutting member which is rotatable disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture. The longitudinal edges of the aperture are preferably sharpened to engage the cutting edges of the tissue cutting member. Vacuum may be provided in the inner lumen of the cutting member to transport tissue therethrough. Rotation, rotational oscillation and/or longitudinal reciprocation of the tissue cutting member is effective to separate a tissue specimen from surrounding tissue. An accessing cannula having an tissue receiving aperture may be concentrically disposed within the probe member and about the tissue cutting member. The tissue cutting edge of the tissue cutting member preferably is longitudinally oriented and may have a cutting angle less than 90° with respect to the longitudinal axis of the tissue cutting member.

Claims

1. A tissue removing device for accessing and collecting a tissue specimen from a target site within a patient, comprising:

a. an elongated probe member which has a longitudinal axis, which has a proximal end configured to be secured to a drive, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an aperture proximal to the tissue penetrating distal tip, said aperture being configured to receive tissue from the target site and being defined in part by a pair of opposed longitudinally oriented tissue cutting edges; and

b. an elongated tissue cutting member which is disposed within the elongated probe member, which has distal and proximal tubular portions, said distal portion having

i. a beveled distal tip with an outer tissue cutting edge that defines a tissue receiving opening, said distal portion being flared outwardly in a distal direction to ensure that the outer tissue cutting edge of the tissue cutting member engages the pair of tissue cutting edges of the elongated probe member, said outer tissue cutting edge lying within a surface that is inclined at an angle of less than 75°

with respect to the longitudinal tissue cutting edges of the elongated probe member and having leading and trailing portions,

ii. an inner lumen extending therein and in fluid communication with the tissue receiving opening, and

iii. a single longitudinally oriented slot in a wall of the distal tubular portion of the tissue cutting member that opens to the trailing portion of the tissue receiving opening in the distal tip, and

said proximal portion being configured to be operably connected to at least one drive unit to move the tissue cutting member to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated probe member by at least one outer tissue cutting edge of the tissue cutting member.

2. The biopsy device of claim 1 wherein the inner lumen of the tissue cutting member is configured to access a vacuum source to transport a tissue specimen through the inner lumen thereof to a tissue collector in fluid communication with the inner lumen.

3. The biopsy device of claim 1, wherein the tissue cutting member is configured for oscillating movement about the longitudinal axis.

4. The biopsy device of claim 3, wherein the tissue cutting member is also configured for reciprocating longitudinal movement.

5. The biopsy device of claim 4, wherein the tissue cutting member is configured for reciprocating longitudinal movement of between about 0.01 inch and about 0.2 inch (0.25-5.1 mm).

6. The biopsy device of claim 1, wherein the tissue cutting member is configured for longitudinal movement along the longitudinal axis.

7. The biopsy device of claim 6, wherein the tissue cutting member is also configured for oscillating movement.

8. The biopsy device of claim 1 wherein the tissue cutting edge of the tissue cutting member has a tissue cutting angle over a substantial part of the length of the edge of the tissue cutting member.

9. The biopsy device of claim 1 wherein the opposed longitudinally oriented tissue cutting edges are parallel.

10. The tissue removing device of claim 1 wherein the distal tubular portion of the tissue cutting member has at least a second opening in a wall thereof.

11. The tissue removing device of claim 10 wherein the second opening in the wall of the distal tubular portion is adjacent to the longitudinally oriented slot in the wall.

12. The tissue removing device of claim 10 wherein the second opening opens to the longitudinally oriented slot.

13. The tissue removing device of claim 10 wherein the distal tubular portion has a third opening in a wall thereof on a side of the distal tubular member opposite to the second opening.

14. The tissue removing device of claim 13 wherein the third opening in the wall of the distal tubular portion is adjacent to the longitudinally oriented slot in the wall.

15. The tissue removing device of claim 14 wherein the third opening opens to the longitudinally oriented slot.

16. The tissue removing device of claim 1 wherein the distal tissue cutting tip has opposed tissue cutting edge portions that engage the opposed longitudinally oriented tissue cutting edges of the elongated probe member.

17. The tissue removing device of claim 3 wherein the elongated tissue cutting member is configured for oscillating movement about the longitudinal axis and longitudinal movement within the elongated tubular member along the longitudinal axis.

18. An elongated tissue cutting member configured for slidable movement within an inner lumen of an outer tubular member of a tissue biopsy device, said outer tubular member having a tissue receiving aperture in a wall thereof defined in part by a pair of opposed longitudinally oriented tissue cutting edges, the elongated tissue cutting member having an elongated shaft with a longitudinal axis, said shaft comprising:

distal tubular portion that flares outwardly in a distal direction with a beveled distal tip having a tissue receiving opening, an outer tissue cutting edge configured to engage the opposed longitudinally oriented tissue cutting edges of the outer tubular member at an angle less than 75°

from the longitudinal axis, the beveled distal tip having leading and trailing portions and the distal tubular portion having a longitudinally oriented, distally expanding slot having an enlarged distal end that opens to the tissue receiving opening in the beveled distal tip at the trailing portion of the beveled distal tip, and

a proximal portion that is configured to be connected to at least one drive unit to move the tissue cutting member to sever from supporting tissue a tissue specimen tissue extending into the tissue receiving aperture of the outer tubular member.

19. The elongated tissue cutting member of claim 18 wherein the elongated shaft has an inner lumen in fluid communication with the opening configured to receive severed tissue.

20. The elongated tissue cutting member of claim 18 wherein the distal tubular portion has at least a second opening in a wall thereof.

21. The elongated tissue cutting member of claim 20 wherein the second opening in the wall of the distal tubular portion is adjacent to the longitudinally oriented slot in the wall.

22. The elongated tissue cutting member of claim 21 wherein the second opening opens to the longitudinally oriented slot.

23. The elongated tissue cutting member of claim 20 wherein the distal tubular portion has a third opening in a wall thereof on a side of the distal tubular member opposite to the second opening.

24. The elongated tissue cutting member of claim 23 wherein the third opening in the wall of the distal tubular portion is adjacent to the longitudinally oriented slot in the wall.

25. The elongated tissue cutting member of claim 24 wherein the third opening opens to the longitudinally oriented slot.