Biopsy device with inner cutter

• US 20040167427A1
• Filed: 02/24/2003
• Published: 08/26/2004
• Est. Priority Date: 02/24/2003
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Quick, Richard L., Lubock, Paul, Louw, Frank, Shabaz, Martin V.
• Granted Patent: US 7,189,206 B2
• Time in Patent Office: Days
• 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
• 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 accessing a desired target site within a patient'"'"'s body and for separating and collecting a tissue specimen from the target site. The device includes a probe member or cannula with a penetrating distal tip, and a tissue cutting member which is disposed within the probe member to cut a tissue specimen from supporting tissue at the biopsy site. This probe is releasably secured to a housing to provide a plurality of discrete orientations of the probe about its longitudinal axis. Vacuum may be provided to the inner lumen of the cutting member to transport tissue through the inner lumen thereof. Rotation (and optionally longitudinal reciprocation) of the tissue cutter is effective to separate a tissue specimen from surrounding tissue at the target site. Vacuum or fluid pressure may be used to move the specimen cut from the target site proximally within the inner lumen defined at least in part by the cutting member for collection. An elongated accessing cannula having an tissue receiving aperture communicating with an inner lumen of the accessing cannula, may be provided with the device and is preferably concentrically disposed within the probe member and about the tissue cutter. The tissue cutting surface of the tissue cutter preferably is longitudinally oriented and may be at an angle with respect to the longitudinal axis of the tissue cutter.

Claims

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

a. a housing having at least one drive unit;

b. an elongated probe member which has a longitudinal axis, which has a proximal end configured to be releasably secured to the drive housing in a plurality of discrete orientations about the longitudinal axis prior to insertion into the patient'"'"'s body, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an open section proximal to the tissue penetrating distal tip configured to receive tissue from the target site; and

c. an elongated tissue cutter which is slidably disposed within the elongated probe member, which has a tissue cutting surface, which defines at least in part an inner lumen extending therein for receiving a tissue specimen, which is operably connected to at least one drive unit to move the tissue cutter to cut a tissue specimen from tissue extending into the open tissue receiving section of the elongated member.

2. The biopsy device of claim 1 wherein the probe includes a rotatable tissue accessing cannula which is slidably disposed concentrically about the tissue cutter, has a proximal end, has a distal end seated against a proximal surface of the tissue penetrating distal tip, has an inner lumen extending therein, has a tissue receiving side port spaced proximal to the distal end thereof in fluid communication with the inner lumen and disposed in the open section of the outer cannula and is operably secured to a drive unit in the housing to rotate the tissue accessing cannula to adjust the operating location of the tissue receiving side port.

3. The biopsy device of claim 1, wherein the cutting surface of the tissue cutter is longitudinally oriented.

4. The biopsy device of claim 2, wherein the cutting surface of the tissue cutter is defined at least in part by an arcuate wall section of the tissue cutter.

5. The biopsy device of claim 3 wherein the arcuate wall section of the tissue cutter has a longer arc length than the arc length of the aperture.

6. The biopsy device of claim 2, wherein the cutting surface of the tissue cutter is longer than the aperture of the tissue accessing cannula.

7. The biopsy device of claim 1 wherein the inner lumen defined at least in part by the tissue cutter 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.

8. The biopsy device of claim 2, wherein the tissue cutter is configured for rotational movement about a longitudinal axis.

9. The biopsy device of claim 8, wherein the tissue cutting member is also configured for reciprocating longitudinal movement.

10. The biopsy device of claim 9, wherein the tissue cutter is configured for reciprocating longitudinal movement of between about 0.01 inch and about 0.1 inch.

11. The biopsy device of claim 3, wherein the arcuate wall section of the tissue cutter has longitudinally oriented cutting surfaces along both edges.

12. The biopsy device of claim 1 wherein the cutting surface of the tissue cutter is longitudinally oriented at an angle with respect to the longitudinal axis of the tissue cutter.

13. The biopsy device of claim 12 wherein the cutting surface of the tissue cutter has a leading distal cutting edge portion and a trailing proximal cutting edge portion.

14. The biopsy device of claim 12 wherein the tissue cutter has a non-cutting surface which extends parallel with the cutting surface.

15. The biopsy device of claim 14 wherein the cutting and non-cutting surfaces of the tissue cutter define in part a tissue receiving aperture.

16. The biopsy device of claim 2, wherein the tissue cutter is configured for longitudinal movement along a longitudinal axis.

17. The biopsy device of claim 16, wherein the tissue cutting member is also configured for reciprocating rotational movement.

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

a. a drive housing which has a plurality of drive units;

b. an outer member which is releasably secured to the drive housing, which has a proximal tubular portion, which has an inner lumen extending within the proximal tubular portion, which has a tissue penetrating distal tip, which has an open section proximal to the tissue penetrating distal tip and which has a supporting strut extending from the penetrating distal tip to the proximal tubular portion;

c. a tissue accessing cannula which is slidably disposed at least in part within the inner lumen of the proximal tubular portion of the outer member, which has an inner lumen extending therein, and which has a tissue receiving aperture spaced proximal to the distal end thereof in fluid communication with the inner lumen of the accessing cannula and which is operably secured to a drive unit in the drive housing to rotate the tissue receiving cannula to adjust the orientation of the tissue receiving aperture; and

d. an elongated tissue cutter which is formed at least in part of a tubular member, which is slidably disposed within the inner lumen of the tissue accessing cannula, which has a tissue cutting surface, which has an inner lumen extending therein configured to receive a tissue specimen cut by the tissue cutter, and which is connected to a drive unit to move the tissue cutter within the inner lumen of the tissue accessing cannula.

19. The biopsy device of claim 18, wherein the cutting surface is parallel to a longitudinal axis of the tissue cutter.

20. The biopsy device of claim 18, wherein the cutting surface of the tissue cutter is defined at least in part by a arcuate wall section thereof.

21. The biopsy device of claim 18 wherein the arcuate wall section of the tissue cutter has a longer arc length than the arc length of the tissue receiving aperture of the tissue accessing cannula.

22. The biopsy device of claim 18, wherein the cutting surface of the tissue cutter is longer than the aperture of the tissue accessing cannula.

23. The biopsy device of claim 18 wherein the tissue accessing cannula has a distal end seated against a proximal surface of the tissue penetrating distal tip of the outer member.

24. The biopsy device of claim 18 wherein the tissue accessing cannula has a distal end seated in a circular groove in a proximal surface of the tissue penetrating distal tip of the outer member.

25. The biopsy device of claim 18 wherein the inner lumen of the tissue cutter is configured to access a vacuum source to transport a cut tissue specimen through the inner lumen thereof to a tissue collector in fluid communication with the inner lumen of the tissue cutter.

26. The biopsy device of claim 18 wherein the arcuate wall section of the tissue cutter has an arc length greater than a width of the aperture in the outer member.

27. The biopsy device of claim 18, wherein the tissue cutter is configured for longitudinal movement along a longitudinal axis.

28. The biopsy device of claim 18, wherein the tissue cutter is configured for reciprocal longitudinal movement.

29. The biopsy device of claim 18, wherein the tissue cutter is configured for reciprocal longitudinal movement of between about 0.01 inch and about 0.1 inch.

30. The biopsy device of claim 18, wherein the arcuate wall section of the tissue cutter has longitudinal oriented cutting surface along both edges.

31. A probe for a tissue biopsy device for accessing and collecting a tissue specimen from a target site within a patient, comprising:

a. an outer member which has a proximal tubular portion configured to be releasably secured to a drive housing, which has an inner lumen extending therein, which has a tissue penetrating distal tip, which has an open section proximal to the penetrating distal tip and a supporting strut extending from the penetrating distal tip to the proximal tubular portion;

b. a tissue accessing cannula which is slidably disposed at least in part within the inner lumen of the tubular portion of the outer member, which has an inner lumen extending therein, and which has a tissue receiving aperture spaced proximal to the distal end thereof in fluid communication with the inner lumen of the accessing cannula and which is configured to be operably secured to a drive unit in a drive housing to rotate the tissue receiving cannula to adjust the orientation of the tissue receiving aperture; and

c. an elongated tissue cutting member which is slidably disposed within the inner lumen of the tissue accessing cannula, which has at least one longitudinal tissue cutting surface, which defines at least in part an inner lumen for receiving tissue cut by the tissue cutting surface, and which is connected to a drive unit to move the tissue cutter within the inner lumen of the tissue accessing cannula.

32. The probe of claim 31 wherein the tissue cutting member is formed at least in part of a tubular member.

33. The probe of claim 32 wherein the tissue cutter is rotatably disposed within the inner lumen of the outer member, has a longitudinal axis, has a longitudinal tissue cutting surface oriented at an angle with respect to the longitudinal axis, has an inner lumen extending therein for receiving tissue cut by the tissue cutting surface and is configured for rotation within the inner lumen of the outer member to cut tissue pulled into the inner lumen of the tissue cutter.

34. The biopsy device of claim 33 wherein the tissue cutter has a non-cutting surface which defines a tissue receiving aperture along with the tissue cutting surface.

35. The biopsy device of claim 34 wherein the non-cutting surface of the tissue cutter is parallel with the cutting surface thereof.

36. The biopsy device of claim 31 wherein the cutting surface of the tissue cutter has a leading distal cutting edge portion and a trailing proximal cutting edge portion.

37. A method of separating a biopsy tissue specimen from supporting tissue at a target site within a patient'"'"'s body, comprising:

a. providing a biopsy device having a biopsy probe comprising;

i. an outer member which is releasably secured to a drive housing, which has an inner lumen extending therein, which has a tissue penetrating distal tip secured thereto, which has an open section proximal to the penetrating distal tip and a supporting strut extending from the penetrating distal tip;

ii. a tissue accessing cannula which is slidably disposed at least in part within the inner lumen of the outer member, which has an inner lumen extending therein, and which has a tissue receiving aperture spaced proximal to the distal end thereof in fluid communication with the inner lumen of the accessing cannula and which is operably secured to a drive unit in the drive housing to rotate the tissue receiving cannula to adjust the orientation of the tissue receiving aperture, and

iii. an elongated tissue cutting member which is formed at least in part of a tubular member, which is slidably disposed within the inner lumen of the tissue accessing cannula, which has at least one tissue cutting surface, which has an inner lumen extending therein for receiving a tissue specimen cut by the tissue cutting surface, and which is connected to a drive unit to move the tissue cutter within the inner lumen of the tissue accessing cannula;

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

c. exposing the aperture of the accessing cannula to tissue at the tissue site;

d. applying a vacuum to the inner lumen of the tissue accessing cannula or the tissue cutter to draw tissue from the tissue site into the inner lumen of the accessing cannula;

e. rotating the tissue cutter to cut tissue drawn into the inner lumen from supporting tissue at the tissue site; and

f. transporting a tissue specimen through the inner lumen of the tissue cutter.

38. The method of claim 37, wherein the tissue cutter is moved longitudinally in addition to rotating to cut tissue.

39. The method of claim 37, wherein the longitudinal movement of the tissue cutter is reciprocating movement.

40. The method of claim 37, wherein pressurized fluid is provided within the inner lumen of the tissue cutter distal to a tissue specimen therein to transport the tissue specimen proximally within the inner lumen of the tissue cutter.

41. A probe for a tissue biopsy device for accessing and collecting a tissue specimen from a target site within a patient, comprising:

a. an outer tubular member which has an inner lumen extending therein, which has a tissue penetrating distal tip, and which has a tissue receiving aperture proximal to the penetrating distal tip in fluid communication with the inner lumen; and

b. an elongated tissue cutter which is formed at least in part of a tubular member, which is rotatably disposed within the inner lumen of the outer member, which has a longitudinal axis, which has a longitudinal tissue cutting surface oriented at an angle with respect to the longitudinal axis, which has an inner lumen extending therein for receiving tissue cut by the tissue cutting surface and which is configured for rotation within the inner lumen of the outer member to cut tissue pulled into the inner lumen of the tissue cutter.

42. The probe of claim 41 wherein the tissue cutter has a non-cutting surface which defines a tissue receiving aperture along with the tissue cutting surface.

43. The probe of claim 42 wherein the non-cutting surface of the tissue cutter is parallel with the cutting surface thereof.

44. The probe of claim 41 wherein the cutting surface of the tissue cutter has a leading distal cutting edge portion and a trailing proximal cutting edge portion.