Biopsy device and insertable biopsy needle module

• US 9,439,631 B2
• Filed: 12/23/2014
• Issued: 09/13/2016
• Est. Priority Date: 03/19/2002
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Heske, Norbert, Heske, Thomas
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US14/580,483
• Publication Number:
  US 20150148702A1
• Time in Patent Office: 630 Days
• US Class Current: 1/1
• 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 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 2017/00128 related to intensity or progress of surgical action
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/0023 disposable
• 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 2017/00734 battery operated
• 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

Abstract

A biopsy device includes a disposable unit including a needle carrier and a biopsy needle. The biopsy needle has a distal portion including a sample chamber, and is configured to rotate around a longitudinal axis. The disposable unit includes a hub portion connected to the biopsy needle proximal to the sample chamber. The needle carrier has a holding portion. The holding portion and the hub portion are collectively configured to permit the biopsy needle to rotate within the needle carrier to rotationally position the sample chamber while restraining rotation of the biopsy needle at a series of rotational detent positions within a range of rotation around the longitudinal axis. Each of the series of rotational detent positions is defined by a resistance to a rotation of the hub portion in the holding portion.

Claims

1. A biopsy device, comprising:

a disposable unit including a needle carrier and a biopsy needle, the biopsy needle having a distal portion including a sample chamber, the biopsy needle configured to rotate around a longitudinal axis that passes through the biopsy needle, and the disposable unit including a hub portion connected to the biopsy needle proximal to the sample chamber;

the needle carrier having a holding portion, the holding portion and the hub portion collectively configured to permit the biopsy needle to rotate within the needle carrier to rotationally position the sample chamber while restraining rotation of the biopsy needle at a series of rotational detent positions within a range of rotation around the longitudinal axis, the holding portion and the hub portion configured such that the hub portion is rotatable within the holding portion at each of the series of rotational detent positions, and wherein each of the series of rotational detent positions is defined by a resistance to a rotation of the hub portion in the holding portion.

2. The biopsy device of claim 1, wherein the sample chamber faces in a rotational angular direction relative to the longitudinal axis, and the hub portion has a visually detectable indicator mark that corresponds to the same rotational angular direction as the sample chamber.

3. The biopsy device of claim 1, wherein the hub portion has a polygon shape having a plurality of polygon surface segments, and the holding portion having at least one surface engagement portion, the at least one surface engagement portion being configured to sequentially engage a respective surface segment of the plurality of polygon surface segments as the hub portion is rotated within the holding portion.

4. The biopsy device of claim 3, wherein the hub portion has a hexagon shape.

5. The biopsy device of claim 3, wherein the hub portion includes an external knob configured to facilitate manual rotation of the biopsy needle.

6. The biopsy device of claim 1, comprising a drive mechanism, the drive mechanism being connected to the biopsy needle and configured to move the biopsy needle in an oscillatory manner to assist in severing tissue.

7. The biopsy device of claim 6, comprising a cutting sheath coaxially carried by the biopsy needle, the cutting sheath being drivably connected to the drive mechanism, and configured for oscillatory driving of the cutting sheath and configured for transmission of a reaction force resulting from the oscillatory driving of the cutting sheath through the cutting sheath to the biopsy needle to move the biopsy needle in oscillation.

8. The biopsy device of claim 6, wherein the drive mechanism is configured to move the biopsy needle in a limited angular-rotational movement of the biopsy needle in alternating first and second rotational directions about the longitudinal axis of the biopsy needle.

9. The biopsy device of claim 6, wherein the drive mechanism is configured to move the biopsy needle in a limited angular-rotational movement of the biopsy needle in alternating first and second rotational directions about the longitudinal axis of the biopsy needle superimposed with a longitudinally oscillating movement of the biopsy needle along the longitudinal axis.

10. A biopsy device, comprising:

a disposable unit including a needle carrier and a biopsy needle, the biopsy needle having a distal portion including a sample chamber, and the disposable unit including a hub portion connected to the biopsy needle proximal to the sample chamber, the needle carrier having a holding portion, the holding portion and the hub portion collectively configured to permit the biopsy needle to rotate within the needle carrier while restraining rotation of the biopsy needle in a series of rotational detent positions within a range of rotation; and

a drive unit having a chamber configured to receive the disposable unit, the drive unit configured to drivably engage the disposable unit to move the biopsy needle.

11. The biopsy device of claim 10, wherein the sample chamber faces in a rotational angular direction relative to a longitudinal axis passing through the biopsy needle, and the hub portion has a visually detectable indicator mark that corresponds to the same rotational angular direction as the sample chamber.

12. The biopsy device of claim 10, wherein the hub portion has a polygon shape having a plurality of polygon surface segments, and the holding portion having at least one surface engagement portion, the at least one surface engagement portion being configured to sequentially engage a respective surface segment of the plurality of polygon surface segments as the hub portion is rotated within the holding portion.

13. The biopsy device of claim 12, wherein the hub portion has a hexagon shape.

14. The biopsy device of claim 10, wherein the hub portion includes an external knob configured to facilitate manual rotation of the biopsy needle.

15. A method of operating a biopsy needle, comprising:

inserting the biopsy needle into tissue at a biopsy site of a host;

rotationally positioning a sample chamber of the biopsy needle at a desired rotational detent position of a series of rotational detent positions around a longitudinal axis of the biopsy needle, wherein each of the series of rotational detent positions is defined by a resistance to a rotation of the biopsy needle;

receiving tissue in the sample chamber of the biopsy needle;

cutting the tissue in the sample chamber to detach a tissue sample from the biopsy site; and

rotating the sample chamber of the biopsy needle to a next rotational detent position of the series of rotational detent positions.

16. The method of claim 15, comprising applying manual external pressure to the host to create pressure about a tissue mass to be sampled at the biopsy site prior to detaching the tissue sample.

17. The method of claim 15, comprising exposing the sample chamber by proximally displacing a cutting sheath that surrounds the sample chamber.

18. The method of claim 17, wherein the cutting includes distally displacing the cutting sheath that surrounds the sample chamber.

19. The method of claim 15, wherein the cutting includes one of rotating blades fixedly attached to the sample chamber and axially displacing blades fixedly attached to the sample chamber.

20. The method of claim 15, wherein the cutting includes driving the biopsy needle in proximal-distal oscillation to assist in severing the tissue.