Biopsy device and biopsy needle module that can be inserted into the biopsy device

• US 8,172,773 B2
• Filed: 03/01/2007
• Issued: 05/08/2012
• 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 F., Heske, Thomas
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US11/680,882
• Publication Number:
  US 20070149893A1
• Time in Patent Office: 1,895 Days
• Field of Search: 600/567, 600/568, 600/562, 600564-566
• US Class Current: 600/567
• 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 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 2017/00734 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 for tissue collection having a housing and a removable element. A power source is contained within the housing and the removable unit includes a biopsy needle module and a pressure source that can be integrated into the housing such that the biopsy device is fully operational without the need for wires or cables extending from the housing to connect to external units. The biopsy needle module includes a biopsy needle and a cutting sleeve, the biopsy needle having a sharpened distal end and a distal opening for collection of tissue, the cutting sleeve having a cutting blade on its distal end and being coaxially positioned with respect to the biopsy needle.

Claims

1. A biopsy device, comprising:

a disposable unit including;

a needle carrier configured to move in a first direction and a second direction opposite to the first direction; and

a biopsy needle having a cutting element with both the biopsy needle and the cutting element coupled to the needle carrier, a drive part coupled to the cutting element, and a sample chamber in the biopsy needle, the cutting element having a cutting blade, the cutting element being configured to move the cutting blade relative to the sample chamber; and

a drive unit configured to receive the disposable unit, the drive unit having a drive member positioned to drive the drive part, the drive unit having a needle-shooting mechanism with a cocked configuration and a released configuration, the needle-shooting mechanism having a spring and a clamping carriage, the clamping carriage being configured to drivably engage the needle carrier;

the drive unit having a fixed stop, the drive member configured to drive the drive part against the fixed stop such that the needle carrier is driven in the second direction to compress the spring of the needle-shooting mechanism to move the needle-shooting mechanism to the cocked configuration;

the drive unit being configured to move the drive part in the second direction to retract the drive part from the fixed stop when the needle-shooting mechanism is in the cocked configuration; and

the drive unit having a user-actuatable control configured to release the needle-shooting mechanism to cause the needle-shooting mechanism to shoot the needle carrier including the biopsy needle simultaneously with the cutting element a distance in the first direction.

2. The device of claim 1, wherein:

the needle carrier has a nut;

the cutting element has a screw that threadably engages the nut, and the drive part includes a driven element that is configured to engage the drive unit to rotate the cutting element and screw, the drive part having a disk;

the spring of the needle-shooting mechanism being configured to store an urging force; and

the screw is configured to rotate to position the disk against the fixed stop as the drive unit drives the driven element, and the screw is configured to force the nut and needle carrier against the urging force of the spring of the needle-shooting mechanism to cock the needle-shooting mechanism.

3. The device of claim 2, wherein the drive member is a drive gear and the driven element is a driven gear that is configured to engage the drive gear to drive the needle carrier in the second direction.

4. The device of claim 1, wherein the drive member includes a drive gear, and the drive part is a driven gear that is configured to engage the drive gear to drive the needle carrier in the second direction.

5. A biopsy device, comprising:

a biopsy needle including a sample chamber and a cutting element having a cutting blade;

a drive unit having a needle-shooting mechanism configured to be switched from a cocked configuration to a released configuration;

the drive unit being configured to cause relative movement of the cutting element and the biopsy needle to cock the needle-shooting mechanism;

the drive unit being configured to move the cutting element in the proximal direction after the needle shooting mechanism is cocked; and

the needle-shooting mechanism being configured to shoot the biopsy needle simultaneously with the cutting element in the distal direction when switched from the cocked configuration to the released configuration.

6. The device of claim 5, further comprising a needle carrier configured to hold the biopsy needle, the drive unit being configured to engage the needle carrier.

7. The device of claim 6, wherein the needle carrier has a nut and the cutting element is coupled to a screw configured to engage the nut.

8. The device of claim 7, wherein:

the drive unit has a stop and the needle-shooting mechanism has a spring configured to generate an urging force;

the drive unit being configured to drive the screw to move a disk coupled to the cutting element against the stop;

the screw being configured to position the disk against the stop and configured to force the nut and needle carrier against the urging force of the spring of the needle-shooting mechanism to place the needle-shooting mechanism in the cocked configuration.

9. The device of claim 8, wherein the drive unit includes a drive gear and the cutting element has a driven gear that is configured to engage the drive gear to move the cutting blade.

10. The device of claim 5, wherein the needle-shooting mechanism is configured to compress a spring when the needle-shooting mechanism is cocked.

11. A method of operating a biopsy device, comprising:

rotating, in a first rotational direction, a threaded element attached to a cutting sheath and threaded through a nut attached to a biopsy needle to cock a cocking apparatus;

after the cocking apparatus is cocked, rotating the threaded element relative to the biopsy needle in a second rotational direction opposite the first direction to position the cutting sheath relative to the biopsy needle for shooting;

releasing the cocking apparatus to shoot the biopsy needle simultaneously with the cutting sheath; and

operating the cutting sheath to harvest a tissue sample.

12. The method of claim 11, wherein the act of rotating in the first rotational direction further comprises urging a portion of the threaded element against a fixed thrust bearing attached to a drive with respect to which the biopsy needle is movable, and driving the biopsy needle against the cocking apparatus as a reaction to the portion of the threaded element being urged against the thrust bearing.

13. The method of claim 11, wherein the cocking apparatus includes a catch, the method comprising locking the biopsy needle in a spring-biased position utilizing the catch, and subsequently releasing the catch to shoot the biopsy needle.

14. A method of operating a biopsy device, comprising:

moving a cutting sheath along a biopsy needle in a first direction to force a member coupled to the cutting sheath against a stop to in turn drive the biopsy needle in a second direction opposite the first direction against an urging force of a cocking apparatus to cock the cocking apparatus;

retracting the cutting sheath;

releasing the cocking apparatus to shoot the biopsy needle simultaneously with the cutting sheath in a direction of the urging force; and

operating the cutting sheath to harvest a tissue sample.

15. The method of claim 14, wherein the moving includes rotating the cutting sheath.

16. The method of claim 14, wherein the moving is a result of rotating a motor in a first rotational direction and the retracting is a result of rotating the motor in a second rotational direction opposite the first rotational direction.

17. The method of claim 16, wherein the moving includes rotating the cutting sheath.

18. A biopsy device, comprising:

a biopsy needle having a sample chamber;

a cutting element arranged coaxially with the biopsy needle, the cutting element having a cutting blade, the cutting element being configured to be movable in a first direction and a second direction opposite the first direction; and

a drive unit configured to hold the biopsy needle and the cutting element;

the drive unit having a needle-shooting mechanism with a cocked configuration and a released configuration;

the drive unit being configured to rotate the cutting element to in turn move the biopsy needle in the second direction to cock the needle-shooting mechanism, the drive unit being configured to then move the cutting element in the second direction;

the needle-shooting mechanism being configured to be switched from the cocked configuration to the released configuration to shoot the biopsy needle simultaneously with the cutting element in the first direction.

19. The device of claim 18, further comprising:

a needle carrier configured to hold the biopsy needle, the needle carrier having a nut;

a screw configured to engage the nut, and the screw is coupled to the cutting element;

a disk coupled to the cutting element;

the drive unit being configured to drive the screw to move the cutting element and the disk;

the drive unit having a stop;

the needle-shooting mechanism having a spring configured to generate an urging force; and

the screw being configured to rotate to position the disk against the stop as the drive unit drives the screw, and the screw being further configured to force the nut and needle carrier against the urging force of the spring of the needle-shooting mechanism to cock the needle-shooting mechanism.

20. The device of claim 19, wherein the drive unit includes a drive gear and the cutting element has a driven gear configured to engage the drive gear to move the cutting element.

21. The device of claim 18, wherein the needle-shooting mechanism has a spring configured to be compressed when the needle-shooting mechanism is cocked.

22. A biopsy device, comprising:

a drive unit configured to receive a replaceable biopsy needle carrier;

the needle carrier having a biopsy needle;

the needle carrier having a screw with a gear;

the drive unit having a needle-shooting mechanism and a toothed drum configured to be driven by a motor, the needle-shooting mechanism having a cocked position and being configured to be releasable from the cocked position, and a catch to maintain the cocked position;

the toothed drum configured to engage the gear to rotate the screw in a first rotational direction to cock the needle-shooting mechanism, the catch thereafter maintaining the cocked position;

the toothed drum configured to rotate the screw in a second rotational direction, opposite the first rotational direction, causing the screw to move the gear progressively along the toothed drum; and

the needle-shooting mechanism configured to be released to shoot the needle carrier wherein the gear slides along the teeth of the toothed drum during a release of the needle-shooting mechanism.

23. The device of claim 22, wherein:

the drive unit has a fixed member;

the needle carrier has a nut and a disk, and the screw is configured to engage the nut;

the screw being configured to rotate to position the disk against the fixed member to force the nut, as the drive unit drives the screw, against a resistance of the needle-shooting mechanism, to cock the needle-shooting mechanism.

24. The device of claim 22, wherein the needle-shooting mechanism has a spring which is compressed when the needle-shooting mechanism is cocked.

25. The device of claim 22, further comprising a cutting sheath connected to the screw, wherein the drum is configured to rotate the cutting sheath in the first direction to sever tissue engaged with the biopsy needle.

26. A biopsy device, comprising:

a biopsy needle unit having a biopsy needle with a sample chamber and a cutting element with a cutting blade and a drive part coupled to the cutting element, the cutting element being configured to be movable in a first direction to move a cutting edge of the cutting element over the sample chamber; and

a drive unit configured to hold the biopsy needle unit, the drive unit having a needle-shooting mechanism;

the drive unit having a stop configured to limit the first direction travel of the cutting element relative to the drive unit;

the drive unit having a drive element, the drive part coupled to the cutting element being configured to be drivingly engageable with the drive element, the drive unit being configured to drive a thrusting portion coupled to the cutting element in the first direction against the stop causing the cutting element to push the biopsy needle against an urging force of the needle-shooting mechanism to cock the needle-shooting mechanism; and

the drive unit being configured to move the thrusting portion in a second direction opposite the first direction away from the stop to position the cutting element;

the needle-shooting mechanism being configured to shoot the biopsy needle unit, causing the drive part to slide along the drive element, while remaining engaged therewith.

27. The device of claim 26, wherein the needle-shooting mechanism generates a resistance and the biopsy needle unit has a nut and the cutting element has a screw that engages the nut, the drive unit being configured to rotate the screw to position the thrusting portion against the stop forcing the nut, as the drive unit drives the screw, against the resistance of the needle-shooting mechanism, to cock the needle-shooting mechanism.

28. The device of claim 27, wherein the drive element includes a toothed drum and the drive part has a driven gear that engages the toothed drum to drive the cutting element.

29. The device of claim 28, wherein the drive element includes a toothed drum and the drive part has a driven gear that engages the toothed drum to drive the cutting element.

30. The device of claim 26, wherein the needle-shooting mechanism has a spring configured to be compressed when the needle-shooting mechanism is cocked.

31. The device of claim 30, wherein the drive element includes a toothed drum and the drive part has a driven gear configured to engage the toothed drum to drive the cutting element, the drive part configured to slide along the toothed drum while remaining engaged therewith when the biopsy needle is shot.

32. A biopsy device, comprising:

a disposable unit including;

a needle carrier,

a biopsy needle supported in the needle carrier, the biopsy needle having a sample recess, and

a cover configured for movement to selectively cover and uncover the sample recess; and

a drive unit configured to be coupled to the disposable unit, the drive unit having a motor drive configured to move the cover and needle carrier in mutually-opposite directions;

the drive unit having a spring, a fixed stop, and a shooting mechanism, the fixed stop being configured to limit the travel of the cover, the shooting mechanism having a support configured to be biased by the spring and configured to engage the needle carrier, the support being configured to be cocked by forcing the support to a cocked position against the spring;

the drive unit being configured to perform a sequential operation to extend the cover beyond a position in which the cover covers the sample recess such that the cover is urged against the stop and further configured to cause the needle carrier to be urged against the support to cock the shooting mechanism in a cocked configuration;

the needle-shooting mechanism being configured to shoot the biopsy needle simultaneously with the cover when the needle-shooting mechanism is switched from the cocked configuration to a released configuration.