Biopsy device for removing tissue specimens using a vacuum

• US 8,109,885 B2
• Filed: 03/17/2003
• Issued: 02/07/2012
• Est. Priority Date: 03/19/2002
• Status: Active Grant

• 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): Hindenburg, Max
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US10/500,522
• Publication Number:
  US 20050203439A1
• Time in Patent Office: 3,249 Days
• Field of Search: 600/565, 600/566, 600/568, 600/562, 600/564, 600/567, 606/167, 606/170
• US Class Current: 600/566
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 39/1055 Rotating or swivel joints in general F16L27/00
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: G01N 1/08 involving an extracting tool, e.g. core bit

Abstract

A biopsy device for taking tissue samples, includes a housing, a removable element and a control panel. The housing contains an electric power source and a tension slide connected to the power source. The tension slide may be brought into a cocked position against the action of a spring by the power source. The removable element is configured for insertion into the housing and includes a biopsy needle unit, a vacuum pressure-generating device and a control panel. The removable element may be provided as a sterile package unit. The biopsy needle unit can be arranged on the tension slide and includes a hollow biopsy needle with a sample removal chamber and a cutting sheath. The biopsy device can be held in one hand and is fully integrated with all components required to perform a vacuum biopsy such that no cables or lines are required to other external units.

Claims

1. A biopsy device for taking tissue samples, comprising:

a housing containing an electric power source and a tension slide, wherein the tension slide is configured to be moved to a cocked position against the action of a first spring, the tension slide configured to be locked in the cocked position by a releasable locking mechanism;

a removable element configured for insertion into the housing to couple the electric power source to the tension slide, comprising;

a biopsy needle unit, comprising a hollow biopsy needle having a sample removal chamber, and a cutting sheath coaxially arranged with the hollow biopsy needle, the cutting sheath having a cutting edge, wherein the biopsy needle unit is arranged on the tension slide, and wherein the electric power source is configured to rotate the cutting sheath to move the tension slide;

a vacuum pressure-generating device; and

a connection element connecting the biopsy needle unit and the vacuum pressure-generating device; and

a control panel attached to the housing, the control panel having a first control device configured to control the electric power source to position the tension slide in the cocked position, and the control panel having a second control device configured to release the releasable locking mechanism when the tension slide is in the cocked position such that the tension slide is moved by the first spring away from the cocked position.

2. The biopsy device according to claim 1, wherein the vacuum pressure-generating device comprises a syringe unit having a cylindrical body and a plunger positioned in the cylindrical body, the cylindrical body having a ventilation opening in an upper part thereof which may be opened to dissipate a created vacuum by retraction of the plunger.

3. The biopsy device according to claim 2, wherein the plunger is movable in a forward and a reverse direction by a controllable actuator coupled to the plunger.

4. The biopsy device according to claim 3, further comprising a motor with gearing contained within the housing, wherein the controllable actuator is drivably coupled to the gearing and is powered by the motor.

5. The biopsy device according to claim 4, wherein the controllable actuator includes a threaded spindle nut mounted on the syringe unit cylindrical body, the threaded spindle nut having a toothed crown.

6. The biopsy device according to claim 5, wherein the motor with gearing is configured to be controlled by measuring the speed of revolution of the motor, the biopsy device being configured such that the plunger in a first step is moved from a distal end of the housing to a first point adjacent but distal the ventilation opening, in a second step is moved first proximal the ventilation opening to open the ventilation opening and dissipate the created vacuum and then distal back to the first point to close the ventilation opening, and in a third step is moved in a distal direction to create excess pressure, and the biopsy device is configured to coordinate the first, second and third steps with sample removal and ejecting of the sample.

7. The biopsy device according to claim 6, wherein a photocell permanently arranged on a motor housing and a pickup arranged on a motor shaft is configured to measure the speed of revolution of the motor.

8. The biopsy device according to claim 7, wherein the biopsy device is configured to control the controllable actuator to set the magnitude of the vacuum and the excess pressure based on appropriate setpoint values in control electronics including the speed of the revolution of the motor.

9. The biopsy device according to claim 2, the biopsy device being configured such that the plunger for generating a vacuum in the syringe unit and in the sample removal chamber is moved in a first step in a proximal direction from the housing distal end to a first point adjacent but distal the ventilation opening.

10. The biopsy device according to claim 9, the biopsy device being configured such that in order to ventilate the system, the plunger in a second step is moved to a second point proximal the ventilation opening, and wherein after the vacuum is dissipated the plunger is moved back to the first point.

11. The biopsy device according to claim 10, the biopsy device being configured such that the plunger in a third step is moved in a distal direction to create an excess pressure in the sample removal chamber.

12. The biopsy device according to claim 2, wherein the syringe unit is configured to communicate vacuum from the cylindrical body to the sample removal chamber.

13. The biopsy device according to claim 1, wherein an inner space of the hollow biopsy needle is connected to an inner space of the vacuum pressure-generating device by the connection element such that an airtight connection is established.

14. The biopsy device according to claim 13, wherein the connection element comprises a flexible hose.

15. The biopsy device according to claim 1, wherein the first control device is configured to control both the tension slide and the cutting sheath.

16. The biopsy device according to claim 1, wherein the biopsy needle unit comprises recesses that are configured to receive brackets on the tension slide.

17. The biopsy device according to claim 1, wherein the electric power source includes a DC motor, and wherein the tension slide is displaced to the cocked position by rotation of a spindle actuator coupled to the cutting sheath, and the spindle actuator is configured for being driven by the DC motor with gears drivably coupled to the spindle actuator.

18. The biopsy device according to claim 17, wherein the cutting sheath is coaxially positioned around the biopsy needle.

19. The biopsy device according to claim 18, wherein the biopsy needle with coaxial cutting sheath and other elements arranged thereon are held at two bearing points in the biopsy needle unit so that the biopsy needle and the cutting sheath can turn individually.

20. The biopsy device according to claim 19, comprising a threaded spindle nut press-fitted into the biopsy needle unit to form one of the two bearing points, the threaded spindle nut being configured to threadably receive the spindle actuator.

21. The biopsy device according to claim 1, wherein the releasable locking mechanism comprises a double-arm lever configured to mechanically lock the tension slide in the cocked position, the double-arm lever configured for adjustment about an axis under spring pressure, wherein a first arm is configured to be acted upon by a pressure spring, and a second arm is configured to engage with a recess of the tension slide.

22. The biopsy device according to claim 1, wherein the electric power source includes a DC motor, and a spindle actuator is coupled to the cutting sheath, wherein a toothed roller is coupled to the DC motor, the toothed roller is engaged with a gear of the spindle actuator.

23. The biopsy device according to claim 22, comprising a base block mounted in the housing, the base block having a holder configured to receive a portion of the biopsy needle unit, wherein the gear of the spindle actuator is configured to thrust against the holder of the base block to cause displacement of the tension slide to the cocked position.

24. The biopsy device according to claim 1, wherein the biopsy needle comprises a narrowing positioned in a lumen of the biopsy needle at a proximal end of the sample removal chamber, the narrowing being positioned at a top portion of the lumen, leaving a passage at a bottom portion of the lumen.

25. The biopsy device according to claim 24, wherein the narrowing comprises 60-75% of the cross section of the lumen.

26. The biopsy device according to claim 24, wherein the narrowing comprises a stopper having a length of approximately 10 mm.

27. The biopsy device according to claim 24, wherein the narrowing is formed as a lip or dog protruding into the cross section of the lumen.

28. The biopsy device according to claim 1, wherein an opening of the sample removal chamber comprises approximately 25% of the cross section of the biopsy needle.

29. The biopsy device according to claim 1, wherein a miniature switch is integrated into an end cover of the housing, wherein the miniature switch is configured to enable the electrical power source when activated.

30. The biopsy device according to claim 29, wherein a switch pin of the miniature switch is activated when a housing cover of the housing presses down the vacuum pressure-generating device.

31. The biopsy device according to claim 1, comprising means on the biopsy needle unit to prevent opening of a housing cover when the tension slide is cocked and the biopsy needle unit is installed.

32. The biopsy device according to claim 1, wherein surfaces are provided on the housing for attaching the biopsy device to a positioning mechanism.

33. The biopsy device according to claim 1, wherein an outer upper contour of the biopsy needle unit corresponds to an inner upper contour of the housing.

34. The biopsy device according to claim 1, wherein a plastic part with knurled disk is mounted by friction locking onto a proximal end of the biopsy needle.

35. The biopsy device according to claim 34, wherein the plastic part comprises a polygon, wherein the plastic part is configured to interact with the biopsy needle unit and is further configured to lock the biopsy needle and thus the sample removal chamber in a selected position when turned by the knurled disk.

36. The biopsy device according to claim 1, wherein a base block is positioned in the center of the housing to support and hold components of the biopsy device.

37. The biopsy device according to claim 36, wherein space for a motor is separated from the removable element by a cover connected to the base block.

38. The biopsy device according to claim 36, wherein space for the electric power source is separated from the removable element by a separation plate connected to the base block.

39. The biopsy device according to claim 1, wherein the control panel comprises functional displays, and the first control device and the second control device are configured as operating switches.

40. The biopsy device according to claim 1, wherein the connection element is connected to the biopsy needle by a first plastic part which is able to rotate with respect to the connection element.

41. The biopsy device according to claim 40, further comprising a second plastic part that is sealed off against the first plastic part by an O-ring.

42. The biopsy device according to claim 1, wherein the removable element is a sterile packaged unit.

43. The biopsy device according to claim 1, further comprising an insert aid having brackets, a cross-piece and a pin, wherein the biopsy needle unit and the vacuum pressure-generating device are embraced by the brackets, and wherein the pin and the cross-piece orient the biopsy needle unit and the vacuum pressure-generating device with respect to a longitudinal axis of the biopsy device.

44. The biopsy device according to claim 43, wherein the insert aid further comprises two holder pieces on an upper side thereof.

45. The biopsy device according to claim 1, wherein the biopsy device is configured to move the cutting sheath approximately 2 mm beyond the distal end of the sample removal chamber in the direction of a tip of the biopsy needle when cutting the tissue sample.

46. The biopsy device according to claim 1, further comprising a coaxial cannula for the positioning of the biopsy needle unit, and further comprising a seal at the proximal end of the coaxial cannula to engage the biopsy needle unit when the biopsy needle unit is introduced into the coaxial cannula.

47. The biopsy device according to claim 46, wherein the coaxial cannula includes one or more spacing pieces inserted between a proximal bearing surface of the coaxial cannula and a distal end surface of a guide roller mounted on the biopsy needle unit.