Biopsy device and insertable biopsy needle module

• US 8,002,713 B2
• Filed: 03/05/2003
• Issued: 08/23/2011
• 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:
  US10/500,518
• Publication Number:
  US 20050165328A1
• Time in Patent Office: 3,093 Days
• Field of Search: 600/565, 600/566, 600/568, 600/562, 600/564, 600/567
• US Class Current: 600/566
• 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 for tissue collection, comprising:

a housing containing a power source; and

a removable element, comprising a biopsy needle module, a pressure source and a hollow connecting element, the biopsy needle module having a biopsy needle, a cutting sleeve and a biopsy needle carrier to which the biopsy needle and the cutting sleeve are mounted, wherein the removable element is configured for insertion into the housing with both the pressure source and the biopsy needle carrier being contained within the housing and with the pressure source and the biopsy needle carrier being spaced apart within the housing, and the hollow connecting element coupled as a fluid coupling between the biopsy needle module and the pressure source;

wherein the housing includes a lower housing segment, a housing lid coupled to the lower housing segment, a first end lid and a second end lid, each of the first end lid and the second end lid being connected to the lower housing segment, wherein the second end lid comprises a first U-shaped opening and a second U-shaped opening, wherein the first U-shaped opening is configured to receive a first portion of the removable element and the second U-shaped opening is configured to receive a second portion of the removable element, and wherein a third portion of the removable element is located between the first U-shaped opening and the second U-shaped opening external to the housing; and

wherein the first end lid comprises a third U-shaped opening at the top thereof, and the third U-shaped opening is configured to receive a portion of the removable element.

2. The biopsy device according to claim 1, the biopsy needle comprising a sharpened distal end and a distal opening for collection of tissue, the cutting sleeve having a cutting blade on the distal end thereof and coaxially positioned with respect to the biopsy needle.

3. The biopsy device according to claim 2, wherein the pressure source comprises a vacuum pressure-generating device having a piston/cylinder arrangement, the vacuum pressure-generating device being connected to a proximal end of the biopsy needle via the hollow connecting element.

4. The biopsy device according to claim 2, further comprising a clamping cradle contained within the housing and a drive unit contained within the housing, the clamping cradle connected to the drive unit.

5. The biopsy device according to claim 4, wherein the biopsy needle module is configured to be connected to the clamping cradle such that the biopsy needle module is longitudinally displaceable by the clamping cradle.

6. The biopsy device according to claim 5, wherein the cutting sleeve is connected to the drive unit, the cutting sleeve being configured to be axially movable relative to the biopsy needle.

7. The biopsy device according to claim 5, wherein the clamping cradle is configured to cause the biopsy needle to penetrate into a patient a predetermined distance upon actuation of the clamping cradle.

8. The biopsy device according to claim 7, wherein the clamping cradle is configured to be set to a plurality of penetration distances for the biopsy needle.

9. The biopsy device according to claim 7, wherein the clamping cradle is configured to be set to a penetration distance for the biopsy needle which is in the range between approximately 15 mm and 25 mm.

10. The biopsy device according to claim 4, wherein a locking mechanism is contained within the housing to lock the clamping cradle, the locking mechanism comprising a handle with an arm, wherein the arm is configured to lock into a depression in the clamping cradle.

11. The biopsy device according to claim 10, wherein the clamping cradle is comprised of a plastic material and the arm is comprised of a metal.

12. The biopsy device according to claim 1, wherein the power source comprises at least one battery.

13. The biopsy device according to claim 1, wherein the lower housing segment has lateral walls of different heights.

14. The biopsy device according to claim 1, further including a guide disposed on the removable element, and wherein the third U-shaped opening is sized to receive the guide of the removable element.

15. The biopsy device according to claim 1, further comprising a control panel attached to the housing, wherein the control panel is connected to the power source.

16. The biopsy device according to claim 15, wherein the control panel is connected to a circuit board.

17. The biopsy device according to claim 16, wherein the circuit board has a programmable microprocessor disposed thereon.

18. The biopsy device according to claim 16, wherein the control panel comprises a control key configured to actuate a clamping cradle, a program key configured to actuate a tissue sampling procedure and a clamping key configured to trigger clamping of the clamping cradle.

19. The biopsy device according to claim 18, wherein the program key is positioned between the control key and clamping key to avoid accidental actuation of the clamping cradle.

20. The biopsy device according to claim 18, wherein each of the keys has a light associated therewith that is configured to indicate whether the key is active.

21. The biopsy device according to claim 18, wherein the clamping key is equipped with a delay circuit.

22. The biopsy device according to claim 1, wherein the housing lid further comprises a longitudinally displaceable locking mechanism.

23. A biopsy device for tissue collection, comprising:

a housing containing a power source, wherein the housing comprises a lower housing segment with lateral walls, a housing lid matched to the lower housing segment and having a longitudinally displaceable locking mechanism mounted to the housing lid and configured to engage a fastening device on the lower housing segment, and a first end lid and a second end lid, each of the first end lid and the second end lid being connected to the lower housing segment;

a removable element, comprising a biopsy needle module, a pressure source and a hollow connecting element, the biopsy needle module having a biopsy needle, a cutting sleeve and a biopsy needle carrier to which the biopsy needle and the cutting sleeve are mounted, wherein the removable element is configured for insertion into the housing with both the pressure source and the biopsy needle carrier being contained within the housing and with the pressure source and the biopsy needle carrier being spaced apart within the housing, and the hollow connecting element coupled as a fluid coupling between the biopsy needle module and the pressure source;

wherein the second end lid comprises a first U-shaped opening and second U-shaped opening, wherein each of the first U-shaped opening and the second U-shaped opening is configured to receive a respective portion of the removable element, with at least a portion of the hollow connecting element being located between the first U-shaped opening and the second U-shaped opening external to the housing; and

wherein the first end lid comprises a third U-shaped opening at the top thereof, the third U-shaped opening sized to receive a portion of the removable element.

24. A biopsy device for tissue collection, comprising:

a housing including a lower housing segment, a housing lid coupled to the lower housing segment, a first end lid, and a second end lid, each of the first end lid and the second end lid being connected to the lower housing segment, wherein the second end lid has a first U-shaped opening and a second U-shaped opening, and the first end lid has a third U-shaped opening;

a unitary removable element including a biopsy needle module, a pressure source, and a hollow connecting element coupled as a fluid coupling between the biopsy needle module and the pressure source; and

the unitary removable element being configured to be mounted to the housing and received at each of the first U-shaped opening, the second U-shaped opening and the third U-shaped opening, with the pressure source being contained within the housing, and with at least a portion of the hollow connecting element being external to said housing in a region between the first U-shaped opening and the second U-shaped opening to establish a fluid path that extends between the first U-shaped opening and the second U-shaped opening external to the housing.

25. The biopsy device of claim 24, wherein the biopsy needle module includes a first portion configured to be received by the first U-shaped opening and the pressure source includes a second portion configured to be received by the second U-shaped opening.

26. The biopsy device of claim 25, wherein the first portion is a round profile portion of the biopsy needle module and the second portion is a nozzle portion of the pressure source.

27. The biopsy device of claim 26, wherein the biopsy needle module includes a biopsy needle and a cutting sleeve coaxially positioned with respect to the biopsy needle, the biopsy needle module further including a guide roller slidably disposed on said cutting sleeve, the guide roller configured for being slidably received by the third U-shaped opening to maintain a position of the guide roller.

28. The biopsy device of claim 26, wherein the biopsy needle module includes a biopsy needle configured to extend outwardly from the housing from the third U-shaped opening, and wherein the fluid path is configured to further extend within the housing through the biopsy needle module between the first U-shaped opening and the third U-shaped opening.

29. The biopsy device of claim 24, wherein the fluid path is configured to further extend through an interior of the housing between the first U-shaped opening and the third U-shaped opening by way of the biopsy needle module.