Firing system for biopsy device

• US 8,366,636 B2
• Filed: 07/08/2005
• Issued: 02/05/2013
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co), Sonion Roskilde A/S
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Videbk, Karsten
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US11/631,718
• Publication Number:
  US 20100210966A1
• Time in Patent Office: 2,769 Days
• Field of Search: 600564-568, 606170-171
• US Class Current: 600/567
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• 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 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 2217/002 Auxiliary appliance
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: G01N 2001/315 Basket-type carriers for tissues

Abstract

A biopsy device for harvesting tissue samples from a suspect tissue mass in a body of a living being, e.g. in percutaneous aspiration biopsy, includes a hollow needle and a sample-receiving device, which is movable in the hollow needle. A first user-operable firing mechanism is provided for causing the hollow needle and the sample-receiving device to be substantially simultaneously displaced in a distal direction, so as to penetrate body tissue at or near the suspect tissue mass. A second user-operable firing mechanism may cause the hollow needle solely to be longitudinally displaced in a distal direction from a position, in which the sample-receiving device projects from the distal end of the hollow needle, to a position, in which the hollow needle essentially accommodates the sample-receiving device, so as to sever the tissue sample from remaining body tissue at the harvesting site.

Claims

1. A handheld biopsy device for harvesting at least one tissue sample from a suspect tissue mass in a body of a living being, comprising:

a hollow needle including a distal end having a circumferential cutting edge;

a needle driving member secured to the hollow needle;

a sample-receiving device with a cavity configured to receive a severed tissue sample, the sample-receiving device configured to be received in the hollow needle and movable therein;

a first user-operable firing mechanism configured to cause the hollow needle and the sample-receiving device to be longitudinally displaced in a distal direction, so as to penetrate body tissue at or near the suspect tissue mass;

a second user-operable firing mechanism configured to cause the hollow needle to be longitudinally displaced relative to the sample-receiving device in a distal direction from a first position, in which the sample-receiving device projects from the distal end of the hollow needle, to a second position, in which the hollow needle essentially accommodates the cavity of the sample-receiving device, so as to sever the tissue sample from remaining body tissue at the harvesting site; and

a handle unit, which completely contains the first and second user-operable firing mechanisms, the first and second user-operable firing mechanisms being configured for selectable operation between a first mode in which the first user-operable firing mechanism and the second user-operable firing mechanism are fired in sequence to facilitate harvesting of the tissue sample, and a second mode in which only the second user-operable firing mechanism is fired to facilitate the harvesting of the tissue sample, and wherein the hollow needle, the sample-receiving device and the needle driving member are comprised in a disposable unit, which is releasably attached to the handle unit.

2. A handheld biopsy device according to claim 1, further comprising a transport device configured to move the sample-receiving device in the hollow needle between a first extended position, in which a distal end of the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, which is proximal with respect to the first position, the transport device having a flexible rack gear connected to the sample-receiving device, the first user-operable firing mechanism having a drive member configured to drivably engage the flexible rack gear during operation of the first user-operable firing mechanism to longitudinally displace the sample-receiving device.

3. A handheld biopsy device according to claim 2, further comprising a first power-driven element configured for selectable drivable coupling to the rack gear, wherein the first power-driven element is drivably coupled to the rack gear to move the sample-receiving unit backward and forward in the hollow needle, and wherein the first power-driven element is uncoupled from the rack gear during operation of the first user-operable firing mechanism.

4. A handheld biopsy device according to claim 2, wherein the first firing mechanism comprises a first compression spring, and wherein the second firing mechanism comprises a second compression spring, the handheld biopsy device further comprising at least one loading mechanism configured to load the first and second compression springs and configured to release the first and second compression springs upon loading thereof.

5. A handheld biopsy device according to claim 4, wherein the first compression spring is connected to the needle driving member.

6. A handheld biopsy device according to claim 5, wherein the first compression spring is connectable to the transport device to longitudinally displace the hollow needle and the sample receiving device upon release of the first user-operable firing mechanism.

7. A handheld biopsy device according to claim 1, further comprising a transport device configured to move the sample-receiving device in the hollow needle between a first extended position, in which a distal end of the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, which is proximal with respect to the first position, wherein the first user-operable firing mechanism comprises a first compression spring, and wherein the second user-operable firing mechanism comprises a second compression spring, the handheld biopsy device further comprising a loading mechanism for loading the first and second compression springs and for releasing the first and second compression springs upon loading thereof, wherein the loading mechanism is configured to, upon loading of the first compression spring, decouple the transport device from the first power-driven element to facilitate the longitudinal displacement of the sample-receiving device by the first user-operable firing mechanism.

8. A handheld biopsy device according to claim 7, wherein the transport device comprises a bendable elongate element.

9. A handheld biopsy device according to claim 1, further comprising a liquid supply unit adapted to comprise a flushing liquid, the liquid supply unit being operatively connected to the cavity of the sample-receiving device through a hollow liquid transport member so as to allow tissue sample ejection by liquid flushing.

10. A handheld biopsy device according to claim 1, further comprising a vacuum pump for generating a suction effect in the cavity of the sample-receiving device, the vacuum pump being in fluid communication with the cavity of the sample-receiving device through a longitudinally extending passage in the sample-receiving device.

11. A handheld biopsy device according to claim 1, wherein the first user-operable firing mechanism is adapted to cause the hollow needle and the sample-receiving device to be displaced essentially simultaneously.

12. A handheld biopsy device according to claim 1, further comprising a control system for the first and second user-operable firing mechanisms, the control system being configured such that only one of said first and second user-operable firing mechanisms can be activated at a time.

13. A handheld biopsy device according to claim 12, wherein the control system is configured to automatically activate the second user-operable firing mechanism after firing of the first user-operable firing mechanism.

14. A handheld biopsy device for harvesting at least one tissue sample from a suspect tissue mass in a body of a living being, comprising:

a hollow needle with a distal end portion adapted to be introduced into the body, the hollow needle including a distal end having a circumferential cutting edge;

a sample-receiving device with a cavity for receiving a severed tissue sample, the sample-receiving device being receivable in the hollow needle and movable therein;

a first firing mechanism configured to cause the hollow needle and the sample-receiving device to be longitudinally displaced in a distal direction, so as to penetrate body tissue at or near the suspect tissue mass;

a second firing mechanism configured to cause the hollow needle to be longitudinally displaced in a distal direction from a first position, in which the sample-receiving device projects from the distal end of the hollow needle, to a second position, in which the hollow needle essentially accommodates the cavity of the sample-receiving device, so as to sever the tissue sample from remaining body tissue at the harvesting site;

a control system configured to control the first firing mechanism and the second firing mechanism;

a trigger element configured to sequentially actuate the first firing mechanism and the second firing mechanism, the trigger element having a first movement segment and a second movement segment; and

a power-driven element configured to move the trigger element, the control system being configured to control the power driven element to move the trigger element such that the first firing mechanism is loaded for firing and then fired during the first movement segment of the trigger element and such that the second firing mechanism is loaded for firing and then fired during the second movement segment of the trigger element.

15. A handheld biopsy device according to claim 14, further comprising:

a transport device configured to move the sample-receiving device in the hollow needle between a first extended position, in which a distal end of the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, which is proximal with respect to the first position; and

a transport power-driven element configured to drive the transport device to move the sample-receiving unit backward and forward in the hollow needle, and

wherein the control system is configured such that the transport device can move the sample-receiving device in the hollow needle between the first extended position and the second retracted position during further movement segments of the trigger element.

16. A handheld biopsy device according to claim 15, wherein said power-driven element configured to move the trigger element and said transport power-driven element are constituted by one motor.

17. A handheld biopsy device according to claim 14, wherein the trigger element comprises a rotatable trigger wheel and the rotatable trigger wheel is configured for rotation by the power-driven element.

18. A handheld biopsy device according to claim 14, further comprising a transport device configured to move the sample-receiving device in the hollow needle between a first extended position, in which a distal end of the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, which is proximal with respect to the first extended position, wherein the trigger element is arranged such that movement thereof in a first direction causes firing of at least one of the first and second firing mechanisms, and such that further movement of the trigger element in the first direction causes movement of the transport device to move the sample-receiving device from the first extended position to the second retracted position.

19. A handheld biopsy device according to claim 18, wherein the trigger element is arranged such that movement thereof in a second direction causes movement of the transport device to move the sample-receiving device from the second retracted position to the first extended position.

20. A handheld biopsy device according to claim 14, wherein the control system comprises an electrically activated solenoid for causing an impart member of the first firing mechanism to move into a path of movement of the trigger element.

21. A handheld biopsy device according to claim 14, further comprising a vacuum pump for generating a suction effect in the cavity of the sample-receiving device, the vacuum pump being in fluid communication with the cavity of the sample-receiving device through a longitudinally extending passage in the sample-receiving device.

22. A handheld biopsy device according to claim 14, wherein the control system is configured such that only one of the first firing mechanism and the second firing mechanism can be activated at a time.

23. A method of harvesting at least one tissue sample from a suspect tissue mass in a body of a living being by using a handheld biopsy device, the method comprising:

introducing a hollow needle of the handheld biopsy device into the body, so as to place a distal end portion of the hollow needle near the suspect tissue mass, the hollow needle including a distal end having a circumferential cutting edge and the hollow needle accommodating a sample-receiving device of the handheld biopsy device, the sample-receiving device having a cavity for receiving the at least one tissue sample, the sample-receiving device being movable in a longitudinal direction in the hollow needle between a first extended position, in which a distal end of the cavity of the sample-receiving device projects from a distal tip of the hollow needle, and a second retracted position, which is proximal with respect to the first position;

selectively coupling the sample-receiving device to a first firing mechanism contained within the handheld biopsy device;

activating the first firing mechanism contained within the handheld biopsy device to thereby cause the hollow needle and the sample-receiving device to be longitudinally displaced in a distal direction, so as to cause a tip of the sample-receiving device and the distal end portion of the hollow needle to penetrate the suspect tissue mass;

uncoupling the sample-receiving device from the first firing mechanism;

activating a retracting mechanism of the handheld biopsy device to retract the hollow needle to a first position, in which the sample-receiving device projects from the distal end of the hollow needle;

activating a second firing mechanism contained within the handheld biopsy device to thereby cause the hollow needle to be longitudinally displaced in the distal direction to a second position, in which the hollow needle essentially accommodates the cavity of the sample-receiving device, so as to sever a first body tissue sample from remaining body tissue at the suspect tissue mass;

activating a transport device of the handheld biopsy device to move the sample-receiving device in the hollow needle to the second retracted position; and

activating an ejection mechanism of the handheld biopsy device to eject said first body tissue sample from the cavity, when the sample-receiving device is in the second retracted position.

24. A method according to claim 23, further comprising, subsequently to ejection of said first body tissue sample from the cavity:

activating the transport device of the handheld biopsy device to move the sample receiving device in the hollow needle to the first extended position;

activating the second firing mechanism of the handheld biopsy device to sever a second body tissue sample;

activating the transport device of the handheld biopsy device to move the sample-receiving device in the hollow needle to the second retracted position; and

activating the ejection mechanism of the handheld biopsy device to eject said second body tissue sample from the cavity, when the sample-receiving device is in the second retracted position.