Length Detection System for Biopsy Device

• US 20080071193A1
• Filed: 07/08/2005
• Published: 03/20/2008
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co), Sonion Roskilde A/S
• Original Assignee: Sonion Roskilde A/S
• Inventors: Olsen, Henrik, Videbaek, Karsten, Reuber, Claus
• Granted Patent: US 8,052,615 B2
• Time in Patent Office: Days
• 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 body of a living being, e.g. in percutaneous aspiration biopsy, includes a handle unit, a hollow needle comprised in a disposable unit, which is releasably attached to the handle unit, and a sample-receiving device, which is movable in the hollow needle between two positions. Tissue is severed when the sample-receiving device is in a first one of the positions, and the severed tissue sample is ejected from the sample-receiving device in a second one of the two positions. A control system is provided for controlling movement of the sample-receiving device and for arresting the sample-receiving device in the second position. The distance between the two positions and/or a length of the hollow needle may be detectable in a calibration cycle, which is automatically initiated upon attachment of the disposable unit to the handle unit. The disposable unit may include electronic memory means for communicating with the control system.

Claims

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

a handle unit;

a longitudinally extending hollow needle with a distal end portion adapted to be introduced into the body, the hollow needle being releasably attached to the handle unit;

a sample-receiving device with a cavity for receiving the at least one severed tissue sample, the sample-receiving device being receivable in the hollow needle and longitudinally displaceable therein between a first extended position, in which the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, in which the cavity is in a proximal position with respect to the distal end portion of the hollow needle, and in which the at least one tissue sample can be ejected from said cavity;

a transport device for moving the sample-receiving device in the hollow needle between the first extended position and the second retracted position;

a control system for controlling movement of the transport device and for arresting the sample-receiving device in the second retracted position;

wherein the hollow needle and the sample-receiving device are comprised in a disposable unit, which is releasably attached to the handle unit, and wherein the control system is configured to automatically detect a distance between the first extended position and the second retracted position of the sample-receiving device.

2. A biopsy device according to claim 1, wherein the disposable unit comprises an electronic memory, and wherein the handle unit comprises an electronic interface for deriving information stored in said electronic memory, the electronic interfacing being configured to communicate said information to the control system.

3. A biopsy device according to claim 2, wherein said information represents a distance between the first extended and the second retracted position of the sample-receiving device.

4. A biopsy device according to claim 1, wherein the sample-receiving device has a pre-defined range of movement between a distal and a proximal extremity, and wherein the control system comprises a sensor for detecting a change in a physical characteristic when the sample-receiving device reaches its proximal extremity.

5. A biopsy device according to claim 4, wherein the transport device comprises a position or movement signal generator for generating a position or movement signal to the control system indicative of the longitudinal position or movement of the sample-receiving device, and wherein the control system is configured to, upon mounting of the hollow needle and the sample-receiving device to the handle unit:

activate the transport device to retract the sample-receiving device to its proximal extremity and to record the position or movement signal in the proximal extremity; and

to

utilize the recorded position signal as a position reference point for subsequent arresting of the sample-receiving device in the second retracted position following tissue harvesting.

6. A biopsy device according to claim 4, wherein the control system comprises at least one pulse-emitting device for producing pulses in dependency of the movement or position of the sample-receiving device, and wherein the proximal extremity of the sample-receiving device is defined by a mechanical stop for the sample-receiving device, and wherein said physical characteristic is defined by a change in the production of pulses.

7. A biopsy device according to claim 6, wherein the pulse-emitting device comprises at least one Hall element.

8. A biopsy device according to claim 4, wherein the transport device receives a driving force from an electrically driven motor, and wherein said sensor comprises a current or voltage sensor for measuring motor current passing through the motor, the proximal extremity being defined by a mechanical stop for the sample-receiving device.

9. A biopsy device according to claim 5, further comprising a transmission axle for transmitting a driving force to the transport device, and wherein the position signal generator comprises a potentiometer mounted on the transmission axle.

10. A biopsy device according to claim 4, wherein the proximal extremity and the second retracted position are at different longitudinal positions relative to the handle unit.

11. A biopsy device according to claim 1, wherein the handle unit, the hollow needle, the sample-receiving device, the transport device and the control system are comprised in a hand-held unit.

12. A biopsy device according to claim 1, wherein the transport device comprises a bendable elongate element.

13. A 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.

14. A 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.

15. A biopsy device according to claim 1, further comprising:

a first user-operable firing mechanism for causing 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; and

a second user-operable firing mechanism for causing 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 said tissue sample from remaining body tissue at the harvesting site.

16. A method of harvesting at least one biopsy tissue sample from a body of a living being, the method comprising:

providing a handle unit;

providing a longitudinally extending hollow needle with a distal end portion adapted to be introduced into the body, the hollow needle being releasably attachable to the handle unit;

providing a sample-receiving device with a cavity for receiving the at least one severed tissue sample, the sample-receiving device being receivable in the hollow needle and longitudinally displaceable therein between a first extended position, in which the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, in which the cavity is in a proximal position with respect to the distal end portion of the hollow needle, and in which the at least one tissue sample can be ejected from said cavity;

attaching the hollow needle with the sample-receiving device to the handle unit;

determining a distance between the first extended position and the second retracted position of the sample-receiving device;

severing the at least one tissue sample when the sample-receiving device is in the first extended position;

displacing the sample-receiving device in the hollow needle towards the second retracted position;

arresting the sample-receiving device in the second retracted position; and

ejecting the at least one tissue sample from the cavity of the sample-receiving device when the sample-receiving device is arrested in the second retracted position.

17. A disposable unit for a biopsy device, the biopsy device comprising a control system, the disposable unit comprising:

a longitudinally extending hollow needle with a distal end portion adapted to be introduced into the body of a living being;

a sample-receiving device with a cavity for receiving the at least one severed tissue sample, the sample-receiving device being receivable in the hollow needle and longitudinally displaceable therein between a first extended position, in which the cavity of the sample-receiving device projects from the distal end portion of the hollow needle, and a second retracted position, in which the cavity is in a proximal position with respect to the distal end portion of the hollow needle, and in which the at least one tissue sample can be ejected from said cavity; and

a device for providing a signal representative of a distance between the first and second positions of the sample-receiving device to said control system.

18. (canceled)