Length detection system for biopsy device

• US 8,992,440 B2
• Filed: 09/26/2011
• Issued: 03/31/2015
• Est. Priority Date: 07/09/2004
• Status: Expired due to Fees

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Reuber, Claus, Videbk, Karsten, Olsen, Henrik Bagger
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/245,305
• Publication Number:
  US 20120071787A1
• Time in Patent Office: 1,282 Days
• Field of Search: 600562-568, 606/167, 606/130, 606/1, 606/34, 606/38, 606/41, 606/42, 606/170, 744/247.4, 744/247.7, 744/249.2, 745/09, 744/12.TA, 343/715, 343/903, 475/149, 475/178, 475/180, 475/263, 521/10, 521/21
• US Class Current: 600/562
• 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 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 device 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 distal end portion of the hollow needle having a cutting edge configured to sever the at least one tissue sample;

a sample-receiving device with a closed distal end and a side accessible cavity proximal to the closed distal end, the cavity configured to receive the at least one tissue sample severed by the cutting edge of the hollow needle, the sample-receiving device configured to be received in the hollow needle and longitudinally displaced 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 of the sample-receiving device 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 configured to move the sample-receiving device in the hollow needle between the first extended position and the second retracted position;

a control system configured to control movement of the transport device and configured to arrest the sample-receiving device in the second retracted position to facilitate retrieval from within the biopsy device of the at least one tissue sample from the cavity;

wherein the hollow needle and the sample-receiving device are comprised in a disposable unit configured to be releasably attached to the handle unit to facilitate disposal of the disposable unit apart from the handle unit such that the handle unit is reusable for multiple biopsy procedures, 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 includes a physical non-transitory electronic memory device, and the handle unit includes the control system and an electronic interface, the control system coupled in electrical communication with the electronic interface, the electronic interface configured to communicate with the physical non-transitory electronic memory device of the disposable unit to derive information stored in the physical non-transitory electronic memory device, and the electronic interface being configured to communicate the information to the control system, and wherein said information represents a distance between the first extended and the second retracted position of the sample-receiving device.

3. 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 the proximal extremity.

4. A biopsy device according to claim 3, 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 disposable unit comprised of the hollow needle and the sample-receiving device to the handle unit:

activate the transport device to retract the sample-receiving device to the 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.

5. A biopsy device according to claim 3, 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.

6. A biopsy device according to claim 5, wherein the pulse-emitting device comprises at least one Hall element.

7. A biopsy device according to claim 3, wherein the transport device is configured to receive a driving force from an electrically driven motor, and wherein said sensor comprises a current or voltage sensor configured to measure motor current passing through the motor, the proximal extremity being defined by a mechanical stop for the sample-receiving device.

8. A biopsy device according to claim 4, 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.

9. A biopsy device according to claim 3, wherein the proximal extremity and the second retracted position are at different longitudinal positions relative to the handle unit.

10. 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.

11. A biopsy device according to claim 1, wherein the transport device comprises a bendable elongate element having an end attached to the sample-receiving device and having a toothed lower surface, and further comprising:

a driven rotatable gear wheel engaged with the toothed lower surface of the transport device; and

a coiling device configured to coil the bendable elongate element as the sample-receiving device is moved by operation of the driven rotatable gear wheel from the first extended position to the second retracted position, relative to the distal end portion of the hollow needle.

12. A biopsy device according to claim 1, further comprising a liquid supply unit adapted to supply a flushing liquid, the liquid supply unit having a sample flushing chamber that is aligned with and operatively connected to the cavity of the sample-receiving device when the sample-receiving device is in the second retracted position so as to allow tissue sample ejection by the liquid flushing.

13. 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.

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

a first user-operable firing mechanism configured to longitudinally displace the hollow needle and the sample-receiving device in a distal direction, so as to penetrate body tissue; and

a second user-operable firing mechanism configured to longitudinally displace the hollow needle 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 covers the cavity of the sample-receiving device so as to sever a respective tissue sample from remaining body tissue at the harvesting site.

15. A disposable unit for a biopsy device, the biopsy device having 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, the distal end portion of the hollow needle having a cutting edge configured to sever at least one tissue sample;

a sample-receiving device with a cavity configured to receive the at least one severed tissue sample, the sample-receiving device configured to be received in the hollow needle and configured to be longitudinally displaced 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 of the sample-receiving device is in a proximal position with respect to the distal end portion of the hollow needle, the second retracted position defining a position within the biopsy device for ejection of the at least one tissue sample from the cavity; and

a transport device configured to move the sample-receiving device in the hollow needle between the first extended position and the second retracted position, wherein the transport device includes;

a bendable elongate element having an end attached to the sample-receiving device and having a tooth surface;

a driven rotatable gear wheel engaged with the toothed surface of the transport device; and

a coiling device configured to coil the bendable elongate element along a longitudinal path defined by the longitudinally extending hollow needle as the sample-receiving device is moved linearly by operation of the driven rotatable gear from the first extended position to the second retracted position, relative to the distal end portion of the hollow needle; and

a physical non-transitory electronic memory device communicatively coupled to the control system, the physical non-transitory electronic memory device being configured to store information representative of a distance between the first extended position and the second retracted position of the sample-receiving device and configured to provide the information to the control system.