Biopsy device for removing tissue specimens using a vacuum

• US 8,016,772 B2
• Filed: 03/01/2007
• Issued: 09/13/2011
• Est. Priority Date: 03/19/2002
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Heske, Thomas, Heske, Norbert F.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Lloyd; Emily M
• Application Number:
  US11/680,942
• Publication Number:
  US 20070149894A1
• Time in Patent Office: 1,657 Days
• Field of Search: 600/564, 600/562, 600565-568
• 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 method for initializing a biopsy device, comprising:

providing a durable drive and a disposable component, the durable drive having a detecting portion, the disposable component including a biopsy needle with a sample chamber selectively covered by a sheath and a vacuum pump coupled in fluid communication with the biopsy needle;

installing the disposable component in the durable drive, the durable drive and the disposable component engaging each other with a gear, and wherein the sample chamber initially is not covered by the sheath;

detecting installation of the disposable component in the durable drive based on an engaging of the detecting portion with the disposable component; and

covering the sample chamber with the sheath upon detection of the installation of the disposable component in the durable drive.

2. A method for controlling a biopsy device, comprising:

providing a durable drive and a disposable component configured to be driven by the durable drive, the disposable component having a biopsy needle with a sample chamber selectively covered by a sheath and a vacuum pump coupled in fluid communication with the biopsy needle, the sheath being initially in a retracted position to uncover the sample chamber so that the sample chamber is open to visual inspection, and the durable drive comprising a sensor for sensing installation of the disposable component;

maintaining the sheath in the retracted position with the sample chamber uncovered, before installing the disposable component in the durable drive;

installing the disposable component in the durable drive;

sensing the installing with the sensor, and automatically operating the durable drive to position the sheath in a covered position wherein the sheath covers the sample chamber; and

maintaining the sheath in the covered position that covers the sample chamber after installing the disposable component in the durable drive until after the biopsy needle is inserted into a host.

3. The method of claim 2, the visual inspection including manually holding a holder that is removed when installing the disposable component in the durable drive.

4. A method for installation of a disposable unit in a durable drive unit, the disposable unit having a biopsy needle and a vacuum pump coupled in fluid communication with the biopsy needle, the biopsy needle having a sample chamber and a sheath that selectively covers and uncovers the sample chamber, and the durable drive unit comprising a sensor for sensing installation of the disposable unit, the method comprising:

providing the disposable unit with the sheath initially in a retracted position that uncovers the sample chamber to permit inspection of the sample chamber before the disposable unit is used in a biopsy operation,

installing the disposable unit in the durable drive unit;

sensing the installing of the disposable unit in the durable drive unit with the sensor;

based on sensing the installing, driving the durable drive unit with the disposable unit installed, wherein the sheath is driven from the retracted position to cover the sample chamber; and

maintaining the sheath in a covered position that covers the sample chamber, after driving the durable drive unit to cover the sample chamber, until after the biopsy needle is inserted into a host.

5. A biopsy device, comprising:

a disposable unit including a biopsy needle and a vacuum pump coupled in fluid communication with the biopsy needle, the biopsy needle having a sample chamber and a sheath that is configured to selectively cover and uncover the sample chamber; and

a durable drive unit configured to be interoperable with the disposable unit when the disposable unit is installed in the durable drive unit,

wherein the sheath is in a retracted position with the sample chamber uncovered to permit inspection of the sample chamber prior to installation in the durable drive unit,

the durable drive unit having a sensor configured to detect installation of the disposable unit in the durable drive unit, the durable drive unit being configured to automatically extend the sheath to cover the sample chamber when the installation of the disposable unit in the durable drive unit is detected by the sensor.

6. The device of claim 5, the durable drive unit having a housing cover configured to push a portion of the disposable unit against the sensor to cause the disposable unit to be detected.

7. The biopsy device of claim 5, wherein the vacuum pump is further configured to generate a positive pressure.

8. A biopsy device, comprising:

a disposable unit including a biopsy needle and a vacuum pump coupled in fluid communication with the biopsy needle, the biopsy needle having a sample chamber and a sheath that is configured to selectively cover and uncover the sample chamber; and

a durable drive unit configured to be interoperable with the disposable unit when the disposable unit is installed in the durable drive unit,

the disposable unit being provided with the sheath in a retracted position with the sample chamber uncovered to permit inspection of the sample chamber prior to installation in the durable drive unit, the durable drive unit is configured with an insertion mode in which the sheath is driven to cover the sample chamber prior to insertion of the biopsy needle into a host,

the durable drive unit having a cover to enclose the disposable unit, the durable drive unit having a sensor configured to detect installation of the disposable unit in the durable drive unit, the cover being configured to push a portion of the disposable unit against the sensor to cause the disposable unit to be detected to initiate the insertion mode.

9. The device of claim 8, the cover being configured to move a portion of the vacuum pump to actuate the sensor to cause the disposable unit to be detected to initiate the insertion mode.

10. A biopsy device, comprising:

a drive unit configured to receive a replaceable biopsy needle carrier unit;

the replaceable biopsy needle carrier unit having a biopsy needle with a sample chamber configured for being selectively covered with a sheath and a vacuum pump coupled in fluid communication with the biopsy needle, the replaceable biopsy needle carrier unit being configured to have an insertion mode in which the sample chamber is covered by the sheath and a load mode in which the sample chamber is uncovered;

the drive unit including a power source, a controller, and a load switch connected to the controller, the drive unit configured to engage the replaceable biopsy needle carrier unit with a gear;

the load switch configured to transmit an initialization signal upon the connection of the replaceable biopsy needle carrier unit to the drive unit; and

the controller configured to respond to the initialization signal by placing the replaceable biopsy needle carrier unit in the insertion mode.

11. The device of claim 10, the drive unit having a cover with a surface, the surface of the cover being configured to dispose at least a portion of the replaceable biopsy needle carrier unit against the load switch when the cover is closed with the replaceable biopsy needle carrier unit in the drive unit to actuate the load switch.

12. The device of claim 10, the replaceable biopsy needle carrier unit having a removable holding device configured to allow the replaceable biopsy needle carrier unit to be handled and installed in the drive unit.

13. The device of claim 10, the replaceable biopsy needle carrier unit including a holding device configured to allow the replaceable biopsy needle carrier unit to be handled and installed in the drive unit, the holding device being configured to be removed from the replaceable biopsy needle carrier unit after installation of the replaceable biopsy needle carrier unit in the drive unit.

14. A biopsy device, comprising:

a disposable unit including a biopsy needle, a vacuum pump and a sheath, the biopsy needle having a sample chamber, the vacuum pump being coupled in fluid communication with the biopsy needle, and the sheath configured to selectively cover and uncover the sample chamber; and

a durable drive unit with which the disposable unit is interoperable when installed in the durable drive unit, the durable drive unit having a housing and a controller contained in the housing operably coupled to the disposable unit when the disposable unit is installed in the durable drive unit,

the sheath having a retracted position with the sample chamber uncovered, wherein the sample chamber is not covered by the sheath prior to installation in the durable drive unit,

the durable drive unit having a sensor communicatively coupled to the controller to detect installation of the disposable unit, the durable drive unit being configured to automatically cover the uncovered sample chamber with the sheath when the installation of the disposable unit in the durable drive unit is detected by the sensor.

15. The biopsy device of claim 14, wherein:

the sensor is an initialization switch;

the housing having a housing cover, and

the disposable unit is configured to be inserted in the housing when the housing cover is open, and the durable drive unit configured such that when the housing cover is closed with the disposable unit in the durable drive unit a portion of the disposable unit presses against the initialization switch to activate the controller to cause the sheath to cover the sample chamber.

16. The biopsy device of claim 15, wherein the vacuum pump includes an elongate cylinder with an axis parallel to a biopsy needle axis, and wherein when the housing cover is closed with the disposable unit in the durable drive unit, a portion of the elongate cylinder is engaged with the initialization switch to activate the controller.

17. The biopsy device of claim 14, wherein the vacuum pump includes an elongate cylinder that is adjacent to the biopsy needle, the elongate cylinder being connected to the biopsy needle by a length of flexible tubing to facilitate communication of a pressure from the elongate cylinder to the biopsy needle.

18. The biopsy device of claim 17, wherein the flexible tubing is U-shaped and a portion of the U-shaped flexible tubing is configured to be located outside said housing after the disposable unit is inserted into the housing.

19. The biopsy device of claim 17, the durable drive unit including a movable shooting device, wherein the biopsy needle is connected to the movable shooting device such that the biopsy needle is configured to move with the shooting device relative to the housing and the elongate cylinder, the flexible tubing being sufficiently flexible to accommodate the movement of the biopsy needle.

20. The biopsy device of claim 14, further comprising:

the vacuum pump having an elongate cylinder and a piston that is sealed and movable inside the elongate cylinder to generate a vacuum in the biopsy needle;

a vacuum motor contained in the housing, the vacuum motor having a drive gear;

the piston having a rack and a toothed crown nut that is configured to mesh with the rack to drive the piston when the toothed crown nut rotates; and

the drive gear of the vacuum motor being configured to mesh with the toothed crown nut.

21. The biopsy device of claim 20, wherein the vacuum pump is configured to fit into a recess in the housing and configured to place the drive gear and the toothed crown nut in mesh when the vacuum pump is placed in the recess.

22. The biopsy device of claim 21, the housing having a housing cover, wherein the housing cover is configured to force the toothed crown nut against the drive gear when the housing cover is closed when the disposable unit is in the durable drive unit.

23. The biopsy device of claim 22, wherein the housing cover is configured to move a portion of the vacuum pump to actuate the initialization switch to activate the controller when the housing cover is closed.

24. The biopsy device of claim 14, wherein:

the housing has an end cover and a housing cover, the housing cover being configured to be opened and closed; and

the sensor is a switch integrated into the end cover of the housing.

25. The biopsy device of claim 24, the housing cover being configured to push a portion of the disposable unit against the switch to cause the disposable unit to be detected to initiate the automatic covering of the sample chamber.

26. The biopsy device of claim 24, wherein the disposable unit is configured for insertion into the housing when the housing cover is open, and the housing cover is configured to cause a portion of the disposable unit to press against the switch to effect the automatic covering of the sample chamber when the housing cover is closed.

27. A biopsy device, comprising:

a disposable unit including a biopsy needle, a vacuum pump and a length of flexible tubing;

the biopsy needle having a cutting sheath;

the vacuum pump including an elongate cylinder positioned adjacent the biopsy needle, the elongate cylinder having a vacuum port at an end thereof, the elongate cylinder having a piston sealed and movable in the elongate cylinder to generate a vacuum when driven;

the length of flexible tubing interposed in fluid communication between the biopsy needle at an end thereof and to the vacuum port of the vacuum pump;

a movable shooting device connected to the biopsy needle, such that the biopsy needle is configured to move with the shooting device relative to the elongate cylinder, the flexible tube being sufficiently flexible to accommodate the movement of the biopsy needle;

a drive for driving the vacuum pump and the biopsy needle;

a controller coupled to the drive;

a switch coupled to the controller; and

a housing configured to contain the switch, the controller, the drive, the movable shooting device, and at least a portion of the disposable unit, the switch being located on the housing and configured to detect an installation of the disposable unit in the housing,

wherein the switch is configured to transmit a signal to the controller upon detection of installation of the disposable unit in the housing, and the controller is configured to respond to the signal by controlling the drive to initialize the biopsy needle to an insertion mode where the biopsy needle is configured for insertion into and subsequent sampling from a host.