MRI biopsy device

• US 9,392,999 B2
• Filed: 12/12/2014
• Issued: 07/19/2016
• Est. Priority Date: 05/21/2004
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Haberstich, Wells D., Raghavendran, Raj G., Hibner, John A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/568,478
• Publication Number:
  US 20150201916A1
• Time in Patent Office: 585 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• 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 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• 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 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2018/00928 by sending a signal to an external energy source
• 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
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2560/0266 for monitoring or limiting apparatus function
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/708 : Breast positioning means
• CPC Class Codes: A61B 5/743 : Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/17 : for soft tissue, e.g. breast-holding devices
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for

Abstract

A magnetic resonance imaging (MRI) compatible core biopsy system uses a biopsy device having intuitive graphical displays and a detachable remote keypad that advantageously allows convenient control even within the close confines afforded by a localization fixture installed within a breast coil that localizes a patient'"'"'s breast and guides a probe of the biopsy device relative to the localized breast. A control module for interactive control and power generation are remotely positioned and communicate and transmit rotational mechanical energy via sheathed cable.

Claims

1. A biopsy device comprising:

an outer cannula having a lateral tissue receiving aperture;

an inner tubular cutter disposed for translation within the cannula;

a sensor responsive to translation position of the inner tubular cutter;

a graphical display attached proximally to the outer cannula operably configured to depict the translation position in response to the sensor.

2. The biopsy device of claim 1, wherein the graphical display comprises a bar graph annotated with longitudinal extents of the lateral tissue receiving aperture relative to indicated translation position of the inner tubular cutter.

3. The biopsy device of claim 1, further comprising a vacuum source communicating with the inner tubular cutter to prolapse tissue into the lateral tissue receiving aperture, the graphical display further operably configured to depict a mode of operation corresponding to the vacuum source.

4. The biopsy device of claim 3, further comprising a mode control and control circuitry responsive to user activation of the mode control to toggle between a plurality of modes of operation, the graphical display including a plurality of indicators illuminated to correspond to a current mode of operation.

5. The biopsy device of claim 4, further comprising a plurality of graphical depictions illustrating each of the plurality of modes of operation.

6. The biopsy device of claim 3, further comprising a lateral lumen attached to the outer cannula and communicating distally to the lateral tissue receiving aperture and proximally to atmosphere.

7. The biopsy device of claim 1, further comprising:

a probe assembly portion containing the inner tubular cutter, a cutter carriage attached to the inner tubular cutter, and a translation shaft engaged for longitudinal translation to the cutter carriage; and

a holster assembly including a rotation member engageable to the translation shaft.

8. The biopsy device of claim 7, wherein the probe assembly further comprises a cutter gear proximally attached to the inner tubular cutter, a rotation shaft having a spur gear portion positioned to engage the cutter gear to impart a rotation to the inner tubular cutter.

9. The biopsy device of claim 8, wherein the holster further comprises a fixed ratio transmission having one rotation output engageable to the translation shaft and a another rotation output engageable to the rotation shaft.

10. The biopsy device of claim 9, further comprising a remotely positioned cutter translation motor coupled via a mechanical drive cable attached to the holster.

11. The biopsy device of claim 10, wherein the mechanical drive cable is attached to an undersurface of the holster to reduce torque loads at the outer cannula.

12. The biopsy device of claim 8, wherein spur gear portion is longitudinally dimensioned to disengage from the cutter gear when all of the inner tubular cutter is retracted proximally to the lateral tissue receiving aperture.

13. The biopsy device of claim 1, wherein the sensor comprises an encoder coupled to the inner tubular cutter.

14. A biopsy device comprising:

(a) a probe assembly comprising;

(i) a cannula having a lateral tissue receiving aperture, and

(ii) a cutter movable relative to the cannula; and

(b) a holster in communication with the probe assembly, wherein the holster comprises a graphical feature comprising;

(i) a first indicator operably configured to depict a selected mode of a plurality of available modes for operating the biopsy device, and

(ii) a second indicator operably configured to depict positioning of the cutter relative to the lateral tissue receiving aperture for each selected mode of the plurality of available modes.

15. The biopsy device of claim 14, wherein the second indicator comprises a plurality of discrete lights, wherein the second indicator is configured to selectively operate particular lights of the plurality of discrete lights based on the position of the cutter relative to the lateral tissue receiving aperture, wherein the plurality of discrete lights are in a linear arrangement.

16. The biopsy device of claim 15 further comprising a sensor, wherein the sensor is responsive to translation of the cutter.

17. The biopsy device of claim 14, wherein the holster further comprises a keypad.

18. The biopsy device of claim 17, wherein the keypad is selectively removable from a receiving deck disposed on the holster.

19. The biopsy device of claim 14, wherein the first indicator comprises a plurality of graphical depictions illustrating each of the modes for operating the biopsy device, wherein at least one of the plurality of graphical depictions corresponds to one or more of the following modes:

(A) a first mode, wherein the first mode is configured to permit a user to advance and retract the cutter,

(B) a second mode, wherein the second mode is configured to permit a user to prolapse tissue into the lateral tissue receiving aperture, or

(C) a third mode, wherein the third mode is configured to permit a user to clear a tissue sample from the cannula.

20. A biopsy device comprising:

(a) a handpiece including a cannula and a cutter, wherein the cutter is movable relative to the cannula, wherein the cannula includes a lateral port for receiving tissue;

(b) a control unit operatively associated with the handpiece; and

(c) a graphical feature disposed on the handpiece, wherein the graphical feature is in communication with the control unit, wherein the graphical feature includes an indicator configured to depict at least one operational mode of the biopsy device.