|Publication number||US20100160818 A1|
|Application number||US 12/719,173|
|Publication date||Jun 24, 2010|
|Filing date||Mar 8, 2010|
|Priority date||Apr 12, 2005|
|Also published as||CA2589569A1, CN101099684A, CN101099684B, EP1859742A1, US8932233, US20060258956, US20150201916|
|Publication number||12719173, 719173, US 2010/0160818 A1, US 2010/160818 A1, US 20100160818 A1, US 20100160818A1, US 2010160818 A1, US 2010160818A1, US-A1-20100160818, US-A1-2010160818, US2010/0160818A1, US2010/160818A1, US20100160818 A1, US20100160818A1, US2010160818 A1, US2010160818A1|
|Inventors||Wells D. Haberstich, Raj G. Raghavendran, John A. Hibner|
|Original Assignee||Ethicon Endo-Surgery, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (1), Classifications (30), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application is a continuation in part of U.S. patent application Ser. No. 11/103,959, “MRI BIOPSY DEVICE LOCALIZATION FIXTURE” to Hughes et al., filed on 12 Apr. 2005, the disclosure of which is hereby incorporated by reference in its entirety.
The present invention relates, in general, to a method of imaging assisted tissue sampling and, more particularly, to an improved method for positioning a biopsy probe with respect to a magnetic resonance imaging (MRI) breast coil for acquiring subcutaneous biopsies and for removing lesions.
Core biopsy devices have been combined with imaging technology to better target a lesion in breast tissue. One such commercially available product is marketed under the trademark name MAMMOTOME™, by Ethicon Endo-Surgery, Inc. An embodiment of such a device is described in U.S. Pat. No. 5,526,822 issued to Burbank, et al., on Jun. 18, 1996, and is hereby incorporated herein by reference. Its handle receives mechanical and electrical power as well as vacuum assist from a remotely positioned control module that is spaced away from the high magnetic field of a Magnetic Resonance Imaging (MRI) machine
As seen from that reference, the instrument is a type of image-guided, percutaneous coring, breast biopsy instrument. It is vacuum-assisted, and some of the steps for retrieving the tissue samples have been automated. The physician uses this device to capture “actively” (using the vacuum) the tissue prior to severing it from the body. This allows the sampling of tissues of varying hardness. In addition, a side opening aperture is used, avoiding having to thrust into a lesion, which may tend to push the mass away, cause a track metastasis, or cause a hematoma that, with residual contrast agent circulating therein, may mimic enhancement in a suspicious lesion. The side aperture may be rotated about a longitudinal axis of the probe, thereby allowing multiple tissue samples without having to otherwise reposition the probe. These features allow for substantial sampling of large lesions and complete removal of small ones.
Vacuum assisted core biopsy devices have been adapted to be safe and compatible with various imaging modalities, including Magnetic Resonance Imaging (MRI). In particular, portions of a biopsy system placed near the magnet core of an MRI machine need to be nonresponsive to the strong magnetic field to prevent becoming drawn toward the magnet core or to malfunction. Further, the MRI machine depends upon sensing extremely weak radio frequency (RF) signals emanated by tissue after being excited by a strong change in the magnetic field. Components placed in the RF shielded MRI suite need to avoid producing electromagnetic interference (EMI) and need to avoid having materials that would distort RF signals sufficient to create artifacts in the MRI scan data.
A successful approach has been to segregate motive power generation, graphical user interface, vacuum assist, and closed loop control in a control module that has typically been placed about 6 feet away from the magnet core to mitigate detrimental interaction with its strong magnetic field and/or sensitive radio frequency (RF) signal detection antennas. An intuitive graphical user interface (GUI) provides a range of preprogrammed functionality incorporated into a control module to efficiently use time in an MRI suite to take tissue samples.
As an example, in U.S. Pat. No. 6,752,768, the disclosure of which is hereby incorporated by reference in its entirety, a control button may be depressed to change a mode of operation of a core biopsy device with this mode displayed remotely on a display.
While a full function GUI has numerous clinical benefits, the clinician may find the control module inconveniently remote during hands-on portions of the procedure. In addition, some MRI machines have such increased sensitivity and/or increased magnet field strength that it is desirable to increase the distance of the control monitor (e.g., 30 feet) from the MRI machine. Further, even if the control monitor is sufficiently close, some clinicians prefer a simplified user interface to simplify training familiarity.
Consequently, a significant need exists for a biopsy system compatible for use in an MRI suite with biopsy controls with enhanced convenience and intuitiveness.
The invention overcomes the above-noted and other deficiencies of the prior art by providing a handpiece of a magnetic resonance imaging (MRI) compatible core biopsy system that includes a graphical user interface that facilitates user control even with vacuum, power generation, and control processing components remotely positioned away from the MRI magnet and sensitive radio frequency (RF) receiving components. Thereby, a clinician may have the full functionality of vacuum assisted core biopsy systems yet not be inconvenienced by the distance from a remotely positioned control module.
These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
An MRI biopsy device advantageously includes is partially disposable for sterility purposes with a reusable portion for economy. Inconvenience of mechanical, electrical, and pneumatical coupling to a remotely placed control portion, necessitated by a strong magnetic field and sensitive RF receiving components of an MRI machine, is mitigated. First, proximal detachable intuitive controls and displays on the MRI biopsy device give interactive control even after insertion into localizing and guiding structures. Second, binding of mechanical coupling to the MRI biopsy device is sensed prior to equipment damage or malfunction. Third, mechanical coupling is moved closer to engagement points between the MRI biopsy device and guiding structures to reduce torque loads, especially those transferred through its distal probe. Fourth, a single mechanical drive cable drives a fixed ratio transmission that translates and rotates a cutter of the distal probe to realize an effective fixed ratio translation/rotation sampling cut without the encumbrance of two mechanical drive cables.
Turning to the Drawings, wherein like numerals denote like components throughout the several views, in
A cable management spool 20 is placed upon a cable management attachment saddle 22 that projects from a side of the control module 12. Wound upon the cable management spool 20 is a paired electrical cable 24 and mechanical cable 26 which are bundled into sheathed cable 27 for communicating control signals and cutter rotation/advancement motions respectively. In particular, electrical and mechanical cables 24, 26 each have one end connected to respective electrical and mechanical ports 28, 30 in the control module 12 and another end connected to a reusable holster portion 32 of the MRI biopsy device 14. An MRI docking cup 34, which may hold the holster portion 32 when not in use, is hooked to the control module 12 by a docking station mounting bracket 36.
An interface lock box 38 mounted to a wall provides a tether 40 to a lockout port 42 on the control module 12. The tether 40 is advantageously uniquely terminated and of short length to preclude inadvertent positioning of the control module 12 too close to the MRI machine. An in-line enclosure 44 may advantageously register the tether 40, electrical cable 24 and mechanical cable 26 to their respective ports 42, 28, 30 on the control module 12.
Vacuum assist is provided by a first vacuum line 46 that connects between the control module 12 and an outlet port 48 of a vacuum canister 50 that catches liquid and solid debris. A tubing kit 52 completes the pneumatic communication between the control module 12 and the MRI biopsy device 14. In particular, a second vacuum line 54 is connected to an inlet port 56 of the vacuum canister 50. The second vacuum line 54 divides into two vacuum lines 58, 60 that are attached to the MRI biopsy device 14. With the MRI biopsy device 14 installed in the holster portion 32, the control module 12 performs a functional check. Saline is manually injected into biopsy device 14 to serve as a lubricant and to assist in achieving a vacuum seal. The control module 12 actuates a cutter mechanism (not shown) in the MRI biopsy device 14, monitoring full travel. Binding in the mechanical cable 26 or within the biopsy device 14 is monitored with reference to motor force exerted to turn the mechanical cable 26 and/or an amount of twist in the mechanical cable 26 sensed in comparing rotary speed or position at each end of the mechanical cable 26.
Just proximal to a display area 61 on the reusable holster portion 32, a remote keypad 62, which is detachable from the reusable holster portion 32, communicates via the electrical cable 24 to the control module 12 to enhance clinician control of the MRI biopsy device 14, especially when controls that would otherwise be on the MRI biopsy device 14 itself are not readily accessible after insertion into the localization fixture 16 and/or placement of the control module 12 is inconveniently remote (e.g., 30 feet away). An aft end thumbwheel 63 on the reusable holster portion 32 is also readily accessible after insertion to rotate the side from which a tissue sample is to be taken.
Left and right parallel upper guides 64, 66 of a localization framework 68 are laterally adjustably received respectively within left and right parallel upper tracks 70, 72 attached to an under side 74 and to each side of a selected breast aperture 76 formed in a patient support platform 78 of the breast coil 18. A base 80 of the breast coil 18 is connected by centerline pillars 82 that are attached to the patient support platform 78 between the breast apertures 76. Also, a pair of outer vertical support pillars 84, 86 on each side spaced about a respective breast aperture 76 respectively define a lateral recess 88 within which the localization fixture 16 resides.
Perpendicular to this X-Y plane extending toward the medial side of the breast is the Z-axis, which typically corresponds to the orientation and depth of insertion of a probe 98 of a disposable probe assembly 100 of the MRI biopsy device 14 or of a sleeve trocar 102 with inserted introducer obturator 104. For clarity, the term Z-axis may be used interchangeably with “axis of penetration”, although the latter may or may not be orthogonal to the spatial coordinates used to locate an insertion point on the patient. Versions of the localization fixture 16 described herein allow a nonorthogonal axis of penetration to the X-Y axis to a lesion at a convenient or clinically beneficial angle. An origin of the spatial coordinates may be imaging the dents imparted to the tissue by the lateral fence 94. Alternatively, a disposable fiducial pointer 106 held by a fiducial holder 108 is filled with an MRI imagable material (e.g., KY jelly, saline, gadolinium) and sealed with a cap 110.
The probe 98, sleeve trocar 102 and fiducial pointer 106 are guided by the localization fixture 16. With particular reference to
The height yoke 126 is a rectangular cuff interrupted in a mid-portion of a distal side to form locking left and right hands 152 respectively which ride vertically in the left and right vertical rectangular slots 136, 138. The locking left and right hands 152 have respective ridged proximal surfaces (not shown) that are selectively drawn proximally into locking engagement by a height locking lever 156 with a ridged surface 158 on a proximal side of each vertical rectangular slot 136, 138. Lifting the height locking lever 156 takes the height yoke 126 out of locking engagement to the pedestal main body 128 as the height yoke 126 is vertically repositioned. For height adjustment, the proximal top surface of the height yoke 126 serves as a sight 160 to read a height measurement scale 162 presented on a proximal surface of the height locking lever 156.
The attachment axle 124 allows rotation so that an axis of penetration may include an upward or downward trajectory. In the illustrative version, proximal corners of the height yoke 126 include angle detents 164 (e.g., −15°, 0°, +15°) that are selectable by an angle lock lever 166. The primary targeting rail 122 includes a distal detent 167 that serves as a home reference for the fiducial holder 108 (
The introducer obturator 104 advantageously incorporates a number of components with corresponding features. A hollow shaft 242 includes a fluid lumen 244 that communicates between an imagable side notch 246 and a proximal port 248. The hollow shaft 242 is longitudinally sized to extend when fully engaging a piercing tip 249 out of the distal end 228 of the sleeve trocar 102. An obturator handle 250 encompasses the proximal port 248 and includes a locking feature 252, which includes a visible angle indicator 254, that engages the sleeve thumbwheel 230 to ensure that the imagable side notch 246 is registered to the lateral aperture 226 in the sleeve trocar 102. An obturator seal cap 256 may be engaged proximally into the obturator handle 250 to close the fluid lumen 244. The obturator seal cap 256 includes a locking or locating feature 258 that includes a visible angle indicator 259 that corresponds with the visible angle indicator 254 on the obturator thumbwheel cap 230. The obturator seal cap 256 may be fashioned from either a rigid, soft, or elastomeric material.
Before mounting the secondary targeting rail 206 onto the primary targeting rail 122 in the first place, the sleeve mount 260 is advantageously adjustably positioned on the secondary targeting rail 206 to set a desired depth of penetration. In particular, a depth guide 290 is formed by a crescent-shaped depth indicator 292 having a lateral channel 296 shaped to engage the top and bottom guide flanges 266, 268. Forward ramped surfaces 298 on the top and bottom of the lateral channel 296 are positioned to engage the ridged ratcheting surfaces 270 on the secondary targeting rail 206, allowing assembly by inserting the depth indicator 292 from a distal end of the secondary targeting rail 206. Frictional engagement thereafter resists further proximal movement and strongly opposes any distal movement, especially from a depth lead screw 300 of the depth guide 290, whose distal end 302 rotates within an outboard hole 304 in the depth indicator 292 and whose proximal end deflects laterally as a depth actuator lever 305 is used to rotate and longitudinally position the depth lead screw 300 therein. A mid portion of the depth lead screw 300 is received in a longitudinal through hole 306 formed in the sleeve mount 260 outboard of its lateral channel 208. For coarse depth adjustment, outer lead threads 307 on the depth lead screw 300 selectively engage the sleeve mount 260 until top and bottom coarse adjust buttons 308, 310 are inwardly depressed into the sleeve mount 260, compressing respective top and bottom coarse adjust compression springs 312, 314. Each coarse adjust button 308, 310 includes a respective vertically elongate aperture 316, 318 whose inward surface presents a worm gear segment 320, 322 to engage the outer lead threads 307 on the depth lead screw 300 when urged into engagement by relaxed coarse adjust compression screws 312, 314.
The disposable probe assembly 100 also has an undersurface that backwardly slides into engagement with the reusable holster portion 32. In particular, a narrowed proximal end 338 is formed into an upper cover 340 with a distal locking arm 342 separated from the upper cover 340 on each side except proximally to present an unlocking button 344 on an exposed surface 346 of the upper cover 340 that is depressed to disengage a locking surface 348 (
A recessed deck 354 in an upper proximal surface of a proximal top cover 356 of the reusable holster portion 32 is shaped to receive the remote keypad 62. A lower shell 358 mates to the proximal top cover 356. The proximal top cover 356 also defines the upper portion of the receiving aperture 352. The recessed deck 354 has a front guide hole 360 and a back locking aperture 362 registered to respectively receive a front tooth 363 and a flexing unlock tab 364 at an aft end of the remote keypad 62 to selectively engage and disengage the keypad 62 from the reusable holster portion 32. The keypad 62 also includes a translation rocker button 366 that has a distal advance, a default neutral, and an aft retract command position. An aft button 368 may be programmed for mode functions such as saline flush.
With particular reference to
The distal thumbwheel 336 and probe 98 are mounted to a cylindrical hub 384, which is a distal portion of the lower shell 358 that extends beyond the mating with the upper cover 340. A sample through hole 386 communicates through the cylindrical hub 384 for receiving a rotating and translating cutter tube 388 (
A distal compression spring 442 and a proximal compression spring 444 respectively reside on the unthreaded distal and proximal over-run portions 438, 440 to urge the threaded longitudinal bore 420 of the cutter carriage 418 back into engagement with the threaded central portion 436 upon reversal of rotation of the elongate translation shaft 422. In particular, the cutter carriage 418 includes a top longitudinal channel 446 that slidingly engages an undersurface of the upper cover 340 (not shown) and a bottom longitudinal guide 448 that engages a longitudinal track 450 on a top surface of the lower shell 358. Thus rotationally constrained, rotation of the elongate translation shaft 422 causes corresponding longitudinal translation of the cutter carriage 418 with distal and aft pairs of gripping flanges 452, 454 maintained laterally to the left to engage respectively distal and proximal races 456, 458 formed on each side of a toothed portion 460 of a cutter spur gear 462, which has a longitudinal bore for applying vacuum.
To that end, the vacuum hose nib 372 is attached to a mounting structure 464 that is gripped between the upper cover 340 and the lower shell 358 to present an orifice 466 within the carriage cavity 390 that is aligned with the longitudinal bore of the cutter gear 462 and that is in fluid communication with the vacuum hose nib 372.
With particular reference to
The center splined driveshaft 375 that is turned by the aft end thumbwheel 63 rotates in turn a shaft 496 whose keyed distal end 498 in turn is engaged to and rotates a pinion gear 500 that is in gear engagement to a proximal spur gear 502 that forms an outer proximal circumference of the sleeve union 474. A cylindrical distal tip 504 of the keyed distal end 498 rotates within an axle hole (not shown) in the lower shell 358. Rotation of the aft end thumbwheel 63 thus rotates the probe 98.
A distal elbow pneumatic fitting 506 is supported in the lower shell 358 to have an upper end 508 communicating with the lateral passage 486 of the sleeve union 474 and an aft end 510 attached to a vent pneumatic conduit 512 supported by the lower shell 358. The other end of the vent pneumatic conduit 512 is attached to a distal end 514 of a proximal elbow pneumatic fitting 516 whose lateral end 518 is open to atmosphere. Sizing of various components that vent atmospheric pressure through the lumen holes 494 from the lateral end 518 are such that a tissue sample may be withdrawn through the probe tube 490. Yet a greater pneumatic draw of air through the vacuum hose nib 372 prior to severing a tissue sample results in a sufficient low pressure at the side aperture 376 to prolapse tissue for severing.
An elongate rotation shaft 520 proximally terminates in the left splined driveshaft 382 that is supported for rotation by a left aft cylindrical bearing 522 having a race about an outer circumference that receives an O-ring 524 and is received in the aft wall 425 of the lower shell 358. A distal end 526 of the elongate rotation shaft 520 is received for rotation in a left distal cylindrical bearing 528 having a race about an outer circumference that receives an O-ring 530 and that is received within the front wall 425 of the lower shell 358. As the cutter carriage 418 advances to position the cutter tube 388 to slide past the side aperture 376, the cutter spur gear 460 engages a spur gear portion 532 of the elongate rotation shaft 520. Rotating the cutter tube 388 in proportion to an amount of rotation advantages secures an effective severing of tissue. Eliminating rotation when not severing advantageously enhances retraction of tissue sample retraction.
In use, in
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.
For example, while closed loop feedback sensing of a component that is related to cutter tube position has various advantages, determination of cutter position may be achieved in other ways consistent with the present invention. For instance, loading on drive components may be sensed at either full advancement and/or full retraction which are used to calibrate an estimate cutter position based on duration of a translation command.
As another example, rather than discrete LED indicators and labeled depictions, applications consistent with aspects of the invention may include a graphical display (e.g., organic liquid crystal display) that is capable of interactive presentations of intuitive instrument status information. Alternatively or in addition, a touch screen capability may be incorporated to allow instrument control input as well as display.
For another example, applications consistent with aspects of the present invention may be used in conjunction with different diagnostic imaging modalities (e.g., ultrasonic, computed tomography (CT).
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US9095366||Apr 29, 2009||Aug 4, 2015||Hologic, Inc.||Tissue cutter with differential hardness|
|U.S. Classification||600/565, 600/564|
|Cooperative Classification||A61B17/3403, A61B10/0266, A61B2017/00911, A61B2017/3411, A61B2018/00928, A61B19/201, A61B2019/205, A61B2019/4857, A61B2560/0462, A61B2560/0266, A61B10/0275, A61B10/0283, A61B2019/5236, A61B2017/00128, A61B2017/00199, A61B2017/00212, A61B19/52, A61B2019/5454, A61B2017/00796, A61B2019/5487, A61B2019/5408, A61B2010/0208, A61B10/0041|
|European Classification||A61B19/20B, A61B19/52, A61B10/02P6N, A61B17/34D|
|May 12, 2010||AS||Assignment|
Owner name: ETHICON ENDO-SURGERY, LLC,PUERTO RICO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ETHICON ENDO-SURGERY, INC.;REEL/FRAME:024369/0626
Effective date: 20100512
Owner name: ETHICON ENDO-SURGERY, LLC, PUERTO RICO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ETHICON ENDO-SURGERY, INC.;REEL/FRAME:024369/0626
Effective date: 20100512
|Jul 9, 2010||AS||Assignment|
Owner name: DEVICOR MEDICAL PRODUCTS, INC., WISCONSIN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ETHICON ENDO-SURGERY, LLC;REEL/FRAME:024656/0727
Effective date: 20100709
|Jul 13, 2010||AS||Assignment|
Owner name: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT, MA
Free format text: SECURITY AGREEMENT;ASSIGNOR:DEVICOR MEDICAL PRODUCTS, INC.;REEL/FRAME:024672/0088
Effective date: 20100709