Method for using an MRI compatible biopsy device with detachable probe

• US 7,769,426 B2
• Filed: 06/12/2002
• Issued: 08/03/2010
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Pyzoha, Jessica Mary, Sebern, Elizabeth Lynn, Freeman, Lynetta Jean, McCoy, Terry Darnell, Hibner, John Anthony
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): RAMIREZ, JOHN FERNANDO
• Application Number:
  US10/171,556
• Publication Number:
  US 20030199754A1
• Time in Patent Office: 2,974 Days
• Field of Search: 600/411, 600/417, 600/429, 600/562, 606/130
• US Class Current: 600/411
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• 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 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI

Abstract

A method for performing Magnetic Resonance Imaging (MRI) guided core biopsies is tendered more accurate and efficient by precisely positioning a disengaged probe assembly with respect to a localization fixture attached to a breast coil platform. The precise position is defined by MRI stereotopic location of suspicious tissue with respect to a fiducial marker on the localization fixture. With the probe inserted, dual lumens in the probe assembly are used for drainage or insertion of fluids as well as inserting diagnostic and therapeutic tools. Core biopsies are performed by engaging a biopsy instrument handle containing a cutter, with the localization fixture providing support and position to the handle. Repeated MRI scans are facilitated by the ability to disengage the handle without risk of displacing the probe assembly from the biopsy site.

Claims

1. A method of performing a biopsy of tissue located at coordinates in a first, second, and third dimension, the method comprising:

(a) localizing a patient'"'"'s breast in a localization fixture, wherein the localization fixture comprises;

(i) a probe assembly comprising;

a proximal end, a distal end, a lumen, an opening in communication with the lumen, wherein the opening is positioned proximate to the distal end, and

an insertion tool operable to selectively block the opening,

(ii) a probe assembly guide coupled to the probe assembly, and

(iii) a compression plate operable to stabilize the patient'"'"'s breast, wherein the compression plate comprises;

elongate slots extending along the first dimension, wherein the slots are spaced apart along the second dimension,

wherein the act of localizing the patient'"'"'s breast comprises compressing at least a portion of the breast with the compression plate;

(b) locating suspicious tissue with an MRI scan;

(c) defining coordinates in the first, second, and third dimensions that correspond to the location of the suspicious tissue;

(d) inserting the probe assembly into the patient'"'"'s breast guided by the probe assembly guide, wherein the probe assembly is inserted along the third dimension, wherein the probe assembly is inserted through one of the elongate slots of the compression plate;

(e) performing a selected one of a diagnostic procedure, surgical procedure and a therapeutic procedure with the probe assembly inserted into tissue and detached from a biopsy instrument;

(e) engaging a handle of the biopsy instrument to the proximal end of the probe assembly, wherein the biopsy instrument comprises a cutter sized to translate in the lumen of the probe assembly, wherein the cutter is retracted in the handle at the initiation of the act of coupling the handle to the probe assembly; and

(f) advancing the cutter through the lumen in the probe assembly to the tissue.

2. The method of claim 1, wherein the probe assembly further comprises a needle, wherein the opening of the probe assembly comprises a cutter opening laterally presented near the distal end of the probe assembly, the probe assembly further comprising a vacuum lumen and a cutter lumen, wherein the cutter lumen is configured to receive the cutter of the biopsy instrument, wherein the vacuum lumen and cutter lumen are both in fluid communication between the proximal end of the probe assembly and the cutter opening of the probe assembly, the method further comprising:

with the biopsy instrument engaged to the probe assembly, applying vacuum through the biopsy instrument and through the lumens of the probe assembly.

3. The method of claim 2, further comprising:

sealing the cutter lumen with an obturator stylet that allows fluid communication between the vacuum lumen and the cutter opening.

4. The method of claim 1, wherein performing the selected one of the diagnostic procedure, surgical procedure and the therapeutic procedure with the probe assembly inserted into tissue and detached from a biopsy instrument further comprises with the biopsy instrument disengaged from the probe assembly, transferring fluid through the inserted probe assembly for a therapeutic treatment.

5. The method of claim 1, wherein performing the selected one of the diagnostic procedure, surgical procedure and the therapeutic procedure with the probe assembly inserted into tissue and detached from a biopsy instrument further comprises inserting a tool through the proximal end of the probe assembly.

6. The method of claim 1, wherein the probe assembly includes a target operable to present an artifact to an MRL machine, the method further comprising:

with the probe assembly inserted into the tissue and the biopsy instrument disengaged, positioning the patient within a closed MRI machine bore and performing an MRI scan.

7. The method of claim 1, further comprising:

coupling a fiducial marker to the localization fixture.

8. The method of claim 1, further comprising:

attaching a tip protector onto the probe assembly, the tip protector including a fiducial marker;

attaching the probe assembly to the probe assembly guide; and

positioning the probe assembly guide for a desired spatial coordinate.

9. The method of claim 1, further comprising:

locating the probe assembly guide to a desired insertion point on the localization fixture; and

using the probe assembly guide to insert the probe to a desired biopsy site at a constrained angle.

10. The method of claim 1, wherein performing the selected one of the diagnostic procedure, surgical procedure and a therapeutic procedure with the probe assembly inserted into tissue and detached from a biopsy instrument comprises imaging the probe assembly to confirm a location of an area of interest in the tissue relative to the inserted probe assembly.

11. A method of a diagnostic imaging guided minimally invasive procedure, comprising:

(a) localizing a human breast in a localization fixture;

(b) stabilizing the human breast using a compression plate including a series of apertures, wherein the act of stabilizing comprises compressing at least a portion of the breast with the compression plate;

(c) diagnostic imaging the human breast to locate a tissue location;

(d) attaching a probe assembly to a probe guide assembly coupled to the localization fixture;

(e) positioning the probe guide assembly to a lateral spatial location on the human breast;

(f) guiding the probe guide assembly along horizontal and vertical directions parallel to the lateral spatial location on the human breast to an insertion angle to position the probe assembly at the tissue location;

(g) inserting the probe assembly into the human breast guided by the probe guide assembly toward a medial side of the human breast, wherein the act of inserting the probe assembly further comprises inserting the probe assembly through one of the apertures of the compression plate;

(h) engaging a handle including a cutter to the probe assembly to obtain a core biopsy sample through the probe assembly, wherein the cutter is fully retracted within the handle when the handle is initially engaged to the probe assembly, such that the cutter does not protrude from the handle when the handle is initially engaged to the probe assembly; and

(i) advancing the cutter relative to the handle and into the probe assembly to sever a tissue sample.

12. The method of claim 11, wherein guiding the probe assembly along the insertion angle further comprises:

using a depth adjustment mechanism to gain mechanical advantage.

13. The method of claim 11, wherein guiding the probe assembly along the insertion angle further comprises referring to depth position indicia.

14. The method of claim 11, wherein positioning the probe assembly to a spatial location on the body portion further comprises:

adjusting the probe guide assembly to a desired horizontal position; and

adjusting the probe guide assembly to a desired vertical position.

15. The method of claim 14 wherein adjusting the probe guide assembly to a desired horizontal and vertical position further comprises referring to horizontal and vertical position indicia.

16. The method of claim 11, wherein the probe assembly includes a cutter lumen and a vacuum lumen in fluid communication with the cutter lumen, and wherein the act of advancing the cutter further comprises:

inserting the cutter through the cutter lumen for severing a tissue sample; and

drawing a vacuum through the vacuum lumen to assist in drawing in the tissue sample into the cutter lumen.

17. The method of claim 16, further comprising:

transferring a fluid through the vacuum lumen to perform a therapeutic treatment to the tissue location.

18. A method for performing a biopsy, the method comprising:

(a) localizing a body portion in a localization fixture, wherein the localization fixture comprises;

(i) a probe assembly comprising;

a proximal end,

a distal end,

a cutter lumen, and

an opening in communication with the cutter lumen, wherein the opening is positioned proximate to the distal end,

(ii) a probe assembly guide coupled to the probe assembly, and

(iii) a compression plate operable to stabilize the body portion, wherein the compression plate comprises apertures arranged along first and second dimensions,

wherein the act of localizing comprises compressing at least a portion of the body portion with the compression plate;

(b) imaging the body portion to determine a tissue location relative to the localization fixture;

(c) determining the tissue location relative to the localization fixture with respect to first, second, and third dimensions;

(d) positioning the probe assembly at the tissue location relative to the first and second dimensions guided by the probe assembly guide;

(e) inserting the probe assembly along the third dimension to place the opening of the probe assembly proximate to the tissue location, wherein the act of inserting comprises inserting the probe assembly through one of the apertures of the compression plate;

(f) imaging the body portion to determine the tissue location relative to the inserted probe assembly;

(g) coupling a handle of a biopsy instrument to the probe assembly, wherein the biopsy instrument comprises a cutter configured to translate through the cutter lumen of the probe assembly, wherein the biopsy instrument is configured to selectively engage with the probe assembly, wherein the cutter is retracted within the handle at the initiation of the act of coupling the handle to the probe assembly;

(h) advancing the cutter of the biopsy instrument through the cutter lumen of the probe assembly; and

(i) severing a portion of tissue at the tissue location with the cutter, wherein the portion of tissue is severed adjacent the opening of the probe assembly.

19. The method of claim 18, wherein the opening of the probe assembly is blocked during the act of inserting the probe assembly into the body portion, the method further comprising unblocking the opening of the probe assembly prior to advancing the cutter of the biopsy instrument.

20. The method of claim 18, the method further comprising substantially restraining movement of the probe assembly guide along the first and second dimensions after the act of positioning the probe guide assembly at the tissue location relative to the first and second dimensions.

21. The method of claim 18, the method further comprising substantially restraining movement of the probe assembly along the third dimension after the act of inserting the probe assembly into the body portion.

22. The method of claim 18, wherein the biopsy instrument comprises a drive mechanism operable to communicate linear and rotational movement to the cutter, wherein the act of advancing the cutter comprises communicating linear movement to the cutter with the drive mechanism, and wherein the act of severing a portion of tissue comprises communicating rotational movement to the cutter with the drive mechanism.

23. The method of claim 18, wherein the biopsy instrument further comprises a window, wherein the window is located proximate to the proximal end of the probe assembly when the biopsy instrument is coupled to the probe assembly, wherein the method further comprises extracting the severed portion of tissue through the window.