MRI biopsy device

• US 20050261581A1
• Filed: 03/10/2005
• Published: 11/24/2005
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Andreyko, Michael J., Hughes, Robert J., Clem, William E., Dietz, Timothy G., Albini, Martin B.
• Granted Patent: US 7,708,751 B2
• Time in Patent Office: Days
• US Class Current: 600/434
• 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 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• 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 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• 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 2090/3933 Liquid markers
• 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 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/708 : Breast positioning means
• 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

Abstract

A localization mechanism, or fixture, is used in conjunction with a breast coil for breast compression and for guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines. The localization fixture includes a three-dimensional Cartesian positionable guide for supporting and orienting an MRI-compatible biopsy instrument, and in particular a sleeve, to a biopsy site of suspicious tissues or lesions. A depth stop enhances accurate insertion, prevents over-insertion or inadvertent retraction of the sleeve. The sleeve receives a probe of the MRI-compatible biopsy instrument and may contain various features to enhance its imagability, to enhance vacuum and pressure assist therethrough, etc.

Claims

1. An apparatus for use with a biopsy device in a medical procedure, comprising:

a guide element selectively positioned parallel to a desired axis of penetration into a patient;

a mount movingly engageable to the guide element and operably configured to support a penetrating portion of the biopsy device aligned to the axis of penetration during insertion; and

a depth limiting member, attachable to a selected one of the mount and guide element, adjustable to arrest the movement of the mount at a predetermined depth of insertion.

2. The apparatus of claim 1, wherein the depth limiting member attaches to the guide element corresponding to the predetermined depth of insertion.

3. The apparatus of claim 2, wherein the depth limiting member includes a receptacle aligned with the axis of penetration operably configured to guide a distal end and to arrest a proximal end of the piercing portion of biopsy device.

4. The apparatus of claim 3, wherein the mount comprises a holster supporting a handle portion of the biopsy device.

5. The apparatus of claim 2, wherein the mount engages a proximal end of the penetrating portion, the depth limiting member registered to abut the mount to arrest movement thereof.

6. The apparatus of claim 5, further comprising a locking mechanism operably configured to resist retraction of the mount from the guide element.

7. The apparatus of claim 6, wherein the locking mechanism comprises a latch engageable between the mount and the depth limiting member.

8. The apparatus of claim 1, further comprising a cradle coupled to the guide element and extending laterally and vertically offset from the axis of penetration.

9. The apparatus of claim 8, wherein the cradle includes a biopsy guide vertically aligned with the axis of penetration and operably configured to movably engage a handle portion of the biopsy device.

10. The apparatus of claim 9, wherein the cradle is vertically aligned below the axis of penetration.

11. The apparatus of claim 1, further comprising a pedestal operatively configured to position the guide element parallel to a desired axis of penetration into a patient.

12. The apparatus of claim 11, wherein the pedestal and guide element include symmetrical engagement features enabling positioning of the guide element on either lateral side of the pedestal.

13. The apparatus of claim 12, wherein the biopsy device further comprises a cutting tube and a cutter mechanism operably configured to rotate and translate the cutting tube along the penetrating portion, the pedestal and guide element operably configured to position and align a distal tip of the penetrating portion of the biopsy device within 5 mm.

14. The apparatus of claim 13, wherein the pedestal and guide element are operably configured to position and align a distal tip of the penetrating portion of the biopsy device within 2 mm.

15. The apparatus of claim 1, further comprising a monocle coupled to a distal portion of the guide element, the monocle proximate to the patient and including a reticule aligned with the axis of penetration.

16. The apparatus of claim 1, further comprising a second guide element movably engageable to the first guide element, the second guide element including the mount adjustably positioned thereon and including the depth limiting member positioned to adjustably arrest the movable engagement between the second guide element and the mount.

17. The apparatus of claim 16, wherein the movable engagement between the first and second element is operably sized to initiate engagement prior to the piercing portion of the biopsy device encountering an insertion point on the patient.

18. The apparatus of claim 16, wherein the first guide element includes a first track, the second guide element further comprises:

a rail operably configured to adjustably position the mount along its length parallel to the axis of penetration; and

a second track surface registered to slidingly mate with the first track of the first guide element.

19. The apparatus of claim 18, wherein the mount includes an engaging knuckle operatively configured to selectively grip the rail of the second guide element to set a coarse depth adjustment.

20. The apparatus of claim 18, wherein the rail of the second guide element is rotatably mounted to the second track.

21. The apparatus of claim 20, wherein one side of the rail includes an engaging surface and another side of the rail includes a nonengaging surface, a selected one of the engaging and nonengaging surfaces rotatingly presented to lock and unlock the mount respectively to the rail.

22. The apparatus of claim 20, wherein the rail includes an outer threaded surface and the mount includes an interior threaded surface engaged to the rail to move corresponding to rotation thereof to fine adjust positioning of the mount.

23. The apparatus of claim 18, wherein the second guide element includes a rail retractably attached to the second track surface.

24. The apparatus of claim 23, wherein the depth limiting member comprises a flange proximally attached and extending from the rail to abut a selected one of a group consisting of the first and second guide elements.

25. The apparatus of claim 18, wherein the mount includes a lateral finger grip proximally actuated to release the mount from engagement to the first guide element.

26. The apparatus of claim 18, wherein the second guide element further comprises a pawl biased into engagement with the first guide element, the mount operably configured to disengage the pawl from the guide element when retracted to remove both the second guide element and the mount from the first guide element.

27. The apparatus of claim 18, wherein a depth measurement scale is positioned on a selected one of the first and second guide elements with a current depth position referenced by the other of the first and second guide elements.

28. The apparatus of claim 27, wherein the depth measurement scale comprises a measurement scale corresponding to a piercing member of a selected length.

29. The apparatus of claim 1, further comprising a biopsy holder comprising a glide sleeve encompassing the mount and the depth limiting member and distally open for insertion onto the first guide element, and comprising a plunger positioned to retract the glide sleeve off of the mount and the depth limiting member after engagement to the first guide element.

30. The apparatus of claim 29, wherein the penetrating portion of the biopsy device comprises a probe and an obturator, the plunger of the biopsy holder further comprises a distally open plunger tube containing a longitudinally positionable plunger arm having a proximal position and distal position wherein the plunger tube is sized to receive at least a selected one of the probe and the obturator.

31. The apparatus of claim 1, further comprising a piercing member attached to the mount.

32. The apparatus of claim 31, wherein the piercing member comprises a sleeve comprising an elongate hollow tube having a side aperture proximate to a distal end and a sleeve hub engaged to the mount, the sleeve sized to receive a selected one of an obturator and the probe of the biopsy device.

33. The apparatus of claim 32, wherein the sleeve includes an open distal end, the obturator including a piercing tip extending from the sleeve, the obturator further comprising a solid shaft with a recess positioned to coincide with the side aperture of the sleeve, the obturator including a locking mechanism attachable to the sleeve hub to align the recess with the side hub.

34. The apparatus of claim 31, wherein the piercing member includes a lumen in fluid communicating between a distal opening and a proximal opening.

35. The apparatus of claim 34, wherein the piercing member comprises a sleeve and a obturator including a hollow shaft defining at least a portion of the lumen.

36. The apparatus of claim 34, wherein the proximal opening of the lumen comprises a selected one of a group consisting of a luege fitting, hose fitting and a syringe fitting.

37. An apparatus for guiding insertion of a probe of a core biopsy device, the apparatus comprising:

compressive members operably configured to localize the patient'"'"'s breast;

a laterally positionable pedestal;

a guide element adjustably vertically positioned on the pedestal parallel to a desired axis of penetration into a patient;

a mount movingly engageable to the guide element and operably configured to support a penetrating portion of the biopsy device aligned to the axis of penetration during insertion; and

a depth limiting member, attachable to a selected one of the mount and guide element, adjustable to arrest the movement of the mount at a predetermined depth of insertion.

38. A method of guiding a penetrating portion of a biopsy device, comprising:

aligning a guide element parallel to and offset from a designated axis of penetration into a patient;

setting a depth limit for penetration; and

slidingly engaging the penetrating portion of the biopsy device to the guide element to effect penetration of the patient along the designated axis of penetration until arrested by the depth limit setting.

39. The method of claim 38, wherein aligning the guide element further comprises:

laterally positioning a pedestal;

vertically positioning the guide element on the pedestal;

attaching a depth limiting member to the guide element; and

wherein slidingly engaging the penetrating portion of the biopsy device to the guide element further comprises movably engaging to the guide element a mount that in turn engages the penetrating portion of the biopsy device.

40. The method of claim 39, further comprising:

positioning on a second guide element a mount operably configured to support the penetrating portion of the biopsy device;

coincidentally sliding the second guide element into engagement with the first guide element until locked at full distal travel;

advancing a mount along the second guide element, the mount supporting the penetrating portion of the biopsy device, until a depth limiting member attached for movement with the mount contacts a selected one of the first and second guide elements arresting further movement.

41. The method of claim 40, further comprising locking the mount to prevent inadvertent retraction during the biopsy procedure.

42. The method of claim 40, further comprising:

coarse adjusting a depth position of the mount on the second guide element prior to engagement to the first guide element; and

fine adjusting a depth position of the mount on the second guide element after engagement to the first guide element.