MRI biopsy apparatus incorporating a sleeve and multi-function obturator

• US 9,795,365 B2
• Filed: 04/24/2013
• Issued: 10/24/2017
• 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: Tsonton, Mark, Dietz, Timothy G., Hibner, John A., Leimbach, Jessica Pyzoha, Andreyko, Michael J., Datta, Keshava, Murray, Michael A.
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US13/869,273
• Publication Number:
  US 20130231586A1
• Time in Patent Office: 1,644 Days
• Field of Search: 600562-568, 60416401-16404, 60416406, 60416409, 6041641, 60416411, 60416501, 60416502, 60416701, 60416703, 60416704, 60416706, 60417003
• 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

An apparatus for use with a minimally invasive medical procedure into human breast tissue includes a cannula and an obturator. The cannula includes an open distal end, a lateral opening proximate to the open distal end, and a longitudinal lumen communicating with the lateral opening and the open distal end. The lumen has a non-circular cross-section. The obturator is sized for insertion into the cannula. The obturator has a distal end extending from the open distal end of the cannula when the obturator is inserted fully into the cannula. The obturator has a recess proximate of the distal end of the obturator. The recess is positioned along a portion of the length of the obturator to align with the lateral opening of the cannula when the obturator is inserted fully into the cannula.

Claims

1. A targeting set for use in a minimally invasive magnetic resonance imaging (MRI) guided procedure for obtaining tissue samples of human breast tissue, the targeting set comprising:

(a) a cannula having an open distal end and an open proximal end sized for receiving a tissue biopsy device for obtaining tissue samples from a breast, wherein the cannula is formed of an MIRI compatible matetial, wherein the cannula further defines a lateral opening having a proximal end and a distal end, wherein the distal end of the lateral opening is proximate to the open distal end of the cannula, wherein the cannula further includes a longitudinal lumen communicating with the lateral opening and the open distal end, the lumen having a non-circular cross-section; and

(b) an obturator, wherein the obturator is formed of an MRI compatible material, wherein the cannula is sized to receive the obturator for targeting purposes prior to receiving the biopsy device for obtaining tissue samples, the obturator having a tissue piercing distal end extending from the open distal end of the cannula when the obturator is inserted fully into the cannula, and the obturator having a recess proximate to the distal end of the obturator, wherein the recess includes a proximal end and a distal end, wherein the recess is positioned along a portion of the length of the obturator such that the proximal and distal ends of the recess are respectively adjacent to the proximal and distal ends of the lateral opening of the cannula when the obturator is inserted fully into the cannula, wherein the lateral opening of the cannula and the recess of the obturator together define a tissue receiving dug-out, wherein the tissue receiving dug-out is configured to receive tissue thereby providing a reference for locating the lateral opening of the cannula under MRI imaging.

2. The targeting set of claim 1, wherein the longitudinal lumen of cannula is configured to receive a biopsy cutter member.

3. The targeting set of claim 2, wherein the obturator is configured to be inserted within the cannula in lieu of the biopsy cutting member.

4. The targeting set of claim 1, wherein the obturator includes a lumen extending from a proximal end of the obturator and communicating with the obturator recess.

5. The targeting set of claim 4, wherein the obturator includes a marker insert with fluid leak passages positioned in the lumen.

6. The targeting set of claim 1, wherein the recess is configured to receive an MRI visible material to enhance local contrast to provide positive identification of the lateral opening of the cannula.

7. The targeting set of claim 1, wherein a selected one of the cannula and the obturator includes a liquid crystal polymer.

8. The targeting set of claim 1, wherein a selected one of the cannula and the obturator includes a poly ether ketone (PEEK) material.

9. The targeting set of claim 1, further includes a hub coupled to the proximal end of the obturator.

10. The targeting set of claim 9, wherein the hub is configured to engage the proximal end of the cannula to align the lateral opening of the cannula proximate to the recess of the obturator.

11. The targeting set of claim 1, wherein the obturator includes a non-circular cross section.

12. A targeting set for use with a minimally invasive magnetic resonance imaging (MRI) guided biopsy procedure into human breast tissue, the targeting set comprising:

(a) a cannula having an open distal end, a lateral opening

proximate to the open distal end, and a longitudinal lumen communicating with the lateral opening and the open distal end, wherein the cannula is formed of an MRI compatible material, wherein the longitudinal lumen is sized to receive a needle of a biopsy device to permit the needle to collect tissue samples though the lateral opening of the cannula; and

(b) an obturator sized for insertion into the cannula in lieu of the needle of the biopsy device, wherein the obturator is formed of an MRI compatible material, the obturator having an open proximal end, a closed tissue piercing distal end, and a lateral recess disposed proximate to the closed

distal end, wherein the closed distal end of the obturator is configured to extend from the open distal end of the cannula when the obturator is inserted fully into the cannula, and wherein the lateral recess of the obturator is disposed along the length of the obturator such that the lateral recess aligns with the lateral opening of the cannula when the obturator is inserted fully into the cannula, wherein the lateral recess of the obturator extends along a longitudinal length matching a longitudinal length of the lateral opening of the cannula; and

wherein the obturator comprises a lumen extending from a proximal end of the obturator and communicating with the lateral recess of the obturator, wherein the lateral recess of the obturator and the lateral opening of the cannula together define a tissue receiving feature when the obturator is inserted fully into the cannula, wherein the tissue receiving feature is configured to receive tissue for visibility of the position of the lateral opening of the cannula under MRI imaging.

13. A targeting assembly for use with a minimally invasive biopsy procedure into human breast tissue under magnetic resonance imaging (MRI) based guidance, the targeting assembly comprising:

(a) a hub;

(b) a cannula extending distally from the hub, wherein the cannula is formed of an MRI compatible material, the cannula including an open distal end, a lateral opening proximate to the open distal end, wherein the lateral opening has a first length, and a longitudinal lumen communicating with the lateral opening and the open distal end, wherein the longitudinal lumen is sized to receive a needle of a biopsy device to collect tissue samples though the lateral opening of the cannula, wherein the lateral opening of the cannula is sized and shaped to correspond to a lateral aperture of the needle of the biopsy device; and

(c) an obturator sized for insertion through the hub and into the cannula in

lieu of the needle of the biopsy device, wherein the obturator is formed of an MRI compatible material, the obturator having a proximal end and a sharp tissue piercing distal end, the distal end extending from the open distal end of the cannula when the obturator is inserted fully into the cannula, and the obturator having a recess proximate to the distal end of the obturator, wherein the recess includes a first portion having the first length, wherein the recess includes a second portion having a second length, wherein the second length is less than the first length, wherein the recess comprises a tapered portion between the first and second portions, wherein the recess is positioned along the length of the obturator to align with the lateral opening of the cannula when the obturator is inserted fully into the cannula, wherein the recess of the obturator and the lateral opening of the cannula together define an MRI targeting notch, wherein the targeting notch is configured to receive tissue, wherein the obturator further comprises a lumen in fluid communication with the recess, wherein the obturator defines the lumen such that the lumen extends through the obturator from the proximal end to the recess, wherein the obturator defines at least a portion of the lumen extending distally into the obturator from the recess, wherein the lumen is sized to define a contrast under MRI imaging between the lumen and the recess when tissue is received within the MRI targeting notch defined by the recess of the obturator and the lateral opening of the cannula, wherein the obturator further defines a vent extending laterally from the lumen through the obturator to an exterior of the obturator, wherein the vent is defined by the obturator at a longitudinal position that is opposite of the recess.

14. A targeting set for use with a minimally invasive biopsy procedure into human breast tissue under magnetic resonance imaging (MRI) guidance, the targeting set comprising:

(a) a cannula formed of an MRI compatible material, wherein the cannula comprises a lateral opening proximate to a distal end and a longitudinal lumen sized to receive a needle of a biopsy device, wherein the lateral opening of the cannula is configured to align with a corresponding lateral aperture of the needle of the biopsy device when the needle is received within the lumen of the cannula;

(b) an obturator including a shaft formed of an MRI compatible material and sized for insertion into the cannula in lieu of the needle of the biopsy device, wherein the obturator comprises a non-circular cross section; and

(c) a recess formed in the obturator proximate to the lateral opening of the cannula, wherein the obturator further comprises an MRI visible material for local contrast to provide positive identification of the lateral opening of the cannula, wherein the MRI visible material is positioned below the recess formed in the obturator, wherein the MRI visible material defines a pair of fluid leak paths, wherein each fluid leak path is positioned to correspond with a proximal or distal end of the recess for visualization of the positioning of the lateral opening of the cannula when the combination of the obturator and the cannula is viewed using MRI imaging.

15. A targeting set for use with a minimally invasive magnetic resonance imaging (MRI) guided, breast biopsy procedure, the targeting set comprising:

(a) a cannula assembly formed of an MRI compatible material, wherein the cannula assembly comprises a cannula and a cannula mount extending outwardly from the cannula, wherein the cannula comprises a lateral opening proximate to a distal end and a longitudinal lumen sized to receive a needle of a biopsy device, wherein the cannula comprises a proximal end;

(b) an obturator including a shaft formed of an MRI compatible material and sized for insertion into the cannula in lieu of the needle of the biopsy device, wherein the obturator comprises a proximal end;

(c) a recess formed in the obturator proximate to the lateral opening of the cannula and operably configured to receive an MRI visible material for local contrast to provide positive identification of the lateral opening of the cannula; and

(d) a hub coupled to the proximal end of the obturator, wherein the hub is configured to engage the proximal end of the cannula to angularly align the lateral opening of the cannula proximate to the recess of the obturator, wherein the hub includes at least one seal, wherein the seal is configured to sealingly engage the obturator.