Single-insertion, multiple sampling biopsy device with linear drive

• US 10,010,307 B2
• Filed: 06/27/2014
• Issued: 07/03/2018
• Est. Priority Date: 08/10/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Thompson, Stanley O., Coonahan, Timothy J., Taylor, Jon
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US14/318,081
• Publication Number:
  US 20140371585A1
• Time in Patent Office: 1,467 Days
• 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 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 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

The present invention provides for exemplary embodiments of a single-insertion, multiple sampling biopsy device. Exemplary embodiments of a single-insertion, multiple sampling device with integrated marker release.

Claims

1. A method of operating a biopsy device, comprising:

positioning a stylet, movable within a cutting cannula, such that a sample acquisition recess of the stylet is positioned at a sample receiving position, relative to the cutting cannula, wherein the cutting cannula is disposed proximally to the sample acquisition recess of the stylet;

operating the cutting cannula to cut a tissue sample from adjacent tissue, the tissue sample being received in the sample acquisition recess of the stylet;

extending a cover member between the stylet and the cutting cannula such that the cover member extends over the tissue sample in the sample acquisition recess of the stylet to contain the tissue sample between the cover member and the stylet; and

moving the stylet, the cover member, and the tissue sample in unison relative to the cutting cannula proximally from the sample receiving position to a sample recovery position, while the cutting cannula is stationary.

2. The method of claim 1, comprising repeating the acts of positioning, operating, extending, and moving to collect another tissue sample.

3. The method of claim 1, wherein following the act of moving the stylet, the cover member, and the tissue sample in unison while the cutting cannula is stationary, the method further including moving the cover member relative to the stylet to expose the tissue sample at a recovery opening in the cutting cannula.

4. The method of claim 1, wherein the act of receiving the tissue sample in the sample acquisition recess of the stylet includes receiving the tissue sample adjacent a bulkhead affixed to the stylet, the bulkhead pushing the tissue sample as the stylet is moved.

5. The method of claim 1, wherein prior to operating the cutting cannula, further comprising suctioning into the sample acquisition recess in the stylet the tissue from which the tissue sample is collected.

6. The method of claim 1, wherein the extending includes axially moving the cover member relative to the stylet and the cutting cannula.

7. The method of claim 1, comprising deploying a tissue marker from a tip of the stylet.

8. The method of claim 1, comprising partially retracting the cover member at the sample recovery position to partially expose the tissue sample while forcing a quantity of pressurized fluid into a space below the cover member to eject the tissue sample from the sample acquisition recess of the stylet.

9. A biopsy device, comprising:

a cannula having a proximal end, a distal end, a distal opening at the distal end, and a recovery opening at the proximal end;

a first elongate element having a first distal end and a sample acquisition recess proximal to the first distal end;

a second elongate element having a second distal end, each of the first elongate element and the second elongate element configured to move within the cannula between the distal opening of the cannula and the recovery opening of the cannula;

the first elongate element and the second elongate element configured for movement with respect to each other, wherein in an open configuration the second distal end of the second elongate element is proximal to the sample acquisition recess of the first elongate element, and in a closed configuration the second elongate element extends over the sample acquisition recess of the first elongate element to surround a volume between the first elongate element and the second elongate element; and

a drive unit coupled to each of the first elongate element and the second elongate element to configure the first elongate element and second elongate element in the open configuration and to configure the first elongate element and second elongate element in the closed configuration, the drive unit configured to move the first elongate element and the second elongate element in unison to move the volume of the closed configuration proximally to the recovery opening of the cannula.

10. The biopsy device of claim 9, wherein the drive unit is configured to move the first elongate element and second elongate element toward the distal opening of the cannula after the first elongate element and second elongate element are moved to the recovery opening of the cannula.

11. The biopsy device of claim 9, wherein the drive unit is configured to move the first elongate element and second elongate element into the open configuration after moving the volume of the closed configuration proximally to the recovery opening of the cannula.

12. The biopsy device of claim 9, the distal end of the cannula distal end has a cutting edge, and the drive unit configured to move the cutting edge of the cannula over the sample acquisition recess, and to thereafter configure the first elongate element and the second elongate element in the closed configuration.

13. The biopsy device of claim 9, wherein the first elongate element has a first bulkhead and a second bulkhead, and the sample acquisition recess is positioned between the first bulkhead and the second bulkhead.

14. The biopsy device of claim 9, wherein the first elongate element is a stylet and the second elongate element is a sheath, the sheath being interposed between the stylet and the cannula.

15. The biopsy device of claim 9, wherein the first elongate element and the second elongate element are shaped like half-cylinders arranged in mirror-image fashion.