Single insertion, multiple sample biopsy device with integrated markers

• US 8,728,003 B2
• Filed: 08/28/2012
• Issued: 05/20/2014
• 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: Taylor, Jon, Thompson, Stanley O., Coonahan, Timothy J., Gray, Gregory A.
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US13/596,806
• Publication Number:
  US 20120323120A1
• Time in Patent Office: 630 Days
• Field of Search: 600/562, 600564-568, 606/167, 606170-171, 604/164.01, 60416411-16412
• US Class Current: 600/564
• 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

Abstract

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

Claims

1. A single-insertion, multiple sample biopsy device, comprising:

a stylet extending along a longitudinal axis between a distal end and a proximal end, the stylet having a tip at the distal end and a hollow interior volume extending from a biopsy port proximate the distal end to the proximal end, the biopsy port being configured to receive tissue;

a cutting cannula that surrounds a portion of the stylet and movable along the longitudinal axis;

an intermediate sleeve coaxially disposed between the stylet and the cutting cannula, the intermediate sleeve being configured to selectively open and close the biopsy port;

a lumen disposed in the interior volume of the stylet;

a bulkhead coupled to a distal end of the lumen;

a transport subassembly coupled to the lumen and to the intermediate sleeve to move the bulkhead and the intermediate sleeve relative to each other along the longitudinal axis between the proximal end and the distal end; and

a fluid pumping mechanism configured to pump fluid into the hollow interior volume of the stylet when the intermediate sleeve partly covers the biopsy port, thereby causing fluid to enter the biopsy port at the distal end thereof and flow along the stylet in a proximal direction.

2. The device of claim 1, where the transport subassembly includes a first pulley coupled to the intermediate sleeve via a member and a second pulley coupled to the bulkhead via the lumen.

3. The device of claim 2, where the member is in fluid communication with a pressurized saline source and the lumen is in fluid communication with one or more of a vacuum and pressurized fluid source.

4. The device of claim 3, comprising a marker disposed in one of the stylet tip and the bulkhead disposed in the stylet, the marker being ejected from at least one of the stylet tip and the bulkhead in an operative condition of the device.

5. The device of claim 1, where the stylet tip includes a marker mounted on the outer surface of the stylet tip, the marker being separated from the stylet tip in an operative condition of the device.

6. The device of claim 5, where the marker is one or more of a hooked marker, a helical marker and a serrated edge marker.

7. The device of claim 1, comprising a marker coupled to one of the stylet tip and the bulkhead, where the marker is one of an annular marker and a split-ring marker.

8. A single-insertion, multiple sample biopsy device, comprising:

a cutting sheath, an intermediate sheath, and a cannula,

the intermediate sheath and the cannula being coaxially aligned with the cutting sheath that surrounds the intermediate sheath, and the intermediate sheath surrounds the cannula, an annular space being defined between the intermediate sheath and the cannula;

the cannula having a distal end with a port where tissue samples are received and a proximal end where samples are delivered;

the intermediate sheath configured to move relative to the cannula to selectively open and close the port;

the cannula having a lumen configured to carry a movable bulkhead, the bulkhead being connected to a suction tube;

a drive mechanism configured to force the suction tube along the cannula to move the bulkhead distally and proximally; and

a fluid pumping mechanism configured to pump fluid into the annular space when the intermediate sheath partly covers the port, thereby causing fluid to enter the port at a distal end thereof and flow along the cannula in a proximal direction.

9. The device of claim 8, wherein the drive mechanism and fluid pumping mechanism are configured to be operable in concert to move the intermediate sheath to partly cover the port, to move the bulkhead proximally, and to convey fluid along the annular space to the port thereby forcing a sample toward the proximal direction.

10. The device of claim 8, further comprising a vacuum pump connected to the suction tube.