Single-insertion, multiple sampling biopsy device usable with various transport systems and integrated markers

• US 8,282,574 B2
• Filed: 08/10/2006
• Issued: 10/09/2012
• 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: Coonahan, Timothy J., Thompson, Stanley O., Taylor, Jon
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/997,404
• Publication Number:
  US 20090227893A1
• Time in Patent Office: 2,252 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 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks

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 biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening and an interior volume adjacent the distal end, the sample opening providing access to the interior volume, the stylet having a recovery position proximal of the distal end;

a first shuttle mounted in the stylet and free to travel from the sample opening to the recovery position, the first shuttle having at least one bulkhead shaped and positioned to push a tissue sample in the first shuttle toward the proximal end of the stylet;

a second shuttle separate from the first shuttle, said first shuttle being configured to move the second shuttle only after the first shuttle has moved a first distance, and configured such that after the first distance the first shuttle and the second shuttle move in tandem; and

a transport subassembly coupled to the first shuttle to move the tissue sample from the sample opening toward the proximal end of the stylet.

4. The device of claim 1, wherein the first shuttle has a distal bulkhead having a surface at least partly normal to a direction of travel of the first shuttle.

5. The device of claim 1, wherein the second shuttle is nested at least partly within the first shuttle, with the first shuttle coupled to the second shuttle in a chain arrangement, each of the first shuttle and the second shuttle having a distal bulkhead that has a surface at least partly normal to a direction of travel of the first shuttle and the second shuttle.

6. The device of claim 1, wherein the transport subassembly includes a spooling tape configured to wind and unwind to transport the first shuttle and the second shuttle in proximal and distal directions, respectively.

7. The device of claim 1, wherein the transport subassembly includes a spooling tape configured to wind and unwind to transport the first shuttle in proximal and distal directions, respectively, the first shuttle being defined by a distal portion of the tape.

8. The device of claim 1, wherein the transport subassembly has a loop that runs between the sample opening and the recovery position, the first shuttle being connected to the loop and the transport subassembly being configured to wind the loop to transport the first shuttle and the second shuttle through the stylet.

9. The device of claim 8, wherein the stylet has a recovery port at the recovery position, the device further comprising a recovery member with an engaging surface, the recovery member being configured to move within the first shuttle while at the recovery position so as to cause the engaging surface to move from a position in the first shuttle toward the recovery port, to facilitate removal of the sample in the first shuttle from the first shuttle through the recovery port.

10. The device of claim 1, wherein the transport subassembly includes a linear actuator.

11. The device of claim 10, wherein the stylet has an internal surface with internal threads, the linear actuator includes a threaded cylindrical member having external threads that mesh with the stylet internal threads, the threaded cylindrical member being configured to rotate within the stylet and is rotatably coupled to the first shuttle.

12. The device of claim 10, wherein the stylet has an internal surface with internal threads, the linear actuator includes a threaded cylindrical member having external threads that mesh with the stylet internal threads, the threaded cylindrical member being configured to rotate within the stylet and is rotatably coupled to the first shuttle and the first shuttle has a member in engagement with the stylet that prevents the rotation of the first shuttle within the stylet.

13. The device of claim 10, wherein the linear actuator includes threaded cylindrical members configured such that when the threaded cylindrical members are nested, one within another, mating pairs of external and internal threads of the threaded cylindrical members are in mesh, and with one of the threaded cylindrical members being rotatably coupled to the first shuttle.

14. The device of claim 10, wherein the linear actuator includes threaded cylindrical members and configured such that when the threaded cylindrical members are nested, one within another, mating pairs of external and internal threads of the threaded cylindrical members are in mesh, and with one of the threaded cylindrical members being rotatably coupled to the first shuttle;

and the first shuttle has a member in engagement with the stylet that prevents the rotation of the first shuttle within the stylet.

2. A biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening and an interior volume adjacent the distal end, the sample opening providing access to the interior volume, the stylet having a recovery position proximal of the distal end;

a first shuttle mounted in the stylet and free to travel from a position at the sample opening to the recovery position, the first shuttle having at least one bulkhead shaped and positioned to push a first sample in the first shuttle toward the proximal end of the stylet;

a transport subassembly coupled to the first shuttle to move the first shuttle in a proximal direction from the sample opening toward the proximal end of the stylet; and

a second shuttle nested at least partly within the first shuttle, the second shuttle having at least one bulkhead shaped and positioned to push a second sample in the second shuttle toward the proximal end of the stylet, and wherein the first shuttle and the second shuttle are configured such that movement of the first shuttle in the proximal direction causes the second shuttle to move proximally only after the first shuttle has moved a distance from the position at the sample opening.

3. The device of claim 2, wherein the transport subassembly is configured to move the first shuttle and the second shuttle consecutively to transport respective samples, with the first shuttle coupled to the second shuttle in a chain arrangement.

15. A method of performing a tissue biopsy, comprising:

severing a first tissue sample from a host within a first shuttle located inside a biopsy needle, the first shuttle being movable within the biopsy needle;

holding the first tissue sample in the first shuttle while moving the first shuttle from a distal end of the biopsy needle toward a proximal end to transport the first tissue sample and to expose a second shuttle at the distal end;

severing a second tissue sample from the host within the second shuttle located inside the biopsy needle, the second shuttle being movable within the biopsy needle;

holding the second tissue sample in the second shuttle while moving the first shuttle and the second shuttle from the distal end of the biopsy needle toward the proximal end to transport the first tissue sample and the second tissue sample; and

the severing steps and holding steps being performed without removing the biopsy needle from the host.

16. The method of claim 15, wherein the first shuttle is connected to a loop and the moving includes revolving the loop around endpoints located at the distal and proximal ends.

17. The method of claim 15, further comprising extending a removal member into the first shuttle at the proximal end and removing the first tissue sample from the first shuttle.

18. The method of claim 15, further comprising applying a vacuum to the biopsy needle prior to severing each of the first tissue sample and the second tissue sample.

19. The method of claim 15, wherein the moving of the first shuttle includes retracting a linear actuator.

20. The method of claim 15, wherein the moving of the first shuttle includes rotating a threaded lumen to which the first shuttle is threaded.

21. The method of claim 15, wherein each instance of the severing and holding steps is done with a different shuttle.

22. The method of claim 15, wherein moving the first shuttle includes separating the first shuttle from a nested set of shuttles that includes the second shuttle.

23. A multiple sample biopsy device, comprising:

a sampling mechanism configured to cut tissue samples;

a chain of paddles connected together and configured such that the chain of paddles are nested together and configured to be pulled as a chain by expanding the chain by pulling only one of the paddles;

the sampling mechanism configured to convey a first tissue sample adjacent a first paddle of the chain of paddles on a proximal side of the first paddle;

a drive configured to move the first paddle of the chain of paddles in the proximal direction less than a distance required for the first paddle to engage a second adjacent paddle of the chain of paddles such that the first paddle moves the first tissue sample proximally without causing the second adjacent paddle to move;

the sampling mechanism configured to convey a second tissue sample adjacent the second adjacent paddle of the chain of paddles on a proximal side of the second paddle; and

the drive configured to move the second adjacent paddle in the proximal direction less than a distance required for the second adjacent paddle to engage a third adjacent paddle of the chain of paddles such that the first paddle and the second adjacent paddle move the first and second tissue samples, respectively, without causing the third adjacent paddle to move.

24. The device of claim 23, wherein the sampling mechanism includes a hollow cannula having an interior, the chain of paddles being arranged in a series within and along the interior.