Self-contained handheld biopsy needle

• US 8,951,208 B2
• Filed: 08/13/2012
• Issued: 02/10/2015
• Est. Priority Date: 08/21/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Almazan, Dan
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/572,782
• Publication Number:
  US 20120310109A1
• Time in Patent Office: 911 Days
• Field of Search: 600562-568, 606/167, 606/170, 606/171, 606/180
• US Class Current: 600/566
• 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence

Abstract

A biopsy device includes an elongate inner sheath rotatably coupled to a first drive mechanism. The elongate inner sheath has a side port that opens to a sample chamber in the elongate inner sheath. An elongate outer sheath is rotatably coupled to a second drive mechanism. The elongate outer sheath is coaxial with the elongate inner sheath. The elongate outer sheath includes a side opening having a cutting edge having a lengthwise orientation. The elongate inner sheath is configured for rotation relative to the elongate outer sheath via the first drive mechanism, and the elongate outer sheath is configured for rotation relative to the elongate inner sheath via the second drive mechanism such that the cutting edge passes over the side port to sever tissue.

Claims

1. A biopsy device, comprising:

a housing;

a biopsy needle configured to project from the housing, the biopsy needle having a first cylindrical member that defines a sample chamber and a side port that opens to the sample chamber, and a second cylindrical member that has a side opening that defines a longitudinally oriented cutting edge, the first cylindrical member and the second cylindrical member being rotatable relative to each other;

a pump coupled to the biopsy needle, the pump configured to generate one of a vacuum and a pressure in the sample chamber;

a prime mover;

a first transmission configured to be driven by the prime mover to operate the pump;

a second transmission configured to be driven by prime mover, the second transmission being configured to rotate at least one of first cylindrical member and the second cylindrical member of the biopsy needle to sever tissue with the longitudinally oriented cutting edge.

2. The biopsy device of claim 1, the first transmission configured to be driven by the prime mover during a first drive interval to operate the pump to generate a vacuum in the sample chamber.

3. The biopsy device of claim 2, the second transmission configured to be driven by the prime mover during a second drive interval to rotate at least one of first cylindrical member and the second cylindrical member of the biopsy needle until the side port of the first cylindrical member and the side opening of the second cylindrical member are in radial alignment.

4. The biopsy device of claim 3, wherein the first drive interval overlaps the second drive interval.

5. The biopsy device of claim 3, the second transmission configured to be driven by the prime mover during a third drive interval to rotate at least one of first cylindrical member and the second cylindrical member of the biopsy needle to sever tissue drawn by vacuum into the sample chamber.

6. The biopsy device of claim 5, wherein the first drive interval overlaps the third drive interval.

7. The biopsy device of claim 5, the first transmission configured to be driven by the prime mover during a fourth drive interval to operate the pump to generate a pressure in the sample chamber.

8. The biopsy device of claim 7, the second transmission configured to be driven by the prime mover during a fifth drive interval to rotate at least one of first cylindrical member and the second cylindrical member of the biopsy needle until the side port of the first cylindrical member and the side opening of the second cylindrical member again are in radial alignment to release the pressure in the sample chamber to expel a tissue sample from the sample chamber.

9. The biopsy device of claim 8, wherein the fourth drive interval overlaps the fifth drive interval.

10. The biopsy device of claim 1, wherein the prime mover comprises a motor, and further comprising a controller configured to selectively operate the motor in forward and reverse directions.

11. A biopsy device, comprising:

a biopsy needle having a first shaft that defines a longitudinal axis, a sample chamber, and a side port leading to the sample chamber, and having a rotatable shaft movably coupled to the first shaft and configured to rotate around the longitudinal axis, the rotatable shaft having a cutting blade configured to cut tissue;

a pump coupled to the biopsy needle and configured to generate a vacuum in the sample chamber to draw tissue into the sample chamber; and

a motor and a transmission mechanism, the transmission mechanism being configured to apply a motive force from the motor to the pump to establish a vacuum in the sample chamber, and configured to transmit motive force from the motor to the biopsy needle to rotate the rotatable shaft to progressively move the cutting blade past the side port to cut a tissue sample.

12. A biopsy device, comprising:

a first drive mechanism;

an elongate inner sheath rotatably coupled to the first drive mechanism, the elongate inner sheath having a side port that opens to a sample chamber in the elongate inner sheath;

a second drive mechanism;

an elongate outer sheath rotatably coupled to the second drive mechanism, the elongate outer sheath being coaxial with the elongate inner sheath, the elongate outer sheath including a side opening having a cutting edge, the cutting edge having a lengthwise orientation,

the elongate inner sheath configured for rotation relative to the elongate outer sheath via the first drive mechanism, and the elongate outer sheath configured for rotation relative to the elongate inner sheath via the second drive mechanism such that the cutting edge passes over the side port to sever tissue.

13. The biopsy device of claim 12, wherein the cutting edge and side port are configured such that as the outer cylindrical member rotates, a progressively greater fraction of the cutting edge passes over the port.

14. The biopsy device of claim 12, wherein the cutting edge and side port are configured such that as the cutting edge is rotated by rotation of the outer cylindrical member, a point of intersection of the cutting edge and a longitudinal edge of the side port translates longitudinally.

15. The biopsy device of claim 12, wherein the inner cylindrical member has a trocar tip.

16. The biopsy device of claim 12, wherein the cutting edge is configured to angularly intersect the side port as the elongate outer sheath and the elongated inner sheath rotate relative to one another.

17. The biopsy device of claim 12, wherein the side port has a longitudinal side surface with at least one barb aligned with a port edge of the side port and configured to be opposite the cutting edge of the outer cylindrical member as the cutting edge advances toward the port edge prior to the elongate outer sheath being rotated to an extent to cover the side port.

18. The biopsy device of claim 12, wherein the inner cylindrical member has a sharp edge partly defining the side port, the sharp edge of the elongate inner sheath configured to be opposite the cutting edge of the elongate outer sheath as the cutting edge is rotated toward the sharp edge of the side port.

19. The biopsy device of claim 12, comprising:

a vacuum pump connected to the sample chamber, the vacuum pump being configured to create a vacuum in the sample chamber;

the second drive mechanism having a first transmission element configured to drive the vacuum pump and a second transmission element configured to rotate the elongate outer sheath to cover and uncover the side port of the elongate inner sheath.

20. The biopsy device of claim 19, wherein the second drive mechanism is configured such that, during an operational cycle the first transmission element is initially displaced at least to begin generating a vacuum, and then, subsequently, the second transmission element rotates the elongate outer sheath.