Biopsy needles

• US 20050054948A1
• Filed: 07/29/2004
• Published: 03/10/2005
• Est. Priority Date: 07/29/2003
• Status: Active Grant

• Current Assignee: Alec S. Goldenberg
• Original Assignee: Alec S. Goldenberg
• Inventors: Goldenberg, Alec S.
• Granted Patent: US 7,278,970 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end

Abstract

In one embodiment, a biopsy needle that is particularly suited for shearing and collecting soft tissue specimens is provided and is formed of an inner tube with a snare at a distal end thereof, an outer cannula, a stylet and a handle assembly. In one aspect of the present invention, the handle assembly includes a spring loaded mechanism described in greater detail below that permits the user to selectively actuate the biopsy needle so that the outer cannula and the inner tube are rapidly advanced beyond the stylet to provide a shearing action of the soft tissue specimen. In one exemplary embodiment, the rapid advancement of the needle to achieve appropriate shear/cutting forces and to facilitate specimen transit into the needle is accomplished by the spring loaded mechanism in which there is coordination between the rapid advancement of the needle over the shaft and activation of the winding down of the snarecoil.

Claims

1. A biopsy needle for collecting a tissue specimen, the needle including an inner tube with a snarecoil operatively connected at a distal end thereof, an outer cannula, a stylet and a handle assembly that includes a biasing mechanism that permits a user to selectively actuate the biopsy needle so that the outer cannula and the inner tube are rapidly advanced over the stylet and beyond a distal end thereof to provide a shearing action of the tissue specimen.

2. The needle of claim 1, wherein the biasing mechanism includes features that provide coordination between the rapid advancement of the outer cannula and the inner tube over the stylet and activation of a winding down of the snarecoil.

3. The needle of claim 2, wherein the features include a pin and a profiled groove arrangement wherein forward axial movement of the outer cannula and inner tube is translated into rotation of the inner tube relative to the outer cannula which causes the snarecoil to at least partially close.

4. The needle of claim 3, wherein the inner tube has the groove formed therein and the pin extends therein such that as the pin travels within the groove as the outer cannula and inner tube advance due to ends of the pin being fixedly coupled to side walls of the handle assembly such that the pin travels axially within one plane.

5. The needle of claim 1, wherein the biasing mechanism includes a torque mechanism that imparts a selective and controlled torque action in the inner tube relative to the outer cannula resulting in activation of a winding down of the snarecoil.

6. The needle of claim 1, wherein the biasing mechanism includes a first biasing mechanism to provide the selective sudden advancement of the inner tube and the outer cannula when a first actuator is activated by a user, the first biasing mechanism including a first biasing element that in an energy storing position is compressed between a body member of the handle assembly and an outer flange associated with the inner tube.

7. The needle of claim 6, wherein a proximal end of the outer tube terminates in a flange that abuts the flange of the inner tube, wherein activation of the first biasing mechanism results in release of the first biasing element causing an axial force to be applied against the flange of the inner tube, whereby the inner tube and the outer cannula are driven axially in tandem a prescribed distance until the flange of the outer cannula contacts a stop surface of the handle assembly.

8. The needle of claim 6, wherein the first biasing mechanism includes a first actuator operatively coupled to pivoting links that terminate in a claw at one end that engages the flange of the inner tube in the energy storing position so as to restrict axial movement of the inner tube and maintain the first biasing element in a compressed state.

9. The needle of claim 1, wherein during a rapid advancement stage, the inner tube and the outer cannula move in tandem and substantially free of rotation relative to one another.

10. The needle of claim 6, wherein the biasing mechanism includes a second biasing mechanism that automatically actuates at a predetermined point when the inner tube and outer cannula are axially advancing after activation of the first biasing mechanism, the inner tube including one of a drive pin and a groove and a housing of the handle assembly including the other of the drive pin and groove such that as the inner tube and the outer cannula axially moves, the drive pin travels within the groove that is helically shaped so as to impart a rotation to the inner tube relative to the outer cannula as the drive pin travels within the helical groove.

11. The needle of claim 10, wherein the second biasing mechanism includes:

a second pivoting member that is pivotably coupled at a first end to a proximal end of the inner tube, with a second end including a claw, the second pivoting member includes a cam slot that receives a fixed pin that is fixed to the housing of the handle assembly such that as the inner tube and outer cannula move axially, the fixed pin travels within the cam slot causing a lifting of the second end;

a retainer ring disposed about the inner tube and being engaged by the claw when the second biasing mechanism is in an energy storing position;

a second biasing element disposed between the proximal end of the inner tube and the retainer ring and in a compressed state in the energy storing position; and

wherein when the second biasing mechanism is activated, the claw lifts off the retainer ring, thereby releasing the retainer ring and the second biasing element.

12. The needle of claim 11, wherein the drive pin contacts the retainer ring such that release of the retainer ring drives the drive pin within guide grooves that are formed in the handle assembly and contain the drive pin in a single plane, the stylet having an opening formed therethrough to accommodate the drive pin, wherein planar advancement of the drive pin in the guide slots and advancement of the drive pin in the helical groove is translated into rotation of the inner tube relative to the outer cannula.

13. The needle of claim 10, wherein the predetermined point occurs prior to the inner tube and the outer cannula reaching the end of their axial travel such that rotation is imparted to the inner tube as it axially advances.

14. The needle of claim 10, wherein the predetermined point occurs after the inner tube and the outer cannula reach ends of their axial travel.

15. The needle of claim 1, further including:

means for generating negative pressure within the needle for causing the specimen to more readily enter the needle, the means including a first seal and a second seal, the first seal being disposed between the stylet and the inner tube that generates a vacuum within a distal portion of the needle during axial travel of the inner tube and the outer cannula facilitating specimen transit into the needle, the second seal being disposed between the outer cannula and the inner tube.

16. The needle of claim 1, wherein the outer cannula has a first window formed therein and the inner tube has a second window which is selectively aligned with the first window when the inner tube is rotated within the outer cannula to a position where the windows at least partially overlap one another after the snarecoil is tightened to permit access to the specimen collected in the needle.

17. A biopsy needle for collecting a tissue specimen, the needle including an inner tube with a snarecoil operatively connected at a distal end thereof, an outer cannula, a stylet and a handle assembly that includes an actuatable axial drive mechanism for rapidly driving the inner tube and the outer cannula, in a longitudinal axial direction, over the stylet to a position where the inner tube and the outer cannula are advanced beyond a distal end of the stylet to provide a shearing action of the tissue specimen, and a torque generating mechanism associated at least in part with the inner tube that is actuatable to translate a torque to the inner tube relative to the outer cannula resulting in activation of a winding down of the snarecoil, the actuation of drive mechanism and the torque generating mechanism being coordinated with one another.

18. The needle of claim 17, further including:

means for generating negative pressure within the needle for causing the specimen to more readily enter the needle, the means including a first seal and a second seal, the first seal disposed between the stylet and the inner tube that generates a vacuum within a distal portion of the needle during axial travel of the inner tube and the outer cannula facilitating specimen transit into the needle, the second seal being disposed between the outer cannula and the inner tube.

19. The needle of claim 17, wherein the outer cannula has a first window formed therein and the inner tube has a second window which is selectively aligned with the first window when the inner tube is rotated within the outer cannula to a position where the windows at least partially overlap one another after the snarecoil is tightened to permit access to the specimen collected in the needle.

20. The needle of claim 17, wherein the torque generating mechanism includes a first torque feature that is associated with a proximal end of the inner tube and is axially movable with inner tube as the inner tube is axially moved in response to actuation of the axial drive mechanism, the first torque feature mating with a second torque feature that is associated with a housing of the handle assembly and is fixed in the axial direction relative to the inner tube, wherein the first torque feature comprises one of a pin and a helical slot and the second torque feature comprises one of a helical slot and a pin, wherein engagement of the first and second torque features concurrently with axial advancement of the inner tube imparts rotation to the inner tube, thereby actuating the snarecoil.

30. The needle of claim 20, wherein the torque generating mechanism includes a second biasing mechanism that automatically actuates at a predetermined point when the inner tube and outer cannula are axially advancing after activation of the axial drive mechanism, the inner tube including one of a drive pin and a groove and a housing of the handle assembly including the other of the drive pin and groove such that as the inner tube and the outer cannula axially moves, the drive pin travels within the groove that is helically shaped so as to impart a rotation to the inner tube relative to the outer cannula as the drive pin travels within the helical groove.

31. The needle of claim 20, wherein the torque generating mechanism includes:

a second pivoting member that is pivotably coupled at a first end to a proximal end of the inner tube, with a second end including a claw, the second pivoting member includes a cam slot that receives a fixed pin that is fixed to the housing of the handle assembly such that as the inner tube and outer cannula move axially, the fixed pin travels within the cam surface causing a lifting of the second end;

a retainer ring disposed about the inner tube and being engaged by the claw when the second biasing mechanism is in an energy storing position;

a second biasing element disposed between the proximal end of the inner tube and the retainer ring and in a compressed state in the energy storing position; and

wherein when the second biasing mechanism is activated, the claw lifts off the retainer ring, thereby releasing the retainer ring and the second biasing element.

32. The needle of claim 31, wherein the drive pin contacts the retainer ring such that release of the retainer ring drives the drive pin within guide grooves that are formed in the handle assembly and contain the drive pin in a single plane, the stylet having an opening formed therethrough to accommodate the drive pin, wherein planar advancement of the drive pin in the guide slots and advancement of the drive pin in the helical groove is translated into rotation of the inner tube relative to the outer cannula.

33. The needle of claim 30, wherein the second biasing mechanism releases stored energy to cause rotation of the inner tube after the inner tube completes its longitudinal axial movement such that the inner tube rotates and remains substantially axially steadfast during actuation of the second biasing mechanism.

21. A biopsy needle for collecting a tissue specimen, the needle including an inner tube with a snarecoil operatively connected at a distal end thereof, an outer cannula and a handle assembly that includes a torque generating mechanism associated at least in part with the inner tube that is actuatable to translate a torque to the inner tube relative to the outer cannula resulting in activation of a winding down of the snarecoil and capture of the specimen.

22. The needle of claim 21, wherein the torque generating mechanism includes a drive pin and a profiled groove arrangement, wherein forward axial movement of the outer cannula and inner tube is translated into rotation of the inner tube relative to the outer cannula which causes the snarecoil to at least partially close.

23. The needle of claim 22, wherein one of drive pin and the profiled groove is associated with a proximal end section of the inner tube and the other of the profiled groove and the drive pin is associated with the handle assembly as is free of association with the inner tube.

24. The needle of claim 23, wherein the one of the drive pin and the inner tube that has the profiled groove travels in an axial direction, while the other of the drive pin and the inner tube remains substantially axially fixed.

25. The needle of claim 22, wherein the inner tube has the profiled groove formed therein in a shape of a helix and the drive pin extends therethrough with ends of the drive pin traveling within axial guide grooves formed in side walls of the handle assembly such that the drive pin travels axially within one plane such that axial travel of the drive pin in the guide grooves is translated into rotation of the inner tube relative to the outer cannula.

26. The needle of claim 21, further including an axial drive mechanism to selectively and rapidly advance the inner tube and the outer cannula over the stylet and beyond a distal end thereof to provide a shearing action of the tissue specimen.

27. The needle of claim 26, wherein the axial drive mechanism includes a first biasing element that in an energy storing position is compressed between a body member of the handle assembly and an outer flange associated with the inner tube and wherein a proximal end of the outer tube terminates in a flange that abuts the flange of the inner tube, wherein activation of the axial drive mechanism results in release of the first biasing element causing an axial force to be applied against the flange of the inner tube, whereby the inner tube and the outer cannula are driven axially in tandem a prescribed distance until the flange of the outer cannula contacts a stop surface of the handle assembly.

28. The needle of claim 27, wherein the axial drive mechanism includes a first actuator operatively coupled to pivoting links that terminate in a claw at one end that engages the flange of the inner tube in the energy storing position so as to restrict axial movement of the inner tube and maintain the first biasing element in a compressed state.

29. The needle of claim 26, wherein during a rapid advancement stage, the inner tube and the outer cannula move in tandem and substantially free of rotation relative to one another.

34. A needle for collecting a specimen comprising:

a stylet;

an inner tube that slidably receives the stylet through a bore formed therethrough;

an outer cannula disposed about the inner tube, wherein during activation of the needle, the inner tube and the outer cannula travel axially over and beyond a distal end of the stylet; and

means for generating negative pressure within the needle for causing the specimen to more readily enter the needle, the means including a first seal and a second seal, the first seal being disposed between the stylet and the inner tube that generates a vacuum within a distal portion of the needle during axial travel of the inner tube and the outer cannula facilitating specimen transit into the needle, the second seal being disposed between the outer cannula and the inner tube.

35. The needle of claim 34, wherein each of the first and second seals comprises an O-ring.

36. A biopsy needle for collecting a tissue specimen, the needle including an inner tube with a snarecoil operatively connected at a distal end thereof, an outer cannula and a handle assembly that includes a torque generating mechanism associated with the inner tube that is actuatable to translate a torque to the inner tube relative to the outer cannula resulting in activation of a winding down of the snarecoil, wherein the outer cannula has a first window formed therein and the inner tube has a second window which is selectively aligned with the first window when the inner tube is rotated within the outer cannula to a position where the windows at least partially overlap one another after the snarecoil is tightened to permit access to the specimen collected in the needle.

37. The needle of claim 36, wherein the windows are offset from one another prior to actuation of the torque generating mechanism.

38. A biopsy needle for collecting a tissue specimen comprising a boring tube and a biasing mechanism operatively connected to the boring tube, the biasing mechanism permitting a user to selectively actuate the needle to cause the boring tube to rapidly advance axially over a stylet and beyond a distal end thereof to provide a shearing action of the tissue specimen as a result of a distal end of the boring tube being driven into the tissue specimen, the needle further including means for generating negative pressure within the needle for causing the specimen to be drawn into the needle, the means including a first seal and a second seal, the first seal disposed between the stylet and the boring tube, the second seal being disposed between the boring tube and another element of the needle, the first and second seals generating a vacuum within the boring tube as the boring tube is axially advanced over the stylet.

39. A biopsy needle for collecting a tissue specimen comprising an a stylet, an inner tube disposed about the stylet, an outer cannula disposed about the inner tube and a handle assembly, wherein the outer cannula has a first window formed therein and the inner tube has a second window which is selectively aligned with the first window when the inner tube is rotated within the outer cannula to a position where the windows at least partially overlap one another to permit retrieval and removal of the specimen collected in the inner tube.