Biopsy instrument with improved needle penetration

• US 20060155210A1
• Filed: 01/10/2005
• Published: 07/13/2006
• Est. Priority Date: 01/10/2005
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Albrecht, Thomas E., Reichel, Lee, Beckman, Andrew T., Perez, Gwendolyn Ruth
• Granted Patent: US 7,470,237 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

The present invention provides a biopsy instrument with improved needle penetration for piercing dense tissue. The device may comprise a needle slidably retained in a housing. The device may further comprise an actuation member that may be adapted to communicate longitudinal motion to the needle in a first direction. The device may further include a propulsion element that provides the needle with return motion in a second direction. The device may be fired multiple times to create repeating reciprocal motion. In one version, the device may reciprocate several times as a result of a single engagement of the actuation member.

Claims

1. A reciprocating needle biopsy device, comprising:

(i) a housing;

(ii) a needle having a proximal portion and a distal portion, said needle being slidably retained at said proximal portion thereof within said housing;

(iii) a firing mechanism adapted to releasably engage said needle, said firing mechanism being adapted to move said needle longitudinally from said default position to said release position, wherein further said firing mechanism is adapted to disengage said needle at said release position;

(iv) a spring comprising a first portion in communication with said needle and a second portion in communication with a fixed portion of said housing, such that said spring is adapted to store potential energy when said needle is moved from said default position to said release position, wherein further said spring is adapted to convert the stored potential energy to kinetic energy once said needle disengages said firing mechanism.

2. The reciprocating needle biopsy device of claim 1, wherein said firing mechanism comprises an actuating member adapted to releasably engage said needle, said actuating member being moveable from a first, non-activated position to a second, activated position.

3. The reciprocating needle biopsy device of claim 1, further comprising a return spring adapted to re-engage said needle with said firing mechanism.

4. The reciprocating needle biopsy device of claim 3, wherein said proximal portion of said needle is fixedly attached to a hub having an outer surface, wherein said hub is moveable from a default position to a release position.

5. The reciprocating needle biopsy device of claim 1, wherein said housing further comprises a damping element to absorb impact sound when said needle is moved to said default position by said spring.

6. The reciprocating needle biopsy device of claim 2, wherein said actuating member comprises a select one of a group consisting of a trigger button and a handle.

7. The reciprocating needle biopsy device of claim 1, wherein said needle is adapted to move less than 0.5 inches between said release position and said default position.

8. The reciprocating needle biopsy device of claim 11, wherein said needle is adapted to move less than 0.2 inches between said release position and said default position.

9. The reciprocating needle biopsy device of claim 1, wherein said firing mechanism comprises:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a linking member having a first end and a second end, wherein said first end is pivotally connected to said actuating member;

(iii) a lever releasably engaged with said needle, said second end of said linking member being pivotally connected to said lever, said lever being slideable from a default position to a release position;

wherein said linking member is adapted to transfer motion from said actuating member to said lever when said actuating member is moved from said first, non-activated position to said second, activated position, causing said lever and said needle to move from said default position to said release position, thereby storing potential energy in said spring;

wherein said needle is further adapted to disengage said lever at said release position, releasing the stored potential energy in the spring.

10. The reciprocating needle biopsy device of claim 9, wherein said lever further comprises a recess on an outer surface thereof and an angled proximal edge.

11. The reciprocating needle biopsy device of claim 10, wherein said needle comprises a post protruding from an outer surface thereof, said post adapted to releasably engage said recess of said lever.

12. The reciprocating needle biopsy device of claim 11, wherein said housing further comprises a fixed wall located distally of said angled proximal edge of said lever, said angled proximal edge being adapted to ride along said fixed wall, said lever being adapted to pivot such that a distal edge of said lever moves progressively farther from said needle until a predetermined point at which said post is adapted to disengage said recess of said lever.

13. The reciprocating needle biopsy device of claim 12, further comprising a lever return spring having a first end in communication with said housing and a second end in communication with said distal edge of said lever such that said spring is adapted to return said lever to said default position after said needle disengages said recess.

14. The reciprocating needle biopsy device of claim 13, wherein said recess comprises an angled distal edge, said angled distal edge adapted to ride over said post of said needle when said lever is returned to said default position such that said post re-engages said recess.

15. The reciprocating needle biopsy device of claim 14, wherein said recess of said lever is divided into multiple subdivisions by one or more partitions.

16. The reciprocating needle biopsy device of claim 15, further comprising one or more cutbacks spaced at predetermined intervals along said angled proximal edge of said lever, such that immediately after said post disengages from a proximal-most subdivision of said recess, said fixed wall is adapted to engage a first of said one or more cutbacks, causing said lever return spring to momentarily return said lever to a substantially horizontal position and said lever to engage said post in a next proximal-most subdivision of said recess.

17. The reciprocating needle biopsy device of claim 16, wherein each of said one or more partitions include an angled distal edge adapted to ride over said post of said needle when said lever is returned to said default position such that said post re-engages a proximal-most portion of said recess.

18. The reciprocating needle biopsy device of claim 1, wherein further said needle is fixedly attached to a hub, said hub being slidable within said housing from said default position to said release position;

wherein said firing mechanism further comprises;

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position, said actuating member comprising a plurality of teeth on an outer surface thereof;

(ii) a gear rotatably attached to said housing, said reciprocal gear comprising a plurality of teeth on an outer surface thereof, said teeth of said gear adapted to meshingly engage said teeth of said actuating member, said outer surface of said reciprocal gear further adapted to engage said hub;

wherein said gear is adapted to rotate in reaction to movement of said actuating member from said first, non-activated position to said second, activated position, said hub and said needle being adapted to move proximally from said default position to said release position;

said hub adapted to disengage said reciprocal gear at said release position;

said spring adapted to convert the stored potential energy to kinetic energy when said hub disengages said gear.

19. The reciprocating needle biopsy device of claim 18, wherein said hub includes a recess on an outer surface thereof and said gear includes a hub-engaging element, said hub-engaging element adapted to releasably mate with said recess.

20. The reciprocating needle biopsy device of claim 18, in which a rotation gear is rotatably connected to said housing, said rotation gear adapted to meshingly engage said reciprocal gear, wherein further said rotation gear is adapted to meshingly engage said hub, such that movement of said actuating member from said first, non-activated position to second, activated position causes both rotational and reciprocating movement of said needle.

21. The reciprocating needle biopsy device of claim 1, wherein said firing mechanism further comprises:

(i) a housing comprising an actuating member located on a distal face thereof, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a lever contained within said housing, said lever adapted to engage said actuating member, said lever being slideable from a first default position to a second release position, said lever being adapted to releasably engage said needle;

wherein movement of said actuating member from said first, non-activated position to said second, activated position causes said lever and said needle to move proximally from said default position to said release position;

wherein said needle is adapted to disengage said lever at said release position.

22. The reciprocating needle biopsy device of claim 21, wherein said proximal portion of said needle comprises a hub that is adapted to engage said lever.

23. The reciprocating needle biopsy device of claim 22, wherein said lever includes a protrusion that is adapted to engage a groove of said hub.

24. The reciprocating needle biopsy device of claim 23, wherein said protrusion is adapted to re-engage said groove of said hub when said return spring returns said lever to said default position.

25. The reciprocating needle biopsy device of claim 21, wherein said lever includes a pin that is adapted to engage an opening in said housing.

26. The reciprocating needle biopsy device of claim 25, wherein said opening includes a sloped surface on a proximal portion thereof, wherein motion of said pin is adapted to move along said sloped surface until said lever is moved out of engagement with said needle at said release position.

27. The reciprocating needle biopsy device of claim 1, wherein said firing mechanism further comprises:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a driving arm having a first end pivotally connected to said actuating member and a second end adapted to releasably engage said needle;

wherein said driving arm is adapted to move said needle from said default position to said release position when said actuating member is moved from said first, non-activated position to said second, activated position;

wherein said needle is adapted to disengage said driving arm at said release position.

28. The reciprocating biopsy needle device of claim 27, wherein said proximal portion of said needle comprises a hub.

29. The reciprocating biopsy needle device of claim 28, wherein a protrusion of said second end of said driving arm is adapted to releasably engage a recess of said hub.

30. The reciprocating biopsy needle device of claim 1, further comprising a cutter element that is adapted to advance distally through said needle independently of said firing mechanism.

31. A reciprocating needle biopsy device, comprising:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a driving member adapted to engage said actuating member, such that movement of said actuating member from said first, non-activated position to said second, activated position causes said driving member to move proximally from a default position to a release position, wherein further said driving member is adapted to disengage said actuating member at said release position;

(iii) a needle having a proximal portion and a distal portion positioned distally of said driving member, said needle retained within said housing at said proximal portion thereof, said needle further being slidable from a resting position to an extended position;

(iv) a compression spring comprising a first portion in communication with said driving member and a second portion in communication with a fixed portion of said housing located proximally of said compression spring;

wherein said compression spring is adapted to store potential energy when said driving member moves from said default position to said release position, said compression spring being adapted to return said driving member distally when said driving member disengages said actuating member, said driving member adapted to propel said needle to said extended position due to propulsion from said spring; and

(v) a dampening element located in said housing distally of said needle, wherein said dampening element is adapted to absorb the impact of said needle against said housing when said needle moves to said extended position and to return said needle to said resting position.

32. The reciprocating needle biopsy device of claim 31, further comprising a return spring that returns said actuating member to said first, non-activated position after said driving member disengages from said actuating member.

33. The reciprocating needle biopsy device of claim 31, wherein said driving member is engaged with said actuating member by a driving arm having a first end pivotally connected to said actuating member and a second end adapted to releasably mate with said driving member.

34. The reciprocating needle biopsy device of claim 31, wherein said second end of said driving arm comprises a protrusion that releasably mates with a recess in an outer surface of said driving member.

35. The reciprocating needle biopsy device of claim 31, wherein said return spring returns said driving arm into engagement with said driving member when said driving member is returned to said default position.

36. The reciprocating needle biopsy device of claim 31, wherein said actuating member comprises a trigger button.

37. The reciprocating needle biopsy device of claim 31, wherein said driving member comprises stainless steel.

38. A reciprocating needle biopsy device, comprising:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position, said housing further comprising a tripping element;

(ii) a needle having a proximal portion and a distal portion, said proximal portion of said needle being slidably retained within said housing, said needle further comprising a lever-engaging element on an outer surface thereof, said needle being moveable from a default position to a release position;

(iv) a lever adapted to receive motion from said actuating member, said lever moveable from a default position to a release position, said lever comprising an angled edge including one or more cutbacks, said tripping element of said housing adapted to ride along said angled surface when said lever moves from said default position to said release position, said lever further comprising a recess on an outer surface thereof, said recess divided into a plurality of subdivisions by one or more partitions, each of said subdivisions of said recess adapted to engage said lever-engaging element of said needle; and

(v) a compression spring comprising a first portion in communication with said needle and a second portion in communication with a first fixed portion of said housing located distally of said needle; and

(vi) a lever return spring comprising a first portion in communication with a distal portion of said lever and a second portion in communication with a second fixed portion of said housing located within said housing proximally and below said point of attachment of said first portion of said lever return spring to said distal portion of said lever.

39. A reciprocating needle biopsy device, comprising:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a lead screw having a proximal portion and a distal portion, said lead screw being rotatably connected to said housing;

(iii) a nut adapted to ride on said lead screw, said nut adapted to engage said actuating member such that movement of said actuating member from said first, non-activated position to said second, activated position causes said nut to transverse said lead screw proximally within said housing;

(iv) a first cam attached to a distal portion of said lead screw, said first cam having a distal face comprising an uneven surface;

(v) a needle having a proximal portion and a distal portion, said proximal portion of said needle adapted to be slidably retained within said housing;

(vi) a second cam attached to said proximal portion of said cam, said second cam having a proximal face comprising an uneven surface, said distal face of said first cam adapted to rotate against said proximal face of said second cam;

(vii) a return spring comprising a first portion in communication with a fixed portion of a distal wall of said housing and a second portion in communication with said proximal portion of said needle.

40. The reciprocating needle biopsy device of claim 39, wherein said actuating member comprises a handle.

41. The reciprocating needle biopsy device of claim 39, further comprising an actuating member return spring that returns said actuating member from a first, non-activated position to a second, activated position.

42. The reciprocating needle biopsy device of claim 39, further including a linking member comprising a first end pivotally connected to said actuating member and a second end pivotally connected to said nut.

43. The reciprocating needle biopsy device of claim 39, wherein said lead screw is approximately 0.5 inches in diameter.

44. The reciprocating needle biopsy device of claim 39, wherein said uneven surface of said first cam comprises a pair of curved ramps and said uneven surface of said second cam comprises a pair of curved ramps, wherein further said curved ramps of said first cam are adapted to engage said curved ramps of said second cam.

45. A reciprocating needle biopsy device, comprising:

(i) a housing comprising an actuating member, said actuating member being moveable from a first, non-activated position to a second, activated position;

(ii) a needle having a proximal portion and a distal portion, said needle being slidably retained at said proximal portion thereof within said housing, wherein said needle is adapted to move proximally within said housing from a default position to a release position;

(iii) a firing mechanism adapted to releasably engage said needle, said firing mechanism being adapted to move said needle proximally from said default position to said release position, wherein further said firing mechanism is adapted to disengage said needle at said release position; and

(iv) a propulsion element comprising a first portion in communication with said needle and a second portion in communication with a fixed portion of said housing, such that said propulsion element is adapted to propel said needle forward after said needle disengages said firing mechanism.

46. The reciprocating needle biopsy device of claim 45, wherein said propulsion element comprises a first magnet having a proximal portion and a distal portion attached to said needle and a second magnet having a proximal portion and a distal portion attached to a fixed portion of said housing proximal of said needle, wherein said proximal portion of said first magnet is charged opposite to said distal portion of said second magnet.

47. The reciprocating needle biopsy device of claim 46, wherein said propulsion element comprises a pneumatic chamber.

48. A reciprocating needle biopsy device, comprising:

(i) a housing;

(ii) a needle having a proximal portion and a distal portion and further comprising a lumen, said needle being slidably retained at said proximal portion thereof within said housing, said needle adapted to move longitudinally within said housing from a default position to a release position;

(iii) a firing mechanism adapted to releasably engage said needle, said firing mechanism being adapted to move said needle longitudinally from said default position to said release position, wherein further said firing mechanism is adapted to disengage said needle at said release position and return said needle to said default position; and

(iv) a cutter adapted to advance distally within said lumen independently of said firing mechanism.

49. A method of penetrating dense tissue and obtaining a tissue sample comprising the steps of:

(i) inserting a needle biopsy device into tissue;

(ii) actuating a reciprocating firing stroke of a needle of said needle biopsy device to penetrate dense tissue before a cutter is advanced through said needle;

(iii) advancing said cutter independently of said movement of said needle to obtain a tissue sample after said needle biopsy device has been placed adjacent the tissue of interest.