HANDHELD BIOPSY DEVICE WITH NEEDLE FIRING

• US 20120109007A1
• Filed: 11/24/2010
• Published: 05/03/2012
• Est. Priority Date: 11/01/2010
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Rhad, Edward A., Hibner, John A., Craig, Harold W., Nuchols, Richard P.
• Granted Patent: US 8,764,680 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/0266 means for severing sample
• 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

Abstract

A biopsy device includes a body, a needle, and a cutter. A motor is operable to both move the cutter relative to the needle and actuate a needle firing assembly to retract and fire the needle relative to the body. The biopsy device also includes a needle rotation assembly that is configured to substantially prevent rotation of the needle about the longitudinal axis when the needle is in a proximal position yet permit rotation of the needle about the longitudinal axis when the needle is in a distal position. A valve assembly of the biopsy device includes a slider that selectively couples a secondary lumen in the needle with either atmospheric air or saline based on the longitudinal position of the slider. The cutter passes through the slider.

Claims

1. A biopsy device, comprising:

(a) a body;

(b) a needle, the needle including a tip and a transverse aperture proximal to the tip, wherein the needle defines a longitudinal axis, wherein the needle is movable relative to the body along the longitudinal axis;

(c) a cutter movable within the needle to sever tissue protruding through the transverse aperture;

(d) a motor operable to move the cutter relative to the needle; and

(e) a needle firing assembly, wherein the needle firing assembly is operable to retract and fire the needle relative to the body along the longitudinal axis, wherein the motor is operable to actuate the needle firing assembly to retract and fire the needle relative to the body along the longitudinal axis.

2. The biopsy device of claim 1, wherein the needle firing assembly is configured to engage the cutter to retract the needle proximally with the cutter as the cutter is retracted from a first distal position to a first proximal position.

3. The biopsy device of claim 2, wherein the needle firing assembly is configured to fire the needle distally when the cutter is advanced from the first proximal position to a second distal position, wherein the second distal position is proximal to the first distal position.

4. The biopsy device of claim 3, wherein the cutter is further movable from the second distal position to a second proximal position after the needle is fired distally, wherein the second proximal position is proximal to the first proximal position.

5. The biopsy device of claim 1, further comprising a first member fixedly secured to the cutter, wherein the needle firing assembly comprises a second member configured to selectively engage the first member, wherein the needle firing assembly is operable to retract the needle relative to the body along the longitudinal axis when at least the following two conditions are met:

(i) the second member is engaged with the first member, and

(ii) the motor is activated to retract the cutter proximally relative to the body.

6. The biopsy device of claim 5, wherein the second member comprises an elongate member resiliently biased to assume a bent configuration, wherein the second member is disengaged from the first member when the elongate member is in the bent configuration, wherein the second member is engaged with the first member when the elongate member is in a substantially straight configuration, the needle firing assembly further comprising a trigger member operable to move the elongate member from the bent configuration to the substantially straight configuration.

7. The biopsy device of claim 5, wherein the body includes a track, wherein the second member comprises a pin disposed in the track, wherein the track is configured to maintain engagement between the first member and the second member as the pin moves along a first portion of the track, wherein the track is configured to permit disengagement of the first member from the second member as the pin moves along a second portion of the track.

8. The biopsy device of claim 5, wherein the first member includes an outwardly extending flange, wherein the second member includes an inwardly extending catch configured to selectively engage the flange.

9. The biopsy device of claim 1, wherein the longitudinal axis defined by the needle passes through the body.

10. The biopsy device of claim 1, wherein the motor is positioned within the body.

21. The biopsy device of claim 1, further comprising an accelerometer, wherein the accelerometer is operable to sense one or both of movement or orientation of the body.

11. A biopsy device, comprising:

(a) a body;

(b) a needle extending distally from the body, the needle including a tip and a transverse aperture proximal to the tip, wherein the needle defines a longitudinal axis, wherein the needle is translatable relative to the body along the longitudinal axis, wherein the needle is selectively rotatable relative to the body about the longitudinal axis;

(c) a cutter movable relative to the needle to sever tissue protruding through the transverse aperture; and

(d) a needle rotation assembly, wherein the needle rotation assembly is configured to substantially prevent rotation of the needle about the longitudinal axis when the needle is in a first longitudinal position, wherein the needle rotation assembly is further configured to permit rotation of the needle about the longitudinal axis when the needle is in a second longitudinal position.

12. The biopsy device of claim 11, wherein the needle rotation assembly comprises a resilient member resiliently biasing the needle to the first longitudinal position, wherein the first longitudinal position is proximal to the second longitudinal position.

13. The biopsy device of claim 11, wherein the needle rotation assembly further comprises a needle rotation member unitarily secured to the needle, wherein the body comprises a needle engagement feature configured and positioned to engage the needle rotation member when the needle is in the first longitudinal position to substantially prevent rotation of the needle about the longitudinal axis, wherein the needle engagement feature is configured and positioned to disengage the needle rotation member when the needle is in the second longitudinal position to permit rotation of the needle about the longitudinal axis.

14. The biopsy device of claim 13, wherein the needle engagement feature comprises a protrusion projecting from an interior surface of the body, wherein the needle rotation member comprises a plurality of recesses circumferentially arrayed about an outer perimeter of the needle rotation member, wherein each of the recesses is configured to receive part of the protrusion based on the angular position of the recesses about the longitudinal axis when the needle is in the first longitudinal position.

15. A biopsy device, comprising:

(a) a body;

(b) a needle associated with the body, wherein the needle defines a first lumen and a second lumen, wherein the first lumen extends along a first longitudinal axis, wherein the second lumen extends along a second longitudinal axis, wherein the needle includes an opening fluidly coupling the first lumen with the second lumen;

(c) a cutter, wherein the cutter is configured to translate relative to the needle to sever tissue;

(d) a valve assembly, comprising;

(i) a valve body having an interior, one or more vent openings in communication with the interior, and one or more saline openings in communication with the interior, wherein the interior is in communication with the second lumen, wherein the one or more vent openings are further in communication with atmospheric air, wherein the one or more saline openings are further in communication with a source of saline,

(ii) a translating member slidably disposed in the valve body, wherein the translating member is configured to selectively couple the second lumen with either the one or more vent openings or the one or more saline openings based on the longitudinal position of the translating member within the valve body,

wherein the cutter extends through the valve body and through the translating member.

16. The biopsy device of claim 15, wherein the translating member is responsive to the longitudinal position of the cutter.

17. The biopsy device of claim 15, further comprising a first member secured to the cutter, wherein the first member is configured to move the translating member distally within the valve body when the cutter is moved distally.

18. The biopsy device of claim 17, further comprising a second member secured to the cutter, wherein the second member is configured to move the translating member proximally within the valve body when the cutter is moved proximally.

19. The biopsy device of claim 15, wherein the cutter defines an outer diameter, wherein the translating member has a bore defining an inner diameter, wherein the inner diameter is greater than the outer diameter such that a gap is provided between the inner diameter of the translating member and the outer diameter of the cutter, the translating member further including a transverse opening in fluid communication with the gap, wherein the transverse opening is configured to provide fluid communication from either the one or more vent openings to the gap or from the one or more saline openings to the gap based on the longitudinal position of the translating member within the valve body.

20. The biopsy device of claim 15, wherein the translating member is configured to, based at least in part on the longitudinal position of the cutter, selectively move between a first longitudinal position, a second longitudinal position, and a third longitudinal position, wherein the second lumen is coupled with the one or more vent openings when the translating member is in the first longitudinal position, wherein the second lumen is coupled with the one or more saline openings when the translating member is in the second longitudinal position, wherein the second lumen is substantially sealed relative to the one or more vent openings and relative to the one or more saline openings when the translating member is in the third longitudinal position.