Biopsy device

• US 10,463,350 B2
• Filed: 05/01/2015
• Issued: 11/05/2019
• Est. Priority Date: 05/01/2015
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Van Liere, Chad C., Schlarb, Rory M.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Shostak, Andrey
• Application Number:
  US15/565,967
• Publication Number:
  US 20180103939A1
• Time in Patent Office: 1,649 Days
• 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

Abstract

A biopsy device is configured wherein a first retraction of a charge handle moves a cannula slide and a sampling slide in unison to charge a sampling spring, to latch the sampling slide to retain the sampling spring in a charged state, and to charge a vacuum system. A second retraction of the charge handle occurs, and a return of the charge handle to the home position moves the cannula slide in a distal direction away from the sampling slide to charge the cannula retract spring and to latch the cannula slide to retain the cannula retract spring in a charged state. A third retraction of the charge handle moves the carriage assembly as a whole in the proximal direction to charge the prime pierce spring and to latch the carriage latch cover member to retain the prime pierce spring in a charged state.

Claims

1. A biopsy device, comprising:

a housing;

a biopsy needle coupled to the housing, the biopsy needle including a stylet and a cannula, the stylet having a side sample port;

a carriage assembly including a carriage slide, a cannula slide, a sampling slide, and a cannula retract spring, the carriage slide having a stylet mount end wall and the cannula slide having a cannula mount end wall;

a charge handle slidably mounted to the housing, the charge handle having a home position and a retracted position;

an actuator mechanism having a cannula retract button;

a sampling spring; and

a vacuum system positioned in the housing and carried by the carriage assembly, wherein the vacuum system is charged to generate a vacuum when the sampling spring is compressed, the vacuum system including a first vacuum pump, a second vacuum pump, a manifold and a control valve, wherein the vacuum system is configured such that;

the first vacuum pump has a first vacuum port,

the second vacuum pump has a second vacuum port,

the manifold has a first vacuum draw port, a second vacuum draw port, and a first vacuum application port,

the control valve has a third vacuum draw port and a second vacuum application port,

the first vacuum port of the first vacuum pump is coupled in fluid communication with the first vacuum draw port of the manifold, the second vacuum port of the second vacuum pump is coupled in fluid communication with the second vacuum draw port of the manifold, the first vacuum application port of the manifold is coupled in fluid communication with the third vacuum draw port of the valve, the second vacuum draw port of the control valve is coupled in fluid communication with a first lumen of the stylet,

the manifold has a first one-way valve coupled in fluid communication with the first vacuum draw port and a second one-way valve coupled in fluid communication with the second vacuum draw port, each of the first one-way valve and the second one-way valve configured to release positive pressure to the atmosphere and to close upon establishment of the vacuum, and

the control valve is operated by actuation of the cannula retract button of the actuator mechanism to apply the vacuum to the side sample port of the stylet simultaneously with movement of the cannula in a proximal direction by a force generated by the cannula retract spring to open the side sample port of the stylet.

2. The biopsy device of claim 1, wherein:

the first vacuum pump includes;

a first cylinder having a first end and a second end, the first end having the first vacuum port and the second end defining a first opening;

a first piston received in the first cylinder through the first opening;

a first plunger attached to the first piston, the first plunger configured to extend from the second end of the first cylinder, the first plunger having a free end having a first head; and

a first vacuum spring interposed between the second end of the cylinder and the first head of the first plunger, the first vacuum spring configured to store mechanical energy when in a compressed state and configured to bias the first piston in the distal direction; and

the second vacuum pump includes;

a second cylinder having a first end and a second end, the first end having the second vacuum port and the second end defining a second opening;

a second piston received in the second cylinder through the second opening;

a second plunger attached to the second piston, the second plunger configured to extend from the second end of the second cylinder, the second plunger having a free end having a second head; and

a second vacuum spring interposed between the second end of the second cylinder and the second head of the second plunger, the second vacuum spring configured to store mechanical energy when in a compressed state and configured to bias the second piston in the distal direction.

3. The biopsy device of claim 2, wherein the first head of the first vacuum pump and the second head of the second vacuum pump are positioned for engagement with the cannula mount end wall of the cannula slide, and wherein each of the first vacuum spring of the first vacuum pump and the second vacuum spring of the second vacuum pump is compressed during a movement of the cannula mount end wall in the proximal direction that occurs prior to the cannula retract spring being charged to an extended state.

4. The biopsy device of claim 3, wherein compression of the first vacuum spring of the first vacuum pump and the second vacuum spring of the second vacuum pump occurs simultaneously with the compression of the sampling spring.

5. The biopsy device of claim 2, wherein the stylet mount end wall includes a first pump mounting hole and a second pump mounting hole,

the first vacuum pump received in the first pump mounting hole with a first proximal cylinder portion having the first vacuum port configured to extend in the proximal direction from the stylet mount end wall and a first distal cylinder portion having the first opening configured to extend in the distal direction from the stylet mount end wall, the first head of the first plunger positioned to engage the cannula mount end wall so as to compress the first vacuum spring when the cannula mount end wall is moved in the proximal direction during a first retraction of the charge handle;

and

the second vacuum pump received in the second pump mounting hole with a second proximal cylinder portion having the second vacuum port configured to extend in the proximal direction from the stylet mount end wall and a second distal cylinder portion having the second opening configured to extend in the distal direction from the stylet mount end wall, the second head of the second plunger positioned to engage the cannula mount end wall so as to compress the second vacuum spring, simultaneously with compression of the first vacuum spring, when the cannula mount end wall is moved in the proximal direction during the first retraction of the charge handle.

6. The biopsy device of claim 1, wherein

the stylet mount wall mounts the stylet, the cannula slide mounts the cannula, the cannula is a cutting cannula, and the sampling slide is movably interposed between the stylet mount wall and the cannula slide;

the biopsy device further comprising a prime pierce spring interposed between the carriage assembly and a portion of the housing; and

the carriage assembly further comprising;

a carriage latch cover member, the cannula slide being longitudinally spaced from and movable relative to the stylet mount wall, the cannula slide having a first latch member, the sampling slide having a second latch member, and the carriage latch cover member having a third latch member;

the sampling spring interposed between the stylet mount wall and the sampling slide; and

the cannula retract spring interposed between, and connected to each of, the sampling slide and the cannula slide;

wherein the biopsy device is configured such that;

a first retraction of the charge handle moves the cannula slide and the sampling slide in unison in the proximal direction to charge the sampling spring, to latch the second latch member of the sampling slide with the carriage latch cover member to retain the sampling spring in a first charged state, and to charge the vacuum system to generate the vacuum;

a first return of the charge handle returns the charge handle to the home position;

a second retraction of the charge handle moves the charge handle to the retracted position;

a second return of the charge handle to the home position moves the cannula slide in a distal direction away from the sampling slide to charge the cannula retract spring and to latch the first latch member of the cannula slide with the carriage latch cover member to retain the cannula retract spring in a second charged state; and

a third retraction of the charge handle moves the carriage assembly as a whole in the proximal direction to charge the prime pierce spring and to latch the third latch member of the carriage latch cover member with the actuator mechanism to retain the prime pierce spring in a third charged state.

7. The biopsy device of claim 6, the actuator mechanism having the cannula retract button, a sample acquisition button, and a pierce button, the biopsy device further configured such that:

the pierce button is actuated to unlatch the third latch member of the carriage latch cover member from the actuator mechanism to release the prime pierce spring from the third charged state to propel the carriage assembly in the distal direction to facilitate a piercing of tissue with the stylet and the cannula;

the cannula retract button is actuated to unlatch the first latch member of the cannula slide from the carriage latch cover member to release the cannula retract spring from the second charged state and move the cannula in the proximal direction to open the side sample port of the stylet, and to simultaneously apply the vacuum to the side sample port to draw tissue into the side sample port; and

the sample acquisition button is actuated to unlatch the second latch member of the sampling slide from the carriage latch cover member to release the sampling spring from the first charged state to propel the cannula in the distal direction to close the side sample port to sever the tissue drawn by vacuum into the side sample port.

8. The biopsy device of claim 1, wherein

the stylet is positioned to extend along a longitudinal axis, the stylet having a first side wall configured to define a first lumen, and the side sample port extends through the first side wall to the first lumen;

the cannula is coaxial with the stylet, the cannula having a second side wall configured to define a second lumen, the cannula having a distal cutting edge;

the housing has a proximal end wall, an intermediate wall, and a distal end portion spaced along the longitudinal axis, the distal end portion has a needle opening, the housing is configured to define a housing chamber between the proximal end wall and the distal end portion, the intermediate wall is interposed between the proximal end wall and the distal end portion, the stylet and the cannula are received through the needle opening, and wherein the proximal direction is from the distal end portion toward the proximal end wall and a distal direction is from the proximal end wall toward the distal end portion;

the actuator mechanism has a pierce button, the cannula retract button, a sample acquisition button, and a carriage latch strike;

the carriage assembly is positioned in the housing chamber, the carriage assembly i configured to move longitudinally as a whole relative to the housing, the carriage assembly includes the carriage slide, a carriage latch cover member, the cannula slide, and the sampling slide, each of the cannula slide and the sampling slide is configured to be movable relative to the carriage slide, the cannula slide has a first latch arm that extends in the proximal direction from the cannula mount end wall, the sampling slide is movably interposed between the stylet mount end wall of the carriage slide and the cannula mount end wall of the cannula slide, the sampling slide has a second latch arm that extends in the distal direction;

the carriage latch cover member has a first latch strike, a second latch strike, and a carriage latch arm, the first latch strike is configured to releasably engage the first latch arm, the second latch strike is configured to releasably engage the second latch arm, and the carriage latch arm is configured to releasably engage the carriage latch strike of the actuator mechanism;

the sampling spring is interposed between the stylet mount end wall and the sampling slide, the sampling spring is configured to store mechanical energy when in a compressed state and is configured to bias the sampling slide in the distal direction, the sampling spring is held in the compressed state when the second latch arm is engaged with the second latch strike;

the cannula retract spring is interposed between, and connected to each of, the sampling slide and the cannula slide, the cannula retract spring is configured to store mechanical energy in an extended state to bias the cannula slide in the proximal direction, the cannula retract spring is releasably held in the extended state when the first latch arm is engaged with the first latch strike and the second latch arm is engaged with the second latch strike; and

a prime pierce spring is interposed between the intermediate wall of the housing and the stylet mount end wall, the prime pierce spring is configured to store mechanical energy when in a compressed state and is configured to bias the carriage assembly as a whole in the distal direction, the prime pierce spring is held in the compressed state when the carriage latch arm is engaged with the carriage latch strike of the actuator mechanism.

9. The biopsy device of claim 1, further comprising:

an indexing mechanism movably coupled to the cannula mount end wall of the cannula slide, the cannula mount end wall having an indexing window, the indexing mechanism configured to selectively cover a portion of the indexing window;

wherein the charge handle has a charge handle latch arm configured to pass through the indexing window when the charge handle is moved to the retracted position, and when the indexing mechanism is positioned to cover the portion of the indexing window, a subsequent movement of the charge handle in the distal direction toward the home position causes the charge handle latch arm to engage the indexing mechanism to move the cannula slide in the distal direction away from the sampling slide to charge the cannula retract spring.

10. The biopsy device of claim 1, the biopsy device further comprising:

an indexing mechanism movably coupled to the cannula mount end wall of the cannula slide,

the charge handle and the indexing mechanism in combination configured to selectively facilitate movement of the sampling slide and the cannula slide collectively as a unit in the proximal direction relative to the carriage slide to charge the sampling spring, to facilitate movement of the cannula slide individually in a distal direction relative to the carriage slide to charge the cannula retract spring, and to facilitate movement of the carriage assembly as a whole in the proximal direction relative to the housing to charge the prime pierce spring.

11. The biopsy device of claim 1, the carriage assembly further comprising:

the cannula mount end wall having an indexing window;

the biopsy device further comprising;

the charge handle having a charge handle latch arm configured to pass through the indexing window; and

an indexing mechanism having a cannula slide indexer and a sampling slide indexer, the cannula slide indexer being rotatably coupled to the cannula mount end wall of the cannula slide, the sampling slide indexer being slidably coupled to the cannula mount end wall of the cannula slide and configured to move in a first direction toward the longitudinal axis, the cannula slide indexer being operably engaged with the sampling slide indexer, the sampling slide indexer being biased by a bias spring in the first direction, the sampling slide indexer having a window blocking plate configured to cover a portion of the indexing window when the sampling slide indexer is moved in the first direction;

wherein the cannula slide indexer is configured to be operably engaged by the first latch arm of the cannula slide to rotate the cannula slide indexer into contact with the sampling slide indexer to move the sampling slide indexer in a second direction opposite to the first direction such that the window blocking plate of the sampling slide indexer does not cover the portion of the indexing window,

wherein the sampling slide indexer is configured to be operably engaged by the second latch arm of the second latch arm of the sampling slide to move the sampling slide indexer in the second direction opposite to the first direction such that the window blocking plate of the sampling slide indexer does not cover the portion of the indexing window, and

wherein when the window blocking plate of the sampling slide indexer is positioned to cover the portion of the indexing window, the charge handle is configured to be moved in a proximal stroke such that the charge handle latch arm passes through the indexing window and passes the window blocking plate of the sampling slide indexer, the charge handle is configured such that a return distal stroke of the charge handle in the distal direction toward the home position causes the charge handle latch arm to engage the window blocking plate to move the cannula slide in the distal direction away from the sampling slide to charge the cannula retract spring.

12. The biopsy device of claim 1, the biopsy device further comprising:

a lower case portion of the housing;

a prime pierce spring interposed between the carriage assembly and the lower case portion of the housing; and

a biasing mechanism interposed between the housing and the charge handle; and

the carriage assembly further comprising;

the cannula slide comprising a first latch arm;

the sampling slide comprising a second latch arm;

the carriage latch cover member comprising a second latch strike;

an indexing mechanism movably coupled to the cannula mount end wall of the cannula slide, the cannula mount end wall having an indexing window, the indexing mechanism configured to selectively cover a portion of the indexing window;

the charge handle having a charge handle latch arm that extends in the proximal direction; and

a biasing spring coupled to the housing and to the charge handle, the biasing spring configured to bias the charge handle in the distal direction to the home position, the charge handle configured for sequential actuations, wherein;

a first retraction of the charge handle moves the sampling slide and the cannula mount end wall that carries the cannula, in unison, by virtue of the first latch arm being engaged with the sampling slide, in the proximal direction to compress the sampling spring and to engage the second latch arm with the second latch strike to retain the sampling spring in the compressed state, the cannula is retracted to expose the side sample port of the stylet, the charge handle is configured to return to the home position by force exerted by the biasing mechanism;

a second retraction of the charge handle passes the charge handle latch arm through the indexing window, and during the return of the charge handle to the home position by force exerted by the biasing mechanism;

the charge handle latch arm engages the indexing mechanism and moves the cannula slide in the distal direction away from the sampling slide which in turn extends the cannula retract spring to an extended state,

the first latch arm releasably engages the first latch strike to retain the cannula retract spring in the extended state, and

the indexing mechanism is sequenced to fully open the indexing window of the cannula slide to disengage the indexing mechanism from the charge handle latch arm,

wherein the cannula is positioned to close the side sample port of the stylet; and

a third retraction of the charge handle moves the carriage assembly as a whole in the proximal direction to compress the prime pierce spring, the carriage latch arm is configured to engage the carriage latch strike of the actuator mechanism to retain the prime pierce spring in the compressed state.

13. The biopsy device of claim 12, the actuator mechanism further comprising a pierce button and a sample acquisition button;

wherein;

an actuation of the pierce button releases the carriage latch arm from the carriage latch strike, the prime pierce spring is released from the compressed state to exert a force to move the carriage assembly, including the stylet and the cannula in unison, in the distal direction;

an actuation of the cannula retract button releases the first latch arm from the first latch strike, the cannula retract spring is released from the extended state to exert a force to move the cannula in the proximal direction and open the side sample port of the stylet; and

an actuation of the sample acquisition button releases the second latch arm from the second latch strike, the sampling spring is released from the compressed state to exert a force to move the cannula in the distal direction to close the side sample port.

14. The biopsy device of claim 1, wherein the stylet has an open first end and a closed second end, the closed second end defining a distal piercing tip.

15. The biopsy device of claim 1, the carriage assembly further comprises a carriage latch cover member;

and

the carriage slide further includes a carriage base;

wherein;

the stylet mount end wall and the carriage base are formed as a unitary carriage structure,

the carriage base is configured to define a U-shaped wall having a U-shaped cross-section that extends in the distal direction from the stylet mount end wall to define an open distal end and an open top,

the carriage latch cover member is configured to attach to the carriage base to cover the open top, and

the open distal end is configured to slidably receive and longitudinally guide the sampling slide and the cannula slide.

16. The biopsy device of claim 2, the biopsy device further comprising:

an indexing mechanism movably coupled to the cannula mount end wall of the cannula slide,

the charge handle and the indexing mechanism in combination configured to selectively facilitate movement of the sampling slide and the cannula slide collectively as a unit in the proximal direction relative to the carriage slide to charge the sampling spring, to facilitate movement of the cannula slide individually in a distal direction relative to the carriage slide to charge the cannula retract spring, and to facilitate movement of the carriage assembly as a whole in the proximal direction relative to the housing to charge the prime pierce spring.

17. The biopsy device of claim 2, the carriage assembly further comprising the cannula mount end wall having an indexing window;

the biopsy device further comprising;

the charge handle having a charge handle latch arm configured to pass through the indexing window; and

an indexing mechanism having a cannula slide indexer and a sampling slide indexer, the cannula slide indexer being rotatably coupled to the cannula mount end wall of the cannula slide, the sampling slide indexer being slidably coupled to the cannula mount end wall of the cannula slide and configured to move in a first direction toward the longitudinal axis, the cannula slide indexer being operably engaged with the sampling slide indexer, sampling slide indexer being biased by a bias spring in the first direction, the sampling slide indexer having a window blocking plate configured to cover a portion of the indexing window when the sampling slide indexer is moved in the first direction;

wherein the biopsy device is configured such that;

the cannula slide indexer is configured to be operably engaged by the first latch arm of the cannula slide to rotate the cannula slide indexer into contact with the sampling slide indexer to move the sampling slide indexer in a second direction opposite to the first direction such that the window blocking plate of the sampling slide indexer does not cover the portion of the indexing window,

the sampling slide indexer is configured to be operably engaged by the second latch arm of the second latch arm of the sampling slide to move the sampling slide indexer in the second direction opposite to the first direction such that the window blocking plate of the sampling slide indexer does not cover the portion of the indexing window,

when the window blocking plate of the sampling slide indexer is positioned to cover the portion of the indexing window, the charge handle is configured to be moved in a proximal stroke such that the charge handle latch arm passes through the indexing window and passes the window blocking plate of the sampling slide indexer, and the charge handle is configured such that a return distal stroke of the charge handle in the distal direction toward the home position causes the charge handle latch arm to engage the window blocking plate to move the cannula slide in the distal direction away from the sampling slide to charge the cannula retract spring.

18. The biopsy device of claim 3, wherein the stylet mount end wall includes a first pump mounting hole and a second pump mounting hole,

the first vacuum pump is received in the first pump mounting hole with a first proximal cylinder portion having the first vacuum port configured to extend in the proximal direction from the stylet mount end wall and a first distal cylinder portion having the first opening configured to extend in the distal direction from the stylet mount end wall, the first head of the first plunger is positioned to engage the cannula mount end wall so as to compress the first vacuum spring when the cannula mount end wall is moved in the proximal direction during a first retraction of the charge handle;

and

the second vacuum pump is received in the second pump mounting hole with a second proximal cylinder portion having the second vacuum port configured to extend in the proximal direction from the stylet mount end wall and a second distal cylinder portion having the second opening configured to extend in the distal direction from the stylet mount end wall, the second head of the second plunger is positioned to engage the cannula mount end wall so as to compress the second vacuum spring, simultaneously with compression of the first vacuum spring, when the cannula mount end wall is moved in the proximal direction during the first retraction of the charge handle.

19. The biopsy device of claim 4, wherein the stylet mount end wall includes a first pump mounting hole and a second pump mounting hole,

the first vacuum pump is received in the first pump mounting hole with a first proximal cylinder portion having the first vacuum port configured to extend in the proximal direction from the stylet mount end wall and a first distal cylinder portion having the first opening configured to extend in the distal direction from the stylet mount end wall, the first head of the first plunger is positioned to engage the cannula mount end wall so as to compress the first vacuum spring when the cannula mount end wall is moved in the proximal direction during a first retraction of the charge handle;

and

the second vacuum pump is received in the second pump mounting hole with a second proximal cylinder portion having the second vacuum port configured to extend in the proximal direction from the stylet mount end wall and a second distal cylinder portion having the second opening configured to extend in the distal direction from the stylet mount end wall, the second head of the second plunger is positioned to engage the cannula mount end wall so as to compress the second vacuum spring, simultaneously with compression of the first vacuum spring, when the cannula mount end wall is moved in the proximal direction during the first retraction of the charge handle.