JP7083927B2 - Biopsy device - Google Patents

Description

Cross-reference of related applications

none.

Field of invention

The present invention relates to a biopsy apparatus, and more specifically to a handheld biopsy apparatus having an integrated vacuum assist function that supports acquisition of a tissue sample.

Description of related technology

The biopsy device has a sample recovery mechanism configured to cut a tissue sample from the patient. The sample recovery mechanism may take the form of a biopsy probe assembly with a biopsy needle having a sample recovery opening. Some physicians performing biopsy procedures prefer self-contained handheld biopsy devices to large console system biopsy devices. There are basically two types of self-contained handheld biopsy devices: semi-disposable biopsy devices and fully disposable biopsy devices.

A typical semi-disposable biopsy device has a reusable handheld drive, to which the disposable probe is freely attached. Reusable handheld drives are typically battery powered and include an electric motor drive mechanism and an integrated vacuum pump to assist sample acquisition and / or recovery. Such biopsy devices are often configured for single insertion multisample (SIMS) procedures. The disposable probe is discarded after being used by one patient, and the handheld drive is stored for reuse.

A typical all-disposable biopsy device has one or more mechanical drive mechanisms such as a spring / latch mechanism, which allows the biopsy device to be manually prepared and fired for tissue sample acquisition. .. Such a simple biopsy device is often configured to obtain one sample with a single insertion. Also, many all-disposable biopsy devices do not have a vacuum to support sample acquisition. Attempts have been made to incorporate a vacuum assist function into a fully disposable biopsy device, but the performance of the semi-disposable biopsy device described above is not as good as that of the semi-disposable biopsy device described above because the vacuum normally generated is insufficient. In addition, in a typical all-disposable biopsy device having a vacuum assist function, a vacuum is generated at the same time as the movement of the cutting cannula that cuts the tissue sample, so that the value of the vacuum is limited when acquiring the tissue sample. In some cases.

What is needed in this technique is entirely disposable, which creates a vacuum before retracting the cutting cannula to expose the sample collection opening of the biopsy needle, facilitating efficient vacuum use. It is a biopsy device that can support sample acquisition and is configured to be easy to use.

The present invention provides a biopsy apparatus and a method of operating the biopsy apparatus.

For example, terms such as "first", "second", and "third" used in front of the element name in this document, such as the first latch member and the second latch member, are the same for the purpose of identification. It distinguishes between distinct elements and does not necessarily imply order unless otherwise specified, and such terms do not prevent further inclusion of similar elements.

The present invention is directed to a biopsy apparatus having, in one embodiment, a housing, a biopsy needle including a stylet and a cannula, and a carriage assembly including a carriage slide, a cannula slide, and a sampling slide. The carriage slide has a stylet assembled end wall and the cannula slide has a cannula assembled end wall. The charge handle is slidably attached to the housing. The charge handle has a fixed position and a retracted position. The biopsy device further includes a vacuum system located within the housing and carried by a carriage assembly. The vacuum system is charged when the sampling spring is compressed to generate a vacuum. The vacuum system includes a first vacuum pump, a second vacuum pump, a manifold and a control valve. The first vacuum pump has a first vacuum port. The second vacuum pump has a second vacuum port. The manifold has a first evacuation port, a second evacuation port, and a first evacuation port. The control valve has a third evacuation port and a second evacuation port. The first vacuum port of the first vacuum pump is coupled to the first vacuum extraction port of the manifold by fluid communication. The second vacuum port of the second vacuum pump is coupled to the second vacuum extraction port of the manifold by fluid communication. The first evacuation port of the manifold is coupled to the third evacuation port of the valve by fluid communication. The second vacuum outlet of the control valve is coupled to the first lumen of the stylet by fluid communication. The manifold has a first one-way valve coupled to the first vacuum outlet in fluid communication and a second one-way valve coupled to the second vacuum outlet in fluid communication. The first one-way valve and the second one-way valve are configured to release positive pressure to the atmosphere and close when a vacuum is established. The control valve is operated by the actuation of the cannula retreat button on the actuation mechanism to evacuate the side sample port of the stylet and at the same time open the side sample port of the stylet by the proximal movement of the cannula due to the force generated by the cannula retreat spring. ..

The present invention, in another embodiment, is directed to a biopsy apparatus comprising a housing having an actuating mechanism. The carriage assembly is movable relative to the housing. The carriage assembly consists of a stylet assembly wall that assembles a stylet with a sample port, a cannula slide that assembles a cutting cannula, a sampling slide that is movably placed between the stylet assembly wall and the cannula slide, and a carriage. Includes latch cover member. The cannula slide is vertically separated and movable with respect to the stylet assembly wall. The cannula slide has a first latch member, the sampling slide has a second latch member, and the carriage latch cover member has a third latch member. The charge handle is slidably attached to the housing. The charge handle has a fixed position and a retracted position. A sampling spring is placed between the stylet assembly wall and the sampling slide. A cannula retracting spring is arranged between the sampling slide and the cannula slide, and the cannula retracting spring is connected to the sampling slide and the cannula slide. A prime piercing spring is placed between the carriage assembly and a portion of the housing. The vacuum system is configured to selectively supply vacuum to the stylet sample port. The biopsy device charges the sampling spring by moving the cannula slide and the sampling slide all at once in the proximal direction by the first retract of the charge handle, and locks the second latch member of the sampling slide to the carriage latch cover member. The sampling spring is kept in a charged state, and the vacuum system is charged to generate a vacuum. The first return of the charge handle returns the charge handle to a fixed position. The second retreat of the charge handle moves the charge handle to the retreat position. The second return of the charge handle to the home position moves the cannula slide distally from the sampling slide to charge the cannula retracting spring and also locks the first latch member of the cannula slide to the carriage latch cover member. Keep the cannula retreat spring in a charged state. The third retract of the charge handle moves the entire carriage assembly proximally to charge the prime piercing spring, and also locks the third latch member of the carriage latch cover member to the actuating mechanism to charge the prime piercing spring. Keep in state.

The present invention, in another embodiment, is directed to a biopsy apparatus comprising a stylet arranged to extend along the vertical axis. The stylet has a first side wall configured to demarcate the first lumen and a side sample port leading to the first lumen through the first side wall. The cannula is coaxial with the stylet. The cannula has a second side wall and a distal cutting edge configured to demarcate the second lumen. The housing has a proximal end wall, an intermediate wall and a distal end separated along the vertical axis. The distal end has a needle opening. The housing is configured to define a housing chamber between the proximal end wall and the distal end. The intermediate wall is located between the proximal end wall and the distal end. Stylets and cannulas are accepted through the needle opening. The proximal direction is from the distal end to the proximal end wall, and the distal direction is from the proximal end wall to the distal end. The charge handle is slidably attached to the housing. The charge handle is configured to move between the home position and the retracted position. The actuating mechanism has a piercing button, a cannula retract button, a sample acquisition button, and a carriage latch strike. The carriage assembly is located inside the housing. The carriage assembly is configured to move vertically with respect to the housing as a whole. The carriage assembly includes a carriage slide, a carriage latch cover member, a cannula slide and a sampling slide. The cannula slide and sampling slide are configured to be movable relative to the carriage slide. The carriage slide has a stylet assembly end wall configured to assemble the stylet. The cannula slide has a cannula assembly end wall configured to assemble the cannula and a first latch arm extending proximally from the cannula assembly end wall. The sampling slide is movably placed between the stylet-assembled end wall of the carriage slide and the cannula-assembled end wall of the cannula slide. The sampling slide has a second latch arm that extends distally. 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 engage freely with the first latch arm. The second latch strike is configured to engage freely with the second latch arm. The carriage latch arm is configured to engage freely with the carriage latch strike of the actuating mechanism. A sampling spring is placed between the stylet assembly end wall and the sampling slide. The sampling spring is configured to store mechanical energy in the compressed state and is configured to urge the sampling slide in the distal direction. The sampling spring is kept in a compressed state when the second latch arm is engaged with the second latch strike. The vacuum system is located inside the enclosure and carried by a carriage assembly. The vacuum system is charged when the sampling spring is compressed to generate a vacuum. A cannula retracting spring is arranged between the sampling slide and the cannula slide, and the cannula retracting spring is connected to the sampling slide and the cannula slide. The cannula retracting spring is configured to store mechanical energy in the stretched state to urge the cannula slide in the proximal direction. The cannula retracting spring is kept open and free when the first latch arm is engaged with the first latch strike and the second latch arm is engaged with the second latch strike. A prime piercing spring is placed between the intermediate wall of the housing and the end wall of the stylet assembly. The prime piercing spring is configured to store mechanical energy in the compressed state and is configured to urge the entire carriage assembly in the distal direction. The prime piercing spring is kept compressed when the carriage latch arm is engaged with the carriage latch strike of the actuating mechanism.

The biopsy device may also include a positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide. The cannula assembly end wall has a positioning window. The positioning mechanism is configured to selectively cover a portion of the positioning window. The charge handle has a charge handle latch arm configured to pass through the positioning window when the charge handle is moved to the retracted position and is distal when the positioning mechanism is arranged to cover a portion of the positioning window. Subsequent movement of the charge handle towards a home position engages the charge handle latch arm with the positioning mechanism to move the cannula slide distally from the sampling slide and charge the cannula retracting spring.

In another embodiment, the present invention is directed to a biopsy apparatus including a housing having a vertical axis. The housing is configured to define the housing chamber. The actuating mechanism has a cannula retract button, a sample acquisition button and a carriage latch strike. A carriage assembly is placed in the housing chamber. The carriage assembly includes a carriage slide with a carriage base and a stylet assembly wall. The carriage assembly further includes a sampling slide, a cannula slide and a carriage latch cover member. The cannula slide is vertically separated from the stylet assembly wall and is movable with respect to the stylet assembly wall. The cannula slide has a first latch arm. The carriage latch cover member has a first latch strike and a second latch strike. The first latch arm is configured to engage freely with the first latch strike. The stylet is fixed and connected to the wallet assembly wall. The stylet is configured to extend along the vertical axis and has a side sample port. The carriage assembly carries the vacuum source. The vacuum source is configured to selectively evacuate the side sample port of the stylet. The cannula is fixed and connected to the cannula slide. The cannula is coaxial with the stylet. The cannula has a distal cutting edge. The sampling slide is movably placed between the stylet assembly wall and the cannula slide. The sampling slide has a second latch arm and a latch arm deflection member. The second latch arm is configured to be releasably engaged with the second latch strike of the carriage latch cover member. The latch arm deflecting member is configured to engage the first latch arm of the cannula slide and deflect the first latch arm towards the carriage base. A sampling spring is placed between the stylet assembly wall and the sampling slide. The sampling spring is kept in a compressed state when the second latch arm is engaged with the second latch strike. A cannula retracting spring is arranged between the sampling slide and the cannula slide, and the cannula retracting spring is connected to the sampling slide and the cannula slide. The cannula retracting spring is mechanically maintained in a freely extended state when the first latch arm engages the first latch strike and the second latch arm engages the second latch strike. Accumulates mechanical energy. The cocking mechanism has a charge handle, an urging spring, and a positioning mechanism. The charge handle is slidably attached to the housing and is urged to a fixed position in the distal direction by an urging spring. The charge handle is configured to move between the home position and the retracted position. The charge handle and positioning mechanism are configured to selectively move the sampling slide and cannula slide in response to a series of operations on the charge handle, and the first retreat of the charge handle causes the sampling slide and cannula slide to move in the proximal direction all at once. Move to compress the sampling spring, engage the second latch arm with the second latch strike to keep the sampling spring in a compressed state and charge the vacuum source, the charge handle is driven by the force exerted by the urging spring. It is configured to return to a fixed position and advance the positioning mechanism to the next selected position. In the second retract of the charge handle, the charge handle is moved to the retracted position, and the charge handle is placed in the fixed position by the force exerted by the urging spring. When returning to, the charge handle engages with the cannula slide, which moves the cannula slide distally, thereby extending the cannula retracting spring to the stretched state and the first latch arm with the first latch strike. Releasably engaged to keep the cannula retracting spring in an extended state, the cannula is placed to close the side sample opening of the stylet. The actuating mechanism releases the first latch arm from the first latch strike by activating the cannula retract button, releases the cannula retract spring and moves the cannula in the proximal direction to force the side sample opening of the stylet. At the same time, a vacuum is applied to the side sample port, and the sample acquisition button is activated to release the second latch arm from the second latch strike, release the sampling spring, and move the cannula in the distal direction to move the side sample port distally. It is configured to exert the force to close.

In another embodiment, the present invention relates to a method of operating a biopsy apparatus, wherein the method is to provide a housing having an actuating mechanism and to provide a movable carriage assembly with respect to the housing. The assembly includes a stylet assembly wall for assembling the stylet, a cannula slide for assembling the cutting cannula, a sampling slide movably placed between the stylet assembly wall and the cannula slide, and a carriage latch cover member. , The carriage assembly is provided and the cannula slide is vertically separated from the stylet assembly wall and is movable with respect to the stylet assembly wall, and at least of the cannula slide, the sampling slide, and the entire carriage assembly. A charge handle that sequentially moves one is provided, and the charge handle has a fixed position and a retracted position. The charge handle is provided and sampling is arranged between the stylet assembly wall and the sampling slide. A spring is provided and a cannula retracting spring is provided between the sampling slide and the cannula slide and is connected to the sampling slide and the cannula slide, and is arranged between the carriage assembly and a part of the housing. A prime piercing spring is provided, a vacuum system that selectively supplies vacuum to the sample port of the stylet is provided, and the cannula slide and the sampling slide are moved simultaneously in the proximal direction to charge the sampling spring and sample. In order to lock the slide to the carriage latch cover member to keep the sampling spring in the charged state and to charge the vacuum system with vacuum, the charge handle is retracted for the first time and the charge handle is moved to the fixed position for the first time. Returning, retracting the charge handle to the retracted position for the second time, moving the cannula slide distal to the sampling slide to charge the cannula retracting spring, and engaging the cannula slide with the carriage latch cover member. In order to stop and keep the retreat spring in the charged state, the charge handle is returned to the fixed position for the second time, and the entire carriage assembly is moved in the proximal direction to charge the prime pierce spring, and the carriage latch cover member. To keep the prime piercing spring in a charged state by locking it to the actuating mechanism, charge Includes retreating the handle for the third time.

One advantage of the present invention is that the biopsy device is entirely disposable.

Another advantage of the present invention is that the biopsy apparatus is entirely mechanical and has no electrical components, so no power supply is required.

According to at least one aspect of the invention, another advantage is that the biopsy device creates a vacuum before retracting the cutting cannula to expose the sample mouth of the biopsy needle, facilitating efficient vacuum use. It is to support sample acquisition.

Another advantage of the present invention is that the biopsy apparatus is configured to be easy to use.

The above advantages may be realized individually or collectively depending on the aspects of the invention utilized in a particular implementation.

By reference to the following description of an embodiment of the invention in conjunction with the accompanying drawings, the above-mentioned features and advantages of the invention and other features and advantages and methods of achieving them will become clearer and the invention will be more pronounced. It is well understood.

It is a perspective view of the biopsy apparatus of this invention. It is a top view of the biopsy apparatus of FIG. It is a side view of the biopsy apparatus of FIG. FIG. 1 is a partially exploded view of the biopsy apparatus of FIG. 1 revealing a carriage assembly. It is a complete exploded view of the biopsy apparatus of FIG. It is a top view of the charge handle of the biopsy apparatus of FIG. FIG. 3 is a top perspective view of the operating mechanism of the biopsy apparatus of FIG. It is a bottom perspective view of the operation mechanism of the biopsy apparatus of FIG. FIG. 5 is a perspective view of the prime piercing carriage of the carriage assembly of FIGS. 4 and 5, wherein the carriage latch cover member is separated from the carriage slide. It is a side view of the carriage latch cover member of FIGS. 4, 5, and 8. It is an enlarged view of the carriage assembly of FIGS. 4 and 5. FIG. 10 is an exploded view showing a portion of the carriage assembly of FIG. 10, revealing a vacuum system, with the carriage latch cover member removed. It is a rear perspective view of the sampling slide of the carriage assembly of FIGS. 4, 5, and 10. FIG. 12A is a front perspective view of the sampling slide of FIG. 12A. It is a perspective view of the cannula slide and the positioning mechanism of the carriage assembly of FIGS. 4, 5, and 10. It is an enlarged perspective view of the cannula slide indexer of the positioning mechanism shown in FIGS. 5 and 13. FIG. 14A is an end view of the cannula slide indexer of FIG. 14A. It is an enlarged perspective view of the sampling slide indexer of the positioning mechanism shown in FIGS. 5 and 13. FIG. 15A is a rear view (proximal) view of the sampling slide indexer of FIG. 15A. Relative of the cannula slide indexer and sampling slide indexer of the positioning mechanism shown in FIGS. 5, 13 and 14A-15B when the biopsy device arrives from the manufacturer and is new and when the biopsy procedure is complete. Indicates the position. After the first retract (proximal) stroke of the charge handle of the biopsy device of FIG. 1 where the sampling spring and vacuum spring are charged, and the second retract (proximal) stroke and second of the charge handle. The relative positions of the cannula slide indexer and the sampling slide indexer of the positioning mechanism shown in FIGS. 5, 13 and 14A-15B before and during the return (distal) stroke are shown. After the second return (distal) stroke of the charge handle of the biopsy device of FIG. 1 where the cannula retract spring is charged, and the third retract (proximal) stroke of the charge handle to charge the prime piercing spring. The relative positions of the cannula slide indexer and the sampling slide indexer of the positioning mechanism shown in FIGS. 5, 13 and 14A to 15B before the above are shown. It is a top view of the subassembly formed by the sampling slide and the cannula slide shown in FIGS. 5, 12A, and 13 before being inserted into the prime piercing carriage of FIG. FIG. 1 shows a top view of the biopsy device, with the upper case removed, the carriage latch cover member separated from the carriage slide, and when the biopsy device is new and the charge handle is in place. , Or reveals the location of the carriage assembly sampling slide, cannula slide and vacuum system after the biopsy tissue sampling cycle of the biopsy device is complete. Showing the biopsy device shown in FIG. 20, the charge handle is in the retracted position and the first retract (proximal) stroke of the charge handle causes the sampling slide and cannula slide to be on the carriage slide of the prime piercing carriage. On the other hand, it is moved collectively in the proximal direction and charges the vacuum spring and sampling spring of the vacuum system at the same time. The biopsy apparatus shown in FIG. 21 shows that when the charge handle is released from the retracted position of FIG. 21, the urging spring discharges and the first return (distal direction) stroke of the charge handle is performed. The charge handle returns to the fixed position. The biopsy apparatus shown in FIG. 22 shows a second retracting (proximal) stroke in which the charge handle reaches the retracting position in the proximal direction to prepare for charging of the cannula retracting spring. The biopsy apparatus shown in FIG. 23 is shown where when the charge handle is released from the retracted position of FIG. 23, the charge handle engages with the cannula slide during the second return (distal direction) stroke and from the sampling slide. Pull the cannula slide distally to charge (extend) the cannula retracting spring and the charge handle will return to its home position. The biopsy device shown in FIG. 24 shows a third retract (proximal direction) of the charge handle in the proximal direction that moves the entire carriage assembly proximally to charge (compress) the prime piercing spring. ) Shows the process. The biopsy apparatus shown in FIG. 25 shows that when the charge handle is released from the retracted position of FIG. 25, the urging spring discharges and a third return (distal direction) stroke of the charge handle is performed. The charge handle returns to the fixed position.

Matching reference characters in some figures indicate matching parts. The illustrations described herein illustrate an embodiment of the invention and should not be construed as limiting the scope of the invention in any way.

Detailed description of the invention

From this, with reference to the drawings, and more specifically with reference to FIGS. 1 to 5, the biopsy apparatus 10 according to the embodiment of the present invention is shown. The biopsy apparatus 10 is configured as a single insertion single sample (SISS) type biopsy apparatus and is a totally disposable, self-contained, totally mechanical vacuum assisted biopsy apparatus. As used in this book, the term "disposable" refers to a device that should be disposed of after use by a single patient. Therefore, the biopsy apparatus 10 should be used to obtain one or more tissue samples from one patient during one biopsy procedure, and the entire biopsy device should be discarded after the biopsy procedure is completed. Is.

With reference to FIGS. 1 to 3, the biopsy apparatus 10 includes a housing 12, a biopsy needle 14, a charge handle 16, and an actuating mechanism 18. The biopsy needle 14 includes a stylet 20 and a cannula 22. In the present embodiment, the housing 12, the charge handle 16, and the operating mechanism 18 are made of plastic, and the stylet 20 and the cannula 22 are made of a metal material such as stainless steel. Hereinafter, when the orientation and operation of the components of the biopsy apparatus 10 will be described in more detail, the distal direction D1 and the proximal direction D2 will be referred to with reference to the vertical axis 23 for convenience. Proximal direction D2 is the longitudinal direction opposite to distal direction D1.

As can be seen in FIGS. 1 to 3, the biopsy needle 14 is located distally D1 from the housing 12 along the vertical axis 23.
Extend to. The stylet 20 and the cannula 22 of the biopsy needle 14 are arranged so as to extend along the vertical axis 23. In this embodiment, as shown in FIGS. 1 to 3, the cannula 22 is located outside the stylet 20, and the cannula 22 is arranged as an outer tube having a coaxial structure including the stylet 20 and the cannula 22. The stylet 20 and the cannula 22 have a size in which the stylet 20 fits snugly and is slidably accepted in the cannula 22, and the inner diameter of the cannula 22 has a tolerance of 0.01 mm (mm) to 1.0 mm. It is slightly larger than the outer diameter of the stylet 20 in the range.

In the description of the present invention, for convenience of the reader's understanding of the present invention shown in the drawings, the general directions such as upper, lower, upper, lower, highest, lowest, right, left, vertical, and horizontal are shown. Terms may be used relative to the orientation of the biopsy apparatus 10 shown in FIGS. 1 and 3-5.

In the orientation shown in FIG. 1, also with reference to FIGS. 4 and 5, the housing 12 includes an upper case portion 24 and a lower case portion 25. The upper case portion 24 is joined to the lower case portion 24 by a removable fastener 27 such as a screw. The upper case portion 24 of the housing 12 has upper slots 24-2 and 24-3 facing the opening 24-1. The opening 24-1 is configured to receive and assemble the actuating mechanism 18. Alternatively, the actuating mechanism 18 may be integrated with the upper case portion 24 of the housing 12 at the position of the opening 24-1. The lower case portion 25 has facing guide rails 25-1 and 25-2, which define the lower slot, and the charge handle 16 together with the facing upper slots 24-2 and 24-3 of the upper case portion 24. Is slidably assembled.

The upper case portion 24 and the lower case portion 25 of the housing 12 jointly define the proximal end wall 26 and the distal end portion 28 separated from the proximal end wall 26 along the vertical axis 23. The distal direction D1 is the direction from the proximal end wall 26 to the distal end 28, for example, from the housing 12 and from the user to the biopsy needle 14. Proximal direction D2 (opposite of distal direction D1) is the direction from the distal end 28 to the proximal end wall 26, eg, to the user.

The housing 12 is configured to define a housing chamber 30 between the proximal end wall 26 and the distal end 28. In this embodiment, the lower case portion 25 of the housing 12 further includes an intermediate wall 32 disposed between the proximal end wall 26 and the distal end wall 28. With reference to FIG. 1, the distal end 28 has a needle opening 12-1 configured to receive the biopsy needle biopsy needle 14, and the vertical axis 23 passes through the needle opening 12-1 and yet. It passes through the vertical range of the biopsy needle 14. The proximal end wall 26 faces the user when the user grips the biopsy device 10 in the usual way.

The charge handle 16 and the actuation mechanism 18 intuitively operate the biopsy device 10 and provide the user with an easy-to-use control function for obtaining a tissue sample from the patient's suspicious tissue through the biopsy needle 14.

The charge handle 16 is used to prepare the biopsy device 10 for performing the biopsy procedure, and prepares the biopsy needle 14 to promote the generation of vacuum and to cut and collect the tissue sample.

As seen in FIGS. 4-6, the charge handle 16 has a U-shaped charge handle body 34, a charge handle end wall 36, and a charge handle latch arm 38. The charge handle latch arm 38 extends in the proximal direction D2 from the charge handle end wall 36 like a cantilever. The charge handle end wall 36 intersects the U-shaped charge handle body 34 laterally to define a handle assembly opening 36-1 (see FIG. 5) having a semicircle beneath the charge handle end wall 36. When assembling, the distal end 28 of the lower case 25 is passed through the handle assembly opening 36-1, and the charge handle end wall 26 is placed on the opposite guide rails 25-1 and 25-2 of the lower case 25. Charge to the laterally separated lower case slots defined by the laterally separated guide rails 25-1, 25-2 and the upper slots 24-2, 24-3 of the upper case 24. The handle 16 is slidably assembled.

The charge handle latch arm 38 has a free end 38-1, and the free end 38-1 has a catch 38-2 that projects laterally. The charge handle latch arm 38 is configured to be rigid in the vertical direction and elastic in the horizontal direction and in a direction substantially perpendicular to the vertical range of the charge handle latch arm 38. As used in this book, the term "generally vertical" is the direction in which there is a deviation range of plus or minus 5 degrees from the vertical.

With reference to FIGS. 4-6, the charge handle 16 is urged in the distal direction D1 by an urging mechanism formed by at least one urging spring, and in this embodiment, between the housing 12 and the charge handle 16. Includes a set of urging springs 39-1, 39-2 arranged in. In the present embodiment, the urging springs 39-1 and 39-2 are coil springs having a contracted / relaxed state. Specifically, the urging spring 39-1 ends with the spring mounting ring 25-3 (see FIGS. 4 and 5) of the lower case portion 25 of the housing 12 and the charge handle end wall of the charge handle 16. It is attached to the spring mounting ring 36-2 (see FIG. 6) of 36. Similarly, the urging spring 39-2 ends with a spring mounting ring 25-4 (see FIGS. 4 and 5) of the lower case portion 25 of the housing 12 and a spring of the charge handle end wall 36 of the charge handle 16. It is attached to the attachment ring 36-3 (see FIG. 6). The charge handle 16 is configured to be held in the user's hand and to move between a fixed (distal) position and a retracted (proximal) position as shown in FIGS.

With reference to FIGS. 1-3 again, the actuating mechanism 18 fires a biopsy needle in the distal direction D1 to perform a puncture into the tissue to be biopsied and evacuate, as will be described in more detail thereafter. It is used to open the sample opening of the meter reading 14 and operate the biopsy meter 14 to initiate a series of operations to cut the tissue sample.

Also with reference to FIGS. 7A and 7B, the actuation mechanism 18 includes and uses a piercing button 40-1, a cannula retracting button 40-2, and three control buttons 40 individually identified as a sample acquisition button 40-3. One can reach these buttons from outside the biopsy device 10. As can be seen in FIG. 7B, each control button 40 has an actuating portion 42-1.
Includes mechanical extensions that function as 42-2, 42-3.

Also, as seen in FIG. 7B, the actuating mechanism 18 further includes a carriage latch strike 44. In this embodiment, the carriage latch strike 44 is configured as an inverted slope and has a downward slope 44-1 which deviates in the proximal direction D2 to define the proximal end face 44-2.

Referring again to FIGS. 4 and 5, the biopsy apparatus 10 further includes a carriage assembly 50 that is disposed and slidably housed in the housing chamber 30 of the housing 12. As will be described in more detail thereafter, the carriage assembly 50 is configured to move vertically with respect to the housing 12 along the vertical axis 23, and is configured to be assembled with the biopsy needle 14.

As seen in FIGS. 4 and 5, the carriage assembly 50 includes a prime piercing carriage 52, a cannula slide 58, a sampling slide 56, and a vacuum system 54. The term "prime" used in this document refers to the function of preparing the biopsy device 10 to perform the tissue puncture function by retracting the stylet 20 and cannula 22 in preparation for "piercing", i.e. the function of cocking. ,means. The term "piercing" means the ability to simultaneously fire the stylet 20 and the cannula 22 in the distal direction D1, whereby the biopsy needle 14 pierces the patient's tissue at the desired location. The term "slide" is a mechanical structure with a guide, configured to move along a predetermined path defined by another mechanical structure. In this embodiment, the prime piercing carriage 52, the cannula slide 58, and the sampling slide 56 are configured to move along a substantially straight path. The term "generally straight path" is a path with a deviation range of plus or minus 3 degrees along the entire length of the path from the straight line.

Also with reference to FIG. 8, the prime piercing carriage 52 includes a carriage slide 60 that functions as a lower prime piercing carriage section and a carriage latch cover member 62 that functions as an upper prime piercing carriage section. Also referring to FIG. 5, the sampling slide 56 and the cannula slide 58 move vertically, individually and collectively with respect to the prime piercing carriage 52 formed by the carriage slide 60 and the carriage latch cover member 62. be able to. The prime piercing carriage 52, sampling slide 56 and cannula slide 58 are made of plastic.

The carriage slide 60 of the prime pierced carriage 52 of the carriage assembly 50 has a carriage base 64 and a stylet assembly end wall 66. In this embodiment, the carriage base 64 and the stylet assembly end wall 66 are formed as a single carriage structure.

The carriage base 64 of the carriage slide 60 is configured to define a U-shaped wall 64-1 having a U-shaped outer surface 64-2 and a U-shaped inner surface 64-3, and is therefore distal to the stylet assembly end wall 66. It has a U-shaped cross section extending to D1, a U-shaped distal edge 66-4, a set of laterally separated superior assembly edges 64-5, 64-6, and a set of laterally separated edges. It defines the isolated recessed slot edges 64-7, 64-8. A vertically oriented prime piercing spring assembly rod 64-9 extends upwardly and proximally from the U-shaped inner surface 64-3.

The U-shaped outer surface 64-2 conforms to the internal shape of the housing chamber 30 and is in sliding contact with the housing chamber 30, and the housing chamber 30 functions as a vertical guide for the carriage assembly 50. The U-shaped distal edge 64-4 defines the open distal end of the carriage slide 60. A set of laterally separated upper assembly edges 64-5, 64-6 and a set of laterally separated recessed slot edges 64-7, 64-8 are the open upper 60 of the carriage slide 60. -2 is further defined.

The stylet assembly end wall 66 has a stylet hole 66-1, a first pump assembly opening 66-2, a second pump assembly opening 66-3, and a prime piercing spring opening 66-4. Have. The prime piercing spring opening 66-4 is axially aligned with the prime piercing spring assembly rod 64-9 of the carriage base 64 of the carriage slide 60. The stylet hole 66-1 is configured to fix and assemble the stylet 20, for example by press fitting and / or adhesive junction. As will be described in more detail later, the first pump assembly opening 66-2 and the second pump assembly opening 66-3 are configured to assemble a set of syringe-type vacuum pumps of the vacuum system 54. ..

With reference to FIGS. 1-5, as best seen in FIG. 8, the stylet 20 of the biopsy needle 14 is internal through a side wall 20-1 configured to define lumen 20-2 and a side wall 20-1. It has a side sample port 20-3 leading to lumen 20-2. The stylet 20 has an open first end 20-4 and a closed second end 20-5. The occluded second end 20-5 defines the distal puncture tip. The lumen 20-2 communicates fluidly with the open first end 20-4 and the side sample port 20-3.

The proximal portion 20-6 of the stylet 20 extends proximally D2 from the stylet-assembled end wall 66, and the distal portion 20-7 of the stylet 20 extends distally D1 from the stylet-assembled end wall 66. Extend to. The distal portion 20-7 of the stylet 20 extends distally D1 beyond the distal range of the carriage base 64 and the carriage latch cover member 62 and is received by the needle opening 12-1 of the housing 12 (FIG. See also 1).

The carriage latch cover member 62 is configured to adhere to a set of laterally spaced upper assembly edges 64-5, 64-6 of the carriage base 64, for example with a snap and / or adhesive. The carriage latch cover member 62 is laterally isolated recessed slot edges 62-1, 62, respectively, vertically opposed to the laterally spaced recessed slot edges 64-7, 64-8 of the carriage base 64. Includes -2. The carriage latch cover member 62 covers the open top 60-2 of the carriage slide 60 and defines an internal area across the carriage base 64 of the carriage slide 60, in which the cannula slide 58 is a stylet-assembled end wall. It can move vertically with respect to 66. Specifically, the U-shaped inner surface 64-3 of the U-shaped wall 64-1 of the carriage slide 60 and the open distal end 60-1 of the carriage slide 60 slidably accept the sampling slide 56 and the cannula slide 58. , Is configured to guide vertically.

The carriage latch cover member 62 is configured to facilitate selective longitudinal coupling and separation of the carriage slide 60 with the sampling slide 56 and the cannula slide 58. The carriage latch cover member 62 has a latch strike 70, a latch strike 72, a carriage latch arm 74, and a deflector arm 76. The carriage latch cover member 62 further includes conduit assembly portions 62-3, 62-4.

In the present embodiment, the latch strike 70 and the latch strike 72 are configured as locking notches. More specifically, the latch strike 70 and the latch strike 72 of the carriage latch cover member 62 are as rectangular openings having a proximal end wall and a distal end wall oriented approximately perpendicular to the vertical axis 23. It is composed.

The carriage latch arm 74 is configured as a cantilever arm with a free end, which free end has a catch 78 that extends upward. The catch 78 is configured as an incline having an upward inclined surface 78-1, and the inclined surface 78-1 deviates in the distal direction D1 to define the distal end surface 78-2. The carriage latch arm 74 is configured to be rigid in the vertical direction and elastic in the directions D3 and D4 (for example, up and down) substantially perpendicular to the vertical range of the carriage latch arm 74. Direction D3 and D4 are opposite directions.

As will be described in more detail later, when the carriage assembly 50 is completely retracted in the proximal direction D2 by the operation of the charge handle 16, the carriage latch arm 74 of the carriage latch cover member 62 is the carriage latch strike 44 of the actuating mechanism 18. The carriage assembly 50 and the housing 12 are engaged until the carriage latch arm 74 is released by the operation of the piercing button 40-1 of the actuating mechanism 18 by freely engaging with the proximal end surface 44-2 (see FIG. 7B). To prevent relative movement between the carriage assembly 50 and the housing 12.

Also referring to FIG. 9, the deflector arm 76 of the carriage latch cover member 62 is configured to be rigid in the vertical direction and rigid in the horizontal direction in a direction substantially perpendicular to the vertical range of the deflector arm 76. .. The deflector arm 76 is configured as a cantilever arm with a free end, which free end has a downward deflector head 80. The deflector head 80 has a downwardly inclined surface 80-1, which the downwardly inclined surface 80-1 deviates in the distal direction D1 and ends at the downwardly inclined surface 80-2.

With reference to FIGS. 4 and 5, the vacuum system 54 is assembled to the carriage assembly 50 and is carried by the carriage assembly 50 and is completely housed in the housing 12 of the biopsy apparatus 10. More specifically, the vacuum system 54 is assembled to the prime piercing carriage 52 of the carriage assembly 50 with reference to FIG.

With reference to FIGS. 5, 10 and 11, the vacuum system 54 includes a vacuum pump 90, a vacuum pump 92, a manifold 94, a control valve 96, flexible connecting conduits 98-1, 98-2, 98-3, and 98-. Includes 4 and.

In particular, referring to FIG. 11, the vacuum pump 90 is a syringe type vacuum pump. The vacuum pump 90 includes an elongated cylinder 100 having a first end 100-1 and a second end 100-2. The tip portion 100-3 extends from the first terminal 100-1, and the tip portion 100-3 defines the first vacuum port 100-4. The second end 100-2 has a first opening 100-5. The first piston 102 is slidably received by the elongated cylinder 100 through the first opening 100-5. The first plunger 104 is attached to or integrated with the first piston 102. The first plunger 104 is configured to extend from the second end 100-2 of the elongated cylinder 100. The first plunger 104 has a free end 104-1 with a head 104-2. A first vacuum spring 106 is arranged between the second end 100-2 of the elongated cylinder 100 and the head 104-2 of the first plunger 104. The first vacuum spring 106 is configured to store mechanical energy when in a compressed state, yet in the direction shown, the first vacuum by urging the first piston 102 in the distal direction D1. It is configured to establish a vacuum at the mouth 100-4.

The vacuum pump 92 is also a syringe type vacuum pump and has the same configuration as the vacuum pump 90. The vacuum pump 92 includes an elongated cylinder 110 having a first end 110-1 and a second end 110-2. A tip portion 110-3 extends from the first end 110-1, and the tip portion 110-3 defines a second vacuum port 110-4. The second end 110-2 defines the second opening 110-5. The second piston 112 is slidably received by the elongated cylinder 110 through the second opening 110-5. The second plunger 114 is attached to or integrated with the second piston 112. The second plunger 114 is configured to extend from the second end 110-2 of the elongated cylinder 110. The second plunger 114 has a free end 114-1 with a head 114-2. A second vacuum spring 116 is arranged between the second end 110-2 of the elongated cylinder 110 and the head 114-2 of the second plunger 114. The second vacuum spring 116 is configured to store mechanical energy when in a compressed state, yet in the orientation shown, the second vacuum by urging the second piston 112 in the distal direction D1. It is configured to establish a vacuum at the mouth 110-4.

The manifold 94 has a first evacuation port 94-1, a second evacuation port 94-2, and a first evacuation port 94-3. The manifold 94 has a first one-way valve 94-4 that is connected to the first vacuum extraction port 94-1 by fluid communication, and a second vacuum extraction port 94-2 that is connected to the second vacuum extraction port 94-2 by fluid communication. It has a one-way valve 94-5. The first one-way valve 94-4 and the second one-way valve 94-5 release positive pressure to the atmosphere in order to promote positive pressure purging from the vacuum pumps 90 and 92 when the sampling spring 182 is charged. It is configured to close when a vacuum is established by the vacuum pumps 90 and 92. In this embodiment, the first one-way valve 94-4 and the second one-way valve 94-5 are duck bill valves.

The control valve 96 has a third vacuum extraction port 96-1 and a second vacuum application port 96-2, and a button actuator 96-3. The button actuator 96-3 selectively controls the fluid communication between the third vacuum extraction port 96-1 and the second vacuum application port 96-2. Also with reference to FIGS. 5, 7A, and 7B, the control valve 96 is operated by the operation of the cannula retreat button 40-2 of the actuating mechanism 18, which activates the button actuator 96-3 of the control valve 96 and the stylet. Simultaneously with the movement of the cannula 22 in the proximal direction D2 with respect to 20, a vacuum is applied at the side sample port 20-3 of the stylet 20 to prepare the biopsy device 10 for tissue sampling.

The first vacuum port 100-4 of the vacuum pump 90 is fluidly coupled to the first vacuum extraction port 94-1 of the manifold 94 via a flexible connection conduit 98-1. The second vacuum port 110-4 of the vacuum pump 92 is fluidly coupled to the second vacuum outlet 94-2 of the manifold 94 via a flexible connection conduit 98-2. The flexible connection conduits 98-1 and 98-2 may take the form of rubber tubular sleeves and are integrated with the manifold 94 in this embodiment. The first evacuation port 94-3 of the manifold 94 is fluidly coupled to the third evacuation port 96-1 of the control valve 96 via a flexible connection conduit 98-3. The second evacuation port 96-2 of the control valve 96 fluidly communicates with the lumen 20-2 at the open first end 20-4 of the stylet 20 via a flexible connecting conduit 98-4. Will be done. The flexible connecting conduits 98-3 and 98-4 may take the form of rubber tubes and are secured to the carriage latch cover member 62 by the conduit assembly portions 62-3, 62-4.

With reference to FIGS. 5, 10 and 11 again, the vacuum pump 90 is received in the first pump assembly opening 66-2 of the stylet assembly end wall 66 of the stylet assembly slider 54, eg press fit and / Alternatively, the proximal cylinder portion 100-6, which is assembled by adhesion and has a first vacuum port 100-4, is configured to extend from the stylet assembly end wall 66 in the proximal direction D2 and has a second opening 100. The distal cylinder portion 100-7 having -5 is configured to extend distally D1 from the stylet assembly end wall 66. Similarly, the vacuum pump 92 is received in the second pump assembly opening 66-3 of the stylet assembly end wall 66 of the stylet assembly slider 54 and is assembled by, for example, press fitting and / or gluing, a second. The proximal cylinder portion 110-6 having the vacuum port 110-4 is configured to extend in the proximal direction D2 from the stylet assembly end wall 66, and the distal cylinder portion 110 having a second opening 110-5. -7 is configured to extend distally D1 from the stylet assembly end wall 66.

With reference to FIGS. 5 and 11, the head 104-2 of the plunger 104 of the vacuum pump 90 and the head 114-2 of the plunger 114 of the vacuum pump 92 are arranged to be engaged by the cannula slide 58. During the first retreat of the charge handle 16 in the proximal direction D2, the cannula slide 58 moves in the proximal direction D2, which causes the pistons / plungers 102/104 and 112/114 of the vacuum pumps 90, 92, respectively, in the proximal direction. Moved by D2. Then, the first vacuum spring 106 of the vacuum pump 90 and the second vacuum spring 116 of the vacuum pump 92 are charged (compressed). The compression of the first vacuum spring 106 of the vacuum pump 90 and the compression of the second vacuum spring 116 of the vacuum pump 92 occur at the same time.

When the first vacuum spring 106 and the second vacuum spring 116 are charged, the pistons / plungers 102/104 and 112/114, respectively, are moved in the proximal direction D2 and the elongated cylinders 100 of the vacuum pumps 90, 92. , 110 is evacuated, or purged, under positive pressure through the one-way valves 94-4, 94-5. After that, when the cannula slide 58 moves in the distal direction D1, the first vacuum spring 106 and the second vacuum spring 116 begin to depressurize, urging the pistons / plungers 102/104 and 112/114 of the vacuum pumps 90 and 92. And move it in the distal direction D1. Due to the movement of the pistons / plungers 102/104 and 112/114 of the vacuum pumps 90 and 92 in the distal direction D1, the first vacuum port 100-4 of the vacuum pump 90 and the second vacuum port 110 of the vacuum pump 92 A vacuum is established at -4 and closes via the one-way valves 94-4 and 94-5 of the manifold 94.

With reference to FIGS. 4, 5, 12A, and 12B, a sampling slide 56 is arranged between the carriage slide 60 and the cannula slide 58 of the prime piercing carriage 52. Also with reference to FIG. 8, the sampling slide 56 of the carriage assembly 50 is configured to be slidably accepted at the open distal end 60-1 of the prime piercing carriage 52.

In particular, with reference to FIGS. 12A and 12B, the sampling slide 56 has an intermediate slide wall 120, a pair of facing sidewalls 122, 124, a latch arm 126, and a latch arm deflection member 128. The intermediate slide wall 120 has a needle hole 120-1, a first pump opening 120-2, a second pump opening 120-3, and a distal surface 120-4. A set of spring mounting rings 120-5, 120-6 extend distally from the distal surface 120-4.

The needle hole 120-1 is configured to slidably accept the stylet 20 of the biopsy needle 14, and the needle hole 120-1 has a size and shape that functions as a bearing guide surface with respect to the stylet 20. The inner diameter of the needle hole 120-1 is slightly larger than the outer diameter of the stylet 20 within a tolerance range of 0.01 mm (mm) to 1.0 mm.

The first pump opening 120-2 is configured to loosely and slidably accept the vacuum pump 90, specifically, the first pump opening 120-2 is the elongated cylinder 100 of the vacuum pump 90 and the first. It is configured to freely pass the plunger 104 of 1 and the first vacuum spring 106. The second pump opening 120-3 is configured to loosely and slidably accept the vacuum pump 92, specifically the second pump opening 120-3 is an elongated cylinder 110 and a first plunger 114. And the first vacuum spring 116 are configured to pass freely.

A set of opposing side walls 122, 124 is joined to the outer periphery of the intermediate slide wall 120 or integrated with the outer periphery of the intermediate slide wall 120. The side wall 122 extends from the intermediate slide wall 120 in the distal direction D1 and the proximal direction D2 and has a curved cross section defining a curved outer surface 122-1. Similarly, the side wall 124 extends from the intermediate slide wall 120 in the distal direction D1 and the proximal direction D2 and has a curved cross section defining a curved outer surface 124-1. The shapes of the side walls 122 and 124 match the shape of the U-shaped inner surface 64-3 of the U-shaped wall 64-1 of the carriage slide 60 (see also FIG. 8). Therefore, the curved outer surfaces 122-1, 124-1 of the pair of opposing side walls 122, 124 of the intermediate slide wall 120 serve as the internal longitudinal guide of the sampling slide 56, the U-shaped wall 64-1 of the carriage slide 60. Sliding contact with the U-shaped inner surface 64-3.

Referring again to FIGS. 12A and 12B, the latch arm 126 is configured as a cantilever arm extending distally D1 from the intermediate slide wall 120, the free end of the cantilever arm having an upward catch 130. The latch arm 126 is configured to be rigid in the vertical direction and elastic in the vertical directions D3 and D4 which are substantially perpendicular to the vertical range of the latch arm 126. With reference to FIG. 12B, the latch arm 126 has a set of vertically opposed tilted surfaces having a downwardly extending bidirectional tilt 126-1 with a set of vertically opposed tilted surfaces. Defines the central vertex 126-2.

Referring again to FIG. 12A, the catch 130 is configured as an incline with an upward inclined surface 130-1, the upward inclined surface 130-1 deviating in the distal direction D1 to define the distal end face 130-2. Extension 126-3 of the latch arm 126 extends distally D1 beyond the distal end face 130-2 and has a proximal L-shaped notch with a floor approximately perpendicular to the distal end face 130-2. Define.

The catch 130 of the latch arm 126 is releasably engaged with the latch strike 72 of the carriage latch cover member 62 (see also FIGS. 8 and 10), and the latch of the carriage latch cover member 62 by the operation of the sample acquisition button 40-3. Until the latch arm 126 is released from the strike 72, the sampling slide 56 is coupled and configured to prevent distal movement of the sampling slide 56 with respect to the carriage slide 60 of the carriage assembly 50.

As seen in FIG. 12B, the latch arm deflection member 128 defines a retention channel 128-1 having a downwardly inclined surface 128-2 and a ceiling 128-3. Ceiling 128-3 extends approximately perpendicularly in the distal direction D1 from the intermediate slide wall 120. The downward inclined surface 128-2 deviates from the upper surface 128-4 of the latch arm deflection member 128 in the proximal direction D2 and connects to the ceiling 128-3.

With reference to FIGS. 5, 8 and 13, the cannula slide 58 of the carriage assembly 50 is also configured to be slidably accepted at the open distal end 60-1 of the prime piercing carriage 52.

As best seen in FIG. 13, the cannula slide 58 has a cannula-assembled end wall 132 and a latch arm 134 extending proximally D2 from the cannula-assembled end wall 132. With reference to FIG. 5, the cannula assembly end wall 132 is longitudinally distally separated from the stylet assembly end wall 66 of the carriage slide 60 along the vertical axis 23. The intermediate slide wall 120 is arranged between the stylet-assembled end wall 66 and the cannula-assembled end wall 132 when viewed in the vertical direction, and the vertical axis 23 from the stylet-assembled end wall 66 and the cannula-assembled end wall 132. Separated along.

With reference to FIGS. 13 and 16-18, the cannula assembly end wall 132 includes a positioning window 132-1, a proximal surface 132-2 and a set of spring mounting rings 132-3, 132-4. A set of spring mounting rings 132-3, 132-4 extend proximally from the proximal surface 132-2.

From the cannula assembly end wall 132, a cannula assembly tube 136 extending in the longitudinal direction extends in the proximal direction D2, and this cannula assembly tube 136 extends from the overhanging proximal end 136-1 and an annular bearing surface. It has 136-2 and a tubular opening 136-3. The cannula 22 is fixedly assembled in the cannula assembly tube 136 of the cannula assembly end wall 132, for example by press fitting and / or gluing.

As can be seen in the isolated portion of FIG. 13, the cannula 22 has a side wall 22-1 configured to demarcate the lumen 22-2 and also has a distal cutting edge 22-3. The proximal portion 22-4 of the cannula 22 extends proximally D2 from the cannula-assembled end wall 132, and the distal portion 22-5 of the cannula 22 extends distally D1 from the cannula-assembled end wall 132. .. The distal portion 22-5 of the cannula 22 is slidably received by the needle opening 12-1 of the housing 12 (see FIG. 1).

The cannula-assembled end wall 132 further includes a set of opposing side walls 138, 140 with a curved cross section, each side wall 138, 140 of the U-shaped inner surface 64-3 of the U-shaped wall 64-1 of the carriage slide 60. It has curved outer surfaces 138-1 and 140-1 that match the shape (see also FIGS. 5 and 8). A pair of opposing side walls 138, 140 of the cannula assembled end wall 132 is a U-shaped inner surface 64 of the U-shaped wall 64-1 of the carriage slide 60 that serves as a vertical guide for the cannula slide 58 in the prime piercing carriage 52. Sliding contact with -3.

Referring again to FIGS. 13 and 16-18, a positioning window 132-1 is located in the lower center of the cannula assembly tube 136, which is a rectangle extending into the cannula assembly end wall 132. It is formed as an opening of. The positioning window 132-1 is arranged between the two vertical guide channels identified laterally as the guide channel 142 and the guide channel 144. The guide channels 142 and 144 are oriented vertically so as to be parallel to the proximal surface 132-2 of the cannula assembly end wall 132. In this embodiment, the guide channel 142 is defined by a vertical structure 142-1 with side slot 142-2, and the guide channel 144 is defined by an upper guide opening 144-1 and a lower guide opening 144-2.

The positioning window 132-1 has a size that freely accepts the charge handle latch arm 38 (see FIG. 6) without locking engagement. However, as will be described in more detail later, the positioning window 132-1 may be partially selectively crossed by a portion of the positioning mechanism 150 and will reach the positioning window 132-1 during the return stroke of the charge handle 16 in the distal direction D1. A portion of the intersecting positioning mechanism 150 may be engaged by a catch 38-2 of the charge handle latch arm 38 of the charge handle 16.

As seen in FIG. 13, the latch arm 134 is configured as a cantilever arm extending proximally D2 from the cannula assembly end wall 132, the free end of the cantilever arm having an upward catch 146. The latch arm 134 is configured to be rigid in the vertical direction and elastic in the vertical directions D3 and D4 which are substantially perpendicular to the vertical range of the latch arm 134. The catch 146 is configured as an incline having an upward inclined surface 146-1, and the inclined surface 146-1 deviates in the proximal direction D2 to define the proximal end surface 146-2. In this embodiment, the extension 134 of the latch arm 134 extends beyond the proximal end face 146-2 in the proximal direction D2 and has a proximally oriented L-shape with a floor approximately perpendicular to the proximal end face 146-2. Define the notch.

The catch 146 of the latch arm 134 of the cannula slide 58 selectively and freely engages with the latch strike 70 of the carriage latch cover member 62, and the latch arm 134 is latched by the operation of the cannula retract button 40-2 (see FIG. 1). Until released from the strike 70, the cannula slide 58 is coupled to the carriage slide 60 to prevent the cannula slide 58 from moving proximally to the carriage slide 60 of the carriage assembly 50.

With reference to FIGS. 13-18, the positioning mechanism 150 includes a cannula slide indexer 152 and a sampling slide indexer 154, and the cannula slide indexer 152 and the sampling slide indexer 154 work together to coordinate various operating steps of the biopsy apparatus 10. do. The cannula slide indexer 152 is configured to swivel around the cannula assembly tube 136 of the cannula slide 58, and the sampling slide indexer 154 is guided by the guide channels 142 and 144 of the cannula slide 58 in directions D3 and D4, eg up and down. , Is configured to move linearly. Here, the directions D3 and D4 are opposite directions, for example, up and down, and the directions D3 and D4 are substantially perpendicular to the vertical axis 23.

With reference to FIG. 13, the cannula slide indexer 152 is selectively operated by the deflection of the latch arm 134 of the cannula slide 58. Also with reference to FIGS. 14A and 14B, in the illustrated embodiment, the cannula slide indexer 152 is configured as an integral structure including an accelerator 156, a lever arm 158, an actuating arm 160 and a torsion spring 162.

The accelerator 156 of the cannula slide indexer 152 has a longitudinal range 156-1 and a cylindrical opening 156-2 configured to be received by the bearing surface 136-2 of the cannula assembly tube 136. Since the inner diameter of the cylindrical opening 156-2 is slightly larger than the outer diameter of the bearing surface 136-2 within the tolerance range of 0.01 mm (mm) to 1.0 mm, the cannula slide indexer 152 around the cannula assembly tube 136. Allows turning (rotation) movement of, and allows turning movement around the vertical axis 23. The accelerator 156 is held by the overhanging proximal end 136-1 on the bearing surface 136-2 of the cannula assembly tube 136.

The lever arm 158 is radially separated from the cylindrical opening 156-2 and is radially separated by a radial distance R1 from the vertical axis 23. Also with reference to FIGS. 16-18, the lever arm 158 is arranged and oriented so as to be selectively engaged by the latch arm 134 of the cannula slide 58. As best seen in FIGS. 14A and 14B, the lever arm 158 has a tangential range 158-1 and a longitudinal range 158-2. The tangential range 158-1 of the lever arm 158 is oriented tangentially along the tangent of the virtual circle corresponding to the radius distance R1 from the accelerator 156 in the direction D5 like a cantilever. Since the cannula slide indexer 152 rotates around the vertical axis 23, the direction D5 is relative, and the actual direction depends on the angular rotation position of the cannula slide indexer 152. The lever arm 158 is configured to be rigid and has a free end 158-4 defining a longitudinal engaging surface 158-5 having a tangential range 158-1 and a longitudinal range 158-2 and having a radius. It may be defined as a plate 158-3 having. The longitudinal engagement surface 158-5 is arranged and oriented so as to be selectively engaged by the lower surface of the latch arm 134 of the cannula slide 58 (see also FIGS. 13 and 16-18).

The actuating arm 160 is radially separated from the cylindrical opening 156-2 and radially separated by a radial distance R2 from the vertical axis 23. The actuating arm 160 has a tangential range 160-1. The tangential range 160-1 of the actuating arm 160 is directed tangentially extending from the accelerator 156 in the direction D6 like a cantilever along the tangent of the virtual circle corresponding to the radius distance R2. Since the cannula slide indexer 152 rotates around the vertical axis 23, the direction D6 is relative, and the actual direction depends on the angular rotation position of the cannula slide indexer 152. However, the direction D6 has a certain relationship with the direction D5, and these are generally opposite directions, and the term "generally opposite" means a linear range (180 degrees) plus or minus 15 degrees. In the present embodiment, the angle range α of the constant relationship of the direction D5 with respect to the direction D6 with respect to the vertical axis 23 may be in the range of 165 degrees to 180 degrees (straight line). The actuating arm 160 is configured to be rigid, has a tangential range 160-1, and is defined as a triangular plate 160-2 with a free end 160-3 and a flat engaging surface 160-4. good.

The torsion spring 162 is radially separated from the cylindrical opening 156-2 and is radially separated from the vertical axis 23 by a radial distance R3. The torsion spring 162 has an outer range 162-1. The outer range 162-1 of the actuating arm 160 is directed to extend from the accelerator 156 like a cantilever. In the orientation of the components seen in FIGS. 5 and 13-14B, the torsion spring 162 is configured to urge the cannula slide indexer 152 and swivel clockwise around the vertical axis 23. Specifically, the torsion spring 162 is configured to be elastic and may be defined as a curved cantilever arm 162-2 having a free end 162-3, the contact surface 162-4 of the cantilever arm 162-2. The cantilever arm 162-2 engages with the spring mounting ring 132-3, etc. (see FIGS. 16 to 18) and the fixed portion of the cannula slide indexer 152, and the cantilever arm 162-2 applies a counterclockwise force to the spring mounting ring 132-3 to perform the cannula slide. Encourage the indexer 152 and turn it clockwise.

With reference to FIGS. 13 and 15A-18, the sampling slide indexer 154 is configured as an integrated plate-like planar structure as a whole, with a base 164, a left slide 166, a right slide 168, a window closing plate 170, and a first. 1 cam arm 172, a second cam arm 174, and a cantilever spring 176 are included. The left slide 166, the right slide 168, the window closing plate 170, the first cam arm 172, and the second cam arm 174 extend vertically from the base 164 in the direction D3. The cantilever spring 176 is located downward from the base 164 in the direction D4.

With reference to FIGS. 16-18, the left slide 166 has a size and shape that is slidably accepted in the side slot 142-2 of the guide channel 142 of the cannula assembly end wall 132 of the cannula slide 58. The right slide 168 has a size and shape that is slidably accepted by the upper guide opening 144-1 and the lower guide opening 144-2 of the guide channel 144 of the cannula assembled end wall 132 of the cannula slide 58.

The window closure plate 170 may be integrated into the left slide 166. The window closure plate 170 is configured as a vertically extending plate that selectively intersects and partially covers the positioning window 132-1 of the cannula assembly end wall 132 of the cannula slide 58. Be oriented. The window closure plate 170 includes a side surface 170-1 and a proximal surface 170-2.

The first cam arm 172 is configured to extend vertically from the base 164. The first cam arm 172 is arranged between the window closing plate 170 and the second cam arm 174 when viewed sideways, and is separated from the window closing plate 170 and the second cam arm 174. The first cam arm 172 is arranged and oriented so as to be selectively engaged by the engaging surface 160-4 of the actuating arm 160 of the cannula slide indexer 152. Specifically, the first cam arm 172 has a free end 172-1 with a radial engaging surface 172-1, the radial engaging surface 172-2 of the actuating arm 160 of the cannula slide indexer 152. Can engage with a flat engaging surface 160-4.

The second cam arm 174 may be integrated with the right slide 168. Second cam arm 1
74 is configured to extend vertically from the base 164. The second cam arm 174 is arranged and oriented so as to be selectively engaged by the bidirectional tilt 126-1 of the latch arm 126 of the sampling slide 56. Specifically, the second cam arm 174 has a free end 174-1 having an engaging surface 174-2, which is the bidirectional tilt 126-of the latch arm 126 of the sampling slide 56. Can engage with 1.

The cantilever spring 176 is configured as a curved cantilever, extends below the bottom of the base 164 and is located below the base 164 in direction D4. In the component orientations seen in FIGS. 5, 13, and 15A-18, the cantilever spring 176 is configured to urge the sampling slide indexer 154 in direction D3 (upward). Specifically, the cantilever spring 176 is configured to be elastic, defined as a cantilever arm 176-1 with a free end 176-2, and the contact surface 176-3 of the cantilever arm 176-1 is the cannula slide 58. Engaging with the pin 132-5 etc. extending in the vertical direction (see FIGS. 16-18) and the fixed part of the cannula slide indexer 152, the cantilever arm 176-1 applies a downward force in the direction D4 toward the pin 132-5. , Sampling slide indexer 154 is urged upward in direction D3.

Referring again to FIG. 5, the driving force provided to drive the various functions of the biopsy apparatus 10 is at least one cannula retracting spring (in this embodiment, a set of cannula retracting springs 180-1, 180-2). Is provided by a sampling spring 182 and a prime piercing spring 184. Those skilled in the art will recognize that the actions of the cannula retracting springs 180-1, 180-2, the sampling springs 182 and the prime piercing springs 184 can be achieved by one spring or by multiple springs. Let's do it.

Referring to FIG. 19, the sampling slide 56 and the cannula slide 58 are assembled into one subassembly and then inserted into the prime piercing carriage 52 along the stylet 20 (see FIG. 8). Specifically, the cannula retracting spring 180 (in this embodiment, two cannula retracting springs are shown as 180-1 and 180-2) is a cannula of the intermediate slide wall 120 of the sampling slide 56 and the cannula slide 58. It is arranged between the assembled end wall 132 and connected to the intermediate slide wall 120 of the sampling slide 56 and the cannula assembled end wall 132 of the cannula slide 58. Specifically, the cannula retracting spring 180-1 ends with the spring mounting ring 120-5 of the intermediate slide wall 120 of the sampling slide 56 and the spring mounting ring 132 of the cannula assembled end wall 132 of the cannula slide 58. Attached to -3. Similarly, the cannula retracting spring 180-2 ends with the spring mounting ring 120-6 of the intermediate slide wall 120 of the sampling slide 56 and the spring mounting ring 132-4 of the cannula assembled end wall 132 of the cannula slide 58. Can be attached to.

As seen in FIG. 19, the latch arm deflector 128 of the sampling slide is configured to engage the latch arm 134 of the cannula slide 58, and the engaged latch arm deflector 128 attaches the latch arm 134 to the carriage base 64. Bend, or bend downwards. More specifically, with reference to FIGS. 12B and 13, the extension 134-1 at the free end of the latch arm 134 is an intermediate slide on the retention channel 128-1 of the intermediate slide wall 120 of the sampling slide 56. Arranged to engage the wall 120, when engaged, the longitudinal movement of the cannula slide 58 in the proximal direction D2 causes the longitudinal movement of the sampling slide 56 in the proximal direction D2.

As can be seen in FIG. 17, the lower surface of the latch arm 134 of the cannula slide 58 engages with the lever arm 158 to rotate the cannula slide indexer 152 counterclockwise around the vertical axis 23, thereby lifting the actuating arm 160. The sampling slide indexer 154 moves upward in the direction D3 by the action of the cantilever spring 176, and the window closing plate 170 is arranged so as to close a part of the positioning window 132-1 of the cannula slide 58, for example, the lower left quadrant. The window closure plate 170 is engaged by a catch 38-2 (also see FIG. 6) of the charge handle latch arm 38 of the charge handle 16.

When the cannula slide 58 is moved from the sampling slide 56 in the distal direction D1, the latch arm 134 is released from the latch arm deflecting member 128, and the latch arm 134 returns to the non-deflected position due to its elasticity, that is, the latch arm 134 is originally Return to the unbent position. As can be seen in FIG. 18, the cannula slide indexer 152 rotates counterclockwise around the vertical axis 23 to its full clockwise position due to the torsional force exerted by the torsion spring 162, pointing the sampling slide indexer 154 downward in direction D4. The window closing plate 170 does not close a part of the positioning window 132-1 of the cannula slide 58.

As can be seen in FIG. 19, the sampling slide 56 is separated from the cannula slide 58 by the minimum allowable distance, and the respective cannula retracting springs 180-1 and 180-2 are placed in the contracted state, but the respective cannula retracting springs 180-1. , 180-2 can be in a slightly stretched state. The term "slightly stretched" means the accumulation of less than 10 percent of the total force obtained from the springs 180-1 and 180-2 in the charged (stretched) state. The terms "charged" and "charged" as used herein refer to the accumulation of mechanical energy by one or more springs. The term "charging" means the act of storing mechanical energy in a storage device in the form of one or more springs. When the cannula retracting spring 180 is in the extended state, the cannula retracting springs 180-1 and 180-2 are charged to the charged state to store mechanical energy.

Also referring to FIG. 5, (a) the catch 130 of the latch arm 126 of the sampling slide 56 is engaged with the latch strike 72 of the carriage latch cover member 62, and (b) the catch of the latch arm 134 of the cannula slide 58. With the 146 engaged with the latch strike 70 of the carriage latch cover member 62, the cannula retracting springs 180-1 and 180-2 are kept free to release in the charged (extended) state. When the catch 146 of the latch arm 134 is released from the latch strike 70, the cannula retracting spring 180 is released from the charged (extended) state and exerts a contractile force to release the cannula assembly end wall 132 and the cannula 22 of the cannula slide 58. It is urged to move in the proximal direction D2 toward the sampling slide 56, thereby exposing the side sample openings 20-3 of the stylet 20.

Referring again to FIG. 5, the sampling spring 182 is arranged between the stylet assembled end wall 66 of the carriage slide 60 of the prime piercing carriage 52 and the intermediate slide wall 120 of the sampling slide 56. In this embodiment, the sampling spring 182 is a coil spring that is charged by compression and stores mechanical energy when it is kept in a charged (compressed) state. The sampling spring 182 is kept in a charged (compressed) state when the catch 130 of the latch arm 126 of the sampling slide 56 is engaged with the latch strike 72 of the carriage latch cover member 62. The sampling spring 182 released from the charged (compressed) state exerts an expanding force and urges the sampling slide 56, and thus the cannula slide 58 and the cannula 22, to move in the distal direction D1.

With reference to FIGS. 4 and 5, the prime piercing spring 184 is arranged between the intermediate wall 32 of the housing 12 and the prime piercing rod 64-9 of the carriage base 64 of the carriage slide 60 of the prime piercing carriage 52. The prime piercing spring 184 is charged to the charged state and stores mechanical energy when in the compressed state. The prime piercing spring 184 can be freely released into a charged (compressed) state when the carriage latch arm 74 of the carriage latch cover member 62 is engaged with the carriage latch strike 44 of the actuating mechanism 18 (see also FIG. 7B). Be kept. At this stage the biopsy device 10 is said to be primed.

When the prime piercing spring 184 is released from the charged (compressed) state, it enters the "piercing" state, and the prime piercing spring 184 exerts an expanding force to fire the entire carriage assembly 50 carrying the biopsy needle 14 in the distal direction D1. That is, it moves rapidly. In other words, the launch of the carriage assembly 50 carrying the biopsy needle 14 causes the stylet 20 and cannula 22 to move simultaneously in the distal direction D1 and the biopsy needle 14 pierces the patient's tissue at the desired location.

With reference to FIG. 5 again, the charge handle 16 and the positioning mechanism 150 form a cocking mechanism as will be described in more detail later.

Also referring to FIGS. 1 and 20-26, the user grips the charge handle 16 and pulls the charge handle 16 from the home position to the retracted position in the proximal direction D2, thereby proximal to the housing 12. The directional stroke, or retreat, is manually performed, whereby the urging springs 39-1 and 39-2 are charged (extended). Although a plurality of urging springs are shown in the present embodiment, those skilled in the art recognize that the actions of the urging springs 39-1 and 39-2 can be achieved by one spring or by a plurality of springs. Will. The user releases the charge handle 16, the urging springs 39-1 and 39-2 contract, and the charge handle 16 moves in the distal direction D1 with respect to the housing 12 in the return (distal direction) stroke, and is in a fixed position. Return to.

In the biopsy 10 shown in FIGS. 20 to 26, the upper case portion 24 is removed and the carriage is shown in order to show various positional relationships of the components in various stages of preparing the biopsy device 10 for collecting the biopsy sample from the patient. The assembly 50 is exposed, the carriage latch cover member 62 is removed from the carriage slide 60 of the prime piercing carriage 52, and the sampling slide 56 and the cannula slide 58 are exposed.

FIG. 20 shows the state when the biopsy apparatus 10 is new and after the biopsy collection cycle is completed. As shown, the urging springs 39-1, 39-2, the vacuum springs 106, 116, the cannula retracting springs 180-1, 180-2, the sampling springs 182, and the prime piercing springs 184 are all discharged. ing.

With reference to FIG. 21, in the first retract (proximal) stroke of the charge handle 16 in the proximal direction D2, the sampling slide 56 and the cannula slide 58 are collectively moved in the proximal direction D2 with respect to the carriage slide 60. , Vacuum springs 106, 116 and sampling spring 182 are charged at the same time. Specifically, when the first retracting (proximal direction) stroke of the charge handle 16 begins, the cannula slide indexer 152 and the sampling slide indexer 154 of the positioning mechanism 150 are arranged as shown in FIG. The charge handle latch arm 38 of the handle 16 freely passes through the positioning window 132-1 of the cannula slide 58, and the charge handle end wall 36 of the charge handle 16 engages with the cannula assembly end wall 132 of the cannula slide 58. When the latch arm 134 of the cannula slide 58 engages, or joins, the intermediate slide wall 120 of the sampling slide 56 and the latch arm 134 of the cannula slide 58 is deflected downward by the latch arm deflector 128 of the sampling slide 56. The proximal movement of the charge handle 16 causes the sampling slide 56 and the cannula slide 58 to be moved together in the proximal direction D2.

In the first retract (proximal) stroke of the charge handle 16 towards the retracted position, the latch arm 134 and the intermediate slide wall 120 of the sampling slide 56 engage to engage the sampling slide 56 and the cannula slide 58 with the cannula 22. Cannula assembly end wall 132 and the end wall 132 of the above move all at once in the proximal direction D2 to charge (compress) the sampling spring 182. At the same time, the proximal movement of the cannula assembly end wall 132 of the cannula slide 58 moves the pistons / plungers 102/104 and 112/114 of the vacuum pumps 90 and 92 in the proximal direction D2, respectively, and the first of the vacuum pumps 90. The vacuum spring 106 of the above and the second vacuum spring 116 of the vacuum pump 92 are charged (compressed).

When the charge handle 16 reaches the retracted position at the end of the first proximal stroke, the catch 130 of the latch arm 126 of the sampling slide 56 turns upward and engages with the latch strike 72 of the carriage latch cover member 62. The sampling spring 182 is kept in a charged (compressed) state. However, even if the latch arm 126 that swivels upward releases the sampling slide indexer 154 toward the upward movement in the direction D3, the charge handle latch arm 38 of the charge handle 16 is provided on the positioning window 132-1 of the cannula slide 58. The charge handle latch arm 38 prevents the sampling slide indexer 154 from extending vertically over a portion of the positioning window 132-1.

In that case, the vacuum springs 106 and 116 are also kept in a charged state only by the vacuum generated inside the vacuum pumps 90 and 92. For example, when the vacuum is released by operating the button 40-2 of the operating mechanism 18, the vacuum springs 106 and 116 try to return to the uncharged state.

The movement of the cannula assembly end wall 132 of the cannula slide 58 in the first proximal stroke retracts the cannula 22 and opens the side sample openings 20-3 of the stylet 20. With reference to FIG. 22, when the charge handle 16 is released, the urging springs 39-1 and 39-2 are discharged and the first return (distal direction) stroke of the charge handle 16 is performed, and the charge handle 16 is set. After returning to the home position and removing the charge handle latch arm 38 from the positioning window 132-1 as shown in FIG. 17, the positioning mechanism 150 advances to the cannula retracted position and the force exerted by the cantilever spring 176. Allows the sampling slide indexer 154 to move upward D3, and when viewed sideways, the window closing plate 170 of the sampling slide indexer 154 is placed over a portion of the positioning window 132-1 of the cannula slide 58, eg, over the lower left quadrant. Will be done.

With reference to FIG. 23, in the second retreat (proximal direction) stroke of the charge handle 16 in the proximal direction D2, the charge handle latch arm 38 of the charge handle 16 enters the positioning window 132-1 of the cannula slide 58. This time, the tapered nose of the catch 38-2 of the charge handle latch arm 38 slidably engages with the side surface 170-1 of the window closing plate 170 of the sampling slide indexer 154 (see FIG. 17). It deflects around the window closure plate 170 and passes through the positioning window 132-1 of the cannula slide 58. Due to the second retreat of the charge handle 16, the charge handle latch arm 3 of the charge handle 16
8 is freely coupled to the cannula assembly end wall 132 of the cannula slide 58 by the positioning mechanism 150.

With reference to FIG. 24, when the charge handle 16 is released, the urging springs 39-1 and 39-2 are discharged, the second return (distal direction) stroke of the charge handle 16 is performed, and the charge handle is fixed. Return to the position. However, in the second return (distal direction) stroke, the catch 38-2 of the charge handle latch arm 38 (see FIG. 6) catches the proximal surface 170-2 of the window closure plate 170 of the sampling slide indexer 154, thereby. The cannula-assembled end wall 132 of the cannula slide 58 is pulled away from the intermediate slide wall 120 of the sampling slide 56 in the distal direction D1, and the cannula 22 is moved in the distal direction D1 by the cannula-assembled end wall 132 of the stylet 20. The side sample port 20-3 is closed. Cannula retracting springs 180-1 and 180-2 extend to a charged (extended) state by the movement of the cannula assembled end wall 132 of the cannula slide 58 moving away from the intermediate slide wall 120 of the sampling slide 56 in the distal direction D1. In order to return the charge handle 16 to the fixed position while pulling the cannula slide 58 to its locking position, the force exerted by the urging springs 39-1 and 39-2 and the mechanical gain associated therewith are the cannula retracting spring 180. It must exceed the force exerted by -1, 180-2 and the mechanical gain associated with it.

Further, the latch arm 134 of the cannula slide 58 is released from the latch arm deflection member 128 of the sampling slide 56 by the distal movement of the cannula assembly end wall 132 of the cannula slide 58 away from the intermediate slide wall 120 of the sampling slide 56. The cannula slide indexer 152 swivels clockwise around the vertical axis 23 due to the force exerted by the torsion spring 162, which causes the actuating arm 160 to swivel downward in direction D4. Movement, the window closure plate 170 of the sampling slide indexer 154 moves downward in direction D4, the positioning window 132-1 of the cannula slide 58 is opened, facilitating the release of the charge handle 16 from the cannula slide 58.

When the charge handle 16 approaches the home position, the catch 146 of the latch arm 134 of the cannula slide 58 is releasably engaged with the latch strike 70 of the carriage latch cover member 62 to keep the cannula retracting spring 180 in the charged (extended) state. .. Further, the catch 130 of the latch arm 126 of the sampling slide 56 is kept in a state of being engaged with the latch strike 72 of the carriage latch cover member 62. The sampling slide 56 is provided by the catch 146 of the latch arm 134 engaged with the latch strike 70 of the carriage latch cover member 62 and the latch arm 126 of the sampling slide 56 engaged with the latch strike 72 of the carriage latch cover member 62. The cannula slides 58 are separated from each other by the maximum separation distance, and the sampling slide 56 and the cannula slide 58 are locked until the catch 146 of the latch arm 134 of the cannula slide 58 is released by the operation of the cannula retract button 40-2. Keep maximum separation distance.

With reference to FIG. 25, the catch 130 of the sampling slide 56 and the catch 146 of the cannula slide 58 are formed by the latch strike 70 and the latch strike 72 of the carriage latch cover member 62 of the prime piercing carriage 52 of the carriage assembly 50. Each is locked, and in the third retracting (proximal) stroke of the charge handle 16 in the proximal direction D2, the entire carriage assembly 50 is moved in the proximal direction D2 and the prime piercing spring 184 is charged (compressed). .. Specifically, when the third proximal stroke of the charge handle 16 begins, the cannula slide indexer 152 and the sampling slide indexer 154 of the positioning mechanism 150 are arranged as shown in FIG. 18 and the charge handle 16 The charge handle latch arm 38 freely passes through the positioning window 132-1 of the cannula slide 58, and the charge handle end wall 36 of the charge handle 16 engages with the cannula assembly end wall 132 of the cannula slide 58 to assemble the carriage. The entire 50 moves in the proximal direction D2. In other words, in the third retreat (proximal direction) stroke of the charge handle 16 toward the retreat position, the sampling slide 56 carrying the stylet 20 and the cannula slide 58 carrying the cannula 22 are simultaneously retracted in the proximal direction D2. By charging (compressing) the prime piercing spring 184, the biopsy needle 14 is prepared for firing.

When the charge handle 16 is retracted at the end of the third proximal stroke (see also FIGS. 7B and 10), the catch 78 of the carriage latch arm 74 engages the carriage latch strike 44 of the actuating mechanism 18. And keep the prime piercing spring 184 in a compressed state.

With reference to FIG. 26, after the charge handle 16 is released, the urging springs 39-1 and 39-2 are discharged to perform the third return (distal direction) stroke of the charge handle 16, and the charge handle 16 is fixed. Return to the position. The biopsy device 10 is now fully prepared, and the vacuum springs 106, 116, the cannula retracting springs 180-1, 180-2, the sampling spring 182, and the prime piercing spring 184 are all charged, and the biopsy device is ready. Ready to perform a vacuum-assisted biopsy procedure with a piercing launch function. It should be appreciated that if the physician performing the biopsy procedure does not choose to perform the puncture firing function, the third retreat / return (proximal / distal) stroke of the charge handle 16 can be omitted.

With reference to FIGS. 1, 7B, and 10, in the puncture firing mode state of the biopsy device 10 of FIG. 26, where the prime piercing spring 184 is charged in the third retreat (proximal direction) stroke, FIGS. 1, 7B, and 10. With reference to 10, the carriage latch arm 74 is released from the carriage latch strike 44, the prime piercing spring 184 is released from the charged (compressed) state, and the biopsy device 10 is released from the state of FIG. 26 by the operation of the piercing button 40-1. The state changes to the state shown in FIG. The prime piercing spring 184 exerts an extension force and rapidly moves the carriage assembly 50 carrying the stylet 20 and the cannula 22 all at once in the distal direction D1 to pierce the tissue and place the biopsy needle 14 at the patient's biopsy site. do.

Next, or without the puncture firing mode, the biopsy device 10 is in the state of FIG. 24, further refer to FIGS. 1, 5, and 10 and by activating the cannula retreat button 40-2, the latch arm 134 of the cannula slide 58. Is released from the latch strike 70 of the carriage latch cover member 62, whereby the cannula retracting spring 180 is released from the charged (extended) state and exerts a compressive force to move the cannula slide 58 and the cannula 22 in the proximal direction D2. The side sample opening 20-3 of the stylet 20 is opened, and the biopsy apparatus 10 changes from the state of FIG. 24 to the state of FIG. 22. At the same time, this operation of the cannula retreat button 40-2 further activates the button actuator 96-3 of the vacuum system 54 to open the control valve 96, and the vacuum generated by the vacuum pumps 90, 92 is the lumen 20 of the stylet 20. It is hung on a flexible connecting conduit 98-4 coupled to -2 by fluid communication, and further hung on a lumen 20-2 at the side sample opening 20-3 of the stylet 20. The tissue near the side sample opening 20-3 of the stylet 20 is drawn into the side sample opening 20-3 by vacuum.

Next, the biopsy apparatus 10 is in the state of FIG. 22, further referring to FIGS. 1, 5, and 10, and by the operation of the sample acquisition button 40-3, the catch 130 of the latch arm 126 is latched by the carriage latch cover member 62. Released from the strike 72, the sampling spring 182 is released from the charged (compressed) state and exerts an extension force to rapidly move the cannula slide 58 carrying the cannula 22 in the distal direction D1, and the biopsy device 10 is shown in FIG. From the state of 22 to the state of FIG. 20, the cannula 22 cuts the tissue at the side sample opening 20-3 of the stylet 20 by the distal cutting edge 22-3 of the cannula 22 and covers the side sample opening 20-3.
That is, the tissue is closed and the tissue drawn into the side sample opening 20-3 of the stylet 20 is retained as a biopsy tissue, and the tissue sample collection is completed.

After collecting the tissue sample, the biopsy needle 14 is removed from the patient, the first retract (proximal direction) stroke is repeated, the cannula 22 is retracted, and the side sample openings 20-3 of the stylet 20 are opened. The vacuum springs 106, 116 and the sampling spring 182 are charged in the first retreat stroke of the charge handle 16, after which the cannula retreat button 40-2 can be activated to purge the vacuum and sample acquisition if no further tissue sample is needed. The sampling spring 182 can be discharged by activating the button 40-3. However, if more tissue sample is needed, the second retract / return stroke is repeated to charge the cannula retracting springs 180-1 and 180-2. The biopsy device 10 is now ready to be manually inserted into the patient and there is no puncture firing. However, if a piercing firing mode is desired, the third retreat stroke of the charge handle 16 is repeated, the prime piercing spring 184 is charged, the biopsy needle 14 is fully retracted, and the stylet 20 is directed towards the patient's tissue. Cannula 22 can be fired at the same time.

The following was disclosed with respect to various aspects of the biopsy apparatus 10.

1.1. Sliding into the housing, a biopsy needle with a stylet and cannula, a carriage slide with a stylet-assembled end wall, a cannula slide with a cannula-assembled end wall, and a carriage assembly with a sampling slide. A biopsy device with a charge handle assembled in, the charge handle has a fixed position and a retracted position, and the biopsy device is further equipped with a vacuum system located in the housing and carried by a carriage assembly. The vacuum system is charged when the sampling spring is compressed to generate a vacuum, the vacuum system includes a first vacuum pump, a second vacuum pump, a manifold and a control valve, and the first vacuum pump is the first. It has one vacuum port, a second vacuum pump has a second vacuum port, and the manifold has a first vacuum extraction port, a second vacuum extraction port, and a first vacuum application port. The control valve has a third evacuation port and a second evacuation port, the first evacuation port of the first vacuum pump is coupled to the first evacuation port of the manifold by fluid communication, and the second. The second evacuation port of the vacuum pump is coupled to the second evacuation port of the manifold by fluid communication, and the first evacuation port of the manifold is connected to the third evacuation port of the valve by fluid communication to control. The second vacuum outlet of the valve is coupled to the first cavity of the stylet by fluid communication, and the manifold is coupled to the first vacuum outlet by fluid communication with the first one-way valve and the second vacuum. It has an extraction port and a second one-way valve coupled by fluid communication, and the first one-way valve and the second one-way valve are configured to release positive pressure to the atmosphere and close when a vacuum is established. The control valve is operated by the actuation of the cannula retreat button on the actuation mechanism to evacuate the side sample port of the stylet and at the same time the side sample port of the stylet is evacuated by the proximal movement of the cannula due to the force generated by the cannula retreat spring. open.

1.2. In the biopsy apparatus according to Section 1.1, the first vacuum pump is a first cylinder having a first end and a second end, the first end being the first. A first piston having a vacuum port and a second end defining a first opening, the first piston, and a first piston that is received by the first cylinder through the first opening. A first plunger attached to, wherein the first plunger is configured to extend from a second end of a first cylinder, the first plunger having a free end having a first head, said. A first vacuum spring located between the first plunger and the second end of the cylinder and the first head of the first plunger, the first vacuum spring is dynamic when in a compressed state. 1. The second vacuum pump is a second cylinder having a first end and a second end, the first end having a second vacuum port and the second end having a second opening. A second piston, a second piston that is received by the second cylinder through the second opening, and a second plunger that is attached to the second piston. The second plunger and the second end of the second cylinder are configured to extend from the second end of the second cylinder and the second plunger has a free end with a second head. A second vacuum spring located between the second head of the second plunger, the second vacuum spring being configured to store mechanical energy in the compressed state and still having a second. Includes the second vacuum spring configured to urge the second piston distally to establish a vacuum at the vacuum port.

1.3. In the biopsy apparatus described in Section 1.2, the first head of the first vacuum pump and the second head of the second vacuum pump are such that they engage the cannula assembly end wall of the cannula slide. Arranged, the first vacuum spring of the first vacuum pump and the second vacuum spring of the second vacuum pump move the cannula assembly end wall proximally before the cannula retracting spring is charged to the extended state. Sometimes compressed.

1.4. In the biopsy apparatus described in Section 1.3, the compression of the first vacuum spring of the first vacuum pump and the compression of the second vacuum spring of the second vacuum pump occur at the same time as the compression of the sampling spring. ..

1.5. The biopsy apparatus according to any one of Sections 1.2 to 1.4, wherein the stylet assembly end wall includes a first pump assembly hole and a second pump assembly hole. , The first vacuum pump is received in the first pump assembly hole, and the first proximal cylinder portion having the first vacuum port is configured to extend proximally from the stylet assembly end wall. The first distal cylinder with the first opening is configured to extend distally from the stylet assembly end wall, with the cannula assembly end wall proximal when the charge handle is first retracted. In order to compress the first vacuum spring when moved in the direction, the first head of the first plunger is arranged to engage the cannula assembly end wall and the second vacuum pump is the second pump assembly. A second proximal cylinder portion that is received in the perforation and has a second vacuum port is configured to extend proximally from the stylet assembly end wall and has a second far end with a second opening. The position cylinder section is configured to extend distally from the stylet assembly end wall and provides a first vacuum spring when the cannula assembly end wall is moved proximally during the first retract of the charge handle. To compress the second vacuum spring at the same time as compressing, the second head of the second plunger is arranged to engage the cannula assembly end wall.

1.6. The biopsy apparatus described in any of the preceding sections, the housing is equipped with an actuating mechanism, the carriage assembly is movable relative to the housing, and the carriage assembly is a stylet that assembles a stylet with a sample port. The cannula slide includes a cannula slide for assembling the assembly wall and the cutting cannula, a sampling slide which is movably arranged between the stylet assembly wall and the cannula slide, and a carriage latch cover member. Can be moved longitudinally separated from the wall, the cannula slide has a first latch member, the sampling slide has a second latch member, and the carriage latch cover member has a third latch member. However, a sampling spring is placed between the stylet assembly wall and the sampling slide, a cannula retreat spring is placed between the sampling slide and the cannula slide, and the cannula retreat spring is a sampling slide and a cannula slide. A prime piercing spring is placed between the carriage assembly and a portion of the housing, and the biopsy device moves the cannula slide and sampling slide in a proximal direction by the first retract of the charge handle. The sampling spring is charged, the second latch member of the sampling slide is locked to the carriage latch cover member to keep the sampling spring in a charged state, and the vacuum system is charged to generate a vacuum. The return of 1 returns the charge handle to the fixed position, the second retract of the charge handle moves the charge handle to the retracted position, and the second return of the charge handle to the fixed position causes the cannula slide in the distal direction from the sampling slide. To charge the cannula retracting spring, and lock the first latch member of the cannula slide to the carriage latch cover member to keep the cannula retracting spring in a charged state, and the third retract of the charge handle causes the carriage. The entire assembly is moved proximally to charge the prime piercing spring, and the third latch member of the carriage latch cover member is locked to the actuating mechanism to keep the prime piercing spring in a charged state.

1.7. In the biopsy device described in Section 1.6, the actuating mechanism has a cannula retract button, a sample acquisition button and a piercing button, and the biopsy device is a carriage from the actuating mechanism by the actuation of the piercing button. The third latch member of the latch cover member is released to release the prime piercing spring from the charged state, propelling the carriage assembly distally to facilitate tissue puncture by the stylet and cannula, and the cannula retract button is activated. By doing so, the first latch member of the cannula slide is released from the carriage latch cover member to release the cannula retracting spring from the charged state, and the cannula is moved in the proximal direction to open the side sample opening of the stylet. At the same time, a vacuum is applied to the side sample port to draw the tissue into the side sample port, and the sample acquisition button is activated to release the second latch member of the sampling slide from the carriage latch cover member and charge the sampling spring. It is further configured to release from the cannula, propel the cannula distally to close the lateral sample opening, and cut the tissue drawn into the lateral sample opening by vacuum.

1.8. In the biopsy apparatus according to any one of Sections 1.1 to 1.6, the stylet is arranged so as to extend along the vertical axis, and the stylet defines the first lumen. It has a first side wall and a side sample port leading to the first lumen through the first side wall, the cannula is coaxial with the stylet, and the cannula is configured to demarcate the second lumen. With a second side wall, the cannula has a distal cutting edge, the housing has a proximal end wall, an intermediate wall and a distal end separated along the vertical axis, and the distal end. Has a needle opening, the enclosure is configured to demarcate the enclosure chamber between the proximal end wall and the distal end, and the intermediate wall is between the proximal end wall and the distal end. Arranged, the stylet and cannula are received through the needle opening, the proximal direction is from the distal end to the proximal end wall, and the distal direction is from the proximal end wall to the distal end. The actuating mechanism has a piercing button, a cannula retraction button, and a sample acquisition button, and also has a carriage latch strike, the carriage assembly is located inside the housing, and the entire carriage assembly is vertical with respect to the housing. Configured to move in the direction, the carriage assembly includes a carriage slide, a carriage latch cover member, a cannula slide and a sampling slide, the cannula slide and the sampling slide are configured to be movable with respect to the carriage slide, and the cannula slide is a cannula assembly. It has a first latch arm that extends proximally from the end wall, and the sampling slide is movably placed between the stylet-assembled end wall of the carriage slide and the cannula-assembled end wall of the cannula slide. , The sampling slide has a second latch arm extending distally, the carriage latch cover member has a first latch strike, a second latch strike and a carriage latch arm, and a first latch strike. Is configured to engage freely with the first latch arm, the second latch strike is configured to engage freely with the second latch arm, and the carriage latch arm is configured to engage with the carriage latch strike of the actuating mechanism. It is configured to engage freely, a sampling spring is placed between the stylet assembly end wall and the sampling slide, and the sampling spring is configured to store mechanical energy in the compressed state. The sampling slide is configured to be distally urged and a second latch arm The sampling spring is kept compressed when engaged with the second latch strike, a cannula retreat spring is placed between the sampling slide and the cannula slide, and the cannula retreat spring is a sampling slide and a cannula slide. Connected to, the cannula retracting spring is configured to store mechanical energy in the stretched state to urge the cannula slide in the proximal direction, with the first latch arm engaged with the first latch strike and still. When the second latch arm is engaged with the second latch strike, the cannula retracting spring is kept open and open, with a prime between the middle wall of the enclosure and the stylet assembly end wall. Piercing springs are placed, the prime piercing springs are configured to store mechanical energy when in compression, yet the entire carriage assembly is configured to urge distally, and the carriage latch arm is the carriage of the actuating mechanism. The prime piercing spring is kept compressed when engaged with the latch strike.

1.9. In the biopsy apparatus described in Section 1.8, the charge handle charges the sampling spring, so that the sampling slide and the cannula slide move integrally in the direction proximal to the carriage slide, and the cannula retracting spring. A single movement of the cannula slide in the distal direction from the sampling slide to charge, and the movement of the entire carriage assembly in the proximal direction to the housing to charge the prime piercing spring, in a series of operations. It is configured to promote sequentially.

1.10 The biopsy device described in any of the preceding sections.

It further comprises a positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide, the cannula assembly end wall has a positioning window, and the positioning mechanism is configured to selectively cover a portion of the positioning window.

The charge handle has a charge handle latch arm configured to pass through the positioning window when the charge handle is moved to the retracted position and is distal when the positioning mechanism is arranged to cover a portion of the positioning window. Subsequent movement of the charge handle towards a home position engages the charge handle latch arm with the positioning mechanism to move the cannula slide distally from the sampling slide and charge the cannula retracting spring.

1.11. The biopsy device according to any of the preceding sections, the cannula retracting spring is a set of laterally spaced springs.

1.12. The biopsy device described in any of the preceding sections, further comprising an urging spring coupled to the housing and the charge handle, which urges the charge handle distally to a fixed position. It is configured as follows.

1.13. In the biopsy apparatus described in Section 1.12, the force exerted by the urging spring is greater than the force exerted by the cannula retracting spring.

1.14. In the biopsy apparatus according to Section 1.12 or Section 1.13, the urging spring is a set of laterally separated springs.

1.15. The biopsy device according to any one of Sections 1.1 to 1.9, provided with a positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide, with a charge handle and positioning mechanism. , To selectively facilitate the integral movement of the sampling slide and the cannula slide in the proximal direction to the carriage slide to charge the sampling spring, and to charge the cannula retracting spring in the distal direction to the carriage slide. It is configured to facilitate the movement of the entire carriage assembly in the proximal direction to the housing in order to facilitate the movement of the cannula slide alone and to charge the prime piercing spring.

1.16. The biopsy apparatus according to any one of Sections 1.1 to 1.9, which is a cannula-assembled end wall having a positioning window and a charge handle latch arm configured to pass through the positioning window. The cannula slide indexer is rotatably coupled to the cannula assembly end wall of the cannula slide and the sampling slide indexer is the cannula assembly of the cannula slide. It is slidably coupled to the end wall and is configured to move in the first direction towards the vertical axis, the cannula slide indexer is operably engaged with the sampling slide indexer, and the sampling slide indexer is an urging spring. The sampling slide indexer is urged in the first direction by a window closure plate configured to cover a portion of the positioning window when the sampling slide indexer is moved in the first direction, rotating the cannula slide indexer. To contact the sampling slide indexer and move the sampling slide indexer in the second direction opposite to the first direction so that the window closing plate of the sampling slide indexer does not cover a part of the positioning window. Is configured to be operably engaged by the first latch arm of the cannula slide, moving the sampling slide indexer in a second direction opposite to the first direction, and the window closure plate of the sampling slide indexer is the positioning 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 so as not to cover a part of the sampling slide indexer, and the window closing plate of the sampling slide indexer is a positioning window. The charge handle is configured to be moved by a proximal stalk to allow the charge handle latch arm to pass through the positioning window and through the window closure plate of the sampling slide indexer. The handle engages the charge handle latch arm with the window closure plate at the return distal stalk of the charge handle towards the distal position and moves the cannula slide distally from the sampling slide to charge the cannula retracting spring. It is configured to do.

1.17. In the biopsy apparatus of Section 1.16, the sampling slide further comprises a slider wall and a latch arm deflector, the second latch arm being configured to extend distally from the slider wall. The second latch arm is configured to be releasably engaged with the second latch strike of the carriage latch cover member, and the latch arm deflection member is configured to engage the first latch arm with the cannula slide indexer of the positioning mechanism. It is configured to engage the first latch arm of the cannula slide and deflect the first latch arm, and the cannula slide indexer is rotated to allow the sampling slide indexer to move in the first direction.

1.18 The biopsy apparatus according to any one of Sections 1.1 to 1.9, which is a positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide, and is a cannula. The assembled end wall has a positioning window, and the positioning mechanism is configured to selectively cover a part of the positioning window, said positioning mechanism, and a charge handle having a charge handle latch arm extending in the proximal direction. An urging spring coupled to the housing and the charge handle, the urging spring further comprising the urging spring configured to urge the charge handle to a fixed position in the distal direction, the charge handle. Is configured for a series of operations, and in the first retreat of the charge handle, the engagement of the first latch arm with the sampling slide causes the sampling slide and the cannula-assembled end wall carrying the cannula to move in a proximal direction all at once. Move to compress the sampling spring, engage the second latch arm with the second latch strike to keep the sampling spring compressed, the cannula retracted to expose the side sample port of the stylet, and the charge handle It is configured to return to a fixed position by the force exerted by the urging mechanism, and in the second retreat of the charge handle, the charge handle latch arm is passed through the positioning window, and the charge handle is placed in place by the force exerted by the urging mechanism. When returning to, the charge handle latch arm engages with the positioning mechanism to move the cannula slide distally from the sampling slide, thereby extending the cannula retracting spring to the extended state and the first latch arm being the first. Releasably engages with the latch strike of the cannula to keep the retractable spring in the extended state, and by advancing the positioning mechanism, the positioning window of the cannula slide is completely opened and the positioning mechanism is released from the charge handle latch arm, and the cannula is released. Is placed to close the side sample opening of the stylet, the third retract of the charge handle moves the entire carriage assembly proximally to compress the prime piercing spring, and the carriage latch arm keeps the prime piercing spring compressed. Therefore, it is configured to engage with the carriage latch strike of the actuating mechanism.

1.19. In the biopsy apparatus described in Section 1.18, the actuation of the piercing button releases the carriage latch arm from the carriage latch strike, the prime piercing spring is released from compression and the carriage assembly contains the stylet and cannula. Is exerted a force to move the cannula in the distal direction all at once, the first latch arm is released from the first latch strike by the operation of the cannula retracting button, and the cannula retracting spring is released from the extended state to move the cannula in the proximal direction. It exerts the force to open the side sample opening of the stylet by moving, and the second latch arm is released from the second latch strike by the operation of the sample acquisition button, and the sampling spring is released from the compressed state and the cannula is displaced in the distal direction. It exerts the force to close the side sample mouth by moving it to.

1.20. In the biopsy apparatus according to any of the preceding sections, the stylet has an open first end and an occluded second end, the occluded second end defining a distal puncture tip. do.

1.21. In the biopsy apparatus described in any of the preceding sections, the carriage slide further includes a carriage base, the stylet assembly end wall and carriage base are formed as a single carriage structure, and the carriage base is a stylet assembly. It is configured to define a U-shaped wall with a U-shaped cross section that extends distally from the end wall and defines the open distal end and the open top, with the carriage latch cover member adhering to the carriage base and the open top. The open distal end is configured to slidably accept and guide the sampling slide and the cannula slide in the vertical direction.

1.22. A biopsy device, the biopsy device includes a housing configured to have a vertical axis to demarcate a housing chamber, an actuating mechanism having a cannula retract button, a sample acquisition button, and a carriage latch strike. A carriage assembly placed in the housing chamber, the carriage assembly includes a carriage slide with a carriage base and a stylet assembly wall, and the carriage assembly further includes a sampling slide, a cannula slide and a carriage latch cover member. The cannula slide is vertically separated from the stylet assembly wall and is movable with respect to the stylet assembly wall, the cannula slide has a first latch arm, and the carriage latch cover member is fixed to the carriage base. The carriage latch cover member has a first latch strike and a second latch strike, and the first latch arm of the cannula slide engages freely with the first latch strike of the carriage latch cover member. A stylet that is fixedly connected to the carriage assembly and the stylet assembly wall, the stylet is configured to extend along the vertical axis, and the stylet has a side sample opening. The stylet and the vacuum source carried by the carriage assembly, the vacuum source being configured to selectively vacuum the side sample openings of the stylet, fixed to the stylet and the cannula slide. Cannula connected to the cannula, the cannula is coaxial with the stylet, and the cannula has a distal cutting edge, a sampling slide that is movably placed between the cannula and the stylet assembly wall and the cannula slide. The sampling slide has a second latch arm and a latch arm deflecting member, the second latch arm being configured to be releasably engaged with a second latch strike of the carriage latch cover member. The arm deflection member engages with the first latch arm of the cannula slide and is configured to deflect the first latch arm towards the carriage base, the sampling slide, the stylet assembly wall and the sampling slide. A sampling spring located between the sampling slides, the sampling slides and the cannula, which are kept in a compressed state when the second latch arm is engaged with the second latch strike. A cannula retracting spring that is located between the slide and connected to the sampling slide and the cannula slide, the cannula retracting spring in which the first latch arm engages the first latch strike and the second. It has the cannula retracting spring, a charge handle, an urging spring, and a positioning mechanism that are releasably kept in an extended state to store mechanical energy when the latch arm is engaged with the second latch strike. It is a cocking mechanism, and the charge handle is slidably attached to the housing and is urged to a fixed position in the distal direction by an urging spring, and the charge handle is configured to move between the fixed position and the retracted position. The positioning mechanism is provided with the cocking mechanism, which is movably coupled to the cannula slide, and in the first retreat of the charge handle, the sampling slide and the cannula slide are moved all at once in the proximal direction to compress the sampling spring. The second latch arm is engaged with the second latch strike to keep the sampling spring in a compressed state and charge the vacuum source, and the charge handle is returned to the fixed position and positioned by the force exerted by the urging spring. The mechanism is configured to advance to the next selection position, the second retract of the charge handle moves the charge handle to the retracted position, and the charge handle returns to its home position by the force exerted by the urging spring. Engages with a positioning mechanism movably coupled to the cannula slide, which causes the cannula slide to move distally, thereby extending the cannula retracting spring to an extended state and the first latch arm being the first latch strike. The cannula retracting spring is kept in an extended state by engaging freely with the cannula, the cannula is arranged to close the side sample opening of the stylet, and the actuating mechanism is from the first latch strike to the first by the actuation of the cannula retracting button. The latch arm is released, the cannula retracting spring is released, and the cannula is moved in the proximal direction to exert the force to open the side sample opening of the stylet. The second latch arm is released from the latch strike of 2, and the sampling spring is released to move the cannula in the distal direction to exert a force for closing the side sample opening.

1.23 In the biopsy apparatus described in Section 1.22, the carriage assembly is configured to move vertically with respect to the housing, with an actuation mechanism having a pierce button and a carriage latch strike, and a carriage latch. A carriage latch cover member having an arm, wherein the carriage latch arm is configured to be releasably engaged with a carriage latch strike, said carriage latch cover member, and proximal and distal ends within the housing. An intermediate wall placed between the carriage and a prime piercing spring placed between the intermediate wall and the stylet assembly wall, so that the prime piercing spring stores mechanical energy when in a compressed state. The prime piercing spring is configured to urge the entire carriage assembly distally and is kept in a compressed state when the carriage latch arm engages the carriage latch strike of the actuating mechanism. Further equipped with a piercing spring, the third retract of the charge handle prior to the operation of the actuating mechanism moves the entire carriage assembly proximally to compress the prime piercing spring, and the carriage latch arm keeps the prime piercing spring compressed. Therefore, it is configured to engage with the carriage latch strike of the actuating mechanism, and the carriage latch arm is released from the carriage latch strike by the activation of the piercing button prior to the activation of the cannula retract button and the sample acquisition button, and the prime piercing spring is released from the compressed state. It exerts the force to move the carriage assembly, stylet and cannula all at once in the distal direction.

1.24. A method of operating a biopsy device, the method of providing a housing with an actuating mechanism and providing a movable carriage assembly with respect to the housing, where the carriage assembly is a stylet to which the stylet is assembled. The cannula slide includes a cannula slide for assembling the assembly wall and the cutting cannula, a sampling slide which is movably arranged between the stylet assembly wall and the cannula slide, and a carriage latch cover member. Provided with the carriage assembly that is longitudinally separated from the wall and movable relative to the stylet-assembled wall, and a charge handle that sequentially moves at least one of the cannula slide, sampling slide, and entire carriage assembly. The charge handle has a fixed position and a retracted position. The charge handle is provided, a sampling spring is provided between the stylet assembly wall and the sampling slide, and the sampling slide is provided. With a cannula retracting spring located between the and the cannula slide and connected to the sampling slide and the cannula slide, and a prime piercing spring located between the carriage assembly and a portion of the housing. , A vacuum system that selectively supplies vacuum to the sample port of the stylet is provided, and the cannula slide and the sampling slide are moved simultaneously in the proximal direction to charge the sampling spring, and the sampling slide is engaged with the carriage latch cover member. In order to stop and keep the sampling spring in the charged state and charge the vacuum system with vacuum, the charge handle is retracted for the first time, the charge handle is returned to the fixed position for the first time, and the charge handle is moved. Retreat to the retracted position for the second time, move the cannula slide distal to the sampling slide to charge the cannula retracting spring, and lock the cannula slide to the carriage latch cover member to charge the cannula retracting spring. To keep it in place, return the charge handle to its home position for the second time, move the entire carriage assembly proximally to charge the prime piercing spring, and lock the carriage latch cover member to the actuating mechanism. Retreat the charge handle for the third time to keep the prime pierce spring charged Including that.

1.25. In the method described in Section 24, the actuating mechanism has a cannula retracting spring, a sample acquisition button and a piercing button, and the method is to release the carriage latch cover member from the actuating mechanism to charge the prime piercing spring from the charged state. To release and propel the carriage assembly distally to facilitate tissue puncture by the stylet and cannula, activate the piercing button and release the cannula slide from the carriage latch cover member to release the cannula retracting spring. To release from the charged state, move the cannula in the proximal direction to open the side sample opening of the stylet, and at the same time, apply a vacuum to the side sample opening to draw tissue into the side sample opening, so that the cannula retract button is activated. To release the sampling slide from the carriage latch cover member, release the sampling spring from the charged state, propel the cannula in the distal direction, close the side sample port, and cut the tissue drawn into the side sample port by vacuum. , Further including activating the sample acquisition button.

Having described the invention for at least one embodiment, one of ordinary skill in the art will recognize that the invention can be further modified within the spirit and scope of the present disclosure. Therefore, variations, uses and indications of the present invention using the general principles of the present invention are within the scope of the present application. Further, deviations from the present disclosure, which are carried out by methods well known or customary in the arts relating to the present invention and are within the scope of the appended claims, are within the scope of the present application. The present invention can also be realized, for example, in the following forms.
[Form 1]
A chassis, a biopsy needle with a stylet and cannula, a carriage slide with a stylet-assembled end wall, a cannula slide with a cannula-assembled end wall, and a carriage assembly with a sampling slide, sliding onto said housing. A biopsy device having a freely assembled charge handle, wherein the charge handle has a fixed position and a retracted position, the biopsy device is disposed within the housing and carried by the carriage assembly. Further equipped with a vacuum system, the vacuum system is charged to generate a vacuum when the sampling spring is compressed, the vacuum system includes a first vacuum pump, a second vacuum pump, a manifold and a control valve.
The first vacuum pump has a first vacuum port.
The second vacuum pump has a second vacuum port.
The manifold has a first evacuation port, a second evacuation port, and a first evacuation port.
The control valve has a third evacuation port and a second evacuation port.
The first vacuum port of the first vacuum pump is coupled to the first vacuum extraction port of the manifold by fluid communication, and the second vacuum port of the second vacuum pump is the second vacuum port of the manifold. The first vacuum application port of the manifold is coupled to the vacuum extraction port of No. 2 by fluid communication, and the first vacuum application port of the manifold is coupled to the third vacuum extraction port of the valve by fluid communication, and the second vacuum extraction of the control valve is performed. The mouth is connected by fluid communication to the first lumen of the stylet.
The manifold has a first one-way valve coupled to the first vacuum outlet by fluid communication and a second one-way valve coupled to the second vacuum outlet by fluid communication. The first one-way valve and the second one-way valve are configured to release positive pressure to the atmosphere and close when a vacuum is established.
The control valve is operated by the operation of the cannula retracting button of the actuating mechanism to apply the vacuum to the side sample opening of the stylet, and at the same time, the proximal direction movement of the cannula due to the force generated by the cannula retracting spring causes the stylet to move. The side sample opening opens,
Biopsy device.
[Form 2]
The first vacuum pump is
A first cylinder having a first end and a second end, wherein the first end has the first vacuum port and the second end defines a first opening. , The first cylinder and
A first piston that is received by the first cylinder through the first opening,
A first plunger attached to the first piston, wherein the first plunger is configured to extend from the second end of the first cylinder, and the first plunger is a first. With the first plunger, which has a free end with a head,
A first vacuum spring disposed between the second end of the cylinder and the first head of the first plunger, the first vacuum spring being mechanical when in a compressed state. Includes the first vacuum spring configured to store energy and to urge the first piston in the distal direction to establish a vacuum at the first vacuum port. ,
The second vacuum pump is
A second cylinder having a first end and a second end, wherein the first end has the second vacuum port and the second end defines a second opening. , The second cylinder and
A second piston that is received by the second cylinder through the second opening, and
A second plunger attached to the second piston, wherein the second plunger is configured to extend from the second end of the second cylinder, and the second plunger is a second. With the second plunger, which has a free end with a head,
A second vacuum spring arranged between the second end of the second cylinder and the second head of the second plunger, when the second vacuum spring is in a compressed state. The second vacuum spring, which is configured to store mechanical energy and urges the second piston in the distal direction in order to establish a vacuum at the second vacuum port. Including,
The biopsy apparatus according to Form 1.
[Form 3]
The first head of the first vacuum pump and the second head of the second vacuum pump are arranged to engage the cannula assembly end wall of the cannula slide and the first vacuum pump said. The first vacuum spring and the second vacuum spring of the second vacuum pump compress when the cannula assembly end wall moves in the proximal direction before the cannula retracting spring is charged to the stretched state. The biopsy apparatus according to the second embodiment.
[Form 4]
The biopsy apparatus according to embodiment 3, wherein the compression of the first vacuum spring of the first vacuum pump and the compression of the second vacuum spring of the second vacuum pump occur at the same time as the compression of the sampling spring.
[Form 5]
The stylet assembly end wall includes a first pump assembly hole and a second pump assembly hole.
The first vacuum pump is received in the first pump assembly hole, and the first proximal cylinder portion having the first vacuum port extends in the proximal direction from the stylet assembly end wall. The first distal cylinder portion having the first opening is configured to extend distally from the stylet assembly end wall and upon first retraction of the charge handle. To compress the first vacuum spring when the cannula assembly end wall is moved in the proximal direction, the first head of the first plunger engages the cannula assembly end wall. Placed,
The second vacuum pump is received in the second pump assembly hole, and the second proximal cylinder portion having the second vacuum port extends in the proximal direction from the stylet assembly end wall. The second distal cylinder portion having the second opening is configured to extend distally from the stylet assembly end wall and the first retract of the charge handle. Sometimes, when the cannula assembly end wall is moved in the proximal direction, the second head of the second plunger is used to compress the first vacuum spring and at the same time compress the second vacuum spring. The biopsy apparatus according to any of embodiments 2 to 4, which is arranged to engage the cannula-assembled end wall.
[Form 6]
The housing is equipped with an actuating mechanism.
The carriage assembly is movable with respect to the housing, and the carriage assembly includes the stylet assembly wall for assembling a stylet having a sample port, the cannula slide for assembling a cutting cannula, and the stylet assembly wall. The sampling slide, which is movably arranged between the cannula slide and the carriage latch cover member, is included, and the cannula slide is vertically separated and movable with respect to the stylet assembly wall. The cannula slide has a first latch member, the sampling slide has a second latch member, and the carriage latch cover member has a third latch member.
A sampling spring is arranged between the stylet assembly wall and the sampling slide.
A cannula retracting spring is arranged between the sampling slide and the cannula slide, and the cannula retracting spring is connected to the sampling slide and the cannula slide.
A prime piercing spring is placed between the carriage assembly and a portion of the housing.
The biopsy device
The cannula slide and the sampling slide are simultaneously moved in the proximal direction by the first retreat of the charge handle to charge the sampling spring, and the second latch member of the sampling slide is used as the carriage latch cover member. It locks to keep the sampling spring in a charged state and also charges the vacuum system to generate a vacuum.
The first return of the charge handle causes the charge handle to return to the fixed position.
The second retreat of the charge handle moves the charge handle to the retreat position.
The second return of the charge handle to the home position moves the cannula slide distally from the sampling slide to charge the cannula retracting spring, and the first latch member of the cannula slide is said. Locked to the carriage latch cover member to keep the cannula retracting spring in a charged state, and the third retract of the charge handle moves the entire carriage assembly in the proximal direction to charge the prime piercing spring. Moreover, the third latch member of the carriage latch cover member is locked to the actuating mechanism to keep the prime piercing spring in the charged state.
The biopsy apparatus according to any of the preceding embodiments.
[Form 7]
The actuating mechanism has a cannula retreat button, a sample acquisition button and a piercing button, and the biopsy device is a biopsy device.
When the piercing button is activated, the third latch member of the carriage latch cover member is released from the operating mechanism to release the prime piercing spring from the charged state, and the carriage assembly is moved toward the distal direction. Promote tissue piercing by the stylet and the cannula,
When the cannula retracting button is activated, the first latch member of the cannula slide is released from the carriage latch cover member to release the cannula retracting spring from the charged state, and the cannula is displaced in the proximal direction. The carriage latch cover is moved to open the side sample port of the stylet, and at the same time, the vacuum is applied to the side sample port to draw the tissue into the side sample port, and the sample acquisition button is activated. The second latch member of the sampling slide is released from the member to release the sampling spring from the charged state, the cannula is propelled in the distal direction to close the side sample opening, and the side sample is closed by vacuum. The biopsy apparatus of embodiment 6, further configured to cut the tissue drawn into the mouth.
[Form 8]
The stylet is arranged so as to extend along the vertical axis, and the stylet reaches the first lumen through a first side wall configured to demarcate the first lumen and the first side wall. Has a side sample port and
The cannula is coaxial with the stylet, the cannula has a second side wall configured to demarcate a second lumen, and the cannula has a distal cutting edge.
The housing has a proximal end wall, an intermediate wall and a distal end separated along the vertical axis, the distal end has a needle opening, and the housing has the proximal end. It is configured to define a housing chamber between the wall and the distal end, the intermediate wall is located between the proximal end wall and the distal end, and the stylet and the cannula Accepted through the needle opening, the proximal direction is from the distal end to the proximal end wall, and the distal direction is from the proximal end wall to the distal end.
The actuating mechanism has a piercing button, a cannula retract button, and a sample acquisition button, and also has a carriage latch strike.
The carriage assembly is arranged in the housing, the carriage assembly is configured to move vertically with respect to the housing, and the carriage assembly includes the carriage slide, the carriage latch cover member, the cannula slide, and the sampling. The cannula slide and the sampling slide are configured to be movable with respect to the carriage slide, including a slide, the cannula slide is a first latch arm extending proximally from the cannula assembly end wall. The sampling slide is movably arranged between the stylet-assembled end wall of the carriage slide and the cannula-assembled end wall of the cannula slide, and the sampling slide extends in the distal direction. Has a second latch arm to put out,
The carriage latch cover member has a first latch strike, a second latch strike, and a carriage latch arm, and the first latch strike is configured to be releasably engaged with 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 actuating mechanism.
A sampling spring is placed between the stylet-assembled end wall and the sampling slide, and the sampling spring is configured to store mechanical energy in a compressed state, and the sampling slide is distal to the sampling slide. The sampling spring is kept in the compressed state when it is configured to urge in the direction and the second latch arm is engaged with the second latch strike.
A cannula retracting spring is arranged between the sampling slide and the cannula slide, the cannula retracting spring is connected to the sampling slide and the cannula slide, and the cannula retracting spring is proximal to the cannula slide. It is configured to store mechanical energy in the extended state for urging in the direction, the first latch arm is engaged with the first latch strike, and the second latch arm is the second latch. When engaged with the strike, the cannula retracting spring is held free to release in the stretched state.
A prime piercing spring is arranged between the intermediate wall of the carriage and the stylet-assembled end wall, and the prime piercing spring is configured to store mechanical energy in a compressed state. The prime piercing spring is kept in the compressed state when the entire carriage assembly is configured to urge the entire carriage assembly in the distal direction and the carriage latch arm is engaged with the carriage latch strike of the actuating mechanism.
The biopsy apparatus according to any one of embodiments 1 to 6.
[Form 9]
The charge handle is
In order to charge the sampling spring, the integral movement of the sampling slide and the cannula slide in the proximal direction with respect to the carriage slide,
A single movement of the cannula slide in the distal direction from the sampling slide to charge the cannula retracting spring.
The biopsy apparatus according to embodiment 8, wherein the movement of the entire carriage assembly in the proximal direction with respect to the housing is sequentially promoted by a series of operations in order to charge the prime piercing spring.
[Form 10]
Further comprising a positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide, the cannula assembly end wall has a positioning window, the positioning mechanism selectively covers a portion of the positioning window. Is configured to
The charge handle has a charge handle latch arm configured to pass through the positioning window when the charge handle is moved to the retracted position, and the positioning mechanism is arranged to cover a part of the positioning window. When so, the subsequent movement of the charge handle towards the home position in the distal direction causes the charge handle latch arm to engage the positioning mechanism to move the cannula slide from the sampling slide in the distal direction. , Charge the cannula retracting spring,
The biopsy apparatus according to any of the preceding embodiments.
[Form 11]
The biopsy apparatus according to any of the preceding embodiments, wherein the cannula retracting spring is a set of laterally spaced springs.
[Form 12]
Any of the preceding, further comprising an urging spring coupled to the housing and the charge handle, the urging spring being configured to urge the charge handle in the distal direction to the home position. The biopsy device according to the embodiment.
[Form 13]
The biopsy apparatus according to embodiment 12, wherein the force exerted by the urging spring is greater than the force exerted by the cannula retreat spring.
[Form 14]
The biopsy apparatus according to embodiment 12 or 13, wherein the urging spring is a set of laterally separated springs.
[Form 15]
A positioning mechanism that is movably coupled to the cannula assembly end wall of the cannula slide.
In order to charge the sampling spring, the charge handle and the positioning mechanism selectively promote the integral movement of the sampling slide and the cannula slide in the proximal direction with respect to the carriage slide, and the cannula retracts. The carriage in the proximal direction to the housing to charge the spring, to facilitate a single movement of the cannula slide in the distal direction with respect to the carriage slide, and to charge the prime piercing spring. Constructed to facilitate movement of the entire assembly,
The biopsy apparatus according to any one of embodiments 1 to 9.
[Form 16]
With the cannula assembly end wall having a positioning window,
A charge handle having a charge handle latch arm configured to pass through the positioning window.
It comprises a positioning mechanism with a cannula slide indexer and a sampling slide indexer, the cannula slide indexer is rotatably coupled to the cannula assembly end wall of the cannula slide, and the sampling slide indexer is the cannula assembly of the cannula slide. The cannula slide indexer is slidably coupled to the end wall and is configured to move in the first direction towards the vertical axis, the cannula slide indexer being operably engaged with the sampling slide indexer, and the sampling slide indexer. Is urged in the first direction by an urging spring, the sampling slide indexer has a window closure plate configured to cover a portion of the positioning window when the sampling slide indexer is moved in the first direction. Have and
The cannula slide indexer is rotated to bring it into contact with the sampling slide indexer, the sampling slide indexer is moved in a second direction opposite to the first direction, and the window closing plate of the sampling slide indexer is the positioning window. The cannula slide indexer is configured to be operably engaged by the first latch arm of the cannula slide so as not to cover said portion of the cannula slide.
The sampling slide indexer is moved in the second direction opposite to the first direction so that the window closing plate of the sampling slide indexer does not cover the part of the positioning window. Is configured to be operably engaged by the second latch arm of the second latch arm of the sampling slide.
The window closure plate of the sampling slide indexer is arranged to cover the portion of the positioning window so that the charge handle latch arm passes through the positioning window and through the window closure plate of the sampling slide indexer. Therefore, the charge handle is configured to be moved by a proximal stalk, and the charge handle brings the charge handle latch arm to the return distal stalk of the charge handle toward the home position in the distal direction. It is configured to engage the window closure plate and move the cannula slide in the distal direction from the sampling slide to charge the cannula retracting spring.
The biopsy apparatus according to any one of embodiments 1 to 9.
[Form 17]
The sample slide is configured such that the slider wall and the second latch arm extend distally from the slide wall, and the second latch arm can be released to a second latch strike of the carriage ratch cover member. The latch arm deflecting member is further provided with a latch arm deflecting member configured to engage with, the latch arm deflecting member engaging with the first latch arm of the cannula slide and deflecting the first latch arm to cannulate the indexing mechanism. 16. The biopsy apparatus of embodiment 16, wherein the cannula slide indexer engages with a slide indexer and is configured to rotate to move the sample slide indexer in a first direction.
[Form 18]
An indexing mechanism provided with an indexing window and configured to selectively cover a part of the indexing window, which is movably connected to the cannula mounting end wall of the cannula slide;
A charge handle with a charge handle latch arm extending in the proximal direction; and the housing and said housing configured to urge the charge handle, which is configured to act in sequence, distally from a home position. Further equipped with an urging spring connected to the charge handle,
The first retreat of the charge handle moves the sample slide and the cannula mounting end wall holding the cannula in a coincidentally proximal direction by a first latch arm engaged with the sample slide and a second latch. The arm engages with a second latch strike to hold the sample spring in a compressed state, and the cannula is retracted to expose the lateral sample port of the stylet and is determined by the force applied by the urging mechanism. It is configured to return to position;
The second retreat of the charge handle is through the index window and the charge handle latch arm is indexed while the force applied by the urging mechanism returns the charge handle to its home position.
The charge handle latch arm engages the indexing mechanism, moving the cannula slide distally from the sample slide and extending the cannula retracting spring to the extended state;
The first latch arm engages releasably with the first latch strike to hold the cannula retracting spring in an extended state;
The indexing mechanism is arranged to fully open the indexing window of the cannula slide, releasing the indexing mechanism from the charge handle latch arm; a third retract of the charge handle moves the entire carriage assembly proximally. The raw according to any one of embodiments 1-9, wherein the prime piercing spring is compressed and the carriage latch arm engages with the carriage latch strike of the actuator mechanism to hold the priming piercing spring in a compressed state. Inspection device.
[Form 19]
When the perforation button is activated, the carriage latch arm is released from the carriage latch strike and the first perforation spring is released from compression, exerting a force to move the carriage assembly with the stylet and cannula distally;
When the cannula retract button is activated, the first latch arm is released from the first latch strike and the cannula retracting spring is released from the extended state to move the cannula proximally and open the stylet's lateral sample port. Apply force,
When the sample capture button is activated, the second latch arm is released from the second latch strike, the sampling spring is released from compression, and the cannula is configured to move distally to close the side sample port. The biopsy apparatus according to embodiment 18.
[Form 20]
The stylet has an open first end and a closed second end, wherein the closed second end defines a distal perforation tip, form 1- 19. The biopsy apparatus according to any one of 19.
[Form 21]
The carriage slide further has a carriage base, the stylet mount end wall and the carriage base are formed as an integral carriage structure, and the carriage base has a U-shaped cross section extending distally from the stylet mounting end wall. The carriage wall is configured to define the open distal end and the open top, the carriage latch cover member is configured to be attached to the carriage base to cover the open top, and the open tip is a sampling slide. The biopsy apparatus according to any one of embodiments 1 to 20, which is configured to slidably accept the cannula slide and move in the longitudinal direction.
[Form 22]
Housing with actuator mechanism;
Stylet mount wall with slides with sample ports;
Between the cutting cannula, the stylet mount wall and the cannula slide that is longitudinally separated from the stylet mounting wall and is movable relative to the stylet mounting wall and has a first latch member. A sample slide with a second latch member and a cannula slide fitted with a carriage latch cover member with a third latch member, movably inserted into the.
A charge handle that has a fixed position and a retracted position and is slidably attached to the housing;
Sample spring inserted between the stylet mounting wall and the sample slide;
A cannula retracting spring inserted between the sampling slide and the cannula slide and connected to each of them;
A first perforated spring sandwiched between the carriage assembly and part of the housing;
Equipped with a vacuum system that selectively evacuates the stylet sample port
The first retreat of the charge handle moves the cannula slide and the sample slide in the proximal direction all at once to charge the sample spring, and latches the second latch member of the sample slide with the carriage latch cover member to release the sample spring. Keep in a charged state and jersey the vacuum state to generate a vacuum;
The first return of the charge handle returns the charge handle to its home position;
The second retreat of the charge handle moves the charge handle to retreat;
When the charge handle is returned to the home position twice, the cannula slide moves distally away from the sample slide, the cannula retracting spring is charged, and the first latch member of the cannula slide is latched by the carriage latch cover member. The spring is retracted with the cannula charged;
The third retract of the charging handle moves the entire carriage assembly in the proximal direction, the first drilling spring is charged, and the third latch member of the carriage latch cover member is latched by the actuator mechanism, the first. A biopsy device configured to hold a perforated spring in a charged state.
[Form 23]
The actuator mechanism has a cannula retract button, a sample supplement button, and a perforation button, and the puncture button is activated to release the latch of the third latch member of the carriage latch cover member from the actuator mechanism to charge the prime piercing spring. Free from and propel the carriage assembly to move simultaneously toward the stylet and distal cannula;
The cannula retract button is activated to unlatch the first latch member of the cannula slide from the carriage latch cover member, release the cannula retracting spring from the charged state, move the cannula proximally and laterally to the stylet. Open the sample port and vacuum the side sample port at the same time;
The sample capture button is activated to disengage the second latch member of the sampling slide from the carriage latch cover member, release the sample spring from the charged state, propel the cannula distally, and close the side sample port. 22. The biopsy apparatus according to embodiment 22.
[Form 24]
It has a first side wall configured to define a first lumen and a lateral sample port extending through the first side wall to the first lumen and on a longitudinal axis. Stylets arranged to extend;
A cannula coaxial with the stylet having a second side wall configured to define a second lumen and a tip cutting edge;
A proximal end wall spaced along the longitudinal axis, an intermediate wall interposed between the proximal end wall and the distal end, and the distal end having a needle opening. The housing is configured to demarcate a containment chamber between the proximal end wall and the distal end, and the stylet and the cannula are received and near through the needle opening. The housing is oriented from the distal end towards the proximal end wall and distally towards the distal end.
A charge handle that is slidably attached to the housing and is configured to move between a fixed position and a retracted position;
Actuator mechanism with pierce button, cannula retract button, sample capture button, and carriage latch strike;
A carriage assembly arranged in the containment chamber, configured to move in the longitudinal direction as a whole with respect to the housing, the carriage slide and the carriage latch cover member, each moving relative to the carriage slide. The carriage slide has a stylet mount end wall configured to mount the stylet, and the cannula slide comprises the cannula. It has a cannula mounting end wall configured to be mounted and a first latch arm extending proximally from the cannula mounting end wall, wherein the sample slide is the stylet mount end wall of the carriage slide. Movably interposed between the cannula slide and the cannula mounting end wall, the sample slide has a second latch arm extending distally.
The carriage latch cover member is configured to be releasably engaged with a first latch strike configured to be releasably engaged with the first latch arm. A carriage assembly comprising a second latch strike and a carriage latch arm configured to be releasably engaged with said carriage latch strike of the actuator mechanism;
A sample spring interposed between the stylet mount end wall and the sample slide, configured to store mechanical energy when in a compressed state, urging the sample slide in the distal direction. A sample spring configured as such and held in the compressed state when the second latch arm engages the second latch strike;
A vacuum system disposed within the housing, charged to generate a vacuum when the sample spring is compressed, and carried by the carriage assembly:
A cannula retracting spring inserted between the sample slide and the cannula slide and connected to each of them, accumulating mechanical energy in an extended state to urge the cannula slide in the proximal direction. When the first latch arm engages with the first latch strike and the second latch arm engages with the second latch strike, it is releasably held in the extended state. A cannula retracting spring; and a prime piercing spring inserted between the intermediate wall of the housing and the stylet mount end wall so as to store mechanical energy when in a compressed state. A prime pierce spring that is configured to urge the entire carriage assembly in the distal direction and is held in the compressed state when the carriage latch arm engages the carriage latch strike of the actuator mechanism. A biopsy device equipped with.
[Form 25]
The charge handle operates continuously,
Collective movement of the sample slide and the cannula slide as one unit in the proximal direction with respect to the carriage slide to charge the sample spring.
With the movement of the individual cannula slides in the distal direction away from the sample slide, charging the cannula retracting spring.
With respect to the overall movement of the carriage assembly in the proximal direction with respect to the housing, charging the prime piercing spring.
24. The biopsy apparatus according to embodiment 24, which is configured to continuously promote.
[Form 26]
Further provided with an indexing mechanism that is movably coupled to the cannula mounting end wall of the cannula slide having the indexing window and configured to selectively cover a portion of the indexing window;
When the charge handle has a charge handle latch arm configured to pass through the indexing window when moved to the retracted position and the indexing mechanism is arranged to cover said portion of the indexing window. Subsequent movement of the charge handle towards the home position in the distal direction causes the charge handle latch arm to engage the indexing mechanism and move the cannula slide in the distal direction away from the sample slide. 25. The biopsy apparatus of embodiment 25, which charges the cannula retreat spring.
[Form 27]
26. The biopsy apparatus according to embodiment 26, wherein the cannula retracting spring is a pair of laterally spaced springs.
[Form 28]
25. The biopsy according to embodiment 25, 26 or 27, further comprising an urging spring coupled to the housing and the charge handle and configured to urge the charge handle to the home position in the distal direction. Device.
[Form 29]
28. The biopsy apparatus of embodiment 28, wherein the force exerted by the urging spring is greater than the force applied by the cannula retreat spring.
[Form 30]
28 or 29, wherein the urging spring is a pair of laterally spaced springs.
[Form 31]
A indexing mechanism movably connected to the cannula mounting end wall of the cannula slide is provided.
The charge handle and the indexing mechanism both selectively charge the sample spring and the collective movement of the sample slide and the cannula slide as one unit in the proximal direction with respect to the carriage slide. Promoting and charging the cannula retracting spring, facilitating individual movement of the cannula slide in the distal direction with respect to the carriage slide, charging the prime piercing spring, the whole in the proximal direction with respect to the housing. 25. The biopsy apparatus according to embodiment 24 or 25, which is configured to facilitate movement of the carriage assembly.
[Form 32]
The cannula mounting end wall has an indexing window;
The charge handle has a charge handle latch arm configured to pass through the index window;
The biopsy device further
A cannula slide indexer rotatably connected to the cannula mounting end wall of the cannula slide, and slidably connected to the cannula mounting end wall of the cannula slide in a first direction towards the longitudinal axis. An indexing mechanism having a sample slide indexer configured to move, wherein the cannula slide indexer is operably engaged with the sample slide indexer, and the sample slide indexer is said by an urging spring. Elevated in a first direction, the sample slide indexer has a window shielding plate configured to cover a portion of the indexing window as the sample slide indexer moves in the first direction. Equipped with a mechanism;
The cannula slide indexer is operably engaged by the first latch arm of the cannula slide so that the window shield of the sample slide indexer does not cover said portion of the indexing window. The slide indexer is configured to rotate to contact the sample slide indexer and move the sample slide indexer in a second direction opposite to the first direction.
The sample slide indexer is operably engaged by the second latch arm of the sample slide so that the window shield of the sample slide indexer does not cover the portion of the index window. The slide indexer is configured to move in the second direction opposite to the first direction.
When the window shield of the sample slide indexer is arranged to cover the portion of the index window, the charge handle is such that the charge handle latch arm passes through the index window and the window shield. The charge handle is configured to move within a proximal stroke to pass through the charge handle latch arm with the window by the distal return distal stroke towards the home position of the charge handle. 25. The biopsy apparatus of embodiment 24 or 25, configured to engage with a shield to move the cannula slide away from the sample slide in the distal direction and charge the cannula retracting spring.
[Form 33]
The sample slide comprises a slider wall and a latch arm deflecting member, the second latch arm is configured to extend distally from the slider wall and the second latch strike of the carriage latch cover member. The latch arm deflecting member is configured to engage releasably with the cannula slide indexer of the indexing mechanism by engaging with the first latch arm of the cannula slide. 32. The biopsy apparatus of embodiment 32, wherein the cannula slide indexer is configured to deflect a first latch arm and is rotated to move the sample slide indexer in the first direction.
[Form 34]
It comprises an indexing mechanism that is movably coupled to the cannula mounting end wall of the cannula slide having an indexing window and is configured to selectively cover a portion of the indexing window;
The charge handle has a charge handle latch extending in the proximal direction;
The biopsy device further
The charge handle configured for continuous actuation is configured to urge the charge handle to the home position in the distal direction and comprises an urging spring coupled to the housing and the charge handle.
Due to the first retract of the charge handle, the sample slide and the cannula mounting end wall carrying the cannula are all at once via the first latch arm that engages the sample slide, said proximally. Moving in the direction, compressing the sample spring, engaging the second latch arm with the second latch strike to hold the sample spring in the compressed state, the cannula of the stylet. Retracted to expose the lateral sample port, the charge handle is configured to return to its home position by the force applied by the urging mechanism;
While the charge handle latch arm passes through the indexing window due to the second retract of the charge handle and the charge handle returns to the home position by the force applied by the urging mechanism.
The charge handle latch arm engages the indexing mechanism to move the cannula slide away from the sample slide in the distal direction, and then extends the cannula retracting spring to the extended state.
The first latch arm is releasably engaged with the first latch strike to hold the cannula retracting spring in the extended state.
The indexing mechanism is arranged so as to completely open the indexing window of the cannula slide and disengage the indexing mechanism from the charge handle latch arm.
The cannula is placed so as to close the lateral sample port of the stylet.
Due to the third retract of the charge handle, the entire carriage assembly moves in the proximal direction to compress the prime piercing spring, and the carriage latch arm holds the prime piercing spring in the compressed state. 25. The biopsy apparatus of embodiment 24 or 25, which is configured to engage the carriage latch strike of the actuator mechanism.
[Form 35]
By activating the piercing button, the carriage latch arm is released from the carriage latch strike, the prime piercing spring is released from the compressed state, and the carriage assembly including the stylet and the cannula is released all at once. , Applying a force to move in the distal direction;
When the cannula retracting button is activated, the first latch arm is released from the first latch strike, and the cannula retracting spring is released from the extended state to move the cannula in the proximal direction. And open the lateral sample port of the stylet;
When the sample capture button is activated, the second latch arm is released from the second latch strike, the sample spring is released from the compressed state, and a force for moving the cannula in the distal direction. 34. The biopsy apparatus according to embodiment 34, which is configured to close the lateral sample port in addition to the above.
[Form 36]
The vacuum system comprises a first vacuum pump, a second vacuum pump, a manifold and a control valve.
The first vacuum pump has a first vacuum port.
The second vacuum pump has a second vacuum port.
The manifold has a first evacuation port, a second evacuation port, and a first evacuation port.
The control valve has a third evacuation port and a second evacuation port.
The first vacuum port of the first vacuum pump is fluidly coupled to the first vacuum lead port of the manifold, and the second vacuum port of the second vacuum pump is The second vacuum draw-in port of the manifold is fluidly coupled and coupled, and the first vacuum application port of the manifold is fluidally coupled to the third vacuum draw-in port of the control valve. The second vacuum draw-in port of the control valve is fluidly coupled to the first lumen of the stylet;
The manifold includes a first one-way valve coupled to the first vacuum port for fluid communication and a second one-way valve coupled to the second vacuum port for fluid communication. Each of the first one-way valve and the second one-way valve releases positive pressure to the atmosphere and is configured to close when a vacuum is established;
The control valve is operated by the actuation of the cannula retracting button of the actuator mechanism and simultaneously moves the cannula in the proximal direction by the force generated by the cannula retracting spring to the lateral sample port of the stylet. The biopsy apparatus of any of embodiments 24-35, wherein a vacuum is applied, thereby opening the lateral sample port of the stylet.
[Form 37]
The first vacuum pump
A first cylinder having a first end having the first vacuum port and a second end defining a first opening;
A first piston that is received into the first cylinder through the first opening;
A first plunger that connects to the first piston and is configured to extend from the second end of the first cylinder and has a free end with a first head; and the first. A first vacuum spring interposed between the second end of the cylinder and the first head of the first plunger to store mechanical energy when in a compressed state. A first vacuum spring configured to urge the first piston in the distal direction to establish a vacuum in the first vacuum port.
The second vacuum pump
A second cylinder with a first end having the second vacuum port and a second end defining a second opening;
A second piston that is received into the second cylinder through the second opening;
A second plunger that connects to the second piston and is configured to extend from the second end of the second cylinder and has a free end with a second head; and the second A second vacuum spring interposed between the second end of the cylinder and the second head of the second plunger to store mechanical energy when in a compressed state. 36, wherein the second piston comprises a second vacuum spring configured to urge the second piston in the distal direction to establish a vacuum in the second vacuum port. Biopsy device.
[Form 38]
The first head of the first vacuum pump and the second head of the second vacuum pump are arranged so as to engage with the cannula mounting end wall of the cannula slide, and the cannula retracting spring. The first vacuum spring of the first vacuum pump and the second of the second vacuum pump during the proximal movement of the cannula mounting end wall that occurs before being charged into the extended state. 37. The biopsy apparatus according to embodiment 37, wherein each of the vacuum springs of the above is compressed.
[Form 39]
The biopsy apparatus according to embodiment 38, wherein the compression of the first vacuum spring of the first vacuum pump and the second vacuum spring of the second vacuum pump occurs at the same time as the compression of the sample spring.
[Form 40]
The stylet mount end wall includes a first pump mounting hole and a second pump mounting hole.
The first vacuum pump is from a first proximal cylinder portion having the first vacuum port configured to extend proximally from the stylet mount end wall and from the stylet mount end wall. Receiving in the first pump mounting hole, along with a first distal cylinder having the first opening configured to extend distally.
The first head of the first plunger to compress the first vacuum spring as the cannula mounting end wall moves in the proximal direction during the first retract of the charge handle. Positioned to engage the cannula mounting end wall,
The second vacuum pump is from a second proximal cylinder portion having the second vacuum port configured to extend proximally from the stylet mount end wall and from the stylet mount end wall. Receiving in the second pump mounting hole, along with a second distal cylinder having the second opening configured to extend distally.
The second head of the second plunger with compression of the first vacuum spring as the cannula mounting end wall moves in the proximal direction during the first retract of the charge handle. The biopsy apparatus of any of embodiments 37-39, positioned to engage the cannula mounting end wall so as to compress the second vacuum spring at the same time.
[Form 41]
The biopsy apparatus of any of embodiments 1-40, wherein the stylet has an open first end and a closed second end defining a distal piercing tip.
[Form 42]
The carriage slide further includes a carriage base, the stylet mount end wall and the carriage base are formed as a single carriage structure, the carriage base extending distally from the stylet mount end wall and opening. The carriage latch cover member is configured to be attached to the carriage base and cover the open top, configured to define a U-shaped wall having a U-shaped cross section that defines the distal end and the open top. The biopsy apparatus according to any one of embodiments 1 to 41, wherein the open distal end is configured to slidably accept and guide the sample slide and the cannula slide in the longitudinal direction.
[Form 43]
With a housing, which has a vertical axis and is configured to define a housing chamber;
An actuator mechanism with a cannula pull-in button, a sample acquisition button, and a carriage latch seat;
Includes a carriage slide located within the housing chamber and having a carriage base and a stylet mount wall, further including a sample slide, a cannula slide and a carriage latch cover member, the cannula slide. Vertically spaced from the stylet mount wall and movable relative to the stylet mount wall, the cannula slide has a first latch arm and the carriage latch cover member. Is fixedly attached to the carriage base, the carriage latch cover member has a first latch seat and a second latch seat, and the first latch arm of the cannula slide is the first latch arm. With a carriage assembly configured to releasably engage the first latch seat of the carriage latch cover member;
With a stylet attached to the stylet mount wall, configured to extend along the vertical axis, and having a side sample port;
With a vacuum source carried on the carriage assembly and configured to selectively apply a vacuum to the side sample port of the stylet;
With a cannula, fixedly coupled to the cannula slide, coaxial with the stylet and having a distal cutting edge;
Movably disposed between the stylet mount wall and the cannula slide, it has a second latch arm and a latch arm deflection member, the latch arm being the carriage latch cover member. The latch arm deflection member is configured to engage releasably with the second latch seat of the cannula slide and engages with the first latch arm of the cannula slide. With a sampling slide configured to deflect the arm towards the carriage base;
With a sampling spring located between the stylet mount wall and the sampling slide and maintained in a compressed state when the second latch arm engages the second latch seat;
Arranged between the sampling slide and the cannula slide and coupled to each of the sampling slide and the cannula slide, the first latch arm engages the first latch seat and said. With a cannula pull-in spring that, when the second latch arm engages with the second latch seat, is maintained in an extended state and stores mechanical energy;
It has a charge handle, a bias spring and an index mechanism, the charge handle is slidably mounted on the housing and biased distally towards the home position by the bias spring to charge the charge. The handle is configured to move between the home position and the retracted position, and the index mechanism is equipped with a trigger mechanism that is movably driven by the cannula slide.
The first retract of the charge handle causes the sampling slide and the cannula slide to move simultaneously in the proximal direction, thereby compressing the sampling spring and causing the second latch arm to move to the second. Engaged with the latch seat, the sampling spring is held in the compressed state and the vacuum source is charged, and the charge handle is returned to the home position by the force exerted by the bias spring. And the index mechanism is configured to be sequentially arranged at the next selection position;
The charge handle is moved to the retracted position by the second pulling of the charge handle, and the charge handle is returned to the home position by the force exerted by the bias spring. Engages with the index mechanism movably driven by the cannula slide, the cannula slide is moved in the distal direction, thereby extending the cannula pull-in spring into the extended state and the first latch. The arm engages the first latch seat to hold the cannula retracting spring in the extended state, and the cannula is arranged to close the side sample port of the stylet;
The actuator mechanism is
The actuation of the cannula retracting button releases the first latch arm from the first latch seat, thereby releasing the cannula retracting spring, exerting a retracting force and moving the cannula in the proximal direction. The vacuum state is applied to the side sample port at the same time as the side sample port of the stylet is opened;
The activation of the sample acquisition button releases the second latch arm from the second latch seat, the sampling spring is released, a force is exerted, the cannula is moved in the distal direction, and the side. A biopsy device configured so that the sample port is closed.
[Form 44]
The carriage assembly is configured to move vertically with respect to the housing as a whole.
With the actuator mechanism having a pierced button and a carriage latch seat;
With the carriage latch cover member having a carriage latch arm configured to releasably engage the carriage latch seat;
With an intermediate wall located between the proximal end wall and the distal end portion within the housing;
Arranged between the intermediate wall and the stylet mount wall, configured to store mechanical energy when in contraction and configured to bias the carriage assembly as a whole in the distal direction. Further comprising a main piercing spring; which is maintained in the contracted state when the carriage latch arm engages with the carriage latch seat of the actuator mechanism.
The third pull-in of the charge handle prior to the operation of the actuator mechanism causes the carriage assembly to be moved proximally as a whole to compress the main piercing spring and the carriage latch arm to be the carriage latch arm. It is configured to engage the carriage latch seat of the actuator mechanism to hold the main piercing spring in the contracted state;
The actuation of the piercing button prior to the activation of the cannula pull-in button and the sample acquisition button releases the carriage latch arm from the carriage latch seat and the main piercing spring from the contracted state. The biopsy apparatus according to embodiment 43, wherein the force for moving the carriage assembly, the stylet, and the cannula all at once in the distal direction is exerted.
[Form 45]
With the process of preparing a housing with an actuator mechanism;
Movable with respect to the housing, the stylet mount wall with the stylet mounted, the cannula slide with the cutting cannula mounted, and the movable between the stylet mount wall and the cannula slide. The cannula slide is vertically spaced from the stylet mount wall and is movable relative to the stylet mount wall, including a placed sampling slide and a carriage latch cover member. There is a process of preparing a carriage assembly;
The process of sequentially moving at least one of the cannula slide, the sampling slide, and the carriage assembly as a whole to prepare a charge handle having a home position and a retracted position;
With the process of preparing a sampling spring placed between the stylet mount wall and the sampling slide;
With the step of preparing a cannula pull-in spring arranged between the sampling slide and the cannula slide and connected to each of the sampling slide and the cannula slide;
With the process of preparing a main piercing spring placed between the carriage assembly and a portion of the housing;
The process of preparing a vacuum system that selectively supplies the vacuum state to the sample port of the stylet;
As the first pull-in, the charge handle is pulled in, the cannula slide and the sampling slite are moved all at once in the proximal direction, the sampling spring is charged, and the sampling slide is moved to the carriage latch cover. -The process of latching with a member to hold the sampling spring in the charged state and charging the vacuum system to the vacuum state;
As the first return, the process of returning the charge handle to the home position;
The process of pulling the charge handle into the pulling position as the second pulling;
As a second return, the charge handle is returned to the home position, the cannula slide is moved distal to the sampling slide, the cannula retracting spring is charged, and the cannula slide is moved to the cannula slide. The process of latching with a carriage latch cover member to hold the cannula pull-in spring in a charged state;
As the third pull-in, the charge handle is retracted, the carriage assembly is moved as a whole in the proximal direction, the main piercing spring is charged, and the carriage latch cover member is latched by the actuator mechanism. A method of operating a biopsy device, comprising a step of holding the main piercing spring in a charged state and;
[Form 46]
The actuator mechanism has a cannula pull-in button, a sample acquisition button, and a piercing button.
Activating the piercing button to unlatch the carriage latch cover member from the actuator mechanism, release the main piercing spring from the charged state, and push the carriage assembly toward the distal direction. , With the step of facilitating simultaneous distal movement of the stylet and the cannula;
Activating the cannula retract button to unlatch the cannula slide from the carriage latch cover member, release the cannula retract spring from the charged state and move the cannula in the proximal direction to the styling. The step of applying the vacuum state to the side sample port at the same time as opening the side sample port of the carriage;
Activating the sample acquisition button to unlatch the sample slide from the carriage latch cover member, release the sampling spring from the charged state, push the cannula in the distal direction, the said. The method of operating a biopsy apparatus according to embodiment 45, further comprising a step of closing the side sample port;

Claims (4)

Housing with actuator mechanism;
A stylet assembly wall with a stylet with a sample port, a cannula slide with a cutting cannula, a sampling slide movably placed between the stylet assembly wall and the cannula slide, and a carriage. A carriage assembly that is movable relative to the housing, including a latch cover member, wherein the cannula slide is longitudinally separated from the stylet assembly wall and relative to the stylet assembly wall. A carriage assembly that is movable, has a first latch member, the sampling slide has a second latch member, and the carriage latch cover member has a third latch member;
A charge handle slidably attached to the housing having a fixed position and a retracted position;
A sampling spring inserted between the stylet assembly wall and the sampling slide;
A cannula retracting spring inserted between the sampling slide and the cannula slide and connected to each of them;
A prime piercing spring sandwiched between the carriage assembly and a portion of the housing; and a vacuum system that selectively evacuates the sample port of the stylet.
The first retreat of the charge handle causes the cannula slide and the sampling slide to move simultaneously in the proximal direction to charge the sampling spring, thereby causing the second latch member of the sampling slide to be moved to the carriage. Latch with a latch cover member to hold the sampling spring in a charged state and charge the vacuum system to generate the vacuum;
The first return of the charge handle returns the charge handle to the home position;
The second retreat of the charge handle causes the charge handle to move to the retreat position;
The second return of the charge handle to the home position causes the cannula slide to move distally away from the sampling slide, the cannula retracting spring is charged, and the first latch member of the cannula slide. Is latched by the carriage latch cover member and the cannula retracting spring is held in a charged state;
The third retract of the charge handle causes the entire carriage assembly to move in the proximal direction, charging the prime piercing spring and latching the third latch member of the carriage latch cover member with the actuator mechanism. A biopsy device configured to hold the prime piercing spring in a charged state. The actuator mechanism has a cannula retract button, a sample acquisition button, and a piercing button, and the biopsy device is a biopsy device.
The piercing button is activated to release the third latch member of the carriage latch cover member from the actuator mechanism to release the prime piercing spring from the charged state and propel the carriage assembly in the distal direction. And promote the simultaneous movement of the stylet and the cannula in the distal direction;
The cannula retracting button is activated to dislatch the first latch member of the cannula slide from the carriage latch cover member, release the cannula retracting spring from the charged state, and disengage the cannula in the proximal direction. Move, open the side sample port of the stylet, and simultaneously evacuate the side sample port ;
The sample acquisition button is activated to release the second latch member of the sampling slide from the carriage latch cover member, release the sampling spring from the charged state, and disengage the cannula in the distal direction. The biopsy apparatus according to claim 1, wherein the biopsy apparatus is configured to propel and close the side sample opening . With a housing having a vertical axis and configured to form a housing chamber;
An actuator mechanism with a cannula retract button, a sample acquisition button, and a carriage latch strike;
A carriage slide located in the housing chamber and having a carriage base and a stylet assembly wall, further including a sampling slide, a cannula slide, and a carriage latch cover member, wherein the cannula slide is the stylet assembly. It is vertically spaced from the wall and is movable with respect to the stylet assembly wall, the cannula slide has a first latch arm, and the carriage latch cover member is fixedly attached to the carriage base. The carriage latch cover member has a first latch strike and a second latch strike, and the first latch arm of the cannula slide is releasably engaged with the first latch strike of the carriage latch cover member. With a carriage assembly configured to
With a stylet that is fixedly connected to the stylet assembly wall, configured to extend along the vertical axis, and has a side sample port ;
With a vacuum source carried on the carriage assembly and configured to selectively apply a vacuum to the side sample port of the stylet;
With a cannula that is fixedly coupled to the cannula slide, coaxial with the stylet, and has a distal cutting edge;
Movably disposed between the stylet assembly wall and the cannula slide, it has a second latch arm and a latch arm deflection member, wherein the second latch arm is the second latch of the carriage latch cover member. Configured to be releasably engaged with the strike, the latch arm deflecting member deflects the first latch arm towards the carriage base so as to engage the first latch arm of the cannula slide. With a sampling slide configured as;
With a sampling spring, which is placed between the stylet assembly wall and the sampling slide and is maintained in a compressed state when the second latch arm engages with the second latch strike;
Arranged between the sampling slide and the cannula slide and connected to each of the sampling slide and the cannula slide, the first latch arm engages the first latch strike and the second latch arm is said. With a cannula retracting spring, which is releasably maintained in an extended state and stores mechanical energy when engaged with a second latch strike;
It has a charge handle, an urging spring, and a positioning mechanism, and the charge handle is slidably attached to the housing and is urged toward a fixed position in the distal direction by the urging spring. The charge handle is configured to move between the home position and the retracted position, and the positioning mechanism comprises a trigger mechanism that is movably coupled to the cannula slide.
The first retreat of the charge handle causes the sampling slide and the cannula slide to move in the proximal direction all at once, thereby compressing the sampling spring and engaging the second latch arm with the second latch strike. The sampling spring is held in a compressed state and the vacuum supply source is charged, and the charge handle is returned to the fixed position by the force exerted by the urging spring and the positioning mechanism is selected as the next. It is configured to be sequentially arranged in position;
The charge handle moves to the retracted position by the second retract of the charge handle, and the charge handle returns to the fixed position by the force exerted by the urging spring, while the charge handle moves to the cannula slide. Engaging with the movably coupled positioning mechanism, the cannula slide is moved in the distal direction, whereby the cannula retracting spring is extended in an extended state and the first latch arm is the first latch. Engaging with the strike to hold the cannula retracting spring in the extended state, the cannula is arranged to close the side sample opening of the stylet;
The actuator mechanism is
The actuation of the cannula retract button releases the first latch arm from the first latch strike, thereby releasing the cannula retracting spring and exerting a retracting force to move the cannula in the proximal direction, the styling. The vacuum state is applied to the side sample port at the same time as the side sample port of the let is opened;
By operating the sample acquisition button, the second latch arm is released from the second latch strike, the sampling spring is released, a force for moving the cannula in the distal direction is exerted, and the side sample opening is closed. A biopsy device configured to. The carriage assembly is configured to move vertically with respect to the housing as a whole, and the biopsy device further comprises.
With the actuator mechanism having a piercing button and a carriage latch strike;
With the carriage latch cover member having a carriage latch arm configured to releasably engage the carriage latch strike;
With an intermediate wall disposed between the proximal end wall and the distal end portion within the enclosure;
Arranged between the intermediate wall and the stylet assembly wall, it is configured to store mechanical energy when in a compressed state and to urge the carriage assembly as a whole in the distal direction. A prime piercing spring that is maintained in the compressed state when the carriage latch arm engages with the carriage latch strike of the actuator mechanism;
The third retreat of the charge handle prior to the operation of the actuator mechanism causes the carriage assembly to be moved in the proximal direction as a whole to compress the prime piercing spring, and the carriage latch arm is the carriage of the actuator mechanism. It is configured to engage the latch strike and hold the prime piercing spring in the compressed state;
The actuation of the piercing button prior to the activation of the cannula retract button and the sample acquisition button releases the carriage latch arm from the carriage latch strike, the prime piercing spring from the compressed state, the carriage assembly and the styling. The biopsy apparatus according to claim 3, wherein the force for moving the let and the cannula all at once in the distal direction is exerted.

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