26) of piercer (22). In some examples, this positioning of the leading edge of tapered edge (46) can aid in the severing of tissue.

Swaged portion (50) is generally defined by a tapering or necking down of the diameter of cannula (42) just proximally of distal end (44). As best seen in FIG. 5, swaged portion (50) is formed by a continuous change in the diameter of cannula (42) as cannula (42) extends distally. As can be seen, the area of cannula (42) oriented proximally relative to swaged portion (50) defines an inner diameter that is generally greater than the outer diameter of cannula (28) of piercer (22). The difference in the inner diameter of cannula (42) and the outer diameter of cannula (28) forms a gap (52) between cannula (42) and cannula (28). This gap (52) extends proximally from swaged portion (50) along the entire length of cannula (42).

As will be described in greater detail below, gap (52) is generally configured to provide communication of atmospheric air through cannula (42) to aid in the transport of tissue samples through piercer (22). Thus, it should be understood that the particular size of gap (52) can depend on a variety of factors such as the size of tissue samples collected, the pressure of vacuum used to transport tissue samples, the speed of transport, and/or etc. By extension, it should therefore be understood that the difference between the inner diameter of cannula (42) and the outer diameter of cannula (28) can likewise be varied by similar factors.

As can be seen in FIG. 5, swaged portion (50) substantially eliminates gap (52) by a reduction in the diameter of cannula (42). In particular, at the beginning of swaged portion (50), the diameter of cannula (42) is equivalent to the outer diameter of cannula (28) plus the amount of diameter desired to form gap (52). As cannula (42) continues to extend distally through swaged portion (50), the diameter of cannula (42) decreases continuously. In the present example, wagged portion (50) involves the inner diameter of cannula (42) necking down to a diameter that is approximately equivalent to the outer diameter of cannula (28) of piercer (22). Thus, at the distal end of swaged portion (50), gap (52) is substantially eliminated through direct contact between the inner diameter of cannula (42) and the outer diameter of cannula (28). It should be understood that the particular fit between cannula (42) and cannula (28) at distal end (44) of cannula (42) can be varied in view of a variety of factors. For instance, in some examples, the fit can be tight enough to substantially seal gap (52) relative to distal end (44) while still permitting cannula (42) to translate relative to cannula (28). In some examples, this fit can be desirable to prevent leakage of atmospheric air into a patient through gap (52). Of course, various alternative fits can be used as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Later in this application specific means and ways to move needle assembly (20) forward and backwards within core needle biopsy device (10) are described. At this point Applicants wish to point out that although they have included specific ways and means to move needle assembly (20) forwards and backwards, they believe, without intending to be bound thereby, that there are many alternative ways to move needle assembly (20) backwards and forwards and these alternative ways should be known to people of ordinary skill in the art of designing biopsy devices.

FIGS. 6 and 7 show various components that can be included within body (12) to control operation of biopsy device (10). As can be seen, the interior of body (12) includes one or more batteries (210), a vacuum pump (220), motors (230, 240), and a drive assembly (100). In the present example, batteries (210), vacuum pump (220), and motors (230, 240) are generally disposed within holster housing (14). Meanwhile, drive assembly (100) is disposed within probe housing (16). Thus, it should be understood that batteries (210), vacuum pump (220), and motors (230, 240) are generally configured to be reusable, while drive assembly (100) is generally configured to be disposable. Additionally, it should be understood that with all these components disposed within body (12), biopsy device (10) is configured as a self-contained tetherless biopsy device, in other examples various components can be disposed remotely relative to body (12). For instance, in some examples batteries (210) can be omitted in favor of a tethered power supply. Similarly, vacuum pump (220) can also be omitted in favor of an external vacuum source. Motors (230, 240) may likewise be omitted in favor of a remote power source in communication with body (12) by a rotary drive cable. Of course, various alternative configuration will be apparent to those of ordinary skill in the art in view of the teachings herein.

FIGS. 7 and 8 show motors (230, 240) in greater detail below. As will be understood, motors (230, 240) are generally configured to translate at least a portion of drive assembly (100) to cock or otherwise prepare cutter (40) and piercer (22) for firing. As can be seen, motors (230, 240) comprise a cutter motor (230) and a piercer motor (240). Cutter motor (230) is generally configured to translate a portion of drive assembly (100) to thereby translate cutter (40). In particular, cutter motor (230) is coupled to a bevel gear (232), which is configured to mesh with a combination gear (234). Combination gear (234) includes both a bevel gear portion (236) and a spur gear portion (238). As will be described in greater detail below, bevel gear (234) is configured to be driven by cutter motor (230) to rotate combination gear (234). Combination gear (234) is then configured to mesh with at least a portion of drive assembly (100) to drive a rack or similar feature to translate cutter (40) from a fired position to a cocked position.

Piercer motor (240) is generally configured to translate a portion of drive assembly to thereby translate piercer (22). In particular, piercer motor (240) is coupled to a bevel gear (242), which is configured to mesh with a combination gear (244). Combination gear (244) includes both a bevel gear portion (246) and a spur gear portion (248). As will be described in greater detail below, bevel gear (244) is configured to be driven by piercer motor (240) to rotate combination gear (244). Combination gear (244) is then configured to mesh with at least a portion of drive assembly (100) to drive a rack or similar feature to translate piercer (22) from a fired position to a cocked position.

Drive assembly (100) includes a cutter drive (110) and a piercer drive (150). As best seen in FIG. 9, cutter drive (110) includes a manipulator (112), a cutter driver (130), and a coil spring (148). As will be described in greater detail below, manipulator (112) is generally configured to manipulate cutter driver (130) into a cocked position, while coil spring (148) is generally configured to fire cutter (40) distally via cutter driver (130). Manipulator (112) defines a hollow interior (114) and includes an upper channel (116), a lower channel (118) and a rack (120). Hollow interior (114) is configured to receive the combination of cutter (40) and cutter driver (130).

Upper and lower channels (116, 118) are configured to permit at least a portion of cutter driver (130) to extend outside of the outer diameter defined by manipulator (112). In the present example, only lower channel (118) is used in this way. However, the presence of upper channel (116) makes manipulator (112) generally symmetrical so that manipulator (112) can be used in other positions. For instance, in some examples manipulator (112) can be positioned so that rack (120) is facing into the page in FIG. 9 as opposed to out of the page. As will be understood, this configuration can permit manipulator (112) to be used interchangeably with a corresponding component of piercer driver (150).

Rack (120) is configured to mesh with spur gear portion (238) of combination gear (234). As will be described in greater detail below, this configuration permits cutter motor (230) to rotate and drive linear translation of manipulator (112). In some circumstances, this linear translation of manipulator (112) can be used to manipulate cutter driver (130) along with cutter (40) to a cocked position where coil spring (148) is loaded to fire cutter (40).

Cutter driver (130) includes a cylindrical body (132) defining a cutter bore (134) and a catch post (136) extending downwardly from cylindrical body (132). Cylindrical body (132) is sized in general correspondence with the diameter of coil spring (148). This relationship between the size of cylindrical body (132) and coil spring (148) permits coil spring (148) to transfer energy to cylindrical body (132) to thereby drive firing of cutter (40).

Cutter bore (134) is sized to receive cutter (40) therein. When cutter drive (110) is fully assembled, cutter bore (134) is coaxial with cutter (40). Additionally, cylindrical body (132) is generally fixedly secured to cutter (40). In some examples, cutter bore (134) is sized to have an interference fit with cannula (42) of cutter (40) to secure cylindrical body (132) to cutter (40). In other examples, the diameter of cutter bore (134) is slightly oversized relative to the outer diameter of cannula (42) of cutter (40). In such examples, cylindrical body (132) can be secured to cutter (40) by adhesion bonding or the like. In still other examples, cylindrical body (132) can be directly overmolded onto the surface of cannula (42) to secure cylindrical body (132) to cutter (40). Of course, other suitable methods of joining cylindrical body (132) to cutter (40) may be used as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Catch post (136) extends downwardly from cylindrical body (132). As will be described in greater detail below, catch post (136) is generally configured to permit cylindrical body (132) to be held against the resilient bias of spring (148). Catch post (136) extends away from cylindrical body (132) for a length sufficient for catch post (136) to protrude from lower channel (118) of manipulator (112). As will be described in greater detail below, this extension permits at least a portion of probe housing (16) to engage catch post (136) and thereby maintain cylindrical body (132) in the cocked position against the resilient bias of coil spring (148).

As best seen in FIG. 10, piercer drive (150) includes a manipulator (152), a piercer driver (180), and a coil spring (198). As will be described in greater detail below, manipulator (152) is generally configured to manipulate piercer driver (180) into a cocked position, while coil spring (198) is generally configured to fire piercer (22) distally via piercer driver (180). Manipulator (152) defines a hollow interior (154) and includes an upper channel (156), a lower channel (158) and a rack (160). Hollow interior (154) is configured to receive the combination of piercer (22) and piercer driver (180).

Upper and lower channels (156, 158) are configured to permit at least a portion of piercer driver (180) to extend outside of the outer diameter defined by manipulator (152). In the present example, only lower channel (158) is used in this way. However, the presence of upper channel (156) makes manipulator (152) generally symmetrical so that manipulator (152) can be used in other positions. For instance, in some examples manipulator (152) can be positioned so that rack (160) is facing out of the page in FIG. 10 as opposed to into the page. As will be understood, this configuration can permit manipulator (152) to be used interchangeably with manipulator (112) described above.

Rack (160) is configured to mesh with spur gear portion (248) of combination gear (244). As will be described in greater detail below, this configuration permits piercer motor (240) to rotate and drive linear translation of manipulator (152). In some circumstances, this linear translation of manipulator (152) can be used to manipulate piercer driver (180) along with piercer (22) to a cocked position where coil spring (198) is loaded to fire piercer (22).

Piercer driver (180) includes a cylindrical body (182) defining a piercer bore (184) and a catch post (186) extending downwardly from cylindrical body (182). Cylindrical body (182) is sized in general correspondence with the diameter of coil spring (198). This relationship between the size of cylindrical body (182) and coil spring (198) permits coil spring (198) to transfer energy to cylindrical body (182) to thereby drive firing of piercer (22).

Piercer bore (184) is sized to receive piercer (22) therein. When piercer drive (150) is fully assembled, piercer bore (184) is coaxial with piercer (22). Additionally, cylindrical body (182) is generally fixedly secured to piercer (22). In some examples, piercer bore (184) is sized to have an interference fit with cannula (28) of piercer (22) to secure cylindrical body (182) to piercer (22). In other examples, the diameter of piercer bore (184) is slightly oversized relative to the outer diameter of cannula (28) of piercer (22). In such examples, cylindrical body (182) can be secured to piercer (22) by adhesion bonding or the like. In still other examples, cylindrical body (182) can be directly overmolded onto the surface of cannula (28) to secure cylindrical body (182) to piercer (22). Of course, other suitable methods of joining cylindrical body (182) to piercer (22) may be used as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Catch post (186) extends downwardly from cylindrical body (182). As will be described in greater detail below, catch post (186) is generally configured to permit cylindrical body (182) to be held against the resilient bias of spring (198). Catch post (186) extends away from cylindrical body (182) for a length sufficient for catch post (186) to protrude from lower channel (158) of manipulator (152). As will be described in greater detail below, this extension permits at least a portion of probe housing (16) to engage catch post (186) and thereby maintain cylindrical body (182) in the cocked position against the resilient bias of coil spring (198).

FIGS. 11A through 12C show an exemplary use of biopsy device (10) to collect one or more tissue samples from a patient, using a single insertion of needle assembly (20). In particular, FIGS. 11A through 11E show the internal operation of biopsy device (10) in detail. As is best seen in FIG. 11A, biopsy device (10) is initially in a fired or initial position. In this position, both piercer (22) and cutter (40) are positioned in a distal-most position corresponding to the position of piercer (22) and cutter (40) after firing. When piercer (22) and cutter (40) are both in the fired or initial position, manipulators (112, 152), piercer driver (180), and cutter driver (130) are all in a distal-most position. Coil springs (148, 198) are also in an uncompressed position.

In preparation for inserting needle assembly (20) into a patient, it can be desirable to first cock needle assembly (20) to permit firing of needle assembly (20) into a suspicious lesion. To cock needle assembly (20), both cutter motor (230) and piercer motor (240) are activated. This causes bevel gears (232, 242) to rotate. Rotation of bevel gears (232, 242) then results in rotation of combination gears (234, 244). Engagement between a spur gear portion (238, 248) of each combination gear (234, 244) and a respective rack (120, 160) causes each manipulator (112, 152) to translate. Manipulators (112, 152) are thus translated proximally by motors (230, 240) from the position shown in FIG. 11A to the position shown in FIG. 11B.

As manipulators (112, 152) are translated proximally, cutter driver (130) and piercer driver (150) are likewise translated proximally by contact between each respective catch post (136, 186) and the distal end of each lower channel (118, 158). Proximal translation of cutter driver (130) and piercer driver (150) causes each coil spring (148, 198) to compress in proportion to the translation. Although not shown, it should be understood that in the present example the interior of probe housing (16) can includes a stop or other geometric feature to provide a mechanical ground for the proximal end of each coil spring (148, 198) to permit compression of each coil spring (148, 198).

Once drive assembly (100) is positioned as shown in FIG. 11B, a portion of probe housing (16) fastens to cutter driver (130) and piercer driver (180). In particular, in the present example probe housing (16) is shown as having resiliently biased latches (17, 18). For instance, a distal latch (17) is configured to selectively couple to catch post (136) of cutter driver (130) to selectively hold cutter driver (130) in the cocked position. Similarly, a proximal latch (18) is configured to selectively couple to catch post (186) of piercer driver (180) to selectively hold piercer driver (180) in the cocked position. Each latch (17, 18) of the present example is integral with probe housing (16) and includes a tooth protruding from a resilient arm. Thus, each latch (17, 18) is generally movable to flex into and out of engagement with cutter driver (130) and piercer driver (180), respectively.

Although the probe housing (16) of the present example includes latches (17, 18), it should be understood that in other examples the same functionality can be accomplished in a variety of ways. For instance, in some examples latches (17, 18) can be replaced with a solenoid or other electromechanical device to selectively hold cutter driver (130) and piercer driver (180) in the cocked position. In other examples, latches (17, 18) can be in the form of other alternative configurations both integral with probe body (16) or configured as a separate component. In all such alternative examples, it should be understood that latches (17, 18) or any other actuator can be connected with each other to promote firing of cutter (40) and piercer (22) in a predetermined sequence. Of course, other alternative configurations will be apparent to those of ordinary skill in the art in view of the teachings herein.

Once drive assembly (100) is cocked as shown in FIG. 11B, potential energy is stored in coil springs (148, 198) such that cutter (40) and piercer (22) are both ready to be fired distally upon release of the potential energy stored in coil springs (148, 198). To release this potential energy, latches (17, 18) can be actuated to disengage cutter driver (130) and piercer driver (180). However, prior to disengaging cutter driver (130) and piercer driver (180) it may be desirable to advance manipulators (112, 152). For instance, in the position shown in FIG. 11B, manipulators (112, 152) are positioned proximally after driving cuter driver (130) and piercer driver (180) proximally. In some uses, it may be desirable to advance manipulators (112, 152) distally ahead of firing to avoid the possibility of manipulators (112, 152) impeding the firing of cutter (40) and piercer (22). To advance manipulators (112, 152) distally, the rotation of cutter motor (230) and piercer motor (240) is reversed until manipulators (112, 152) are positioned as shown in FIG. 11C.

Once manipulators (112, 152) are positioned as shown in FIG. 11C, drive assembly (100) is prepared for firing. In the present use, piercer (22) is fired first to penetrate a suspicious lesion. Piercer (22) is fired by actuating proximal latch (18) as shown in FIG. 11D. Actuation of proximal latch (18) results in disengagement of proximal latch (18) with catch post (186) of piercer driver (180). With catch post (186) disengaged, piercer driver (180) is free to translate distally using energy supplied by coil spring (198). Since piercer driver (180) is fixedly secured to piercer (22), piercer (22) likewise translates distally.

The firing of piercer (22) that results from the actuator shown in FIG. 11D can be seen by comparing FIGS. 12A and 12B. As can be seen, piercer (22) is initially positioned proximate to a suspicious lesion (SL) as shown in FIG. 12A. Once piercer (22) is fired as described above, piercer (22) advances distally into the suspicious lesion (SL) as shown in FIG. 12B. It should be understood that this movement of piercer (22) can result in minimal displacement of the suspicious lesion (SL), thereby avoiding migration of the suspicious lesion (SL) and enhancing the quality of any collected tissue samples.

After piercer (22) is fired into the suspicious lesion (SL), it may be desirable to acquire a tissue sample by advancing cutter (40) relative to piercer (22). In particular, once piercer (22) is fired into the suspicious lesion (SL), tissue can prolapse into lateral aperture (26) of piercer (22). In some uses, the prolapse of tissue into lateral aperture (26) may occur through internal tension within the tissue. In other uses, vacuum can be applied to lumen (27) of piercer (22) to provide a force to assist with prolapsing tissue into lateral aperture (26).

Once tissue is prolapsed into lateral aperture (26) of piercer (22), a tissue sample can be severed using cutter (40). In particular, cutter (40) can be fired by first actuating distal latch (17) as shown in FIG. 11E. Actuation of distal latch (17) disengages catch post (136) of cutter driver (130). Disengagement of catch post (136) permits cutter driver (130) to freely translate distally. Accordingly, upon disengagement of catch post (136), cutter driver (130) will fire distally by energy provided by coil spring (148). Since cutter driver (130) is fixedly secured to cutter (40), cutter (40) will likewise fire distally into the position shown in FIGS. 11E and 12C.

The firing of cutter (40) that results from the actuation shown in FIG. 11E can be seen by comparing FIGS. 12B and 12C. As can be seen, cutter (40) is initially positioned proximate to the suspicious lesion (SL) immediately before firing, as shown in FIG. 12B. Once cutter (40) is fired, distal end (44) is translated distally past lateral aperture (26) of piercer (22), as shown in FIG. 12C. As distal end (44) passes lateral aperture (26), the tissue sample is severed.

Next it may be desirable to transport the severed tissue sample through lumen (27) of piercer (22) and into tissue sample holder (80). To transport the severed tissue sample, a vacuum is applied to lumen (27) of piercer (22). Such vacuum can be supplied by way of tissue sample holder (80) to urge the severed tissue sample into tissue sample holder (80). As vacuum is applied, a proximal force will build on the proximal end of the severed tissue sample. Once the proximal force is sufficiently large, the severed tissue sample will begin to move proximally through lumen (27) of piercer (22). However, movement of the severed tissue sample can cause negative pressure to build in the distal end of the severed tissue sample. Accordingly, it may be desirable to also supply either atmospheric air or back pressure to the distal end of the severed tissue sample. Such atmospheric air or back pressure is supplied in the present example by gap (52) that is defined by cutter (40). In the present example, atmospheric air is supplied continuously through lumen (48) by way of the proximal end of cutter (40). However, it should be understood that in other examples valving or other fluid control mechanisms can be used to regulate the supply of atmosphere.

Although atmosphere is supplied continuously to cutter (40), it should be understood that atmosphere is only selectively supplied to piercer (22) by cutter (40). For instance, after a tissue sample is severed, gap (52) of cutter (40) is positioned such that gap (52) is in fluid communication with lateral aperture (26). Thus, atmospheric air can flow freely from cutter (40) and into piercer (22). However, when distal end (44) of cutter (40) is positioned proximally relative to lateral aperture (26), lateral aperture (26) is not in fluid communication with gap (52) and flow of atmospheric air to lateral aperture (26) is prevented.

Once the severed tissue sample has been transported to tissue sample holder (80), it may be desirable to collect one or more additional tissue samples. To collect additional tissue samples, cutter (40) and piercer (22) are both retracted using motors (230, 240). This retraction also cocks both cutter (40) and piercer (22) so that the same tissue sample collection process described above can be repeated until a desired number of tissue samples are collected or tissue sample holder (80) is filled.

Exemplary Combinations

The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

Example 1

A core needle biopsy device, comprising: a needle assembly having a hollow piercer disposed within a hollow cutter, wherein the cutter has a distal tip and a swaged portion proximate to the distal tip; and a drive assembly configured to selectively cock and fire the piercer and the cutter.

Example 2

The core needle biopsy device of Example 1, wherein the swaged portion is tapered to form a gap between the piercer and the cutter proximally of the distal tip of the cutter.

Example 3

The core needle biopsy device of Example 2, wherein the piercer has a sharp tip and a lateral aperture proximate to the sharp tip, wherein the gap defined by the swaged portion of the cutter is configured to supply atmospheric air to the lateral aperture of the piercer when the distal tip is disposed proximally relative to the lateral aperture.