Biopsy samples have been obtained in a variety of ways in various medical procedures using a variety of devices. Biopsy devices may be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise. For instance, some biopsy devices may be fully operable by a user using a single hand, and with a single insertion, to capture one or more biopsy samples from a patient. In addition, some biopsy devices may be tethered to a vacuum module and/or control module, such as for communication of fluids (e.g., pressurized air, saline, atmospheric air, vacuum, etc.), for communication of power, and/or for communication of commands and the like. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected with another device.
Merely exemplary biopsy devices and biopsy system components are disclosed in U.S. Pat. No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No. 6,162,187, entitled “Fluid Collection Apparatus for a Surgical Device,” issued Dec. 19, 2000; U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for a Surgical Biopsy Device,” issued Oct. 8, 2008; U.S. Pat. No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device,” issued May 10, 2011; U.S. Pat. No. 8,241,226, entitled “Biopsy Device with Rotatable Tissue Sample Holder,” issued Aug. 14, 2012; U.S. Pat. No. 8,764,680, entitled “Handheld Biopsy Device with Needle Firing,” issued Jul. 1, 2014; and U.S. Pat. No. 9,955,955, entitled “Biopsy Device with Slide-In Probe,” issued May 1, 2018. The disclosure of each of the above-cited U.S. patents is incorporated by reference herein.
Additional exemplary biopsy devices and biopsy system components are disclosed in U.S. Pub. No. 2009/0131821, entitled “Graphical User Interface For Biopsy System Control Module,” published May 21, 2009, now abandoned; U.S. Pub. No. 2010/0160819, entitled “Biopsy Device with Central Thumbwheel,” published Jun. 24, 2010, now abandoned; and U.S. Pub. No. 2014/0039343, entitled “Biopsy System,” published Feb. 6, 2014, now abandoned. The disclosure of each of the above-cited U.S. patent Application Publications is incorporated by reference herein.
In some contexts, a biopsy device can be configured with a reusable holster and a disposable probe. Such a configuration can be desirable to increase economies of use by enabling more expensive parts to be reused and less expensive parts to be discarded. However, this configuration results in the need for mechanisms to couple holster to a probe. In some examples, such a mechanism can be provided by one or more hooks that engage a corresponding camming feature. Although this style of mechanism provides an advantage in terms of simplicity, it can limit feedback provided to an operator during coupling. In absence of such feedback, an operator may not be confident that the coupling between the holster and the probe is secure. Thus, there is a need to provide a mechanism for coupling a probe and a holster that provides enhanced feedback to an operator.
While several systems and methods have been made and used for obtaining a biopsy sample, it is believed that no one prior to the inventor has made or used the invention described in the appended claims.
While the specification concludes with claims which particularly point out and distinctly claim this technology, it is believed this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present technology, and together with the description serve to explain the principles of the technology; it being understood, however, that this technology is not limited to the precise arrangements shown.
The following description of certain examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the technology. As will be realized, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
As will be discussed in greater detail below, probe (100) and holster (200) are generally configured for coupling to each other. Some variations of biopsy device (10) may include one or more sensors (not shown), in probe (100) and/or in holster (200), that is/are configured to detect when probe (100) is coupled with holster (200). Such sensors or other features may further be configured to permit only certain types of probes (100) and holsters (200) to be coupled together. In addition, or in the alternative, such sensors may be configured to disable one or more functions of probes (100) and/or holsters (200) until a suitable probe (100) and holster (200) are coupled together. In one merely illustrative example, probe (100) includes a magnet (not shown) that is detected by a hall effect sensor (not shown) or some other type of sensor in holster (200) when probe (100) is coupled with holster (200). As yet another merely illustrative example, coupling of probe (100) with holster (200) may be detected using physical contact between conductive surfaces or electrodes, using RFID technology, and/or in numerous other ways as will be apparent to those of ordinary skill in the art in view of the teachings herein. Of course, such sensors and features may be varied or omitted as desired.
Biopsy device (10) of the present example is configured to mount to a table or fixture and be used under stereotactic guidance. Of course, biopsy device (10) may instead be used under ultrasound guidance, MM guidance, PEM guidance, BSGI guidance, or otherwise. It should also be understood that biopsy device (10) may be sized and configured such that biopsy device (10) may be operated by a single hand of a user. In particular, a user may grasp biopsy device (10), insert needle (110) into a patient's breast, and collect one or a plurality of tissue samples from within the patient's breast, all with just using a single hand. Alternatively, a user may grasp biopsy device (10) with more than one hand and/or with any desired assistance. In some settings, the user may capture a plurality of tissue samples with just a single insertion of needle (110) into the patient's breast. Such tissue samples may be pneumatically deposited in tissue sample holder (300), and later retrieved from tissue sample holder (300) for analysis. While examples described herein often refer to the acquisition of biopsy samples from a patient's breast, it should be understood that biopsy device (10) may be used in a variety of other procedures for a variety of other purposes and in a variety of other parts of a patient's anatomy (e.g., prostate, thyroid, etc.). Various exemplary components, features, configurations, and operabilities of biopsy device (10) will be described in greater detail below; while other suitable components, features, configurations, and operabilities will be apparent to those of ordinary skill in the art in view of the teachings herein.
As shown in
As noted above, rotation of gear (212) provides rotation of needle (110) relative to probe (100). In the present example, gear (212) is rotated by rotating knob (210). In particular, knob (210) is coupled with gear (212) by a series of gears (not shown) and shafts (not shown), such that rotation of knob (210) rotates gear (212). A second knob (210) extends from the other side of holster (200). By way of example only, such a needle rotation mechanism may be constructed in accordance with the teachings of U.S. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As another merely illustrative example, a needle rotation mechanism may be constructed in accordance with the teachings of U.S. Pub. No. 2010/0160819, the disclosure of which is incorporated by reference herein. In some other versions, needle (110) is rotated by a motor. In still other versions, needle (110) is simply rotated by rotating thumbwheel (116). Various other suitable ways in which rotation of needle (110) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that some versions may provide no rotation of needle (110).
Holster (200) also includes a firing rod (226) and fork (222), which couple with needle (110) and fire needle (110) distally. By way of example only, such firing may be useful in instances where biopsy device (10) is mounted to a stereotactic table fixture or other fixture, with tip (112) adjacent to a patient's breast, such that the needle firing mechanism may be activated to drive needle (110) into the patient's breast. The needle firing mechanism may be configured to drive needle (110) along any suitable range of motion, to drive tip (112) to any suitable distance relative to fixed components of probe (100).
In the present example, the needle firing mechanism is coupled with needle (110) via a firing rod (226) and a firing fork (222). Firing rod (226) and firing fork (222) are unitarily secured together. Firing fork (222) includes a pair of prongs (224) that receive hub member (120) of needle (110) therebetween. Prongs (224) are positioned between annular flange (118) and thumbwheel (116), such that needle (110) will translate unitarily with firing rod (226) and fork (222). Prongs (224) nevertheless removably receive hub member (120), such that fork (222) may be readily secured to hub member (120) when probe (100) is coupled with holster (200); and such that hub member (120) may be readily removed from fork (222) when probe (100) is decoupled from holster (200). Prongs (224) are also configured to permit hub member (120) to rotate between prongs (224). Other suitable components, configurations, and relationships will be apparent to those of ordinary skill in the art in view of the teachings herein. The internal components of the needle firing mechanism of the present example are configured and arranged as described in U.S. Pat. No. 8,858,465, entitled “Biopsy Device with Motorized Needle Firing,” issued Oct. 14, 2014, the disclosure of which is incorporated by reference herein.
Holster (200) includes motors (not shown) to drive gear (230) to thereby rotate and translate cutter (150). In addition, a motor can be used to rotate a rotatable member (not shown) of tissue sample holder (300). Holster (200) also includes a motor (not shown) that is operable to drive firing rod (226), to thereby arm and fire needle (110). All motors referred to herein are contained within holster (200) in the present example and receive power from vacuum control module (400) via cable (90). In addition, data may be communicated between vacuum control module (400) and holster (200) via cable (90). As will be described in greater detail below, such data may be used by control module (400) to display certain graphical user interface screens on a touchscreen (410) integrated into control module (400). In some other versions, one or more motors are powered by one or more batteries located within holster (200) and/or probe (100). It should therefore be understood that, as with other components described herein, cable (90) is merely optional. As yet another merely illustrative variation, motors may be powered pneumatically, such that cable (90) may be substituted with a conduit communicating a pressurized fluid medium to holster (200). As still other merely illustrative variation, cable (90) may include one or more rotary drive cables that are driven by motors that are located external to holster (200). It should also be understood that two or three of the motors may be combined as a single motor. Other suitable ways in which various the motors may be driven will be apparent to those of ordinary skill in the art in view of the teachings herein.
Probe (100) of the present example includes a needle (110) extending distally from probe (100) that is inserted into a patient's tissue to obtain tissue samples. These tissue samples are deposited in a tissue sample holder (300) at the proximal end of probe (100). As shown in
Probe (100) also includes a chassis (106) and a top housing (102), which are fixedly secured together. As best seen in
Needle (110) of the present example comprises a cannula (113) having a tissue piercing tip (112), a lateral aperture (114) located proximal to tip (112), and a hub member (120). Tissue piercing tip (112) is configured to pierce and penetrate tissue, without requiring a high amount of force, and without requiring an opening to be pre-formed in the tissue prior to insertion of tip (112). Alternatively, tip (112) may be blunt (e.g., rounded, flat, etc.) if desired. By way of example only, tip (112) may be configured in accordance with any of the teachings in U.S. Pat. No. 8,801,742, entitled “Needle Assembly and Blade Assembly for Biopsy Device,” issued Aug. 12, 2014, the disclosure of which is incorporated by reference herein. As another merely illustrative example, tip (112) may be configured in accordance with at least some of the teachings in U.S. Pub. No. 2013/0150751, the disclosure of which is incorporated by reference herein. Other suitable configurations that may be used for tip (112) will be apparent to those of ordinary skill in the art in view of the teachings herein.
Lateral aperture (114) is sized to receive prolapsed tissue during operation of device (10). A hollow tubular cutter (not shown) having a sharp distal edge is located within needle (110). The cutter is operable to rotate and translate relative to needle (110) and past lateral aperture (114) to sever a tissue sample from tissue protruding through lateral aperture (114). For instance, the cutter may be moved from an extended position to a retracted position, thereby “opening” lateral aperture (114) to allow tissue to protrude therethrough; then from the retracted position back to the extended position to sever the protruding tissue. As will be described in greater detail below, needle (110) may be rotated to orient lateral aperture (114) at any desired angular position about the longitudinal axis of needle (110). Such rotation of needle (110) is facilitated in the present example by hub member (120), which is described in greater detail below.
Although not shown, it should be understood that needle (110) can include various internal components to subdivide the interior of needle (110) into multiple lumens. Such a multiple lumen configuration for needle (110) may be desirable in some examples to provide a lumen for the cutter and a lumen for atmospheric vent. An example of such a configuration is disclosed in U.S. Pat. No. 7,918,803, entitled “Methods and Devices for Automated Biopsy and Collection of Soft Tissue,” issued Apr. 5, 2011, the disclosure of which is incorporated by reference herein. Of course, as with any other component described herein, any other suitable configurations may be used. A plurality of external openings (not shown) may also be formed in needle (110), and may be in fluid communication with any one or more lumens included therein. Such external openings may be configured in accordance with the teachings of U.S. Pub. No. 2007/0032742, entitled “Biopsy Device with Vacuum Assisted Bleeding Control,” published Feb. 8, 2007, the disclosure of which is incorporated by reference herein. Of course, as with other components described herein, such external openings in needle (110) are merely optional.
Hub member (120) of the present example is overmolded about needle (110), such that hub member (120) and needle (110) rotate and translate unitarily with each other. By way of example only, needle (110) may be formed of metal, and hub member (120) may be formed of a plastic material that is overmolded about needle (110) to unitarily secure and form hub member (120) to needle (110). Hub member (120) and needle (110) may alternatively be formed of any other suitable material(s), and may be secured together in any other suitable fashion. Hub member (120) includes an annular flange (118) and a thumbwheel (116). Gear (130) is slidably and coaxially disposed on a proximal portion of hub member (120) and is keyed to hub member (120), such that rotation of gear (130) will rotate hub member (120) and needle (110); yet hub member (120) and needle (110) may translate relative to gear (130). Gear (130) is rotatably driven by gear (212). Alternatively, needle (110) may be rotated by rotating thumbwheel (116). Various other suitable ways in which manual rotation of needle (110) may be provided will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that rotation of needle (110) may be automated in various ways, including but not limited to the various forms of automatic needle rotation described in various references that are cited herein.
As noted above, the cutter is operable to simultaneously translate and rotate relative to needle (110) to sever a tissue sample from tissue protruding through lateral aperture (114). This rotation and translation is accomplished by rotation of gear (140). Although not shown, it should be understood that in some examples, gear (140) is coupled to one or more components to provide simultaneous translation and rotation of the cutter. By way of example only, the foregoing cutter actuation components can be configured in accordance with at least some of the teachings of U.S. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As yet another merely illustrative example, the cutter may be rotated and/or translated using pneumatic motors, etc. Still other suitable ways in which the cutter may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.
Tissue sample holder (300) of the present example provides a plurality of discrete chambers that are configured to receive tissue samples that are severed by the cutter and communicated proximally through a lumen defined by the cutter. In some examples, tissue sample holder (300) can include one or more tissue receiving trays (not shown) that are removably engaged with a rotatable member (not shown). In this configuration, the rotatable member can be configured for selective rotation within an outer cover (302) of tissue sample holder (300). As a result, the rotatable member can be selectively rotated to collect one or more tissue samples within each of the plurality of discrete chambers. It should be understood that the rotatable member and/or trays can be configured in numerous other ways. By way of example only, the rotatable member and/or the trays can be configured in accordance with at least some of the teachings of U.S. Pat. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As another merely illustrative example, the rotatable member and/or the trays can be configured in accordance with at least some of the teachings of U.S. Pat. No. 8,702,623, the disclosure of which is incorporated by reference herein.
As noted above, probe (100) is generally configured to be removably coupled to holster (200). As best seen in
Adjacent to each opening (150), chassis (106) further defines a cam feature (152) associated with each opening (150). Each cam feature (152) is generally configured to engage a corresponding prong (208) of holster (200) to provide a friction or interference fit between chassis (106) and prong (208). Thus, probe (100) is generally releasably secured to holster (200) by engagement between each cam feature (152) of probe (100) and each prong (208) of holster (200).
As best seen in
As described above, probe (100) can be configured to include resilient tabs (104) to provide some locking functionality when probe (100) is coupled to holster (200). However, in some examples it may be desirable to configure a probe similar to probe (100) with locking functionality as well as mechanisms to provide an operator with affirmative feedback on such locking. Such feedback mechanisms may be desirable to increase user confidence in locking because actual coupling mechanism may be obscured by probe structures similar to top housing (102) and/or chassis (106). Although various examples of probe lock mechanisms are described below, it should be understood that various alternative probe lock mechanisms may be used as will be apparent to those of ordinary skill in the art without departing from the nature and spirit of the various examples described herein.
As with needle (110) described above, it should be understood that needle (610) can likewise include various internal components to subdivide the interior of needle (610) into multiple lumens. Such internal components can be configured in accordance with one or more of the teachings of U.S. Pat. No. 7,918,803, entitled “Methods and Devices for Automated Biopsy and Collection of Soft Tissue,” issued Apr. 5, 2011, the disclosure of which is incorporated by reference herein.
As also with needle (110) described above, needle (610) of the present example can include a hub member (620) for receiving fork (222) of holster (200). Hub member (620) of the present example is substantially similar to hub member (120) described above. For instance, hub member (620) of the present example is overmolded about needle (610), such that hub member (620) and needle (610) rotate and translate unitarily with each other. Likewise, hub member (620) includes an annular flange (618) and a thumbwheel (616).
Also like with needle (110) described above, needle (610) of the present example can include a cutter (not shown) configured to rotate and translate within the interior of needle (610) to sever a tissue sample from tissue protruding through lateral aperture (614). This rotation and translation is accomplished by rotation of a gear (640). Although not shown, it should be understood that in some examples, gear (640) is coupled to one or more components to provide simultaneous translation and rotation of the cutter. By way of example only, the foregoing cutter actuation components can be configured in accordance with at least some of the teachings of U.S. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As yet another merely illustrative example, the cutter may be rotated and/or translated using pneumatic motors, etc. Still other suitable ways in which the cutter may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.
As best seen in
Returning to
Unlike probe (100) described above, probe (600) of the present example includes a probe lock (660) that is generally configured to provide affirmative feedback to an operator when coupling probe (600) to holster (200) and also provide a locking mechanism to prevent decoupling of probe (600) from holster (200). As best seen in
As best seen in
Each indicator (664, 666) is configured to provide an affirmative indicator to an operator related to the position of lock member (662) within probe (600) and thereby indicate the operational status probe lock (660) (e.g., locked or unlocked). For instance, in the present example, each indicator (664, 666) protrudes from an opposite side of body (668). As will be described in greater detail below, this positioning permits at least a portion of a particular indicator (664, 666) to protrude from top housing (602), while the other indicator (666, 664) is flush or retracted within top housing (602). In addition, each indicator is configured as button or actuator. As will be described in greater detail below, in some circumstances, this configuration permits either indicator (664, 666) to be used to move or otherwise actuate lock member (662) within probe (600).
Each indicator (664, 666) defines a corresponding prong gap (665, 667). As will be described in greater detail below, each prong gap (665, 667) is configured to permit a prong (208) of holster (200) to pass though chassis (606) and into the interior of probe (600) during coupling of probe (600) to holster (200). In other words, each prong gap (665, 667) is configured to provide clearance for entry of a given prong (208) of holster (200) into probe (600).
Body (668) is shaped to define a bridge gap (676) and an attachment point (678). Bridge gap (676) is sized and shaped to provide clearance for various internal components of probe (600), while still permitting lock member (662) to move within the interior of probe (600). As will be described in greater detail below, attachment point (678) is configured to provide a point attachment for resilient member (698), such that resilient member (698) can couple to body (668). As will also be described in greater detail below, attachment point (678) is generally oriented towards one side of body (668) to promote specific movement of body (668) under the influence of resilient member (698).
Body (668) further includes a flex latch (670) protruding proximally from a proximal surface of body (668). Flex latch (670) is generally configured to provide selective engagement with at least a portion of chassis (606) to thereby provide a release mechanism for lock member (662). As will be described in greater detail below, flex latch (670) is configured to be responsive to a specific prong (208) of holster (200) to cause automatic transitioning of probe lock (660) from an unlocked configuration to a locked configuration. As such, it should be understood that at least a portion of flex latch (670) can be configured to have some generally flexible yet resilient material properties.
Flex lock (670) includes a curved portion (672) and a toothed end (674). Curved portion (672) extends proximally from body (668) and then curves laterally away from the initial axis of extension. In other words, curved portion (672) generally forms a hook or catch shape. The thickness of curved portion (672) can also be configured to provide some flexibility to flex lock (670), while also providing some resiliency. As will be described in greater detail below, this configuration generally promotes the ability of flex lock (670) to flex or move in response to engagement with a specific prong (208) of holster (200).
Curved portion (672) terminates in a toothed end (674). Toothed end (674) generally provides a flat surface configured to releasably engage with at least a portion of chassis (606). As will be described in greater detail below, toothed end (674) is generally configured to engage retainer (680) to hold lock member (662) in a given position until acted upon by a specific prong (208) of holster (200).
As best seen in
Unlike chassis (106) described above, chassis (606) of the present example defines retainer (680) extending upwardly from a lower surface of chassis (606). Retainer (680) is positioned adjacent to an opening (650). Although retainer (680) of the present example is configured as being generally integral with chassis (606), it should be understood that in other examples retainer (680) can be a separate component fastened or otherwise secured to chassis (606).
Retainer (680) generally includes a wedge portion (682) defining a ramp (684) and a flat surface (686). As will be understood, wedge portion (682) is generally configured to engage with flex lock (670) to manipulate flex lock (670) through various positions. Thus, it should be understood that the particular geometry of wedge portion (682) is generally configured to manipulate flex lock (670). In connection with this, ramp (684) is generally configured to push flex lock (670) proximally in response to lateral movement of lock member (662) to direct flex lock (670) into engagement with flat surface (686). Thus, ramp (684) is sloped proximally towards flat surface (686). As will be described in greater detail below, flat surface (686) is configured to provide a surface for toothed end (674) of flex lock (670) to engage retainer (680).
Flex lock (670) and retainer (680) of the present example are shown as being oriented on a particular side of chassis (606). Thus, as will be described in greater detail below, both flex lock (670) and retainer (680) are configured to engage with a particular prong (208) of holster (200). However, it should be understood that in other examples, both flex lock (670) and retainer (680) can be positioned on an opposite side of chassis (606) to engage with another prong (208). Similarly, in other examples, flex lock (670) can retainer (680) can be replicated in multiple positions relative to chassis (606) to engage multiple prongs (208) of holster (200). Still, various alternative configurations for flex lock (670) and retainer (680) will be apparent to those of ordinary skill in the art in view of the teachings herein.
Chassis (606) further includes an attachment post (690). Attachment post (690) is generally configured to provide another point of attachment for resilient member (698), which extends between attachment post (690) and attachment point (678) of body (668). Thus, it should be understood that resilient member (698) is generally configured to provide tension between attachment post (690) and attachment point (678). To provide a suitable amount of tension, attachment post (690) is positioned on an opposite side of chassis (606) relative to attachment point (678).
Resilient member (698) of the present example is configured as a coil spring with hooks on each end that are configured to couple resilient member (698) to attachment point (678) and attachment post (690). Although resilient member (698) is shown as a coil spring, it should be understood that other examples can include other components configured to provide tension such as an elastomeric band or shape memory alloy. As will be described in greater detail below, resilient member (698) is generally configured to pull lock member (662) transversely across chassis (606) towards attachment post (690) to thereby transition probe lock (660) from the unlocked configuration to the locked configuration.
In other operations, probe (600) can be provided to an operator with probe lock (660) in the locked configuration. This may be an undesirable condition prior to coupling of probe (600) to holster (200) because probe lock (660) may interfere with prongs (208) of holster (200). Thus, in some operations, an operator may desire to transition probe lock (660) to the unlocked configuration prior to coupling of probe (600) to holster (200). To do so, an operator can push lock indicator (666) transversely relative to the longitudinal axis of probe (600) until unlock indicator (664) protrudes from top housing (602). At this stage, probe (600) is ready for coupling to holster (200).
To initiate coupling of probe (600) to holster (200), an operator can align probe (600) with holster (200) such that each opening (650) of probe (600) is aligned with each prong (208) of holster (200) as shown in
Once probe (600) is positioned as shown in
To lock each prong (208) onto each corresponding cam feature (652), probe (600) is translated distally relative to holster (200) as shown in
During coupling of probe (600) to holster (200), probe lock (660) also operates automatically to shift from the unlocked configuration to the locked configuration. When shifting to the unlocked or locked status is indicated by protrusion of either unlock indicator (664) or lock indicator (666) from top housing (602). Additionally, in some examples, the transition from an unlocked to locked configuration can be accompanied with an audible “click,” “ping,” or “ding” to further provide affirmative feedback of locking.
As best seen in
As shown in
Once toothed end (674) of flex lock (670) is disengaged from flat surface (686) of retainer (680), lock member (662) is free to translate laterally within probe (600) relative to the longitudinal axis of probe (600) (e.g., perpendicular relative to the longitudinal axis). With this expanded degree of freedom, resilient member (698) can pull lock member (662) from the position shown in
In the locked configuration, lock member (662) is positioned such that unlock indicator (664) is positioned generally within the perimeter of chassis (606), while lock indicator (666) is positioned generally outside the perimeter of chassis (606). In this position, each prong gap (665, 667) is also positioned away from prongs (208). Consequently, each indicator (664, 666) is positioned adjacent to the distal surface of each prong (208). Thus, each indicator (664, 666) physically locks each prong (208) into engagement with cam feature (652) to prevent decoupling of probe (600) from holster (200).
Once probe (600) is coupled to holster (200) as described above, a biopsy procedure can be performed. At the conclusion of such a procedure, an operator may desire to decouple probe (600) from holster (200) for disposal of probe (600) and reuse of holster (200). To decouple probe (600) from holster (200), the procedure described above can be repeated. In particular, an operator can press lock indicator (666) to move lock member (662) back to the unlocked position shown in
Once lock member (662) is moved, unlock indicator (664) indicates to an operator that probe (600) is unlocked by generally protruding beyond the outer perimeter of chassis (606). An operator can then remove probe (600) by pulling probe (600) proximally relative to holster (200) to disengage each prong (208) from each corresponding cam feature (652).
As with needle (610) described above, it should be understood that needle (910) can likewise include various internal components to subdivide the interior of needle (910) into multiple lumens. Such internal components can be configured in accordance with one or more of the teachings of U.S. Pat. No. 7,918,803, entitled “Methods and Devices for Automated Biopsy and Collection of Soft Tissue,” issued Apr. 5, 2011, the disclosure of which is incorporated by reference herein.
As also with needle (610) described above, needle (910) of the present example can include a hub member (920) for receiving fork (222) of holster (200). Hub member (920) of the present example is substantially similar to hub member (620) described above. For instance, hub member (920) of the present example is overmolded about needle (910), such that hub member (920) and needle (910) rotate and translate unitarily with each other. Likewise, hub member (920) includes an annular flange (918) and a thumbwheel (916).
Also like with needle (610) described above, needle (910) of the present example can include a cutter (not shown) configured to rotate and translate within the interior of needle (910) to sever a tissue sample from tissue protruding through lateral aperture (914). This rotation and translation is accomplished by rotation of a gear (940). Although not shown, it should be understood that in some examples, gear (940) is coupled to one or more components to provide simultaneous translation and rotation of the cutter. By way of example only, the foregoing cutter actuation components can be configured in accordance with at least some of the teachings of U.S. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As yet another merely illustrative example, the cutter may be rotated and/or translated using pneumatic motors, etc. Still other suitable ways in which the cutter may be actuated will be apparent to those of ordinary skill in the art in view of the teachings herein.
Probe further includes gears (not shown) similar to gears (640, 630) described above. As with gears (640, 630), the gears in the present example can be exposed through an opening in chassis (906) to drive a cutter actuation mechanism and rotation of needle (910). As similarly discussed above with respect to gears (640, 630), each gear in the present example can mesh with a corresponding gear (212, 230) of holster (200) when probe (900) and holster (200) are coupled together.
Although not shown, it should be understood that probe (900) of the present example can be equipped with a tissue sample holder similar to tissue sample holders (300, 800) described above. As with tissue sample holders (300, 800) described above, the tissue sample holder of the present example can provide a plurality of discrete chambers that can be configured to receive tissue samples severed by the cutter and communicated proximally through a lumen defined by the cutter. In some examples, the tissue sample holder can include one or more tissue receiving trays (not shown) that are removably engaged with a rotatable member (not shown). In this configuration, the rotatable member can be configured for selective rotation within an outer cover (not shown) of the tissue sample holder. As a result, the rotatable member can be selectively rotated to collect one or more tissue samples within each of the plurality of discrete chambers. It should be understood that the rotatable member and/or trays can be configured in numerous other ways. By way of example only, the rotatable member and/or the trays can be configured in accordance with at least some of the teachings of U.S. Pat. Pub. No. 2008/0214955, the disclosure of which is incorporated by reference herein. As another merely illustrative example, the rotatable member and/or the trays can be configured in accordance with at least some of the teachings of U.S. Pat. No. 8,702,623, the disclosure of which is incorporated by reference herein.
Like probe (600) described above, probe (900) of the present example also includes a probe lock (960) that is generally configured to provide affirmative feedback to an operator when coupling probe (900) to holster (200) and also provide a locking mechanism to prevent decoupling of probe (900) from holster (200). Probe lock (960) is generally similar to probe lock (660) described above. However, unlike probe lock (660), probe lock (960) of the present example is generally configured for manual actuation rather than incorporating one or more automatic actuation features.
As best seen in
Lock member (962) includes an unlock indicator (964), a lock indicator (966), and a body (968) disposed between each indicator (964, 966). As will be described in greater detail below, lock member (962) is generally configured for manual translation within probe (900) to move from an unlocked position to a locked position while also affirmatively indicating the transition to an operator.
Each indicator (964, 966) is configured to provide an affirmative indicator to an operator related to the position of lock member (962) within probe (900) and thereby indicate the operational status probe lock (960) (e.g., locked or unlocked). For instance, in the present example, each indicator (964, 966) protrudes from an opposite side of body (968). As will be described in greater detail below, this positioning permits at least a portion of a particular indicator (964, 966) to protrude from top housing (902), while the other indicator (966, 964) is flush or retracted within top housing (902). In addition, each indicator is configured as button or actuator. As will be described in greater detail below, in some circumstances, this configuration permits either indicator (964, 966) to be used to move or otherwise actuate lock member (962) within probe (900).
Each indicator (964, 966) defines a corresponding prong gap (965, 967). As will be described in greater detail below, each prong gap (965, 967) is configured to permit a prong (208) of holster (200) to pass though chassis (906) and into the interior of probe (900) during coupling of probe (900) to holster (200). In other words, each prong gap (965, 967) is configured to provide clearance for entry of a given prong (208) of holster (200) into probe (900).
Body (968) is shaped to define a bridge gap (976), but structures similar to attachment point (678) are omitted. Bridge gap (976) is sized and shaped to provide clearance for various internal components of probe (900), while still permitting lock member (962) to move within the interior of probe (900).
Unlike body (668) described above, body (968) of the present example omits structures similar to flex latch (670). Instead, body (968) further includes a tracer arm (970) extending proximally from a proximal surface of body (968). Tracer arm (970) is generally configured to move a magnet or other component as lock member (962) moves to provide certain signals to holster (200). In particular, tracer arm (970) extends proximally from body (968) to avoid impediment of operation of any components such as prongs (208). An inverted cup (972) is positioned on the proximal end of tracer arm (970). Although not shown, it should be understood that in the present example a magnet can be disposed in cup (972). In this configuration, the magnet is slid by tracer arm (970) along the surface of chassis (906). As will be described in greater detail below, some versions of holster (200) can include a hall effect sensor or other device positioned to correspond to the magnet. Such a sensor can then send signals to vacuum control module (400) to identify the position of lock member (962) and thus the state of probe lock (960).
Body (968) further includes a unlock detent (974) and a lock detent (978). As best seen in
In use, probe lock (960) is used similarly to probe lock (660) described above. For instance, as similarly described above, the operation begins with probe (900) detached from holster (200). In some operations, probe (900) is provided to an operator with probe lock (960) in the unlocked configuration. In this configuration, lock member (962) is oriented such that at least a portion of unlock indicator (964) is protruding from top housing (902) of probe (900).
In other operations, probe (900) can be provided to an operator with probe lock (960) in the locked configuration. This may be an undesirable condition prior to coupling of probe (900) to holster (200) because probe lock (960) may interfere with prongs (208) of holster (200). Thus, in some operations, an operator may desire to transition probe lock (960) to the unlocked configuration prior to coupling of probe (900) to holster (200). To do so, an operator can push lock indicator (966) transversely relative to the longitudinal axis of probe (900) until unlock indicator (964) protrudes from top housing (902). At this stage, probe (900) is ready for coupling to holster (200).
To initiate coupling of probe (900) to holster (200), an operator can align probe (900) with holster (200) such that a plurality of openings (950) of probe (900) are correspondingly aligned with prongs (208) of holster (200). Probe (900) is then placed into the top of holster (200) with each prong (208) of holster (200) being inserted into each opening (950) of probe (900).
Once probe (900) is positioned with prongs (208) inside openings (950), probe (900) is mated with holster (200), but not yet locked in position. In particular, prongs (208) are merely inserted into openings (950), but not locked onto a corresponding cam feature (952) of a plurality of cam features (952).
To lock each prong (208) onto each corresponding cam feature (952), probe (900) is translated distally relative to holster (200). Alternatively, holster (200) can be translated proximally relative to probe (900) or some combination of both probe (900) and holster (200) being translated relative to each other. Regardless, this proximal translation causes each prong (208) to engage each cam feature (952) to lock probe (900) to holster (200) by interference or friction fit.
Unlike the operation described above with respect to probe (600), probe lock (960) of the present example does not lock automatically. Instead, as shown in
Once probe (900) is fully distally advanced such that prong (208) of holster (200) is fully engaged with cam feature (952), lock member (962) can be manually actuated to transition probe lock (960) to the locked configuration. This transition is initiated by an operator pressing unlock indicator (964) inwardly to move lock member (962) perpendicularly relative to the longitudinal axis of probe (900). This movement positions lock member (962) such that unlock indicator (964) is positioned generally within the perimeter of chassis (906), while lock indicator (966) is positioned generally outside the perimeter of chassis (906). In this position, each prong gap (965, 967) is also positioned away from prongs (208). Consequently, each indicator (964, 966) is positioned adjacent to the distal surface of each prong (208). Thus, each indicator (964, 966) physically locks each prong (208) into engagement with cam feature (952) to prevent decoupling of probe (900) from holster (200).
As described above, the transition from the unlocked configuration to the locked configuration can be tracked using tracking arm (970), cup (972), a magnet disposed within cup (972) and a hall effect sensor disposed within holster (200). In some operations, vacuum control module (400) can interpret signals from the hall effect sensor and generate a graphical indication of the status of probe lock (960) (e.g., locked or unlocked). By way of example only, such a graphical indication could be a graphical representation of a padlock in an unlocked or locked configuration. This graphical representation can also be color coded in some examples. In addition, it should be understood that in some examples, software in vacuum control module (400) can be coded with certain software lockout features to prevent use of holster (200) until probe (900) is locked thereto. Alternatively, vacuum control module (400) can be configured to sound an audible alarm if an operator attempts operation of holster (200) without probe (900) locked thereto. Regardless, it should be understood that tracking arm (970) and cup (972) can be used to provide yet another means of feedback to an operator to confirm that probe (900) is securely locked to holster (200).
Once probe (900) is coupled to holster (200) as described above, a biopsy procedure can be performed. At the conclusion of such a procedure, an operator may desire to decouple probe (900) from holster (200) for disposal of probe (900) and reuse of holster (200). To decouple probe (900) from holster (200), the procedure described above can be repeated. In particular, an operator can press lock indicator (966) to move lock member (962) back to the unlocked position shown in
Once lock member (962) is moved, unlock indicator (964) indicates to an operator that probe (900) is unlocked by generally protruding beyond the outer perimeter of chassis (906). An operator can then remove probe (900) by pulling probe (900) proximally relative to holster (200) to disengage each prong (208) from each corresponding cam feature (952).
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.
A biopsy device comprising: a probe including a probe body and a needle extending distally from the probe body; a holster, wherein the probe is releasably couplable to the holster; and a probe lock, wherein the probe lock includes a lock member configured to move laterally relative to a longitudinal axis defined by the needle to both selectively lock the probe to the holster and to provide an affirmative indication of locking of the probe to the holster.
The biopsy device of Example 1, wherein the lock member is configured to automatically transition from an unlocked position to a locked position upon coupling of the probe to the holster.
The biopsy device of Example 1, wherein the probe lock includes a release mechanism, wherein the release mechanism is configured to respond to a portion of the holster to automatically release the lock member from an unlocked position.
The biopsy device of Example 1, wherein the probe includes a retainer, wherein the probe lock includes a flex lock extending from the lock member, wherein the flex lock is configured to engage the retainer to releasably hold the lock member in an unlocked position.
The biopsy device of Example 4, wherein the flex lock is resiliently biased to engage the retainer, wherein the flex lock is configured to disengage from the retainer in response to engagement between at least a portion of the holster and the flex lock.
The biopsy device of Examples 4 or 5, wherein the lock member is configured for manual actuation from a locked position to the unlocked position, wherein the flex lock is configured to engage the retainer upon manual actuation of the lock member to the unlocked portion from the locked position.
The biopsy device of Example 1, wherein the lock member is configured to be manually actuated between an unlocked position and a locked position.
The biopsy device of any one or more of Examples 1 through 7, wherein the probe lock is configured to provide affirmative feedback to an operator indicating when the probe is selectively locked to the holster.
The biopsy device of any one or more of Examples 1 through 8, wherein the lock member is configured to extend outwardly from a portion of the probe body to provide affirmative feedback to an operator indicating when the probe is selectively locked to the holster.
The biopsy device of any one or more of Examples 1 through 9, wherein the probe lock is configured to transition between an unlocked configuration and a locked configuration, wherein the lock member is configured to extend from a first side of the probe body when the probe lock is in the unlocked configuration, wherein the lock member is configured to extend from a second side of the probe body when the probe lock is in the locked configuration.
The biopsy device of any one or more of Examples 1 through 10, wherein the probe lock is configured to provide an audible sound to an operator indicating when the probe is selectively locked to the holster.
The biopsy device of Example 1, wherein the probe lock further includes a flex lock, a resilient member, and a retainer, wherein the flex lock is configured to releasably fasten to the retainer to hold the lock member in an unlocked position against a resilient bias of the resilient member.
The biopsy device of Example 12, wherein the retainer includes a ramp and a flat surface, wherein the flex lock includes a curved portion terminating in a toothed end, wherein the toothed end of the flex lock is configured to engage the flat surface of the retainer to hold the lock member in an unlocked position against a resilient bias of the resilient member.
The biopsy device of Example 13, wherein the ramp of the retainer is configured to flex the curved portion of the flex lock to thereby move the toothed end into engagement with the flat surface of the retainer.
The biopsy device of Examples 13 or 14, wherein the curved portion of the flex lock is configured to deform upon engagement of the toothed end with at least a portion of the holster.
A probe for use with a holster of a biopsy device, the probe comprising: a probe body; a needle extending distally from the probe body; and a probe lock including a lock member, wherein the lock member includes an unlock indicator and a lock indicator, wherein the lock member is configured to translate within the probe body to alternatingly expose the unlock indicator and the lock indicator relative to the exterior of the probe body.
The probe of Example 16, wherein the lock member is movable relative to the probe body between am unlocked position and a locked position, wherein the probe lock is configured to lock the probe to the holster when the lock member is in the locked position.
The probe of Examples 16 or 17, wherein the lock member defines a first gap associated with the unlock indicator, wherein the lock member further defines a second gap associated with the lock indicator, wherein the lock member is configured to translate laterally within the probe body to move the first gap and the second gap relative to a respective opening of a pair of openings in the probe body.
The probe of any or more of Examples 16 through 18, wherein the probe lock further include a magnet, wherein the magnet is configured to move in connection with the lock member to communicate a position of the lock member to the holster.
A method for releasably securing a probe to a holster, the method comprising: aligning a plurality of prongs of the holster with a corresponding plurality of openings in a chassis of the probe; inserting each prong of the plurality of prongs into a corresponding opening of the plurality of openings in the chassis; driving the probe distally relative to the holster; and locking the probe to the holster by moving a lock member of a probe lock laterally relative to a longitudinal axis defined by the probe to physically block at least one prong of the plurality of prongs from movement relative to the probe, wherein moving the lock member further indicates locking of the probe to the holster.
The method of Example 20, wherein the step of locking the probe to the holster includes automatically moving the lock member in response to contact between at least one prong and a flex lock of the probe lock.
The method of Example 20, wherein the step of locking the probe to the holster includes manually actuating the lock member.
The method of any one or more of Examples 20 through 22, further comprising unlocking the probe from the holster by moving the lock member of the probe lock laterally relative to the longitudinal axis in a reverse direction relative to the movement during the step of locking.
The method of any one or more of Examples 20 through 23, wherein the step of locking the probe to the holster further includes moving a magnet disposed within the probe relative to a hall effect sensor disposed within the holster.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
This application claims priority to U.S. Provisional Application Ser. No. 62/985,079, entitled “Slide-Lock for Biopsy Device,” filed on Mar. 4, 2020, the disclosure of which is incorporated by reference herein.
Number | Date | Country | |
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62985079 | Mar 2020 | US |
Number | Date | Country | |
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Parent | PCT/US21/20598 | Mar 2021 | US |
Child | 17900241 | US |