阅读说明：本技术 具有集成真空储存器的活检装置 (Biopsy device with integrated vacuum reservoir ) 是由 安德鲁·P.·诺克 于 2020-04-23 设计创作，主要内容包括：一种与活检装置一起使用的探针。所述活检装置具有限定样本室的组织样本保持器和可移除地固定到所述探针的套壳。所述探针包括壳体。所述壳体在其内限定真空室。所述真空室与所述组织样本保持器的所述样本室连通。(A probe for use with a biopsy device. The biopsy device has a tissue sample holder defining a sample chamber and a holster removably secured to the probe. The probe includes a housing. The housing defines a vacuum chamber therein. The vacuum chamber is in communication with the sample chamber of the tissue sample holder.)

1. A probe for use with a biopsy device having a tissue sample holder defining a sample chamber and a sheath removably secured to the probe, the probe comprising:

a housing defining a vacuum chamber therein, the vacuum chamber in communication with the sample chamber of the tissue sample holder.

2. The probe of claim 1, further comprising a cutter for severing a tissue sample, the cutter extending through the vacuum chamber and in communication with the tissue sample holder.

3. The probe of claim 1, further comprising a cutter driver and a cutter for severing a tissue sample, the cutter driver configured to translate and rotate the cutter, both the cutter driver and the cutter partially disposed within the vacuum chamber.

4. The probe of any one or more of claims 1 to 3, the vacuum chamber comprising four fluid reservoirs separated by a plurality of internal walls.

5. The probe of any one or more of claims 1 to 3, the vacuum chamber comprising a plurality of fluid reservoirs separated by one or more inner walls extending axially, laterally, or a combination thereof within the probe.

6. The probe of any one or more of claims 1 to 5, the vacuum chamber defining a first volume that is larger than a second volume defined by the tissue sample holder.

7. The probe of any one or more of claims 1 to 5, the vacuum chamber defining a first volume that is 10 to 20 times greater than a second volume defined by the tissue sample holder.

8. The probe of any one or more of claims 1 to 7, the housing of the probe comprising an upper housing and a lower housing coupled together and defining an interface, the interface being substantially free of sharp edges.

9. The probe of any one or more of claims 1 to 7, the housing of the probe comprising an upper housing and a lower housing coupled together and defining an interface, the lower housing being self-centering relative to the upper housing.

10. The probe of any one or more of claims 1 to 9, further comprising a first gear and a second gear rotatably connected by a shaft, the first gear being exposed with respect to an exterior of the housing, the second gear being disposed within the vacuum chamber and sealed with respect to the exterior of the housing by a seal engaged with the shaft.

11. A handheld, cordless biopsy device for collecting one or more tissue samples, the biopsy device comprising:

a casing having a motor and a vacuum pump coupled to the motor;

a probe removably coupled to the casing, the probe including a housing having a vacuum port in communication with the vacuum pump of the casing, the housing defining a vacuum reservoir in communication with the vacuum port; and

a tissue sample holder defining a sample chamber configured to receive a tissue sample therein, the sample chamber in communication with the vacuum reservoir of the probe.

12. The biopsy device of claim 11, the vacuum reservoir comprising a plurality of reservoirs separated by one or more interior walls and interconnected by an opening disposed within each of the one or more interior walls.

13. The biopsy device of claim 11 or 12, the probe further comprising a cutter and a cutter drive configured to translate and rotate the cutter, at least a portion of the cutter and the cutter drive being disposed within the vacuum reservoir.

14. The biopsy device of claim 11 or 12, the probe further comprising a cutter and a cutter drive, the cutter drive configured to translate and rotate the cutter, at least a portion of the cutter and the cutter drive disposed within the vacuum reservoir, the opening of at least one of the one or more inner walls configured to receive the cutter and a portion of the cutter drive while providing fluid flow between two of the plurality of fluid reservoirs.

15. The biopsy device of any one or more of claims 11-13, the probe further comprising a valve assembly configured to provide selective venting to a portion of the probe, the valve assembly being fluidly isolated from the vacuum reservoir.

16. The biopsy device of any one or more of claims 11-13, the probe further comprising a vent chamber and a valve assembly disposed within the vent chamber and configured to provide selective venting to a portion of the probe, the vent chamber being fluidly isolated from the vacuum reservoir.

17. The biopsy device of any one or more of claims 11-13, the probe further comprising a valve assembly configured to provide selective venting to a portion of the probe, the valve assembly being fluidly isolated from the vacuum reservoir while also being disposed within a portion of the vacuum reservoir.

18. The biopsy device of any one or more of claims 11-17, the vacuum reservoir defining a total fluid volume of about 175 cc.

19. The biopsy device of any one or more of claims 11-17, the housing of the probe comprising first and second housings configured to be coupled together to seal the vacuum reservoir from an exterior of the probe.

20. A method for use with a biopsy device having a probe, a tissue sample holder, and a sheath, the method comprising:

inserting the needle of the probe into tissue;

translating a cutter distally within the needle to sever a tissue sample; and

the vacuum pressure supplied by the vacuum pump within the casing is drawn from a vacuum reservoir defined by the housing of the probe to deliver the severed tissue sample through the cutter and into the tissue sample holder.

Background

Biopsy samples have been obtained in a variety of ways in various medical procedures using a variety of devices. The biopsy device may be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other guidance. For example, some biopsy devices may be fully capable of being operated by a user using a single hand, and capturing one or more biopsy samples from within a patient with a single insertion. Further, some biopsy devices may be tethered to a vacuum module and/or control module, such as for the transfer of fluids (e.g., compressed air, saline, atmospheric air, vacuum, etc.), for the transfer of electrical power, and/or for the transfer of commands, etc. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected to another device. Other biopsy devices may be fully or at least partially operable without being tethered or otherwise connected to another device.

Biopsy devices, which are merely exemplary, are disclosed in the following documents: U.S. Pat. No. 5,526,822 entitled "Method and Apparatus for Automated Biopsy and Soft Tissue Collection (Method and Apparatus for Automated Biopsy and Collection of Soft Tissue)" published at 18.6.1996; U.S. patent No. 6,086,544 entitled "Control Apparatus for an Automated Surgical Biopsy Device (Control Apparatus for an Automated Surgical Biopsy Device)" issued at 11/7/2000; U.S. patent No. 6,626,849 entitled "MRI Compatible Surgical Biopsy Device (MRI Compatible Surgical Biopsy Device") issued 9/30/2003; U.S. patent No. 7,442,171 entitled "Remote control Thumbwheel for a Surgical Biopsy Device" (published on 28.10.2008); U.S. patent No. 8,764,680 entitled "hand held Biopsy Device with Needle Firing" (published 7/7 2014); U.S. patent No. 9,345,457 entitled "Presentation of Biopsy Sample by Biopsy Device (Presentation of Biopsy Sample by Biopsy Device)" issued at 24.5.2016; U.S. publication No. 2006/0074345 entitled "Biopsy device and Method" (Biopsy Apparatus and Method), published on 6.4.2006, has been abandoned; U.S. publication No. 2009/0171242 entitled "Clutch and valve System for cordless Biopsy Device" (published 2009, 7, 2); U.S. publication No. 2010/0152610 entitled "manually Actuated cordless Biopsy Device with Pistol Grip (Hand activated thermal Biopsy Device with Pistol Grip)" published on 6/17/2010; and U.S. publication No. 2012/0310110 entitled "Needle Assembly and Blade Assembly for Biopsy Device" published on 12/6/2012. The disclosures of each of the above-referenced U.S. patents, U.S. patent application publications, and U.S. non-provisional patent applications are incorporated herein by reference.

In some cases, it may be desirable to use a biopsy device that is not tethered to a vacuum source, controller, or other peripheral accessory. For example, in an ultrasound guided biopsy procedure, a cordless biopsy device may be desirable because the nature of the procedure is fully handheld without the use of support structures, guides, manipulators, or other devices associated with manipulation of the biopsy device. When the biopsy device is fully handheld, manipulation of the biopsy device may be impeded by a tether tethered to a peripheral item. Thus, a cordless biopsy device may be desirable in some situations.

Where the biopsy device is a cordless biopsy device, all of the components required to operate the biopsy device are incorporated into the biopsy device itself in a compact, hand-held package. This constraint can result in certain trade-offs in operation. For example, to supply a vacuum, an on-board vacuum pump may be used. With this configuration, one such trade-off is the absence of a vacuum canister commonly used in corded biopsy devices. The presence of the vacuum tank increases the volume of the vacuum system. This additional volume may provide a smoothing effect on the vacuum pressure as the biopsy device uses more or less vacuum during various stages of operation. Without such a vacuum canister in a cordless biopsy device, the vacuum pressure may be more unstable when the biopsy device goes through various operating phases where more or less vacuum is required. Thus, in the case of a cordless biopsy device, it may be desirable to include a function to smooth the vacuum pressure as the biopsy device passes through different stages of operation.

While several systems and methods have been made and used to obtain biopsy samples, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.

Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the present biopsy device, it is believed that the present biopsy device will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and wherein:

FIG. 1 depicts a perspective view of an exemplary biopsy device;

FIG. 2 depicts a perspective view of the biopsy device of FIG. 1 showing the holster detached from the probe;

FIG. 3 depicts a schematic diagram of exemplary electrical and/or electromechanical components of the case of FIG. 2;

FIG. 4 depicts a perspective cross-sectional view of the probe of FIG. 2;

FIG. 5 depicts an exploded perspective view of the probe of FIG. 2;

FIG. 6 depicts a front cross-sectional view of the needle actuation assembly of the probe of FIG. 2;

FIG. 7 depicts a front cross-sectional view of the probe of FIG. 2; and is

FIG. 8 depicts a schematic diagram showing the relationship between valve status and cutter position.

The figures are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the figures. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention; it should be understood, however, that the invention is not limited to the precise arrangements shown.

Detailed Description

The following description of certain examples of biopsy devices should not be taken to limit the scope of the present biopsy device. Other examples, features, aspects, embodiments, and advantages of biopsy devices 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 biopsy devices. As will be appreciated, the biopsy device can have other different and obvious aspects, all without departing from the spirit of the biopsy device. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

It should be understood 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. Thus, and where necessary, the disclosure as explicitly set forth herein takes precedence over 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.

I. Overview of an exemplary biopsy device

Fig. 1 shows an exemplary biopsy device (10) comprising a probe (20) and a holster (30). It should be appreciated that the biopsy device (10) of the present example is generally configured as a cordless biopsy device. Thus, biopsy device (10) is typically independent of all components included within probe (20) or holster (30) that are required for operation. Although the biopsy device (10) of the present example is shown and described as a cordless biopsy device (10), it should be understood that the teachings herein may be readily applied to biopsy devices having other configurations, including corded configurations.

The probe (20) includes a needle assembly (100) extending at least partially distally from a housing of the probe (20). The needle assembly (100) is insertable into tissue of a patient to obtain a tissue sample, as described below. The biopsy device (10) also includes a tissue sample holder (40) in which the tissue sample is placed. By way of example only, the probe (20) may be a disposable component and the casing (30) may be a reusable component to which the probe (20) may be coupled, as shown in fig. 2. The use of the term "sheath" herein should not be construed as requiring any portion of the probe (20) to be inserted into any portion of the sheath (30). Indeed, in one configuration for the biopsy device (10), the probe (20) may simply be positioned on top of the holster (30). Alternatively, a part of the probe (20) may be inserted into the sheath (30) to fix the probe (20) to the sheath (30). In yet another configuration, a portion of the sheath (30) may be inserted into the probe (20). Further, the probe (20) and the casing (30) may be integrally formed as a single unit.

In configurations where the probe (20) and the casing (30) are separable components, a port and/or seal (32) may be provided on the casing (30) to couple with a second port and/or seal (26) on the probe (20) such that a vacuum generated by a vacuum pump (50) within the casing (30) may be fluidly connected to the probe (20). The casing (30) may also provide a gear (34) or gears that mate and engage with corresponding gears (310) on the probe (20). It should be understood that the configuration depicted in fig. 2 to transmit vacuum and power between the casing (30) and the probe (20) is merely exemplary. In some versions, U.S. patent No. 8,206,316 entitled "cordless Biopsy Device with Reusable Portion" issued on 26/6/2012, which may be incorporated by reference herein in accordance with its disclosure; and/or U.S. publication No. 2012/0065542 entitled "Biopsy Device Tissue Sample Holder with Removable Tray" (Biopsy Device Tissue Holder with Removable Tray) published 3, 15, 2012 to construct such a construct.

With the hub (30) and probe (20) connected, the vacuum pump (50) may generate a vacuum within the needle assembly (100) via the tissue sample holder (40) and the cannular cutter (60). However, it should be understood that the vacuum may be provided in other ways. For example, the vacuum pump (50) may be independent of the sheath (30) and probe (20), and may simply be coupled to an appropriate port on the biopsy device (10) by a vacuum tube. Biopsy Device (10) may also be issued on 7/1/2014, incorporated by reference herein in accordance with its disclosure, U.S. patent No. 8,764,680 entitled "hand held Biopsy Device with Needle Firing member"; and/or U.S. publication No. 2012/0065542 entitled "Biopsy Device Tissue Sample Holder with Removable Tray" (Biopsy Device Tissue Holder with Removable Tray) published 3, 15, 2012. Other suitable structural and functional combinations for the probe (20) and the housing (30) will be apparent to those of ordinary skill in the art in view of the teachings herein.

Exemplary case

The casing (30), shown schematically in fig. 3, includes a vacuum pump (50), a motor (70), a control module (1000), one or more buttons (54), a vacuum sensor (52), and any other suitable electrical and/or electromechanical components. The vacuum pump (50) of the present example includes a conventional diaphragm pump mechanically coupled to a motor (70). The vacuum sensor (52) is coupled to the vacuum pump (50) or along any vacuum path of the vacuum pump such that the vacuum sensor (52) can determine a level of vacuum generated by the vacuum pump (50). The vacuum sensor (52) is electrically coupled to the control module (1000) such that the vacuum sensor (52) can output a signal indicative of the degree of vacuum to the control module (1000). In the illustrated construction, the motor (70) is operable to translate and/or rotate the cutter (60) in response to actuation of one or more of the buttons (54), as will be described below, and activate the vacuum pump (50), although this is merely optional, and a second motor (not shown) may be provided to run the vacuum pump (50). In particular, the motor may be coupled to the cutter actuation assembly (300) and may be activated by the control module (1000) upon actuation of one or more of the buttons (54). Such a cutter actuation assembly (300) may rotate the gear (34). As described above, gear (34) meshes with gear (310) in probe (20), allowing motor (70) to translate and/or rotate cutter (60). Other various configurations for the case (30) may be provided as will be apparent to those of ordinary skill in the art in view of the teachings herein. By way of example only, U.S. patent 8,206,316 entitled "cordless Biopsy Device with Reusable Portion" (thermal Biopsy Device with Reusable Portion) "issued on month 6, 26 of 2012, which disclosure is incorporated herein by reference, may be used to describe other features of the cutter actuation assembly (300) and/or holster (30) and/or probe (20); and/or its disclosure, are incorporated by reference herein, at least some of the teachings of U.S. patent No. 8,764,680 entitled "hand-held Biopsy Device with Needle Firing" issued on 7/1 2014.

Exemplary probes

Fig. 4 depicts a cross-sectional view of the probe (20), showing the needle assembly (100), cutter actuation assembly (300), probe housing (22, 24), and tissue sample holder (40). The needle assembly (100) includes a needle portion (110) and a valve assembly (200). As will be described in greater detail below, the needle assembly (100) is generally operable to pierce tissue, wherein a cutter (60) may be placed to sever a tissue sample from a patient and deliver the tissue sample to a tissue sample holder (40). More specifically, a needle portion (110) of the needle assembly (100) is inserted into tissue of a patient. The cutter actuation assembly (300) is then operable to selectively actuate the cutter (60) to the open position after pressing one or more of the buttons (54). Once the cutter (60) is actuated to the open position by the cutter actuation assembly (300), tissue may be prolapsed into the needle portion (110) by means of the vacuum delivered through the cutter (60). The cutter (60) can then be selectively actuated to a closed position by means of the cutter actuation assembly (300), thereby severing prolapsed tissue from the patient. The vent assembly (300) is then operable to selectively vent a portion of the needle portion (110) to atmosphere, thereby creating a pressure differential between the proximal and distal ends of the prolapsed tissue. The pressure differential then delivers the prolapsed tissue through the cutter (60) to the tissue sample holder (40).

A. Exemplary cutter Assembly

The cutter actuation assembly (300) includes a series of gears (310, 312). The gears (310, 312) are configured to simultaneously translate and rotate the cutter (60). In the illustrated construction, the gear (310) is coupled with the motor (70) when the probe (20) is attached to the casing (30) by the gear (30). In particular, two gears (310, 312) are mounted on a single shaft (314) such that the gears (310, 312) rotate together. Thus, the gear (310) is driven by the gear (34) of the casing (30), which also drives the gear (312). The gear (312) meshes with a cutter gear (316). As will be described in more detail below, cutter gear (316) may then translate and rotate cutter (60) while being driven to rotate by gear (310) via gear (312).

As shown in fig. 5, the cutter actuation assembly (300) also includes a screw (320) overmolded or otherwise secured to the cutter (60) such that the screw (320) and cutter (60) rotate and translate integrally. The screw (320) includes external threads (322) and one or more passages (324) extending through the threads (322). The one or more channels (324) are configured to slidably engage corresponding protrusions (318) defined by the cutter gear (316). In this configuration, rotation of the cutter gear (316) is transmitted to the screw (320), which ultimately transmits rotation to the cutter (60).

The threads (322) are configured to engage corresponding internal threads (28) defined within an opening (29) of the probe housing (24). As the screw (320) rotates, the engagement between the threads (322) and the threads (28) causes the screw (320) to translate relative to the probe housing (24). Thus, rotation of the cutter gear (316) is generally configured to provide translation of the screw (320) and cutter (60) via engagement between the threads (322) and the threads (28). It should be understood that other configurations may be provided using different gear (310, 312, 316) arrangements. Further, a configuration involving an additional motor (70) may be used. Various suitable motor (70) and gear (310, 312, 316) combinations will be apparent to those of ordinary skill in the art in view of the teachings herein. Indeed, the cutter actuation assembly (300) may be constructed in accordance with at least some of the teachings of U.S. patent 8,206,316 entitled "cordless Biopsy Device with Reusable Portion" issued on 26/6/2012, the disclosure of which is incorporated herein by reference. In other examples, the cutter actuation assembly (300) may be configured in accordance with at least some of the teachings of U.S. publication No. 2019/0008493 entitled "Apparatus for allowing Visualization of a Biopsy Sample During Tissue resection (Apparatus to below Biopsy Sample Visualization During Tissue resection)" disclosed on day 1, month 10, 2019, the disclosure of which is incorporated herein by reference.

It should be appreciated that the gears (310, 312) are generally fluidly isolated from each other by a seal (315) disposed on the shaft (314). In particular, gear (310) is typically exposed to the atmosphere such that gear (310) may mesh with gear (34) of casing (30). At the same time, the gear (312) is fluidly isolated from the atmosphere. As will be described in greater detail below, such a configuration is generally configured to permit a vacuum to flow within at least some of the space occupied by the gear (312), while still allowing the gear (312) to be rotated by the gear (34) of the casing (30) via the gear (310).

B. Exemplary needle portion

Fig. 5 shows an exemplary needle portion (110). The needle portion (110) includes a cannula (120), a tissue piercing tip (140), and a lateral aperture (150). As shown, the sleeve (120) is positioned on top of the sleeve (120). Although not shown, it should be understood that the cannula (120) defines a lumen therein for receiving the cutter (60). In some examples, the cannula (120) defines a plurality of lumens therein, such as one lumen for receiving the cutter (60) and one lumen for communicating atmospheric air and/or vacuum to the lateral aperture (150). Although the needle portion (110) of the present example is shown as having a generally circular cross-section, it should be understood that other cross-sectional shapes may be used. Indeed, in some examples, the needle portion (110) may be composed of a combination of circular and elliptical tubes to form an elliptical cross-section. In other examples, the needle portion (110) may consist of only a circular tube, forming a generally figure 8-shaped cross-section. Alternatively, the needle portion (110) may be composed of two square tubes, forming a substantially square cross-section. In other constructions, however, the Needle portion (110) may be constructed in accordance with at least some of the teachings of U.S. patent No. 8,801,742 entitled Needle Assembly and Blade Assembly for Biopsy Device (Needle Assembly and Blade Assembly for Biopsy Device), issued 8.8.2014, the disclosure of which is incorporated herein by reference.

The cannula (120) is generally configured to receive the cutter (60) and permit translation and rotation of the cutter (60) within a lumen defined by the cannula (120). The cannula (120) further includes a lateral aperture (150). The lateral aperture (150) is sized to receive prolapsed tissue during operation of the biopsy device (10). Thus, tissue may be received by the lateral aperture (150) for severing a tissue sample by the cutter (60) under the influence of vacuum from the vacuum pump (50).

In use, the cutter (60) may be moved through various positions, such as a closed position, an open position, and a final intermediate position. Each location may correspond to a particular stage in the tissue sample extraction process. For example, the cannula (120) may penetrate tissue of the patient when the cutter (60) is in the closed position. In the closed position, the cutter (60) is in its distal-most position relative to the lateral aperture (150). Thus, the cannula (120) can successfully penetrate tissue without capturing any surrounding tissue that may impede penetration. In the open position, the cutter (60) is in its distal-most proximal position relative to the lateral aperture (150). This state may correspond, for example, to a position in which the cannula (120) is oriented within the patient, at which a tissue sample may be taken. With the cutter (60) in a distal-most proximal position relative to the lateral port (150), a vacuum may be applied through the lateral port (150) to prolapse tissue of the patient. Finally, when cutter (60) is in the neutral position, cutter (60) is in a position between its distal-most and proximal-most positions relative to lateral aperture (150). In this position, the cutter (60) may be in motion from a closed position or an open position to a closed or open position, respectively. For example, cutter (60) may be moved from an open position to a closed position such that cutter (60) may sever a tissue sample. Alternatively, the cutter may be moved from a closed position to an open position so as to allow prolapse of the patient's tissue through the lateral aperture (150). These various positions correspond to various pneumatic states of the valve assembly (200), as will be described in further detail below. It should be appreciated that the various positions of the cutter (60) and corresponding stages in the tissue extraction process are merely exemplary, and other suitable combinations will be apparent to those of ordinary skill in the art in light of the teachings herein.

The tissue piercing tip (140) is shown as having a generally conical body. The shape of the tissue piercing tip (140) is merely exemplary, and many other suitable shapes may be used. For example, the tissue piercing tip (140) may be in the shape of a blade protruding from the needle portion (110), regardless of the conical body. In still further variations, the tissue piercing tip (140) may have flat blade portions of varying shapes and configurations. It will be apparent to those of ordinary skill in the art in view of the teachings herein that other various configurations for the tissue piercing tip (140) and for the needle portion (110) may generally be provided. By way of example only, the Needle portion (110) may be constructed in accordance with at least some of the teachings of U.S. Pat. No. 8,801,742 entitled "Needle Assembly and Blade Assembly for Biopsy Device (Needle Assembly and Blade Assembly for Biopsy Device") issued on 8.8.2014, the disclosure of which is incorporated herein by reference.

C. Exemplary valve Assembly

Returning to fig. 4, the probe (20) is shown as including a valve assembly (200). The valve assembly (200) in this example is generally configured to provide atmospheric venting to the needle portion (110). In some examples, such atmospheric venting may be supplied between the exterior of the cutter (60) and the interior of the cannula (120). In other examples, the cannula (120) may define a separate lumen for providing atmospheric air to the distal end of the cutter (60). Of course, one of ordinary skill in the art will appreciate in view of the teachings herein that various alternative configurations may be used.

In this example, a valve assembly (200) is schematically shown. Accordingly, it should be understood that the valve assembly (200) may take a variety of forms. For example, in some examples, the valve assembly (200) may include a manifold (not shown) and a spool valve body (not shown). In such examples, the manifold may couple the valve assembly (200) to a proximal end of the needle portion (110) of the needle assembly (100). At the same time, the spool valve body may be moved relative to one or more vent openings in the manifold under the influence of a cutter (60) to transition the valve assembly (200) from a vent state to a sealed state. By way of example only, the manifold and/or spool Valve body may be constructed in accordance with at least some of the teachings of U.S. patent No. 10,206,665 entitled "Biopsy Device with Translating Valve Assembly" issued 2019, 19, the disclosure of which is incorporated herein by reference.

In use, movement of the spool body may be controlled at least in part by movement of the cutter (60). For example, in some examples, the valve assembly (200) may be configured to vent a space between the cutter (60) and the cannula (120) when the cutter (60) is disposed in the distal position. Atmospheric air may then flow freely through the manifold and into the space between the cutter (60) and the cannula (120). Such a position may correspond to severing a tissue sample using cutter (60). Thus, it will be appreciated that after the tissue sample has been severed, venting is provided to the needle portion (110) to facilitate delivery of tissue through the cutter (60). In other examples, it may be desirable to substantially seal the needle portion (110) from the atmosphere. For example, in the intermediate position, tissue may prolapse into the lateral orifice (150). In such cases, it may be desirable to seal the needle portion (110) to prevent vacuum from escaping through the interface between the cutter (60) and the cannula (120). Thus, in this case, the spool body may be positioned by the cutter (60) such that the spool body seals the manifold. Of course, various other additional or alternative pneumatic states may be used as will be apparent to those of ordinary skill in the art in view of the teachings herein. By way of example only, suitable pneumatic states may be in accordance with at least some teachings of U.S. patent No. 10,206,665 entitled "Biopsy Device with Translating Valve Assembly" issued 2019, 2, 19, the disclosure of which is hereby incorporated by reference.

D. Exemplary Integrated vacuum reservoir

In some examples, it may be desirable to provide a biopsy device, such as biopsy device (10), with one or more reservoirs for vacuum. For example, some corded biopsy devices may typically use one or more vacuum canisters in an external vacuum system. It may be desirable to use a vacuum tank to provide additional volume for vacuum. This additional volume may make the vacuum system as a whole more resistant to vacuum pressure drops caused by sudden fluctuations in vacuum flow during biopsy. In other words, the additional volume for vacuum may make the vacuum pressure more consistent over time. It is generally desirable to increase the consistency of the vacuum pressure to permit larger sample sizes, increased response times, and improved delivery of the sample through the biopsy device.

In contrast, in cordless biopsy devices, such as biopsy device (10), a vacuum canister is typically not used because the entire vacuum system is integrated into the biopsy device itself. Without a vacuum tank or other similar structure, the overall volume of the vacuum system is reduced. This reduction in volume may result in a vacuum system that is more susceptible to sudden fluctuations in vacuum flow, thereby creating a more unstable vacuum pressure during the biopsy procedure. Thus, in some instances, it may be desirable to incorporate structures and features into the biopsy device to provide additional volume to the vacuum system. While various exemplary biopsy device configurations are described below, it will be appreciated that various modifications may be made without departing from the spirit of the examples disclosed herein.

As shown in fig. 5, the probe (20) is formed of an upper case (22) and a lower case (24). Both the upper housing (22) and the lower housing (24) are configured to couple to one another to form a fluid-tight seal such that an interior of the probe (20) is substantially sealed from the atmosphere. To facilitate sealing, the lower shell (24) defines a geometry that is generally free of hard corners and/or hard edges. Additionally, the proximal and distal ends of the lower housing (24) are tapered to provide self-centering when the lower housing (24) is coupled to the upper housing (22). Such a configuration is typically configured to permit the lower housing (24) to be easily sealed from the upper housing (22), thereby sealing the interior of the probe (20) from the atmosphere. Although the lower shell (24) (and corresponding portion of the upper shell (22)) of the present example is shown as having a particular geometry, it should be understood that various alternative geometries may be used, as long as such shapes generally lack hard edges and corners and/or are self-centering.

The upper housing (22) and lower housing (24) of the present example are typically configured to be coupled by ultrasonic welding. Thus, the particular geometry of the lower shell (24) is configured to promote adhesion to the upper shell (22) during ultrasonic welding by the absence of hard edges and corners and the self-centering configuration of the upper shell (22) and the lower shell (24). While the use of ultrasonic welding is described herein as being suitable for coupling the upper housing (22) and the lower housing (24), it should be understood that in other examples, various alternative coupling mechanisms may be used. For example, in some examples, the upper housing (22) and the lower housing (24) may be coupled by an adhesive, such as an epoxy. In other examples, the upper housing (22) and the lower housing (24) may be coupled by mechanical fastening with one or more gaskets disposed between the upper housing (22) and the lower housing (24) to provide a seal. Other examples of coupling of the upper housing (22) and the lower housing (24) may also be used, as will be apparent to those of ordinary skill in the art in view of the teachings herein.

Fig. 4,6 and 7 show detailed views of the interior of the probe (20). It can be seen that the upper and lower housings (22, 24) together define one or more vacuum reservoirs or chambers (410, 412, 414, 416) and a plenum (420) therein. The vacuum reservoirs (410, 412, 414, 416) are all generally configured to be in fluid communication with each other so as to provide a flow of vacuum from the port (24) to the tissue sample holder (40). As will be described in more detail below, the vacuum reservoirs (410, 412, 414, 416) are generally configured to provide an increased volume to the vacuum system to make the vacuum system generally more resistant to sudden changes in vacuum flow during a procedure, such as during a biopsy procedure.

The shape of each vacuum reservoir (410, 412, 414, 416) is generally defined by the configuration of the upper and lower housings (22, 24). For example, in the present example, the upper and lower housings (22, 24) define one or more interior walls (430) that define separate compartments within the interior of the probe (20) corresponding to each vacuum reservoir (410, 412, 414, 416). In this example, three interior walls (430) are used to form four separate vacuum reservoirs (410, 412, 414, 416). However, it should be understood that in other examples, different wall configurations may be used to provide different corresponding vacuum reservoir (410, 412, 414, 416) configurations. Indeed, in this example, the particular configuration of the inner wall (430) is merely to provide rigidity to the probe (20). Thus, in other examples, more or fewer interior walls (430) may be used, or even eliminated altogether, depending on the desired physical characteristics of the probe (20). Further, although the inner wall (430) of the present example is shown as dividing the interior of the probe (20) vertically, in other examples, the inner wall (430) may divide the interior of the probe (20) horizontally, or in a combination of vertical and horizontal.

The inner wall (430) generally includes one or more openings (432) to facilitate fluid flow between each vacuum reservoir (410, 412, 414, 416). The openings (432, 434) may take a variety of forms. For example, in the present example, some of the inner walls (430) include fluid openings (432) configured to accommodate only fluid flow. Meanwhile, other interior walls (430) include cutter openings (434) configured to accommodate movement of the cutter (60), one or more components of the cutter actuation assembly (300), and the fluid flow. In either type of opening (432, 434), it should be understood that each opening (432, 434) is generally configured to not impede the flow of vacuum in one process. Thus, the vacuum flow rate through a given opening (432, 434) is typically greater than the flow rate of the entire vacuum system so as not to impede the operation of the vacuum system. Alternatively, each inner wall (430) may include a plurality of openings (432, 434) having different configurations to likewise facilitate the flow of vacuum without impeding the operation of the vacuum system.

The upper probe housing (22) and the lower probe housing (24) further define a vent chamber (420) disposed distal to the vacuum reservoir (410, 412, 414, 416). The plenum (420) is generally fluidly isolated from the vacuum reservoir by a distal wall (422). Thus, it should be appreciated that the distal wall (422) is configured to isolate the plenum (420) from the vacuum reservoir (410, 412, 414, 416). Thus, the distal wall (422) may include various seals, gaskets, or other features to permit various operational components, such as the cutter actuation assembly (300), to pass through the distal wall (422) while maintaining fluid isolation.

The vent chamber (420) is generally configured to provide an operating space for the valve assembly (200). As described above, the valve assembly (200) may be configured to provide venting to the needle assembly (100) from the atmosphere. Thus, in some examples, the upper probe housing (22) and/or the lower probe housing (24) may include various external vents or vent passages to maintain the vent chamber (420) at atmospheric pressure. It should be understood, however, that the plenum (420) need not be at atmospheric pressure. For example, in some examples, the valve assembly (200) itself may be fluidly isolated from the remainder of the probe (20) and have a direct fluid connection to the atmosphere through a tube or passage. In such examples, the plenum (420) may serve as another vacuum reservoir similar to the vacuum reservoirs (410, 412, 414, 416) described above. Thus, it should be understood that in some examples, the distal wall (422) may also include openings similar to the openings (432, 434) described above to facilitate using the plenum (420) as another vacuum reservoir.

As described above, the gears (310, 312) are generally fluidly isolated from each other by a seal (315) disposed on the shaft (314). The fluid isolation is generally configured to facilitate fluid isolation of the vacuum reservoir (410, 412, 414, 416) from an exterior of the probe (20). For example, gear (310) is typically exposed to the exterior of probe (20) to mesh with gear (34) of case (30). At the same time, the gear (312) is disposed inside the upper (22) and lower (24) probe housings and is thus fluidly isolated from the exterior of the probe (20). The seal (315) provides fluid isolation between the gears (310, 312) by sealingly engaging the shaft (314). Thus, the gears (310) are configured to drive rotation of the gears (312) at atmospheric pressure, while the gears (312) are exposed to a vacuum pressure that does not create any fluid leakage paths between the gears (310, 312). Thus, the gears (310, 312) may together provide power to the cutter actuation assembly (300) from the casing (30) without substantially interfering with the operation of the vacuum reservoir (410, 412, 414, 416).

Fig. 7 provides an exemplary view of the vacuum flow through the probe (20). It can be seen that the vacuum is provided by the housing (30) at the port (26). Vacuum is then drawn through port (26) and into vacuum reservoir (416), where the vacuum can freely circulate within vacuum reservoir (416). The vacuum may then freely enter the vacuum reservoir (414) through an opening (434) in the inner wall (430) adjacent the vacuum reservoir (416). Vacuum may also circulate freely within the vacuum reservoir (414). The vacuum may then freely enter the vacuum reservoir (412) through an opening (434) in the inner wall (430) between the vacuum reservoir (414) and the vacuum reservoir (412). The vacuum may then circulate freely within the vacuum reservoir (412). Vacuum may then freely enter the vacuum reservoir (410) through an opening (432) in the inner wall (430) between the vacuum reservoir (412) and the vacuum reservoir (410). The vacuum may then circulate freely within the vacuum reservoir (412).

Once the vacuum has passed through all of the vacuum reservoirs (410, 412, 414, 416), the vacuum may pass through openings (432) in the inner wall (430) adjacent the tissue sample holder (40) and into the tissue sample holder (40). Vacuum may be passed from the tissue sample holder (40) into the cutter (60), where it may travel through the cutter (60) to draw a tissue sample through the lateral aperture (150) during a sampling sequence. The cutter (60) may then sever the tissue sample, and a vacuum may be used to transport the severed tissue sample through the cutter (60) and into the tissue sample holder (40). The sampling sequence may then be repeated as necessary to collect a plurality of tissue samples within the tissue sample holder (40).

It should be appreciated that the above-described sampling sequence may produce a variable vacuum flow rate at various stages of the sampling sequence. For example, during aspiration of a tissue sample through the lateral orifice (150), the vacuum flow rate may be relatively high. The vacuum flow rate may also be relatively high during the transport of the severed tissue sample through cutter (60). In other cases, the vacuum flow may be relatively low at other stages, such as during severing of a tissue sample. In other cases, such as during retraction of the cutter (60) relative to the lateral port (150), the vacuum flow may be relatively moderate or nominal. Thus, it should be appreciated that periods of relatively high vacuum flow may result in relatively high vacuum volume consumption, while periods of relatively low vacuum flow may result in relatively low vacuum volume consumption. Nevertheless, in all these phases, the casing (30) provides a continuous vacuum flow, regardless of the specific phase of the sampling sequence. Thus, cutter (60) and tissue sample holder (40) may be aspirated on vacuum reservoirs (410, 412, 414, 416) to consume more or less of the volumetric vacuum without exceeding the continuous vacuum flow provided by casing (30). Overall, this results in a more continuous vacuum pressure over time.

The particular amount of volume provided by the vacuum reservoir (410, 412, 414, 416) may vary depending on the particular configuration of the vacuum reservoir (410, 412, 414, 416). Although the vacuum reservoirs (410, 412, 414, 416) may be configured in a variety of ways to provide a variety of specific volumes, the present example is configured to provide a volume of about 10 to 20 times relative to a vacuum system directly connected to the tissue sample holder (40). In some examples, the vacuum reservoirs (410, 412, 414, 416) collectively provide a volume that is 10 to 20 times the volume of the tissue sample holder (40). In other examples, the vacuum reservoirs (410, 412, 414, 416) collectively provide a volume of about 175 cc. Of course, one of ordinary skill in the art will appreciate in view of the teachings herein that various other alternative volumes may be used.

Fig. 8 schematically depicts the above principle. In particular, fig. 8 shows an algorithm (500) that includes movement of the cutter (60) relative to the cannula (120), the algorithm being represented by a graphical representation (510) that includes a graphical representation (520) of the lateral orifice (150). The movement of cutter (60) is shown in line (530) for the entire range of travel of cutter (60). Line (540) represents the pneumatic state of the valve assembly (200) during a tissue sampling sequence.

Lines (550) and (560) show the pneumatic state of the lumen extending through cutter (60). Here, separate lines are provided to provide a comparison between this example and an example without vacuum reservoirs (410, 412, 414, 416) (e.g., directly supplying vacuum to tissue sample holder (40)). For example, line (550) shows an example of vacuum pressure over time in an example without vacuum reservoirs (410, 412, 414, 416).

It can be seen that the vacuum pressure shown by line (550) varies substantially over time. These variations in vacuum pressure are caused by variations in the volumetric consumption of the increased vacuum throughout the sampling sequence, resulting in an overload of the continuous vacuum pressure supplied by the casing (30). In contrast, line (560) shows the change in vacuum pressure over time in this example including vacuum reservoirs (410, 412, 414, 416). It can be seen that the vacuum pressure is substantially stable over time due to the additional volume provided by the vacuum reservoir (410, 412, 414, 416) for expansion and contraction of the vacuum. Thus, it should be appreciated that the vacuum reservoirs (410, 412, 414, 416) in this example are configured to generally provide a vacuum pressure smoothing effect over time. This effect is generally desirable for increased response time, improved tissue sample delivery, collection of larger tissue samples, and more consistent and reliable operation of biopsy device (10). While lines (550, 560) show certain specific frequencies and amplitudes of vacuum pressure over time, it should be understood that in other examples, the frequencies and amplitudes of vacuum pressure over time may vary depending on various conditions. Indeed, it should be understood that the lines (550, 560) are primarily used to illustrate the conceptual differences described above.

It should be understood 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. Thus, and where necessary, the disclosure as explicitly set forth herein takes precedence over 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.

Embodiments of the devices disclosed herein may be designed to be disposed of after a single use, or they may be designed for multiple uses. In either or both cases, the embodiments can be reconstituted for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, subsequent cleaning or replacement of particular pieces, and subsequent reassembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting reconstituted device are all within the scope of the present application.

By way of example only, embodiments described herein may be processed prior to surgery. First, new or used instruments can be obtained and cleaned as needed. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container (e.g., a plastic or TYVEK bag). The container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma rays, x-rays, or high energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container may keep the instrument sterile until the sealed container is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

V. exemplary combination

The following examples are directed 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 limit the scope of coverage of any claims that may be presented in this or a later application of this application at any time. There is no disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Thus, no aspect or feature mentioned below should be considered critical unless the inventors or successors of interest to the present invention expressly state otherwise at a later date. If any claim including additional features than those mentioned below is made in this application or in a subsequent submission relating to this application, then for any reason relating to patentability, it should not be assumed that those additional features have been added.

Example 1

A probe for use with a biopsy device having a tissue sample holder defining a sample chamber and a hub removably secured to the probe, the probe comprising a housing defining a vacuum chamber within the housing, wherein the vacuum chamber is in communication with the sample chamber of the tissue sample holder.

Example 2

The probe of embodiment 1, further comprising a cutter for severing a tissue sample, wherein the cutter extends through the vacuum chamber and is in communication with the tissue sample holder.

Example 3

The probe of embodiment 1, further comprising a cutter driver and a cutter for severing a tissue sample, wherein the cutter driver is configured to translate and rotate the cutter, wherein both the cutter driver and the cutter are partially disposed within the vacuum chamber.

Example 4

The probe of any one or more of embodiments 1 to 3, wherein the vacuum chamber comprises four fluid reservoirs separated by a plurality of interior walls.

Example 5

The probe of any one or more of embodiments 1-3, wherein the vacuum chamber comprises a plurality of fluid reservoirs separated by one or more inner walls extending axially, laterally, or a combination thereof within the probe.

Example 6

The probe of any one or more of embodiments 1-5, wherein the vacuum chamber defines a first volume, wherein the first volume is greater than a second volume defined by the tissue sample holder.

Example 7

The probe of any one or more of embodiments 1-5, wherein the vacuum chamber defines a first volume, wherein the first volume is 10 to 20 times greater than a second volume defined by the tissue sample holder.

Example 8

The probe of any one or more of embodiments 1 to 7, wherein the housing of the probe comprises an upper housing and a lower housing coupled together and defining an interface, wherein the interface is substantially free of sharp edges.

Example 9

The probe of any one or more of embodiments 1 to 7, wherein the housing of the probe comprises an upper housing and a lower housing coupled together and defining an interface, wherein the lower housing is self-centering relative to the upper housing.

Example 10

The probe of any one or more of embodiments 1 to 9, further comprising a first gear and a second gear rotatably connected by a shaft, wherein the first gear is exposed with respect to an exterior of the housing, wherein the second gear is disposed within the vacuum chamber and sealed with respect to the exterior of the housing by a seal engaged with the shaft.

Example 11

A handheld, cordless biopsy device for collecting one or more tissue samples, wherein the biopsy device comprises: a casing having a motor and a vacuum pump coupled to the motor; a probe removably coupled to the casing, wherein the probe includes a housing having a vacuum port in communication with the vacuum pump of the casing, wherein the housing defines a vacuum reservoir in communication with the vacuum port; and a tissue sample holder defining a sample chamber configured to receive a tissue sample therein, wherein the sample chamber is in communication with the vacuum reservoir of the probe.

Example 12

The biopsy device of embodiment 11, wherein the vacuum reservoir comprises a plurality of containers separated by one or more interior walls and interconnected by an opening disposed within each of the one or more interior walls.

Example 13

The biopsy device of embodiment 11 or 12, wherein the probe further comprises a cutter and a cutter driver configured to translate and rotate the cutter, wherein at least a portion of the cutter and the cutter driver are disposed within the vacuum reservoir.

Example 14

The biopsy device of embodiment 11 or 12, wherein the probe further comprises a cutter and a cutter driver configured to translate and rotate the cutter, wherein at least a portion of the cutter and the cutter driver are disposed within the vacuum reservoir, wherein the opening of at least one of the one or more inner walls is configured to receive the cutter and a portion of the cutter driver while providing fluid flow between two of the plurality of fluid reservoirs.

Example 15

The biopsy device of any one or more of embodiments 11-13, wherein the probe further comprises a valve assembly configured to provide selective venting to a portion of the probe, wherein the valve assembly is fluidly isolated from the vacuum reservoir.

Example 16

The biopsy device of any one or more of embodiments 11-13, wherein the probe further comprises a vent chamber and a valve assembly disposed within the vent chamber and configured to provide selective venting to a portion of the probe, wherein the vent chamber is fluidly isolated from the vacuum reservoir.

Example 17

The biopsy device of any one or more of embodiments 11-13, wherein the probe further comprises a valve assembly configured to provide selective venting to a portion of the probe, wherein the valve assembly is fluidly isolated from the vacuum reservoir while also being disposed within a portion of the vacuum reservoir.

Example 18

The biopsy device of any one or more of embodiments 11-17, wherein the vacuum reservoir defines a total fluid volume of about 175 cc.

Example 19

The biopsy device of any one or more of embodiments 11-17, wherein the housing of the probe comprises a first housing and a second housing, wherein the first housing and the second housing are configured to couple together to seal the vacuum reservoir from the exterior of the probe.

Example 20

The biopsy device of any one or more of embodiments 11-19, wherein the vacuum pump is continuously driven by the motor.

Example 21

A method for use with a biopsy device having a probe, a tissue sample holder, and a sheath, the method comprising: inserting the needle of the probe into tissue; translating a cutter distally within the needle to sever a tissue sample; the vacuum pressure supplied by the vacuum pump within the casing is drawn from a vacuum reservoir defined by the housing of the probe to deliver the severed tissue sample through the cutter and into the tissue sample holder.

Example 22

The method of embodiment 21, wherein the step of drawing the vacuum pressure comprises supplying a continuous flow of vacuum from the vacuum pump of the enclosure to the vacuum reservoir.

Example 23

The method of embodiment 22, wherein the vacuum pressure in the step of drawing the vacuum pressure is substantially continuous as the severed tissue sample is conveyed through the cutter.

Example 24

The method of any one or more of embodiments 21-23, further comprising translating the cutter proximally within the needle after delivering the severed tissue sample through the cutter; and drawing another vacuum pressure from the vacuum reservoir provided by the vacuum pump within the casing as the cutter translates proximally.

Example 25

The method of embodiment 24, wherein the another vacuum pressure is substantially the same as the vacuum pressure supplied during delivery of the severed tissue sample.

While various embodiments of the present invention have been shown and described, 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 such potential modifications have been mentioned, and others will be apparent to those of ordinary skill in the art. For example, the above examples, embodiments, geometries, materials, dimensions, proportions, steps, and the like are illustrative and not required. The scope of the present invention should, therefore, be determined with reference to the appended claims, and should not be limited to the details of construction and operation shown and described in the specification and drawings.