Vacuum vent and fluid biopsy system and method

Abstract

A vacuum vent and fluid delivery biopsy system includes a collection cannister and a biopsy device. The collection cannister is configured to retain tissue collected from a body with the biopsy device while preventing air from contacting the tissue. The biopsy device is configured to deliver the tissue to the collection cannister responsive to a vacuum being applied to the biopsy device. The biopsy device includes an outer cannula moveable along an axis to enter into the body and to at least partially remove the tissue from the body. The biopsy device further includes an inner cannula including a sampling aperture configured to cooperate with the outer cannula to sever, retain, and remove the tissue. The inner cannula delivers the tissue through the biopsy device and to the collection cannister responsive to the vacuum being applied to the biopsy device.

Description

VACUUM VENT AND FLUID BIOPSY SYSTEM AND METHODRELATED APPLICATIONS[00011 This application claims priority to and all the benefits of U.S. Provisional Patent Application No. 63 / 603,422, filed November 28, 2023, the contents of which are hereby incorporate by reference herein in their entirety.BACKGROUND

[0002] A biopsy is generally known as procedure to remove tissue or a sample from a human body, animal, etc. The removed sample may be tested in a laboratory for further examination and diagnosis. Traditional tissue biopsies have been used to identify abnormalities within the tissue of the organ based upon architectural, structural, or morphological changes to the tissue rather than biological changes. As our understanding of disease state creation and progression in the human body have advanced, it is now additionally advantageous to understand the biological changes occurring as well. In one example, a biopsy device may be used to extract the tissue to examine the molecular state and biological activity of the removed tissue. In this regard, it is possible to determine not only if a patient has cancerous or non-cancerous cells but also genetic alterations that have occurred via protein and Ribonucleic acid (RNA) changes, which may be used to better define more targeted therapies to mitigate the progression of the disease or possibly even provide a cure.[0003) However, adverse environmental factors such as air, temperature and time can and do impact biological factors of tissues when removed from their natural substrate within the body. For example, air is an oxidizing agent and not found within the microenvironment of a tumor bed. Thus, if the sample or removed tissue is exposed to air, the biological activity may be altered and the molecular state of the removed sample changed, which jeopardizes the biological integrity and informational content of the tissue sample. In this case, the results of the biopsy may not be accurate or reliable.SUMMARY

[0004] According to an exemplary aspect, a vacuum vent and fluid delivery system is provided. The system includes a collection cannister and a biopsy device. The collection cannister is configured to retain tissue collected from a body while preventing air from contacting the tissue. The biopsy device is operably coupled to the collection cannister and configured to deliver the tissue to the collection cannister responsive to a vacuum being applied to the biopsy device. The biopsy device includes an outer cannula moveable along an axis to enter into the body and to at least partially remove the tissue from the body. The biopsy device further includes an inner cannula including a sampling aperture cooperating with the outer cannula to sever, retain and remove the tissue. The inner cannula delivers the tissue through the biopsy device and to the collection cannister responsive to the vacuum being applied to the biopsy device.

[0005] According to an exemplary aspect, an apparatus comprising a biopsy device is provided. The biopsy device includes an outer cannula and an inner cannula. The outer cannula is moveable along an axis to enter into a body and to at least partially remove the tissue from the body. The inner cannula includes a sampling aperture cooperating with the outer cannula to remove the tissue. The inner cannula delivers the tissue to a collection cannister in response to a vacuum being applied by a vacuum source.

[0006] According to an exemplary aspect, a biopsy device configured to be coupled to a collection canister and a vacuum source for applying suction to the biopsy device is provided. The biopsy device includes an outer cannula. The device also includes an inner cannula at least partially disposed within the outer cannula and moveable relative to the outer cannula along an axis between a first position and a second position. The inner cannula includes a sampling aperture configured to cooperate with the outer cannula to sever and collect tissue. The movement of the inner cannula relative to the outer cannula along the axis from the first position to the second position is configured to route suction from the vacuum source to the sampling aperture to draw the tissue from the sampling aperture through the inner cannula and out to the collection canister.

[0007] According to an exemplary aspect, a biopsy device configured to be coupled to a collection canister is provided. The biopsy device includes an outer cannula. The biopsy device also includes an inner cannula at least partially disposed within the outer cannula,the outer cannula being moveable relative to the inner cannula along an axis between a first position and a second position. The inner cannula includes a sampling aperture configured to cooperate with the outer cannula during moving from the first position to the second position to sever and collect tissue. The movement of the outer cannula relative to the inner cannula along the axis from the first position to the second position is configured to couple the sampling aperture to a source of storage media to be drawn through the inner cannula with the tissue and delivered to the collection canister by the suction from the vacuum source.(0008] According to an exemplary aspect, a biopsy device includes an outer cannula and an inner cannula at least partially disposed within the outer cannula, the outer cannula being moveable relative to the inner cannula along an axis between a first position and a second position. The inner cannula includes a sampling aperture configured to cooperate with the outer cannula during moving from the first position to the second position to sever and collect tissue. The outer cannula includes a distal end portion having a distal edge and a proximal edge, the distal edge and the proximal edge defining an aperture through which the inner cannula extends. The sampling aperture is fixed in a radially offset position from the distal edge of the aperture relative to the axis.(0009] According to an exemplary aspect, a biopsy device includes an outer cannula and an inner cannula at least partially disposed within the outer cannula and including a sampling aperture configured to cooperate with the outer cannula to sever and collect tissue. The inner cannula is moveable relative to the outer cannula along an axis from a first position to a second position to expose the sampling aperture to the tissue. The outer cannula is moveable relative to the inner cannula along the axis from a third position to a fourth position when the inner cannula is in the second position to cooperate with the sample aperture to sever the tissue.(0010] According to an exemplary aspect, a collection canister configured to be coupled to a vacuum source and a biopsy device for suctioning tissue from the biopsy device for storage in the collection canister is provided. The collection canister includes a storage vessel defining a volume for receipt and collection of tissue and storage media from the biopsy device. The canister also includes a cap releasably couplable to the storage vessel, the cap defining a tissue delivery aperture configured to be coupled to a tissue sample linefrom the biopsy device and a vacuum aperture configured to be coupled to a vacuum line from the vacuum source. The canister also includes a filter attached to the cap and in fluid communication with the vacuum aperture, the filter defining a channel including a proximal end portion in fluid communication with the vacuum aperture and a distal end portion in fluid communication with the volume of the storage vessel. The canister also includes a floating member disposed within the channel and configured to move along the channel to seal off the vacuum aperture based on an ammount of the tissue and storage media collected in the volume.(0011] According to an exemplary aspect, a method for collecting tissue from a body is provided. The method includes applying a vacuum to a biopsy device to collect tissue from a body and moving a first cannula relative to a second cannula to sever the tissue from the body. The method further includes transferring the severed tissue from the body in response to the vacuum being applied to the biopsy device.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Aspects of the present disclosure are pointed out with particularity in the appended claims. However, other features of the various aspects will become more apparent and will be best understood by referring to the following detailed description in conjunction with the accompany drawings in which:

[0013] FIG. 1 depicts a vacuum vent and fluid delivery system according to an exemplary aspect.

[0014] FIG. 2 depicts an exploded view of a biopsy according to an exemplary aspect.(0015] FIG. 3 depicts a biopsy device in a ready position state according to an exemplary aspect.

[0016] FIG. 4 depicts an inner cannula receiving body of a biopsy device when in a ready position state according to an exemplary aspect.

[0017] FIG. 5 depicts a media plenum of a biopsy device when in a ready position state according to an exemplary aspect.

[0018] FIGS. 6A and 6B depict a top view and a bottom view of a base of a biopsy device, respectively, according to an exemplary aspect.|0019] FIG. 7 depicts a bottom view of a slider body of a biopsy device according to an exemplary aspect.

[0020] FIG. 8 depicts a partial cross-sectional perspective view of a slider body, base, and actuation plunger of a biopsy device when in a ready position state according to an exemplary aspect.

[0021] FIG. 9 depicts a biopsy device when in an exposed position state according to an exemplary aspect.

[0022] FIG. 10 depicts an inner cannula receiving body of a biopsy device when in an exposed position state according to an exemplary aspect.

[0023] FIG. 11 depicts a biopsy device when in a fired position state according to an exemplary aspect.

[0024] FIG. 12 depicts a media plenum of a biopsy device when in a fired position state according to an exemplary aspect.

[0025] FIG. 13 depicts a partial cross-sectional view of inner and outer cannulas of a biopsy device when in a fired position state according to an exemplary aspect.

[0020] FIG. 14 depicts a partial cross-sectional view of a slider body, base, and actuation plunger of a biopsy device when in a fired position state according to an exemplary aspect.

[0027] FIG. 15 depicts a configuration of an inner cannula and an outer cannula of a biopsy device according to an exemplary aspect.

[0028] FIG. 16 depicts another configuration of an inner cannula and an outer cannula of a biopsy device according to an exemplary aspect.

[0029] FIG. 17 depicts sealing elements of an outer cannula receiving body and media plenum of a biopsy device according to an exemplary aspect.

[0030] FIG. 18 depicts an outer cannula receiving body of a biopsy device according to an exemplary aspect.

[0031] FIG. 19 depicts an alternative outer cannula receiving body of a biopsy device according to an exemplary aspect.|0032] FIG. 20 depicts a collection canister according to an exemplary aspect.

[0033] FIG. 21 depicts a cap and filter of a collection cannister according to an exemplary aspect.

[0034] FIG. 22 depicts a cap and fdter of a collection cannister with a mesh removed from the filter according to an exemplary aspect.

[0035] FIG. 23 depicts a cap and a filter barrel of a collection cannister according to an exemplary aspect.

[0036] FIGS. 24 A and 24B further depict a filter barrel of a collection cannister according to an exemplary aspect.

[0037] FIG. 25 depicts an alternative view of a cap and filter cap of a collection cannister according to an exemplary aspect.

[0038] FIG. 26 depicts an internal volume of a storage vessel of a collection cannister according to an exemplary aspect.

[0039] FIG. 27 depicts a method for operating a vacuum vent and the fluid delivery system according to an exemplary aspect.DETAILED DESCRIPTION

[0040] As required, detailed aspects are disclosed herein; however, it is to be understood that the disclosed aspects are merely exemplary and may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

[0041] It is generally recognized that tissue biopsies have become increasingly molecular in nature. Thus, the profiling of collected tissue from biopsy devices is gaining significant interest. Under a molecular analysis, it is desirable for the tissue be in a high biological and efficacity condition. To this end, it is also desirable to preserve the tissue as it was in the body from the molecular standpoint to the point in which the collected tissue is later examined and assessed from a chemical perspective. In other words, it is desirable to have an overwhelming match between the tissue while within the body and the tissue after removal and collection from the body for diagnostic purposes.

[0042] Degradation is a concern when examining tissues that are removed from the body. One potential problem is, for example, that once the tissue is removed from the body, thedegradation to such tissue occurs almost immediately, such as from exposure to atmosphere. Traditional biopsy devices inherently enable exposure to the atmosphere. The removed tissue may be inserted in storage media (or fluid) such as, for example, Formalin. In the case of the use of Formalin, the storage medium is designed to protect and fix the architectural / morphological structure of the removed tissue, but it also alters and generally renders the removed tissue biologically inactive from a chemical perspective. If the removed tissue is stored in a biologically friendly media, such as in a saline (e.g., phosphate-buffered saline PBS), lactated ringer, or even specially formulated cocktails which target the biological preservation of specific elements such as protein, RNA, inter and intra cellular signaling, etc., it is possible to maintain the biological efficacy of the tissue as if the tissue was still within the body.

[0043] Described herein are tissue cutting devices (or biopsy devices) that are suited for surgical applications. While the biopsy devices may be used in connection with neurosurgical applications such as the removal of spine and brain tissue, it is understood that the disclosed biopsy devices may not be limited to these applications and may be applicable to other surgical applications and treatment protocols.

[0044] A biopsy device according to an exemplary aspect may be configured to provide media to removed tissue to help keep the removed tissue intact physically and architecturally as the removed tissue traverses through the biopsy device and back to a collection cannister, and also help the tissue avoid undesired contact with external fluids such as air. The media may also preserve the integrity of the collected tissue under different desired or predetermined temperatures. The media may also replace the volumes within the biopsy device occupied by the tissue, thus allowing the free flow of the collected tissue in the media to be delivered to the collection cannister.

[0045] A biopsy device according to an exemplary aspect may also be configured to be placed in various states. A vacuum may be continuously applied to the biopsy device, or more particularly to an inner cannula of the biopsy device, during transition of the device through the various states. In the ready position states, both an inner cannula and outer cannula of the biopsy device may be disposed in a retracted position. A sharp cutting tip defined at the distal end portion of the inner cannula may extend distally from the outer cannula in this state so as to pierce through tissue. Additional or alternatively, a samplingaperture of the inner cannula disposed at the distal end portion of the inner cannula may be covered by the outer cannula in this state. On transition the exposed position state, the inner cannula may move relative to the outer cannula and in a distal direction from the retracted position to an extended position, such that the sampling aperture of the inner cannula is positioned distally of a distal end portion of the outer cannula. In this state, vacuum may continue to be applied to the biopsy device, and corresponding entry pathways positioned within the vacuum loop formed by the biopsy device may be sealed to help ensure that air does not pass to the tissue to be removed.(0046] On transition to the fired position state, the outer cannula may move relative to the inner cannula and in the distal direction from the retracted position to an extended position so as to cover the sampling aperture of the inner cannula, and in the process cooperate with the sampling aperture to sever the tissue positioned within the sampling aperture for collection therein. Contemporaneously, media may be flowed to the sampling aperture through a channel formed between the inner and outer cannulas, and suction provided to the inner cannula may move the combined media and tissue back through the inner cannula and toward a collection cannister.(0047] Similar to the biopsy device, a collection cannister according to an exemplary aspect may be considered hermetically sealed such that the combined media and tissue is not exposed to air. The collection cannister may include a filter for removing the media and allow the tissue to pass to a suitable solution for storage and later examination.

[0048] Methods and systems for acquiring and biologically preserving tissue samples for use in diagnosis and the development of personalized medicine regimens are also disclosed. The systems disclosed herein may permit transport of excised tissue samples, while protecting the tissue samples from, for example, adverse environmental stress. These and other aspects will be discussed in more detail below.

[0049] FIG. 1 depicts a perspective view of a vacuum vent and fluid biopsy system (“the system”) 100 in accordance with one exemplary aspect. The system 100 may include a biopsy device 102, a vacuum source 104, and a collection cannister 106. In general, the biopsy device 102 may be configured to remove tissue from a body (e.g., human, animal, etc.). Suction applied to the biopsy device 102 from the vacuum source 104 may beconfigured to draw the removed tissue through the biopsy device 102 and into the collection cannister 106 for storage and preservation.The system 100 may further include a media source 108. A media line 110 may be coupled, or more particularly selectively coupled, to the biopsy device 102 for transferring a media that is in the form of a liquid from the media source 108 to the biopsy device 102. The media source 108 (e.g., vessel, container, etc.) may thus provide the media to the biopsy device 102 via the media line 110. The biopsy device 102 may be configured to mix the received media with the removed tissue for provision to the collection cannister 106. More specifically, a vacuum line 112 may be coupled, or more particularly selectively coupled, between the biopsy device 102 and the vacuum source 104. The vacuum line 112 may be configured to apply suction from the vacuum source 104 to the biopsy device 102 to draw the mixed media and tissue back through the biopsy device 102 and into the collection cannister 106.(0051] The biopsy device 102 may advantageously be considered as hermetically sealed in that the collected tissue as removed from the body has limited or no exposure to contaminating fluid such as air or liquid that is outside of the seal formed by the biopsy device 102. It is advantageous to prevent air from intruding within the collected tissue so as to help prevent degradation of the collected tissue and ensure reliable and accurate diagnostics when performed on the collected tissue. Additionally, sealing of the biopsy device 102 provides for, among other things, an efficient delivery of suction, fluids and flow within a fluidic circuit.(0052 The collection cannister 106 may also be considered hermetically sealed to help ensure that external fluid such as air does not contact the collected tissue once the collected tissue is stored therein. The collection cannister 106 may include a storage medium for storing the collected tissue and / or media. The collection cannister 106 may be configured so that the vacuum source 104 provides the suction to the biopsy device 102 via the vacuum line 112 through the collection cannister 106.|0053] The level of suction may be sufficient to draw the collected tissue sample and media from the media source 108 through the biopsy device 102 and to the collection cannister 106. The configuration and overall functionality performed by the collection cannister 106 will be discussed in more detail below. In some implementations, the vacuum source 104may continuously apply the suction to the biopsy device 102 as the biopsy device 102 is in and transitions between various states, such as the ready position state, exposed position state, and fired position state. The various positions associated with the components of the biopsy device 102 in each state are also described in more detail below.

[0054] FIG. 2 depicts an exploded view of the biopsy device 102 according to an exemplary aspect. As shown in FIGS. 1 and 2, the biopsy device 102 may include a handle assembly 114, a base 116, an inner cannula 118, and an outer cannula 120. The handle assembly 114 may generally form a proximal end portion of the biopsy device 102, and the cannulas 118, 120 may generally form a distal end portion of the biopsy device 102. As used herein, “proximal” may be understood to mean towards the practitioner holding the biopsy device 102, away from the surgical site and / or body to which the biopsy device 102 is applied, and “distal” may be understood to mean away from the practitioner, towards the surgical site and / or body to which the biopsy device 102 is applied.

[0055] The handle assembly 114 may include a handling member 122 and an actuation plunger 124. The handling member 122 and the actuation plunger 124 may be coupled to one another and / or may be integrated with one another, such that the actuation plunger 124 extends distally from and is moveable with the handling member 122 along an axis 126.

[0056] The base 116 may include a grasping member 128 and a holding body 130. The grasping member 128 may define a plurality of openings 131 A, 13 IB that allow the user’s fingers to be inserted therethrough to hold the base 116 while the handle assembly 114 is moved relative to the base 116, such as along the axis 126 and via manipulation of the handling member 122. The holding body 130 of the base 116 may be configured to retain a media plenum 132 of the biopsy device 102 in a fixed longitudinal position relative to the base 116, such that the handle assembly 114 is also moveable relative to the media plenum 132 along the axis 126. The media plenum 132 may be configured to communicate media from the media source 108 to a sampling aperture 134 via the outer cannula 120 to assist in movement and preservation of a tissue sample through the biopsy device 102 and into the collection cannister 106 as described herein.

[0057] The outer cannula 120 and inner cannula 118 each may be insertable into a body to aid in collecting tissue from the body. The inner cannula 118 may be configured to be at least partially disposed within the outer cannula 120, and may be configured to slidablymove longitudinally and bi-directionally relative to the outer cannula 120, such as along the axis 126, and such as via manipulation of the handling member 122. Similarly, the outer cannula 120 may be configured to slidably move longitudinally and bi-directionally relative to inner cannula 118, such as along the axis 126, such as via manipulation of the handling member 122.

[0058] The inner cannula 118 may include a proximal end portion 136 and a distal end portion 138, and may define a lumen 140 extending therebetween. The lumen 140 may be open at the proximal end portion 136 of the inner cannula 118 to receive the vacuum line 112. Conversely, the lumen 140 may closed at the distal end portion 138 of the inner cannula 118. In some implementations, the distal end portion 138 of the inner cannula 118 may define a sharp cutting point to pierce through tissue (see, e.g., FIG. 3).The inner cannula 118 may also define the sampling aperture 134 in a side wall of the inner cannula 118. The sampling aperture 134 may be in fluid communication with the lumen 140, and may be disposed at the distal end portion 138 of the inner cannula 118. The sampling aperture 134 may be configured to cooperate with a distal end portion 142 of the outer cannula 120 to sever and collect the tissue from a body. The distal end portion 142 of the outer cannula 120 may define an angled cutting tip, discussed in more detail below. Contemporaneously with the severing and collection of tissue, media may be provided to a channel formed between the inner cannula 118 and outer cannula 120 via the media plenum 132, and drawn by the suction applied to the biopsy device 102 down the channel to be combined with the tissue collected in the sampling aperture 134. The sampling aperture 134 may thus generally serve as an inlet to enable the tissue and the media to enter the lumen 140 of the inner cannula 118.|OO60] After the tissue and media enters the lumen 140 of the inner cannula 118, suction applied to the lumen 140 from the vacuum source 104 may cause the combined media and tissue to traverse back through the lumen 140 and out of the biopsy device 102 to the collection cannister 106. The media may serve to protect the collected tissue as the collected tissue traverses back through the biopsy device 102 and to the collection cannister 106. Specifically, the media may be provided to the removed tissue to keep the removed tissue intact physically and architecturally as the removed tissue traverses through the biopsy device 102 and back to the collection cannister 106. The media may also preservethe integrity of the collected tissue under different desired or predetermined temperatures. The media may further replace the volumes occupied by the tissue within the biopsy device 102 as the tissue is moved therethrough to the collection cannister 106, thus helping to avoid generation of a negative pressure within the biopsy device 102 that inhibits a free flow of the collected tissue in the media to the collection cannister 106.

[0061] In general, the biopsy device 102 may be configured such that the suction from the vacuum source 104 is applied to the sampling aperture 134 through the length of the inner cannula 118 before and during the moment in which the tissue is collected into the sampling aperture 134 of the inner cannula 118. This suction may then be maintained to pull the removed tissue and media through the biopsy device 102 and to the collection cannister 106.

[0062] The biopsy device 102 may generally be configured so that longitudinal movement of the handle assembly 114 relative to the axis 126 causes corresponding movement of the inner cannula 118 and outer cannula 120 relative to the axis 126 and each other. For instance, according to one aspect, the biopsy device 102 may also include a slider body 144 and a biasing member 146. The slider body 144 may be slidably coupled to the base 116 such that the slider body 144 is slidable relative to the base 116 along the axis 126. A proximal end portion 147 of the outer cannula 120 may be coupled to the slider body 144 so as to be moveable with the slider body 144 along the axis 126.

[0063] For instance, according to one exemplary aspect, the slider body 144 may include an outer cannula receiving body 148 configured to receive the proximal end portion 147 of the outer cannula 120. The outer cannula receiving body 148 may also be configured to fix the outer cannula 120 relative to the slider body 144 so that the outer cannula 120 is moveable with the slider body 144 along the axis 126.

[0064] The outer cannula receiving body 148 may be disposed on a side of the slider body 144 that is opposite a side of the slider body 144 slidably engaged with the base 116. The outer cannula receiving body 148 may include a distal end portion 150 and a proximal end portion 152, and may be configured to receive the proximal end portion 147 of the outer cannula 120 through an opening in the distal end portion 150. It will be appreciated that the outer cannula 120 may not extend completely through the outer cannula receiving body 148. In other words, the outer cannula 120 may not pass through the proximal end portion152 of the outer cannula receiving body 148. The media plenum 132, which may be held distal to the outer cannula receiving body 148, may define a lumen that extends therethrough and is aligned with the outer cannula receiving body 148 so as to enable the outer cannula 120 to extend through the media plenum 132 to the outer cannula receiving body 148.

[0065] The outer cannula 120 may define a lumen 154 extending between and through the proximal end portion 147 and distal end portion 142 of the outer cannula 120. The inner cannula 118 may disposed within the lumen 154 of the outer cannula 120, and may be longer than the outer cannula 120, such that the inner cannula 118 may proximally extend out the proximal end portion 147 of the outer cannula 120 when the biopsy device 102 is assembled. The proximal end portion 136 of the inner cannula 118 may be coupled to the handle assembly 114, or more particularly the handling member 122 of the handle assembly 114, such that the inner cannula 118 may be moveable with the handle assembly 114 along the axis 126. In some implementations, the handle assembly 114, or more particularly the handling member 122 of the handle assembly 114, may define a lumen 156 extending therethrough and through which the proximal end portion 136 of the inner cannula 118 extends, such that at least part of the proximal end portion 136 proximally extends from the handle assembly 114. This proximally extending part may form a coupler for receiving the vacuum line 112 to apply suction to the lumen 140 of the inner cannula 118 as described herein.

[0066] According to one exemplary aspect, the base 116 may also include and / or define an inner cannula receiving body 160 disposed between the slider body 144 and the handling member 122. The inner cannula 118 may extend through and be slidable along the axis 126 relative to the inner cannula receiving body 160, such as upon corresponding movement of the handle assembly 114.

[0067] The biasing member 146, which may be realized as a spring, may be disposed between the slider body 144 and the base 116. The biasing member 146 may be configured to bias the slider body 144, and correspondingly the outer cannula 120, in a distal direction along the axis 126 relative to the base 116. For instance, in one exemplary aspect, the basing member 146 may be disposed between the outer cannula receiving body 148 and the inner cannula receiving body 160. When the biasing member 146 is realized as a spring,the inner cannula 118 may proximally extend from the outer cannula receiving body 148 to the inner cannula receiving body 160 through the spring.As explained in more detail below, the actuation plunger 124 of the handle assembly 114 may include a distal protrusion 162 operatively coupled with to slider body 144. Proximal movement of the handle assembly 114 relative to the base 116 may cause the distal protrusion 162 to slide the slider body 144 in the proximal direction along the axis 126 relative to the base 116, causing compression of the biasing member 146 until the slider body 144 engages a sear mechanism 164 (see, e.g., FIG. 5A) of the base 116 that holds the slider body 144 in a retracted position. The outer cannula 120, which may be coupled to and moveable with the slider body 144, may likewise move in the proximal direction along the axis 126 relative to the base 116 to be held in a retracted position. The inner cannula 118, which may be coupled to and moveable with the handle assembly 114, may likewise move in the proximal direction along the axis 126 relative to the base 116 to a retracted position with such movement of the handle assembly 114. The outer cannula 120 and inner cannula 118 both being in such a retracted position relative to the base 116 may correspond to the biopsy device 102 being in a ready position state.[ (H)691 As described above, according to one exemplary aspect, the biopsy device 102 may be selectively disposed in multiple states, namely a ready position state, an exposed position state, and a fired position state. The ready position state may generally correspond to the state of the biopsy device 102 before entry into the body. In this state, the user may place the biopsy device 102 proximate to the desired tissue that is to be removed. Once at the desired spot, the biopsy device 102 may be selectively transitioned to the exposed position state in which the distal end portion 138 of the inner cannula 118, including the sampling aperture 134, is moved along the axis 126 relative to the outer cannula 120 to distally extend from the distal end portion 142 of the outer cannula 120. Such movement may occur as a result of the handle assembly 114 being distally moved along the axis 126 relative to the base 116, such as from a position corresponding to the ready position state to a position corresponding to the exposed position state.

[0070] After the desired tissue is positioned within the exposed sampling aperture 134, the biopsy device 102 may be selectively transitioned to the fired position state in which the biasing member 146 is released and the outer cannula 120 is distally moved along the axis126 relative to the base 116 to cover the sampling aperture 134 of the inner cannula 118. Such movement may occur as a result of the handle assembly 114 being further distally moved along the axis 126 relative to the base 116 from the position corresponding to the exposed position state to a position corresponding to the fired position state. In such position, the distal protrusion 162 of the actuation plunger 124 may release the sear mechanism 164, causing the outer cannula 120 to snap in the distal direction. This motion may operate to sever and collect the tissue in the sampling aperture 134.[00711 Throughout all of these states, suction from the vacuum source 104 may be applied to the inner cannula 118. Upon severing of the tissue, such suction may draw media and the severed tissue through the inner cannula 118 and out to the collection cannister 106. As noted above, the components of the biopsy device 102 may be configured to sever and collect tissue while preventing external fluid (e.g., air) from reaching the tissue collected by the inner cannula 118 as the biopsy device 102 is selectively transitioned among these states.READY POSITION STATE|(H)72[ FIG. 3 depicts the biopsy device 102 in the ready position state according to an exemplary aspect. In general, to initiate the process of obtaining the tissue from the body, it may be desirable to first place or position the biopsy device 102 in the ready position state. To place the biopsy device 102 in the ready position mode, the handling member 122 may be drawn proximally back along the axis 126 relative to the base 116. In response to the handling member 122 being drawn back relative to the base 116, the inner cannula 118 may move (or slide) proximally along the axis 126 relative to the base 116. Further with the handling member 122 being drawn back relative to the base 116, the spring 146 may compress between the base 116 and the slider body 144, or more particularly between the inner cannula receiving body 160 and the outer cannula receiving body 148, until the slider body 144 engages with the sear mechanism 164 of the base 116, described in more detail below.

[0073] The inner cannula 118 may include a vacuum vent 166. The vacuum vent 166 may be in fluid communication with the lumen 140 of the inner cannula 118, and may be formed in a side wall of the inner cannula 118 that extends along a longitudinal axis of the innercannula 118 between the proximal end portion 136 and distal end portion 138. The vacuum vent 166 may define a fluid pathway generally transverse to a longitudinal axis of the inner cannula 118. The vacuum vent 166 may be generally positioned at the proximal end portion 136 of the inner cannula 118, and / or in a side of the inner cannula 118 that is opposite a side of the inner cannula that faces the base 116.

[0074] When the biopsy device 102 is in the ready position state, the vacuum vent 166 may be disposed, uncovered, between the inner cannula receiving body 160 and the handling member 122. The vacuum vent 166 may thus be exposed to the ambient environment. In this case, the suction provided by vacuum source 104 on the inner cannula 118 may draw fluid (e.g., air) from the ambient environment external to the biopsy device 102 into the vacuum vent 166 and back to the vacuum source 104. It may be recognized that in this state, neither the outer cannula 120 nor the inner cannula 118 may have yet been inserted into a body.(0075] FIG. 4 illustrates a detailed view of the inner cannula receiving body 160 according to an exemplary aspect when the biopsy device 102 in the ready position state. As shown in the illustrated example, the inner cannula receiving body 160 may include a sealing element 168 configured to seal the vacuum vent 166 when the inner cannula 118 is positioned thereunder (e.g., in the exposed and fired position states). A cap 170, such as a plug, may also be provided at a proximal end portion of the inner cannula receiving body 160 to further mitigate air flow to the sealing element 168. Generally, when the biopsy device 102 is not in the ready position state, the vacuum vent 166 may be positioned under (or within) the sealing element 168 to close the vacuum being applied to the inner cannula 118.

[0076] FIG. 5 illustrates a detailed view of the media plenum 132 of the biopsy device 102 according to an exemplary aspect when the biopsy device 102 is in the ready position state. The media plenum 132 may include a proximal end portion 172 and a distal end portion 174 opposite the proximal end portion 172. A proximal end portion cap 176 may be positioned on the proximal end portion 172 of the media plenum 132, and a distal end portion cap 178 may be positioned on the distal end portion 174 of the media plenum 132. Each of proximal end portion cap 176 and the distal end portion cap 178 may include a central opening to enable the outer cannula 120 to pass therethrough. The proximal endportion cap 176 and the distal end portion cap 178 may be fixed to the media plenum 132 via interference fit, adhesive, ultrasonic welding, etc.

[0077] A proximal sealing element 180 may be positioned within the media plenum 132 adjacent to the proximal end portion cap 176, and a distal sealing element 182 may be positioned adjacent to the distal end portion cap 178. The proximal end portion cap 176 may hold the proximal sealing element 180 in place within the media plenum 132, and the distal end portion cap 178 may hold the distal sealing element 182 in place within the media plenum 132. Each of the proximal sealing element 180 and the distal sealing element 182 may include an additional portion that is smaller in diameter for assembly purposes. The utilization of the proximal end portion cap 176, the proximal sealing element 180, the distal end portion cap 178, and the distal sealing element 182 may provide the added measure of preventing air or fluid intrusion into the media plenum 132. Similarly, the proximal end portion cap 176 and the distal end portion cap 178 may prevent media from leaking outwardly from the media plenum 132.

[0078] The media plenum 132 may further include an inlet 184 disposed between the proximal sealing element 180 and distal sealing element 182. The inlet 184 may be in fluid communication with the volume defined by the media plenum 132 between proximal sealing element 180 and distal sealing element 182, and may be configured to selectively receive the media line 110 so that fluid communicated from the media source 108 is communicated into the volume defined by the media plenum 132 between proximal sealing element 180 and distal sealing element 182.

[0079] The outer cannula 120 may include an opening 186. The opening 186 may be in fluid communication with the lumen 154 of the outer cannula 120, and may be formed in a side wall of the outer cannula 120 that extends along a longitudinal axis of the outer cannula 120 between the proximal end portion 147 and distal end portion 142. The opening 186 may define a fluid pathway generally transverse the longitudinal axis of the outer cannula 120. The opening 186 may be generally positioned at the proximal end portion 147 of the outer cannula 120, and / or on a side of the outer cannula 120 that is opposite a side of the outer cannula 120 that faces the base 116.[O080| When the biopsy device 102 is in the ready position state, the opening 186 may be disposed outside the media plenum 132, or more particularly between the media plenum132 and the outer cannula receiving body 148. As such, media may not flow from the media plenum 132 to the sampling aperture 134.[0(1811 Operation of the handle assembly 114, slider body 144, and base 116 as the biopsy device 102 is placed in the ready position state will now be described according to an exemplary aspect in reference to FIGS. 6-8. FIGS. 6A and 6B illustrate a top view of the base 116 and a bottom view of abase 116, respectively, of the biopsy device 102 according an exemplary aspect. In reference to FIG. 6A, the base 116 may include the sear mechanism 164 and a guiding mechanism 188. The guiding mechanism 188 may generally include a plurality of rails 190A, 190B. The plurality of rails 190A, 190B may be configured to receive the slider body 144 and enable the slider body 144 to move (or slide) along the axis 126 relative to the base 116. The sear mechanism 164 may be flexible and configured to engage with the slider body 144 when slid in a proximal direction relative to the base 116 to a position corresponding to the ready position state. FIG. 6B illustrates an underside of the base 116 in addition to an underside of the sear mechanism 164.|0082j FIG. 7 illustrates a bottom view of the slider body 144 of the biopsy device 102 according to an exemplary aspect. The bottom of the slider body 144 may define a channel 192 extending between a proximal end portion 194 and distal end portion 196 of the slider body 144. The channel 192 may be defined by a recessed surface 198 forming a floor of the channel 192 and a pair of inward facing side walls 200 A, 200B each running between the proximal and distal end portions 194, 196 of the slider body 144 and extending downwards from the recessed surface 198 to form the sides of the channel 192. The channel 192 may be closed at the proximal end portion 194 of the slider body 144 by an inward facing wall 202 running between the side walls 200A, 200B and extending downward from the recessed surface 198. Conversely, the channel 192 may be open at the distal end portion 196 of the slider body 144.[O083| The slider body 144 may further include one or more protrusions 204 each extending outwards from the recessed surface 198 within the channel 192. The protrusions 204 may be disposed generally adjacent the distal end portion 196 of the slider body 144. For instance, as shown in the illustrated example, the slider body 144 may include a pair of protrusions 204A, 204B each extending downward from the recessed surface 198 adjacent the distal end portion 196 of the slider body 144. The protrusions 204A, 204Bmay be disposed opposite one another against different ones of the side walls 200A, 200B forming the channel 192. Each protrusion 204A, 204B may include an inclined proximal surface 206 that slopes outwards from the recessed surface 198 in the distal direction, and a distal wall 208 that extends generally perpendicular from the recessed surface 198.

[0084] As noted above, the slider body 144 may be slidable relative to the base 116. To this end, the slider body 144 may include outer edges 210A, 210B each extending between the proximal and distal end portions 194, 196 of the slider body 144. When the biopsy device 102 is assembled, the outer edges 210A, 210B may be configured to be positioned within the rails 190A, 190B, respectively, which allows the slider body 144 to move along the axis 126 relative to the base 116. The distal protrusion 162 of the actuation plunger 124 may also be disposed within the channel 192 between the wall 202 and the protrusion(s) 204 to effect movement of the slider body 144 relative to the base 116.[0085 FIG. 8 illustrates an interface between the base 116 and the slider body 144 when the base 116 and the slider body 144 are coupled to one another with the biopsy device 102 being in the ready position state. FIG. 8 depicts the slider body 144 without the outer edges 210A, 174B as originally shown in FIG. 7 to help illustrate the manner in which the slider body 144 engages the base 116 in the ready position state. It will be recognized that the outer edges 210A, 174B may be present on the slider body 144.

[0086] As shown in the illustrated example, the distal protrusion 162 of the actuation plunger 124 may be disposed in the channel 192 and slidable within the channel 192 relative to the slider body 144. As the user pulls the handling member 122 in a proximal direction relative to the base 116, the distal protrusion 162 may engage the wall 202 of the slider body 144, and thereby pull the slider body 144 in the proximal direction relative to the base 116 with the movement of the handling member 122 in the proximal direction. Such movement may operate to compress the biasing member 146 between the slider body 144 and the base 116 as described above.

[0087] In addition, as the user continues to pull the handling member 122 in the proximal direction and relative to the base 116, the inclined proximal surface(s) 206 of the protrusion(s) 204 (as positioned on the opposite side of the slider body 144 from the wall 202) may engage a complementary inclined surface 212 of the sear mechanism 164, causing the sear mechanism 164 to deflect downward. Responsive to the protrusion(s) 204of the slider body 144 passing over the inclined surface 212 of the sear mechanism 164, the sear mechanism 164 may deflect upward to engage the distal wall(s) 208 of the protrusion(s) 204 on the slider body 144 to maintain the biasing member 146 in a compressed state, and correspondingly hold the slider body 144 in the ready position.EXPOSED POSITION STA TE

[0088] FIG. 9 illustrates the biopsy device 102 having been transitioned to the exposed position state from the ready position state in accordance with an exemplary aspect. The exposed position state may correspond to the sampling aperture 134 of the inner cannula 118 being exposed and no longer covered by the outer cannula 120. To transition to the exposed position state, the handling member 122 may be pushed distally along the axis 126 relative to the base 116 to initiate the operation of retrieving the tissue in the body. As shown, the inner cannula 118 may slide proximally along the axis 126 within the outer cannula 120 and relative to the base 116 to a position in which the sampling aperture 134 is positioned distally of the distal end portion 142 of the outer cannula 120 and ready to collect the tissue in the body. As noted above, once the user has located the desired spot on the body to remove the tissue, the exposed inner cannula 118 may be advanced into the desired tissue so that the desired tissue is disposed in the sampling aperture 134.

[0089] During transition of the biopsy device 102 to the exposed position state, the distal protrusion 162 of the actuation plunger 124 may move within the channel 192 of the slider body 144 from the wall 202 towards the sear mechanism 164 of the base 116, but not yet fully engage the sear mechanism 164 to release the outer cannula 120.

[0090] The vacuum vent 166 of the inner cannula 118 may be closed in the exposed position state, such that the suction applied from the vacuum source 104 is routed to the sampling aperture 134. FIG. 10 provides a detailed view of the inner cannula receiving body 160 of the base 116 in the exposed position state according to one exemplary aspect. As shown in the illustrated example, the vacuum vent 166 of the inner cannula 118 may have moved within the inner cannula receiving body 160, and may be surrounded by the sealing element 168. The sealing element 168 and the cap 170 may serve to prevent air from flowing into the inner cannula receiving body 160. The cap 170 may retain and / or hold the sealing element 168 in place. In one example, the cap 170 may form aninterference fit with an opening formed in the proximal end portion of the inner cannula receiving body 160 to hold the sealing element 168 in place. In other examples, the cap 170 may be fixed within the inner cannula receiving body 160 via adhesive, ultra-sonic welding or other suitable mechanisms.(00911 In comparison, the general positioning of the outer cannula 120, or more particularly the opening 186 of the outer cannula 120, relative to the media plenum 132 may remain the same between the ready position state and the exposed position state. In other words, such as shown in FIG. 5, the opening 186 of the outer cannula 120 may still be positioned proximal to the proximal end portion 172 of the media plenum 132, such that media is not communicated from the media source 108 to the lumen 154 of the outer cannula 120. During transition to the exposed position mode, the inner cannula 118 may advance relative to the base 116 along the axis 126 in the distal direction while the position of the outer cannula 120 remains in place relative to the base 116.FIRED POSITION STATE

[0092] FIG. 11 illustrates the biopsy device 102 after having been transitioned from the exposed position state to the fired position state in accordance with an exemplary aspect. The fired position state may correspond the outer cannula 120 having advanced along the axis 126 in the distal direction relative to the base 116 to cover the sampling aperture 134 of the inner cannula 118. Such movement may operate to sever tissue disposed in the sampling aperture 134. In the fired position state, the tissue collected in the sampling aperture 134 may be drawn, along with media, proximally through the inner cannula 118 to the collection cannister 106 for storage and subsequent examination. In the fired position state, the biopsy device 102 may maintain a closed fluid loop (or closed vacuum loop) between the vacuum line 112, the media line 110, and the tissue collected by the outer cannula 120 and the inner cannula 118.

[0093] In general, the positioning of the inner cannula 118, or more particularly the vacuum vent 166 of the inner cannula 118, relative to the inner cannula receiving body 160, may remain the same between the exposed position state and the fired position state. In other words, as shown in FIG. 10, the vacuum vent 166 of the inner cannula 118 may remain within the inner cannula receiving body 160 and surrounded by the sealing element168 to create a hermetic seal for preventing air from intruding into the vacuum vent 166. Such position may operate to primarily route the suction provided by the vacuum source 104 to the sampling aperture 134.|(M.I94 In comparison, the position of the opening 186 of the outer cannula 120 relative to the media plenum 132 in the fired position state may have changed from the exposed position state. FIG. 12 illustrates a detailed view of the media plenum 132 of the biopsy device 102 that may correspond the fired position state according to an exemplary aspect. As shown in the illustrated example, the opening 186 of the outer cannula 120 may now be aligned with the inlet 184 of the media plenum 132, such as to receive the media from the media source 108.|W95| FIGS. 12 and 13 further illustrate a fluid flow 220 of media 222 and severed tissue 224 within the biopsy device 102 that may correspond to the fired position state according to an exemplary aspect. The fluid flow 220 may occur under the suction provided to the biopsy device 102 from the vacuum source 104. As described herein, such fluid flow 220 may prevent external fluid such as air from contacting the collected tissue 224 severed from the body and aid in the free flow of the tissue 224 through the biopsy device 102 to the collection cannister 106.

[0096] As shown in the illustrated example, media 222 may flow into the media plenum 132 from the media source 108 via the inlet 184. From there, the media 222 may flow into the opening 186 of the outer cannula 120 and through a channel 226 formed between the outer cannula 120 and the inner cannula 118 toward the sampling aperture 134. In particular, the media 222 may reach the tissue 224 positioned within the sampling aperture 134. For instance, when the channel 226 is flooded with the media 222, the media 222 may be pulled into the sampling aperture 134 by the suction that is being applied and mix with the severed tissue 224.

[0097] The suction provided by the vacuum source 104 may then pull the mixed media and tissue 222, 224 proximally through the inner cannula 118 and out to the collection cannister 106. During such movement the media 222 may replace the volume taken up by the mixed media and tissue 222, 224 so as to aid in the free flow of the tissue 224 to the collection cannister 106. The media 222 may also aid in flushing the collected tissue 224 within the sampling aperture 134 when the collected tissue has an overall diameter that isgreater than an inner diameter of the inner cannula 118. From the biopsy device 102, the mixed media and tissue 222, 224 may enter the vacuum line 112. The vacuum line 112 may then deliver the mixed media and tissue 222, 224 to the collection cannister 106. The biopsy device 102 may help prevent external fluid such as air from intruding into the mixed media and tissue 222, 224 throughout the entire fluid flow 220 while the biopsy device 102 is in the firing position state. Thus, the mixed media and tissue 222, 224 may be examined with less risk of the molecular integrity of the collected tissue 224 being compromised due to the presence of air.(0098] FIG. 14 illustrates an interface between the base 116 and the slider body 144 when the base 116 and the slider body 144 are coupled to one another with the biopsy device 102 being in the fired position state according to an exemplary aspect. As shown in the illustrated example, the handling member 122 may now be positioned directly proximate to the base 116, or more particularly the inner cannula receiving body 160, given that the handling member 122 has been pushed along the axis 126 in the distal direction relative to the base 116. The inner cannula 118 among other components are not shown in FIG. 14 to aid in description. However, as discussed above, it will be recognized that such components may also be present in biopsy device 102 according to the exemplary aspect.(0099] In response to the handling member 122 being moved along the axis 126 relative to the base 116 from a position corresponding to the exposed position state to a distally located position corresponding to the fired position state, the distal protrusion 162 of the actuation plunger 124 may move further distally within the channel 192 of the slider body 144. The distal protrusion 162 may include curved portion 228 disposed on a bottom-distal end portion of the distal protrusion 162 that contacts the sear mechanism 164 during such movement, causing the sear mechanism 164 to flex downward in a direction that may be generally perpendicular to the axis 126. Such contact between the curved portion 228 and the sear mechanism 164 may cause the sear mechanism 164 to disengage from the slider body 144. In response to the sear mechanism 164 disengaging from the slider body 144, the biasing member 146 may cause the slider body 144, and correspondingly the outer cannula 120, to advance distally along the axis 126 relative to the base 116 to cover the sampling aperture 134 of the inner cannula 118. Such movement may also operate to the sever the tissue disposed in the sampling aperture 134.10100] FIG. 15 illustrates a configuration of the inner and outer cannulas 118, 120 according to an exemplary aspect. As shown in the illustrated example, the distal end portion 142 of the outer cannula 120 may include a cutting edge 230 defining an aperture 232 through which a longitudinal axis LA of the outer cannula 120 extends, and through which the inner cannula 118 is configured to extend. The cutting edge 230 may include a distal end portion 234 and a proximal end portion 236 that together define the aperture 232 so as to be angled relative to the longitudinal axis LA of the outer cannula 120.[01011 The inner cannula 118 may include a cutting edge 237 defining a distal end portion 238 of the sampling aperture 134 opposite a proximal end portion 240 of the sampling aperture 134. The cutting edge 237 of the inner cannula 118 and the cutting edge 230 of the outer cannula 120 may have dissimilar angles with respect to the longitudinal axis LA of the inner and outer cannulas 118, 120, which may create a scissor like action between the cutting edges 230, 237 when engaging the tissue therebetween. For instance, the cutting edge 237 of the inner cannula 118 may be generally perpendicular to the longitudinal axis LA, while the cutting edge 230 of the outer cannula 120 may be angled relative to the longitudinal axis LA as described above. The dissimilar angles of the cutting edges 230, 237 may also help eliminate edge collisions between the outer cannula 120 and the inner cannula 118 when transitioning to the fired position state. For example, having the edges of the outer cannula 120 and the inner cannula 118 at different angles may minimize or mitigate the condition in which the edges 230, 237 of the inner and outer cannulas 118, 120 come into contact with each other at more than a single point. If on the other hand the edges 230, 237 of the inner and outer cannulas 118,120 were parallel, such edges may collide along an entire edge simultaneously which may damage the cutting edges.[0.102] As shown in the illustrated example, according to one exemplary aspect, the inner and outer cannulas 118, 120 may be radially positioned relative to each other such that the sampling aperture 134, and / or the cutting edge 237 of the inner cannula 118 defining the distal end portion 238 of the sampling aperture 134, may be aligned with the distal end portion 234 of the cutting edge 230 of the outer cannula 120. In other words, the inner and outer cannulas 118, 120 may be radially positioned relative to each other such that an axis extending between the distal end portion 238 and the proximal end portion 240 of thesampling aperture 134 extends through both a general center of the cutting edge 237 and a general center (e.g., apex) of the distal end portion 234 of the cutting edge 230.[6103 | As illustrated in FIG. 16, according to alternative aspects, the inner and outer cannulas 118, 120 may be radially positioned relative to each other such that the sampling aperture 134, and / or the cutting edge 237 of the inner cannula 118 defining the distal end portion 238 of the sampling aperture 134, is radially offset from each of the distal end portion 234 and proximal end portion 236 of the cutting edge 230 of the outer cannula 120. In other words, the inner and outer cannulas 118, 120 may be radially positioned relative to each other such that an axis extending between the distal end portion 238 and proximal end portion 240 of the sampling aperture 134 extends through a general center of the cutting edge 237, and generally between or at point where the distal and proximal end portions 234, 236 of the cutting edge 230 meet.

[0104] This configuration may help further prevent damaging contact between the cutting edges 230, 237 of the inner and outer cannulas 118, 120, improving the longevity of the biopsy device 102 and the quality of the collected tissue samples. Then the sampling aperture 134 is initially placed against tissue to be collected, such tissue may case the distal end portion 138 of the inner cannula 118 to flex outward from the longitudinal axis LA. As the outer cannula 120 slides over the inner cannula 118 to sever the tissue, the distal end portion 138 of the inner cannula 118 may flex back towards the longitudinal axis LA. In some instances, the movement back to the longitudinal axis LA may be overcompensated such that the distal end portion 138 of the inner cannula 118 passes across the longitudinal axis LA before stabilizing along the longitudinal axis LA. By configuring the inner and outer cannulas 118, 120 with a radial offset as described above, the level of contact between the cutting edges 230, 237 of the inner and cannulas 118, 120 may be reduced relative to the sampling aperture 134, and correspondingly the cutting edge 237 of the inner cannula 118, being radially aligned with the proximal end portion 236 or the distal end portion 234 of the cutting edge 230.

[0105] Referring now to both FIGS. 15 and 16, the distal end portion 138 of the inner cannula 118 may include a sharp angled tip 242 for initially piercing and penetrating the tissue 224 to be removed. According to some aspects, a portion 244 of the outer cannula 120 disposed between the distal end portion 238 of the sampling aperture 134 and thecutting edge 230 may have a smaller outer diameter and / or inner diameter than that of a portion 246 of the outer cannula 120 extending proximally from the portion 244 to the proximal end portion 147 of the outer cannula 120. The portion 244 of the outer cannula 120 may thus be suaged to a smaller diameter relative to the portion 246 to more closely match the outer diameter of the inner cannula 118. The channel 226 may be formed or grooved by a larger radial clearance between the outer cannula 120 and the inner cannula 118 along the portion 246 relative to the portion 244. This arrangement may allow for the desired rate of media flow while maintaining a relatively tight clearance adjacent the cutting edges 230, 237 for optimal cutting action.

[0106] In some examples, the outer cannula 120, or more particularly the portion 246 of the outer cannula 120, may have an outer diameter of 0.0015 inches to provide a gap (or the channel 226) between the inner and outer cannulas 118, 120 for the media. Additionally or alternatively, the portion 244 of the outer cannula 120 proximal the portion 246 may include a smaller diameter to create a smaller clearance between the inner and outer cannulas 118, 120 for cutting or slicing the tissue from the body.SEALS FOR SLIDER ASSEMBL F

[0107] FIG. 17 illustrates a perspective view of a sealing element 252 of the outer cannula receiving body 148 and the proximal sealing element 180 of the media plenum 132 of the biopsy device 102 according to an exemplary aspect. As shown in the illustrated example, the sealing element 252 may include an opening 254 to enable the inner cannula 118 to pass through the sealing element 252. Similarly, the proximal sealing element 180 may include an opening 256 to enable the outer cannula 120 to pass through the proximal sealing element 180. Each of the sealing elements 180, 252 may be configured to help prevent external fluids such as air from entering into the fluid path defined by the biopsy device 102. In some examples, the sealing elements 180, 252 may be realized as O-rings fitted within the lumens defined by the media plenum 132 and outer cannula receiving body 148 respectively.

[0108] FIG. 18 illustrates a side view of the outer cannula receiving body 148 of the biopsy device 102 according to an exemplary aspect. As noted above, media 222 may flow from the media plenum 132 into the channel 226 formed between the outer cannula 120 and theinner cannula 118. The sealing element 252, and all other sealing elements present within the outer cannula receiving body 148, may serve as a barrier to prevent the flow of the media 222 from flowing out of the channel 226 proximally from the outer cannula receiving body 148. Similarly, in reference to FIG. 17, the proximal sealing element 180, and all other sealing elements present within the media plenum 132, may serve as a barrier to prevent the flow of the media 222 from leaking outwardly from the media plenum 132.

[0109] FIG. 19 illustrates an alternative outer cannula receiving body 148 A that may be incorporated into the biopsy device 102 according to an exemplary aspect. As shown in the illustrated example, the outer cannula receiving body 148 A may include a proximal end portion 258 and a distal end portion 260, and define a lumen 262 extending through the proximal and distal end portions 258, 260. The lumen 262 may be configured to receive the proximal end portion 147 of the outer cannula 120 from the distal end portion 260. A sealing element 264, which may be realized as one or more O-rings, may be disposed within the lumen 262 between the proximal end portion 147 of the outer cannula 120 and the proximal end portion 258 of the outer cannula receiving body 148 A.

[0110] A proximal end portion cap 266 may be disposed in the lumen 262 and fixed to the proximal end portion 258 of the outer cannula receiving body 148A to help seal the lumen 262 at the proximal end portion 258 and hold the sealing element 264 in place relative to the lumen 262. The proximal end portion cap 266 may also define a protrusion 268 extending proximally from the outer cannula receiving body 148 for supporting a distal end portion 270 of the spring 146. Each of the sealing element 264 and the proximal end portion cap 266 may define a lumen therethrough for passage of the inner cannula 118. More specifically, the lumens defined by these components may have a diameter larger than an outer diameter of the inner cannula 118 to allow passage of the inner cannula 118 therethrough, but smaller than an outer diameter of the outer cannula 120 to prevent the outer cannula 120 from being slide all the way through the outer cannula receiving body 148A. The outer cannula receiving body 148A may further include a glue well 272 for fixing the proximal end portion 147 of the outer cannula 120 in place within the outer cannula receiving body 148 A.COLLECTION CANNISTER (ASSEMBLY)|0111| FIG. 20 illustrates a perspective view of the collection cannister (or cannister assembly) 106 of the vacuum vent and the fluid biopsy system 100 according to an exemplary aspect. The collection cannister 106 may include a cannister cap 301, a filter cap (or filter) 302, a storage vessel 303, a tissue delivery tube 304, and a seal (or cork) 306. The underside of the cannister cap 301 may be configured to be releasably coupled to the top of the storage vessel 303, such as via threaded engagement. The cannister cap 301 may include a tissue port 312 extending outwardly on a side opposite the storage vessel 303 and defining an open ended lumen in fluid communication with an interior volume of the storage vessel 303. The tissue port 312 may be configured to receive the vacuum line 112 from the biopsy device 102, through which the mixed media and tissue 222, 224 from the biopsy device 102 may be provided to the collection cannister 106 when the biopsy device 102 is in the fired position state. The filter cap 302 may also include a vacuum port 316 extending on the side opposite the storage vessel 303 and defining an open ended lumen in separate fluid communication with the interior volume of the storage vessel 303. The vacuum port 316 may be configured to receive a further vacuum line 320 from the vacuum source 104, by which suction from the vacuum source 104 may be applied to the biopsy device 102 via the vacuum line 112 and collection cannister 106.

[0112] The filter cap 302 may be configured to prevent the collected tissue samples that were previously delivered to the collection cannister 106 from being inadvertently suctioned out of the collection cannister 106, such as in the event fluid should fill the collection cannister 106 beyond a certain limit. To this end, the filter cap 302 may be configured to be disposed within the interior volume of the storage vessel 303 and coupled to the underside of the cannister cap 301, such as to be in fluid communication with the lumen defined by the vacuum port 316. The tissue delivery tube 304 may be in fluid communication with the lumen defined by the tissue port 312, and may be configured to transfer the collected tissue 224 received via the vacuum line 112 to a desired part the interior volume of the storage vessel 303, as described in more detail below. The cork 306 may operate as a reducer for a diameter difference between the lumen defined by the tissue port 312 and a diameter of the vacuum line 112 to maintain a seal therebetween.1'01.13| FIG. 21 illustrates a perspective view of the cannister cap 301 and filter 302 of the collection cannister 106 according to an exemplary aspect. As shown in the illustrated example, the filter 302 may include a filter mesh 324 to preclude the tissue 224 that is included with the media 222 when the mixed media and tissue 222, 224 is received at the collection cannister 106 via the vacuum line 112 from being removed (suctioned out) from the collection cannister 106. The filter 302 may also include a filter barrel 328 that is coupled to an underside of the cannister cap 301 to retain the media 222 that does pass through the filter mesh 324. FIG. 22 illustrates a view of the filter 302 with the filter mesh 324 being removed according to an exemplary aspect. An adhesive may be used to fix or attach the filter mesh 324 to the filter barrel 328. As shown, at least a portion the filter barrel 328 may be recessed within the underside of the cannister cap 301.

[0114] FIGS. 23, 24A, and 24B illustrate further views of the filter barrel 328 of the collection cannister 106 according to an exemplary aspect. As shown in the illustrated example, the filter 328 include a floating member 332 (e.g., valve ball) that floats based on the amount of media 222 that is collected in the filter barrel 328. The filter barrel 328 may define a channel 336 to enable the floating member 332 to move therein based on the amount of media 222 that is retained by the filter 302. The channel 336 may be arranged to have a different diameters and / or configurations. The diameter of the channel 336 may decrease near the top of the filter barrel 328 such that the floating member 332 operates as a seal once the floating member 332 reaches the top of the filter barrel 328, such as to prevent the media 222 from exiting the filter barrel 328 and into the vacuum line 320 responsive to the media 222 completely filing the filter barrel 328. FIG. 23A generally depicts a position of the floating member 332 when no media 222 may present within the filter barrel 328. Thus, in this case, the floating member 332 may positioned at the bottom of the filter barrel 328.

[0115] FIG. 25 illustrates another view of the cannister cap 301 and filter cap 302 of the collection cannister 106 according to an exemplary aspect. The filter cap 302 may be attached to the underside of the cannister cap 301 via an interference fit. FIG. 26 illustrates a view of the storage vessel 303 according to an exemplary aspect. As described above, the tissue delivery tube 304 may be configured to deliver the tissue 224 received via the vacuum line 112 to a collection fluid 370 that is retained in the collection cannister 106.In general, the tissue delivery tube 304 may be configured to deliver the tissue 224 under a surface 371 of the collection fluid 370 to help further ensure that air does not intrude or disturb the collected tissue 224. The collection fluid 370 may be a saline (e.g., phosphate- buffered saline PBS) or other suitable fluid, etc. This condition may also keep the tissue 224 from being damaged by gently slowing the tissue down as the tissue exits the tissue delivery tube 304. Without the liquid, the tissue may splatter or stick onto the wall of the storage vessel 303.

[0116] FIG. 27 depicts a method 400 for operating the vacuum vent and the fluid biopsy system 100. In operation 402, the biopsy device 102 may be placed in a ready position mode. In the ready position mode, the biopsy device 102 may be positioned proximate or adjacent to the desired tissue to be removed. The handling member 122 (or the actuation plunger 124) may be moved in a proximal direction relative to the base 116 thereby exposing the vacuum vent 166 on the inner cannula 118 to atmosphere. In this state, the vacuum source 104 may continue to apply the vacuum to the inner cannula 118 to draw air external to the biopsy device 102 through the vacuum vent 166. In response to the handling member 122 being moved in the proximal direction, the opening 186 of the outer cannula 120 may not be aligned with the inlet 184 of the media plenum 132 and / or disposed within the media plenum 132 so that the media is not provided to opening 186 of the outer cannula 120. Both the inner cannula 118 and outer cannula 120 may also be disposed in a retracted position relative to the base 116. In operation 404, the inner cannula 118 of the biopsy device 102 may be inserted into a desired area (or desired tissue) of interest or inserted into an area adjacent to the desired area (or tissue) of interest.(0117] In operation 406, the biopsy device 102 may be placed in the exposed position state. The handling member 122 (or the actuation plunger 124) may be moved in the distal direction and relative to the base 116, which may operate to extend the inner cannula 118 and the sampling aperture 134 distally of the outer cannula 120 to collect the desired tissue within the sampling aperture 134 (see also FIG. 9). In this state, the vacuum source 104 may continue to apply the vacuum to the inner cannula 118, and the vacuum vent 166 may be positioned within inner cannula receiving body 160 and be covered, closed, and / or sealed by the sealing element 168. Also, the opening 186 of the outer cannula 120 may still not be aligned with the inlet 184 of the media plenum 132 and / or not be disposedwithin the media plenum 132 such that the media is not provided to opening 186 of the outer cannula 120.

[0118] In operation 408, the biopsy device 102 may be placed in the fired position state. For example, the outer cannula 120 may be advanced to cover the sampling aperture 134 of the inner cannula 118 to remove or sever the tissue from the body. In this state, the vacuum source 104 may continue to apply the vacuum to the inner cannula 118, and the vacuum vent 166 may remain positioned within inner cannula receiving body 160 so as to be covered, closed, and / or sealed by the sealing element 168. Also in this state, the opening 186 of the outer cannula 120 may moves distally relative to the base 116 and into the media plenum 132, such as to be aligned with the inlet 184, to receive media from the media line 110. Once the media passes through the opening 186, the media may then flow through the channel 226 formed by, or defined by, the outer cannula 120 and the inner cannula 118 toward sampling aperture 134. Specifically, the channel 226 may be flooded and the media may then be pulled into the sampling aperture 134 by the vacuum that is being applied. The collected tissue and media may then traverse back through the biopsy device 102 in the proximal direction.

[0119] In operation 410, the media and the collected tissue may be delivered from the biopsy device 102 to the collection cannister 106 via to the vacuum line 112. The collection cannister 106 may include the collection fluid 370 configured to directly receive the collected tissue from the vacuum line 112 and help prevent the collected tissue from being exposed to air.(0120] While exemplary aspects are described above, it is not intended that these aspects describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various aspects may be combined to form further aspects of the disclosure.

[0121] It should be understood that one or more steps within a method may be executed in different order (or concurrently) without altering the principles of the present disclosure. Further, although each of the examples is described above as having certain features, any one or more of those features described with respect to any example of the disclosure can be implemented in and / or combined with features of any of the other examples, even if thatcombination is not explicitly described. In other words, the described examples are not mutually exclusive, and permutations of one or more examples with one another remain within the scope of this disclosure.

Claims

What is claimed is:

1. A biopsy device configured to be coupled to a collection canister and a vacuum source for applying suction to the biopsy device, the biopsy device comprising: an outer cannula; and an inner cannula at least partially disposed within the outer cannula and moveable relative to the outer cannula along an axis between a first position and a second position, the inner cannula including a sampling aperture configured to cooperate with the outer cannula to sever and collect tissue, wherein the movement of the inner cannula relative to the outer cannula along the axis from the first position to the second position is configured to cause suction from the vacuum source to be provided to the sampling aperture to draw the tissue from the sampling aperture through the inner cannula and out to the collection canister.

2. The biopsy device of claim 1, wherein the sampling aperture is covered by the outer cannula in the first position and is distal to the outer cannula in the second position.

3. The biopsy device of claim 1 or 2, wherein the inner cannula comprises a vacuum vent that is selectively covered responsive to the movement of the inner cannula relative to the outer cannula along the axis from the first position to the second position.

4. The biopsy device of claim 3, wherein the sampling aperture is located at a distal end portion of the inner cannula and the vacuum vent is located at a proximal end portion of the inner cannula.

5. The biopsy device of claim 3 or 4, further comprising: an inner cannula receiving body through which the inner cannula passes; a seal disposed between the inner cannula receiving body and the inner cannula; and a handle positioned proximal to the inner cannula receiving body and coupled to a proximal end portion of the inner cannula for moving the inner cannula relative to the outer cannula along the axis between the first position and the second position, wherein the vacuum vent is disposedbetween the handle and inner cannula receiving body in the first position and is in engagement with the seal in the second position.

6. The biopsy device of any one of claims 1-5, wherein the outer cannula is moveable relative to the inner cannula along the axis from a third position to a fourth position when the inner cannula is in the second position to cooperate with the sample aperture to sever the tissue.

7. The biopsy device of claim 6, wherein the movement of the outer cannula relative to the inner cannula along the axis from the third position to the fourth position is configured to couple the sampling aperture to a source of storage media.

8. The biopsy device claim 7, wherein the outer cannula comprises a proximal end portion and a distal end portion, defines a lumen extending through the proximal and distal end portions and in which the inner cannula is at least partially disposed, and defines an opening to the lumen between the proximal and distal end portions of the outer cannula, wherein the opening is selectively placed in communication with the source of storage media responsive to the movement of the outer cannula from the third position to the fourth position.

9. The biopsy device of claim 8, wherein the opening is disposed at the proximal end portion of the outer cannula.

10. The biopsy device of claim 8 or 9, further comprising: a media plenum including a port configured to be selectively coupled to the source of storage media and through which the outer cannula passes; and a proximal seal and a distal seal disposed within the media plenum and surrounding the outer cannula, wherein the opening is disposed proximal to the media plenum when the outer cannula is in the third position and is disposed within the media plenum when the outer cannula is in the fourth position.

11. The biopsy device of any one of claims 6-10, further comprising:a biasing member coupled to a proximal end portion of the outer cannula and configured to bias the outer cannula to the fourth position; a sear mechanism configured to releasable hold the biasing member in a compressed configuration such that the outer cannula is held in the third position; and a handle moveable along the axis from a fifth position to a sixth position distal to the fifth position and a seventh position distal to the sixth position, wherein the inner cannula is configured to move from the first position to the second position responsive to the handle being moved from the fifth position to the sixth position, and wherein the sear mechanism is configured to release the biasing member responsive to the handle being moved from the sixth position to the seventh position.

12. The biopsy device of claim 11, wherein the handle is coupled to a proximal end portion of the inner cannula such that the inner cannula moves along the axis with axial movement of the handle, and further comprising: a slider body including an outer cannula receiving body coupled to the proximal end portion of the outer cannula such that the outer cannula moves along the axis with axial movement of the slider body; a plunger including a proximal end portion coupled to the handle such that the plunger moves along the axis with axial movement of the handle; and a base including the sear mechanism and an inner cannula receiving body through which the inner cannula passes, the slider body being slidably coupled to the base with a distal end portion of the plunger being disposed between and slider body and the base, wherein the biasing member is disposed around the inner cannula and between the inner cannula receiving body and the outer cannula receiving body, wherein axial movement handle away from the base causes the plunger to slide the slider body relative to the base in a proximal direction to compress the biasing member and engage a distal end portion of the slider body with the sear mechanism, and wherein axial movement of the handle towards the base causes the plunger to disengage the sear mechanism from the slider body and, responsive to the disengagement, the compressed biasing member to move the outer cannula from the third position to the fourth position.

13. The biopsy device of any one of claims 6-12, wherein the outer cannula includes a distal end portion having a distal edge and a proximal edge, the distal and proximal edges defining an aperture through which the inner cannula extends, and wherein the sampling aperture is fixed in a radially offset position from each of the distal and proximal edges relative to a longitudinal axis of the inner cannula.

14. A biopsy device configured to be coupled to a collection canister, a vacuum source for applying suction to the biopsy device, and a source of storage media, the biopsy device comprising: an outer cannula; and an inner cannula at least partially disposed within the outer cannula, the outer cannula being moveable relative to the inner cannula along an axis between a first position and a second position, and the inner cannula including a sampling aperture configured to cooperate with the outer cannula during moving from the first position to the second position to sever and collect tissue, wherein the movement of the outer cannula relative to the inner cannula along the axis from the first position to the second position is configured to couple the sampling aperture to a source of storage media to be drawn through the inner cannula with the tissue and delivered to the collection canister by the suction from the vacuum source.

15. The biopsy device claim 14, wherein the outer cannula comprises a proximal end portion and a distal end portion, defines a lumen extending through the proximal and distal end portions and in which the inner cannula is at least partially disposed, and defines an opening to the lumen between the proximal and distal end portions of the outer cannula, wherein the opening is selectively placed in communication with the source of storage media responsive to the movement of the outer cannula from the first position to the second position.

16. The biopsy device of claim 15, wherein the opening is disposed at the proximal end portion of the outer cannula.

17. The biopsy device of claim 15 or 16, further comprising: a media plenum including a port configured to be selectively coupled to the source of storage media and through which the outer cannula passes; anda proximal seal and a distal seal disposed within the media plenum and surrounding the outer cannula, wherein the opening is disposed proximal to the media plenum when the outer cannula is in the first position and is disposed within the media plenum when the outer cannula is in the second position.

18. A biopsy device comprising: an outer cannula; and an inner cannula at least partially disposed within the outer cannula, the outer cannula being moveable relative to the inner cannula along an axis between a first position and a second position, and the inner cannula including a sampling aperture configured to cooperate with the outer cannula during the movement from the first position to the second position to sever and collect tissue, wherein the outer cannula includes a distal end portion having a distal edge and a proximal edge, the distal and proximal edges defining an aperture through which the inner cannula extends, and, wherein the sampling aperture is fixed in a radially offset position from each the distal and proximal edges of the relative to a longitudinal axis of the inner cannula.

19. The biopsy device of claim 18, wherein the sampling aperture includes a proximal end portion and a distal end portion and includes an elongated axis extending between the proximal and distal end portions, wherein the elongated axis extends between the distal and proximal edges.

20. A biopsy device comprising: an outer cannula; and an inner cannula at least partially disposed within the outer cannula and including a sampling aperture configured to cooperate with the outer cannula to sever and collect tissue, wherein the inner cannula is moveable relative to the outer cannula along an axis from a first position to a second position to expose the sampling aperture to the tissue, and wherein the outer cannula is moveable relative to the inner cannula along the axis from a third position to a fourth position when the inner cannula is in the second position to cooperate with the sample aperture to sever the tissue.

21. The biopsy device of claim 20, further comprising: a biasing member coupled to a proximal end portion of the outer cannula and configured to bias the outer cannula to the fourth position; a sear mechanism configured to releasable hold the biasing member in a compressed configuration such that the outer cannula is held in the third position; and a handle moveable along the axis from a fifth position to a sixth position distal to the fifth position and a seventh position distal to the sixth position, wherein the inner cannula is configured to move from the first position to the second position responsive to the handle being moved from the fifth position to the sixth position, and wherein the sear mechanism is configured to release the biasing member responsive to the handle being moved from the sixth position to the seventh position.

22. The biopsy device of claim 21, wherein the handle is coupled to a proximal end portion of the inner cannula such that the inner cannula moves along the axis with axial movement of the handle, and further comprising: a slider body including an outer cannula receiving body coupled to the proximal end portion of the outer cannula such that the outer cannula moves along the axis with axial movement of the slider body; a plunger including a proximal end portion coupled to the handle such that the plunger moves along the axis with axial movement of the handle; and a base including the sear mechanism and an inner cannula receiving body through which the inner cannula passes, the slider body being slidably coupled to the base with a distal end portion of the plunger being disposed between and slider body and the base, wherein the biasing member is disposed around the inner cannula and between the inner cannula receiving body and the outer cannula receiving body, wherein axial movement handle away from the base causes the plunger to slide the slider body relative to the base in a proximal direction to compress the biasing member and engage a distal end portion of the slider body with the sear mechanism, and wherein axial movement of the handle towards the base causes the plunger to disengage the sear mechanism from the slider body and, responsive to the disengagement, the compressed biasing member to move the outer cannula from the third position to the fourth position.

23. A collection canister configured to be coupled to a vacuum source and a biopsy device for suctioning tissue from the biopsy device for storage in the collection canister, the collection canister comprising: a storage vessel defining an interior volume for receipt and collection of tissue from the biopsy device; a cap releasably couplable to the storage vessel, the cap defining a tissue delivery port configured to be coupled to a first vacuum line from the biopsy device and a vacuum port configured to be coupled to a second vacuum line from the vacuum source; and a tissue delivery tube defining in fluid communication with tissue delivery port and extending from the tissue delivery port to a bottom of the storage vessel to deposit tissue samples received from the first vacuum line below a surface of storage media included in the interior volume.

24. The collection canister of claim 23, further comprising: a filter attached to the cap and in fluid communication with the vacuum port, the filter defining a channel including a proximal end portion adjacent the vacuum port and a distal end portion disposed within the interior volume of the storage vessel; and a floating member disposed within the channel and configured to move along the channel to seal off the vacuum port based on an ammount of contents in the interior volume.

25. A vacuum vent and fluid delivery system comprising: a collection canister; a vacuum source; and a biopsy device configured to be selectively coupled to the collection canister and to the vacuum source for applying suction to the biopsy device, the biopsy device comprising: an outer cannula; and an inner cannula at least partially disposed within the outer cannula and moveable relative to the outer cannula along an axis between a first position and a second position, the inner cannula including a sampling aperture configured to cooperate with the outer cannula to sever and collect tissue,wherein responsive to the movement of the inner cannula relative to the outer cannula along the axis from the first position to the second position, the biopsy device is configured apply the suction from the vacuum source to the sampling aperture to draw the tissue from the sampling aperture through the inner cannula and out to the collection canister.

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