Device and system for managing a bodily tissue ex vivo

The containment device addresses the fragility and inefficiency of existing ex vivo tissue management systems by using inner and outer body cavities and a lid cavity to maintain temperature control, enhancing tissue preservation and storage duration.

WO2025128811A1PCT designated stage expired Publication Date: 2025-06-19THE GENERAL HOSPITAL CORP
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Patent Information

Application Number
PCT/US2024/059753
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-12-12
Filing Date
2024-12-12
Publication Date
2025-06-19

AI Technical Summary

Technical Problem

Existing devices for managing bodily tissues ex vivo are fragile, expensive, prone to leaks, and can inadvertently injure the tissue due to temperature instability and negative pressure.

Method used

A containment device with a body defining a containment chamber that can receive the bodily tissue, featuring inner and outer body cavities to regulate temperature, and a lid with its own cavity to maintain temperature control, all while being isolated from the surrounding atmosphere.

Benefits of technology

The device effectively maintains the bodily tissue at a predetermined temperature, preventing injury and extending storage duration, while being durable and cost-effective.

✦ Generated by Eureka AI based on patent content.

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Abstract

A containment device for managing a bodily tissue ex vivo includes a body. The body defines a chamber configured to selectively receive the bodily tissue being managed. An inner body cavity is fluidically separate from and located adjacent to a plurality of sides of the chamber. A lid is for selectively closing the chamber. An inner lid cavity is located adjacent to at least one of the plurality of sides of the chamber when the chamber is closed via the lid. The inner lid and body cavities are configured to selectively receive a temperature regulating fluid so as to maintain at least one of the bodily tissue and the chamber at a predetermined temperature. The inner lid and body cavities are each closed to surrounding atmosphere such that the temperature regulating fluid received in the inner lid and body cavities are isolated from the surrounding atmosphere.
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Description

DEVICE AND SYSTEM FOR MANAGING A BODILY TISSUE EX VIVORelated Application

[0001] This application claims priority from U.S. Provisional Application No. 63 / 608,867, filed 12 December 2023, the subject matter of which is incorporated herein by reference in its entirety.Technical Field

[0002] This disclosure generally relates to a containment device for managing a bodily tissue ex vivo. This disclosure also generally relates to an ex vivo bodily tissue management system.Background

[0003] The difficulty of preserving bodily tissues (e.g., organs) ex vivo contributes to the supply of available and / or viable donor bodily tissues not meeting the demand. Experimenting with preservation techniques / devices have led to advances in the field. For example, preservation experiments have led to the realization that supercooling donor organs may greatly increase their storage duration. However, when running such preservation experiments, it is desirable to tightly control the temperature of the ex vivo bodily tissue so as to adequately preserve the ex vivo bodily tissue and not cause significant injury thereto.

[0004] While certain devices (e.g., organ chambers) have been developed with features for helping to control the temperature of the ex vivo bodily tissue, these devices may be fragile (e.g., when formed from glass), expensive, prone to leaks, and / or may inadvertently injure the ex vivo bodily tissue (e.g., due to negative pressure acting on the ex vivo bodily tissue and / or temperature instability).Summary

[0005] In an aspect, alone or in combination with any other aspect, a containment device for managing a bodily tissue ex vivo comprises a body. The body defines a containment chamber configured to selectively receive an entirety of the bodily tissue being managed. The body has an inner body cavity fluidically separate from and located adjacent to a plurality of sides of the containment chamber. A lid is for selectively closing the containment chamber. The lid has an inner lid cavity locatedadjacent to at least one of the plurality of sides of the containment chamber when the containment chamber is closed via the lid. Each of the inner lid cavity and the inner body cavity is configured to selectively receive a temperature regulating fluid so as to maintain at least one of the bodily tissue and the containment chamber at a predetermined temperature. Each of the inner lid cavity and the inner body cavity is closed to surrounding atmosphere such that the temperature regulating fluid received in the inner lid cavity and inner body cavity is isolated from the surrounding atmosphere.

[0006] In an aspect, alone or in combination with any other aspect, the containment chamber is configured to selectively expose bodily tissue therein to a managing fluid.

[0007] In an aspect, alone or in combination with any other aspect, an ex vivo bodily tissue management system comprises a containment device. The containment device comprises at least one body cavity port via which a temperature regulating fluid is selectively circulated into and out from an inner body cavity of the body, and at least one lid cavity port via which the temperature regulating fluid is selectively circulated into and out from an inner lid cavity of the lid. A temperature regulating fluid source is selectively fluidically connected to each of the inner body cavity via the body cavity port and the inner lid cavity via the lid cavity port. The temperature regulating fluid is selectively circulated between the temperature regulating fluid source and the inner body and lid cavities.Brief Description of the Drawings

[0008] For a better understanding, reference may be made to the accompanying drawings, in which:

[0009] Fig. 1 is a perspective top view of a containment device for managing a bodily tissue ex vivo according to one aspect of the present invention;

[0010] Fig. 2 is a cross-sectional view of the aspect of Fig. 1 ;

[0011] Fig. 3 is an exploded view of a portion of the aspect of Fig. 1 ;

[0012] Fig. 4 is a perspective top view of a portion of the aspect of Fig. 1 ;

[0013] Fig. 5 is a detail view of a portion of the aspect of Fig. 4;

[0014] Fig. 6 is a partially exploded view of a portion of the aspect of Fig. 1 ;

[0015] Fig. 7A is an exploded view of a portion of the aspect of Fig. 6;

[0016] Fig. 7B is a bottom view of a portion of the aspect of Fig. 7A;

[0017] Fig. 7C is an exploded view of a portion of the aspect of Fig. 6, including at least one element in an alternative configuration;

[0018] Fig. 8 is a perspective top view of a portion of the aspect of Fig. 1 ;

[0019] Fig. 9 is an exploded view of the aspect of Fig. 8;

[0020] Fig. 10-11 schematically illustrates an ex vivo bodily tissue management system, including the system in an example use configuration and environment;

[0021] Fig. 12 schematically illustrates the aspect of Fig. 10 in another example use configuration;

[0022] Fig. 13 is a perspective top view of the containment device of the aspect of Fig. 1 , including a portion of the containment device in an alternative configuration;

[0023] Fig. 14 is a cross-sectional view of the aspect of Fig. 13;

[0024] Fig. 15 is an exploded view of a portion of the aspect of Fig. 13;

[0025] Fig. 16 is cross-sectional view of the containment device of the aspect of Fig. 1 , including a portion of the containment device in an alternative configuration;

[0026] Fig. 17 is a cross-sectional view of the containment device of the aspect of Fig. 16;

[0027] Fig. 17A is an enlarged view of portion 17A of the aspect of Fig. 17;

[0028] Fig. 18 schematically illustrates the ex vivo bodily tissue management system having the containment device of the aspect of Fig. 16, including the system in an example use configuration;

[0029] Fig. 19 is a perspective top view of the containment device of the aspect of Fig. 1 , including a portion of the containment device in an alternative configuration; and

[0030] Fig. 20 schematically illustrates the aspect of Fig. 12 in an alternative use configuration.Description of Aspects of the Disclosure

[0031] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0032] As used herein, the term “user” can be used interchangeably to refer to an individual who prepares for, assists with, and / or performs the operation of a tool and / or an individual who prepares for, assists with, and / or performs a procedure.

[0033] As used herein, the singular forms “a,” “an” and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” as used herein, can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0034] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0035] As used herein, phrases such as “between X and Y” can be interpreted to include X and Y.

[0036] As used herein, the phrase “at least one of X and Y” can be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time. In contrast, the phrase “at least one of X” can be interpreted to include one or more Xs.

[0037] It will be understood that when an element is referred to as being “on,” “attached” to, “connected” to, “contacting,” etc., another element, it can be directly on, attached to, connected to or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on” or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may not have portions that overlap or underlie the adjacent feature.

[0038] Spatially relative terms, such as “below,” “lower,” “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the Figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the Figures. For example, if a device in the Figures is inverted, elements described as “below” other elements or features would then be oriented “above” the other elements or features.

[0039] It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or Figures unless specifically indicated otherwise.

[0040] The invention comprises, consists of, or consists essentially of the following features, in any combination.

[0041] Figs. 1 -2 illustrate a containment device 100 for managing a bodily tissue ex vivo. As used herein, the term “bodily tissue” refers to any tissue of an organism, including tissue that is suitable for being transplanted into a recipient and tissue that is suitable for being used in scientific research. Bodily tissue can include, for example,muscle tissue, such as, for example, skeletal muscle, smooth muscle, or cardiac muscle. Specifically, bodily tissue can include a group of tissues forming an organ such as, e.g., the skin, lungs, cochlea, heart, bladder, liver, kidney, or other organ. In another example, bodily tissue can include nervous tissue such as, e.g., a nerve, the spinal cord, or another component of the peripheral or central nervous system. In still another example, bodily tissue can include a group of tissues forming a bodily appendage such as, e.g., an arm, a hand, a finger, a thumb, a foot, a toe, or another bodily appendage. The containment device 100 may be used, or used in a system, to help preserve the ex vivo bodily tissue for medical research, analysis (e.g., to assess its viability for transplantation and / or for assessing its viability with a particular recipient), and / or treatment (e.g., treatment prior to a transplantation to enhance the bodily tissue’s viability and / or functionality post-transplantation).

[0042] The containment device 100 includes a body 102. As shown in Figs. 1 -4, the body 102 has an outer body part 304 and an inner body part 306 that is separate from the outer body part 304, though the body 102 may be configured such that the outer and inner body parts 304, 306 are integrally formed together as a single monolithic piece. The outer body part 304 includes a base portion 308 having a first or external base surface 310 that faces longitudinally opposite to and is spaced longitudinally from a second or internal base surface 312. The term “longitudinal” is used herein to indicate a substantially vertical direction, in the orientation of at least Figs. 1 -4, and substantially parallel to the arrow “L” in Fig. 1 . At least one support foot 314 (shown here as four support feet 314) may extend longitudinally from the external base surface 310. The outer body part 304 also includes a wall portion 316 that extends longitudinally from the internal base surface 312 to a longitudinally facing rim 318 of the outer body part 304. The rim 318 is spaced longitudinally from and faces longitudinally opposite to the external base surface 310. The wall portion 316 includes a first or external wall surface 320 that faces laterally opposite to, and is spaced laterally from, a second or internal wall surface 322. The term “lateral” is used herein to indicate one or more directions lying on a plane that extends substantially perpendicularly to the “longitudinal” direction and is substantially parallel to the horizontal direction, in the orientation of Figs. 1 -4.

[0043] The wall portion 316 may be defined by at least one outer body wall 317, where each outer body wall 317 includes the external and internal wall surfaces 320, 322. In the example configuration of Figs. 1 -4, the wall portion 316 includes four outer body walls 317 that together define a substantially square or rectangular configurationfor the wall portion 316. The shape of the wall portion 316 thus may be adjusted as desired by altering the number and / or shape of the outer body walls 317.

[0044] The outer body part 304 may optionally include one or more outer body slots 319 that, as will be described in more detail below, function as a thermal insulator. In the example configuration of Figs. 1 -4, the outer body part 304 includes four outer body slots 319. Each outer body slot 319 in this example configuration extends longitudinally from the external base surface 310 into an associated outer body wall 317 such that at least a portion of each outer body slot 319 is located laterally between the external and internal wall surfaces 320, 322 of its associated outer body wall 317. Therefore, the number of outer body slots 319 may, in certain configurations, directly correspond to the number of outer body walls 317, though, in other configurations, the outer body part 304 may be constructed such that the number of outer body slots 319 is differs from that of the outer body walls 317. Although the outer body slots 319 are each shown as extending inwardly from the external base surface 310, the outer body part 304 may be configured such that at least one of the outer body slots 319 extends inwardly from any other external surface of the outer body part 304. Furthermore, although the outer body slots 319 are shown being “open” to the surrounding atmosphere such that air can flow into / out of the outer body slots 319, at least one of the outer body slots may be isolated from the surrounding atmosphere (e.g., by being spaced from each external surface of the outer body part 304). The at least one isolated body outer body slot 319, when present, may be pre-filled with a gas (e.g., air or any other desired gas) prior to being sealed off from the surrounding atmosphere or may be configured as a vacuum cavity.

[0045] The outer body part 304 may have one or more body cavity openings 324 that extend laterally from the external wall surface 320 to the internal wall surface 322. The outer body part 304 of the example configuration shown in Figs. 1 -4 includes two body cavity openings 324 that are laterally spaced from one another. Each body cavity opening 324 may include a large diameter portion 326 extending from the external wall surface 320 to an opening contact surface 328, and a small diameter portion 330 extending laterally from the large diameter portion 326 (i.e., from the opening contact surface 328) to the internal wall surface 322. The body cavity openings 324 and / or the outer body slots 319 (when provided) may be positioned such that they are spaced from and not in fluid communication with one another. For example, the lateral distance between the body cavity openings 324, the lateral length of the outer body slots 319, the longitudinal height of the outer body slots 319, and / or the general relative positioning of the body cavity openings 324 to the outer body slots 319 may be selected such that thebody cavity openings 324 and the outer body slots 319 are isolated from one another. In one further example, the longitudinal height of at least one of the outer body slots 319 (e.g., an outer body slot 319 that is on the same outer body wall 317 as a body cavity opening 324) may vary along the lateral length of the outer body slot 319. In particular, the longitudinal height of a lateral portion of an outer body slot 319 that is longitudinally aligned with a body cavity opening 324 may be less than lateral portions of the outer body slot 319 that are not longitudinally aligned with a body cavity opening 324.Therefore, by varying the longitudinal height(s), each lateral portion of an outer body slot 319 that is longitudinally aligned with a body cavity opening 324 may be longitudinally spaced from such body cavity opening 324.

[0046] The inner body part 306 similarly includes a base portion 332 and wall portions 334. More specifically, the base portion 332 of the inner body part 306 has a first or external base surface 336 that faces longitudinally opposite to, and is spaced longitudinally from, a second or internal base surface 338 of the inner body part 306. The wall portion 334 of the inner body part 306 extends longitudinally from the internal base surface 338 of the inner body part 306 to a longitudinally facing rim 340 of the inner body part 306. The rim 340 of the inner body part 306 is spaced longitudinally from, and faces longitudinally opposite to, the external base surface 336 of the inner body part 306. The wall portion 334 of the inner body part 306 includes a first or external wall surface 342 that faces laterally opposite to and is spaced laterally from a second or internal wall surface 344 of the inner body part 306.

[0047] The inner body part 306 defines a containment chamber 246 that is configured to selectively receive an entirety of a bodily tissue being managed. In particular, the containment chamber 246 is defined by the internal base surface 338 and the internal wall surface 344 of the inner body part 306. While the bodily tissue may be received directly on the internal base surface 338 of the inner body part 306, the bodily tissue may be received on any other surface in the containment chamber 246.

[0048] In addition to having base and wall portions 332, 334, the inner body part 306 includes a flange portion 248 extending laterally from the external wall surface 342. The flange portion 248 may be positioned along the external wall surface 342 such that it is located substantially longitudinally opposite to the base portion 332 and defines or includes at least a portion of the inner body part’s rim 340. The inner body part 306 may be removably or substantially permanently connected to the wall portion 316 of the outer body part 304 at the flange portion 248. In particular, the flange portion 248 may include a flange recession 250 defined by a lateral recession surface 252 (which faces laterallyopposite to the internal wall surface 344 of the inner body part 306) and a longitudinal recession surface 254 (which extends perpendicularly from the lateral recession surface 252 and faces longitudinally opposite to the inner body part's rim 340). When the inner body part 306 is connected to the outer body part 304, the wall portion 316 of the outer body part 304 is at least partially seated in the flange recession 250. More specifically, when the inner body part 306 is connected to the outer body part 304, the internal wall surface 322 of the outer body part 304 laterally contacts, or is laterally adjacent to, the lateral recession surface 252 and the rim 318 of the outer body part 304 longitudinally contacts, or is longitudinally adjacent to, the longitudinal recession surface 254.

[0049] The inner body part 306 of the example configuration shown in at least Figs. 1 -4 is securely connected to the outer body part 304 via an adhesive, though, as discussed below, the inner and outer body parts 306, 304 may be mutually connected in any other desired manner. For example, the engagement of the inner and outer body parts 306, 304 may be one of a screw and screw hole engagement, a magnetic engagement, hook and loop engagement, a nail and nail hole engagement, a snap-fit engagement, an adhesive engagement, a screw and nut engagement, a split pin engagement, a button engagement, a press-fit engagement, a brazed / soldered / welded engagement, any other suitable engagement, or any combination thereof. It is contemplated that for some engagement mechanisms, interposing a body sealing member (e.g., a resilient or rigid ring or washer) longitudinally and / or laterally between the outer and inner body parts 304, 306 may help bolster and / or form a fluidtight seal between the outer and inner body parts 304, 306. For example, although the adhesive engagement provides a fluidtight seal between the outer and inner body parts 304, 306, including the body sealing member may help strengthen the seal.

[0050] Although the inner body part 306 includes a recession 250 for receiving a portion of the outer body part 304, the outer body part 304 may instead or also be configured to have a recession for receiving a portion (e.g., the flange portion 248) of the inner body part 306. Furthermore, alternative embodiments of the body 102 may omit the recession 250.

[0051] As shown in Fig. 2, when connected to one another, an inner body cavity 256 of the body 102 is at least partially defined by the outer and inner body parts 304, 306 collectively. In particular, the wall portion 334 of the inner body part 306 extends at least partially into the outer body part 304 such that the external base surface 336 of the inner body part 306 is longitudinally adjacent to, but spaced from, the internal base surface 312 of the outer body part 304. The external wall surface 342 of the inner body part 306is similarly located laterally adjacent to, but spaced from, the internal wall surface 322 of the outer body part 304. Therefore, the inner body cavity 256 may be at least partially defined by the inner body part’s external wall surface 342 and external base surface 336 and the outer body part’s internal base surface 312 and internal wall surface 322. An internal flange surface 258 of the flange portion 250 may extend from the external wall surface 342 of the inner body part 306 to the internal wall surface 322 of the outer body part 304. This internal flange surface 258 thus may also define a portion of the inner body cavity 256.

[0052] The inner body cavity 256 may be configured to selectively receive a temperature regulating fluid therein. More specifically, the containment device 100 may include at least one body cavity port 360 via which the temperature regulating fluid may be selectively circulated into and out from the inner body cavity 256. In the example configuration of Figs. 1-4, the containment device 100 includes two body cavity ports 360 that are laterally spaced from one another. Each body cavity port 360 comprises a respective one of the body cavity openings 324 and a cavity connector 362. Each cavity connector 362 is selectively received in, and occludes, the body cavity opening 324. The cavity connectors 362 may include engagement portions 364 for preventing the cavity connectors 362 from undesirably egressing from the body cavity openings 324 when the cavity connectors 362 are received therein. For example, the engagement portions 364 may provide for a threading engagement, a press-fit or frictional fit engagement, a separately provided fastener (not shown), adhesive or welding, and / or any other type of engagement suitable for selectively maintaining the cavity connectors 362 in the body cavity openings 324.

[0053] The cavity connectors 362 may also include connecting portions 366 via which the cavity connectors 362 are selectively connected to a temperature regulating fluid source (e.g., via a line or otherwise). Therefore, when the cavity connectors 362 are connected to the temperature regulating fluid source, the temperature regulating fluid may be circulated into and out from the inner body cavity 256 via at least one of the cavity connectors 362 and the body cavity openings 324. The connecting portions 366 may be configured to provide a Luer taper connection, a press-fit or frictional-fit connection, a threaded connection, a separately provided fastener (not shown), and / or any other type of connection suitable for selectively maintaining each of the cavity connectors 362 connected to a fluid-carrying line and / or any other medical instrument / device.

[0054] The body cavity ports 360 may each also include at least one cavity sealing member 368 (e.g., a resilient or rigid ring or washer) interposed, and at least partially forming a fluidtight seal, between the body 102 and the cavity connectors 362. For example, each body cavity port 360 may include a cavity sealing member 368 directly contacting and interposed laterally between a portion of a respective cavity connector 362 and a respective opening contact surface 328. Although the cavity sealing members 368 are shown as being separate from their respective cavity connectors 362, the cavity sealing members 368 may be formed integrally with their cavity connectors 362 as a single monolithic piece. A press-fit or frictional fit engagement of the cavity connectors 362 in their body cavity openings 324 or forming the cavity connectors 362 with the outer body part 304 as a single monolithic piece also or instead may provide the fluidtight-seal functionality. In such configurations, the cavity sealing members 368 may be included or omitted as desired. Regardless of how the fluidtight seal is formed, providing such functionality helps prevent temperature regulating fluid from leaking out of the inner body cavity 256 during use.

[0055] It should be appreciated that, other than the body cavity openings 324, the inner body cavity 256 is closed to surrounding atmosphere. Therefore, by occluding the body cavity openings 324 with the cavity connectors 362 and providing a fluidtight seal between the cavity connectors 362 and the body 102, the body cavity openings 324 can be functionally “closed,” thereby closing the inner body cavity 256 to the surrounding atmosphere. Closing the inner body cavity 256 to the surrounding atmosphere isolates the temperature regulating fluid received in the inner body cavity 256 from the surrounding atmosphere and, thus, provides for the temperature of the received temperature regulating fluid to be more consistent and manageable than if the inner body cavity 256 and received temperature regulating fluid were exposed to the surrounding atmosphere. Closing the inner body cavity 256 may also at least partially prevent the temperature regulating fluid from being contaminated and / or from leaking out of the inner body cavity 256 during use.

[0056] The inner body cavity 256 is also fluidical ly separate from the containment chamber 246. However, the inner body cavity 256 is configured to receive the temperature regulating fluid therein so as to maintain at least one of the bodily tissue and the containment chamber 246 at a predetermined temperature. Therefore, while the inner body cavity 256 is fluidical ly separate from the containment chamber 246, the inner body cavity 256 is located adjacent to a plurality of sides of the containment chamber 246. Furthermore, when the outer body slots 319 are present, the air / gas inthe outer body slots 319 at least partially reduces the transfer of heat through the outer body 304, and thus at least partially thermally insulates the containment chamber 246 and / or the inner body cavity 256.

[0057] As shown in Figs. 1-4, the containment chamber 246 may be defined to have an upper chamber side 270 (which is adjacent to the rim 340 of the inner body part 306), a lower chamber side 272 (which is adjacent to the inner body part’s base portion 332 and spaced longitudinally from the upper chamber side 270), and at least one lateral chamber side 274 extending longitudinally between the upper and lower chamber sides 270, 272. The at least one lateral chamber side 274 is adjacent to, and at least partially defined by, the internal wall surface 344 of the inner body part 306. Therefore, the number of lateral chamber sides 274 corresponds to (e.g., directly corresponds to) the interior geometry of the inner body part 306. In the example configuration shown in Figs. 1-4, the containment chamber 246 may include four lateral chamber sides 274 as a result of the inner body part’s internal wall surface 344 having a substantially square or rectangular configuration. The amount of lateral chamber sides 274 and the overall shape of the containment chamber 246 thus may be adjusted as desired by altering at least the internal geometry of the inner body part 306.

[0058] The inner body cavity 256 may be located adjacent to at least the lower chamber side 272 and the at least one lateral chamber side 274. In other words, the inner body cavity 256 may be located longitudinally adjacent to the lower chamber side 272 and laterally adjacent to each lateral chamber side 274, though the inner body cavity 256 may be modified to also be longitudinally adjacent to at least a portion of the upper chamber side 270.

[0059] The containment device 100 may also include one or more chamber ports 476. In the example configuration shown in Figs. 1 -5, the containment device includes four chamber ports 476. Each chamber port 476 comprises a body chamber opening 578 extending from an exterior of the body 102 to the containment chamber 246. In particular, the inner body part 306 may include a port projection 380 extending from at least one of the inner body part’s rim 340 and the inner body part’s internal wall portion 344. The port projection 380 may include a first projection surface 382 facing away from the containment chamber 246. A second projection surface 384 faces toward the containment chamber 246 and is located such that the second projection surface 384 defines a portion of the containment chamber 246. Each body chamber opening 578 extends from the first projection surface 382 (i.e., from an exterior of the body 102) to the second chamber surface 384 (i.e., to the containment chamber 246).

[0060] Each chamber port 476 also includes a dual-sided chamber connector 586 occluding and extending completely through an associated body chamber opening 578. Therefore, a first connecting portion 588 of the chamber connector 586 is located in ambient space outside the exterior of the body 102, while a second connecting portion 590 of the chamber connector 586 is spaced from the first connecting portion 588 and located inside the containment chamber 246. Each of the first and second connecting portions 588, 590 may be configured to provide a Luer taper connection, a press-fit or frictional-fit connection, a threaded connection, a separately provided fastener (not shown), a ball-and-socket connection, and / or any other type of connection suitable for selectively maintaining each of the chamber connectors 586 connected to a separate fluid-carrying line and / or any other medical device / instrument.

[0061] Via their associated chamber connectors 586, the chamber ports 476 may each be adapted for use in delivering a managing fluid to at least one of the bodily tissue and the containment chamber 246 and for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber 246. For example, at least one of the chamber ports 476 may be selected for use in delivering the managing fluid and, thus, may be fluidically connected to a managing fluid source via an associated first connecting portion 588. At least one other of the chamber ports 476 may be selected for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber 246 and, thus, may be fluidically connected to an exterior pump / reservoir via an associated first connecting portion 588. The second connecting portion 590 of each chamber connector 586 may be fluidically connected to at least one of the bodily tissue and the containment chamber 246 via a fluid line for the delivery and / or removal of the managing fluid.

[0062] As an aside, the term “managing fluid,” as used herein, refers to be any fluid capable of improving or maintaining the vitality of the bodily tissue. Improving or maintaining vitality can include one or more of the following: maintenance of appropriate osmotic pressure, maintenance of appropriate oncotic pressure, maintenance of appropriate temperature, inhibition of decay, inhibition of microbial growth, waste removal, and the like. A few examples of such a managing fluid commonly used are various culture medias, blood, and oxygenated blood.

[0063] Each chamber connector 586 may be selectively maintained in an associated body chamber opening 578 via an engagement portion 592 in any desired manner. As shown in Figs. 4-5, for example, the engagement portion 592 of each chamber connector 586 may include threads and be located adjacent to the first connectingportion 588 such that each threaded engagement portion 592 is at least partially located in the ambient space outside the exterior of the body 102. Locking members 594 (shown here, by way of example, as one or more threaded nuts) may be threadably attached to the threaded engagement portions 592 to help prevent the chamber connectors 586 from egressing from their predetermined position in the body chamber openings 578.

[0064] Instead of including a separate locking member 594, at least one of the body chamber openings 578 may be threaded for selectively threadably engaging the threaded engagement portions 592. As another alternative, each connecting portion 588, 590 may include an opening that extends entirely laterally through the chamber connector 586. The opening in the chamber connector 586 may selectively receive a locking member 594 (e.g., a R-pin, a split pin, a lock washer, a split ring, a cotter pin, and / or a linchpin) to maintain the chamber connector 586 in the desired position.

[0065] The chamber connectors 586 may also include a flange portion 596 located adjacent to the second connecting portions 590 such that the flange portions 596 are positioned in the containment chamber 246 during use. The flange portions 596 may be dimensioned and configured so as to not be able to pass through the body chamber openings 578. The flange portions 596 may thus functionally work with the engagement portions 592 in helping to maintain the chamber connectors 586 connected to the body 102.

[0066] The chamber ports 476 may each also include at least one chamber sealing member 598 (e.g., a resilient or rigid ring or washer) interposed, and at least partially forming a fluidtight seal, between the body 102 and the chamber connectors 586. For example, each chamber port 476 may include a chamber sealing member 598 directly contacting and interposed laterally between the flange portion 596 of a respective chamber connector 586 and the second projection surface 384. The chamber sealing members 598 may be separate from their respective chamber connectors 586 or may be formed integrally with their respective chamber connectors 586 as a single monolithic piece. A press-fit or frictional fit engagement of the chamber connectors 586 in their body chamber openings 578 also or instead may provide the fluidtight-seal functionality. In such a configuration, the chamber sealing members 598 may be included or omitted as desired. Regardless of how the fluidtight seal is formed, providing such functionality helps prevent managing fluid from leaking out of the containment chamber 246 during use.

[0067] Under certain conditions, managing fluid that has already been exposed to the bodily tissue in the containment chamber 246 may “pool” or “collect” within the containment chamber 246 (e.g., at or adjacent to the lower chamber side 272), at least temporarily. It may be desirable to distance the bodily tissue at least partially from the pooled or collected managing fluid (e.g., so as to maintain a clear visual of the bodily tissue). In such case, the containment device 100 may include a support plate 6100 received (e.g., removably received) in the containment chamber 246. As shown in Fig. 2, the support plate 6100 functionally divides the containment chamber 246 into a first or upper chamber portion 2102 (which is adjacent to and / or includes the upper chamber side 270) and a second or lower chamber portion 2104 (which is longitudinally adjacent to the upper chamber portion 2102 and is adjacent to or includes the lower chamber side 272).

[0068] The support plate 6100 is configured to receive the bodily tissue thereon such that the received bodily tissue is located in the upper chamber portion 2102. As shown in Fig. 6, the support plate 6100 may be perforated (i.e., may have openings) for permitting managing fluid that is delivered directly or indirectly to the bodily tissue in the upper chamber portion 2102 to flow from the upper chamber portion 2102 into the lower chamber portion 2104. Therefore, through use of the support plate 6100, the bodily tissue is at least partially separated from the managing fluid that is contained within lower chamber portion 2104. However, in certain containment device embodiments and / or use configurations, containment chamber 246 may be filled with the managing fluid such that the managing fluid is present in both the upper and lower chamber portions 2102, 2104. Having at least a portion of the upper chamber 2102 filled with the managing fluid is useful in certain situations to help prevent the bodily tissue in the upper chamber portion 2102 from drying out.

[0069] The support plate 6100 may be maintained in position in the containment chamber 246 via at least one shoulder 6106 of the inner body part 306. Each shoulder includes a lateral shoulder surface 6108 and a longitudinal shoulder surface 6110. Each lateral shoulder surface 6108 extends substantially longitudinally from the inner body part’s internal base surface 338. Each longitudinal shoulder surface 6110 extends substantially laterally from the inner body part’s internal wall surface 344 to the lateral shoulder surface 6108 and is configured to receive (e.g., directly receive) the support plate 6100 thereon in a shelf-type manner. As shown in the example configuration of at least Fig. 6, the inner body part 306 may include a single annular shoulder 6106 having a lateral shoulder surface 6108 that defines a substantially circular lower chamberportion 2104. However, the inner body part 306 may have any number of shoulders 6106 for supporting the support plate 6100 and any lateral and / or longitudinal shoulder surface 6108, 6110 geometry for defining a predetermined and desired shape of the lower chamber portion 2104.

[0070] Depending on the composition of the managing fluid, the individual components of the managing fluid may separate from one another when held in the lower chamber portion 2104 for a predetermined period of time. For example, when blood is a used as a managing fluid for perfusing the bodily tissue, the blood may split into a substantially solid red and white blood cell mass component (i.e., a red blood cell mass) and a substantially liquid component (plasma). If the blood is left unmixed in the lower chamber portion 2104 for longer than a predetermined period of time, there is a chance that only one of the blood’s components (or more of one component versus the other) could be removed and recirculated into the containment chamber / the bodily tissue, potentially leading to a suboptimal perfusion.

[0071] In view of the above, the containment device 100 may include an agitator 6112 that agitates (and, thus, mixes) the managing fluid in the lower chamber portion 2104 when actuated, though certain embodiments of the containment device 100 may be selectively omit the agitator 6112. As shown in Figs. 6-7B, the agitator 6112 may substantially be a cone-shaped disk that is rotatable relative to the inner body part 306 to agitate / mix the managing fluid in the lower chamber portion 2104. The agitator 6112 may have a first or upper agitator surface 7114 and a second or lower agitator surface 7116. The agitator 6112 may be at least partially rotatably supported in the lower chamber portion 2104 via the lower agitator surface 7116. For example, the inner body part 306 may include a support projection 2118 (Fig. 2) that extends longitudinally from the inner body part’s internal base surface 338. As shown in Fig. 2, the agitator 6112 may be positioned on the support projection 7118 such that the support projection 21 18 contacts the lower agitator surface 7116 (e.g., in a complementary shaped recession 7119 on the lower agitator surface 7116) and rotatably supports the agitator 6112. This “one-point” contact between the agitator 61 12 and the inner body part’s internal base surface 338 helps to prevent or at least partially reduce red blood cell lysis when the managing fluid is blood by limiting the number of friction or “rubbing” contact points between the agitator 6112 and the inner body part’s internal base surface 338.

[0072] As shown in Figs. 2 and 6-7B, the agitator 6112 may also be at least partially rotatably supported in the lower chamber portion 2104 via the upper agitator surface 7114. For example, the upper agitator surface 7114 may include an agitator support7120 projecting longitudinally therefrom. The agitator support 7120 may contact the support plate 6100 (e.g., in a complementary shaped recession on a lower surface of the support plate 6100). This contact at least partially rotatably supports the agitator 6112 on its upper agitator surface side so that the agitator 6112 may selectively rotate relative to each of the inner body part 306 and the support plate 6100. Alternatively, the agitator 6112 may be configured so as to not contact the support plate 6100. In such a configuration, the agitator support 7120 may be omitted or at least spaced from the support plate 6100. It is also contemplated that the longitudinal length of the agitator support 7120 may be such that a user may grab the agitator support (e.g., with two fingers) to selectively remove the agitator 6112 from the containment chamber 246.

[0073] The upper agitator surface 7114 may also include one or more agitating projections 7124 (shown here as two agitating projections 7124) extending longitudinally therefrom, though certain embodiments of the agitator 61 12 may be free of any agitator projections 7124. The agitating projections 7124 increase the contact surface between the managing fluid and the agitator 6112 in the lower chamber portion 2104, thereby producing a stronger agitation than would otherwise be possible.

[0074] The agitator 6112 may be configured to be actuated via magnetic stimuli. In particular, as shown in Fig. 7A-B, the agitator 61 12 may have at least one magnet 7126 (shown here as two magnets 7126) inserted in an agitator body portion 7128 of the agitator 6112. For example, each magnet 7126 may be received in a magnet receiving depression 7127 that extends inward from the lower agitator surface 7116. In the example configuration shown in Figs. 7A-B, the magnets 7126 may include magnet openings 7129 into which receiving projections 7131 of the agitator body portion 7128 longitudinally extend when the magnets 7126 are received in the magnet receiving depressions 7127. The receiving projections 7131 each extend longitudinally outward from longitudinally facing depression end surfaces 7133 the magnet receiving depressions 7127. The inclusion of the receiving projections 7131 and the magnet openings 7129 helps with centering the magnets 7126 in the magnet receiving depression 7127, and thus with at least partially balancing the agitator 6112 in the containment chamber 246. However, in certain agitator configurations (such as the one shown in Fig. 7C), the magnets may be free from magnet openings 7129 and the agitator body portion 7128 may be free from the receiving projections 7131 in order to simplify the design of the agitator 6112. Regardless of whether the agitator 6112 includes the magnet openings 7129 and receiving projections 7131 or not, each magnet 7126 may be covered and, thus, at least partially isolated from the managing fluid, via amagnet cap 7130. In use, the agitator 6112 is selectively urged to rotate in response to the magnets 7126 being subject to a particular magnetic field.

[0075] Although the agitator 6112 has been described as being a cone-shape disk that rotates to mix managing fluid within the lower chamber portion 2104, the agitator 6112 may have any desired geometric and movement characteristics for agitating managing fluid within the lower chamber portion 2104. For example, the agitator 6112 may have a substantially square, rectangular, elliptical, triangular, cylindrical, or any other desirably shaped geometry and may move in a linear, rotary, oscillatory, chaotic, or any other desired manner to agitate the managing fluid. Furthermore, although the agitator 6112 has been described as being actuated via magnetic stimuli, the agitator 6112 may be selectively actuated via any other desired stimuli, such as, e.g., electrical or acoustic stimuli.

[0076] Returning to Figs. 1-2, the containment device 100 may also include a lid 1132 for selectively closing the containment chamber 246. As shown in Figs. 8-9, the lid 1132 includes a lid body 9134 and a lid cap 9136 that is separate from the lid body 9134, though the lid 1132 may be configured such that the lid body 9134 and the lid cap 9136 are integrally formed together as a single monolithic piece. The lid body 9134 includes a base portion 9138 having a first or external base surface 9140 that faces longitudinally opposite to and is spaced longitudinally from a second or internal base surface 9142. The lid body 9134 also includes a wall portion 9144 that extends longitudinally from the external base surface 9140 to a longitudinally facing rim 9146 of the lid body 9134. The lid body’s rim 9146 is spaced longitudinally from and faces longitudinally opposite to the lid body’s external base surface 9140. The wall portion 9144 of the lid body 9134 includes a first or external wall surface 9148 that faces laterally opposite to and is spaced laterally from a second or internal wall surface 9150.

[0077] The lid body 9134 may have one or more lid cavity openings 9152 that extend laterally from the external wall surface 9148 to the internal wall surface 9150. The lid body 9134 of the example configuration shown in Figs. 8-9 includes two lid cavity openings 9152 that are laterally spaced from one another. Each lid cavity opening 9152 may include a large diameter portion 9154 extending from the external wall surface 9148 to an opening contact surface 9156, and a small diameter portion 9158 extending laterally from the large diameter portion 9154 (i.e., from the opening contact surface 9156) to the internal wall surface 9150.

[0078] The lid cap 9136 includes a first or external cap surface 9160 that faces longitudinally opposite to and is spaced longitudinally from a second or internal capsurface 9162. As shown in Fig. 2, the lid cap 9136 may include a cap recession 2164 at which the lid cap 9136 is removably or substantially permanently connected to the lid body 9134. In particular, the cap recession 2164 may include a lateral cap recession surface 2166 extending longitudinally from the internal cap surface9, and a longitudinal cap recession surface 2168 that extends laterally (e.g., perpendicularly) from the lateral cap recession surface 2166 and faces longitudinally opposite to the external cap surface 9160.

[0079] The wall portion 9144 of the lid body 9134 may have a complementary body recession 2170 at which the lid cap 9136 is connected. The body recession 2170 may include a lateral body recession surface 2172 extending longitudinally from the lid body’s rim 9146, and a longitudinal body recession surface 2174 that extends laterally (e.g., perpendicularly) from the lateral body recession surface 2172 and faces longitudinally opposite to the internal base surface 9142 of the lid body 9134.

[0080] When the lid cap 9136 is connected to the lid body 9134, the cap and body recessions 2164, 2170 mutually receive and contact one another. More specifically, when the lid cap 9136 is connected to the lid body 9134, the lateral cap recession surface 2166 laterally contacts or is laterally adjacent to the lateral body recession surface 2172 and the longitudinal cap recession surface 2168 longitudinally contacts or is longitudinally adjacent to the longitudinal body recession surface 2174. While both the lid cap 9136 and the lid body 9134 are shown as having respective recessions 2164, 2170 at which the lid body 9134 and the lid cap 9136 are connected, the lid body 9134 and lid cap 9136 may be connected in any other desired manner (even if at least one of the lid cap 9136 and the lid body 9134 was formed without its associated recession 2164, 2170).

[0081] The lid cap 9136 of the example configuration shown in at least Figs. 2 and 8- 9 is securely connected to the lid body 9134, for example, via an adhesive, though, the lid cap 9136 and lid body 9134 may be mutually connected in any other desired manner. For example, the engagement of the lid cap 9136 to the lid body 9134 may be one of a screw and screw hole engagement, a magnetic engagement, hook and loop engagement, a nail and nail hole engagement, a snap-fit engagement, an adhesive engagement, a screw and nut engagement, a split pin engagement, a button engagement, a press-fit engagement, a brazed / soldered / welded engagement, any other suitable engagement, or any combination thereof. It is contemplated that for some engagement mechanisms, interposing a lid sealing member (e.g., a resilient or rigid ring or washer) longitudinally and / or laterally between the lid cap 9136 and the lid body 9134may help bolster and / or form a fluidtight seal between the lid cap 9136 and the lid body 9134. For example, although the adhesive engagement provides a fluidtight seal between the lid cap 9136 and the lid body 9134, including the lid sealing member may help strengthen the seal.

[0082] As shown in Fig. 2, when connected to one another, an inner lid cavity 2176 of the lid 1132 is at least partially defined by the lid body 9134 and the lid cap 9136 collectively. In particular, the lid cap 9136 is connected to the lid body 9134 such that the internal cap surface 9162 of the lid cap 9136 is longitudinally adjacent to, but spaced from, the external base surface 9140 of the lid body 9134. Therefore, the inner lid cavity 2176 may be at least partially defined by the lid body’s internal wall surface 9150 and external base surface 9140 and the lid cap’s internal cap surface 9162.

[0083] The inner lid cavity 2176 may be configured to selectively receive the temperature regulating fluid therein. More specifically, the containment device 100 may include at least one lid cavity port 9178 via which the temperature regulating fluid may be selectively circulated into and out from the inner lid cavity 2176. In the example configuration of Figs. 8-9, the containment device includes two lid cavity ports 9178 that are laterally spaced from one another. Each lid cavity port 9178 comprises a respective one of the lid cavity openings 9152 and a cavity connector 362. The cavity connectors 362 used in conjunction with the lid 1132 have substantially the same structure and function as described above with respect to the cavity connectors 362 used in conjunction with the body 102, and thus such structure(s) and function(s) will not be described in their entirety at this point, for brevity. Therefore, each cavity connector 362 is selectively received in, engaged to, and occludes the lid cavity opening 9152. When the lid's cavity connectors 362 are connected to the temperature regulating fluid source, the temperature regulating fluid may be circulated into and out from the inner lid cavity 2176 via at least one of the lid’s cavity connectors 362 and the lid cavity openings 9152.

[0084] The lid cavity ports 9178 may each also include at least one cavity sealing member 368 (e.g., a resilient or rigid ring or washer) interposed, and at least partially forming a fluidtight seal, between the lid body 9134 and the lid’s cavity connectors 362. For example, each lid cavity port 9178 may include a cavity sealing member 368 directly contacting and interposed laterally between a portion of a respective cavity connector 362 and a respective opening contact surface 9156. Although the lid’s cavity sealing members 368 are shown as being separate from their respective cavity connectors 362, the lid’s cavity sealing members 368 may be formed integrally with the respective cavity connectors 362 as a single monolithic piece. A press-fit or frictional fit engagement ofthe lid’s cavity connectors 362 in their lid cavity openings 9152 or forming the lid’s cavity connectors 362 with the lid body 9134 as a single monolithic piece may also or instead provide the fluidtight-seal functionality. In such configurations, the cavity sealing members 368 may be included or omitted as desired. Regardless of how the fluidtight seal is formed, providing such functionality helps prevent temperature regulating fluid from leaking out of the inner lid cavity 2176 during use.

[0085] It should be appreciated that, other than the lid cavity openings 9152, the inner lid cavity 2176 is closed to surrounding atmosphere. Therefore, by occluding the lid cavity openings 9152 with the lid's cavity connectors 362 and providing a fluidtight seal between the lid’s cavity connectors 362 and the lid 1 132, the lid cavity openings 9152 can be functionally “closed,” thereby closing the inner lid cavity 2176 to the surrounding atmosphere. Closing the inner lid cavity 2176 to the surrounding atmosphere isolates the temperature regulating fluid received in the inner lid cavity 2176 from the surrounding atmosphere and, thus, provides for the temperature of the received temperature regulating fluid to be more consistent and manageable than if the inner lid cavity 2176 and received temperature regulating fluid were exposed to the surrounding atmosphere. Closing the inner lid cavity 2176 may also at least partially prevent the temperature regulating fluid from being contaminated and / or from leaking out of the inner lid cavity 2176 during use.

[0086] As shown in Fig. 2, the lid 1 132 can be selectively joined to the body 102 to close the containment chamber 246. In particular, the lid 1132 can be placed on the body 102 such that the internal base surface 9142 of the lid body 9134 contacts the rim 340 of the inner body part 306. The lid 1 132 may also include an overhang portion 2180 that extends from the internal base surface 9142 of the lid body 10134 and laterally surrounds at least a portion of the body 102 (e.g., a portion of the inner body part’s flange portion 248 and / or a portion of the outer body part’s wall portion 316). The overhang portion 2180, when present, helps with isolating the containment chamber 246 from the surrounding atmosphere when the lid 1132 is joined to the body 102. Therefore, the overhang portion 2180, when present, at least partially prevents the containment chamber 246 and / or the bodily tissue therein from being contaminated during use. Furthermore, as is shown in Figs. 1 -2 and 8-9, the geometry of the lid body 9134 may be configured to accommodate and fit around the port projection 380 such that access to the first connecting portions 588 of the chamber connectors 586 is not disrupted when the containment chamber 246 is closed via the lid 1132. In particular, the lid body 9134 may define a U-shaped portion 9182 surrounding three lateral sides ofthe port projection 380 when the lid 1132 is joined to the body 102. The lid body’s internal base surface 9142 at the U-shaped portion 9182 may be at least partially angled so as to contact a portion of the port projection 380 when the containment chamber 246 is closed.

[0087] Returning to Fig. 2, when the containment chamber 246 is closed via the lid 1132, the inner lid cavity 2176 may be located longitudinally adjacent to (but f I uid ically separate from) the upper chamber side 270 of the containment chamber 246, though the inner lid cavity 2176 may be modified to also be laterally adjacent to at least one lateral chamber side 274. Just as with the inner body cavity 256, the inner lid cavity 2176 is also configured to receive the temperature regulating fluid therein so as to maintain at least one of the bodily tissue and the containment chamber 246 at a predetermined temperature. While each of the inner body and lid cavities 256, 2176 receive the temperature regulating fluid, the inner body and lid cavities 256, 2176 are not directly fluidically connected to one another (i.e., the inner body and lid cavities 256, 2176 are fluidically separate from one another in the containment device 100).

[0088] The containment device 100 thus provides for a substantially complete temperature regulating coverage of the containment chamber 246 (and, accordingly, the bodily tissue in the containment chamber 246) because the inner lid cavity 2176 and the inner body cavity 256 collectively overlie at least a portion (e.g., a substantial portion) of each of the chamber sides 270, 272, 274. The term “overlie” is used herein to indicate that the inner lid cavity 2176 and / or inner body cavity 256 are at least partially interposed between a respective chamber side 270, 272, 274 and an ambient space. Having such a substantially complete temperature regulating coverage facilitates desired control over the temperature of the containment chamber 246 and / or of the bodily tissue in the containment chamber 246.

[0089] As shown in Figs. 10-11 , the containment device 100 described above may be a component of an ex vivo bodily tissue management system 10184. The system 10184 may also include a temperature regulating fluid source 10186 having one or more user- or algorithmically-controlled temperature regulating mechanisms for selectively heating and cooling temperature regulating fluid TF to a desired temperature. The temperature regulating fluid source 10186 may also include one or more pumps and / or one or more internal reservoirs for selectively circulating the temperature regulating fluid TF between the temperature regulating fluid source 10186 and the inner body and lid cavities 256, 2176. In the example configuration shown in Figs. 10-11 , the temperature regulating fluid source 10186 is selectively fluidically connected to the inner body cavity256 via at least one of the body cavity ports 360, and selectively fluidical ly connected to the inner lid cavity 2176 via at least one of the lid cavity ports 9178. More specifically, the system 10184 may include a plurality of temperature regulating fluid lines 10188 selectively fluidically connecting the inner body and lid cavities 256, 2176 to the temperature regulating fluid source 10186. Each temperature regulating fluid line 10188 thus may have a first end 10188a connected to the connecting portion 366 of an associated one of the body and lid cavity ports 360, 9178 via a Luer taper connector 10189 (e.g., a luer lock-type Luer taper connector, as is shown in the Figures, or a slip tip-type connector) or any other suitable connector, and a second end 10188b connected to the temperature regulating fluid source 10168. Because the body 102 includes two body cavity ports 360, one of the body cavity ports 360 may be selected for use in temperature regulating fluid intake, while the other of the body cavity ports 360 may be selected for use in temperature regulating fluid removal, though at least one of the body cavity ports 360 can be selected for use in sequentially intaking and removing temperature regulating fluid. Similarly, one of the lid cavity ports 9178 may be selected for use in temperature regulating fluid intake, while the other of the lid cavity ports 9178 may be selected for use in temperature regulating fluid removal, though at least one of the lid cavity ports 9178 may be selected for use in sequentially intaking and removing temperature regulating fluid.

[0090] By circulating the temperature regulating fluid TF between the temperature regulating fluid source 10186 and the inner body and lid cavities 256, 2176 and controlling the temperature of the temperature regulating fluid TF via the temperature regulating fluid source 10186, the temperature of at least one of the containment chamber 246 and the bodily tissue BT in the containment chamber 246 can be maintained at a predetermined and desired temperature. As discussed above, the structural configurations of and temperature regulating coverage provided by the inner body and lid cavities 256, 2176 help the user maintain tight control over the temperature of the containment chamber 246 and / or of the bodily tissue BT in the containment chamber 246.

[0091] The system 10184 may also include a managing fluid source containing a managing fluid (e.g., blood or oxygenated blood or culture media) for improving or maintaining the vitality of the bodily tissue BT. The managing fluid source may have one or more reservoirs for selectively storing the managing fluid, one or more user- or algorithmically-controlled treatment mechanisms (e.g., a heater, a cooler, a oxygenator, a nutrient distributor, one or more sensors, or any other desired component) forselectively maintaining and / or achieving a desired condition for the managing fluid, and / or one or more pumps for selectively delivering the managing fluid to at least one of the bodily tissue BT and the containment chamber. Therefore, the managing fluid source may be used for perfusing the bodily tissue with, e.g., blood or a blood analogue to help preserve the bodily tissue ex vivo for medical research, analysis, and / or treatment.

[0092] The managing fluid source 10190 is selectively fluidically connected to at least one of the bodily tissue BT and the containment chamber 246 via at least one of the chamber ports 476 for selectively delivering the managing fluid to at least one of the bodily tissue BT and the containment chamber 246. As shown in the example configuration of Figs. 10-11 , for example, a first delivery line 10192 has a first end 10192a selectively connected (e.g., via another Luer taper connector 10189) to the first connecting portion 588 of a first selected one of the chamber ports 476, and a second end 10192b selectively connected to the managing fluid source 10190. A second delivery line 10194, on the other hand, has a first end 10194a selectively connected to (e.g., inserted into a natural or created orifice of) the bodily tissue BT that is received on the support plate 6100 in the upper chamber portion 2102, and a second end 10194b selectively connected (e.g., via another Luer taper connector 10189) to the second connecting portion 590 of the first selected chamber port 476. Therefore, via the managing fluid source 10190, the first and second delivery lines 10192, 10194, and the first selected chamber port 476, managing fluid may be selectively delivered directly to the bodily tissue BT in the containment chamber 246. However, if desired, the first end 10194a of the second delivery line 10194 may be positioned in the upper chamber portion 2102 such that the bodily tissue BT is instead indirectly exposed to the managing fluid.

[0093] As discussed above, at least a portion of the managing fluid that has been exposed to the bodily tissue BT generally flows through the support plate 6100 from the upper chamber portion 2102 into the lower chamber portion 2104. While contained in the lower chamber portion 2104, the agitator 61 12 may be actuated to agitate (and, thus mix) the managing fluid in the lower chamber portion 2104 so as to help prevent the managing fluid’s individual components (e.g., solid and liquid components) from separating from one another. The system 10184 may thus include an actuator 11196 via which the user may actuate the agitator 6112 as desired. When the agitator 6112 is configured to respond to magnetic stimuli, the actuator 11196 may be a magnetic field actuator that is positioned proximate to the agitator 6112 (e.g., longitudinally below theexternal base surface 310 of the outer body part 304) and selectively emits a particular magnetic field that responsively causes the agitator 6112 to move / rotate as desired.

[0094] Managing fluid contained within the lower chamber portion 2104 may be selectively removed from the containment chamber 246 (and the containment device 100 as a whole) via at least one drain line 10198, 10202. As shown in the example configuration of Figs. 10-11 , for example, a first drain line 10198 has a first end 10198a inserted into the lower chamber portion 2104 such that a drain opening 11200 through which managing fluid enters the first drain line 10198 is positioned in or adjacent to the managing fluid contained in the lower chamber portion 2104. A second end 10198b of the first drain line 10198 is selectively connected (e.g., via another Luer taper connector 10189) to the second connecting portion 590 of a second selected one of the chamber ports 476. A second drain line 10202, one the other hand, has a first end 10202a connected (e.g., via another Luer taper connector 10189) to the first connecting portion 588 of a second selected chamber port 476, and a second end 10202b connected to a negative pressure source 10204.

[0095] The negative pressure source 10204 may be a pump or any other device configured to selectively remove managing fluid from the containment chamber 246 (e.g., from the lower chamber portion 2104) via an application of negative pressure (i.e., a suction force) to the containment chamber 246. Therefore, via the negative pressure source 10204, the first and second drain lines 10198, 10202, and the second selected chamber port 476, managing fluid may be selectively removed from the containment chamber 246. The negative pressure source 10204 may be fluidically connected to a reservoir for safely containing the removed managing fluid. Alternatively or additionally, the negative pressure source 10204 may be fluidically connected to (and, optionally, integrated in a single unit with) the managing fluid source 10190 such that removed managing fluid may be treated by and / or stored in a reservoir of the managing fluid source 10190 for reuse (e.g., for recirculation into the containment chamber 246 and / or the bodily tissue BT). It is also contemplated that a positive pressure source (not shown) could be provided to assist with managing fluid movement as desired, and one of ordinary skill in the art can readily provide a suitable pressure source of any type for such purpose.

[0096] As shown in Fig. 1 1 , the first end 10198a of the first drain line 10198 is inserted through the support plate 6100 into the lower chamber 2104 and positioned such that the drain opening 11200 is not directly aligned with the bodily tissue BT received in the containment chamber 246. In other words, the drain opening 11200 ispositioned such that the drain opening 11200 is at least one of longitudinally and laterally offset from the bodily tissue received in the containment chamber 246. This arrangement helps protect the bodily tissue BT from being injured, or otherwise negatively impacted by, the negative pressure provided by the negative pressure source 10204.

[0097] As shown in Fig. 12, the first end 10198a of the first drain line 10198 may be connected to the bodily tissue BT instead of being positioned freely in the lower chamber portion 2104. For example, the first end 10198a may be connected directly to the bodily tissue BT by being inserted into a natural or created orifice of the bodily tissue BT, or may be connected indirectly to the bodily tissue BT via a medical instrument (e.g., a cannula) that is inserted into the natural or created orifice of the bodily tissue BT. Such an arrangement helps directly pull managing fluid from the bodily tissue BT, though the negative pressure applied by the negative pressure source 10204 may be tailored so as to avoid negative impact upon the bodily tissue BT.

[0098] While only two of the chamber ports 476 are depicted as being in use in Figs. 10-12, the remaining chamber ports 476 may additionally or instead be used for delivering managing fluid from the managing fluid source 10190, removing fluid from the containment chamber 246 and / or the bodily tissue BT via the negative pressure source 10204, and / or may be used for connecting at least one of the bodily tissue BT and the containment chamber 246 to any other medical device(s) or instrument(s) for selectively providing chemicals and / or assay agents to, selectively taking tissue or fluid samples from, selectively measuring the temperature of the containment chamber 246 and / or the bodily tissue BT (e.g., via a thermocouple), and / or any other selective manipulation or measurement of at least one of the bodily tissue BT and an environment in containment chamber 246. For example, even when the first drain line 10198 is inserted directly into the bodily tissue BT, a portion of the managing fluid that has already been exposed to the bodily tissue BT may seep into the lower chamber portion 2104. Therefore, at least one additional drain line may operatively connect the negative pressure source 10204 to the lower chamber portion 2104 for the selective removal of managing fluid therefrom.

[0099] At least one of the body 102 (e.g., outer body part 304 and / or the inner body part 306), the lid 1132 (e.g., the lid body 9134 and / or the lid cap 9136), and the nonmagnet portions of the agitator 6112 may be at least partially formed from acrylic or another durable plastic. Forming the body 102 and the lid 1132 from, e.g., acrylic provides for a relatively low cost, durable containment device 100 that is scalable to a desired size. At least one of the body 102 (e.g., outer body part 304 and / or the innerbody part 306) and the lid 1132 (e.g., the lid body 9134 and / or the lid cap 9136), however, may instead be at least partially formed from any other desired material, such as, e.g., glass. Furthermore, at least one of the body 102, the lid 1132, and the nonmagnet portions of the agitator 6112 may be transparent or at least semi-transparent to allow a user to visually access interior portions of the containment device 100 (e.g., the containment chamber 246, the inner body cavity 256, and / or the inner lid cavity 2176), though at least one of the body 102, the lid 1132, and the non-magnet portions of the agitator 6112 may be opaque as desired.

[0100] Although the system 10184 has been shown as utilizing at least one of the drain lines 10198, 10202 for removing managing fluid from the containment chamber 246, the body 102 of containment device 100 may also or instead have at least one drain port 13206 (shown here as one drain port 13206) for removing managing fluid. For example, as shown in Figs. 13-15, the drain port 13206 may comprise an outer drain opening 15208 (which extends laterally from the outer body part’s external wall surface 320 to its internal wall surface 322), an inner drain opening 15210 (which extends laterally from the inner body part’s external wall surface 342 to its internal wall surface 344), and a drain connector 13212. The outer and inner drain openings 15208, 15210 may be located adjacent to the lower chamber side 274 of the containment chamber 246 for helping to remove managing fluid contained adjacent to the lower chamber side 272 (e.g., in the lower chamber portion 2104). Furthermore, the drain opening 11200 of the containment device configuration shown in Figs. 13-15 is defined by the outer and inner drain openings 15208, 15210. The drain opening 11200 thus is not directly aligned with (i.e., is longitudinally and / or laterally offset from) the bodily tissue BT when the bodily tissue BT is received in the containment chamber 246.

[0101] The drain port 13206 also includes a sleeve 15214 of the inner body part 306 that extends laterally from the inner body part’s external wall surface 342. The sleeve 15214 is adjacent to, and extends about, the inner drain opening 15210 on the inner body part’s external wall surface 342. The sleeve 15214 may be spaced (e.g., spaced radially) from the inner drain opening 15210 on the inner body part’s external wall surface 342 such that a portion of the inner body part’s external wall surface 342 is inside the sleeve 15214 and extends between the inner drain opening 15210 and the sleeve 15214.

[0102] When the outer and inner body parts 304, 306 are joined together, the sleeve 15214 extends in the inner body cavity 256 from the inner body part’s external wall surface 342 to the outer body part’s internal wall surface 322. The sleeve 14214 ispositioned and contacts the outer body part’s internal wall surface 322 such that the sleeve 14214 is adjacent to, and extends about, the outer drain opening 14208 on the outer body part's internal wall surface 322. The sleeve 15214 thus functions as a bridge to f I uidically connect the outer and inner drain openings 15208, 15210, without creating a leakage point or a significant disruption in the inner body cavity 256.

[0103] Although the outer and inner drain openings 15208, 15210 are shown as extending in the lateral direction through the outer and inner body parts 304, 306, the body 102 may instead be configured such that at least one of the outer and inner drain openings 15208, 15210 extends longitudinally. For example, the outer drain opening 15208 may be configured to extend longitudinally from the outer body part’s external base surface 310 to its internal base surface 312, and / or the inner drain opening 15210 may be configured to extend longitudinally from the inner body part’s external base surface 336 to its internal base surface 338. In configurations where the outer drain opening 15208 extends longitudinally from the outer body part’s external base surface 310 to its internal base surface 312 and the inner drain opening 15210 extends longitudinally from the inner body part’s external base surface 336 to its internal base surface 338, the sleeve 15214 extends longitudinally in the inner body cavity 256 from the inner body part’s external base surface 336 to the outer body part’s internal base surface 312 to fluidically connect the outer and inner drain openings 15208, 15210.

[0104] The drain connector 13212 is selectively received in and occludes at least the outer drain opening 15208. A portion of the drain connector 13212 may also be selectively received in the sleeve 15214 so as to make contact (e.g., sealing contact) with the inner body part’s external wall surface 342 inside the sleeve 15214. The drain connector 13212 may include an engagement portion 15216 for preventing the drain connector 13212 from undesirably egressing from at least the outer drain opening 15208 when received therein. For example, the engagement portion 15216 may provide for may provide for a threaded engagement, a press-fit or frictional fit engagement, a separately provided fastener (not shown), adhesive or welding, and / or any other type of engagement suitable for selectively maintaining the drain connector 362 in at least the outer drain openings 15208.

[0105] The drain connector 13212 may also include a connecting portion 13218 via which the drain connector 13212 is selectively connected to, e.g., the negative source 13204 (e.g., via a drain line or otherwise). Therefore, when the drain connector 13212 is connected to the negative pressure source 10204, managing fluid in the containment chamber 246 (e.g., the lower chamber portion 2104) may be removed from thecontainment chamber 246 via at least one of the drain connector 13212, the inner drain opening 15210, and the outer drain opening 15208. The connecting portion 13218 may be configured to provide a Luer taper connection, a press-fit or frictional-fit connection, a threaded connection, a separately provided fastener (not shown), and / or any other type of connection suitable for selectively maintaining the drain connector 13212 connected to a separate fluid-carrying line and / or any other medical device / instrument.

[0106] The drain port 13206 may also include at least one drain sealing member 15220, 15222 (e.g., a resilient or rigid ring or washer) interposed, and at least partially forming a fluidtight seal, between the body 102 (e.g., the outer and inner body parts 304, 306) and the drain connector 13212. For example, the drain port 13206 may include a first drain sealing member 15220 directly contacting and interposed laterally between a portion of the drain connector 13212 (e.g., a flange portion 14224 of the drain connector 13212) and a portion of the outer body 304 (e.g., a beveled portion 15225 of the outer drain opening 15208 that is adjacent the outer body part’s external wall surface 320). The drain port 13206 may also include a second drain sealing member 15222 directly contacting and interposed laterally between a portion of the drain connector 13212 (e.g., the engagement portion 15216 of the drain connector 13212) and a portion of the inner body part 306 (e.g., a portion of the inner body part’s external wall surface 342 that is within the sleeve 15214). The second drain sealing member 15222 thus may be at least partially located within the sleeve 15214.

[0107] Although the first and second drain sealing members 15220, 15222 are formed separately from and subsequently joined to the drain connector 13212, the first and second drain sealing members 15220, 15222 may be formed integrally with the drain connector 13212 as a single monolithic piece. As other alternatives or additions, a press-fit or frictional fit engagement of the drain connector 13212 in at least one of outer drain opening 15208, inner drain opening 15210, and the sleeve 15214 or forming the drain connector 13212 with at least one of the outer and inner body parts 304, 306 as a single monolithic piece may provide the fluidtight-seal functionality. In such configurations, the first and second drain sealing members 15220, 15222 may be included or omitted as desired. Regardless of how the fluidtight seal is formed, providing such functionality may help prevent fluid leaks during use.

[0108] Although the managing fluid source 10190 may include a mechanism (heater / cooler) for selectively maintaining and / or achieving a desired temperature for the managing fluid, the containment device 100 itself may also or instead be configured to include features for maintaining and / or achieve the desired temperature for themanaging fluid. In particular, as shown in the example containment device configuration of Figs. 16-17, the containment device 100 may also include one or more managing fluid regulating ports 16234. Each managing fluid regulating port 16234 comprises a regulating opening 17236 extending from an exterior of the body 102 to the inner body cavity 256 when the outer and inner body parts 304, 306 are joined together. In particular, the regulating opening 17236 may extend completely through the inner body part’s rim 340 (e.g., at the flange portion 248) such that, when the inner body part 306 is joined to the inner body part 304, the regulating opening 17236 extends longitudinally from an exterior portion of the rim 340 to the inner body cavity 256.

[0109] Each managing fluid regulating port 16234 also includes a dual-sided regulating connector 16238 occluding and extending completely through an associated regulating opening 17236. Therefore, a first connecting portion 17240 of the regulating connector 16238 is located in ambient space outside the exterior of the body 102, while a second connecting portion 17242 of the regulating connector 16238 is spaced from the first connecting portion 17240 and located inside the inner body cavity 256. Each of the first and second connecting portions 17240, 17242 may be configured to provide a Luer taper connection, a press-fit or frictional-fit connection, a threaded connection, a separately provided fastener (not shown), and / or any other type of connection suitable for selectively maintaining each of the regulating connectors 16238 connected to a separate fluid-carrying line and / or any other medical device / instrument.

[0110] Each regulating connector 16238 may be selectively maintained in an associated regulating opening 17236 via an engagement portion 17244 in any desired manner. As shown in Figs. 16-17, for example, the engagement portion 17244 of each regulating connector 16238 may include threads and be located adjacent to the first connecting portion 17240 such that each threaded engagement portion 17244 is at least partially located in the ambient space outside the exterior of the body 102. Locking members 16246 (shown here, by way of example, as one or more threaded nuts) may be threadably attached to the threaded engagement portions 17244 to help prevent the regulating connectors 16238 from egressing from their predetermined position in the regulating openings 17236.

[0111] Instead of including a separate locking member 16246, at least one of the regulating openings 17236 may be threaded for selectively threadably engaging the threaded engagement portions 17244. As another alternative, each connecting portion 17240, 17242 may include an opening that extends entirely laterally through the regulating connector 16238. The opening in the regulating connector 16238 mayselectively receive a locking member 16246 (e.g., a R-pin, a split pin, a lock washer, a split ring, a cotter pin, and / or a linchpin) to maintain the regulating connector 16238 in the desired position.

[0112] The regulating connectors 16238 may each also include a flange portion 17248 located adjacent to the second connecting portions 17242 such that the flange portions 17248 are positioned in the inner body cavity 256 during use. The flange portions 17248 may be dimensioned and configured so as to not be able to pass through the regulating openings 17236. The flange portions 17248 may thus functionally work with the engagement portions 17244 in helping to maintain the regulating connectors 16238 connected to the body 102.

[0113] The regulating ports 16234 may each also include at least one regulating sealing member 17250 (e.g., a resilient or rigid ring or washer) interposed, and at least partially forming a fluidtight seal, between the body 102 and the regulating connectors 16238. For example, each regulating port 16234 may include a regulating sealing member 17250 directly contacting and interposed laterally between the flange portion 17248 of a respective regulating connector 16238 and the inner body part 306 (e.g., the rim 340 and / or flange 248 of the inner body part 306). The regulating sealing members 17250 may be separate from their respective regulating connectors 16238 or may be formed integrally with their respective regulating connectors 16238 as a single monolithic piece. A press-fit or frictional fit engagement of the regulating connectors 16238 in their regulating openings 17236 also or instead may provide the fluidtight-seal functionality. In such a configuration, the regulating sealing members 17250 may be included or omitted as desired. Regardless of how the fluidtight seal is formed, providing such a seal helps prevent temperature regulating fluid from leaking out of the inner body cavity 256 during use.

[0114] As shown in Fig. 17, a MF regulating line 17252 may have a first and second ends 17252a, 17252b selectively connected to (e.g., by being inserted over) the second connecting portions 17242 of the regulating connectors 16238 so as to fluidically connect the regulating connectors to one another. The regulating connectors 16238 and the MF regulating line 17252 thus define a conduit that extends through and is closed off from (e.g., not in fluid communication with) the inner body cavity 256.

[0115] In the example use configuration shown in Fig. 18, a first delivery line 18254 has a first end 18254a selectively connected (e.g., via a Luer taper connector 10189) to the first connecting portion 17240 of a first selected one of the regulating ports 16234, and a second end 18254b selectively connected to the managing fluid source 10190. Asecond delivery line 18256 has a first end 18256a selectively connected (e.g., via another Luer taper connector 10189) to the first connecting portion 17240 of a second selected one of the regulating ports 16234, and a second end 18256b selectively connected to the first connecting portion 588 of a first selected one of the chamber ports 476. Although not shown in Fig. 18, a third delivery line (similar to the second delivery line(s) 10194 discussed above in relation to Figs. 10-12) may have a first end in the upper chamber portion 2102 and / or connected to the bodily tissue BT, and a second end connected to the second connecting portion 590 of the first selected chamber port 476. Therefore, via the managing fluid source 10190, the first, second, and third delivery lines 18254, 18256, the MF regulating line 17252, the first selected chamber port 476, and the first and second selected regulating ports 16234, managing fluid may be selectively delivered to the bodily tissue BT in the containment chamber 246.

[0116] As discussed in the above, the managing fluid flows through the MF regulating line 17252 prior to being delivered to the bodily tissue BT and / or the containment chamber 246. The managing fluid thus travels in the MF regulating line 17252 through the inner body cavity 256 and the temperature regulating fluid TF contained therein. Accordingly, the temperature regulating fluid TF in the inner body cavity 256 may be utilized to maintain or achieve a predetermined temperature for the managing fluid, without undesirably mixing the managing fluid with the temperature regulating fluid.

[0117] Managing fluid contained within the lower chamber portion 2104 may be removed from the containment chamber 246 via at least one drain line 18258. Although not shown in the example configuration of Fig. 18, a first drain line (similar to the first drain line(s) 10198 discussed above in relation to Figs. 10-12) may be inserted into the lower chamber portion 2104 such that a drain opening through which managing fluid enters the first drain line is positioned in or adjacent to the managing fluid contained in the lower chamber portion 2104. A second end of the first drain line may be selectively connected (e.g., via another Luer taper connector 10189) to the second connecting portion 590 of a second selected one of the chamber ports 476. A second drain line 18258, one the other hand, has a first end 18258a connected (e.g., via another Luer taper connector 10189) to the first connecting portion 588 of a second selected chamber port 476, and a second end 18258b connected to the negative pressure source 10204. Therefore, via the negative pressure source 10204, the first and second drain lines 18258, and the second selected chamber port 476, managing fluid may be selectively removed from the containment chamber 246.

[0118] In some instances, it may be desirable to remove and replace and / or remove, clean, and reinsert the MF regulating line 17252. Therefore, the outer and inner body parts 304, 306 may be removably connected to one another so that MF regulating line 17252 may be accessed via the removal of one of the outer and inner body parts 304, 306 from the other of the outer and inner body parts 304, 306. In the example configuration shown in Fig. 16, for example, the outer and inner body parts 304, 306 are removably connected to one another via a plurality of screws 16260, though any other connecting / engagement mechanism that provides such a removable connection / engagement may be provided instead of or in addition to the screws 16260.

[0119] Furthermore, the embodiment of the containment device 100 that includes the removably connected inner and outer body parts 304, 306 (or in any other embodiment of the containment device 100) may include a body sealing member 17262 (as previously discussed) interposed between the outer and inner body parts 304, 306 to help bolster and / or form a fluidtight seal between the outer and inner body parts 304, 306. For example, as shown in Figs. 17-17A, at least a portion of the body sealing member 17262 may be disposed in a groove 17264 of the outer body part 304 such that the body sealing member 17262 is interposed directly between and directly contacts each of the outer and inner body parts 304, 306 to help bolster and / or form a fluidtight seal between the outer and inner body parts 304, 306.

[0120] Some or any configuration(s) of the containment device 100 and / or the system 10184 may include one or more features for selectively holding at least one of the lines at a predetermined position in the containment chamber 246. For example, as shown in Figs. 19-20, at least one arm 19264 may be selectively provided in the containment chamber 246. Each arm 19264 shown in the example configuration of Figs. 19-20 includes first and second arm portions 19266, 19268 that are articulatable relative to one another, though at least one of the arms 19264 more or less arm portions. A first end of the first arm portion 19266 includes a line connector 19270 for selectively holding / engaging a selected line (which may be a delivery and / or a drain line). In the example configuration shown in Figs. 19-20, the line connector 19270 is c- shaped and provides for a press-fit or fictional fit engagement with a selected one of the lines, though the line connector 19270 may be configured to provide any other suitable engagement mechanism / method for selectively holding / engaging a selected line. An opposite, second end of the first arm portion 19270 includes a first portion 19272 of a first ball-and-socket joint 19274.

[0121] A first end of the second arm portion 19268 includes a second portion 19276 of the first ball-and-socket joint 19274 such that the first and second arm portions 19266, 19268 can be articulated relative to one another. In the example configurations shown in Figs. 19-20, the first portion 19272 of the first ball-and-socket joint 19274 is the “ball” or ball-shaped surface of the first ball-and-socket joint 19274, while the second portion 19276 is the “socket” or cup-like depression of the first ball-and-socket joint 19274. However, at least one of the arms 19264 may instead be configured such that the first portion 19272 of the first ball-and-socket joint 19274 is the “socket”, while the second portion 19276 of the first ball-and-socket joint 19274 is the “ball”. An opposite, second end of the second arm portion 19268 includes a first portion 19278 of a second ball-and-socket joint 19280.

[0122] In the example configuration shown in Figs. 19-20, the second connecting portion 590 of at least one of the chamber connectors 586 is / includes a second portion of the second ball-and-socket joint 19280 such that the second arm portion 19268 can be articulated relative to its corresponding chamber connector 586. In the example configurations shown in Figs. 19-20, the first portion 19278 of the second ball-and- socket joint 19280 is the “socket” or cup-like depression of the second ball-and-socket joint 19280, while the second portion (i.e., the second connecting portion 590 of the chamber connector 586) is the “ball” or ball-shaped surface of the second ball-and- socket joint 19280. However, at least one of the arms 19264 and / or the chamber connectors 586 may instead be configured such that the first portion 19278 of the second ball-and-socket joint 19280 is the “ball”, while the second portion of the second ball-and-socket joint 19280 is the “socket”.

[0123] Although each chamber connector 586 of Figs. 19-20 that has a second connecting portion 590 formed as a portion of a second ball-and-socket joint 19280 is constructed without a first connecting portion 588, at least one of these chamber connectors 586 may be alternatively constructed with the first connecting portion 588. Furthermore, instead of being formed from a corresponding second connecting portion 590, the second portion of at least one second ball-and-socket joint 19280 may be a separate piece that is selectively attached to the corresponding second connecting portion 590.

[0124] As shown in Fig. 20, via the selective articulation provided by the first and second ball-and-socket joints 19274, 19280, the line connector 19270 of each provided arm 19264 may be selectively manipulated into a predetermined position for holding aselected one of the lines 10194, 10198 in a predetermined position / orientation in the containment chamber 246.

[0125] Although certain features have only been shown and described in regard to one example containment device configuration and / or system configuration, it should be appreciated that each feature of one of the containment device configurations and / or system configurations may be imported into any other containment device configuration and / or system configuration.

[0126] In summary, a person having ordinary skill in the art will understand that the present disclosure provides the below example aspects, whether they be alone or in combination with one another.

[0127] Example aspect 1 : a containment device for managing a bodily tissue ex vivo, comprising: a body defining a containment chamber configured to selectively receive an entirety of the bodily tissue being managed, the body having an inner body cavity fl uidically separate from and located adjacent to a plurality of sides of the containment chamber; and a lid for selectively closing the containment chamber, the lid having an inner lid cavity located adjacent to at least one of the plurality of sides of the containment chamber when the containment chamber is closed via the lid, each of the inner lid cavity and the inner body cavity being configured to selectively receive a temperature regulating fluid so as to maintain at least one of the bodily tissue and the containment chamber at a predetermined temperature, each of the inner lid cavity and the inner body cavity being closed to surrounding atmosphere such that the temperature regulating fluid received in the inner lid cavity and inner body cavity is isolated from the surrounding atmosphere.

[0128] Example aspect 2: The containment device of example aspect 1 , wherein the plurality of sides of the containment chamber include an upper chamber side, a lower chamber side spaced vertically from the upper chamber side, and at least one lateral chamber side extending vertically between the upper and lower chamber sides, the inner lid cavity being located adjacent to at least the upper chamber side when the containment chamber is closed via the lid, the inner body cavity being located adjacent to at least the lower chamber side and the at least one lateral chamber side.

[0129] Example aspect 3: The containment device of any of example aspects 1 -2, further comprising: at least one body cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner body cavity; and at least one lid cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner lid cavity.

[0130] Example aspect 4: The containment device of example aspect 3, wherein the at least one body cavity port comprises a body cavity opening extending from an exterior of the body to the inner body cavity, and a body cavity connector selectively received in and occluding the body cavity opening and via which the inner body cavity is selectively fluidically connected to a source of the temperature regulating fluid, and wherein the at least one lid cavity port comprises a lid cavity opening extending from an exterior of the lid to the inner lid cavity, and a lid cavity connector selectively received in and occluding the lid cavity opening and via which the inner lid cavity is selectively fluidically connected to the source of the temperature regulating fluid.

[0131] Example aspect 5: The containment device of any of example aspects 1 -4, wherein the lid includes a lid body and a lid cap separate from and connected to the lid body, the inner lid cavity being at least partially defined by the lid body and the lid cap collectively.

[0132] Example aspect 6: The containment device of any of example aspects 1 -5, wherein the body includes an outer body part and an inner body part separate from and connected to the outer body part, the inner body part defining the containment chamber and having a portion extending into the outer body part, the inner body cavity being at least partially defined by the outer and inner body parts collectively.

[0133] Example aspect 7: The containment device of any of example aspects 1 -6, wherein the body has at least one outer body slot therein for thermally insulating at least one of the containment chamber and the inner body cavity.

[0134] Example aspect 8: The containment device of example aspect 7, wherein each outer body slot extends inwardly from an exterior surface of the outer body part.

[0135] Example aspect 9: The containment device of any of example aspects 1 -8, further comprising a plurality of chamber ports, each chamber port adapted for use in delivering a managing fluid to at least one of the bodily tissue and the containment chamber and for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber.

[0136] Example aspect 10: The containment device of example aspect 9, wherein at least one of the chamber ports is selected for use in delivering the managing fluid to at least one of the bodily tissue and the containment chamber, at least one of the chamber ports being selected for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber.

[0137] Example aspect 11 : The containment device of any of example aspects 9-10, wherein at least one of the chamber ports comprises a body chamber openingextending from an exterior of the body to the containment chamber, and a dual-sided chamber connector occluding and extending completely through the body chamber opening such that a first connecting portion of the chamber connecter is located in ambient space outside the exterior of the body and a second connecting portion of the chamber connector is spaced from the first connecting portion and located inside the containment chamber.

[0138] Example aspect 12: The containment device of any of example aspects 1-11 , wherein the bodily tissue in the containment chamber is configured to selectively receive a managing fluid, the containment device further comprising: a plurality of managing fluid regulating ports, each managing fluid regulating port extending from an exterior portion of the body to the inner body cavity; and a managing fluid regulating line fluidically connecting two associated managing fluid regulating ports together such that managing fluid selectively flows from a first one of the associated managing fluid regulating ports to the other via the managing fluid regulating line, the managing fluid regulating line extending through the inner body cavity such that the temperature regulating fluid in the inner body cavity at least partially maintains or achieves a predetermined temperature for the managing fluid that selectively flows through the managing fluid regulating line.

[0139] Example aspect 13: The containment device of any of example aspects 1-12, wherein the bodily tissue in the containment chamber is configured to selectively receive a managing fluid, the containment device further comprising an agitator that agitates managing fluid within the containment chamber when actuated.

[0140] Example aspect 14: The containment device of example aspect 13, wherein the agitator is actuated via magnetic stimuli.

[0141] Example aspect 15: The containment device of any of example aspects 13- 14, further comprising a support plate in the containment chamber dividing the containment chamber into first and second chamber portions, the support plate being configured to selectively receive the bodily tissue thereon such that the received bodily tissue is located in the first chamber portion, the second chamber portion being configured to contain managing fluid that flows from the first chamber portion into the second chamber portion, the agitator being located in the second chamber portion so as to selectively agitate the managing fluid in the second chamber portion.

[0142] Example aspect 16: The containment device of any of example aspects 1-15, wherein the containment chamber is configured to selectively expose bodily tissue therein to a managing fluid, the containment device further comprising a drain openingin the containment chamber through which managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the drain opening not being directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.

[0143] Example aspect 17: The containment device of example aspect 16, further comprising at least one drain port via which the managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the at least one drain port comprising: the drain opening, the drain opening extending from an external surface of the body to the containment chamber; and a drain connector selectively received at least partially in the drain opening and selectively connectable to a drain line.

[0144] Example aspect 18: An ex vivo bodily tissue management system, comprising: the containment device of any of example aspects 1 -17, the containment device further comprising at least one body cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner body cavity, and at least one lid cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner lid cavity; and a temperature regulating fluid source selectively fl uidically connected to each of the inner body cavity via the at least one body cavity port and the inner lid cavity via the at least one lid cavity port, the temperature regulating fluid being selectively circulated between the temperature regulating fluid source and the inner body and lid cavities.

[0145] Example aspect 19: The system of example aspect 18, wherein the containment device further comprises a plurality of chamber ports, each chamber port being adapted for use in delivering a managing fluid to at least one of the bodily tissue and the containment chamber and for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber, the system further comprising: a managing fluid source selectively fluidically connected to at least one of the bodily tissue and the containment chamber via at least one of the chamber ports for selectively delivering the managing fluid to at least one of the bodily tissue and the containment chamber.

[0146] Example aspect 20: The system of example aspect 19, further comprising: at least one delivery line having a first delivery line end inserted into the bodily tissue and a second delivery line end connected to an associated chamber port, the managing fluid being selectively delivered from the managing fluid source to the bodily tissue via the at least one delivery line and the associated chamber port; and at least one drain linehaving a first drain end inserted into at least one of the containment chamber and the bodily tissue, a second drain end of the at least one drain line being connected to an associated chamber port, the managing fluid being selectively removed from at least one of the bodily tissue and the containment chamber via the at least one drain line and the associated chamber port of the at least one drain line.

[0147] Example aspect 21 : The system of example aspect 20, wherein the first drain end of the at least one drain line is inserted into the containment chamber and positioned such that a drain opening of the drain line through which managing fluid enters the drain line is not directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.

[0148] Example aspect 22: The system of example aspect 19, further comprising: a plurality of managing fluid regulating ports, each managing fluid regulating port extending from an exterior portion of the body to the inner body cavity; a managing fluid regulating line fluidical ly connecting two associated managing fluid regulating ports together such that managing fluid selectively flows from a first one of the associated managing fluid regulating ports to the other via the managing fluid regulating line, the managing fluid regulating line extending through the inner body cavity; a first delivery line having a first end connected to the managing fluid source and a second end connect connected to a first one of the managing fluid regulating ports; a second delivery line having a first end connected to a second one of the managing fluid regulating ports and a second end connected to a selected chamber port; and a third delivery line having a first end inserted into the bodily tissue and a second end connected to the selected chamber port, the managing fluid being selectively delivered from the managing fluid source to the bodily tissue via the first, second, and third delivery lines, the managing fluid regulating line, the selected chamber port, and the first and second regulating ports, the managing fluid selectively flowing through the inner body cavity in the managing fluid regulating line is maintained at or achieve a predetermined temperature via the temperature regulating fluid in the inner body cavity.

[0149] Example aspect 23: The system of claim 22, further comprising a drain line having a first end inserted into at least one of the containment chamber and the bodily tissue, a second end of the drain line being connected to a second selected chamber port, the managing fluid being selectively removed from at least one of the bodily tissue and the containment chamber via the drain line and the second selected chamber port.

[0150] Example aspect 24: The system of example aspect 18, wherein the bodily tissue in the containment chamber is configured for selective exposure to a managingfluid, the containment device including a drain opening in the containment chamber through which managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the drain opening not being directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.

[0151] Example aspect 25: The system of example aspect 24, further comprising at least one drain port via which the managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the at least one drain port comprising: the drain opening, the drain opening extending from an external surface of the body to the containment chamber; and a drain connector selectively received at least partially in the drain opening and selectively connectable to a drain line.

[0152] Example aspect 26: The system of any of example aspects 18-25, wherein the bodily tissue in the containment chamber is configured for selective exposure to a managing fluid, the containment device including an agitator that selectively agitates managing fluid that has already been exposed to the bodily tissue in the containment chamber.

[0153] Example aspect 27: The system of example aspect 26, wherein a support plate of the containment device is in the housing and divides the containment chamber into first and second chamber portions, the support plate being configured to selectively receive the bodily tissue thereon such that the received bodily tissue is located in the first chamber portion, the second chamber portion being configured to contain managing fluid that flows from the first chamber portion into the second chamber portion, the agitator being located in the second chamber portion so as to agitate the managing fluid in the second chamber portion when actuated, the system further comprising: an actuator proximate to the agitator and via which selectively actuates the agitator.

[0154] Example aspect 28: The system of any of example aspects 18-27, further comprising at least one arm in the containment chamber for selectively holding and / or maintaining at least one line at a predetermined position in the containment chamber.

[0155] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means / options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shownhave not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate subcomponents, with either of these formations involving any suitable stock or bespoke components and / or any suitable material or combinations of materials. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified-a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.

[0156] Other aspects, objects, and advantages may be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

I claim:1 . A containment device for managing a bodily tissue ex vivo, comprising: a body defining a containment chamber configured to selectively receive an entirety of the bodily tissue being managed, the body having an inner body cavity fluidically separate from and located adjacent to a plurality of sides of the containment chamber; and a lid for selectively closing the containment chamber, the lid having an inner lid cavity located adjacent to at least one of the plurality of sides of the containment chamber when the containment chamber is closed via the lid, each of the inner lid cavity and the inner body cavity being configured to selectively receive a temperature regulating fluid so as to maintain at least one of the bodily tissue and the containment chamber at a predetermined temperature, each of the inner lid cavity and the inner body cavity being closed to surrounding atmosphere such that the temperature regulating fluid received in the inner lid cavity and inner body cavity is isolated from the surrounding atmosphere.

2. The containment device of claim 1 , wherein the plurality of sides of the containment chamber include an upper chamber side, a lower chamber side spaced vertically from the upper chamber side, and at least one lateral chamber side extending vertically between the upper and lower chamber sides, the inner lid cavity being located adjacent to at least the upper chamber side when the containment chamber is closed via the lid, the inner body cavity being located adjacent to at least the lower chamber side and the at least one lateral chamber side.

3. The containment device of claim 1 , further comprising: at least one body cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner body cavity; and at least one lid cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner lid cavity.

4. The containment device of claim 3, wherein the at least one body cavity port comprises a body cavity opening extending from an exterior of the body to the inner body cavity, and a body cavity connector selectively received in and occluding the body cavity opening and via which the inner body cavity is selectively fluidically connected to a source of the temperature regulating fluid, and wherein the at least one lid cavity port comprises a lid cavity opening extending from an exterior of the lid to the inner lid cavity, and a lid cavity connector selectively received in and occluding the lid cavity opening and via which the inner lid cavity is selectively fluidically connected to the source of the temperature regulating fluid.

5. The containment device of claim 1 , wherein the lid includes a lid body and a lid cap separate from and connected to the lid body, the inner lid cavity being at least partially defined by the lid body and the lid cap collectively.

6. The containment device of claim 1 , wherein the body includes an outer body part and an inner body part separate from and connected to the outer body part, the inner body part defining the containment chamber and having a portion extending into the outer body part, the inner body cavity being at least partially defined by the outer and inner body parts collectively.

7. The containment device of claim 1 , wherein the body has at least one outer body slot therein for thermally insulating at least one of the containment chamber and the inner body cavity.

8. The containment device of claim 1 , further comprising a plurality of chamber ports, each chamber port adapted for use in delivering a managing fluid to at least one of the bodily tissue and the containment chamber and for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber.

9. The containment device of claim 8, wherein at least one of the chamber ports is selected for use in delivering the managing fluid to at least one of the bodily tissue and the containment chamber, at least one of the chamber ports being selected for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber.

10. The containment device of claim 8, wherein at least one of the chamber ports comprises a body chamber opening extending from an exterior of the body to the containment chamber, and a dual-sided chamber connector occluding and extending completely through the body chamber opening such that a first connecting portion of the chamber connecter is located in ambient space outside the exterior of the body and a second connecting portion of the chamber connector is spaced from the first connecting portion and located inside the containment chamber.11 . The containment device of claim 1 , wherein the bodily tissue in the containment chamber is configured to selectively receive a managing fluid, the containment device further comprising: a plurality of managing fluid regulating ports, each managing fluid regulating port extending from an exterior portion of the body to the inner body cavity; and a managing fluid regulating line fluidically connecting two associated managing fluid regulating ports together such that managing fluid selectively flows from a first one of the associated managing fluid regulating ports to the other via the managing fluid regulating line, the managing fluid regulating line extending through the inner body cavity such that the temperature regulating fluid in the inner body cavity at least partially maintains or achieves a predetermined temperature for the managing fluid that selectively flows through the managing fluid regulating line.

12. The containment device of claim 1 , wherein the bodily tissue in the containment chamber is configured to selectively receive a managing fluid, the containment device further comprising an agitator that agitates managing fluid within the containment chamber when actuated.

13. The containment device of claim 12, wherein the agitator is actuated via magnetic stimuli.

14. The containment device of claim 12, further comprising a support plate in the containment chamber dividing the containment chamber into first and second chamber portions, the support plate being configured to selectively receive the bodily tissue thereon such that the received bodily tissue is located in the first chamber portion, the second chamber portion being configured to contain managing fluid that flows from the first chamber portion into the second chamber portion, the agitator being located in the second chamber portion so as to selectively agitate the managing fluid in the second chamber portion.

15. The containment device of claim 1 , wherein the containment chamber is configured to selectively expose bodily tissue therein to a managing fluid, the containment device further comprising a drain opening in the containment chamber through which managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the drain opening not being directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.

16. The containment device of claim 15, further comprising at least one drain port via which the managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the at least one drain port comprising: the drain opening, the drain opening extending from an external surface of the body to the containment chamber; and a drain connector selectively received at least partially in the drain opening and selectively connectable to a drain line.

17. An ex vivo bodily tissue management system, comprising: the containment device of claim 1 , the containment device further comprising at least one body cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner body cavity, and at least one lid cavity port via which the temperature regulating fluid is selectively circulated into and out from the inner lid cavity; and a temperature regulating fluid source selectively fluidically connected to each of the inner body cavity via the at least one body cavity port and the inner lid cavity via theat least one lid cavity port, the temperature regulating fluid being selectively circulated between the temperature regulating fluid source and the inner body and lid cavities.

18. The system of claim 17, wherein the containment device further comprises a plurality of chamber ports, each chamber port being adapted for use in delivering a managing fluid to at least one of the bodily tissue and the containment chamber and for use in removing the managing fluid from at least one of the bodily tissue and the containment chamber, the system further comprising: a managing fluid source selectively fluidically connected to at least one of the bodily tissue and the containment chamber via at least one of the chamber ports for selectively delivering the managing fluid to at least one of the bodily tissue and the containment chamber.

19. The system of claim 18, further comprising: at least one delivery line having a first delivery line end inserted into the bodily tissue and a second delivery line end connected to an associated chamber port, the managing fluid being selectively delivered from the managing fluid source to the bodily tissue via the at least one delivery line and the associated chamber port; and at least one drain line having a first drain end inserted into at least one of the containment chamber and the bodily tissue, a second drain end of the at least one drain line being connected to an associated chamber port, the managing fluid being selectively removed from at least one of the bodily tissue and the containment chamber via the at least one drain line and the associated chamber port of the at least one drain line.

20. The system of claim 19, wherein the first drain end of the at least one drain line is inserted into the containment chamber and positioned such that a drain opening of the drain line through which managing fluid enters the drain line is not directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.21 . The system of claim 18, further comprising: a plurality of managing fluid regulating ports, each managing fluid regulating port extending from an exterior portion of the body to the inner body cavity; a managing fluid regulating line fluidically connecting two associated managing fluid regulating ports together such that managing fluid selectively flows from a first one of the associated managing fluid regulating ports to the other via the managing fluid regulating line, the managing fluid regulating line extending through the inner body cavity; a first delivery line having a first end connected to the managing fluid source and a second end connect connected to a first one of the managing fluid regulating ports; a second delivery line having a first end connected to a second one of the managing fluid regulating ports and a second end connected to a selected chamber port; and a third delivery line having a first end inserted into the bodily tissue and a second end connected to the selected chamber port, the managing fluid being selectively delivered from the managing fluid source to the bodily tissue via the first, second, and third delivery lines, the managing fluid regulating line, the selected chamber port, and the first and second regulating ports, the managing fluid selectively flowing through the inner body cavity in the managing fluid regulating line is maintained at or achieve a predetermined temperature via the temperature regulating fluid in the inner body cavity.

22. The system of claim 17, wherein the bodily tissue in the containment chamber is configured for selective exposure to a managing fluid, the containment device including a drain opening in the containment chamber through which managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the drain opening not being directly aligned with the bodily tissue when the bodily tissue is received in the containment chamber.

23. The system of claim 22, further comprising at least one drain port via which the managing fluid that has already been exposed to the bodily tissue is removed from the containment chamber, the at least one drain port comprising: the drain opening, the drain opening extending from an external surface of the body to the containment chamber; and a drain connector selectively received at least partially in the drain opening and selectively connectable to a drain line.

24. The system of claim 17, wherein the bodily tissue in the containment chamber is configured for selective exposure to a managing fluid, the containment device including an agitator that selectively agitates managing fluid that has already been exposed to the bodily tissue in the containment chamber.

25. The system of claim 24, wherein a support plate of the containment device is in the housing and divides the containment chamber into first and second chamber portions, the support plate being configured to selectively receive the bodily tissue thereon such that the received bodily tissue is located in the first chamber portion, the second chamber portion being configured to contain managing fluid that flows from the first chamber portion into the second chamber portion, the agitator being located in the second chamber portion so as to agitate the managing fluid in the second chamber portion when actuated, the system further comprising: an actuator proximate to the agitator and via which selectively actuates the agitator.

Citation Information

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