Patent Description:
Organ perfusion is commonly used for ex vivo maintenance and transportation of excised organs (i.e. for maintenance of the organ while isolated from the body). A perfusion fluid (known as a 'perfusate') is used to supply oxygen and nutrients to the cells and tissues within the harvested organ, and to remove carbon dioxide and other waste. The excised organ is typically placed inside an organ chamber and connected at the primary artery or arteries to a fluid system. The fluid system supplies the organ with perfusate, which may pass through capillary beds in the organ and into the veins, and is then excreted from the organ's primary vein or veins.

For example, as illustrated in <FIG>, in the typical 'hanging heart' method for perfusing an excised heart <NUM>, the heart is hung inside an organ chamber <NUM>. Aorta <NUM> of heart <NUM> is sutured with suture <NUM> to cannula <NUM> and vena cava <NUM> is sutured with suture <NUM> to cannula <NUM>. Perfusate may flow to and from a fluid system (not shown) and in and out of the heart through tubes <NUM> and <NUM> which are coupled to cannulas <NUM> and <NUM>, respectively. Pulmonary artery <NUM> may also be connected to cannula <NUM>. As shown, cannula <NUM> is downward pointing, such that fluids can collect at base <NUM> of chamber <NUM> and drained through drain <NUM>.

<CIT> discloses a device comprising the features of the preamble of claim <NUM>.

New apparatus, systems, and methods for supporting an excised organ during perfusion are desirable.

In accordance with the present invention, there is provided a device for supporting and connecting an excised organ during perfusion as defined in claim <NUM>. The device includes a resilient and flexible sheet having a first portion for contacting and supporting the organ thereon, and a second portion comprising an opening for forming a connection between the organ and a conduit to allow fluid communication between the conduit and the organ; and a magnetic material embedded in the second portion of the sheet for magnetically securing the connection between the conduit and the organ.

In another aspect of the disclosure, the first portion includes a first material having a first Shore hardness value, and the second portion includes a second material having a second Shore hardness value, the first Shore hardness value being lower than the second Shore hardness value.

In another aspect of the disclosure, the first Shore hardness value is selected from <NUM>-<NUM> to <NUM>-<NUM> to allow the first portion of the sheet to conform to an external shape of the organ when the organ is supported on the sheet.

In another aspect of the disclosure, a section in the second portion of the sheet at the opening has a Shore hardness value higher than 0A, selected to limit distention of the section of the sheet under an applied fluid pressure in the opening.

In another aspect of the disclosure, the sheet comprises a silicone. In another aspect of the disclosure, different portions of the sheet include different silicone materials having different Shore hardness values.

In another aspect of the disclosure, the magnetic material includes particulate magnets or ferromagnetic particulates dispersed around the opening for magnetically attracting a magnetic connector attached to the organ.

In another aspect of the disclosure, the sheet includes a magnetic connector embedded in the sheet for coupling with an external magnetic connector.

In another aspect of the disclosure, the magnetic connector embedded in the sheet comprises a flange mounted on or connectable to the conduit.

In another aspect of the disclosure, the opening of the sheet includes a first opening for receiving an end of a cannula connected to the organ, a second opening for fluid communication therethrough, and a fluid channel in the sheet connecting the first opening and the second opening.

In another aspect of the disclosure, the sheet has a first side and a second side, the first opening is on the first side of the sheet and the channel extends between the first side and the second side within the sheet.

In another aspect of the disclosure, the second opening is at an edge of the sheet between the first side and the second side.

In another aspect of the disclosure, the sheet includes a throughhole to allow a fluid tubing to pass therethrough.

In another aspect of the disclosure, the sheet includes a reinforcing frame in the second portion, which may comprise a urethane material.

In another aspect of the disclosure, the organ is a heart, and the second portion of the sheet has a plurality of openings comprising a first opening for fluid communication with an aorta of the heart, a second opening for fluid communication with a pulmonary artery of the heart, and a third opening for fluid communication with an atrium of the heart.

In another aspect of the disclosure, the connection includes attachment of a cannula attached to the organ to a tubing attached to the sheet.

In some embodiments, a cannula attached to a sheet described herein by the connection may include a pressure sensor port for coupling with a pressure sensor, or may include an integrated pressure sensor in the cannula. During use, the pressure sensor may be used to detect or measure a pressure in the fluid channel of the cannula and thus the corresponding pressure at a part of the organ that is connected to the cannula.

In another aspect of the disclosure, the sheet may be mounted inside a chamber, the chamber including a plurality of ports for connecting a plurality of fluid conduits to the organ supported on the sheet.

In another aspect of the disclosure, the chamber comprises a plurality of mounting posts having different heights, and the sheet is mounted on the mounting posts and is inclined such that the first portion is lower than the second portion.

In another aspect of the disclosure, there is provided a kit comprising the support device and a set of external magnetic connectors each configured for connecting with a respective cannula. The kit may include a first connector for connecting with an artery of a heart, and a second connector for connecting with an atrium of the heart, and a third connector for connecting with an aorta of the heart.

Other aspects, features, and embodiments of the present disclosure will become apparent to those of ordinary skill in the art upon review of the following description of specific embodiments in conjunction with the accompanying figures.

In the figures, which illustrate, by way of example only, embodiments of the present disclosure,.

It has been observed that conventional organ chambers do not provide an environment that mimics the natural environment inside the body and can produce excessive stress on an excised organ under perfusion such as when a heart is perfused with the "hanging heart" method. Excised organs may thus suffer tissue damage as a result. For example, excessive stress can be generated by the weight of the heart when the heart is hung, as illustrated in <FIG>. The hanging of an excised heart using the hanging heart method can add mechanical stress to the arteries or veins of the heart as the weight of the heart is supported by the arteries or veins. The mechanical stress may extend to the entire heart and may cause tissue damage. Further, there is a risk that the cannulation of the arteries or veins may fail, which may lead to disconnection of the heart from the perfusion apparatus, which in turn can lead to catastrophic results.

It has also been observed that it may be inconvenient to connect an excised organ to a fluid system using conventional connection techniques used for existing fluid systems. For example, it is time consuming to attach a cannula to an organ by suturing. Repeated attachment and detachment of the cannula to an artery or vein, which may be required to change the mode of perfusion, also increases risk of tissue damage. For example, an excised heart may be perfused in a "resting mode" or a "working mode," which may require re-configuration of perfusion circuit and disconnection and reconnection of the sutured connections to the heart. Further, reconfiguration of the perfusion circuit and the connections to the organ may be necessary for other reasons. The organ may also need to be reoriented in the organ chamber during perfusion. When reconfiguration of the connections to the perfused organ requires removal of the sutures and re-suturing to a different cannula, the disconnecting and re-connecting process can be time-consuming and lead to increased risk of tissue damage.

It has been realized by the present inventor that a support device as disclosed herein can be conveniently used to support an excise organ and provide for quick connection to arteries and veins of the excised organ (such as a heart, lungs, a liver, or a kidney) for or during ex vivo perfusion of the organ.

The support device includes a resilient and flexible sheet to support the organ thereon during perfusion. The sheet may include a soft portion, on which the organ may rest. The soft portion may be made of a material that conforms to the external shape of the organ, which may avoid some mechanical stresses that are typically placed on the organ during a conventional perfusion process. The sheet material may be selected so that the organ is supported in a way that mimics the way the organ is supported naturally in vivo.

Further, the sheet may include one or more connectors that allow the organ to be quickly placed in fluid communication with a fluid system. For example, the sheet may include one or more magnetic couplers. The sheet may also include one or more mechanical couplers or connectors.

The connector may have a conduit in fluid communication with a fluid system, allowing for quick connection to the fluid system.

The sheet has a magnetic coupler for coupling to an external magnetic connector. The external magnetic connector may be attached to an artery or vein of an excised organ, for example by suturing. The magnetic coupler has a conduit which can be placed in fluid communication with a fluid system. The magnetic coupler includes a magnetic or ferromagnetic material embedded within the sheet for magnetically coupling to the external magnetic connector, thereby creating a fluid-tight seal between the external magnetic connector and the magnetic coupler. Thus, external magnetic connectors may easily and quickly connect to the conduit, thereby placing the excised organ in fluid communication with the fluid system. The magnetic coupler allows easy and quick reconfiguration, disconnection and reconnection, without the need to remove suturing or to re-suture. Notably, the sutures coupling the external magnetic connector to the artery or vein do not need to be removed and re-sutured to reconfigure the organ. Instead, the external magnetic connector may be de-coupled from the magnetic connector then coupled to the same or another magnetic connector. The magnetic connection also allows convenient alignment and sealing of the fluid conduits, and securing of the connection without the need to use other tightening mechanisms such as threaded connection or clamps. The magnetic coupler is conveniently embedded in the supporting sheet as will be further described below.

In an embodiment, the sheet also includes a mechanical coupler coupled to a cannula. During use, the cannula coupled to the mechanical coupler may be attached to an artery or vein of an excised organ. A flanged rim of the cannula may be encapsulated within the sheet during a molding process. The mechanical coupler has a channel which can be placed in fluid communication with a fluid system. The channel wall of the mechanical coupler may be made of a material that mimics the natural resistance of an artery or vein inside the human body, thereby providing the excised organ with an environment that more closely mimics the natural environment within the body.

Reference is now made to <FIG>, illustrating schematically a support device <NUM> mounted in an organ perfusion chamber <NUM> and coupled to a fluid system <NUM> for perfusing excised organ <NUM>, in accordance with an example embodiment. Support device <NUM> is mounted inside perfusion chamber <NUM> and supports organ <NUM> on an upper side thereof. Arteries and veins of organ <NUM> are placed in fluid communication with fluid system <NUM> for perfusing organ <NUM>.

As depicted in <FIG>, support device <NUM> includes three connectors <NUM>, each placed in fluid communication with fluid system <NUM> through a conduit <NUM>. However, in different embodiments the number of connectors <NUM> on the support device may vary. An artery or vein of organ <NUM> may also be connected to fluid system <NUM> directly (i.e. without interfacing through support device <NUM>), or via a connector <NUM>.

<FIG> illustrate an example embodiment of support device <NUM>. In this embodiment, device <NUM> includes a resilient and flexible sheet <NUM> having a soft portion <NUM> and a rigid portion <NUM>. Soft portion <NUM> of sheet <NUM> is configured for contacting and supporting the organ thereon on an upper side <NUM> of sheet <NUM>. The rigid portion <NUM> is more rigid than the soft portion <NUM> but may still be somewhat resilient and flexible. That is rigid portion <NUM> may be semirigid. The soft portion <NUM> also still has sufficient strength and rigidity to provide the desired support for the organ.

Rigid portion <NUM> has at least one connector <NUM> for forming and securing a connection between the organ (not shown) and a conduit to allow for fluid communication between the conduit and the organ. In one embodiment as depicted, rigid portion <NUM> of sheet <NUM> includes a magnetic coupler <NUM>, a mechanical coupler <NUM>, and a throughhole <NUM> (which are also collectively referred to as "connectors <NUM>").

Magnetic coupler <NUM> is configured to allow for fluid communication between an organ (not shown) and conduit <NUM>. Magnetic coupler <NUM> includes magnetic or ferromagnetic particulates <NUM>, such as iron dust, embedded in rigid portion <NUM> of sheet <NUM> around opening <NUM> of rigid portion <NUM>. Opening <NUM> is in fluid communication with conduit <NUM>. Conduit <NUM> is attached to lower side <NUM> of sheet <NUM> and can be coupled to fluid system <NUM> (see <FIG>) using a conduit <NUM> (<FIG>).

Magnetic coupler <NUM> may be magnetically coupled to an external magnetic connector, which, for example, may be any of the magnetic connectors <NUM>, <NUM>', <NUM>" described below and illustrated in <FIG>. External magnetic connector <NUM> may be secured to an artery or vein of an organ (e.g. by suturing) prior to, or after, coupling to magnetic coupler <NUM>. External magnetic connector <NUM> includes a magnet that couples with particulates <NUM> to bias magnetic coupler <NUM> and magnetic connector <NUM> towards each other to secure the connection. When the magnetic coupling is strong enough, a fluid-tight seal may be formed, so that a fluid may flow through the connection without leaking.

Mechanical coupler <NUM> is configured to allow for fluid communication between an organ (not shown) and channel <NUM>. In one embodiment, mechanical coupler <NUM> includes a cannula <NUM> with a flanged end <NUM> (as shown in <FIG>) coupled to rigid portion <NUM>, as illustrated in <FIG>. Flanged end <NUM> of cannula <NUM> may be encapsulated within sheet <NUM> during a molding process.

Alternatively, cannula <NUM> may be mechanically coupled to sheet <NUM>. Mechanical coupler <NUM> may include a mechanical coupling mechanism, such as a circular groove with a lip around opening <NUM> for coupling flanged end <NUM> of cannula <NUM> to rigid portion <NUM> of sheet <NUM>.

Cannula <NUM> is in fluid communication with opening <NUM>, and opening <NUM> is in fluid communication with a fluid channel <NUM>. Channel <NUM> can be coupled to fluid system <NUM> using a conduit <NUM> (see <FIG>). Channel <NUM> may be provided in a layer <NUM> of sheet <NUM> molded to the lower side <NUM> of sheet <NUM> (see <FIG>). In alternative embodiment, a fluid channel <NUM>' in fluid communication with opening <NUM> may be embedded in rigid portion <NUM> of sheet <NUM> as illustrated in <FIG>.

Throughhole <NUM> is provided and configured to allow a fluid tubing to pass through sheet <NUM>, where the fluid tubing allows fluid communication to or from the supported organ through sheet <NUM>.

Accordingly, one or more veins and/or arteries of the organ resting on soft portion <NUM> can be coupled to the fluid system via one or more of connectors <NUM>, thereby allowing for quick attachment and reconfiguration of the connection of the supported organ to fluid system <NUM>.

The selection of the implementation, number, positioning, and size of the connectors <NUM> may vary in various embodiments.

The number of connectors <NUM> provided in rigid portion <NUM> of sheet <NUM> may vary in dependence on the type of organ (e.g. a heart, lungs, kidney, and liver) that sheet <NUM> is configured to support. For example, three or four connectors <NUM> may be provided for perfusion of a heart, as will be explained. Similarly, two or three connectors <NUM> may be provided for perfusion of a pair of lungs, a kidney, or a liver.

Connectors <NUM> are generally positioned in rigid portion <NUM> of sheet <NUM> to allow for a connector <NUM> to couple to a specific vein or artery of a specific organ type to be supported on sheet <NUM>. The connectors <NUM> may further be arranged to be close to the respective locations of the corresponding veins and arteries of the particular organ type to be supported, taking into consideration the position and size of the organ when it is supported on sheet <NUM>. Further, in some embodiments, the median or average metrics of the size and position of the veins and arteries of the specified organ type may be used in determining the relative positioning of the respective connectors <NUM> on sheet <NUM> with respect to one another. In other embodiments, a custom sheet <NUM> may be made for a particular organ by obtaining exact measurements for a particular organ using imaging techniques and using the measurements to determine the positioning of the connectors <NUM> on sheet <NUM> relative to one another.

In one embodiment, an embedded reinforcing frame <NUM> is provided on rigid portion <NUM> of sheet <NUM> to provide increased rigidity. Further, reinforcing frame <NUM> may conveniently elevate rigid portion <NUM> and connectors <NUM> relative to the soft portion <NUM>, thereby bringing connectors <NUM> closer to the veins and arteries of the supported organ on the soft portion <NUM> of sheet <NUM>. The elevated rigid portion <NUM> may also help to reduce accumulation (pooling) of blood or the perfusion fluid at the bottom of the supported organ, and allow better drainage of fluids towards the lower edge of sheet <NUM>. In some embodiments, soft portion <NUM> may also include perforations <NUM> to allow fluids to drain through sheet <NUM>.

Further, frame <NUM> may aid in de-airing the heart. For example, to complete de-airing of the heart, the heart is optimally positioned with the aorta elevated relative to the pulmonary veins (which are connected to the left atrium). During use, the heart may be slowly filled with a perfusate through the left atrium, which is placed at the lowest level. When the liquid level slowly rises up within the heart, air within the heart is pushed out through the elevated aorta. Once the heart is fully filled with the perfusate, the aorta may be connected to fluid system <NUM>.

In some embodiments, reinforcing frame <NUM> may include beams arranged in a triangle. The connectors <NUM> may generally be positioned inside the frame <NUM> (e.g. inside the triangle formed by frame <NUM>) such that connectors <NUM> remain elevated during use with an organ resting on sheet <NUM>. In one example, one of the beams of the triangular frame may extend along an edge of sheet <NUM>, and the other two beams may extend from the respective corners on this edge of sheet <NUM> diagonally across rigid portion <NUM> of sheet <NUM> towards a central section of sheet <NUM> within rigid portion <NUM> and connect with one another at the central section. Frame <NUM> may also include additional beams or bars to provide additional support. Further, it will be appreciated that frame <NUM> may be shaped and configured differently in different embodiments.

In some embodiments, reinforcing frame <NUM> may be made of a flexible polyurethane material. The flexible polyurethane material may be more rigid than rigid portion <NUM> of sheet <NUM>. Other materials that are biocompatible and are stiffer than rigid portion <NUM> of sheet <NUM> may also be suitable in different embodiments.

Soft and rigid portions <NUM>, <NUM> of sheet <NUM> may be made, at least in part, of a silicone material. Different portions of sheet <NUM> may be made of different silicone materials having different Shore hardness values. Additionally or alternatively, different thicknesses of the same silicone material may be used. Sheet <NUM> may be formed of a single layer by any suitable process such as molding or extrusion processes. Sheet <NUM> may also be formed of multiple layers bonded to one another, and various components such as iron dusts or magnets may be sandwiched between two adjacent layers.

In one embodiment, soft portion <NUM> of sheet <NUM> is made at least in part of a material having a low Shore hardness. The low Shore hardness value of soft portion <NUM> of sheet <NUM> allows soft portion <NUM> to conform to the external shape of the organ when the organ is supported on the sheet, while still providing sufficient support. In one embodiment, the Shore hardness value of soft portion <NUM> of sheet <NUM> is selected from the range of <NUM>-<NUM> to <NUM>-<NUM>. One example of such a material is the Ecoflex® cured silicone rubber manufactured by Smooth-On, Inc. In other words, soft portion <NUM> of sheet <NUM> is made, at least in part, of a material classified as being an extra-soft material. Other materials that are biocompatible and have a similar Shore hardness value may also be suitable for use with soft portion <NUM> of sheet <NUM>.

In one embodiment, a section of rigid portion <NUM> of sheet <NUM> at the connectors <NUM> is made, at least in part, of a material having a Shore hardness value that is greater than that of soft portion <NUM>. The higher Shore hardness value is selected to limit distention of the section of rigid portion <NUM> of sheet <NUM> at the connectors <NUM> under an applied fluid pressure during operation. In one embodiment, the Shore hardness value of the section of rigid portion <NUM> of sheet <NUM> at the connectors <NUM> is selected from the range of 0A to 2A. One example of such a material is the Dragon Skin® FX-Pro silicone rubber manufactured by Smooth-On, Inc. In other words, the section of rigid portion <NUM> of sheet <NUM> at the connectors <NUM> is made, at least in part, of a material classified as being a soft material. Other materials that are biocompatible and have a similar Shore hardness value may also be suitable for use with rigid portion <NUM> of sheet <NUM>.

In one embodiment, sheet <NUM> is made of one or more types of silicone material having an indent <NUM> to define soft portion <NUM>. Indent <NUM> reduces the thickness of the silicone material within the soft portion <NUM>, thereby increases the softness of this portion of the sheet <NUM> and allows this sheet portion to conform more easily to the external shape of the supported organ. Indent <NUM> may be defined in a mold used to make sheet <NUM>.

Rigid portion <NUM> may therefore be thicker and less soft as compared to soft portion <NUM>. A thicker, more rigid portion <NUM> can provide more stable connection between the organ and the connected conduits or fluid system. Further, the increased thickness of rigid portion <NUM> allows more convenient inclusion and configuration of magnetic or other couplers or connecters, fluid channels, and reinforcing frame, or other components and features within the rigid portion, and allows attachment of other devices such as conduits or tubings and valves, sensors or the like to sheet <NUM>. For example, some of these components may be embedded inside the rigid portion <NUM> of sheet <NUM>. In one example, the soft portion <NUM> of sheet <NUM> has a thickness of <NUM>, while the rigid portion <NUM> of sheet <NUM> has a thickness of <NUM>.

In one embodiment, sheet <NUM> is configured for use with perfusion of a heart and has a length of <NUM> and a width of <NUM> and has a soft portion (for example, as defined by indent <NUM>) having a length of <NUM> and a width of <NUM>.

In one embodiment, sheet <NUM> may include a rim (not shown) around the edges thereof, which may be made of a relatively thick silicone, to prevent the sheet from tearing during use and storage. The rim may be made of a thicker edge of the silicone or rubber material, such as that used for the rigid portion <NUM> of sheet <NUM>, or alternatively, a polyurethane material, such as that used for reinforcing frame <NUM>.

In one embodiment, sheet <NUM> may include mounting holes <NUM>, one placed at each corner thereof, for mounting sheet <NUM> in an organ perfusion chamber <NUM> (<FIG>).

In one embodiment, sheet <NUM> may be shaped or formed by a molding process. An example mold <NUM> (<FIG>) for forming a sheet <NUM> having two mechanical couplers <NUM> and a magnetic coupler <NUM> is shown. Mold <NUM> has cavities <NUM>, <NUM> surrounded by side walls <NUM> shaped for forming sheet <NUM>. Cavity <NUM> is for forming rigid portion <NUM> and cavity <NUM> is for forming soft portion <NUM>. Notably, cavity <NUM> is deeper than cavity <NUM> for forming a sheet <NUM> having a rigid portion <NUM> that is thicker than soft portion <NUM>. Reinforcing frame <NUM> may be positioned inside cavity <NUM> for encapsulation with rigid portion <NUM>.

An additional cavity <NUM> may be provided for forming magnetic coupler <NUM>. An elbow-shaped core <NUM> may be positioned inside cavity <NUM> to form a conduit <NUM>. Core <NUM> may extend from an upper side of mold <NUM> to a lower side of mold <NUM> (<FIG>). On the lower side of mold <NUM>, core <NUM> is surrounded by walls <NUM>, used to form elbow <NUM>. Magnetic or ferromagnetic materials (e.g. iron dust) may be placed inside cavity <NUM> for encapsulation with magnetic coupler <NUM>.

An additional cavity <NUM> may be provided for forming each mechanical coupler <NUM>. Core <NUM> may be positioned inside cavity <NUM> to form channel <NUM>. Core <NUM> may extend below cavity <NUM> to form layer <NUM> of sheet <NUM>. Core <NUM> may also be used to form opening <NUM> in channel <NUM> (<FIG>). A cannula <NUM> having flanged base <NUM> may be placed inside each cavity <NUM> for encapsulation with mechanical coupler <NUM>.

Mold <NUM> may include protrusions <NUM> positioned at the corners of cavity <NUM> to form mounting holes <NUM>.

One or more liquefied materials, such as different types of silicone rubbers having different stiffness properties, may be poured into the cavities of mold <NUM> to form elements of sheet <NUM>. For example, a relatively soft silicone may be poured into cavity <NUM> to form soft portion <NUM> of sheet <NUM>. Further, a relatively rigid silicone may be poured cavity <NUM> to form rigid portion <NUM> of sheet <NUM>. Yet another, stiffer silicone may be poured into cavity <NUM> to form elbow <NUM>. Accordingly, different materials may be poured into different cavities of mold <NUM> to achieve the desired characteristics of sheet <NUM>. The different materials may bond to one another without substantially mixing with one another.

Each material may cure and harden at a specific temperature. For example, the Ecoflex® cured silicone rubber that may be used for soft portion <NUM> of sheet <NUM> cures after being placed at a temperature of <NUM> Celsius for <NUM> minutes, and the Dragon SkinO FX-Pro silicone rubber that may be used for rigid portion <NUM> of sheet <NUM> cures after being placed at a temperature of <NUM> Celsius for <NUM> minutes. Once the materials cure, the mold <NUM> may be removed.

Reference is now made to <FIG>, which illustrate an organ perfusion chamber <NUM> having sheet <NUM> mounted inside the chamber <NUM>. Chamber <NUM> has a plurality of ports <NUM> for connecting a plurality of fluid conduits <NUM> to fluid system <NUM> (<FIG>). Fluid conduits may also be connected to connectors <NUM> of sheet and therethrough to the organ supported on sheet <NUM>.

Sheet <NUM> is mounted inside chamber <NUM> in a generally extended position to provide a platform of sufficient size for the organ to rest thereon. As depicted, four mounting posts <NUM>, <NUM> are provided and positioned in chamber <NUM>, relatively positioned to match the relative positions of mounting holes <NUM> of sheet <NUM>, for mounting sheet <NUM>. Sheet <NUM> may be coupled and affixed to mounting posts <NUM> in any suitable manner.

In one embodiment, as illustrated in <FIG>, two short mounting posts <NUM> are provided and configured for mounting the lower edge of soft portion <NUM> at a lower height and two tall mounting posts <NUM> are provided and configured for mounting the upper edge of rigid portion <NUM> of sheet <NUM> at a higher height that is higher than the lower height, such that sheet <NUM> is inclined when mounted and soft portion <NUM> is lower in height than rigid portion <NUM>.

In one embodiment, the incline of sheet <NUM>, once mounted in chamber <NUM>, may range from <NUM> to <NUM> degrees relative to the horizontal plane. This configuration allows the aorta of the heart to be positioned at an elevated level relative to the pulmonary veins of the heart to aid in de-airing of the heart during perfusion.

Optionally, chamber <NUM> may include a drainage conduit <NUM> to allow for fluids that collect in chamber <NUM>, such as perfusate, to flow to fluid system <NUM>.

Reference is now made to <FIG>, illustrating magnetic coupler <NUM> being coupled to magnetic connector <NUM>, and <FIG>, illustrating magnetic coupler <NUM> in isolation.

Magnetic or ferromagnetic particulates <NUM>, such as iron dust, are dispersed or distributed in areas surrounding opening <NUM> for magnetically coupling to an external magnetic connector, so as to establish quick connection and secure the connection between conduit <NUM> and a supported organ <NUM>. The iron dust may be made of iron particles of very small sizes, such as in the range of <NUM>-<NUM>. The small size of the iron dust (or other particulates) allows rigid portion <NUM> to retain most of its flexibility and resilience. Further, small particulates may be more conveniently embedded than larger components during a molding process for forming the sheet <NUM>. However, other magnetic or ferromagnetic particulates, including granulates, may be used in different embodiments.

Particulates <NUM> may be embedded within sheet <NUM>. In one embodiment, particulates <NUM>, such as iron dust, may be embedded in sheet <NUM> during molding of sheet <NUM>. For example, iron dust may be added to a liquid silicone material in cavity <NUM> of mold <NUM>. Once the liquid silicone material cures, the iron dust will be encapsulated within the silicone material, thereby embedding the iron dust within sheet <NUM>.

The external magnetic connector <NUM> may be coupled to the supported organ <NUM> such as by suturing, as illustrated in <FIG>. Alternatively, organ <NUM> may be coupled to a cannula (not shown) which is inserted into conduit <NUM> of connector <NUM>.

When magnetic coupler <NUM> is magnetically coupled with the external magnetic connector <NUM>, opening <NUM> and conduit <NUM> in external magnetic connector <NUM> are aligned and in seal-tight connection to allow fluid communication between organ <NUM> and conduit <NUM>, as illustrated in <FIG>.

Conduit <NUM> of external magnetic connector <NUM> is thus placed in fluid communication with conduit <NUM>. Conduit <NUM> interfaces at a first end <NUM> with opening <NUM> of rigid portion <NUM>, and interfaces at a second end with an opening <NUM> for fluid communication therethrough. Opening <NUM> can be connected to fluid conduit <NUM> and to fluid system <NUM>, thereby placing organ <NUM> in fluid communication with fluid system <NUM>.

Conduit <NUM> may be formed in an elbow <NUM> attached to lower side <NUM> of sheet <NUM>. An upper side of elbow <NUM> and lower side <NUM> of sheet <NUM> may be molded together; particularly if both sheet <NUM> and elbow <NUM> are made of the same or similar materials such as silicones. Nonetheless, if sheet <NUM> and elbow <NUM> different materials, a section of the mold defining elbow <NUM> can be filled with a first material and a section of the mold defining sheet <NUM> can be filled with a second material. Alternatively, elbow <NUM> may be encapsulated or mechanically locked to sheet <NUM> during the molding process. Alternatively, elbow <NUM> may be attached to lower side <NUM> using a waterproof adhesive, for example, an adhesive suitable for bonding silicone.

Elbow <NUM> may be made of any suitable material, such as a silicone, polyurethane, PVC, other plastics, or metal material. Elbow <NUM> may be made of a rigid and stiff material to allow for a high rate of flow of pressurized fluids through conduit <NUM>.

In an alternative embodiment, shown in <FIG>, larger sized magnets or ferromagnetic pieces <NUM>' may be embedded into rigid portion <NUM>. The size of the magnets or ferromagnetic pieces may range from about <NUM> to a few centimeters. Further, in an alternative embodiment, shown in <FIG>, a single magnetic or ferromagnetic flange <NUM>" may be embedded within rigid portion <NUM>.

Pieces <NUM>' or flange <NUM>" may also be embedded within sheet <NUM>. In one embodiment, pieces <NUM>' or flange <NUM>" may be embedded in sheet <NUM> during molding of sheet <NUM>. For example, pieces <NUM>' or flange <NUM>" may be added to a liquid silicone material in cavity <NUM> of mold <NUM>. Once the liquid silicone material cures, the pieces <NUM>' or flange <NUM>" will be encapsulated within the silicone material, thereby embedding the pieces <NUM>' or flange <NUM>" within sheet <NUM>.

Reference is now made to <FIG>, showing example external magnetic connectors <NUM>, <NUM>', and <NUM>" for use with magnetic coupler <NUM>. Each of magnetic connectors <NUM>, <NUM>', and <NUM>" may be configured and sized for coupling with magnetic coupler <NUM>.

Each of the magnetic connectors <NUM>, <NUM>', and <NUM>" has a cannula <NUM> having an upper rim <NUM> for coupling the cannula to an artery or vein of an organ (e.g. by suturing) and a lower rim <NUM> for coupling the cannula to a magnetic coupler <NUM>. Upper and lower rims <NUM>, <NUM> are connected to one another by a hollow tube defining a conduit <NUM> to allow for fluid communication between the rims.

A magnetic flange <NUM> is mounted on lower rim <NUM>. Magnetic flange <NUM> has an inner diameter that is smaller than the outer diameter of cannula <NUM>, to allow for flange <NUM> to be mounted on lower rim <NUM>. Magnetic flange <NUM> may be mounted by passing the flange <NUM> through upper rim <NUM>. Accordingly, upper rim <NUM> may be deformable to allow for flange <NUM> to pass through.

When magnetic connector <NUM> with magnetic flange <NUM> is brought close to magnetic coupler <NUM>, magnetic flange <NUM> is magnetically attracted towards the particulates <NUM>, and lower rim <NUM> will be biased to contact and pressed against magnetic coupler <NUM> around opening <NUM>. That is, magnetic flange <NUM> applies a downward force pressing lower rim <NUM> against sheet <NUM>, forming a fluid-tight seal between sheet <NUM> and magnetic connector <NUM>. Conveniently, conduit <NUM> can be easily aligned with the opening <NUM> of sheet <NUM>.

In some embodiments, a magnet may be embedded within lower rim <NUM> to replace the separate magnetic flange <NUM>.

Magnetic connectors <NUM>, <NUM>', and <NUM>" are of similar design and construction, except that their upper and lower rims <NUM>, <NUM> are sized differently to match the sizes of the particular tissue opening to which they are to be attached and the size of the particular opening in the sheet <NUM> with which they are to be aligned. Cannula <NUM> may be angled to accommodate an upper rim <NUM> that is wider than the lower portion of cannula <NUM>, as illustrated in <FIG> and <FIG>.

The upper rims <NUM> of the magnetic connectors <NUM>, <NUM>', and <NUM>" are shown to have different outer diameters, selected to conform to the diameter of a selected artery or vein, and which may range from <NUM> to <NUM>. For example, magnetic connector <NUM> is configured for coupling to an atrium of a heart (i.e. the left or right atrium), and magnetic connector <NUM>' is configured for coupling to an artery of a heart (i.e. the aorta or the pulmonary artery). Accordingly, upper rim <NUM> of magnetic connector <NUM>' has a wider diameter than upper rim <NUM> of magnetic connector <NUM>, as the arteries of heart are narrower in diameter than the atrial connections. In one embodiment, the outer diameter of upper rim <NUM> of connector <NUM>' is approximately <NUM>, and the outer diameter of upper rim <NUM> of connector <NUM> may is approximately <NUM>.

Similarly, the lower rims <NUM> of the magnetic connectors <NUM>, <NUM>', and <NUM>" are shown to have different outer diameters, and which may range from <NUM> to <NUM>. It will be understood that the diameter of a lower rim <NUM> may vary to match the diameter of magnetic coupler <NUM>.

Similarly, the cannula <NUM> of the magnetic connectors <NUM>, <NUM>', and <NUM>" are also shown have to have different outer diameters at the point of connection with lower rim <NUM>, and which may range from <NUM> to <NUM>. It will be understood that the diameter of a cannula <NUM> may vary to match the diameter of an opening <NUM>.

In one embodiment, the body of magnetic connectors <NUM>, <NUM>', and <NUM>" is made of a rigid biocompatible plastic (such as nylon, polycarbonate, or other acrylic) to allow for fluid communication through conduit <NUM> thereof. Magnetic flange <NUM> may be made of a magnetic material providing sufficient downward force.

Reference is now made to <FIG>, illustrating mechanical coupler <NUM> having a cannula <NUM> attached thereto, and <FIG>, illustrating mechanical coupler <NUM> without cannula <NUM>.

Mechanical coupler <NUM> may have attached thereto cannula <NUM>. In some embodiments, as shown in <FIG>, cannula <NUM> has a flanged end <NUM>. Flanged end <NUM> may be encapsulated into the material of sheet <NUM> during the molding process. To allow for the encapsulation of flanged end <NUM>, in one embodiment, flanged end <NUM> includes ribs <NUM> extending outwardly to secure a circular rim <NUM> to flanged end <NUM>. Ribs <NUM> and circular rim <NUM> define a plurality of voids <NUM>. During the molding process, voids <NUM> may be filled with a liquefied material used to define rigid portion <NUM> of sheet <NUM>. When the liquefied material cures, flanged end <NUM> becomes encapsulated in rigid portion <NUM> of sheet <NUM>, thereby securing cannula <NUM> to mechanical coupler <NUM> and creating a fluid-tight seal.

Alternatively, as illustrated in <FIG>, mechanical coupler <NUM> may include a flexible lip <NUM> in upper side <NUM> of sheet <NUM> around opening <NUM> for securing cannula <NUM> into sheet <NUM>. To secure cannula <NUM> in sheet <NUM>, flexible lip <NUM> extends partially over a groove in sheet <NUM>. Cannula <NUM> may be inserted into sheet <NUM> by flexing flexible lip <NUM> upwards and inserting lower rim <NUM> of cannula <NUM> into the groove of sheet <NUM>. Flexible lip <NUM> then secures cannula <NUM> into the groove by biasing down against the lower rim of cannula <NUM> as it flexes to its original position, thereby creating a fluid-tight seal.

To connect opening <NUM> to an artery or vein of an organ <NUM>, organ <NUM> is connected to an upper rim <NUM> of cannula <NUM> (e.g. upper rim <NUM> may be sutured onto the artery or vein of organ <NUM>), as shown in <FIG>.

Opening <NUM> of sheet <NUM> is in fluid communication with fluid channel <NUM>. Fluid channel <NUM> extends between an upper side and a lower side of a layer <NUM> attached to the lower side <NUM> of sheet <NUM>. In some embodiments, layer <NUM> and sheet <NUM> may be molded together. Alternatively, layer <NUM> may be attached to lower side <NUM> of sheet <NUM> using a waterproof adhesive, for example, an adhesive made for bonding silicone.

Fluid channel <NUM> interfaces at one end with opening <NUM> and interfaces at the second end with an opening <NUM> on a side of sheet <NUM> for fluid communication therethrough. Opening <NUM> can be connected to a fluid conduit <NUM> and to fluid system <NUM>, thereby placing organ <NUM> in fluid communication with fluid system <NUM>. Fluid may flow through opening <NUM> on upper side <NUM> of sheet <NUM> to opening <NUM> through fluid channel <NUM>, and then through fluid conduits <NUM>. Similarly, fluid may flow in the opposite direction.

As will be appreciated, the flow of fluid through fluid channel <NUM> is expected to apply a force, F, against the walls of layer <NUM>, which may cause the channel to distend, as shown in <FIG>. Notably, in <FIG>, the undistended walls of channel <NUM> are shown in phantom to better illustrate this effect.

Further, the degree of distention of fluid channel <NUM> will depend on the rate of flow of the fluid, as well as the resistance of the material used to define the channel and the thickness of the material.

Further, fluid channel <NUM> may have a wall thickness chosen in dependence on the expected rate of flow of the fluid within fluid channel <NUM> and the maximum allowable pressure on the wall of fluid channel <NUM>. For example, the wall thickness of fluid channel <NUM> may be chosen in accordance with Barlow's formula, which defines the relationship between the internal pressure caused by a fluid in a conduit ('P'), the wall thickness the conduit ('t'), the maximum allowable stress on the material - which may correspond to the stiffness of the material - ('S'), and the outside diameter of the conduit ('D') as P = 2St/D. Accordingly, a rigid material having a thin wall may behave similarly to a soft material having a thick wall.

The material used to form channel <NUM> may also be chosen depending on the intended use of the channel - i.e. based on which artery or vein of a particular organ the channel may be coupled to, as the internal pressure created by the fluid may vary in each artery and vein of an organ.

In one embodiment, channel <NUM> is configured for receiving perfusate from the pulmonary artery of a heart. Inside the human body, the pulmonary artery carries deoxygenated blood from the right ventricle of the heart to the lungs through the very-low resistance, high capacitance blood vessels of the pulmonary vasculature. Accordingly, it may be advantageous to mimic the very-low resistance of the pulmonary vasculature during perfusion of the heart. Channel <NUM> may thus be advantageously made of a very soft material (e.g. with a Shore value of <NUM>-<NUM>, such as the Ecoflex® cured rubber, with a wall thickness of <NUM>) to replicate the very-low resistance of the pulmonary vasculature.

Similarly, in another embodiment, channel <NUM> is configured for receiving perfusate from the aorta of a heart. Inside the human body, the pulmonary artery carries oxygenated blood from the left ventricle of the heart to the entire body through the blood systemic vasculature. The systemic vasculature provides a high resistance against the flow of the blood. Accordingly, it may be advantageous to mimic the high resistance of the systemic vasculature during perfusion of the heart. Channel <NUM> may thus be advantageously made of a hard material (e.g. a silicone with a Shore value of 2A, such as Dragon Skin® FX-Pro, with a wall thickness of <NUM>) to replicate the high resistance of the systemic vasculature. This may allow the channel to distend in a manner that resembles the "Windkessel" effect that occurs in the aorta inside the body.

In yet another embodiment, channel <NUM> is configured for providing perfusate to an atrium of the heart. In this case, a very low resistance pathway leading into the atrium is preferable, as the low resistance allows the pump pumping perfusate into the atrium to operate more efficiently. Accordingly, it may be advantageous to form channel <NUM> into a tube of a similar diameter as a fluid conduit <NUM> coupled to channel <NUM>.

Reference is now made to <FIG>, illustrating an alternative embodiment of mechanical coupler <NUM>' being coupled to cannula <NUM>. Notably, cannula <NUM> is removably attached to mechanical coupler <NUM>'. Cannula <NUM> may be inserted into and may pass through opening <NUM> to allow for fluid to flow to or from organ <NUM> through channel <NUM>. Cannula <NUM> may have an outer diameter that closely matches the inner diameter of opening <NUM> such that cannula <NUM> and sheet <NUM> frictionally and sealing engage one another to secure the connection and prevents fluid leakage through any gap between cannula <NUM> and sheet <NUM> at opening <NUM>.

Further, it will be appreciated that mechanical coupler <NUM>' may include a magnetic or ferromagnetic material (not shown) embedded in sheet <NUM> around opening <NUM> such that when a magnetic material is also embedded in or otherwise provided on cannula <NUM>, cannula <NUM> may be magnetically coupled and attached to sheet <NUM> around opening <NUM>. In such a case, the magnetic portion around opening <NUM> can be considered a magnetic coupler instead of a mechanical coupler.

Reference is now made to <FIG>, illustrating an alternative embodiment of mechanical coupler <NUM>" having a fluid channel <NUM>' embedded within rigid portion <NUM> of sheet <NUM>, extending between upper side <NUM> and lower side <NUM> of sheet <NUM>.

Reference is now made to <FIG>, illustrating the use of throughhole <NUM>. As depicted, a fluid tubing <NUM> coupled to organ <NUM> is inserted in, and passes through the throughhole <NUM>. Throughhole <NUM> extends from upper side <NUM> to lower side <NUM> of sheet <NUM> and is configured and sized to allow the fluid tubing <NUM> (e.g. a cannula) attached to organ <NUM> to pass therethrough. A cannula or other rigid plastic tube can be received in throughhole <NUM> and connected to fluid conduit <NUM> and to fluid system <NUM>, thereby placing organ <NUM> in fluid communication with fluid system <NUM>. The size of the throughhole <NUM> may be marginally larger than the outer size of the tubing <NUM>.

In operation, an excised heart <NUM> may be supported and connected using sheet <NUM> as illustrated in <FIG>. Sheet <NUM> may be mounted on mounting posts <NUM>, <NUM> of chamber <NUM> (not shown in <FIG>, but see <FIG>; also see <FIG>) during use. The heart <NUM> may be connected to a fluid system <NUM> through sheet <NUM> as illustrated in <FIG>. A sample and simplified fluid system <NUM> is partially shown in <FIG>, which includes a pump <NUM> and a fluid source <NUM>. However, it should be understood that fluid system <NUM> may also include or employ additional components such as a heat exchanger, an oxygenator, and various sensors and valves, or the like.

Cannula <NUM> is connected at one end, for example, by suturing, to aorta <NUM> of heart <NUM>. Cannula <NUM> passes through throughhole <NUM>. Cannula <NUM> is also connected at a second end to fluid conduit <NUM>, which is in fluid communication with fluid source <NUM> (through S1), thereby allowing fluid communication between aorta <NUM> and fluid source <NUM>.

Mechanical coupler <NUM> has attached thereto cannula <NUM>. Cannula <NUM> may also be sutured onto pulmonary artery <NUM> of heart <NUM>. Pulmonary artery <NUM> may thus be in fluid communication with fluid channel <NUM> (not shown but see <FIG>). Opening <NUM> (not shown) of fluid channel <NUM> is in fluid communication with fluid source <NUM> of fluid system <NUM> via fluid conduit <NUM> (through S2).

Magnetic coupler <NUM> is coupled to magnetic connector <NUM>, which is in turn attached at upper rim <NUM>, for example, by suturing, to pulmonary veins <NUM> of heart <NUM>. Conduit <NUM> is in fluid communication with pump <NUM> of fluid system <NUM> via fluid conduit <NUM> (through P1). Conduit <NUM> connects pump <NUM> and fluid source <NUM>. Thus, pump <NUM> causes perfusate to flow from source <NUM> and into pulmonary veins <NUM>.

In addition, vena cava <NUM> of heart <NUM> may be connected to a fluid conduit <NUM> without interfacing through a connector <NUM> of sheet <NUM>. Fluid conduit <NUM> is in fluid communication with pump <NUM> (through P2), thereby allowing perfusate to flow into or out of vena cava <NUM>.

After vena cava <NUM> is connected to fluid system <NUM>, perfusate flows through vena cava <NUM> and fills the right atrium and the right ventricle. However, the right atrium and the right ventricle are also filled by the coronary sinus veins (not shown), which receive blood from the oblique vein of the left atrium (not shown). Accordingly, establishing a quick connection between vena cava <NUM> and fluid system <NUM> using a connector <NUM> is not necessary. The coronary sinus veins will also fill the right atrium and the right ventricle using perfusate from the left atrium (which receives perfusate from the pulmonary veins <NUM>). Nonetheless, a variant (not shown) of sheet <NUM> may include an additional connector <NUM> for establishing a quick connection between vena cava <NUM> and fluid system <NUM>.

Before or after being connected to the fluid system <NUM>, heart <NUM> may be placed on upper side <NUM> of soft portion <NUM> of sheet <NUM>. Due to the softness of the material of soft portion <NUM>, the soft portion <NUM> will conform to the external shape of heart <NUM> when heart <NUM> is supported on sheet <NUM>, as illustrated in <FIG>.

After being connected, heart <NUM> may be perfused in "working mode". The term "working mode" refers to coronary perfusion throughout a heart by ventricular filling via the left atrium and ejection from the left ventricle via the aorta driven by the heart's contractile function and regular cardiac rhythm. In working mode, pump <NUM> supplies perfusate to the right atrium via vena cava <NUM> and to left atrium via pulmonary veins <NUM> of heart <NUM>, via fluid conduits <NUM> and <NUM> respectively. Perfusate then flows from the right atrium into the right ventricle and out of pulmonary artery <NUM>, returning to source <NUM> via fluid conduit <NUM>. Similarly, perfusate then flows from the left atrium into the left ventricle and out of aorta <NUM>, returning to source <NUM> via fluid conduit <NUM>. Furthermore, sufficient pressure in aorta <NUM> will lead to perfusion of the heart muscle through flow of conditioned perfusate into the coronary arteries of the heart. Further information in this regard is provided in <CIT> and in <CIT>.

Heart <NUM> may also be perfused in "resting mode". The term "resting mode" refers to a method of perfusing a heart with a nutrient-rich oxygenated solution in a reverse fashion via the aorta. The backwards pressure causes the aortic valve to shut thereby forcing the solution into the coronary arteries. "Resting mode" is also known as the preservation mode or the Langendorff perfusion. In resting mode, pump <NUM> directs pressure into aorta <NUM>. As will be apparent to persons skilled in the art, suitable fluid pressure in the aorta <NUM> will lead to flow of conditioned perfusate from fluid conduit <NUM> into the coronary arteries, which branch off from the aorta <NUM>. If the pressure in aorta <NUM> is sufficient, perfusate will move through the coronary arteries into capillary beds inside the walls of the heart, thereby providing oxygen and nutrients to the heart muscle. Perfusate will then move from the capillary beds into the coronary veins, moving carbon dioxide and wastes away from the heart muscle. The coronary veins empty into the right atrium of heart <NUM>, leading to a flow of perfusate from the right atrium, through the right ventricle, and into the pulmonary artery <NUM>. In this manner, perfusate containing carbon dioxide and wastes is moved into fluid subsystem <NUM> and returned to source <NUM>.

Organ perfusion kits may be provided and may include a support device <NUM> including sheet <NUM>, a chamber <NUM>, and external connectors for use with connectors <NUM> of sheet <NUM>. The kits may include different components suitable for perfusion of a specific organ type (e.g. a heart, lungs, a kidney, or a liver). The external connectors may include a variety of external magnetic connectors (e.g. connectors <NUM>, <NUM>', <NUM>") and cannulae (e.g. cannula <NUM>, cannula <NUM>). In one example embodiment suitable for perfusion of a heart, a variety of external magnetic connectors are provided, including a first external magnetic connector suitable for connecting to an artery of the heart, a second external magnetic connector suitable for connecting to atrium of the heart, and a third external magnetic connector suitable for connecting to an aorta of the heart.

As will be apparent to a person of ordinary skill in the art, a sheet for use in supporting an organ during perfusion may have different types of connectors <NUM> as previously illustrated. For example, as illustrated in <FIG>, a sheet <NUM> has a plurality of mechanical couplers <NUM>, each being in fluid communication with a channel <NUM>. Mechanical couplers <NUM> may be implemented in a manner similar to mechanical coupler <NUM>, and channels <NUM> may be implemented in a manner similar to channel <NUM>. Similarly, as illustrated in <FIG>, a sheet <NUM> has a plurality of magnetic couplers <NUM>, each being in fluid communication with a conduit <NUM>. Magnetic couplers <NUM> may be implemented in a manner similar to magnetic coupler <NUM>, and conduits <NUM> may be implemented in a manner similar to conduit <NUM>. Further, magnetic or ferromagnetic material <NUM> may surround all of the magnetic coupler <NUM> in sheet <NUM>.

In some embodiments, one or more pressure sensors may be incorporated into a conduit or connector in the sheet of the support device. For example, a pressure sensor may be installed in a connector or cannula attached to the sheet.

In a particular example embodiment, cannula <NUM> may be modified to include a port for mounting a pressure sensor. The modified cannula is illustrated with cannula <NUM> shown in <FIG>, which has a pressure sensor port <NUM>. One end of pressure sensor port <NUM> is in fluid communication with the central fluid channel <NUM> in cannula <NUM>. The other end <NUM> of pressure sensor port <NUM> is configured to be coupled to a pressure senor to allow the pressure sensor be conveniently mounted on or in the pressure sensor port <NUM>. End <NUM> of the pressure sensor port <NUM> may have any suitable mating structure for engaging a desired pressure sensor. As illustrated, end <NUM> may have a luer connector fitting structure. The luer structure may have a standard luer taper for convenient fitting with various types of pressure sensors, or even other sensors. The fitting may comply with an International Organization for Standardization (ISO) standard such as the ISO <NUM> standard.

As illustrated in <FIG>, a pressure sensor <NUM>, which has a corresponding coupling such as luer connector fitting structure, may be coupled to the pressure sensor port <NUM>. The mounted pressure sensor <NUM> can detect and measure a fluid pressure in the fluid channel <NUM> during use. Cannula <NUM> may be configured and installed on the support sheet at a suitable location for connection with the aorta of a supported heart. Pressure sensor <NUM> may be connected to a control system or a controller by wired or wireless connection for monitoring and controlling the pressure at the aorta.

In another embodiment, a similar cannula <NUM> as illustrated in <FIG> may be provided for connection with a pulmonary artery. The structure of cannula <NUM> is similar to cannula <NUM> and also includes a pressure sensor port <NUM> in fluid communication with its fluid channel <NUM> and having a luer connector end <NUM> for coupling with a pressure sensor. However, cannula <NUM> has been modified and configured, and may be positioned, for connecting with the pulmonary artery of the supported heart to measure the fluid pressure at the pulmonary artery. As illustrated, the top end portion <NUM> of cannula <NUM> may be slightly curved or bent, and shaped for more convenient connection with the pulmonary artery.

Of course, in these and other embodiments, pressure sensors or connection ports for pressure sensors may also be provided at other parts or locations on the support device.

The pressure sensors may be used to remotely measure and control the pressures in the fluid conduits embedded in the support sheet at various locations. The pressure sensors or ports for mounting the pressure sensors may be integrated into a support device described above. Suitable pressure sensors known to those skilled in the art may be used for this purpose.

In some embodiments, other types of sensors, such as one or more of flow rate meters, temperature sensors, or the like, may be included in or connected to one or more conduits in the sheet or cannulae attached to the sheet. These sensors may be used to monitor and control the fluid flows and the conditions of the fluid flowing through the conduits and connections provided by the sheet.

Selected Embodiments of the present invention may be used in a variety of fields and applications. For example, they may have applications in transplantation surgery and research.

Other features, modifications, and applications of the embodiments described here may be understood by those skilled in the art in view of the disclosure herein.

The word "include" or its variations such as "includes" or "including" will be understood to imply the inclusion of a stated integer or groups of integers but not the exclusion of any other integer or group of integers.

It will also be understood that the word "a" or "an" is intended to mean "one or more" or "at least one", and any singular form is intended to include plurals herein.

It will be further understood that the term "comprise", including any variation thereof, is intended to be open-ended and means "include, but not limited to," unless otherwise specifically indicated to the contrary.

Claim 1:
A device (<NUM>) for supporting and connecting an excised organ (<NUM>) during perfusion, comprising:
a resilient and flexible sheet (<NUM>, <NUM>) having
a first portion (<NUM>) for contacting and supporting the organ thereon, and
a second portion (<NUM>) comprising an opening (<NUM>, <NUM>) for forming a connection (<NUM>) between the organ and a conduit (<NUM>, <NUM>) to allow fluid communication between the conduit and the organ;
characterized in that
a magnetic material (<NUM>, <NUM>', <NUM>") is embedded in the second portion of the sheet for magnetically coupling with an external magnetic connector (<NUM>, <NUM>', <NUM>") to secure the connection between the conduit and the organ.