Aortic cannula for ex vivo organ care system

Abstract

To provide an aortic cannula for ex vivo organ care system.SOLUTION: An aortic cannula for use in an ex vivo organ care system is provided, comprising: a cannula body that comprises a fitting adapted to connect to an organ care system, and an aorta interface to contact an aorta; and a pivot arm strap operably connected to a pivot mount, wherein the pivot mount allows the pivot arm strap to uniformly contact the aorta to hold the aorta on the aorta interface.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Related Applications This application is related to application Ser. No. 62 / 215,825, filed Sep. 9, 2015, and entitled "Aortic Cannula for Ex Vivo Organ Care System," which is incorporated herein by reference in its entirety.

[0002] The present invention relates to an aortic cannula for an ex vivo organ management system. [Background technology]

[0003] Technical Field The present invention relates generally to medical devices, and in particular to aortic cannulas, for use in ex vivo organ management systems. Specifically, the present invention relates to aortic cannulas used to return perfusate to or deliver perfusate from the heart while maintaining an organ ex vivo in physiological or near-physiological conditions.

[0004] background Current organ preservation techniques typically involve cryopreservation of organs in a chemical perfusion solution on ice. However, the use of conventional approaches results in trauma that increases as a function of the length of time the organ is maintained ex vivo. These time constraints limit the number of recipients that can be reached from a given donor location, thereby limiting the recipient pool for harvested hearts. Even within the time limit of a few hours, the heart can be significantly damaged.

[0005] Effective preservation of ex vivo organs also offers many other advantages. For example, extended ex vivo preservation allows for more careful monitoring and functional testing of harvested organs. This, in turn, allows for earlier detection and possible repair of defects in the harvested organ, further reducing the likelihood of transplant failure. The ability to perform simple repairs on organs also allows many organs with minor defects to be salvaged, whereas current transplantation techniques require such organs to be discarded. In addition, a more effective match between the organ and the specific recipient may be achieved, further reducing the likelihood of eventual organ rejection.

[0006] Improved ex vivo organ care has been achieved through the use of ex vivo organ care systems that maintain organs in physiological or near-physiological conditions. The systems not only maintain the organ at physiological temperature, but in the case of the heart, the systems maintain perfusion fluid flowing through the organ. The systems also measure and monitor electrical impulses in the heart. Ex vivo organ care systems in which the heart is maintained in physiological or near-physiological conditions ex vivo are described in application Ser. No. 11 / 822,495, entitled "Systems for monitoring and applying electrical currents in an organ perfusion system," and in application Ser. No. 11 / 822,495, entitled "Method for ex-vivo organ care and for using lactate as an indication of donor organ status." and U.S. Patent No. 5,929,999 entitled "Compositions, methods and devices for maintaining an organ," which are incorporated herein by reference.

[0007] To maintain physiological or near-physiological perfusate flow through the heart, the organ must be interfaced with the system via the aorta. This interface is achieved via an aortic cannula. Current aortic cannula designs result in organ displacement, difficulty maintaining a fluid seal, and injury to the aorta. Often, these designs This relies solely on the cable tie in contact with the aorta to secure the aortic cannula to the aorta. Depending on the size of the aorta and the size of the aortic cannula, there is a risk of laceration if the cable tie exerts too much tension on the aortic tissue, or a risk of leakage if the cable tie does not exert enough tension. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 8,304,181 [Patent Document 2] U.S. Patent No. 8,409,846 Summary of the Invention [Problem to be solved by the invention]

[0009] Therefore, there is a need for an aortic cannula that is easy for healthcare workers to deploy, creates a seal with the aorta, reduces aortic displacement, and minimizes trauma to the aorta.

[0010] In view of the foregoing, there is a need for improved devices and methods for use in ex vivo organ management systems for attaching the aorta to the system. [Means for solving the problem]

[0011] summary In one aspect, the present invention includes an aortic cannula for use with an ex vivo organ management system and a method of use thereof. One aspect of the present invention includes an aortic cannula, the aortic cannula comprising a cannula body, the cannula body further comprising a fitting adapted to be coupled to the organ management system, an aortic interface for contacting the aorta, and a pivot arm strap operably coupled to a pivot mount, wherein the pivot mount evenly contacts the pivot arm strap with the aorta to retain the aorta on the aortic interface. In one aspect, the aortic cannula further comprises a pivot arm coupled to the pivot arm strap and the pivot mount, such that when the pivot arm is moved toward the cannula body by rotation about the pivot mount, the pivot arm strap moves away from the cannula body. In another aspect of the aortic cannula, the pivot arm and pivot arm strap are a single-piece component. In another aspect, the aortic cannula includes a spring that applies pressure to the pivot arm strap to retain the aorta on the aortic interface. In another embodiment of the aortic cannula, the dowel pin communicates with a spring to rotate the pivot arm around the dowel pin. In another embodiment of the aortic cannula, the pivot arm further includes a grip pad used to depress the top of the pivot arm. In another embodiment of the aortic cannula, the grip pad is textured. In another embodiment of the aortic cannula, the grip pad is removable. In another embodiment of the aortic cannula, the pivot arm strap further includes a loop and guide that holds a cable tie around the pivot arm strap. In another embodiment, the aortic cannula further includes a window sized to standardize compression exerted on the aorta by the cable tie, such that the same amount of pressure is exerted on the aorta for a given cable tie tension regardless of the size of the pivot arm strap. In another embodiment, the aortic cannula further includes a connector used to reversibly secure the aortic cannula to the organ chamber.In another embodiment of the aortic cannula, the connector is a threaded locking nut. In another embodiment of the aortic cannula, the aortic interface is textured.

[0012] One aspect of the invention involves a method of using an aortic cannula to place a heart in fluid communication with an organ management system, the method comprising: placing an aortic cannula sized to fit into the aorta of the heart; the aortic cannula includes a cannula body, the cannula body further including a fitting adapted to be tethered to an organ management system, an aortic interface that contacts the aorta, and a pivot arm strap operably coupled to the pivot mount, the pivot mount evenly contacting the pivot arm strap with the aorta to hold the aorta on the aortic interface; depressing the pivot arm so that the pivot arm rotates about the dowel pin and the pivot arm strap moves away from the cannula body; placing the cannula into the aorta; releasing the pivot arm; tying a cable tie around the pivot arm strap to hold the aorta in place; and inserting the tapered fitting into the organ management system. In one embodiment, the method further includes suturing a surgical felt pledget onto the aorta before placing the aorta onto the aortic cannula.

[0013] That is, the gist of the present invention relates to the following. Item 1 a fixture adapted to be coupled to an organ management system; and Aortic interface for contacting the aorta a cannula body including: A pivot arm strap operably connected to the pivot mount 1. An aortic cannula for use in an ex vivo organ management system, comprising: a pivot mount that evenly contacts a pivot arm strap with the aorta to hold the aorta on an aortic interface. [Effects of the Invention]

[0014] The present invention may provide an aortic cannula for an ex vivo organ management system. [Brief explanation of the drawings]

[0015] The following drawings illustrate exemplary embodiments of the present invention. [Figure 1] FIG. 1 illustrates a diagram showing an aortic cannula in one embodiment. [Figure 2a] FIG. 2a illustrates a side view of a cannula body in one embodiment. [Figure 2b] FIG. 2b illustrates a side view of a cannula body and spring pocket according to one embodiment. [Figure 2c] FIG. 2c illustrates a side view of a cannula body in one embodiment. [Figure 3a] FIG. 3a illustrates one embodiment of a pivot arm. [Figure 3b] FIG. 3b illustrates a side view of a pivot arm and strap according to one embodiment. [Figure 3c] FIG. 3c illustrates another view of the pivot arm and strap according to one embodiment. [Figure 3d] FIG. 3d illustrates another view of the pivot arm and strap according to one embodiment. [Figure 3e] FIG. 3e illustrates a top view of a pivot arm and strap according to one embodiment. [Figure 4] FIG. 4 illustrates a diagram showing the shape of the cannula body texture in one embodiment. [Figure 5] FIG. 5 illustrates a top view of a pivot mount according to one embodiment. [Figure 6] FIG. 6 illustrates a tip holder according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0016] Detailed Description Cannula body FIG. 1 illustrates an aortic cannula 100 in one embodiment. The aortic cannula device 100 includes a cannula body 114, a locking nut 102, and a pivot arm 140. The cannula body 114 may include three sub-components: a tapered fitting 108, a tapered midsection 130, and an aortic interface 132. These sub-components can be seen in FIG. 1 and in various side views of the cannula body 114 shown in FIGS. 2a-2b. In one embodiment, the cannula The body 114 is made of injection molded clear polycarbonate. Those skilled in the art will appreciate that the cannula body may be made from other types of plastics or any other suitable material.

[0017] Those skilled in the art will appreciate that the shape of the cannula body 114 should be generally cylindrical, but the opening may be completely It will be appreciated that the tapered fitting 108, tapered midsection 130, and aortic interface 132 do not have to be entirely circular. The three sub-components, tapered fitting 108, tapered midsection 130, and aortic interface 132, may be of different lengths relative to one another. Also, the different sub-components may be made from a single piece, and the sub-components may have the same diameter. Those skilled in the art will also appreciate that the angle of taper of the tapered fitting 108, tapered midsection 130, and aortic interface 132 sub-components will depend on the shape of the aortic interface, such as the diameter of the human aorta. It is recognized that variations are possible provided that the diameter falls within the typical range of diameters.

[0018] One end of the aortic cannula 100 forms a tapered fitting 108. The tapered fitting is sized to mate with a female connector on an organ chamber (not shown) to create a seal. The threaded locking nut 102 shown in Figure 1 is used to reversibly secure the aortic cannula 100 to the organ chamber (not shown). The locking nut 102 has four blades 104 extending from its outer surface that are used to grip and turn the locking nut 102. In one embodiment, the wings 104 are rectangular. Those skilled in the art will appreciate that the wings 104 may be any shape or may be omitted. The locking nut 102 extends from the bottom end of the locking nut to the inside. and has a lip that fits over a locking ridge 110 and into a locking groove 112 on the cannula body 114. The locking groove 112 and locking ridge 110 can be seen in Figures 1 and 2a-2b. Nut 102 may be secured to cannula body 114 using other mechanisms known to those skilled in the art. Once locking nut 102 is placed in locking groove 112, aortic cannula 100 is securely fastened to the organ chamber (not shown) by rotating locking nut 102. Perfusion fluid may be perfused into the heart through the cannula without leakage. Those skilled in the art will appreciate that other designs may be used to attach aortic cannula 100 to the organ chamber to prevent leakage.

[0019] Those skilled in the art will appreciate that the aortic cannula 100 can be easily inserted into an organ management system, or any other tube, Those skilled in the art will also understand that in embodiments where the male-female connection between the aortic cannula 100 and the organ management system (not shown) is tight enough to prevent leakage, the locking nut 102 may be omitted. Those skilled in the art will also understand that the locking nut 102 may be omitted from the aortic cannula 100, as is commonly used in the art to create a flow path between two tubes. It is recognized that other types of connectors may be substituted.

[0020] The tapered midsection 130 extends from the bottom end of the tapered fitting 108 to the top end of the aortic interface 132. The tapered midsection 130 is the smallest of the aortic interface 132 sizes. The tapered intermediate section 130 reaches a final diameter. The tapered intermediate section 130 helps ensure smooth fluid flow from the aortic interface 132 to the tapered fitting 108. The tapered intermediate section 130 also helps minimize air trapping and hemolysis, improving hemodynamics due to smooth transitions in the flow path. The tapered intermediate section 130 has a pivot mount 122 and a spring pocket 106. The pivot mount 122 and the spring pocket 106 can be integrated with the tapered intermediate section 130. In one embodiment, the tapered intermediate section 130 is a stent with two aortic interfaces 132 and 106 shown in FIGS. 1 and 2b. The cannula body 114 has a pivot mount 122 and two spring pockets 106. The pivot mounts 122 are located on each side of the cannula body 114. Those skilled in the art will appreciate that more than one pivot mount 122 and spring pocket 106 may be used. As shown in FIG. 5, one embodiment , the pivot mount 122 has a circular central hole 138 sized to receive the dowel pin 120. Spring pocket 106 is disposed on cannula body 114 and provides space for a torsion spring (not shown). Dowel pin 120 passes through one side of a central hole 138 on integral pivot mount 122, through the center of the torsion spring in spring pocket 106, and into the integral pivot mount 122. The torsion spring fits through the other side of the central bore 138 on the pivot mount 122. The torsion spring is oriented in the spring pocket 106 such that pressing down on the pivot arm compresses the spring. One end of the torsion spring resides in a spring end pocket 134 on the thumb pad 116, as seen in FIG. 3a. Those skilled in the art will appreciate that there are various ways to allow the pivot mount 122 to pivot or rotate so that the aorta for attachment to the cannula body 114 can fit into the cannula body 114 during manipulation. In one embodiment, the pivot The mount 122 may be injection molded polycarbonate, acetyl or any suitable material. It is made from

[0021] Those skilled in the art will also recognize that the torsion spring may be replaced with other types of spring-loaded mechanisms or omitted entirely. The torsion spring may also be replaced with a molded leaf spring on the pivot arm or grip pad. By using a molded leaf spring, the dowel pin may be omitted and the same may be achieved using a cylindrical boss or similar structure on the cannula body 114. It can perform a function.

[0022] An aortic interface 132 is disposed adjacent the tapered intermediate section 130. The aortic interface 132 may be of constant diameter and sized to fit within the aorta. The diameter of the venous interface 132 may be between 0.5 and 2 inches. In some embodiments, The diameter of the aortic interface 132 can be 0.75 to 1.125 inches. Preferably, in some embodiments, the diameter of the aortic interface is 0.75 inches, 0.875 inches, 1 inch, or 1.125 inches. The aortic interface 132 can be smooth or textured. FIG. 1 illustrates texture 128 on the aortic interface 132 to help prevent the aorta from slipping off the cannula body 114. In the embodiment shown in FIG. 1, the aortic cannula 100 prevents the aorta from slipping beyond the ends of the texture 128. 4 is a cross-sectional view of one embodiment of texture 128. Texture 128 can be any shape. In one embodiment, texture 128 includes coaxial ridges that extend around aortic interface 132, and the coaxial ridges extend beyond the aortic interface 132. It is angled at a 45 degree angle on the side and perpendicular to the cannula body 114 on its top side. The aorta slides easily over the aortic interface 132, but the aorta slides over the aortic interface 132. The protuberances are prevented from slipping off the aorta interface 132. Preferably, the protuberances are approximately 0.005 inches high. However, one skilled in the art will appreciate that the textured features may be of any shape that will allow the aorta to be positioned around the aortic interface 132 and remain in place while minimizing trauma to the tissue. It will be appreciated that the aortic interface 132 may be sized to aid in the retention of the aorta. In one embodiment, the radial end of the aortic interface 132 does not have a ridge to minimize trauma to the tissue. Alternatively, one skilled in the art will recognize that ridges can be designed to minimize tissue trauma and hold the aorta in place.

[0023] Pivot Arm The pivot arm 140 is connected to the pivot mount 122. Figures 3a-e show an embodiment of the present invention. Different views of the pivot arm and pivot arm strap (below) are illustrated. The pivot arm 140 allows the device 100 to conform to and grip aortas of different thicknesses. In one embodiment, the cannula body 114 includes two pivot arms 140 connected to two pivot mounts 122 on the cannula body. One skilled in the art will understand that the number of pivot arms 140 corresponds to the number of pivot mounts 122. The pivot arm 140 includes a grip pad 116, a sliding pivot window 118, and a strap 124. The sliding pivot window 118 allows the strap 124 to maintain even contact with the aorta throughout its range of movement. The grip pads 116 may be smooth or have a surface that prevents the user's fingers from slipping. The grip pad 116 may include features such as molded ridges or other textures for improved grip. The grip pad may be any shape, preferably spherical. In some embodiments, the grip pad 116 may be removable. In other embodiments, a reusable tool that attaches to the pivot arm 140 may be used in place of the grip pad 116. The dowel pin 120 allows the pivot arm 140 to rotate about the dowel pin 120 when actuated. The pivot arm 140 may be made of injection molded acetyl or any material with similar properties. The pivot arm 140 may be made of any material. Those skilled in the art will recognize that while sliding pivots offer certain advantages over fixed pivot points, fixed pivot points may also be used. Some embodiments may include a locking mechanism to hold the pivot arm 140 in a released position.

[0024] Pivoting Arm Strap Pivot arm strap 124 is connected to pivot arm 140. The pivot arm strap is best seen in Figures 1 and 3. As shown in Figure 1, in one embodiment, The needle body 114 includes two pivot arm straps 124 that are connected to two pivot arms 140. Those skilled in the art will appreciate that the number of pivot straps 124 corresponds to the number of pivot arms 140. It will be appreciated that the pivot arm straps 124 and sliding pivot window 118 allow the cannula body 114 to evenly grip the aorta. The pivot arm straps 124 are designed to be stiff enough to hold the aorta, yet remain flexible enough to conform to the aorta and minimize tissue damage. The pivot arm straps 124 are curved. The pivot arm strap 124 optionally has a loop 136 and guide 142 for maintaining a cable tie (not shown) around the pivot arm strap 124. The cable tie is made of a flexible nylon material or a material with similar properties. When the cable tie is attached to the loop 136 Once threaded and inserted into guide 142, the cable tie is tightened to the desired tension. The amount that the cannula ties are tightened is the same for all sizes of cannula. The window 126 in the pivot arm strap 124 standardizes the pressure applied to the aorta by varying the surface area of ​​the strap that contacts the aorta. Therefore, the size of the window 126 varies depending on the pressure applied to the aorta. The size of the window 126 varies depending on the size of the cable tie. The cable ties were calculated to exert the same compression on the aorta for a size 100 device. Thus, the compression on the aorta holds the aorta in place without damaging the tissue. Alternatively, those skilled in the art will appreciate that cable ties may be used for each size of device 100. It will be appreciated that the pivot arm 140 and pivot arm strap 124 may be tightened to a particular tension using a cable tie. Also, other mechanisms for pinching the aorta to hold it in place, such as a hose clamp or tension strap, may be used in place of the cable tie. Furthermore, the pivot arm strap 124 and window 126 may be different shapes and sizes. Alternatively, the window may be omitted. Those skilled in the art will also appreciate that the pivot arm 140 and pivot arm strap 124 may be single-piece components. Also, Those skilled in the art will appreciate that the inner surface of the pivot arm strap 124 may be smooth or may be It is understood that certain textures may be provided for different traction.

[0025] In one embodiment, the aorta is secured to the cannula body. By pushing down, the pivot arm 140 moves around the sliding pivot window 118 and the torsion spring is compressed. The pivot arm 140 rotates around the dowel pin 120 within the sliding pivot window 118. When the grip pad 116 is released, the pivot arm strap 124 moves away from the cannula body 114, which creates space in the aorta to position the cannula in a more favorable manner than if the pivot point were fixed. When the grip pad 116 is released, a torsion spring (not shown) pulls the pivot arm strap 124 away from the cannula body 114. By applying pressure to the aorta, the aorta is temporarily held in place. To maintain alignment and concentricity of the pivot arm 140 to the cannula body 114 throughout its full range of rotation, the strap closes over the aorta and the sliding pin The bolt window 118 changes the pivot point, which allows the strap 124 to be evenly positioned over the aorta. The cable tie is then threaded through the loop 136 and between the guides 142. The cable ties are tightened to a predetermined tension. Those skilled in the art will appreciate that the cable ties may be replaced with other mechanisms for securing the pivot arm straps 124. In this case, the cable tie may be preassembled in the loop 136 .

[0026] pledget In some embodiments, the user may suture surgical felt pledgets to the aorta. The pledgets provide a non-sliding barrier between the pivot arm strap 124 and the cannula body 114, providing an additional measure of maintaining the aorta in the cannula body 114. Four sets of two pledgets (one inner, one outer) are evenly spaced around the aorta and sutured. Those skilled in the art will recognize that more or fewer pledgets may be used. In one embodiment, the aorta is positioned such that the pledget is directly above the space between the pivot arms 140 to prevent the pledget from sliding through the space between the two sides of the pivot arm strap 124. The pledget is positioned over the cannula body 114 so that it does not penetrate any part of the aorta. It will be appreciated that the pledget may be placed in any orientation, end up, relative to the pivot arm strap. The pledget may be a standard surgical felt pledget. Alternatively, the pledget may be an injection molded stiff, elastomeric pledget made of a high durometer material, such as silicone or similar material. Those skilled in the art will appreciate that the pledget may be replaced with other materials that adhere to tissue and provide an anchor to prevent the device from sliding between the strap and cannula body or damaging the tissue. Examples of these materials include, but are not limited to, a continuous ring of material that adheres to tissue, Examples of such a material include staples.

[0027] Tip Holder Figure 6 shows a tip holder 601. Tip holder 601 is generally cylindrical, but may be of other shapes. The tip holder may have a handle 603. The handle allows a user to The tip holder 601 may have any shape that allows it to hold the aortic cannula 100. The tip holder 601 may also have threads 602. The locking nut 102 may screw onto the threads 602. The tip holder 601 may also have a stopper 604 that protrudes from the tip holder 601 and provides a stopping point for the locking nut 102. Those skilled in the art will appreciate that other designs may be used to attach the locking nut to the tip holder. Alternatively, the tip holder may be secured to the aortic cannula 100 using other mechanisms known to those skilled in the art. Once secured, the tip holder may be secured to the aortic cannula 100. It may be used to hold the aortic cannula 100 with or without the heart positioned on the cannula 100. [Example]

[0028] Example 1 The aortic cannula 100 can be used to connect the heart to an organ chamber (not shown). The aortic cannula 100 opens and holds the aorta in place, allowing perfusate to flow back to the heart. In one embodiment, to deploy the aortic cannula, the user first inserts the aortic cannula 100 into the aorta 100 sized to fit the heart. In one embodiment, the aortic cannula 100 is selected by measuring the aorta. The user presses down on the thumb pad 116 on the spring-loaded pivot arm. When the user presses down on the grip pad 116, the pivot arm 140 moves down in the sliding pivot window 118. By rotating about the elbow 120, the pivot arm strap 124 moves away from the cannula body 114. The thumb pad is then released and moved, creating space for placement of the cannula in the aorta. The user may place the cannula into the aorta. The user then releases the thumb pad, and the pivot arms 140 close onto the aorta. The pivot arms 140 may be operated simultaneously or individually. Pressure created by the torsion springs temporarily holds the aorta in place. The user may adjust the position of the aorta, if necessary, so that it fully engages with the cannula body 114. The user then threads the loop 136 and guide 142 in the pivot arm strap 124. The user then tightens the cable tie to hold the aorta in place. In some embodiments, the cable tie may be tightened using a tool that tightens the cable tie to a predetermined force. The user inserts the tapered fitting 108 into the organ chamber (not shown). The user then tightens the locking nut 102. One skilled in the art will appreciate that in some embodiments, the aortic cannula 100 may be placed into the organ chamber first, and then the aorta. It will be appreciated that the aortic cannula 100 may be secured to the aortic cannula 100.

[0029] The present invention includes the following aspects. [1] a fixture adapted to be connected to an organ management system; and Aortic interface for contacting the aorta a cannula body including: A pivot arm strap operably connected to the pivot mount 1. An aortic cannula for use in an ex vivo organ management system, comprising: a pivot mount that evenly contacts a pivot arm strap with the aorta to hold the aorta on an aortic interface. [2] The aortic cannula described in [1], further comprising a pivot arm connected to the pivot arm strap and the pivot mount, wherein the pivot arm strap moves away from the cannula body when the pivot arm is moved toward the cannula body by rotation around the pivot mount. [3] The aortic cannula according to [2], wherein the pivot arm and the pivot arm strap are single-piece components. [4] The aortic cannula of [1], further comprising a spring that applies pressure to the pivot arm strap to hold the aorta on the aortic interface. [5] The aortic cannula of [4], wherein the dowel pin communicates with a spring to rotate the pivot arm about the dowel pin. [6] The aortic cannula of [1], wherein the pivot arm further includes a grip pad used to depress the top of the pivot arm. [7] The aortic cannula described in [6], wherein the grip pad is textured. [8] The aortic cannula according to [6], wherein the grip pad is removable. [9] The aortic cannula of [1], wherein the pivoting arm strap further includes a loop and guide for holding a cable tie around the pivoting arm strap.

[10] The aortic cannula described in [9], further comprising a window of a size for standardizing the compression exerted on the aorta by the cable tie so that for a given cable tie tension, the same amount of pressure is exerted on the aorta regardless of the size of the pivot arm strap.

[11] The aortic cannula of [1], further comprising a connector used to reversibly secure the aortic cannula to the organ chamber.

[12] The aortic cannula according to

[11] , wherein the connector is a threaded fixing nut.

[13] The aortic cannula described in [1], wherein a specific texture is provided at the aortic interface.

[14] a fixation nut configured to reversibly fix the aortic cannula to the organ chamber assembly; a cannula body, wherein the cannula body comprises: a tapered fitting sized to couple to the organ chamber assembly; an aortic interface sized to fit within the aorta; and a tapered intermediate section extending from the tapered fitting to the aortic interface; and Pivot Mount Including, a pivot arm operably connected to the pivot mount, the pivot arm comprising: a grip pad that can be used to depress the top of the pivot arm; a pivoting arm strap configured to hold the aorta against the aortic interface; and a sliding pivot window configured to allow the pivot arm strap to maintain contact with the aorta throughout its range of movement; including, Dowel pin connecting pivot mount to sliding pivot window 1. An aortic cannula for use in an ex vivo organ management system, comprising: a pivot arm configured to rotate about a dowel pin.

[15] The aortic cannula according to

[14] , further comprising a tip holder configured to be connected to the fixation nut.

[16] An aortic cannula as described in

[14] , in which a specific texture is provided at the aortic interface.

[17] The aortic cannula of

[14] , further comprising a spring that applies pressure to the pivot arm strap to hold the aorta on the aortic interface.

[18] The aortic cannula of

[17] , wherein the gripping pad compresses the spring when depressed.

[19] The aortic cannula of

[14] , wherein the pivoting arm strap further comprises a loop and a guide for maintaining the cable tie around the pivoting arm strap.

[20] The aortic cannula of

[19] , further comprising a window of a size for standardizing the compression exerted on the aorta by the cable tie so that, for a given cable tie tension, the same amount of pressure is exerted on the aorta regardless of the size of the pivot arm strap.

[21] A method of using an aortic cannula to position a heart in fluid communication with an organ management system, the method comprising: selecting an aortic cannula sized to fit into the aorta of the heart; Here, the aortic cannula is a cannula body, wherein the cannula body comprises: a fixture adapted to be coupled to an organ management system; and Aortic interface for contacting the aorta including, A pivot arm strap operably connected to the pivot mount the pivot mount evenly contacts the pivot arm strap with the aorta to hold the aorta on the aortic interface. depressing the pivot arm so that the pivot arm rotates about the dowel pin and moves the pivot arm strap away from the cannula body, wherein the dowel pin operably connects the pivot mount to the pivot arm; placing an aortic interface in the aorta; releasing the pivot arm; tying a cable tie around the pivot arm strap to hold the aorta in place around the aortic interface; and Inserting the tapered fitting into the organ management system A method comprising:

[22] The method of

[21] , further comprising the step of suturing a surgical felt pledget to the aorta before placing the aorta in the aortic cannula.

[23] The method of

[21] , further comprising using a fixation nut to reversibly fix the aortic cannula to the organ management system.

Claims

1. a fixture adapted to be coupled to an organ management system; and Aortic interface for contacting the aorta a cannula body including: A pivot arm strap operably connected to the pivot mount 1. An aortic cannula for use in an ex vivo organ management system, comprising: a pivot mount that evenly contacts a pivot arm strap with the aorta to hold the aorta on an aortic interface.

2. 2. The aortic cannula of claim 1, further comprising a pivot arm connected to the pivot arm strap and the pivot mount, wherein the pivot arm strap moves away from the cannula body when the pivot arm is moved toward the cannula body by rotation about the pivot mount.

3. 3. The aortic cannula of claim 2, wherein the pivot arm and the pivot arm strap are a single piece component.

4. 10. The aortic cannula of claim 1, further comprising a spring that applies pressure to the pivot arm strap to hold the aorta on the aortic interface.

5. 5. The aortic cannula of claim 4, wherein the dowel pin communicates with a spring for rotating the pivot arm about the dowel pin.

6. The aortic cannula of claim 1 , wherein the pivot arm further includes a grip pad used to depress the top of the pivot arm.

7. 7. The aortic cannula of claim 6, wherein the grip pad is textured.

8. 7. The aortic cannula of claim 6, wherein the gripping pad is removable.

9. The aortic cannula of claim 1 , wherein the pivoting arm strap further comprises a loop and a guide for retaining a cable tie around the pivoting arm strap.

10. 10. The aortic cannula of claim 9, further comprising a window of a size for standardizing the compression exerted on the aorta by the cable tie so that, for a given cable tie tension, the same amount of pressure is exerted on the aorta regardless of the size of the pivot arm strap.

11. 10. The aortic cannula of claim 1, further comprising a connector used to reversibly secure the aortic cannula to the organ chamber.

12. 12. The aortic cannula of claim 11, wherein the connector is a threaded locking nut.

13. The aortic cannula of claim 1 , wherein the aortic interface is textured.

14. a locking nut configured to reversibly secure the aortic cannula to the organ chamber assembly; a cannula body, wherein the cannula body comprises: a tapered fitting sized to couple to the organ chamber assembly; an aortic interface sized to fit within the aorta; and a tapered intermediate section extending from the tapered fitting to the aortic interface; and Pivot Mount Including, a pivot arm operably connected to the pivot mount, the pivot arm comprising: a grip pad that can be used to depress the top of the pivot arm; a pivoting arm strap configured to hold the aorta against the aortic interface; and a sliding pivot window configured to allow the pivot arm strap to maintain contact with the aorta throughout its range of movement; including, Dowel pin connecting pivot mount to sliding pivot window 1. An aortic cannula for use in an ex vivo organ management system, comprising: a pivot arm configured to rotate about a dowel pin.

15. The aortic cannula of claim 14, further comprising a tip holder configured to be coupled to the locking nut.

16. The aortic cannula of claim 14, wherein the aortic interface is textured.

17. 15. The aortic cannula of claim 14, further comprising a spring that applies pressure to the pivot arm strap to hold the aorta on the aortic interface.

18. 18. The aortic cannula of claim 17, wherein the gripping pad compresses the spring when depressed.

19. The aortic cannula of claim 14, wherein the pivoting arm strap further comprises a loop and a guide for maintaining the cable tie around the pivoting arm strap.

20. 20. The aortic cannula of claim 19, further comprising a sized window for standardizing the compression exerted on the aorta by the cable tie so that, for a given cable tie tension, the same amount of pressure is exerted on the aorta regardless of the size of the pivot arm strap.

21. 1. A method of using an aortic cannula to place a heart in fluid communication with an organ management system, the method comprising: selecting an aortic cannula sized to fit into the aorta of the heart; Here, the aortic cannula is a cannula body, wherein the cannula body comprises: a fixture adapted to be coupled to an organ management system; and Aortic interface for contacting the aorta including, A pivot arm strap operably connected to the pivot mount the pivot mount evenly contacts the pivot arm strap with the aorta to hold the aorta on the aortic interface. The pivot arm rotates around the dowel pin and the pivot arm strap secures the cannula. depressing the pivot arm to move it away from the body, wherein the dowel pin operably connects the pivot mount to the pivot arm; placing an aortic interface in the aorta; releasing the pivot arm; tying a cable tie around the pivot arm strap to hold the aorta in place around the aortic interface; and Inserting the tapered fitting into the organ management system A method comprising:

22. 22. The method of claim 21, further comprising suturing a surgical felt pledget to the aorta prior to placing the aorta in the aortic cannula.

23. 22. The method of claim 21, further comprising using a locking nut to reversibly secure the aortic cannula to the organ management system.

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