Aortic Cannula for an Ex Vivo Organ Management 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 No. 62 / 215,825, filed on September 9, 2015, the entire disclosure of which is hereby incorporated by reference herein, and having the invention title "Aortic Cannula for Ex Vivo Organ Care System".

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

Background Art

[0003] Technical Field The present invention generally relates to medical devices for use in an ex vivo organ care system, and in particular to an aortic cannula. Specifically, the present invention relates to an aortic cannula used to return perfusion fluid to the heart or deliver perfusion fluid from the heart while maintaining an organ ex vivo in a physiological or near-physiological state.

[0004] Background Current organ preservation techniques typically involve cryopreserving an organ 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 to whom a given donor's organ can be delivered, 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 the harvested organs. This in turn enables earlier detection of defects in the harvested organs and possible repair, as well as reducing the likelihood of transplant failure. The ability to perform simple repairs in the organs also allows many organs with minor defects to be saved, which would currently be required to be discarded with current transplant techniques. Also, more effective matching between the organ and a specific recipient can be achieved, and the likelihood of ultimate organ rejection can be reduced.

[0006] Improved ex vivo organ management is achieved by using an ex vivo organ management system that maintains the organ in a physiological or near-physiological state. The system not only maintains the organ at physiological temperature, but in the case of the heart, the system maintains the perfusion fluid flowing through the organ. The system also measures and monitors electrical stimulation in the heart. An ex vivo organ management system in which the heart is maintained ex vivo in a physiological or near-physiological state is described in Application No. 11 / 822495, the title of the invention being "Systems for monitoring and applying electrical currents in an organ perfusion system", Patent Document 1, the title of the invention being "Method for ex-vivo organ care and for using lactate as an indication of donor organ status", and Patent Document 2, the title of the invention being "Compositions, methods and devices for maintaining an organ", which are hereby incorporated by reference.

[0007] To maintain a physiological or near-physiological flow of fluid through the heart, the organ must be connected to the system via the aorta. This connection is achieved via an aortic cannula. Current aortic cannula designs result in organ displacement, difficulty maintaining liquid seals, and damage to the aorta. Often these designs rely only on cable ties in contact with the aorta to secure the aorta and aortic cannula. Depending on the size of the aorta and the size of the aortic cannula, there is a risk of laceration due to the cable tie exerting too much tension on the aortic tissue, or a risk of leakage if the cable tie does not exert sufficient tension.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0009] Accordingly, there is a need for an aortic cannula that is easy for a healthcare worker to deploy, creates intimate contact with the aorta, reduces aortic displacement, and minimizes damage to the aorta.

[0010] In view of the foregoing, there is a need for an improved device for attaching the aorta to a system and a method of use in an ex vivo organ management system.

Means for Solving the Problems

[0011] Summary In one aspect, the present invention includes an aortic cannula and a method of using the same for use with an ex vivo organ management system. One aspect of the present invention includes an aortic cannula, the aortic cannula including a cannula body, the cannula body further including a fixture adapted to be connected to an organ management system, an aortic interface for contacting the aorta, and a pivot arm strap operably connected to a pivot mount, wherein the pivot mount evenly contacts the pivot arm strap against the aorta for holding the aorta on the aortic interface. In one aspect, the aortic cannula further includes the pivot arm strap and a pivot arm connected to the pivot mount, such that when the pivot arm is moved towards the cannula body by rotation around the pivot mount, the pivot arm strap moves away from the cannula body. In another aspect of the aortic cannula, the pivot arm and the pivot arm strap are parts of a single piece. In another aspect, the aortic cannula includes a spring for applying pressure to the pivot arm strap for holding the aorta on the aortic interface. In another aspect of the aortic cannula, a dowel pin communicates with the spring for rotating the pivot arm around the dowel pin. In another aspect of the aortic cannula, the pivot arm further includes a grip pad used for pushing down the top of the pivot arm. In another aspect of the aortic cannula, the grip pad is textured. In another aspect of the aortic cannula, the grip pad is removable. In another aspect of the aortic cannula, the pivot arm strap further includes a loop and a guide for holding a cable tie around the pivot arm strap. In another aspect, the aortic cannula further includes a size window for standardizing the compression of the aorta by the cable tie, such that for a given cable tie tension, the same amount of pressure is applied to the aorta regardless of the size of the pivot arm strap. In another aspect, the aortic cannula further includes a connector used for reversibly fixing the aortic cannula to an organ chamber.In another aspect of the aortic cannula, the connector is a threaded fixing nut. In another aspect of the aortic cannula, a specific texture is provided on the aortic interface.

[0012] One aspect of the present invention includes a method of using an aortic cannula for positioning the heart to be in fluid communication with an organ management system, the method comprising: selecting an aortic cannula sized to fit the aorta of the heart, wherein the aortic cannula includes a cannula body, the cannula body further including a fixture adapted to be connected to the organ management system, an aortic interface that contacts the aorta, and a pivot arm strap operably connected to a pivot mount, the pivot mount evenly contacting the pivot arm strap to the aorta for holding the aorta on the aortic interface; depressing the pivot arm such that the pivot arm rotates around a 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 a tapered fixture into the organ management system. In one aspect, the method further comprises suturing surgical felt wadding onto the aorta before placing the aorta on the aortic cannula.

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

Advantages of the Invention

[0014] According to the present invention, a aortic cannula for an ex vivo organ management system can be provided.

Brief Description of the Drawings

[0015] The following drawings illustrate exemplary embodiments of the present invention.

Figure 1

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Modes for Carrying Out the Invention

[0016] Detailed Description Cannula body FIG. 1 is a view showing the aortic cannula 100 in one aspect. The aortic cannula device 100 includes a cannula body 114, a fixing nut 102, and a pivot arm 140. The cannula body 114 may include a tapered fixture 108, a tapered intermediate portion 130, and an aortic interface 132, which are three sub-components. These sub-components can be seen in FIG. 1 and various side views of the cannula body 114 shown in FIGS. 2A-2B. In one aspect, the cannula body 114 is made of injection-molded transparent polycarbonate. However, those skilled in the art will understand that the cannula body can be made of other types of plastics or any other suitable material.

[0017] Those skilled in the art will recognize that the shape of the cannula body 114 should generally be cylindrical, but the opening does not need to be perfectly circular. The three sub-components, the tapered fixture 108, the tapered intermediate portion 130, and the aortic interface 132, can have different lengths relative to each other. Also, different sub-components can be made from a single part, and the sub-components can have the same diameter. Those skilled in the art will also recognize that the taper angles of the sub-components, the tapered fixture 108, the tapered intermediate portion 130, and the aortic interface 132, can be different as long as the aortic interface reaches a diameter within the typical range of the diameter of the human aorta.

[0018] One end of the aortic cannula 100 forms a tapered fixture 108. The tapered fixture is sized to connect to a female connector on an organ chamber (not shown) to create a seal. The threaded retaining nut 102 shown in FIG. 1 is used to reversibly secure the aortic cannula 100 to an organ chamber (not shown). In one aspect, the retaining nut 102 has four vanes 104 that extend from the outer surface of the retaining nut and are used to grasp and turn the retaining nut 102. In one aspect, the vanes 104 are rectangular. Those skilled in the art will understand that the vanes 104 can be of any shape or can be omitted. The retaining nut 102 can have a lip that projects inwardly from the bottom end of the retaining nut and fits over a securing ridge 110 on the cannula body 114 and into a securing groove 112. The securing groove 112 and the securing ridge 110 can be seen in FIGS. 1 and 2a - 2b. Alternatively, the retaining nut 102 can be secured to the cannula body 114 using other mechanisms known to those skilled in the art. Once the retaining nut 102 is placed in the securing groove 112, the aortic cannula 100 is securely fastened to the organ chamber (not shown) by rotating the retaining nut 102. Perfusate can be perfused through the cannula to the heart without leakage. Those skilled in the art will understand that other designs can be used to attach the aortic cannula 100 to the organ chamber to prevent leakage.

[0019] Those skilled in the art will understand that the aortic cannula 100 can be connected to an organ management system, or any other tube, device or flow path. Also, those skilled in the art will understand that the retaining nut 102 can be omitted in an aspect where the male - female connection between the aortic cannula 100 and an organ management system (not shown) is sufficiently tight to prevent leakage. Those skilled in the art will also recognize that the retaining nut 102 can be replaced with other types of connectors commonly used in the art to create a flow path between two tubes.

[0020] The tapered intermediate portion 130 extends from the bottom end of the tapered fixture 108 to the upper end of the aortic interface 132. The tapered intermediate portion 130 reaches the final diameter of the size of the aortic interface 132. The tapered intermediate portion 130 aids in ensuring a smooth fluid flow from the aortic interface 132 to the tapered fixture 108. The tapered intermediate portion 130 also aids in minimizing air traps and hemolysis and improving hemodynamics for smooth movement in the flow path. The tapered intermediate portion 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 portion 130. In one aspect, the tapered intermediate portion 130 has two pivot mounts 122 and two spring pockets 106 as shown in FIGS. 1 and 2b. The pivot mounts 122 are disposed on respective sides of the cannula body 114. One skilled in the art will understand that one or more pivot mounts 122 and spring pockets 106 can be used. As shown in FIG. 5, in one aspect, the pivot mount 122 has a circular central hole 138 sized to receive a dowel pin 120. The spring pocket 106 is disposed on the cannula body 114 and provides a space for a torsion spring (not shown). The dowel pin 120 is adapted to pass through one face of the central hole 138 in the integrated pivot mount 122, through the center of the torsion spring in the spring pocket 106, and through the other face of the central hole 138 in the integrated pivot mount 122. The torsion spring is oriented in the spring pocket 106 to compress the spring by pushing down on the pivot arm. One end of the torsion spring is in a spring end pocket 134 on the thumb pad 116 as seen in FIG. 3a. One skilled in the art will understand that there are various ways to enable the pivot mount 122 to rotate or pivot such that the pivot mount 122 can be adapted to the cannula body 114 during operation of the cannula body 114 for attachment to the aorta. In one aspect, the pivot mount 122 is made of injection molded polycarbonate, acetyl or any suitable material.

[0021] One skilled in the art will also recognize that the torsion spring can be replaced with or completely omitted in favor of other types of spring loading mechanisms. The torsion spring can also be replaced with a formed leaf spring on the pivot arm or grip pad. By using a formed leaf spring, the dowel pin can be omitted and the same function can be performed using a cylindrical boss or similar structure on the cannula body 114.

[0022] The aortic interface 132 is disposed adjacent to the tapered intermediate portion 130. The aortic interface 132 can have a constant diameter and can be sized to fit within the aorta. The diameter of the aortic interface 132 can be from 0.5 to 2 inches. In some embodiments, the diameter of the aortic interface 132 can be from 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 can have a specific texture. FIG. 1 illustrates a texture 128 on the aortic interface 132 to assist in preventing the aorta from slipping off the cannula body 114. In the embodiment shown in FIG. 1, the aortic cannula 100 is positioned within the aorta such that the aorta does not rise above the end of the texture 128. FIG. 4 is a cross-sectional view of one embodiment of the texture 128. The texture 128 can be of any shape. In one embodiment, the texture 128 includes a coaxial ridge that extends around the aortic interface 132, the coaxial ridge being inclined at an angle of 45 degrees on its lower surface and perpendicular to the cannula body 114 on its upper surface. This design allows the aorta to slide easily over the aortic interface 132 while preventing the aorta from slipping off the aortic interface 132. Preferably, the ridge is about 0.005 inches in height. However, one of ordinary skill in the art will understand that the texture features can be of any shape and can be sized to assist in positioning the aorta around the aortic interface 132 while minimizing damage to the tissue. In one embodiment, the radial ends of the aortic interface 132 do not have a ridge to minimize trauma to the tissue. Alternatively, one of ordinary skill in the art will recognize that a ridge can be designed to minimize tissue trauma and hold the aorta in place.

[0023] Pivot arm The pivot arm 140 is coupled to the pivot mount 122. FIGS. 3a - e illustrate different views of the pivot arm and the pivot arm strap (described below) in one embodiment. The pivot arm 140 enables the device 100 to conform to different thicknesses of the aorta and grasp the aorta. In one embodiment, the cannula body 114 includes two pivot arms 140 that are coupled to two pivot mounts 122 on the cannula body. One of ordinary skill 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 enables the strap 124 to maintain even contact with the aorta throughout its range of movement. The grip pad 116 may be smooth or may include features such as molded ridges or other textures to prevent the user's fingers from slipping. The grip pad can be of any shape and may preferably be spherical. In some embodiments, the grip pad 116 may be removable. In other embodiments, a reusable tool attached to the pivot arm 140 may be used in place of the grip pad 116. The dowel pin 120 enables the pivot arm 140 to rotate around the dowel pin 120 when it is actuated. The pivot arm 140 is made of injection - molded acetyl or any material having similar properties. One of ordinary skill in the art will recognize that there are certain advantages provided by sliding the pivot beyond a fixed pivot point, although a fixed pivot point may also be used. Some embodiments may include a locking mechanism for holding the pivot arm 140 in the released position.

[0024] Pivot arm strap The pivot arm strap 124 is connected to the pivot arm 140. The pivot arm strap is best seen in FIGS. 1 and 3. As shown in FIG. 1, in one aspect, the cannula body 114 includes two pivot arm straps 124 that are connected to two pivot arms 140. One of ordinary skill in the art will understand that the number of pivot straps 124 corresponds to the number of pivot arms 140. The pivot arm strap 124 and the sliding pivot window 118 allow the cannula body 114 to evenly grasp the aorta. The pivot arm strap 124 is designed to be rigid enough to hold the aorta, but maintains sufficient flexibility to conform to the aorta and minimize tissue damage. The pivot arm strap 124 is curved. Optionally, the pivot arm strap 124 has a loop 136 and a 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 having similar properties. When the cable tie is passed through the loop 136 and inserted into the guide 142, the cable tie is tightened to the desired tension. The amount by which the cable tie is tightened is the same for all sizes of cannulas. 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. Thus, the size of the window 126 varies according to the size of the aorta. The size of the window 126 is calculated such that when the cable tie is tightened, the cable tie applies the same compression to the aorta for all sizes of the device 100. Thus, the compression applied to the aorta holds the aorta in place without damaging the tissue. One of ordinary skill in the art will understand that alternatively, the cable tie can be tightened to a specific tension for each size of the device 100. Also, other mechanisms for pinching to hold the aorta in place, such as a hose clamp or a tension strap, can be used instead of the cable tie. Further, the pivot arm strap 124 and the window 126 can be of different shapes and sizes. Alternatively, the window can be omitted. One of ordinary skill in the art will also understand that the pivot arm 140 and the pivot arm strap 124 can be parts of a single piece.Moreover, one of ordinary skill in the art will understand that the inner surface of the pivot arm strap 124 can be smooth or can be provided with a specific texture for additional traction.

[0025] In one aspect, the aorta is secured to the cannula body. The user depresses the grip pad 116, and the pivot arm 140 moves around the sliding pivot window 118, compressing the torsion spring. The pivot arm 140 rotates around the dowel pin 120 within the sliding pivot window 118, and the pivot arm strap 124 moves away from the cannula body 114, creating space in the aorta for positioning the cannula in a more favorable manner than when the pivot point is fixed. Releasing the grip pad 116 causes the torsion spring (not shown) to apply pressure to the pivot arm strap 124, temporarily holding the aorta in place. To compensate for variations in tissue thickness and maintain the placement and concentricity of the pivot arm 140 relative to the cannula body 114 throughout the full range of rotation, the strap closes over the aorta and the sliding pivot window 118 varies the pivot point. This causes the strap 124 to be evenly positioned over the aorta. Next, the cable tie is passed through the loop 136 and between the guides 142. The cable tie is tightened to a predetermined tension. One of ordinary skill in the art will understand that the cable tie can be replaced with other mechanisms for securing the pivot arm strap 124. In some aspects, the cable tie can be preassembled within the loop 136.

[0026] Absorbent cotton In some embodiments, the user may suture surgical felt cotton pledgets to the aorta. The cotton pledgets provide a barrier that does not slide between the pivot arm strap 124 and the cannula body 114, so the cotton pledgets serve as an additional measure for maintaining the aorta against the cannula body 114. Four sets of two (one inner and one outer) cotton pledgets are evenly placed around and sutured to the aorta. One of ordinary skill in the art will recognize that more or fewer cotton pledgets may be used. In one embodiment, the aorta is positioned on the cannula body 114 such that the cotton pledgets do not come directly over the space between the pivot arms 140 to prevent the cotton pledgets from sliding through the space between the two sides of the pivot arm strap 124. One of ordinary skill in the art will recognize that the cotton pledgets may be placed anywhere on the aorta and in any orientation with one end up relative to the pivot arm strap. The cotton pledgets may be standard surgical felt cotton pledgets. Alternatively, the cotton pledgets may be injection molded rigid, elastomeric cotton pledgets made of a high durometer material such as silicone or a similar material. One of ordinary skill in the art will understand that the cotton pledgets may be replaced with other materials that adhere to tissue and provide an anchor to prevent the device from sliding between the strap and the cannula body or damaging the tissue. Examples of such materials include, but are not limited to, a continuous ring of tissue-adhering material, or a staple.

[0027] Tip Holder Figure 6 shows the tip holder 601. The tip holder 601 is generally cylindrical, but may have other shapes. The tip holder has a handle 603. The handle can take any shape that enables the user to hold the tip holder 601. The tip holder 601 may also have a thread 602. The fixing nut 102 can be screwed onto the thread 602. The tip holder 601 may also have a stopper 604 that protrudes from the tip holder 601 and serves as a stopping point for the fixing nut 102. Those skilled in the art will understand that other designs may be used to attach the fixing nut to the tip holder. Alternatively, the tip holder may be fixed to the aortic cannula 100 using other mechanisms known to those skilled in the art. Once fixed, the tip holder can be used to hold the aortic cannula 100 whether or not the heart is positioned on the aortic cannula 100.

Example

[0028] Example 1 The aortic cannula 100 can be used to connect the heart to an organ chamber (not shown). Since the aortic cannula 100 releases and holds the aorta in place and returns the perfusate to the heart, the heart can be maintained in a nearly physiological state. In one aspect, to deploy the aortic cannula, the user first selects an aortic cannula 100 sized to fit the heart. In one aspect, the aortic cannula 100 can be selected by measuring the aorta. The user depresses the thumb pad 116 on the spring-loaded pivot arm. When the user depresses the grip pad 116, the pivot arm 140 rotates about the dowel pin 120 in the sliding pivot window 118, the pivot arm strap 124 moves away from the cannula body 114, creating a space for placing the cannula in the aorta. The user can place the cannula in the aorta. The user then releases the thumb pad and the pivot arm 140 closes over the aorta. The pivot arms 140 can be operated simultaneously or individually. The pressure created by the torsion spring temporarily holds the aorta in place. The user can adjust the position of the aorta, if necessary, so that the aorta engages the cannula body 114 sufficiently. The user then places a cable tie through 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 aspects, a tool that tightens the cable tie to a predetermined force can be used to tighten the cable tie. The user inserts the tapered fixture 108 into an organ chamber (not shown). The user then tightens the fixing nut 102. Those skilled in the art will recognize that in some aspects, the aortic cannula 100 can be placed in the organ chamber first and then the aorta can be secured to the aortic cannula 100.

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

[10] The aortic cannula according to [9], further including a size window for standardizing the compression applied to the aorta by the cable tie such that, for a given cable tie tension, the same amount of pressure is applied to the aorta regardless of the size of the pivot arm strap The aortic cannula according to [1], further comprising a connector used to reversibly fix the aortic cannula to the organ chamber. The aortic cannula according to

[11] , wherein the connector is a threaded fixing nut. The aortic cannula according to [1], wherein a specific texture is provided on the aortic interface.

[14] A fixing nut configured to reversibly fix the aortic cannula to the organ chamber assembly, A cannula body, wherein the cannula body is A tapered fixture sized to be connected to the organ chamber assembly, An aortic interface sized to fit within the aorta, and A tapered intermediate portion extending from the tapered fixture to the aortic interface, and A pivot mount comprising A pivot arm operably connected to the pivot mount, wherein the pivot arm is A grip pad that can be used to push down the top of the pivot arm, A pivot arm strap configured to hold the aorta against the aortic interface, and A sliding pivot window configured to maintain contact with the aorta through the range of movement in the pivot arm strap, including, and A dowel pin connecting the pivot mount to the sliding pivot window An aortic cannula for use in an ex vivo organ management system, comprising The aortic cannula, wherein the pivot arm is configured to rotate around the dowel pin.

[15] The aortic cannula according to

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

[16] The aortic cannula according to

[14] , wherein a specific texture is provided on the aortic interface.

[17] The aortic cannula according to

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

[18] The aortic cannula according to

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

[19] The aortic cannula according to

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

[20] The aortic cannula according to

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

[21] A method of using an aortic cannula for positioning the heart in fluid communication with an organ management system, the method comprising: selecting an aortic cannula sized to fit the aorta of the heart; wherein the aortic cannula comprises: a cannula body, wherein the cannula body comprises: a fixture adapted to be connected to an organ management system, and an aortic interface for contacting the aorta; and a pivot arm strap operably connected to a pivot mount, wherein the pivot mount evenly contacts the pivot arm strap against the aorta to hold the aorta on the aortic interface; pushing down on the pivot arm such that the pivot arm rotates around a dowel pin and the pivot arm strap moves away from the cannula body, where the dowel pin operably connects the pivot mount to the pivot arm; positioning the aortic interface into the aorta; releasing the pivot arm; To hold the aorta in a fixed position around the aortic interface, the step of tying a cable tie around the pivot arm strap, and the step of inserting the tapered fixture into the organ management system A method comprising:

[22] The method according to

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

[23] The method according to

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

Claims

1. An aortic cannula for use in an ex vivo organ management system, the aortic cannula comprising: A cannula body, wherein the cannula body: A fixture adapted to be connected to an ex vivo organ management system, and An aortic interface adapted to contact the inner surface of the aorta of an ex vivo heart Including a face, A pivot arm including a pivot arm strap, wherein the pivot arm strap is Operably connected to a pivot mount, the pivot mount being such that after the inner Surface of the aorta contacts the aortic interface, the aorta is placed on the aortic interface To hold it on, the pivot arm strap is adapted to move into contact with the outer surface of the aorta And A fixing nut, wherein the fixing nut is adapted to reversibly fix the aortic cannula to the organ chamber of an ex vivo organ management system, Including an aortic cannula.

2. The aortic cannula according to claim 1, wherein the cannula body includes a tapered intermediate portion.

3. The aortic cannula according to claim 2, wherein the tapered intermediate portion extends from a first end of the cannula body to a second end of the cannula body and has a larger diameter at the second end than at the first end.

4. The aortic cannula according to claim 1, wherein the aortic interface has a diameter of 1.5 cm to 5 cm.

5. The fixing nut includes an end portion and a lip protruding inwardly from the end portion, the cannula body includes a fixing ridge and a fixing groove, and the lip is adapted to fit over the fixing ridge on the cannula body and into the fixing groove on the cannula body. The aortic cannula according to claim 1.

6. The aortic cannula according to claim 5, wherein the fixing nut includes an outer surface and a plurality of vanes extending from the outer surface, and the plurality of vanes are adapted to be grasped and rotated to turn the fixing nut.

7. Including a tip holder, wherein the tip holder includes a handle adapted such that the fixing nut can be screwed onto the cannula body. The aortic cannula according to claim 1.

8. An ex vivo organ management system including the aortic cannula according to claim 1.

9. An ex vivo organ management system including an aortic cannula, wherein the aortic cannula A cannula body, wherein the cannula body: A fixture adapted to be connected to an ex vivo organ management system, and a large artery interface adapted to contact the inner surface of the aorta of the ex vivo heart, including a pivot arm including a pivot arm strap, where the pivot arm strap is operatively connected to a pivot mount, the pivot mount being adapted to move the pivot arm strap into contact with the outer surface of the aorta to hold the aorta on the large artery interface after the inner surface of the aorta contacts the large artery interface, and a sliding pivot window, where the sliding pivot window is adapted to allow the pivot arm strap to maintain contact with the aorta throughout the range of movement, including an ex vivo organ management system.

10. The ex vivo organ management system according to claim 9, wherein the pivot arm includes a grip pad.

11. The ex vivo organ management system according to claim 10, wherein the grip pad includes a plurality of formed ridges.

12. The ex vivo organ management system according to claim 9, wherein the pivot arm includes a dowel pin, and the dowel pin is adapted to allow the pivot arm to rotate around the dowel pin.

13. The ex vivo organ management system according to claim 12, wherein the pivot mount includes an opening, and the opening of the pivot mount is adapted to receive the dowel pin of the pivot arm.

14. The ex vivo organ management system according to claim 12, wherein the cannula body includes a spring pocket.

15. The ex vivo organ management system according to claim 14, wherein the spring pocket is adapted to receive a torsion spring.

16. The ex vivo organ management system according to claim 15, wherein the torsion spring is adapted to be compressed in response to pushing down the pivot arm.

17. The ex vivo organ management system according to claim 9, wherein the cannula body includes a tapered intermediate portion.

18. The ex vivo organ management system according to claim 9, including a fixing nut, where the fixing nut is adapted to reversibly fix the aorta cannula to the organ chamber assembly of the ex vivo organ management system.

19. The ex vivo organ management system according to claim 9, wherein the large artery interface has a diameter of 1.5 cm to 5 cm. ​ ​ ​ ​ ​

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