Aortic cannula with intra-aortic balloon and side port for cardioplegia delivery and aortic vent suction

Abstract

An aortic cannula includes a tubular body extending along a central axis from a first end to a second end, and having three separate lumens. A side port is formed in an outer surface of the tubular body at the second end of the tubular body. The first lumen is formed within the tubular body to supply blood flow to an aorta of a subject. The second lumen delivers an embolic protection device to the aorta of the subject, where the second lumen is contained within the first lumen and is coaxial with the central axis of the tubular body. The third lumen is fluidically coupled to the side port to provide delivery of a cardioplegia solution and / or aortic root vent suction.

Description

AORTIC CANNULA WITH INTRA AORTIC BALLOON AND SIDE PORT FOR CARDIOPLEGIA DELIVERY AND AORTIC VENT SUCTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 519,077, filed on August 11, 2023, and entitled “AORTIC CANNULA WITH INTRAAORTIC BALLOON AND SIDE PORT FOR CARDIOPLEGIA DELIVERY AND AORTIC VENT SUCTION,’’ which is herein incorporated by reference in its entirety.BACKGROUND

[0002] During cardiac surgery, the patient is cannulated with an aortic cannula at the ascending aorta for connection to a heart-lung machine (i.e., a cardiopulmonary bypass machine). In order to separate the heart from the ascending aorta, a cross clamp is typically applied proximal to the cannula and a cardioplegia cannula is inserted proximal to the cross clamp to arrest the heart via the coronaries. The cross clamp application is necessary to isolate the heart during the surgery, but comes with risks of aortic injury and dislodging plaque leading to stroke, and so on.SUMMARY OF THE DISCLOSURE

[0003] The present disclosure addresses the aforementioned drawbacks by providing an aortic cannula that includes a tubular body extending along a central axis from a first end to a second end and having a first, second, and third lumen. A side port is arranged at the second end of the tubular body. The first lumen is formed within the tubular body to supply blood flow to an aorta of a subject. The second lumen delivers an embolic protection device to the aorta of the subject, where the second lumen is contained within the first lumen and is coaxial with the central axis of the tubular body. The third lumen is fluidically coupled to the side port to deliver a cardioplegia solution to the aorta of the subject or to provide aortic root vent suction.

[0004] In some examples, the aortic cannula includes a third lumen that is offset from the central axis of the tubular body. The third lumen may be contained entirely within the tubular body; may be contained partially within the first lumen and may partially extend outward from an outer surface of the tubular body; or may be coupled to an outer surface of the tubular body.

[0005] Additionally or alternatively, the aortic cannula may include an embolic protection device arranged within the second lumen. The embolic protection device may include a mesh net slidably arranged within the second lumen, where the mesh net has an undeployed state when arranged within the second lumen and a deployed state when arranged outside of the second lumen. The mesh net may have a conical shape when in the deployed state. Additionally or alternatively, the mesh net may be composed of a shape-memory material. The shape-memory material may be a shape-memory alloy (e.g., nitinol) or a shapememory polymer.

[0006] The aortic cannula may also include an occlusion balloon coupled to the outer surface of the tubular body at the second end of the tubular body and distal to the side port.

[0007] In some examples, the third lumen is fluidically coupled to the side port to deliver a cardioplegia solution to the aorta of the subj ect. Additionally or alternatively, the third lumen is fluidically coupled to the side port to provide aortic root vent suction of the aorta of the subj ect.

[0008] The first lumen may be separated into a first portion and a second portion by an interior wall spanning an internal volume of the first lumen. In some examples, the second lumen is formed within and extends through this interior wall.

[0009] In still other aspects the present disclosure provides an aortic cannula that includes a tubular body extending along a central axis from a first end to a second end and having a first, second, and third lumen. The aortic cannula also includes side port arranged at the second end of the tubular body, a mesh net slidably arranged within the second lumen, and an occlusion balloon coupled to an outer surface of the tubular body at the second end of the tubular body and distal to the side port. The first lumen is formed within the tubular body to supply blood flow to an aorta of a subject. The second lumen is contained within the first lumen and is coaxial with the central axis of the tubular body. The third lumen is fluidically coupled to the side port. The mesh net is slidably arranged within the second lumen and has an undeployed state when arranged within the second lumen and a deployed state when delivered to the aorta of the subject from an interior of the second lumen. When in the deployed state, the mesh net provides embolic protection of the aorta of the subject.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 shows an example aortic cannula having an intra-aortic occlusion balloon, side port for cardioplegia solution delivery and / or aortic root vent suction, and embolic protection device.

[0011] FIG. 2 shows a cross section of one example of the tubular body- of the aortic cannula.

[0012] FIG. 3 shows a cross section of another example of the tubular body of the aortic cannula.

[0013] FIG. 4 shows a cross section of yet another example of the tubular body of the aortic cannula.

[0014] FIG. 5 shows a cross section of still another example of the tubular body of the aortic cannula.

[0015] FIG. 6A illustrates an aortic cannula positioned within the aortic arch, in which the occlusion balloon and embolic protection device are both in an undeployed state.

[0016] FIG. 6B illustrates an aortic cannula positioned within the aortic arch, in which the occlusion balloon and embolic protection device are both in a deployed state.DETAILED DESCRIPTION

[0017] Described here is an aortic cannula with an intra-aortic balloon and side port for cardioplegia delivery' and / or aortic vent suction. The disclosed aortic cannula overcomes the drawbacks of existing aortic cannula designs that can present a risk of aortic injury and dislodging plaque leading to stroke. In general, the disclosed aortic cannula includes a balloon that inflates after insertion of the cannula to isolate the heart from the rest of the body. This balloon helps reduce the risk of dislodging plaque leading to a stroke. The aortic cannula also includes a side port for cardioplegia delivery and / or aortic root vent suction. Accordingly, the disclosed aortic cannula includes three-in-one device with ascending aorta root balloon occlusion, cardioplegia / root vent, and cannula for full body perfusion via a heart-lung machine (i. e. , cardiopulmonary bypass machine).

[0018] With reference to FIG. 1, an example aortic cannula 10 is shown. The aortic cannula 10 includes a tubular body 12 that extends along a central axis 14 from a first end 16 (e.g., a proximal end) to a second end 18 (e.g., a distal end). An occlusion balloon 20 is coupled to the outer surface 22 of the tubular body 12. An embolic protection device 24 extends through the tubular body 12 to capture and prevent any embolic debris from flowing into the patient'scirculatory system. The embolic protection device 24 generally includes a mesh net 26 that is deployable beyond the second end 18 of the tubular body 12. A side port 28 is formed in the outer surface 22 of the tubular body 12 proximal to the occlusion balloon 20. The side port 28 allows for cardioplegia delivery and / or aortic root vent suction. In an example configuration, the aortic cannula 10 may be a 24 French (“Fr”) cannula.

[0019] The tubular body 12 may be composed of a flexible material such that the aortic cannula 10 may be positioned within the aorta of a subject. The tubular body 12 generally includes three separate lumens extending therethrough: a first lumen 30 that provides full body perfusion via a connected heart-lung machine, a second lumen 32 to deliver an embolic protection device into the aorta, and a third lumen 34 to deliver cardioplegia and / or provide for aortic root vent suction. Additionally, a separate lumen may be provided to deliver fluid to expand the occlusion balloon 22 coupled to the aortic cannula 10. The first lumen 30 and the second lumen 32 extend fully from the first end 16 to the second end 18 of the tubular body 12, whereas the third lumen 34 extends from the first end 16 of the tubular body 12 to the side port 28.

[0020] The first lumen 30 may generally include a first portion 36 and a second portion 38 that are separated by an interior wall 40 within the tubular body 12. This interior wall 40 can provide support for the second lumen 32 and / or the third lumen 34.

[0021] For instance, in one example configuration the second lumen 32 can be coaxial with the central axis 14 of the tubular body 12, as illustrated in FIG. 2. Here, the interior wall 40 spans from one side of the first lumen 30 to the other side, with the second lumen 32 formed within and extending through the interior wall 40. Also shown in the example illustrated in FIG. 2, the third lumen 34 is offset from the central axis 14 of the tubular body 12. Like the second lumen 32, the third lumen 34 can be formed within and extending through the interior wall 40 that separates the first portion 36 and second portion 38 of the first lumen 30. In the illustrated example, the third lumen 34 is formed on one side of the inner w all of the tubular body 12.

[0022] In FIG. 2. the interior wall 40 spans from the inner wall of the tubular body 12 to the second lumen 32 and from the second lumen 32 to the third lumen 34. In other examples, the interior wall 40 may span from the inner wall of the tubular body 12 to the second lumen 32, which may then be in contact with the third lumen 34 (as shown in FIG. 3) such that the interior wall 40, second lumen 32, and third lumen 34 collectively provide for the separation of the first portion 36 and second portion 38 of the first lumen 30.

[0023] Also in FIG. 2, the third lumen 34 is contained entirely within the first lumen 30 of the tubular body 12. In other examples, the third lumen 34 may extend partially or wholly beyond the outer surface 22 of the tubular body 12. For instance, as shown in FIGS. 4 and 5, the third lumen 34 may be formed within and extending through the outer wall 22 of the tubular body 12, such that the third lumen 34 extends partially within the first lumen 30 and partially beyond the outer surface 22 of the tubular body 12. The third lumen 34 may have a circular cross section (as shown in FIGS. 3 and 5), an elliptical cross section (as shown in FIGS. 2 and 4), or any other suitable cross-sectional shape. Similarly, the first lumen 30 and the second lumen 32 may have circular cross sections, as illustrated in FIGS. 2-5, or may have other cross- sectional shapes (e g., elliptical, or the like).

[0024] An embolic protection device 24 may be provided via the aortic cannula 10. For example, the second lumen 32 of the tubular body 12 may deliver the embolic protection device 24 to the interior lumen of the aorta or other artery. In a non-limiting example, the embolic protection device 24 may include a mesh net 26 that functions as an embolic protection net. The mesh net 26 may be arranged at, or otherwise coupled to, the distal end of a catheter, guidewire, or other device that is moveable within the second lumen 32.

[0025] In these instances, the second lumen 32 may be sized such that the embolic protection device 24 and the mesh net 26 (in its undeployed state) can be slid through the second lumen 32. Sliding the embolic protection device 24 and mesh net 26 out of the second lumen 32 causes the mesh net 26 to expand into its deployed state. In the deployed state, the mesh net 26 makes contact with the inner wall of the aorta, so as to prevent any embolic debris from flowing through the patient’s circulatory' system. In general, the holes in the mesh net 26 are sized to prevent the flow of embolic debris (e.g., dislodged plaque) through the mesh net 26. while allowing the flow of blood through the mesh net 26.

[0026] The mesh net 26 is composed of a material such that the mesh net 26 is flexible enough to be collapsed into its closed (undeployed) state by sliding the embolic protection device 24 and mesh net 26 back into the second lumen 32, or otherwise actuating the mesh net 26 into its undeployed state. Further, the mesh net 26 may be composed of a material such that the mesh net 26 will expand into a defined shape when in its deployed state. For example, the mesh net 26 may be composed of one or more shape-memory' materials or smart materials. As one non-limiting example, the mesh net 26 can be composed of a shape-memory' alloy, such as nitinol or the like. As another non-limiting example, the mesh net 26 can be composed of a shape-memory polymer, such as polyurethane or block copolymers thereof, and the like.

[0027] In its deployed state, the mesh net 26 can be shaped such that its diameter decreases from its proximal end 42 to its distal end 44 at the tip of the embolic protection device 24. As one example, the mesh net 26 can have a generally conical shape. In its deployed state, the outer diameter of the mesh net 26 at its proximal end 42 is sized so as to make contact with the inner diameter of the aortic arch, other artery, or other bodily lumen into which the aortic cannula 10 is deployed. In this way, when the mesh net 26 is expanded it presses against the inner wall of the aorta, thereby holding the mesh net 26 in place and preventing any embolic debris from passing beyond the mesh net 26. In this deployed state, embolic debris is carried by blood flow into the opening of the mesh net 26 where it is then captured and retained by the mesh net 26.

[0028] Because the mesh net 26 is compliant, it can advantageously be sized such that the outer diameter of the mesh net 26 at its greatest radial extent (e.g., at the proximal end 42 of the mesh net 26) is greater than the inner diameter of the aorta. In this way, the mesh net 26 will have a more secure adherence to the inner wall of the aorta by providing an expansive force (e.g.. radial tension) against the inner wall of the aorta. Thus, the mesh net 26 can be oversized relative to the aorta.

[0029] As a non-limiting example, the occlusion balloon 22 is coupled to the exterior surface 20 of the tubular body 12 of the aortic cannula 10. The occlusion balloon 22 is fluidically coupled to the tubular body 12 such that the occlusion balloon 22 is in fluid communication with a source of fluid (not shown) coupled to the proximal end of the aortic cannula. Accordingly, the source of fluid can selectively provide a fluid (e.g., liquid or gas) through a lumen in, or coupled to, the tubular body 12 and into the occlusion balloon 22 in order to inflate, fill, or otherwise expand the occlusion balloon 22 outward from the exterior surface 20 of the tubular body 12, as illustrated in FIGS. 6 A and 6B. When the occlusion balloon 22 is inflated, the pressure of the exterior surface of the occlusion balloon 22 anchors the aortic cannula 10 in place within the aorta 46, other blood vessel, or other bodily lumen into which the aortic cannula 10 has been deployed.

[0030] As shown in FIG. 6B, when the occlusion balloon 22 is fully inflated, it may occlude the entire lumen of the aorta 46. In this inflated state, the occlusion balloon 22 allows for the retention of cardioplegia solution delivered to the aorta 46 via the side port 28, while also eliminating the need for cross-clamping the aorta 46. To deflate the occlusion balloon 16, the provided fluid is removed (e.g., via a lumen of, or coupled to, the tubular body 12).

[0031] The side port 28 is fluidically coupled to the third lumen 34 to provide for the delivery of a cardioplegia solution to the interior of the aorta 46 and / or to provide aortic root vent suction. In the former example, the third lumen 34 may be fluidically coupled to a cardioplegia solution source. During a cardiac surgery procedure, cardioplegia solution can be administered to the aorta 46 via the side port 28. In the latter example, the third lumen 34 may be coupled to an aortic root vent, such that suction can be provided to the aortic root via the side port 28. During a cardiac surgery procedure, suction provided via the side port 28 can be used to indirectly empty the left ventricle.

[0032] The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.

Claims

CLAIMS1. An aortic cannula, comprising: a tubular body extending along a central axis from a first end to a second end; a side port arranged at the second end of the tubular body; a first lumen formed within the tubular body to supply blood flow to an aorta of a subject; a second lumen to deliver an embolic protection device to the aorta of the subject, wherein the second lumen is contained within the first lumen and is coaxial with the central axis of the tubular body; and a third lumen fluidically coupled to the side port.

2. The aortic cannula of claim 1, wherein the third lumen is offset from the central axis of the tubular body.

3. The aortic cannula of claim 2, wherein the third lumen is contained entirely within the tubular body, and wherein the side port is formed in an outer surface of the tubular body at the second end of the tubular body.

4. The aortic cannula of claim 2, wherein the third lumen is contained partially within the first lumen and partially extends outward from an outer surface of the tubular body, and wherein the side port is formed in an outer surface of the tubular body at the second end of the tubular body.

5. The aortic cannula of claim 2, wherein the third lumen is coupled to an outer surface of the tubular body, and wherein the side port is formed in an outer surface of the third lumen.

6. The aortic cannula of claim 1 , comprising an embolic protection device arranged within the second lumen.

7. The aortic cannula of claim 6, wherein the embolic protection device comprises a mesh net slidably arranged within the second lumen, wherein the mesh net has anundeployed state when arranged within the second lumen and a deployed state when arranged outside of the second lumen.

8. The aortic cannula of claim 7, wherein the mesh net has a conical shape when in the deployed state.

9. The aortic cannula of claim 7, wherein the mesh net is composed of a shapememory material.

10. The aortic cannula of claim 9, wherein the shape-memory material is a shapememory alloy.

11. The aortic cannula of claim 10, wherein the shape-memory alloy comprises ni tinol.

12. The aortic cannula of claim 9, wherein the shape-memory material is a shapememory polymer.

13. The aortic cannula of claim 1, comprising an occlusion balloon coupled to an outer surface of the tubular body at the second end of the tubular body and distal to the side port.

14. The aortic cannula of claim 1, wherein the third lumen is fluidically coupled to the side port to deliver a cardioplegia solution to the aorta of the subject.

15. The aortic cannula of claim 1, wherein the third lumen is fluidically coupled to the side port to provide aortic root vent suction of the aorta of the subject.

16. The aortic cannula of claim 1, wherein the first lumen is separated into a first portion and a second portion by an interior wall spanning an internal volume of the first lumen.

17. The aortic cannula of claim 16. wherein the second lumen is formed within and extends through the interior wall.

18. An aortic cannula, comprising: a tubular body extending along a central axis from a first end to a second end; a side port arranged at the second end of the tubular body: a first lumen formed within the tubular body to supply blood flow to an aorta of a subject; a second lumen contained within the first lumen and coaxial with the central axis of the tubular body; a third lumen fluidically coupled to the side port; a mesh net slidably arranged within the second lumen, wherein the mesh net has an undeployed state when arranged within the second lumen and a deployed state when delivered to the aorta of the subject from an interior of the second lumen, wherein when in the deployed state the mesh net provides embolic protection of the aorta of the subject; and an occlusion balloon coupled to an outer surface of the tubular body at the second end of the tubular body and distal to the side port.

19. The aortic cannula of claim 18. wherein the mesh net has a conical shape when in the deployed state.

20. The aortic cannula of claim 18. wherein the mesh net is composed of a shapememory material.

21. The aortic cannula of claim 20, wherein the shape-memory material is a shape-memory alloy.

22. The aortic cannula of claim 21, wherein the shape-memory alloy comprises nitinol.

23. The aortic cannula of claim 20. wherein the shape-memory material is a shape-memory polymer.

24. The aortic cannula of claim 1, wherein the third lumen is offset from the central axis of the tubular body.

25. The aortic cannula of claim 24. wherein the third lumen is contained entirely within the tubular body, and wherein the side port is formed in an outer surface of the tubular body at the second end of the tubular body.

26. The aortic cannula of claim 24, wherein the third lumen is contained partially within the first lumen and partially extends outward from an outer surface of the tubular body, and wherein the side port is formed in an outer surface of the tubular body at the second end of the tubular body.

27. The aortic cannula of claim 24. wherein the third lumen is coupled to an outer surface of the tubular body, and wherein the side port is formed in an outer surface of the third lumen.

28. The aortic cannula of claim 18, wherein the third lumen is fluidically coupled to the side port to deliver a cardioplegia solution to the aorta of the subject.

29. The aortic cannula of claim 18, wherein the third lumen is fluidically coupled to the side port to provide aortic root vent suction of the aorta of the subject.

30. The aortic cannula of claim 18. wherein the first lumen is separated into a first portion and a second portion by an interior wall spanning an internal volume of the first lumen.

31. The aortic cannula of claim 30. wherein the second lumen is formed within and extends through the interior wall.

Images