HEART ASSIST SYSTEM AND METHODS

• US 20150335801A1
• Filed: 05/19/2015
• Published: 11/26/2015
• Est. Priority Date: 05/20/2014
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C., Hudgins, Robert G., Dockter, John
• Granted Patent: US 9,861,728 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/122 Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/859 Connections therefor
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

A system for drawing blood from a heart of a patient, includes a blood pump, an outflow cannula and a flexible cannula assembly. The cannula assembly further includes a flexible cannula body including a proximal end, a distal end, an inner wall defining a lumen, and an outer wall. A tip is coupled with the distal end of the cannula body, and an anchor is coupled to the tip. The anchor is configured to engage an internal structure of the heart and resists movement of the cannula assembly in at least one direction along the flexible cannula body. A ring member is configured to be coupled to the heart wall and is positioned at least partially around the outer wall of the cannula body proximally relative to the tip. The ring member is further configured to provide hemostasis between the heart wall and the cannula body.

Claims

1. A system for drawing blood from a heart of a patient, comprising:

a blood pump having an inlet and an outlet;

an outflow cannula configured to fluidly communicate the outlet to a patient circulatory system;

a flexible cannula assembly configured to extend through an external wall of the heart, and to an internal structure of the heart to fluidly communicate a chamber of the heart and the inlet, the cannula assembly further comprising;

a flexible cannula body including a proximal end, a distal end, an inner wall defining a lumen, and an outer wall,

a tip coupled with the distal end of the cannula body, and

an anchor coupled to the tip, the anchor configured to engage the internal structure of the heart and operable to resist movement of the cannula assembly in at least one direction along a lengthwise central axis of the flexible cannula body; and

at least one ring member configured to be coupled to the external wall and positioned at least partially around the outer wall of the cannula body proximally relative to the tip, the at least one ring member further configured to provide hemostasis between the external wall and the cannula body.

2. The system of claim 1, wherein the at least one ring member is further configured to facilitate tissue ingrowth for securing the at least one ring member to the external wall of the heart.

3. The system of claim 1, wherein the at least one ring member defines an aperture sized to interference fit with the outer wall of the cannula body.

4. The system of claim 1, wherein the at least one ring member further comprises:

a radially inner portion defining an aperture sized to interference fit with the outer wall of the cannula body; and

a radially outer portion at least partially encapsulating the inner portion and including a porous polymeric structure for facilitating tissue ingrowth.

5. The system of claim 4, wherein the inner portion further comprises a polymeric or rubber-like material.

6. The system of claim 4, wherein at least a portion of the inner layer is positioned axially inward of the outer member.

7. The system of claim 1, wherein the at least one ring member further comprises:

a radially outer edge at least partially surrounding a central axis; and

a tab extending radially outward from the outer edge.

8. The system of claim 1, wherein the at least one ring member further comprises:

a first ring member having a first side and a second side, the first ring member configured to be coupled to the external wall such that the first side generally abuts the external wall; and

a second ring member configured to be coupled to the second side of the first ring member.

9. The system of claim 8, wherein the second ring member includes a plurality of barbs for engaging the first ring member.

10. The system of claim 1, wherein the at least one ring member is movable relative to the cannula assembly.

11. A method of drawing blood from a heart of a patient using a flexible cannula assembly including a cannula body having a proximal end, a distal end, and a lumen therebetween, and a tip coupled to the distal end of the cannula body, the method comprising:

introducing distal portion of a flexible cannula assembly including a tip through an external wall of the heart such that the tip is in fluid communication with a first chamber of the heart;

advancing the cannula assembly through an internal structure of the heart that separates the first chamber from a second chamber, until the tip is in fluid communication with the second chamber;

deploying an anchor coupled to the tip in order to secure the tip to the internal structure;

coupling a proximal end of the cannula body to an inlet of a pump;

sealing the cannula body to the external wall of the heart to provide hemostasis between the external wall and the cannula body; and

operating the pump to draw blood through the tip from the second chamber and into the lumen of the cannula body.

12. The method of claim 11, wherein the external wall is a right atrial wall, a right ventricular wall, or a left atrial wall.

13. The method of claim 11, wherein the internal structure is an intra-atrial septum, an intra-ventricular septum, or a heart valve.

14. The method of claim 11, further comprising:

placing at least one ring member around an outer wall of the cannula body, the at least one ring member defining an aperture sized to interference fit with the outer wall of the cannula body; and

coupling the at least one ring member to the external wall of the heart;

wherein the at least one ring member further comprises a first ring member having a first side and a second side, and a second ring member including a plurality of barbs, and the method further comprises;

coupling the first ring member to the external wall such that the first side generally abuts the external wall; and

coupling the second ring member to the second side of the first ring member by engaging the barbs with the first ring member.

15. A system for securing a flexible cannula assembly to an external wall and an internal structure of a heart of a patient, comprising:

a flexible cannula assembly, further comprising;

a flexible cannula body including a proximal end, a distal end, an inner wall defining a lumen, and an outer wall,

a tip coupled with the distal end of the cannula body, and

an anchor coupled to the tip, the anchor configured to engage the internal structure of the heart and operable to resist movement of the cannula assembly in at least one direction along a lengthwise central axis of the flexible cannula body; and

at least one ring member configured to be coupled to the external wall and positioned at least partially around the outer wall of the cannula body proximally relative to the tip, the at least one ring member further configured to provide hemostasis between the external wall and the cannula body.

16. A method of securing a flexible cannula assembly to an external wall and an internal structure of a heart of a patient, the flexible cannula assembly including a cannula body having a proximal end, a distal end, and a lumen therebetween, and a tip coupled to the distal end of the cannula body, the method comprising:

introducing distal portion of a flexible cannula assembly including a tip through an external wall of the heart such that the tip is in fluid communication with a first chamber of the heart;

advancing the cannula assembly through an internal structure of the heart that separates the first chamber from a second chamber, until the tip is in fluid communication with the second chamber;

deploying an anchor coupled to the tip in order to secure the tip to the internal structure;

placing at least one ring member around an outer wall of the cannula body, the at least one ring member defining an aperture sized to interference fit with the outer wall of the cannula body; and

coupling the at least one ring member to the external wall of the heart to provide hemostasis between the external wall and the cannula body, wherein the at least one ring member is spaced proximally from the tip.

17. A delivery system for delivering a cannula assembly to a heart of a patient, comprising:

a flexible cannula assembly including a cannula body having a proximal portion and a distal portion; and

a delivery sheath including a set of rigid jaws movable between an open configuration and a closed configuration, wherein the jaws define a lumen in the closed configuration to receive the cannula assembly for traveling to the heart as a unit with the cannula assembly.

18. The delivery system of claim 17, wherein:

at least a portion of an outer wall of the cannula body includes a first cross-sectional dimension; and

at least a portion of the lumen of the delivery sheath includes a second cross-sectional dimension smaller than the first cross-sectional dimension such that the jaws must be in the open configuration to move the delivery sheath relative to the cannula assembly in at least one direction.

19. The delivery system of claim 18, wherein a proximal portion of the outer wall of the cannula body includes the first cross-sectional dimension and a distal portion of the outer wall of the cannula body includes a third cross-sectional dimension smaller than the second cross-sectional dimension, such that the lumen is configured to receive at least the distal portion of the cannula body for traveling to the heart as a unit with the cannula assembly.

20. The delivery system of claim 17, wherein:

in the closed position, each of the jaws extends substantially parallel to a central axis of the lumen.

21. The delivery system of claim 17, wherein:

the lumen is essentially circular in cross section.

22. The delivery system of claim 17, wherein the delivery sheath further comprises:

a proximal portion and a distal portion, the lumen extending between the proximal portion and the distal portion; and

a seal element at the proximal portion of the delivery sheath configured to seal at least the proximal portion when the delivery sheath receives at least a portion of the cannula assembly.

23. The delivery system of claim 22, wherein the seal element defines an aperture when the jaws are in the closed configuration.

24. The delivery system of claim 23, wherein the aperture is sized to be in an interference fit with an outer cross-sectional dimension of the cannula body such that the seal member provides hemostasis between the delivery sheath and the cannula body when the delivery sheath receives at least a portion of the cannula assembly.

25. The delivery system of claim 22, wherein the seal element includes a first portion coupled to one of the jaws and a second portion coupled to the other of the jaws.

26. The delivery system of claim 22, wherein the seal element further comprises a lubricious element configured to reduce the frictional force between the seal element and the cannula body as the cannula assembly moves relative to the delivery sheath.

27. The delivery system of claim 17, wherein the delivery sheath further comprises:

a set of handle members hingedly coupled to one another, each of the handle members coupled to one of the jaws and being operable to move the jaws relative to one another and between the open configuration and closed configuration.

28. The delivery system of claim 27, further comprising:

a locking mechanism operably coupled to at least one of the jaws or at least one of the handle members, the locking mechanism having a first locking state and a second locking state;

wherein the jaws are permitted to move relative to one another when the locking mechanism is in the first locking state and prevented from moving relative to one another when the locking mechanism is in the second locking state.

29. The delivery system of claim 27, wherein:

the jaws extend along an axis; and

at least a portion of each of the handle members is positioned at an angle relative to the axis.

30. The delivery system of claim 17, further comprising:

a balloon catheter adapted to expand and engage the delivery sheath to enable the delivery sheath to traverse an external wall or an internal structure of the heart.

31. The delivery system of claim 30, wherein the balloon catheter is adapted to expand and engage the cannula assembly to allow relative movement between the cannula assembly and the delivery sheath.

32. The delivery system of claim 17, further comprising:

a stop member coupled to at least one of the cannula assembly or the delivery sheath, the stop member configured to allow a predetermined amount of movement of the cannula assembly relative to the delivery sheath.

33. The delivery system of claim 32, wherein:

the stop member is removably coupled to the cannula assembly.

34. A method of implanting a circulatory assist system for assisting in the flow of blood through a patient circulatory system, the circulatory assist system comprising a flexible cannula assembly for directing blood from the heart of a patient, the cannula assembly comprising a cannula body including a proximal end, a distal portion, and a lumen therebetween, the method comprising:

directing a guide-element through an external wall of the heart;

further directing the guide-element into the heart such that a distal portion of the guide element is positioned adjacent to an internal structure of the heart;

inserting a delivery system over the guide-element, through the external wall and adjacent the internal structure, wherein the delivery system includes the cannula assembly and a delivery sheath having a set of rigid jaws movable between an open configuration and a closed configuration, wherein the jaws define a lumen in the closed configuration to receive the cannula assembly for movement relative thereto;

moving the cannula assembly relative to the delivery sheath such that at least a distal portion of the cannula extends distally from the delivery sheath;

coupling the distal portion of the cannula assembly to the internal structure;

retracting the delivery sheath towards a proximal portion of the cannula assembly and back through the external wall; and

moving the jaws to the open configuration and further retracting the delivery sheath.

35. The method of claim 34, further comprising:

moving the jaws from the open configuration to the closed configuration; and

loading the cannula assembly into the lumen of the delivery sheath.

36. The method of claim 34, wherein the cannula assembly further comprises a tip coupled with the distal portion of the cannula assembly, and at least a first anchor coupled to the tip, the first anchor configured to be deployed from a contracted state to an expanded state, wherein the first anchor is configured to engage the internal structure of the heart in the expanded state, and coupling the distal portion of the cannula assembly to the internal structure further comprises:

moving the cannula assembly relative to the delivery sheath so as to deploy the first anchor from the contracted state into the expanded state, thereby engaging the internal structure.

37. The method of claim 36, wherein the cannula assembly further comprises a second anchor coupled to the tip and configured to be deployed from a contracted state to an expanded state, wherein the second anchor is configured to engage an opposite side of the internal structure in the expanded state as the first anchor;

and the method further comprises;

moving the delivery sheath relative to the cannula assembly so as to deploy the second anchor from the contracted state into the expanded state, thereby engaging the internal structure.

38. The method of claim 36, wherein the delivery system further comprises a stop member coupled to at least one of the cannula assembly or the delivery sheath, and moving the cannula assembly relative to the delivery sheath so as to deploy the first anchor further comprises:

moving the cannula assembly relative to the delivery sheath a predetermined distance until the stop member prevents further movement of the cannula assembly relative to the delivery sheath.

40. The method of claim 34, further comprising:

directing a distal end of a piercing device through the external wall of the heart; and

advancing the distal end of the piercing device adjacent to the internal structure of the heart;

wherein directing the directing a guide-element through the external wall of the heart and further directing the guide-element adjacent to the internal structure of the heart includes directing the guide element through a lumen of the piercing device.

41. The method of claim 34, wherein the external wall is a right atrial wall and the internal structure is an intra-atrial septum.

42. The method of claim 34, further comprising:

creating an incision substantially near an intercostal space and directing the guide-element from the incision through the intercostal space and to the heart.

43. The method of claim 42, wherein the intercostal space is a fourth intercostal space, fifth intercostal space, or sixth intercostal space.

44. The method of claim 43, further comprising:

further retracting the delivery sheath and removing the delivery sheath through the incision.

45. The method of claim 34, wherein the delivery sheath further comprises a set of handle members operable to move the jaws relative to one another and between the open and closed configurations, and a locking mechanism operably coupled to at least one of the jaws or at least one of the handle members configured to selectively permit or prevent movement of the jaws, and the opening the jaws further comprises:

unlocking the locking mechanism.

46. The method of claim 34, wherein at least a portion of an outer wall of the cannula body includes a first cross-sectional dimension, and the lumen of the delivery sheath includes a second cross-sectional dimension smaller than the first cross-sectional dimension, and the method further comprises:

moving the delivery sheath in the closed configuration in a proximal direction relative to the cannula assembly until reaching the portion of the cannula body having the first cross-sectional dimension; and

moving the jaws to the open configuration once a proximal portion of the jaws contacts or approaches the portion of the cannula body having the first cross-sectional dimension so as to allow further proximal movement of the delivery sheath relative to the cannula assembly.

47. The method of claim 34, wherein the cannula assembly further comprises a tip coupled to the distal portion of the cannula assembly, and first and second anchors coupled to the tip, each of the first and second anchors being configured to be deployed from a contracted state to an expanded state, wherein the first and second anchors are configured to engage opposite sides of a heart tissue in the expanded state, and the method further comprises:

directing the cannula assembly into a first end of the delivery sheath in the closed configuration such that the first and second anchors are folded in a first direction to the contracted state;

moving at least the distal portion of the cannula assembly out of the first end or a second opposing end of the delivery sheath such that one of the first or second anchors exits from the first end or second end of the delivery sheath and deploys into the expanded state; and

moving the distal portion back towards the first end or the second end of the delivery sheath such that the expanded first or second anchor folds in a second direction opposite of the first direction and into the contracted state.

48. The method of claim 34, wherein inserting the delivery system further comprises:

coupling a first ring member to the external wall of the heart, the ring defining an aperture;

directing the delivery system through the aperture and through the external wall; and

pulling the first ring member in a direction generally away from the heart as the delivery system is directed through the aperture and through the external wall.

49. The method of claim 48, wherein coupling the ring member further comprises:

sewing the first ring member to the external wall of the heart.

50. The method of claim 48, wherein the first ring member includes an outer edge at least partially circumscribing a central axis, and a tab extending from the outer edge, and pulling the first ring member further comprises:

pulling the tab in the direction generally away from the heart.

39. The method of 38, further comprising:

decoupling the stop member from the cannula assembly and/or the delivery sheath, before retracting the delivery sheath towards the proximal portion of the cannula assembly.