Devices, methods and systems for establishing supplemental blood flow in the circulatory system

• US 9,572,917 B2
• Filed: 02/25/2009
• Issued: 02/21/2017
• Est. Priority Date: 08/30/2006
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Marseille, Oliver, Kerkhoffs, Wolfgang
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US12/392,623
• Publication Number:
  US 20090182188A1
• Time in Patent Office: 2,918 Days
• Field of Search: 600/16, 607/126, 607/122, 604/93.01, 604/264, 623/1.11, 623/1.15, 623/3.1, 606/215
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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 60/20 Type thereof
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

Devices, systems and methods for establishing a blood flow conduit between a chamber in a heart of a patient and a remote location. A blood inflow cannula having an outer surface and proximal and distal end portions. The distal end portion is configured for insertion into the chamber of the heart. First and second anchor elements have respective maximum width dimensions extending outwardly from the outer surface of the cannula. The first anchor element is positioned more distally than the second anchor element defining a tissue receiving space therebetween. The maximum width dimension of the first anchor element may be larger than the maximum width dimension of the second anchor element in use. The first anchor element is configured to be positioned inside the heart chamber and the second anchor element is configured to be positioned outside the heart chamber with heart tissue held in the tissue receiving space therebetween.

Claims

1. A device for establishing a blood flow conduit between a chamber in a heart of a patient and a remote location, the device comprising:

a cannula having an outer surface, proximal and distal end portions, and a lumen extending between the proximal and distal end portions, the distal end portion including an opening communicating with the lumen of the cannula for allowing blood flow therethrough, the distal end portion and opening being configured for insertion into the chamber of the heart; and

first and second anchor elements permanently fixed to the outer surface of the cannula and having respective maximum width dimensions extending radially outwardly from the outer surface of the cannula, the first anchor element being positioned more distally than the second anchor element and defining a tissue-receiving space therebetween, and the maximum width dimension of the first anchor element being larger than the maximum width dimension of the second anchor element, whereby the first anchor element is configured to be positioned inside the heart chamber and the second anchor element is configured to be positioned outside the heart chamber with heart tissue held in the tissue-receiving space therebetween and the first and second anchor elements are each further configured to directly contact the heart tissue therebetween.

2. The device of claim 1, wherein at least one of the first or second anchor elements further comprises an annular disc shaped element.

3. The device of claim 1, wherein at least one of the first or second anchor elements is formed from a pliable, resilient material.

4. The device of claim 1, wherein the cannula is a blood flow catheter configured to be introduced into the venous system of the patient in order to percutaneously direct the distal end portion into the chamber of the heart.

5. The device of claim 4, wherein the first and second anchor elements are configured to be movable between first, compact states during introduction via the venous system and second, expanded states for positioning on opposite sides of the heart tissue.

6. The device of claim 5, wherein the first and second anchor elements are self-expandable into the second, expanded states.

7. The device of claim 1, wherein the first and second anchor elements are formed to allow ingrowth of tissue.

8. A catheter system for establishing a blood flow conduit between a chamber in a heart of a patient and a remote location, the system comprising:

a delivery catheter;

a blood inflow catheter configured to be directed into the venous system of the patient via the delivery catheter, the blood inflow catheter having an outer surface, proximal and distal end portions, and a lumen extending between the proximal and distal end portions, the distal end portion is configured to be inserted into the chamber of the heart and includes an opening that communicates with the lumen for allowing blood flow therethrough; and

first and second anchor elements carried on and permanently fixed to the distal end portion and having respective maximum width dimensions extending radially outwardly from the outer surface of the blood inflow catheter, the first anchor element being positioned more distally than the second anchor element and defining a tissue-receiving space therebetween, and the maximum width dimension of the first anchor element being larger than the maximum width dimension of the second anchor element, whereby the first anchor element is configured to be positioned inside the heart chamber and the second anchor element is configured to be positioned outside the heart chamber such that heart tissue is held in the tissue-receiving space therebetween and the first and second anchor elements are each further configured to directly contact the heart tissue therebetween.

9. The system of claim 8, wherein at least one of the first or second anchor elements further comprises an annular disc shaped element.

10. The system of claim 8, wherein at least one of the first or second anchor elements is formed from a pliable, resilient material.

11. The system of claim 8, wherein the first and second anchor elements are configured to be movable between first, compact states during introduction via the venous system and second, expanded states for positioning on opposite sides of the heart tissue.

12. The system of claim 11, wherein the first and second anchor elements are self-expandable into the second, expanded states.

13. The system of claim 12, wherein the delivery catheter is configured to be a restraining member to maintain the first and second anchor elements in the first, compact states.

14. The system of claim 8, wherein the first and second anchor elements are formed to allow ingrowth of tissue.

15. A supplemental blood flow assist device for increasing blood flow between a chamber in a heart of a patient and a remote location in the circulatory system of the patient, the device comprising:

a blood pump having an inlet and an outlet, the outlet being adapted for connection to the remote location in the circulatory system of the patient;

a cannula having an outer surface, proximal and distal end portions, and a lumen extending between the proximal and distal end portions, the proximal end portion being configured to be coupled to the inlet of the blood pump and the distal end portion is configured to be inserted into the chamber of the heart and having an opening that communicates with the lumen of the cannula for allowing blood flow therethrough; and

first and second anchor elements carried on and permanently fixed to the distal end portion and having respective maximum width dimensions extending radially outwardly from the outer surface of the cannula, the first anchor element being positioned more distally than the second anchor element and defining a tissue-receiving space therebetween, and the maximum width dimension of the first anchor element being larger than the maximum width dimension of the second anchor element, whereby the first anchor element is configured to be positioned inside the heart chamber and the second anchor element is configured to be positioned outside the heart chamber with heart tissue held in the tissue-receiving space therebetween and the first and second anchor elements are each further configured to directly contact the heart tissue therebetween.

16. The device of claim 15, wherein at least one of the first or second anchor elements further comprises an annular disc shaped element.

17. The device of claim 15, wherein at least one of the first or second anchor elements is formed from a pliable, resilient material.

18. The device of claim 15, wherein the cannula is a blood flow catheter configured to be introduced into the venous system of the patient in order to percutaneously direct the distal end portion into the chamber of the heart.

19. The device of claim 18, further comprising a delivery catheter configured to receive the blood flow catheter such that the distal end portion of the blood flow catheter is deliverable to the heart.

20. The device of claim 18, wherein the first and second anchor elements are configured to be movable between first, compact states during introduction via the venous system and second, expanded states for positioning on opposite sides of the heart tissue.

21. The device of claim 20, wherein the first and second anchor elements are self-expandable into the second, expanded states.

22. The device of claim 15, wherein the first and second anchor elements are formed to allow ingrowth of tissue.

23. A method of establishing blood flow from a chamber in a heart of a patient to a remote location for providing supplemental blood flow from the heart, the method comprising:

inserting at least a portion of a distal end portion of a cannula into the chamber of the heart, the distal end portion including an opening that is in fluid communication with a lumen of the cannula for allowing blood flow therethrough, the distal end portion further including first and second anchor elements permanently fixed thereto, each anchor element having a maximum width dimension in a direction perpendicular to a lengthwise axis of the cannula, the lengthwise axis extending from a proximal end portion of the cannula to the distal end portion, and the first anchor element having a larger maximum width dimension than the second anchor element;

placing the first anchor element inside the chamber and contacting an inside surface of tissue defining the chamber; and

placing the second anchor element outside the chamber and contacting an outside surface of the tissue defining the chamber.

24. The method of claim 23, wherein placing the first and second anchor elements further comprises:

pushing the first and second anchor elements into the chamber; and

pulling only the second anchor element outside of the chamber thereby leaving the first anchor element inside the chamber.

25. The method of claim 23, wherein the cannula is a catheter, and inserting at least a portion of a distal end portion of the catheter further comprises directing the catheter through the venous system of the patient from a location remote from the heart.

26. The method of claim 23, further comprising:

connecting the proximal end portion of the cannula in fluid communication with a blood pump located remotely from the heart of the patient.

27. The method of claim 23, further comprising:

tightening the tissue between the first and second anchor elements.

28. The method of claim 27, wherein tightening the tissue further comprises:

applying at least one purse string suture to the tissue.

29. A method of establishing blood flow from a chamber in a heart of a patient to a remote location for providing supplemental blood flow from the heart, the method comprising:

inserting a distal end portion of a cannula into the chamber of the heart, the distal end portion including an opening in fluid communication with a lumen of the cannula for allowing blood flow therethrough, the distal end portion further including first and second anchor elements permanently fixed thereto, with the first anchor element being located more distally than the second anchor element and a tissue-receiving space being located between the first and second anchor elements, the first and second anchor elements each having respective maximum width dimensions extending radially outwardly from an outer surface of the cannula, the maximum width dimension of the first anchor element being larger than the maximum width dimension of the second anchor element;

pulling the more proximally-located second anchor element out of the chamber;

engaging the more proximally-located second anchor element in contact with an outside surface of tissue defining the chamber; and

engaging the first anchor element in contact with an inside surface of the chamber such that the tissue is retained in the tissue-receiving space and the cannula is in fluid communication with the chamber.

30. The method of claim 29, wherein the cannula is a catheter, and inserting the distal end further comprises:

directing the distal end portion through the venous system of the patient from a location remote from the heart.

31. The method of claim 29, wherein at least the second anchor element is resilient and pliable, and the pulling the second anchor element out of the chamber further comprises forcing the second anchor element through an aperture in the tissue such that the anchor element assumes a more compact state until the second anchor element emerges from the aperture at a location outside the chamber.

32. The method of claim 29, wherein the chamber is the left atrium of the heart.

33. The method of claim 29, further comprising:

connecting the proximal end portion of the cannula in fluid communication with a blood pump located remotely from the heart of the patient.

34. The method of claim 29, further comprising:

tightening the tissue between the first and second anchor elements.

35. The method of claim 34, wherein tightening the tissue further comprises:

applying at least one purse string suture to the tissue.

36. A cannula system for establishing blood flow between a chamber of a heart and a remote location, comprising:

a trocar;

a cannula including proximal and distal end portions and a lumen extending therebetween that is configured to receive the trocar therein, the cannula further including first and second anchor elements permanently fixed to the distal end portion and having respective maximum width dimensions extending radially outwardly from the outer surface of the cannula, the first anchor element being positioned more distally than the second anchor element and defining a tissue-receiving space therebetween and the first and second anchor elements are each further configured to directly contact the heart tissue therebetween, and the maximum width dimension of the first anchor element being larger than the maximum width dimension of the second anchor element; and

an expandable element associated with the trocar and configured to temporarily engage the interior of the cannula during a process of inserting the distal end into the heart chamber.

37. The cannula system of claim 36, wherein the expandable element further comprises a balloon-like element.