Inflow cannula and blood flow assist system

• US 9,717,830 B2
• Filed: 10/28/2015
• Issued: 08/01/2017
• Est. Priority Date: 10/28/2015
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US14/924,842
• Publication Number:
  US 20170119943A1
• Time in Patent Office: 643 Days
• Field of Search: 600 16
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 60/20 Type thereof
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• 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

A system and method of drawing blood from the heart of a patient. The system includes a blood pump, an outflow cannula, and a flexible cannula assembly. The flexible cannula assembly includes a cannula body, a tip, and first and second anchors. The cannula body includes a proximal end coupled to the inlet of the blood pump, a distal end including a first locking element coupled to the tip. The first anchor has a first plurality of arms and is coupled to the tip and adapted to engage the internal surface of the heart wall. The second anchor includes a second plurality of arms and a second locking element and is slidably positioned on the outer wall of the cannula body and adapted to engage the first locking element of the distal end of the cannula body to couple the second anchor to the external surface of the heart wall.

Claims

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

a blood pump including an inlet and an outlet;

an outflow cannula adapted to fluidly communicate the outlet of the blood pump to the circulatory system of the patient; and

a flexible cannula assembly adapted to extend through a heart wall having internal and external surfaces, the flexible cannula assembly further comprising;

a cannula body including a proximal end, a distal end including a first locking element, an inner wall defining a lumen, and an outer wall, the proximal end being coupled to the inlet of the blood pump;

a tip coupled with the distal end of the cannula body;

a first anchor including a first plurality of arms, the first anchor being coupled to the tip and adapted to engage the internal surface of the heart wall and operable to resist movement of the cannula assembly in at least one direction along a lengthwise direction of the cannula body; and

a second anchor including a second plurality of arms and a second locking element, the second anchor positioned on the outer wall of the cannula body, wherein the second locking element slidably engages the first locking element of the distal end of the cannula body to couple the second anchor to the external surface of the heart wall.

2. The system of claim 1, further comprising:

at least one ring member adapted to be coupled to the external surface and positioned at least partially around the outer wall of the cannula body, the at least one ring member further adapted to provide homeostasis between the external surface of the heart wall and the cannula body.

3. The system of claim 1, wherein the cannula body further comprises:

an alignment mark located along at least a portion of the lengthwise axis of the cannula body to position at least one of the first and second plurality of arms to avoid obstructing the left pulmonary veins.

4. The system of claim 1, wherein one of the first plurality of arms is separated by more than about 120 degrees from the other arms of the first plurality of arms, and configured to be placed against the internal surface of the heart wall between the left pulmonary veins to avoid obstructing the left pulmonary veins.

5. The system of claim 1, wherein one of the second plurality of arms is separated by more than about 120 degrees from the other arms of the second plurality of arms, and configured to be placed against the external surface of the heart wall between the left pulmonary veins to avoid obstructing the left pulmonary veins.

6. The system of claim 1, wherein the second plurality of arms is curved towards the external surface of the heart wall around the central axis of the cannula body.

7. The system of claim 1, wherein second teeth of the second locking element are configured to engage first teeth of the first locking element in a plurality of locking positions to accommodate varying heart wall thicknesses.

8. The system of claim 1, wherein second teeth of the second locking element are configured to threadably engage first teeth of the first locking element.

9. The system of claim 7, wherein the shape of at least one of the first and second teeth causes the force required to couple the first and second teeth to be less than the force required to decouple the first and second teeth.

10. A method of securing a flexible cannula assembly to both internal and external surfaces of a heart wall of a patient, the flexible cannula assembly including a cannula body including a proximal end, a distal end having a first locking element, an inner wall defining a lumen, and an outer wall, and a tip coupled to the distal end of the cannula body, the method comprising:

introducing the tip through the external and internal surfaces of the heart wall, such that the tip is in fluid communication with a first chamber of the heart;

deploying a first anchor including a first plurality of arms, the first anchor being coupled to the tip to secure the flexible cannula assembly to the internal surface of the heart wall;

moving a second anchor including a second plurality of arms and a second locking element distally towards the external surface of the heart wall;

coupling the first locking element of the distal end of the cannula body to the second locking element of the second anchor to secure the flexible cannula assembly to the external surface of the heart wall;

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

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

11. The method of claim 10, further comprising:

coupling at least one ring member to the external surface of the heart wall, the at least one ring member defining an aperture sized to create an interference fit with an outer surface of the cannula body.

12. The method of claim 10, wherein moving the second anchor further comprises:

using an alignment mark located on at least a portion of the lengthwise axis of the cannula body to position the second plurality of arms to avoid obstructing a vein.

13. The method of claim 10, wherein deploying the first anchor further comprises:

deploying the first anchor so one arm of the first plurality of arms is separated by more than about 120 degrees from the other arms of the first plurality of arms.

14. The method of claim 10, wherein moving the second anchor further comprises:

deploying the second anchor so one arm of the second plurality of arms is separated by more than about 120 degrees from the other arms of the second plurality of arms.

15. The method of claim 10 wherein coupling the first locking element further comprises:

coupling the first locking element so that the second plurality of arms of the second anchor are curved towards the external surface of the heart wall.