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

• US 9,132,216 B2
• Filed: 05/16/2014
• Issued: 09/15/2015
• Est. Priority Date: 02/11/2010
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C., Marseille, Oliver, Kerkhoffs, Wolfgang
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/279,735
• Publication Number:
  US 20140249357A1
• Time in Patent Office: 487 Days
• Field of Search: 607/116
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• 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 60/205 Non-positive displacement blood pumps
• 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 cannula for insertion through a biologic tissue. The cannula includes a shaft having proximal and distal end portions with a lumen therebetween. The cannula further includes a tip having a proximal end portion, a distal tip end, and a lumen therebetween. The proximal end portion of the tip is secured to the distal end portion of the shaft so that the lumen of the tip is in fluid communication with the lumen of the shaft. The tip includes an opening that extends proximally relative to the distal tip end to permit the flow of fluid into the lumen of the tip even in the event that the distal tip end becomes obstructed.

Claims

1. A blood circulation assist system for increasing blood flow between a chamber in a heart of a patient and an artery of the patient, the blood circulation assist system comprising:

(i) a blood pump having an inlet and an outlet;

(ii) an inflow cannula including;

(a) a shaft comprising proximal and distal end portions and a lumen extending therebetween; and

(b) a tip configured to extend through a tissue of the heart, the tip having a proximal end portion, a distal tip end, and a lumen extending therebetween, the proximal end portion of the tip being secured to the distal end portion of the shaft such that the lumen of the tip is in fluidic communication with the lumen of the shaft, the tip having a first distal tip opening at the distal tip end and a second opening extending proximally relative to the distal tip end and that is in fluid communication with the lumen of the tip, wherein the second opening of the tip is configured to permit blood to be continuously drawn into the lumen of the tip even in the event the distal tip opening becomes obstructed,

(c) wherein the tip further includes an outer surface having a frusto-conical shape that has a proximal portion and converges distally,

(d) the outer surface includes a shoulder configured to abut a first side of the tissue of the heart when the tip is positioned through the tissue of the heart, and

(e) the shoulder is integrally formed at the proximal portion of the frusto-conical shape; and

(iii) an outflow cannula having proximal and distal end portions and a lumen extending therebetween, the proximal end portion being configured to be coupled to the artery.

2. The blood circulation assist system of claim 1, wherein the tip further includes a first anchor that is configured to be deployed from a contracted state to an expanded state, wherein the first anchor is configured to engage at least one side of the tissue of the heart in the expanded state and is operable to resist movement of the tip in at least one direction along a lengthwise central axis of the tip.

3. The blood circulation assist system of claim 2, wherein the first anchor further comprises a plurality of struts extending generally transverse to the lengthwise central axis of the tip.

4. The blood circulation assist system of claim 3, wherein the first anchor further includes a porous polymeric structure coupled with the plurality of struts and facilitating tissue in-growth for securing the first anchor to the tissue of the heart.

5. The blood circulation assist system of claim 2 further comprising:

a second anchor located proximal to the first anchor on the tip, the second anchor operable to prevent a movement of the tip in a distal direction.

6. The blood circulation assist system of claim 5, wherein the second anchor further comprises a plurality of struts extending generally transverse to the lengthwise central axis of the tip.

7. The blood circulation assist system of claim 6, wherein the second anchor further includes a porous polymeric structure coupled with the plurality of struts and facilitating tissue in-growth for securing the second anchor to the tissue of the heart.

8. The blood circulation assist system of claim 1, wherein the outer surface includes an anti-thrombotic coating.

9. The blood circulation assist system of claim 1, wherein the proximal end portion of the tip includes an outer surface having a coating that promotes thrombus formation.

10. The blood circulation assist system of claim 1, wherein the second opening extending proximally includes at least one notch extending proximally from the distal tip end and between the lumen and an outer surface of the tip.

11. The blood circulation assist system of claim 1, wherein the second opening extending proximally includes a plurality of notches extending proximally from the distal tip end and between the lumen and an outer surface of the tip, the plurality of notches being spaced circumferentially around the tip.

12. The blood circulation assist system of claim 1, wherein the second opening extending proximally includes an inclined edge extending proximally from the distal tip end, wherein the inclined edge is angled relative to a lengthwise central axis of the tip.

13. The blood circulation assist system of claim 12, wherein the tip further includes a third opening extending proximally relative to the distal tip end, the third opening including at least one notch or at least one aperture.