Ventricular pump coupling

• US 20070106315A1
• Filed: 10/17/2006
• Published: 05/10/2007
• Est. Priority Date: 10/19/2005
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: Transmyo, Inc.
• Inventors: Radovancevic, Branislav, Hsia, Alex, Gregoric, Igor
• Granted Patent: US 8,343,028 B2
• Time in Patent Office: Days
• US Class Current: 606/158
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• 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 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/863 Apex rings

Abstract

A device and method for creating a connection with the left ventricle of a heart are provided. A seal member capable of moving between a folded position and an open position is attached to the end of a conduit. An introducer capable of moving between a first and second position allows for the expansion of the seal member into an open position. A clamp component is positioned outside of the heart to provide an axial clamping force with the wall of the heart so that a seal is created between the seal member and the wall of the heart.

Claims

1. A device for creating a sealed connection at an opening in a wall of a heart, comprising:

a conduit, having an end;

a seal member attached to the end of the conduit and capable of moving between a folded position and an open position to expand the seal member so that the seal member has a cross-dimension that is larger than a cross-dimension of the opening in the wall of the heart; and

a clamp component to be positioned outside of the heart, the seal member and the clamp component being movable relative to one another to produce an axial clamping force with the wall of the heart between the clamp component and the seal member so that a seal is created between the seal member and the wall of the heart.

2. A device as claimed in claim 1, wherein the seal member has a ribbed surface to engage the wall of the heart.

3. A device as claimed in claim 1, further comprising at least one expansion spring within the seal member to expand the seal member within the heart.

4. A device as claimed in claim 1, wherein the seal member is molded silicone having a biocompatible coating.

5. A device as claimed in claim 1, further comprising an introducer being secured for movement between first and second positions relative to the conduit, in the first position, the introducer maintaining the seal member in the folded position to allow for insertion of the seal member through the opening into the heart and, in the second position, the introducer allowing for expansion of the seal member so that the seal member has a cross-dimension that is larger than a cross-dimension of the opening in the wall of the heart.

6. A device as claimed in claim 5, wherein the introducer has retractable fingers.

7. A device as claimed in claim 5, wherein the introducer is rotatable into a locked position to prevent movement of the introducer in the axial direction relative to the conduit.

8. A device as claimed in claim 5, wherein the introducer is tapered on one end and is slideably engaged with a stop on the seal member to prevent movement of the introducer in the axial direction relative to the conduit.

9. A device as claimed in claim 5, wherein the introducer is selected from at least one of nitinol or stainless steel.

10. A device as claimed in claim 5, wherein the introducer passively allows the seal member to expand to an open position.

11. A device as claimed in claim 10, wherein the seal member expands under a spring force.

12. A device as claimed in claim 1, further comprising a wire frame, plastic deformation of at least a portion of the wire frame causing expansion of the seal member.

13. A device as claimed in claim 12, wherein movement of the conduit relative to the wire frame causes deformation of the portion of the wire frame.

14. A device as claimed in claim 1, wherein the clamp component has an epicardial seal piece having an inner and outer diameter to engage the wall of the heart.

15. A device as claimed in claim 14, wherein the clamp component has a flange being attached to the epicardial seal piece.

16. A device as claimed in claim 15, wherein the clamp component has a mounting piece being attached to the flange, and a locking mechanism is attached to the mounting piece.

17. A device as claimed in claim 16, wherein the locking mechanism has a plurality of teeth to close the locking mechanism, the locking mechanism engaging the introducer and the flange to produce the axial clamping force.

18. A device as claimed in claim 16, wherein the locking mechanism is polytetrafluoroethylene.

19. A device as claimed in claim 15, wherein the flange has an outer diameter and an inner diameter having a plurality of teeth.

20. A system for assisting a left ventricle of a heart, comprising:

a connector being connectable to an opening in the wall of the left ventricle of the heart, the connector having a conduit, a seal member attached to an end of the conduit and capable of moving between a folded position and an open position to expand the seal member so that the seal member has a cross-dimension that is larger than a cross-dimension of the opening in the wall of the heart, and a clamp component to be positioned outside of the heart, the seal member and the clamp component being movable relative to one another to produce an axial clamping force with the wall of the heart between the clamp component and the seal member so that a seal is created between the seal member and the wall of the heart;

a pump having an inlet and outlet;

a motor for driving the pump;

an energy source for operating the motor; and

an outflow tube having a first end and a second end, wherein the first end is connected to the outlet of the pump and the second end is connectable to a blood vessel.

21. A system as claimed in claim 20, further comprising an inflow tube having a first end and a second end, wherein the first end of the inflow tube is attached to the connector and the second end of the inflow tube is connected to the inlet of the pump.

22. A system as claimed in claim 21, wherein the inflow tube is attached to the conduit through a friction fit allowing blood to pass from the heart when the introducer is in the second position and the seal member is in an open position.

23. A method for creating a sealed connection at an opening in a wall of a heart, comprising:

inserting an introducer and a seal member, in a folded position, through an opening in the wall of the heart;

expanding the seal member to an open position within the heart so that the seal member has a cross-dimension that is larger than a cross-dimension of the opening in the wall of the heart; and

moving a clamp component relative to the seal member to create an axial clamping force with the wall of the heart between the clamp component and the seal member so that a seal is created between the seal member and the wall of the heart.