Apparatus for aiding the flow of blood through patient's circulatory system

• US 20060178731A1
• Filed: 02/09/2005
• Published: 08/10/2006
• Est. Priority Date: 02/09/2005
• Status: Abandoned Application

• Current Assignee: Numed LLC
• Original Assignee: Numed LLC
• Inventors: Tower, Allen J.
• Application Number:
  US11/054,688
• Publication Number:
  US 20060178731A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• 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 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/435 with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves
• CPC Class Codes: A61M 60/898 the blood pump being a membrane blood pump and the membrane acting as inlet valve

Abstract

A percutaneous implanted device for temporarily sustaining a patient awaiting a heart transplant. The device includes a radially expandable stent mounted upon the balloon section of a balloon catheter. A venous biological valve is mounted at each end of the stent and an inflatable annular-shaped diaphragm is secured to the stent between the valves, which permit the flow of blood in one direction and prevent the flow of blood in the opposite direction. The diaphragm is attached to a pump which inflates the diaphragm after the stent is implanted in a blood vessel in relation to the heart'"'"'s rhythm to assist the heart in moving blood through the patient'"'"'s circulatory system.

Claims

1. A percutaneous implanted apparatus for temporarily sustaining a patient awaiting a heart transplant that includes:

a radially expandable stent having a first collapsible valve secured to one end of said stent and a second collapsible valve secured to the other end of said stent, said valves being configured so that the valves open to pass a flow in one direction and close to block the flow in the opposite direction;

means for percutaneously implanting the stent into a blood vessel leading to or away from the heart and expanding the stent against the inner wall of the blood vessel;

a radially expandable diaphragm having a first cylindrical outer membrane secured to the stent between said valves and a second cylindrical inner membrane, said membranes being joined together at each end of said diaphragm to establish an inflatable chamber between the two membranes; and

means for inflating and deflating said diaphragm to assist the flow of blood being conducted through said blood vessel.

2. The apparatus of claim 1, wherein said means for implanting said stent is a balloon catheter.

3. The apparatus of claim 1, wherein said valves are biological venous valves, each of which is contained within a vein that is sutured to said stent.

4. The apparatus of claim 3, wherein the wall thickness of each vein is reduced to between 50 percent and 90 percent of its original thickness.

5. The apparatus of claim 1, wherein said means for inflating and deflating said diaphragm is a pump.

6. The apparatus of claim 5 that further includes control means for regulating said pump in response to the diastolic and systolic rhythm of the patient.

7. The apparatus of claim 1, wherein said inner membrane is fabricated of a material that is permeable to the inflation fluid at the pump pressure.

8. The apparatus of claim 7, wherein said outer membrane is fabricated of a polyurethane material and the inner membrane is fabricated of a material selected from the group consisting of Teflon, nylon, and EPTFe.

9. The apparatus of claim 1, wherein said outer membrane is joined to the inner membrane by a thermal bond.

10. The apparatus of claim 7, wherein said inflation fluid is oxygen.

11. A method of temporarily sustaining a patient awaiting a heart transplant that includes the steps of:

mounting a biological valve upon either end of a collapsible stent so that the valves operate to allow a fluid to flow in one direction through said stent and block the flow of said fluid in the opposite direction;

securing a radially expandable diaphragm to the inside of said stent between said valves;

connecting the diaphragm to a source for inflating and deflating said diaphragm;

percutaneously implanting the stent in a collapsed condition within a blood vessel leading to or away from the heart and expanding the stent into contact with the inner wall of the blood vessel; and

inflating and deflating said diaphragm in relation to the patient'"'"'s diastolic and systolic rhythm.

12. The method of claim 11 that includes the further step of mounting the collapsed stent upon the balloon section of a balloon catheter for implanting the stent within said blood vessel.

14. The method of claim 11 that includes the further step of fabricating section of said diaphragm of a material that is permeable to oxygen at the inflation pressure.

15. The method of claim 14 that includes the further step of pumping oxygen into said diaphragm to inflate said diaphragm.

16. The method of claim 15 that includes the further steps of monitoring the heart'"'"'s circulator rhythm and regulating the inflation and deflation of said diaphragm in response to said rhythm.

13. The method of clam 11, wherein said biological valves are venous tricuspid valves and arranging said valves pass blood flowing in one direction and prevent the blood from flowing in the opposite direction.