Vessel or Sac Wall Treatment and a Cardiac Assist Device

• US 20080194905A1
• Filed: 03/02/2005
• Published: 08/14/2008
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: Peter William Walsh
• Original Assignee: Peter William Walsh
• Inventors: Walsh, Peter William
• Granted Patent: US 7,766,814 B2
• Time in Patent Office: Days
• US Class Current: 600/17
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 60/157 mechanically acting upon the inside of the patient's blood vessel structure, e.g. contractile structures placed inside a vessel
• CPC Class Codes: A61M 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/869 Compliance chambers containing a gas or liquid other than blood to compensate volume variations of a blood chamber

Abstract

The present invention provides a device and method of treating a vessel in a human or animal body.

Claims

1. A method of treating a vessel in a human or animal body, said method including the steps of:

preparing a patient;

identifying a site in said vessel requiring treatment;

positioning an implantable device against a portion of tubular or sac wall of said vessel at said site, whereby load applied to said vessel is borne by said wall and said device, said vessel being assisted by said device when said wall and said device acts upon said load, said device including an energy storage means which is charged with a pressure or energy charge by means of said load being applied to said vessel.

3. A method as claimed in claim 1 or 2, wherein said pressure or energy charge is an energy charge which is at least in part produced by elastic deformation of said device.

4. A method as claimed in any one of claims 1 to 3, wherein operation of said device results in a system containing said vessel operating in a less stiff and or more compliant manner than would have been present from said portion of said wall at said site as untreated.

5. A method as claimed in any one of claims 1 to 4, wherein said energy storage means releases said pressure or energy charge to enable said device to assist said wall when said wall acts upon said load.

6. A method as claimed in any one of claims 1 to 5, wherein said device includes at least one elastomeric component, said elastomeric component being adapted to release energy to assist said vessel.

7. A method as claimed in claim 5 or 6 wherein said device or said energy storage means releases said pressure or energy charge in response to unloading of said vessel.

8. A method as claimed in any one of the preceding claims wherein said method includes positioning a cuff, which is a part of said device, around said wall.

9. A method as claimed in any one of the preceding claims wherein said energy storage means is a windkessel.

10. A method as claimed in any one of the preceding claims wherein said energy storage means includes a compressible media chamber which when compressed stores said pressure or energy charge.

11. A method as claimed in any one of the preceding claims wherein the compliance of said device is modifiable at the time of implant by inflation.

12. A method as claimed in claim 11, wherein compliance is modified by inflation with one, or a combination of more than one, of the following media:

a bio-compatible fluid;

liquid silicone;

liquid saline;

a liquid containing a contrast agent (x-ray viewable);

a gel solution that expands with temperature to a final operating volume at 37°

degrees Celsius;

uncured or liquid polymer which thermoset, at 37°

C. or via activation by light or heat;

a heat activated gel;

elastin;

collagen;

elastin and collagen in combination;

air;

a polymer that cures or thermosets after injecting gas, carbon dioxide, helium, or air or other compressible media.

13. A method as claimed in any one of the preceding claims wherein said vessel is a blood vessel.

14. A method as claimed in any one of the preceding claims wherein said load applied to said vessel being borne by said wall and said device is in the systolic phase of a cardiovascular system.

15. A method as claimed in any one of the preceding claims wherein when said wall and said device acts upon said load in the diastolic phase of a cardiovascular system.

16. A method as claimed in any one of claims 1, or 3 to 15 when appended to claim 1 only, wherein said device is positioned externally onto said vessel.

17. A method as claimed in any one of claims 1, or 3 to 15 when appended to claim 1 only, wherein said device is positioned within said vessel.

18. A method as claimed in any one of claims 2 to 15 when appended to claim 2 only, wherein said device is positioned between cut ends of said vessel to replace said site.

2. A method of treating a vessel in a human or animal body, said method including the steps of:

preparing a patient;

identifying a site in said vessel requiring treatment;

replacing all or a portion of said vessel requiring treatment with an implantable device, whereby load applied to the vessel is borne by said device, said vessel being assisted by said device when said device acts upon said load, said device including an energy storage means which is charged with a pressure or energy charge by means of said load being applied to said vessel.

19. A treatment or assistance device for operating in or with a tubular or sac wall of a vessel in a human or animal body, said device including a changeable volume portion which is adapted to interact with said vessel so as to modify the volume of said vessel;

and an energy storage means functioning with said changeable volume portion whereby a decrease in the volume of said changeable volume portion creates a pressure or energy charge in said energy storage means, said pressure or energy charge being able to be subsequently released to cause said changeable volume portion to increase in volume.

20. A device as claimed in claim 19, wherein said changeable volume portion is a cuff member which includes an inflatable portion, said cuff member and said inflatable portion being able to be positioned around said vessel.

21. A device as claimed in any one of claims 19 or 20, wherein said energy storage means is a pressure storage means such as a windkessel.

22. A device as claimed in claim 19, wherein said pressure storage means includes at least one valve, or at least one respective valve, to control the rate of charging and the rate of discharging of said pressure charge.

23. A device as claimed in claim 19 or 20, wherein said changeable volume portion is constructed at least in part from an elastomeric material, said elastomeric material being said energy storage means.

24. A device as claimed in any one of claims 19, 20 or 22, wherein said changeable volume portion is a graft or a stent graft, or a part thereof and said energy storage means is an elastomeric material which forms said graft, said stent graft part or said part thereof.

25. A device as claimed in any one of claims 19 to 24, wherein said changeable volume portion and said energy storage means are primed with a threshold or reference pressure.

26. A device as claimed in claim 25, wherein media with which the changeable volume portion is primed with one or more of the following media:

a bio-compatible fluid;

liquid silicone;

liquid saline;

a liquid containing a contrast agent which is x-ray viewable;

a gel or other solution that expands with temperature to a final operating volume at 37°

degrees Celsius;

elastin;

collagen;

elastin and collagen in combination;

air, carbon dioxide, helium;

or a gas.

27. A device as claimed in any one of claims 19 to 26, wherein said energy storage means includes a compressible fluid chamber.

28. A device as claimed in claim 27, wherein media with which said energy storage means is primed is one or more of the following compressible media:

air, carbon dioxide, helium, gas, other compressible media.

29. A device as claimed in any one of claims 19 to 28, wherein said changeable volume portion includes a generally inextensible outer portion whereby any change of volume is confined to being within the volume defined by said outer portion.

30. A device as claimed in any one of claims 19 to 29, wherein said device is adapted, at least in part, to be implanted into a human or animal body.

31. A device a claimed in claim 30, wherein said a changeable volume portion and said pressure charging means are implanted in said human or animal body.

32. A device a claimed in claim 30, wherein said a changeable volume portion is implanted in said human or animal body while said energy storage means, if separate from said changeable volume portion, is located outside of said human or animal body.

33. A device as claimed in any one of claims 19 to 32, wherein said changeable volume portion is joined to ends of said vessel.

34. A device as claimed in any one of claims 19 to 32, wherein said changeable volume portion is attached externally to said vessel.

35. A device as claimed in any one of claims 19 to 32, wherein said changeable volume portion is attached intraluminally in the vessel.

36. The use of a device as claimed in any one of claims 19 to 35, wherein said device is used to treat or assist a blood carrying vessel.

37. The use of a device as claimed in claim 36, wherein said device is used to repair the compliance of a portion of said vessel.

38. The use of a device as claimed in claim 36 or 37, wherein said device is used to modify the systolic and diastolic characteristics of said vessel to thereby improve cardiovascular performance.