Vessel or sac wall treatment and a cardiac assist device

• US 7,766,814 B2
• Filed: 03/02/2005
• Issued: 08/03/2010
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: Peter William Walsh
• Original Assignee: Peter William Walsh
• Inventors: Walsh, Peter William
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US10/584,807
• Publication Number:
  US 20080194905A1
• Time in Patent Office: 1,980 Days
• Field of Search: 600 16- 18, 600/31, 623/3.17
• 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 for time dependent pressure dampening or diastolic time dependent pressure discharge;

positioning an implantable device against a portion of wall of said vessel at said site, whereby load applied to said vessel is borne by said wall and said implantable device, said vessel being assisted by said implantable device when said wall and said implantable device act upon said load, said implantable device including an energy storage device which is charged by said load being applied to said vessel, the energy storage device being charged with a charge selected from the group of a pressure charge and an energy charge;

said implantable device operating as a closed system; and

positioning said energy storage device extraluminally with respect to said vessel.

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

3. A method as claimed in claim 1, wherein said energy storage device releases said charge to enable said implantable device to assist said wall when said wall acts upon said load.

4. A method as claimed in claim 3, wherein said energy storage device releases said charge in response to unloading of said vessel.

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

6. A method as claimed in claim 1, wherein said method includes positioning a cuff, which is a part of said implantable device, around said vessel positioned to reduce the diameter and therefore the stress-strain profile of the vessel to operate in a less stiff and more compliant manner over a physiological range of loads.

7. A method as claimed in claim 1, wherein said energy storage device is a deformable reservoir.

8. A method as claimed in claim 1, wherein said energy storage device includes a compressible media chamber which when compressed stores said charge.

9. A method as claimed in claim 8, wherein said energy storage device includes a non-compressible media chamber having communicable passage with a compressible media chamber.

10. A method as claimed in claim 1, wherein the compliance of said device is modifiable at the time of implant by inflation.

11. A method as claimed in claim 10, wherein compliance is modified by inflation with at least 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 polymer which thermoset at 37°

C., liquid polymer which thermoset, at 37°

, polymer which thermoset via activation by light, uncured polymer which thermosets by heat;

a heat activated gel;

elastin;

collagen;

elastin and collagen in combination;

air;

gas;

a polymer that cures after injecting gas, carbon dioxide, helium, or air;

a polymer that thermoses after injecting gas, carbon dioxide, helium, or air; and

other compressible media.

12. A method as claimed in claim 1, wherein said vessel is a blood vessel.

13. A method as claimed in claim 1, wherein said load applied to said vessel being borne by said wall and said implantable device, thereby charging said implantable device, is in the systolic phase of a cardiovascular system.

14. A method as claimed in claim 1, wherein said implantable device discharges energy acting on said vessel in the diastolic phase of a cardiovascular system.

15. A method as claimed in claim 1, wherein said implantable device is positioned between cut ends of said vessel to replace said site.

16. A method as claimed in claim 1, wherein the compliance of said vessel is modifiable at the time of implant by inflation of said device.

17. The method of claim 1, wherein charges imparted to the energy storage device are provided exclusively by the load being applied to said vessel.

18. The method of claim 1, wherein the implantable device operates as a completely passive device.

19. The method of claim 1, wherein compliance of the implantable device is modifiable after implantation by adjusting an inflation pressure thereof.

20. The method of claim 1, wherein compliance of the vessel is modifiable after implantation of the implantable device by adjusting an inflation pressure of the implantable device.

21. The method of claim 1, wherein the vessel is the aorta.

22. The method of claim 1, wherein the implantable device is positioned over a treatment site where a part of the vessel has been removed.

23. A treatment device for operating with a wall of a vessel in a body, said treatment 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 device functioning with said changeable volume portion whereby a decrease in the volume of said changeable volume portion creates a charge in said energy storage device, said charge being able to be subsequently released to cause said changeable volume portion to increase in volume, said energy storage device being extraluminal with respect to said vessel, said energy storage device absorbing energy when loaded, and releasing energy when unloaded.

24. A device as claimed in claim 23, 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, or a portion of said vessel, said device shaped to fit said vessel curvature at said vessel treatment site.

25. A device as claimed in claim 24, wherein said cuff contains said changeable volume portion and said energy storage device.

26. A device as claimed in claim 25, wherein said energy storage device is a compressible media chamber which is compressed or loaded by said vessel cuff inner portion, changing it'"'"'s changeable media volume portion by compressing the chamber'"'"'s media in a manner proportional to said applied load at said vessel treatment site, thereby absorbing part of said applied load, dampening said applied load and charging said device, said device releasing its charge when applied load is reduced.

27. A device as claimed in claim 23, wherein said energy storage device is a pressure storage device such as a deformable reservoir.

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

29. A device as claimed in claim 23, wherein said changeable volume portion is selected from the group including, a graft, a stent graft, a part of a stent, and a part of a stent graft.

30. A device as claimed in claim 23, wherein said changeable volume portion and said energy storage device are primed with a threshold or reference pressure.

31. A device as claimed in claim 23, wherein said changeable volume portion is primed with at least one 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 that expands with temperature to a final operating volume at 37°

degrees Celsius, 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; and

a gas.

32. A device as claimed in claim 23, wherein said energy storage device includes a compressible media chamber.

33. A device as claimed in claim 32, wherein media with which said energy storage device is primed is at least one of the following compressible media:

air;

carbon dioxide, helium, and gas.

34. A device as claimed in claim 23, 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.

35. A device as claimed in claim 34, wherein said energy storage device is a compressible media chamber which when compressed or loaded, absorbs part of said charge, and a non-compressible media chamber having communicable passage with said vessel cuff, said vessel cuff inner portion changing it'"'"'s changeable volume portion by transfer of fluid to said non-compressible media chamber, said non-compressible media chamber acting on said compressible media chamber in a manner proportional to said applied load at said vessel treatment site.

36. A device as claimed in claim 23, wherein said changeable volume portion is joined to ends of said vessel.

37. A device as claimed in claim 23, wherein said device is used to treat a blood carrying vessel.

38. A device as claimed in claim 37, wherein said treatment device is used to repair the compliance of a portion of said vessel.

39. A device as claimed in claim 37, wherein said treatment device is used to modify the systolic and diastolic characteristics of said vessel to thereby improve cardiovascular performance.

40. A device as claimed in claim 23, wherein said device is used to treat a blood carrying vessel graft prosthesis.

41. The device of claim 23, wherein the changeable volume portion and energy storage device operate as a closed system.

42. The device of claim 23, wherein charges imparted to the energy storage device are provided exclusively via the changeable volume portion.

43. The device of claim 23, wherein the treatment device operates as a completely passive device.