| 5263481 | Electrode system with disposable gel | November, 1993 | Axelgaard | 600/392 |
| 5558617 | Cardiac compression band-stay-pad assembly and method of replacing the same | September, 1996 | Heilman et al. | 600/16 |
| 5820542 | Modified circulatory assist device | October, 1998 | Dobak et al. | 600/16 |
| 5961440 | Heart wall tension reduction apparatus and method | October, 1999 | Schweich, Jr. et al. | 600/16 |
| 6024096 | Anterior segment ventricular restoration apparatus and method | February, 2000 | Buckberg | 128/898 |
| 6110100 | System for stress relieving the heart muscle and for controlling heart function | August, 2000 | Talpade | 600/37 |
| 6183411 | External stress reduction device and method | February, 2001 | Mortier et al. | 600/16 |
| 6221104 | Anterior and interior segment cardiac restoration apparatus and method | April, 2001 | Buckberg et al. | 623/3.1 |
| 6264602 | Stress reduction apparatus and method | July, 2001 | Mortier et al. | 600/16 |
| 6695768 | Adjustable periventricular ring/ring like device/method for control of ischemic mitral regurgitation and congestive heart disease | February, 2004 | Levine et al. | 600/37 |
| 6887192 | Heart support to prevent ventricular remodeling | May, 2005 | Whayne et al. | 600/16 |
| WO/2001/078625 | October, 2001 | ENDOVENTRICULAR DEVICE FOR THE TREATMENT AND CORRECTION OF CARDIOMYOPATHIES |
Vasan et al., “Diastolic Heart Failure-No Time to Relax”, New England Journal of Medicine, vol. 344, pp. 56-59, Nov. 4, 2001, 5 pages.
Opie, “The Heart Physiology, From Cell to Circulation,” 3rd Edition, Lippincott-Raven publishers, 1998, Chapter 12, Ventricular Function, pp. 343-389.
Mandinov et al., “Diastolic Heart Failure,” Cardiovascular Research, vol. 45, Issue 4, Mar. 2000, pp. 813-825, 20 pages.
Paulus et al., “How to Diagnose Diastolic Heart Failure,” European Study Group on Diastolic Heart Failure, European Heart Journal, 1998, vol. 19, pp. 990-1003.
Gandhi et al., “The Pathogenesis of Acute Pulmonary Edema Associated with Hypertension”, New England Journal of Medicine, vol. 344:17-22, Jan. 4, 2001, 8 pages.
Sweitzer et al., “Diastolic Heart Failure: Miles to Go Before We Sleep,” American Journal of Medicine, vol. 109, Issue 8, Dec. 1, 2000, p. 683-685., 5 pages.
Braunwald, “Heart Failure,” Harrison's Principles of Internal Medicine, 14th Edition, McGraw Hill Publishers, Chapter 233, pp. 1287-1298.
Grauer, “Heart Failure, Diastolic Dysfunction and the Role of the Family Physician,” American Family Physician, Apr. 14, 2001, vol. 63, Issue 8, p. 1483, 4 pages.
Philbin et al., “Systolic Versus Diastolic Heart Failure in Community Practice: Clinical Features, Outcomes, and the use of Angiotensin-Converting Enzyme Inhibitors,” American Journal of Medicine, Dec. 1, 2000, vol. 109, pp. 605-613.
Morris-Thurgood et al., “Pacing in Heart Failure: Improved Ventricular Interaction in Diastole Rather than Systolic Re-Synchronization,” European Society of Cardiology, Euorpace, 2000, vol. 2, pp. 271-275.
1. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby said device includes at least one elastic component featuring physicochemical property and behavior of elasticity, whereby said at least one elastic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts an elastic type of said radially outward expansive force or pressure to said wall region of the left ventricle.
2. The method of claim 1, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, exhibiting said physicochemical property and behavior of elasticity.
3. The method of claim 1, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure metal, a metal alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of elasticity.
4. The method of claim 1, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure metal selected from the group consisting of pure tungsten metal, pure platinum metal, and, pure titanium metal, a metal alloy selected from the group consisting of a nitinol alloy, and, a stainless steel alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of elasticity.
5. The method of claim 1, wherein said wall region of the left ventricle is inner wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle, and potentially exerts a pushing type of said elastic radially outward expansive force or pressure to said inner wall surface of the left ventricle.
6. The method of claim 5, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions.
7. The method of claim 5, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
8. The method of claim 5, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
9. The method of claim 5, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
10. The method of claim 5, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby said elastic arms or extensions are circular or helical around central longitudinal axis of said at least one elastic lower basal section or ring formation.
11. The method of claim 5, whereby said device is an integral single complex said elastic component featuring at least one elastic element or mechanism functioning and structured as a spring connected to a plurality of at least two ventricular wall contact elements positioned adjacent to and along said inner wall surface of the left ventricle.
12. The method of claim 1, wherein said wall region of the left ventricle is outer wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said outer wall surface of the left ventricle, and potentially exerts a pulling type of said elastic radially outward expansive force or pressure to said outer wall surface of the left ventricle.
13. The method of claim 12, whereby said device is an integral single said elastic component having geometry, shape, and, form, selected from the group consisting of at least partially cylindrical, partially annular, partially conical, fully cylindrical, fully annular, and, fully conical, relative to central longitudinal axis of said elastic component.
14. The method of claim 12, whereby said device is an integral single said elastic component having geometry, shape, and, form, selected from the group consisting of at least partially cylindrical, partially annular, partially conical, fully cylindrical, fully annular, and, fully conical, relative to central longitudinal axis of said elastic component, with a surface incompletely solid as a cut-out or hollow pattern including a plurality of hollow cells.
15. The method of claim 1, wherein said wall region of the left ventricle is intermediate wall region of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle, and potentially exerts a pulling and pushing type of said elastic radially outward expansive force or pressure to said intermediate wall region of the left ventricle.
16. The method of claim 15, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions.
17. The method of claim 15, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
18. The method of claim 15, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
19. The method of claim 15, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
20. The method of claim 1, wherein said wall region of the left ventricle is intermediate wall region and inner wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle and potentially exerts a pulling and pushing type of said elastic radially outward expansive force or pressure to said intermediate wall region of the left ventricle, and, whereby said at least one elastic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle and potentially exerts a pushing type of said elastic radially outward expansive force or pressure to said inner wall surface of the left ventricle.
21. The method of claim 20, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions.
22. The method of claim 20, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
23. The method of claim 20, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
24. The method of claim 20, whereby said device is an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
25. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby said at least one component has variable geometry, shape, and, form, whose surfaces and volumes are characterized by at least one physical aspect or descriptor selected from the group consisting of smooth, flat, rough, ridged or bumpy, jagged, wavy, saw-toothed, bent, planar, non-planar, closed, open, completely solid featuring no cut-out or hollow pattern, incompletely solid featuring a said cut-out or hollow pattern, and, combinations thereof.
26. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; whereby said device further includes at least one component or mechanism for anchoring, adhering, and/or, attaching, at least one part or region of said device to said at least one part of wall region of the left ventricle where said device is configured; and whereby said anchoring, adhering, and/or, attaching, component or mechanism is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material having variable geometry, shape, form, and, dimensions, whereby said anchoring, adhering, and/or, attaching, component or mechanism exhibits (i) physicochemical properties and behavior selected from the group consisting of anchoring, adhering, attaching, and, combinations thereof, and, exhibits (ii) physicochemical properties and behavior which are (1) selected from the group consisting of non-interfering, additive, and, synergistic, with said functionality of said at least one component, (2) minimally disturbing to overall functionality of the heart during a cardiac cycle, and, (3) biocompatible.
27. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and wherein step (a), said device is inserted into place using a minimally invasive surgical procedure.
28. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, and, wherein step (b), said pre-determined magnitude is a pressure in a range of about 5 mm Hg to about 20 mm Hg.
29. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, and, wherein step (c), left ventricular end diastolic pressure (LVEDP) is reduced down to a range of about 6 mm Hg to about 12 mm Hg during said ventricular diastole of the heart.
30. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, wherein step (b), said pre-determined magnitude is a pressure in a range of about 5 mm Hg to about 20 mm Hg, and, wherein step (c), left ventricular end diastolic pressure (LVEDP) is reduced down to a range of about 6 mm Hg to about 12 mm Hg during said ventricular diastole of the heart.
31. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby said device includes at least one magnetic component featuring physicochemical property and behavior of magnetic repulsion, whereby said at least one magnetic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts a magnetic repulsion type of said radially outward expansive force or pressure to said wall region of the left ventricle.
32. The method of claim 31, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, exhibiting said physicochemical property and behavior of magnetic repulsion.
33. The method of claim 31, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure magnetic metal, a magnetic metal alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of magnetic repulsion.
34. The method of claim 31, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure magnetic metal selected from the group consisting of pure iron metal, pure nickel metal, and, pure cobalt metal, a magnetic metal alloy selected from the group consisting of a neodymium iron alloy, and, a samarium cobalt alloy, and, combinations thereof.
35. The method of claim 31, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said magnetic repulsion radially outward expansive force or pressure to said wall region of the left ventricle.
36. The method of claim 35, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
37. The method of claim 35, whereby said magnetic elements or magnets are rectangular or bar magnets.
38. The method of claim 35, whereby said magnetic elements or magnets are disc or edge magnets.
39. The method of claim 31, whereby said at least one magnetic component is enclosed inside a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material having variable geometry, shape, form, and, dimensions, exhibiting physicochemical properties and behavior which are (1) selected from the group consisting of non-interfering, additive, and, synergistic, with said magnetic repulsion functionality of said device, (2) minimally disturbing to overall functionality of the heart during a cardiac cycle, and, (3) biocompatible.
40. The method of claim 31, wherein said wall region of the left ventricle is inner wall surface of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle, and potentially exerts a pushing type of said magnetic repulsion radially outward expansive force or pressure to said inner wall surface of the left ventricle.
41. The method of claim 40, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pushing type of magnetic repulsion radially outward expansive force or pressure to said inner wall surface of the left ventricle.
42. The method of claim 41, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said inner wall surface of the left ventricle.
43. The method of claim 41, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said inner wall surface of the left ventricle.
44. The method of claim 41, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said inner wall surface of the left ventricle.
45. The method of claim 41, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
46. The method of claim 41, whereby said magnetic elements or magnets are rectangular or bar magnets.
47. The method of claim 41, whereby said magnetic elements or magnets are disc or edge magnets.
48. The method of claim 31, wherein said wall region of the left ventricle is outer wall surface of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said outer wall surface of the left ventricle, and potentially exerts a pulling type of said magnetic repulsion radially outward expansive force or pressure to said outer wall surface of the left ventricle.
49. The method of claim 48, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pulling type of magnetic repulsion radially outward expansive force or pressure to said outer wall surface of the left ventricle.
50. The method of claim 49, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said outer wall surface of the left ventricle.
51. The method of claim 49, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said outer wall surface of the left ventricle.
52. The method of claim 49, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said outer wall surface of the left ventricle.
53. The method of claim 49, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
54. The method of claim 49, whereby said magnetic elements or magnets are rectangular or bar magnets.
55. The method of claim 49, whereby said magnetic elements or magnets are disc or edge magnets.
56. The method of claim 31, wherein said wall region of the left ventricle is intermediate wall region of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle, and potentially exerts a pulling and pushing type of said magnetic repulsion radially outward expansive force or pressure to said intermediate wall region of the left ventricle.
57. The method of claim 56, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pulling and pushing type of magnetic repulsion radially outward expansive force or pressure to said intermediate wall region of the left ventricle.
58. The method of claim 56, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said intermediate wall region of the left ventricle.
59. The method of claim 56, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said intermediate wall region of the left ventricle.
60. The method of claim 56, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said intermediate wall region of the left ventricle.
61. The method of claim 56, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
62. The method of claim 56, whereby said magnetic elements or magnets are rectangular or bar magnets.
63. The method of claim 56, whereby said magnetic elements or magnets are disc or edge magnets.
64. An in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein said device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude; (c) allowing the heart to undergo ventricular diastole, during which said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart; and whereby said device includes at least one elastic component featuring physicochemical property and behavior of elasticity, whereby said at least one elastic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts an elastic type of said radially outward expansive force or pressure to said wall region of the left ventricle, and, whereby said device includes at least one magnetic component featuring physicochemical property and behavior of magnetic repulsion, whereby said at least one magnetic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts a magnetic repulsion type of said radially outward expansive force or pressure to said wall region of the left ventricle.
65. The method of claim 64, whereby said at least one elastic component is structurally separate from said at least one magnetic component, whereby said device functions as an additive combination of said at least one elastic component and of said at least one magnetic component for said exerting said radially outward expansive force or pressure to said at least one part of wall region of the left ventricle during ventricular diastole.
66. The method of claim 64, whereby said at least one elastic component is structurally integrated with said at least one magnetic component, whereby said device functions as an integrative combination of said at least one elastic component and of said at least one magnetic component for said exerting said radially outward expansive force or pressure to said at least one part of wall region of the left ventricle during ventricular diastole.
67. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and whereby said at least one component has variable geometry, shape, and, form, whose surfaces and volumes are characterized by at least one physical aspect or descriptor selected from the group consisting of smooth, flat, rough, ridged or bumpy, jagged, wavy, saw-toothed, bent, planar, non-planar, closed, open, completely solid featuring no cut-out or hollow pattern, incompletely solid featuring a said cut-out or hollow pattern, and, combinations thereof.
68. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, whereby said at least one component has variable geometry, shape, and, form, whose surfaces and volumes are characterized by at least one physical aspect or descriptor selected from the group consisting of smooth, flat, rough, ridged or bumpy, jagged, wavy, saw-toothed, bent, planar, non-planar, closed, open, completely solid featuring no cut-out or hollow pattern, incompletely solid featuring a said cut-out or hollow pattern, and, combinations thereof, and whereby said anchoring, adhering, and/or, attaching, component or mechanism is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material having variable geometry, shape, form, and, dimensions, whereby said anchoring, adhering, and/or, attaching, component or mechanism exhibits (i) physicochemical properties and behavior selected from the group consisting of anchoring, adhering, attaching, and, combinations thereof, and, exhibits (ii) physicochemical properties and behavior which are (1) selected from the group consisting of non-interfering, additive, and, synergistic, with said functionality of said at least one component, (2) minimally disturbing to overall functionality of the heart during a cardiac cycle, and, (3) biocompatible.
69. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and whereby said at least one component is inserted into place using a minimally invasive surgical procedure.
70. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, whereby said pre-determined magnitude is a pressure in a range of about 5 mm Hg to about 20 mm Hg.
71. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, whereby left ventricular end diastolic pressure (LVEDP) is reduced down to a range of about 6 mm Hg to about 12 mm Hg during said ventricular diastole of the heart.
72. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and whereby type of said radially outward expansive force or pressure exerted to said at least one part of wall region of the left ventricle by said at least one component is selected from the group consisting of pushing, pulling, and, pulling and pushing, whereby said pre-determined magnitude is a pressure in a range of about 5 mm Hg to about 20 mm Hg, and, whereby left ventricular end diastolic pressure (LVEDP) is reduced down to a range of about 6 mm Hg to about 12 mm Hg during said ventricular diastole of the heart.
73. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and comprising at least one elastic component featuring physicochemical property and behavior of elasticity, whereby said at least one elastic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts an elastic type of said radially outward expansive force or pressure to said wall region of the left ventricle.
74. The device of claim 73, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, exhibiting said physicochemical property and behavior of elasticity.
75. The device of claim 73, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure metal, a metal alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of elasticity.
76. The device of claim 73, whereby said at least one elastic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure metal selected from the group consisting of pure tungsten metal, pure platinum metal, and, pure titanium metal, a metal alloy selected from the group consisting of a nitinol alloy, and, a stainless steel alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of elasticity.
77. The device of claim 73, wherein said wall region of the left ventricle is outer wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said outer wall surface of the left ventricle, and potentially exerts a pulling type of said elastic radially outward expansive force or pressure to said outer wall surface of the left ventricle.
78. The device of claim 73, comprising an integral single said elastic component having geometry, shape, and, form, selected from the group consisting of at least partially cylindrical, partially annular, partially conical, fully cylindrical, fully annular, and, fully conical, relative to central longitudinal axis of said elastic component.
79. The device of claim 73, comprising an integral single said elastic component having geometry, shape, and, form, selected from the group consisting of at least partially cylindrical, partially annular, partially conical, fully cylindrical, fully annular, and, fully conical, relative to central longitudinal axis of said elastic component, with a surface incompletely solid as a cut-out or hollow pattern including a plurality of hollow cells.
80. The device of claim 73, wherein said wall region of the left ventricle is inner wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle, and potentially exerts a pushing type of said elastic radially outward expansive force or pressure to said inner wall surface of the left ventricle.
81. The device of claim 80, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions.
82. The device of claim 80, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
83. The device of claim 80, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
84. The device of claim 80, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
85. The device of claim 80, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby said elastic arms or extensions are circular or helical around central longitudinal axis of said at least one elastic lower basal section or ring formation.
86. The device of claim 80, comprising an integral single complex said elastic component featuring at least one elastic element or mechanism functioning and structured as a spring connected to a plurality of at least two ventricular wall contact elements positioned adjacent to and along said inner wall surface of the left ventricle.
87. The device of claim 73, wherein said wall region of the left ventricle is intermediate wall region of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle, and potentially exerts a pulling and pushing type of said elastic radially outward expansive force or pressure to sad intermediate wall region of the left ventricle.
88. The device of claim 87, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions.
89. The device of claim 87, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
90. The device of claim 87, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
91. The device of claim 87, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
92. The device of claim 73, wherein said wall region of the left ventricle is intermediate wall region and inner wall surface of the left ventricle, whereby said at least one elastic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle and potentially exerts a pulling and pushing type of said elastic radially outward expansive force or pressure to said intermediate wall region of the left ventricle, and, whereby said at least one elastic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle and potentially exerts a pushing type of said elastic radially outward expansive force or pressure to said inner wall surface of the left ventricle.
93. The device of claim 92, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions.
94. The device of claim 92, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions.
95. The device of claim 92, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
96. The device of claim 92, comprising an integral single said elastic component featuring a plurality of elastic arms or extensions having different geometry, shape, form, and, dimensions, longitudinally and radially extending by a variable angle from at least one elastic lower basal section or ring formation, whereby lower end regions of said elastic arms or extensions are integral and continuous with each other by way of said at least one elastic lower basal section or ring formation.
97. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart. (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and comprising at least one magnetic component featuring physicochemical property and behavior of magnetic repulsion, whereby said at least one magnetic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts a magnetic repulsion type of said radially outward expansive force or pressure to said wall region of the left ventricle.
98. The device of claim 97, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, exhibiting said physicochemical property and behavior of magnetic repulsion.
99. The device of claim 97, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure magnetic metal, a magnetic metal alloy, and, combinations thereof, exhibiting said physicochemical property and behavior of magnetic repulsion.
100. The device of claim 97, whereby said at least one magnetic component is constructed from a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material is selected from the group consisting of a pure magnetic metal selected from the group consisting of pure iron metal, pure nickel metal, and, pure cobalt metal, a magnetic metal alloy selected from the group consisting of a neodymium iron alloy, and, a samarium cobalt alloy, and, combinations thereof.
101. The device of claim 97, whereby said at least one magnetic component is enclosed inside a material selected from the group consisting of a single type of material, and, a plurality of different types of materials, said material having variable geometry, shape, form, and, dimensions, exhibiting physicochemical properties and behavior which are (1) selected from the group consisting of non-interfering, additive, and, synergistic, with said magnetic repulsion functionality of said device, (2) minimally disturbing to overall functionality of the heart during a cardiac cycle, and, (3) biocompatible.
102. The device of claim 97, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said magnetic repulsion radially outward expansive force or pressure to said wall region of the left ventricle.
103. The device of claim 102, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
104. The device of claim 102, whereby said magnetic elements or magnets are rectangular or bar magnets.
105. The device of claim 102, whereby said magnetic elements or magnets are disc or edge magnets.
106. The device of claim 97, wherein said wall region of the left ventricle is inner wall surface of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said inner wall surface of the left ventricle, and potentially exerts a pushing type of said magnetic repulsion radially outward expansive force or pressure to said inner wall surface of the left ventricle.
107. The device of claim 106, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pushing type of magnetic repulsion radially outward expansive force or pressure to said inner wall surface of the left ventricle.
108. The device of claim 107, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said inner wall surface of the left ventricle.
109. The device of claim 107, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said inner wall surface of the left ventricle.
110. The device of claim 107, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said inner wall surface of the left ventricle.
111. The device of claim 107, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
112. The device of claim 107, whereby said magnetic elements or magnets are rectangular or bar magnets.
113. The device of claim 107, whereby said magnetic elements or magnets are disc or edge magnets.
114. The device of claim 97, wherein said wall region of the left ventricle is outer wall surface of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said outer wall surface of the left ventricle, and potentially exerts a pulling type of said magnetic repulsion radially outward expansive force or pressure to said outer wall surface of the left ventricle.
115. The device of claim 114, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pulling type of magnetic repulsion radially outward expansive force or pressure to said outer wall surface of the left ventricle.
116. The device of claim 115, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said outer wall surface of the left ventricle.
117. The device of claim 115, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said outer wall surface of the left ventricle.
118. The device of claim 115, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said outer wall surface of the left ventricle.
119. The device of claim 115, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
120. The device of claim 115, whereby said magnetic elements or magnets are rectangular or bar magnets.
121. The device of claim 115, whereby said magnetic elements or magnets are disc or edge magnets.
122. The device of claim 97, wherein said wall region of the left ventricle is intermediate wall region of the left ventricle, whereby said at least one magnetic component is positioned adjacent to at least one part of said intermediate wall region of the left ventricle, and potentially exerts a pulling and pushing type of said magnetic repulsion radially outward expansive force or pressure to said intermediate wall region of the left ventricle.
123. The device of claim 122, whereby said at least one magnetic component features at least two separated bipolar magnetic elements or magnets each having two opposite magnetic poles of a north pole and a south pole, and same said poles of said at least two separated magnetic elements or magnets are positioned facing each other for generating said pulling and pushing type of magnetic repulsion radially outward expansive force or pressure to said intermediate wall region of the left ventricle.
124. The device of claim 123, whereby said magnetic elements or magnets are disposed in a same horizontal plane or row along curvature of said intermediate wall region of the left ventricle.
125. The device of claim 123, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows along curvature of said intermediate wall region of the left ventricle.
126. The device of claim 123, whereby said magnetic elements or magnets are disposed in a combination of a plurality of different horizontal planes or rows and in a combination of a plurality of different vertical planes or columns, along curvature of said intermediate wall region of the left ventricle.
127. The device of claim 123, whereby said magnetic elements or magnets are selected from the group consisting of rectangular or bar magnets, disc or edge magnets, and, combinations thereof.
128. The device of claim 123, whereby said magnetic elements or magnets are rectangular or bar magnets.
129. The device of claim 123, whereby said magnetic elements or magnets are disc or edge magnets.
130. An in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) said device is operatively connected in a rest condition to the left ventricle of the heart, (b) said potential radially outward expansive force or pressure of said at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, (c) said pre-determined magnitude of said potential radially outward expansive force or pressure of said at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to said wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during said ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart, and comprising (i) at least one elastic component featuring physicochemical property and behavior of elasticity, whereby said at least one elastic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts an elastic type of said radially outward expansive force or pressure to said wall region of the left ventricle, and, (ii) at least one magnetic component featuring physicochemical property and behavior of magnetic repulsion, whereby said at least one magnetic component is positioned adjacent to said at least one part of wall region of the left ventricle and potentially exerts a magnetic repulsion type of said radially outward expansive force or pressure to said wall region of the left ventricle.
131. The device of claim 130, whereby said at least one elastic component is structurally separate from said at least one magnetic component, whereby said device functions as an additive combination of said at least one elastic component and of said at least one magnetic component for said exerting said radially outward expansive force or pressure to said at least one part of wall region of the left ventricle during ventricular diastole.
132. The device of claim 130, whereby said at least one elastic component is structurally integrated with said at least one magnetic component, whereby said device functions as an integrative combination of said at least one elastic component and of said at least one magnetic component for said exerting said radially outward expansive force or pressure to said at least one part of wall region of the left ventricle during ventricular diastole.
133. An anatomically-compatible and physiologically-compatible in vivo device for improving diastolic function of either the left or right ventricle of the heart, comprising: at least one elastic component that is capable of being operatively connected to the external surface of the left or right ventricle of the heart by means of one or more connecting elements, wherein said at least one elastic component comprises a plurality of essentially longitudinal members which are arranged such that the lateral separation between adjacent longitudinal members may be increased or decreased in response to elastic deformation of said elastic component, and wherein said essentially longitudinal members are arranged relative to each other such that said elastic component is curved in both the vertical and horizontal planes, such that the inner surface of said elastic component may be adapted to the curvature of the external ventricular surface of the heart, or a portion thereof, such that said at least one elastic component is capable of exerting both a radially outward expansive force and a tangentially-directed force on the external surface of the left ventricular wall to which said component may be connected by means of said one or more connecting elements.
134. The device according to claim 133, wherein the elastic component comprises a plurality of elongated members, each of said elongated members having one end connected to, and continuous with, a base element, said base element being of a size and shape such that it is capable of either fully or partially encircling the apical region of the heart, and wherein said elongated members are arranged such that they are capable of being disposed in an essentially longitudinal manner along the external ventricular surface of the heart, such that free ends of said elongated members are directed towards the base of the heart.
135. The device according to claim 134, wherein the base element is provided in an annular shape.
136. The device according to claim 133, wherein the elastic component comprises a wire spring, wherein said wire spring is bent such that it contains one or more angled portions, each angled portion comprising either an inferiorly-directed or a superiorly-directed apex that is formed at the junction of two essentially-longitudinally disposed lengths, and wherein said spring is capable of being connected to the external ventricular surface of the heart in an essentially horizontal orientation.
137. The device according to claim 133, wherein said device comprises two or more elastic components.
138. The device according to claim 137, wherein each elastic component comprises a wire spring, wherein said wire spring is bent such that it contains one or more angled portions, each angled portion comprising either an inferiorly-directed or a superiorly-directed apex that is formed at the junction of two essentially-longitudinally disposed lengths, and wherein said spring is capable of being connected to the external ventricular surface of the heart in an essentially horizontal orientation.
139. The device according to claim 137, wherein each elastic component comprises an elastic component including a plurality of elongated members, each of said elongated members having one end connected to, and continuous with, a base element, said base element being of a size and shape such that it is capable of either fully or partially encircling the apical region of the heart, and wherein said elongated members are arranged such that they are capable of being disposed in an essentially longitudinal manner along the external ventricular surface of the heart, such that free ends of said elongated members are directed towards the base of the heart.
140. The device according to claim 133, wherein the at least one elastic component is constructed from a material selected from the group consisting of tungsten, platinum, titanium, nitinol alloy, stainless steel alloy, and, combinations thereof.
141. The device according to claim 133, wherein the maximal value of the radially outward expansive pressure exerted on said at least one part of wall region of the ventricle is in a range of about 5 mm Hg to about 40 mm Hg.
142. A connecting element for use in connecting the device according to claim 133 to the external ventricular surface of the heart, wherein said element is a girdle in the form of a thin fabric patch, extending from the lateral borders of which is a plurality of tabs arranged in contralateral pairs, wherein each tab is capable of being joined to its contralateral partner, thereby forming a loop into which may be inserted a portion of the device which is to be connected to said organ or tissue.
143. A connecting element for use in connecting the device according to claim 133 to the external ventricular surface of the heart, wherein said element is provided in the form of a transmural or intramural anchor.
144. A connecting element for use in connecting the device according to claim 133 to the external ventricular surface of the heart, wherein said element is provided in the form of a tube constructed of a biocompatible material.
145. The connecting element according to claim 144, wherein the biocompatible material is Dacron™.
146. The connecting element according to claim 144, wherein the biocompatible material is polytetrafluorethylene (PTFE).
147. Connecting elements for use in connecting the device according to claim 133 to the external ventricular surface of the heart, wherein said elements are provided in a form selected from the group consisting of biocompatible pins, biocompatible needles, biocompatible spikes, biocompatible screws, biocompatible clamps, biocompatible glue, surgical sutures, and, combinations thereof.
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to methods and devices for improving ventricular function of the heart and, more particularly, to an in-vivo method and device for improving diastolic function of the left ventricle of the heart.
Heart failure is commonly defined as the inability of the left ventricle, herein, also referred to as LV, to generate an adequate cardiac output at rest or during exertion, while operating at a normal or enhanced LV filling pressure. Congestive heart failure (CHF) is a clinical syndrome in which heart failure is accompanied by the symptoms and signs of pulmonary and/or peripheral congestion. Heart failure is most commonly associated with impaired LV systolic function. A widely used index for quantifying systolic function is ‘ejection fraction’ (EF), defined as the ratio of stroke volume to end-diastolic volume, which can be estimated using techniques such as radiocontrast, radionuclide angiography, and/or, echocardiography. The normal value of EF is 0.67±0.08, which is frequently depressed in systolic heart failure even when the stroke volume is normal. A value of EF≧0.50 is commonly used as an indicator of normal systolic function. It is notable, however, that as much as 30–50% of all patients with typical symptoms of congestive heart failure have a normal or slightly reduced ejection fraction, that is, a value of EF≧0.45.
In these patients, diastolic dysfunction is implicated as a major contributor of congestive heart failure. In some patients, systolic and diastolic heart failure coexist. The most common form of heart failure, the one caused by coronary arteriosclerosis, is an example of combined systolic and diastolic failure, as described in “Braunwald's Heart Disease: Review and Assessment”, third edition, 1997, Saunders Company Publishers. There are about 4.6 million people in the United States with heart failure, and about 550,000 are being reported annually, as indicated by Vasan, R. S., and Benjamin, E. J., in “Diastolic Heart Failure—No Time To Relax”, New England Journal of Medicine 2001, 344: 56–59. Also indicated therein, is that the mortality rate from diastolic heart failure (DHF), 5–12% annually, is about four times that among persons without heart failure and half that among patients with systolic heart failure, and that, nonetheless, rates of hospitalization and health care associated with diastolic heart failure rival those associated with systolic heart failure.
Primary diastolic dysfunction is typically observed in patients with hypertension and hypertrophic or restrictive cardiomyopathy, but can also occur in a variety of other clinical disorders and has a particularly high prevalence in the elderly population. Aging is associated with ‘physiologic’ diastolic dysfunction due to the increase in LV muscle mass and changes in passive elastic properties of the myocardium, hence, the concern of an increase in the incidence of diastolic dysfunction as the aging of the western world population progresses.
For the purpose of clearly understanding, and implementing, the following described preferred embodiments of the present invention, relevant details, description, and, definitions of selected terms, well known to one of ordinary skill in the art, of physiological and pathological aspects, mechanisms, and functions, of the heart, in general, and of the ventricles and atria, in particular, are provided herein. Additional details, description, and, definitions of terms, thereof, are readily available in the scientific literature.
The left ventricle is the chamber on the left side of the heart that receives oxygenated arterial blood from the left atrium and contracts to drive it into the aorta for distribution to the body. The right ventricle is the chamber on the right side of the heart that receives deoxygenated venous blood from the right atrium and drives it into the pulmonary artery in order to receive oxygen from the lungs. Diastole is the normal rhythmically occurring relaxation and dilatation (stretching, expansion, dilation) of the heart cavities (ventricles), during which the cavities are filled with blood. Atrial contraction occurs during the last stage of diastole of the ventricle and aids ventricular filling. Systole is the rhythmic contraction of the heart, especially of the ventricles, by which blood is driven through the aorta and pulmonary artery after each dilation or diastole.
Ventricular filling starts just after mitral valve opening. As the LV pressure decreases below that in the left atrium, the phase of rapid or early filling of the LV accounts for most of ventricular filling. LV filling temporarily stops as pressure in the atrium and left ventricle equalize, commonly known as the phase of diastasis, occurring prior to atrial contraction and during which little blood enters the filled left ventricle. Atrial contraction increases the pressure gradient from the atrium to the left ventricle to renew filling. When the LV fails to relax normally, as in ‘LV hypertrophy’, increased atrial contraction can enhance late filling. Relaxation (inactivation of contraction) is a dynamic process that begins at the termination of contraction and occurs during isovolumetric relaxation and early ventricular filling. ‘Myocardial elasticity’ is the change in muscle length for a given change in force. ‘Ventricular compliance’ is the change in ventricular volume for a given change in pressure, and, ‘ventricular stiffness’ is the inverse of compliance.
The ‘preload’ is the load present before contraction has started and is provided by the venous return that fills the ventricle during diastole. The ‘Frank Starling law of the heart’ states that the larger the volume of the heart, the greater the energy of its contraction and hence the stroke volume is larger. In other words, when the preload increases, the left ventricle distends (widens, expands) and the stroke volume increases, as described by Opie, H. L., in “The Heart Physiology, From Cell To Circulation”, third edition, Lippincott-Raven publishers, 1998. The pressure-volume relation curves are an accepted description of the ventricular function.
FIG. 1, adapted from the previously cited “Braunwald's Heart Disease: Review and Assessment” reference, is a schematic diagram illustrating a typical pressure-volume loop of a normal subject (dotted line) and a patient with diastolic dysfunction (solid line), wherein dashed lines, between the letters ‘a’ and ‘b’, and, ‘c’ and ‘d’, represent the diastolic pressure-volume relation of the normal subject, and, the patient with diastolic dysfunction, respectively. FIG. 1 shows that isolated diastolic dysfunction is characterized by a shift in the pressure-volume loop to the left. Contractile performance is normal, associated with an ejection fraction (EF) value ≧0.45, with a normal or slightly decreased stroke volume. However, LV (left ventricular) pressures throughout diastole are increased, at a common diastolic volume equal to about 70 ml/m 2 . In the patient with diastolic failure, LV end diastolic pressure is about 25 mm Hg, compared with an LV end diastolic pressure of about 5 mm Hg in the normal subject. Thus, diastolic dysfunction increases the modulus of chamber stiffness. A main objective of treating the patient with diastolic dysfunction is to cause the diastolic pressure-volume relation curve (dashed line between ‘c’ and ‘d’) to go back to the diastolic pressure-volume relation curve (dashed line between ‘a’ and ‘b’, also indicated by the arrow), of the normal subject, by decreasing the end diastolic LV pressure for the same LV volume.
The fundamental problem in diastolic heart failure (DHF) is the inability of the left ventricle to accommodate blood volume during diastole at low filling pressures, as described by Mandinov, L., Eberli, F. R., Seiler, C., and Hess, M. O., in “Diastolic Heart Failure”, Cardiovacular Res. 2000, 45: 813–825. Initially, hemodynamic changes may be manifested only in an upward displacement of the diastolic pressure-volume curve in the presence of a normal end-diastolic volume with inappropriate elevation of LV diastolic, left atrial and pulmonocapillary pressure (as previously described above, with reference to FIG. 1). More severe resistance to LV filling may cause inadequate filling even in enhanced diastolic pressure with an additional leftward shift of the diastolic pressure-volume relation, resulting in a decreased end diastolic volume and depressed stroke volume, as described by Mandinov, L., et al.
Currently, four different pathophysiological mechanisms are known and used for understanding and/or explaining diastolic heart failure (DHF), combinations of which may readily take place in a particular patient: (1) slow isovolumic left ventricular relaxation, (2) slow early left ventricular filling, (3) reduced left ventricular diastolic distensibility, and, (4) increased left ventricular chamber stiffness or increased myocardial muscle stiffness, as described in the report, “How To Diagnose Diastolic Heart Failure: European Study Group On Diastolic Heart Failure”, European Heart Journal, 1998, 19: 990–1003.
Slow isovolumic left ventricular relaxation, (1), refers to a longer time interval between aortic valve closure and mitral valve opening and a lower negative peak ventricular dP/dt. Regional variation in the onset, rate, and extent of myocardial lengthening is referred to as ‘diastolic asynergy’; temporal dispersion of relaxation, with some fibers commencing to lengthen later than others, is referred to as ‘asynchrony’. Slow early left ventricular filling, (2), is a result of slow myocardial relaxation, segmental incoordination related to coronary artery disease and the atrioventricular pressure gradient. Reduced left ventricular diastolic distensibility, (3), refers to an upward shift of the LV pressure-volume relation on the pressure-volume plot, irrespective of a simultaneous change in slope. Reduction in LV end diastolic distensibility is usually caused by extrinsic compression of the ventricles as in cardiac tamponade. Increased LV chamber stiffness or increased myocardial muscle stiffness, (4), as manifested by a shift to a steeper ventricular pressure-volume curve, is due to processes such as ventricular hypertrophy, endomyocardial fibrosis, disorders with myocardial infiltration (for example, amyloidosis) and replacement of normal, distensible myocardium with non-distensible fibrous scar tissue in healed infarct zones.
The previously cited European Study Group proposed criteria for the diagnosis of DHF. Accordingly, simultaneous presence of the following three criteria is considered obligatory for establishing a diagnosis of DHF: (1) evidence of CHF, (2) normal or mildly abnormal LV systolic function, (3) evidence of abnormal LV relaxation, filling, diastolic distensibility, or, diastolic stiffness.
Pulmonary edema is the result of the increase in pulmocapillary pressure and is due to a shift of liquid from the intravascular compartment to the lung interstitial compartment. Pulmonary edema is frequently associated with hypertension. Gandhi, S. K. et al., in “The Pathogenesis Of Acute Pulmonary Edema Associated With Hypertension”, New England Journal of Medicine, 2001, 344: 17–22, have contradicted the hypothesis that pulmonary edema, apparently associated with hypertension, in patients with preserved ejection fraction, is due to transient systolic dysfunction. They found that the LV ejection fraction and the extent of regional wall motion measured during the acute episode of hypertensive pulmonary edema were similar to those measured after the resolution of the congestion, when the blood pressure was controlled, thus concluding that the pulmonary edema was due to diastolic rather than systolic heart failure.
The management of diastolic heart failure is difficult. There have been no large-scale, randomized controlled trials of therapy in diastolic heart failure, and there remains substantial disagreement about the appropriate therapy for this disease, according to Sweitzer, N. K., and Stevenson, L. W., in “Diastolic heart Failure: Miles To Go Before We Sleep”, American Journal of Medicine, 2000, 109: 683–685. Medical therapy of diastolic dysfunction is often empirical and lacks clear-cut pathophysiologic concepts, as indicated in previously cited Mandinov, L. et al. No single drug presently exists which selectively enhances myocardial relaxation without negative effects on LV contractility or pump function, and thus, there is a significant need for a new therapeutic approach for this particular type of heart disease.
Treatment of diastolic heart failure may be logically divided into three areas or categories: (1) removal of the precipitating cause, (2) correction of the underlying cause, and, (3) control of the congestive heart failure state. Treatment goals that have been advocated, by previously cited Mandinov, L. et al., and, by Braunwald, E., in “Heart Failure”, Harrison's Principles of Internal Medicine, fourteenth edition, McGraw Hill publishers, are as follows:
1. Reduction of central blood volume. Reduction of salt intake and use of diuretics (usually, loop diuretics). Diuretics are effective in reducing pulmonary congestion, shifting the pressure-volume relation downwards. However, they must be used with care because the volume sensitivity of patients with diastolic dysfunction bears the risk that excessive diuresis may result in a sudden drop in stroke volume. Because of the steep pressure-volume relationship, a small decrease in diastolic volume will cause a large decrease of the filling pressure, and will result in a drop in stroke volume, and thus, in cardiac output.
2. Reduction of workload. Reduction of physical activity, maintenance of emotional rest and use of vasodilators. Vasodilators, such as sodium nitroprusside or ACE inhibitors reduce the filling pressure and the afterload in all patients, and elevate cardiac output. Reduction of an elevated left ventricular end diastolic pressure may improve subendocardial perfusion, thus improving myocardial contraction. Nonetheless, vasodilators have not been useful in the management of isolated diastolic heart failure and are more effective in combined heart failure, as indicated in the previously cited Braunwald, E. text. Vigorous control of hypertension is imperative in patients with heart failure caused by diastolic dysfunction, because control of hypertension may prevent progression or partially reverse the disorder by addressing the primary cause of most cases, as described by Grauner, K., in “Heart Failure, Diastolic Dysfunction And The Role Of The Family Physician”, American Family Physician, 2001, 63: 1483–1486.
3. Improvement of LV relaxation. In particular, by using calcium channel blockers or ACE inhibitors. Ca 2+ channel blockers have been shown to improve myocardial relaxation and enhance diastolic filling. These drugs may be best matched to the pathophysiology of relaxation disturbances due to their ability to decrease cytoplasmic calcium concentration and reduce afterload. However, currently, use of Ca 2+ channel blockers is limited due to their negative inotropic effects (negative influence on the systolic function of the heart), and clinical trials have not clearly proven them to be beneficial.
4. Regression of LV hypertrophy. In particular, decrease in wall thickness and removal of excess collagen by ACE inhibitors and AT-2 antagonists or Spironolactone. Philbin, E. F., Rocco, T. A., Lindenmuth, N. W., Ulrich, K., and Jenkins, O. L., in “Systolic Versus Diastolic Heart Failure In Community Practice: Clinical Features, Outcomes, And The Use Of ACE Inhibitors”, American Journal of Medicine, 2000, 109: 605–613, have shown that the use of ACE inhibitors in patients with ejection fraction equal to or greater than 0.50 was associated with a better NYHA class (New York Heart Association functional and therapeutic classification for stages of heart failure) after discharge from hospitalization, but had no significant effect on mortality or hospital readmission. ACE inhibitors and AT-2 antagonists effect blood pressure, reduce afterload, and effect the myocardium via the local renin-angiotensin system. These effects are important for regression of LV hypertrophy, and improvement of elastic properties of the myocardium.
5. Maintenance of atrial contraction and control of heart rate. In particular, by using beta-blockers and/or antiarrhythmics. Beta-blockers reduce blood pressure and myocardial hypertrophy. The positive effect on diastolic dysfunction is mainly due to slowing of the heart rate and not to a primary improvement in isovolumic relaxation or the diastolic properties of the left ventricle.
6. NO donors. NO (Nitric Oxide) donors have been shown to exert a relaxant effect on the myocardium, which is associated with a decrease in LV end diastolic pressure. In patients with severe LV hypertrophy, an increased susceptibility to NO donors has been documented, which may be beneficial for the prevention of diastolic dysfunction.
7. Heart transplantation. Heart transplantation is a definitive treatment for end stage heart failure.
8. Biventricular pacing. Biventricular pacing improves uncoordinated contraction due to left bundle branch block or other conduction abnormalities with wide ‘QRS complex’ (P-Q-R-S-T waveform) of an electrocardiogram, which are common in patients with CHF. Morris-Thurgood, J. A., Turner, M. S., Nightingale, A. K., Masani, N., Mumford, C., and, Frenneaux, M. P., in “Pacing In Heart Failure: Improved Ventricular Interaction In Diastole Rather Than Systolic Re-synchronization”, Europace 2000, 2: 271–275, have shown that left ventricular pacing acutely benefits congestive heart failure patients with pulmonary capillary wedge pressure greater than 15 mm Hg, irrespective of left bundle branch block. They suggested the beneficial mechanism might be related to an improvement of ventricular interaction in diastole (VID) rather than ventricular systolic re-synchronization. According to their suggestion, LV pacing in patients with high LV end diastolic pressure, will delay right ventricular filling and allow greater LV filling before the onset of VID. Biventricular pacing, however, has not been clinically proven effective in the treatment of patients with diastolic heart failure.
To one of ordinary skill in the art, there is thus a need for, and it would be highly advantageous to have an in-vivo method and device for improving diastolic function of the left ventricle of the heart, while minimally disturbing systolic function of the heart. Moreover, there is a need for such a method and device which is biocompatible and is specially configured for compact and long-term reliable use in humans.
SUMMARY OF THE INVENTION
The present invention relates to an in-vivo method and device for improving diastolic function of the left ventricle of the heart.
Thus, according to the present invention, there is provided an in-vivo method for improving diastolic function of the left ventricle of the heart, comprising the steps of: (a) operatively connecting a device in a rest condition to the left ventricle of the heart, wherein the device includes at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole; (b) allowing the heart to undergo ventricular systole, during which the potential radially outward expansive force or pressure of the at least one component dynamically increases to a pre-determined magnitude; and (c) allowing the heart to undergo ventricular diastole, during which the pre-determined magnitude of the potential radially outward expansive force or pressure of the at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to the wall region of the left ventricle, for reducing intracardiac hydrostatic pressure during the ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart.
According to another aspect of the present invention, there is provided an in-vivo device for improving diastolic function of the left ventricle of the heart, comprising: at least one component featuring physicochemical property and behavior for potentially exerting a radially outward expansive force or pressure to at least one part of wall region of the left ventricle during ventricular diastole, whereby: (a) the device is operatively connected in a rest condition to the left ventricle of the heart, (b) the potential radially outward expansive force or pressure of the at least one component dynamically increases to a pre-determined magnitude during ventricular systole of the heart, and (c) the pre-determined magnitude of the potential radially outward expansive force or pressure of the at least one component is dynamically converted into a corresponding kinetic radially outward expansive force or pressure applied to the wall region of the left ventricle during ventricular diastole of the heart, for reducing intracardiac hydrostatic pressure during the ventricular diastole, thereby, improving the diastolic function of the left ventricle of the heart.
The present invention successfully addresses and at the least, minimizes, and, ideally, eliminates, symptoms of diastolic heart failure. The present invention overcomes shortcomings, inadequacies, and, limitations, of currently known and employed techniques for treating diastolic heart failure, by providing an effective, efficient, and, reliable, in-vivo method and device for improving diastolic function of the left ventricle of the heart, while minimally disturbing systolic function of the heart. Moreover, in addition to the present invention primarily applied for treating subjects having symptoms of diastolic heart failure, by reducing intraluminal hydrostatic pressure (LV filling pressure) of the left ventricle during the ventricular diastolic stage of the cardiac cycle, thereby, improving diastolic function of the left ventricle of the heart, while minimally disturbing systolic function of the heart, the present invention can be used in a variety of other cardiac related and/or non-related monitoring applications, such as pressure measurement applications, and, therapeutic applications, such as in drug delivery applications. For example, the method and device of the present invention can be implemented with inclusion and appropriate integration of a procedure and apparatus for time controlled drug delivery or release to the body, in general, and, to the cardiac region, in particular.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
In the drawings:
FIG. 1 is a schematic diagram illustrating a typical pressure-volume loop of a normal subject and a patient with diastolic dysfunction;
FIGS. 2A and 2B are schematic diagrams illustrating a two-dimensional planar view, and, a perspective view, respectively, of a first general type of exemplary ventricular device for implementing specific case (a) of the first principle preferred embodiment of the method, of positioning the at least one elastic component of the ventricular device adjacent to the inner wall surface of the left ventricle, in accordance with the present invention;
FIG. 3A is a schemat