ANISOTROPIC REINFORCEMENT AND RELATED METHOD THEREOF

• US 20120029266A1
• Filed: 04/02/2010
• Published: 02/02/2012
• Est. Priority Date: 04/06/2009
• Status: Abandoned Application

• Current Assignee: University of Virginia
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Holmes, Jeffrey W., Ailawadi, Gorav, Fomovsky, Gregory M.
• Application Number:
  US13/263,170
• Publication Number:
  US 20120029266A1
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations

Abstract

Anisotropic reinforcements and synthetic materials are provided in which the fibers, mesh, weave, or otherwise interlaced or networked components thereof are oriented in one direction so as to create greater stiffness in the one direction of the patch relative to other directions of the reinforcement. Methods of producing such anisotropic reinforcements are provided. The anisotropic reinforcements are advantageously suitable for the surgical repair of incisions, openings, defects, etc. of the cardiovascular system and allow healing to occur while preserving mechanical function, particularly ventricular function.

Claims

1. A reinforcement for communication with the heart, wherein said reinforcement is configured to create stiffness in one direction relative to other directions of said reinforcement, for reinforcing a region of the heart for improving heart function.

2. The reinforcement of claim 1, wherein said configuration is achieved by an attachment technique of said reinforcement to the heart.

3. The reinforcement of claim 1, wherein said configuration is provided whereby said reinforcement has said configuration prior to said reinforcement attached to said heart.

4. The reinforcement of claim 1, wherein said configuration is provided by both of:

an attachment technique of said reinforcement to the heart; and

as said configuration is provided prior to the attachment technique to the heart.

5. The reinforcement of claim 1, wherein said heart function comprises pump function.

6. The reinforcement of claim 1, wherein said heart function comprises at least one of the following:

systolic function or contraction of the heart.

7. The reinforcement of claim 1, wherein said improving heart function comprises resisting longitudinal stretching of the region of the heart.

8. The reinforcement of claim 7, wherein said resisting longitudinal stretching of the region of the heart occurs during myocardial contractions.

9. The reinforcement of claim 7, wherein said improving heart function further comprises allowing normal circumferential and radial deformation of the region of the heart.

10. The reinforcement of claim 1, wherein said improving heart function comprises resisting circumferential stretching of the region of the heart.

11. The reinforcement of claim 10, wherein said resisting circumferential stretching of the region of the heart occurs during myocardial contractions.

12. The reinforcement of claim 10, wherein said improving heart function further comprises allowing normal longitudinal and radial deformation of the region of the heart.

13. The reinforcement of claim 1, wherein said heart function comprises at least one of the following:

cardiac output, ejection fraction, volumes, stroke volume, pressures, end-diastolic volume (EDV), end-systolic volume (ESV), energetics, energetic efficiency, and need for inotropic support.

14. The reinforcement of claim 1, wherein said region of the heart comprises at least one of the following:

at least a portion of a wall, at least a portion of an ischemic, at least a portion of an infarct, at least a portion of an epicardial surface, and at least a portion of an inner surface.

15. The reinforcement of claim 1, wherein said communication comprises at least one of:

adhesion, attachment, or suture.

16. The reinforcement of claim 1, wherein said reinforcement comprises at least one of:

graft, patch, member, local-reinforcement, substrate, material, wire, local-reinforcing member, members applied to the heart, members into the heart, support, brace, buttress, coating, augmentation, and fortification.

17. The reinforcement of claim 1, wherein said reinforcement comprises a patch with at least substantially parallel slit apertures or elongated apertures in said patch to decrease stiffness of the patch in the direction at least substantially perpendicular to said slit apertures or elongated apertures.

18. The reinforcement of claim 1, wherein said reinforcement provides flexibility in the one direction at least substantially perpendicular to the stiffness.

19. The reinforcement of claim 1, wherein said reinforcement comprises fibers oriented in the one direction of said reinforcement to create stiffness in the one direction relative to fibers other directions of said reinforcement.

20. The reinforcement of claim 19 wherein said fibers oriented in the one direction of said reinforcement comprise a plurality of fibers relative to said fibers in the other directions of said reinforcement.

21. The reinforcement of claim 19, wherein said fibers in the one direction of said reinforcement are oriented in at least a substantially straight line relative to randomly or stochasticly placed fibers in other directions of said reinforcement.

22. The reinforcement of claim 19, wherein said fibers in the one direction of said reinforcement are tight relative to fibers in other directions of said reinforcement.

23. The reinforcement of claim 19, wherein the fibers in the one direction of said reinforcement arc less slack relative to fibers in other directions of said reinforcement.

24. The reinforcement of claim 19, wherein pores or apertures within the fibers in the one direction of said reinforcement are in closer proximity to each other than pores or apertures within said fibers in other directions of said reinforcement.

25. The reinforcement of claim 19, wherein said fibers oriented in the one direction of said reinforcement are denser relative to said fibers in other directions of said reinforcement.

26. The reinforcement of claim 19, wherein said fibers oriented in the one direction of said reinforcement are locally-reinforced in the one direction relative to said fibers in other directions of said reinforcement.

27. The reinforcement of claim 26, wherein said fiber local-reinforcement comprises at least one of:

additional fibers, natural fibers, synthetic fibers, mesh, collagen fibers, metals, wires, cloth, biocompatible metals, or a combination thereof.

28. The reinforcement of claim 27, wherein said biocompatible metals may comprise at least one of:

stainless steel, titanium, metal alloys, or a combination thereof.

29. The reinforcement of claim 28, wherein the metal alloys may comprise at least one of:

In—

Ti, Fe—

Mn, Ni—

Ti, Ag—

Cd, Au—

Cd, Au—

Cu, Cu—

Al—

Ni, Cu—

Au—

Zn, Cu—

Zn, Cu—

Zn—

Al, Cu—

Zn—

Sn, Cu—

Zn—

Xe, Fe₃Be—

Fe₃Pt, Ni—

Ti—

V, Fe—

Ni—

Ti—

Co, Cu—

Sn or a combination thereof.

30. The reinforcement of claim 1, wherein said reinforcement comprises a synthetic material.

31. The reinforcement of claim 30, wherein said synthetic material may comprise at least one of tantalum gauze, stainless steel mesh, DACRON, ORLON, FORTISAN, nylon, knitted polypropylene (MARLEX), microporous expanded-polytetrafluoroethylene (GORE-TEX), Dacron-reinforced silicone rubber (SILASTIC), polyglactin 910 (VICRYL), polyester (MERSILENE), polyglycolic acid (DEXON), or a combination thereof.

32. The reinforcement of claim 1, wherein said stiffness of said reinforcement is configured to be aligned in a substantially longitudinal direction of the heart.

33. The reinforcement of claim 1, wherein said stiffness of said reinforcement is configured to be aligned in a substantially circumferential direction of the heart.

34. The reinforcement of claim 1, wherein said stiffness of said reinforcement is configured to be at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

35. The reinforcement of claim 1, wherein said stiffness of said reinforcement is configured to be aligned at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

36. The reinforcement of claim 1, wherein said stiffness of said reinforcement is configured to be aligned with the direction of greatest stretching of the region of the heart.

37. The reinforcement of claim 1, wherein said reinforcement comprises fibers aligned in at least a substantially single direction for increased stiffness of said reinforcement in the direction of fiber alignment relative to directions of fiber nonalignment.

38. The reinforcement of claim 37, wherein the fibers are aligned longitudinally in said at least substantially single direction in said reinforcement to result in increased stiffness in the longitudinal direction.

39. The reinforcement of claim 37, wherein said fibers are aligned in said at least substantially single direction is along said reinforcement'"'"'s longitudinal axis.

40. The reinforcement of claim 37, wherein said fibers aligned in said at least substantially single direction are a larger size relative to the size of said fibers in other directions of said reinforcement.

41. The reinforcement of claim 37, wherein said fibers aligned in said at least substantially single direction are locally-reinforced in said at least substantially single direction relative to said fibers in other directions of said reinforcement.

42. The reinforcement of claim 1, wherein said reinforcement comprises interwoven fibers, wherein a plurality of said interwoven fibers are oriented at least substantially in a single direction within said reinforcement to produce increased stiffness in said at least substantially single direction relative to other directions.

43. The reinforcement of claim 42, wherein said other directions include at least substantially perpendicular, transverse or diagonal thereto.

44. The reinforcement of claim 42, wherein the plurality of fibers are oriented in the longitudinal direction of said reinforcement relative to fibers in the substantially circumferential, radial, perpendicular, or diagonal directions of said reinforcement.

45. The reinforcement of claim 42, wherein the plurality of fibers are the same number and/or material as the fibers comprising said reinforcement.

46. The reinforcement of claim 42, wherein the plurality of fibers are different in number and/or material from the fibers comprising said reinforcement.

47. The reinforcement of claim 1, wherein said reinforcement comprises strips of a stiffer material relative to at least some non-strip areas, wherein said strips are configured for attachment to the region of the heart such that the longitudinal axis of said strips are oriented in a direction desirable for reinforcing the heart.

48. The reinforcement of claim 47, wherein said strips are integrally connected and/or separate from one another.

49. The reinforcement of claim 47, wherein said stiff material comprises cardiovascular fabrics.

50. The reinforcement of claim 47, wherein said longitudinal axis of said strips are configured to be aligned in a substantially longitudinal direction of the heart.

51. The reinforcement of claim 47, wherein said longitudinal axis of said strips are configured to be aligned in a substantially circumferential direction of the heart.

52. The reinforcement of claim 47, wherein said longitudinal axis of said strips are configured to be at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

53. The reinforcement of claim 47, wherein said longitudinal axis of said strips are configured to be aligned at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

54. The reinforcement of claim 1, wherein at least a portion of said reinforcement is stiff relative to other portions of said reinforcement to create at least one stiff regions substantially in one direction of said reinforcement.

55. The reinforcement of claim 54, wherein said reinforcement is anisotropic.

56. The reinforcement of claim 54, wherein said at least one relative stiff portion is tight relative to other regions of reinforcement.

57. The reinforcement of claim 54, wherein said at least one relative stiff portion is less slack relative to said other portions of said reinforcement.

58. The reinforcement of claim 54, wherein said at least one relative stiff portion is denser relative to said other portions of said reinforcement.

59. The anisotropic reinforcement of claim 54, wherein said at least one relative stiff portion is further locally-reinforced relative to said other portions of said reinforcement.

60. The anisotropic reinforcement of claim 59, wherein said local reinforcement comprises at least one of:

fibers, additional fibers, natural fibers, synthetic fibers, mesh, collagen fibers, metals, cloth, wires, fabric, braid, or biocompatible metals.

61. The reinforcement of claim 60, wherein the biocompatible metals may comprise at least one of stainless steel, titanium, metal alloys, or a combination thereof.

62. The reinforcement of claim 61, wherein the metal alloys may comprise at least one of In—

Ti, Fe—

Mn, Ni—

Ti, Ag—

Cd, Au—

Cd, Au—

Cu, Cu—

Al—

Ni, Cu—

Au—

Zn, Cu—

Zn, Cu—

Zn—

Al, Cu—

Zn—

Sn, Cu—

Zn—

Xe, Fe₃Be, Fe₃Pt, Ni—

Ti—

V, Fe—

Ni—

Ti—

Co, Cu—

Sn or a combination thereof.

63. The reinforcement of claim 54, wherein said at least one relatively stiff portion is aligned longitudinally in at least a substantially single direction in said reinforcement to result in increased stiffness in the longitudinal direction of said reinforcement.

64. The reinforcement of claim 54, wherein at least one relatively stiff portion is aligned in at least a substantially single direction along said reinforcement'"'"'s longitudinal axis, relative to the said other portions of said reinforcement.

65. The reinforcement of claim 64, wherein said other portions include at least substantially perpendicular, transverse or diagonal regions of said reinforcement.

66. The reinforcement of claim 54, wherein at least one relatively stiff portion is oriented in the longitudinal direction of said reinforcement relative to regions in the substantially circumferential, radial, perpendicular, or diagonal directions of said reinforcement.

67. The anisotropic reinforcement of claim 54, wherein said reinforcement provides flexibility in a direction at least substantially perpendicular to said at least one relatively stiff portions.

68. The reinforcement of claim 1, wherein said reinforcement is chemically treated to create anisotropy.

69. The reinforcement of claim 1, wherein said reinforcement is mechanically treated to create anisotropy.

70. The reinforcement of claim 69, wherein mechanical treatment comprises at least one of:

grinding, finishing, abrading, inflating, shrinking, directionally-specific shrinking, inducing tension, slacking, coating, and expanding.

71. The reinforcement of claim 1, wherein said reinforcement comprises a material comprising at least one of:

shape memory material or structure, pre-stressed material or structure, recoil material or structure, active recoil material or structure, pre-shaped material or structure, or a combination thereof.

72. The reinforcement of claim 71, wherein said shape memory material is nitinol

73. The reinforcement of claim 1, wherein fibers oriented in one direction of said reinforcement are distributed over a smaller range of angles to produce stiffness in a direction, relative to other directions have fibers distributed over a larger range of angles.

74. The reinforcement of claim 1, wherein said reinforcement comprises smaller alignment angles in one direction of said reinforcement to produce stiffness in the one direction relative to fibers having larger angles of alignment.

75. The reinforcement of claim 74, wherein the stiffness in the one direction of said reinforcement comprises fibers oriented having the alignment angles within about 10 degrees to less than about 90 degrees relative to the local circumferential axis of said reinforcement.

76. The reinforcement of claim 74, wherein the stiffness in the one direction of said reinforcement comprises fibers oriented having the alignment angles within about 20 degrees to about 70 degrees relative to the local circumferential axis of said reinforcement.

77. The reinforcement of claim 74, wherein the stiffness in the one direction of said reinforcement comprises fibers oriented having the alignment angles within about 25 degrees to about 50 degrees relative to the local circumferential axis of said reinforcement.

78. The reinforcement of claim 74, wherein the stiffness in the one direction of said reinforcement comprises fibers oriented having the alignment angles within about 30 degrees to about 45 degrees relative to the local circumferential axis of said reinforcement.

79. The reinforcement of claim 1, wherein said reinforcement is configured to provide at least one of:

drug treatment, cellular therapy, pacing capabilities, stern cell therapy, or mechanical integrity.

80. A reinforcement for communication with a heart possessing an infarction, whereby said reinforcement is configured to create stiffness in one direction relative to other directions of said reinforcement, to preferentially reinforce one direction of the infarct region of the heart wall.

81. The reinforcement of claim 80, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region

82. The reinforcement of claim 80, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

83. The reinforcement of claim 80, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially aligned with the longitudinal direction of the heart.

84. The reinforcement of claim 80, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially aligned with the circumferential direction of the heart.

85. A method for improving heart function, said method comprising:

communicating

a reinforcement with the heart, wherein said reinforcement is configured to create stiffness in one direction relative to other directions of said reinforcement, for reinforcement of the wall of the heart for said improved pump function.

86. A method for improving heart function, said method comprising:

determining the direction to reinforce an infarction;

providing an anisotropic reinforcement with selective reinforcement for said determined direction; and

communicating said anisotropic reinforcement with the heart for reinforcing said infarction.

87. The method of claim 86, wherein said determining comprises a clinical assessment or medical practitioner assessment of the infarction.

88. The method of claim 86, wherein said determining comprises imaging the infarction.

89. The method of claim 88, wherein the imaging comprises assessment of infarct stretching.

90. The method of claim 88, wherein imaging comprises the use of at least one of:

MRI, X-Ray, CAT Scan, or Ultrasound technology.

91. The method of claim 86, wherein said providing comprises weaving tight fibers in one direction relative to other directions of said reinforcement to produce stiffness in the one direction relative to other directions of said reinforcement.

92. The method of claim 91, wherein said providing further comprises weaving loose fibers in the other directions of the anisotropic reinforcement relative to the one direction.

93. The method of claim 86, wherein said providing comprises weaving dense fibers in one direction of the anisotropic reinforcement relative to other directions of the anisotropic reinforcement to produce stiffness in the one direction relative to other directions of the anisotropic reinforcement.

94. The method of claim 93, wherein said providing an further comprises weaving loose fibers in the other directions of the anisotropic reinforcement relative to the one direction.

95. The method of claim 86, wherein said providing comprises weaving straight, tight, or stretched fibers in a single direction of the anisotropic reinforcement relative to other directions of the anisotropic reinforcement to produce stiffness in the single direction, relative to other directions of the anisotropic reinforcement.

96. The method of claim 95, wherein said providing an anisotropic reinforcement with selective reinforcement further comprises weaving randomly or stochastically oriented fibers in the other directions of the anisotropic reinforcement relative to the one direction.

97. The method of claim 95, wherein said providing further comprises weaving slack or unstretched fibers in the other directions of the anisotropic reinforcement relative to the one direction.

98. The method of claim 97, wherein the slack or unstretched fibers comprise at least one of:

coiled, curved, or zig-zag fibers.

99. The method of claim 86, wherein said providing comprises weaving small pores or apertures within fibers comprising one direction of the anisotropic reinforcement relative to other directions of the anisotropic reinforcement to create stiffness in the one direction relative to the other directions of the anisotropic reinforcement.

100. The method of claim 99, wherein said providing further comprises weaving larger pores or apertures in the other directions of the anisotropic reinforcement relative to the one direction of the anisotropic reinforcement.

101. The method of claim 86, wherein said providing comprises cutting slits or elongated apertures in said anisotropic reinforcement along the one direction of said anisotropic reinforcement so that said anisotropic reinforcement stiffens selectively in the direction parallel to said slits or apertures.

102. The method of claim 86, wherein said providing comprises chemically, treating said reinforcement to render it anisotropic, such to create stiffness in one direction relative to other directions of the anisotropic reinforcement.

103. The method of claim 86, wherein said providing comprises mechanically treating said reinforcement to render it anisotropic, such to create stiffness in one direction relative to other directions of said reinforcement.

104. The method of claim 103, wherein mechanical treatment comprises at least one of:

grinding, finishing, abrading, inflating, shrinking, directionally-specific shrinking, inducing tension, slacking, coating, or expanding.

105. The method of claim 86, wherein said providing comprises locally-reinforcing said anisotropic reinforcement.

106. The method of claim 105, wherein said local-reinforcement comprises at least one of:

additional fibers, natural fibers, synthetic fibers, mesh, collagen fibers, metals, wires, cloth, or biocompatible metals.

107. The method of claim 106, wherein the biocompatible metals may comprise at least one of stainless steel, titanium, metal alloys, or a combination thereof.

108. The method of claim 107, wherein the metal alloys may comprise at least one of In—

Ti, Fe—

Mn, Ni—

Ti, Ag—

Cd, Au—

Cd, Au—

Cu, Cu—

Al—

Ni, Cu—

Au—

Zn, Cu—

Zn, Cu—

Zn—

Al, Cu—

Zn—

Sn, Cu—

Zn—

Xe, Fe₃Be, Fe₃Pt, Ni—

Ti—

V, Fe—

Ni—

Ti—

Co, Cu—

Sn or a combination thereof.

109. The method of claim 86, wherein said anisotropic reinforcement is a synthetic material.

110. The method of claim 109, wherein said synthetic material may comprise at least one of tantalum gauze, stainless steel mesh, DACRON, ORLON, FORTISAN, nylon, knitted polypropylene (MARLEX), microporous expanded-polytetrafluoroethylene (GORE-TEX), Dacron-reinforced silicone rubber (SILASTIC), polyglactin 910 (VICRYL), polyester (MERSILENE), polyglycolic acid (DEXON), or a combination thereof.

111. The method of claim 86, wherein said communicating comprises at least one of adhering, attaching and suturing said anisotropic reinforcement with said heart.

112. The method of claim 86, wherein said infarctions heal while resisting circumferential

stretching, and deform normally in the longitudinal and radial directions during myocardial contractions.

113. The method of claim 86, wherein said infarctions heal while resisting longitudinal stretching, and deform normally in the circumferential and radial directions during myocardial contractions.

114. The method of claim 86, wherein said direction to reinforce the infarction is determined to be the longitudinal direction of the heart.

115. The method of claim 86, wherein said direction to reinforce the infarction is determined to be the circumferential direction of the heart.

116. The method of claim 86, wherein said direction to reinforce the infarction is determined to be a direction at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

117. The method of claim 86, wherein said direction to reinforce the infarction is determined to be a direction at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

118. The method of claim 86, further comprising providing information to a surgeon or skilled practitioner regarding proper placement of said reinforcement.

119. The method of claim 118, wherein said information is provided at one or more of the following locations:

on a surface of said reinforcement;

on packaging associated with said reinforcement;

on a packing label associated with said reinforcement; and

/or in a set of instructions associated with said reinforcement.

120. The method of claim 118, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement around the circumference of an incision, opening, or defect undergoing repair.

121. The method of claim 118, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement around the circumference of the heart.

122. The method of claim 118, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement in the longitudinal direction of an incision, opening, or defect undergoing repair.

123. The method of claim 118, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement in the longitudinal direction of the heart.

124. A method for improving heart function, said method comprising:

determining the direction to reinforce an infarction; and

configuring a reinforcement, said configuration in accordance with said determined direction,and for selectively reinforcing said infarction.

125. The method of claim 124, wherein said selective reinforcement is anisotropic.

126. The method of claim 125, wherein said determining comprises a clinical assessment or medical practitioner assessment of the infarction.

127. The method of claim 125, wherein said determining comprises imaging the infarction.

128. The method of claim 124, wherein said configuration comprises:

providing said reinforcement, wherein said reinforcement has anisotropic properties; and

communicating said reinforcement so as to further provide additional anisotropic properties.

129. The method of claim 128, wherein said communicating comprises at least one of:

adhering, attaching, and suturing said reinforcement with said heart.

130. The method of claim 124, wherein said configuring comprises:

communicating said reinforcement to said heart to form an anisotropic reinforcement with the heart.

131. The method of claim 130, wherein said communicating comprises at least one of:

adhering, attaching, and suturing said anisotropic reinforcement with said heart.

132. The method of claim 124, wherein said direction to reinforce the infarction is determined to he the longitudinal direction of the heart.

133. The method of claim 124, wherein said direction to reinforce the infarction is determined to be the circumferential direction of the heart.

134. The method of claim 124, wherein said direction to reinforce the infarction is determined to be a direction at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

135. The method of claim 124, wherein said direction to reinforce the infarction is determined to be a direction at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

136. The method of claim 124, further comprising providing information to a surgeon or skilled practitioner regarding proper placement of said reinforcement.

137. The method of claim 136, wherein said information is provided at one or more of the following locations:

on a surface of said reinforcement;

on packaging associated with said reinforcement;

on a packing label associated with said reinforcement; and

/or in a set of instructions associated with said reinforcement.

138. The method of claim 136, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement around the circumference of an incision, opening, or defect undergoing repair.

139. The method of claim 136, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement around the circumference of the heart.

140. The method of claim 136, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement in the longitudinal direction of an incision, opening, or defect undergoing repair.

141. The method of claim 136, wherein said reinforcement provides stiffness in one direction relative to other directions of said reinforcement, and wherein said information instructs the surgeon or skilled practitioner to align said one direction of said reinforcement in the longitudinal direction of the heart.

142. A method of reinforcing a heart possessing an infarction, whereby said reinforcing creates a reinforcement to provide stiffness in one direction relative to other directions of said reinforcement, to preferentially reinforce one direction of the infarct region of the heart wall.

143. The method of claim 142, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially aligned with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

144. The reinforcement of claim 142, wherein said preferential reinforcement provides said stiffness in at least one direction of said reinforcement that is at least substantially transverse with the underlying muscle fiber direction of the heart and/or collagen fiber direction of said infarct region.

145. The method of claim 142, wherein said reinforcing improves heart function.

146. (canceled)