Prevention of myocardial infarction induced ventricular expansion and remodeling

• US 7,988,727 B2
• Filed: 10/04/2004
• Issued: 08/02/2011
• Est. Priority Date: 04/27/2001
• Status: Active Grant

• Current Assignee: Cormend Technologies, LLC
• Original Assignee: Cormend Technologies, LLC
• Inventors: Santamore, William P., Lesniak, Jeanne M.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/958,063
• Publication Number:
  US 20050080402A1
• Time in Patent Office: 2,493 Days
• Field of Search: 623 111- 149, 623 236- 237, 623/3.1, 623/904, 606/16, 600/374, 600/375
• US Class Current: 623/2.42
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61K 38/1841 : Transforming growth factor [TGF]
• CPC Class Codes: A61K 47/02 : Inorganic compounds
• CPC Class Codes: A61K 47/42 : Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 49/0013 : Luminescence
• CPC Class Codes: A61K 49/04 : X-ray contrast preparations
• CPC Class Codes: A61K 9/0024 : Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/14 : Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

A method for direct therapeutic treatment of myocardial tissue in a localized region of a heart having a pathological condition. The method includes identifying a target region of the myocardium and applying material directly and substantially only to at least a portion of the myocardial tissue of the target region. The material applied results in a physically modification the mechanical properties, including stiffness, of said tissue. Various devices and modes of practicing the method are disclosed for stiffening, restraining and constraining myocardial tissue for the treatment of conditions including myocardial infarction or mitral valve regurgitation.

Claims

1. A method for direct localized therapeutic treatment of myocardial tissue in heart having a pathological condition comprising the steps of:

identifying a target region of the myocardium to be stiffened, restrained, or constrained, the target region comprising at least one of a peri-infarct region and an infarct region; and

applying a device intramurally to at least a portion of the myocardial tissue of the target region substantially identified in the identifying step to physically modify the mechanical properties of said tissue and limit motion in at least one of the peri-infarct region and the infarct region,

wherein said applying step includes applying material intramyocardially.

2. The method of claim 1, wherein geometry and wall stress of the infarct or peri-infarct tissue is altered.

3. The method of claim 2, wherein the infarct region is reduced or shrunk.

4. The method of claim 3, wherein expansion of the infarct or peri-infarct tissue during systole is limited.

5. The method of claim 1, wherein the infarct or peri-infarct tissue is physically modified by at least one of stiffening, restraining, and constraining.

6. The method of claim 1, wherein the modified mechanical properties include an increase in systolic performance.

7. The method of claim 6, wherein the modified mechanical properties include substantially no decrease in global diastolic performance.

8. The method of claim 1, wherein the device is utilized without external stimulation.

9. The method of claim 1, wherein said target region includes a myocardial infarct.

10. The method of claim 1, wherein said target region at least in part underlies the papillary muscles associated with a cardiac valve.

11. The method of claim 10, wherein said cardiac valve is the mitral valve.

12. The method of claim 1, wherein the device is a tubular structure positioned between at least first and second anchors.

13. The method of claim 12, wherein the tubular structure includes slots configured to provide lateral flexibility.

14. The method of claim 13, wherein the tubular structure includes cutouts configured to modify the tubular structure'"'"'s lateral and longitudinal flexibility.

15. The method of claim 14, wherein the cutouts are configured to provide lateral shortening and limited lateral lengthening.

16. The method of claim 12, wherein the at least first and second anchors are end portions of the tubular structure.

17. The method of claim 1, wherein said applying step includes employing a guide catheter.

18. The method of claim 17, wherein the guide catheter is inserted through the femoral artery, threaded through the aorta and inserted retrograde through the aortic valve into the left ventricle (LV).

19. The method of claim 18, wherein the guide catheter is placed against the endocardial surface of the LV.

20. The method of claim 19, further comprising:

placing a puncture device through the guide catheter to make a puncture into the endocardium.

21. The method of claim 20, further comprising:

inserting a guidewire until it is located distal to the myocardial infarct and the distal peri-infarct region.

22. The method of claim 21, further comprising:

introducing the device over the guidewire to the target region.

23. The method of claim 17, wherein said catheter is employed percutaneously.

24. The method of claim 1, wherein geometry and wall stress of the infarct or peri-infarct tissue is altered.

25. The method of claim 24, wherein the infarct region is reduced or shrunk.

26. The method of claim 25, wherein expansion of the infarct or peri-infarct tissue during systole is limited.

27. The method of claim 1, wherein the infarct or peri-infarct tissue is physically modified by at least one of stiffening, restraining, and constraining.

28. A method of treating at least one of a heart having experienced a myocardial infarction and a heart with abnormal heart wall motion, the method comprising:

identifying and locating at least one of;

normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue in the myocardium of the heart; and

placing a self-anchoring mechanical device in at least one of the normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue to restrict or limit motion in at least one of the infarcted tissue, peri-infarcted tissue and ischemic tissue,

wherein the mechanical device is positioned within the myocardial tissue and does not exit the tissue, and wherein the mechanical device is configured to shorten along its longitudinal axis over time.

29. The method of claim 28, further comprising placing the mechanical device such that it extends from normal myocardial tissue across the target tissue region and into the infarct tissue region.

30. The method of claim 28, further comprising placing the mechanical device such that it spans the entire infarct tissue region.

31. The method of claim 28, wherein:

the mechanical device comprises anchor points in the myocardium; and

the mechanical device allows the anchor points to move closer together and restricts a distance between the anchor points to substantially a predetermined value.

32. The method of claim 31, wherein the mechanical device comprises a spring member.

33. The method of claim 28, wherein the mechanical device comprises at least one of:

a plurality of particles; and

at least one rod,

wherein upon encapsulation of the device within the myocardium, the myocardium is stiffened.

34. The method of claim 28, wherein the mechanical device comprises at least one of:

a shape memory alloy;

a bio-absorbable material;

a material that absorbs fluid; and

a material that shortens when its temperature is raised.

35. A method of treating mitral valvular regurgitation in a human heart, the method comprising:

providing a self-anchoring mechanical device;

identifying a target region of a myocardium of the heart; and

positioning the self-anchoring mechanical device intramurally within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve by decreasing distension of the heart in a region of the base of the papillary muscle.

36. The method as recited in claim 35, wherein the self anchoring mechanical device comprises a longitudinal axis, the method further comprising:

positioning the longitudinal axis substantially parallel to the endocardial surface in an apex-to-base direction.

37. The method as recited in claim 35, wherein the target region comprises the apex of the heart.

38. The method as recited in claim 35, wherein the target region comprises a wall of the left ventricle.

39. The method as recited in claim 35, wherein the identified target region comprises at least one of normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue, and wherein the self-anchoring mechanical device restricts or limits motion in at least one of the infarcted tissue, peri-infarcted tissue and ischemic tissue.

40. The method as recited in claim 35, wherein the self-anchoring mechanical device is positioned within the tissue of the heart such that no part of the self-anchoring mechanical device exits from the heart tissue once placed.

41. The method as recited in claim 40, further comprising:

positioning the self-anchoring mechanical device in a portion of the infarcted tissue to restrict or limit motion in at least one of a peri-infarcted tissue region and an infarcted tissue region of the infarcted tissue.

42. The method as recited in claim 35, wherein the mechanical device is configured to shorten along its longitudinal axis over time.

43. The method as recited in claim 35, wherein the mechanical device comprises a spring member.

44. The method as recited in claim 43, wherein the mechanical device is placed in one of:

a relaxed condition; and

a pre-stretched condition.

45. The method as recited in claim 44, wherein the mechanical device is maintained in the pre-stretched condition by at least one of:

a stiff member coupled to the spring member; and

at least one spacer comprising bio-absorbable material placed within the spring member.

86. The method as recited in claim 35, wherein the target region comprises the apex of the heart.

46. A method of treating a heart, the method comprising:

providing a restraining device having a distal anchor and a proximal anchor;

embedding the distal anchor of the device in heart tissue; and

embedding the proximal anchor in the heart tissue,

wherein the restraining device is substantially positioned in a mid-wall of the heart.

47. The method as recited in claim 46, further comprising:

orienting the restraining device to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.

48. The method as recited in claim 46, further comprising:

orienting the restraining device approximately parallel to an endocardial surface in an apex-to-base direction; and

adjusting a tension of the restraining device to decrease a distance from a base of a papillary muscle to a mitral valve plane.

49. The method as recited in claim 46, further comprising:

orienting the restraining device approximately parallel to a circumferential plane of the heart.

50. A method of treating at least one of a heart having experienced a myocardial infarction and a heart with abnormal heart wall motion, the method comprising:

identifying and locating at least one of;

normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue in the myocardium of the heart; and

placing a self-anchoring mechanical device in at least one of the normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue to restrict or limit motion in at least one of the infarcted tissue, peri-infarcted tissue and ischemic tissue, the mechanical device being placed such that it extends from normal myocardial tissue across the target tissue region and into the infarct tissue region.

51. The method of claim 50, further comprising placing the mechanical device such that it spans the entire infarct tissue region.

52. The method of claim 50, wherein:

the mechanical device comprises anchor points in the myocardium; and

the mechanical device allows the anchor points to move closer together and restricts a distance between the anchor points to substantially a predetermined value.

53. A method for direct localized therapeutic treatment of myocardial tissue in heart having a pathological condition comprising the steps of:

identifying a target region of the myocardium to be stiffened, restrained, or constrained, the target region comprising at least one of a peri-infarct region and an infarct region;

performing a minithoracotomy; and

applying a device intramurally, via the minithoracotomy, to at least a portion of the myocardial tissue of the target region substantially identified in the identifying step to physically modify the mechanical properties of said tissue and limit motion in at least one of the peri-infarct region and the infarct region.

54. The method of claim 53, wherein geometry and wall stress of the infarct or peri-infarct tissue is altered.

55. The method of claim 54, wherein the infarct region is reduced or shrunk.

56. The method of claim 55, wherein expansion of the infarct or peri-infarct tissue during systole is limited.

57. The method of claim 53, wherein the infarct or peri-infarct tissue is physically modified by at least one of stiffening, restraining, and constraining.

58. The method of claim 53, wherein the modified mechanical properties include an increase in systolic performance.

59. The method of claim 58, wherein the modified mechanical properties include substantially no decrease in global diastolic performance.

60. The method of claim 53, wherein the device is utilized without external stimulation.

61. The method of claim 53, wherein said target region includes a myocardial infarct.

62. The method of claim 53, wherein said target region at least in part underlies the papillary muscles associated with a cardiac valve.

63. The method of claim 62, wherein said cardiac valve is the mitral valve.

64. The method of claim 53, wherein the device is a tubular structure positioned between at least first and second anchors.

65. The method of claim 64, wherein the tubular structure includes slots configured to provide lateral flexibility.

66. The method of claim 65, wherein the tubular structure includes cutouts configured to modify the tubular structure'"'"'s lateral and longitudinal flexibility.

67. The method of claim 66, wherein the cutouts are configured to provide lateral shortening and limited lateral lengthening.

68. The method of claim 64, wherein the at least first and second anchors are end portions of the tubular structure.

69. The method of claim 53, wherein geometry and wall stress of the infarct or peri-infarct tissue is altered.

70. The method of claim 69, wherein the infarct region is reduced or shrunk.

71. The method of claim 70, wherein expansion of the infarct or peri-infarct tissue during systole is limited.

72. The method of claim 53, wherein the infarct or peri-infarct tissue is physically modified by at least one of stiffening, restraining, and constraining.

73. A method of treating mitral valvular regurgitation in a human heart, the method comprising:

providing a self-anchoring mechanical device;

identifying a target region of a myocardium of the heart; and

positioning the self-anchoring mechanical device intramurally within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve, the self-anchoring mechanical device being positioned within the tissue of the heart such that no part of the self-anchoring mechanical device exits from the heart tissue once placed, the self-anchoring mechanical device being positioned in a portion of the infarcted tissue to restrict or limit motion in at least one of a peri-infarcted tissue region and an infarcted tissue region of the infarcted tissue

74. The method of as recited in claim 73, wherein the position of the base of said at least one papillary muscle is adjusted by decreasing distension of the heart in a region of the base of the papillary muscle.

75. The method as recited in claim 73, wherein the self anchoring mechanical device comprises a longitudinal axis, the method further comprising:

positioning the longitudinal axis substantially parallel to the endocardial surface in an apex-to-base direction.

76. The method as recited in claim 73, wherein the target region comprises the apex of the heart.

77. The method as recited in claim 73, wherein the target region comprises a wall of the left ventricle.

78. The method as recited in claim 73, wherein the identified target region comprises at least one of normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue, and wherein the self-anchoring mechanical device restricts or limits motion in at least one of the infarcted tissue, peri-infracted tissue and ischemic tissue.

79. The method as recited in claim 73, wherein the mechanical device is configured to shorten along its longitudinal axis over time.

80. The method as recited in claim 73, wherein the mechanical device comprises a spring member.

81. The method as recited in claim 80, wherein the mechanical device is placed in one of:

a relaxed condition; and

a pre-stretched condition.

82. The method as recited in claim 81, wherein the mechanical device is maintained in the pre-stretched condition by at least one of:

a stiff member coupled to the spring member; and

at least one spacer comprising bio-absorbable material placed within the spring member.

83. A method of treating mitral valvular regurgitation in a human heart, the method comprising:

providing a self-anchoring mechanical device;

identifying a target region of a myocardium of the heart; and

positioning the self-anchoring mechanical device intramurally within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve,

wherein the mechanical device is configured to shorten along its longitudinal axis over time.

84. The method as recited in claim 83, wherein the position is adjusted by decreasing distension of the heart in a region of the base of the papillary muscle.

85. The method as recited in claim 83, wherein the self anchoring mechanical device comprises a longitudinal axis, the method further comprising:

positioning the longitudinal axis substantially parallel to the endocardial surface in an apex-to-base direction.

87. The method as recited in claim 83, wherein the target region comprises a wall of the left ventricle.

88. The method as recited in claim 83, wherein the identified target region comprises at least one of normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue, and wherein the self-anchoring mechanical device restricts or limits motion in at least one of the infarcted tissue, peri-infracted tissue and ischemic tissue.

89. The method as recited in claim 83, wherein the self-anchoring mechanical device is positioned within the tissue of the heart such that no part of the self-anchoring mechanical device exits from the heart tissue once placed.

90. The method as recited in claim 89, further comprising:

positioning the self-anchoring mechanical device in a portion of the infarcted tissue to restrict or limit motion in at least one of a peri-infarcted tissue region and an infarcted tissue region of the infarcted tissue.

91. The method as recited in claim 83, wherein the mechanical device comprises a spring member.

92. The method as recited in claim 91, wherein the mechanical device is placed in one of:

a relaxed condition; and

a pre-stretched condition.

93. The method as recited in claim 92, wherein the mechanical device is maintained in the pre-stretched condition by at least one of:

a stiff member coupled to the spring member; and

at least one spacer comprising bio-absorbable material placed within the spring member.

94. A method of treating mitral valvular regurgitation in a human heart, the method comprising:

providing a self-anchoring mechanical device;

identifying a target region of a myocardium of the heart; and

positioning the self-anchoring mechanical device intramurally within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve,

wherein the mechanical device comprises a spring member, the spring member being placed in one of a relaxed condition and a pre-stretched condition, the spring member being maintained in the pre-stretched condition by at least one of a stiff member coupled to the spring member and at least one spacer comprising bio-absorbable material placed within the spring member.

95. The method of as recited in claim 94, wherein the position of the base of said at least one papillary muscle is adjusted by decreasing distension of the heart in a region of the base of the papillary muscle.

96. The method as recited in claim 94, wherein the self anchoring mechanical device comprises a longitudinal axis, the method further comprising:

positioning the longitudinal axis substantially parallel to the endocardial surface in an apex-to-base direction.

97. The method as recited in claim 94, wherein the target region comprises the apex of the heart.

98. The method as recited in claim 94, wherein the target region comprises a wall of the left ventricle.

99. The method as recited in claim 94, wherein the identified target region comprises at least one of normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue, and wherein the self-anchoring mechanical device restricts or limits motion in at least one of the infarcted tissue, peri-infracted tissue and ischemic tissue.

100. The method as recited in claim 94, wherein the self-anchoring mechanical device is positioned within the tissue of the heart such that no part of the self-anchoring mechanical device exits from the heart tissue once placed.

101. The method as recited in claim 100, further comprising:

positioning the self-anchoring mechanical device in a portion of the infarcted tissue to restrict or limit motion in at least one of a peri-infarcted tissue region and an infarcted tissue region of the infarcted tissue.

102. The method as recited in claim 94, wherein the mechanical device is configured to shorten along its longitudinal axis over time.