Prevention of myocardial infarction induced ventricular expansion and remodeling

• US 20050080402A1
• Filed: 10/04/2004
• Published: 04/14/2005
• Est. Priority Date: 04/27/2001
• Status: Active Grant

• Current Assignee: Cormend Technologies, LLC
• Original Assignee: Myomend, Inc.
• Inventors: Santamore, William P., Lesniak, Jeanne M.
• Granted Patent: US 7,988,727 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• 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

1-15. -15. (canceled)

16. A method of direct localized therapeutic treatment of a heart, the method comprising:

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

applying a self-anchoring mechanical device directly to a portion of the myocardial tissue of the identified target region,

whereby motion of the myocardial tissue of the identified target region is at least one of;

restricted and limited.

17. The method of claim 16, wherein the mechanical device is applied substantially only to the portion of the myocardial tissue of the identified target region.

18. The method of claim 16, wherein the myocardial tissue of the identified target region comprises infarcted tissue resulting from a myocardial infarction.

19. The method of claim 18 wherein the target region comprises a peri-infarcted region and wherein:

applying the mechanical device further comprises applying the mechanical device to the peri-infarcted region.

20. The method of claim 19, further comprising:

selecting the mechanical device from a group comprising;

a button device;

a clamshell device;

a stiffening device;

a restraining device; and

a constraining device.

21. The method as recited in claim 16, wherein the device further comprises at least one of:

genes;

stem cells;

a biologic;

a drug; and

a therapeutic material.

28. The method of claim 20, wherein the mechanical device comprises a spring member.

29. The method of claim 28, wherein the mechanical device is placed in one of:

a relaxed condition; and

a pre-stretched condition.

30. The method of claim 29, wherein the mechanical device is maintained in the pre-stretched condition by at least one of:

a stiff wire member coupled to the spring member; and

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

22. A method of treating a heart having experienced a myocardial infarction, the method comprising:

identifying and locating at least one of;

non-ischemic 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 non-ischemic 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.

23. The method of claim 22, wherein the mechanical device is positioned within the myocardial tissue and does not exit the tissue.

24. The method of claim 22, further comprising:

placing the mechanical device such that it extends from non-ischemic myocardial tissue across the target tissue region and into the infarct tissue region.

25. The method of claim 22, further comprising:

placing the mechanical device such that it spans the entire infarct tissue region.

26. The method of claim 22, 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.

27. The method of claim 26, wherein the mechanical device comprises a spring member.

31. The method of claim 22, wherein the mechanical device comprises at least one of:

a plurality of particles; and

at least one rod,

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

32. The method of claim 22, wherein the mechanical device shortens along its longitudinal axis over time.

33. The method of claim 32, 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.

34. A method of treating a heart with abnormal heart wall motion, the method comprising:

identifying and locating at least one of;

non-ischemic 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 non-ischemic 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.

35. The method of claim 34, wherein the mechanical device is positioned within the myocardial tissue and does not exit the tissue.

36. The method of claim 34, further comprising:

placing the mechanical device such that it extends from non-ischemic myocardial tissue across the target tissue region and into the infarct tissue region.

37. A device for placement in a myocardium of a heart, the device comprising:

means for attaching to the myocardium at two or more attachment locations; and

means for restricting, to substantially a predetermined value, a distance between at least two attachment locations.

38. The device as recited in claim 37, wherein the attaching means comprise at least one of:

a button device;

a clamshell device;

a stiffening device;

a restraining device; and

a constraining device.

39. The device as recited in claim 37, wherein the restricting means comprise at least one of:

a spring member;

a shape memory alloy;

a bio-absorbable material;

a material that absorbs fluid; and

a material that shortens when its temperature is raised.

40. The device as recited in claim 37, wherein the attaching means comprise at least one of:

a bulb portion;

an umbrella;

a hook;

a barb; and

a screw.

41. The device as recited in claim 37, wherein at least one of the attaching means and the restricting means comprise:

a shape memory alloy;

a button device;

a clamshell device;

a stiffening device;

a restraining device; and

a constraining device.

42. The device as recited in claim 37, wherein the restricting means comprise:

means for decreasing the distance between at least two attachment locations over time.

43. The device as recited in claim 42, wherein the decreasing means comprise at least one of:

a spring member;

a shape memory alloy;

a bio-absorbable material;

a material that absorbs fluid; and

a material that shortens when its temperature is raised.

44. The device as recited in claim 37, further comprising at least one of:

genes;

stem cells;

a biologic;

a drug; and

a therapeutic material.

45. A device for reducing stress in myocardial tissue, comprising:

a substantially tubular body having proximal and distal portions;

a first self-expanding anchor located at the proximal portion; and

a second self-expanding anchor located at the distal portion,

wherein the tubular body comprises a lumen having a proximal opening in the proximal portion and a distal opening in the distal portion.

46. The device as recited in claim 45, wherein the stress is physiological stress.

47. The device as recited in claim 45, further comprising at least one of:

genes;

stem cells;

a biologic;

a drug; and

a therapeutic material.

48. The device as recited in claim 45, wherein placement of the device is facilitated by positioning a guidewire through the lumen from the proximal opening to the distal opening.

49. The device as recited in claim 45, wherein at least one of the first and second self-expanding anchors are formed by:

cutting a plurality of circumferentially spaced lengthwise slots through a wall of the tubular body; and

forming at least one section of tubular body material between the plurality of slots into a bulb type portion extending from an external surface of the tubular body.

50. The device as recited in claim 45, wherein at least one of the first and second self-expanding anchors are formed by:

cutting a plurality of circumferentially spaced lengthwise slots through a wall of the tubular body; and

forming at least one section of tubular body material between the plurality of slots into a barb type portion extending from an external surface of the tubular body.

51. The device as recited in claim 45, further comprising a plurality of circumferentially spaced lengthwise slots through a wall of the tubular body and at least one of the first and second self-expanding anchors comprise at least one of:

a bulb type portion formed from at least one section of tubular body material between the plurality of slots and extending from an external surface of the tubular body; and

a barb type portion formed from at least one section of tubular body material between the plurality of slots and extending from an external surface of the tubular body.

52. The device as recited in claim 51, wherein each bulb type portion and barb type portion is elastically deflectable back into a tubular geometry.

53. The device as recited in claim 45, wherein the tubular body is formed from a shape memory alloy.

54. The device as recited in claim 45, further comprising:

a third self-expanding anchor located at an intermediate portion of the tubular body located between the proximal and distal portions.

55. The device as recited in claim 45, wherein the tubular body is formed so as to be flexible to allow motion in all axes.

56. The device as recited in claim 55, wherein the tubular body is further formed to resist elongation.

57. The device as recited in claim 45, wherein the tubular body comprises an intermediate portion between the proximal and distal portions, the device further comprising:

a plurality of transverse slots positioned in the intermediate portion of the tubular body,

whereby the intermediate portion is flexible in all axes.

58. The device as recited in claim 45, further comprising a spring portion disposed in an intermediate portion of the tubular body between the proximal and distal portions, and further comprising at least one of:

a stiff wire member coupled to the spring portion; and

at least one spacer comprising bio-absorbable material placed within the spring portion,

whereby the wire member and the spacer maintain the spring portion in a pre-stretched condition.

59. The device as recited in claim 45, further comprising:

an intermediate portion disposed between the proximal and distal portions,

wherein the intermediate portion is configured to maintain a substantially constant length between the proximal and distal portions.

60. The device as recited in claim 59, wherein the substantially constant length is maintained along a longitudinal axis of the device that conforms to a delivery path in a heart within which the device is inserted.

61. The device as recited in claim 59, wherein the substantially constant length is maintained along a longitudinal axis of the device.

62. The device as recited in claim 45, further comprising:

an intermediate portion disposed between the proximal and distal portions,

wherein the intermediate portion is configured to prevent a distance between the proximal and distal portions from substantially exceeding a predetermined value.

63. A method of direct localized therapeutic treatment of a heart, the method comprising:

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

applying a self-anchoring mechanical device directly to a portion of the myocardial tissue of the identified target region to limit substantial lengthening of myocytes in the target region.

64. The method as recited in claim 63, wherein:

the target region is in a heart with dilated cardiomyopathy.

65. The method as recited in claim 63, wherein the target region is in a heart with mitral valvular regurgitation.

66. The method of claim 63, 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.

67. The method of claim 63, wherein the target region comprises a wall of the left ventricle.

68. 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 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.

69. The method of claim 68, wherein the position is adjusted by decreasing distension of the base.

70. The method of claim 68, 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.

71. The method of claim 68, wherein the target region comprises the apical base of the heart.

72. The method of claim 68, wherein the target region comprises a wall of the left ventricle.

73. The method of claim 68, 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.

74. The method of claim 71, 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.

75. The method of claim 73, 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.

76. The method of claim 68, wherein the mechanical device shortens along its longitudinal axis over time.

77. The method of claim 68, wherein the mechanical device comprises a spring member.

78. The method of claim 77, wherein the mechanical device is placed in one of:

a relaxed condition; and

a pre-stretched condition.

79. The method of claim 78, wherein the mechanical device is maintained in the pre-stretched condition by at least one of:

a stiff wire member coupled to the spring member; and

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

80. A method of treating mitral valvular regurgitation, the method comprising:

introducing into the heart, via an artery, a steerable catheter;

positioning the steerable catheter in the left ventricle and against the endocardial surface of the left ventricle;

inserting a pre-shaped guidewire, via the steerable catheter, into the heart tissue SO as to be substantially positioned in the mid-wall and approximately parallel to the endocardial surface in an apex-to-base direction;

withdrawing the steerable catheter;

advancing a deployment catheter over the inserted guidewire to contact the endocardial surface;

advancing a restraining device, having a distal anchor and a proximal anchor, through the deployment catheter toward the heart tissue;

releasing a distal anchor on the restraining device from a distal end of the deployment catheter and embedding the distal anchor of the device in the heart tissue;

withdrawing the deployment catheter; and

releasing the proximal anchor on the restraining device from the distal end of the deployment catheter and embedding the proximal anchor in the heart tissue to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.

81. The method as recited in claim 80, further comprising:

adjusting an amount of tension between the distal anchor and the proximal anchor on the restraining device, the tension urging the anchors toward one another, as the deployment catheter is withdrawn.

82. The method as recited in claim 81, further comprising:

embedding the proximal anchor in the heart tissue while the device is under tension.

83. The method as recited in claim 80, wherein:

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

84. The method as recited in claim 80, wherein the heart tissue in which the restraining device is positioned comprises at least one of:

peri-infarcted heart tissue;

infarcted heart tissue;

ischemic heart tissue; and

viable heart tissue.

85. A method of treating mitral valvular regurgitation, 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 and oriented approximately parallel to an endocardial surface in an apex-to-base direction to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.

86. The method as recited in claim 85, further comprising:

adjusting an amount of tension between the distal anchor and the proximal anchor on the restraining device, the tension urging the anchors toward one another.

87. The method as recited in claim 86, further comprising:

embedding the proximal anchor in the heart tissue while the device is under tension.

88. The method as recited in claim 85, wherein:

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

89. The method as recited in claim 85, wherein the heart tissue in which the restraining device is positioned comprises at least one of:

peri-infarcted heart tissue;

infarcted heart tissue;

ischemic heart tissue; and

non-ischemic heart tissue.

90. The method of claim 86, wherein the restraining device comprises a spring member and adjusting the amount of tension of the restraining device comprises at least one of:

placing the restraining member in a relaxed condition; and

placing the restraining member in a pre-stretched condition.

91. The method of claim 90, further comprising at least one of:

providing a stiff wire member coupled to the spring member; and

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

92. 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.

93. The method as recited in claim 92, further comprising:

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

94. The method as recited in claim 92, further comprising:

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

95. The method as recited in claim 94, further comprising:

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

96. The method as recited in claim 92, further comprising:

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

97. A method of treating a heart with mitral valvular regurgitation as recited in claim 92.

98. A method of treating a heart in which a myocardial infarction has occurred as recited in claim 92.

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

introducing into the heart, via an artery, a steerable catheter;

positioning the steerable catheter in the left ventricle and against the endocardial surface of the left ventricle;

inserting a pre-shaped guidewire into the heart tissue, via the steerable catheter, so as to be substantially positioned in the mid-wall;

withdrawing the steerable catheter;

advancing a deployment catheter over the inserted guidewire to contact the endocardial surface;

advancing a restraining device, having a distal anchor and a proximal anchor, through the deployment catheter toward the heart tissue;

releasing a distal anchor on the restraining device from a distal end of the deployment catheter and embedding the distal anchor of the device in the heart tissue;

withdrawing the deployment catheter; and

releasing the proximal anchor on the restraining device from the distal end of the deployment catheter and embedding the proximal anchor in the heart tissue.

100. The method as recited in claim 99, further comprising:

positioning the guidewire to enter the heart tissue approximately parallel to the endocardial surface in an apex-to-base orientation.

101. The method as recited in claim 99, further comprising:

positioning the guidewire to enter the heart tissue approximately parallel to a circumferential plane of the heart.

102. A method of treating a heart with abnormal wall motion as recited in claim 99.

103. A method of treating a heart having experienced a myocardial infarction as recited in claim 99.