Source: http://www.google.com/patents/US20020065544?dq=7,177,838
Timestamp: 2017-12-18 11:30:37
Document Index: 221818915

Matched Legal Cases: ['art.\n13', 'art.\n21', 'art.\n52', 'art.\n60', 'art.\n91', 'art.\n99', 'art.\n130', 'art.\n138', 'art.\n167', 'art.\n168', 'art.\n169', 'art.\n170', 'art.\n174', 'art.\n175', 'art.\n176', 'art.\n180', 'art.\n181', 'art.\n182', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

Patent US20020065544 - Medical electrical lead having variable bending stiffness - Google Patents
An elongated coronary vein lead having a variable stiffness lead body and most preferably adapted to be advanced into a selected coronary vein for delivering a pacing or defibrillation signal to a predetermined region of a patient's heart, such as the left ventricle is disclosed. A method of pacing and/or...http://www.google.com/patents/US20020065544?utm_source=gb-gplus-sharePatent US20020065544 - Medical electrical lead having variable bending stiffness
Publication number US20020065544 A1
Application number US 09/947,065
Also published as DE10058105A1, US6556873, US6741893
Publication number 09947065, 947065, US 2002/0065544 A1, US 2002/065544 A1, US 20020065544 A1, US 20020065544A1, US 2002065544 A1, US 2002065544A1, US-A1-20020065544, US-A1-2002065544, US2002/0065544A1, US2002/065544A1, US20020065544 A1, US20020065544A1, US2002065544 A1, US2002065544A1
Inventors Karel Smits
Patent Citations (5), Referenced by (63), Classifications (6), Legal Events (6)
Medical electrical lead having variable bending stiffness
US 20020065544 A1
Claims(185)
1. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
(a) an elongated lead body comprising proximal and distal sections, the elongated lead body defining axial distances which increase distally;
(b) at least one electrode for sensing or electrically stimulating the heart;
(c) a proximal end comprising an electrical connector, the connector being contiguouos with the proximal section of the lead body;
(d) a distal end contiguous with the distal section of the lead body;
(e) at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector;
wherein the distal section of the lead body further comprises at least first, second, and third segments, the first and third segments having bending stiffnesses which are greater than the bending stiffness of the second segment, the distal section of the lead body and the first, second and third segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position.
2. The medical electrical lead of claim 1, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
1.5 ≤ S bs S bf ≤ 100.
3. The medical electrical lead of claim 1, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
2 ≤ S bs S bf ≤ 10.
4. The medical electrical lead of claim 1, wherein the bending stiffness of the first segment (Sbs) is at least two times that of the bending stiffness of the second segment (Sbf).
5. The medical electrical lead of claim 1, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is selected from the group consisting of at least about 2.2, at least about 2.4, at least about 2.6, at least about 2.8, at least about 3.0, at least about 4, at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 20, at least about 30, at least about 40, at least about 50, and at least about 100.
6. The medical electrical lead of claim 1, wherein the second segment is disposed between the first and third segments.
7. The medical electrical lead of claim 1, wherein the bending stiffness of the distal section of the lead body increases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
8. The medical electrical lead of claim 1, wherein the bending stiffness of the distal section of the lead body decreases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
9. The medical electrical lead of claim 1, wherein the lengths of the first, second and third segments are selected according to a particular venous anatomy in which the lead is to be implanted.
10. The medical electrical lead of claim 1, wherein the lead assumes a substantially straight shape prior to implantation.
11. The medical electrical lead of claim 1, wherein the lead body has at least one pre-formed curve disposed therein.
12. The medical electrical lead of claim 1, wherein the distal section of the lead body and the first, second and third segments thereof are dimensioned and configured for use in a coronary sinus or cardiac vein of the heart.
13. The medical electrical lead of claim 1, wherein a fixation device is attached to the lead body.
14. The medical electrical lead of claim 13, wherein the fixation device is selected from the group consisting of a helical screw, a barb, a hook, at least one tine, and at least one arm.
15. The medical electrical lead of claim 13, wherein the fixation device is disposed near the distal end.
16. The medical electrical lead of claim 1, wherein the lead body is configured to permit preferential bending thereof along at least one pre-determined bending plane.
18. The medical electrical lead of claim 1, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally symmetric.
19. The medical electrical lead of claim 1, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally asymmetric.
20. The medical electrical lead of claim 19, wherein the at least one electrode and the lead body are dimensioned and configured such that when the lead is appropriately implanted within a venous portion of the heart the rotationally asymmetric segment may be employed by a physician to orient placement of the at least one electrode such that the electrode is pressed against or directed towards a selected portion of the heart.
21. The medical electrical lead of claim 1, wherein the lead body is configured and dimensioned such that when the lead is implanted within a venous portion of the human heart the second segment is located in portions of the venous portion which exhibit the greatest curvature.
22. The medical electrical lead of claim 1, wherein the second segment is disposed proximally from the first segment, the first and second segments are contiguous with one another along a junction, and the junction is located along the lead body at an axial position such that when the lead is implanted within a venous anatomy of the human heart the junction is located near an end of a curve in the venous anatomy.
23. The medical electrical lead of claim 1, wherein the lead body comprises a first asymmetric cross-section configured for implantation in a first preferred orientation in pre-determined distal-most portions of the heart's venous anatomy where bending radii are small, a second asymmetric cross-section configured for implantation in a second preferred orientation different from the first orientation in pre-determined portions of the heart's venous anatomy located proximal from the distal-most portions thereof.
24. The medical electrical lead of claim 1, wherein the first, second and third segments comprise means for changing the bending stiffness of the lead body as a function of axial distance selected from the group consisting of coils having variable pitch as a function of axial distance, coils having variable winding as a function of axial distance, coils having variable diameter as a function of axial distance, coils having variable pitch as a function of axial distance, the lead body having variable diameter as a function of axial distance, progressively adding more material to the lead body as a function of axial distance, adding more coils to the lead body as a function of axial distance, varying lead body insulation thickness as a function of axial distance, varying lead body insulation type as a function of axial distance, progressively incorporating more ring-shaped members into the lead body as a function of axial distance, varying electrode structure as a function of axial distance, varying electrode positioning as a function of axial distance, including members having changing bending stiffness along an outside portion of the lead body, disposing a member internally in the lead body having variable thickness as a function of axial distance, flattening portions of the lead body, and incorporating depressions into the lead body.
25. The medical electrical lead of claim 1, wherein the first, second and third segments comprise means for changing the bending stiffness of the lead body as a function of axial distance x selected from the group consisting of varying the bending modulus as a function of axial distance x of the material from which the lead body is formed, varying the density as a function of axial distance x of the material from which the lead body is formed, varying the composition as a function of axial distance x of a polymer from which the lead body is formed, varying the amount of cross-linking as a function of axial distance x in a polymer from which the lead body is formed, varying the flexule moduli as a function of axial distance x of the material from which the lead body is formed, varying the amount of a first polymer included, blended or mixed in a second polymer as a function of axial distance x, a shape-memory alloy member capable of having its bending stiffness be varied through selective activation of pre-determined portions thereof as a function of axial distance x, varying the composition of polymers included in the lead body as a function of axial distance x.
26. The medical electrical lead of claim 1, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the first segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
27. The medical electrical lead of claim 1, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
28. The medical electrical lead of claim 1, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein or a posterior cardiac vein of the heart a left ventricle of the heart may be electrically stimulated.
29. The medical electrical lead of claim 1, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an oblique left atrail vein of the heart a left atrium of the heart may be electrically stimulated.
30. The medical electrical lead of claim 1, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a middle portion of a great cardiac vein a right ventricle of the heart may be electrically stimulated.
31. The medical electrical lead of claim 1, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left atrium of the heart may be electrically stimulated.
32. The medical electrical lead of claim 1, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left ventricle of the heart may be electrically stimulated.
33. The medical electrical lead of claim 1, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a middle cardiac vein electrical stimulation of apical portions of the heart may be effected.
34. The medical electrical lead of claim 1, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a posterior cardiac vein electrical stimulation of basal portions of the heart may be effected.
35. The medical electrical lead of claim 1, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein electrical stimulation of basal portions of the heart may be effected.
36. The medical electrical lead of claim 1, wherein at least one of the first segment, the second segment and the third segment has a length selected from the group consisting of about 8 mm, between about 5 mm and about 10 mm, between about 5 mm and about 12 mm, and between about 5 mm and about 50 mm.
37. The medical electrical lead of claim 1, wherein at least a portion of the lead body has an outer diameter selected from the group consisting of between about 1 mm and about 2 mm, about 0.5 mm, about 3 mm, and exceeding 3 mm.
38. The medical electrical lead of claim 1, wherein the at least one electrode further comprises a cathode and an anode, the anode and the cathode being separated from one another along the lead body by a distance selected from the group consisting of between about 4 mm and about 12 mm, between about 5 mm and about 10 mm, between about 5 mm and about 7 mm, and about 5 mm, between about 20 mm and about 50 mm, about 60 mm, and about 15 mm.
39. The medical electrode of claim 1, wherein the lead body further comprises a lumen formed therein for accepting a stylet.
40. The medical electrical lead of claim 1, wherein the distal section of the lead body comprises a plurality of first, second and third segments having first and second and third lengths, respectively, and wherein the second segments are configured and dimensioned to be located in or along first curves having first radii of curvature in a venous anatomy of the heart, and wherein the first and third segments are configured and dimensioned to be located in or along second curves having second radii of curvature, the first radii being smaller than the second radii.
41. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
(a) a lead body having proximal and distal sections;
(c) a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body;
(d) a distal end connected to the distal section of the lead body;
wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position.
42. The medical electrical lead of claim 41, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
43. The medical electrical lead of claim 41, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
44. The medical electrical lead of claim 41, wherein the bending stiffness of the first segment (Sbs) is at least two times that of the bending stiffness of the second segment (Sbf).
45. The medical electrical lead of claim 41, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is selected from the group consisting of at least about 2.2, at least about 2.4, at least about 2.6, at least about 2.8, at least about 3.0, at least about 4, at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 20, at least about 30, at least about 40, at least about 50, and at least about 100.
46. The medical electrical lead of claim 41, wherein the bending stiffness of the distal section of the lead body increases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
47. The medical electrical lead of claim 41, wherein the bending stiffness of the distal section of the lead body decreases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
48. The medical electrical lead of claim 41, wherein the lengths of the first and second segments are selected according to a particular venous anatomy in which the lead is to be implanted.
49. The medical electrical lead of claim 41, wherein the lead assumes a substantially straight shape prior to implantation.
50. The medical electrical lead of claim 41, wherein the lead body has at least one pre-formed curve disposed therein.
51. The medical electrical lead of claim 41, wherein the distal section of the lead body and the first and second segments thereof are dimensioned and configured for implantation within a coronary sinus or cardiac vein of the heart.
52. The medical electrical lead of claim 41, wherein a fixation device is attached to the lead body.
53. The medical electrical lead of claim 41, wherein the fixation device is selected from the group consisting of a helical screw, a barb, a hook, at least one tine, and at least one arm.
54. The medical electrical lead of claim 41, wherein the fixation device is disposed near the distal end.
55. The medical electrical lead of claim 41, wherein the lead body is configured to permit preferential bending thereof along at least one pre-determined bending plane.
56. The medical electrical lead of claim 41, wherein the lead body is configured to permit three dimensional bending thereof along at least two pre-determined bending planes.
57. The medical electrical lead of claim 41, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally symmetric.
58. The medical electrical lead of claim 41, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally asymmetric.
59. The medical electrical lead of claim 58, wherein the at least one electrode and the lead body are dimensioned and configured such that when the lead is appropriately implanted within a venous portion of the heart the rotationally asymmetric segment may be employed by a physician to orient placement of the at least one electrode such that the electrode is pressed against or directed towards a selected portion of the heart.
60. The medical electrical lead of claim 41, wherein the lead body is configured and dimensioned such that when the lead is implanted within a venous portion of the human heart the second segment is located in portions of the venous portion which exhibit the greatest curvature.
61. The medical electrical lead of claim 41, wherein the second segment is disposed proximally from the first segment, the first and second segments are contiguous with one another along a junction, and the junction is located along the lead body at an axial position such that when the lead is implanted within a venous anatomy of the human heart the junction is located near an end of a curve in the venous anatomy.
62. The medical electrical lead of claim 41, wherein the lead body comprises a first asymmetric cross-section configured for implantation in a first preferred orientation in pre-determined distal-most portions of the heart's venous anatomy where bending radii are small, a second asymmetric cross-section configured for implantation in a second preferred orientation different from the first orientation in pre-determined portions of the heart's venous anatomy located proximal from the distal-most portions thereof.
63. The medical electrical lead of claim 41, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance selected from the group consisting of coils having variable pitch as a function of axial distance, coils having variable winding as a function of axial distance, coils having variable diameter as a function of axial distance, coils having variable pitch as a function of axial distance, the lead body having variable diameter as a function of axial distance, progressively adding more material to the lead body as a function of axial distance, adding more coils to the lead body as a function of axial distance, varying lead body insulation thickness as a function of axial distance, varying lead body insulation type as a function of axial distance, progressively incorporating more ring-shaped members into the lead body as a function of axial distance, varying electrode structure as a function of axial distance, varying electrode positioning as a function of axial distance, including members having changing bending stiffness along an outside portion of the lead body, disposing a member internally in the lead body having variable thickness as a function of axial distance, flattening portions of the lead body, and incorporating depressions into the lead body.
64. The medical electrical lead of claim 41, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance x selected from the group consisting of varying the bending modulus as a function of axial distance x of the material from which the lead body is formed, varying the density as a function of axial distance x of the material from which the lead body is formed, varying the composition as a function of axial distance x of a polymer from which the lead body is formed, varying the amount of cross-linking as a function of axial distance x in a polymer from which the lead body is formed, varying the flexule moduli as a function of axial distance x of the material from which the lead body is formed, varying the amount of a first polymer included, blended or mixed in a second polymer as a function of axial distance x, a shape-memory alloy member capable of having its bending stiffness be varied through selective activation of pre-determined portions thereof as a function of axial distance x, varying the composition of polymers included in the lead body as a function of axial distance x.
65. The medical electrical lead of claim 41, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the first segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
66. The medical electrical lead of claim 41, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
67. The medical electrical lead of claim 41, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein or a posterior cardiac vein of the heart a left ventricle of the heart may be electrically stimulated.
68. The medical electrical lead of claim 41, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an oblique left atrail vein of the heart a left atrium of the heart may be electrically stimulated.
69. The medical electrical lead of claim 41, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a middle portion of a great cardiac vein a right ventricle of the heart may be electrically stimulated.
70. The medical electrical lead of claim 41, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left atrium of the heart may be electrically stimulated.
71. The medical electrical lead of claim 41, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left ventricle of the heart may be electrically stimulated.
72. The medical electrical lead of claim 41, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a middle cardiac vein electrical stimulation of apical portions of the heart may be effected.
73. The medical electrical lead of claim 41, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a posterior cardiac vein electrical stimulation of basal portions of the heart may be effected.
74. The medical electrical lead of claim 41, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein electrical stimulation of basal portions of the heart may be effected.
75. The medical electrical lead of claim 41, wherein at least one of the first segment, the second segment and the third segment has a length selected from the group consisting of about 8 mm, between about 5 mm and about 10 mm, between about 5 mm and about 12 mm, and between about 5 mm and about 50 mm.
76. The medical electrical lead of claim 41, wherein at least a portion of the lead body has an outer diameter selected from the group consisting of between about 1 mm and about 2 mm, about 0.5 mm, about 3 mm, and exceeding 3 mm.
77. The medical electrical lead of claim 41, wherein the at least one electrode further comprises a cathode and an anode, the anode and the cathode being separated from one another along the lead body by a distance selected from the group consisting of between about 4 mm and about 12 mm, between about 5 mm and about 10 mm, between about 5 mm and about 7 mm, and about 5 mm, between about 20 mm and about 50 mm, about 60 mm, and about 15 mm.
78. The medical electrode of claim 41, wherein the lead body further comprises a lumen formed therein for accepting a stylet.
79. The medical electrical lead of claim 41, wherein the distal section of the lead body comprises a plurality of first and second segments having first and second lengths, respectively, and wherein the second segments are configured and dimensioned to be located in or along first curves having first radii of curvature in a venous anatomy of the heart, and wherein the first segments are configured and dimensioned to be located in or along second curves having second radii of curvature, the first radii being smaller than the second radii.
80. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured to impart a distally directed force to the distal end of the lead when the segments are subjected to a bending moment resulting in a sufficient curvature of the distal section of the lead body.
81. The medical electrical lead of claim 80, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
82. The medical electrical lead of claim 80, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
83. The medical electrical lead of claim 80, wherein the bending stiffness of the first segment (Sbs) is at least two times that of the bending stiffness of the second segment (Sbf).
84. The medical electrical lead of claim 80, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is selected from the group consisting of at least about 2.2, at least about 2.4, at least about 2.6, at least about 2.8, at least about 3.0, at least about 4, at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 20, at least about 30, at least about 40, at least about 50, and at least about 100.
85. The medical electrical lead of claim 80, wherein the bending stiffness of the distal section of the lead body increases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
86. The medical electrical lead of claim 80, wherein the bending stiffness of the distal section of the lead body decreases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
87. The medical electrical lead of claim 80, wherein the lengths of the first and second segments are selected according to a particular venous anatomy in which the lead is to be implanted.
88. The medical electrical lead of claim 80, wherein the lead assumes a substantially straight shape prior to implantation.
89. The medical electrical lead of claim 80, wherein the lead body has at least one pre-formed curve disposed therein.
90. The medical electrical lead of claim 80, wherein the distal section of the lead body and the first and second segments thereof are dimensioned and configured for implantation within a coronary sinus or cardiac vein of the heart.
91. The medical electrical lead of claim 80, wherein a fixation device is attached to the lead body.
92. The medical electrical lead of claim 91, wherein the fixation device is selected from the group consisting of a helical screw, a barb, a hook, at least one tine, and at least one arm.
93. The medical electrical lead of claim 91, wherein the fixation device is disposed near the distal end.
94. The medical electrical lead of claim 80, wherein the lead body is configured to permit preferential bending thereof along at least one pre-determined bending plane.
95. The medical electrical lead of claim 80, wherein the lead body is configured to permit three dimensional bending thereof along at least two pre-determined bending planes.
96. The medical electrical lead of claim 80, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally symmetric.
97. The medical electrical lead of claim 80, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally asymmetric.
98. The medical electrical lead of claim 97, wherein the at least one electrode and the lead body are dimensioned and configured such that when the lead is appropriately implanted within a venous portion of the heart the rotationally asymmetric segment may be employed by a physician to orient placement of the at least one electrode such that the electrode is pressed against or directed towards a selected portion of the heart.
99. The medical electrical lead of claim 80, wherein the lead body is configured and dimensioned such that when the lead is implanted within a venous portion of the human heart the second segment is located in portions of the venous portion which exhibit the greatest curvature.
100. The medical electrical lead of claim 80, wherein the second segment is disposed proximally from the first segment, the first and second segments are contiguous with one another along a junction, and the junction is located along the lead body at an axial position such that when the lead is implanted within a venous anatomy of the human heart the junction is located near an end of a curve in the venous anatomy.
101. The medical electrical lead of claim 80, wherein the lead body comprises a first asymmetric cross-section configured for implantation in a first preferred orientation in pre-determined distal-most portions of the heart's venous anatomy where bending radii are small, a second asymmetric cross-section configured for implantation in a second preferred orientation different from the first orientation in pre-determined portions of the heart's venous anatomy located proximal from the distal-most portions thereof.
102. The medical electrical lead of claim 80, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance selected from the group consisting of coils having variable pitch as a function of axial distance, coils having variable winding as a function of axial distance, coils having variable diameter as a function of axial distance, coils having variable pitch as a function of axial distance, the lead body having variable diameter as a function of axial distance, progressively adding more material to the lead body as a function of axial distance, adding more coils to the lead body as a function of axial distance, varying lead body insulation thickness as a function of axial distance, varying lead body insulation type as a function of axial distance, progressively incorporating more ring-shaped members into the lead body as a function of axial distance, varying electrode structure as a function of axial distance, varying electrode positioning as a function of axial distance, including members having changing bending stiffness along an outside portion of the lead body, disposing a member internally in the lead body having variable thickness as a function of axial distance, flattening portions of the lead body, and incorporating depressions into the lead body.
103. The medical electrical lead of claim 80, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance x selected from the group consisting of varying the bending modulus as a function of axial distance x of the material from which the lead body is formed, varying the density as a function of axial distance x of the material from which the lead body is formed, varying the composition as a function of axial distance x of a polymer from which the lead body is formed, varying the amount of cross-linking as a function of axial distance x in a polymer from which the lead body is formed, varying the flexule moduli as a function of axial distance x of the material from which the lead body is formed, varying the amount of a first polymer included, blended or mixed in a second polymer as a function of axial distance x, a shape-memory alloy member capable of having its bending stiffness be varied through selective activation of pre-determined portions thereof as a function of axial distance x, varying the composition of polymers included in the lead body as a function of axial distance x.
104. The medical electrical lead of claim 80, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the first segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
105. The medical electrical lead of claim 80, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
106. The medical electrical lead of claim 80, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein or a posterior cardiac vein of the heart a left ventricle of the heart may be electrically stimulated.
107. The medical electrical lead of claim 80, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an oblique left atrail vein of the heart a left atrium of the heart may be electrically stimulated.
108. The medical electrical lead of claim 80, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a middle portion of a great cardiac vein a right ventricle of the heart may be electrically stimulated.
109. The medical electrical lead of claim 80, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left atrium of the heart may be electrically stimulated.
110. The medical electrical lead of claim 80, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left ventricle of the heart may be electrically stimulated.
111. The medical electrical lead of claim 80, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a middle cardiac vein electrical stimulation of apical portions of the heart may be effected.
112. The medical electrical lead of claim 80, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a posterior cardiac vein electrical stimulation of basal portions of the heart may be effected.
113. The medical electrical lead of claim 80, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein electrical stimulation of basal portions of the heart may be effected.
114. The medical electrical lead of claim 80, wherein at least one of the first segment, the second segment and the third segment has a length selected from the group consisting of about 8 mm, between about 5 mm and about 10 mm, between about 5 mm and about 12 mm, and between about 5 mm and about 50 mm.
115. The medical electrical lead of claim 80, wherein at least a portion of the lead body has an outer diameter selected from the group consisting of between about 1 mm and about 2 mm, about 0.5 mm, about 3 mm, and exceeding 3 mm.
116. The medical electrical lead of claim 80, wherein the at least one electrode further comprises a cathode and an anode, the anode and the cathode being separated from one another along the lead body by a distance selected from the group consisting of between about 4 mm and about 12 mm, between about 5 mm and about 10 mm, between about 5 mm and about 7 mm, and about 5 mm, between about 20 mm and about 50 mm, about 60 mm, and about 15 mm.
117. The medical electrode of claim 80, wherein the lead body further comprises a lumen formed therein for accepting a stylet.
118. The medical electrical lead of claim 80, wherein the distal section of the lead body comprises a plurality of first and second segments having first and second lengths, respectively, and wherein the second segments are configured and dimensioned to be located in or along first curves having first radii of curvature in a venous anatomy of the heart, and wherein the first segments are configured and dimensioned to be located in or along second curves having second radii of curvature, the first radii being smaller than the second radii.
119. An elongated implantable medical electrical lead for electrically stimulating a human heart or sensing electrical signals originating therefrom, comprising:
wherein the distal section of the lead body comprises at least first and second segments, the first segment having a bending stiffness Sb1, the second segment having a bending stiffness Sb2, Sb1 not equalling Sb2, the first segment, and the second segment being configured and characterized such that a distally directed force is imparted to the distal end of the lead when the first and second segments are subjected to a bending moment resulting in a sufficient curvature of the lead body, the bending moment being provided by an external force applied to the lead.
120. The medical electrical lead of claim 119, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
121. The medical electrical lead of claim 119, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is defined by the equation:
122. The medical electrical lead of claim 119, wherein the bending stiffness of the first segment (Sbs) is at least two times that of the bending stiffness of the second segment (Sbf).
123. The medical electrical lead of claim 119, wherein the ratio of the bending stiffness of the first segment (Sbs) in respect of the second segment (Sbf) is selected from the group consisting of at least about 2.2, at least about 2.4, at least about 2.6, at least about 2.8, at least about 3.0, at least about 4, at least about 5, at least about 6, at least about 7, at least about 8, at least about 9, at least about 10, at least about 20, at least about 30, at least about 40, at least about 50, and at least about 100.
124. The medical electrical lead of claim 119, wherein the bending stiffness of the distal section of the lead body increases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
125. The medical electrical lead of claim 119, wherein the bending stiffness of the distal section of the lead body decreases distally in step-wise, monotonic, exponential or logarithmic fashion, or a combination or mixture thereof.
126. The medical electrical lead of claim 119, wherein the lengths of the first and second segments are selected according to a particular venous anatomy in which the lead is to be implanted.
127. The medical electrical lead of claim 119, wherein the lead assumes a substantially straight shape prior to implantation.
128. The medical electrical lead of claim 119, wherein the lead body has at least one pre-formed curve disposed therein.
129. The medical electrical lead of claim 119, wherein the distal section of the lead body and the first and second segments thereof are dimensioned and configured for implantation within a coronary sinus or cardiac vein of the heart.
130. The medical electrical lead of claim 119, wherein a fixation device is attached to the lead body.
131. The medical electrical lead of claim 130, wherein the fixation device is selected from the group consisting of a helical screw, a barb, a hook, at least one tine, and at least one arm.
132. The medical electrical lead of claim 130, wherein the fixation device is disposed near the distal end.
133. The medical electrical lead of claim 119, wherein the lead body is configured to permit preferential bending thereof along at least one pre-determined bending plane.
134. The medical electrical lead of claim 119, wherein the lead body is configured to permit three dimensional bending thereof along at least two pre-determined bending planes.
135. The medical electrical lead of claim 119, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally symmetric.
136. The medical electrical lead of claim 119, wherein the bending stiffness of at least one of the first segment and the second segment is rotationally asymmetric.
137. The medical electrical lead of claim 136, wherein the at least one electrode and the lead body are dimensioned and configured such that when the lead is appropriately implanted within a venous portion of the heart the rotationally asymmetric segment may be employed by a physician to orient placement of the at least one electrode such that the electrode is pressed against or directed towards a selected portion of the heart.
138. The medical electrical lead of claim 119, wherein the lead body is configured and dimensioned such that when the lead is implanted within a venous portion of the human heart the second segment is located in portions of the venous portion which exhibit the greatest curvature.
139. The medical electrical lead of claim 119, wherein the second segment is disposed proximally from the first segment, the first and second segments are contiguous with one another along a junction, and the junction is located along the lead body at an axial position such that when the lead is implanted within a venous anatomy of the human heart the junction is located near an end of a curve in the venous anatomy.
140. The medical electrical lead of claim 119, wherein the lead body comprises a first asymmetric cross-section configured for implantation in a first preferred orientation in pre-determined distal-most portions of the heart's venous anatomy where bending radii are small, a second asymmetric cross-section configured for implantation in a second preferred orientation different from the first orientation in pre-determined portions of the heart's venous anatomy located proximal from the distal-most portions thereof.
141. The medical electrical lead of claim 119, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance selected from the group consisting of coils having variable pitch as a function of axial distance, coils having variable winding as a function of axial distance, coils having variable diameter as a function of axial distance, coils having variable pitch as a function of axial distance, the lead body having variable diameter as a function of axial distance, progressively adding more material to the lead body as a function of axial distance, adding more coils to the lead body as a function of axial distance, varying lead body insulation thickness as a function of axial distance, varying lead body insulation type as a function of axial distance, progressively incorporating more ring-shaped members into the lead body as a function of axial distance, varying electrode structure as a function of axial distance, varying electrode positioning as a function of axial distance, including members having changing bending stiffness along an outside portion of the lead body, disposing a member internally in the lead body having variable thickness as a function of axial distance, flattening portions of the lead body, and incorporating depressions into the lead body.
142. The medical electrical lead of claim 119, wherein the first and second segments comprise means for changing the bending stiffness of the lead body as a function of axial distance x selected from the group consisting of varying the bending modulus as a function of axial distance x of the material from which the lead body is formed, varying the density as a function of axial distance x of the material from which the lead body is formed, varying the composition as a function of axial distance x of a polymer from which the lead body is formed, varying the amount of cross-linking as a function of axial distance x in a polymer from which the lead body is formed, varying the flexule moduli as a function of axial distance x of the material from which the lead body is formed, varying the amount of a first polymer included, blended or mixed in a second polymer as a function of axial distance x, a shape-memory alloy member capable of having its bending stiffness be varied through selective activation of pre-determined portions thereof as a function of axial distance x, varying the composition of polymers included in the lead body as a function of axial distance x.
143. The medical electrical lead of claim 119, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the first segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
144. The medical electrical lead of claim 119, wherein the lead body is configured and dimensioned such that when the lead is implanted within the heart the second segment is disposed in a distal portion of one of a great cardiac vein, a middle cardiac vein, a coronary sinus, a small cardiac vein, a posterior cardiac vein, an oblique left atrial vein, and an anterior cardiac vein.
145. The medical electrical lead of claim 119, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein or a posterior cardiac vein of the heart a left ventricle of the heart may be electrically stimulated.
146. The medical electrical lead of claim 119, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an oblique left atrail vein of the heart a left atrium of the heart may be electrically stimulated.
147. The medical electrical lead of claim 119, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within a middle portion of a great cardiac vein a right ventricle of the heart may be electrically stimulated.
148. The medical electrical lead of claim 119, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left atrium of the heart may be electrically stimulated.
149. The medical electrical lead of claim 119, wherein the lead body and the at least one electrode are configured and dimensioned such that when the lead is appropriately implanted within an anterior cardiac vein a left ventricle of the heart may be electrically stimulated.
150. The medical electrical lead of claim 119, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a middle cardiac vein electrical stimulation of apical portions of the heart may be effected.
151. The medical electrical lead of claim 119, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a posterior cardiac vein electrical stimulation of basal portions of the heart may be effected.
152. The medical electrical lead of claim 119, wherein the at least one electrode further comprises an anode and a cathode, and wherein the lead body and the anode and the cathode are configured and dimensioned such that when the lead is appropriately implanted within a great cardiac vein electrical stimulation of basal portions of the heart may be effected.
153. The medical electrical lead of claim 119, wherein at least one of the first segment, the second segment and the third segment has a length selected from the group consisting of about 8 mm, between about 5 mm and about 10 mm, between about 5 mm and about 12 mm, and between about 5 mm and about 50 mm.
154. The medical electrical lead of claim 119, wherein at least a portion of the lead body has an outer diameter selected from the group consisting of between about 1 mm and about 2 mm, about 0.5 mm, about 3 mm, and exceeding 3 mm.
155. The medical electrical lead of claim 119, wherein the at least one electrode further comprises a cathode and an anode, the anode and the cathode being separated from one another along the lead body by a distance selected from the group consisting of between about 4 mm and about 12 mm, between about 5 mm and about 10 mm, between about 5 mm and about 7 mm, and about 5 mm, between about 20 mm and about 50 mm, about 60 mm, and about 15 mm.
156. The medical electrode of claim 119, wherein the lead body further comprises a lumen formed therein for accepting a stylet.
157. The medical electrical lead of claim 119, wherein the distal section of the lead body comprises a plurality of first and second segments having first and second lengths, respectively, and wherein the second segments are configured and dimensioned to be located in or along first curves having first radii of curvature in a venous anatomy of the heart, and wherein the first segments are configured and dimensioned to be located in or along second curves having second radii of curvature, the first radii being smaller than the second radii.
158. A system for electrically stimulating, or sensing electrical signals originating from, a human heart, the system comprising:
(a) an implantable cardiac stimulator, and
(b) an elongated implantable medical electrical lead for electrically stimulating the heart or sensing electrical signals originating therefrom, comprising:
(i) an elongated lead body comprising proximal and distal sections, the elongated lead body defining axial distances which increase distally;
(ii) at least one electrode for sensing or electrically stimulating the heart;
(iii) a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body;
(iv) a distal end contiguous with the distal section of the lead body;
(v) at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector;
159. The system of claim 158, wherein the cardiac stimulator is selected from the group consisting of a pacemaker, an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a pacer-cardioverter-defibrillator (PCD), and an implantable defibrillator.
160. A system for electrically stimulating, or sensing electrical signals originating from, a human heart, the system comprising:
(i) a lead body having proximal and distal sections;
(iv) a distal end connected to the distal section of the lead body;
161. The system of claim 160, wherein the cardiac stimulator is selected from the group consisting of a pacemaker, an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a pacer-cardioverter-defibrillator (PCD), and an implantable defibrillator.
162. A system for electrically stimulating, or sensing electrical signals originating from, a human heart, the system comprising:
163. The system of claim 162, wherein the cardiac stimulator is selected from the group consisting of a pacemaker, an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a pacer-cardioverter-defibrillator (PCD), and an implantable defibrillator.
164. A system for electrically stimulating, or sensing electrical signals originating from, a human heart, the system comprising:
wherein the distal section of the lead body comprises at least first and second segments, the first segment having a bending stiffness Sb1, the second segment having a bending stiffness Sb2, Sb1 not equalling Sb2, the first segment, and the second segment being configured and characterized such that a distally directed force is imparted to the distal end of the lead when the first and second segments are subjected to a bending moment resulting in a sufficient curvature of the distal section of the lead body, the bending moment being provided by an external force applied to the lead.
165. The system of claim 164, wherein the cardiac stimulator is selected from the group consisting of a pacemaker, an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a pacer-cardioverter-defibrillator (PCD), and an implantable defibrillator.
166. A method of electrically stimulating a patient's heart with an implantable cardiac stimulator and an elongated implantable medical electrical lead, the lead comprising an elongated lead body comprising proximal and distal sections, the elongated lead body defining axial distances which increase distally, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end contiguous with the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, the distal section of the lead body further comprising at least first, second, and third segments, the first and third segments having bending stiffnesses which are greater than the bending stiffness of the second segment, the distal section of the lead body and the first, second and third segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the method comprising:
(a) providing the cardiac stimulator;
(b) providing the medical electrical lead;
(c) transvenously inserting and positioning the lead through a coronary sinus and into a coronary vein in the the heart,
(d) operatively connecting the connector of the lead to the cardiac stimulator; and
(e) delivering at least one electrical pulse originating in the cardiac stimulator through the lead and the at least one electrode to the heart.
167. The method of claim 166, wherein the at least one electrical pulse is a pacing pulse, the method further comprising delivering a pacing pulse to the heart.
168. The method of claim 166, wherein the at least one electrical pulse is a defibrillation pulse, the method further comprising delivering a pacing pulse to the heart.
169. The method of claim 166, the method further comprising employing a stylet when inserting and positioning the lead in the heart.
170. The method of claim 166, the method further comprising employing a guide catheter when introducing the lead into the coronary sinus.
171. The method of claim 170, the method further comprising removing the guide catheter after the lead has been inserted through the coronary sinus.
172. A method of electrically stimulating a patient's heart with an implantable cardiac stimulator and an elongated implantable medical electrical lead, the lead comprising a lead body having proximal and distal sections, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end connected to the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the method comprising:
173. The method of claim 172, wherein the at least one electrical pulse is a pacing pulse, the method further comprising delivering a pacing pulse to the heart.
174. The method of claim 172, wherein the at least one electrical pulse is a defibrillation pulse, the method further comprising delivering a pacing pulse to the heart.
175. The method of claim 172, the method further comprising employing a stylet when inserting and positioning the lead in the heart.
176. The method of claim 172, the method further comprising employing a guide catheter when introducing the lead into the coronary sinus.
177. The method of claim 176, the method further comprising removing the guide catheter after the lead has been inserted through the coronary sinus.
178. A method of electrically stimulating a patient's heart with an implantable cardiac stimulator and an elongated implantable medical electrical lead, the lead comprising a lead body having proximal and distal sections, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end connected to the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured to impart a distally directed force to the distal end of the lead when the segments are subjected to a bending moment resulting in a sufficient curvature of the distal section of the lead body, the method comprising:
179. The method of claim 178, wherein the at least one electrical pulse is a pacing pulse, the method further comprising delivering a pacing pulse to the heart.
180. The method of claim 178, wherein the at least one electrical pulse is a defibrillation pulse, the method further comprising delivering a pacing pulse to the heart.
181. The method of claim 178, the method further comprising employing a stylet when inserting and positioning the lead in the heart.
182. The method of claim 178, the method further comprising employing a guide catheter when introducing the lead into the coronary sinus.
183. The method of claim 182, the method further comprising removing the guide catheter after the lead has been inserted through the coronary sinus.
184. A method of making an elongated implantable medical electrical lead, the lead comprising an elongated lead body comprising proximal and distal sections, the elongated lead body defining axial distances which increase distally, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end contiguous with the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, the distal section of the lead body further comprising at least first, second, and third segments, the first and third segments having bending stiffnesses which are greater than the bending stiffness of the second segment, the distal section of the lead body and the first, second and third segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the method comprising:
(a) providing the at least one electrode;
(b) providing the at least one electrical conductor;
(c) providing the electrical connector;
(d) operatively connecting the electrical connector to the proximal end of the electrical conductor;
(e) operatively connecting the distal end of the electrical conductor to the at least one electrode;
(f) providing the lead body; and
(g) incorporating the at least one electrical conductor, the at least one electrode, the electrical connector and the lead body into the lead.
185. A method of making an elongated implantable medical electrical lead, the lead comprising a lead body having proximal and distal sections, at least one electrode for sensing or electrically stimulating the heart, a proximal end comprising an electrical connector, the connector being contiguous with the proximal section of the lead body, a distal end connected to the distal section of the lead body, at least one electrical conductor having proximal and distal ends, the distal end of the conductor being operatively connected to the at least one electrode, the proximal end of the conductor being operatively connected to the electrical connector, wherein the distal section of the lead body comprises at least first and second adjoining segments, the first segment being relatively stiff, the second segment being relatively flexible, the first and second segments being configured and dimensioned to assume a minimum stored mechanical energy implantation position when the lead is implanted within the coronary venous anatomy of the heart such that additional mechanical energy from an external source must be exerted upon the lead body along an axial direction to move the lead axially from the minimum stored mechanical energy implantation position, the method comprising:
This patent application hereby incorporates by reference herein, in its entirety, co-pending U.S. patent application Ser. No.______, filed Nov.—, 1999 for “Medical Electrical Lead Having Bending Stiffnesses Which Increase In The Distal Direction” to Smits having Attorney Docket No. P-7718.
U.S. Pat. No. Title
5,951,597 Coronary sinus lead having expandable matrix anchor
5,935,160 Left ventricular access lead for heart failure pacing
5,931,864 Coronary venous lead having fixation mechanism
5,931,819 Guidewire with a variable stiffness distal portion
5,925,073 Intravenous cardiac lead with wave shaped fixation
5,897,584 Torque transfer device for temporary transvenous
5,871,531 Medical electrical lead having tapered spiral fixation
5,855,560 Catheter tip assembly
5,833,604 Variable stiffness electrophysiology catheter
5,810,867 Dilation catheter with varied stiffness
5,803,928 Side access “over the wire” pacing lead
5,755,766 Open-ended intravenous cardiac lead
5,755,765 Pacing lead having detachable positioning member
5,749,849 Variable stiffness balloon catheter
5,733,496 Electron beam irradiation of catheters to enhance
5,639,276 Device for use in right ventricular placement and method
for using same
5,628,778 Single pass medical electrical lead
5,605,162 Method for using a variable stiffness guidewire
5,531,685 Steerable variable stiffness device
5,499,973 Variable stiffness balloon dilatation catheters
5,437,632 Variable stiffness balloon catheter
5,423,772 Coronary sinus catheter
5,330,521 Low resistance implantable electrical leads
5,308,342 Variable stiffness catheter
5,144,960 Transvenous defibrillator lead and method of use
5,111,811 Cardioversion and defibrillation lead system with
electrode extension into the Coronary sinus and
great vein
4,930,521 Variable stiffness esophageal catheter
4,215,703 Variable stiffness guide wire
08/794,175 Single Pass Medical Electrical Lead
08/794,402 Single Pass Medical Electrical Lead with Cap Electrodes
[0014]FIG. 1 shows a partial cross-sectional view of a human heart with one embodiment of a lead of the present invention in combination with a cardiac stimulator;
[0015]FIG. 2 shows a partial cross-sectional view of a heart having one embodiment of a lead of the present invention disclosed therein;
[0018]FIGS. 5A and 5B show two different embodiments of a lead body of the present invention in cross-section;
[0019]FIGS. 6A and 6B illustrate combined cross-sectional and perspective views of two different lead bodies of the present invention;
[0020]FIG. 7 illustrates an enlarged cross-sectional view of one embodiment of a lead of the present invention disposed within portions of the venous anatomy;
[0023]FIG. 11A-11D is a stylized cross-section of the venous anatomy within which various embodiments of the present invention may be implanted;
[0024]FIG. 12A illustrates three different positions within which various embodiments of the present invention may be located within the human heart;
FIGS. 13 illustrates a single pass dual chamber embodiment of a lead of the present invention;
[0027]FIG. 14 illustrates another embodiment of the present invention, where a lead is adapted for implantation within various portions of the venous anatomy;
[0028]FIG. 15 illustrates several methods of implanting a lead of the present invention within a human heart and electrically stimulating same.
[0029]FIG. 1 shows human heart 1 with medical electrical lead 10 of the present invention implanted therein. Proximal end 20 of medical electrical lead 10 is connected to implantable cardiac stimulator 30 by means of connector or terminal 18. Cardiac stimulator 30 may be a pacemaker, an implantable pulse generator (IPG), an implantable cardiodefibrillator (ICD), a pacer-cardioverter-defibrillator (PCD), or any other type of similar cardiac stimulator well known in the art. Medical electrical lead 10 comprises proximal portion 20, distal portion 22 and lead body 12. Tip 50 is disposed at the distalmost end of lead 10. As shown in FIG. 1, lead 10 enters right atrium 3 and then winds its way through ostium 11 into coronary sinus 13 and then through great cardiac vein 23 to the distalmost portion thereof. Medical electrical lead 10 comprises one or more electrodes 14 disposed thereon for pacing, sensing and/or defibrillating heart 1.
Expressed mathematically, the ratio of bending stiffnesses of stiff sections 2 and flexible sections 4 of lead 10 of the present invention may be, by way of example only, the following: 1.5 ≤ S bs S bf ≤ 100 ( eq .  1 ) 1.5 ≤ S bs S bf ≤ 20 ( eq .  2 ) 2 ≤ S bs S bf ≤ 10 ( eq .  3 ) 2 ≤ S bs S bf ≤ 5 ( eq .  4 )
When lead 10 is advanced through coronary sinus 13 into great cardiac vein 23 and then into posterior cardiac vein 17, for example, lead 10 will assume a winding, almost wave-shaped configuration, such that distal portion 22 is curved at the transition between coronary sinus 13 and posterior cardiac vein 17 as well as along the pathway of posterior cardiac vein 17.
FIGS. 3A-3C illustrate various principles associated with the foregoing discussion concerning FIGS. 1 and 2. The principle of a relatively straight lead having variable bending stiffness as a function of lead position is based on two mechanical laws: (1) a mechanical body subjected to an external load or deformation assumes a shape which minimizes the potential mechanical energy stored in that body; and (2) variation of the stored potential energy in a body with displacement of the body results from an external force acting thereon. The external force (F) equals the derivative of energy (E) with respect to displacement (x) as shown below: F =  E  x ( eq .  5 )  E  x = ϕ b · R b R b ·  S b  x = ϕ b ·  S b  x ( eq .  6 )
where Sb=bending stiffness, Rb=bending radius and φb is the bend angle.
In FIG. 3A the additional energy stored in curved flexible section 4 of lead body 12 is defined by the force F required to displace lead 12 into the position shown along with the change in displacement dX. FIGS. 3B and 3C illustrate that the amount of bending energy required to bend lead body 12 through an approximate 90° curvature is greater for the geometry shown in FIG. 3C than is that illustrated in FIG. 3B. This is because stiff section 2 is located in the curved section of lead body 12 is FIG. 3C. Greater bending energy is therefore required to bend lead body 12 into the configuration shown in FIG. 3C than the configuration shown in FIG. 3B, where flexible section 4 is disposed along most of the curved section. In other words, the lead configuration shown in FIG. 3B is mechanically more stable than is the configuration shown in FIG. 3C because the configuration of FIG. 3B achieves a lower stored mechanical energy level.
Applying the law of minimum stored mechanical energy to the distal section of lead 10, we can draw the following conclusions. When lead 10 is implanted in coronary sinus 13 and great cardiac vein 23, mechanical energy is stored in those curved sections of lead 10 which are located in the transition from coronary sinus 13 to coronary vein 23 or 17. Such stored mechanical energy is proportional to the stiffness of lead 10 and the length being curved, as well as to the curvature (which is the inverse of the bending radius). Assume that the curvature is determined mainly by the venous anatomy, that the angle or curvature is about 90° and that the bend radius is about 5 mm. Such a curve will be maintained by forces acting on both sides of the lead body. The energy stored in lead body 12 is proportional to the average stiffness in the curved section.
[0051]FIG. 4C shows lead 10 having a series of contiguous alternating relatively flexible and relatively stiff sections 2 and 4, respectively. Lead 10 shown in FIG. 4C exhibits a number of points of bilateral stability separated by a distance equal to the length of relatively flexible and relatively stiff sections 4 and 2, respectively. Such a lead configuration has the advantage that a tip or electrode thereof may be placed at any of several positions along one or more coronary veins. That is, the embodiment of lead 10 shown in FIG. 4C has a number of different minimum mechanical energy storage positions which it may assume within the venous anatomy of a patient. The relative lengths of relatively flexible portions 4 and relatively stiff portions 2 may be varied according to the radii of the different venous curves which are anticipated to be encountered during lead implantation.
Referring now to FIGS. 5A and 5B, there are shown in cross-section lead body 12 exhibiting symmetric equal bending stiffnesses around each axis of bending in FIG. 5A and lead body 12 having asymmetric unequal bending stiffnesses around each axis of bending in FIG. 5B. Thus, lead 10 shown in FIG. 5A may be bent in any direction from 0° to 360° without any change in bending moment being required. Contrariwise, lead 10 shown in FIG. 5B requires more bending moment when lead 10 is bent in the directions of 0° and 180°, while less bending moment is required when lead 10 is bent in the 90° and 270° directions.
[0056]FIGS. 6A and 6B illustrate lead bodies which require asymmetric bending moments as a function of angular direction. In order to maintain minimal mechanical energy, lead body 12 illustrated in FIG. 5B will attempt to orient itself along the plane of the curve within which it is disposed such that bending preferentially occurs over the lead axis along the most flexible lead cross-section (e.g., the 90° and 270° orientations). This characteristic may be exploited so that lead body 12 may be oriented such that an electrode disposed along or near such a section exhibiting asymmetric bending stiffness is strategically placed within a vein. Thus, for example, a pacing or defibrillation electrode 14 disposed near such an asymmetric bending stiffness section may be oriented towards the myocardium (which may be beneficial in obtaining low pacing thresholds and improved sensing of signals).
[0057]FIG. 6A illustrates the natural orientation which the lead of FIG. 5B will assume within a curved portion of the venous anatomy. The lead configuration shown in FIG. 6B is one which requires maximum mechanical energy and therefore will not be assumed by lead 10 when disposed in a curved section of the venous anatomy.
Assuming the embodiment of the present invention illustrated in FIGS. 5B and 6A is employed for implantation within a desired portion of the venous anatomy, such a lead will have two orientations where stored mechanical energy will be achieved, namely at φ=90° or φ=270°, assuming that the bending stiffness of the lead is equal in those opposite directions. Electrode 14(b) may be positioned on one side or the other of lead body 12 to stimulate a desired portion of the heart as shown in FIG. 7. Such positioning may be confirmed through the use of x-ray or echo identification of the orientation of electrode 14(b). If required, lead 10 may be rotated through 180° such that electrode 14(b) faces a desired direction.
[0060]FIG. 8A illustrates lead 10 of the present invention having multiple electrodes 14 of the present invention disposed thereon. More particularly, lead 10 comprises pacing electrodes 14 c, 14 b and 14 d as well as coil defibrillation electrode 14 a. Beneath lead 10 in FIG. 8A are shown FIGS. 8B and 8C exhibiting two different examples of possible bending stiffness profiles. The bending stiffness profile exhibited in FIG. 8B has only a single portion 4 of decreased flexibility adjoining two relatively stiff sections 2 located proximally and distally in respect thereof. Contrariwise, the bending force profile illustrated in FIG. 8C exhibits an alternating sequence of relatively flexible sections 4 and relatively stiff sections 2. As noted above, flexible sections 4 of lead 10 are optimally positioned along portions of the venous anatomy which exhibit the greatest curvature to thereby retain lead 10 within a desired portion of a cardiac vein.
[0061]FIG. 9A shows another embodiment of lead 10 of the present invention, where pacing electrodes 14 c and 14 b are located proximally and distally from coil defibrillation electrode 14 a. FIGS. 9B and 9C illustrate two examples of bending stiffness profiles for the lead of FIG. 9A, where bending stiffness varies as a function of axial distance X in the manner shown.
It is well know that metal parts such as electrode surfaces tend to maintain their mechanical properties over time. Polymeric materials from which lead body 12 is customarily formed, however, may exhibit low grade creep characteristics (e.g., low stress relaxation), and may therefore exhibit bending modulii which are not dependent on temperature or fluid saturation. In order not to lose the desired bending stiffness properties of the present invention to the extent that destabilization might occur after implantation, materials for forming lead body 12 of the present invention include silicone rubber and polyurethane. Other implantable grade materials are, of course, contemplated in the present invention, including but not limited to, PEBAX, PTFE,and ETFE.
[0068]FIG. 10A illustrates one embodiment of the present invention where coils having variable pitch are embedded within lead body 12 to thereby impart variations in bending stiffness to lead body 12 as a function of axial distance x. Tightly wound pre-stressed coils are disposed along relatively stiff sections 2, while loosely wound coils are disposed in relatively flexible sections 4. Note that the coils shown in FIGS. 10A-10C. may, of course, be employed in conjunction with or as a part of defibrillation electrodes or electrical conductors, or in conjunction with pacing or sensing electrodes or electrical conductors.
[0069]FIG. 10B illustrates one embodiment of the invention where the diameter of the coils disposed within lead body 12 is varied to thereby impart variations in bending stiffness to lead body 12 as a function of axial distance x. Large diameter coiled portions form relatively flexible portions 4, while small diameter coiled portions form relatively stiff portions 2.
[0070]FIG. 10C illustrates another embodiment of the present invention where variations in coil pitch are employed to impart variations in bending stiffnesses to lead body 12 as a function of axial distance x. Low pitch sections form relatively flexible portions 4 while large pitch sections form relatively stiff sections 2. Both sections 2 and 4 are most preferably space wound. Of course, combinations of FIGS. 10A, 10B and 10C also fall within the scope of the present invention.
[0071]FIG. 10D illustrates an embodiment of the present invention where portions of lead body 12 are carved, ablated or otherwise removed from lead body 12 or not included therein during formation to create preferentially oriented relatively flexible sections 4 adjoining relatively rigid sections 2.
[0072]FIG. 10E illustrates one embodiment of the present invention where coils disposed in lead body 12, and which may constitute or form part of one or more pacing, sensing or defibrillation electrodes or electrical conductors, are embedded in a relatively stiff material such as a polymeric substance.
The relatively stiff sections within which the coils are embedded exhibit increased bending stiffness relative to those sections of lead body 12 where the coils are not embedded within the relatively stiff material.
[0074]FIG. 10F illustrates one embodiment of the invention where variations in the thickness or type of lead body insulation are employed to impart variations in bending stiffness to lead body 12 as a function of axial distance x.
[0075]FIG. 10G illustrates one embodiment of the present invention where increased rigidity is imparted to certain sections of lead body 12 by disposing ring shaped relatively stiff members beneath the outer insulation of lead 10, and where the relatively stiff members adjoin relatively flexible portions of lead body 12.
[0076]FIG. 10H illustrates one embodiment of the present invention where relatively stiff members are positioned on the outside of the outer insulation of lead body 12 to thereby impart variations in bending stiffness to lead body 12 as a function of axial distance x. Note that relatively stiff members 2 shown in FIGS. 10G and 10H may include electrodes or electrode surfaces specifically designed and adapted for the purpose of not only stimulating the heart but also to provide variations in bending stiffness as a function of axial distance x according to the particular design parameters corresponding to the portion of the venous anatomy within which lead 10 is to be disposed.
[0077]FIG. 10I illustrates one embodiment of the present invention where an electrical conductor coil 48 is disposed about an internal member exhibiting bending stiffnesses which vary as a function of axial distance x owing to increased thicknesses over relatively stiff sections 2 and decreased thicknesses over relatively flexible sections 4.
[0078]FIG. 10J illustrates one embodiment of the present invention where opposing sections of tubing forming lead body 12 are flattened without perforating or making holes in the tubing to thereby impart increased flexibility to lead body 12 along one direction.
[0079]FIG. 10K shows the lead body illustrated in FIG. 10J rotated through 90° such that flattened portions 2 are viewed from above.
[0080]FIG. 10L illustrates one embodiment of the present invention where the diameter of lead body 12 and/or the thickness of an outer layer forming part of lead body 12 is varied as a function of axial distance x to thereby impart variations in bending stiffness as a function of axial distance x. In the embodiment of the present invention illustrated in FIG. 10L, not only may the diameter of lead body 12 be varied to impart changes in bending stiffness as a function of axial distance x, but also such variations may be effected in asymmetric manner such that lead body 12 is radially asymmetric in cross-section and has a preferential bending axis which will preferentially be disposed along the vein within which it is implanted.
[0081]FIG. 10M illustrates yet another embodiment of the present invention, where lead body 12 has incorporated therein a flat rivet shaped material which is twisted along pre-selected portions thereof to provide preferential orientation of lead 10 when implanted within the human body. Alternating portions 2 and 4 may be of such lengths and orientations as to provide one or more preferred orientations for lead 10 within the venous anatomy according to the particular requirements at hand, e.g., implantation within the middle cardiac vein, great cardiac vein, coronary sinus, oblique left atrial vein, small cardiac vein, and/or posterior cardiac vein.
[0082]FIG. 10M shows another embodiment of the present invention where lead 10 exhibits variations in bending stiffness along axial direction x. Flattened portions 2 interposed between relatively flexible portions 4 provide increased stiffness or rigidity to sections 2. Relatively stiff sections may also serve to orient electrodes 14 (not shown) such that electrodes 14 may be positioned to stimulate a selected portion of the heart more efficiently, as well as to provide improved sensing of intra-cardiac signals.
It is contemplated in the present invention that means of varying the bending stiffness of the distal section of a lead of the present invention other than those described here and above respective FIGS. 10A-10M fall within the scope of the present invention. For example, the material from which lead body 12 is formed may be varied compositionally or otherwise as a function of axial distance x, to thereby effectuate changes in the bending stiffness thereof. The degree to which a polymer forming lead body 12 is cross-linked may be varied as a function of axial distance x. The density of the polymers 5 or other materials employed to form lead body 12 may be varied as a function of axial distance x. The molecular weight of the polymers or other materials from which lead body 12 is formed may be varied as a function of axial distance x. A flexible tubular member containing a shape-memory tube may be included in a lumen extending along a central axis of the lead body, and a control system may then selectively heat portions of the shape-memory tube to change the bending stiffness or shape thereof. The foregoing and other methods of varying the bending stiffness of the distal section of a lead body of the present invention are contemplated in the present invention. See, for example, U.S. Pat. No. 5,437,632 for “Variable stiffness balloon catheter”; U.S. Pat. No. 5,499,973 for “Variable stiffness balloon dilatation catheters”; U.S. Pat. No. 5,531,685 for “Steerable variable stiffness device”; U.S. Pat. No. 5,639,276 for “Device for use in right ventricular placement and method for using same”; U.S. Pat. No. 5,833,604 for “Variable stiffness electrophysiology catheter”; and U.S. Pat. No. 5,733,496 for “Electron beam irradiation of catheters to enhance stiffness”, the disclosures of which are hereby incorporated by reference herein, each in its respective entirety.
[0084]FIG. 11 A is a stylized cross-section of the venous anatomy with which the present invention is principally concerned. Note that the various veins are illustrated stylistically and are not shown to scale. In FIG. 11A, one lead of the present invention is shown disposed in great cardiac vein 23 such that distalmost relatively rigid section 2 is located near the distal end of great cardiac vein 23. Distalmost relatively flexible section 4 is located immediately proximal from distalmost section 2 and is disposed along that portion of great cardiac vein 23 exhibiting the greatest curvature. Other sections 2 and 4 located proximally from distalmost relatively flexible section 4 are also shown in FIG. 11A. The lead geometry shown in FIG. 11A results in better retention of lead 10 within great cardiac vein 23 than would otherwise be achieved owing to the differences in stiffness of sections 2 and 4.
FIGS. 11B-11D illustrate positioning of lead 10 within various coronary veins according to various methods of pacing and/or defibrillating. FIG. 11 B shows one embodiment of lead 10 of the present invention positioned within the anterior cardiac vein in a location suitable for pacing the left atrium. FIG. 11C shows one embodiment of lead 10 of the present invention located in a position suitable for pacing the left ventricle from the posterior cardiac vein. FIG. 11D shows one embodiment of lead 10 of the present invention positioned within the posterior cardiac vein such that a first electrode is aligned with the left atrium and the second electrode is aligned with the left ventricle.
[0090]FIG. 12A illustrates still further embodiments of the present invention and methods of practicing same. In FIG. 12A, three different positions for various embodiments of medical electrical lead 10 of the present invention are shown: (1) for apical pacing of the heart, and (2) and (3) for basal pacing or other stimulation of the heart. Lead 10 shown positioned within middle cardiac vein 19 has cathode 14(b) and anode 14(a) disposed near distal end 22 thereof for effecting apical pacing and/or defibrillation of heart 1. Medical electrical lead 10 of the present invention shown implanted in posterior cardiac vein 17 is positioned such that anode 14(a) and cathode 14(b) may pace and/or defibrillate the heart from a more basal position. Similarly, lead 10 shown implanted in great cardiac vein 23 has electrodes 14(a) and 14(b) positioned for basal pacing and/or defibrillation of heart 1.
[0096]FIG. 12C shows an embodiment of the present invention where more basal stimulation of patient's heart 1 is desired. Contrariwise, the embodiment of the present invention shown in FIG. 12D is configured such that electrodes 14(a) and 14(b) may be positioned deeper within a selected cardiac vein to permit more apical stimulation of heart 1.
[0101]FIG. 13 shows one embodiment of the present invention comprising single pass dual chamber lead 10. The distal portion of lead 10 extends into Posterior cardiac vein 17. Proximal from electrodes 14(a) and 14(b) of distal portion 22 of lead 10 are located electrodes 14(c) and 14(d) positioned in Coronary sinus 13. Electrodes 14(c) and 14(d) are positioned to stimulate the left atrium, while electrodes 14(a) and 14(b) are positioned to stimulate the left ventricle. The preferred distance between electrodes 14(c) and 14(d) ranges between about 20 mm and about 50 mm, but may be as large as about 60 mm or as little as about 15 mm. Lead 10 may also be implanted in great cardiac vein 23 such that distal electrodes 14(b) and 14(a) stimulate the left ventricle therefrom. Placement within posterior cardiac vein 17 of lead 10 shown in FIG. 13 permits apical pacing of the left ventricle to be accomplished whereas positioning of lead 10 in great cardiac vein 23 permits basal pacing of the left ventricle.
[0102]FIG. 14 illustrates another embodiment of the present invention, where lead 10 is adapted for implantation within right atrium 3, coronary sinus 13 and a selected cardiac vein. The distal tip 50 of lead 10 is disposed in the selected cardiac vein, while proximal therefrom a portion of lead 10 having bending stiffness characteristics which differ from those of the distalmost portions of lead 10. More particularly, and referring now to FIG. 14 again, it will be seen that distal portion 22 of lead 10 is characterized in having a bending stiffness profile which alternates between relatively stiff portions 2 and relatively flexible portions 4. Proximal from such sections of alternating relatively stiff and relatively flexible sections 2 and 4 there is disposed a section of lead body 12 in which bending stiffness increases in the distal direction, most preferably in the manner shown in FIG. 14. Note, however, that the increase in bending stiffness shown over those portions of lead 10 illustrated in FIG. 14 intended for implantation in right atrium 3, and optionally at least portions of coronary sinus 13, may increase monotonically, exponentially, step-wise or logrithmically. The important point is that bending stiffness over the portion of the lead implanted within the right atrium and optionally at least portions of the Coronary sinus have an increasing bending stiffness to create a force which will have a tendency to push the lead in the distal direction, even after implantation.
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U.S. Classification 607/122, 607/4
Cooperative Classification A61N1/0563, A61N2001/0585