Apparatus and method for implanting left ventricular pacing leads within the coronary sinus

• US 20040215139A1
• Filed: 12/22/2003
• Published: 10/28/2004
• Est. Priority Date: 12/20/2002
• Status: Abandoned Application

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Cohen, Todd
• Application Number:
  US10/744,591
• Publication Number:
  US 20040215139A1
• Time in Patent Office: Days
• US Class Current: 604/95.04
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A steerable catheter comprises a flexible tubular body having a proximal end, a distal end, and at least one lumen; an inflatable annular balloon positioned on or near the distal end of the tubular body; at least one electrode positioned on or near the distal end of the tubular body; and a handle attached to the proximal end of the tubular body. The handle cooperates with the distal end of the tubular body to steer the catheter. The catheter is especially useful in placing pacemaker or defibrillator leads in the heart or coronary sinus. Additionally, the invention also provides a device and platform for providing a variety of medical technologies including angiography, venography, angioplasty, stenting, valvuloplasty, embolization, drug delivery, and additional therapy delivery (e.g., laser, radiofrequency energy, ultrasound, microwave, etc).

Claims

1. A steerable catheter comprising:

a flexible tubular body having a proximal end, a distal end, and at least one lumen;

an inflatable annular balloon positioned on or near the distal end of the tubular body;

at least one electrode positioned on or near the distal end of the tubular body; and

a handle attached to the proximal end of the tubular body,

wherein the handle cooperates with the distal end of the tubular body to steer the catheter.

2. The catheter of claim 1, wherein the tubular body can be rotated and the distal end of the tubular body can be bent to steer the catheter.

3. The catheter of claim 1, wherein the tubular body comprises an inflation lumen in fluid communication with the annular balloon.

4. The catheter of claim 1, wherein there are at least two electrodes.

5. The catheter of claim 1, wherein each electrode has a proximally extending wire that extends through the handle to a connector.

6. The catheter of claim 5, wherein each wire extends through a lumen in the tubular body.

7. The catheter of claim 5, wherein each wire extends through the sidewall of the tubular body.

8. The catheter of claim 1, wherein contrast fluid can be delivered through a lumen in the tubular body.

9. The catheter of claim 1, wherein a guidewire can be placed in a lumen in the tubular body.

10. The catheter of claim 9, wherein the guidewire can be used to facilitate delivery of a pacing lead, defibrillator lead, catheter or stent.

11. The catheter of claim 1, wherein the handle is ergonomic.

12. The catheter of claim 1, wherein the handle has an axial lumen in fluid communication with at least one lumen of the catheter.

13. The catheter of claim 1, wherein at least one steering or pull wire or cord extends proximally from at or near the distal end of the tubular body to the handle.

14. The catheter of claim 13, wherein the handle engages each steering or pull wire or cord and has a mechanism to activate each steering or pull wire or cord to cause the catheter distal end to bend or deflect for steering purposes.

15. The catheter of claim 13, wherein each steering or pull wire or cord extends through a lumen in the tubular body.

16. The catheter of claim 1, wherein the tubular body has a distal section with a radius of curvature and a proximal section and the catheter has means to adjust the radius of curvature of the distal section while maintaining the proximal section substantially straight.

17. The catheter of claim 1, wherein at least one lumen in the tubular body has a diameter of from about 0.01 to about 0.40 inches.

18. The catheter of claim 1, wherein the tubular body has a total length of from about 40 to about 200 cm.

19. The catheter of claim 18, wherein the total length is from about 40 to about 110 cm.

20. The catheter of claim 19 which is intended for access from upper extremity body vessels.

21. The catheter of claim 17, wherein the total length is from about 90 to about 200 cm.

22. The catheter of claim 21 which is intended for access from lower extremity body vessels as well as the upper extremity body vessels.

23. The catheter of claim 1, wherein the distal end of the tubular body can be visualized fluoroscopically to facilitate anatomic placement.

24. The catheter of claim 1, wherein placement of the catheter in the coronary sinus can be confirmed fluoroscopically by the catheter crossing the spine in the left anterior oblique projection and by an atrioventricular electrogram recording confirming this position.

25. The catheter of claim 1, wherein the at least one electrode facilitates recording electrical activity or specific structure potentials.

26. The catheter of claim 1, wherein there are at least two electrodes.

27. The catheter of claim 1, wherein each electrode is annular and has a width of from about 1 to about 4 mm.

28. The catheter of claim 27, wherein two electrodes are positioned about 2 to about 5 mm apart and the inflatable balloon is proximal to these electrodes by from about 1 to about 20 mm.

29. The catheter of claim 27, wherein two electrodes are positioned about 2 to about 5 mm apart, the inflatable balloon is proximal to these electrodes by from about 1 to about 5 mm, and two additional electrodes positioned about 2 to about 5 mm apart are positioned about 2 to about 5 mm proximal to the inflatable balloon.

30. The catheter of claim 1, wherein an array of electrodes is arranged to facilitate mapping, pacing, sensing, and/or catheter ablation of a variety of arrhythmias.

31. The catheter of claim 1 which is available in a variety of different definable curvature capabilities designed to engage the coronary sinus vein or other vessels.

32. The catheter of claim 1, wherein the distal portion of the tubular body can be bent to different radii of curvature.

33. The catheter of claim 31, wherein the catheter may have a secondary bend.

34. The catheter of claim 1, wherein the inflatable balloon is a high pressure balloon.

35. The catheter of claim 34 which is suitable for performing angioplasty.

36. The catheter of claim 33 which is capable of delivering a stent.

37. The catheter of claim 34 which can be used to deliver a stent to a particular stenotic vessel or stenotic corporeal structure, dilating the vessel or stricture, and, optionally, delivering the stent, to resolve an obstruction.

38. The catheter of claim 1, wherein the distal end of the tubular body comprises means for performing catheter ablation.

39. The catheter of claim 36, wherein a plurality of ablation means are aligned along the distal surface of the tubular body in a configuration to create a linear ablation.

40. The catheter of claim 36, wherein a plurality of ablation means are aligned along the distal surface of the tubular body in a configuration to create a circumferential ablation.

88. A kit for implanting a pacing or defibrillator lead comprising:

a catheter of claim 1 and

a pacemaker or defibrillator lead arranged within a lumen of the catheter.

89. The kit of claim 88 which also includes an introducer sheath.

90. The kit of claim 89 which includes two introducer sheaths of different lengths.

91. The kit of claim 88 which includes more than one catheter of claim 1, wherein each catheter has a different pre-formed radius of curvature at its distal end.

96. The kit of claim 95, wherein the catheter is a steerable catheter of claim 1.

105. The method for implanting a pacemaker lead inside the coronary sinus vein as described in claim 100 which includes:

(a) use of a steerable lumen balloon tip catheter;

(b) cannulation and placement of a catheter of claim 1 and advancement of said sheath beyond the coronary sinus ostium to secure the sheath;

(c) pulling back said catheter such that the balloon tip is just outside the introducer sheath which lies in the proximal component of the coronary sinus vein;

(d) inflation of the balloon to occlude the proximal portion of the coronary sinus vein;

(e) injection of contrast through the lumen of said catheter to fluoroscopically image the coronary sinus vein and its branches;

(f) removal of said catheter from the introducer sheath;

(g) placement of a pacemaker lead into said sheath and advancement ventricular branch of the coronary sinus;

(h) testing the pacing and sensing function of said lead to assure thresholds and function;

(i) removal of said sheath over the lead while maintaining the lead appropriate location;

(j) securing the lead end to the floor of the device pocket; and

(k) attaching lead to device.

109. The catheter of claim 105, wherein the tubular body can be rotated an the distal end of the tubular body can be bent to steer the catheter.

41. A catheter for temporary pacing or sensing purposes, which comprises:

a flexible tubular body having a proximal end, a distal end, and at least one lumen;

an inflatable annular balloon positioned on or near the distal end of the tubular body;

at least one electrode positioned on or near the distal end of the tubular body; and

a handle attached to the proximal end of the tubular body,

wherein the handle cooperates with the distal end of the tubular body to steer the catheter and the catheter functions as a temporary pacing or sensing lead.

42. The catheter of claim 41, wherein the catheter functions as a temporary pacing or sensing lead in the coronary sinus vein.

43. A steerable catheter comprising:

a flexible tubular body having a proximal end, a distal end, and at least one lumen and at least one steering or pull wire or cord extending form the distal end to the proximal end; and

a handle attached to the proximal end of the tubular body,

wherein the handle cooperates with the at least one steering or pull wire or cord to steer the distal end of the catheter and at least one lumen facilitates delivery of contrast fluid.

44. The catheter of claim 43, wherein an inflatable annular balloon is positioned at or near the distal end of the tubular body.

45. The catheter of claim 43, wherein at least one electrode is positioned at or near the distal end of the tubular body.

46. The catheter of claim 43, wherein an array of electrodes is arranged to facilitate mapping, pacing, sensing, and/or catheter ablation of a variety of arrthymias.

47. A steerable catheter comprising:

a flexible tubular body having a proximal end, a distal end, and at least one lumen;

at least one radiopaque marker positioned on or near the distal end of the tubular body; and

a handle attached to the proximal end of the tubular body,

wherein the handle cooperates with the distal end of the tubular body to steer the catheter.

48. The catheter of claim 47, wherein the tubular body can be rotated and the distal end of the tubular body can be bent to steer the catheter.

49. The catheter of claim 47, wherein contrast fluid can be delivered through a lumen in the tubular body.

50. The catheter of claim 47, wherein a guidewire can be placed in a lumen in the tubular body.

51. The catheter of claim 50, wherein the guidewire can be used to facilitate delivery of a pacing lead, defibrillator lead, catheter or stent.

52. The catheter of claim 47, wherein the handle is ergonomic.

53. The catheter of claim 47, wherein at least one steering or pull wire or cord extends proximally from at or near the distal end of the tubular body to the handle.

54. The catheter of claim 53, wherein each steering or pull wire or cord extends through a lumen in the tubular body.

55. The catheter of claim 47, wherein the tubular body has a distal section with a radius of curvature and a proximal section and the catheter has means to adjust the radius of curvature of the distal section while maintaining the proximal section substantially straight.

56. The catheter of claim 47, wherein at least one lumen in the tubular body has a diameter of from about 0.01 to about 0.40 inches.

57. The catheter of claim 47, wherein the tubular body has a total length of from about 40 to about 200 cm.

58. The catheter of claim 57, wherein the total length is from about 40 to about 110 cm.

59. The catheter of claim 57, wherein the total length is from about 90 to about 200 cm.

60. The catheter of claim 47, wherein the distal end of the tubular body can be visualized fluoroscopically to facilitate anatomic placement.

61. The catheter of claim 47, wherein placement of the catheter in the coronary sinus can be confirmed fluoroscopically by the catheter crossing the spine in the left anterior oblique projection and by an atrioventricular electrogram recording confirming this position.

62. The catheter of claim 47 which is available in a variety of different definable curvature capabilities designed to engage the coronary sinus vein or other vessels.

63. The catheter of claim 47, wherein the distal portion of the tubular body can be bent to different radii of curvature.

64. The catheter of claim 62, wherein the catheter may have a secondary bend.

65. The catheter of claim 47, wherein the distal end of the tubular body comprises means for performing catheter ablation.

66. The catheter of claim 64, wherein a plurality of ablation means are aligned along the distal surface of the tubular body in a configuration to create a linear ablation.

67. The catheter of claim 64, wherein a plurality of ablation means are aligned along the distal surface of the tubular body in a configuration to create a circumferential ablation.

68. The catheter of claim 47 which can be used for performing a venogram or an angiogram.

69. A steerable introducer sheath comprising:

a flexible tubular body having a proximal end, a distal end, an axial lumen, and at least one axial separation line extending from the proximal end to the distal end;

at least one electrode positioned at or near the distal end of the tubular body;

a hub or handle having a hemostatic seal or valve secured to the proximal end of the flexible tubular body,

wherein the hub has at least one weakened axial line so that it may be manually separated along said at least one axial line.

70. The introducer sheath of claim 69 which has an inflatable balloon at the distal end of the flexible tubular body, said balloon being attached to the flexible tubular body in a manner which permits axial separation of the body.

71. The introducer sheath of claim 69, wherein the hub or handle cooperates with the distal end of the tubular body to steer the sheath.

72. The introducer sheath of claim 69, wherein at least one steering or pull wire or cord extends proximally from at or near the distal end of the tubular body to the handle.

73. The introducer sheath of claim 71, wherein each steering or pull wire or cord extends through a lumen in the tubular body.

74. The introducer sheath of claim 69, wherein the tubular body has a distal section with a radius of curvature and a proximal section and the catheter has means to adjust the radius of curvature of the distal section while maintaining the proximal section substantially straight.

75. The introducer sheath of claim 69, wherein the hub or handle has a primary access port which is axially aligned with the axial lumen of the flexible tubular body.

76. The introducer sheath of claim 69, wherein the flexible tubular body has a length of from about 40 cm to about 200 cm and a lumen diameter of from about 2 F to about 12 F.

77. The introducer sheath of claim 69, wherein a lumen has sufficient diameter to pass a pacemaker or defibrillator lead.

78. The introducer sheath of claim 69, wherein a second axial separation line is formed on the flexible tubular body parallel to said at least one axial separation line.

79. The introducer sheath of claim 69, wherein the hub or handle has two weakened axial lines in alignment with the two axial separation lines on the flexible tubular body.

80. The introducer sheath of claim 78, wherein the two axial separation lines are separated by an arc in the range from about 30°

to about 180°

.

81. The introducer sheath of claim 80, wherein an inflatable balloon is asymmetrically disposed on the flexible tubular body so that it does not extend into the about 30°

to about 180°

region between the separation lines.

82. The introducer sheath of claim 80, further comprising an inflation port on the hub and an inflation lumen in the flexible body, wherein the port is connected to the lumen and the lumen is connected to the balloon.

83. The introducer sheath of claim 69, further comprising a flush port on the hub.

84. The introducer sheath of claim 69, wherein the electrodes are shaped so that they remain intact when the tubular body is split.

85. The introducer sheath of claim 83, wherein the electrodes have a half-moon or semicircular shape.

92. A kit for implanting a pacing or defibrillator lead comprising:

an introducer sheath of claim 69;

a dilator;

a syringe;

a needle; and

at least one guidewire.

93. The kit of claim 92 which also contains a pacemaker or defibrillator lead.

94. The kit of claim 92 which includes a second introducer sheath.

95. The kit of claim 92 which includes a steerable catheter.

86. A steerable catheter for internal cardioversion or defibrillation, comprising:

a flexible tubular body having a proximal end, a distal end, an axial lumen, and at least one axial separation line extending from the proximal end to the distal end;

an inflatable annular balloon positioned on or near the distal end of the tubular body;

a plurality of electrodes at or near the distal end of the tubular body and proximal to the balloon;

a hub or handle secured to the proximal end of the flexible tubular body,

wherein the distal end of the catheter is advanced into the pulmonary artery or coronary sinus vein to perform internal cardioversion or defibrillation.

87. In an improved introducer sheath comprising an elongated flexible tubular body having a proximal end and a distal end and a hub secured to the proximal end, the improvement which comprises an inflatable balloon mounted on the flexible body near the distal end thereof and means for opening an axial passage along the entire length of the flexible body and hub so that the catheter can be withdrawn over a proximal structure on a device disposed within a body lumen.

97. A system for implanting a catheter within a patient, comprising:

a first introducer sheath comprising a flexible tubular body having a proximal end, a distal end, and an axial lumen, and a hub having a hemostatic seal or valve secured to the proximal end of the flexible tubular body, and

a second, longer introducer sheath comprising a flexible tubular body having a proximal end, a distal end, and an axial lumen, and a hub having a hemostatic seal or valve secured to the proximal end of the flexible tubular body,

wherein the second introducer sheath can be introduced through the axial lumen of the first introducer sheath and is slidable and rotatable within.

98. The system of claim 97, wherein the flexible tubular body of the first introducer sheath has at least one axial separation line extending from the proximal end to the distal end.

99. The system of claim 97, wherein the hub of the first introducer sheath has at least one weakened axial line so that it may be manually separated along said at least one axial line.

100. The system of claim 97, wherein the flexible tubular body of the second introducer sheath has at least one axial separation line extending from the proximal end to the distal end.

101. The system of claim 97, wherein the flexible tubular body of the second introducer sheath has at least one electrode positioned at or near the distal end of the tubular body.

102. The system of claim 97, wherein the hub of the second introducer sheath has at least one weakened axial line so that it may be manually separated along said at least one axial line,

103. A system for implanting a catheter in a patient, comprising:

a first introducer sheath comprising a flexible tubular body having a proximal end, a distal end, an axial lumen, and at least one axial separation line extending from the proximal end to the distal end; and

a hub having a hemostatic seal or valve secured to the proximal end of the flexible tubular body, wherein the hub has at least one weakened axial line so that it may be manually separated along said at least one axial line, and

a second, longer introducer sheath comprising a flexible tubular body having a proximal end, a distal end, an axial lumen, and at least one axial separation line extending from the proximal end to the distal end;

at least one electrode positioned at or near the distal end of the tubular body;

a hub having a hemostatic seal or valve secured to the proximal end of the flexible tubular body, wherein the hub has at least one weakened axial line so that it may be manually separated along said at least one axial line,

wherein the second introducer sheath can be introduced through the axial lumen of the first introducer sheath and is slidable and rotatable within.

104. A method for implanting a pacemaker lead inside the coronary sinus vein to pace the left ventricle of the heart, which comprises the steps of:

(a) percutaneously inserting an long introducer sheath into the subclavian vein (cepahlic vein or equivalent);

(b) advancing a steerable lumen catheter through the introducer into the right heart;

(c) placing a curve on the catheter once outside of the distal end of the introducer sheath;

(d) moving the catheter backwards and forwards to cannulate the coronary sinus vein under fluoroscopy;

(e) varying the curvature of said catheter while moving it back and forth to find the coronary sinus vein ostium;

(f) optionally injecting puffs of contrast through the lumen of said catheter to help confirm that one is inside the coronary sinus vein;

(g) exchanging said catheter for a different curvature to cannulate the coronary sinus if necessary (i.e., small, medium, large, and extra large curvatures);

(h) advancing a long sheath over the catheter once well inside the coronary sinus vein to have stable access to the coronary sinus;

(i) pulling out the catheter and placing a pacemaker lead into the introducer sheath and directing it into a branch of the coronary sinus vein which is a left ventricular branch;

(j) checking pacing and sensing thresholds of said pacemaker lead and establishing adequate left ventricular pacing;

(k) removing said sheath over the lead while maintaining the lead in stable position within the coronary sinus vein branch; and

(l) securing said catheter to the floor of the pacemaker pocket and attaching the lead to a device to help pace the heart.

106. A method for implanting a pacemaker lead inside the coronary n to pace the left ventricle of the heart, which comprises the steps of:

(a) percutaneously accessing an upper chest, extremity or neck vein;

(b) placing an introducer into said vein;

(c) inserting a steerable pacemaker lead catheter system which is d of;

(i) 2-6 F pacemaker lead with an axial lumen and bipolar electrodes (ii) a proximal connector with an internal lumen with locking or stylet or pull cord for steering said lead; and

(iii) a removable handle with a steerable mechanism for pulling and releasing said stylet or pull cord to steer said lead into the branch of the coronary sinus vein;

(d) advancing said steerable lead system with attached handle into said introducer and moving it back and forth with varying curvatures until the coronary sinus ostium is engaged;

(e) optionally administering puffs of contrast to visualize location;

(f) optionally using the electrodes to help define location once connected to an electrogram recording system;

(g) once in the coronary sinus possibly removing the stylet or pull cord and handle and placing a soft steerable guidewire through the central lumen and advancing it into an appropriate coronary sinus branch;

(h) advancing the pacing lead and then following said guidewire to the intended location to pace the left ventricle;

(i) removing the guidewire;

(j) testing the pacing and sensing to confirm appropriateness;

(k) if in step (j) the pacing and sensing are not appropriate, the lead is pulled back and the guidewire is positioned in another location and the procedure repeated until adequate pacing and sensing are achieved;

(l) removing the sheath over the lead while making sure the tip of the lead does not dislodge;

(m) securing the proximal area of the lead to the floor of the device pocket using a lead sleeve or bullet to protect the lead; and

(n) attaching the lead to the device and the remainder of the leads etc.

107. A method for implanting a pacemaker lead inside the coronary sinus vein to pace the left ventricle of the heart as described in claim 106, in which the left ventricular pacing lead uses conventional nonlocking or screw in stylets optionally curved manually to direct the lead into the coronary sinus vein.

108. A steerable catheter comprising:

a flexible tubular body having a proximal end, a distal end, and at least one lumen;

at least one radiopaque marker positioned on or near the distal end of the tubular body; and

a handle attached to the proximal end of the tubular body,

wherein the handle cooperates with the distal end of the tubular body to steer the catheter and the distal end of the catheter forms a bent configuration of greater than at least 0°

.

110. The catheter of claim 108, wherein the distal end of the catheter forms a bent configuration of at least about 180°

.

111. The catheter of claim 110, wherein the distal end of the catheter forms a bent configuration of at least about 270°

.

112. The catheter of claim 111, wherein the distal end of the catheter forms a bent spiral configuration of at least about 270°

.

113. The catheter of claim 108, wherein there are a plurality of lateral openings on the distal end of the tubular body adjacent and/or proximal to the bent configuration.

114. The catheter of claim 108, wherein a guidewire can be placed in a lumen in the tubular body.

115. The catheter of claim 114, wherein the guidewire can be advanced to cause the bent configuration to straighten.

116. The catheter of claim 108, wherein the handle is ergonomic.

117. The catheter of claim 108, wherein at least one steering or pull wire or cord extends proximally from at or near the distal end of the tubular body to the handle.

118. The catheter of claim 117, wherein each steering or pull wire or cord extends through a lumen in the tubular body.

119. The catheter of claim 108, wherein the tubular body has a distal section with a radius of curvature and a proximal section and the catheter has means to adjust the radius of curvature of the distal section while maintaining the proximal section substantially straight.

120. A steerable introducer sheath comprising:

a flexible tubular body having a proximal end, a distal end, an axial lumen, and at least one axial separation line extending from the proximal end to the distal end;

at least one radio-opaque marker positioned at or near the distal end of the tubular body;

a hub or handle having a hemostatic seal or valve secured to the proximal end of the flexible tubular body,

wherein the hub has at least one weakened axial line so that it may be manually separated along said at least one axial line.

121. The introducer sheath of claim 120 which has an inflatable balloon at the distal end of the flexible tubular body, said balloon being attached to the flexible tubular body in a manner which permits axial separation of the body.

122. The introducer sheath of claim 120, wherein the hub or handle cooperates with the distal end of the tubular body to steer the sheath.

123. The introducer sheath of claim 120, wherein at least one steering or pull wire or cord extends proximally from at or near the distal end of the tubular body to the handle.

124. The introducer sheath of claim 122, wherein each steering or pull wire or cord extends through a lumen in the tubular body.

125. The introducer sheath of claim 120, wherein the tubular body has a distal section with a radius of curvature and a proximal section and the catheter has means to adjust the radius of curvature of the distal section while maintaining the proximal section substantially straight.

126. The introducer sheath of claim 120, wherein the hub or handle has a primary access port which is axially aligned with the axial lumen of the flexible tubular body.

127. The introducer sheath of claim 120, wherein the flexible tubular body has a length of from about 40 cm to about 100 cm and a lumen diameter of from about 2 F to about 12 F.

128. The introducer sheath of claim 120, wherein a lumen has sufficient diameter to pass a pacemaker or defibrillator lead.

129. The introducer sheath of claim 120, wherein a second axial separation line is formed on the flexible tubular body parallel to said at least one axial separation line.

130. The introducer sheath of claim 120, wherein the hub or handle has two weakened axial lines in alignment with the two axial separation lines on the flexible tubular body.

131. The introducer sheath of claim 129, wherein the two axial separation lines are separated by an arc in the range from about 30°

to about 180°

.

132. The introducer sheath of claim 131, wherein an inflatable balloon is asymmetrically disposed on the flexible tubular body so that it does not extend into the about 30°

to about 180°

region between the separation lines.

133. The introducer sheath of claim 131, further comprising an inflation port on the hub and an inflation lumen in the flexible body, wherein the port is connected to the lumen and the lumen is connected to the balloon.

134. The introducer sheath of claim 120, further comprising a flush port on the hub.

135. The introducer sheath of claim 120, wherein the radio-opaque markers have a half-moon or semicircular shape.