Methods and apparatus for lead placement on a surface of the heart

• US 20030212446A1
• Filed: 05/10/2002
• Published: 11/13/2003
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: Cerebral Vascular Applications, Inc.
• Inventors: Kaplan, Aaron V., Hahnen, Kevin F.
• Granted Patent: US 7,610,104 B2
• Time in Patent Office: Days
• US Class Current: 607/129
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

The methods and apparatus for lead placement on a surface of the heart are employed using an elongated body having proximal and distal end portions. The body defines a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the heart surface. The elongated body is adapted for insertion between a pericardium and an epicardial surface. At least a portion of the body may have a non-circular cross-sectional shape adapted to retain the body orientation between the pericardium and the epicardial surface.

Claims

1. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, a substantial length of the elongated body being adapted for insertion between a pericardium and an epicardial surface and the body being adapted for directional control by the user to position the distal outlet at a desired location between the pericardium and the epicardial surface.

3. The apparatus of claim 1 wherein the body has sufficient length to allow insertion of the body between the pericardium and the epicardial surface via a sub-xyphoid transcutaneous point of entry.

4. The apparatus of claim 3 wherein the elongated body between the proximal inlet and the distal outlet of the lead receiving passageway has a length in the range of 10 cm to 40 cm.

9. The apparatus of claim 1 wherein the body defines a plurality of lumen extending between a proximal inlet and a distal outlet.

10. The apparatus of claim 1 wherein the distal end portion of the body is thinner than a more proximal portion of the body.

15. The apparatus of claim 1 further comprising an elongated guide wire having a proximal end and a distal end and being received within the lead receiving passageway to facilitate lead placement.

16. The apparatus of claim 1 wherein the body includes a vacuum lumen having a proximal opening and a distal opening which is located in proximity to the distal outlet, the vacuum lumen being connected to a vacuum source at the proximal opening so as to provide force to hold the distal outlet against the surface of the heart.

17. The apparatus of claim 1 wherein the body defines a dedicated guide wire lumen extending between a guide wire inlet and a guide wire outlet which is disposed in proximity to the distal outlet, and an elongated guide wire having a proximal end and a distal end and being received within the guide wire lumen.

18. The apparatus of claim 1 wherein the proximal inlet of the lead receiving passageway is located between the proximal end portion and distal end portion of the body.

19. The apparatus of claim 1 wherein the proximal inlet of the lead receiving passageway is located at the proximal end portion of the body.

20. The apparatus of claim 1 further including a handle located at the proximal end portion of the body.

21. The apparatus of claim 1 wherein the body defines a fluid delivery lumen having a proximal opening and a distal opening which is located in proximity to the distal outlet, the fluid delivery lumen being in fluid communication with a fluid source at the proximal opening so as to introduce a fluid to a pericardial space.

22. The apparatus of claim 1 further including an endoscope carried by the body having a proximal end and a distal end which is located in proximity to the distal outlet, the proximal end of the endoscope being connected to an operator-readable output device so as to view the surface of the heart in proximity to the distal end of the endoscope.

23. The apparatus of claim 1 further including an elongated flexible element having a proximal end and a distal end and being disposed in at least a portion of the body which is inserted between the pericardium and the epicardial surface, the element being adapted to retain a desired shape corresponding to a surface of the heart.

24. The apparatus of claim 23 wherein the elongated flexible element is a wire carried by the body.

25. The apparatus of claim 1 wherein the elongated body defines a longitudinal axis and at least a portion of the body is curved relative to the longitudinal axis.

26. The apparatus of claim 25 wherein at least a portion of the body is curved in the range of approximately 10 degrees to 80 degrees.

27. The apparatus of claim 1 further including an elongated sleeve disposed circumferentially relative to the body, the sleeve being adapted to control the curvature of the body relative to a longitudinal axis.

167. The apparatus of claim 1 wherein the distal outlet is positioned at the distal end portion of the body and is adapted to place the lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

2. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, at least a portion of the body having a non-circular cross-sectional shape.

5. The apparatus of claim 2 wherein a portion of the non-circular shape has a concave surface.

6. The apparatus of claim 2 wherein a portion of the non-circular shape has a convex surface.

7. The apparatus of claim 2 wherein a portion of the non-circular shape has a planar surface.

8. The apparatus of claim 2 wherein the portion of the body with the non-circular shape has a width greater than the thickness.

11. The apparatus of claim 2 wherein the non-circular portion has an upper surface and a lower surface and the distal outlet of the lead receiving passageway is located in the lower surface.

12. The apparatus of claim 2 wherein the non-circular portion has an upper surface and a lower surface, the upper surface being convex in a transverse direction and at least a portion of the lower surface being concave in a transverse direction.

13. The apparatus of claim 2 wherein the non-circular portion has an upper surface and a lower surface, the upper surface being convex in a transverse direction and at least a portion of the lower surface being planar in a transverse direction.

14. The apparatus of claim 2 wherein the non-circular portion has an upper surface and a lower surface, the upper surface being convex in a transverse direction and at least a portion of the lower surface being convex in a transverse direction.

28. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway including a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, at least one temporary pacing electrode disposed at least in proximity to the distal outlet for contact with the surface of the heart, and a conductor extending through the elongated body from the electrode to the proximal end portion of the body for contact with an electric pacing signal source.

29. The apparatus of claim 28 wherein the temporary pacing electrode is a bipolar electrode.

30. The apparatus of claim 28 wherein the temporary pacing electrode is adapted to pace the heart by contact with the epicardial surface.

31. The apparatus of claim 28 wherein at least a portion of the elongated body has a non-circular shape adapted to retain the body at a selected angular orientation so as to orient the distal outlet in the desired direction.

32. The apparatus of claim 28 wherein the body has sufficient length to allow insertion of the body between the pericardium and the epicardial surface via a sub-xyphoid transcutaneous point of entry.

33. The apparatus of claim 32 wherein the elongated body between the proximal inlet and the distal outlet of the lead receiving passageway has a length in the range of 10 cm to 40 cm.

34. The apparatus of claim 28 wherein at least one temporary pacing electrode is located in a lower surface of the body.

35. The apparatus of claim 28 wherein the temporary pacing electrode is a monopolar electrode.

36. The apparatus of claim 28 wherein at least two temporary pacing electrodes are disposed at least in proximity to the distal outlet.

37. The apparatus of claim 28 further including an elongated probe having a proximal end and a distal end and being removably inserted into the lead receiving passageway prior to insertion of the lead, the temporary pacing electrode being disposed at the distal end of the probe and located at the distal outlet while the probe is inserted into the lead receiving passageway for contact with the surface of the heart, the proximal end of the probe being in contact with an electrical pacing signal source.

38. The apparatus of claim 28 wherein at least one temporary pacing electrode is disposed adjacent the distal outlet.

39. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, at least one steering member extending through the elongated body from the distal end portion to a more proximal portion of the body, the steering member being adapted to move the distal end portion of the body in at least one plane when force is applied to the steering member at the proximal end portion the body.

40. The apparatus of claim 39 wherein the elongated body is adapted to place the lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

41. The apparatus of claim 40 wherein the elongated body is adapted to place the lead on an epicardial surface of the heart.

42. The apparatus of claim 39 wherein the steering member moves the distal end portion of the body when tensile force is applied to the steering member.

43. The apparatus of claim 39 wherein the steering member moves the distal end portion of the body when compressive force is applied to the steering member.

44. The apparatus of claim 39 wherein the steering member moves the distal end portion of the body when torsional force is applied to the steering member.

45. The apparatus of claim 39 wherein the steering member includes one or more separate members.

46. The apparatus of claim 39 wherein the steering member includes a plurality of wires.

47. The apparatus of claim 39 further including a steering collar axially spaced from the distal end portion of the body, the collar being in operative engagement with the steering member so that movement of the steering collar causes movement of the distal end portion.

48. The apparatus of claim 39 wherein the steering member is adapted to move the distal end portion of the body in at least two planes.

49. The apparatus of claim 39 wherein the elongated body defines a longitudinal axis and at least the distal end portion of the body is curved relative to the longitudinal axis.

50. The apparatus of claim 49 wherein the steering member is adapted to move the distal end portion of the body from a curved position to a less curved position.

51. The apparatus of claim 49 wherein the steering member is adapted to move the distal end portion of the body so as to increase the relative curvature of at least the distal end portion of the body relative to the longitudinal axis.

52. The apparatus of claim 39 wherein at least the distal end portion of, the body is curved relative to the longitudinal axis in at least one plane in the range of approximately 10 degrees to 80 degrees.

53. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a passageway which includes at least one inlet adapted to receive an elongated guide wire and a lead, the passageway having a lead outlet and a guide wire outlet which is distally located on the body in relation to the lead outlet, the lead outlet being sufficiently sized to allow passage of the lead for contact with the surface of the heart, the guide wire outlet being sufficiently sized and oriented to allow passage of the guide wire forward of the distal end portion of the body, the guide wire outlet being smaller than the lead outlet to avoid extension of the lead beyond of the distal end portion of the body.

54. The apparatus of claim 53 lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

55. The apparatus of claim 54 wherein the elongated body is adapted to place the lead on an epicardial surface of the heart.

56. The apparatus of claim 53 wherein the lead outlet distally tapers to the guide wire outlet.

57. The apparatus of claim 53 wherein the portion of the body at the guide wire outlet is thinner than a more proximal portion of the body.

58. The apparatus of claim 53 wherein the body in proximity to at least one of the lead outlet and guide wire outlet has a non-circular shape.

59. The apparatus of claim 53 wherein the body has an upper surface and a lower surface and the lead outlet is located in the lower surface.

60. The apparatus of claim 53 wherein the body has an upper surface and a lower surface and the guide wire outlet is located in the lower surface.

61. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact to the surface of the heart; and

a Doppler sensor disposed at least in proximity to the distal outlet and being in communication with an operator-readable output device.

62. The apparatus of claim 61 wherein the elongated body is adapted to place the lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

63. The apparatus of claim 62 wherein the elongated body is adapted to place the lead on an epicardial surface of the heart.

64. The apparatus of claim 61 wherein at least a portion of the elongated body has a non-circular shape adapted to retain the body at a selected angular orientation so as to orient the distal outlet in the desired direction.

65. The apparatus of claim 61 wherein the body has an upper surface and a lower surface and the Doppler sensor is located in the lower surface.

66. The apparatus of claim 61 wherein the Doppler sensor is disposed adjacent the distal outlet.

67. The apparatus of claim 62 further including an elongated probe having a distal end and a proximal end and being removably inserted into the lead receiving passageway prior to insertion of the lead, the Doppler sensor being disposed at the distal end of the probe and located at the distal outlet while the probe is inserted within the lead receiving passageway, the Doppler sensor being in communication with the operator-readable output device at the proximal end of the probe.

141. The apparatus of claim 61 wherein the Doppler sensor is fixed to the distal end portion of the body.

142. The apparatus of claim 61 wherein the Doppler sensor is removably inserted into the body.

143. The apparatus of claim 142 further including an elongated sensing device having a distal end carrying the Doppler sensor, the sensing device being removably insertable into the lead receiving passageway.

68. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, a substantial length of the elongated body being adapted for insertion between a pericardium and an epicardial surface and the body being adapted for directional control by the user to position the distal outlet at a desired location between the pericardium and the epicardial surface, and an expandible member carried by the body and disposed in proximity to the distal outlet.

69. The apparatus of claim 68 wherein the elongated body is adapted to place the lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

70. The apparatus of claim 69 wherein the elongated body is adapted to place the lead on an epicardial surface of the heart.

71. The apparatus of claim 68 wherein an inflation lumen is defined by the body and extends between the expandible member and an inflation source at the proximal end of the body, the expandible member being in communication with the inflation lumen so as to allow expansion of the expandible member.

72. The apparatus of claim 68 wherein the expandible member is a balloon.

73. The apparatus of claim 68 wherein the expandible member includes at least one biasing member which expands to hold the distal outlet against the epicardial surface.

74. The apparatus of claim 68 wherein the expandible member is circumferentially disposed on the body in proximity to the distal outlet.

75. The apparatus of claim 68 wherein the expandible member is circumferentially non-aligned relative to the distal outlet.

76. The apparatus of claim 68 wherein the body has an upper surface and a lower surface and the expandible member is disposed on the upper surface.

77. The apparatus of claim 68 wherein the body has an upper surface and a lower surface and the expandible member is disposed on the upper surface and the lower surface.

166. The apparatus of claim 68 wherein the expandible member is adapted to be selectively expanded to hold the distal outlet against the epicardial surface.

170. The apparatus of claim 68 wherein the expandible member is an elastomeric membrane.

78. A method of placing a lead on a surface of a heart comprising the steps of:

providing an apparatus having an elongated body which includes a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with a selected lead placement site, a substantial length of the body being adapted for insertion between a pericardium and an epicardial surface and the body being adapted for directional control by the user to position the distal outlet at a desired location between the pericardium and the epicardial surface;

introducing the body into the space between the epicardial surface and the pericardium;

extending the lead from the body; and

engaging the lead with a surface of the heart; and

withdrawing the apparatus.

79. The method of claim 78 wherein the step of engaging includes engaging the lead with the epicardial surface of the heart.

80. The method of claim 78 wherein the steps are performed from a sub-xiphoid access location.

81. The method of claim 78 wherein the step of engaging includes engaging a plurality of leads with selected one of an epicardial surface and endocardial surface of the heart.

82. The method of claim 78 wherein the step of providing includes at least one steering member extending through the elongated body from the distal end portion to the proximal end portion of the body, the steering member being adapted to move the distal end portion of the body in at least one plane when force is applied to the steering member at the proximal end portion the body, and further including the step of applying a force to the steering member to move the distal end portion of the body so as to orient the distal outlet for lead placement.

83. The method of claim 78 further including the steps of providing an elongated guide wire having a proximal end and a distal end, inserting the guide wire into the body, extending the distal end of the guide wire beyond the distal end portion of the body, and guiding the body to a selected lead placement site with the aid of the guide wire.

84. The method of claim 78 wherein the step of providing includes at least one expandible member carried by the body disposed in proximity to the distal outlet and adapted to be selectively expanded to hold the distal outlet against a selected lead placement site, and further including the step of expanding the expandible member.

85. The method of claim 78 wherein the step of providing includes a vacuum lumen having a proximal opening and a distal opening which is located in proximity to the distal outlet, the vacuum lumen being connected to a vacuum source at the proximal opening so as to provide force to hold the distal outlet against the surface of the heart, and including the step of providing suction force.

86. The method of claim 78 wherein the step of providing includes a fluid delivery lumen defined by the body, the fluid delivery lumen having a proximal opening and a distal opening which is located in proximity to the distal outlet, the fluid delivery lumen being in fluid communication with a fluid source at the proximal opening, and including the step of introducing a fluid to a surface of the heart.

87. The method of claim 78 wherein the step of providing includes a longitudinal axis defined by the body and at least part of the lead receiving passageway being adapted to allow removal of the lead from the body in a direction transverse to the axis of the body, and wherein the step of extending includes removing the lead from the body in a direction transverse to the axis of the body.

88. The method of claim 78 wherein the step of introducing includes introducing the body into the space between the epicardial surface and the pericardium a distance approximately between 20 cm to 30 cm.

89. A method of placing a lead on a surface of a heart comprising the steps of:

providing an apparatus having an elongated body which includes a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, and the apparatus including a Doppler sensor disposed in proximity to the distal outlet and being in communication with an operator-readable output device;

introducing the body into the space between the epicardial surface and the pericardium;

placing the sensor in contact with the epicardial surface at a selected location;

detecting whether the sensor or distal outlet is in proximity to a coronary artery of the heart;

moving the body if necessary to a selected lead placement site so as to avoid placement of the lead in proximity to the coronary artery;

extending the lead from the distal outlet;

engaging the lead with a surface of the heart; and

withdrawing the apparatus.

90. The method of claim 89.wherein the step of engaging includes engaging the lead with the epicardial surface of the heart.

91. The method of claim 89 wherein the steps are performed from a sub-xiphoid access location.

92. The method of claim 89 wherein the step of engaging includes engaging a plurality of leads with selected one of an epicardial surface and endocardial surface of the heart.

93. The method of claim 89 wherein the step of placing includes placing a lower surface of the body in contact with the epicardial surface.

94. The method of claim 89 wherein the steps of detecting and moving are repeated at least once so as to avoid placement of the lead in proximity to the coronary artery.

95. The method of claim 89 wherein the step of providing includes at least a portion of the body having a non-circular shape adapted to retain the body at a selected angular orientation so as to orient the distal outlet in the desired direction.

96. The method of claim 89 wherein the step of introducing includes introducing the body into the space between the epicardial surface and the pericardium a distance approximately between 20 cm to 30 cm.

144. The method of claim 89 wherein the step of providing includes the Doppler sensor being fixed to the distal end portion of the body.

145. The method of claim 89 wherein the step of providing includes the Doppler sensor being removably inserted into the body, and further including the step of inserting the Doppler sensor into the body.

146. The method of claim 145 wherein the step of providing further includes an elongated sensing device having a distal end carrying the Doppler sensor, the sensing device being removably insertable into the lead receiving passageway.

147. The method of claim 145 further including the step of removing the Doppler sensor from the body before insertion of the lead.

97. A method of placing a lead on a surface of a heart comprising the steps of:

providing an apparatus having an elongated body which includes a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with a selected lead placement site, at least one temporary pacing electrode disposed in proximity to the distal outlet for contact with the surface of the heart, the electrode being in electrical communication with a pacing signal source;

introducing the body into the space between the epicardial surface and the pericardium;

placing the electrode in contact with a surface of the heart at a selected location;

pacing the heart with a pacing signal to determine whether the selected location is suitable for lead placement;

engaging the lead with the surface of the heart.

98. The method of claim 97 wherein the step of introducing includes introducing the body into the space between the epicardial surface and the pericardium a distance approximately between 20 cm to 30 cm.

99. The method of claim 97 wherein the step of pacing includes providing electrical pulses to the heart.

100. The method of claim 97 wherein the step of engaging includes engaging the lead with the epicardial surface of the heart.

101. The method of claim 97 wherein the steps are performed from a sub-xiphoid access location.

102. The method of claim 97 wherein the step of engaging includes engaging a plurality of leads with selected one of an epicardial surface and endocardial surface of the heart.

103. The method of claim 97 wherein the step of providing includes at least a portion of the body having a non-circular shape adapted to retain the body at a selected angular orientation so as to orient the distal outlet in the desired direction.

104. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body having a longitudinal axis and including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a distal outlet and a more proximal inlet for receiving a lead therethrough for contact with the surface of the heart, the elongated body being adapted for insertion between the pericardium and the epicardial surface, at least part of the lead receiving passageway being adapted to allow removal of the lead from the body in a direction transverse to the axis of the body.

105. The apparatus of claim 104 wherein at least a portion of the body has a non-circular shape adapted to retain the body at a selected angular orientation between the pericardium and the epicardial surface so as to orient the distal outlet in the desired direction.

106. The apparatus of claim 104 wherein the elongated body is adapted to place the lead on a surface of the heart which is selected one of an epicardial surface and an endocardial surface.

107. The apparatus of claim 106 wherein the elongated body is adapted to place the lead on an epicardial surface of the heart.

108. The apparatus of claim 104 wherein the body has a longitudinally disposed circumferential opening proximally extending from the distal outlet.

109. The apparatus of claim 108 wherein the body defines a U-shape in the transverse direction.

110. The apparatus of claim 104 wherein the body includes at least one longitudinally disposed portion having a proximal end and a distal end, the longitudinally disposed portion being adapted to be removed from the remaining portion of the body.

111. The apparatus of claim 110 wherein the longitudinally disposed portion has a concave inner surface.

112. The apparatus of claim 110 wherein the longitudinally disposed portion has a convex outer surface.

113. The apparatus of claim 110 wherein the longitudinally disposed portion is slidably removable from the remaining portion of the body.

114. The apparatus of claim 110 wherein at least one longitudinally disposed portion is rotatable relative to the remaining portion of the body.

116. The apparatus of claim 104 wherein the body includes at least one longitudinally disposed seam extending from the distal outlet, the seam being adapted to separate along at least a portion thereof.

117. The apparatus of claim 116 wherein the seam has a thinner wall thickness than the remaining portion of the body.

118. The apparatus of claim 116 wherein the seam is formed by overlapping sections of the body.

119. The apparatus of claim 116 wherein the seam is formed by two interlocking longitudinal edges of the body.

120. The apparatus of claim 119 wherein one longitudinal edges has a projection and the other longitudinal edge has a recess, the projection being received by the recess to form the lead receiving passageway.

121. Epicardial lead for placement on an epicardial surface of a heart comprising:

an elongated outer insulative sheath having a longitudinal axis and including a proximal end portion and a distal end portion, and an inner conductive member having a distal section and being adapted to rotate relative to the sheath and adapted to extend through the distal end portion of the sheath, at least selected one of the distal end portion and the distal section having an acute angle relative to the longitudinal axis.

122. The epicardial lead of claim 121 wherein a sensor is carried by the distal end portion of the sheath, the sensor being electrically connected to an operator-readable output device at the proximal end portion so as to assist in lead placement on the epicardial surface.

123. The epicardial lead of claim 122 wherein the sheath defines a sensor lumen which receives the sensor, the sensor being adapted to move distally relative to the distal end portion of the sheath.

124. The epicardial lead of claim 121 wherein the distal section of the inner conductive member is curved relative to the longitudinal axis.

125. The epicardial lead of claim 124 wherein the distal section has an angle relative to the longitudinal axis in the range of 10 degrees to 80 degrees.

126. The epicardial lead of claim 121 wherein at least a portion of the distal section has a non-linear shape.

127. The epicardial lead of claim 121 wherein at least a portion of the distal section has a linear shape.

128. The epicardial lead of claim 121 wherein the distal end portion of the sheath is curved relative to the longitudinal axis.

129. The epicardial lead of claim 128 wherein the distal end portion has an angle relative to the longitudinal axis in the range of 10 degrees to 80 degrees.

130. The epicardial lead of claim 121 wherein the distal end portion defines a transverse opening relative to the longitudinal axis.

131. Epicardial lead for placement on an epicardial surface of a heart comprising:

an elongated outer insulative sheath having a longitudinal axis and including a proximal end portion and a distal end portion, and an inner conductive member which is adapted to rotate relative to the sheath and adapted to extend through the distal end portion of the sheath, the distal end portion of the sheath being adapted to move between at least two positions, a first position in alignment with the longitudinal axis of the sheath and a second position disposed at an acute angle relative to the longitudinal axis of the sheath.

132. The epicardial lead of claim 131 further including a steering member having a proximal end and a distal end and extending from the distal end portion to the proximal end portion, the steering member being adapted to move the distal end portion of the sheath between the first position and the second position when force is applied to the proximal end of the steering member.

133. The epicardial lead of claim 132 wherein the steering member is a wire.

134. The epicardial lead of claim 131 wherein a hinge is disposed adjacent the distal end portion to allow movement of the distal end portion between the first position and the second position.

135. The epicardial lead of claim 131 wherein the distal end portion includes a biasing member which normally biases the distal end portion to the second position.

136. The epicardial lead of claim 135 wherein the biasing member is a spring.

137. The epicardial lead of claim 131 wherein the inner conductive member includes a distal section for engaging the epicardial surface of the heart.

138. The epicardial lead of claim 137 wherein at least a portion of the distal section has a non-linear shape for contact with the epicardial surface of the heart.

139. The epicardial lead of claim 137 wherein at least a portion of the distal section has a linear shape for contact with the epicardial surface of the heart.

140. The epicardial lead of claim 137 wherein at least a portion of the distal section has a helical shape.

148. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body defining a longitudinal axis and including a proximal end portion and distal end portion, a lead receiving passageway being defined within the body and extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with a surface of the heart, and at least one steering member adapted to move the distal end portion of the body in at least one plane, wherein the body has sufficient torsional stiffness for rotational movement relative to the longitudinal axis about 360 degrees.

149. The apparatus of claim 148 further including an annular expandible member carried by the body disposed in proximity to the distal outlet and adapted to be selectively expanded so as to hold the distal outlet against the surface of the heart.

150. The apparatus of claim 149 wherein the expandible member is a balloon.

151. The apparatus of claim 148 further including at least one temporary pacing electrode disposed at least in proximity to the distal outlet for contact with the surface of the heart, and a conductor extending from the electrode through the body to a more proximal portion of the body for electrical connection to a pacing signal source.

152. The apparatus of claim 148 further including a Doppler sensor disposed in proximity to the distal outlet for contact with the surface of the heart and being in communication with an operator readable output device to indicate the presence of a coronary artery in proximity to the distal outlet so as to avoid placement of the lead on a coronary artery.

153. The apparatus of claim 152 wherein the Doppler sensor is fixed to the distal end portion of the body.

154. The apparatus of claim 152 wherein the Doppler sensor is removably inserted into the body.

155. The apparatus of claim 154 further including an elongated sensing device having a distal end carrying the Doppler sensor, the sensing device being removably insertable into the lead receiving passageway.

165. The apparatus of claim 148 in which the cross-sectional shape of the body is generally circular.

156. A method of placing a lead on a surface of a heart comprising the steps of:

providing an apparatus having an elongated body which includes a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with a selected lead placement site, and at least one steering member being adapted to move the distal end portion of the body in at least one plane, wherein the body has sufficient torsional stiffness for rotational movement relative to the longitudinal axis about 360 degrees;

introducing the body into the space between the epicardial surface and the pericardium;

manipulating the steering member to move the distal outlet in the desired direction for lead placement;

rotating the body as necessary so as to orient the distal outlet in the desired direction for lead placement;

extending the lead from the body; and

engaging the lead with selected one of an epicardial surface and endocardial surface of the heart; and

withdrawing the apparatus.

157. The method of claim 156 wherein the step of providing includes an annular expandible member carried by the body disposed in proximity to the distal outlet and adapted to be selectively expanded so as to hold the distal outlet against an epicardial surface, and wherein the method further includes the step of enlarging the expandible member after the step of introducing the body into the space between the epicardial surface and the pericardium.

158. The method of claim 157 wherein the expandible member is a balloon.

159. The method of claim 156 wherein the step of providing includes at least one temporary pacing electrode disposed at least in proximity to the distal outlet for contact with the surface of the heart, and a conductor extending from the electrode through the body to a more proximal portion of the body for electrical connection to a pacing signal source, and wherein the method further includes the steps of placing the electrode in contact with the surface of the heart at a selected location, and pacing the heart with a pacing signal to determine whether the selected location is suitable for lead placement.

160. The method of claim 156 whether the step of providing includes a Doppler sensor disposed in proximity to the distal outlet for contact with the surface of the heart and being in communication with an operator readable output device to indicate the presence of a coronary artery in proximity to the distal outlet so as to avoid placement of the lead on a coronary artery, and wherein the method further includes the steps of placing the sensor in contact with a surface of the heart at a selected location and detecting whether the sensor or distal outlet is in proximity to a coronary artery of the heart, and moving the body if necessary to a selected lead placement site so as to avoid placement of the lead in proximity to the coronary artery.

161. The method of claim 160 wherein the step of providing includes the Doppler sensor being fixed to the distal end portion of the body.

162. The method of claim 160 wherein the step of providing includes the Doppler sensor being removably inserted into the body, and wherein the method further includes the step of inserting the Doppler sensor into the body.

163. The method of claim 162 wherein the step of providing further includes an elongated sensing device having a distal end carrying the Doppler sensor, the sensing device being removably insertable into the lead receiving passageway.

164. The method of claim 162 further including the step of removing the Doppler sensor from the body.

168. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, at least a portion of the body having a non-circular shape adapted to retain the body orientation between the pericardium and the epicardial surface, at least one steering member extending through the elongated body from the distal end portion to a more proximal portion of the body, the steering member being adapted to move the distal end portion of the body in at least one plane when force is applied to the steering member at the proximal end portion the body.

169. An apparatus for placing a lead on a surface of a heart comprising:

an elongated body including a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the surface of the heart, the elongated body being adapted for insertion between the pericardium and the epicardial surface and at least a portion of the body having a non-circular shape adapted to retain the body orientation between the pericardium and the epicardial surface, and an expandible member carried by the body and disposed in proximity to the distal outlet.

171. A method of placing a lead on a surface of a heart comprising the steps of:

providing an apparatus having an elongated body which includes a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with a selected lead placement site, at least a portion of the body having a non-circular shape to retain the body orientation between a pericardium and an epicardial surface;

introducing the portion of the body having the non-circular shape into the space between the epicardial surface and the pericardium;

extending the lead from the body; and

engaging the lead with a surface of the heart; and

withdrawing the apparatus.