DELIVERY DEVICE FOR CARDIAC HARNESS

• US 20090043152A1
• Filed: 10/23/2008
• Published: 02/12/2009
• Est. Priority Date: 11/07/2003
• Status: Abandoned Application

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: FISHLER, MATTHEW G., LAU, LILIP, MAR, CRAIG
• Application Number:
  US12/257,299
• Publication Number:
  US 20090043152A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A delivery system for providing and deploying a cardiac harness over a heart. The delivery system includes an introducer tube having a plurality of distal fingers biased into a compressed delivery diameter. A dilator tube is slidably mounted within the introducer tube for dilating the fingers into an expanded diameter for deploying a suction cup into secure attachment with the heart. The suction cup is used to manipulate the heart as the cardiac harness is also deployed from the dilator tube over the suction cup, and over the heart. The suction cup is shaped to securely attach to the apex of the heart in one embodiment.

Claims

1-64. -64. (canceled)

65. A delivery system usable to deploy a cardiac device to the heart in a minimally invasive manner, the cardiac device having at least one electrical lead, the delivery system comprising:

an introducer device having a distal end and a proximal end with a plurality of flexible fingers located at a distal end;

a bias device configured to apply a bias force that tends to move the fingers inward toward each other into a delivery diameter;

a dilator device being movably located within the introducer device and having a distal end configured to be moved into contact with the fingers to provide opposing force against the biasing force to expand the fingers outwardly into an expanded diameter, which is larger than the delivery diameter, the dilator device configured to deploy the cardiac device at its distal end; and

a suction device having a tube through which a negative pressure may be communicated to the suction device so that the suction device may be attached to the heart by means of the negative pressure, the tube being located through the dilator device, wherein movement of the tube after the suction device is attached to the heart will permit manipulation of the heart.

66. The delivery system of claim 65, wherein the dilator device is also configured to deploy the suction device at its distal end.

67. The delivery system of claim 65, wherein the dilator device is further configured to receive the electrical lead of the cardiac device through its length.

68. The delivery system of claim 65, wherein the bias device comprises an elastic band disposed about the exterior of the fingers to impart a compressive bias force on the fingers tending to move them inwardly to the delivery diameter.

69. The delivery system of claim 65, wherein the fingers comprise proximal ends connected to a body of the introducer device and open distal ends, the distal ends each having an outward bend at which location the bias device is located.

70. The delivery system of claim 69, wherein the angle of the bend and the length of the finger distal to the bend are limited such that when at the delivery diameter, the outer diameter of the distal ends of the fingers is less than the outer diameter of the introducer device.

71. The delivery system of claim 65, wherein:

the distal end of the dilator device is configured to receive the cardiac device prior to deployment; and

the dilator device is configured to be slidable within the introducer device such that the distal end of the dilator device makes contact with the fingers causing them to move outwards to the expanded diameter at which the distal end of the dilator device may slide to the distal end of the introducer from which location the cardiac device may be deployed to the heart.

72. The delivery system of claim 65, wherein the suction device is located at the distal end of the dilator device, wherein sliding the dilator device distally in the introducer device extends the suction device beyond the distal end of the introducer device so that the suction device may be attached to the heart by means of applying a negative pressure to the suction device by the negative pressure tube.

73. The delivery system of claim 72, wherein the suction device has a tapered exterior so that the cardiac device may slide over the suction device as it is deployed to the heart.

74. The delivery system of claim 73, wherein the suction device is shaped in the form of a cup with an opening configured to attach to the apex of the heart.

75. The delivery system of claim 74, wherein the shape of the cup comprises a proximal end having a proximal diameter, a tapered section at which the cup tapers outwardly to a distal end, the distal end having a diameter that is larger than the proximal diameter.

76. The delivery system of claim 65, wherein the distal end of the dilator device is configured to receive both the cardiac device and the suction device for movement through the expanded fingers of the introducer device at which time the suction device may be deployed to attach to the heart and the cardiac device may be deployed to the heart.

77. The delivery system of claim 65, wherein the force of attachment of the suction device to the heart and the connection of the negative pressure tube to the suction device are strong enough to withstand pulling the negative pressure tube to manipulate the heart to facilitate deployment of the cardiac device over the suction device and into engagement with the heart.

78. The delivery system of claim 77, wherein the force of attachment of the suction device to the heart and the connection of the negative pressure tube to the suction device are strong enough such that the heart may be lifted and elongated by pulling the negative pressure tube.

79. The delivery system of claim 65, wherein the suction device may be deployed from the introducer device to attach to the heart when the dilator has not yet been moved distally to dilate the fingers of the introducer device.

80. The delivery system of claim 65, wherein the introducer device, the bias device, the dilator device, and the suction device are configured to be withdrawn after deployment of the cardiac device.

81. The delivery system of claim 65, wherein the dilator device has an outer diameter that is smaller than an inner diameter of the introducer device, the dilator device being slidable within the introducer device.

82. The delivery system of claim 65, further comprising an ejection tube having an outer diameter that is smaller than an inner diameter of the dilator device and located for slidable movement in the dilator device, the ejection tube having a distal end comprising a plate that fills the entire inner diameter of the ejection tube, the plate having a plurality of lumina for receiving leads of the cardiac device and for receiving the negative pressure tube of the suction device, wherein the dilator device is configured such that when slid distally, the dilator device will push the cardiac device and suction device out of the dilator tube so that they may be advanced into contact with the heart, wherein the ejection tube is further configured to be withdrawn proximally from the leads and tube so that the ejection tube is clear of the leads and tube.

83. A delivery system usable to deploy a cardiac device to the heart in a minimally invasive manner, the delivery system comprising:

a cardiac harness having a plurality of electrical leads;

an introducer tube having a distal end and a proximal end with a plurality of flexible fingers located at a distal end;

a bias device configured to apply a bias force that tends to move the fingers inward toward each other into a delivery diameter;

a dilator tube being slidably located within the introducer tube and having a distal end configured to be moved into contact with the fingers to provide opposing force against the biasing force to expand the fingers outwardly into an expanded diameter, which is larger than the delivery diameter; and

a suction device having a negative pressure tube through which a negative pressure may be communicated to the suction device so that the suction device may be attached to the heart by means of the negative pressure, the negative pressure tube being located through the dilator device, wherein movement of the negative pressure tube after the suction device is attached to the heart will permit manipulation of the heart; and

wherein the distal end of the dilator tube is configured to receive both the cardiac harness and the suction device for movement through the expanded fingers of the introducer tube at which time the suction device may be deployed to attach to the heart and the cardiac harness may be deployed over the heart, wherein the suction device having a tapered exterior so that the cardiac harness may slide over the suction device as it is deployed to the heart.

84. The delivery system of claim 83, wherein the bias device comprises an elastic band disposed about the exterior of the fingers to impart a compressive bias force on the fingers tending to move them inwardly to the delivery diameter.

85. The delivery system of claim 84, wherein the fingers comprise proximal ends connected to a body of the introducer device and open distal ends, the distal ends each having an outward bend at which location the bias device is located.

86. The delivery system of claim 83, wherein the introducer tube and the dilator tube are oval in cross-sectional shape.

87. A delivery system usable to deploy a medical device to an organ of the body in a minimally invasive manner, the medical device having at least one electrical lead, the delivery system comprising:

an introducer device having a distal end and a proximal end with a plurality of flexible fingers located at a distal end;

a bias device configured to apply a bias force that tends to move the fingers inward toward each other into a delivery diameter;

a dilator device being movably located within the introducer device and having a distal end configured to be moved into contact with the fingers to provide opposing force against the biasing force to expand the fingers outwardly into an expanded diameter, which is larger than the delivery diameter, the dilator device configured to deploy the cardiac device at its distal end; and

a suction device having a tube through which a negative pressure may be communicated to the suction device so that the suction device may be attached to the organ by means of the negative pressure, the tube being located through the dilator device, wherein movement of the tube after the suction device is attached to the organ will permit manipulation of the organ.

88. The delivery system of claim 87, wherein the dilator device is also configured to deploy the suction device at its distal end.

89. The delivery system of claim 87, wherein the dilator device is further configured to receive the electrical lead of the medical device through its length.

90. The delivery system of claim 87, wherein the bias device comprises an elastic band disposed about the exterior of the fingers to impart a compressive bias force on the fingers tending to move them inwardly to the delivery diameter.

91. The delivery system of claim 87, wherein the fingers comprise proximal ends connected to a body of the introducer device and open distal ends, the distal ends each having an outward bend at which location the bias device is located.

92. The delivery system of claim 87, wherein the distal end of the dilator device is configured to receive both the medical device and the suction device for movement through the expanded fingers of the introducer device at which time the suction device may be deployed to attach to the organ and the medical device may be deployed to the organ.

93. The delivery system of claim 92, wherein the force of attachment of the suction device to the organ and the connection of the negative pressure tube to the suction device are strong enough to withstand pulling the negative pressure tube to manipulate the organ to facilitate deployment of the cardiac device over the suction device and into engagement with the organ.

94. The delivery system of claim 87, wherein the force of attachment of the suction device to the organ and the connection of the negative pressure tube to the suction device are strong enough such that the organ may be lifted and elongated by pulling the negative pressure tube.