Subcutaneous electrode and lead with temporary pharmacological agents
First Claim
Patent Images
1. An implantable lead system, comprising:
- a lead comprising a lead body, the lead body comprising a proximal end, a distal end, and a midpoint equidistant from the proximal and distal ends;
a cardiac electrode coupled to the lead body, the electrode and lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue;
a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal of the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and
a pharmacological agent provided along at least a major portion comprising at least a quarter of the lead body length, the pharmacological agent having a coverage that provides a temporary therapeutic treatment.
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Accused Products
Abstract
An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.
142 Citations
111 Claims
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1. An implantable lead system, comprising:
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a lead comprising a lead body, the lead body comprising a proximal end, a distal end, and a midpoint equidistant from the proximal and distal ends; a cardiac electrode coupled to the lead body, the electrode and lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal of the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and a pharmacological agent provided along at least a major portion comprising at least a quarter of the lead body length, the pharmacological agent having a coverage that provides a temporary therapeutic treatment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An implantable system, comprising:
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a can; a lead comprising a lead body, the lead body extending from the can and comprising a proximal end, and distal end, and a midpoint between the proximal and distal ends; a cardiac electrode coupled to the lead body, the electrode and the lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal of the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and a pharmacological agent provided along at least a major portion comprising at least a quarter of the lead body length, the pharmacological agent having a coverage that provides a temporary therapeutic treatment. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22)
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23. An implantable lead, comprising:
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a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends; a cardiac electrode coupled to the lead body, the electrode and lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and a pharmacological agent provided on at least a major portion of the lead body, including the electrically active portions of the electrode, the pharmacological agent having a coverage that provides a temporary therapeutic treatment, the electrically active portions of the electrode remaining electrically active for delivering cardiac stimulation energy through the pharmacological agent at the electrically active portions after provision of the pharmacological agent. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. An implantable lead, comprising:
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a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends; a cardiac electrode assembly coupled to the lead body, the electrode assembly and the lead body configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and a plurality of pharmacological agents provided along at least a major portion of the lead, the pharmacological agents providing a plurality of temporary therapeutic treatments to the subcutaneous non-intrathoracic tissue, at least one of the pharmacological agents providing a temporary therapeutic treatment. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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59. A method of lead implantation, comprising:
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delivering into subcutaneous non-intrathoracic chest tissue along the rib cage, a cardiac lead comprising a lead body, a proximal end, a distal end, a midpoint between the proximal and distal ends, a proximal portion, a distal portion, a cardiac electrode, a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead, the cardiac lead having a pharmacological agent along at least a major portion of the lead body; fixing the proximal portion of the lead body to a proximal portion of the tunnel using the at least one of the fixation elements situated proximal to the midpoint and fixing the distal portion of the lead body to a distal portion of the tunnel using the at least one other of the fixation elements situated distal of the midpoint; and delivering the pharmacological agent from the lead body to subcutaneous non-intrathoracic chest tissue substantially surrounding the lead body, the pharmacological agent providing a temporary therapeutic treatment. - View Dependent Claims (60, 61, 62, 63, 64)
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65. An implantable lead, comprising:
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a lead body comprising a proximal end, a distal end, and a midpoint equidistant from the proximal and distal ends; a cardiac electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement in a patient; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body; and means for delivering a pharmacological agent from at least a major portion of the lead body to subcutaneous non-intrathoracic tissue substantially surrounding the lead body. - View Dependent Claims (66, 67, 68, 69, 70, 71)
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72. An implantable system, comprising:
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a can; a lead comprising a lead body, a proximal end, a proximal portion, a distal end a midpoint equidistant from the proximal end and the distal end, and a distal portion, provided with the can; a cardiac electrode coupled to the lead body, the electrode and lead body configured for subcutaneous non-intrathoracic placement within a tunnel surgically formed within subcutaneous non-intrathoracic tissue of a patient; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of the proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of the distal portion of the lead body to a distal portion of the tunnel; and a pharmacological agent provided on the can, a major portion of the lead body, and the electrically active portions of the electrode, the pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue adjacent the can, lead body, and electrode, respectively, the electrically active portions of at least the electrode remaining electrically active for delivering cardiac stimulation energy through the pharmacological agent after provision of the pharmacological agent. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
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83. An implantable lead configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue, comprising:
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a lead body comprising a proximal end, a distal end, and a midpoint between the proximal and distal ends; a plurality of pharmacological agents provided on a major portion of the lead body, the pharmacological agents providing a plurality of temporary therapeutic treatments to the subcutaneous non-intrathoracic tissue; a plurality of fixation elements disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation elements situated proximal to the midpoint such that the at least one of the fixation elements is closer to the proximal end than the distal end of the lead body, the at least one of the fixation elements configured to facilitate fixation of a proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation elements situated distal of the midpoint such that the at least one other of the fixation elements is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation elements configured to facilitate fixation of a distal portion of the lead body to a distal portion of the tunnel; and an electrode coupled to the lead body, the electrode configured for subcutaneous non-intrathoracic placement within a patient, wherein a first pharmacological agent is provided on at least electrically active portions of the electrode, and the electrically active portions of the electrode remain electrically active for delivering cardiac stimulation energy through the first pharmacological agent after provision of the first pharmacological agent. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98)
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99. An implantable system, comprising:
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a can; a lead provided with the can, the lead including a lead body, a proximal end, a proximal portion, a distal end, a distal portion, a midpoint equidistant from the distal and proximal ends, and an electrode, coupled to the lead body, the lead body and electrode configured for placement within a tunnel surgically formed in subcutaneous non-intrathoracic tissue; a plurality of fixation tines disposed along the lead body in a spaced relationship between the distal and proximal ends, at least one of the fixation tines situated proximal to the midpoint such that the at least one of the fixation tines is closer to the proximal end than the distal end of the lead body, the at least one of the fixation tines configured to facilitate fixation of the proximal portion of the lead body to a proximal portion of the tunnel, and at least one other of the fixation tines situated distal of the midpoint such that the at least one other of the fixation tines is closer to the distal end than the proximal end of the lead body, the at least one other of the fixation tines configured to facilitate fixation of the distal portion of the lead body to a distal portion of the tunnel; a first pharmacological agent provided on at least the proximal portion of the lead, the first pharmacological agent providing a temporary therapeutic treatment; and a second pharmacological agent provided on the can, the second pharmacological agent providing a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. - View Dependent Claims (100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111)
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Specification