ELECTRODE INSERTION TOOLS, LEAD ASSEMBLIES, KITS AND METHODS FOR PLACEMENT OF CARDIAC DEVICE ELECTRODES
First Claim
1. A tool for use in subcutaneous insertion of a lead electrode assembly, the tool comprising:
- a proximal end having a handle;
a distal end including a dissecting tip shaped for separating subcutaneous tissue to form a channel therethrough, and an engaging structure disposed adjacent to the dissecting tip; and
a shaft extending between the proximal and distal ends;
wherein the engaging structure is configured to directly engage a portion of an associated lead assembly.
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Accused Products
Abstract
Insertion tools, lead assemblies, kits, and methods for placement of cardiac device electrodes. In some embodiments, an insertion tool having a proximal end and a distal, dissecting end includes a structure configured to receive or engage a structure on a lead assembly. Some embodiments include a lead assembly having an end including a structure configured for engaging the distal end of an associated insertion tool. Some embodiments include kits or systems including both an insertion tool and a lead assembly, each having a structure for engaging the other. In these embodiments, the engaging structures may take several forms including threads, small posts, circular or semi-circular receiving members, and/or a slot. Some embodiments also include methods for placement of cardiac device electrodes with the assistance of an associated insertion tool, wherein the cardiac device electrodes are associated with a lead assembly having an end configured to engage a distal, dissecting portion of an associated insertion tool.
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Citations
20 Claims
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1. A tool for use in subcutaneous insertion of a lead electrode assembly, the tool comprising:
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a proximal end having a handle; a distal end including a dissecting tip shaped for separating subcutaneous tissue to form a channel therethrough, and an engaging structure disposed adjacent to the dissecting tip; and a shaft extending between the proximal and distal ends; wherein the engaging structure is configured to directly engage a portion of an associated lead assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method of implanting a lead assembly for a cardiac stimulus system, the method comprising:
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creating a first incision and a second incision; providing an introducer tool having a proximal end with a handle and a distal end having a dissecting tip and a lead engagement structure for engaging an associated lead assembly; advancing the introducer tool into the first incision toward the second incision such that the dissecting tip dissects subcutaneous tissue and the lead engagement structure is exposed to subcutaneous tissue and fluids; exposing at least the lead engagement structure at the second incision; providing a lead assembly having at least a distal end with a tool engagement structure configured to engage the lead engagement structure; securing the distal end of the lead assembly to the distal end of the introducer tool by twisting engagement of the lead engagement structure to the tool engagement structure; and pulling the introducer tool handle to draw a portion of the lead assembly into the subcutaneous tissue between the first and second incisions. - View Dependent Claims (15, 16)
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17. A lead assembly for a cardiac stimulus system, the lead assembly comprising:
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a distal end comprising at least a first electrode and a distal tip; and a proximally extending shaft including an electrical conductor coupled to the first electrode; wherein the distal end further comprises an engagement structure configured for direct engagement with an associated introducer tool and a receiving portion for receiving the distal end of the associated introducer tool such that, when an associated introducer tool is received in the receiving portion, the distal tip of the lead assembly extends over and around a portion of the associated introducer tool. - View Dependent Claims (18, 19, 20)
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Specification