Subcutaneous leads and methods of implant and explant
First Claim
1. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:
- a distal region having at least one electrode and an anchoring structure; and
a proximal region having a proximal end for coupling to an implantable cardiac stimulus device;
wherein at least one electrical connector electrically couples the proximal end to the at least one electrode;
characterized by the anchoring structure being relatively inflexible and sized such that it cannot be passed through subcutaneous tissue without extensive dissection so that, in order to implant the lead electrode, the proximal region must be pulled through tissue by securing an insertion tool to the proximal end and pulling the proximal end with the insertion tool without passing the distal region more than minimally into a tissue pocket.
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Accused Products
Abstract
New and/or alternative designs for implantable leads that have fixation structures to keep leads at a desired location after implant. Fixation structure may take several forms that create distally located fixation for use primarily in subcutaneous implantation. Some examples include new and/or alternative methods of implanting such leads. Some examples also include fixation structures, such as a suture sleeve, that can be attached to a lead for fixation thereof. Some further examples show methods of implanting a subcutaneous lead, and others include methods of extracting implanted subcutaneous leads.
60 Citations
16 Claims
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1. An implantable lead electrode for subcutaneous implantation in a patient and adapted for use in a cardiac stimulus or monitoring system, the lead electrode comprising:
- a distal region having at least one electrode and an anchoring structure; and
a proximal region having a proximal end for coupling to an implantable cardiac stimulus device;
wherein at least one electrical connector electrically couples the proximal end to the at least one electrode;
characterized by the anchoring structure being relatively inflexible and sized such that it cannot be passed through subcutaneous tissue without extensive dissection so that, in order to implant the lead electrode, the proximal region must be pulled through tissue by securing an insertion tool to the proximal end and pulling the proximal end with the insertion tool without passing the distal region more than minimally into a tissue pocket. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
- a distal region having at least one electrode and an anchoring structure; and
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9. A method of implanting an implantable lead electrode in a subcutaneous location,
wherein the implantable lead electrode the lead electrode comprises: -
a distal region having at least one electrode and an anchoring structure; and a proximal region having a proximal end for coupling to an implantable cardiac stimulus device; wherein at least one electrical connector electrically couples the proximal end to the at least one electrode; characterized by the anchoring structure being relatively inflexible and sized such that it cannot be passed through subcutaneous tissue without extensive dissection so that, in order to implant the lead electrode, the proximal region must be pulled through tissue by securing an insertion tool to the proximal end and pulling the proximal end with the insertion tool without passing the distal region more than minimally into a tissue pocket; the method comprising; making an upper sternal incision on the chest of a patient; making a xiphoid incision on the chest of the patient, the upper sternal incision being superior of the xiphoid incision; making a lateral incision on the chest of the patient relatively near the patient'"'"'s left axilla; pulling the proximal end of the lead electrode through the upper sternal incision to the xiphoid incision; pulling the proximal end of the lead electrode to the lateral incision; and
coupling the proximal end of the lead electrode to an implantable medical device canister;wherein the pulling steps are completed such that the anchoring structure is passed into the patient'"'"'s tissue near the upper sternal incision to allow closing of the upper sternal incision, but without passage through of the anchoring structure through patient tissue toward the xiphoid incision. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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Specification