Substernal placement of a pacing and/or defibrillating electrode
Inventors
Reddy, G. Shantanu • Tockman, Bruce A.
Assignees
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Publication Number
US-11123547-B2
Publication Date
2021-09-21
Expiration Date
Abstract
New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, substernally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.
Core Innovation
The invention provides a method of placing a lead for an implantable cardiac therapy system by positioning the lead at a desired location along the posterior of the sternum, superior to the ventricles of the patient’s heart. The insertion tool or insertion sheath is advanced percutaneously to a position near the xiphoid along the back side of the sternum, away from the patient’s heart and pericardium, and is shaped to direct a member passed therethrough against the back side of the sternum.
The lead is then pushed through the insertion tool or insertion sheath into the desired posterior sternal position without first tunneling any instrument to the desired location. Dependent refinements specify anatomical regions such as at or above the sternal angle, between the second and third ribs, level with the thymus, even with the aortic arch, or even with the stop of the superior vena cava.
The disclosed approach also includes embodiments in which an anchor is placed on the posterior side of the sternum near the sternal angle and is connected to a tension element or tether, with the lead introduced and secured relative to the anchor. In addition, a curved shaft and biased path around the xiphoid toward the posterior sternal side are disclosed to enable lead advancement, together with localization and visualization options.
A canister may be installed in the patient’s left axilla, and a proximal end of the lead is subcutaneously tunneled to the left axilla and coupled to the canister. The disclosed workflow examples further include subsequent tunneling of the lead proximal end to a left-axilla subcutaneous canister after placing the lead along the posterior of the sternum.
Claims Coverage
The document provides two independent method claims covering lead placement along the posterior of the sternum superior to the ventricles without first tunneling any instrument to the desired location. Across the independent claims, there are two main inventive feature clusters.
Percutaneous insertion tool advanced near the xiphoid to direct a member against the back of the sternum without pre-tunneling
Without first tunneling any instrument to the desired location, advancing an insertion tool percutaneously to a position near the xiphoid of the patient along the back side of the sternum, wherein the insertion tool is shaped to direct a member passed therethrough against the back of the sternum.
Lead pushed through the insertion tool into a posterior sternal position superior to the ventricles
Pushing the lead through the insertion tool into the desired position using the advancing tool, wherein the desired position is along the posterior of the sternum, superior to the ventricles of the patient's heart.
Percutaneous insertion sheath around the xiphoid away from the heart and pericardium along the backside of the sternum
Without first tunneling any instrument to the desired location, advancing an insertion sheath percutaneously around the patient's xiphoid, away from the patient's heart and pericardium, and along a backside of the patient's sternum, wherein the insertion sheath is shaped to preferentially direct a member passed therethrough against the backside of the sternum.
Lead distal end pushed through insertion sheath into a posterior sternal position at least superior to the ventricles
Pushing a distal end of the lead through the insertion sheath into the desired position using an advancing tool, wherein the desired position is along the posterior of the sternum, at least superior to the ventricles of the patient's heart.
Across both independent claims, the asserted coverage centers on percutaneous advancement of an insertion tool or sheath near the xiphoid along the posterior or back side of the sternum away from the heart and pericardium, followed by pushing the lead through the tool or sheath into a desired posterior sternal location that is superior to the ventricles.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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