Systems and methods for placing heart leads

Abstract

Devices, systems, and methods for the localization of body lumen junctions and other intraluminal structure are disclosed. Various embodiments permit clinicians to identify and locate lesions and / or anatomical structures within a lumen and accurately place leads and / or devices within a lumen, through determining the intralumen conductance and / or cross-sectional area at a plurality of locations within the body lumen.

Description

PRIORITY[0001]The present application is a continuation patent application that is related to, and claims the priority benefit of, U.S. patent application Ser. No. 12 / 503,341, filed Jul. 15, 2009, which is a continuation patent application that is related to, and claims the priority benefit of, U.S. patent application Ser. No. 12 / 522,432, filed Jul. 8, 2009, which is related to, claims the priority benefit of, and is a U.S. national stage patent application of International Patent Application Serial No. PCT / US2008 / 000833, filed Jan. 23, 2008, which is related to and claims the priority benefit of: (I) U.S. Provisional Patent Application Ser. No. 60 / 881,840, filed Jan. 23, 2007; and (2) International Patent Application Serial No. PCT / US2007 / 015239, filed Jun. 29, 2007, which (a) claims priority to U.S. Provisional Patent Application Ser. No. 60 / 817,422, filed Jun. 30, 2006; (b) claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 10 / 782,149, filed Feb....

AI Technical Summary

Benefits of technology

[0018]Various embodiments of devices, systems, and methods for localization of body lumen junctures are disclosed herein. At least some of the disclosed embodiments allow a clinician to identify desired anatomical structures with a higher spatial resolution than with conventional techniques. For example, in certain embodiments, a clinician may use embodiments of the devices, systems and methods disclosed herein to accurately identify various bifurcations branching off of the coronary sinus. A clinician may further use the embodiments described herein to accurately place a lead within a coronary sinus or a bifurcation branching therefrom. In certain other embodiments, a clinician may use embodiments of the devices, systems and methods disclosed herein to create a conductance profile of an aorta that is capable of showing the locations of lesions or other structures. In this manner, conductance profile can be used to accurately treat an aortic aneurysm by employing a stent.

Problems solved by technology

Such procedures require precise placement of the implanted devices within the target lumens, and can result in severe complications if such implantations are inaccurate.

When an area of the aortic wall weakens, the pressure of the blood flowing through the weakened area causes the vessel wall to balloon out, forming a blood-filled aneurysm sack.

Although most aneurysms are initially small, aneurysms tend to enlarge over time.

Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture.

Aortic aneurysms are the most common form of arterial aneurysm and are life threatening due to the massive internal bleeding that results from rupture.

Left untreated, the AAA may rupture, resulting in rapid and usually fatal hemorrhaging.

Although the mortality rate for an aortic aneurysm is extremely high (about 75-80%), there is also considerable mortality and morbidity associated with surgical intervention to repair an aortic aneurysm.

In addition, substantial morbidity accompanies the procedure, resulting in a protracted recovery period.

Finally, the procedure entails a substantial risk of mortality.

While surgical intervention may be required in spite of these risks, certain patients may not be able to tolerate the stress of intra-abdominal surgery.

For example, securing the stent to a diseased region of the aorta will result in a faulty seal that will not adequately reroute the blood flow away from the aneurysmic region, thereby resulting in a reoccurrence of the condition.

As accurate placement of the stent is critical, visualization of the aortic structure has been an obstacle for proper navigation during delivery of the stent.

However, magnetic resonance imaging is expensive and time consuming to obtain, and the results exhibit limited spatial resolution.

CHF is a disease condition in which the heart fails to function efficiently as a pump and cannot provide sufficient blood flow and / or pressure to satisfy the normal circulatory needs of a patient.

A patient with acute CHF often experiences sudden shortness of breath, fainting, and irregular heart beats that require frequent emergency room treatments.

In its chronic form, CHF leads to repeated hospital stays, a deterioration in quality of life, and significant costs to the healthcare system.

In about 30% of CHF patients, the disease process compromises the myocardium's ability to contract, which thereby alters the conduction pathways through the heart.

When a patient exhibits damage to the electrical system of the heart, as is often seen in patients with CHF, severe issues may arise.

Disruption of the conductance pathways through the heart can cause a delay in the beginning of right or left ventricular systole and thereby induce asynchronous atrial and ventricular activation.

Alterations in ventricular contractility frequently compromise the ability of the failing heart to eject blood and may consequently increase the severity of the regurgitant flow through the mitral valve.

In patients exhibiting these severe symptoms, the intraventricular conduction delays lead to clinical instability associated with a greatly increased risk of death.

Due to the required placement of the third lead, the implantation and maintenance of a CRT device are associated with a greater risk than the implantation and maintenance of a standard pacemaker device.

Primarily, it is a difficult procedure to advance the pacing lead into the coronary sinus and cardiac veins and, thus, implantation fails in approximately 8% of patients.

Further, in approximately 6% of patients, implantation is compromised by dissection or perforation of the coronary sinus or cardiac vein.

This process, however, is not particularly accurate and does not provide a detailed profile of the coronary sinus.

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