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10/15/09 - USPTO Class 607 |  1 views | #20090259272 | Prev - Next | About this Page  607 rss/xml feed  monitor keywords

Bundle of his stimulation system

USPTO Application #: 20090259272
Title: Bundle of his stimulation system
Abstract: A system for therapeutically stimulating a His bundle includes an implantable pulse generator and a multi-polar medical electrical lead. The generator is configured for subcutaneous implantation and to generate a pacing stimulus. The lead includes a connector assembly, a flexible tubular body, a distal tip assembly and coil conductors. The body extends intravascularly from the generator to a location proximate the His bundle and includes a proximal end, a distal end, and a longitudinal lumen. The tip assembly includes an electrode, a fixation helix, and a shank portion. The helix extends to a location proximate the His bundle and is operable as an electrically isolated electrode. The shank portion extends within the lumen and includes a receptacle for receiving a stylet tip. The conductors extend longitudinally through the lumen and are coupled to the electrode and the helix. One or both of the conductors defines a stylet lumen. (end of abstract)



Agent: Faegre & Benson LLP Patent Docketing - Intellectual Property (32469) - Minneapolis, MN, US
Inventors: G. Shantanu Reddy, Matthew S. Finlay
USPTO Applicaton #: 20090259272 - Class: 607 28 (USPTO)

Bundle of his stimulation system description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20090259272, Bundle of his stimulation system.

Brief Patent Description - Full Patent Description - Patent Application Claims
  monitor keywords CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 61/045,168, filed on Apr. 15, 2008, entitled “Bundle of HIS Stimulation System,” which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to medical electrical leads for use in cardiac rhythm management systems. In particular, the present invention relates to medical electrical leads configured for mapping and pacing the bundle of His in a heart of a patient.

BACKGROUND

Cardiac rhythm management systems are useful for electrically stimulating a patient\'s heart to treat various cardiac arrhythmias. A proposed method of electrically stimulating the heart includes stimulating the His bundle located proximate to the apex of the triangle of Koch in the right atrium of the heart. By directly stimulating the bundle of His, both the right and left ventricles can be physiologically activated, potentially avoiding pacing induced dyssynchrony present with right ventricular apex pacing. There is a continuing need for improved His bundle lead designs and assemblies.

SUMMARY

In a first aspect, the present invention is a system for therapeutically stimulating a His bundle of a patient\'s heart including an implantable pulse generator and a multi-polar medical electrical lead. The implantable pulse generator is configured for subcutaneous implantation in the patient and to generate an electrical pacing stimulus. The lead is operatively coupled to the pulse generator to deliver the pacing stimulus to cardiac tissue proximate the His bundle and includes a proximal connector assembly, a flexible tubular body, a distal tip assembly and first and second coil conductors. The proximal connector assembly is configured to mechanically and electrically couple the lead to the pulse generator. The body is dimensioned to extend at least partially intravascularly from the pulse generator to a location proximate the His bundle. The body includes a proximal end coupled to the proximal connector, a distal end opposite the proximal end and a longitudinal conductor lumen extending from the proximal end of the body to the distal end of the body. The distal tip assembly is fixedly coupled to the distal end of the body and includes a first electrode spaced from the distal end of the body, a fixation helix, and a shank portion. The fixation helix is fixedly coupled to the lead body and extends distally of the first electrode. The fixation helix has a sharpened distal tip and is operable as a second electrode electrically isolated from the first electrode and is dimensioned to extend to a location proximate the His bundle. The shank portion extends proximally of the first electrode and the fixation helix within the conductor lumen and includes a proximal face having a receptacle for receiving and engaging a stylet tip. The first and second coil conductors extend longitudinally through the conductor lumen and are electrically and mechanically coupled to the first electrode and the fixation helix, respectively. Either one or both of the first and second coil conductors defines a stylet lumen.

In a second aspect, the present invention is a system including a pulse generator configured to generate an electrical pacing stimulus, a separable, splittable or slittable guide catheter configured to deliver electrical stimulation to a His bundle of a patient\'s heart, and an implantable medical electrical lead sized to be slidably received within an open lumen of the catheter. The catheter includes a proximal shaft having a proximal end, a pre-curved distal portion extending distally from the proximal shaft and terminating in a distal tip, an open lumen extending longitudinally from the proximal end of the shaft portion to the distal tip, at least one electrode proximate the distal tip, and an electrically conductive member extending from at least the proximal end of the shaft portion to the electrode. The pre-curved distal portion includes a series of contiguous pre-formed curved segments, each having a different radius of curvature and extending along a different arc length than each immediately adjacent segment. The distal portion is configured to locate the distal tip proximate an atrial wall of the heart adjacent the His bundle when the proximal shaft portion is at least partially located in a superior vena cava of the heart. The electrically conductive member electrically couples the electrode to an external device for mapping electrical activity of the heart. The implantable medical electrical lead includes a proximal connector assembly configured to mechanically and electrically couple the lead to the pulse generator, a flexible tubular body, a distal tip assembly, first and second coil conductors and a stylet. The flexible tubular body is dimensioned to extend at least partially intravascularly from the pulse generator through the patient\'s superior vena cava to a location proximate the His bundle. The body includes a proximal end coupled to the proximal connector, a distal end opposite the proximal end, and a longitudinal conductor lumen extending from the proximal end of the body to the distal end of the body. The distal tip assembly is fixedly coupled to the distal end of the body and includes a first electrode positioned adjacent to the distal end of the body, a fixation helix fixedly coupled to the body and extending distally of the first electrode, and a shank portion extending proximally of the first electrode and the fixation helix within the conductor lumen. The fixation helix is operable as a second electrode electrically isolated from the first electrode and is further dimensioned to extend from a wall of a right atrial septum to a location proximate the His bundle. The shank portion includes a proximal face having a receptacle for receiving and engaging a stylet tip. The first and second coil conductors extend longitudinally through the conductor lumen and are electrically and mechanically coupled to the first electrode and the fixation helix, respectively. Either one or both of the first and second coil conductors defines a stylet lumen. The stylet has a proximal end and a distal end including an engaging feature configured to mate with and engage the receptacle on the shank portion of the lead distal tip assembly. The stylet is configured to transmit a torque applied at its proximal end to the distal tip assembly to cause rotation of the fixation helix and the lead body.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a His bundle stimulation and pacing system including a pulse generator and a lead implanted in a patient\'s heart according to an embodiment of the present invention.

FIG. 2A is a plan view of a lead of the His bundle stimulation and pacing system of FIG. 1 according to an embodiment of the present invention.

FIG. 2B is a cross-sectional view of the lead of FIG. 2A according to an embodiment of the present invention.

FIG. 3 is a side view of a distal tip assembly of the lead of FIGS. 2A and 2B according to an embodiment of the present invention.

FIG. 4 is a perspective view of a bullet-nose distal tip assembly of the His bundle stimulation and pacing system of FIG. 1 according to an embodiment of the present invention.

FIG. 5 is an enlarged view of a double helix of a distal tip assembly of the His bundle stimulation and pacing system of FIG. 1 according to an embodiment of the present invention.

FIG. 6 is an enlarged view of a helix with an electrode of a distal tip assembly of the His bundle stimulation and pacing system of FIG. 1 according to an embodiment of the present invention.



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