Catheter for use in recording his electrogram alternans and application to various conditions

Abstract

The invention relates to a catheter useful in recording His electrogram alternans. The catheter includes a catheter probe containing at least one row of receiving poles positioned at an edge of the catheter probe, equidistantly spaced from each other.

Claims

1. A method for determining His electrogram alternans (HEA) from a His bundle of cardiac tissue, said His bundle comprising a superior His domain and an inferior His domain comprising inserting an apparatus for receiving electrical signals from an His bundle of cardiac tissue through a human blood vessel, said apparatus comprising a catheter tip portion at one end and a flexible elongate member at the other end, wherein said catheter tip portion comprises a first and a second row of parallel, receiving electric poles positioned at a first and a second edge on a flat surface of said catheter tip portion, wherein any two of said parallel receiving electric poles in a horizontal row are separated from each other at a distance equal to the distance between any other pair of corresponding receiving electric poles in a horizontal row, wherein said catheter probe is from about 6 cm to about 10 cm in length, and from about 3 mm to about 5 mm in width or diameter, and positioning said catheter tip portion on said His bundle of cardiac tissue, so that the first row of receiving electric poles align along said superior His domain and said second row of receiving electric poles align along said inferior His domain, to determine said HEA.

2. The method of claim 1, wherein said HEA comprises a SHE (superior His electrogram) and an IHE (inferior His electrogram).

3. The method of claim 1, wherein said blood vessel is a vein.

4. The method of claim 1, wherein said blood vessel is an artery.

5. A method for determining His electrogram alternans (HEA) from a His bundle comprising a superior His domain and an inferior His domain of cardiac tissue, comprising inserting an apparatus for receiving an electrical signal from an His bundle of cardiac tissue through a human blood vessel, said apparatus comprising a catheter tip portion at one end and a flexible elongate member at the other end, wherein said catheter tip portion comprises a first and a second row of parallel, receiving electric poles positioned at a first and a second edge on a surface of said catheter tip portion, wherein any two of said parallel receiving electric poles in a horizontal row are separated from each other at a distance equal to the distance between any other pair of corresponding receiving electric poles in a horizontal row, wherein said catheter probe is from about 6 cm to about 10 cm in length, and from about 3 mm to about 5 mm in width or diameter, and positioning said catheter tip portion on said His bundle of cardiac tissue, so that the first row of receiving electric poles are aligned along the superior His domain and the second row of receiving electric poles align along the inferior His domain, to determine said HEA.

6. The method of claim 5, wherein said electric HEA comprises a SHE (superior His electrogram) and an IHE (inferior His electrogram).

7. The method of claim 6, wherein said blood vessel is a vein.

8. The method of claim 6, wherein said blood vessel is an artery.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 labeled PRIOR ART shows a commercially available electrophysiology catheter.

(2) FIG. 2a labeled PRIOR ART shows various types of electrophysiology catheter tips.

(3) FIG. 2b labeled PRIOR ART shows typical ring type electrodes as used in the field.

(4) FIG. 3 shows various embodiments of the invention as elaborated herein.

(5) FIG. 3a shows an embodiment with circular or oval configuration.

(6) FIG. 3b shows an embodiment with a half circle configuration.

(7) FIG. 3c shows an embodiment with a rectangle or square configuration.

(8) FIG. 3d shows an embodiment with one row of poles.

(9) FIG. 4 shows a schematic view of the His bundle its fibers, and preferred placement of electrode pole onto the superior (open circles) and inferior (closed circles) bundle.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(10) Referring now to the drawings, one example of a preferred embodiment of the invention is shown, in FIG. 3. In FIG. 3, one sees different configurations a, b, c, and d, of the tip of a catheter in accordance with the invention. The different configurations of the tip of the catheter are shown, so as to depict geometries which are useful in determining HE alternans. The tip of the catheter must be configured so as to rest stably on the cardiac structure known as the His bundle. Shown in FIGS. 3a-3c, respectively, are circular oval, and rectangular (square) configurations. These embodiments are all bilaterally symmetrical. The configurations can also be other shapes, such as semi-circles, squares, or rectangles.

(11) Configurations shown in FIGS. 3A, 3B, and 3C all show two rows of parallel, receiving electric poles. These are shown by 102a, b, c, and d and 103a, b, c, and d in FIG. 3A, and these indicia apply for each figure. The poles are positioned at the end of the catheter, and the distance between an two poles in a horizontal row is the same for all others in that row. Similarly, the vertical distance between two corresponding poles is the same for all corresponding poles. Finally, the distance between terminal pole and the end of the catheter is always the same in a given catheter.

(12) As the His bundle is a relatively small structure, the electric receiving poles are small, preferably from about 1 mm to 2 mm in diameter. Spacing of the electric receiving poles in a row from each other is about 2-4 mm.

(13) The catheter tip of the invention may vary in size, however, as it must be inserted through a peripheral blood vessel into the chamber of the heart where the His bundle is located, preferably the tip is from about 3-5 mm wide (or, from about 3-5 mm in diameter if a circular or semicircular configuration is used). The tip is from about 6 to about 10 cm in length, and may present receiving poles along its full length, or part of its length. If the poles are only presented along a position of the length, it is preferred that they be at the distal end of the tip, relative to the catheter lead. Poles should be presented as close to the edges of the tip as possible. The poles can be configured in the shapes discussed supra.

(14) The materials used to make the catheter tip are the standard materials used to make catheters, and these will be readily familiar to those of ordinary skill in the art. Exemplary materials for the body of the tip are polyurethanes, with platinum, iridium, or alloys thereof being used to manufacture the receiving poles. Other materials will be known to the skilled artisan and need not be provided here.

(15) Each row should contain the same number of electric receiving poles, when the catheter employs two rows. Each row must contain at least two poles, but preferably contains at least 4-8.

(16) In a further embodiment of the invention, depicted in FIG. 3d, the catheter only records one of the two HE values (SHE or IHE, i.e., superior or inferior His electrogram alternans). In this embodiment, the requirements of parallel rows are not present; however, the other dimensionalities apply here as well.

(17) In operation, the catheter of the invention functions in a manner set forth in FIG. 4. FIG. 4 shows a rough schematic of the His bundle, 201. It can be seen that the His bundle has superior inferior positions 202 and 203. In operation, the end of the catheters shown in FIG. 3 are configured to fit precisely on top of the His bundle, such that the receiving poles record both the superior His electrogram value, and the inferior His electrogram value. The catheter end depicted in 3d is used to record one or the other of these values. Fitting of the catheter tip onto the His bundle can be accomplished via, for example, using an external control mechanism to curve the tip to the degree necessary.

(18) The skilled artisan will recognize that this catheter tip or probe is integrally connected to a flexible, elongate member, which is suitably small so as to pass easily through a blood vessel, e.g., a vein leading to a heart.

(19) Other embodiments of the invention will be clear to the skilled artisan and need not be set forth herein.

(20) The terms and expression which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expression of excluding any equivalents of the features shown and described or portions thereof, it being recognized that various modifications are possible within the scope of the invention.