Surface mapping electrode sets

[54] SURFACE MAPPING ELECTRODE SETS

[75] Inventor: Stanley R. Hess, Miami, Fla.

[73] Assignee: Cordis Corporation, Miami, Fla.

[21] Appl. No.: 5,314

[22] Filed: Jan. 16,1987

Related U.S. Application Data

[63] Continuation of Ser. No. 650,192, Sep. 13, 1984, abandoned.

[51] Int. CI.4 A61B 5/04

[52] U.S. a 128/639; 128/644;

128/798

[58] Field of Search 128/639-644,

128/419 P, 783-786, 789, 798, 802

[56] References Cited

U.S. PATENT DOCUMENTS

4,144,889 3/1979 Tyers et al 128/419 P X

4,323,081 4/1982 Wiebusch 128/419 P X

4,354,509 10/1982 Strahwald et al 128/639 X

4,365,634 12/1982 Bare et al 128/798 X

4,381,789 5/1983 Naser et al 128/798

4,407,303 10/1983 Akerstrom 128/786 X

4,510,939 4/1985 Brenman et al 128/639

4,522,212 6/1985 Gelinas et al 128/419 P X

4,537,198 8/1985 Corbett 128/639

4,628,937 12/1986 Hess et al 128/642

FOREIGN PATENT DOCUMENTS

2709668 9/1978 Fed. Rep. of Germany 128/639

1523263 8/1978 United Kingdom 128/642

OTHER PUBLICATIONS

Johnston et al.; "Body Tissue Transducer"; IBM Technical Disclosure Bulletion, vol. 6, No. 8, 1-1964, pp. 13-14.

Primary Examiner—Kyle L. Howell

Assistant Examiner—Angela D. Sykes

Attorney, Agent, or Firm—Lockwood, Alex, Fitzgibbon

& Cummings

[57] ABSTRACT

A surface mapping electrode set assembly is provided which includes a plurality of insulated, elongated wires, each of which terminates at a distal end head portion of the assembly. The electrodes of the mapping electrode set are generally arcuate portions of the wires, each generally arcuate electrode projecting through a slit in the administration surface of the assembly while the distal tip portion of the wire remains beneath such administration surface.

15 Claims, 14 Drawing Figures

4,690.

1

SURFACE MAPPING ELECTRODE SETS

This application is a continuation of application Ser. No. 650,192, filed Sept. 13, 1984, now abandoned. 5

BACKGROUND OF THE INVENTION

This invention generally relates to cardiac mapping, more particularly to surface mapping electrode sets and the making of same, which surface mapping electrode 1° sets are suitable for conducting epicardial and/or endocardial mapping. Electrode sets according to this invention include an administration portion or head, a plurality of insulated wires that are positioned generally longitudinally adjacent to each other and that each have a 15 distal end embedded within the head portion which has an administration surface. Making the electrode set includes slitting the insulation of the administration surface at locations above the electrodes, and each portion of each electrode that is exposed by each slit is 20 pulled or bent outwardly to form a generally arcuate electrode that projects through the slit. The plurality of thus formed generally arcuate electrodes form a set of electrodes that are suitable for mapping of cardiac sur- ^ faces.

Mapping electrode sets for epicardial and endocardial mapping of heart signals have been provided in the past. Typically, these mapping electrode sets are utilized during cardiac surgery in order to sense the cardiac 3Q signal and report it to the surgical team through appropriate display and/or printout devices. The surgical team may observe the reported data and immediately utilize the data in connection with a surgical procedure, or the data may be collected for subsequent analysis. 35 Such mapping involves timing that is based upon the leading edge of an excitation wave through conductive tissue of the heart. Generally, mapping procedures include the induction of tachycardia while the mapping electrode is positioned on the cardiac tissue by the sur- 40 geon.

Various structures of mapping electrode sets have been developed or proposed. Many of these structures require somewhat complicated and difficult fabrication techniques. Also, these mapping electrode sets typically 45 include electrodes that are the distal tips of the wires which transmit the signals to the data receiving unit, which distal tips project beyond the administration surface of the mapping device. Often, these projecting distal tips of the electrode wires must be modified in 50 some manner in order to provide a suitable electrode. For example, the distal tips may have a very small diameter or have somewhat sharp edges, both of which increase the possibility of penetration thereby of heart tissue or of trauma to the heart. 55

Techniques are available for modifying such wire tips in order to minimize the possibility of heart penetration or trauma. Included are means for modifying the configuration of the wire tip. Often, because the wires used in mapping devices are exceptionally thin, efforts to 60 minimize heart tissue penetration and trauma most advantageously include increasing the size of the tip, such as by adding a blunt or spherical member thereto or by reshaping the tip. One type of acceptable procedure is to subject the wire tip to inert gas shielded arc welding, 65 particularly inert gas welding that utilizes a non-consumable tungsten electrode, this procedure being known as TIG.

148 2

Another important consideration regarding mapping electrode sets is that they are disposable. Accordingly, economic factors strongly favor the use of components and procedures that minimize or decrease the cost of the mapping electrode set. It is also important that the mapping electrode set provide the surgeon with the ability to accurately position the electrodes at a desired location on the outside or inside surface of the heart so that the surgeon can very accurately determine the precise location of the blocked area of the tissue to be surgically removed or treated. Surface mapping electrode sets should therefore be easily maneuverable by the fingers of the surgeon.

SUMMARY OF THE INVENTION

These various needs and desirable attributes are achieved by the present invention which provides a surface mapping electrode set assembly that includes a plurality of insulated wires which are positioned generally adjacent to each other and which have distal end tips that are embedded within a head portion of the assembly such that these tips are beneath the administration surface of the assembly. Each electrode for surface mapping is formed from a section of the wire that is generally proximally spaced from the embedded distal tip, each such section projecting through a slit in the administration surface. Various numbers of electrodes can be provided on the assembly in this manner, and the wires provide electrical communication between the electrode and the signal recording or display device. Each surface mapping electrode set exhibits some degree of maneuverability and bendability in order to provide the surgeon with a device that can be positively and firmly positioned onto the surface of most portions of the heart.

It is accordingly a general object of the present invention to provide an improved surface mapping electrode set and method of making same.

Another object of the present invention is to provide an improved surface mapping electrode set that is economical and easily manufactured.

Another object of the present invention is to provide an improved surface mapping electrode set that includes electrodes which are structured to minimize the likelihood of their penetration into heart tissue or of heart trauma associated therewith.

Another object of the present invention is to provide an improved surface mapping electrode set assembly that provides generally arcuate electrodes along the administration surface thereof.

Another object of this invention is to provide an improved mapping electrode set assembly and method that can be readily manufactured with a variety of different numbers of electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects of the present invention will be apparent from the following description of the invention, taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a top plan view of a basic embodiment of this invention, which utilizes a ribbon electrode assembly;

FIG. 2 is a bottom plan view of the embodiment illustrated in FIG. 1;

FIG. 3 is an elevational view of the embodiment illustrated in FIG. 1;