Leadless cardiac pacer

• US 4,256,115 A
• Filed: 01/14/1980
• Issued: 03/17/1981
• Est. Priority Date: 12/20/1976
• Status: Expired due to Term

• Current Assignee: American Technology Incorporated (Emerson Electric Company)
• Original Assignee: American Technology Incorporated (Emerson Electric Company)
• Inventors: Bilitch, Michael
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/111,776
• Time in Patent Office: 428 Days
• Field of Search: 128/419 E, 128/419 P, 128/419 PG, 128/419 PS, 128/784, 128/785
• US Class Current: 607/9
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A leadless battery operated cardiac pacemaker is embodied in a small disc-like case for attachment beneath the pericardium directly to the heart muscle. One electric lead is curled and serves also as a means for both physically and electrically attaching the case to the heart muscle. The other lead surrounds the one lead and is drawn into surface to surface electric contact with body tissue to close the circuit. Solid state redundant circuitry makes provision to serve as a safety feature against possible malfunction.

Claims

1. A leadless cardiac pacemaker for attachment to a heart muscle on the exterior surface beneath the pericardium, said pacemaker comprising a case of tissue compatible material having a circumferentially rounded perimeter presenting respective outer and inner faces,

said case having a smooth imperforate surface throughout its exterior with the inner face adapted to contact the heart muscle and having an area smaller than the area of the contacted portion of the heart muscle, an annular perimetrical area between said faces being transversely arcuate,

a solid state electronic pacer circuitry unit including a solid state power source hermetically encapsulated in said case,

a cathode centrally mounted in fixed position on said inner face,

said cathode comprising a contact wire with a section thereof exterior to the case being bare, said wire having a captive end in fixed position on one face of said case and electrically connected to said unit, said bare section comprising a tissue penetrating and fastening strand of material having an overall length exceeding the width by many times and projecting outwardly of said case, the penetrating and fastening strand being of resilient character

and having a muscle penetrating tip whereby upon insertion into the heart muscle the penetrating and fastening portion draws the case against the exterior of the heart muscle, and anode with an exposed portion surrounding said cathode and in fixed position on the same face of said case as said cathode,

said anode comprising a tissue contacting area mounted on the inner face of the case and in position flush with said inner face and being electrically connected to said unit,

there being an area of dielectric material on the case forming a part of said inner face separating said anode and said cathode.

2. A leadless cardiac pacemaker as in claim 1 wherein said inner face is concave and the area of said inner face on both sides of said anode comprises dielectric material.

3. A leadless cardiac pacemaker as in claim 2 wherein the maximum transverse dimension of said case is about 3.8 centimeters, the breadth of said anode is about 0.2 centimeter, and the area on each side of said anode is about 0.4 centimeter.

4. A leadless cardiac pacemaker as in claim 1 wherein the depth of the case is about one-third the maximum transverse dimension, the inner face is concave with a depth of about 0.2 centimeter at the center and the mass is less than 50 grams.

5. A leadless cardiac pacemaker as in claim 1 wherein said cathode comprises both a single electric contact and the sole fastening means between said case and the interior of the heart muscle.

6. A leadless cardiac pacemaker as in claim 1 wherein said tissue penetrating and fastening portion comprises a helicoid of bare conducting material throughout its exposed length.

7. A leadless cardiac pacemaker as in claim 6 wherein the helicoid comprises about two and one-half turns having a length of about 0.4 centimeter and a diameter of about 0.4 centimeter.

8. A leadless cardiac pacemaker as in claim 6 wherein said helicoid comprises the sole attachment means for said pacemaker to the heart muscle and the sole electric contact for said cathode, said helicoid being adapted throughout its entire length to be embedded in the heart muscle when the adjacent inner face of the case is in engagement with the exterior of the heart muscle.

9. A leadless cardiac pacemaker installation for a human heart at a location between the exterior of a wall of the heart and the pericardium, said installation including a case of tissue compatible material having a circumferentially rounded perimeter presenting respective outer and inner faces and a thickness substantially less than the minimum transverse dimension, said case having an annular transversely arcuate perimetrical area between said faces, the entire surface of said faces and the perimetrical area therebetween being smooth and imperforate,

a solid state electronic pacer circuitry unit including a solid state power source hermetically encapsulated in said case,

a cathode centrally mounted in fixed position on said inner face, said cathode comprising a contact wire with a helicoid bare section thereof exterior to the case, said wire having a captive end in fixed position in said case and electrically connected to said unit, said helicoid bare section being a tissue penetrating and fastening portion with an overall length projecting outwardly of the case and extending partway through the wall of the heart,

an anode with an exposed portion surrounding said cathode and in fixed position on the case and relative to said cathode, said anode comprising a tissue contacting area mounted on the same face as said cathode and in position flush with said inner face and in engagement with the wall of the heart, said anode being electrically connected to said unit, said case having a position lodged in a space between the pericardium and the wall of the heart with the pericardium in engagement with the outer face of the case.