Electrical leads for cardiac stimulators and related methods and means

• US 4,000,745 A
• Filed: 08/05/1968
• Issued: 01/04/1977
• Est. Priority Date: 08/05/1968
• Status: Expired due to Term

• Current Assignee: Edward M. Goldberg
• Original Assignee: Edward M. Goldberg
• Inventors: Goldberg, Edward M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US04/750,218
• Time in Patent Office: 3,074 Days
• Field of Search: 128/404, 128/418, 128/419 P, 339/67, 339/96, 339/108 R
• US Class Current: 607/127
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

The electrical leads for cardiac stimulators comprise an insulated electrical conductive section and a lead-in securing section including a helical member which may be screwed into the heart muscle. Preferably, there is interposed between these two sections a non-insulated electrical conducting section which becomes embedded in the heart upon insertion of the electrical lead. If there is any breakage between the lead-in securing section and the rest of the electrical lead, electrical impulses are still supplied to the heart by the cardiac stimulator.

An insertion tool is provided to attach the electrical lead to the heart.

This invention relates to methods and means for attaching a pacemaker or cardiac stimulator to the heart of animals and humans. It also relates to a cardiac stimulator system for S-A node heart blockage and a method for resisting coronary insufficiency.

The beat of human and animal hearts is controlled by electrical impulses entering the atrium and passing through to the ventricles. When the travel of these electrical impulses from the atrium to the ventricles is partially or totally impeded this condition is referred to as a "heart block". For some time heart blocks have been corrected by attaching "cardiac stimulators", small generators of electrical impulses, through electrical leads to the malfunctioning heart.

Cardiac stimulators have been used to pace the heart in synchronous and non-synchronous manners. In synchronous pacing suitable equipment is connected to the atrium to pick up the beat of the atrium. This electrical beat is coordinated with electrical impulses sent by a cardiac stimulator attached to the ventricles to achieve "synchronous" beating between the atrium and the ventricles.

In non-synchronous pacing the cardiac stimulator is merely attached to the ventricle and the beating of the ventricles and atrium is not in complete harmony. The efficiency of the heart is reduced in non-synchronous pacing approximately 20%, but since it requires fewer attachments to the heart non-synchronous pacing has been the most commonly used pacing system.

Heretofore a thoracotomy was commonly required to attach a cardiac stimulator to the heart and the electrical leads were sutured into electrical contact with the heart. This technique has numerous disadvantages. Firstly, a thoracotomy, which requires a large incision in the chest or thorax, is drastic surgery and has a relatively high mortality rate. Secondly, suturing the electrical leads into the electrical contact with the heart causes severe trauma to the heart, which it is desirable to minimize.

An intravenous connection has also been used to attach electrical leads of a cardiac stimulator to the heart. In this technique the electrical lead is passed through a vein into the heart where it is held by fibrilla located in close proximity to the heart valve through which the lead is passed. There are, however, many disadvantages to this technique also, including: the possibility of damage to the vein during insertion, such as vein perforation; the failure to securely attach the electrical lead to the heart; and the possibility of perforating the heart wall with the electrical lead during insertion or after attachment has been completed.

It is therefore desirable to provide methods and means for attaching a cardiac stimulator to the heart of an animal or human which do not require a thoracotomy, have less traumatic effect upon the heart and securely attach the electrical leads to the heart.

It is therefore an object of the present invention to provide an electrical lead for a cardiac stimulator which may be securely attached to the heart of an animal or human without the trauma caused by suturing an electrical lead onto the heart.

It is a further object to provide an electrical lead for a cardiac stimulator which may be attached to the heart through less drastic surgical procedures than a thoracotomy.

It is another object to provide an electrical lead for a cardiac stimulator which may be easily, yet firmly, attached to the heart.

It is yet another object to provide an improved electrical lead utilizing an insertion tool for securing the lead to the heart.

It is another object to provide a cardiac stimulator system which is corrective of S-A node blockage.

Claims

1. An electrical lead that may be screwed into an organ which comprises an insulated electrical conducting section and a lead-in securing section with a longitudinally rigid helical member which may be screwed into the organ.

2. The electrical lead of claim 1 including a non-insulated electrical conducting section between said insulated electrical conducting section and said lead-in securing section.

3. The electrical lead of claim 2 wherein said insulated and non-insulated electrical conducting sections comprise a spring helical wire with insulation and without insulation, respectively.

4. The electrical lead of claim 1 wherein said helical member has a free end and is tapered in diameter toward said free end.

5. The electrical lead of claim 1 wherein said helical member is electrically conductive and electrically connected to said insulated electrical conducting section.

6. An electrical lead that may be screwed into an organ which comprises a first electrical lead and a second electrical lead, said first electrical lead comprising an insulated electrical conducting section and a lead-in securing section with a longitudinally rigid helical member which may be screwed into the organ, the second electrical lead comprising an insulated electrical conducting section and a non-insulated electrical conducting section, said second electrical lead being wrapped about the insulated conducting section of said first electrical lead.

7. The electrical lead of claim 6 wherein said first electrical lead includes a non-insulated electrical conducting section between the insulated electrical conducting section and the lead-in securing section.

8. An electrical lead for a cardiac stimulator which comprises a first electrical lead and a second electrical lead, said first electrical lead comprising an insulated electrical conducting section, a lead-in securing section including a longitudinally rigid, sharply pointed helical member which may be screwed into the heart, and a non-insulated electrical conducting section between said other sections, said second electrical lead comprising an insulated electrical conducting section and a non-insulated electrical conducting section, said insulated and non-insulated electrical sections of said first and second electrical leads being made of spring helical wire with and without insulation, respectively, said second electrical lead being wound within the spaces of the insulated electrical conducting section of said first electrical lead and having its non-insulated section adjacent to and spaced from the non-insulated section of said first electrical lead.

9. A method of attaching an electrical lead of a cardiac stimulator to a heart which comprises utilizing an electrical lead which may be screwed into the heart, providing access to the heart through mediastinoscopy, and screwing the electrical lead into the heart for attachment thereto.

10. A method of attaching an electrical lead of a cardiac stimulator to a heart which comprises obtaining access to the heart and screwing a free end of the electrical lead into the heart.

11. The method of claim 10 wherein an insertion tool is utilized to grip said free end of said electrical lead and rotated to screw the electrical lead into the heart.

12. A method of attaching an electrical lead of a cardiac stimulator system to the heart, said electrical lead comprising an insulated electrical conducting section of spring helical wire and a lead-in securing section, comprising placing an insertion tool into said spring helical wire of the electrical conducting section and extending said insertion tool through said spring helical wire until it engages said lead-in securing section of said electrical lead, obtaining access to the heart, screwing the lead-in securing section into the heart with said insertion tool and withdrawing said insertion tool from said electrical lead.

13. The method of claim 12 wherein said electrical lead has a non-insulated electrical conducting section between said insulated conducting section and said lead-in securing section and said electrical lead is screwed into the heart so that said non-insulated electrical conducting section is also in the heart.

14. The method of claim 12 wherein said electrical lead is the first of two similar electrical leads attached to a terminal connector plug disconnectably attached to a stimulator, including after said first electrical lead has been attached to said heart the second electrical lead is wrapped about an insertion tool the number of times said second electrical lead is to be screwed into the heart, said second electrical lead being wrapped about said insertion tool in the opposite direction in which it is screwed into the heart, placing the insertion tool into the spring helical wire of the electrical conducting section of the second electrical lead and extending said insertion tool through said spring helical wire until it engages the lead-in securing section, screwing the lead-in securing section of the second electrical lead into the heart with said insertion tool and withdrawing said insertion tool from said electrical lead.

15. An electrical lead that may be screwed into an organ which comprises an insulated electrical conducting section and a lead-in securing section with a hollow member having a helical thread about its periphery which may be screwed into the organ.

16. The electrical lead of claim 15 wherein said helical member has a free end and is tapered in diameter toward its free end.

17. The electrical lead of claim 15 wherein said hollow member is electrically conductive and electrically connected to said insulated electrical conducting section.

18. An electrical lead for a cardiac stimulator which comprises an insulated electrical conducting section and a lead-in securing section with a longitudinally rigid helical member which may be screwed into the heart.

19. An electrical lead for a cardiac stimulator that may be screwed into a heart which comprises an insulated electrical conducting section, a non-insulated electrical conducting section and a lead-in securing section, and non-insulated electrical conducting section being between said other sections, the insulated electrical conducting section and the non-insulated electrical conducting section comprising a spring helical wire with and without insulation, respectively, said non-insulated electrical conducting section comprising no more than a few turns of said non-insulated spring helical wire, said lead-in securing section comprising an electrically conductive, longitudinally rigid, sharply pointed helical wire.

20. The electrical lead of claim 19 including terminal connector means to attach it to a cardiac stimulator.

21. An electrical lead that may be screwed into an organ which comprises a hollow insulated electrical conducting section and a substantially coaxial lead-in securing section with a longitudinally rigid helical member which may be screwed into the organ, said conducting section and said securing section being alignable along a substantially straight line.

22. An electrical lead for a cardiac stimulator which comprises a hollow insulated electrical conducting section and a substantially coaxial lead-in securing section with a longitudinally rigid helical member which may be screwed into the heart, said conducting section being alignable along a substantially straight line.

23. In a body implantable electrode assembly that includes a flexible insulated conductor projecting from a connector and wherein the distal end of the conductor is adapted for attachment to a body organ, the improvement which comprises:

a. a conductor having its uninsulated distal end region formed as a rigid helix, and

b. key engageable means on at least one convolution intermediate the ends of the rigid helix, whereby a slender key means that is admitted coaxially of the rigid helix may engage the key engageable means for screwing the helix into an organ.

24. The invention set forth in claim 23 wherein:

a. said conductor comprises a flexible wire cable, and

b. at least one convolution of said cable which is next in the proximal direction from said rigid distal end is uninsulated.

25. An electrical lead for attachment to a body organ which comprises:

a. an insulated electrical conducting section;

b. a non-insulated electrical conducting section electrically connected to said insulated electrical conducting section; and

c. a sutureless securing means to hold said insulated electrical conducting section in electrical contact with said body organ, said sutureless securing means including means which extend into and attach to said body organ upon rotation of said sutureless securing means into said body organ to attach said electrical lead to said body organ.