Subcutaneous electrode with improved contact shape for transthoracic conduction

• US 7,274,962 B2
• Filed: 05/21/2004
• Issued: 09/25/2007
• Est. Priority Date: 09/18/2000
• Status: Expired due to Fees

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Rissmann, William J., Bardy, Gust H., Sanders, Gary H., Cappato, Riccardo
• Primary Examiner(s): Schaetzle; Kennedy
• Application Number:
  US10/850,848
• Publication Number:
  US 20040215308A1
• Time in Patent Office: 1,222 Days
• Field of Search: 607/116, 607/119, 607/122, 607/126, 607/129, 607/130, 607/131, 607/120, 607/121, 607/125, 607/5, 128/899, 600372-375, 600/377, 600/386, 600/393, 600/585, 606/108
• US Class Current: 607/5
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

Electrical cardiac therapy devices including electrode assemblies having openings for receiving an electrode insertion tool, and methods of inserting such electrode assemblies. The opening(s) are defined on the electrode assemblies to allow an insertion tool to be coupled to the electrode assembly and then used to push the electrode assembly into place.

Claims

1. An implantable cardiac stimulus lead electrode assembly for use with an implantable cardiac stimulus device, the assembly comprising:

an elongated lead with a proximal portion and a distal portion;

a cardiac stimulus electrode coupled to the distal portion of the lead; and

a tubular appendage disposed on the distal portion of the lead, the tubular appendage configured for engagement with a lead insertion tool;

wherein;

the lead includes a backing layer;

the appendage includes a portion of the backing layer formed into a tubular configuration; and

the tubular appendage includes a single sheet of material that includes at least a portion that is placed in a rolled configuration to form the tubular appendage.

2. The assembly of claim 1, wherein the tubular appendage has a cross-section that is substantially cylindrical in shape.

3. The assembly of claim 1, wherein the tubular appendage includes a distal edge, and the distal edge is sloped.

4. An implantable cardiac stimulus lead electrode assembly for use with an implantable cardiac stimulus device, the assembly comprising:

an elongated lead with a proximal portion and a distal portion;

a cardiac stimulus electrode coupled to the distal portion of the lead; and

a tubular appendage disposed on the distal portion of the lead, the tubular appendage configured for engagement with a lead insertion tool;

wherein;

the lead includes a backing layer;

the appendage includes a portion of the backing layer formed into a tubular configuration;

the tubular appendage includes a substantially rectangular sheet;

the sheet is rolled over and two substantially parallel sides of the sheet are placed in close proximity to one another to form the tubular appendage; and

the tubular appendage is stitched to the lead.

5. An implantable cardiac stimulus lead electrode assembly for use with an implantable cardiac stimulus device, the assembly comprising:

an elongated lead with a proximal portion and a distal portion;

a cardiac stimulus electrode coupled to the distal portion of the lead; and

a tubular appendage disposed on the distal portion of the lead, the tubular appendage configured for engagement with a lead insertion tool;

wherein;

the lead includes a backing layer;

the appendage includes a portion of the backing layer formed into a tubular configuration;

the tubular appendage includes first, second and third sheets of material; and

the first sheet is attached to the lead, and the second and third sheets are attached to the first sheet to form the tubular appendage.

6. The assembly of claim 5, wherein the appendage has a cross-section that is substantially triangular in shape.

7. The assembly of claim 5, wherein the first sheet is stitched to the lead and the second and third sheets are stitched to the first sheet.

8. An implantable cardiac stimulus lead electrode kit for use with an implantable cardiac stimulus device, the kit comprising:

an elongated lead with a proximal portion and a distal portion, the lead including a cardiac stimulus electrode coupled to the distal portion of the lead, and a tubular appendage disposed on the distal portion of the lead; and

a lead insertion tool adapted to mate with the tubular appendage for pushing insertion of the elongated lead subcutaneously within a patient;

wherein;

the cardiac stimulus electrode includes a backing layer;

the appendage includes a portion of the backing layer formed into a tubular configuration; and

the tubular appendage includes a single sheet of material that includes at least a portion that is placed in a rolled configuration to form the tubular appendage.

9. The kit of claim 8, wherein the tubular appendage has a cross-section that is substantially cylindrical in shape.

10. The kit of claim 8, wherein the appendage has a cross-section that is substantially triangular in shape.

11. The kit of claim 8, further comprising an implantable cardiac therapy delivery device including an outer housing and circuitry for producing a therapeutic electrical signal, and the proximal portion of the lead is adapted to be coupled to the housing for electrical communication with the circuitry.

12. The kit of claim 11, wherein the outer housing includes an electrode thereon.

13. The kit of claim 8, wherein the tubular appendage includes a distal edge, and the distal edge is sloped.

14. An implantable cardiac stimulus lead electrode kit for use with an implantable cardiac stimulus device, the kit comprising:

an elongated lead with a proximal portion and a distal portion, the lead including a cardiac stimulus electrode coupled to the distal portion of the lead, and a tubular appendage disposed on the distal portion of the lead; and

a lead insertion tool adapted to mate with the tubular appendage for pushing insertion of the elongated lead subcutaneously within a patient;

wherein;

the cardiac stimulus electrode includes a backing layer;

the appendage includes a portion of the backing layer formed into a tubular configuration; and

the tubular appendage includes first, second and third sheets of material; and

the first sheet is attached to the lead, and the second and third sheets are attached to the first sheet to form the tubular appendage.

15. An implantable cardioverter defibrillator comprising:

a housing;

an electrical circuit located within the housing;

an elongated lead with a proximal portion and a distal portion, the proximal portion of the lead adapted to be coupled to the housing for electrical communication with the electrical circuit;

an electrode coupled to the distal portion of the lead; and

a tubular appendage disposed on the distal portion of the lead, the tubular appendage configured for engagement with a lead insertion tool;

wherein;

the lead is a subcutaneous lead;

the electrode is a subcutaneous electrode; and

the tubular appendage includes a single sheet of material that includes at least a portion that is placed in a rolled configuration to form the tubular appendage.

16. The implantable cardioverter defibrillator of claim 15, wherein the housing is sized and configured for subcutaneous implantation within a patient.

17. The implantable cardioverter defibrillator of claim 15, wherein the housing includes a subcutaneous electrode thereon.