Implantable device

• US 20040098055A1
• Filed: 08/22/2003
• Published: 05/20/2004
• Est. Priority Date: 02/27/2001
• Status: Active Grant

• Current Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Inventors: Eckerdal, Johan, Obel, Martin, Kroll, Mark, Micski, Eva
• Granted Patent: US 7,203,550 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An apparatus for treating an infection which may occur in the biofilm which surrounds an implanted cardiac stimulation device, e.g., a cardioverter-defibrillator)ICD) or pacemaker. Such inflections are relatively untreatable by conventional antibiotics treatments. Thus, explanting of the implanted devices may be required. Accordingly, the present apparatus provides an electrical treatment that enables a biocide, i.e., an antibiotic, to successfully treat the infection within the biofilm and thus avoid the necessity to explant the device. Furthermore, the present invention provides this electrical treatment in a manner to not interfere with the stimulation pulses of the cardio stimulation device by alternatively delivering current pulses during atrial and ventricular refractory periods or a high frequency square wave at a frequency that exceeds the frequency response of the heart muscle.

Claims

1. A cardiac stimulating device for stimulating a patient'"'"'s heart comprising an infection control apparatus, the cardiac stimulating device comprising:

at least one electrical current generator for generating an infection control current;

detection apparatus for determining a refractory period following the heart'"'"'s stimulation;

a controller for periodically causing the electrical current generator to generate an infection control current during said refractory-period;

the entire external surface of said device being electrically conductive;

a switching means for connecting said external surface to said current generator;

said stimulating device being connectable to at least one heart electrode lead whose electrode Is adapted to be implanted close to the patients heart,

said heart electrode lead'"'"'s surface at the part proximate to the stimulating device being conductive and being capable to be connected to said current generator,

said proximate part extending to a position which after implantation is situated at a location beyond the entry into the venous system and before the entry into the superior vena cava,

said electrode being connected to said current generator for receiving the infection control current which flows from the conductive external surface and proximal part of the heart electrode lead to treat infections surrounding the external surface of said cardiac stimulating device.

2. The cardiac stimulating device according to claim 1, wherein the device comprises a housing with an electrically conductive external surface and a header or connector top with an external electrically conductive surface.

3. The cardiac stimulating device of claims 1-2, wherein the infection control current generator is used in combination with a biocide.

4. The cardiac stimulating device of claims 1-2, wherein the infection control current generator is used in combination with systemic application of antibiotics to the patient'"'"'s body.

5. The cardiac stimulating device of claims 14 wherein the infection control current generator is remotely activated.

6. The cardiac stimulating device of claim 5, wherein the infection control current generator is activated upon detection of an infection.

7. The cardiac stimulating device of claims 1-4, wherein the infection control current generator is prophylactically activated upon implantation of the stimulating device.

8. The cardiac stimulating device of claims 1-7, wherein the electrical current generator, detection apparatus, and controller correspond to the other circuitry shared by the cardiac stimulating device.

9. The cardiac stimulating device of claims 1-8, wherein the electrode corresponds to an electrode used by the cardiac stimulating device for sensing/stimulating the patient'"'"'s heart.

10. The cardiac stimulating device of claims 1-9:

wherein the at least one electrode comprises;

a first electrode implanted within the heart'"'"'s right atrium; and

a second electrode implanted within the heart'"'"'s right ventricle;

wherein the at least one current generator comprises;

a first current generator for driving the first electrode; and

a second current generator for driving a second electrode;

wherein the detection apparatus comprises;

a first sense amplifier coupled to the first electrode for detecting the refractory period of the right atrium; and

a second sense amplifier coupled to the second electrode for detecting the refractory period of the right ventricle; and

wherein the controller causes a first infection control current to flow from the first electrode to the housing during the refractory period of the right atrium and a second infection control current to flow from the second electrode to the housing during the refractory period of the right ventricle.

11. The cardiac stimulating device of claims 1-9, wherein the detection apparatus is a sense amplifier which detects the refractory period of the right atrium by sensing an intrinsic P-wave.

12. The cardiac stimulating device of claims 1-9, wherein the detection apparatus is a sense amplifier which detects the refractory period of the right atrium by sensing an evoked P-wave.

13. The cardiac stimulating device of claims 1-9 wherein the detection apparatus is a sense amplifier which detects the refractory period of the right ventricle by sensing an intrinsic R-wave.

14. The cardiac stimulating device of claims 1-9 wherein the detection apparatus is a sense amplifier which detects the refractory period of the right ventricle by sensing an evoked R-wave.

15. The cardiac stimulating device of claims 1-9, wherein the detection apparatus determines the refractory period according to a time period following stimulation of the patient'"'"'s heart.

16. The cardiac stimulating device of claims 1-15, wherein the cardiac stimulating device is a pacemaker.

17. The cardiac stimulating device of claim 16, wherein at least one electrode operates in a bipolar mode.

18. The cardiac stimulating device of claims 1-15, wherein the cardiac stimulating device is an implantable cardioverter defibrillator (ICD).

19. A cardiac stimulating device for stimulating a patient'"'"'s heart comprising an infection control apparatus, the cardiac stimulating device comprising:

at least one electrical current generator for generating a square wave infection control current;

the entire external surface of said device being electrically conductive;

said external surface being being capable of being coupled to said current generator;

said stimulating device being connectable to at least one heart electrode lead whose electrode is implanted close to the patient'"'"'s heart,

said heart electrode lead'"'"'s surface at the part proximate to the stimulating device being conductive and being capable to be connected to said square wave current generator,

said proximate part extending to a position which after implantation is situated at a location beyond the entry into the venous system and before the entry into the superior vena cava,

said electrode being connected to said square wave current generator for receiving the infection control current which flows from the conductive housing and proximal part of the heart electrode lead to treat infections surrounding the pulse generator housing.

20. The cardiac stimulating device according to claim 19, wherein the device comprises a housing with an electrically conductive external surface and a header or connector top with an external electrically conductive surface.

21. The cardiac stimulating device of claim 19, wherein the square wave current is at a frequency in the range of 1 to 10 kHz.

22. The cardiac stimulating device of claims 19-21, wherein the infection control current generator is used in combination with a biocide.

23. The cardiac stimulating device of claims 19-21, wherein the infection control current generator is used in combination with systemic application of antibiotics to the patient'"'"'s body.

24. The cardiac stimulating device of claims 19-23 wherein the infection control current generator is remotely activated.

25. The cardiac stimulating device of claims 19-24, wherein the infection control current generator is activated upon detection of an infection.

26. The cardiac stimulating device of claims 19-24 wherein the infection control current generator is prophylactically activated upon implantation of the stimulating device.

27. The cardiac stimulating device of claims 19-26, wherein the electrode corresponds to an electrode used by the cardiac stimulating device for sensing/stimulating the patient'"'"'s heart.

28. The cardiac stimulating device of claims 19-27, wherein the cardiac stimulating device is a pacemaker.

29. The cardiac stimulating device of claims 19-27, wherein the cardiac stimulation device is an implantable cardioverter defibrillator (ICD).