WO2002068043A1

WO2002068043A1 - Implantable heart stimulator

Info

Publication number: WO2002068043A1
Application number: PCT/SE2002/000346
Authority: WO
Inventors: Johan Eckerdal; Martin Obel; Eva Micski
Original assignee: St. Jude Medical Ab
Priority date: 2001-02-27
Filing date: 2002-02-26
Publication date: 2002-09-06
Also published as: DE60203267T2; US20040093036A1; SE0100661D0; EP1365833A1; EP1365833B1; DE60203267D1; US7242980B2

Abstract

An implantable heart stimulator, comprises a pulse generator for delivering electric stimulation pulses to a patient's heart (21) through a lead (14) connectable to said pulse generator, possibly through a connector top (12) on a of pulse generator housing (10). The pulse generator housing is electrically conductive. IN an infection control apparatus for such a heart stimulator the exterior surfaces of the possible connector top and of a proximal part (16) of the lead are electrically conductive. The proximal lead part extends to a position, which after implantation of the lead is situated between a location beyond the entry to the venous system and the entry into vena cava superior. The generator housing and the electrically conductive surfaces of the proximal lead part and of the possible connector top are adapted to form a first electrode and at least one second counter electrode (19) is adapted to be loacted outside subcutaneous pulse generator pocket in which the pulse generator is located after implantation. A curent source is provided to supply an electric infection control current between the electrodes.

Description

IMPLANTABLE HEART STIMULATOR

Technical Field

The present invention relates to an infection control apparatus for an im- plantable heart stimulator comprising a pulse generator for delivering electric stimulation pulses to a patient's heart through a lead connectable to said pulse generator, possibly through a connector top on a pulse generator housing, said pulse generator housing being electrically conductive.

Background

Implantable heart stimulator pocket infection is a severe complication which often ends up in explantation of the stimulator. The reason therefor is that conventional treatment with antibiotics cannot eradicate the infection. This seems to depend on the circumstance that the bacteria live in a biofilm formed around the exterior surfaces of the implanted stimulator, which film blocks antibiotics. The bacteria may also live passively on a very low metabolism and can therefore not be treated successfully by antibiotics.

A method of enhancing the effect of antibiotics by applying an electrical field across the biofilm is described in US 5,312,813. This method is based on findings by J.W. Costerton et.al. Their studies have shown that the infection can be completely cured and no explantation has to take place by applying an electric field or a small current across the biofilm during antibiotic treatment, cf. also ASAIO Journal 1992, p.M174 - M178, Khoury et.al, "Prevention and Control of Bacterial Infections Associated with Medical Devices", and Antimicrobial Agents and Chemotherapy, Vol.38, No. 12, Dec.1994, p.2803-2809, Costerton et.al., "Mechanism of Electrical Enhancement of Efficacy of Antibiotics in Killing Biofilm Bacteria" In these studies, generally, a low electric current of the order of 15-400 μA/cm² is applied onto the infected surface while they were immersed in a buffer with antibiotics. In the most successful studies a total killing of microorganisms was reported after only 8 hours of current and antibiotic treatment - tobramycin 2.5 mg/l, 15-400 μA/cm², during 8h. This effect has been termed "the bioelectric effect".

These studies suggest that the electric field need to be applied in close proximity to the infected implant. A passive electric field will not due, but a current should be conducted between electrodes in the biofluid surrounding the implanted device. A possible explanation to the observed effect is that electrochemically generated products are needed for the bioelectric effect to occur. At the titanium surface, titanium being normally used in heart stimulator housings, the following electrochemical processes take place.

At the anode:

1 ) 2 H₂O _-> O₂ + 4 H⁺ +4 e-

2) 2 Cl- _ Cl₂ + 2 e- 3) Ti + 2 H₂O _→ TiO₂ + 4 H⁺ + 4 e-

At the cathode:

1 ) O₂ + 2 H₂O + 4 e-_> 4 OH-

2) 2 H₂O + 2 e- _» H₂ + 2 OH"

It is supposed that primarily the produced oxygen and chloride gases have an influence on the biofilm attached to the surface. It is also supposed that the fact that the pH-value is lowered at the anode and increased at the cathode is significant for the influence and viability of the biofilm. An infection that is initiated in the stimulator pocket will also often start to spread along the lead. The polymer surface of the lead may be a substrate for the bacteria and makes it easy for the bacteria to attach. At the time when a pocket infection is clinically manifested, in many cases the infection has already spread some distance from the stimulator pocket along the lead. As the bioelectric effect is concentrated to parts in conjunction with or in close proximity to conducting surfaces of the implant, it is the purpose of the present invention to extend these conducting active surfaces to practically the whole exterior surface of the implant, such that it can be current covered.

Disclosure of the invention

This purpose is obtained by an apparatus of the type defined in the introductory portion of the description and having the characterising features of claim 1 . As discussed above the bioelectric effect is limited to conducting surfaces of the implanted device or to the immediate proximity thereof. With the present invention a design is obtained which makes it possible to extend the bioelectric effect to traditionally non conducting surfaces of an implanted heart stimulator, like a pacemaker or a cardioverter - defibrillator (ICD). By making also exterior surfaces of the proximal part of the lead and a possible connector top electrically conductive all exterior stimulator surfaces located within the subcutaneous implant pocket and a part of the lead extending from the pocket are electrically conductive, and by adapting these electrically conductive surfaces to form at least two separate elec- trodes and providing a current source to supply an electric infection control current between these electrodes all exterior surfaces will be current coated, and the bioelectric effect will be extended to all surfaces within the pocket and also to the exterior surface of the proximal part of the lead. By making the normally non-conducting surfaces of the connector top and the lead electrically conducting not only effective treatment of infections within the pocket is possible, but spreading of the infection from the pocket along the lead is prevented. The lead will in this way benefit from the bioelectric effect and thus it is prevented that bacteria reach the endocardium giving rise to endocarditis.

According to an advantageous embodiment of the apparatus according to the invention an electrically conducting polymer is applied on said exterior surfaces of the proximal part of said lead and said possible connector top. In this way traditionally non-conducting surfaces of a heart stimulator are made electrically conductive. An example of a polymer suitable for this purpose is an electrically conducting polymer marketed under the trademark ELASTOSIL. According to another advantageous embodiment of the apparatus according to the invention an electrically conducting coil is applied around said proximal part of the lead. In this way the proximal part of the lead is made not only electrically conductive but the wear resistance of the lead is improved.

According to still another advantageous embodiment of the apparatus ac- cording to the invention the exterior surfaces of the proximal part of the lead and of said possible connector top are treated by ion implantation technology or so-called lon-Beam-Assisted-Deposition. This technique is especially well suited for making stimulator connector tops or headers of epoxy electrically conductive. Other possi- ble coating technologies are Physical Vapour Deposition, PVD, or Chemical Vapour Deposition, CVD, or any sputtering process.

It has been found that oxide layers, especially titanium oxide layers but also other metal oxide layers, may be found when such metals are used in the DC current environment dealt with in conjunction with the present invention. These oxide layers may cause an uneven current distribution which is detrimental to the infection control effect. The current may also be lowered due to increased impedance because of the oxide layer to a point at which the effect on bacteria in the biofilm is no longer effective. The formation of such oxide layers is avoided, according to an advantageous embodiment of the apparatus according to the in^¬ vention, by coating the generator housing, and other metallic surfaces that may become oxidised due to the DC current, with one of the metals platinum, palladium or iridium or any other metal with similar electro-chemical characteristics or an alloy of these metals According to still other advantageous embodiments of the apparatus according to the invention said counter electrode is an implantable electrode, suitably designed to be positioned on said lead for implantation into the patient's heart, preferably a heart stimulation electrode is forming said counter electrode. The need of a separate implanted counter electrode is then eliminated. In this case the electrical infection treatment has to be performed such that it does not interfere with stimulation pulses of the heart stimulator. Thus the treatment has to be restricted to the heart's refractory periods, or, alternatively, an infection treatment current of such a high frequency is used that the heart is not affected.

According to yet other advantageous embodiments of the apparatus ac- cording to the invention said counter electrode is formed of a large surface defi- brillation electrode, said counter electrode can be designed for external application to the patient's skin, preferably formed of a patch electrode for external application to the patient's skin. By using large surface electrodes the current density will be lower and a uniform current distribution is more easily obtained. When using an external current source, which is natural particularly in case of a counter electrode for external application, a galvanic connecting means is provided to galvanically connect to said current source to implanted electrodes through the patient's skin according to an advantageous embodiment of the apparatus according to the invention. According to other advantageous embodiments of the apparatus according to the invention means are provided to inductively couple said externally located current source to said electrodes.

According to other advantageous embodiments of the apparatus accord- ing to the invention the inductive coupling means comprise a thin inductive coil attached to the outer surface of the pulse generator housing and electrically connected to the electrodes or an inductive coil positioned inside the pulse generator housing and electrically connected to the electrodes. Such thin coils, which are manufactured preferably by screen printing, will not require much space and will consequently contribute to a compact stimulator construction. Such a coil might also be used as a telemetry coil.

According to still another advantageous embodiment of the apparatus according to the invention a rectifying means is connected between said coil and one of the electrodes to supply a DC current to the electrodes. According to other advantageous embodiments of the apparatus according to the invention with said current source located externally an electrolytic connecting means is provided for electrolytically connecting said current source to said first electrode. Said electrolytic connecting means preferably comprises an additional electrode for external application to the patient's skin, separated from said counter electrode and in electrolytic contact with said first electrode, said current source being connected to said counter electrode and to said additional electrode. The biofluid of the patient's body can then serve as electrolytic medium. In this way the great advantage of a non-invasive connection without transcutaneous wires is obtained. When using two external (patch) electrodes the current distribu- tion on the housing and implanted electrode respectively might be non-uniform. This can be, at least partly, remedied by repositioning the external electrodes during the treatment, such that all implanted surfaces are coated by an adequate quantity of current.

The present invention also relates to a heart stimulator comprising a pulse generator for delivering electric stimulation pulses to a patient's heart through a lead, connectable to said pulse generator, possibly through a connector top on a pulse generator housing, said pulse generator housing be electrically conductive, which stimulator is characterised by an apparatus as disclosed above. Brief Description of the Drawings

To explain the invention in greater detail embodiments of the apparatus according to the invention will now be described with reference to the drawings, on which Figure 1 shows schematically a heart stimulator with a lead provided with a coil on its proximal part, Figure 2 shows an embodiment with a large surface ventricular defibrillating electrode as counter electrode, Figure 3 shows schematically a heart stimulator with a surface mounted coil on the exterior of the stimulator housing for inductively connecting an external current source to the electrode forming parts of the implant, and Figure 4 shows an embodiment of the invention with an external patch electrode as counter electrode.

Description of Preferred Embodiments

In the apparatus according to the invention a. o. the proximal part of the lead extending to a position which after implantation of the lead is situated between a location beyond the entry into the venous system and the entry into vena cava superior, is made electrically conductive. This can be realised in several different ways. Thus the proximal part can be made electrically conductive by e.g. applying an electrically conducting polymer on its surface or by ion implantation technology or lon-Beam-Assisted-Deposition (IBAD). In figure 1 another example of making a proximal lead part electrically conductive is shown. Thus figure 1 shows schematically an implantable heart stimulator 2 having a connector top 4 to which a lead 6 is connected. The proximal part of the lead 6 is made electrically conductive by wrapping a metallic coil 8 around this part of the lead. The metallic coil 8 will also improve the wear resistance of the lead 6.

The connector top or header 4 is often made of epoxy and IBAD is a suit- able technique for making such a connector top conductive

Figure 2 shows an embodiment with electrically conductive exterior surfaces of the generator housing 10, the connector top 12 and the proximal part 16 of the lead 14. The generator housing 10, the connector top 12 and the proximal part 16 of the lead 14 are forming one electrode, whereas a large surface right ventricular defibrillating electrode 19 on the lead 14 is used as counter electrode. The pulse generator battery can be operable to deliver an infection control electric current i between this defibrillation electrode 19 and the electrode formed by the conductive housing 10, the connector top 12 and the proximal lead part 16 to de- stray bacteria residing in a biofilm on the implanted stimulator. This electrical treatment current i must not interfere with the stimulating function of the heart stimulator and is therefore delivered during the heart's 21 refractory period.

Other examples of implantable indifferent electrodes are disclosed in e.g. US 5,510,766 and US 5,814,076, these electrodes, however, being used for other purposes.

The electric infection control requires a comparatively high amount of energy and therefore an external power source is normally needed. Transcutaneous electric connections to implanted electrodes increase the risk of recontamination of the wound and discomfort for the patient. It would therefore be a great advantage to use a non-invasive method for the energy supply.

Figure 3 shows an example of supplying electric current for infection control from an external source by electromagnetic induction. Thus a super thin surface mounted coil 18 is attached to the exterior surface of the stimulator housing 20. This coil 18 can be manufactured by e.g. screen printing. A polymeric isolation film 22 is provided to electrically isolate the coil 18 from the stimulator housing 20.

One end 24 of the coil 18 is electrically connected to the housing 20, while the other end is connected to a diode 26 integrated in the epoxy connector head 28. The diode 26, in its turn, is connected to a counter electrode 31.

By applying a high frequency electromagnetic field by an external energy source located in the proximity of the stimulator, a current will be generated in the coil 18. The diode 26 will allow current in only one direction for permitting the electrochemical processes necessary for the bioelectric effect to occur.

As an alternative, the coil can be implemented inside the stimulator housing. One end of the coil is then connected to the stimulator housing, whereas the other end of the coil is connected via a diode to an external counter electrode.

Figure 4 shows an embodiment with the pulse generator housing 10, the connector top 112 and the proximal part 116 of the lead 114 forming one electrode, whereas an external patch electrode 122, intended for application on the patient's skin, is used as counter electrode. In this case an external current source 124 is used for delivering treatment current i. When therapy had to be applied in this case, an electrically conductive needle 126, connected to the current source 124, is inserted through the patient's skin to make contact with a pulse generator housing 10. This embodiment has the advantage that only minor modifications of existing hardware are needed, viz. making connector top 112 and outer surface of the proximal lead part 116 electrically conducting.

Numerous variations and modifications of the above described embodiments of galvanically connection as shown in figure 4 and inductive coupling of an externally located current source to implanted electrodes as exemplified in figure 3 are of course possible. As another alternative a connecting means can be used for electrolytically connecting an external current source to an implanted electrode. The electrolytic connecting means can comprise an additional electrode for external application to the patient's skin, separated from the counter electrode and in electrolytic contact with said first electrode via the body biofluid. By connecting the current source to the counter electrode and to this additional electrode a non- invasive method of connecting the current source is obtained.

When using external electrodes these electrodes should preferably be positioned such that those parts of the infection control current, which pass through the heart, are minimised.

Claims

1. An infection control apparatus for an implantable heart stimulator comprising a pulse generator for delivering electric stimulation pulses to a patient's 5 heart (21 ) through a lead (6,14,114) connectable to said pulse generator, possibly through a connector top (4,12,28,112) on a pulse generator housing (2,10,20,110), said pulse generator housing being electrically conductive, characterized in that the exterior surfaces of said possible connector top (4,12,28,112) and of a proximal part (8,16,116) of the lead (6,14,114) are electrically conductive, said proximal o part extending to a position which after implantation of the lead is situated between a location beyond the entry into the venous system and the entry into vena cava superior, said generator housing (2,10,20,110) and said electrically conductive surfaces of said proximal lead part and of said possible connector top being adapted to form a first electrode, and in that at least one second counter electrode 5 (19,31 ,122) is adapted to be located outside the subcutaneous pulse generator pocket in which the pulse generator is located after implantation, a current source being provided to supply an electric infection control current between said electrodes.

o 2. The apparatus according to claim 1 , characterized in that an electrically conducting polymer is applied on said exterior surfaces of the proximal part (16,116) of said lead (14,114) and of said possible connector top (4,12,28,112).

3. The apparatus according to claim 1 , characterized in that an electrically 5 conducting coil (8) is applied around said proximal part of said lead (6).

4. The apparatus according to claim 1 , characterized in that said exterior surfaces of the proximal (16,116) of said lead (14,114) and of said possible connector top (4,12,28,112) are treated by ion implantation technology or so-called 0 lon-Beam-Assisted-Deposition or Physical Vapour Deposition, or Chemical Vapour Deposition, or any other sputtering process.

5. The apparatus according to any one of the preceding claims, characterized in that said generator housing (2,10,20,110) is coated with one of the metals platinum, palladium or iridium or any other metal with similar electro-chemical characteristics, or an alloy of these metals.

6. The apparatus according to any one of the preceding claims, character- ized in that said counter electrode (19 ) is an implantable electrode.

7. The apparatus according to claim 6, characterized i that said counter electrode is designed to be positioned on said lead (14) for implantation into the patient's heart (21 ).

8. The apparatus according to claim 6 or 7, characterized in that a heart stimulation electrode is forming said counter electrode.

9. The apparatus according to any one of the claims 1 - 6, characterized in that said counter electrode is formed of a large surface defibrillation electrode.

10. The apparatus according to any one of the claims 1 - 9, said current source being externally located, characterized in that means (18) are provided to inductively couple said externally located current source to said electrodes.

11. The apparatus according to claim 10, characterized in that said inductive coupling means comprise a thin inductive coil (18) attached to the pulse generator housing (20) and electrically connected to the electrodes.

12. The apparatus according to claim 11 , characterized i that a rectifying means (26) is connected between said coil (18) and one of the electrodes.

13 The apparatus according to any one of the claims 1 - 5, characterized ⁱⁿ that said counter electrode is designed for external application to the patient's skin.

14. The apparatus according to claim 13, characterized in that said counter electrode is formed of a patch electrode (122) for external application to the patient's skin.

15. The apparatus according to claims 13 or 14, said current source (124) being externally located, characterized in that a galvanic connecting means (126) is provided to galvanically connect said current source (124) to implanted electrodes through the patient's skin.

16. The apparatus according to claims 13 or 14, said current source being externally located, characterized in that an electrolytic connecting means is provided for electrolytically connecting said current source to said first electrode through the patient's skin.

17. The apparatus according to claim 16, characterized in that said electrolytic connecting means comprises an additional electrode for external application to the patient's skin, separated from said counter electrode and in electrolytic contact with said first electrode, said current source being connected to said counter electrode and to said additional electrode.

18. The apparatus according to any one of the claims 1 - 9, characterized in that said current source is formed of an electric pulse generator battery.

9. A heart stimulator comprising a pulse generator for delivering electric stimulation pulses to a patient's heart (21 ) through a lead (6,14,114) connectable to said pulse generator, possibly through a connector top (4,12,28,112) on a pulse generator housing (2,10,20,110), said pulse generator housing being electrically conductive, characterized by an apparatus according to any one of the preceding claims.