Abstract:
A method for treating cardiac arrhythmia includes infusing an agent, adapted to facilitate treating the arrhythmia, directly into a cardiac vein and delivering a defibrillating shock between two electrodes.

Description:
TECHNICAL FIELD  
       [0001]     The present invention generally relates to implantable medical devices, and more particularly relates to treating and preventing arrhythmia, and also to lowering the defibrillation threshold for a patient, using an implantable medical device.  
       BACKGROUND  
       [0002]     Implantable defibrillation devices known in the art of cardiac rhythm management typically include one or a number of electrical leads coupled to a device. The device is typically implanted in a subcutaneous pocket and the lead(s) extend therefrom via a transvenous route into a patient&#39;s heart in order to carry electrical pulses, from the device, for pacing, sensing, and defibrillation. A lead is implanted within the heart so that lead electrodes, coupled to conductors carried within a lead body, are positioned for proper sensing and efficient pacing and defibrillation stimulation. An outer shell or can of the device itself is often used as a defibrillation electrode (‘active can’) in conjunction with one or more defibrillation electrodes carried on a lead body. A shadow area of the electrodes and the implanted position of each electrode are factors determining a threshold of shocking energy required to defibrillate the heart (defibrillation threshold—DFT). One commonly used shocking vector is formed between a right ventricular (RV) defibrillation electrode and a device implanted within a left pectoral region implanted device (RV-can); another further includes a third defibrillation electrode positioned within a superior vena cava (SVC), which is electrically common with the can of the device (RV-SVC+can). It would be desirable to augment defibrillation therapy with a means to reduce DFT&#39;s or to maintain acceptable DFT&#39;s when the other factors, related to shadow area and shocking vectors, are compromised in order to achieve other objectives. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0003]     The present invention will hereinafter be described in conjunction with the following drawing figures, wherein like numerals denote like elements, and  
         [0004]      FIG. 1  is a schematic view, from a posterior perspective, of a defibrillation device, according to one embodiment of the present invention, coupled to a heart; and  
         [0005]     FIGS.  2 A-C are a schematic section views, from an anterior perspective, of defibrillation devices, according to alternative embodiments, coupled to a heart. 
     
    
     DETAILED DESCRIPTION  
       [0006]     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.  
         [0007]     Embodiments of the present invention are in part based on the present inventors&#39; finding of transmural endomyocardial and epicardial retention of infused Indian ink suspension when delivered into a posterior cardiac vein (PCV) or postero-lateral cardiac vein (PLCV) of the canine left ventricle. The Indian ink is used during cardiac fluid delivery studies as an indicator of a tissue&#39;s ability to receive an agent by diffusion. Viewing a large cardiac surface area of about 4.0 cm×1.5 cm×1.2 cm on the posterior lateral aspect of the left ventricle revealed a demonstrable ink presence, and endomyocardial cross sectional segments also revealed the ink presence. Histological sections made from the left ventricle posterior section corroborated the other ink retention findings.  
         [0008]     The ink retention findings are beneficial because the left ventricle posterior region presents perhaps the greatest challenge to defibrillation therapy for ventricular tachycardia and ventricular fibrillation patients. The posterior region is a low current/electric field density gradient region during defibrillator energy pulse delivery and may respond better to defibrillation therapy if administered an agent for lowering the defibrillation threshold. Embodiments of the present invention are also based in part on the inventors&#39; observation that a PCV or a PLCV is centrally located to provide convenient access for an elongated device such as a lead or a catheter to the left ventricle. Embodiments of the present invention include delivering either an anti-arrhythmic drug or an agent adapted to lower myocardial tissue resistivity, such as a hypertonic saline solution, through an occluded or non-occluded cardiac vein, i.e. the PCV or the PLCV, to facilitate defibrillation therapy.  
         [0009]     According to one embodiment of the invention, a defibrillation device includes fluid delivery capability along with pacing sensing and defibrillation capability.  FIG. 1  is a schematic view, from a posterior perspective, of a defibrillation device  10  coupled to a heart  30  according to one embodiment of the present invention. According to the illustrated embodiment, defibrillation device  10  includes a can  11  enclosing a battery, electronic circuitry and other components adapted to generate electrical pulses for pacing, sensing and defibrillation and a fluid pump; can  11  is coupled to an electrical lead  14  and a fluid delivery catheter  16  via a connector header  12  and may further serve as a defibrillation electrode. The fluid pump may alternately be enclosed in a separate can; according to either embodiment the fluid pump may include a reservoir, which may be refilled via an injection port, and a peristaltic pump, which propels a bolus of infusate out from the reservoir through catheter  16 ; an example of such a pump is the Medtronic SynchroMed™. The fluid pump may alternately include an osmotic exchange mechanism that self replenishes the reservoir thereby precluding the need for manual trans-dermal reservoir replenishment.  
         [0010]      FIG. 1  further illustrates catheter  16  implanted within a PCV  32  along a left ventricular posterior region  36 ; an infusion port  161  of catheter  16  is positioned within PCV  32 , which branches off from a coronary sinus  31 , approximately 2 to 3 cm from coronary sinus  31  according to one embodiment. PCV  32  may be occluded prior to infusion by means of a polymeric collar  162  formed about catheter  16  and positioned proximal to infusion port  161 ; collar  162  can be made from an elastomer capable of swelling upon absorption of moisture or an inflatable balloon known to those skilled in the art. Defibrillation device  10  can also be adapted to infuse anti-arrhythmic fluids to an occluded coronary sinus  31  to treat atrial fibrillation as well.  
         [0011]     FIGS.  2 A-B are schematic section views, from an anterior perspective, wherein an implant site, according to some embodiments, for lead  14  can be seen.  FIG. 2A  illustrates a defibrillation system including can  11  implanted in a left pectoral region and lead  14  implanted in a right ventricular apex; lead  14  includes a right ventricular electrode  141  (RV electrode) and a superior vena cava defibrillation electrode  142  (SVC electrode); can  11  further serves as another electrode electrically common with SVC electrode  142 , according to some embodiments. According to one embodiment, a vector for high voltage defibrillation is formed between RV electrode  141  and a pair of can  11  and SVC electrode  141  (RV-can+SVC); according to alternate embodiments either second defibrillation electrode  142  or can  11  is not included as an electrode in the system (i.e. alternate vectors include RV-SVC and RV-can).  FIG. 2B  illustrates another embodiment of the present invention wherein SVC electrode  142  is not included and a coronary sinus defibrillation electrode  162  is incorporated on catheter  16 , replacing SVC electrode  142  in the aforementioned shocking vectors.  FIG. 2C  illustrates yet another embodiment of a defibrillation system, wherein catheter  16  includes a cardiac vein defibrillation electrode  161  (CV electrode) intended to form a shocking vector with can  11 , which is positioned in a right pectoral region as opposed to the left pectoral region as previously illustrated. It should be noted that CV electrode  161  may be implanted in any of the veins passing along left ventricular posterior region  36  ( FIG. 1 ) according to various embodiments of the present invention.  
         [0012]     Although not shown, the defibrillation devices of FIGS.  2 A-C further include one or more additional electrodes, which may be included in lead  14  and or catheter  16 , for sensing cardiac activity so that the devices may determine when heart  30  is fibrillating. According to the present invention, a DFT for a defibrillating shock is influenced by fluid infusion, for example via catheter  16 . According to one method of the present invention, once ventricular fibrillation (VF) detection criteria are met, capacitor charging for a high voltage shock commences and the fluid infusion pump is activated to infuse, via catheter  16 , either an anti-arrhythmic agent, or an agent adapted to lower myocardial tissue resistivity or a mixture of the two agents into one or more appropriate cardiac veins, for example PCV  32  illustrated in  FIG. 1 . Examples of anti-arrhythmic agents include but are not limited to amiodarone, ibutelide and procainamide and an example of an agent lowering myocardial tissue resistivity is an electrolyte-based fluid such as a hypertonic saline solution. After infusion, if VF detection criteria are still met, a high voltage shock is delivered, but if fibrillation has ceased, the shock is aborted. The inventors determined that as little as about 3% NaCl in deionized water infused into a cardiac vein has the potential to substantially reduce a DFT. According to some embodiments, a volume of infused agent is between approximately 5 ml and 40 ml.  
         [0013]     A shadow area of defibrillation electrodes, i.e. electrodes  141 ,  142 ,  161 ,  162  and can  11 , may be smaller than that of those commonly employed because the system also includes the infusion means, described above, which decreases DFT&#39;s. According to some embodiments of the present invention, any or all of electrodes  141 ,  142 ,  161  and  162  have a diameter less than approximately 0.08 inch or even less than approximately 0.06 inch.  
         [0014]     According to one embodiment, a method further determines whether the fluid reservoir needs replenishing; more particularly, defibrillation devices include a detector that determines whether the fluid level in the reservoir is at or below a predetermined level indicating that the reservoir needs replenishing. If the fluid is at or below the predetermined level, an alarm or other alerting device alerts the patient, physician, or other user.  
         [0015]     From the above, it is clear that the present invention in its various embodiments facilitates transmural spread and retention of saline or other anti-arrhythmic agents in localized heart regions. Construction methods and materials, which may be employed to realize the defibrillation devices described herein, are well known to those skilled in the art. Further, the apparatus of the present invention provides flexibility in drug delivery and, when combined with the methods of the present invention, may effectively and quickly treat and terminate atrial or ventricular fibrillation.  
         [0016]     While some exemplary embodiments have been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist and the embodiments described herein are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the invention as set forth in the appended claims and the legal equivalents thereof.