Treatment of excess weight by neural downregulation in combination with compositions

Abstract

A method and system for designing a therapy or for treating a condition associated with excess weight in a subject comprising applying a neural conduction block to the vagus nerve at a blocking site with the neural conduction block selected to at least partially block nerve impulses on the vagus nerve at the blocking site and administering a composition comprising an effective amount of an agent that alters the energy balance of the subject.

What is claimed is: 
     
         1 . A system for designing a therapy including a therapy signal and an agent that alters the energy balance of a subject comprising:
 at least one electrode configured to be implanted within a body of the patient beneath a skin layer and placed at a vagus nerve, the electrode also configured to apply therapy to the vagus nerve upon application of a therapy signal to the electrode;   an implantable impulse generator for placement in the body of the patient beneath the skin layer, the implantable impulse generator being configured to generate the therapy signal and to transmit the therapy signal to the electrode, the implantable impulse generator being coupled to an implanted antenna;   an external component configured to couple to a first external antenna configured to be placed above the skin layer and adapted to communicate with the implanted antenna across the skin layer through radiofrequency communication, the external component including a plurality of selectable operating modules, each operating module being associated with a different set of operations available for selection by a user;   an external programmer configured to communicatively couple to the external component via a second port, the external programmer being configured to provide therapy instructions comprising parameters for each therapy cycle to the external component, wherein the external component is configured to send the therapy instructions to the implantable impulse generator via the external antenna and the implanted antenna, and the parameters comprise a therapy signal selected to downregulate activity on the vagus nerve with an on time period and off time period, the off time period selected to allow partial recovery of nerve function; and the external programmer being configured to allow the user to select an agent that alters energy balance in the patient based on the health profile of the patient and the side effects of the agent.   
     
     
         2 . The system of  claim 1 , wherein the implantable component is configured to deliver a therapy cycle comprising an electrical signal having a frequency of at least 300 Hz, an on time of at least 30 seconds, and an off time that allows for partial recovery of the nerve function. 
     
     
         3 . The system of  claim 1 , wherein the external programmer is configured to provide therapy instructions comprising parameters for the therapy cycle to the external component, wherein the parameters of the therapy cycle comprise an electrical signal with a frequency of at least 300 Hz with an on time of at least 30 seconds and an off time that allows partial recovery of nerve function. 
     
     
         4 . The system of  claim 1 , wherein the implantable component is configured to generate therapy signals for a treatment period. 
     
     
         5 . The system of  claim 4 , wherein the treatment period is at least 1 hour. 
     
     
         6 . The system of  claim 5 , wherein the external programmer is configured to provide therapy instructions to the external component comprising multiple therapy cycles in a treatment period. 
     
     
         7 . The system of  claim 6 , wherein the external program is configured to provide therapy instructions to the external component comprising at least 10 therapy cycles in a treatment period. 
     
     
         8 . The system of  claim 1 , wherein the external programmer includes a personal computer. 
     
     
         9 . The system of  claim 1 , wherein the external programmer is configured to obtain patient data, wherein the patient data comprises data obtained from the implantable component and patient data concerning the health profile of the patient. 
     
     
         10 . The system of  claim 9 , wherein the health profile comprises the presence or absence of conditions selected from the group consisting of diabetes, hypertension, cardiac condition, liver disorder, a renal disorder and combinations thereof. 
     
     
         11 . The system of  claim 10 , wherein the external programmer is configured to obtain data about dosages and side effects of agents that alter energy balance. 
     
     
         12 . The system of  claim 11 , wherein the agents that alter energy balance comprise agents that enhance the sensation of satiety, agents that decrease appetite, agents that block the absorption of fat or other nutrients, agents that inhibit enzymes that digest fat, agents that are thermogenic, or combinations thereof. 
     
     
         13 . The system of  claim 12 , wherein the agents are selected from the group consisting of: ghrelin, ghrelin agonists, ghrelin antagonists, leptin agonist, leptin antagonists, ciliary neurotrophic factor (CNTF), CNTF analogues, amylin, and amylin analogues. 
     
     
         14 . The system of  claim 13 , wherein the agents are selected from the group consisting of: sibutramine, fenfluramine, phentermine, dexphenfluoramine, flouxetine, and bupropion. 
     
     
         15 . The system of  claim 13 , wherein the agents are selected from the group consisting of: sibutramine, leptin, leptin agonists, leptin analogues, CNTF, and CNTF analogues. 
     
     
         16 . The system of  claim 13 , wherein the agents are selected from the group consisting of: GLP-1, PYY, CKK, and oxyntomodulin. 
     
     
         17 . The system of  claim 13 , wherein the agents are selected from the group consisting of: phentermine, fenfluramine, dexfenfluramine, endocannabinoid receptor antagonists, ghrelin antagonists, orexin antagonists, somatostatin receptor agonist, GLP-1, PYY, and cholecystokinin agonists. 
     
     
         18 . A method of selecting parameters for a therapy cycle for an implantable device and of selecting an agent, wherein the therapy cycle and the agent alter energy balance in a subject comprising:
 a. selecting parameters of a therapy cycle to be applied to a vagus nerve to provide weight loss to the subject, wherein the parameters comprise an electrical signal having a frequency of 300 Hz or greater, having an on time of at least 30 seconds, and having an off time that allows partial recovery of the nerve;   b. communicating the selected parameters to the implantable device using the system of  claim 1  and delivering at least 10 therapy cycles during a treatment period, and   c. selecting an agent and a dosage of agent that alters the energy balance of the subject based on the health profile of the subject and the side effects of the agent using an external programmer of the system of  claim 1 .   
     
     
         19 . The method of  claim 18 , further comprising selecting the parameters of the therapy cycle based on the body mass index of the subject. 
     
     
         20 . The method of  claim 19 , wherein the subject has a body mass index of at least 25 or greater. 
     
     
         21 . The method of  claim 18 , wherein the health profile of the subject indicates the presence or absence of a condition selected from the group consisting of hypertension, diabetes, cardiac disease, liver disease, renal disease and combinations thereof. 
     
     
         22 . The method of  claim 18 , wherein the side effects of the agent are selected from the group consisting of cardiac arrhythmias, cardiac valve disease, seizures, increased blood pressure, depression, anxiety, diarrhea, increased fat in the stool and combinations thereof. 
     
     
         23 . The method of  claim 18 , wherein the agents that alter energy balance comprise agents that enhance the sensation of satiety, agents that decrease appetite, agents that block the absorption of fat or other nutrients, agents that inhibit enzymes that digest fat, agents that are thermogenic, and combinations thereof. 
     
     
         24 . The method of  claim 18 , wherein communicating the selected parameters using the system of  claim 1  comprises communicating the selected parameters from the external programmer to the external component, and communicating the selected parameters from the external component to the implantable device. 
     
     
         25 . The method of  claim 24 , wherein the external programmer is configured to obtain patient data, wherein the patient data comprises data obtained from the implantable component and data concerning the health profile of the patient. 
     
     
         26 . The method of  claim 18 , wherein the external programmer is configured to obtain data about dosages and side effects of agents that alter energy balance.