Devices and methods for treatment of heart failure via electrical modulation of a splanchnic nerve

Abstract

Disclosed herein is a device, and method for treating heart failure by electrically modulating a splanchnic nerve with an implantable device.

What is claimed is: 
     
         1 . A method of selecting a patient for a greater splachnic nerve blocking procedure to treat heart failure or symptoms associated with heart failure in the patient, comprising:
 evaluating the patient's splachnic vascular capacitance and determining whether or not the splachnic vascular capacitance is below normal;   if the evaluated splachnic vascular capacitance is below normal, identifying a target greater splachnic nerve for a blocking procedure, wherein identifying the target greater splachnic nerve comprises temporarily blocking the identified greater splachnic nerve and measuring a physiological response to determine if the temporarily blocking produced a desired clinical result;   if the temporary blocking produced the desired clinical result, performing the blocking procedure on the identified greater splachnic nerve.   
     
     
         2 . The method of  claim 1 , wherein the evaluating step comprises performing at least one of an orthostatic stress test, a fluid challenge, an exercise test, and a drug challenge. 
     
     
         3 . The method of  claim 1 , wherein the temporarily blocking step comprises electrically stimulating a greater splachnic nerve. 
     
     
         4 . The method of  claim 1 , wherein performing the blocking procedure on the identified greater splachnic nerve comprises performing the blocking procedure with an implanted device. 
     
     
         5 . A nerve cuff adapted to deliver blocking therapy and further adapted to confirm the the blocking therapy, comprising:
 a cuff sized and configured to be positioned around a greater splanchnic nerve;   at least first, second, and third blocking therepy electrodes secured to the cuff and axially spaced from one another;   at least one confirmation and stimulation electrode secured to the cuff and axially spaced from the first, second and third blocking therepy electrodes.   
     
     
         6 . The nerve cuff of  claim 5 , wherein a distance between adjacent pairs of the first, second, and third blocking therepy electrodes is 1 to 2 mm. 
     
     
         7 . The nerve cuff of  claim 5 , wherein the at least one confirmation and stimulation electrode comprises first and second confirmation and stimulation electrodes. 
     
     
         8 . The nerve cuff of  claim 7 , wherein a distance between the first and second confirmation and stimulation electrodes is 2-3 mm. 
     
     
         9 . A method of using the nerve cuff in  claim 5 , comprising:
 delivering blocking therepy with the first, second, and third blocking therepy electrodes to the greater splanchnic nerve;   ceasing the delivery of blocking therepy;   subsequent to the cessation step, stimulating the greater splachnic nerve with the at least one confirmation and stimulation electrode; and   recording extracellular action potentials resulting from the stimulating step with at least one of the first, second, and third blocking therepy electrodes.   
     
     
         10 . A method of increasing exercise capacity in a patient by blocking a greater splanchnic nerve, comprising:
 detecting that a patient has started to exercise; and   after detecting that the patient has started to exercise and in response to the detection, delivering blocking therapy to a greater splanchnic nerve to increase the exercise capacity in a patient.   
     
     
         11 . The method of  claim 10 , wherein delivering the blocking therapy comprising deliverying the blocking therepy with an implanted nerve cuff secured to the greater splanchnic nerve. 
     
     
         12 . The method of claiim  10 , further comprising assessing the effectiveness of the blocking therapy. 
     
     
         13 . The method of  claim 12 , further comprising monitoring therapy effectiveness by measuring physiological signals. 
     
     
         14 . A method of treating heart failure or symptoms associated with heart failure in a human patient, comprising:
 in a patient with heart failure or symptoms associated with heart failure;   surgically accessing at least one thoracic nerve and optionally deflating the lung proximate to that nerve; and   affixing an implantable neuromodulation device for applying nerve blocking therapy to said at least one nerve, said device comprising a stimulus producer for producing a nerve stimulus, and a delivery member for delivering stimulus to said nerve,   wherein said stimulus has parameters able to cause a reversible blockage to the nerve conduction along the at least one thoracic nerve.   
     
     
         15 . The method of  claim 14 , wherein the implantable neuromodulation device is affixed using a surgically implantable nerve cuff. 
     
     
         16 . The method of  claim 14 , wherein said nerve is a greater splanchnic nerve, and at least one of a left greater splanchnic nerve and a right greater splanchnic nerve. 
     
     
         17 . The method of  claim 14 , wherein surgically accessing is selected from the group consisting of transthoracic, transabdominal, percutaneous, access or any combination thereof. 
     
     
         18 . A method of treating heart failure or symptoms associated with heart failure in a human patient, comprising:
 in a patient with heart failure or symptoms associated with heart failure,   thoracoscopically accessing at least one greater splanchnic nerve and optionally deflating the lung proximate to that nerve,   affixing an implantable neuromodulation device with a nerve cuff to said at least one nerve, said device further comprising a pulse generator, a detection member for detecting at least one physiological parameter, and at least one lead for delivering stimulus to said nerve through said nerve cuff,   wherein said stimulus has parameters able to cause a reversible blockage to the nerve conduction along the at least one greater splanchnic nerve.