Abstract:
The present disclosure relates to EBS methods for stimulation of the vagus or vagal nerve for weight loss and the like. According to one aspect of the present disclosure, the method of weight loss includes the steps of percutaneously placing at least one EBS needle at a predetermined location of the body in close proximity to the vagus nerve; and energizing at least a distal tip of each EBS needle to treat the vagus nerve at the location of the distal tip of the EBS needle.

Description:
BACKGROUND 
       [0001]    1. Technical Field 
         [0002]    The present disclosure relates to surgical methods and, more particularly, to energy-based methods for stimulation of the vagus or vagal nerve for weight loss and the like. 
         [0003]    2. Background of Related Art 
         [0004]    In the United States, excess weight or obesity is a problem for a majority of the population. A 1999 National Health and Nutrition Examination Survey concluded that 61% of American adults are overweight or obese and the percentage of people becoming overweight continues to rise. People who are overweight or obese are generally more prone to ailments such as high-blood pressure, heart disease, and diabetes. 
         [0005]    In order to lose weight and combat the conditions associated with excess weight, many individuals partake in numerous methods and/or procedures to lose weight. For example, individuals attempt diets, undertake exercise routines or regimens, purchase and use weight reduction equipment or weight reduction drugs, and the like, or undergo surgical procedures. 
         [0006]    Surgery for obesity has included liposuction, gastroplasty and gastric bypass procedures. Gastroplasty, which is also known as stomach stapling, involves constructing a 15 to 30 mL pouch along the lesser curvature of the stomach. A modification of this procedure involves the use of an adjustable band that wraps around the proximal stomach to create a small pouch. 
         [0007]    Referring to  FIGS. 1 and 2 , it is known that the vagus nerve “V” plays an important role in mediating afferent information from the stomach to the satiety center in the brain. The vagus nerve “V” arises directly from the brain but, unlike the other cranial nerves, extends beyond the head. At its furthest extension the vagus nerve “V” reaches the lower parts of the intestines. 
         [0008]    The vagus nerve “V” is the dominant nerve of the gastrointestinal (GI) tract, the right and left branches or nerve afferents “V 1 , V 2 ”, respectively, of the vagus nerve “V” connect the GI tract to the brain. After leaving the spinal cord, the vagal afferents transport information regarding that tract to the brain of the patient “P”. In the lower part of the chest, the left vagus “V 2 ” rotates, becomes the anterior vagus, and innervates the stomach “S”. The right vagus “V 1 ” rotates to become the posterior vagus, which branches into the celiac division and innervates the duodenum and proximal intestinal tract. 
         [0009]    It has been discovered that the afferent vagal fibers from the stomach wall increase their firing rate when the stomach is filled, thus sending satiety signals to the brain. These satiety signals cause the individual to either terminate the meal and/or inhibit further feeding for some time afterward. During this postabsorptive (fasting) period, the satiety signals slowly dissipate until the drive to eat again takes over. 
         [0010]    A method of treating patients with obesity by bilateral stimulation of the patient&#39;s vagus nerve, in which a stimulating electrical signal is applied to one or both branches of the vagus, is disclosed in U.S. Pat. No. 6,587,719, issued Jul. 1, 2003. Generally, vagus nerve stimulation procedures have adopted cardiac pacemaking technology in which a “cardiac pacemaker-like” device is permanently implanted in the patient and connected specific locations of the vagus nerve in order to electrically effect and/or stimulate those specific locations. 
       SUMMARY 
       [0011]    The present disclosure relates to energy-based methods for stimulation of the vagus or vagal nerve for weight loss and the like. 
         [0012]    According to an aspect of the present disclosure, a method for performing a treatment on a human body includes the steps of placing a distal tip of at least one energy-based stimulation (EBS) needle proximal to the vagus nerve of the body; and energizing each EBS needle such that the distal tip thereof treats the vagus nerve. 
         [0013]    According to another aspect of the present disclosure, a method of weight loss involving EBS of the vagus nerve is provided. The method includes the steps of percutaneously placing at least one EBS needle at a predetermined location of the body proximal to the vagus nerve; and energizing at least a distal tip of each EBS needle to treat the vagus nerve at the location of the distal tip of the EBS needle. 
         [0014]    The method may further include the step of placing a distal tip of a plurality of EBS needles at predetermined locations along a length of the vagus nerve. The method may further include the step of connecting each EBS needle to an EBS generator. The method may still further include the step of monitoring a temperature of the vagus nerve at each location of EBS needle placement. 
         [0015]    The method may include the step of energizing each EBS needle with an RF waveform. The RF waveform may have a frequency above about 50 kHz. Each EBS needle may be energized with one of a continuous wave and a pulsed wave. 
         [0016]    The method further includes the step of maintaining a temperature of the vagus nerve at each location of EBS needle placement below a threshold level, wherein the threshold level is 42° C. 
         [0017]    The EBS needles may be placed at least at a location adjacent the vagus nerve where the vagus nerve innervates the stomach. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    Further features and advantages of the invention will become readily apparent from the following specification and from the drawings, in which: 
           [0019]      FIG. 1  is a schematic illustration depicting vagal nerves in a patient; 
           [0020]      FIG. 2  is an illustration depicting vagal nerve innervations to the visceral organs; 
           [0021]      FIG. 3  is a schematic illustration of an EBS system according to an aspect of the present disclosure; 
           [0022]      FIG. 4  is a schematic illustration of the EBS system of  FIG. 3  shown operatively placed within a patient for energy-based stimulation of the vagal nerve; and 
           [0023]      FIG. 5  is a schematic illustration of the EBS system of  FIG. 3  shown operatively placed within the patient for energy-based stimulation of the vagal nerve, according to another aspect of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    As seen in  FIG. 3 , an energy-based system (EBS) according to an embodiment of the present disclosure is generally designated as  100 . EBS  100  includes an energy-based generator  110 , at least one EBS acupuncture needle  120   a - 120   c  connectable to generator  110 , and an electrical conduit  130  interconnecting each EBS needle  120   a - 120   c  to EBS generator  110 . 
         [0025]    EBS generator  110  is operable to generate and deliver any suitable therapeutic energy-based stimulus to each EBS needle  120   a - 120   c  in order to deliver this energy-based stimulus to a target tissue, which may produce weight loss effects. In one embodiment, the therapeutic energy-based stimulation may include a stimulating RF waveform having frequencies above approximately 50 kHz. In some embodiments, the stimulating RF waveform may include continuous or pulsed wave applications at any duty cycle. For example, the pulsed wave application may produce bursts of energy at a rate of approximately 2 bursts per second (i.e., 2 Hz of 20 msec duration each). Also, the tip of each EBS needle  120   a - 120   c  is to be maintained at a temperature level that is less than or equal to 42° C. for a period of 120 sec. In some embodiments, the energy-based stimulus may include, for example, pulsed lasers through fiber optics, ultrasonic, piezoelectric, or microwave. 
         [0026]    With continued reference to  FIG. 3 , each EBS needle  120   a - 120   c  includes a respective needle probe  122   a - 122   c  extending or extendable from a respective handle or hub  126   a - 126   c . Each needle probe  122   a - 122   c  may be solid or hollow and may be fabricated from a suitable electrically conductive, rigid material, such as stainless steel. If needle probe  122   a - 122   c  is hollow, a cooling fluid may be circulated through a hollow cavity thereof in any suitable manner. In addition, an additional lumen in the hollow cavity may allow for the introduction of any suitable local anesthetic. An exterior surface of each needle probe  122   a - 122   c  may be coated with a suitable friction reducing material, such as TEFLON (PTFE) to aid in the percutaneous insertion of each needle probe  122   a - 122   c  into the body. Additionally, each needle probe  122   a - 122   c  may be coated with a suitable electrically insulative material along substantially an entire length thereof. 
         [0027]    A distal tip  124   a - 124   c  of each needle probe  122   a - 122   c  may be exposed for transmission of an energy-based stimulus therefrom. Each distal tip  124   a - 124   c  may be sharpened in order to facilitate percutaneous tissue penetration and precise energy application, or may have an extended surface exposure to provide a broader area of effect in areas where the vagus nerve has a broad innervation field, such as around the stomach and/or intestines. 
         [0028]    As seen in  FIG. 3 , electrical conduit  130  may be connected to each needle probe  122   a - 122   c  via hubs  126   a - 126   c . Alternatively, an end of electrical conduit  130  may be selectively electrically connected to at least one needle probe  122   a - 122   c  either prior to or after insertion of needle probe  122   a - 122   c  into the body. A clip (e.g., an alligator clip or other suitable connector) may be used to connect the end of electrical conduit  130  to a proximal end of needle probe  122   a - 122   c.    
         [0029]    Each EBS needle  120   a - 120   c  may include a respective temperature sensor  128   a - 128   c  disposed at a respective distal tip  124   a - 124   c  thereof. Each temperature sensor  128   a - 128   c  is electrically connected to EBS generator  110 . Temperature sensors  128   a - 128   c  may form a component of a feedback control loop “C” capable of automatically adjusting an energy output of EBS generator  110 . The energy output of EBS generator  110  may be adjusted so that the temperature of the body tissue in the proximity of distal tips  124   a - 124   c  of EBS needles  120   a - 120   c  does not exceed a threshold level that may result in local tissue damage. The tip of each EBS needle  120   a - 120   c  is to be maintained at a temperature level that is less than or equal to 42° C. for a period of 120 sec. 
         [0030]    In accordance with some embodiments of the present disclosure, EBS system  100  may be used to treat various ailments, including and not limited to weight management and/or weight loss. In operation, at least one EBS needle  120   a - 120   c  is placed at a specific treatment location on the human body, which specific treatment location coincides with known acupuncture meridians, and stimulated with radio frequency energy. 
         [0031]    In one embodiment, as seen in  FIG. 4 , treatment of the vagus nerve “V” or at least one of the right and left branches or nerve afferents “V 1 , V 2 ”, respectively, may include percutaneous insertion and placement of at least one EBS needle  120   a - 120   c  adjacent the vagus nerve “V”. A distal tip  124  of at least one EBS needle  120  may be placed in close proximity to or adjacent to the vagus nerve “V” at a location where the vagus nerve “V” innervates the stomach “S”. With distal tip  124  of each EBS needle  120  placed in close proximity to the vagus nerve “V”, at a location adjacent the stomach “S”, EBS generator  110  is activated to transmit EBS energy to distal tip  124  to treat the vagus nerve “V” at said location. 
         [0032]    In an embodiment where RF energy is utilized, each EBS needle  120  may be stimulated with an RF waveform including frequencies above about  50 kHz and may include either continuous wave or pulsed wave application at any duty cycle. During application of the RF energy to each EBS needle  120 , sensors  128  may monitor the temperature at each insertion site and provide feedback, via control loop “C”, to EBS generator  110 . EBS generator  110  may be configured to adjust the parameters of the RF energy transmitted to each EBS needle  120  in response to the feedback from sensors  128 . EBS generator  110  may adjust the parameters of the RF energy being transmitted so that the temperature of the vagus nerve “V” does not exceed a threshold that may result in local tissue damage. For example, the threshold temperature for the vagus nerve “V” may not exceed about 42° C. 
         [0033]    Additional branches of the vagus nerve “V” may be energy-based stimulated and/or treated, including and not limited to the superior and recurrent laryngeal nerves, the meningeal nerves, the auricular nerves, the pharyngeal nerves, the cardiac nerves, the bronchial nerves, the gastric nerves, the hepatic nerves, the celiac nerves, and the renal rami, pharyngeal, pulmonary, and esophageal plexus, and the anterior and posterior trunks. The auricular branch provides accessible access to the vagus nerve “V” due to its location in the ear lobe. 
         [0034]    While a single EBS needle  120  has been shown in  FIG. 4  as being inserted and/or placed in close proximity to the vagus nerve “V” it is envisioned and within the scope of the present disclosure, as seen in  FIG. 5 , that a plurality of EBS needles  120   a - 120   c  may be inserted into patient “P”, such that respective distal tips  124   a - 124   c  thereof are placed at difference locations along the length of the vagus nerve “V” and/or a plurality of EBS needles  120   d - 120   f  may be inserted into patient “P”, such that respective distal tips  124   d - 124   f  thereof are placed in close proximity to a single location along the length of the vagus nerve “V”. 
         [0035]    The foregoing description is merely a disclosure of particular embodiments and is no way intended to limit the scope of the invention. Other possible modifications are apparent to those skilled in the art and all modifications are to be defined by the following claims.