Abstract:
A magnetic gastric reduction device includes magnetic elements adapted to couple to a stomach and a sensor adapted to detect stomach properties. The device also includes a control device operably coupled to the magnetic elements. The control device is adapted to operably communicate with the sensor and is configured to control the magnetic elements based on a property of the stomach detected by the sensor to cause the magnetic elements to selectively compress or decompress the stomach.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims priority to, and the benefit of, U.S. Provisional Application Ser. No. 61/175,153 filed May 4, 2009, the entire contents of which are hereby incorporated by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to gastric reduction devices and, more particularly, to the use of magnetic devices to selectively adjust the capacity of the stomach. 
     2. Background of Related Art 
     To alleviate or improve morbid obesity, various bariatric procedures have been developed to reduce the volume of food that can be ingested within a particular time period. These procedures include various forms of stomach reduction, gastro-intestinal bypass and laparoscopic banding methods. While these known procedures are effective in the treatment of morbid obesity, the clinical implementation of devices for procedures such as laparoscopic banding, remains difficult. Further, once devices such as gastric bands are implemented, readjusting the device requires invasive procedures and manual readjusting. 
     SUMMARY 
     According to an embodiment of the present disclosure, a magnetic gastric reduction system includes magnetic elements adapted to couple to a stomach and a sensor adapted to detect stomach properties. The device also includes a control device operably coupled to the magnetic elements. The control device is adapted to operably communicate with the sensor and is configured to control the magnetic elements based on a property of the stomach detected by the sensor to cause the magnetic elements to selectively compress or decompress the stomach. 
     According to another embodiment of the present disclosure, a gastric suppression device includes one or more electrodes adapted to couple to a stomach and one or more sensors adapted to detect stomach properties. A control device is operably coupled to the one or more electrodes and is adapted to operably communicate with the one or more sensors. The control device is configured to control the one or more electrodes based on the stomach properties detected by the sensor to cause the one or more electrodes to selectively compress the stomach. 
     According to another embodiment of the present disclosure, a method of performing a gastric suppression procedure includes the steps of coupling one or more magnetic elements to a stomach and detecting one or more properties of the stomach. The method also includes the step of controlling the one or more magnetic elements to selectively suppress at least a portion of the stomach based on the one or more detected properties of the stomach. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the presently disclosed gastric reduction device are disclosed herein with reference to the drawings wherein: 
         FIG. 1  is a schematic view of a magnetic gastric reduction device wrapped around a stomach in accordance with an embodiment of the present disclosure; 
         FIG. 2  is a schematic view of a magnetic gastric reduction device wrapped around a stomach in accordance with another embodiment of the present disclosure; 
         FIG. 3  is a schematic view of a magnetic gastric reduction device wrapped around a proximal portion of a stomach in accordance with another embodiment of the present disclosure; 
         FIG. 4  is a cross-sectional view of a magnetic gastric reduction device wrapped around a stomach in accordance with another embodiment of the present disclosure; 
         FIG. 5  is a schematic view of a gastric reduction control system in accordance with an embodiment of the present disclosure; and 
         FIG. 6  is a schematic view of a gastric reduction control system in accordance with another embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     Embodiments of the presently disclosed gastric reduction device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding element in each of the several views. 
     Throughout this description, the term “proximal” will refer to the portion of the device closest to the operator and the term “distal” will refer to the portion of the device furthest from the operator. 
     Referring to  FIG. 1 , a flexible magnetic strip  10  is shown attached to a portion  12  of a stomach “s”. A second flexible magnetic strip  20  (shown in phantom) is attached to an opposing side of stomach “s” that mirrors portion  12  of stomach “s”. The magnetic strips  10 ,  20  are kept in place relative to stomach “s” via suturing or other structures for fastening. More specifically, each of the strips  10 ,  20  include one or more anchor holes  25  defined therethrough. Each anchor hole  25  is adapted to receive a suture attachment  27  (e.g., staples, tacks, sutures) therethrough for securing the strips  10 ,  20  to the stomach “s”. In use, strip  10  is magnetically attracted to strip  20 , and vice-versa, such that a specific volume of the stomach may be selectively restricted or reduced, as discussed in further detail below. 
     In embodiments, each of magnetic strips  10 ,  20  may be formed from a magnetic sheet material. In other embodiments, magnetic strips  10 ,  20  may be formed from a matrix of magnets or inductive coils. 
     In another embodiment shown in  FIG. 2 , a flexible gastric pad  100  is shown attached to a portion  12  of stomach “s”. A second pad  120  (shown in phantom) is attached to a corresponding portion (not shown) of stomach “s” that mirrors portion  12  of stomach “s”. Pads  100 ,  120  are kept in place relative to stomach “s” via suturing or other fastening devices (e.g., staples, tacks, sutures). More specifically, each of the pads  100 ,  120  include one or more anchor holes  125  defined therethrough. Each anchor hole  125  is adapted to receive a suture attachment  27  therethrough for securing the pads  100 ,  120  to the stomach “s”. In use, pad  100  is magnetically attracted to pad  120 , and vice-versa, such that a specific volume of the stomach “s” may be selectively restricted or reduced, as discussed in further detail below. 
     In embodiments, magnetic pads  100 ,  120  may include a grid of magnetic elements  130 , shown in phantom in the illustrated embodiment of  FIG. 2 . Magnetic elements  130  may be any combination of permanent magnets, electromagnets, and/or magnetic sheet materials. Magnetic elements  130  may be magnetized electronically or electromagnetically. More specifically, each magnetic element  130  may be magnetically adjusted in either manner discussed above independently or in unison with other magnetic elements  130  to contour the stomach “s” by reducing or restricting specific portions of the stomach “s”. 
     In another embodiment shown in  FIG. 3 , a flexible band  305  is shown banded around a proximal pouch area  307  of a stomach “s”. Band  305  is kept in place relative to proximal pouch area  307  via suturing or other fastening devices (e.g., staples, tacks, sutures). More specifically, band  305  includes one or more anchor holes  325  defined therethrough. Each anchor hole  325  is adapted to receive a suture attachment  27  therethrough for securing the band  305  to the proximal pouch  307  of stomach “s”. 
     In embodiments, band  305  may be, for example, a grid of electromagnets, a grid of permanent magnets, and/or a sheet of magnetic materials. Band  305  may be magnetized electronically or electromagnetically. In use, the band  305  is magnetized to adjust band  305  such that a specific volume of the stomach “s” may be selectively restricted or reduced, as discussed in further detail below. 
       FIG. 4  shows a cross-section of a stomach “s” having a gastric reduction device  350  attached thereto. Gastric reduction device  350  includes a pair of magnetic reduction elements  360  and  370  disposed on opposing sides of stomach “s”. Elements  360  and  370  may be, for example, a pair of flexible gastric strips ( FIG. 1 ), a pair of flexible gastric pads ( FIG. 2 ), or a band ( FIG. 3 ). Additionally or alternatively, elements  360 ,  370  may be formed as a magnetic reduction matrix ( FIGS. 5 and 6 ) that at least partially encompasses stomach “s”, as will be discussed in further detail below. In the illustrated embodiment, a pair of sensor layers  380  and  390  are disposed between elements  360  and  370 , respectively, and an outer surface of the stomach “s”. Sensor layers  380  and  390  are adapted to monitor pressure on the stomach, pulse oximetry, tissue oximetry, tissue vitality and/or tissue resiliency. In embodiments, sensor layers  380  and  390  may be formed as part of elements  360  and  370 . Elements  360  and  370  are kept in place relative to stomach “s” via suturing. More specifically, elements  360 ,  370  may include one or more anchor holes (not shown) defined therethrough. Each anchor hole is adapted to receive a suture attachment  355  (e.g., staples, tacks, sutures) therethrough for securing gastric reduction device  350  and sensor layers  380 ,  390  to an outer surface of the stomach “s”. 
     A sensor probe  375  may extend from sensor layer  380  and/or  390  through the surface of the stomach “s”. The sensor probe  375  is adapted to sense gastric secretions inside a pocket “p” of the stomach “s”. As best shown in  FIG. 4 , the pocket “p” of stomach “s” is a volume defined within the outer periphery of the stomach “s” that changes in accordance with the pressure applied by gastric reduction device  350  on stomach “s”. 
     In another embodiment shown in  FIG. 5 , a gastric reduction control system  300  includes a magnetic reduction matrix  330  adapted to that at least partially encompass a stomach “s”. Matrix  330  is operably coupled to an implantable control device  310 . Implantable control device  310  is adapted to communicate with an external control device  340  to facilitate control of the magnetic reduction matrix  330  to adjust the pressure on the stomach “s” or, more specifically, restrict a specific volume of the stomach “s”. As illustrated in  FIG. 5 , magnetic reduction matrix  330  is embodied as a grid of magnetic elements  335 . In other embodiments, magnetic reduction matrix  330  may be incorporated within, for example without limitation, a flexible gastric strip ( FIG. 1 ), a flexible gastric pad ( FIG. 2 ), or a flexible band ( FIG. 3 ). In the illustrated embodiment, magnetic reduction matrix  330  is comprised of magnetic elements  335  in a grid-like configuration. Elements  335  may be, for example, electromagnets, permanent magnets, permanent magnetic sheet material, neuro-stimulating electrodes, suppression-type electrodes, or any combination thereof. 
     External control device  340  is adapted to operate external to a patient and operably communicate with implantable control device  310 . External control device  340  includes an inductive coil  342 , a charge controller  344 , a microcontroller  346 , and an RF transmitter/receiver  348 . External control device  340  may be coupled to a suitable power source (e.g., AC line voltage, a battery, etc.) to provide power to microcontroller  346 , charge controller  344 , RF transmitter/receiver  348 , and inductive coil  342 . External control device  340  is adapted to operably communicate via RF transmitter/receiver  348  with a display device  338  adapted to display sensory data, as will be discussed in further detail below. 
     Implantable control device  310  is implanted within the patient and may be affixed to magnetic reduction matrix  330  or, alternatively, may be disposed within magnetic reduction matrix  330 . Implantable control device  310  includes a battery  312 , a microcontroller  314 , an R.F. transmitter/receiver  316 , a charging circuit  318 , and an inductive coil  320 . The microcontroller  314  and RF transmitter/receiver  316  are powered by the battery  312 . The battery  312  is, in turn, charged by the inductive coil  320  via the charging circuit  318 . 
     Using electrical current generated by a suitable power source, inductive coil  342  of external control device  340  generates an electromagnetic field from which inductive coil  320  of implantable control device  310  wirelessly draws energy. Inductive coil  320  converts the energy drawn from inductive coil  342  back into electrical current and charging circuit  318  charges the battery  312  with the converted electrical current. In this manner, no electrical leads or conductors from the implantable control device  310  to the external control device  340  are necessary to charge the battery  312 . That is, no electrical leads or conductors from implantable control device  310  and/or magnetic reduction device  330  are external relative to the patient. As such, battery  312  may be charged non-conductively from a source (i.e., external control device  340 ) external to the patient. 
     As discussed above, battery  312  powers microcontroller  314  and RF transmitter/receiver  316 . The microcontroller  314  is interfaced with the magnetic reduction device  330  and various sensors associated therewith such as, for example, sensor probe  375  and sensor layers  380 ,  390  ( FIG. 4 ). Based on sensory feedback from the sensors and/or clinician feedback, the microcontroller  314  adjusts the magnetic reduction device  330  by magnetizing or demagnetizing any one or more magnetic elements  335  to adjust the pressure applied by the magnetic reduction device  330  on the stomach “s”. More specifically, the microcontroller  314  may alter the voltage supplied to each magnetic element  335 , thereby altering the magnetic field strength of specific elements  335  and/or specific rows or sections of elements  335 , which, in turn, increases or decreases the attraction between opposing elements  335 , opposing rows of elements  335 , and/or opposing sections of elements  335 . 
     Sensory data from the sensors (e.g., sensor probe  375 , sensor layers  380 ,  390 ) may be transmitted from implantable control device  310  via RF transmitter/receiver  316  for subsequent storage and/or clinical review. Further, based on the transmitted sensory data, system adjustments, system status, and/or battery status may be determined. For example, RF transmitter/receiver  348  of external control device  340  may be adapted to communicate with RF transmitter/receiver  316  of implantable control device  310  to receive sensory data therefrom. RF transmitter/receiver  348  is adapted to transmit the received sensory data to the display device  338 . The display device  338 , in turn, enables clinicians to analyze the sensory data. Further, clinicians may communicate system settings and/or software updates (i.e., via RF transmitter/receiver  348  or any suitable transmitting device) to microcontroller  314  of implantable control device  310  through RF transmitter/receiver  316 . 
     Sensory data received by RF transmitter/receiver  348  that is specific to the status of battery  312  (e.g., battery level, battery condition, etc.) may be utilized by microcontroller  346  to conduct electrical current (e.g., from a suitable power source) to inductive coil  342 , as discussed herein above. The amount of electrical current conducted to inductive coil  342  is controlled by charge controller  344  in accordance with the needs of battery  312  as indicated via the sensory data. As discussed hereinabove, utilizing the electrical current, inductive coil  342  generates an electromagnetic field from which inductive coil  320  of implantable control device  310  wirelessly draws energy. 
     In embodiments, microcontroller  314  of implantable control device  310  may operate in any one of various modes of operation to control the matrix  330 . For example, based on sensory feedback from the sensors and/or clinician feedback, microcontroller  314  may compress a specific volume of stomach “s” when sensory feedback indicates that the patient is hungry or eating (e.g., based on sensed gastric secretions). In this scenario, microcontroller  314  may minimize the amount of time that stomach “s” is compressed or restricted to allow for the intake of food. In another scenario, if sensors or a clinician detect an illness, pregnancy, and/or consistent altered eating habits, microcontroller  314  or the clinician may terminate operation of gastric reduction control system  300  until subsequent reactivation once sufficient health of the patient is determined by the sensors or the clinician. 
     In embodiments, system  300  may incorporate a timer to compress the stomach “s” for predetermined time periods and/or a specific time of the day. 
     In other embodiments, system  300  or, more particularly microcontroller  314 , may include a voice recognition software application adapted to process voice commands from the patient and/or the clinician to selectively control the matrix  330 . 
     In another embodiment shown in  FIG. 6 , a gastric reduction control system  400  includes a magnetic reduction matrix  430  that is adapted to at least partially encompass a stomach “s”. Matrix  430  is operably coupled to an implantable control device  410 . Implantable control device  410  is adapted to communicate with an external control device  440  to facilitate control of the magnetic reduction matrix  430  to adjust the pressure on the stomach “s” or, more specifically, restrict a specific volume of the stomach “s”. As illustrated in  FIG. 6 , magnetic reduction matrix  430  is embodied as a grid of magnetic elements  460  (e.g., permanent magnets, electromagnets, etc.). Gastric reduction control system  400  is substantially as described above with respect to gastric reduction control system  300  of  FIG. 5  and will only be described to the extent necessary to explain its difference. 
     External control device  440  is adapted to operate external to a patient and operably communicate with implantable control device  410 . External control device  440  includes a charge controller  442 , a microcontroller  446 , and an RF transmitter/receiver  444 . External control device  440  may be coupled to a suitable power source (e.g., AC line voltage, a battery) to provide power to microcontroller  446 , charge controller  444 , and RF transmitter/receiver  448 . External control device  440  is adapted to operably communicate via RF transmitter/receiver  444  with a display device  438  adapted to display sensory data, as will be discussed in further detail below. 
     Implantable control device  410  is implanted within the patient and may be affixed to magnetic reduction matrix  430  or, alternatively, may be disposed within magnetic reduction matrix  430 . Implantable control device  410  includes a battery  412 , a microcontroller  414 , an R.F. transmitter/receiver  416 , and a conductive charging circuit  418 . The conductive charging circuit  418  includes an electrical lead  420  adapted to extend from implantable control device  410  and externally from the patient. Electrical lead  420  is adapted to connect conductive charging circuit  418  to external control device  440 , as will be discussed in further detail below. The microcontroller  414  and RF transmitter/receiver  416  are powered by the battery  412 . The battery  412 , in turn, is charged by the conductive charging circuit  418 . More specifically, the charge controller  442  regulates electrical current from the external control device  440  to the conductive charging circuit  418  based on sensory feedback from sensors (e.g., sensor probe  375 , sensor layers  380 ,  390 ) and/or clinician feedback. Conductive charging circuit  418  conductively charges the battery  412  with the electrical current from external control device  440  and/or a suitable power source operably coupled thereto. 
     As discussed above, battery  412  powers microcontroller  414  and RF transmitter/receiver  416 . The microcontroller  414  is interfaced with the magnetic reduction device  330  and various sensors (e.g., sensor layers  380  and  390 ) associated therewith. Based on sensory feedback from the sensors and/or clinician feedback, the microcontroller  414  adjusts the magnetic reduction device  430  by magnetizing or demagnetizing any one or more magnetic elements  460  to adjust the pressure applied by magnetic reduction device  430  on the stomach “s”. 
     As described above with respect to magnetic reduction device  330  of  FIG. 5 , sensory data from the sensors (e.g., sensor probe  375 , sensor layers  380 ,  390 ) may be transmitted from implantable control device  410  via RF transmitter/receiver  416  for subsequent storage and/or clinical review (e.g., via display  438 ). 
     For any one of the above described embodiments, an MRI or CAT scan may be taken of the abdomen of a patient to determine geometry and/or dimensions specific to the stomach of that patient. Based on this information, custom alterations may be made to conform a magnetic reduction device to the contours of a stomach prior to implementation. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.