Magnetic gastric reduction device

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.

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.

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 toFIG. 1, a flexible magnetic strip10is shown attached to a portion12of a stomach “s”. A second flexible magnetic strip20(shown in phantom) is attached to an opposing side of stomach “s” that mirrors portion12of stomach “s”. The magnetic strips10,20are kept in place relative to stomach “s” via suturing or other structures for fastening. More specifically, each of the strips10,20include one or more anchor holes25defined therethrough. Each anchor hole25is adapted to receive a suture attachment27(e.g., staples, tacks, sutures) therethrough for securing the strips10,20to the stomach “s”. In use, strip10is magnetically attracted to strip20, 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 strips10,20may be formed from a magnetic sheet material. In other embodiments, magnetic strips10,20may be formed from a matrix of magnets or inductive coils.

In another embodiment shown inFIG. 2, a flexible gastric pad100is shown attached to a portion12of stomach “s”. A second pad120(shown in phantom) is attached to a corresponding portion (not shown) of stomach “s” that mirrors portion12of stomach “s”. Pads100,120are kept in place relative to stomach “s” via suturing or other fastening devices (e.g., staples, tacks, sutures). More specifically, each of the pads100,120include one or more anchor holes125defined therethrough. Each anchor hole125is adapted to receive a suture attachment27therethrough for securing the pads100,120to the stomach “s”. In use, pad100is magnetically attracted to pad120, 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 pads100,120may include a grid of magnetic elements130, shown in phantom in the illustrated embodiment ofFIG. 2. Magnetic elements130may be any combination of permanent magnets, electromagnets, and/or magnetic sheet materials. Magnetic elements130may be magnetized electronically or electromagnetically. More specifically, each magnetic element130may be magnetically adjusted in either manner discussed above independently or in unison with other magnetic elements130to contour the stomach “s” by reducing or restricting specific portions of the stomach “s”.

In another embodiment shown inFIG. 3, a flexible band305is shown banded around a proximal pouch area307of a stomach “s”. Band305is kept in place relative to proximal pouch area307via suturing or other fastening devices (e.g., staples, tacks, sutures). More specifically, band305includes one or more anchor holes325defined therethrough. Each anchor hole325is adapted to receive a suture attachment27therethrough for securing the band305to the proximal pouch307of stomach “s”.

In embodiments, band305may be, for example, a grid of electromagnets, a grid of permanent magnets, and/or a sheet of magnetic materials. Band305may be magnetized electronically or electromagnetically. In use, the band305is magnetized to adjust band305such that a specific volume of the stomach “s” may be selectively restricted or reduced, as discussed in further detail below.

FIG. 4shows a cross-section of a stomach “s” having a gastric reduction device350attached thereto. Gastric reduction device350includes a pair of magnetic reduction elements360and370disposed on opposing sides of stomach “s”. Elements360and370may 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, elements360,370may 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 layers380and390are disposed between elements360and370, respectively, and an outer surface of the stomach “s”. Sensor layers380and390are adapted to monitor pressure on the stomach, pulse oximetry, tissue oximetry, tissue vitality and/or tissue resiliency. In embodiments, sensor layers380and390may be formed as part of elements360and370. Elements360and370are kept in place relative to stomach “s” via suturing. More specifically, elements360,370may include one or more anchor holes (not shown) defined therethrough. Each anchor hole is adapted to receive a suture attachment355(e.g., staples, tacks, sutures) therethrough for securing gastric reduction device350and sensor layers380,390to an outer surface of the stomach “s”.

A sensor probe375may extend from sensor layer380and/or390through the surface of the stomach “s”. The sensor probe375is adapted to sense gastric secretions inside a pocket “p” of the stomach “s”. As best shown inFIG. 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 device350on stomach “s”.

In another embodiment shown inFIG. 5, a gastric reduction control system300includes a magnetic reduction matrix330adapted to that at least partially encompass a stomach “s”. Matrix330is operably coupled to an implantable control device310. Implantable control device310is adapted to communicate with an external control device340to facilitate control of the magnetic reduction matrix330to adjust the pressure on the stomach “s” or, more specifically, restrict a specific volume of the stomach “s”. As illustrated inFIG. 5, magnetic reduction matrix330is embodied as a grid of magnetic elements335. In other embodiments, magnetic reduction matrix330may 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 matrix330is comprised of magnetic elements335in a grid-like configuration. Elements335may be, for example, electromagnets, permanent magnets, permanent magnetic sheet material, neuro-stimulating electrodes, suppression-type electrodes, or any combination thereof.

External control device340is adapted to operate external to a patient and operably communicate with implantable control device310. External control device340includes an inductive coil342, a charge controller344, a microcontroller346, and an RF transmitter/receiver348. External control device340may be coupled to a suitable power source (e.g., AC line voltage, a battery, etc.) to provide power to microcontroller346, charge controller344, RF transmitter/receiver348, and inductive coil342. External control device340is adapted to operably communicate via RF transmitter/receiver348with a display device338adapted to display sensory data, as will be discussed in further detail below.

Implantable control device310is implanted within the patient and may be affixed to magnetic reduction matrix330or, alternatively, may be disposed within magnetic reduction matrix330. Implantable control device310includes a battery312, a microcontroller314, an R.F. transmitter/receiver316, a charging circuit318, and an inductive coil320. The microcontroller314and RF transmitter/receiver316are powered by the battery312. The battery312is, in turn, charged by the inductive coil320via the charging circuit318.

Using electrical current generated by a suitable power source, inductive coil342of external control device340generates an electromagnetic field from which inductive coil320of implantable control device310wirelessly draws energy. Inductive coil320converts the energy drawn from inductive coil342back into electrical current and charging circuit318charges the battery312with the converted electrical current. In this manner, no electrical leads or conductors from the implantable control device310to the external control device340are necessary to charge the battery312. That is, no electrical leads or conductors from implantable control device310and/or magnetic reduction device330are external relative to the patient. As such, battery312may be charged non-conductively from a source (i.e., external control device340) external to the patient.

As discussed above, battery312powers microcontroller314and RF transmitter/receiver316. The microcontroller314is interfaced with the magnetic reduction device330and various sensors associated therewith such as, for example, sensor probe375and sensor layers380,390(FIG. 4). Based on sensory feedback from the sensors and/or clinician feedback, the microcontroller314adjusts the magnetic reduction device330by magnetizing or demagnetizing any one or more magnetic elements335to adjust the pressure applied by the magnetic reduction device330on the stomach “s”. More specifically, the microcontroller314may alter the voltage supplied to each magnetic element335, thereby altering the magnetic field strength of specific elements335and/or specific rows or sections of elements335, which, in turn, increases or decreases the attraction between opposing elements335, opposing rows of elements335, and/or opposing sections of elements335.

Sensory data from the sensors (e.g., sensor probe375, sensor layers380,390) may be transmitted from implantable control device310via RF transmitter/receiver316for 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/receiver348of external control device340may be adapted to communicate with RF transmitter/receiver316of implantable control device310to receive sensory data therefrom. RF transmitter/receiver348is adapted to transmit the received sensory data to the display device338. The display device338, in turn, enables clinicians to analyze the sensory data. Further, clinicians may communicate system settings and/or software updates (i.e., via RF transmitter/receiver348or any suitable transmitting device) to microcontroller314of implantable control device310through RF transmitter/receiver316.

Sensory data received by RF transmitter/receiver348that is specific to the status of battery312(e.g., battery level, battery condition, etc.) may be utilized by microcontroller346to conduct electrical current (e.g., from a suitable power source) to inductive coil342, as discussed herein above. The amount of electrical current conducted to inductive coil342is controlled by charge controller344in accordance with the needs of battery312as indicated via the sensory data. As discussed hereinabove, utilizing the electrical current, inductive coil342generates an electromagnetic field from which inductive coil320of implantable control device310wirelessly draws energy.

In embodiments, microcontroller314of implantable control device310may operate in any one of various modes of operation to control the matrix330. For example, based on sensory feedback from the sensors and/or clinician feedback, microcontroller314may 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, microcontroller314may 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, microcontroller314or the clinician may terminate operation of gastric reduction control system300until subsequent reactivation once sufficient health of the patient is determined by the sensors or the clinician.

In embodiments, system300may incorporate a timer to compress the stomach “s” for predetermined time periods and/or a specific time of the day.

In other embodiments, system300or, more particularly microcontroller314, may include a voice recognition software application adapted to process voice commands from the patient and/or the clinician to selectively control the matrix330.

In another embodiment shown inFIG. 6, a gastric reduction control system400includes a magnetic reduction matrix430that is adapted to at least partially encompass a stomach “s”. Matrix430is operably coupled to an implantable control device410. Implantable control device410is adapted to communicate with an external control device440to facilitate control of the magnetic reduction matrix430to adjust the pressure on the stomach “s” or, more specifically, restrict a specific volume of the stomach “s”. As illustrated inFIG. 6, magnetic reduction matrix430is embodied as a grid of magnetic elements460(e.g., permanent magnets, electromagnets, etc.). Gastric reduction control system400is substantially as described above with respect to gastric reduction control system300ofFIG. 5and will only be described to the extent necessary to explain its difference.

External control device440is adapted to operate external to a patient and operably communicate with implantable control device410. External control device440includes a charge controller442, a microcontroller446, and an RF transmitter/receiver444. External control device440may be coupled to a suitable power source (e.g., AC line voltage, a battery) to provide power to microcontroller446, charge controller444, and RF transmitter/receiver448. External control device440is adapted to operably communicate via RF transmitter/receiver444with a display device438adapted to display sensory data, as will be discussed in further detail below.

Implantable control device410is implanted within the patient and may be affixed to magnetic reduction matrix430or, alternatively, may be disposed within magnetic reduction matrix430. Implantable control device410includes a battery412, a microcontroller414, an R.F. transmitter/receiver416, and a conductive charging circuit418. The conductive charging circuit418includes an electrical lead420adapted to extend from implantable control device410and externally from the patient. Electrical lead420is adapted to connect conductive charging circuit418to external control device440, as will be discussed in further detail below. The microcontroller414and RF transmitter/receiver416are powered by the battery412. The battery412, in turn, is charged by the conductive charging circuit418. More specifically, the charge controller442regulates electrical current from the external control device440to the conductive charging circuit418based on sensory feedback from sensors (e.g., sensor probe375, sensor layers380,390) and/or clinician feedback. Conductive charging circuit418conductively charges the battery412with the electrical current from external control device440and/or a suitable power source operably coupled thereto.

As discussed above, battery412powers microcontroller414and RF transmitter/receiver416. The microcontroller414is interfaced with the magnetic reduction device330and various sensors (e.g., sensor layers380and390) associated therewith. Based on sensory feedback from the sensors and/or clinician feedback, the microcontroller414adjusts the magnetic reduction device430by magnetizing or demagnetizing any one or more magnetic elements460to adjust the pressure applied by magnetic reduction device430on the stomach “s”.

As described above with respect to magnetic reduction device330ofFIG. 5, sensory data from the sensors (e.g., sensor probe375, sensor layers380,390) may be transmitted from implantable control device410via RF transmitter/receiver416for subsequent storage and/or clinical review (e.g., via display438).

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.