Patent Application: US-91170392-A

Abstract:
the present invention provides a system for delivering electrical impulses of suitable magnitude and frequency to the inner lining of the gastrointestinal tract . the system senses the motor activity of the intestinal tract , thus providing feedback as to the body &# 39 ; s response to the imposed electrical stimulation . further , the system monitors critical parameters of gastrointestinal luminal contents , such as ph . moreover , the system may include a delivery port for administration of fluids or materials to the gastrointestinal tract , and / or for removing fluids or materials from the gastrointestinal tract . preferably , the system penetrates the skin surface and the inner lining of the gastrointestinal tract , in the stomach , intestine , or colon . the invention provides embodiments which can be adapted for easy removal for placement on a short - term basis , as well as embodiments having a longer - lasting design for placement on a relatively permanent basis .

Description:
in describing preferred embodiments of the present invention illustrated in the drawings , specific terminology is employed for the sake of clarity . however , the invention is not intended to be limited to the specific terminology so selected , and it is to be understood that each specific element includes all technical equivalents which operate in a similar manner to accomplish a similar purpose . patients with many of the entities listed in table 1 are potential candidates for a system according to the present invention , particularly when the gastric motility / gastric dysrhythmia disorders are chronic , severe , and / or recalcitrant to medical therapies . these gastric disorders may be treated with drugs , but in many instances a non - pharmacologic management may be preferred . under some conditions , drug therapy is almost always ineffective ( post - partial gastrectomy gastroparesis ) and pacemaker therapy may be ideal for such patients . successful pacing at the normal 3 cpm frequency should reduce patients &# 39 ; symptoms . gastric emptying also may be improved to some extent depending upon the underlying condition of the gastric smooth muscle . in addition , the present invention offers the possibility of delivering virtually any drug or nutrient solution required for patient care . the system also offers the capacity for gastric pacing and for recording gastric myoelectrical activity , depending upon the needs of the patients . finally , in addition to clinical uses the present invention may be used in a variety of animal and human research settings in which gastric contractions , gastric myoelectrical activity , gastric pacing and gastric ph are measured in response to selected stimuli . furthermore , the inventive device may be used to pace the small intestine or colon in patients who have some disease that causes ineffective and non productive intestine peristalsis . referring generally to the drawing figures , a tube 230 penetrates the skin surface ss and is held in position against the inner lining il of the gastrointestinal tract . the tube 230 is preferably made of a flexible , medically acceptable plastic polymer or composite material . an inner fixative device 240 , preferably made of a soft plastic polymer or other medically acceptable non - irritating material is provided to ensure that the device is not accidentally removed . in embodiments which are designed for easy removal , the inner fixative device 240 is made soft and compressible . however , in embodiments which are to remain in place for longer periods of time , the inner fixative device 240 is made of a firmer and more durable medically acceptable material . according to a preferred embodiment of the present invention , the fixative device 240 is not sutured to the gastrointestinal mucosa , but is held stationary with respect to the mucosa by a lock member 220 which surrounds and holds tube 230 at its entry point into the skin surface ss . extending from the fixative device 240 are a number of stimulative electrodes 312 , 314 , 316 , and 318 , disposed at the ends of respective pre - bent and insulated tentacles . these electrodes are preferably bipolar electrodes ( each having two electrodes ) . the stimulative electrode - bearing tentacles are preferably made of non - irritating , soft projectiles of prefabricated material that house wires leading to electrode tips . in a preferred embodiment , three or four electrodes function as stimulative electrodes for the gastrointestinal tract . this plurality of electrodes are provided , to ensure that there will always be some contact between at least one of the stimulative electrodes and the gastrointestinal mucosa . the pre - bent shape of the electrode - varying tentacles causes them to bend backward toward the mucosal surface of the gastrointestinal tract , so that the tentacles and protruding electrodes must be soft and non - abrasive to the gastrointestinal mucosa . further , the manner in which the tentacles are shaped should be , as illustrated , gently bending toward the mucosa and contacting it with the furthest tips of the electrodes . also illustrated is a ph electrode 320 at the end of a ph probe . the ph probe and electrode are also manufactured of a medically acceptable , soft material , although the ph electrode is placed so that it does not touch the mucosa of the gastrointestinal tract . also extending from the fixative device 240 is an elongated soft tubing 338 connected to a soft , expanded polymer tip 330 . a pressure transducer 332 extends from tube 338 , and is placed within a sensor bulb 330 . pressure transducer 332 transmits information representing the pressure activity of the motor complex generated by the muscular activity in the gastrointestinal tract . this pressure transducer 332 allows measurement of the gastrointestinal tract &# 39 ; s response to electrode stimulation . inside the soft tubing 338 are electrical connections terminating in bipolar sensing electrodes 334 , 336 . preferably , the sensing electrodes are designed to extend outward to touch the sides of the gastrointestinal tract , relaying information back to sensing equipment to be described below . the sensor bulb 330 itself floats freely in the distal gastrointestinal tract . an optional second floating bulb 340 is placed at the end of an elongated soft tube 348 . two stimulative bipolar electrodes 342 and 344 extend therefrom , and stimulate lower portions of the gastrointestinal tract in the same manner that stimulative electrodes 312 , 314 , 316 , 318 stimulate the stomach lining . the wires leading from stimulative electrodes 312 , 314 , 316 , 318 , 342 , 344 , the wires from sensor electrodes 334 , 336 , and from ph electrode 320 , as well as the sensor line from pressure transducer 332 , pass through tube 230 to a terminal plug 210 . removably connected to terminal plug 210 is a cable , generally indicated as element 212 . cable wires corresponding to the aforementioned wires are schematically illustrated as elements 124 , 134 , 144 , 164 within cable 212 . cable 212 leads to a small portable control and monitoring unit 100 , which governs the control and monitoring of the various electrodes and sensors . preferably , cable 212 is removably attachable to terminal plug 210 , to allow easy removal or substitution of unit 100 . control and monitoring unit 100 uses basic technology similar to that in a medtronic 5375 pulse generator , but applies the technology in a novel manner . according to the invention , control and monitoring unit 100 can have any or all of a wide variety of capabilities . within control and monitoring unit 100 are various elements , not all of which need be present in any given embodiment . a current source , schematically illustrated as element 110 , is controlled by an external current adjusting means , illustrated as a knob 112 . the output of current source 110 is input to a schematically illustrated current switch 120 . an external manual pulse rate adjusting means , schematically illustrated as knob 122 , determines the frequency of repetition of the current pulses which are output by current switch 120 , in pulses per minute ( ppm ). current pulses generated by the arrangement of current source 110 and current switch 120 pass along path 124 to stimulative electrodes 312 , 314 , 316 , 318 , in the stomach , and optional stimulative electrodes 342 , 344 in the intestinal tract below the stomach . of course , the current pulses may be generated using other means , such as ac current sources which have controllable frequency - responsive outputs . for example , voltage - controlled oscillators which provide an output current waveform of suitable shape and frequency in response to a voltage input to it , may be employed . thus , the illustration of current source 110 and switch 120 in fig1 is very schematic in nature , emphasizing the separate control of magnitude and pulse frequency . in addition to stimulative functions , various sensing functions are provided by unit 100 . for example , a ph receiver 130 receives information from ph electrode 320 along path 134 . an optional ph display 132 , here illustrated as a digital lcd or led display , is provided on the outside of the unit . a connector plug 138 is provided to transmit ph measurements from ph receiver 130 to an external ph recording device 430 , allowing a history of ph readings to be recorded for later analysis . similarly , pressure receiver 140 is provided , to receive pressure measurements from pressure transducer 332 passed along path 144 . an optional pressure display device 142 , here illustrated as an analog dial display , may be provided on the outer face of the unit . a plug 148 is provided to transmit pressure measurements history from pressure receiver 140 to an external pressure recording device 440 , allowing a history of pressure readings to be recorded for later analysis . further , a muscular activity receiver 150 is provided , and receives sensed electrical muscular activity from sensor electrodes 334 , 336 that are passed along path 154 . an optional electrical muscle activity display 152 is provided on the exterior of the unit , and is illustrated as an analog dial display . a plug 158 is provided , to transmit electrical muscle activity from electrical muscle activity receiver 150 to an external electrical muscle activity recorder 450 , for recording a history of muscle activity for later analysis . according to an alternative embodiment of the present invention , a delay detector 162 and threshold comparator 164 are provided . the stimulative electrical pulses on path 124 constitute a first input to delay sensor 162 . a second input to delay sensor 162 is connected to a sensing mechanism lower in the gastrointestinal tract , such as muscle activity sensing line 154 . during operation , delay sensor 162 determines the delay between an imposed stimulative electrical pulse on path 124 , and any response thereto on path 154 . if a certain amount of time has passed after the application of a stimulative pulse is greater than a certain time threshold th , then comparator 164 causes switch 120 to apply another pulse . if no response is measured before expiration of a given time period greater than th , delay sensor 162 times out , sending a timeout signal to comparator 164 so that comparator 164 activates switch 120 . it is understood that elements 162 , 164 are schematic in nature , and may be implemented using components other than those specifically suggested by the arrangement in fig1 . as appreciated by those skilled in the art , elements 162 , 164 complete a feedback loop . the feedback loop ensures that application of stimulative pulses to electrodes 312 , 314 , 316 , 318 causes a measurable change in the small intestine si . sensor electrodes 334 , 336 pass sensed contractions in the small intestine along path 154 to delay element 162 . during operation , if an electrical impulse is not sensed within a certain time period , another stimulative pulse is automatically delivered , as schematically indicated by the input to switch 120 . thus , the arrangement of delay element 162 and comparator 164 serves to override the manual setting , in pulses per minute , of element 122 . in the event that a substantial number of pulses are caused by the arrangement of elements 162 , 164 , without any feedback from sensor electrodes 334 , 336 , additional action is required . for example , the magnitude of the current can be set to a higher level , using control element 112 . the patient or the doctor can be alerted to the condition by a visual or auditory indicator ( not illustrated ). unit 100 is provided with an on - off switch 194 which controls application of power from battery 190 to the various unit components described above , via a power switch 192 . preferably , a &# 34 ; battery low &# 34 ; sensor 196 is provided , and illuminates a warning indicator 198 to alert the user that battery 190 needs to be recharged or replaced . an optional feature of the present invention is a port 232 extending from the exterior of the body into the gastrointestinal tract , generally parallel to the various wires 124 , 134 , 144 , 154 . port 232 is provided to allow fluids or materials to be delivered from outside the body into the gastrointestinal tract . alternatively or additionally , port 232 can be used to remove fluids or materials from the gastrointestinal tract . a suitable means is provided for closing the port when administration or removal of material is not taking place , the means being indicated schematically by a plug 214 . tube 230 may either be a solid core polymer of medically soft and non - irritating material , or it may have a hollow core to form port 232 . in one embodiment , tube 230 may be a short length of polymer that fits substantially flush with the skin surface ss . alternatively , as shown in fig2 a , it may be a longer extension . it may be coiled outside the skin surface ss , allowing it to be taped to the skin surface ss . control and monitoring unit 100 , being a portable and detachable device , may be anchored to the body or skin surface by straps , an elastic holder around the waist area , or other suitable attachment means . the components of the illustrated embodiment , with the exception of cable 212 , control and monitoring unit 100 , and external recording devices 430 , 440 , 450 , may be inserted either surgically or endoscopically into the gastrointestinal tract . when using the endoscopic approach , using either fiber optic or video gastrointestinal endoscopes , elements of the present invention can be placed in the same way and using the same techniques as the placement of percutaneous enterogastrostomy tubes that are currently being used . an example of such placement technique is the bower peg tube , and insertion and removal system , from a theremedics , inc ., corepack , inc ., wheeling , ill . 60090 . like other known systems and devices , the bower peg tube and delivery system are used for feeding patients who are unable to take in adequate nutrition by mouth . unfortunately , these known tubes and devices have no ability to electrically stimulate or &# 34 ; pace &# 34 ; the mucosa of the gastrointestinal tract . being primarily intended for use as a direct access to the gastrointestinal tract , they lack the flexibility and comprehensive advantages of the present invention . the structure and operation of a preferred embodiment of the invention having been described above , various individual components may be implemented as follows . control and monitoring unit 100 may be adapted from the medtronic 5375 demand pacemaker . this existing pacemaker is manufactured by medtronic inc ., 3055 old highway eight , post office box 1453 , minneapolis , minn . 55440 . preferably , the electrical pacing stimulus according to the gastrointestinal pacemaker is 1 . 8 milliseconds , with the pacing rate in a suitable number of pulses per minute ( such as 3 ppm ) as described above . the stimulus current amplitude adjustment would be from 0 . 1 to 10 milliamperes . the sensitivity of sensed voltage measurements is from 0 . 5 to 10 millivolts . the system may be powered by a 9 volt alkaline battery , for example , but a suitable rechargeable battery may also be used . elements related to ph sensing measurement and recording , elements 320 , 134 , 130 , 132 , 138 , 430 , may be implemented in a manner similar to the ambulatory ph data recorder model no . adr 2200 , available from narco biosystems , a division of international biomedical , inc ., 8508 cross park drive , austin , tex . 78754 - 4557 . in the illustrated embodiment , only the ph electrode 320 is present in the patient &# 39 ; s body ; however , with continued miniaturization , a recording system can actually be placed through port 232 for local measurement and recordation , and still be readily available for removal if needed . stimulative electrodes 312 , 314 , 316 , 318 may be modeled after bipolar electrodes made by cordis europa n . v ., 9301 lj roden , the netherlands . these electrodes are insulated , the metallic elements being made of gold or platinum . in operation , it is envisioned that the stimulative electrodes 312 , 314 , 316 , 318 would be simultaneously fired through a conductive path through cable 310 . pressure transducer 332 may be modeled after a sorenson transpac ii , list 42574 - 04 - 14 , abbott critical care systems , abbott labs hospital products division , north chicago , ill . 60064 . a transpac ii disposable transducer , list 42558 - 01 mk5 - 04dtnvf , also available from abbott labs [ list 41233 - 01 , lot 54 - 028 - sn01 ], may also be used . the system would be filled with fluid , and connected to a pressure transducer for direct readout to a suitable pressure recorder 440 . this is in contrast to the illustrated embodiment , in which a local pressure receiver 140 and readout 142 are built into the control and monitoring unit 100 . modifications and variations of the above - described embodiments of the present invention are possible , as appreciated by those skilled in the art in light of the above teachings . it will readily be appreciated that embodiments of the present invention may be made without using all the elements shown in the drawing figures . for example , fewer or more electrodes may be employed than are illustrated in the drawings . also , one or more of the ph electrode 320 , pressure transducer 332 , stimulative electrodes 312 , 314 , 316 , 318 , 342 , 344 , or sensor electrodes 334 , 336 , may be omitted from a particular embodiment if the patient &# 39 ; s medical condition does not warrant such stimulation or monitoring . it is therefore to be understood that , within the scope of the appended claims and their equivalents , the invention may be practiced otherwise than as specifically described . 1 . sarna s . in vivo myoelectrical activity : methods , analysis , and interpretation . in : schultz s , wood jd , eds . handbook of physiology , the gastrointestinal system . baltimore : waverly press , 1988 : 817 - 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808 . 8 . bisset wm , devane sp , milla pj . gastric antral dysrhythmias in children with idiopathic intestinal pseudo - obstruction . j gastrointestinal motility 1989 ; 1 : 53 ( abstract ). 9 . abell tl , malagelada j - r , lucas ar et al . gastric electromechanical and neurohormonal function in anorexia nervosa . gastroenterology 1987 ; 93 : 958 - 965 . 10 . geldof h , van der schee ej , smout ajpm et al . myoelectrical activity of the stomach in gastric ulcer patients : an electrogastrographic study . j . gastrointestinal motility 1989 ; 1 : 122 - 130 . 11 . koch kl , stern rm , vasey m , botti jj , creasy gw , dwyer a . gastric dysrhythmias and nausea of pregnancy . dig dis sci 1990 ; 35 : 961 - 968 . 12 . stern rm , koch kl , stewart wr , lindblad im . spectral analysis of tachygastria recorded during motion sickness . gastroenterology 1987 ; 93 : 92 - 97 . 13 . you ch , lee ky , chey wr , dwyer ae . gastric electromyography in normal and abnormal states in humans . functional disorders of the digestive tract . ed . wy chey , raven press , new york , 1983 ; 167 - 173 . 14 . abell tl , malagelada j - r . glucagon - evoked gastric dysrhythmias in humans shown by an improved electrogastrographic technique . gastroenterology 1985 ; 88 : 1932 - 1940 . 15 . hamilton jw , bellahsene be , richelderfer m , webster jh , bass p . human electrogastrograms : comparison of surface and mucosal recordings . dig dis sci 1986 ; 31 : 33 - 39 . 16 . sawchuk a , canal d , grosfeld jl , et al . electrical pacing of the roux limb resolves delayed gastric emptying . j surg res 1987 ; 42 : 635 - 41 . 17 . waldhausen j , courtney t , schirmer b . postoperative pacing for gastric antral distension [ abstract ] j gastroenterol mot 1989 ; 1 : 66 .