WO2002038217A2 - Implantable neuromuscular stimulator for the treatment of gastrointestinal disorders - Google Patents
Implantable neuromuscular stimulator for the treatment of gastrointestinal disorders Download PDFInfo
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- WO2002038217A2 WO2002038217A2 PCT/US2001/049706 US0149706W WO0238217A2 WO 2002038217 A2 WO2002038217 A2 WO 2002038217A2 US 0149706 W US0149706 W US 0149706W WO 0238217 A2 WO0238217 A2 WO 0238217A2
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- gastrointestinal tract
- patient
- control module
- sensor
- stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
Definitions
- This invention is in the field of devices for the treatment of gastrointestinal disorders in human subjects.
- At least 8% of the population has acid reflux, also known as gastroesophageal reflux disease (GERD), that is not controlled by the current treatment of choice - ion pump inhibitors that block acid production and other medications that affect contraction of the esophagus and gastroesophageal sphincter.
- GFD gastroesophageal reflux disease
- narcotics e.g., narcotics, antihypertensive, anti-inflammatories.
- the main problem is lack of sequential action of the gut musculature (e.g. loss of gastrocolic reflex due to diabetes, neuropathies, and medications such as narcotics, tranquilizers, and antidepressants).
- Familoni et al. have shown in the dog model that the optimal frequency for stimulating stomach contraction is at four to five times the intrinsic rate of five cycles per minute. Familoni, B.O. et al., Electrical stimulation at a frequency higher than basal rate in human stomach, Dig. Dis. Sci., 1997 May; 42(5): 892-7. For the stomach, stimulation of one part will produce appropriate contraction of the whole stomach because the stomach acts as a syncytium (an integrated whole). While recent results of stimulation of the stomach in dogs have demonstrated efficacy in achieving motility (see Mintchev, M.P. et.
- Familoni in U.S. Patent No. 5,861,014 describes a system to sense and identify abnormal stomach electrical signals and to stimulate the stomach responsively to treat the detected gastric rhythm abnormalities. Familoni does not disclose the use of a system that involves the esophageal sphincter and would work for acid reflux, nor does he disclose the detecting of normal function and the use of the detected delays in normal gastrointestinal tract function to set the delays for triggering successive stimulation of gastrointestinal tract organs. Bourgeois in U.S. Patent No. 6,026,326 describes primarily enhancements to the Familoni invention for treating gastric rhythm abnormalities.
- the present invention envisions an implantable neuromuscular stimulator with multiple (two or more) outputs producing sequential, prolonged pulses of 0.5 msec to 5 msec. Sequential and appropriate activation of the GI tract is produced by electrical stimulation pulses that are timed at intervals consistent with normal patterns of GI tract function for the specific spacing of the electrodes. In addition to creating gastrointestinal tract function similar to normal, this process has the potential to reeducate the GI tract to function near to normal patterns without stimulation.
- Important areas for electrode placement include the upper esophagus, lower esophageal sphincter, stomach, duodenum, small intestine (optional) and the large bowel (colon - optional).
- the present invention is a neuromuscular stimulator for sequential responsive stimulation to restore normal GI function.
- the most likely scenario for treating acid reflux will involve electrodes placed at the esophageal sphincter and stomach wall.
- the stimulator When initiated, the stimulator will close the esophageal sphincter and start a timer.
- the stomach electrodes At the end of a preset time (e.g. 0.5-2 hours) the stomach electrodes will be energized to empty the stomach.
- the device will turn off all stimulation and be ready for the next sequence.
- Stimulation may be patient initiated from external device. This device may include buttons for initiating the sequence of stimulation and buttons for temporary suspension of the program to allow snacking.
- the sequence can begin automatically when no food has passed through the esophagus for a preset period of time (e.g. 10 min). Eating or drinking is easily characterized by a higher frequency of swallowing than is typical of just normal saliva swallowing. After the meal is over and the sequence has been started, if additional food or drink or just normal saliva swallowing is detected by signals picked up by an electrode on the esophagus, the system may go into suspend mode for a specified period of time (e.g. 1 to 10 sec).
- a specified period of time e.g. 1 to 10 sec.
- the stimulator would typically involve two to four electrodes acting as sensing and/or stimulating electrodes.
- the control module will have data recording capabilities and a physician's workstation similar to that described by Fischell et. al in U.S. Patent No. 6,016,449.
- the physician's workstation would have the capability to retrieve the data recorded by the control module and to program the specific functionality of the control module including parameters for stimulation and detection of gastrointestinal tract function.
- additional types of sensors other than electrodes may be used for identifying motion or actions by parts of the gastrointestinal tract. These additional sensors could include temperature sensors, motion sensors (accelerometers) and pressure sensors to sense pressure within a gastrointestinal tract structure or pressure changes caused by expansion or contraction of a gastrointestinal tract structure.
- Gastrointestinal tract hurry can be produced by stimulation of the stomach and/or small intestine.
- the closed loop system envisioned would detect food being swallowed and/or stomach activity and responsively stimulate the gastrointestinal tract to increase the speed of passage of food through the small intestine. This technique should be less invasive than current surgical methods to reduce nutrient uptake and if not successful, surgery can still be performed.
- Gastrointestinal tract stimulation according to the invention may be continuous, intermittent, or responsive to patient initiation or gastrointestinal tract activity detection.
- Another object of the invention is to have a system for restoration of normal gastrointestinal tract function by sequential stimulation signals applied to two or more electrodes placed on or near the structures of the gastrointestinal tract. Another object of this invention is to use the sensing of gastrointestinal tract activity to initiate responsive stimulation to the gastrointestinal tract.
- Still another object of this system is to have data recording capability within the control module.
- Yet another object of the present invention is to have external equipment including a patient initiating device.
- Yet another object of the present invention is to have external equipment including a physician's workstation for reading out recorded data and programming the gastrointestinal tract stimulator.
- Still another object of the system is to sense sphincter contraction or relaxation in order to activate electrical stimulation of the sphincter.
- Still another object of the system is to sense sphincter contraction and augment or assist this with electrical stimulation and/or trigger assistance from an artificial sphincter.
- This has applications for any sphincter system (e.g. gastroesophageal, pyloric, anal, bladder or urethra).
- Yet another object of the present invention is to stimulate the stomach and/or small intestine to produce gastrointestinal hurry where the speed of the passage of food through the gastrointestinal tract is increased so as to reduce the absorption of nutrients as a means to achieve weight loss for obese patients.
- FIG. 1 is a sketch of a portion of the human gastrointestinal tract, having an implanted stimulator control module with attached electrodes.
- FIG. 2 is a block diagram of the electronic circuitry of the implanted control module illustrated in FIG. 1.
- FIG. 1 illustrates the configuration of an implantable system 10 for the treatment of gastrointestinal disorders as it would be implanted under the skin of a human body, the system including a control module 20, electrodes 15 A, 15B, 15C, 15D, 15E, 15F, 15G, and 15H with leads 17A, 17B, 17C, 17D, 17E, 17F, 17G, and 17H connected through a connector 7 to the control module 20.
- the control module 20 is permanently implanted into the patient's abdomen. It is also envisioned that the control module 20 could be located in the patient's chest like a heart pacemaker or in the patient's abdominal wall.
- Each of the electrodes 15A through 15H would be placed at a specific site along the patient's GI tract.
- the connecting leads 17A through 17H would be run from the control module 20 underneath the skin and then be connected to the electrodes 15A through 15H.
- FIG. 1 shows only eight active electrodes 15 A, 15B, 15C, 15D, 15E, 15F, 15G, and 15H with connecting leads 17A, 17B, 17C, 17D, 17E, 17F, 17G, and 17H, more than eight active electrodes with connecting leads may be used with the present invention.
- FIG. 1 specifically shows electrode sets 11, 12, 13 and 14 as follows: Electrode set 11 with electrodes 15A and 15B is located on the esophagus between the esophageal sphincter and the mouth. The electrodes 15A and 15B are connected to the control module 20 by the leads 17A and 17B. Sutures 9 surgically placed during system implantation, hold the electrodes 15A and 15B against the surface of the esophagus. Although two electrodes 15A and 15B are shown here for the electrode set 11, more than two electrodes or a single electrode referenced to a common ground (such as the case of the control module 20) may be used. The electrode set 11 is used with the present invention for detection of food or liquid passing through the esophagus.
- Electrode set 12 with electrodes 15C and 15D is located on the esophageal sphincter between the esophagus and the stomach.
- the electrodes 15C and 15D are connected to the control module 20 by the leads 17C and 17D.
- Sutures 9 surgically placed during system implantation, hold the electrodes 15C and 15D against the surface of the esophagus.
- two electrodes 15C and 15D are shown here for the electrode set 12, more than two electrodes or a single electrode referenced to a common ground such as the case of the control module 20 may be used.
- the electrode set 12 is used with the present invention to provide electrical stimulation to maintain closure of the esophageal sphincter. Such closure will prevent acid reflux.
- electrode set 12 can be used as a "power assist" device to sense inadvertent relaxation of the esophageal sphincter and apply stimulation responsively to keep it closed.
- Electrode set 13 with electrodes 15E and 15F is located on the surface of the stomach.
- the electrodes 15E and 15F are connected to the control module 20 by the leads 17E and 17F.
- two electrodes 15E and 15F are shown here for the electrode set 13, more than two electrodes or a single electrode referenced to a common ground such as the case of the control module 20 may be used.
- the electrode set 13 is used with the present invention to provide electrical stimulation to encourage speedy digestion of food by the stomach during which the electrode set 12 will keep the esophageal sphincter closed to avoid acid reflux.
- Electrode set 13 can also be used to produce gastrointestinal hurry speeding the passage of food through the gastrointestinal tract to reduce nutrient uptake for obese patients.
- Electrode set 14 with electrodes 15G and 15H is located on the surface of the duodenum.
- the electrodes 15G and 15H are connected to the control module 20 by the leads 17G and 17H.
- Sutures 9 surgically placed during system implantation, hold the electrodes 15G and 15H against the surface of the stomach.
- two electrodes 15G and 15H are shown here for the electrode set 14, more than two electrodes or a single electrode referenced to a common ground such as the case of the control module 20 may be used.
- the electrode set 14 is used with the present invention to provide electrical stimulation to encourage contraction of the duodenum to assist in emptying the stomach during which the electrode set 12 will keep the esophageal sphincter closed to avoid acid reflux.
- the electrode set 14 can also be used to produce gastrointestinal hurry speeding the passage of food through the gastrointestinal tract to reduce nutrient uptake for obese patients.
- the terminology “the electrodes 15A through 15N” is meant to include all electrodes 15 A, 15B, 15C, ... to 15N, inclusive, where N may be any integer greater than or equal to 1. Similar terminology using the words “through” or “to” for other groups of objects (i.e., leads 17A through 17N) will have a similar inclusive meaning.
- the control module 20 is also shown connected to leads 171 through 17N that connect to additional gastrointestinal tract electrodes 151 through 15N.
- the electrodes 151 through 15N may be located on the small intestine, large intestine and/or bowel as needed to properly stimulate normal function of the entire gastrointestinal tract.
- Each electrode 15A through 15N can be used for either sensing electrical signals from the gastrointestinal tract or for stimulating the gastrointestinal tract to cause the opening or closing of the esophageal sphincter or contractions of digestive organs like the stomach, duodenum, small intestine, large intestine or bowel.
- the combination of sensing with timed stimulation allows the system 10 the ability to replicate normal gastrointestinal tract function.
- the system in many cases would work like a demand pacemaker, i.e. when a specific gastrointestinal tract organ is functioning normally, it is not stimulated, but when it fails to function properly, stimulation is applied. For example during digestion by the stomach if the esophageal sphincter is not closed, acid reflux can occur.
- Typical stimulation signals to close the esophageal sphincter would be one to 30 biphasic pulses over a 1 second period repeating every 5 to 60 seconds, each pulse being between 0.5 and 2 milliseconds long.
- the peak-to-peak voltage and current should be between 1 to 25 volts (peak to peak) and 1 to 20 milliamps.
- Lin et al. have shown that 4 milliamp pulses of 300 ms duration applied to the stomach work well. Lin, Z.Y. et al., Effects of pacing parameters on entrainment of gastric slow waves in patients with gastroparesis, Am. J. Physiol., 1998 Jan; 274(1 Pt 1): GI 86-91.
- Mintchev et al. report that 50 Hz 14 volt signals are effective.
- Mintchev, M.P. et al. Microprocessor controlled movement of liquid gastric content using sequential neural electrical stimulation, Gut, 1998 Nov.; 43(5): 607-11.
- each organ can be stimulated in sequence with appropriate delays set to emulate the normal delays associated with movement of food through the gastrointestinal tract. For example, when food is sensed by electrode set 11, any stimulation of the electrode set 12 is immediately stopped to allow the esophageal sphincter to open.
- the intensity and frequency of the signals received by the control module 20 from the esophagus electrodes 15A and 15B can allow differentiation of a saliva swallow from a meal. Eating or drinking is easily characterized by a higher frequency of swallowing than is typical of just normal saliva swallowing. Once a period of 5 to 60 seconds have passed without significant swallowing, the esophageal sphincter would be closed (if needed) by stimulation of the electrode set 12.
- each stimulation function is sequential with appropriate delays so as to closely resemble normal gastrointestinal tract function, but with delays, durations, and sequences modified as desired to achieve advantageous clinical results.
- Initiation of the gastrointestinal tract stimulation can be automated or can be initiated by the patient by use of an external device that can send signals to the control module 20. See, for example, the external data interface illustrated in Figure 2 of U.S. Patent No. 6,016,449 to Fischell, et al.; an external magnet coupled with a magnetic field detector in the control module 20 might also be used in an embodiment of the invention. Also the patient would have the capability to override the system to cause contraction or relaxation at any time.
- the appropriate delays and settings for each patient may be different. It is envisioned that in patients with occasional normal gastrointestinal tract function, that recordings of the sequence of muscle contractions in the gastrointestinal tract can be stored by the control module and used by the physician to determine the appropriate stimulation delays and settings. A completely automated system is also envisioned that would analyze the delays associated with normal gastrointestinal tract function and automatically set appropriate stimulation parameters.
- sensors other than electrodes may be used for identifying motion or actions by parts of the gastrointestinal tract.
- additional sensors could include temperature sensors, motion sensors (accelerometers) and pressure sensors to sense pressure within a gastrointestinal tract structure or pressure changes caused by expansion or contraction of a gastrointestinal tract structure.
- the sensory system can utilize electrical activity of muscle or mechanical changes in the size of the gut.
- electrodes might be placed in an expandable matrix such that the distance between electrodes or the curvature of the electrodes sensed by changes in inductance or capacitance could signal contraction or relaxation of the underlying muscle.
- FIGS. 1 and 2 lines connecting boxes on block diagrams or on software flow charts will each be labeled with an element number. Lines without arrows between boxes or other elements shall indicate a single lead.
- a physical connection namely a lead or group of leads (data bus) over which analog or digital signals may be sent.
- FIG. 2 is a block diagram of the implantable system 10 and the external equipment
- the leads 17A through 17N from the electrodes 15A through 15N, and the lead 18 from a common electrode 16, are shown connected to both an event detection sub-system 30 and a stimulation sub-system 40. In one embodiment of the invention, it is also envisioned to use the case of the control module 20 of FIG. 1 as the common (or indifferent) electrode 16.
- the leads 17A through 17N carry EEG signals 21A through 21N from the electrodes 15A through 15N to the event detection sub-system 30.
- the electrodes 15A through 15N can be energized by the stimulation sub-system 40 via the leads 17A through 17N to electrically stimulate the patient's GI tract using the stimulation signals 412A through 412N respectively.
- the electrodes 15A through 15N and 16 shown here are connected to both the event detection sub-system 30 and the stimulation sub-system 40, it should be apparent that a separate set of electrodes and associated leads could be used with each sub-system. Furthermore, it is envisioned that any one or more of the electrodes 15A through 15N could be electrically connected (i.e., shorted) to the electrode 16 or to each other. This would be accomplished by appropriate switching circuitry in the stimulation sub-system 40.
- one or more of the leads 17A through 17N could instead be connected to other types of sensors.
- sensors could include temperature sensors, motion sensors (accelerometers) and pressure sensors to sense pressure within a gastrointestinal tract structure or pressure changes caused by expansion or contraction of a gastrointestinal tract structure.
- the event detection sub-system 30 receives neural electrical signals 21A through 21N (referenced to a system ground 19 connected to the lead 18 from the common electrode 16) and processes them to identify gastrointestinal events such as a swallowing.
- a central processing system 50 with a central processor 51 and memory 55 acts to control and coordinate all functions of the implantable system 10.
- a first interconnection 52 is used to transmit programming parameters and instructions to the event detection sub-system 30 from the central processing system 50.
- a second interconnection 53 is used to transmit signals to the central processing system 50 identifying the detection of a neurological event by the event detection sub-system 30.
- the second interconnection 53 is also used to transmit EEG and other related data for storage in the memory 55.
- the central processor 51 can command the stimulation sub-system 40 via a third interconnection 54 to transmit electrical signals to any one or more of the electrodes 15A through 15N via the leads 17A through 17N. It is anticipated that, if appropriate, electrical signals 412A to 412N, inclusive, are transmitted to certain locations along the GI tract, a normal GI tract function can be produced. It may also be necessary for the stimulation subsystem 40 to temporarily disable the event detection sub-system 30 via a fourth interconnection 29 when stimulation is imminent so that the stimulation signals are not inadvertently interpreted as a neurological event by the event detection sub-system 30.
- the stimulation sub-system 40 may also be engaged to perform continuous or periodic stimulation to one or more of the GI tract electrodes 15A through 15N, inclusive. These signals may be used for example to keep the esophageal sphincter closed during stomach food processing or to prevent acid reflux.
- electrical stimulation from the stimulation sub-system 40 can include any of a wide range of frequencies from approximately 2 Hz to approximately 200 Hz. Details of a signal generator capable of generating waveforms over such a frequency range are well known in the art of electronics design.
- a power supply 90 provides power to each component of the system 10.
- Power supplies for comparable implantable devices such as heart pacemakers and heart defibrillators are well known in the art of implantable electronic devices.
- Such a power supply typically utilizes a primary (non-rechargeable) storage battery with an associated d-c to d-c converter to obtain any voltages required for the implantable system 10.
- the power supply could use a rechargeable battery that is charged by means of a coil of wire in the control module 20 that receives energy by magnetic induction from an external coil that is placed outside the patient but in close proximity to the control module 20.
- the implanted coil of wire could also be located remotely from control module 20 but joined to it by electrical leads.
- Such technology is well known from the rechargeable cardiac pacemaker.
- the same pair of coils of wire could be used as inductive transducers to provide power to the implanted system 10 when it is desired to read out stored telemetry, reprogram some portion of the implanted system 10, or replenish a rechargeable battery.
- the central processing system 50 is connected to a data communication sub-system 60, thereby allowing data stored in the memory 55 to be retrieved by the patient's physician via a wireless communication link 72.
- An external data interface 70 can be directly connected to the physician's workstation 80 via a traditional serial data connection 74 (such as an RS-232 interface). Alternately, the serial connection may be made trans-telephonically, via modems 85 and 750 and a phone line 75 from the patient's home to the physician's workstation 80.
- Software in the computer section of the physician's workstation 80 allows the physician to read out a history of events detected by the implantable system 10, including neural signal information, hi a preferred embodiment of the invention, the physician's workstation 80 also allows the physician to specify or alter any programmable parameters of the implantable system 10.
- a buzzer 95 connected to the central processor 51 via a link 92 can be used to notify the patient that a neurological event has occurred, the implanted system 10 is about to deliver stimulation, or that the implanted system 10 is not functioning properly.
- the buzzer could provide a mechanical vibration (typically an acoustic signal) or an electrical stimulation "tickle,” either of which could be perceived by the patient.
- a real time clock 91 is used for timing and synchronizing various portions of the implanted system 10 and also to enable the system to provide the exact date and time corresponding to each neurological event that is detected by the implantable system 10 and recorded in the memory 55.
- a fifth interconnection 96 is used to send data from the central processor 51 to the real time clock 91 in order to set the correct date and time in the clock 91.
- the various interconnections between sub-systems e.g., the illustrated interconnections 29, 52, 53, 54, 56, 57, 92, 93 and 96
- the operation of the system 10 of FIG. 2 for detecting and treating gastrointestinal tract dysfunction would typically be as follows:
- the event detection sub-system 30 continuously processes the signals 21A through 21N carried by the leads 17A through 17N from the N electrodes 15A through 15N.
- the event detection sub-system 30 When an event is detected (e.g. a swallow), the event detection sub-system 30 notifies the central processor 51 via the second interconnection 53 that an event has occurred. 3. The central processor 51 then identifies the appropriate stimulation action and time delay and after the delay triggers the stimulation sub-system 40 via the third interconnection 54 to electrically stimulate the patient's gastrointestinal tract with electrical signals in order to activate appropriate gastrointestinal tract function, using any one, several or all of the electrodes 15 A through 15N. For example, a sequence of sending a signal to electrodes 15Ca and 15D of FIG.
- the stimulation sub-system 40 also sends a signal via the fourth interconnection 29 to the event detection sub-system 30 to disable event detection during stimulation to avoid an undesired input into the event detection sub-system 30.
- the central processor system 50 will store received sensor signals and event related data received from the event detection sub-system 30 via the second interconnection 53 over a time from X minutes before the event to Y minutes after the event for later analysis by the patient's physician.
- the value of X and Y may be set from as little as approximately 0.1 minutes to as long as approximately 2 hours.
- the central processor 51 may generate a "buzz" to notify the patient that an event has occurred and the system is working by sending a signal via the link 92 to the buzzer 95.
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CA002428383A CA2428383A1 (en) | 2000-11-09 | 2001-11-09 | Implantable neuromuscular stimulator for the treatment of gastrointestinal disorders |
EP01992248A EP1331967A2 (en) | 2000-11-09 | 2001-11-09 | Implantable neuromuscular stimulator for the treatment of gastrointestinal disorders |
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US09/710,194 | 2000-11-09 | ||
US09/710,194 US6591137B1 (en) | 2000-11-09 | 2000-11-09 | Implantable neuromuscular stimulator for the treatment of gastrointestinal disorders |
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WO2002038217A3 WO2002038217A3 (en) | 2002-10-31 |
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US6591137B1 (en) | 2003-07-08 |
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