US20170224986A1 - Submucosal gastric implant device and method - Google Patents
Submucosal gastric implant device and method Download PDFInfo
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- US20170224986A1 US20170224986A1 US15/494,313 US201715494313A US2017224986A1 US 20170224986 A1 US20170224986 A1 US 20170224986A1 US 201715494313 A US201715494313 A US 201715494313A US 2017224986 A1 US2017224986 A1 US 2017224986A1
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- 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
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- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0507—Electrodes for the digestive system
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- 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
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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- A61B2017/00238—Type of minimally invasive operation
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
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Abstract
A device, system and method for diagnosing and treating gastric disorders is provided. A submucosal gastric implant device is placed within the submucosal layer of a patient's stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall and may use multiple electrode pairs for sequential stimulation. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a therapeutic delivery device. The implant may be programmed to respond to sensed information or signals. The device may be modular with a portion of the device accessible outside the stomach wall for removal and replacement. An endoscopic delivery system prepares and delivers the functional device through the esophagus and into the stomach where it is placed through an opening in the mucosa into the submucosal layer of the stomach wall. The endoscopic instruments may be used to prepare a cavity in the submucosal layer of the stomach wall and deliver the device to the prepared cavity and if appropriate close the opening in the mucosa.
Description
- This application is a divisional of U.S. patent application Ser. No. 10/109,296, filed Mar. 26, 2002, which claims the benefit of U.S. Provisional Application No. 60/337,194, filed Dec. 6, 2001, and is a continuation-in-part of U.S. patent application Ser. No. 09/847,884, filed May 1, 2001, now U.S. Pat. No. 6,535,764; the full disclosures of which are incorporated herein by reference in their entirety for all purposes.
- This invention relates to an implantable device, a system and a method for electrically stimulating the stomach wall to effect gastric motility or otherwise treat gastrointestinal related disorders. One aspect in particular relates to a device and method for implanting a gastric stimulator in the submucosal layer of the stomach wall. This invention also relates to treating or diagnosing stomach conditions or disorders by implanting a functional device in a submucosal layer of the stomach wall.
- Various organs of the gastrointestinal tract such as the stomach, small intestine and colon contain cells that are believed to govern the organs' periodic contractile behavior. In healthy humans, in certain regions of the organs, these cells generate and propagate rhythmic electrical signals. In general, several types of electrical potential activities have been observed in the gastrointestinal tract. Consistent slow wave or pacesetter potentials have been observed and higher frequency spike activity has been observed. The pacesetter potentials are continuously propagating, relatively low frequency, cyclic depolarizations of the smooth muscle cell lining. The higher frequency spike bursts generally correspond with smooth muscle contractile activity and peristalsis. In general, when the spike burst activity occurs, it appears to be at a fixed time delay with respect to the slow wave potentials. It is believed that when the pacesetter potentials are combined with a chemical or neural excitation of the cells, smooth muscle contractile activity occurs. Also it is believed that the pacesetter potentials control and coordinate the frequency and direction of the contractions.
- Electrical stimulation of the gastrointestinal tract has been proposed to treat motility related disorders and other gastrointestinal diseases or conditions. The electrical stimulation has been proposed in a number of forms, such as, e.g., pacing, electrical contractile stimulation or other stimulation, e.g., to treat nausea or obesity. Electrical pacing of the gastrointestinal tract is generally defined as a periodic electrical stimulation that captures and/or controls the frequency of the pacesetter potential or slow wave activity of the gastrointestinal organ (including in a retrograde direction). Electrical contractile stimulation generally refers to stimulation that directly causes or results in muscular contraction associated with the gastrointestinal tract. In some disease states, dysrhythmias of the gastric pacesetter potentials may be present. The result of the abnormal pacesetter potentials may be gastric retention of food. Electrical stimulation of gastric tissue has been proposed to induce peristalsis. Electrical stimulation has also been proposed to treat obesity by altering gastric motility, or by stimulating neural pathways. For example, one treatment method causes the stomach to retain food for a greater duration. Electrical stimulation has also been proposed to slow the gastric emptying to treat a disorder known as dumping syndrome where the stomach empties at an abnormally high rate into the small intestine causing various gastrointestinal disorders. In particular, electrical pacing of gastric pacesetter potentials has been proposed to induce regular rhythms for the pacesetter potentials with the intent of inducing regular or controlled gastric contractions.
- Within the stomach, at least one pacemaker region has been identified near the interface of the fundus and the corpus along the greater curvature. This region has been one target for gastric pacing. Peristalsis controlled by this region is believed to serve to mix and break down food and propel small particles through the pylorus into the duodenum. It is believed that gastric emptying of liquids is controlled by the fundus. This region is believed to create with characteristic contractions, a pressure gradient between the fundus, pylorus and duodenum that relates to the rate of gastric emptying.
- An early attempt at a gastric stimulation device included an electrode at the end of a nasogastric tube or catheter. The nasogastric tube was passed into the stomach transnasally. Electrical stimulation was applied through the electrode on the end of the tube using an external stimulator unit. The return electrode was placed on the abdomen. This device required a transnasal procedure whenever stimulation was required.
- Other devices used to pace the stomach have generally been implanted by accessing the outside of the stomach through an opening in the abdomen, either through open surgery or laparoscopic surgery. Electrodes have been attached to the stomach wall with attached leads extending through the abdomen.
- These procedures involve implanting a pacemaker device in a subcutaneous or sub-muscular pocket. The devices are anchored into the subcutaneous or sub-muscular pocket initially by a suture anchor and eventually by fibrous tissue ingrowth around the unit. The pacemaker device housing is typically constructed of a titanium or stainless steel material with connectors molded into an epoxy header. The devices are thin in one dimension so that they are less visible when implanted directly under the skin or muscle layer. Therefore, in order to accommodate the necessary battery capacity, the devices are widely shaped, e.g. round or kidney shaped in the other two dimensions. The leads extend from the unit's epoxy header to a stimulation site remote from the pacemaker unit.
- A gastrointestinal pacemaker having phased multi-point stimulation has been proposed with electrodes placed in multiple points around the GI tract including on the inner or outer surface of the stomach. As described, the device could be preprogrammed or include an implantable pacemaker detachably coupled to the multiple electrodes in their various locations, and including an electronic controller that may be programmed by using an external programmer to set stimulation parameters. The implantable pacemaker is located remote from the stimulation sites.
- Some gastric stimulation procedures have proposed electrical stimulation in response to sensing electrical pulses within the stomach within a particular range. Additionally, a device has been proposed to sense electrical parameters to determine the fullness of an organ and the absence of muscular contraction, and to deliver electrical muscular contraction stimulation to the organ in response.
- In general, the currently proposed gastric electrical stimulation procedures are relatively invasive and require accessing the stomach through the abdomen, e.g., in an open or a laparoscopic procedure. The units have relatively wide dimensions in one plane. Accordingly, it would be desirable to provide a less invasive procedure and device for electrically stimulating the stomach. It would also be desirable to provide a device in which various components are accessible for removal or replacement, particularly in a less invasive procedure.
- A machine that places a nylon tag has been proposed for attaching a “payload” to the inner wall of a stomach. The machine places the tag through the stomach wall and back into the stomach in a manner that causes folding of the stomach wall and may cause tissue damage when the smooth muscle of the stomach wall contracts.
- It would therefore be desirable to provide a means and method for implanting, a functional device having therapeutic or diagnostic functions, within the stomach wall, so that the stomach wall is protected from damage from mechanical stresses and forces due to the attachment of the stimulator device. It would further be desirable to employ such a device and method that at the same time protect the functional device from the stomach's corrosive environment, or churning or grinding forces, and peristaltic movement, typical when food is digested and passed out of the stomach into the intestinal tract.
- The present invention provides a device, system and method for diagnosing and treating gastric conditions or disorders. According to one embodiment of the invention, a functional device is implanted in the submucosal layer of the stomach wall. The functional device may have one or more therapeutic or diagnostic functions. For example, therapeutic functions may include delivering medication or gene therapy treatment, electrical stimulation of a muscle layer of the stomach wall or associated nerves of the stomach; and diagnostic functions may include sensing electrical parameters, pressure, movement, temperature, utilizing diagnostic ultrasound with an acoustic transducer, or measuring other parameters to determine conditions of the stomach or effectiveness of treatment such as electrical stimulation.
- An externally transmitted telemetric signal may be used to actuate treatment. For example, the release of the medication or other substance may be actuated by an external RF signal received by electronics in the device housing. Sensed diagnostic information may also be transmitted from the implanted device to an external receiver/controller that may record or evaluate the sensed information.
- The present invention further provides a method of implanting such a device in the stomach wall. According to one embodiment, at least a portion of the functional device is implanted into the submucosal layer of the stomach wall.
- The stomach wall may be accessed in an endoscopic, laparoscopic or open surgical procedure wherein an opening is made in the stomach wall and the implant is placed through the opening into the submucosal layer. In one variation, a pocket is formed in the stomach wall and the submucosal layer is dissected. The implant is then placed within the submucosal layer. In one embodiment, endoscopic instruments are used to access the stomach wall through the patient's esophagus.
- The present invention further provides a device, system and method for gastric electrical stimulation. Electrical stimulation is generally defined herein to mean any application of an electrical signal or of an electromagnetic field to tissue of the stomach for a therapeutic or diagnostic purpose. In one embodiment, an electrical stimulation signal entrains a slow wave signal of the stomach smooth muscle that is clinically absent, weak or of an undesirable frequency or repetition rate, is sporadic or otherwise not optimal. Also the stimulator may be designed to trigger the spike burst electrical activity of the smooth muscle associated with smooth muscle contractions. The signals may also be designed to inhibit smooth muscle pacing potentials to reduce smooth muscle contractions. The signals may also be designed to disrupt the natural waveform and effectively alter the existing or inherent pacing. The stimulator may also be designed to affect nerves associated with the stomach. In one variation, the device is designed to facilitate or expedite mixing or breaking down of food matter or liquids in the stomach. In another variation, the device is designed to control, facilitate or expedite movement of food matter or liquids through the stomach and into the small intestine. In another variation, the device is designed to stimulate the stomach to delay passage of food from the stomach and into the small intestine. Other stimulation effects are also contemplated, including but not limited to using stimulation to treat nausea, obesity or pain symptoms. The stimulation may affect the smooth muscle contractions and/or nerves associated with the stomach.
- The stimulation electrodes provide stimulation either by way of a preprogrammed pulse generator or one that is programmed or revised when the device is implanted in the stomach, e.g. based on sensed parameters or response to stimulation and/or to optimize various parameters, e.g., impedance, current density, etc. The stimulator is preferably provided with RF or other signal transmission and reception capabilities. The signal transmission capabilities may be used for telemetric communication between the stimulator and an external device, e.g. to communicate data to the external device or to receive additional programming information, command signals or stimulation signals from the external device. The stimulator may also combine the electrical stimulation feature with other therapeutic or diagnostic functions such as, e.g., drug delivery.
- The stimulating device of the present invention resides within the submucosal layer, between the muscle layer (comprising several muscle layers, i.e., the oblique, circular and longitudinal layers) and mucosal layer of a patient's stomach wall. One embodiment of the device includes: an electronics unit containing the electronic circuitry of the device with at least one stimulating electrode that when implanted is in electrical contact with a muscle layer of the stomach wall. One or more stimulating electrodes may be located on the electronics unit housing or may be otherwise coupled to the housing and located within the submucosal layer. The housing may be implanted in the submucosa and electrodes coupled to the housing may be deployed from within the submucosa into contact with the muscle layer. Alternatively a housing may be removably attached to the stomach wall and removably connected to an electrode portion implanted in the stomach wall. The housing thus may be exchanged while the electrode portion remains implanted in the stomach wall, e.g. when the batteries need replacement. The stimulation is provided through at least one stimulating electrode and preferably through at least one pair of bipolar electrodes. Alternatively a remote return electrode may be provided in a monopolar device. The stimulator device may be powered by a battery included with the device or may be inductively powered, e.g. by an external source.
- Various means for maintaining the electrodes in position, i.e., with respect to the muscle layer may be provided as well. Such other means may include for example, anchors, sutures, anti-rotation mechanisms and device shape design.
- The stimulation device is constructed of a size and shape such that it can be deployed through the mouth and esophagus with the A/C of an endoscope. As such, the stimulator is of a generally small profile when delivered to the implant site. It is preferred that the implant be constructed and/or implanted so that the electrode predictably maintains electrical contact with a muscle layer of the stomach wall. Accordingly, the device may be constructed of a configuration or shape that prevents device rotation, or may be constructed so that device rotation or movement does not interfere with the electrode/muscle layer contact.
- One aspect of the invention may include a means for maintaining the device in proper orientation so that the electrodes, sensors or other transducers on the device maintain contact with a preferred area or layer of the stomach wall, i.e., so that the electrodes, sensors or other transducers are preferentially facing a desired wall within a submucosal space, e.g. a muscle layer. An anti-rotation means may be provided that prevents rotation of the implant around axes that would move electrodes, sensors or transducers away from intimate contact with a desired area of the stomach wall, such as, e.g., a muscle layer or mucosal layer.
- The shape of the implant, may, for example, have a broad aspect when viewing that side of the device intended to be in contact with a particular layer of the stomach wall (e.g., a muscle layer or mucosal layer); i.e., the top-view of the device has relatively large length and width dimensions with respect to the height dimension of the device given by its side-views.
- In one embodiment, the aspect ratio of the device, defined as the width of a side-view divided by the height of the device is larger than about 1, preferably larger than about 1.4 and more preferably larger than about 1.8.
- In an alternative embodiment, an anti-rotation means may be provided that prevents rotation of the implant about an axis parallel to an intended tissue plane of contact. A device in one variation is dimensioned so that the aspect ratio of the device viewed along an axis parallel to the intended plane of contact is greater than one and preferably greater than 1.4 and more preferably greater than 1.8. The aspect ratio as used herein is the width to height ratio of the aspect viewed along a particular axis. In another variation, the anti-rotation device comprises and extendible or expandable portion or member that extends into a position that prevents rotation of the electrodes away from contact with the muscle layer.
- In another embodiment, an anti-rotation means may be provided that prevents rotation of the implant about an axis parallel to a common plane on which the pair of surface stimulating electrodes lie. Accordingly, a device in such embodiment is dimensioned so that the aspect ratio of the device viewed along an axis parallel to plane on which a pair of surface stimulating electrodes lie is greater than one and preferably greater than 1.4 and more preferably greater than 1.8. The width in this particular embodiment may be defined by a plane on which a pair of surface stimulating electrodes lies.
- The implant may have a relatively small profile when implanted and may be altered to have a different shape when implanted, to prevent rotation and/or provide optimal sensor/transducer/electrode contact with the stomach wall layer, e.g., a mucosal or muscle layer.
- The surface of the implant may be designed to promote encapsulation or tissue ingrowth, e.g. by choice of material, coatings or surface texture. It may be desirable to provide tissue ingrowth at or near the electrodes to ensure good contact between the electrodes and the tissue to be stimulated. Such encapsulation or tissue ingrowth may help prevent movement of the implant and in particular, a rotational movement in which the contact between the electrodes and stomach muscle layer may be lost. Thus the electrodes or surrounding area may be coated with a material such as P-15, which is a commercially available compound that promotes cellular adhesion and tissue ingrowth.
- The device or portions of the device may be constructed of or coated with substances that promote or inhibit tissue ingrowth. For example, it may be desirable to inhibit tissue ingrowth in general so that the device may be easily explanted. Thus, the implant may be coated with or constructed of a material that inhibits such tissue ingrowth.
- The device components are constructed of biocompatible materials that allow it to remain in the environment of the stomach within the stomach wall for the life of the device, e.g., several weeks, months or more. The housing of the electronics unit or shell may be constructed with medical grade titanium, tantalum or alloys of these metals. Alternatively, the housing may also be constructed out of suitable inert polymers, for example, from the polyolefin family, e.g., HDPE (high density polyethylene), PP (polypropylene), UHMWPE (ultra high molecular weight polyethylene), or fluoropolymer such as PTFE (polytetrafluoroethylene) FEP (fluorinated ethylene propylene) and other members. PMP (polymethylpentene), polysulfone, PMMA (polymethylmethacrylate) may also be used. Softer materials may be used, such as, e.g., silicones, C-Flex™, polyurethanes, co-polymer nylons (e.g. PEBAX).
- The electrodes are preferably made of corrosion resistant metals and alloys such as, e.g. platinum, iridium, gold, tantalum, titanium, stainless steel or alloys of one or more of these metals, e.g., a platinum/iridium alloy. The electrodes may be mounted directly on the housing or placed on a flexible tail or tether. Electrodes are preferably coupled to the electronic circuitry through sealed electrical contacts or through leads extending into the housing through molded corrosion resistant materials such as those described above.
- A preferred system of the present invention includes an endoscopic delivery system for delivering the stimulator through the esophagus and into the stomach where it is implanted in the stomach wall. The electronics unit is deployed by first identifying a site for implantation, then preparing an opening in the mucosa to access the submucosal layer for implanting the device, then placing the device through the opening into the submucosal layer and then if desired or necessary, closing the cavity. According to one variation, after preparing the opening in the mucosal layer, a pocket or cavity is prepared in the submucosal layer to receive the device.
- An endoscope and associated instruments are used to prepare the selected site in the stomach wall, for implanting a stimulator. A knife, needle or cutting instrument may be used to prepare an opening in the mucosa to access the submucosal layer. According to one embodiment, a material or solution is injected into the site for implanting the device, to form a bleb or blister in the submucosal layer. The material or solution may also break down some of the submucosal tissue to form a pocket. Alternatively or additionally, a tissue dissector may be used to prepare a cavity. The tissue dissector may be a blunt dissector, for example, a blunt tool, an expandable compliant or non-compliant balloon, or another mechanically expanding device, or a cutting blade. The dissector may also be a device using an energy source to break down or cut tissue such as an electrosurgical cutting or coagulating device, or an ultrasonic or laser device.
- The system further includes an endoscopic instrument or instruments for delivering the stimulator to the prepared cavity and, if desired or necessary, for closing the cavity. The instruments for delivering the stimulator may include means for determining the rotational orientation of the implant so that the electrodes can be placed in a position interfacing and in contact with a muscle layer of the stomach wall. Stabilizing instruments may be provided to stabilize the endoscope and associated instruments and/or to stabilize or grasp the stomach wall or tissue during preparation of the cavity for implantation of the stimulator. A further aspect of the invention provides instruments and mechanisms for closing the opening in the mucosal layer of the stomach wall after implanting the stimulator in the submucosa.
- One embodiment of the system includes a flexible endoscope or endoscopic instrument, for locating a preferred site in the stomach for device attachment. In one embodiment, the endoscope or endoscopic instrument comprises electrodes that may be placed on the inside of the stomach wall to measure electrical activity or impedance, or to deliver test stimulation pulses to identify optimal stimulation parameters or locations
- In addition to the device being capable of stimulating the stomach wall, the electrodes of the device may also be used for diagnostic purposes. For example, the electrodes may be used to sense and observe electrical activity in the stomach wall. Such sensing may be used over time to identify patterns, diagnose diseases and evaluate effectiveness of various treatment protocols. For example irregular or lack of EMG or EGG (electrogastrogram) activity may be sensed. Stimulation may be provided in response to sensed EMG or EGG activity or lack of activity.
- In one variation, sensors can be included in the device or separately for sensing various parameters of the stomach. The sensors may be mounted on the stimulator housing, or by other means, for example, in an independently attached device for example attached with an anchor or within the submucosa. The stimulation device may include a mechanical sensor that senses, for example, stomach wall contractions. In one embodiment a device implanted in the stomach wall includes a pressure sensor that is arranged to measure pressure change due to contractions of surrounding tissue. Alternatively, electrical sensors may detect changes in impedance due to changes in wall thickness from smooth muscle contractions. Other examples of such sensors may include, for example, pH sensors, impedance sensors, pressure sensors, strain gauges, and temperature measuring devices such as a thermocouple.
- The stimulation device may be programmed to deliver stimulation in response to sensing electrical parameters or other sensed parameters. The device may also be user controlled, where the recipient of the device or treating practitioner is able to externally activate the device, for example by using an external unit which delivers a control signal via telemetry. A temperature sensor may be used, for example, to determine when food has been ingested, by a change in temperature. The device may begin stimulating the stomach upon detecting sudden change in temperature. Pressure sensors may be used to sense motility patterns, e.g. presence, strength or frequency of contractions. Mean pressure shifts may be observed to identify fundal contractility. The stimulation device may also use sensed parameters to program or reprogram the device stimulation program. For example, by measuring impedance changes through a circuit coupled to the electrodes (e.g., delivering a constant current or voltage across the electrodes to determine impedance) or determining the contractile behavior of the stomach using a strain gauge, in response to stimulation pulses, the effectiveness of the stimulation pulses may be monitored and adjusted to provide optimal response. The stimulation program may also include an automatic adjustment in response to changes in pressure measurement.
- An alternative feature of the invention may provide multiple pairs of stimulation electrodes at different points on the stomach wall, The electrode pairs may be on a single device such that they are in communication with each other by way of electrical connectors such as wires, etc. The multiple electrode pairs may be on individual devices separately implanted, whereby a first device, i.e., a master, delivers a first set of stimulation pulses. Slave devices, sensing the first stimulation pulses, follow with additional stimulation pulses at the different points in the stomach. The slave devices may respond after sensing a first stimulation pulse or in response to a sensed parameter indicating that the first stimulation pulses have been effectively delivered (e.g., changes in pressure, contractions of the stomach, or propagated depolarization signals etc.) The slave devices may be programmed to provide stimulation or alter their stimulation protocols based on the presence, absence or a measured parameter of the first stimulation pulse sensed by the slave device. The slave device may also be programmed to provide stimulation or alter their stimulation protocols based on the sensed degree of response from the first stimulation pulses by the master device, for example, by sensing the degree of muscle contraction or a resulting depolarization induced by the pacing pulse or a resulting inherent pulse generated by the stomach wall. (as opposed to the original stimulation signal). The implanted devices may be capable of being either a master or slave device. The implant's function may be selected after the device has been implanted, to provide a number of possible configurations.
- Embodiments of various aspects of the invention are described in the following detailed description.
-
FIG. 1A is a partial cross sectional view of a system of a first embodiment of the present invention in use in placing an electric stimulator in a patient's stomach wall. -
FIG. 1B is an enlarged partial cross section of the stimulator ofFIG. 1A implanted in the submucosal layer of a stomach wall. -
FIG. 2A is a top view of a first embodiment a functional device of the invention. -
FIG. 2B is a side view of the functional device ofFIG. 2A . -
FIG. 3 is a perspective view of a second embodiment of a functional device of the present invention. -
FIG. 4 is a perspective view of a third embodiment of a functional device of the present invention. -
FIG. 5A is a perspective view of a fourth embodiment of a functional device in a configuration for delivery. -
FIG. 5B is a perspective view of the functional device ofFIG. 5A in an open position with an instrument for opening the functional device. -
FIG. 5C is a cross-sectional view of the functional device ofFIG. 5B with the cross section taken along thelines 5C-5C. -
FIG. 5D illustrates an instrument to be used in accordance with the embodiment ofFIGS. 5A-C . -
FIG. 5E is an end view of the functional device ofFIG. 5B in its open position with the electrodes adjacent to an implant wall. -
FIG. 5F is a side view of the functional device ofFIG. 5B in its open position with the electrodes adjacent to an implant wall. -
FIG. 5G is a perspective view of a stomach wall with an intended plane of tissue contact and the functional device ofFIG. 5A in an open position illustrating a plane defined by electrodes on the device and various axes of potential rotation.FIG. 6A illustrates a fifth embodiment of a functional device in a first position within a sleeve and coupled to an endoscope for delivery. -
FIG. 6B illustrates the functional device and endoscope ofFIG. 6A after the functional device has been deployed within a submucosal pocket. -
FIG. 6C illustrates the functional device and endoscope ofFIG. 6B after the functional device has been deployed within a submucosal pocket and is disengaged from the endoscope. -
FIG. 7 illustrates a cross section of a sixth embodiment of a functional device of the present invention comprising a therapeutic agent delivery mechanism for implanting in the submucosal layer of the stomach wall. -
FIG. 8 is a perspective view of a seventh embodiment of a functional device of the present invention wherein the functional device has multiple electrode pairs. -
FIG. 9A illustrates an eighth embodiment of a functional device of the present invention wherein the stimulator has multiple electrode pairs. -
FIG. 9B illustrates a side partial cross sectional view of the implant ofFIG. 9A as it is being implanted in a submucosal pocket. -
FIG. 9C illustrates a side partial cross sectional view of the implant ofFIG. 9A in place in the submucosal pocket. -
FIG. 10A illustrates a ninth embodiment of a functional device of the present invention in which the device has multiple electrode pairs. -
FIG. 10B illustrates an enlarged view of the electrical connector between the housing and the elongate member or the stimulator illustrated inFIG. 10A -
FIG. 11 is a partial cross section of a master/slave arrangement of stimulators implanted in a stomach wall. -
FIG. 12 illustrates a cross section of a stimulator showing exemplary electrical connections between the electronic circuitry and the surface electrodes of the stimulator. -
FIG. 13 illustrates a schematic diagram of the circuit of an electronic stimulator of the present invention. -
FIG. 14 illustrates a schematic diagram of the circuit of a programmer/recorder of the present invention. -
FIGS. 15A and 15B illustrate exemplary stimulation waveforms that may be delivered according to the invention. -
FIGS. 16A and 16B illustrate endoscopic instruments used to prepare a bleb in the submucosal layer of the stomach wall. -
FIGS. 17A-17G are side partial cross sectional views of an embodiment of the invention in which a balloon is used to prepare a pocket in the submucosal layer for receiving a submucosal implant. -
FIGS. 18A-18E are side partial cross sectional views of another embodiment of the invention in which a balloon is used to prepare a pocket in the submucosal layer for receiving a submucosal implant. -
FIGS. 19A and 19B are side partial cross sectional views of another embodiment of the invention in which a balloon is used to prepare a pocket in the submucosal layer for receiving a submucosal implant. -
FIGS. 20A-20H are side partial cross sectional views of another embodiment of the invention in which a balloon is used to prepare a pocket in the submucosal layer for receiving a submucosal implant, wherein the method and device include using a guidewire device and method for locating a guidewire within the submucosal layer of the stomach wall. -
FIG. 21A is a perspective view of a distal end of a blunt dissection device used to prepare a cavity in the submucosal layer of the stomach wall. -
FIG. 21B is a side partial cross sectional view of a cutting instrument preparing an opening in the mucosal layer of the stomach wall. -
FIG. 21C is a side partial cross sectional view of the blunt dissector ofFIG. 21A in use in preparing a cavity in the submucosal layer of the stomach wall. -
FIG. 22 illustrates an exploded perspective view of the distal end of a modular blunt dissector/endoscope. -
FIG. 23A is a perspective view of a distal end of an endoscopic dissecting instrument in accordance with an embodiment of the invention. -
FIG. 23B is a side view of the dissecting instrument ofFIG. 23A in a closed position. -
FIG. 23C is a side view of the dissecting instrument ofFIG. 23A in an open position. -
FIG. 24A is a side view of a dissecting instrument in accordance with another embodiment in a closed position. -
FIG. 24B is a side view of the dissecting instrument ofFIG. 24A in an open position. -
FIG. 25A is a side view of a dissecting instrument in accordance with another embodiment in a closed position. -
FIG. 25B is a side view of the dissecting instrument ofFIG. 25A in an open position. -
FIG. 26A is a perspective view of an electrosurgical dissecting instrument in accordance with an embodiment of the invention. -
FIG. 26B is a top cross-sectional view of the instrument ofFIG. 26A along theline 26B-26B. -
FIGS. 27A-27E are side partial cross sectional views of a knife and the dissector ofFIGS. 26A-B in use in preparing a pocket in the submucosal layer of the stomach wall. -
FIG. 28A is a perspective view of the distal end of an endoscope and stabilization device of the invention. -
FIG. 28B is a side partial cross sectional view of the endoscope and stabilization device ofFIG. 28A in use in preparing a pocket in the stomach wall. -
FIG. 29 illustrates a side partial cross-sectional view of a distal end of an alternative embodiment of an endoscope stabilization device and delivery device in use in placing a stimulator of the present invention within the submucosa of the stomach wall. -
FIG. 30 illustrates a side partial cross-sectional view of the distal end of another embodiment of an endoscope, and stabilization and delivery devices in use in placing a stimulator of the present invention within the submucosa of the stomach wall. -
FIGS. 31A-31D illustrate side partial cross sectional views of a delivery device placing a stimulator of the present invention within the submucosa of the stomach wall. -
FIG. 31E is a perspective view of the implant ofFIGS. 31A-D .FIG. 31F is a perspective view of an alternative implant for use in the method described with respect toFIGS. 31A-D -
FIGS. 32A-D illustrate side cross sectional views of an incision closure device of the present invention in which the opening in the stomach wall for device placement is closed. -
FIGS. 33A-E illustrate side partial cross sectional views of a wound closure device in use in a method for closing the opening formed in the stomach wall. -
FIGS. 34A-C illustrate side perspective and side partial cross sectional views of another wound closure device and method for closing the opening formed in the stomach wall. -
FIG. 35 is a side view of a tissue welding instrument in use according to an embodiment of the invention. -
FIG. 36A is a side view of an endoscope to be used according to the present invention. -
FIG. 36B is a front view of the distal end of an endoscope to be used according to the present invention. -
FIG. 37 illustrates a side partial cross sectional view of another wound closure device and method for closing the opening formed in the stomach wall. - Referring to
FIGS. 1A and 1B , astimulator 10 is illustrated implanted in thestomach wall 104 of thestomach 100. Thestimulator 10 lies within the submucosal layer oftissue 104 b between themucosal layer 104 a and themuscle layer 104 c. Themuscle layer 104 c comprises oblique, circular and longitudinal muscle layers. - According to one embodiment of a method of the invention, an endoscope and associated instruments are used implant a functional device in a submucosal layer of the stomach wall. An opening is formed in the mucosal layer to access the submucosal layer and the functional device is implanted through the opening into the submucosal layer. In one embodiment, the instruments are used to prepare a cavity or pocket in the submucosal layer at the selected site of the stomach wall, for implanting a functional device. In one embodiment, a bleb or blister is first formed in the submucosal layer of the stomach wall. A pocket is then formed in the bleb by dissecting the connective tissue of the submucosal layer. A stimulator device is then placed in the submucosal pocket so that stimulation electrodes are in electrical contact with a muscle layer of the stomach wall, i.e., one or more of the various muscle layers. If desired, the opening formed in the mucosal wall when accessing the submucosal layer, is then closed so that it may heal, enclosing the implant in the submucosal pocket. Various embodiments of the method for implanting a functional device in the submucosal layer of the stomach wall will be evident from the description of the implants and instruments below.
- As illustrated in
FIG. 1A , to implant the device in the stomach, anendoscope 110 is used with various instruments as will be described in more detail below. Aflexible endoscope 110 is used to locate animplantation site 105 within thestomach 100 and implant thestimulator device 10 at thesite 105 within thestomach wall 104 of a patient. Theflexible endoscope 110 may be of the type that is typically used by gastroenterologists in treating the upper gastrointestinal tract and in accessing the esophagus or stomach. The endoscope allows the physician to visualize while performing procedures on the upper gastrointestinal tract. The flexible endoscope may be, for example, a flexible fiber optic endoscope utilizing optic fibers for imaging or a video endoscope that uses a CCD (charge coupled device) to provide video images. Such endoscopes typically include a fiber optic light guide and a complex objective lens at the distal end to focus the image. - As illustrated in
FIGS. 36A-36B , theendoscope 110 comprises an elongate tube having aproximal handle portion 106 and adistal portion 115. The endoscope includes an aspiration/instrument channel 112 and irrigation/air channel 113. The aspiration/instrument channel 112 may be used for instruments if not otherwise required in a procedure. The aspiration/instrument channel 112 extends through theendoscope 110 and provides an opening through which surgical instruments may be inserted to reach thesite 105. The instruments described with respect to the various embodiments herein may be introduced through the aspiration/instrument channel 112, through an opening in an overtube, or alternatively, the instrument may be inserted alongside of theendoscope 110, for example in an attached guide or sheath. Fiber opticlight sources 93 for illuminating the stomach site, extend through a fiber optic channel. Avideo lens 94 is located at the distal end of the endoscope, for receiving and focusing the image that is transmitted back through a channel in theendoscope 110. Correspondingvideo output 96,ports 98 for light source input, irrigation, and aspiration andport 99 for instruments, are located on theproximal handle portion 106.Knobs proximal handle 106 for left/right and up/down steering mechanisms, respectively, that are used to steer the distal portion of the endoscope in a manner that is generally known to one of ordinary skill in the art. Thedistal portion 115 of theendoscope 110 includes a steerabledistal end 117. - During the procedure the patient is given a numbing agent that helps to prevent gagging. As shown in
FIG. 1A , theendoscope 110 is passed through themouth 101,pharynx 102, into theesophagus 103 and into thestomach 100. If desired, an overtube may be used to protect the esophagus, which may become irritated with repeated insertion and removal of instruments. The overtube may also help prevent instruments and devices from inadvertently dropping into the trachea. In addition, an overtube may serve to protect the tools from the bacteria in the mouth and esophagus so that such bacteria are not passed on to the stomach wall. The overtube may also include additional channels for inserting additional instruments. As an alternative to an overtube, additional instruments may be attached to the outside of the endoscope and inserted through the esophagus. - Preferably the instruments inserted into the patient's stomach are coated with an antibacterial material, in particular, the instruments that are used to pierce or otherwise come in contact with the stomach wall. As illustrated in
FIG. 1A theendoscope 110 is extended into thestomach 100 to asite 105 in thestomach 100 at which thestimulator 10 is being implanted. Additionally or alternatively, an endoscope or a tool inserted through the esophagus may be used to detect intrinsic gastric electrical activity to help pinpoint the optimal site for a stimulator and/or electrode implantation in the stomach wall. In such a case, sensing electrodes are coupled to the distal end of the endoscope or tool, with conductors extending out of the endoscope or patient's esophagus to a unit having a controller for receiving sensed electrical activity and identifying a surgical site for stimulator implantation. - Referring to
FIGS. 2A-2B , astimulator 10 of a first embodiment is illustrated. Thestimulator 10 is constructed in a disc-like shape. Thestimulator 10 comprises ahousing 20 having a relatively flat, broadtop surface 21 withsurface electrodes sensor 13 located thereon. The diameter d of the top surface is greater in comparison to the height h of the side (FIG. 2B ) of thestimulator 10. The disc shape maintains the device in proper orientation so that theelectrodes muscle layer 104 c of thestomach wall 104.FIG. 2B illustrates anaspect 15 of all side views of thestimulator 10. The aspect ratio of theaspect 15 is the width of the side view (diameter d) divided by the height h of the side view, and is greater than about one, preferably greater than about 1.4 and more preferably greater than about 1.8. - When implanted the
electrodes muscle layer 104 c of thestomach wall 104. Thestimulator 10 includes a battery 144 (FIGS. 12 and 13 ) and electronic circuitry 25 (FIGS. 12 and 13 ) coupled to theelectrodes sensor 13. Theelectronic circuitry 25 andbattery 144 provide stimulating electronic pulses through theelectrodes housing 20 may also include a radiopaque marker 27 (e.g., sprayed onto a location in the housing 20) so that the device may be appropriately oriented when implanted, and so that its location and orientation may be identified after it has been implanted. - The
housing 20 of thestimulator 10 is preferably constructed of a saline corrosion resistant material such as a medical grade titanium, tantalum or alloys of these or other metals. Alternatively, the housing may also be constructed out of suitable inert polymers, for example, from the polyolefin family, e.g., HDPE (high density polyethylene) PP (polypropylene), UHMWPE (ultra high molecular weight polyethylene), or fluoropolymer such as PTFE (polytetrafluoroethylene) FEP (fluorinated ethylene propylene) and other members. PMP (polymethylpentene), polysulfone, PMMA (polymethylmethacrylate) may also be used. The surface of thehousing 20 is preferably coated with an antibiotic material, such as gentamicin or silver/silver salts coating. Theelectrodes -
FIG. 3 illustrates a cylindrical shapedimplantable stimulator 30 with rounded edges and comprising ahousing 34 havingelectrodes sensor 33 located thereon. The cylindrical shape permits relatively easy delivery through the esophagus and into the stomach and implantation into the stomach wall due to its narrow geometry. The rounded configuration prevents damage to the stomach wall when implanted.Battery 144 andelectronic circuitry 25 are included in thehousing 34 to provide stimulation pulses, sensing and telemetric communication as described herein with reference toFIGS. 13 and 14 . -
FIG. 4 illustrates a cylindrically shapedimplant 35 comprising ahousing 36 withring electrodes sensor 39 located thereon. The cylindrical shape permits relatively easy delivery into the stomach and implantation into the stomach wall due to its narrow geometry. Thering electrodes cylindrical housing 36. Theelectrodes sensor 39 are coupled toelectronic circuitry 25 andbatteries 144 to provide stimulation pulses, sensing and telemetric communication as described herein with reference toFIGS. 13 and 14 . -
FIGS. 5A-G illustrate an alternative embodiment of the invention in which the implant's shape may be altered after implanting. According to this embodiment, once the device is implanted the shape is changed from having a relatively low profile or aspect ratio that permits introduction through the esophagus, to a relatively higher profile or aspect ratio for preventing device rotation within the submucosal pocket. Theimplant 40 comprises ahousing 44 with anelectrode pair sensor 43 located on thehousing 44. Theelectrode pair sensor 43 are coupled toelectronic circuitry 25 and abattery 144 for sensing, stimulation and telemetry as described herein with reference toFIGS. 13 and 14 .FIG. 5A illustrates theimplant 40 in a first and closed position andFIGS. 5B, 5C, 5E, 5F and 5G illustrate theimplant 40 in a second and open position. - The
housing 44 comprises twohalves battery 144 andelectronic circuitry 25. In the implant's first position, twohalves halves opening 48 in thehousing 44 provides access for a magnetic hexkey instrument 49. The hexkey instrument 49 comprises concentric inner hex key 49 a andouter hex key 49 b that rotate with respect to each other. Theopening 48 in the housing ends in an inner hex opening 48 a for receiving the inner hex key 49 a to stabilize theimplant 40, and an outer hex opening 48 b for receiving theouter hex key 49 b for rotating thepinion wheel 46. Thepinion wheel 46 engagesracks 47 so that when thepinion wheel 46 is rotated, thehalves - In the first position, the implant has a relatively small profile that enables passing the implant into the stomach through the narrow esophagus. In this first position, the implant has a relatively small aspect when viewing its side view along
axis 40 b. This small aspect enables passing the implant through the esophagus. Once theimplant 40 is placed within the stomach at astimulation site 105 with the electrodes in contact with a desired portion of thestomach wall 104, theimplant 40 is expanded to provide a geometry increasing the aspect ratio of the side-view of the device viewed alongaxis 40 b (FIG. 5E ) and by doing so, preventing rotation aboutaxis 40 b (FIG. 5G ) and maintaining electrode contact with the desired portion of thestomach wall 104. The aspect ratio from the vantage of eitheraxis 40 a oraxis 40 b is greater than 1, preferable greater than about 1.4, and more preferably greater than about 1.8. - The
muscle wall layer 104 c of thestomach wall 104 defines at least one plane p1 on which an intended area of electrode contact lies. Theaxis 40 a is parallel to the plane p1. Also theaxis 40 b is parallel to the plane p1. Thus the aspect ratio of the aspect viewed from theaxis 40 a (FIG. 5F ) and the aspect ratio of the aspect viewed from theaxis 40 b (FIG. 5E ) are sufficiently large to prevent rotation about either of theaxes FIG. 5G ), and away from a position of intimate electrode contact with themuscle layer 104 c within the submucosal pocket into which the stimulator orimplant 40 is implanted. - The electrodes define at least one plane p2 (
FIG. 5G ) that may provide contact area for contacting themuscle layer 104 c of thestomach wall 104. Theaxis 40 a is parallel to the plane p2. Also theaxis 40 b is parallel to the plane p2. Thus the aspect ratio of the aspect viewed from theaxis 40 a (FIG. 5F ) and the aspect ratio of the aspect viewed from theaxis 40 b (FIG. 5E ) are sufficiently large to prevent rotation about either of theaxes muscle layer 104 c within the submucosal pocket into which the stimulator orimplant 40 is implanted. The aspect ratio in either of these variations, from the vantage of eitheraxis 40 a oraxis 40 b, is greater than one, preferable greater than about 1.4, and more preferably greater than about 1.8. -
FIGS. 6A-C illustrate another embodiment of the invention in which the implant's shape may be altered after implanting. Animplant 50 comprises acylindrical housing 54 with a pair ofwings 55 folded around thecylindrical housing 54 in a first position (FIG. 6A ) in which the implant has a relatively small profile that enables passing theimplant 50 into the stomach through the narrow esophagus. Theimplant 50 in a second position (FIGS. 6B and 6C ) has itswings 55 unfolded to expose theelectrodes sensor 53 located on thehousing 54. The unfoldedwings 55 provide a means for preventing rotation of theimplant 50 within the submucosal pocket into which it is implanted. Thewings 55 are preferably made of a biocompatible elastic material such as, e.g., silicone, polyurethane, etc., and are bonded to thecylindrical housing 54. -
FIG. 6A illustrates theimplant 50 in its first position as it is inserted through an esophagus into a patient's stomach. Aninstrument 56 for grasping or holding theimplant 50 is inserted through thechannel 112 in theendoscope 110 with agrasper 57 at its distal end for grasping aknob 59 on thecylindrical implant 50 to grasp or hold theimplant 50. Atransparent sleeve 58 is placed over the distal end of theendoscope 110. Theimplant 50 is initially located within thetransparent sleeve 58 in its first position with thewings 55 folded. Thetransparent sleeve 58 is placed in the submucosal pocket where theimplant 50 is to be placed. Theinstrument 56 is rotated so that theelectrodes muscle layer 104 c adjacent the submucosa. The location of theimplant 50 with respect to the stomach wall may be visualized through theendoscope 110 through thetransparent sleeve 58. Theimplant 50 may also have a mark that enables the determination of the orientation of theimplant 50 observed through theendoscope 110. Once in place, the graspinginstrument 56 is advanced out of theendoscope 110 to extend theimplant 50 from thetransparent sleeve 58 at which time theelastic wings 55 expand, extend and open in place within the submucosal pocket (FIG. 6B ). Theanti-rotation wings 55 maintain theelectrodes FIG. 6C , once theimplant 50 is in place, thegrasper 57 releases theimplant 50 and theinstrument 56 is removed. -
FIG. 7 illustrates an alternatefunctional device 120 of the present invention for implanting in the submucosal layer of the stomach where the functional device comprises a drug or therapeutic agent delivery mechanism. Thedevice 120 includes ahousing 123 having abattery 144 andelectronic circuitry 25. Theelectronic circuitry 25 is coupled to adrug reservoir 121 and pump 122 for delivering a drug through anoutlet port 127 in thehousing 123. Atubular wall 125 provides aconduit 126 from thereservoir 121 to theoutlet port 127. Thereservoir 121 is configured to hold a plurality of doses of a therapeutic agent that may be released according to a regimen or may be released continuously over time. Theoutlet port 127 opens into the submucosal layer when thedevice 120 is implanted. The supply of the therapeutic agent may also be replenished after the therapeutic agent has been depleted, for example, by delivering the substance through theoutlet port 127 or other port into thereservoir 121, e.g., with a flexible endoscopic or laparoscopic micro-cannula. Asensor 128 on thehousing 123 is coupled to theelectronic circuit 25 and may be used to sense various parameters of the stomach or stomach wall, e.g., as described with respect to various embodiments herein. - In use, the
electronic circuitry 25 controls the action of thepump 122 by delivering a control signal throughconnectors 129 coupling theelectronic circuitry 25 to thedrug pump 122. Theelectronic circuitry 25 may be preprogrammed to control drug or substance delivery according to a certain regimen or protocol, typically over a prescribed treatment duration. Theelectronic circuitry 25 may determine the timing and amount of drug to be delivered based on such a preprogrammed regimen stored in memory in thecircuitry 25. Alternatively, the programs may be altered based conditions sensed by the sensor or other diagnostic information. The program may be telemetrically communicated to theelectronic circuitry 25 by way of an external controller. Also the parameters of the drug delivery or the control of the delivery itself may be actuated by an external control signal or by an external controller. When a control signal from the electronic circuitry is delivered to thepump 122, thepump 122 delivers the drug from thereservoir 121, through theconduit 126 and out theoutlet port 127. - Multiple electrode pairs and multiple stimulators may be configured for use in a number of applications. A particular waveform, pulse or series of pulses may not be sustaining stimulation and contractions over a distance. Thus, the multiple electrode pairs may be used to stimulate in a sequence according to a program. Also the sequential stimulation may be useful in timing the propagation of the stimulation pulses or resulting muscle contractions. Also, the stimulation pulses sent by one set of stimulation electrodes may be used to trigger pulses to be sent by the receiving stimulator. Additionally, the electrodes and/or sensors at other locations may help provide information that allows adjusting of the stimulation parameters. Stimulation parameters may be selected based on sensed feedback from one or more of the sensors that are located adjacent the electrode pairs or with electrode pairs used to sense information. For example, stimulation by one set of electrode pairs at one location may or may not elicit a response at a second location where another set of electrode pairs and a sensor are located.
- Parameters sensed at the second location by the sensor or by the electrodes may indicate that an adjustment should be made in the stimulation at the first location or the second location to provide a desired response. For example, a pressure sensor or strain gauge at a second location may sense the existence of, i.e., the presence or absence of contractions indicating that the stimulation is not effective in a particular area. The electrodes at the second or further location may be used to sense the signal delivered from the first electrode pair or may sense a resulting pacing signal or depolarization signal subsequent to and resulting from the initial stimulation signal. Presence, absence or degree of the signal may provide information that indicates the stimulation signal parameters should be changed. The parameters of the stimulation from the first location may be altered and programmed according to sensed feedback to optimize the stimulation parameters or sequence selection. Also in response, the stimulation at the second location may be adjusted to optimize the response. The sensed information may be telemetrically transmitted to an external receiver/processor that determines a new set of stimulation parameters and telemetrically programs the master stimulator in response. The multiple electrode pairs may be selected from at least three electrodes that may be configured into at least three independent electrode pairs at different times. Thus selectable electrode pairs are configurable to deliver electrically independent stimulating signals. A first electrode pair may be selected from the at least three electrodes by a control circuit based on a program to deliver a stimulating signal. Then according to a predetermined program or feedback, a second electrode pair may be selected from the at least three electrodes to deliver a second electrically independent stimulating signal.
- The multiple electrode pair and multiple stimulator embodiments described herein may also be configured in a master/slave arrangement for propagating stimulation through a plurality of electrode pairs in a predetermined or concurrently determined pattern, wherein the master device triggers the stimulation signals provided by the slave devices.
- One particular application of a master/slave device may be in a gastroparetic stomach, e.g., where the stomach is not effectively transmitting slow waves or burst pulses along all or a portion of the stomach wall. The master slave devices may be used to boost the slow wave or burst pulse signals if, when and where such pulses are failing to produce stomach wall contractions. According to one embodiment, the master device transmits either a telemetry signal or a stimulating signal that is received by one or more slave devices. The signal indicates that the master device has sent out a stimulation pulse. The master or slave device will then wait a predetermined time during which it is sensing whether a slow wave signal or a contraction is induced at the location of the slave device. Accordingly, sensor associated with the slave device may be used to sense presence or absence of slow wave signals, presence or absence of burst activity, or a resulting muscle contraction, e.g., by mechanically measuring contractions. If such a wave or contraction is not sensed then the slave device will deliver a stimulation pulse or the master device will determine an alternative stimulation protocol, program or sequence involving one or more slave devices. Thus in a series of slave devices, the stimulation pulses may be boosted at the particular slave device where the slow wave or contractions cease to effectively exist. According to one variation, the slave device that subsequently delivers a stimulation pulse, may then act as a master. The method may be repeated with subsequent slave devices until the desired slow wave propagation or contractions result.
- Multiple electrode pairs may be in communication with each other either through wired communications or wireless communications. Various multiple electrode pair embodiments that may be arranged in various modes as described herein, are illustrated in
FIG. 8 ,FIGS. 9A-C ,FIGS. 10A-B , andFIG. 11 . -
FIG. 8 illustrates animplant 60 having a plurality ofhousings flexible connectors housings flexible connectors connectors housing sensors top surface housings 60 a-c. When implanted the electrodes 61 a-c, and 62 a-c are oriented so that they face and are in electrical contact with themuscle layer 104 c of the stomach. The geometry ofimplant 60 helps it resist rotation aboutaxis 64 a oraxis 64 b, within the submucosal pocket into which it is implanted. The aspect ratio of theimplant 60 from the vantage point ofaxis 64 a oraxis 64 b is greater than about one, preferably greater than About 1.4 and more preferably greater than about 1.8. The implant includes at least onebattery 144 and oneelectronic circuitry 25, and, may include anelectronic circuitry 25 andbattery 144 for each of thehousings 60 a-c to supply electrical stimulation pulses to the electrode pairs 61 a, 62 a; 61 b, 62 b; and 61 c,62 c, sensing and telemetric communication. -
FIG. 9A illustrates another embodiment of the invention in which the stimulator includes multiple electrode pairs. In this particular embodiment, a tail orelongate member 72 extends from the main device body orhousing 71. Thestimulator 70 comprises ahousing 71 with anelongate member 72 attached to its end. Thestimulator 70 includes alumen 88 extending longitudinally through theelongate member 72 and thehousing 71 from an opening 89 a in theelongate member 72 to anopening 89 b in thehousing 71. Theelongate member 72 comprises a plurality of electrode pairs, 73, 75, 77 andsensors electrodes sensors electronic circuitry 25 andbattery 144 as described in detail herein with reference toFIGS. 13 and 14 , by way of insulated electrical connections extending through theelongate member 72 into thehousing 71 where theelectronic circuitry 25 andbattery 144 are located. Anadditional sensor 79 is provided on thehousing 71 for sensing parameters of the environment or tissue adjacent thehousing 71. Thesensor 79 is also electrically coupled to theelectronic circuitry 25. -
FIGS. 9B and 9C illustrate a method of implanting thestimulator 70 ofFIG. 9A . InFIG. 9B , aguidewire 87 has been placed into apocket 90 formed in thesubmucosal layer 104 b. The placement of theguidewire 87 and preparation of thepocket 90 is done in a similar manner as the preparation of the pocket shown inFIGS. 20A-20G . After thepocket 90 has been prepared, the dissection instruments are removed, leaving aguidewire 87 in place. Thestimulator 70 is placed over theguidewire 87 with theguidewire 87 extending through thelumen 88 of the stimulator. Theelongate member 72 placed over the guidewire first with thehousing 71 following theelongate member 72 as the stimulator is placed into thepocket 90. As illustrated inFIG. 9C , thestimulator 70 is in place in thepocket 90 and the guidewire is removed throughopenings stimulator 70. - As an alternative to
FIGS. 9A-C ,FIGS. 10A-B illustrate a variation of a device having an elongate member with multiple electrode pairs. According to the embodiment, thestimulator 680 comprises ahousing 681 and a removable attachableelongate member 692. Thehousing 681 includes aneedle 684 for attaching the device to astomach wall 104. Thehousing 681 includes anopen chamber 682 for receiving a portion of thestomach wall 104 for attachment. Thechamber 682 includes anopening 687 coupled to avacuum pipe 688 external to thechamber 682 of the housing. Thevacuum pipe 688 has an openproximal end 689 for coupling through an elongate tube to a vacuum source. - The
needle 684 extends from a first proximal side of thedevice 683, distally through thechamber 682 piercing thestomach wall 104, to an opposite distal side of thedevice 686. Aknob 685 is located on the outside of thefirst side 683 of thedevice 680. Theknob 685 enables an instrument to grasp and advance or retract theneedle 684 into or from thehousing 681. Thehousing 681 containselectronic circuitry 25 and abattery 144 that are coupled to each other byconnectors 691. - The
device 680 is attached to the stomach wall by applying a suction thoughvacuum pipe 688 tochamber 682 to draw a portion of thestomach wall 104 into thechamber 682, and then attaching thedevice 680 by advancing theneedle 684 distally through the tissue in thechamber 682. As theneedle 684 extends through thechamber 682, it pierces through the stomach wall from the inside of the stomach wall to the outside through a fold in thestomach wall 104 and back through the stomach wall to the inside of thestomach wall 104. - The
stimulator device 680 further comprises anelongate member 692 connected to thehousing 681 byconnector 700 show in more detail inFIG. 10B . Theelongate member 692 includes bipolar ring electrode pairs 695 a-b, 696 a-b located at spaced locations along theelongate member 692. The electrodes 695 a-b, 696 a-b are coupled toelectronic circuitry 25 within thehousing 691 by way of connectors as described with reference toFIG. 10B . The multiple electrodes and electronic circuitry may be configured in a similar manner as the multiple electrode pairs described above. Additional electrode pairs may be used and the elongate member may extend through a substantial portion of the submucosa in the greater curvature of the stomach. - The
elongate member 692 may be removably attached to thehousing 681 of thedevice 680 throughmale connector 700 so that the electronics and batteries may be replaced by removing thehousing 681 while leaving theelongate member 692 in place. A new housing with new batteries and electronic circuitry may subsequently be implanted and attached to theelongate member 692. Themale connector 700 is located on the proximal end of theelongate member 692 and has electrical contact rings 701 a-d coupled to contacting electrical wires 702 a-d extending distally through theelongate member 692 toelectrodes 696 a-b and 695 a-b respectively. Thehousing 691 includes afemale connector 690 located on thedistal end 686 of thehousing 681 for receiving themale connector 700. Thefemale connector 690 compriseselectrical contacts 690 a-d that are coupled through wires to theelectronic circuit 25 in thehousing 681. Thedistal end 686 of thehousing 681 includes amagnet 697 for removably coupling with theelongate member 692. Theelongate member 692 includes aflanged portion 703 that engages thedistal end 686 of thehousing 681. Theflanged portion 703 includes amagnet 704 that engages themagnet 697 on thehousing 681. When theconnectors electrical contacts 690 a-d are in electrical contact with the ring contacts 701 a-d to provide electrical communication between the electrodes and theelectronic circuit 25. - To implant the
elongate member 692, asuture 694 or wire attached to theend 693 of theelongate member 692 may be placed through a portion of the stomach wall with a hollow needle so that a T-shapedend 696 extends back through themucosa 104 a and inside thestomach 100. Thesuture 694 is then pulled through thestomach wall 104 where theelongate member 692 is to be implanted, using an endoscopicgrasping tool 698 that grasps the T-shapedend 696 of thesuture 694, drawing theelongate member 692 into thesubmucosa 104 b. Thesuture 694 is then cut using anendoscopic cutting instrument 699. - To remove the
elongate member 692 from thehousing 681, theelongate member 692 is stabilized using an endoscopic grasping tool while thehousing 681 is removed using another endoscopic grasping instrument. - Referring to
FIG. 11 a master/slave arrangement of stimulators is illustrated. The stimulators 401-405 are implanted in submucosal pockets in a manner consistent with the procedures and instruments described herein. The stimulators may be attached to the stomach wall by other means, such as, for example, by attaching the stimulator using an anchor to the stomach wall. Afirst stimulator 401 is implanted, e.g., at the fundus/body transition on the greater curvature of the stomach.Additional stimulators - The stimulators 401-405 can be programmed to function as a master device or a slave device. In one embodiment, initial commands, e.g., initial stimulation or command signals received by the slave devices, are dictated by the device designated as the master device. In turn, the slave devices follow the commands of the master device. The master slave arrangement also may provide a low power consumption method of communication between the devices. This method of communication between devices involves sensing of the device electrical pulses, which are conducted through the stomach tissue.
- The multiple electrode pairs as illustrated in
FIG. 11 , are on individual stimulators 401-405 that are endoscopically implanted in a series along the greater curvature of the patient's stomach from the fundus to the antrum and used to stimulate, i. e, to effect peristalsis by sequential electrical stimulation. Using an external programmer and communication via RF telemetry, the most orad device (stimulator 401) is identified by a serial number or other identifier, and designated as master device. The other stimulators 402-405 are also identified and designated, in the aborad direction as a first slave, second slave, third slave, and fourth slave. Themaster stimulator 401 will start to electrically stimulate the stomach at a set frequency. Each master device electrical stimulation pulse that is conducted through the stomach tissue, will almost immediately (negligible delay) be sensed by the slave devices 402-405. The slave devices 402-405 will in turn emit an electrical stimulation pulse with a set time delay determined by their order (i.e., first, second third or fourth slave). The slave devices 402-405 may also have a set refractory period that begins after receiving the first electrical pulse delivered by themaster device 401, so as not to respond to the electrical pulses of the other slave devices. The first slave's time delay will be the shortest. The fourth slave's time delay will be the longest. This sequential electrical stimulation of the stomach using the implanted stimulators 401-405 may, e.g., induce an artificial peristaltic wave propagating from the fundus to the antrum. One advantage of this method of communication between stimulators is that the amount of energy required is significantly less than if each stimulator's stimulation pulse was triggered by an RF telemetry communication from an external transmitter. - In a variation of an embodiment, the
master device 401 emits a burst of electrical stimulation pulses to be duplicated by each of the slave devices 402-405, with an individually set time delay. The slave devices may be programmed to sense and count the fast burst pulse originating from the master. After no pulse is received any more within a set time interval after receipt of the last pulse, the set refractory period of the slave device will start and the slave will emit a duplicate of the master signal after the set time delay. - The slave devices may also be capable of measuring a parameter of the sensed first stimulation signal that indicates the effectiveness of the stimulation signal, and respond accordingly to optimize the stimulation signal delivered by the slave device. The slave devices 402-405 may also respond to a sensed parameter indicating that the first stimulation pulses have or have not effectively been delivered, e.g., by a pressure transducer measuring contractions of the stomach, or by detecting or failing to detect a resulting inherent pacing signal (as opposed to the original stimulation signal). The stimulators 401-405 may be capable of being either a master or slave device. The stimulators' functions may be selected before or after the stimulators 401-405 have been implanted, to provide a number of possible configurations.
- Referring to
FIG. 12 a cross section of animplant 80 withelectronic circuitry 25 andbattery 144 is illustrated. Theelectronic circuitry 25 andbattery 144 described with respect toFIG. 12 are also used or may be used in connection with any of the other implants or stimulators described herein. Thebattery 144 is coupled to theelectronic circuitry 25 to provide power to thecircuitry 25 for sensing, telemetry and stimulation pulses. Theelectronic circuitry 25 is electrically coupled toelectrodes sensor 83 throughconnectors electronic circuitry 25 is described in more detail inFIG. 13 . - Referring to
FIG. 13 , theelectronic circuitry 25 is illustrated. In use, once the stimulator or implant (e.g., 10, 30, 40, 50, 60, 70, 80, 350, or 337) is deployed, electrical stimulation is to electrodes (11, 12, 31, 32, 37, 38, 41, 42, 51, 52, 61 a, 62 a, 61 b, 62 b, 61 c, 62 c, 73, 75, 77, 81, 82, 351 or 352) throughelectronic circuitry 25. Electronic stimulation may be provided for various therapeutic or diagnostic purposes. The electrical stimulation patterns of the implant are either pre-programmed, can be externally programmed via telemetry, or are autonomously controlled using incorporated sensors to provide feedback information. - The sensors of the implants are adapted to sense parameters of the stomach. The sensing may be used to determine a condition of the stomach that may indicate that stimulation should or should not be provided, i.e., whether to turn the stimulator on or off and what stimulation parameters to use. The sensing may also be used to provide information, for example on whether the stimulation is providing a desired response or how effective given stimulation parameters may be. The sensor may be, for example, a sensor for measuring contraction in the stomach such as a strain gauge, pressure sensor or electrical sensor.
- The programming, monitoring and reprogramming of the stimulator may be controlled in part by an external controller that communicates with the stimulator via telemetry.
- The
electronic circuitry 25 is capable of producing various types of programmable waveforms.FIGS. 15A and 15B illustrate examples of stimulation waveforms that may be used in stimulating the smooth muscle layer of the stomach wall.FIG. 15A illustrates a waveform design for stimulating the stomach wall at a pacing rate. In one embodiment, thewaveform 501 has a pulse amplitude of 1 to 30 mA, a pulse width of between 0.1 and 500 ms, and a frequency of about between 2 to 12 cycles per minute (this corresponds to a repetition period of between 5 to 30 seconds).FIG. 15B illustrates an alternative waveform design for stimulating the stomach wall. Thewaveform 502 utilizes bursts of pulses rather than a single pulse. The burst repetition rate is selected, preferably, to be between about 2 to 12 cycles per minute (this corresponds to a burst repetition period of between 5 to 30 seconds). The duration of a pulse in this example is between about 100 μs and 20 ms, and has an amplitude of about 1-30 mA. The frequency of the burst pulses during a burst period is about 50 Hz to 10K·Hz corresponding to a pulse repetition period of 100 s to 20 ms. The burst duration can vary from about 0.1 ms to 1 second. As is well known to those skilled in the art, there are many different types of electrical stimulation programs and strategies which can be utilized for providing electrical stimulation parameters through thecircuitry 25, the principal focus being providing electrically stimulating parameters for the stomach. Stimulation may also be done utilizing phasic, unipolar or asymmetric stimulation waveforms. - One embodiment of the
electronic circuitry 25 is illustrated inFIG. 13 . The electronic circuitry may be on a chip or otherwise have a standard configuration that may be used in a number of different diagnostic or therapeutic functions in various embodiments of the functional device. Theelectronic circuitry 25 of the stimulator is located in the housings of the various implants described herein. Thecircuitry 25 comprises a microprocessor orcontroller 140 for controlling the operations of theelectronic circuitry 25, aninternal clock 141, andbattery device 144 such as a pair of lithium iodine batteries for powering the various components of thecircuitry 25. As such, thecontroller 140 andbattery device 144 are coupled to each of the major components of the circuit as would be apparent to one of ordinary skill in the art. Thecontroller 140 is coupled tostimulation driver 142, which is coupled to stimulatingelectrodes 11, 12 (or any of the other electrodes described herein for delivering stimulation pulses) that are used to provide electrical stimulation in accordance with programmed parameters. - The
controller 140 is coupled toROM 143, which contains the program instructions for thecontroller 140 and any other permanently stored information that allows the microprocessor/controller 140 to operate. Thecontroller 140 addresses memory inROM 143 throughaddress bus 143 a and theROM 143 provides the stored program instruction to thecontroller 140 viadata bus 143 b. - The
controller 140 controls the RF coil 14S, which communicates with an external control or programming device 160 (FIG. 11 ), preferably via a modulated RF signal.Processor 140 is coupled to abuffered oscillator 151 that provides an RF signal to be emitted from theRF coil 145. The RF signal is preferably at about 100 kHz to 5 MHz so that the signal is efficiently transmitted through tissue. Thecontroller 140 controls theoscillator 151 and provides data, for example, various sensed data such as pressure, pH, temperature, strain, impedance, electrical activity (EMG) etc., to be modulated with the RF signal to be delivered through theRF coil 145. When the RF coil 14S is receiving an external telemetry signal, the bufferedoscillator 151 is disabled. Telemetry signals received on theRF coil 145 are detected in adetector circuit 151 a and to communicatedcontroller 140. Thedetector circuit 151 a is preferably selected based on the modulation used for telemetry signals. - One or
more sensors 147 a (e.g., strain gauge), 147 b (e.g., pressure), 147 c (e.g., pH), 147(d) temperature, orelectrodes 11, 12 (for sensing EMG, EGG, or impedance as well as providing stimulation), may be coupled to thecontroller 140 through ND converters (with amplifiers) 146 a, 146 b, 146 c, 146 d, 146 e which convert a representative analog electrical signal into a digital signal. Suitable types of these sensors are generally known in the art and may be located within, on, or external to the housing or other portions of the of the stimulator, such as the attachment mechanism or elongate member. -
Controller 140 is coupled to RAM 150 via anaddress bus 150 a for addressing a location inRAM 150 and abi-directional data bus 150 b for delivering information to and from RAM ISO. TheRAM 150 includesevent memory 148 that temporarily stores data recorded by sensors 147 a-d orelectrodes 11, 12 (or other electrode pairs described herein).RAM 150 also includes aprogrammable memory 149 which may be programmed, for example, by anexternal programmer 160. The data stored in the programmable memory may include specifications for the electrical stimulation operating modes, (e.g., waveform, type of stimulations: for pacing, inducing contraction or other type) and various procedure parameters, (e.g., when to deliver a drug or electrical stimulation). Such programming may be done in response to sensed information, or, it may be done automatically by an external controller or as desired by a treating physician, etc. Sensed data acquired from sensors 147 a-d andelectrodes controller 140 may be stored inevent memory 148 in theRAM 150. The data stored in theevent memory 148 may be sent intermittently as data bursts via theRF coil 145, as opposed to continuously, in order to save battery power. - The
electrode stimulation driver 142 to theelectrodes external programmer 160, or they may be set in response to sensory feedback. The same electrode outputs are used to sense impedance throughimpedance circuit 153 and to sense electrical activity, which is delivered through A/C converter 146 e. Theelectrodes coupling capacitors electrical stimulation driver 142 and the inputs of A/C converters - The
impedance circuit 153 comprises a constantcurrent source oscillator 154 that oscillates at a frequency of 50-100 kHz, and an A/C converter 146 f coupled to thecontroller 140. Theoscillator 154 provides a constant current source throughelectrodes electrodes C converter 146 f to a digital signal representative of impedance. A/C converter 146 f has a bandwidth that includes the 50 kHz frequency signal while filtering out the electrical stimulation signal that is delivered to theelectrodes electrical stimulation driver 142, and the EMG signal that is sensed by theelectrodes C converter 146 f A/C converter 146 e, has a bandwidth that filters out the 50-100 kHz signal. Further, when a stimulation signal is being delivered, thecontroller 140 does not receive signals from A/C converters electronic circuitry 25, though using the same electrodes. - An additional circuit 158 (or a plurality of such circuits) may be provided in the
electronic circuitry 25 that are comprised of the same components and are configured as A/C converter 146 e,impedance circuit 153 andstimulation driver 142. Such circuit may provide stimulation, impedance, EMG or EGG sensing for an additional pair of electrodes. - The
battery 144 has its output supplied to a DC-to-DC converter 144 a to provide a higher voltage, which is utilized for electrical stimulation pulses. The DC-to-DC converter 144 a is conventional and provides an output voltage of 15 to 20 volts. Further, thecircuitry 25 may include one ormore drivers controller 140 provides a signal to a driver 152 a-d based on a preset program inROM 143 and/or on sensed parameters stored inRAM 150. The circuit may also include a steppingdriver 156 coupled to a stepper motor, for example, an precise drug delivery mechanism. -
FIG. 14 illustrates theelectronic circuitry 163 forexternal programmer 160. Theelectronic circuitry 163 comprises: a microprocessor orcontroller 170 for controlling the operations of the electronic circuitry, aninternal clock 171, and apower source 174 such as a battery device for powering the various components of thecircuit 163. As such, thecontroller 170 andbattery device 174 are coupled to each of the major components of the circuit as would be apparent to one of ordinary skill in the art. Thecontroller 170 is coupled to aspeaker 167 for that provides audible alerts and adisplay 166 such as a CRT to display data such as recorded data, sensed parameters, treatment parameters and status of the device (e.g. position or battery charge status). Thecontroller 170 is coupled through abuffer 164 toexternal input device 165 that is used to provide program parameter input, e.g. from a user, for a user to request data displayed in a desired format throughdisplay 166 orspeaker 167, or to turn the device on and off. Theexternal programmer 160 is also provided with anexternal data port 168 to interface with a computer and provide a means for bi-directional communication of data or commands. The computer may provide programming or data to the controller/microprocessor 170. A user may also interface with the computer to provide treatment protocols or changes in protocols, etc. Also, a user may control the turning on and off of the stimulation program. - The
controller 170 is coupled to ROM•173, which contains the program instructions for thecontroller 170 and any other permanently stored information that allows the microprocessor/controller to operate. Thecontroller 170 addresses memory inROM 173 throughaddress bus 173 a and theROM 173 provides the stored program instructions to thecontroller 170 viadata bus 173 b. Thecontroller 170 controls theRF coil 175, which communicates with stimulator electronic circuitry 25 (FIG. 13 ) through itsRF coil 145.Processor 170 is coupled to anoscillator 172 that provides an RF signal, preferably having a characteristic frequency of 500 kHz or higher, to be emitted from theRF coil 175. Thecontroller 170 controls theoscillator 172 and provides data to be modulated with the RF signal, for example, programming information, stimulation parameters, etc. TheRF coil 175 also receives information transmitted via RF signal fromRF coil 145 on the stimulatorelectronic circuitry 25 such as various sensed data, e.g., pressure, pH, impedance, electrical activity (EMG) etc. The received RF signal is passed throughdemodulator 176 and is transmitted to thecontroller 170. The data is delivered to the event memory 178 inRAM 177 by way ofdata bus 177 b for temporary storage. The data may be retrieved fromRAM 177 by addressing the storage location via theaddress bus 177 a. - Event memory 178 temporarily stores data recorded by sensors 147 a-147 and
electrodes external programmer 160, until the data is downloaded onto a computer using theexternal data port 168. TheRAM 177 also includes aprogrammable memory 179 which may be programmed, for example, to specify operating modes such as waveform, frequency, etc. which programming is then telemetrically communicated to the stimulatorelectronic circuitry 25. The modes and parameters can either be set using anexternal programmer 160 or set in response to sensory feedback. - In an alternative embodiment, the device includes a housing, electrodes and minimal electronics and an electromagnetic coil. This device is powered by an external electromagnetic coil, which is placed on the patient's abdomen near the implanted device. The electrical stimulation parameters are controlled real-time by an external unit.
- In an alternative embodiment, the device includes a housing, electrodes and minimal electronics and an electromagnetic coil. This device is powered by an external electromagnetic coil, which is placed on the patient's abdomen near the implanted device. The electrical stimulation parameters are controlled real-time by an external unit.
-
FIGS. 16A and 16B illustrate a first step in one embodiment of a method of implanting a gastric stimulator in the submucosal layer of a stomach and instruments used in the method. According toFIGS. 16A and 16B , ableb 200 is formed in thesubmucosal layer 104 b of thestomach wall 104. Thebleb 200 is formed to prepare a space in the submucosal layer for receiving an implant. Ahollow needle catheter 210 is extended through thechannel 112 in theendoscope 110 located in a patient's stomach. Theneedle tip 211 of thecatheter 210 is used to pierce themucosal layer 104 a so that thetip 211 is located in thesubmucosal layer 104 b. A fluid is injected into thesubmucosal layer 104 b to form the bleb 200 (or blister) (FIG. 16B ). A number of different fluids may be used for this purpose, e.g., a saline solution, a viscous fluid such as sodium hyaluronate, or a chemical agent that cuts, breaks down, or dissolves a desired amount of submucosal connective tissue. Some chemical agents that may be suitable include KOH, acids and enzymes such as a peptase enzyme solution, proteases/colagenases, papain, bromelain, ficin, chymotrypsin and urokinase. When using a chemical agent, it may be desirable to flush or dilute the agent and/or evacuate the resulting loose material after introducing the agent into the submucosa. - According to an embodiment of the invention, once a
bleb 200 is formed, the connective tissue within thesubmucosal layer 104 b is dissected, cut, broken down, dissolved, or removed to form a pocket where the stimulator is to be placed. A number of alternative methods and instruments are described herein to prepare the stomach wall to implant a gastric stimulator. -
FIGS. 17A-G illustrate one embodiment in which a balloon with a guidewire is used to dissect connective submucosal tissue. According to this embodiment as illustrated inFIG. 17A , ahollow needle 220 having alumen 221 is placed through themucosal layer 104 a at location A, into thebleb 200, advanced through thesubmucosal layer 104 b, and out of thebleb 200 through themucosal layer 104 a at location B. As illustrated inFIG. 17B , aflexible guidewire 222 is placed through thehollow needle 220. Theguidewire 222 includes a T-shapedend 223 so that when theneedle 220 is withdrawn (FIG. 17C ), the T-shapedend 223 remains outside themucosal layer 104 a, preventing theguidewire 222 from being withdrawn while theguidewire 222 extends back through thesubmucosal layer 104 b and out through theendoscope 110. Theguidewire 222 is then used to guide aballoon catheter 224 over theguidewire 222 so that theballoon 225 is placed within thebleb 200 in thesubmucosal layer 104 b in an uninflated state (FIG. 17D ). Inflation medium is delivered through an inflation lumen in theballoon catheter 224 to inflate the balloon 225 (FIG. 17E ) whereby apocket 202 is formed in the submucosal layer. Theballoon 225 is then deflated and retracted. A cutting instrument such as ascissors 227 is introduced through theendoscope 110 and is used to cut off the T-shaped end 223 (FIG. 17F ) so that theguidewire 222 can be pulled out, leaving apocket 202 in thesubmucosal layer 104 b. Theballoon 225 may be either a compliant or non-compliant balloon that either expands elastically or expands to a predetermined volume. - Referring now to
FIGS. 18A-E a second embodiment is illustrated in which a balloon is used to dissect the connective tissue in thesubmucosal layer 104 b. A hollowendoscopic needle 230 containing a balloon tippedinstrument 231 having acompliant balloon 232 on the distal end of theinstrument 231, is placed at the opening 201 (formed in themucosal wall 104 a when thebleb 200 is formed (FIG. 14A )), and into thesubmucosal layer 104 b (FIG. 14B ). Theendoscopic needle 230 is retracted leaving theballoon 232 at theopening 201 within thesubmucosa 104 b (FIG. 14C ). Theballoon 232 is inflated by introducing an inflation medium through theinflation lumen 233 in theinstrument 231. (FIG. 14D ). Theopening 201 is relatively small so as to prevent theballoon 232 from exiting thesubmucosa 104 b when theballoon 232 is inflated. As it is inflated, theballoon 232 expands distally as well as radially to dissect the submucosal tissue. Theballoon 232 in this embodiment made of a compliant or non-compliant material. Theballoon 232 is then deflated and withdrawn leaving apocket 203 in thesubmucosa 104 b. (FIG. 14E ). -
FIG. 19 illustrates an alternative to the embodiment ofFIGS. 18A-E in which the balloon tippedinstrument 241 has a foldedballoon 242 on the distal end of theinstrument 241. Theballoon 242 is placed into thesubmucosal layer 104 b (FIG. 19A ). Anatraumatic tip 245 of a slidingrod 244 is attached to the inside of the distal end of theballoon 242. Therod 244 extends through theinstrument 241 and may be manipulated externally of the endoscope through which it is inserted. Therod 244 may be distally advanced to A/C in dissecting the submucosal connective tissue, as theballoon 242 is inflated when an inflation medium is introduced through theinflation lumen 243 in theinstrument 241. (FIG. 19B ). Therod 244 may also orient the expansion of theballoon 242 in a desired direction. -
FIGS. 20A-H illustrate a self-guiding guidewire device in use with a balloon dissection tool. The self-guidinginstrument 260 comprises aflexible guidewire 261 with aball tip 262 at its distal end and a stiffhollow tubing 263 such as a hypotube through which theguidewire 261 extends. Theflexible guidewire 261 may slide in and out of thetubing 263 to provide desired degree of flexibility, stiffness, or buckle or kink resistance of the unsupported length of the guidewire at the distal end of theinstrument 260. The degree of flexibility or buckle resistance may be varied at different times during the placement of theguidewire 261 inside thesubmucosal layer 104 b. As illustrated inFIG. 20A , theinstrument 260 is placed near theopening 201 formed in themucosal layer 104 a, and theguidewire tip 262 extends slightly out of thetubing 263 into thesubmucosal layer 104 b of thebleb 200. Thetip 262 is preferably rounded to some extent to prevent puncturing of themuscle layer 104 c or themucosal layer 104 a while having a sufficiently small surface area to allow it to relatively easily advance through thesubmucosal layer 104 b. Theguidewire 261 is sufficiently flexible to prevent puncturing of themuscle layer 104 c or themucosal layer 104 a while being sufficiently stiff to prevent buckling as theguidewire 261 is inserted. As illustrated inFIG. 20B , theguidewire 261 becomes more deflectable at the distal end of theinstrument 260 as it is advanced distally out of the tubing into the submucosal layer. Theatraumatic ball tip 262 in combination with aflexible guidewire 261 prevent puncture of the muscle layer. At some point in the procedure, theguidewire 261 may be too flexible and may buckle, kink or may fail to further advance into the submucosal layer 10 b. As illustrated inFIG. 20C , the length ofguidewire 261 extending out of thetubing 263 is shortened by advancing thetubing 263 distally over the guidewire {and into the bleb 200) so that the distal end is less deflectable and/or prone to buckling and may be advanced further. These steps may be repeated, varying the deflectability of the distal end of theinstrument 260 until theguidewire 261 is in a desired location. The guidewire may also be designed to optimize the flexing and anti-buckling characteristics so that it is suitable for placement within a submucosal layer with or without a hypotube. In one embodiment, various parameters of the wire are selected so that the submucosal insertion into over 5 to 10 cm of the submucosa may be achieved without perforation of the mucosa or muscle layers. In one example of a suitable embodiment, a stainless steel wire is used having an outer diameter of 0.020 inches with a wire bending stiffness of 654 Nmm2. and a ball size of 0.040 inches. Once theguidewire 261 is in place in thesubmucosa 104 b, thetubing 263 is retracted and aballoon catheter 265 is advanced over the guidewire 261 (FIG. 20D ) and into thesubmucosa 104 b (FIG. 20E ). Theballoon catheter 265 has aballoon 266 at its distal end, a lumen 267 (FIG. 20H ) extending through it for slidably receiving theguidewire 261, and aninflation lumen 268 for delivering an inflation medium to theballoon 266. As illustrated inFIG. 20F , theballoon 266 is inflated after being positioned in thebleb 200, to dissect the submucosal connective tissue. Theguidewire 261 andballoon catheter 265 are withdrawn, leaving apocket 204 formed in the submucosal tissue, for receiving a gastric stimulator. (FIG. 20G ). Although theballoon 266 is illustrated as an elastic balloon, a non-compliant balloon may be used as well. - As illustrated in
FIG. 20H , an additional feature of theguidewire 261 provides aoptic fiber 269 extending through the wire and terminating at theball tip 262 which is made of a clear plastic material. Light may be carried down theoptic fiber 269 to illuminate theball tip 262. This provides additional information on the location of thetip 262 in thesubmucosal layer 104 b, as thetip 262 is being insert into the stomach wall. The light will be visible when observing the procedure through an endoscope as the guidewire is inserted into thesubmucosal layer 104 b. The ball tip may also be tapered. The guidewire may also be formed of a pre-tensioned coil that deflects when a given force is applied to the tip. -
FIGS. 21A-21C illustrate a mechanical blunt dissector and method of dissecting thesubmucosal layer 104 b. Theblunt dissector instrument 270 comprises a tapered, wedge-like, bluntdistal end 271 on an elongateflexible member 272, preferably having a flexible coil outer tube to provide sufficient axial stiffness in combination with flexibility. As illustrated inFIG. 21B , an RF needle orscalpel 273 have anRF cutting tip 274 is used to create anopening 208 through themucosa 104 a into thesubmucosa 104 b. As illustrated inFIG. 21C , the bluntdistal end 271 is placed within theopening 208 into thesubmucosal layer 104 b and is used to mechanically dissect the tissue. -
FIG. 22 illustrates ablunt dissector connector 275 comprising acap 276 to be placed on the end of anendoscope 110 and having a wedge-like, tapered, bluntdistal end 277. The bluntdistal end 277 is made of a clear material that allows visualization through an endoscope as the blunt dissector is being placed through theopening 201 and as it is used to dissect thesubmucosal tissue 104 b. -
FIGS. 23A-23C illustrate an alternative embodiment of a mechanical dissecting instrument that may be used to dissect the submucosal tissue. The dissectinginstrument 280 comprises anelongate member 281 formed of a flexible coil and having aslidable push rod 282 slidable within a lumen extending through the length of theelongate member 281 and coupled to adistal linking member 283 of adistal end effector 284. Thedistal end effector 284 of theinstrument 280 comprises fourlinkages links slidable push rod 282 and twolinks slidable push rod 282. Thelinks elongate member 281 and are hingingly coupled tolinks distal linking member 283. In a closed position as illustrate inFIG. 23B , thepush rod 282 extends distally so that the links 285-288 are relatively parallel and the profile of theend effector 284 is relatively narrow. In an open position as illustrated inFIG. 23C , thepush rod 282 is retracted, to shorten and widen theend effector 284 as the linkages hinge with respect to one another. When placed in the bleb, as theend effector 284 opens, it dissects adjacent submucosal tissue. -
FIGS. 24A and 24B illustrate ablunt dissector 290 similar to the blunt dissector ofFIGS. 23A-C except that rather than using a push rod, ascrew type rod 292 is used where a threadedscrew 293 is formed in thescrew rod 292 and thedistal end 294 of theelongate member 291 is threaded to receive the threadedscrew 293. Theend effector 296 is shown in a narrow closed position inFIG. 24A . Therod 292 is retracted by rotating therod 292 and thescrew 293 and thus shortening theend effector 296 so that thelinkages 295 rotate to an open position. -
FIGS. 25A and 25B illustrate anotherblunt dissector 300 comprising anelongate member 301 formed of a flexible coil and having aslidable push rod 305 slidable within a lumen extending through the length of theelongate member 301 and thepush rod 305 having adistal end 306 extending distally through an opening in thedistal end 302 of theelongate member 301. Flexible expandingarms 304 are coupled to thedistal end 302 of the elongate member and to thedistal end 306 of thepush rod 305. As illustrated inFIG. 25A , thepush rod 305 is extended so that theflexible arms 304 are substantially parallel to provide a narrow device profile. As illustrated inFIG. 25B , thepush rod 305 is retracted so that the flexible expandingarms 304 bend so that they can dissect submucosal tissue when located in thebleb 200 to form a pocket in the submucosal layer. In this embodiment, the flexible arms are preferably constructed of an elastic or superelastic material, such as, a Nickel Titanium alloy. -
FIGS. 26A-26B illustrate an electrosurgical blunt dissector for use in dissecting thesubmucosal layer 104 b. Theblunt dissector instrument 310 comprises a tapered, wedge-like, bluntdistal end 311 on an elongateflexible member 312. Thedistal tip 314 of theend 311 comprises anelectrode 315 that is coupled to aconducting wire 316 extending through the elongateflexible member 312 and coupled to an RF energy source outside the patient's body. The wedge separates themucosal layer 104 a and themuscle layer 104 c and prevents perforation of either layer while theelectrode 315 cuts the submucosal connective tissue. In this embodiment, a monopolar device is illustrated and a return electrode is placed on the patient's body. Bipolar or multipolar electrodes may be used as well. As an alternative, other energy sources may be used to break down the submucosal tissue as well. For example, a laser device or an ultrasonic device may be used as well. - The use of the electrosurgical dissector of
FIGS. 26A-26B is illustrated inFIGS. 27A-27E . After ableb 200 is formed (FIG. 27A ) aknife 317 having asharp tip 318 is placed through the endoscope against themucosal layer 104 a to cut anopening 209 in the mucosal layer to access the submucosa (FIG. 27B ). Alternatively, thetip 318 may be an electrosurgical knife used to cut an opening in the mucosa. (Also, electrosurgical energy of theblunt dissector 310 may be used to cut through themucosa 104 a to enter into thesubmucosal layer 104 b.) Amulti-prong retractor 307 is introduced through anauxiliary guide 319 attached to the outside of theendoscope 110. Theretractor 307 comprises aretractable sheath 308 and threeprongs 309 on the distal end of theretractor 307. As illustrated inFIG. 27B , theprongs 309 are held in a closed position by thesheath 308. Thesheath 308 is placed at theopening 209 in the mucosa, and thesheath 308 is retracted, allowing theprongs 309 to spring open as illustrated inFIG. 27C . Theretractor 307 assists in providing access into the bleb through theopening 209, and securing and stabilizing the tissue while preparing the opening and/or inserting the implant. The blunt dissector is then placed at theopening 209 into thesubmucosa 104 b (FIG. 27C ). Within thesubmucosal layer 104 b, the electrosurgical energy may be supplied to theelectrode 315 to assist in dissecting the tissue as needed (FIG. 27D ). The wedge shape of thedistal end 311 helps maintain the tool's position within and throughsubmucosal layer 104 b. The wedge shape of thedistal end 311 may also assist in mechanically dissecting without the application of electrosurgical energy to provide apocket 205 for receiving the gastric stimulator (FIG. 27E ). - Referring to
FIGS. 28A and 28B , a tissue stabilization device is illustrated in which the tissue is stabilized with respect to the instrument. Asheath 320 extends along the length of theendoscope 110 and is attached to the outer circumference of theendoscope 110 with a band ortape 321. Asuction instrument 322 comprises anelongate member 323 extending through thesheath 320. Theelongate member 323 has asuction device 324 on its distal end, extending distally out of thesheath 320. Thesuction device 324 comprises awindow 325 opening into avacuum chamber 326. Theelongate member 323 comprises a lumen extending from a proximal end, through theelongate member 323, and ending in anopening 327 into thevacuum chamber 326. Thesuction instrument 322 can slide in either direction within the lumen of thesheath 320 and may be locked into position by a locking mechanism, preferably on the proximal end. The lumen extending through theelongate member 323 is coupled to a vacuum source for applying a vacuum pressure to thesuction device 324 through theelongate member 323. - The
suction instrument 322 is illustrated in use inFIG. 28B . Thesuction device 324 is located near animplant site 105, e.g. near a bleb formed in thestomach wall 104, and is oriented with thewindow 325 facing the stomach wall. Thewindow 325 is placed against the stomach wall and a vacuum is applied through theelongate member 323 into thevacuum chamber 326 so that thesuction instrument 322 is engaged with the stomach wall. Thestomach wall 104 is thereby stabilized relative to theendoscope 110 and a balloon of aballoon catheter 328 such as one of those described in more detail herein, is placed within the bleb and expanded to form a pocket within the submucosal layer. -
FIG. 29 illustrates an alternative stabilizinginstrument 330 that is placed through thesheath 320 described with reference toFIGS. 28A and 28B . The stabilizinginstrument 330 comprises anelongate member 331 having anactuating wire 332 extending from anend effector 334 on the distal end 333 of theinstrument 330 to a proximal manipulating end (not shown) outside of theendoscope 110. Theend effector 334 comprises agrasping pincer 335, which is illustrated grasping amucosal flap 336 forming a portion of theopening 201 in themucosal wall 104 a into thesubmucosal layer 104 b. The graspingpincer 335 holds the stomach wall for stabilization and also holds themucosal flap 336 to access thepocket 206 formed in thesubmucosal layer 104 b. The graspingpincer 335 is actuated by manipulatingwire 332. As illustrated inFIG. 33 , animplant 337 is guided into thepocket 206 with an endoscopicgrasping tool 338 that grasps aknob 339 on theimplant 337 to manipulate theimplant 337 into place. Once in place, the graspingpincer 335 releases themucosal flap 336 and the graspingtool 338 releases theknob 339 of theimplant 337. - Referring to
FIG. 30 , an alternative to the stabilizinginstrument 330 shown inFIG. 33 , is illustrated. The stabilizinginstrument 340 ofFIG. 30 comprises anelongate member 341 having anend effector 344 comprising avacuum pad 345. A lumen extends through theelongate member 34 from theend effector 344 to the proximal end (not shown), which is coupled to a vacuum source. Thevacuum pad 345 of theend effector 344 comprises a plurality of openings so that the vacuum applied through thepad 345 is relatively evenly distributed. Thevacuum pad 345 is placed near themucosal flap 336 and a vacuum is applied. The stabilizinginstrument 340 holds the stomach wall for stabilization and also holds themucosal flap 336 to further open theopening 201 and access thepocket 206 formed in thesubmucosal layer 104 b. The endoscopicgrasping tool 338 guides theimplant 337 into thepocket 206 as described above with reference toFIG. 33 , and once in place the vacuum pressure is released and theinstruments -
FIGS. 31A-31F illustrate an alternative device, device delivery system and method of the present invention. A bullet shapedimplant 350 provides for a relatively atraumatic insertion through theopening 201 into thepocket 207 formed in thesubmucosal layer 104 b of the stomach wall. After the implant is inserted, theopening 201 may re-close due to the elastic nature of themucosal wall 104 a. Thus, acute closure of theopening 201 may not be required as it may heal on its own without further intervention. The device includessurface electrodes muscle layer 104 c of the stomach wall and asensor 349. When inserted into thepocket 207, the electrodes are oriented facing themuscle layer 104 c. Theimplant 350 also comprises a lumen 353 (FIG. 31E ) through a portion of theimplant 350 so that it may be guided into place over aguidewire 354. Theimplant 350 a ofFIG. 31F has aside hole 353 a for receivingguidewire 354 and may alternatively be used in the procedure described with respect toFIGS. 31A-D . - A pushing
instrument 357 is provided for pushing theimplant 350 into place within thepocket 207. The pushinginstrument 357 may be introduced through achannel 112 in theendoscope 110 through which the placement of theimplant 350 is visualized. Thedistal end 358 of the pushinginstrument 357 includes amagnetic hex head 359 and theimplant 350 has ahex opening 355 for receiving thehex head 359. A magnetic coupling or temporary attachment is provided between thedistal end 358 of the pushinginstrument 357 and theimplant 350. The pushinginstrument 357 also has aguidewire lumen 360 for receiving theguidewire 354 therethrough. - In use, as illustrated in
FIG. 31A aguidewire 354 with a T-shapedend 354 a is placed through the submucosal pocket in a manner such as that described with reference toFIGS. 17A-G . The pushinginstrument 357 is inserted through thechannel 112 in theendoscope 110 and thehex head 359 is coupled to thehex opening 355 in theimplant 350. When connected, thelumen 353 of theimplant 350 and theguidewire lumen 360 of the pushinginstrument 357 are coaxially aligned. Theimplant 350 and the pushing instrument are placed over the guidewire throughlumen 353 andguidewire lumen 360 and theguidewire 354 guides theimplant 350, pushinginstrument 357 andendoscope 110 to theopening 201 in the stomach wall. Amark 356 is made on the proximal end of theimplant 350 that indicates the rotational orientation of the implant and thus the rotational position of theelectrodes mark 356 can be seen through theendoscope 110 and is used to rotationally align theimplant 350 so that theelectrodes muscle layer 104 c when the implant is in place. - As illustrated in
FIG. 31B , theimplant 350 is placed within the pocket by distally advancing the pushinginstrument 357 out of thechannel 112. The hex connection formed of thehex head 359 and thehex opening 355 allows the pushinginstrument 357 to be rotated to properly align theimplant 350. After the device is properly placed, the pushinginstrument 357 is disengaged by inserting asheath 348 through thechannel 112 in theendoscope 110 and over the pushinginstrument 357. Thesheath 348 engages theimplant 350 while theinstrument 357 is disengaged from theimplant 350. The T-shapedend 354 a of theguidewire 354 is cut so theguidewire 354 may be removed. - Once an implant is in place, it may be desirable to temporarily hold and prevent migration of the electrical stimulation device until some fibrous encapsulation develops. A resorbable bioadhesive may be used for such purpose. It may also be desirable to close the pocket at the incision site in the mucosa.
-
FIGS. 32A-D illustrate a device and method for closing theopening 201 in the stomach wall after the implant has been placed within thesubmucosal layer 104 b. As illustrated inFIG. 32A mucosal flaps 362, 363 are separated and form opening 201 to be closed. - A wound closure instrument 361 comprising a
hollow needle 364 at its distal end. The instrument 361 contains aclosure device 367 in alumen 365 extending though the instrument 361 and opening at the distal end of theneedle 364. The instrument 361 further comprises apush rod 366 arranged to advance theclosure device 367 distally out of thehollow needle 364. Theclosure device 367 is made of a super elastic material such as a Nickel Titanium alloy. Theclosure device 367 comprises ends 368, 369 that tend to curl towards each other. In use, as illustrated inFIG. 32B , thehollow needle 364 pierces theflaps closure device 367 is loaded into thelumen 365 in thehollow needle 364 in a straight position. As illustrated inFIG. 32C , thepush rod 366 advances theend 368 of theclosure device 367 out of thehollow needle 364 so that theend 368 curls to engage theflap 362. As illustrated inFIG. 32D , thehollow needle 364 is retracted and theend 369 curls in to engage theflap 363. The curled ends 368, 369 of the closure device draw theflaps opening 201. -
FIGS. 33A-E illustrate an alternative device and method for closing theopening 201 in the stomach wall after the implant has been placed within thesubmucosal layer 104 b. As illustrated in previousFIG. 32A ,mucosal flaps FIG. 33A illustrates aneedle 370 with a flexibleelastic wire 371 attached to theneedle 370. Theelastic wire 371 is made of a superelastic material, such as a Nickel-Titanium alloy, and tends towards a coiled configuration. As illustrated inFIGS. 33B-C an endoscopicgrasping tool 374 grasps theneedle 370 and pulls it throughflaps FIG. 33D , thewire 371 tends toward its coiled configuration and thus draws theflaps FIG. 33E , after thewire 371 is drawn through theflaps endoscopic cutting instrument 375 cuts the wire from theneedle 370, leaving thewire 371 in place closing theflaps -
FIGS. 34A-34C illustrate aneedle 376 andwire 377 used to join flaps be sewn through theflaps wire 377 is sewn through multiple points so that coiledportions 378 of the wire are left at each entry and exit point. -
FIG. 35 illustrates a bipolarelectrosurgical welding device 380 in use in closing the wound by electrosurgically welding flaps 384, 385 together. Thewelding device 380 includes articulatingdistal members bipolar electrodes members flaps electrodes flaps electrodes flaps - Alternative means for closing the wound or opening 201 may be used, such as, for example, a clip applier, suturing device or a bonding agent such as cyanoacrylate.
FIG. 37 illustrates the use of a bioadhesive orfiller 391 to fill in theopening 201 and thereby join theflaps - The stimulator or functional device of the present invention may be configured to be implanted in the submucosa of a stomach wall. In addition to the size and rounded shape of the implant, relatively compliant, flexible or softer biocompatible materials may be used. Such materials may be selected so that the hardness of the material is similar to the hardness of the muscle layer of the stomach wall.
- The stimulator or functional device of the present invention may be configured to communicate to an external recorder or controller by way of telemetry. They may be battery powered or powered by inductive coupling. A plurality of functional devices may be implanted the stomach wall. The functional devices may be programmed to respond to information or signals delivered by other functional devices whether the signals are delivered from one device to another through conductors, by telemetry or whether the signals are delivered, e.g. through the stomach wall or medium within the stomach.
- The device may be implanted using on or more of the steps described herein. The implant may be implanted in an open or laparoscopic procedure as well as endoscopically through the esophagus. The implant is placed by forming an opening in the stomach wall to access the submucosa and the device is then implanted in the submucosa. One or more of the steps of forming a bleb, preparing a pocket and closing the opening may be used in the procedure in any of these types of procedures whether the submucosal layer is accessed from the outside of the stomach or the inside of the stomach.
- Various means including but not limited to those specifically described are contemplated for preventing loss of electrical contact of the electrodes with the muscle layer, including various expanding members, suturing and anchoring and implantation means that anchor the electrodes in contact with the muscle layer and device configurations. Portions of the device may remain outside of the stomach wall, particularly for easy access to remove and replace portions of the device such as battery units.
- While the invention has been described with reference to certain embodiments, it will be understood that variations and modifications may be made within the scope of the following claims. Such modifications may include substituting elements or components, which perform substantially the same function in substantially the same way to achieve substantially the same result that the invention can be practiced with modification within the scope of the following claims.
Claims (20)
1. A method for implanting a device in a stomach wall comprising the steps of:
providing an implant device for treating or diagnosing a condition of the stomach;
forming an opening in the stomach wall to access the submucosal layer; and
inserting the implant device into the submucosal layer.
2. The method for implanting a device in a stomach wall of claim 1 wherein the step of providing an implant device comprises providing a gastric stimulator comprising a housing having at least one stimulating electrode thereon, sA/C stimulator being configured to provide electrical stimulation pulses to the stomach wall when in electrical contact with the stomach wall.
3. The method for implanting a device in the stomach wall of claim 2 wherein the step of providing a stimulator comprises providing an electronic circuit with the stimulator wherein the electronic circuit is configured to telemetrically communicate with an external controller arranged to control the electrical stimulation pulses to the stomach wall.
4. The method for implanting a device in the stomach wall of claim 2 wherein the step of providing a stimulator comprises providing a sensor on the housing and an electronic circuit with the stimulator, wherein the sensor is coupled to the electronic circuit and wherein the electronic circuit is configured to telemetrically communicate with an external controller to provide information sensed by the sensor to the external controller.
5. The method for implanting a device in a stomach wall of claim 2 wherein the step of inserting the implant device comprises orienting the implant device so that the at least one stimulating electrode is preferentially facing a layer of the stomach wall so that it is in electrical contact with the layer of the stomach wall.
6. The method for implanting a device in a stomach wall of claim 1 wherein the device comprises an anti-rotation element.
7. The method for implanting a device in a stomach wall of claim 1 wherein the step of providing an implant device comprises providing a therapeutic agent delivery device configured to release a therapeutic agent when implanted in the stomach wall.
8. The method of claim 1 further comprising the step of forming a pocket in the submucosal layer of the stomach wall before inserting the implant device in the pocket.
9. The method for implanting a device in a stomach wall of claim 8 wherein the step of forming a pocket in a submucosal layer of the stomach wall comprises:
forming a bleb in the submucosal layer of the stomach wall; and
forming a pocket in the bleb.
10. The method for implanting a device in a stomach wall of claim 9 wherein the step of forming a bleb comprises:
endoscopically accessing a mucosal layer of the stomach wall;
endoscopically inserting a needle through the mucosal layer into the submucosal layer of the stomach wall; and
injecting a substance through the needle into the submucosal layer.
11. The method for implanting a device in a stomach wall of claim 1 wherein the step of inserting the implant device comprises removably coupling the implant device to a distal end of an endoscopic instrument; inserting the implant device into the submucosal layer using the endoscopic instrument; and uncoupling the implant device from the endoscopic instrument.
12. The method for implanting a device in a stomach wall of claim 11
wherein the step of providing an implant device comprises providing a gastric stimulator comprising a housing having at least one stimulating electrode thereon, sA/C stimulator being configured to provide electrical stimulation pulses to the stomach wall when in electrical contact with the stomach wall; and
wherein the step of inserting the implant device into the submucosal layer using the endoscopic instrument comprises orienting the gastric stimulator so that the at least one stimulating electrode is facing a muscle layer of the stomach wall.
13. The method for implanting a device in the stomach wall of claim 1
wherein the step of providing an implant device comprises providing a lumen through at least a portion of the implant device, and
wherein the step of inserting the implant device comprises placing a guide through the lumen and guiding the implant device into the submucosal layer.
14. A method for electrically stimulating a stomach wall comprising the steps of:
providing a gastric stimulator comprising a housing, at least one electrode coupled to the housing and an electronic circuit coupled to the at least one electrode and configured to deliver electrically stimulating pulses to a stomach wall;
implanting the gastric stimulator in a submucosal layer of the stomach wall so that the at least one electrode is in electrical contact with a muscle layer of the stomach wall from within the submucosal layer; and
delivering stimulating pulses to the muscle layer through the at least one electrode.
15. The method for electrically stimulating a stomach wall of claim 14 wherein the step of implanting the gastric stimulator in the submucosal layer of the stomach wall comprises implanting the stimulator by endoscopically accessing the patient's stomach wall; and inserting the stimulator through a mucosal layer into the submucosal layer.
16. The method for electrically stimulating a stomach wall of claim 15 wherein the step of implanting the gastric stimulator comprises:
forming a bleb in the submucosal layer of the stomach wall;
forming a pocket in the bleb; and
inserting the gastric stimulator in the pocket.
17. The method for electrically stimulating a stomach wall of claim 14 wherein the step of delivering stimulating pulses comprises telemetrically communicating with the electronic circuit from an external controller to control the electrical stimulation pulses delivered to the stomach wall.
18. The method for electrically stimulating a stomach wall of claim 14 wherein the step of providing a stimulator further comprises providing a sensor on the housing coupled to the electronic circuit and further comprising the step of sensing a parameter of the stomach with the sensor and controlling stimulation parameters based upon information sensed by the sensor.
19. The method for electrically stimulating a stomach wall of claim 18 wherein the step of controlling the stimulation parameters based upon information sensed by the sensor comprises controlling the stimulation parameters with the electronic circuit and wherein the electronic circuit is configured to telemetrically communicate with an external controller to provide information sensed by the sensor to the external controller and further comprising the step of telemetrically communicating sensed information from the electronic circuit to the external controller, and wherein the step of controlling the stimulation parameters based upon information sensed by the sensor comprises controlling the stimulation parameters with the external controller.
20. The method for electrically stimulating a stomach wall of claim 14 wherein the step of inserting the gastric stimulator comprises orienting the gastric stimulator so that at least one stimulating electrode is preferentially facing a layer of the stomach wall so that it is in electrical contact with the layer of the stomach wall.
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US9668690B1 (en) | 2017-06-06 |
CA2445880A1 (en) | 2002-11-14 |
EP1390100A2 (en) | 2004-02-25 |
CA2445880C (en) | 2012-04-03 |
WO2002089655A3 (en) | 2003-04-17 |
AU2002340624B2 (en) | 2007-06-07 |
WO2002089655A2 (en) | 2002-11-14 |
EP1390100A4 (en) | 2006-01-04 |
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