Patent Application
20120232361
This invention relates to a bariatric or intraluminal device for weight loss, and ancillary items such as sizing, and monitoring.
Obesity has been steadily increasing worldwide and poses serious health risks, which if untreated, can become life threatening. There are various methods for reducing weight such as diet, exercise, and medications but often the weight loss is not sustained. Significant advances have been made in the surgical treatment of obesity. Surgical procedures such as the gastric bypass and gastric banding have produced substantial and lasting weight loss for obese patients. These procedures and products have been shown to significantly reduce health risks over time, and are currently the gold standard for bariatric treatment.
Although surgical intervention has been shown to be successful at managing weight loss, both procedures are invasive and carry the risks of surgery. Gastric bypass is a highly invasive procedure which creates a small pouch by segmenting and/or removing a large portion of the stomach and rerouting the intestines permanently. Gastric bypass and its variations have known complications. Gastric banding is an invasive procedure which creates a small pouch in the upper stomach by wrapping a band around the stomach to segment it from the lower stomach. Although the procedure is reversible, it also carries known complications.
Less invasive or non-invasive devices that are removable and capable of significant weight loss are desirable. Using scientific means to properly place or size these non-invasive bariatric devices at the time of placement provides a greater potential that the device or surgical procedure will perform as intended with a reduced level of complications. This provides a higher level of confidence for the physician and improved device acceptance by the patient.
The bariatric instrument or accessory described herein is an intraluminal instrument or accessory with a sensor to be used with a bariatric or intraluminal device or procedure to monitor one or more parameters inside the gastrointestinal (GI) track including the esophagus, stomach and intestines. The parameter could be pressure, force, peristalsis, pH, motion, tension, pH, temperature, chemical, glucose, hormonal, or other. The instrument is preferably separate from the bariatric or intraluminal device and will typically be constructed with a shaft for placement down the esophagus and possibly an arm for manipulation. In contrast, the device accessory is preferably attached to or contacting the bariatric or intraluminal device and may be removed after the device is placed.
The instrument or device accessory could be used as a guide during placement of a bariatric device to monitor placement, performance, adjustments or other data as needed. The bariatric instrument or accessory is used when placing a bariatric or intraluminal device or performing a bariatric surgical procedure that induces weight loss by a variety of weight loss mechanisms. These weight loss mechanisms could include gastric intake restriction, with devices such as an adjustable gastric band, gastric bypass, sleeve gastrectomy, or gastric valves. The instrument could be used to ensure that the band or bypass anastomosis is placed in the proper location and that the band is adjusted to a proper volume. The weight loss mechanism could also include space occupying devices such as an inflatable intragastric balloon or other similar devices, where the instrument is used to ensure proper fill volumes are achieved to engage the stretch receptors and to lose weight. The weight loss mechanism could also include reduced gastric emptying, gastric sleeves or intestinal sleeves for malabsorption. The weight loss mechanism could also include devices that distend the stomach, apply pressure to the stomach or engage a satiety response, such as applying pressure to the cardia of the stomach to engage a neurohormonal response. In these cases, the instrument could be used to gather data on where the device is placed to ensure the force is adequate to engage the satiety response, but not so great that it induces nausea. The instrument or accessory equipped with sensors can gather placement or adjustment data to customize the placement and/or fit to the patient for improved long term performance.
To ensure that the bariatric or intraluminal device or procedure has applied an appropriate amount of force or pressure within the gastrointestinal track, the instrument could contain one or more sensors to measure one or more patient parameters such as force or pressure. Such a sensor could be in direct contact with the patient, could have intermittent contact with the patient, could not be in direct contact the patient to gather intraluminal pressure or other parameters or could be any combination of the above. The sensor could sense a variety of parameters such as force, pressure, stress, peristalsis, motion, pH, temperature, chemical, glucose, or other appropriate parameters, or various parameter combinations. Preferably, such parameter(s) could be read real time during the implant surgery, placement, medical intervention, operation, or adjustment.
The sensor could be wireless or could be wired. Whether a wired or wireless sensor is used, the external controller may have the capability to gather and record data. The external controller may also contain the ability to perform analysis of the collected data for further diagnostic capabilities. The external controller may have the capability to gather the data and display it in a variety of presentations. It may display raw data, averages, or it could analyze the data and diagnose a generalized state as being appropriate or inappropriate. For example, an inappropriate state might be displayed with a red light while an appropriate state might be indicated with a green light. Similarly, the display could be shown in a lighted bar graph where a more appropriate state is indicated by more bars and a less appropriate state is indicated by less bars. Where a wired sensor is used, the external controller could be connected and integrated into the instrument for reading the parametric data. Where a wireless sensor is used, an external controller could be connected and integrated into the instrument or the external controller could be a separate unit for ease of handling or to increase the display size without encumbering the instrument use. Further description of the wireless and wired sensors is included below.
The instrument or device accessory could contain one sensor or multiple sensors. It could also employ an array of sensors that are positioned on top of or integrated into a thin, flexible sheet or element. This element could take a variety of shapes including a strip, disk, frusto-cone, sphere, a portion of any of these or other. Where an array of sensors is used, the display may show a 2D or 3D color plot or graphical representation of the pressure mapping across the sensor array. A variety of visual displays could be used to represent the state of the device condition. The sensor arrays could be located on a single arm or multiple arms. The single arm could take the form of a loop, a curved wire, a spiral, cylinder, cone or multiples of these, or other shapes and multiples, to cover a region of interest. The instrument arm or arms could articulate to allow for manipulation for ideal positioning of the instrument during the procedure. The instrument could have a narrow cross-section to allow it to fit down the working channel of a gastroscope. Alternatively, it may require a larger sizing for additional features such as articulating arms, but would preferably be sized small enough to fit down the esophagus next to the gastroscope, and long enough for proper manipulation outside the body. Where there are expanding or articulating features, the instrument or accessory may have adequate ability to collapse into a long narrow profile to facilitate placement down the esophagus. The instrument would preferably be smooth and contoured to reduce the potential for tissue irritation.
The sensor could be in indirect contact with the patient such as being contained inside of a sizing balloon or inside of a tube where the GI tract contacts the balloon or tube and the sensor is inside. The sensor could be sealed inside the balloon or tube to measure the pressure or force variant or it could monitor other conditions in an unsealed condition.
The instrument could be reusable or disposable. After the device placement, adjustment, or procedure was completed, the instrument would be removed.
The instrument or device accessory could be made of many different materials or combinations of materials. For an instrument, the materials would be acid resistant for transient contact with the stomach for single or repeat use. For a device accessory that is intended to remain on the device, the accessory may need more acid resistant properties.
Elements of the device could be made of Nitinol, shape memory plastics, shape memory gels, stainless steel, superalloys, titanium, silicone, elastomers, teflons, polyurethanes, polynorborenes, styrene butadiene co-polymers, cross-linked polyethylenes, cross-linked polycyclooctenes, polyethers, polyacrylates, polyamides, polysiloxanes, polyether amides, polyether esters, and urethane-butadiene co-polymers, other polymers, or combinations of the above, or other suitable materials.
The detailed description set forth below in connection with the appended drawings is intended as a description of presently-preferred embodiments of the invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
In the most basic embodiment, the instrument 20 could contain a central shaft 22 that seamlessly connects to a single arm 24 which contains one or more sensors 28. This embodiment has sensors that are in direct tissue contact with the patient. For example, an intragastric bariatric device 10 is placed that has a cardiac element 12 which delivers direct force to the proximal cardiac portion of the stomach, and an esophageal element 14 that delivers force to the esophagus. See
As an alternative, the single arm 24 could have an array of sensors integrated into a sheet or shaped surface to better characterize the pressure profile of the contact surface. See
The instrument 20 may have a display to monitor the real-time pressure or force being exerted to guide the physician during placement, and this display could be external to the patient. The display could be small and integrated into the instrument 20 or it could be more sophisticated and contained in a separate unit.
Preferably, the sensors would be adapted to accurately monitor very low pressures with fine resolution, low hysteresis and would be adapted for tissue contact. The sensors could have a very small surface contact area or could have a wider surface contact area.
The instrument 20 could contain wireless or wired sensors 28. Where wired sensors 28 are used on the instrument 20, the wires used to transmit data could be contained inside an instrument shaft 22, and data could be sent directly from the sensor to the display for monitoring, or to a microprocessor for analysis and then to the display. The microprocessor or external controller could be integrated directly into the instrument or the instrument could plug into a separate external controller 86 as both shown in
In addition, the sensor 28 and or memory module of the instrument 20 or accessory 30 may be communicatively coupled with a transmitter, a receiver, or both, to allow communication of data or other information with outside receivers and transmitters. The transmitter may transmit signals received from the sensor, or signal data stored in the memory module.
In another embodiment, the instrument 20 could have a single arm 24 with multiple sensors 28 or an array of sensors 29.
In another embodiment, the instrument sensor 28 may have direct tissue contact with the patient. For example, an intragastric bariatric device 10 is placed that has a cardiac element 12 which delivers direct force to the proximal cardiac portion of the stomach, and an esophageal element 14 that delivers force to the esophagus. See
Although several of the embodiments above describe use with bariatric devices, the instrument 20 may also be applicable to non-bariatric devices such as stents, feeding tubes, or other intraluminal non-bariatric devices where parameter detection is desirable. For the purposes of the claims, the term “intraluminal device” shall include both bariatric and non-bariatric intraluminal devices.
Use of wireless sensor 28 would allow for an alternative to an instrument 20, in the form of an accessory 30 that is temporarily or permanently attached to the bariatric device 10 for its placement. See
There could be attachment element features on the bariatric device 10 or other intraluminal device that the accessory 30 could attach to or other features such as a magnet, mechanical feature, biodegradable adhesive or substrate or other features could be used as attachment elements to temporarily connect the accessory 30 to the bariatric or intraluminal device 10. The accessory 30 could also be designed with the intent to disassociate from the bariatric device 10 and pass naturally through the intestines to eliminate the need for removal. For example, the accessory 30 could use an attachment element of biodegradable materials or materials that break down in stomach acid to allow the 30 to disassociate and pass. In such case, the accessory 30 may be attached to the bariatric device 10 for a short period of time, but not intended for long term placement. In other embodiments, the attachment element could be adapted for permanent or semi-permanent attachment to the bariatric or intraluminal device, which might include long-lasting adhesives, mechanical connections, Velcro, or other suitable attachment mechanisms.
In the accessory 30, the wireless sensor 28 could collect and store data over time which could then be wirelessly transmitted to an external controller under physician or patient control. The storage could take place in a memory module, which may be integrated with the sensor or separate. The memory module may use solid state or flash memory, or other suitable data memory devices.
The sensor 28 could be passive or active. In the case where the sensor 28 is active, it would require a power source such as an implantable battery. This would allow the sensor 28 to query on a routine basis and store the data in a memory module. The data could also be retrieved and down loaded, preferably by an external controller, but also by any other suitable device capable of retrieving the signals. Alternatively, the sensors 28 could be passive and require power to query the sensors 28 from an external source such as induction. The external controller could have the ability to inductively power the sensor remotely from outside the body, and remotely communicate with the sensor(s) 28 and/or the memory module to collect and download data. Alternatively or in addition to powering the sensors 28, induction may be used to power an on-board signal transmitter of the accessory 30 so that the stored and/or present values generated by the sensors 28 may be retrieved by the external controller or other suitable device.
The accessory 30 could also contain a sensor array 29 to better characterize the interface between the stomach and the bariatric device 10. For example, the sensor array 29 could substantially match the surface or a portion of the surface of the bariatric device 10.
Another use for the embodiment of the instrument depicted in
Sensors 28 could be used to gather important patient data to understand performance, positioning, patient status or whether an adjustment needs to be performed for an adjustable bariatric device 10, or whether a bariatric device 10 needs to be replaced or resized. The sensed parameter could detect whether the bariatric device 10 was not in an ideal condition, and display this information to an external controller 86.
Appropriate algorithm(s) may determine and/or control the ideal parameter condition(s), or such condition(s) could be based on a parameter range. For example, the data could be collected from the sensor 28 for a fixed time period. The microprocessor in the external controller 86 could then calculate the average over time, the minimum, the maximum, the standard deviation or the variation in standard deviation over time, or other suitable analysis. Based on the analysis, the microprocessor in the external controller 86 could determine whether the bariatric device 10 was in the ideal position or adjustment state.
Where an accessory 30 with a wireless sensor 28 is used, the sensor monitoring could be performed after placement while the patient is eating or drinking This could also be performed with an instrument 20. The data could be collected, analyzed and used as a guide during the next adjustment. As the patient consumes, the esophageal and stomach peristaltic waves will increase in intensity as they propel the food or drink from the mouth to the stomach. A sensor 28 could detect when these waves increase in amplitude, frequency, and pressure. The parameter detected by the sensor 28 could be read on the external controller by the physician, and then the physician could alter the placement as needed or adjust the bariatric device 10 as needed. The physician could then query the sensor 28 again to determine whether the bariatric device 10 was in the ideal settings.
Another use for this invention would be for placing an intragastric balloon 16. See
In another embodiment, the instrument 20 could be used when placing a gastric band 18, performing a gastric bypass procedure, or other bariatric surgical procedure. See
As a variation of the concepts above, the instrument 20 could contain integrated memory, such as a memory module to allow storage of patient and device data. This could include but is not limited to the serial number of the device, the patient's information such as name, patient number, height, weight; the physicians name, the adjustment history including the date and time, the adjustment parameters and the sensed parameters. It could record weight tracking, BMI or other data as needed which could be queried by an external controller. This data could also be transferred into a physician's patient tracking database for ease of patient tracking Similarly, this data could be downloaded and tracked on an internet tracking website, where the patient could log on and see their history and progress. The patient could add information to the website such as weight or an eating log, adverse events or other conditions that the physician or patient would like to track.
This invention may be industrially applied to the development, manufacture, and use of instruments and accessories for bariatric devices for weight loss purposes.
This application is a national stage application under 35 USC §371 of PCT Patent Application No. PCT/US2010/057530, filed Nov. 19, 2010, which claims the benefit of U.S. Provisional Patent Application No. 61/263,330 filed Nov. 20, 2009.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US10/57530 | 11/19/2010 | WO | 00 | 5/17/2012 |
| Number | Date | Country | |
|---|---|---|---|
| 61263330 | Nov 2009 | US |
