The present invention is directed to intragastric devices used for the treatment of obesity, and in particular to devices and systems for placement in and adjacent to the stomach cavity.
Over the last 50 years, obesity has been increasing at an alarming rate and is now recognized by leading government health authorities, such as the Centers for Disease Control (CDC) and National Institutes of Health (NIH), as a disease. In the United States alone, obesity affects more than 60 million individuals and is considered the second leading cause of preventable death. Worldwide, approximately 1.6 billion adults are overweight, and it is estimated that obesity affects at least 400 million adults.
Obesity is caused by a wide range of factors including genetics, metabolic disorders, physical and psychological issues, lifestyle, and poor nutrition. Millions of obese and overweight individuals first turn to diet, fitness and medication to lose weight; however, these efforts alone are often not enough to keep weight at a level that is optimal for good health. Surgery is another increasingly viable alternative for those with a Body Mass Index (BMI) of greater than 40. In fact, the number of bariatric surgeries in the United States was estimated to be about 400,000 in 2010.
Examples of surgical methods and devices used to treat obesity include the LAP-BAND® (Allergan Medical of Irvine, Calif.) gastric band and the LAP-BAND AP® (Allergan). However, surgery might not be an option for every obese individual; for certain patients, non-surgical therapies or minimal-surgery options are more effective or appropriate.
In the early 1980s, physicians began to experiment with the placement of intragastric balloons to reduce the size of the stomach reservoir, and consequently its capacity for food. Once deployed in the stomach, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger. These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program. These balloons are typically cylindrical or pear-shaped, generally range in size from 200-500 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, an inert gas, water, or saline.
One such inflatable intragastric balloon is described in U.S. Pat. No. 5,084,061 and is commercially available as the BioEnterics Intragastric Balloon System (“BIB System,” sold under the trademark ORBERA). The BIB System comprises a silicone elastomer intragastric balloon that is inserted into the stomach and filled with fluid. Conventionally, the balloons are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the patient. Placement of the intragastric balloon is non-surgical, trans-oral, usually requiring no more than 20-30 minutes. The procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement of such balloons is temporary, and such balloons are typically removed after about six months. Removing the balloon requires deflation by puncturing with a gastroscopic instrument, and either aspirating the contents of the balloon and removing it, or allowing the fluid to pass into the patient's stomach. Clinical results with these devices show that for many obese patients, the intragastric balloons significantly help to control appetite and accomplish weight loss.
Some attempted solutions for weight loss by placing devices in the stomach result in unintended consequences. For instance, some devices tend to cause food and liquid to back up in the stomach, leading to symptoms of gastroesophageal reflux disease (GERD), a condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus. Also, the stomach acclimates to some gastric implant devices, leading to an expansion of stomach volume and consequent reduction in the efficacy of the device.
Therefore, despite many advances in the design of intragastric obesity treatment devices, there remains a need for improved devices that can be implanted for longer periods than before or otherwise address certain drawbacks of intragastric balloons and other such implants.
The present invention addresses the above-described problems by providing passive intragastric apparatuses and methods for inducing satiety and therefore treating obesity. Such passive devices do not autonomously change shape, but instead react within the stomach to induce satiety. The devices may take up volume within the stomach, thus reducing the intake capacity. Additionally, the devices may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, to stimulate satiety-inducing nerves. Also, a number of devices slow gastric filling by impeding flow through the esophageal sphincter. A number of devices combine two or more of these satiety-inducing features. Methods of implant are disclosed including compressing the devices within a delivery tube and transorally advancing the devices through the esophagus to be deployed within the stomach. Removal of the devices occurs in the reverse.
Each of the implants described herein is formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.
In accordance with a first preferred embodiment, a passive intragastric obesity treatment implant comprises an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter. A shallow conical ring is sized to contact the interior stomach walls adjacent to the esophageal sphincter with a central through hole centered at the esophageal sphincter, and a thin, flexible tether connects the esophageal stent to the conical ring. A plurality of thin anchor legs extend from a distal rim of the conical ring, the legs made of a resilient material. Finally, a shallow cup member attaches to the anchor legs opposite from the conical ring and is sized to create large spaces between the conical ring and the cup member, the anchor legs having a sufficient length such that the cup member contacts an interior stomach wall opposite the esophageal sphincter. There are desirably four anchor legs, and the tether is preferably relatively flexible while the anchor legs are relatively stiffer to transmit compressive forces from the cup member to the conical ring.
Another aspect of the present application is a passive intragastric obesity treatment implant that comprises an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter. A cardia-stimulating pillow having perforations and a central opening align with the esophageal sphincter to permit food to pass therethrough. A flexible tether secures the cardia-stimulating pillow to the esophageal stent. A balloon-like pillow smaller than the cardia-stimulating pillow and having perforations therein connects to the cardia-stimulating pillow via a thin relatively stiff tube, the tube having a length sufficient to maintain contact of the cardia-stimulating pillow against the cardia and the balloon-like pillow against the stomach wall opposite the esophageal sphincter. The cardia-stimulating pillow preferably comprises a substantially disk-shaped member having large spoke-like through holes for passage of food. The cardia-stimulating pillow may further include a central hub connected to both the tube and tether. The esophageal stent may be a tubular stent or a coil of elastic material, such as Nitinol. In one embodiment, the cardia-stimulating pillow and the balloon-like pillow are molded with relatively thick walls to maintain their as-molded shape without inflation, and each includes holes to allow stomach juices to freely flow in and out.
In accordance with another embodiment, a passive intragastric obesity treatment implant includes an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter. An enlarged cardia-stimulating pillow tethers to the esophageal stent to abut the esophageal opening and is open to the esophagus, the pillow including an artificial stoma opening to the stomach cavity. A plurality of balloon-like pillows having perforations stack against the cardia-stimulating pillow so as to reach the interior stomach wall opposite the esophageal sphincter and thus maintain contact of the cardia-stimulating pillow against the cardia. The artificial stoma may be an aperture in a flexible diaphragm such that the artificial stoma has a variable diameter. The implant may further comprise an anti-rotation leg attached to an outer one of the balloon-like pillows. Preferably, wherein there are two balloon-like pillows each having a substantially hemispherical shape and arranged so that their equatorial planes abut. Desirably, the balloon-like pillows are molded with relatively thick walls to maintain their as-molded shape without inflation, and each includes holes to allow stomach juices to freely flow in and out. The cardia-stimulating pillow may be tethered to the esophageal stent by a collapsible tubular connector between the esophageal stent and the cardia-stimulating pillow, the tubular connector permitting food to flow therethrough from the esophagus into the interior of the pillow.
A further passive intragastric obesity treatment implant of the present application comprises an esophageal mounting stent sized to anchor within the esophagus just above the esophageal sphincter, the stent having a configuration that allows it to change its outer diameter while maintaining an inner diameter aperture substantially constant. An enlarged cardia-stimulating umbrella tethered to the esophageal stent has a contracted columnar shape for delivery and an expanded splayed out shape that abuts against the cardia surrounding the esophageal sphincter. The esophageal mounting stent may have an accordion-like spiral structure include a plurality of triangular membranes that are each bordered on two sides by an upper strut and a lower strut, with an outer edge being free. The cardia-stimulating umbrella preferably comprises a plurality of strips splayed outward from a central hub, and flexible webbing extending between the strips, wherein the strips are relatively stiff in comparison to the webbing. The central hub is preferably an open ring for food to pass therethrough.
A further understanding of the nature and advantages of the invention will become apparent by reference to the remaining portions of the specification and drawings.
Features and advantages of the present invention will become appreciated as the same become better understood with reference to the specification, claims, and appended drawings wherein:
The present invention is directed to a variety of different intragastric devices that passively treat obesity by taking up space within the stomach or contacting areas in and around the stomach to induce feelings of satiety. Furthermore, some devices described herein affect the rate of stomach intake. It should be understood that a number of the disclosed devices provide more than one of these passive aspects, and also that any disclosed structure could be combined with another disclosed structure unless physically impossible. As such, combinations of the passive satiety-inducing features disclosed herein, even if not explicitly stated, are contemplated. The term “passive” refers primarily to a lack of any moving parts within the devices, but in general to the inert nature of the various devices. A passive device as defined herein, however, is not one that cannot affect change or stimulate the stomach, but rather one that may do so without any physical or chemical changes to its basic makeup.
Lower down in the stomach the antrum connects the body to the pylorus, which leads into the duodenum. Below the stomach, the duodenum leads into the upper part of the small intestine (not shown); the jejunum makes up about one-third of the small intestine. The region of the stomach that connects to the duodenum is the pylorus. The pylorus communicates with the duodenum of the small intestine via the pyloric sphincter (valve). This valve regulates the passage of chyme from stomach to duodenum and it prevents backflow of chyme from duodenum to stomach.
The intragastric device 60 shown in
Wire-like anchor legs 70 attach to and push up against the conical ring 68. The legs 70 are made of a springy material and slightly folded, with a pre-load spring force, which pushes the conical ring 68 upward against the cardia walls of the stomach. The conical ring 68 includes a central through hole centered at the esophageal sphincter through which food passes. The legs 70 mount at their opposite ends, to a wide, thin cup 72, which is shallow like the upper conical ring 68. The purpose of the cup 72 is to cushion the legs 70 against the greater curvature of the stomach, where it rests/presses. The shallow cup 72 is sized to create large spaces between itself and the conical ring 68, and between the legs 70, so that food may easily pass therethrough. There are preferably at least four legs 70 as shown for even compression of the conical ring 68 against the cardia, though more than four may be used.
For device insertion and removal, a lubricated, Teflon or similar material, thin-walled tube (not shown) would be inserted down the esophagus, and partially into the stomach, with the device 60 compressed and pre-loaded inside the tube. Then the device would be maintained in its location by using a foot-ended wire or similar obturator, to bear on the compressed mass, and the tube would be pulled back up the esophagus, and extracted through the mouth, leaving the device in place. While the tube is removed, the device would “spring open” to its original/non-compressed shape.
An alternative cardia-stimulating device 80 shown in
The cardia-stimulating pillow 84 has a central opening that aligns with the esophageal sphincter to permit food to pass therethrough. In the illustrated embodiment, the cardia-stimulating pillow 84 comprises a substantially disk-shaped member having large spoke-like through holes for passage of food. Specifically, a series of spoke-like through holes 92 in the pillow 84 open to a top-facing central recess or concavity above a hub member 91 and provide a passageway for food passing down the esophagus into the stomach. There are 6 spoke-like holes 92 as shown, though more or less could be used. The hub member 91 connects to inward extensions 93 of the pillow 84 and to both the tube 86 and tether 90, thus providing a central structural support for these elements. Both the top and bottom surfaces of the pillow 84 are scalloped, as best seen in
Both the pillows 84 and 88 are hollow balloon-like structures that take up volume in the stomach and are intended to cushion the device ends against the stomach walls, helping to prevent ulceration. These uninflated “balloons” are molded with relatively thick walls, so they maintain their as-molded shape without inflation. Holes 94 in the sides of the pillows 84 and 88 allow stomach juices to freely flow in and out. Furthermore, a series of holes are provided in the tube 86 to permit free flow of stomach juices.
While consuming a meal, the stomach is known to produce peristaltic convolutions throughout. As such movement occurs, the device 80 is squeezed, thereby applying intermittent pressure to the cardia area of the stomach. That is, contraction of the stomach walls reduces the distance across the stomach walls and necessarily places the stiff tube 86 in compression, which pushes the cardia-stimulating pillow 84 against the cardia. Such pressure is known to stimulate the release of satiety-inducing hormones, thus reducing meal time and food intake.
Another cardia-stimulating device 100 is shown in
The outer pillow 108 bears against the Greater Curvature of the stomach and sandwiches the middle pillow 106 against the stomach pouch 104. Holes 110 in the pillows 106, 108 permit stomach juices to flow freely through. In the illustrated embodiment, the balloon-like pillows 106, 108 each have a substantially hemispherical shape and are arranged so that their equatorial planes abut and their spherical surfaces face away from one another. This helps absorb forces from the stomach wall and transfer them to the stomach pouch 104.
A tubular leg 112, extending from the outer pillow 108 serves as an anti-rotational feature, to help keep the esophageal tube 103 from twisting, and therefore obstructing flow-through of food. That is, the tubular leg 112 tends to maintain the orientation shown, pointing down the relatively shallow sloping length of the stomach, rather than rotating up to areas of greater curvature.
The cross-section of the esophageal tube 103 is seen in
A stoma opening 114 in the stomach pouch 104 allows emptying of food into the biological stomach for normal digestion to occur. As food accumulates in the artificial stomach pouch 104, it fills and applies pressure to the cardia. Such pressure is known to trigger release of satiety-inducing hormones, so eating will taper and cease prematurely. Since a smaller than normal quantity of food has been ingested, weight loss could occur. This cardial pressure from nearby retained food is (currently) thought to be the primary mechanism that allows external gastric bands to function as it does. Additionally, the rate at which the entire stomach fills is slowed by the artificial stomach pouch 104.
An alternative version of the cardia-stimulating device 100′ is shown in
Esophageal deployment of the device 100 can be achieved by the pre-assembled components' ability to collapse and fit comfortably into a Teflon or similar low friction tube. The device 100 may come pre-loaded in this configuration. The pre-loaded delivery tube is fed down the esophagus where the stent 102 is permitted to expand. Then the lower portion of the device is deployed into the stomach. For device removal, an empty tube is fed down the esophagus, as far down as the stent. Next, a standard grabber can be inserted down the tube and the entire device can be grabbed and pulled into the tube. Then the tube is removed with the device re-loaded inside.
A still further device 140 designed to stimulate the cardia and induce feelings of satiety is seen in
The esophageal mounting stent 144 must not interfere with the normal function of the esophagus and must provide sufficient holding capability (no migration within esophagus). The stent 144 has geometry as seen in
Therefore, the stent 144 is designed to accommodate the reduction in esophageal diameter that occurs during peristalsis while still maintaining an unobstructed pathway for a bolus to pass. It is believed that by offering minimal resistance to the natural peristaltic contractions of the esophagus, the device is less likely to migrate. Added resistance to migration can be achieved by assembling multiple esophageal mounting components in series with one another, all connected to the tether 146. The stent 144 may be assembled from a metal mesh similar to existing esophageal stents in order to give the component sufficient structural rigidity. The orientation and design of the mesh needs to be one such that the deformation shown in
The tether 146 seen in
The gastro-esophageal umbrella 142 exerts pressure on the stomach walls. The umbrella 142 comprises a plurality of struts or strips 156 splayed outward from a lead-in hub 154, and flexible webbing 158 extending between the strips 156. The natural or relaxed shape of the umbrella 142 is splayed open, as seen in
While not shown, the outer surface of the intragastric implants disclosed herein may further include additional uneven surface features such as small rounded bumps or protrusions, quill-like extensions, dimples or recesses, and the like. These features, upon contact with the inner stomach wall of the patient may further trigger hormone release or otherwise aid the patient in feeling full. Such features may be particularly effective for those embodiments which stimulate the cardia. The examples in
For instance,
Another example of exterior stimulation features is seen in
It should be noted that the bumps 212, quill-like extensions 222, or recesses 235 shown in
It should also be stated that any of the embodiments described herein may utilize materials that improve the efficacy of the device. For example, a number of elastomeric materials may be used including, but not limited to, rubbers, fluorosilicones, fluoroelastomers, thermoplastic elastomers, or any combinations thereof. The materials are desirably selected so as to increase the durability of the device and facilitate implantation of at least six months, and preferably more than 1 year.
Material selection may also improve the safety of the device. Some of the materials suggested herein, for example, may allow for a thinner wall thickness and have a lower coefficient of friction than the current device which may aid in the natural passage of the balloon through the GI tract should the device spontaneously deflate.
The implantable devices described herein will be subjected to clinical testing in humans. The devices are intended to treat obesity, which is variously defined by different medical authorities. In general, the terms “overweight” and “obese” are labels for ranges of weight that are greater than what is generally considered healthy for a given height. The terms also identify ranges of weight that have been shown to increase the likelihood of certain diseases and other health problems. Applicants propose implanting the devices as described herein into a clinical survey group of obese patients in order to monitor weight loss.
The clinical studies will utilize the devices described above in conjunction with the following parameters.
Materials:
Purposes:
General Implant Procedures:
One exemplary implant procedure is listed below.
End Point Criteria:
Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
Certain embodiments are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
Furthermore, references may have been made to patents and printed publications in this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.
Specific embodiments disclosed herein may be further limited in the claims using “consisting of” or “consisting essentially of” language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.
In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.
The present application claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 61/485,009, filed May 11, 2011, and to 61/394,592, filed Oct. 19, 2010, the disclosures of which are incorporated by reference herein.
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